2015 NDI 6WS---FDA Aff & Neg

AFF

1AC

1AC---Pharma Advantage
Surveillance of whistleblowers enables widespread FDA
corruption this enables Big Pharma to reap huge benefits
Mercola 12 (Dr. Mercola, anonymous whistleblower against the FDA, Shocking
Story Reveals How the FDA Is Recklessly Abandoning Drug Safety, August 13,
2012, http://articles.mercola.com/sites/articles/archive/2012/08/13/drug-safetywhistleblower.aspx)//ghs-VA
In the wake of shocking reports on how the FDA , terrified of being outed for its questionable
practices, spied on its own employees in the hopes of rooting them out before
they could become whistleblowers, a new story has emerged on how deep the deceit
goes. From marginalizing safety reports to not reading them at all and then going
ahead and approving the drugs in questionthe FDA once more stands accused of being little
more than a rubber-stamping agency for Big Pharma. Explosive revelations of an intensive
spy operation by the FDA on its own scientists emerged last month. Using sophisticated spy software, the agency tracked and
logged every move made by the targeted individuals. The program even intercepted personal emails and copied documents on their

targeted scientists had expressed concern over the

agency's approval of dangerous medical imaging devices for mammograms and
personal thumb drives. The

colonoscopies, which they believe expose patients to dangerous levels of radiation. Now, another whistleblower has stepped
forward, and what he has to say about the agency's drug safety reviews is shocking even to the jaded... Former FDA Reviewer
Speaks Out About Systemic Suppression of Safety Ronald Kavanagh was a drug reviewer for the FDA in the Center for Drug
Evaluation and Research from 1998 to 2008. In a recent interview he reveals how the FDA bypassed or ignored safety issues on
major drugs approved during his employment. In an interview for the online news magazine Truth-Out, he tells Martha Rosenberg1:
"In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears

managers at CDER have placed the nation

at risk by corrupting the evaluation of drugs and by interfering with our
ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were
the dishonest employee. There is also irrefutable evidence that

clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances,
from presenting findings at advisory committees. In 2007, formal policies were instituted so that speaking in any way that could
reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug's approval - which
of course was our job as drug reviewers - management would reprimand us, reassign us, hold secret meetings about us, and worse.
Obviously in such an environment, people will self-censor." According to Kavanagh, people would be shocked if they knew just how
malleable safety data is. As examples, he points out that human studies are typically too short and contain too few subjects to get a
clear picture of potential risks. In such a scenario, even a single case of a serious adverse event must be taken very seriously, and
data from other longer term safety studies also need to be carefully analyzed. Kavanagh claims he has seen drug reviews where the
medical safety reviewer completely failed to make such evaluations prior to the drug's approval. FDA Actively Thwarts Serious

There's no telling how many ineffective and/or dangerous

drugs and medical devices have been approved and ushered into market
through sheer intimidation and bullying, either by pharmaceutical companies or FDA
management. Perhaps even more shocking are the revelations that some of the internal rules and regulations of the FDA
Safety Investigations

are clearly designed to thwart serious safety reviews from the get-go. According to Kavanagh: "[H]uman clinical pharmacology trials
are typically done in Europe, yet clinical pharmacology reviewers at FDA have been barred from analyzing this information prior to
studies being conducted in the US. Without being able to do this, we are unable to detect evidence of risks early and cannot provide
guidance that would help with the development of the drug in terms not only of safety and proving efficacy, but also with the
efficiency and cost effectiveness of the drug's development." Another loophole that can put your health in serious jeopardy is that
drug companies are not required to include adverse events on the drug's label if the adverse reaction is: Below a certain

certain
serious and potentially lethal adverse events that eventually resulted in a
drug being withdrawn from the market would not have had any mention of
the adverse events made in the labeling at all." Kavanagh also claims to have discovered
percentage, and/or Below double the rate of the adverse event found in a placebo According to Kavanagh: "By this rule,

another common loophole used by pharmaceutical companies to circumvent safety issues. They'd simply submit bits and pieces of
data to different places, effectively preventing the reviewer to pull it all together. Then, because the safety issues falsely appeared
to be negligible, it would be decided that no further evaluation would be necessary... "On one occasion, the company even told me
they were going to call upper management to get a clear requirement for approval that they did not want to fulfill eliminated, which
I then saw happen. On another occasion a company clearly stated in a meeting that they had "paid for an approval," Kavanagh says.
"Sometimes

we were literally instructed to only read a 100-150 page

summary and to accept drug company claims without examining the actual
data, which on multiple occasions I found directly contradicted the summary document. Other times I was ordered not to review
certain sections of the submission, but invariably that's where the safety issues would be. This could only occur if FDA management
was told about issues in the submission before it had even been reviewed. In addition, management would overload us with huge
amounts of material that could not possibly be read by a given deadline and would withhold assistance. When you are able to dig in,
if you found issues that would make you turn down a drug, you could be pressured to reverse your decision or the review would then
be handed off to someone who would simply copy and paste whatever claims the company made in the summary document."

Kavanagh discusses some of the

dangerous drugs that were approved in the face of unequivocal safety concerns. One is the
nerve gas drug pyridostigminea prophylactic drug against the nerve
agent Soman. The drug was approved under the "Animal Rule," which allows drugs to be approved based on animal data
Examples of Dangerous Drug Approvals In his interview,

alone. There were multiple problems with this approval. First, the animal studies did not reflect how the drug would be used in
humans. Second, the drug actually increases lethality if nerve agents other than Soman are used. According to Kavanagh: "This

both FDA and DoD public documents acknowledge

increased lethality with other nerve agents such as Sarin, and DoD and
other government documents that are public also document that Saddam
Hussein was not using Soman and was instead using these other nerve
agents exclusively. Yet because I raised this as an objection, I was immediately replaced as the primary reviewer so
information was not secret -

that I could not document my concerns and so that pyridostigmine could be approved. It's since been proposed that if we ever face
the prospect of nerve agents in the future, that this approval will be used as a justification to convince the President at that time to
waive informed consent without presenting a full picture." Pediatric drugs also end up posing unnecessary risks due to the FDA's
failure to adequately review safety risks, and the many scientific loopholes employed by pharmaceutical companies. For example,
the following flawed parameters are typically used in pediatric drug studies: Dosages are based on approved adult dosages, without
regard for metabolic differences between a developing child's body and an adult Exposure studies oftentimes use overweight
children, and include too few children to adequately evaluate risks No allowances are made for race, age, puberty, or actual weight
Dangers to pregnant women and their developing fetuses are also frequently ignored.

All in all, the FDA

appears to be engaged in a systematic hush-operation designed to give

just about anything Big Pharma develops the green light . Essentially,
dangerous drugs are given a rubber stamp of approvalthe necessary goahead to make obscene profits while killing and injuring hundreds of
thousands of people every year. It is, quite simply, inexcusable. The mainstream media has a lot to answer
for as well, as their lack of reporting on these issues contributes to the problem by keeping a lid on reality. According to Kavanagh:
"FDA's response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then simply
add a watered down warning in the labeling. In fact, when patients exhibit drug toxicity, it is usually attributed to an underlying
condition which we know is likely to make the drug toxicity worse. This also allows the toxicity to be dismissed as being unrelated to
the drug in any way. Consequently, toxicities are only attributed to the drug when the evidence is irrefutable. Thus the majority of
cases where there is a contributing factor are simply dismissed. When you do raise potential safety issues, the refrain that I heard
repeatedly from upper management was"where are the dead bodies in the street?" Which I took to mean that we only do something
if the press is making an issue of it." FDA Safety Reviewers Made to Fear for Their Lives?
Kavanagh was not surprised to learn about the agency's retaliation against the five whistleblowers, giving several examples of how
he was personally intimidated, to the point of fearing for his life, and the safety of his children! "After FDA management learned I
had gone to Congress about certain issues, I found my office had been entered and my computer physically tampered with,"
Kavanagh tells Rosenberg. "... After I gave Representative Waxman's (D-CA) office a USB drive with evidence, FDA staff was
admonished that it was prohibited to download information to USB drives. Then, after I openly reported irregularities in an
antipsychotic drug review and FDA financial collusion with outsiders to Senator Grassley's office and the House Committee on
Oversight and Government Reform, I was threatened with prison if I should release trade secret information to Congress... [T]he
Food Drug and Cosmetics Act explicitly allows communication of trade secrets by FDA employees to Congress, but since most
people are unaware of this, FDA management can use the threat of jail for violation of the Trade Secrets Act, not only to discourage
reviewers, but in my case they got Senator Grassley's staff to destroy the evidence I provided them. The threats, however, can be
much worse than prison. One manager threatened my children - who had just turned 4 and 7 years old - and in one large staff
meeting, I was referred to as a 'saboteur.' Based on other things that happened and were said, I was afraid that I could be killed for
talking to Congress and criminal investigators."

We Now Know What Domestic Surveillance of

Whistleblowers Looks Like

The following video features attorney, Stephen Kohn, executive director of the

National Whistleblowers Center and attorney for the FDA whistleblowers in the recently revealed FDA spy operation against them2.

we now have a glimpse into what domestic surveillance of

whistleblowers looks like in this country with the modern technological
"For the first time,

developments," Kohn says. "The agency [sought] to destroy the reputation of

these whistleblowers forever." FDA Failures Place Health of Americans and
Nation at Grave Risk

The FDA's mission statement reads as follows: "The FDA is responsible for protecting the

public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our
nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by
helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get
the accurate, science-based information they need to use medicines and foods to improve their health." In 2007, a report bearing

the FDA
cannot fulfill its stated mission because: Its scientific base has eroded and its scientific organizational
the revealing title "FDA Science and Mission at Risk" by the Subcommittee on Science and Technology3, detailed how

structure is weak Its scientific workforce does not have sufficient capacity and capability, and Its information technology (IT)
infrastructure is inadequate Furthermore, the report found that "the

development of medical products

based on "new science" cannot be adequately regulated by the FDA, and
that the agency does not have the capacity to carry out risk assessment
and analysis. Additionally, the agency's science agenda "lacks coherent structure and vision, as well as effective
coordination and prioritization." The fact that the FDA does not have its ducks in a row; has sorely misplaced its priorities; and is not
working to fulfill its mission is clearly evidenced in the numerous cases where hundreds and sometimes thousands of complaints
about dangerous drugs (like Vioxx and Avandia), vaccines (like Gardasil), and additives (like aspartame) are stubbornly ignored,
while SWAT-style teams armed to the teeth are sent to raid supplement makers, whole food businesses, organic farmers, and raw

According to the
Science and Technology Subcommittee's report, the failures of the FDA is
dairies when oftentimes not a single incidence of harm can be attributed to their products.

placing the health of Americans, and indeed the economic health of the
entire nation, at grave risk : "The FDA constitutes a critical component of
our nation's healthcare delivery and public health system. The FDA , as much as
any public or private sector institution in this country, touches the lives, health and wellbeing of all Americans and is integral
to the nation's economy and its security. The FDA's responsibilities for protecting the health of Americans are farreaching. The FDA protects our nation's food supply through regulatory activities designed to cover 80 percent of the food consumed
in this country. The FDA also regulates all drugs, human vaccines, and medical devices, and hence plays a critical role in ensuring

The FDA is also central to the

economic health of the nation, regulating approximately $1 trillion in
consumer products or 25 cents of every consumer dollar expended in this
country annually.. Thus, the nation is at risk if FDA science is at risk . The
Subcommittee concluded that science at the FDA is in a precarious position: the Agency
suffers from serious scientific deficiencies and is not positioned to meet
current or emerging regulatory responsibilities."
the appropriate safety and efficacy of rapidly emerging medical products. ...

Big Pharmas reach is global---its underpinned by FDA

corruption
Hagopian 15 Joachim Hagopian is a West Point graduate and former US Army officer with a
masters degree in Clinical Psychology, The Evils of Big Pharma Exposed, 1/18/15,
http://www.globalresearch.ca/the-evils-of-big-pharma-exposed/5425382//OF

To further control the global health system, Big Pharma has largely
dictated whats been taught in medical schools throughout North America, heavily subsidizing them as a means of
dictating the conventional dogma thats standard curriculum down to even the textbooks. Several years ago a revolt at Harvard amongst med students and faculty went public. For a
long time now doctors have been educated primarily to treat their patients with drugs, in effect becoming drug pushing, pharmaceutical whores, mere foot soldiers in Big Pharmas war
on health. Starting in the final year of med school, Big Pharma insidiously hones in on young med students, seductively wining and dining prospective physicians, showering them with
money in the form of educational handouts, gifts, trips and perks galore to recruit its legions of loyal, thoroughly indoctrinated drug peddlers around the world. Thousands of doctors in
the US are on Big Pharma payrolls. Typically early on in their careers physicians are unwittingly co-opted into this corrupt malaise of an irreparable system thats owned and operated by
Big Pharma. And heres

why the drug companies control the global healthcare empire.

Since 1990 Big Pharma has been pumping at least $150 million that we know about (and no doubt lots more we dont know about) buying off politicians who no longer represent the
interests of their voting public. Thanks to Big Law via last springs Supreme Court decision, current campaign financing laws permit unlimited, carte blanche bribery power for Americas
most wealthy and powerful to fill the pockets of corrupt politicians with absolutely no oversight. Though the corporate buyoff of other nations around the globe may not appear quite so
extreme and blatantly criminal as in the United States, international drug companies make certain that every national government allows full access and flow of their prescription drugs

because far
more money is spent on the healthcare industry in the US, twice as much
as the next nation Canada and equal to the next ten combined, its no
surprise that hapless Americans end up having to pay far higher
exorbitant costs for their made-in-the-USA drugs than anyone else on the
planet. The average US citizen spends about $1000 on pharmaceutical drugs each year, 40% higher than Canadians. Big Pharma also invests more dollars into advertising than
into each nation, including rubber stamped approval by each nations regulatory body to ensure global maximization of record setting profit. But

any other industry in America, transmitting its seductively deceptive message direct to its consumers, explicitly giving them marching orders to request specific drugs from their doctors.
In 2012 alone, pharmaceutical corporations paid nearly $3.5 billion to market their drugson television, radio, internet, magazines, saturating every media outlet. Their message
pleasure, relief, peace of mind, joy, love and happiness are all just a pill away. No problem or pain in life cant be conquered by a quick fix - compliments of Big Pharma. Much of Big
Pharmas success over the last couple decades has been the result of specifically targeting special new populations to con and win over, resorting to creating new diseases and maladies
to entice troubled, stressed out, gullible individuals into believing theres something abnormally wrong with them, that they are among always a growing segment of our population who
quietly suffer from whatever discomforting symptoms, deficits, dysfunctions, ailments, syndromes and disorders that enterprising Big Pharma connives to slyly invent, promote, package
and sell. This unethical practice has been called disease mongering. Drug companies today operate no different from the snake oil salesmen of yesteryear. Saturating the market with
their alluring, promising ads, check out any half hour of national network news on television targeting the baby boomer and geriatric crowd and youll notice 95% of the commercials are
all brought to you by none other than Big Pharma. Of course they pay big bucks for slick ad marketing campaigns that shrewdly target the oldsters most apt to suffer health problems in
addition to being virtually the only Americans left still watching the nightly network news. Three out of four people under 65 in the US today recognize that mainstream news media is
nothing less than pure Gov. Corp. propaganda. Also in recent years Big Pharma has become deceitfully masterful at repackaging and rebranding old meds at higher prices ever in search
of expanded consumers. Its a lot easier and far less money to engage in this unethical industry-wide practice of recycling an old pill than to manufacture a new one. Prozac became the
biggest drug sold until it was learned that it caused so many people to kill themselves or others, especially adolescents. Then Eli Lilly deceptively repackaged and relabeled it under the
less threatening name Sarafem at a much higher price tailored to target unsuspecting women seeking relief from menstrual pain. Like Prozac as another Selective Serotonin Reuptake
Inhibitor antidepressant, Paxil was suddenly repackaged as the cure-all for shyness under the guise of treating social anxiety. Taking full advantage of knowing that millions of humans
feel unsure of themselves dealing with strangers and groups, Big Pharma to the rescue exploiting peoples nervousness by clinically labeling it as social anxiety and reintroducing the
antidepressant pink pill as their panacea to personal happiness, lifelong self-confidence and success in life. This most prevalent industry pattern of reusing the same old drugs all dressed
up with new custom designed names for new purposes on new custom designed populations for yet more price gouging is nothing less than resorting to a predatory practice of criminal
false advertising.

Perhaps as sinister as any aspect of the drug business is how Big

Pharma has completely taken over the FDA . A recent Harvard study
slammed the FDA making the accusation that it simply cannot be
trusted because its owned and operated by Big Pharma. With complete autonomy and control,
now pharmaceutical companies knowingly market drugs that carry high risk dangers for consumers. But because they so tightly control its supposed regulatory gatekeeper, drugs are
commonly mass marketed and before the evidence of potential harm becomes overwhelming, by design when the slow bureaucratic wheels turn issuing a drug recall, billions in profit
have already been unscrupulously reaped at the deadly expense of its victims. Additionally, doctors, pharmacists and patients rarely even hear about important recalls due to dangerous

Many FDA approved drugs like

FenPhen, Vioxx, Zohydro and Celebrex kill hundreds before theyre finally
removed from the shelf. This withholding the truth from the professionals and public consumers is yet more evidence that Big
Pharma protects its profits more than people.
side effects or contamination. Yet hundreds of Big Pharma drugsare recalled every year.

Scenario 1 is the TPP:

Big pharma advocates pressure TPP negotiators into slashing
access to generics worldwide
Lazare 15 (Sarah, Common Dreams, staff writer, 7/10/15, Latest TPP Draft
Benefits Big Pharma By Slashing Access to Generics,
http://www.commondreams.org/news/2015/07/10/latest-tpp-draft-benefits-bigpharma-slashing-access-generics, Accessed 7/25/15)//LD
With another round of Trans-Pacific Partnership negotiations slated for the
end of this month, the administration of President Barack Obama is aiming to force
developing nations to adopt Big Pharma-friendly policies that are so bad for
public health Obama himself has opposed them in the United States. Citing leaked drafts of the
agreement, as well as officials "familiar with the latest May 11 version," Bloomberg journalist Peter
Gosselin reported Friday that the deal is likely to include provisions that are
almost certain to hike medicine costs while slashing access to generic drugs
around the world: "At stake: hundreds of billions of dollars or more in extra
costs that consumers may have to pay if the proposals make it harder for
cheaper generics to win approval." In the negotiations, Obama is pursuing

corporate-friendly policies he has rejected at home. For example, "U.S. negotiators want to
win makers of advanced drugs 12 years of exclusivity for data that might
otherwise help competitors produce similar, cheaper versions ," wrote Gosselin.
However, the Obama administration has sought, within the United States, to reduce that period to seven years. But it doesn't stop
there. "Negotiators

are also seeking language to make it easier for the big

drugmakers to win 'secondary' patents to strengthen their control over
products," Gosselin continued. But domestically, the administration "has proposed changing U.S. law to make it harder to get
such add-ons," Gosselin explained. Obama is poised to not only foist these policies on other countries, but to trap the U.S. in them

the United States "has negotiators pressing the

regions developing countries to sign onto a schedule for adopting the
stronger rules, reversing previous exemptions to allow them easier access
to cheap medicines." Obama is reportedly meeting opposition from countries involved in the negotiations. Meanwhile,
as well. What's more, said Gosselin,

global civil society and social movement groups have staged their strong opposition to the deal with protests, open letters, and
organizing. However, resistance would likely be even greater if the contents of the talks were shared with the global public. Under
negotiation since at least 2008,

the deal is poised to be the largest corporate agreement

in history yet has been negotiated in extreme secrecy, with almost all of what's publicly known about the deal revealed
through leaks. It includes the U.S. and 11 Pacific Rim countriesAustralia,
Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru,
Singapore, and Vietnamwhich together account for 40 percent of the world's GDP. The information that is
publicly available is bleak. In a recent video, humanitarian organization Doctors Without
Borders/Medecins Sans Frontieres put it bluntly: "As it stands today, the
TPP is slated to become the most harmful trade agreement ever for access
to medicines." As Common Dreams previously reported, the TPP would be a huge boon for
pharmaceutical corporations while posing a threat to public health on a
global scale. The deal also makes domestic health programs vulnerable, including Medicare. The watchdog group Public
Citizen recently warned: "Pharmaceutical companies could attempt to exploit the
general language of the annex to mount challenges to Medicare and
health programs in many TPP negotiating countries." Concerns with the
deal extend far beyond access to medicines, however, with civil society
groups sounding the alarm about the deal's implications for democracy,
the environment, and corporate power. Among its many provisions, the agreement includes an
"investor-state dispute settlement" system (ISDS)which creates secret tribunals that allow multinationals to sue governments for
loss of "expected future profit."

Generics are the only way to solve for pandemics---cheap

access
Orsi et al 3 (6/25, Fabienne, Lia Hasenclever, Beatriz Fialho, Paulo Tigre,
Benjamin Coriat, Anti-AIDS Policy and Generic Drugs. Lessons from the Brazilian
Public Health Program, http://www.lepublieur. com/anrs/ecoaids8.pdf)
some 20 years of fight against the AIDS pandemic, has led to
outcomes that seem totally different from the ones predicted by the proponents of
strong protection. This is because the multinational companies, sitting on their monopolies and
protected by international law, have not at all delocalized their activities to the South . On the
The evidence, after

contrary, after the clauses that used to be beneficial to the locally established firms were suspended, certain

multinational companies began to abandon some of their facilities in the Sout h,

regrouping their world- wide manufacturing units in an attempt to achieve economies of scale [7]. [17].
Furthermore, even before generics began to be produced and distributed locally,

multinational drugs

manufacturers did anything but lower their prices . In other words, they preempted a
situation in which access to treatment remained totally out of reach for patients in
the South. Lastly, local firms, the vast majority of whom lack sufficient R&D
capabilities, have tended to regress rather than progress . As for the fine chemicals firms that
used to produce active principles. Brazil witnessed a mass destruction of its stock of
manufacturing once the free-trade agreements that were signed in 1994 came into effect (remember that
TRIPS are only one aspect of the general agreements signed under the WTO framework). In addition, it was only
once the Brazilian authorities made a commitment to local production that the multinational firms, for once under
considerable pressure, began to lower prices visibly. In other words, aside from its remarkable effects in terms of
Public Health, one of the main achievements of the Brazilian program is that it provided unambiguous elements for
dealing with key issues in the country's political economy. 4. For all of these reasons, the ensuing phase (the 2001

WTO members now openly admitting that it is

essential that countries facing epidemic threats be able to use compulsory
licenses of patented drugs. Depending on whether this statement of intent is followed by tangible
after-effects and enacted in law. the circumstances surrounding the continuation of the battle
against tliis epidemic could vary greatly14. The United States' recent opposition (the U.S. is the only
Doha Declaration) has been crucial, with

country to refuse a compromise text accepted by the 143 other countries represented in Geneva) was a disastrous
signal for the wealthy nations to send to the countries of the South. In any event, and even if "South-South" exports

the
Brazilian experience clearly shows that the use of a "compulsory licensing"
clause (or the credible threat to use it) constitutes a key strategic tool for achieving
the significantly lower prices of drugs that are needed to fight the
epidemic.
of ARVs and other active principles are finally authorized (something that was refused in Geneva in 2002).

Disease causes extinction

Keating 9 (Joshua, Foreign Policy web editor, The End of the World, 11-13-09,
http://www.foreignpolicy.com/articles/2009/11/13/the_end_of_the_world?page=full,)
How it could happen: Throughout history,

plagues have brought civilizations to their

knees. The Black Death killed more off more than half of Europe's population in the Middle Ages. In 1918, a flu
pandemic killed an estimated 50 million people, nearly 3 percent of the
world's population, a far greater impact than the just-concluded World War I. Because of
globalization, diseases today spread even faster - witness the rapid worldwide spread of
H1N1 currently unfolding. A global outbreak of a disease such as ebola virus -- which has
had a 90 percent fatality rate during its flare-ups in rural Africa -- or a mutated drug-resistant
form of the flu virus on a global scale could have a devastating, even
civilization-ending impact . How likely is it? Treatment of deadly diseases has improved since
1918, but so have the diseases. Modern industrial farming techniques have been blamed for the outbreak of

as the worlds population grows and humans move

into previously unoccupied areas, the risk of exposure to previously
unknown pathogens increases. More than 40 new viruses have emerged
since the 1970s, including ebola and HIV. Biological weapons experimentation has added
a new and just as troubling complication.
diseases, such as swine flu, and

Scenario 2 is India:
Big Pharma lobbies decimate Indian medical industry--intellectual property law revisions
Cox 13 (Joseph, Vice, 10/18/13, Surprise! Big Pharma Don't Want Developing
Countries Having Access to Cheap Medicine,
https://www.vice.com/en_uk/read/american-lobbyists-are-fighting-to-halt-theavailability-of-affordable-medicine-to-the-3rd-world, Accessed 7/24/15)//LD
India has done an incredible job of keeping
medicine cheap enough that its citizens can afford to buy whatever it is
that they need. Most importantly, it avoids handing out patents for drugs unless they're completely new or have some
sort of therapeutic advantage over already-available treatments, meaning that the vast majority of lifesaving medicines are free to be replicated and sold by any company that
wishes to do so. For example, in 2012, German Big Pharma company Bayer were
charging $4,500 (2,780) per month for a kidney and liver cancer
medicine. Deeming that a little too pricey in a country where the average yearly wage is around a quarter of that number,
the Indian government granted a license to manufacturer Natco to
produce a generic alternative to the branded medicine, as long as they paid some
royalties to Bayer. As a result, the price of the medicine decreased by a massive 97
percent. However, aggressive lobbying from US pharmaceutical companies is
set to change all that. America's pharmaceutical plutocrats are attempting
to revise intellectual property laws in India, meaning that many people
seeking treatment will be forced to buy expensive US imports instead of
domestically produced replicas. Which obviously isn't great news for the 96.9 percent of citizens living with
less than $5 (3) a day. In most drug-producing countries that aren't India , once a drug has
been developed and a first patent filed and granted, pharmaceutical companies then engage in a
practice called "evergreening". That practice basically involves undermining access to
affordable medicines by using a variety of tactics to extend the company's
monopoly on the drug past its initial 20-year patent period . By obtaining multiple
secondary patents, often for trivial modifications to the original, companies are able to protect their
product for decades, preventing production of cheaper generic replicas .
Because Indian patent law forbids evergreening , the country's generic pharmaceutical companies
have been able to produce affordable versions of foreign medicines to suit their nation's income. But it's that law
that's coming under pressure from the US government and international
drug companies, with both institutions wanting India to allow
evergreening, therefore further tightening the companies' grasp on drug
monopolies. That, of course, means that low-cost generic medicines will simply
disappear, leaving India's sick the choice of whether to submit to severe poverty in order to raise the cash for US imports, or
forego treatment altogether. Either way, India loses. Nolitha Tsilana, a Mdecins Sans Frontires nurse, delivers TB
pills to a patient in Khayelitsha township, Cape Town. (Photo courtesy of Mdecins Sans Frontires) And it's just not
those needing medical treatment in India who should be worried about the
lobbying. India has been referred to as "the pharmacy of the developing
world", exporting more than half of its generic medicine to the world's
Compared to a number of other nations,

poorest countries every year. And the exports include more than just paracetamol and basic painkillers; the
Indian pharmaceutical industry produces treatments for life-threatening
diseases, like hepatitis C and HIV treatments that the countries
importing them don't have the resources to make themselves . In fact,
speaking to Rohit Malpani from Mdecins Sans Frontires (an organisation that relies
heavily on affordable generic drugs), he stressed that even a tiny alteration in the law
"would have enormous impacts on public health systems in sub-Saharan
Africa, Latin America and Southeast Asia". The crushing irony of the whole thing is that the
vast majority of medicines taken in the US and those distributed by US aid
programmes are of the generic variety, many of which are developed by Indian
manufacturers. So that's Indians, US aid agencies, Mdecins Sans Frontires, the world's
poor and vulnerable and US citizens that US pharmaceutical companies
could be screwing over with the proposed change in law. According to the letter sent to President Obama that
outlines the proposals to force India into buying American-made medicine, Representatives Erik Paulsen, John Larson and 170 other
members of Congress are "deeply concerned about the growing trade imbalance between the United States and India". The

lobbyists claim that India is "harming" US industry by "jeopardising jobs

and innovation here at home" and having "a negative impact on []
investment in the United States". You'd been forgiven for thinking that these were the words of a right-wing
venture capitalist with no ability to value human life over the prospect of making a little more money. But Rohit pointed out that the
support is "decidedly non-partisan", saying that "we don't see any empathy or understanding of the measures that the Indian
government or other governments are taking to ensure affordable medicine prices. In some ways, we often see very little space
between the approaches of either political party". Medicine distributed in Kenya by Mdecins Sans Frontires. (Photo courtesy of
Sven Torfinn / Mdecins Sans Frontires) Paulsen and his patriotic friends are also worried that other countries may take up India's
abhorrent stance on producing medicine domestically for the benefit of its own people and join the attack on America's economy,
because "[India] is a thought leader among emerging countries". The justification the lobbyists have provided for their attack is that
the Indian government's attitude towards producing affordable alternatives is illegal that they're breaking intellectual property
laws by replicating branded drugs. However, Rohit told me that "every sort of impartial legal expert has validated India's measures
as being consistent with global trade rules". Rather than just take Rohits word for it, I consulted a report from the World Health
Organisation (WHO). The report explained that member states should "consider, whenever necessary, adapting national legislation
in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights". These
flexibilities in the law include compulsory licenses, just like the one awarded to Natco to produce a cheaper alternative to the kidney
and liver cancer medication that Bayer were trying to peddle for almost 100 times more. After approaching Pfizer one of the main
pharmaceutical companies behind the lobbying and being bounced between multiple media departments, I wasn't provided any
comment. Instead, I was forwarded testimony that Chief Intellectual Property Counsel Roy Waldron delivered to the House of
Representatives back in June. He stated that India's actions lower their ability to "provide faster access to life-saving medicines", and
that the country was a "hostile innovation and investment environment". Which basically translates to: " Because

Indians have made their own medicine that people there can actually afford,
nobody wants to waste thousands of dollars on the stuff we make that does
exactly the same thing. Which is a mean and selfish thing to do to
America's billionaire pharmaceutical bosses."

Indian pharma strength is key to their soft power

Jha 12The Hindu
(Prem Shankar, Let India unleash its soft power, http://www.thehindu.com/opinion/lead/let-india-unleash-its-softpower/article2854513.ece, dml)
And why stop at food grains? In drought-struck regions, contaminated water kills much faster than hunger and

The Indian pharmaceuticals industry is the envy of

the world, because it produces and sells medicines at a tenth to a thirtieth of the retail prices abroad. Can
Delhi not buttress its food aid with medicines and vitamins? This will give an entirely
new meaning to the concept of Soft Power for, unlike the West in its present
incarnation, it would be seeking to build influence by protecting and preserving, not
destroying; by expanding peoples' futures instead of ending them in darkness. We have been relatively
takes the very young and the very old first.

slow to realise our full potential for the exercise of soft power. This could be because of our
too-ready acceptance of a concept that was created by an American to address American foreign policy concerns. In
Joseph Nye's original definition, soft power originated in the capacity to attract others to your country's culture,
values and institutions. Indian policymakers have taken this to heart and relied mainly upon India's open society,
democratic institutions, lack of aggressive intent and willingness to share the burden of U.N. peacekeeping and

It is only in the
last half-decade, as the Westphalian international order crumbled and India's neighbourhood became
increasingly unstable, that New Delhi has begun to explore the economic dimensions of
soft power' seriously. Afghanistan has been the focus of its initial efforts, and its success is attested to by
policing the global commons, to garner respect and support in the international community.

the threat (irrational though it is) that Pakistan feels from it.

Prevents extinction
Diamond 7 senior fellow at Stanfords Hoover Institution(Larry, Times of India,
"India, Take the Lead,"
timesofindia.indiatimes.com/Opinion/Editorial/LEADER_ARTICLE_India_Take_The_Lea
d/articleshow/2617945.cm)
India is becoming a global power. In the years to come,
With its economic might, its military power, and
its "soft power" all increasing steadily, India will find it increasingly difficult to
continue its traditional foreign policy of non-alignment and non-intervention . Americans are
Whether it wants to be so or not, whether it is ready for this role or not,
India will have to decide what kind of global power it wants to be.

in an awkward position to appeal to another rising power to promote democracy, as our own engagement for demo-cracy abroad over time has contained
more than a little neocolonialism, unilateralism and hypocrisy. However, in the last three decades, this has been partially supplanted by increasingly
effective efforts (especially when multilateral, practical and soft-spoken) to assist democratic development around the world. One must also acknowledge
the serious problems with India's own democracy: tenacious poverty and inequality, troubling levels of political violence and criminality in some states,
and a fragmented political party system that makes it difficult to take decisions. In the face of acute challenges, it is understandable for India to want to be

the established democracies of the world share a strong

common interest in trying to bring about a more democratic world, and India's help
is sorely needed in this cause. The global balance of power, of economic energy,
and of moral authority is tilting from North to South. And the global environment for
democracy is less favourable than at any time since the fall of the Berlin Wall , as an oilable to focus on its own problems. Yet

rich Russia turns its back on Europe and democracy, a booming authoritarian China casts a lengthening shadow over Asia and now Africa as well, and
democracy gasps for life in such crucially important countries as Pakistan, Bangladesh, Thailand, the Philippines, Nigeria and Venezuela.

There are

still a lot more democracies in the world than there were in 1989, but the
momentum is reversing, and many democracies are in danger . There are several reasons why India
should care. First, India's own democracy could be affected by what happens regionally and globally. Recall that emergency rule fell upon India at a lowpoint for democracy in Asia and the world. Democracies thrive in regions where they enjoy the reinforcing legitimacy and mutual security of other

by engaging other democracies around the world, India will also draw
solidarity and some lessons that could be useful for its own democratic reform . All
democracies in the world today are imperfect, and we all need to learn from one another. Third, a more democratic world will be
a more secure world for us all. Democracies do not go to war against one another.
And they do a much better job of advancing human well-being and protecting the
environment. Moreover, terrorism emanates disproportionately from authoritarian
soil. We are threatened in common with a global crisis of climate change that dwarfs
anything human civilisation has ever confronted. And the pathologies of badly
governed states terrorism, crime, corruption, environmental stress, infectious
disease spill across borders more quickly and vengefully than ever before . India does
not need a radical reorientation of its foreign policy in order to make a difference to democracy in the world. It has an exceptionally
rich history of democratic practice and experience to share with other developing
democracies. Some of the obvious realms of experience that India has to share include: the evolution and functioning of federalism, the
democracies. Second,

management of ethnic and religious conflict, the constitutional court, state and local government, electoral administration, the independent mass media

and civil society. A very useful first step would be to bring practitioners and scholars from emerging democracies to India for periods of time to study how
democracy works and has developed here. New institutions could be established and existing Indian think tanks and organisations could be supported to
host such visits. Of course the United States does quite a bit of this. But how relevant is the highly expensive and decentralised American (or even
European) model of democracy for Asia and Africa? We would all be better off sending more democrats to countries like India and South Africa. And
conducting these exchanges would be an excellent and also ethical way for India to extend its soft power at a time when China is doing so for much more

If India were to establish an institution to coordinate and

organise exchanges with democrats around the world, richer democracies in the
world would want to join with it and help to fund it. And in the near term, we have a ready potential vehicle. The
brazenly commercial and strategic ends.

UN Democracy Fund has recently been established, with a substantial budget that includes sizable contributions from India and the United States. It is a
natural candidate to provide early support for such a new initiative.

democracy because doing so is in

India should join the worldwide movement for

's own national interest

India
, not because the West asks it. But the
democratic West has obligations to India that it must fulfil in the process. If we are asking India to play more of a leader-ship role on the world stage, than
we must make room for that leadership. This should include India's permanent membership on the UN Security Council and its inclusion in global agendasetting dialogues, such as the G8.

Scenario 3 is Africa:
Big Pharma campaigns wreck the local African pharmaceutical
industry---blocks IPR amendments
Kardas-Nelson 14 (Mara, award-winning journalist who focuses on health, environment,
international development, local culture and women's issues, work has appeared in North American,
European and African publications, including Al Jazeera, AlterNet, The Nation and the Mail & Guardian,
4/29/14, Hand in Hand With US Government, Big Pharma Pushes for More Profits, http://www.truthout.org/news/item/23279-hand-in-hand-with-us-government-big-pharma-pushes-for-more-profits,
Accessed 7/24/15)//LD

South African Minister of Health Aaron Motsoaledi cried foul:

he was publicly pissed about a US-created astroturf campaign (a faux "grassroots
movement" actually led by moneyed interests) meant to undermine the country's efforts to
lower drug prices through amending its intellectual property (IP)
legislation. Labeling the plot as being of "satanic magnitude" and tantamount to
"genocide," Motsoaledi slammed the creators of the campaign, a veritable who's
who of pharmaceutical companies and conservative, pro-business groups. The tripartite alliance
In January of this year,

responsible for the plot consisted of Public Affairs Engagement (PAE), a DC-based PR firm headed by US Ambassador James
Glassman, formerly the undersecretary of state for public diplomacy and public affairs in the George W. Bush administration; the
Pharmaceutical Research and Manufacturers of America, or PhRMA, one of the most powerful drug industry bodies on the planet;

The group would

seek to persuade the South African public that strong intellectual property
policy is good for investment and that the country's health woes are a result of a failed public health system
and a local pharmaceutical body, Innovative Pharmaceutical Association of South Africa (IPASA).

rather than patent laws and the price of medicines. The draft South African policy that the groups sought to undermine seeks to
more strictly define how patents should be given, what is patentable and what measures the government can take if pharmaceutical
patents negatively impact public health, all in an attempt to stem rising health costs. With its burgeoning middle class, "diseases of
the rich" like diabetes, hypertension, obesity, heart disease and cancers are on the rise. This, matched with a high rate of HIV, TB,
and other historically "poor" diseases, and coupled with the excessive cost of patented drugs, means that drugs are in high demand,
but prices are sometimes inaccessibly high. The astroturfing plot was simple: For just under half a million dollars, paid for in large
part by PhRMA, the US public relations firm would support IPASA's efforts to stem South Africa's IP reform by setting up a puppet
front group, to be named Forward South Africa and led from Washington DC. The group would seek to persuade the South African
public that strong intellectual property policy is good for investment and that the country's health woes are a result of a failed public

South Africa is trying to stem

costs just as pharmaceutical companies want a bigger slice of its pie - with
its growing wealth, its patent-friendly laws and its sick population, South
Africa looks like a deliciously ripe, relatively untapped market . If South Africa pushes
health system rather than patent laws and the price of medicines. What's more,

back, not only could current and future profits be reduced within the country, but also, and more importantly, other emerging
economies that also appeal to pharma could follow suit, eliminating potential profits for companies hungry for new markets. It's easy
to see how

multinational pharmaceutical companies would be scared of South

Africa's potential reforms. The country currently offers IP protection beyond what is required under international
law and does not review patents before they are granted. As a result, it hands out thousands of drug patents annually and readily
gives out multiple patents on a singular medicine, offering monopoly protection on a single drug for decades. Nearly all of the
country's pharmaceutical patents are granted to multinational firms, and the country's department of trade and industry cites drugs
as a key reason for South Africa's trade deficit. The country is also a continental leader that other African countries and middleincome countries look to for general policy guidance. Motsoaledi's harsh words in reaction to the PAE-led scandal represent anger,
but not necessarily shock: After all, the country has dealt with US and industry meddling in its pharmaceutical policy before. In 1998,
Nelson Mandela's administration was sued by dozens of pharmaceutical companies in reaction to the country's attempts to make
minor amendments to its drug laws (the case was eventually dropped in 2001, after years of public pressure). The PAE-led

US
pharmaceutical companies, with the help of high-profile Americans
connected to the US government, pressure poorer countries battling high
rates of disease to ensure that the IP playing field is set as they like it .
astroturfing campaign, which has died in the wake of public outcry, is just one example of many in which

Local pharma production is key to African health and economic

growth
ADBG 14 (African Development Bank Group, 4/6/14, Revitalizing Africas
pharmaceutical industry, http://www.afdb.org/en/news-andevents/article/revitalizing-africas-pharmaceutical-industry-13289/, Accessed
7/24/15)//LD
Africas pharmaceutical industry has great potential for boosting
economic growth and creating jobs. Given current sustained and rapid economic
growth, the African pharmaceutical industry, like that of other emerging markets, is
expected to grow tremendously in the coming years. Pharmerging markets across the
world show the potential for rapid growth in the industry. In the past five years Chinas pharmaceutical industry grew 20%, Russias

the African continent has been home to

some of the fastest-growing economies in the world, creating a large
window of opportunity for the development of the pharmaceutical sector .
14%, Indias 11% and Brazils 7%. During the past decade

The growing numbers of Africans with significant disposable income and spending power, the strong demographic dynamics,
including fast urbanization, steady economic growth in most parts of the continent, and improved infrastructure in both rural and

Investments in the pharmaceutical

sector are investments in the health sector with the greatest potential both
in terms of financial viability and individual deal size. Job creation prospects are also immense all along the
urban areas are all potential drivers of Africas pharmaceutical boom.

pharmaceutical value chain. Although it is relatively small in global terms (worth US $23.1 billion in 2011, or less than 2% of the

Africas pharmaceutical industry is the fastest growing in the

world and is driven by a small number of countries: South Africa, Nigeria, Ghana, some Eastern African
countries and North Africa. Local production remains weak and limited : local manufacturers
global market),

produce 25 to 30% of pharmaceuticals and less than 10% of medical supplies that are on the African market. The pharmaceutical
industry is mostly composed of small, privately owned companies that serve their national markets, and there are few large
manufacturers (Aspen

in South Africa is in the top 10 largest generic

manufacturers in the world) as well as public sector manufacturers. Africa bears the
greatest burden of disease in the world, but in most cases depends on
externally developed and procured drugs, vaccines, medical devices and diagnostics to
support the health of its people, which significantly affects health expenditures and household incomes.
The need for drugs is tremendous: 75% of the worlds HIV/AIDS cases, 90% of the deaths from malaria and the majority of
tuberculosis cases are all in Africa. In addition, the rise of non-communicable diseases, coupled with the burden of communicable
ones and emergent infections, require new medical services and new treatments.

There is clear momentum in

Africa for developing the pharmaceutical industry. African Heads of State

stressed the potential for local production and technology transfer in the Pharmaceutical
Manufacturing Plan for Africa. Developing the pharmaceutical industry on the continent would contribute to removing financial
barriers to medicines and improving access to essential medicines. Still, the conditions for the private sector to bloom have not been
met.

Epidemics in Africa cause regional instability and wars

Brantly 14 (Dr. Kent, House Subcommittee on Africa, Global Health, Global
Human Rights, and International Organizations, 9/17/14, Global Efforts to Fight
Ebola, http://docs.house.gov/meetings/FA/FA16/20140917/102676/HHRG-113-FA16Wstate-BrantlyK-20140917.pdf, Accessed 7/24/15)//LD
As Ebola spreads throughout West Africa, there is increasing civil unrest
that could easily lead to regional instability . I had one patient in early July who died
after spending two days in our Ebola Treatment Unit. Although we tried to explain the cause of death to her family,
some of themwith the help of a witch doctor determined that she died because of a curse placed on her by her

sought revenge, which meant taking the life of the person they
thought was responsible. In societies like this, where fear and distrust of authority
are the norm, many still deny that Ebola is real and actively seek other explanations
for the deaths of their loved ones. There are many conspiracy theories, including the
belief that Ebola is a government plot for monetary gain. You can see how this sort of thinking can easily
lead to large-scale violence. There is a palpable sense of tension on the
streets that is priming the pump of society for skirmishes that could
quickly lead to war. The world cannot afford to allow more conflict in this
region that is home to dictators-in-hiding and terrorist groups like Boko Haram.
This epidemic must be brought to a halt as soon as possible to regain order and rebest friend. They

establish confidence in local governments. Since I fell sick less than two months ago, the death toll from Ebola has
tripled. At that rate of growth, there will be hundreds of thousands of deaths within the next nine months. This is a
global problem, and the U.S. must take the lead immediately to extinguish the hellish fire of Ebola before it

We cannot wait for international agencies tied up in

bureaucracy or organizations that rely on volunteers and funding from
private donors. The longer we wait, the greater the cost of the battlein dollars and lives. We must act
consumes entire nations.

immediately and decisively to bring healing and stability to the people of West Africa, the African continent, the
United States, and the entire world.

African conflicts cause great power war

Glick 7 (Caroline senior Middle East fellow at the Center for Security Policy,
Condis African holiday, p. http://www.centerforsecuritypolicy.org/home.aspx?
sid=56&categoryid=56&subcategoryid=90&newsid=11568)
Africa is a dangerous and strategically vital place. Small wars, which rage
continuously, can easily escalate into big wars. Local conflicts have regional and
The Horn of

global aspects. All of the conflicts in this tinderbox , which controls shipping
lanes from the Indian Ocean into the Red Sea, can potentially give rise to regional, and indeed global

conflagrations between competing regional actors and global powers . Located

in and around the Horn of Africa are the states of Eritrea, Djibouti, Ethiopia, Somalia, Sudan and Kenya. Eritrea, which gained independence from Ethiopia
in 1993 after a 30-year civil war, is a major source of regional conflict. Eritrea has a nagging border dispute with Ethiopia which could easily ignite. The two
countries fought a bloody border war from 1998-2000 over control of the town of Badme. Although a UN mandated body determined in 2002 that the
disputed town belonged to Eritrea, Ethiopia has rejected the finding and so the conflict festers. Eritrea also fights a proxy war against Ethiopia in Somalia
and in Ethiopia's rebellious Ogaden region. In Somalia, Eritrea is the primary sponsor of the al-Qaida-linked Islamic Courts Union which took control of
Somalia in June, 2006. In November 2006, the ICU government declared jihad against Ethiopia and Kenya. Backed by the US, Ethiopia invaded Somalia last
December to restore the recognized Transitional Federal Government to power which the ICU had deposed. Although the Ethiopian army successfully
ousted the ICU from power in less than a week, backed by massive military and financial assistance from Eritrea, as well as Egypt and Libya, the ICU has
waged a brutal insurgency against the TFG and the Ethiopian military for the past year. The senior ICU leadership, including Sheikh Hassan Dahir Aweys
and Sheikh Sharif Ahmed have received safe haven in Eritrea. In September, the exiled ICU leadership held a nine-day conference in the Eritrean capital of
Asmara where they formed the Alliance for the Re-Liberation of Somalia headed by Ahmed. Eritrean President-for-life Isaias Afwerki declared his country's
support for the insurgents stating, "The Eritrean people's support to the Somali people is consistent and historical, as well as a legal and moral obligation."
Although touted in the West as a moderate, Ahmed has openly supported jihad and terrorism against Ethiopia, Kenya and the West. Aweys, for his part, is
wanted by the FBI in connection with his role in the bombing of the US embassies in Kenya and Tanzania in 1998. Then there is Eritrea's support for the
Ogaden separatists in Ethiopia. The Ogaden rebels are Somali ethnics who live in the region bordering Somalia and Kenya. The rebellion is run by the
Ogaden National Liberation Front (ONLF) which uses terror and sabotage as its preferred methods of warfare. It targets not only Ethiopian forces and
military installations, but locals who wish to maintain their allegiance to Ethiopia or reach a negotiated resolution of the conflict. In their most
sensationalist attack to date, in April ONLF terror forces attacked a Chinese-run oil installation in April killing nine Chinese and 65 Ethiopians. Ethiopia, for
its part has fought a brutal counter-insurgency to restore its control over the region. Human rights organizations have accused Ethiopia of massive human
rights abuses of civilians in Ogaden. Then there is Sudan. As Eric Reeves wrote in the Boston Globe on Saturday, "The brutal regime in Khartoum, the
capital of Sudan, has orchestrated genocidal counter-insurgency war in Darfur for five years, and is now poised for victory in its ghastly assault on the
region's African populations." The Islamist government of Omar Hasan Ahmad al-Bashir is refusing to accept non-African states as members of the hybrid
UN-African Union peacekeeping mission to Darfur that is due to replace the undermanned and demoralized African Union peacekeeping force whose
mandate ends on December 31. Without its UN component of non-African states, the UN Security Council mandated force will be unable to operate
effectively. Khartoum's veto led Jean-Marie Guehenno, the UN undersecretary for peacekeeping to warn last month that the entire peacekeeping mission
may have to be aborted. And the Darfur region is not the only one at risk. Due to Khartoum's refusal to carry out the terms of its 2005 peace treaty with
the Southern Sudanese that ended Khartoum's 20-year war and genocide against the region's Christian and animist population, the unsteady peace may
be undone. Given Khartoum's apparent sprint to victory over the international community regarding Darfur, there is little reason to doubt that once victory
is secured, it will renew its attacks in the south.

The conflicts in the Horn of Africa have regional

and global dimensions. Regionally, Egypt has played a central role in sponsoring and fomenting conflicts. Egypt's meddling
advances its interest of preventing the African nations from mounting a unified challenge to Egypt's colonial legacy of extraordinary rights to the waters of
the Nile River which flows through all countries of the region.

1AC---Whistleblowing Advantage
Status quo surveillance is damaging credibility---only plan has
potential to solve
Nakashima and Rein 12 (Ellen Nakashima, national security reporter for The
Washington Post, Lisa Rein, covers the federal workforce and issues that concern
the management of government, FDA lawyers authorized spying on employees,
senator says, July 16, 2012, https://www.washingtonpost.com/world/nationalsecurity/2012/07/16/gJQAoNvLpW_story.html)//ghs-VA
Congressional investigators said Monday that the chief counsels office at the Food and Drug Administration authorized wide-ranging

In a
letter to the FDA, Sen. Charles E. Grassley (R-Iowa) said that his staff had learned that
the spying was explicitly authorized , in writing by the agencys top
surveillance of a group of the agencys scientists, the first indication that the effort was sanctioned at the highest levels.

legal office. The FDAs actions represent serious impediments to the right
of agency employees to make protected disclosures about waste, fraud, abuse,
mismanagement, or public safety, wrote Grassley, who demanded that the agency release a copy of the memo authorizing the
surveillance and the name of the FDA official who requested it. FDA spokeswoman Erica Jefferson said that the agency is looking into
the matter. She said that the surveillance was limited in scope and reiterated that it was relegated to government computers. We
did not impede or interfere with any employee communication to Congress, their staff, media or federal investigators, she said. The
disclosure marked the latest turn in an investigation of the FDAs past efforts to monitor the communications of a group of its

the FDA secretly

collected thousands of private e-mails that the employees sent to one
another, members of Congress, journalists, lawyers and others. The FDA acknowledged Friday that targeted surveillance of
doctors who were expressing concerns about the safety of medical devices. As part of the effort,

five employees began in mid-2010, but it said that was not ongoing today, according to a letter sent to Grassley by Jeanne Ireland,
the agencys assistant commissioner for legislation. The FDA said Monday that the computer surveillance was limited to five

The
targeting of the employees communications, including e-mail and other
online activities, was reported by The Washington Post in January. The agency monitored personal e-mail
employees. But an internal document shows that the agency targeted at least seven employees beginning in 2010.

accounts accessed from government computers, took electronic snapshots of computer desktops and reviewed documents saved on
hard drives. The New York Times reported over the weekend that the scope of the surveillance was wider than first suspected, with
the agency creating a database of 80,000 pages of computer documents collected from the scientists communications. The
database, apparently posted inadvertently online by an FDA contractor, included an FDA scoping document of targets for future email interception that included congressional staff members. Also captured were draft complaints being prepared by the scientists to
the Office of Special Counsel, an independent federal agency that investigates disclosures of government wrongdoing and retaliation

OSC special
counsel Carolyn Lerner warned federal agencies that monitoring their
employees personal e-mail violated the law if the intent was to retaliate
against whistleblowers. The White House distributed her warning to agencies across the government, an
against those who report it. The OSC is investigating the FDAs monitoring of its employees. In June,

acknowledgment by the Obama administration that there are limits to employee surveillance. Two years ago, the FDAs parent
agency, the Department of Health and Human Services, reminded it that employees have a right to air their concerns to Congress
and journalists. The reminder accompanied a rejection by the HHS inspector general of the FDAs request that it pursue a criminal
investigation of the scientists activities. Grassley, a member of the Senate Judiciary Committee, has been seeking answers from the
FDA since January on the extent of the surveillance and who authorized it. On Friday, he accused the agency of stonewalling him
after officials there responded to his inquiries by saying in a letter they are still identifying and gathering evidence in the matter.
It

is simply not credible that FDA went to such great lengths over the
course of two years to monitor employees personal e-mail accounts , then spent
six months crafting a reply to my questions about it, and yet still cannot identify who authorized the spying, he said. FDA
computers post a warning to users, visible when they log on, that they should have no reasonable expectation of privacy in any
data passing through or stored on the system, and that the government may intercept any such data at any time for any lawful
government purpose. Internal documents obtained under the Freedom of Information Act by the scientists, some of whom have been

FDA was concerned that they had improperly disclosed confidential business information about several medical devices used to screen patients for colon cancer and
fired, show that the
breast cancer.

Effective whistleblowing is key to reduce corruption

LaBovick 12 LaBovick Law Group (quoting the whistleblowers attorney) is a consumer
plaintiffs law firm, Illegal FDA Surveillance of Whistleblowers, 8/3/12, https://www.labovick.com/quitam/illegal-fda-surveillance-whistleblowers-2//OF

the New York Times issued an article that uncovered a U.S.

government secret spying program that targeted a group of
whistleblowers working for the Food and Drug Administration (FDA). The
government program that the story uncovered is illegal. It shows how high government
officials used a spy program that intended to undermine federal
employees rights to lawfully report significant health threats and
concerns to Congress, law enforcement officials and the American people.
On July 14, 2012,

Stephen M. Kohn, the Executive Director of the National Whistleblower Center and the head attorney for the FDA

employees do not give up their First or Fourth

Amendment rights while holding government positions . Kohn stated that it is in
whistleblowers stressed that these

fact more important for government workers to make note of wrongdoing

in order to expose crimes, misconduct, corruption and wasted taxpayer
dollars. In reference to the news article, Stephen M. Kohn also stated: We hope that the
revelations in todays New York Times will mark a turning point in the
battle to stop the retaliatory surveillance of whistleblowers who risk their
careers to report misconduct. Mr. Kohn hopes that the individuals responsible for attempting to
prevent FDA agents from uncovering serious health and safety violations will be punished.

FDA whistleblower policy spills over to all governmental

organizations and these protections are important to prevent
abuses of power
HCOGR 14 HEARING BEFORE THE COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM HOUSE OF
REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS LIMITLESS SURVEILLANCE AT THE FDA: PROTECTING THE
RIGHTS OF FEDERAL WHISTLEBLOWERS http://www.gpo.gov/fdsys/pkg/CHRG-113hhrg87176/pdf/CHRG113hhrg87176.pdf, this except is taken from page 4.CC

The Federal workforce is a highly trusted

force, and trust is what we depend on. At times, it is clear that that trust
is broken and, when it is, there are appropriate remedies. But until that
trust is broken, we depend on a skilled and motivated workforce that believes, as they should, that they are
I am not suggesting that. Just the opposite.

not working for Big Brother, that, in fact, they are trusted in their VerDate Aug 31 2005 11:40 Mar 31, 2014 Jkt
000000 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 C:\DOCS\87176.TXT APRIL 4 roles and not being unreasonably

For that reason, we are holding this hearing

today not as just an indictment of the FDA, which I think Senator Grassley will
speak to, but as a recognition that all Federal employees need to be
protected from an unreasonable activity, which, at least in this chairmans
opinion, is part of what went on at the FDA in targeting these five
whistleblowers. Again, I will put the rest of my opening statement in the record. And I yield to the ranking
spied on or targeted for disciplinary action.

member. Mr. CUMMINGS. Thank you very much, Mr. Chairman. Today we examine two distinct, but related, issues.
First, we will review allegations that the FDA employees leaked trade secret and other confidential business
information from companies seeking FDA approval of medical device applications. We will also review allegations by
these employees that they were whistleblowers concerned about the safety of these medical devices and that the

Whistleblowers play a critical role

in rooting out waste, fraud, and abuse at Federal agencies and making our
government more effective and efficient. They sometimes risk their
careers. They sometimes risk their reputations to challenge the abuse of
power. Our committee must take every allegation very seriously with regard to retaliation. I have said it before
FDA retaliated against them by monitoring their computers.

and I will say it again. We must at every point protect our whistleblowers. I am committed to that, and we are all
committed to that.

Whistleblower protection in the G20 has the unique ability to

set international norms for anti-corruption policy
Wolfe et al 14 Simon, Head of Research, Blueprint for Free Speech Visiting Scholar, University of
Melbourne Law School Whistleblower protection rules in g20 countries the next action plan,
http://app.griffith.edu.au/news/wp-content/uploads/2014/06/Whistleblower-Protection-Rules-in-G20-CountriesAction-Plan-June-2014.pdf.CC

As critical players in the global economy, G20 countries are in an ideal

position to promote transparency and anti-corruption initiatives in
government and corporations alike. These initiatives are of particular import in the wake of the
global financial crisis, and as political instability and citizen unrest persist in many regions and countries both
within and outside the G20. History has shown that economic growth and
development cannot be sustained if they are built on corrupt practices.
Given their significant role in shaping financial systems and practices worldwide, G20 countries have a special
responsibility to build sustainability into these processes. The G20 itself acknowledges that corruption increases
costs for businesses and causes the loss of billions of dollars in economic activity. The G20 also recognises that all
of its members can take practical steps to reduce the costs of corruption for growth and development. As an
illustration of this, all but two G20 countries have signed and ratified the UN Convention against Corruption, and all
but four have implemented the OECD AntiBribery Convention. In terms of whistleblower protection, G20 countries
have taken various steps that are at different stages of development. As will be seen below, considerable progress

the experience of G20 countries

that action to implement this commitment is not easy. The whistleblower
frameworks of most G20 countries still fall measurably short of recognised
international standards. Some countries lag significantly behind prevailing best practices, thus
can be noted and acknowledged. However, the analysis confirms

offering neither protections nor disclosure opportunities for whistleblowers. Many G20 countries did not fulfil their
own pledge to establish whistleblower protections by the end of 2012. The fact that the task remains only partially
complete in 2014, dictates the need for a better analysis of where the key problem areas lie. Although formal legal
practice on whistleblower protection dates back 25 years in some countries, it is only recently that effective laws
and procedures have begun to be studied comparatively, in sufficient detail to enable this kind of analysis. While

one explanation for patchy progress is a lack of political will, G20 and
other countries have lacked detailed insight into the critical problem areas
on which action might be focused. To guide G20 countries in fulfilling their commitments under
the G20 Anti-Corruption Action Plan, the OECD in 2011 released an in-depth report that catalogues and details
many whistleblower laws and practices currently in place within G20 counties. The analysis presented here builds
on this report. The OECD report also includes a compendium of best practices and guiding principles necessary for
whistleblower laws to be effective. These standards take into account the diversity of legal systems in G20
countries. This offers sufficient flexibility to enable countries to effectively apply such principles in accordance with
their own legal systems.

US is key to the G20 shaping international anti-corruption

norms
Bloom 10 (Lauren Bloom, graduated from Georgetown University Law, General
Counsel and Vice President for Governmental Affairs at Navy Mutual Aid Association,
General Counsel & Director of Professionalism at American Academy of Actuaries,
Why We Need New Whistleblower Rules, 11/11/10, 7/13/15, MEM)
Still, is there a real need for the new whistleblower rules ? Apparently, yes. Transparency

International, an international corruption watchdog group, recently released its 2010 Corruptions Perceptions Index.
Embarrassingly, the United States lost its place among the 20 least corrupt nations on the list, falling to number 22
based on perceptions that, in the US, financial regulatory oversight is less effective and political campaign funding
is less transparent than they ought to be. Transparency International's President, Nancy Boswell, has been quoted
as saying that "the American public is concerned that there is an integrity deficit here, that ethics isn't as foremost
as it should be." Perhaps the new whistleblower rules will help remedy that concern. And why is all of this of interest

leaders of the top 20

world economies are working to take on corruption . At its June meeting in Toronto, the
G20 issued a blunt declaration that corruption "threatens the integrity of
markets, undermines fair competition, distorts resource allocation,
destroys public trust and undermines the rule of law." Put another way,
corruption creates an unstable and untrustworthy environment that
heightens investment risk. Ordinarily, one would expect the United States to
take a leading role in defining the G20's anti- corruption efforts. If the
United States is widely perceived as being less concerned about
corruption than it should be, however, its credibility in the G20 summits
and similar settings can only be diminished. The G20 countries have clearly expressed their
concerns about corruption. That means they'll move forward to combat it with or without the United States. Far
better for the US to help shape international anti-corruption initiatives
than for US companies to be stuck with whatever the other G-20 nations
ultimately develop.
to investors? Just ask the participants in this week's G20 Summit in Seoul, where

In a corrupt state, government and corporate interest become

intertwined and create economic nationalism which
perpetuates more corruption---empirics prove
Yorgos et al 8 (Rizopoulos, Corruption and economic nationalism evidence
from the Russian oil sector, professor at the universite paris Diderot,
http://idec.gr/iier/new/CORRUPTION%20CONFERENCE/Rizopoulos%20Sergakis%20%20Corruption%20and%20Ecoonomic%20Nationalism.pdf.CC)
Two strategies describe the patterns of corruption in the evolution of
Business State Interaction in Russia: the corruption networks during the State Capture period (early, mid and late 1990s)
and the emergency of the rent seeking from the super bureaucratic elite during the Business Capture period (1999 to present).

During the State Capture period (Hellman 1998), corruption in Russia has
entered the phase whereby individually isolated criminal transactions
have formed a well organized and coordinated corruption networks. State
weakness has long been a feature key of the creation of this kind of networks. The breakdown of the administrative system (early

created a range of opportunities to take over business, using formerly

state-owned property, and making money on the structural distortions that
that have been typical for the planned economy. The distortions gave rise to a transformational rent. Meanwhile, weakened
and half-destroyed public institutions in Russia were unable to build an
effective resistance to the attempts of various informal interest groups to
1990s)

The
patron-client relationship from certain networks of individual ties between
officials and particular corporate interests in commercial and financial
spheres. Sometimes these connections involved the bribing of a particular bureaucrat in the interests of a specific
capture and privatize this rent. These groups organized and set up for a joint extraction of profit from corrupted activities.

organization. But in most of the cases, officials must join a network of shared services where no bribes are received or passed on. In
such situations, the obligation to join a corruption network is accompanied with mercenary temptations: as a rule, compensation is a
stake in the network profits. These are illegal payments which are in proportion to the officials government position and function in

The corruption networks formed are both vertical

and horizontal. The vertical relationships are informal, illegal
interdependences between bureaucrats within the organization. The
horizontal ones are between different agencies and other structures . These
the corrupt transactions (Rimsky, 2004).

relationships are used for organized implementation of corrupt transactions that are aimed at: personal enrichment; allocation of
budget funds in favor of the networks; enhancement of the networks illegal profits; or, receipt of competitive advantages by
financial and commercial structures within the corrupt network to generate future earnings. Obtaining financial resources is
practically always the leading goal of each corruption network. These interrelations are specifically directed to the fulfillment of

state funds in favor of its structure and profitability,

or receiving of competitive financial advantages for members of the
networks. It is important to stress that the accumulation of financial resources and the involvement of federal officials in
corrupt transactions, distribution of

allocating them from the federal source in favor of corruption networks in the main goal of each network. This financial structure
transfers money to confidential accounts and then redistributes the funds among the network members (Mendras, 1998). Generally,
the holders of these accounts use free economic zones throughout Russia, such as Ingushetia, Kakmyk and Far East regions. It often
occurs that the same financial structure simultaneously finances several corruption networks. For instance, one bank department
conducts business with a specific ministry, other departments of the same bank, with another ministry. Initially in Russia, the only
means to generate capital was from the rights to oversee banking transactions and state ownership of industry. Therefore,

corruption networks in Russia developed from the basis of existing state

structures, which, before privatization, were in control of the state . Corruption
networks were created for financing the operations by the structures engaged in the export of raw materials. These networks simply
tried to undermine the state structures that were bringing in the fast earnings. Thus corruption networks receive financing from the
export of oil and gas, energy, transportation and defense subsidies. Each Russian corruption network includes three basic
subsystems: the commercial or financial branch; government officials; and, law enforcement. The commercial converts the received
privileges into cash. The government officials provide cover at the decision making level. This group includes officials whose status
guarantees the desired outcomes. Because most of these decisions are coordinated between several ministries, there are also
interdepartmental groups. However, the relationships and decisions are usually shaded by the state interests, which makes them
very difficult to detect. The protection of corruption networks is provided by law enforcement, which provides information, destroys
compromising files, or even closes criminal cases. A large company was created in a form of multiple structures, including an offshore corporation. It is owned by former Russian citizens, leaders of two criminal groups and two influential businessmen .

good example of such a corporation can be seen in Gazprom , the Russian United
Power Systems and Lukoil. The company literally controls one of the Russian
Federation regions, i.e., completely determines the results of the
elections, legislative processes, supervises law enforcement bodies, and
large and small businesses in the region. It owns large business in some other region and through its
governor supports the opposition to the government. Through the Moscow based banks, a company provides direct communication

with enormous
networks, operate in sphere of business, financial institutions, and federal
and regional government structures. After the election of Putin In practice there are two ways to form a
with the President of the Russian Federation administration. As a result, all company structures,

corruption network. One is from below and the other is from above. To form a corruption network from below, a successful,
expanding business company needs a relationship and contacts with higher-level officials. Such connections and contacts are made
through expensive gift giving and bribes. Therefore, officials lobby the interests of a few companies, banks, and businesses. If the
official does not have enough authority, he starts seeking connections with higher level bureaucrats. Thus, local or regional
corruption networks gradually grow into networks at the national level. These national networks, as a rule, are very large and the
same official can simultaneously be a member of different networks. To form a corruption network from above, high-ranking officials
select loyal subordinates who construct the network. The purpose of such actions is to maintain strict personal relations focused on
certain operations for the sake of the organization. Economic losses from the corruption, during the State Capture period, can be
examined from two perspectives. There is money which remains in the country and is invested, ultimately being spent on goods and
services. There is also a direct outflow of capital abroad, which is close to $2 billion per month. In some cases, 90% of the
international loans escape abroad, both in the form of illegal appropriations and embezzlement, and in the form of kickbacks to the
international officials responsible for the loan decisions. Therefore, the problem of corruption is directly linked to capital exports and
money laundering. Despite the negative impact, most of Russian businessmen agree that corruption creates the mechanism for
overcoming its complicated legal and administrative systems. In conditions where transaction costs are unacceptably high, the
corruption is actually a salvation. The Business Capture period (1999 to present) consolidated mainly the federal bureaucracy.
Putins election implies a redistribution of cards and new policy orientations: the emergency of the new federal super elite. The

super elite concerns a circle of politicians and top bureaucrats, which, having ascended to the highest level of authority, face the
need to take into account not only the interests of the groups they arose from, but also strategic interests of the nation (Zudin,

At this time, the relations between big business and the federal
government were fundamentally changed. In contrast to the situation in
the 1990s, the link between economic nationalism and corruption is the
use by individual bureaucrats to directly capture business. The collective
interests of a bureaucratic body are personified by its head executive.
Such individuals can extract a much larger volume of rent than their
subordinates are able to, and can do this on a regular basis. It is only to be expected that such high-ranking
2003).

officials try to expand the sphere of competence and responsibility of their departments as this involves an expansion of potential
rent. The consolidation of a department in itself will widen the range of many opportunities for corruption and rent seeking behavior,
because in this case business clients will be forced to interact with a monopolistic department instead of individual bureaucrats. As a
consequence, the prices for services charged by this monopoly can be higher. At the same time, a consolidated department will
also be more capable of guaranteeing the fulfillment of its obligations, because the officers responsible tend to have a higher rank,
and the decisions of high-ranking officials are more difficult to revise. In the business community, the situation is quite different. It is
very hard for a single businessman to achieve individual privileges, especially since such privileges can be contested by other
actors. In this contexte, collective actions seem not only less costly, but could also render more reliable results. Oligarchic
enterprises, on the other hand, emerged mostly out of informal arrangements with the authorities. Each of the oligarchs maintained
their own contacts with representatives of the state. Their business was a kind capitalization of these contacts

Economic nationalism creates a backlash against globalization

and the interconnected nature of states
Roubini 14 Nouriel, Economic insecurity and the rise of nationalism, He served as a senior adviser to the White House
council of economic advisers and the US Treasury and is a professor of economics at New York University's Stern School of Business,
http://www.theguardian.com/business/economics-blog/2014/jun/02/economic-insecurity-nationalism-on-the-rise-globalisation-nourielroubini.CC
In the immediate aftermath of the 2008 global financial crisis, policymakers' success in preventing the Great Recession from turning

now the backlash

against globalisation and the freer movement of goods, services, capital,
labour, and technology that came with it has arrived. This new nationalism takes
different economic forms: trade barriers, asset protection, reaction
against foreign direct investment, policies favouring domestic workers
and firms, anti-immigration measures, state capitalism, and resource
nationalism. In the political realm, populist, anti-globalisation, anti-immigration, and in some cases outright racist and
into Great Depression II held in check demands for protectionist and inward-looking measures. But

antisemitic parties are on the rise. These forces loath the alphabet soup of supranational governance institutions the EU, the UN,
the WTO, and the IMF, among others that globalisation requires. Even the internet, the epitome of globalisation for the past two
decades, is at risk of being balkanised as more authoritarian countries including China, Iran, Turkey, and Russia seek to restrict
access to social media and crack down on free expression. The main causes of these trends are clear. Anaemic economic recovery
has provided an opening for populist parties, promoting protectionist policies, to blame foreign trade and foreign workers for the
prolonged malaise. Add to this the rise in income and wealth inequality in most countries, and it is no wonder that the perception of

Nowadays,
both advanced economies (like the United States, where unlimited
financing of elected officials by financially powerful business interests is
simply legalised corruption) and emerging markets (where oligarchs often
dominate the economy and the political system) seem to be run for the
few. Advertisement For the many, by contrast, there has been only secular stagnation, with depressed employment and
stagnating wages. The resulting economic insecurity for the working and middle
classes is most acute in Europe and the eurozone, where in many
countries populist parties mainly on the far-right outperformed
mainstream forces in last weekend's European parliament election. As in the 1930s, when the Great Depression gave
rise to authoritarian governments in Italy, Germany and Spain and a similar trend now may be underway. If income and
job growth do not pick up soon, populist parties may come closer to power
at the national level in Europe, with anti-EU sentiments stalling the process of European
a winner-take-all economy that benefits only elites and distorts the political system has become widespread.

economic and political integration. Worse, the eurozone may again be at risk: some countries (the UK) may exit the EU; others (the
UK, Spain, and Belgium) eventually may break up. Even in the US, the economic insecurity of a vast white underclass that feels
threatened by immigration and global trade can be seen in the rising influence of the extreme right and Tea Party factions of the
Republican party. These groups are characterised by economic nativism, anti-immigration and protectionist leanings, religious
fanaticism, and geopolitical isolationism. A variant of this dynamic can be seen in Russia and many parts of eastern Europe and
central Asia, where the fall of the Berlin Wall did not usher in democracy, economic liberalisation, and rapid output growth. Instead,
nationalist and authoritarian regimes have been in power for most of the past quarter-century, pursuing state-capitalist growth
models that ensure only mediocre economic performance. In this context, President Vladimir Putin's destabilisation of Ukraine
cannot be separated from his dream of leading a "Eurasian Union" a thinly disguised effort to recreate the former Soviet Union. In
Asia, too, nationalism is resurgent. New leaders in China, Japan, South Korea, and now India are political nationalists in regions
where territorial disputes remain serious and long-held historical grievances fester. These leaders as well as those in Thailand,
Malaysia, and Indonesia, who are moving in a similar nationalist direction must address major structural-reform challenges if they
are to revive falling economic growth and, in the case of emerging markets, avoid a middle-income trap. Economic failure could fuel
further nationalist, xenophobic tendencies and even trigger military conflict. The Middle East remains a region mired in
backwardness. The Arab spring triggered by slow growth, high youth unemployment, and widespread economic desperation has
given way to a long winter in Egypt and Libya, where the alternatives are a return to authoritarian strongmen and political chaos. In
Syria and Yemen, there is civil war; Lebanon and Iraq could face a similar fate; Iran is both unstable and dangerous to others; and
Afghanistan and Pakistan look increasingly like failed states. In all of these cases, economic failure and a lack of opportunities and
hope for the poor and young are fuelling political and religious extremism, resentment of the west and, in some cases, outright
terrorism. In the 1930s, the failure to prevent the Great Depression empowered authoritarian regimes in Europe and Asia, eventually

This time, the damage caused by the Great Recession is

subjecting most advanced economies to secular stagnation and creating
major structural growth challenges for emerging markets. This is ideal
terrain for economic and political nationalism to take root and flourish.
Today's backlash against trade and globalisation should be viewed in the
context of what, as we know from experience, could come next .
leading to the second world war.

Causes war
Von Mises 10 Ludwig, Economic nationalism is a philosophy of war, Ludwig von
Mises was the acknowledged leader of the Austrian School of economic thought, a
prodigious originator in economic theory, and a prolific author,
https://mises.org/library/economic-nationalism-philosophy-war

Popular opinion sees the source of the conflicts which bring about the civil
wars and international wars of our age in the collision of "economic"
interests inherent in the market economy. Civil war is the rebellion of the "exploited" masses against the
"exploiting" classes. Foreign war is the revolt of the "have-not" nations against those nations who have appropriated to themselves an unfair share of the
earth's natural resources and, with insatiable greed, want to snatch even more of this wealth destined for the use of all. He who in face of these facts
speaks of the harmony of the rightly understood interests is either a moron or an infamous apologist of a manifestly unjust social order. No intelligent and

It is
certainly true that our age is full of conflicts which generate war. However,
these conflicts do not spring from the operation of the unhampered
market society. It may be permissible to call them economic conflicts because they concern that sphere of human life which is, in common
honest man could fail to realize that there prevail today irreconcilable conflicts of material interests which can be settled only by recourse to arms.

speech, known as the sphere of economic activities. But it is a serious blunder to infer from this appellation that the source of these conflicts are

It is not capitalism that produces them, but

precisely the anticapitalistic policies designed to check the functioning of
capitalism. They are an outgrowth of the various governments'
interference with business, of trade and migration barriers and
discrimination against foreign labor, foreign products, and foreign capital.
None of these conflicts could have emerged in an unhampered market
economy. Imagine a world in which everybody were free to live and work as entrepreneur or as employee where he wanted and how he chose,
conditions which develop within the frame of a market society.

and ask which of these conflicts could still exist. Imagine a world in which the principle of private ownership of the means of production is fully realized, in
which there are no institutions hindering the mobility of capital, labor, and commodities, in which the laws, the courts, and the administrative officers do
not discriminate against any individual or group of individuals, whether native or alien. Imagine a state of affairs in which governments are devoted
exclusively to the task of protecting the individual's life, health, and property against violent and fraudulent aggression. In such a world the frontiers are
drawn on the maps, but they do not hinder anybody from the pursuit of what he thinks will make him more prosperous. No individual is interested in the
expansion of the size of his nation's territory, as he cannot derive any gain from such an aggrandizement. Conquest does not pay and war becomes
obsolete. In the ages preceding the rise of liberalism and the evolution of modern capitalism, people for the most part consumed only what could be

produced out of raw materials available in their own neighborhood. The development of the international division of labor has radically altered this state of
affairs. Food and raw materials imported from distant countries are articles of mass consumption. The most advanced European nations could do without
these imports only at the price of a very considerable lowering of their standard of living. They must pay for the badly needed purchase of minerals,
lumber, oil, cereals, fat, coffee, tea, cocoa, fruit, wool, and cotton by exporting manufactures, most of them processed out of imported raw materials. Their
vital interests are hurt by the protectionist trade policies of the countries producing these primary products. Imagine a world in which the principle of
private ownership of the means of production is fully realized. In such a world, conquest does not pay and war becomes obsolete. Two hundred years ago
it was of little concern to the Swedes or the Swiss whether or not a non-European country was efficient in utilizing its natural resources. But today
economic backwardness in a foreign country, endowed by rich natural resources, hurts the interests of all those whose standard of living could be raised if

The principle of each nation's

unrestricted sovereignty is in a world of government interference with
business a challenge to all other nations. The conflict between the havenots and the haves is a real conflict. But it is present only in a world in
which any sovereign government is free to hurt the interests of all peoples
its own included by depriving the consumers of the advantages a
better exploitation of this country's resources would give them . It is not sovereignty as
a more appropriate mode of utilizing this natural wealth were adopted.

such that makes for war but sovereignty of governments not entirely committed to the principles of the market economy. Liberalism did not and does not
build its hopes upon abolition of the sovereignty of the various national governments, a venture which would result in endless wars. It aims at a general
recognition of the idea of economic freedom. If all peoples become liberal and conceive that economic freedom best serves their own interests, national
sovereignty will no longer engender conflict and war. What is needed to make peace durable is neither international treaties and covenants nor
international tribunals and organizations like the defunct League of Nations or its successor, the United Nations. If the principle of the market economy is
universally accepted, such makeshifts are unnecessary; if it is not accepted, they are futile. Durable peace can only be the outgrowth of a change in
ideologies. As long as the peoples cling to the Montaigne dogma and think that they cannot prosper economically except at the expense of other nations,

Yet
economic nationalism is unavoidable where there is government
interference with business. Protectionism is indispensable where there is
no domestic free trade. Where there is government interference with
business, free trade even in the short run would frustrate the aims sought
by the various interventionist measures. It is an illusion to believe that a
nation would lastingly tolerate other nations' policies which harm the vital
interest of its own citizens. Let us assume that the United Nations had been established in the year 1600 and that the Indian
peace will never be anything other than a period of preparation for the next war. Economic nationalism is incompatible with durable peace.

tribes of North America had been admitted as members of this organization. Then the sovereignty of these Indians would have been recognized as
inviolable. They would have been given the right to exclude all aliens from entering their territory and from exploiting its rich natural resources which they
themselves did not know how to utilize. Does anybody really believe that any international covenant or charter could have prevented the Europeans from
invading these countries? Many of the richest deposits of various mineral substances are located in areas whose inhabitants are too ignorant, too inert, or
too dull to take advantage of the riches nature has bestowed upon them. If the governments of these countries prevent aliens from exploiting these
deposits, or if their conduct of public affairs is so arbitrary that no foreign investments are safe, serious harm is inflicted upon all those foreign peoples
whose material well-being could be improved by a more adequate utilization of the deposits concerned. It does not matter whether the policies of these
governments are the outcome of a general cultural backwardness or of the adoption of the now fashionable ideas of interventionism and economic
nationalism. The result is the same in both cases. There is no use in conjuring away these conflicts by wishful thinking. What is needed to make peace

What generates war is the economic philosophy almost

universally espoused today by governments and political parties. As this
philosophy sees it, there prevail within the unhampered market economy
irreconcilable conflicts between the interests of various nations . Free trade harms a
durable is a change in ideologies.

nation; it brings about impoverishment. It is the duty of government to prevent the evils of free trade by trade barriers. We may, for the sake of argument,
disregard the fact that protectionism also hurts the interests of the nations which resort to it. But there can be no doubt that protectionism aims at
damaging the interests of foreign peoples and really does damage them. It is an illusion to assume that those injured will tolerate other nations'

. The philosophy of
protectionism is a philosophy of war. The wars of our age are not at
variance with popular economic doctrines; they are, on the contrary, the
inescapable result of a consistent application of these doctrines . The League of
protectionism if they believe that they are strong enough to brush it away by the use of arms

Nations did not fail because its organization was deficient. It failed because it lacked the spirit of genuine liberalism. It was a convention of governments
imbued with the spirit of economic nationalism and entirely committed to the principles of economic warfare. While the delegates indulged in mere
academic talk about good will among the nations, the governments whom they represented inflicted a good deal of evil upon all other nations. The two
decades of the League's functioning were marked by each nation's adamant economic warfare against all other nations. The tariff protectionism of the
years before 1914 was mild indeed when compared with what developed in the 1920s and '30s viz., embargoes, quantitative trade control, foreignexchange control, monetary devaluation, and so on. The prospects for the United Nations are not better, but rather worse. Every nation looks upon
imports, especially upon imports of manufactured goods, as upon a disaster. It is the avowed goal of almost all countries to bar foreign manufactures as
much as possible from access to their domestic markets. Almost all nations are fighting against the specter of an unfavorable balance of trade. They do
not want to cooperate; they want to protect themselves against the alleged dangers of cooperation.

1AC---Plan
Plan: The Food and Drug Administration should substantially
curtail surveillance of employees suspected of being
whistleblowers.

1AC---Solvency
Electronic surveillance precludes whistleblowing
Johnson 12 [January 31, 2012 Reporter for Federal Times
http://archive.federaltimes.com/article/20120131/IT03/201310302/FDA-whistle-blowers-lawsuit-raises-questionsabout-email-surveillance FDA whistle-blowers' lawsuit raises questions about email surveillance] (Vaibhav)

top FDA managers

monitored and seized emails from their personal Gmail and Yahoo
accounts for at least two years. Documents they obtained through the Freedom of Information Act
and other means show that FDA began monitoring electronic conversations in 2009 ,
The six filed a lawsuit Jan. 25 in U.S. District Court of Washington, claim that

after the employees expressed concerns to the incoming Obama administration and Congress that FDA had
approved unsafe medical devices, Stephen Kohn, executive director of the National Whistleblowers Center and
attorney for the six employees, said in an interview with Federal Times. Until now, Kohn said he hadn't heard of

FDA's electronic equipment policy allows

employees to use government devices and systems for personal use but
warns that information created, stored or transmitted on a government
device is public information, unless exempted by law . The policy also instructs
office managers to monitor and review "all activities" using government
electronic equipment and disclose the content of inappropriate
documents. "If they are doing just basic monitoring to make sure people
aren't violating the law," that's one thing, Kohn said. "The biggest problem with what
has occurred here is that they targeted whistleblowers." Targeted
monitoring, he said, could have a chilling effect on potential whistleblowers
who fear their complaints will not be kept confidential.
agencies carrying out this type of surveillance.

Pharma Advantage

2AC---Ext. Corruption k2 Pharma

FDA corruption enables big Pharma to reap in huge profits
Collins 15 Sam P.K. Collins (Citing NYU researchers) is a health reporter for ThinkProgress, Study
Finds Disturbing Examples Of The FDA Failing To Disclose Scientific Fraud, 2/11/15,
http://thinkprogress.org/health/2015/02/11/3621855/fda-transparency-study//OF

The communication issue that Steinbrook mentions may stem from

publication bias defined as the tendency of researchers, editors, and
pharmaceutical companies to tout the positive outcomes of research while
sweeping the negative findings under the rug. That could create an outcome
that advances their agenda , whether its securing a medications place on the market or telling a
This issue is not new to the FDA , an agency that
has long enjoyed a profitable relationship with pharmaceutical companies .
The passage of the Prescription User Drug Fee Act in 1992 sped up the
drug approval process using fees collected from Big Pharma companies . The
increased workload caused deficiencies within the federal agencys drug
approval process, including the manner in which researchers conduct
clinical trials. A 2005 report found that nearly 20 percent of authors in clinical drug
trials said they personally knew of lies made in research going back at
least 10 years. In 2007, the agency attempted to curb publication bias with the passage of the Food and
specific narrative about a health issue.

Drug Administration Acts, which would require researchers to register clinical trials of FDA-regulated products at

mandate, however, did little to compel researchers to fully

disclose the findings of their studies, positive or negative . A 2009 investigation
ClinicalTrials.gov. The

published in Nature, an international weekly science journal, found that fewer than half of studies published in peerreviewed journals followed these guidelines. Of the clinical trials that complied with the regulations, the findings of
more than 50 percent of them didnt make it into academic journals, mainly because investigators didnt think that
the negative results would interest readers.

Handling investigations into potentially

faulty research in-house often allows the FDA to keep the drugs in
question on pharmacy shelves , even with no additional evidence of their
safety or efficacy. Such was the case in early 2010 when the federal agency zeroed in a Houston-based
pharmaceutical research firm that tested more than 100 drugs, including chemotherapy compounds and
prescription painkillers. While FDA officials determined more than 1,400 drug trials conducted within a span of five
years to be tainted, industry officials remained reluctant to issue recalls and retest the medication out of fear of
alarm[ing] the public and the providers for a large portion of drugs. If there are problems with the scientific
studies, as there have been in this case, then

the FDAs review of those problems needs

to be transparent , David Kessler, who sat at the helm of the FDA from 1990 to 1997, told ProPublica in
2013. Putting its reviews in public view would let the medical community understand the basis for the agencys
actions. The FDA may be right here, but if it wants public confidence, they should be transparent. Otherwise its just

Whenever the FDA actively investigates allegations of

researchers wrongdoing, investigators generate a host of documents
including 483 Forms, Establishment Inspection Reports, and Warning Letters that often leave
observers asking more questions. The edits of key portions of the documents can make it
a black box.

difficult for those who read them to decipher the name and sponsor of the study, the drug involved in the clinical
trial, and the effect of the misconduct on the reliability of the results. Earlier this week, Charles Seife, lead author of
the new JAMA study, described his attempt to gather data from 600 FDA clinical trial investigation documents in an
article published on Slate. He said that his team of university students ultimately found the information they sought
in less than 100 reports. In the piece, Seife calls on the FDA to stop protecting drug companies and excusing the
actions of those who manufacture scientific findings, saying that the agency has lost the public trust by putting

patients at risk. The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the
market are proven safe and effective by reputable scientific trials, Seife writes. Yet, over and over again,

the

agency has proven itself willing to keep scientists, doctors, and the public
in the dark about incidents when those scientific trials turn out to be less
than reputable . It does so not only by passive silence, but by active deception. Its a sign that
the FDA is deeply captured, drawn firmly into the orbit of the
pharmaceutical industry that its supposed to regulate.

FDA corruption is used to profit big pharmaceutical companies

Fauber and Fiore 15 John Fauber is a reporter with the Journal Sentinel, and Kristina Fiore
is a reporter with MedPage Today, Opana gets FDA approval despite history of abuse, limited
effectiveness in trials, 4/9/2015, http://www.jsonline.com/watchdog/watchdogreports/opana-gets-fdaapproval-despite-history-of-abuse-limited-effectiveness-in-trials-b99494132z1-303198321.html//OF

in the midst of a growing national opioid epidemic, the U.S. Food and
Drug Administration approved the new narcotic painkiller Opana. It was a
familiar drug. Known generically as oxymorphone, the drug is 10 times as
potent as morphine when injected. Under the name Numorphan, it had been abused in the
1960s and '70s until it was removed from the market. And now there is a familiar problem.
After initially approving Opana as both an immediate-release and extended-release product, the FDA in
December 2011 approved a formulation designed to prevent abuse by
making the drug tough to crush or dissolve. But users have been able to foil
the anti-injection mechanism and have continued to shoot up Opana. In
addition to overdose risk, the abuse of Opana by injection has been associated with
a blood-clotting disorder and permanent organ damage a problem that didn't
In 2006,

occur with the earlier version. And it has been tied to a recent outbreak of HIV in rural Indiana as well as a surge in
hepatitis C infections in Kentucky, Tennessee, West Virginia and Virginia. When the FDA approved Opana,
manufactured by Endo Pharmaceuticals, the drug joined more than a dozen other narcotic painkillers on the market.

"There certainly didn't seem to be a need for it," said James Roberts, a
professor of emergency medicine at Drexel University College of Medicine in Philadelphia. "There
are plenty of narcotics around for pain relief." As Numorphan, the drug's popularity among
addicts was due to its quick and sustained effect, according to the 1974 report "Drugs
and Addict Lifestyle" by the National Institute on Drug Abuse. The report said the drug which carried the street
name "blues" was used primarily by white males. The report focused on 309 Philadelphia-area Numorphan
addicts who were interviewed in 1970, with many saying they preferred the drug over heroin. The drug was taken
off the market in 1979. Asked about the basis for approving Opana, FDA spokesman Eric Pahon said opioids are
important medications for the treatment of pain, when used properly. "The FDA is concerned about the misuse and
abuse of prescription opioids, which is a serious public health challenge, and is working in many ways to help
prescribers and patients make the best possible choices about how to use these powerful drugs," he wrote in an
email. "We must balance this effort, however, with ensuring prescribers and patients maintain access to these
medications and a variety of treatment options are available." The extended release version of Opana alone
generated 756,000 prescriptions and sales of $385 million in 2013, according to data supplied by IMS Health, a drug
market research firm. Since 2009, its annual sales have ranged from $246 million to $640 million. In an email, Endo
spokeswoman Heather Zoumas-Lubeski said the drug "was approved by the FDA based upon its demonstration of
safety and effectiveness in clinical trials and its successful submission of an application for approval." Drug's
reappearance A Milwaukee Journal Sentinel/MedPage Today examination found

oxymorphone's

reappearance on the market followed a pattern identified in past

investigations, including cozy relationships between regulators and drug

company executives and the use of questionable clinical testing methods

allowed by the FDA. Endo Pharmaceuticals was a frequent participant at
meetings of an organization funded by pain drug companies that brought together
pharmaceutical executives and federal regulators during the 2000s, records show. The group, known as IMMPACT,

investigation examined
how federal health industry officials, members of academia and executives
of companies that make pain drugs held private meetings at expensive
hotels at least once a year beginning in 2002, according to emails obtained through a
public records request. Each year, a handful of drug companies paid up to $35,000
each to send a representative to the meetings, where they could discuss
clinical trial design with FDA officials. In 2014, two U.S. senators wrote to the medical school
was the subject of a 2013 Journal Sentinel/MedPage Today investigation. That

dean at the University of Rochester demanding financial records related to the IMMPACT meetings. A researcher at
the school was a co-founder of the group. Sens. Joe Manchin (D-W.Va.) and David Vitter (R-La.) wrote that they were
"deeply troubled by allegations that the FDA gave manufacturers of prescription drugs the opportunity to pay
thousands of dollars to the University of Rochester Medical Center for the privilege to attend private meetings with
FDA officials." Pahon, the FDA spokesman, said it is misleading to describe the sessions as private meetings
between FDA officials and members of industry. Though the meetings were invitation only, he said, they were
attended by a variety of government officials, academics and pain advocates. "These were large scientific meetings
at which the outside experts almost always outnumbered the attending companies," he said. "We are not aware of
any separate, private meetings between FDA and pharmaceutical companies during or as a result of IMMPACT
meetings." He said the meetings had no bearing on the approval of Opana and did not include the discussion of any

Those
meetings did help lead to a new approach to winning approval of drugs
known as "enriched enrollment." The approach, which is faster and less
expensive for drug-makers, allows companies to weed out people who don't respond well to a drug or
who can't tolerate taking it before an actual clinical trial for the drug begins. Independent doctors say that
approach makes it much more likely a drug will be found effective and win FDA
approval. More importantly, experts say, drugs tested that way are not likely to
reflect what will happen when a medication gets on the market and is
prescribed for large numbers of people. When Endo first tried to get
Opana approved in 2003, the FDA said the drug didn't appear effective enough
in clinical trials. It also raised safety concerns after several postoperative pain patients overdosed on the
drug. So Endo conducted new clinical trials using enriched enrollment. In those
particular product or the standards for FDA approval of pain products. 'Enriched enrollment'

trials, only the patients who initially responded to the drug were entered into the trial, where they were given either
Opana or a placebo. The idea was that the drug's effects can be clearly demonstrated in comparison to a placebo,
because it is already known to work for these patients. Pahon of the FDA said companies use a variety of strategies
to select those in the general population in which the effect of a drug can be more shown. He would not say
whether the FDA encouraged Endo to use the enriched enrollment approach for Opana. When the drug was
approved in 2006, the FDA's own medical review acknowledged that, given the enriched study design, " one

could argue that the results may not be generalizable to the wider chronic
pain population." Opana is not the only opioid approved using enriched
enrollment. In 2013, drug-maker Zogenix used the strategy to win
approval for Zohydro, a high-dose, hydrocodone-only drug that was
originally approved without any abuse-deterrent mechanisms. The FDA
approved that drug despite its own advisory committee voting 11-2
against it . "The FDA should be in the business of requiring high-quality
evidence and not shortcut evidence," said Lewis Nelson, a medical toxicologist at NYU Langone

Medical Center. "Unfortunately,

they're under pressure to make pharmaceuticals

available to the general public ."

Corruption fuels big pharma

Loudon and Graham 12 Interview between Dr. David Graham (senior drug safety
researcher at the FDA), and Manette Loudon, the lead investigator for Dr. Gary Null, The FDA Exposed:
An Interview With Dr. David Graham, the Vioxx Whistleblower, October 2012,
http://www.lef.org/Magazine/2012/10/The-FDA-Exposed-An-Interview-With-Dr-David-Graham/Page01//OF
MANETTE: In that same PBS program, you were also quoted saying, " The

organizational structure
within the CDER is currently geared towards the review and approval of
new drugs. When a serious safety issue arises at post marketing, the
immediate reaction is almost always one of denial, rejection and heat.
They approved the drugs, so there can't possibly be anything wrong with
it. This is an inherent conflict of interest." Based on what you're saying it appears that the
FDA is responsible for protecting the interests of pharmaceutical companies and not the American people. Do you

the FDA
is not able to adequately protect the American public. It's more interested
believe the FDA can protect the public from dangerous drugs? DR. GRAHAM: As currently configured,

in protecting the interests of industry. It views industry as its client, and

the client is someone whose interest you represent. Unfortunately, that is the way the
FDA is currently structured. Within the Center for Drug Evaluation and Research about 80 percent of the
resources are geared towards the approval of new drugs and 20 percent
is for everything else. Drug safety is about five percent. The "gorilla in the living room" is new drugs
and approval. Congress has not only created that structure, they have also
worsened that structure through the PDUFA, the Prescription Drug User
Fee Act, by which drug companies pay money to the FDA so they will
review and approve its drug. So you have that conflict as well. MANETTE: When
did that go into effect? DR. GRAHAM: The Prescription Drug User Fee Act came into play in 1992. It was passed by
Congress as a way of providing the FDA with more funds so that it could hire more physicians and other scientists to
review drug applications so that drugs would be approved more quickly. For industry, every day a drug is held up
from being marketed, represents a loss of one to two million dollars of profit.

The incentive is to

review and approve the drugs as quickly as possible, and not stand in the
way of profit-making.

The FDA cooperates with that mandate. MANETTE: And what about those new

drugs? Are they any better than what already exists on the market? DR. GRAHAM: It's a myth that is promulgated
not only by industry but also by the FDA itself. It's a misperception that our lawmakers in Congress have as well and

Industry is saying there are all these lifesaving

drugs that the FDA is slow to approve and people are dying in the streets
because of it. The fact is that probably about two-thirds to three-quarters
of the drugs that the FDA reviews are already on the market and are being
reviewed for another indication. So, for example, if I've got a drug that can treat bronchitis and
they've been fed this line by industry.

now it's going to be used to treat a urinary tract infection well, that's a new indication. But it's the same drug and

There is nothing lifesaving there. There is

nothing new. There is nothing innovative. A very small proportion of drugs
represent a new drug that hasn't been marketed before. Most of those drugs are no
we already know about the safety of the drug.

breakthrough drugs - the ones that

really make a difference in patients' lives and represent a revolution in
pharmacology - we're talking about maybe one or two drugs a year . Most of
better than the ones that exist. If you want to talk about

them aren't breakthroughs and most of them aren't lifesaving, but they get treated as if they were.

**TPP Scenario**

2AC---Ext. Pharma TPP Kills Generics

Big pharmas version of the TPP decimates the generic drug
industry---stricter protections for biologics
Overly 15 (Jeff, Law360, 7/17/15, Big Pharma's TPP Protections For Biologics
Face New Attacks, http://www.law360.com/articles/680522/big-pharma-s-tppprotections-for-biologics-face-new-attacks, Accessed 7/22/15)//LD
generic-drug industry advocates
and public health experts on Friday denounced proposals in the Trans-Pacific Partnership
to strengthen exclusivity protections for brand-name biologics, warning
that the provisions would seriously harm access to affordable copycat
medicines. The objections were voiced in a media briefing with Democratic Reps. Jan Schakowsky of Illinois and Rosa
Law360, New York (July 17, 2015, 4:37 PM ET) -- A group of lawmakers,

DeLauro of Connecticut as well as representatives of Mylan Inc., AARP, Doctors Without Borders and the American Foundation for
AIDS Research. The briefing represented a marked contrast with advocacy from Republicans whove steadfastly supported robust

At issue are draft

provisions of the TPP that would expand monopoly power for branded
biologics, in part by extending the 12 years of U.S. market exclusivity to
the other 11 countries that are parties to the deal. Those parties instead prefer biologics
TPP protections for biologics, which have shown great potential to fulfill unmet medical needs.

exclusivity ranging from zero to eight years. If the 12-year standard goes through, it would weaken biosimilars overseas and
effectively doom Democratic efforts to dial back the 12-year standard domestically. This

is a bad deal for

people around the world who are fighting disease and [for people] here at
home as well, said Schakowsky, ranking member on the trade panel of the House Energy and Commerce Committee.
Other concerns relate to the TPPs proposed system of so-called patent linkage, which refers to generic-drug approval depending on

Critics say the draft TPP would introduce a

much stricter form of patent linkage for biologics than currently exists in
the TPP countries, making it all but impossible for biosimilars to get
around hundreds of patents that can cover biologics. In the TPP, the U.S.
government is asking for all the countries to block generic approval
without a single safeguard that we use at home, Nawel Rojkjaer, Mylans senior director of
international affairs, told reporters. Speakers on Friday also warned that the TPP will be used as a
template for future trade agreements, meaning that any agreements on
intellectual property protections could eventually spread to many more
nations. Such expansion would be particularly significant in the context of
pricey biologics that can strain the budgets of advanced economies and be
unattainable for developing nations unless steep discounts are offered . Rohit
Malpani, a policy director at Doctors Without Borders, labeled the draft
provisions life-threatening and asserted that they amount to wholesale
rejection by the U.S. government of its commitment to ensuring access to
affordable medicines in developing countries. One of the most curious aspects of the proposals
the existence of valid patents for a branded product.

is that they are emerging from a Democratic White House that has been consistently critical of the U.S. market protections afforded

Clouding matters further is the fact that TPP negotiations are

conducted in secret, forcing the public to rely on leaked documents and
barring lawmakers from providing clear updates on talks. Schakowsky on Friday only
to biologics.

offered vague descriptions of how the biologic exclusivity provisions have evolved, saying that there have been a number of
changes ... but none have sufficiently addressed the problems." The TPP patent provisions have been quietly discussed behind the
scenes for some time. For example, public disclosures by the Biotechnology Industry Organization describe tens of thousands of
dollars in quarterly payments to Akin Gump Strauss Hauer & Feld LLP for lobbying on TPP patent protections going back to at least
2011.

A key meeting among TPP trade ministers is set for July 28-31 in Maui,

Hawaii, to iron out remaining wrinkles in the deal, meaning that the years of closed-door jockeying
on biologics could be coming to a head.

2AC---AT: Generics Bad

Generics are good - alleviates unfair medicinal distribution and
doesnt harm the pharmaceutical industry
Harrelson 1 (John, TRIPS, Pharmaceutical Patents, and the HIV/AIDS Crisis:
Finding the Proper Balance between Intellectual Property Rights and Compassion,
http://heinonline.org/HOL/LandingPage?
handle=hein.journals/wlsj7&div=12&id=&page=)
One reason cited for the high cost of HTV treatment is that the cost of bringing a drug from idea, through
development, testing and approval to market is about $500 million.'" Shannon S.S. Herzteld, senior vice president of
international affairs at Pharmaceutical Research and Manufacturers of America (PhRMA) states " '[f]or every 15,000
compounds that you look at, three become medicines. Of those three, one makes a profit. . .The International
Federation of Pharmaceutical Manufacturers Association (IFPMA), representing research-based pharmaceutical
companies in over fifty countries, argues that compulsory licensing only benefits the company receiving the
license.1" IFPMA further argues that granting an adequate period of exclusive rights is the only way to promote

A second
argument against compulsory licensing, is that it leads to drugs of lower quality.'5
This argument, however, is not persuasive because drug quality does not directly
correlate with compulsory licensing.15* Industry standards in the country granting the
compulsory license would be responsible for the manufacturing quality.159 Despite the
opposition of the pharmaceutical industry to compulsory licensing, many developing countries have
traditionally avoided the high costs of drugs by developing generic equivalents .'60
Compulsory licensing can decrease the cost of pharmaceutical drugs by seventy-five
percent or more.'61 For example, in India, one can obtain a two dollar generic form of
Pfizer's patented fluconazole, an AIDS related meningitis drug, that originally cost seventeen
dollars.162 An argument in favor of allowing compulsory licensing is that compulsory licensing will
promote increased sales that will offset lower prices .'" As a result of the increased sales, if a
reasonable license fee is granted, pharmaceutical companies will not be significantly harmed
Furthermore, developing countries account for only ten percent of pharmaceutical
profits internationally, with Africa accounting for only 1.6%.163 Therefore, compulsory Licensing in
these countries will not impact the ability of pharmaceutical companies to
innovation.1SS Without innovation, patients will suffer from lack of new treatments in the future.'56

make sufficient profits

to support research and development.166 The United States has been accused

of being hypocritical in its opposition to compulsory licensing.'67 The United States has required compulsory
licensing to the military on satellite technology and night-vision glasses for public interest reasons.163 Several
United States statutes provide for compulsory licensing. For example, the United States government can issue a
compulsory license for air pollution control patents,'69 for nuclear power paten ts,,7n for public health related
patents,171 and for items needed for government use.'72

India proves generics are a huge success and key to spurring

medicinal development
Lanoszka 3 (Ana, International Political Science Review, The Global Politics of
Intellectual Property Rights and Pharmaceutical Drug Policies in Developing
Countries, http://www.jstor.org.turing.library. northwestern.edu/stable/1601639)
India has argued within the WTO that compulsory licensing is perfectly justified with
respect to pharmaceutical inventions because the public interest should prevail when it comes to
assuring the supply of life-saving medicines. Compulsory licensing can create a

strong domestic generic drug industry and is generally associated with greater
competition and lower consumer prices. It can also lead to a necessary transfer of
technology to less developed countries. Prior to the global consolidation of the pharmaceutical
industry in the past decade, compulsory licenses had been routinely used in North America
and Europe to facilitate the distribution of new (generic or not) medications. The use of
generic medicines, in turn, has resulted in important economies for the public healthcare
system, thereby contributing to its viability and the protection of public health . The World
Health Organization (WHO) has endorsed the legitimacy of measures to promote the use
of generic drugs as a means of protecting public health . In its resolution of the Revised Drug
Strategy, the WHO (1999) encourages its members "to explore and review their options under relevant international
agreements, including trade agreements, to safeguard access to essential drugs."

Current Pharmaceutical Prices prohibit developing countries

from accessing medicine.
Pecoul et al 99 (Benard, Pierre Chirac, Patrice Trouiller, Jacques Pinel, Access to
Essential Drugs in Poor Countries A Lost Battle?
A study sponsored by US pharmaceutical companies shows
that granting drug patents does not tend to increase the price of drugs on the
market.30 This study, however, does not examine the prices of new innovative drugs and
declares that, logically, the price of these new drugs should be higher . Naturally, when
Increasingly Prohibitive Prices?

the manufacturing company is assured that its product cannot be copied, it holds a stronger position to negotiate
prices with public health authorities. Moreover, the liberalization of international pharmaceutical trade entails the
development of parallel imports between countries where the same drug is sold at different prices.

Pharmaceutical companies, which are consequently less inclined to grant

significantly lower prices to less developed countries , may instead set unique worldwide prices or delay marketing their drugs in developing countries.28 In either case,
access to drugs is jeopardized. WHO's Revised Drug Strategy and the essential drugs concept
are still key strategies to help improve access to essential drugs and worldwide
health. The essential drugs concept is evidence based, is simple, promotes equity, and is rooted in firm public
health principles. WHO's assistance to countries and advocacy work to promote the essential drugs concept and
support countries in the formulation and implementation of national drug policies has resulted in change for the
better. This strategy is a proven success but it needs to be continued and strengthened, and new ways of

the following
recommendations are made with respect to the 4 main issues that have been
developed in this article. Procurement of Quality Drugs To improve the quality of
existing drugs and their procurement, it is important to develop a permanent "Observatory of Drug Quality,"
implementation have to be explored, given the changing context. In this spirit,

established by WHO in collaboration with organizations involved in the provision of essential drugs (eg, UNICEF,
World Bank, the European Union, and nongovernmental organizations), that would oversee the implementation of
adequate and effective control procedures. The practical knowledge acquired by international organizations to
ensure the quality of generic drugs must be shared with health authorities in developing countries. Invitations to
bid, required by big sponsors such as the World Bank, European Union, and the US Agency for International

procurement of drugs should

be centralized at a national level to rein- force the responsibility of governments to
make procurement, quality control, stock management, and distribution of essential
drugs a priority.
Development, must combine quality criteria and lower costs. Furthermore,

Empirics prove IPR doesnt spur investment and hurts

domestic growth of pharmaceuticals
Scherer 2k (F.M., Taking Stock: The Law and Economics of Intellectual Property Rights: The
Pharmaceutical Industry and World Intellectual Property Standards,
http://www.lexisnexis.com.turing.library.northwestern.edu/hottopics/lnacademic/?
verb=sr&csi=7362&sr=AUTHOR(Scherer)%2BAND%2BTITLE(TAKING+STOCK
%3A+THE+LAW+AND+ECONOMICS+OF+INTELLECTUAL+PROPERTY+RIGHTS
%3A+The+Pharmaceutical+Industry+and+World+Intellectual+Property+Standards)%2BAND
%2BDATE%2BIS%2B2000)

Italy
did not grant drug product patents. A thriving "knock-off" drug industry emerged ,
Evidence on the first of these possibilities is provided by the experience of Italy. During the 1950s and 1960s,

selling drugs at bargain prices in the home market and becoming the world's leading exporter of new drugs to other
nations that also denied patent protection to drug products. n10 During the 1970s ,

however, multinational
enterprises challenged the Italian law, and in 1978, the Italian Supreme Court ruled that the law
denying drug product patents was unconstitutional. It ordered that the law be amended and that
the Italian authorities begin accepting drug patent applications immediately .
Analyses of events during the decade that followed yield three principal
conclusions: (1) no significant increase in Italian drug R&D expenditures relative to
world trends; (2) no significant increase in the number of new drug entities
introduced by Italian firms; and (3) a sharp deterioration of the Italian trade balance
in drugs into the negative realm as export sales faltered and multinational firms
imported many of their products into Italy from elsewhere in Europe. In addition, numerous
Italian drug manufacturers were acquired by multinational firms seeking to strengthen their
foothold in the Italian market. It is unclear why Italy failed to make the transition from drug imitator to drug
innovator. It may be that a decade is too short a time to do so, or price controls may have impaired domestic
market incentives for the development of pioneering drugs. Also, Italy lacked the university research infrastructure
and cooperative university-industry relationships needed to nourish drug innovation. What is clear is that leadership
in the production and export of knock-off drugs to nations lacking product patent protection shifted to India. There
is little evidence on the second possibility--an increase in the targeting of drug development efforts toward lowincome nations' health problems by multinational drug companies. An early investigation of this possibility and also

the anticipation of domestic future product patent protection [*2251]

stimulated Indian manufacturers' new drug discovery efforts up to 1997 yielded
equivocal findings. n11 What some multinational drug companies have done is to donate already developed
the hypothesis that

drugs such as Zithromax (effective against trachoma blindness), Ivermectin (effective against river blindness), and
Albendazole (effective against lymphatic filariasis parasites) to especially poor nations with a high incidence of such
diseases. n12 Four pharmaceutical companies led the list of U.S. corporations, ranked by the total amount of money
devoted to philanthropic giving in 1998.

IPR kill Pharmaceutical Industry Innovation

Glasgow 1 (Lara J, Stretching the Limtis of Intellectual Property Rights: Has the
Pharmaceutical Industry Gone Too Far,
http://www.heinonline.org.turing.library.northwestern.edu /HOL/Page?
handle=hein.journals/idea41&id=239&collection=journals&index=journals/idea#24
4)
One of the primary justifications advanced by intellectual property law proponents for
asset protection is the incentive such protection provides inventors to invest in risky
or otherwise costly endeavors necessary to create innovative works that may
contribute to the public good. An examination of the findings presented in this article, however, suggests

that this justification is not being met when dealing with the pharmaceutical
industry. The risk inherent in bringing brand name drugs to market cannot be used to validate
the strong intellectual property protection that has been described in the present article. "The top
10 drug companies are reported to spend on average about 20 percent of their revenues on research and
development.*"" These companies have "so many drugs in the pipeline at any given time that they can count on
being able to bring a certain number of drugs to market regularly."'*' To illustrate just how financially sound the drug
business actually is, consider the research and development costs of the large drug companies relative to their
profits. The top ten drug companies report profits averaging 30% of their revenuesa substantial margin.1** "[l]n
1999, the pharmaceutical industry realized on average an 18.6 percent return on revenues," which exceeds that of
commercial banking (15.8%)."* These profits are over and above the considerable governmental assistance
available from the National Institutes of Health (NIH) that subsidize much of the early pre-clinical research, as well
as favorable tax treatment that enables a rate of 16.2%."' It is difficult, therefore, to characterize an industry that is

the American drug

industry fails to achieve true innovation. While the benefits enjoyed by consumers for the hundreds
of recently launched drugs cannot be underestimated, it is difficult to reconcile the observation that
many other new drugs add little to the therapeutic arsenal except expense and
consistently the most profitable industry in the United States as risky.Despite low risks,

confusion for consumers. Recall the layering of patents that are secured on several elements of a blockbuster drug
so as to preserve its monopoly power and profit potential; or the cleaning up of old drugs in order to secure a new

The surplus of "me-too" drugs

additionally exemplifies the dearth of innovation in the drug industry. For instance, there
patent on what is essentially a minimal variation on the old version.

are currently several effective drugs to treat high cholesterol, yet each one varies modestly in terms of therapeutic
benefit. To make a profitable cholesterol drug, a company need only synthesize a chemical derivative of a

With some
extensive marketing, the new drug can then return revenues to the maker with
minimal research and development costs. Thus, instead of expending funds on
research and development for drugs that treat ailments not yet treatable , many
drug companies attempt to focus on developing patentable5 distinct derivatives of
preexisting drugs. The American drug industry cannot be cited as the world leader in
pharmaceutical innovation. "The United States accounts for 36 percent of global pharmaceutical research
preexisting blockbuster drug that is sufficiently capable of meeting the requirements of patentability.

and development.""1 "Europe accounts for 37 percent and Japan for 19 percent."'" Many other countries contribute
significantly to the research and development of new drugs, many operating under government regulations that

The evidence suggests that the

extension of patent rights over the past decad e, due to exploitation of various legislative
loopholes and clever patent applications, does little to stimulate the research and development
of new therapies
provide far less protection for individual intellectual property rights.

**India Scenario**

2AC---AT: Indian Pharma Resilient

Now is key---Modi is softening hardline Indias hardline on
IPR---recent pact proves
Kaushik 2/15 (Preetam, Mumbai Correspondent, SwissInfo, 2/15/15, Is the tide
against Big Pharma in India turning?, https://www.swissinfo.ch/eng/is-the-tideagainst-big-pharma-in-india-turning-/41271018, Accessed 7/28/15)//LD
A recent ruling by the Delhi High Court in favour of Novartis patent on the
respiratory drug Onbrez could be more than a temporary victory for Big
Pharma in its war in India to protect intellectual property. In January the court barred Cipla from making or selling a cheaper copy of Onbrez, citing
infringement of patents held by the Swiss company. The decision lends support to a growing belief
among industry analysts that the government of Narendra Modi is slowly
distancing itself from an approach to make blockbuster drugs available to
poor patients at a tiny fraction of the price at which they are sold in the
west. This is accomplished using the following approach: give Western pharma firms only limited patent protection for their drugs in India and make
it very difficult for them to receive a patent for enhanced versions of patented medicines. Big Pharma want to protect their patents arguing that the hefty
price tag of their drugs is justified by the high costs involved in research and development. Generic firms such as Cipla do not make such investments
and are hence able to offer drugs at lower prices, a Novartis spokesperson said in response to the Delhi court decision. However, analyst Rahul Dev from
Tech Corp Legal cautions that, when regarded from a neutral standpoint, the ruling is totally in line with existing laws, rules and judicial precedents. For
example, the Indian patents act provides provisions for revocation of patent rights in case such rights are against public interest. (Keystone) BIG PHARMA

Perhaps more indicative of the tide turning in favour of Big Pharma is

a recent pact signed by Modi during his visit to the United States , where he
agreed to set up a bilateral working group on intellectual property as part
of the Trade Policy Forum. This was a sign that India is ready to allow the US a role in
its decisions on intellectual property, including those for drugs . It indicates that
the US has managed to get the Modi government to provide it with a
US pact

forum from which to pressure India to adopt tougher patent protection

measures, said Raghuram Selvaraju, managing director and senior healthcare analyst at New York-based MLV & Cos Equity Research
department. According to Selvaraju, the recent decision by the Indian government to revoke
the price controlling powers of the National Pharmaceutical Pricing
Authority (NPPA) is yet a clearer indication that the Modi government is more
than ready to lessen its hostility towards mutinational pharmaceutical
companies. In July 2014, the Indian government capped the prices of 108 medicines, in addition to the 348 drugs that were brought under the
essential list of medicines following the Drug Price Control Order in 2012. However, only two months later, the government instructed the NPPA to revoke
the guidelines that gave it the power to fix prices of drugs that are not on the national list of essential medicines. If the government is removing the

this would seem to be an indication that

the Modi administration is bowing to external pressures to make life
easier for Western pharmaceutical companies, said Selvaraju. Fierce fight Big Pharmas
fight for protecting patent rights has been particularly fierce in India characterised by the worlds biggest generics industry, adolescent patent
laws, growing demand for medicines and an inability to pay for them than anywhere else. (Reuters) A HEALTHY BALANCE? 2 Sci & Tech Business For more than three
decades, India refused to recognise pharmaceutical patents, allowing domestic firms to
ability of regulators to control the prices of essential medicines,

copy medicines to make them cheap. However, after the country joined the World Trade Organization (WTO) in 1995, it had to change its patent policy. But

The countrys
patent system also has a provision for compulsory licensing under which
the government can force a firm to license a patented drug to a generic
company under a WTO pact. Indian patent law looks similar to Western law, except for the provision that the Indian government can amend it
the patent law it launched in 2005 denies evergreening - making minor alterations to existing drugs to secure a new patent.

on a case-by-case basis to enable access to lifesaving medicines for those who would not be able to get access to such medications if they are allowed to

be priced as brand-name products, explains Selvaraju. While one section of the amended Indian Patents Act allows drug companies to obtain product
patents for new medicines, another permits only breakthrough innovations and bars new use of known drugs. Swiss firms including Novartis and Roche
have had a tough time in India. Since 2006, Novartis has been fighting to win a patent for the enhanced form of Glivec. It lost the fight to protect the
patent for the major cancer drug in the Supreme Court in 2013. Legal battles In the case of Roche, it lost a courtroom battle to Cipla for its blockbuster
lung cancer drug Tarceva. The court ruled that Ciplas generic Erlocip did not violate Roches patent. In addition to Novartis and Roche, German pharma

Big Pharma are willing

to put up the fight in India and other developing nations where demand
for life-saving drugs is surging. Rising incomes and rates of chronic disease may push drug sales in India from $12 billion
in 2010 to $74 billion in 2020, according to consulting firm PwC. Nearly three quarters of the sales are expected to come from generic drugs. Going
by the court ruling against Cipla, revoking of price caps on non-essential drugs and the decision to set up a patent
working group with the US, there is ample reasons for Big Pharma to believe that the
Indian government will be a less fierce foe in their struggle for patent
protection.
giant Bayer AG and US firm Gilead Sciences have also been entangled in legal war over patented drugs.

2AC---Ext. Wrecks Indian Pharma

Big Pharma locks out the Indian medical industry---specifically
generics
Carter 13 (Zach, senior political economy writer for Huffington Post, Obama
Administration, Congress Intensify Opposition To Global Generic Drug Industry,
http://www.huffingtonpost.com/2013/06/28/obama-generic-drugs_n_3513011.html)
The Obama administration and members of Congress are pressing India to
curb its generic medication industry. The move comes at the behest of
U.S. pharmaceutical companies, which have drowned out warnings from
public health experts that inexpensive drugs from India are essential to
providing life-saving treatments around the world. Low-cost generics from
India have dramatically lowered medical costs in developing countries and
proved critical to global AIDS relief programs; about 98 percent of the drugs purchased by
President George W. Bush's landmark PEPFAR AIDS relief program are generics from India. Before Indian companies

But
India's generic industry has also cut into profits for Pfizer and other U.S.
and European drug companies. In response, these companies have sought
to impose aggressive patenting and intellectual property standards in
India, measures that would grant the firms monopoly pricing power over
new drugs and lock out generics producers.
rolled out generic versions priced at $1 a day, AIDS medication cost about $10,000 per person per year.

2AC---Ext. India k2 Generics

India is key to producing generics the American model is too
focused on IPR
Kumar, writer for Pakistani newspaper The Dawn, 2/17/ 2014
(Anand, US concerns about Indian generic drugs,
http://www.dawn.com/news/1087496)
India is one of the largest exporters of generic drugs to the US , ties
between the two nations are often tetchy over issues relating to protection of patents
and intellectual property rights and the quality of drugs that are manufactured in India. A major crisis is
THOUGH

currently brewing between the two countries over the issue, with the bipartisan US International Trade Commission
(USITC) launching an investigation backed by both the US Senate finance committee and the House of
Representatives ways and means committee on Trade, investment and industrial policies in India: effects on the
US economy. And later this month, the US Trade Representative (USTR) will also start hearings as a prelude to its
Special 301 report, reviewing IPR rules and practices by Americas trade partners. Trade bodies, activists and other
organisations both from the US and India have begun lobbying for or against the Indian pharmaceutical industry.

The US Chamber of Commerce, for instance, has demanded that the USTR
classify India as a Priority Foreign Country, which is a label generally
given to the worst intellectual property offenders and which could result
in trade sanctions. We highlight India as a country with particular challenges with respect to intellectual
property protections, the global intellectual property center of the chamber told the bipartisan commission.
Because India has not shown a record of engagement on these issues and the environment has deteriorated
significantly since last year, we are now recommending that India be designated a Priority Foreign Country. Last

India annoyed the international pharmaceutical industry and several western

governments when it denied patents to cancer drugs Glivec (by Novartis) and Nexavar
(Bayer) and allowed domestic producers to churn out generic versions of these
year,

expensive drugs. Even the Indian Supreme Court dismissed the plea by Novartis for patent protection of its blood
cancer drug. The Indian Patent Office also gave a compulsory licence allowing a domestic firm to make Nexavar,
Bayers advanced kidney cancer drug by paying a revised royalty of seven per cent. Organisations that are
testifying against India include the Alliance for Fair Trade with India, the National Association of Manufacturers, the
International Intellectual Property Alliance, Pharmaceutical Research and Manufacturers of America and the
Biotechnology Industry Organisation. But non-profits including Public Citizen and Doctors without Borders, besides a
few academics are backing India. Recently, some pharmaceutical industry groups have criticised Indias patent

Indias practice
complies with the WTOs agreement on trade-related intellectual property rights.
rules and practices, Peter Mayburdak of Public Citizen, told the commission. But

Representatives from the Confederation of Indian Industry, the Indian Pharmaceutical Alliance (IPA), the US-India
Business Council and others are defending Indias IPR and patent regime at the hearings. According to the
submission by the IPA, after India implemented the TRIPS agreement in 2005, over 1,500 patents have been
granted to nine leading international pharma firms, for products and compositions and for manufacturing processes.
When

the innovator pharmaceutical industry talks of denial of patents, it

is not talking of patents for medicinal products in general , but actually of
second or third patents for the same product, it said.

2AC---Ext. India k2 Global Health

Indian pharma leadership key to global health.
Neelakantan 8/21consejero general global de Cipla Limited
(Murali, Indian Pharmaceutical Industry: Affordable Access to Healthcare for all,
http://abcmundial.com/en/news/brics/technology/3838-indian-pharmaceutical-industry-affordable-accesshealthcare-all/, dml)

The story of the Indian pharma sector could well have been like the IT sector if only
enough attention was paid to its achievements and the huge impact it has had on
healthcare around the world. Unlike other manufacturing or heavy industries in
India, the pharma sector is innovative, widely acknowledged as making a

global impact

in the treatment of diseases like HIV AIDS[1] and also able to

support the healthcare needs of the world [2]. The fact that Indian factories are licensed to produce
3,685 drugs compared with 3,815 made within the UK suggests that Indian factories meet global quality standards
and are able to produce complex drugs.[3] While news of regulators visiting Indian manufacturing facilities and
finding fault with processes is widely reported, very little is said about how routine this is. Gerald Heddell, director
of inspections, enforcement and standards at the MHRA, stressed that the number of problems identified by
regulators in India was in proportion to the volume of medicines they produced. When we look back over 110
inspections we conducted over the last two years in India, we had significant concerns with 9 or 10 companies, he

India stands
out because it is just such a big supplier.[4] The Indian pharma Industry produces
about 20% [5] of the global generic drugs with the US accounting for nearly 28 per
cent of Indian pharmaceutical exports[6], followed by the European Union at 18 per cent and
Africa at over 17 per cent.[7] This should be a clear acknowledgement of the global
leadership that Indian pharma industry has achieved which would have been
impossible without following global quality standards . Another popular criticism of
Indian pharma has been that there is insufficient investment in innovation and R&D .
Despite over 500 new drugs being discovered by Indian pharma companies
during 1985 2005, there seems a perception that India thrives on copying foreign products[8]. A recent study
by Evaluate[9], a leading independent specialist pharma consultancy, reports that there is little
difference in the investment by innovators and generics and it is just a myth that innovators
invest heavily in research while generics dont. Despite well publicised claims of the Western
world, there seems to be a marked decrease in R&D investments[10] and this
trend is expected to continue.[11] When one realises that almost 50% of the European
pharma patents are either lying dormant or filed in order to block competitors [12] one
wonders how innovation is being defined and encouraged . Is it innovation if
said. That does not represent a statistically higher proportion than in other parts of the world.

the effect is

stifling further innovation

and competition and creating

barriers for improvements? Indian pharma industry has clearly demonstrated that it
has the potential to be a part of the solution for universal access to healthcare. Indias
strength is innovating to improve global access to medicines as opposed to
developing more and more me too drugs which have been traditionally defined by
the West as innovation. There is now a growing acknowledgment that the existing IPR regime
that is being touted by the West doesnt foster innovation. As such, the current patent
system is itself reeling from the ill effects of patent assertion entities (trolls) that do
not produce anything of value but merely hold patents with a view to threatening

businesses with infringement actions to obtain licensing revenue . Patents have other
flaws that relate to monopoly power, both because it harms consumers who have to pay high
prices and because it can hinder improvements and subsequent innovations.[ 13]
Static distortions , too little incentive for original research, and wasteful
duplication of research are some of the most serious problems of the
patent system.[14]In addition to TRIPs - compliant patent regimes which ostensibly promote innovation and
discourage copying, the next generation of barriers to competition seems to be set up as global standards. Just as
IPR was addressed by the WTO in TRIPs, the more recent barriers are likely to be in the form of harmonised
regulations. Patent linkage[15] (in Canada and the US for example) denies access to markets on a mere allegation
of patent infringement. Despite the US Supreme Court[16] indicating that patent linkage needs to be reconsidered
and access to medicines should not be denied on allegation of patent infringement and recent attempts by Italy to
introduce a system of patent linkage resulted in a notice from the European Commission asking for the removal of
these provisions from Italian law,[17] patent linkage is a real barrier to competition in healthcare which is beset with

Data exclusivity extends the term of monopoly enjoyed by patent

holders and keeps out competition and innovation without any benefits to society.
This concept does not exist in sectors other than pharma and there seems to be no real
unaffordable drugs.

rationale for pharma to get special treatment. In fact, data exclusivity raises several ethical and moral issues.

Countries have always been allowed to customise their IP policy and regulation
based on their unique local conditions. Some countries are more technologically
proficient than others, and this distinction may warrant separate norms in areas of
technology that they are strong in.[18] Even where harmonisation has been accepted as a concept, like
the EU for example, it has been implemented in a manner that is sympathetic to the local conditions of individual

Indias strength and expertise lies in developing drugs which are

accessible for patients across the globe. Indias stand on IPR regime
acknowledges that diverse countries cannot be forced to one uniform regulatory
system. This principled stand was recently demonstrated during the Bali round of talks on the Trade Facilitation
Agreement.[19] In the background of the Trans Pacific and Trans Atlantic Partnerships being negotiated, India
has the opportunity to demonstrate leadership in the global market place
by pioneering the opposition to using harmonisation as a proxy for barriers to
competition. While the US and its allies may officially oppose Indias view of the IPR regime they have
realised that the key to their sustainable development is the ability of government
to ensure that healthcare is accessible to everyone, not just the rich. Cost of
healthcare has increased significantly causing an alarming number of patients to go off treatment,
risk importing counterfeits[20] or in many cases, declare bankruptcy[21]. The issue of access to
healthcare in the developing world has , despite some efforts by the UN, The Global Fund, PEPFAR and
other aid institutions, not had the impact that it should have . There is a realisation, albeit
unarticulated, that Indian Pharma companies have the potential to be, like Indian technology
companies averted the y2K crisis, a key element of the solution to world's healthcare
countries.

crisis. Now is a great opportunity for India to demonstrate leadership in

IPR regimes as more and more countries like South Africa and Brazil are following
Indias example .

**Africa Scenario**

2AC---Africa Econ Addon

African economic growth is key to global economic growth
Stetter 9 (Ernst, Secretary General of Federation for European Progressive
Studies, Why Africa matters! The economic crisis and Africa, Contribution to the
Shadow GN 2009, February 4 and 5, http://www.fepseurope.eu/fileadmin/downloads/globalisation/090204_Stetter_Africa.pdf)
Africa is still
struggling to address the multiple challenges facing the continent, this includes poverty, underdevelopment, protracted conflicts, environmental degradation, HIV/AIDS pandemic,
tuberculosis and malaria. It has been suggested that all over Africa, poverty is a common
denominator and it is not surprising that peoples immune systems have been damaged. Reports on Africas
If there is no doubt that Africa is endowed with abundant natural resources, it is also true that

HIV/AIDS pandemic have all come to the conclusion that HIV/AIDS on the continent is closely associated to poverty.
It is clear that the absence of technological investment and the contemning human resource capacity has

the
new scramble for natural resources in the continent is likely to create a new
awareness of the geopolitical importance of the African region. Therefore, Africa
prevented Africa from making optimal use of its abundant resources for the benefit of its people. Nevertheless,

remains a critical partner for the worlds economic viability .

However, for Africa

to benefit more from its vast natural resources it must be finally enabled to add value to these products rather than
export them raw to Europe and elsewhere in the developed world. Africa needs to be helped in manufacturing
value-added products that yield higher profit and income to African economies. In addition, there are, at least, five
significant factors that provide a plausible explanation as to why Africa matters, especially concerning Europe:

The history of Africa has been a

history of integration into the European economy and markets. Therefore, Africa has
historically held a significant place in the European economy, trade and
Firstly, it is the history of Africa and its relationship with Europe.

investments . If Africa matters to Europe it matters also to the globalised world.

Secondly, there is also the inherent link between environment and sustainable development. While the history of
Africa and its integration into the European economy is clearly defined by historical circumstances, the

Environmentally, Africa matters to the world

because it provides the largest capacity in the world necessary for maintaining
environmental aspects are not clearly discernible.

equilibrium in the biosphere and avoid further depletion of the ozone

layer . At the same time the raid of depletion of Africas biodiversity including
its tropical forests, medicinal plants remain threatened by the levels of poverty on
the continent. Africas most prevailing source of energy is biomass which means depletion and an exponential
raid of its forestation. If this is left to continue, the World will suffer serious climate
change

which is likely to erode its socio-economic prosperity and a consequent negative impact to its

population. This is an area which needs a strong partnership with the rest of the world, to protect its environment

Africa matters because it still provides easy

market access to Europe, the US and China and can give , in some cases, extraordinary
investment opportunities with high rates of return . With the changing political climate in the
and avoid further depletion of the ozone layer. Thirdly,

continent towards democracy, respect for the rule of law and protection of human and peoples rights the
investment climate in Africa could rapidly change. The historical and cultural links, geographical proximity, and
deep knowledge and understanding of the continent gives international European investors a comparative
advantage over Northern America and Asia, including China.

With these investments the average

rate of growth in Africa has been increasing most significantly in most African countries ranging
from 3% to 7% in many countries during recent years. The income disparities in the continent have been

narrowing and the purchasing power parity increasing. This, coupled with the population of the
continent, provides a market with huge potential especially for European goods. Indeed,
any visitor to Africa would quickly realize that there is still a very significant quantity of European products traded in
the continent. However, if you are in Europe you can hardly see the presence of African products on the market.
This is mainly because Africa cannot compete in the European market either because of European subsidies or
other protectionist measures that stifle Africas competitiveness and ability to sell in the European market. This
problem needs to be addressed to ensure the sustainability of African-European partnership. Fourthly, Africa
matters because of its abundance nature of human resources which provided the back-bone of industrialisation in

Africa is richly
endowed with mineral reserves. The continent ranks first in terms of the amount of
global reserves of bauxite, chromites, cobalt, diamond and gold. It also ranks first in
terms of palladium, phosphates, platinum group metals, titanium minerals,
vanadium and zircon. Africa was, and still is, among the worlds largest exporters . An
Europe. Africa is a rich continent and not as poor as it is depicted elsewhere in the world.

ecological survey realised by the mineral industries of Africa has estimated that production in Africa alone accounts
as much as 80 % of the worlds platinum group metals, 55% of chromites, 49 % of the palladium, 45% of the
vanadium and up to 55 % of the worlds gold and diamond. Moreover, Africa has emerged as a critical exporter of
cheap and skilled labor that has been instrumental in moving Europes economy forward.

Econ decline causes nuclear war

Hutchinson 14 (Martin, Business and Economics Editor at United Press
International, MBA from Harvard Business School, former international merchant
banker, 1-3-14, The chilling echoes of 1914, a century on Wall Street Journal)
http://online.wsj.com/articles/william-galston-secular-stagnation-may-be-for-real1409095263,
The years before 1914 saw the formation of trade blocs separated by high tariff
barriers. Back then, the world was dominated by several roughly equivalent powers, albeit with different strengths
and weaknesses. Today, the world is similarly multi-polar. The United States is in a position of clear leadership, but
China is coming up fast. Europe is weaker than it was, but is still a force to be reckoned with. Japan, Russia, Brazil,
India are also too powerful to ignore. A hundred years ago, big international infrastructure projects such as the
Berlin-Baghdad Railway, and before it the Suez Canal, were built to protect favored trading. Todays equivalent may
be the bilateral mining partnerships forged between, for instance, China and mineral-rich African states. Today, the
World Trade Organization offers some defence against tariffs. But protectionism could be become entrenched if
prolonged economic stagnation leads countries to pursue their own narrow interests. Germany, Austria, Russia and
France lost between 20 and 35 percent of national output between 1913 and 1918, according to Angus Maddisons
data used in Stephen Broadberrys The Economics of World War One: A Comparative Analysis. British GDP
declined in 1914 and 1915, but grew 15 percent over the four years, as did the U.S. economy. The 37 million

if history were to repeat itself,

global conflict could be both more universal and more destructive. Nuclear weapons
proliferate. Warped diplomatic anger could lead to the deployment of chemical
and biological devices. Electromagnetic pulses could wipe out our fragile
electronic networks. Like the assassination of Archduke Ferdinand that sparked World War One, the catalyst for
military and civilian casualties may tell a more accurate story but
the

cataclysm might be something quite surprising. A global run on bank and other investment assets or an outbreak of
hyperinflation, maybe? These threats get more serious the more policymakers pump up equity, bond, property and

If global wealth evaporates, or is proven to be an illusion, todays largely

cordial global entente could be smashed with precipitous speed.
banking bubbles.

Whistleblowing Advantage

2AC---Ext. WB Solves Cred

Whistleblower protections enable better FDA accountability
FDA 9 A group of FDA whistleblowers writing a letter to the presidential transition team, FDA
Whistleblowers Letter to Obama Transition Team, 1/7/2009,
http://www.whistleblowers.org/storage/whistleblowers/documents/FDAwhistleblowers/letter2transitiont
eam.pdf//OF
We, physicians and scientists at FDA, seek your immediate attention for change and reform at FDA. To bring real

it is absolutely necessary that Congress pass, and the

President sign, new legislation providing the strongest possible
protections for all government employees, especially physicians and
scientists, who speak out about wrongdoing and corruption that interferes
with their mission and responsibility to the American public. We
change and reform to FDA,

desperately need honesty without fear of retaliation

for our evaluations and

as well as accountability and transparency, to

become the law and thus the foundation of the FDA mission and workplace. We totally
recommendations on medical devices,

agree with the following statement of President Oban1a:22 Often the best source of information about waste,
fraud, and abuse in government is an existing government employee committed to public integrity and willing to
speak out. Such acts of courage and patriotism, which can sometimes save lives and often save taxpayer dollars,
should be encouraged rather than stifled. We need to empower federal employees as watchdogs of wrongdoing and
partners in performance.

Barack Obama will strengthen whistleblower laws to

protect federal workers who expose waste, fraud, and abuse of authority
in government. Obama will ensure that whistleblowers have full access to
courts and due process. As President Obama has emphasized, he intends to govern the nation and to
bring about change from the bottom up. We believe that, as applied to FDA, this means a complete restructuring of
the evaluation and approval process such that it is driven by science and carried out by clinical and scientific
experts in their corresponding areas of expertise who are charged with review of regulatory submissions in
accordance with the laws, rules and regulations. It is necessary that FDA expert physicians and scientists approve
final regulatory determinations of safety and effectiveness, rather than multiple layers of managers who are not
qualified experts and who often ignore scientific evidence and the law. President Obama has also emphasized the

His Transparency Policy should be

mandatory for all FDA regulatory decisions and associated documentation.
need for complete transparency in government.

The long-standing FDA practice of secret meetings and secret communications between FDA managers and
regulated industry must be strictly prohibited. Complete transparency in the regulatory decision-making process
would serve as a deterrent to wrongdoing and an incentive for excellence.

2AC---Ext. WB k2 Transparency
FDA Whistleblowing is critical to transparency.
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R.
Allison Professor of Law, Texas Tech University School of Law and Director, What to
Do When You Can't Hear the Whistleblowing: A Proposal to Protect the Public's
Health by Providing Whistleblower Protection for Medical Researchers, 2011 / 2012,
lexis)//ghs-VA
One
aspect of this is the reliance on income from drug trials which is why
academic medical centers were eager to host clinical trials and were, therefore,
Section IV outlined the financial dependence of academic medicine on the pharmaceutical industry.

interested in remaining on good terms with their sponsors. The influence is just as strong, however, when the
clinical trials are over, and the drug companies are marketing their new drug. This is because the same physicians
whose institutions hosted the trials are also in a position to promote a specific product directly through talks given
to other doctors and much more broadly by putting their names to articles which change clinical standards and
therefore increase the need for a specific drug. This can either be done by visits from pharmaceutical
representatives known as detailing or more directly by physicians talking to their peers at pharmaceutical companysponsored conferences. n193 The details of [*44] the extent of both of these activities have been coming to light
through the hearings conducted by the Senate Finance Committee, Chaired by Senator Charles Grassley of Iowa,
n194 who is conducting an on-going investigation of conflicts of interest between physicians and pharmaceutical

To prevent situations in which doctors are directly paid by or

hold shares in pharmaceutical industries, the late Senator Edward Kennedy and
Senator Grassley proposed the Physician Payments Sunshine Act of 2009 that
would "provide for transparency in the relationship between physicians
and [applicable] manufacturers" with respect to payments and other transfers of value and
companies. n195

physician ownership or investment interests in manufacturers. n196 [*45] The message is clear. If Emory insists on
the disclosure to the NIH, it may well jeopardize their receipt of future grants. This means not just the individual

A whistleblower could serve at

least two important functions in these situations. First, he or she could disclose the
financial arrangements themselves. Second, given both the investigators and the universities'
financial interest in the study, a whistleblower would be even more valuable in
disclosing harm to human subjects or lack suppression of negative results .
doctor but the institution itself will suffer serious financial loss.

2AC---WB Info Good

Lack of whistleblowers increases the risk to participants and
the public.
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R.
Allison Professor of Law, Texas Tech University School of Law and Director, What to
Do When You Can't Hear the Whistleblowing: A Proposal to Protect the Public's
Health by Providing Whistleblower Protection for Medical Researchers, 2011 / 2012,
lexis)//ghs-VA
... Part II of this article reviews the dangers to the public from participating in clinical drug trials research and from
taking prescription drugs. ... Because there is no positive international law mandating that private companies
running clinical trials (Clinical Research Organizations) comply with the relevant domestic laws of the clinical
studies' sponsors, the resulting "regulatory vacuum" makes it difficult for these countries to ensure the welfare of
trial participants and forces them to rely on foreign data and foreign review processes. ... Although the early stages
of drug testing, in which the subjects are healthy volunteers, are still primarily conducted by pharmaceutical
companies, it is fair to say that any study involving a subject who is already ill is overseen both by employees of
pharmaceutical companies and by doctors who work for or are associated with the hospitals which both provide
treatment and serve as a site for research. ... While there has always been a close relationship between the
physicians who ran clinical drug trials in their hospitals and the companies who sponsored them, drug companies

given both
the investigators and the universities' financial interest in the study, a
whistleblower would be even more valuable in disclosing harm to human
subjects or lack suppression of negative results. . ... The system of law and
regulation in the United States to provide protection against retaliation
for insiders who know of dangers to the public's health and safety during human
subject research or drug development is as fragmented and inconsistent as regulating the
research itself. ... The lack of protection for whistleblowers means that those
with the best information about dangers to participants in medical research and to
the patients, who will eventually use the products developed from, the scientists,
researchers, and doctors conducting the experiments and analyzing the data, risk their jobs and their
futures if they bring this information to light either within their own
company, to government regulators or to the press.
are increasingly becoming intertwined with the actual operation of these institutions. ... Second,

Whistleblowing prevents potential danger, which causes

controversy.
Bard 13 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R.
Allison Professor of Law, Texas Tech University School of Law and Director, Putting
Patients First: How the FDA Could Use Its Existing Powers To Reduce Post-Market
Adverse Events, 2013, lexis)//ghs-VA
F. Effective Solutions 1. Expanding Whistleblower Protection This article asserts that the burden for creating early
detection systems, including whistleblower protection, should be on the drug companies themselves because they
are the ones with the greatest financial interest in the drug's success and the greatest access to information about

Congress has already identified extending whistleblowing

protection for employees of pharmaceutical companies as an important
method of ensuring compliance with federal anti-fraud laws such as Dodd-Frank
n99 and the Affordable Care Act. n100 Whistleblower protection must, then, extend to
every individual who may come into contact with information about
potential dangers. Moreover,

dangers to the public's health. This protection must be geared to what these people know,
substance based, not how they know it, job title based. n101 This section provides some suggestions for how that
change should occur. [*530] 2. Models of Strong Whistleblower Protection in Recent Federal Statutes In the last ten
years, there has been significant interest by Congress in extending protection to consumers from corporate fraud by
developing new statutes, and amending old ones, that provide strong incentives for whistleblowers as well as
greater protection from employer retaliation. The Sarbanes-Oxley Act (SOX) exceeds all previous federal
whistleblower statutes by actually requiring disclosure. n102 It was enacted in response to a series of public
scandals in which companies' outside lawyers and accountants failed to report what was obvious fraud and wrongdoing. n103 Another enhancement to a whistleblowing statute is the provision of an incentive for a whistleblower
such as is available in the 2010 Dodd-Frank Consumer Protection Act. n104 Dodd-Frank amends both SOX n105 and
the False Claims Act n106 to provide greater protection against retaliation for whistleblowers. n107 [*531] For
example, companies must now prove by clear and convincing evidence that they would have terminated a

increased
whistleblower protection provided by federal statutes are a model of what
more could be done to protect employees of pharmaceutical companies who
bring forward information about a potential danger associated with a drug
for which their company is either seeking approval or which is already on
the market.
whistleblower even if they were unaware of his complaints. n108 These examples of

2AC---AT: SQ Solves Protections

Current laws and protections are fractured and inefficient
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R.
Allison Professor of Law, Texas Tech University School of Law and Director, What to
Do When You Can't Hear the Whistleblowing: A Proposal to Protect the Public's
Health by Providing Whistleblower Protection for Medical Researchers, 2011 / 2012,
lexis)//ghs-VA
Existing Whistleblower Protection Laws Don't Work Existing statutes
are of little use in protecting those with knowledge of danger from human subject
VI. Why

research because the location and employment status of potential whistleblowers are so broad. Most existing
whistleblower statutes privilege employment status as a starting point for offering protection against retaliation. In
many cases this is reasonable because the most likely source of retaliator is the specific entity for which the

the area of drug development employment status is

far too narrow. Because not all who report are employed by the company,
they do not face retaliation from their employer. This is especially true in the case of
whistleblower works. However,

doctors, scientists, and their staffs ("researchers"), n246 who de- [*55] sign and run the clinical trials before, and
sometimes after, the drugs go on the market. Despite their important role, researchers who see problems and who
express their concerns, even within their own institutions, do so at the risk of their careers and livelihood. n247

There are model statutes that provide protection based on the content of
the information, rather than on employment status. They must be the foundation of any
new FDA rule. The system of law and regulation in the United States to provide protection against retaliation for
insiders who know of dangers to the public's health and safety during human subject research or drug development

Arguing that the current laws

intended to encourage whistleblowing were ineffective , former Supreme
Court Justice Souter described the uncoordinated and inconsistent federal
and state whistleblowing statutes as inadequate because the protection they provided
is as fragmented and inconsistent as regulating the research itself.

was "piecemeal," 'patchwork," and "hodgepodge." n248 It is the lack of comprehensive protection over research

Another
problem is that the existing laws often narrowly describe who [*56] is
protected for disclosing various kinds of information. Professor Richard
Moberly, an expert in whistleblower law, described research showing that
in the existing statutory and common law "[p]rotections consistently fail
to redress retaliation against whistleblowers, in large part because whistleblowers fail to fit
and over whistleblowers that makes it so easy to hide dangers at every stage of the process.

their claim into the narrowly-drawn boundaries of the law." n249 A system this broken cannot be fixed by a stroke of

protection of the public must be pursued using several different

legal and policy interventions.
the pen. Rather,

Whistleblower protections are based on employment status

which doesnt protect FDA employees.
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R.
Allison Professor of Law, Texas Tech University School of Law and Director, What to
Do When You Can't Hear the Whistleblowing: A Proposal to Protect the Public's
Health by Providing Whistleblower Protection for Medical Researchers, 2011 / 2012,
lexis)//ghs-VA
2. Federal Whistleblower Laws There are at least twenty-one federal statutes that incorporate explicit whistleblower protection for
employees of private companies. n276 These include "protect[ing] employees who report violations of various airline, commercial

motor carrier, consumer product, environmental, financial reform, food safety, health care reform, nuclear, pipeline, public
transportation agency, railroad, maritime and securities laws," and are overseen by the Occupational Safety & Health Administration
(OSHA) through its office of the Whistleblower Protection Program (OWPP). n277 The OWPP defines its protection as follows, The
Occupational Safety and Health Act (OSH Act) and a number of other laws protect workers against retaliation for complaining to their
employers, unions, [*65] the Occupational Safety and Health Administration (OSHA), or other government agencies about unsafe or
unhealthful conditions in the workplace, environmental problems, certain public safety hazards, and certain violations of federal
provisions concerning securities fraud, as well as for engaging in other related protected activities. n278 According to the Act,
"[w]histleblowers may not be transferred, denied a raise, have their hours reduced, or be fired or punished in any other way because
they have exercised any right afforded to them under one of the laws that protect whistleblowers." n279 However, even if the OWPP
could effectively manage the retaliation complaints it receives, it would not provide protection for those who learn of danger to the
public's health and safety unless that danger was of the type prohibited by a federal law or regulation. Here again, the
fragmentation of human subject research is a substantial barrier to comprehensive whistleblower protection. The question isn't then

State Whistleblower
Laws Do Not Protect Most Medical Researchers Most states provide some kind of legal protection to
whether there are federal statutes protecting whistleblowers; it is whether they are effective. C.

their employees who disclose waste, fraud, or abuse in government. n280 Thirty-nine states have whistleblower statutes that
provide general whistleblower protection to public employees; twenty-three states provide general protection for all employees; and,

The literature
describing the flaws of this existing system, usually called a patchwork, is extensive.
The failure of the existing statutes comes from their misplaced emphasis
on the employment status of the whistleblower rather than the potential danger to the public if
the potential whistleblower does not feel safe disclosing what she knows. For example, most whistleblower laws
protect only those individuals who have disclosed information exactly in
the manner described by the statute. An individual with knowledge of a danger to the public's health or
fourteen states provide specific protection to persons reporting certain environmental misconduct. n281

safety may find herself fired because she reported it to her direct supervi- [*66] sor rather than public entity specified by a specific
statute. n282 States vary widely both in the terms of who is defined as a whistleblower and what protections are available to meet
the criteria. These statutes protect researchers working at state universities, but the

protection offered them is far

from complete. In addition, by definition, statutes intended to protect state employees would not be available for
researchers at private universities. For example, a physician overseeing a drug trial at the University of California at Berkley will
have different protection if he or she reports a dangerous situation involving human protection than one at Stanford University who
may well be over- seeing a trial of the same drug. This lack of consistency is exactly what concerned Justice Souter in Garcetti who
wrote, "[T]he current understanding of statutory protection: individuals doing the same sorts of governmental jobs and saying the
same sorts of things addressed to civic concerns will get different protection depending on the local, state, or federal jurisdictions
that happened to employ them." n283

2AC---Econ Addon
Status quo has a chilling effect whistleblowers need to be
able to openly disclose info to save the FDA billions of dollars.
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R.
Allison Professor of Law, Texas Tech University School of Law and Director, What to
Do When You Can't Hear the Whistleblowing: A Proposal to Protect the Public's
Health by Providing Whistleblower Protection for Medical Researchers, 2011 / 2012,
lexis)//ghs-VA
A. Lack of Constitutional Protection 1. Medical Researchers Are Not Protected by the First Amendment? In Garcetti v. Cebalos, the Supreme Court
concluded that there is no First Amendment protection for employees of public institutions who disclose information against the wishes of their employers.
n250 Finding that wrongdoing is part of their jobs makes it unlikely that medical researchers employed by public universities would have First Amendment
protection from retaliation for disclosing their concerns about dangers to the public's health from a clinical trial or a newly issued prescription drug. n251
Those who argue Garcetti v. Ceballos has not resulted in any diminution of whistleblower protection for public employees because the plaintiff, Mr. Ce-

The minority's strongest objection was the

chilling effect this decision would have, and it specifically identified the
reduced protections for whistleblowers by eliminating any possible extension of First Amendment rights. n253
Although employees of state universities will still have the state whistleblower protection, these statutes are often narrowly
focused on reports about waste fraud and abuse in state government and
would not apply to a study funded privately. n254 The Supreme Court recently reaffirmed the importance
[*57] ballos, was not himself a whistleblower miss the point. n252

of these regulations, writing that "[e]xposing governmental inefficiency and misconduct is a matter of considerable significance" but pointed to a
"powerful network of legislative enactments-such as whistle-blower protection laws and labor [*58] codes-available to those who seek to expose
wrongdoing." n255 However, noting an inconsistency between the Court's holding in Pickering and Garcetti, Justice Souter wrote, [It] is not a whit less true
when an employee's job duties require him to speak about such things: when, for example, a public auditor speaks on his discovery of embezzlement of
public funds, when a building inspector makes an obligatory report of an attempt to bribe him, or when a law enforcement officer expressly balks at a
superior's order to violate constitutional rights he is sworn to protect. (The majority, however, places all these speakers beyond the reach of First
Amendment protection against retaliation.) n256 Furthermore, despite the existence of both federal and state whistleblower statutes, most people know
that disclosing information one's employer chooses to keep secret will likely lead not only to being fired but also to becoming unemployable. The lack of
protection for whistleblowers means that those with the best information about dangers to participants in medical research and to the patients, who will
eventually use the products developed from, the scientists, researchers, and doctors conducting the experiments and analyzing the data, risk their jobs
and their futures if they bring this information to light either within their own company, to government regulators or to the press. n257 It is as an
employee of a public institution that a research scientist would be able to claim protections beyond that available to those employed by private
universities or indeed private companies. n258 Interpreting Garcet- [*59] ti, the Fifth Circuit found that there was no constitutional protection "when a
public employee raises complaints or concerns up the chain of command at his workplace about his job duties." n259 Writing four years after Garcetti,
however, it is possible to see that Garcetti is already being cited to support ruling against professors engaged in disputes with administrators at public
universities. n260 , n261 a. Federal whistleblower law provides little protection for federal employees and none for private employees There is a long
tradition of government employees as whistleblowers in the United States. In a 1991 article describing the role that whistleblow- [*60] ers play in the

Federal whistleblowers have exposed alleged

defense contractor accounting improprieties, described possible
misconduct and federal prison mismanagement, highlighted
mismanagement of federal health care for Native Americans, questioned
the administration of the United States' system of justice, and alleged
numerous improprieties in the administration of federal agencies . Whistleblowing
can occur at high and low levels of the federal government. Whistleblowers can save the federal
federal government, n262 Professor Bruce D. Fisher wrote,

government--and federal taxpayers--billions of dollars . Whistleblowers can

serve as a vital communication link between the middle echelon federal
employee, who sees the workings and shortcomings of federal programs on a daily basis, and the policy-makers in
Congress. n263 Yet, the title of Professor Fisher's article, The Whistleblower Protection Act of 1989: A False Hope for Whistleblowers, reflects the
fact that despite substantial efforts on the part of Congress to provide a regulatory scheme to protect whistleblowers, they still very much face retaliation
and, in many cases, disgrace. All federal employees, including scientists, are protected under the existing federal whistleblower statute. n264 However,
that act is focused narrowly and weakly enforced. Whatever protection it provides federal employees is inadequate to protect human subjects or
consumers of prescription drugs. n265 In not just health and safety issues but rather in all areas of possible wrong- doing, the federal government has
moved beyond a passive posture [*61] of relying on laws that protect those who come forward to laws which both provide bounties as an incentive and
punishments for not doing so. b. Characterizing hiding information about a drug as a false claim against the government Congress has long seen the need
for providing protection to federal employees who learn of fraud, waste, or abuse in government as well as employees of private companies who receive
federal money, but this protection does not usually extend to dangers to the public's health and safety. Writing to sixteen of the largest pharmaceutical
companies on July 1, 2010, Senator Chuck Grassley of Iowa demanded that they each send his Committee their company's policies on protecting
whistleblowers. As he explains in a press release, The False Claims Act is a proven success in both identifying and deterring fraud and recovering
fraudulently obtained taxpayer dollars. The more that can be done to create awareness of it, the more good it can do.

My appeal to

drug makers is based on the fact that they have a public responsibility to
safeguard the tax dollars that pay for their products, and promoting a Congress has long seen the
need for providing protection to federal employees who learn of fraud, waste or abuse in government culture where those who speak up about possible
fraud are rewarded rather than retaliated against is one way to fulfill that responsibility . . . . There can never be too many taxpayer watchdogs, so I see
this letter as an opportunity to foster a mindset that recognizes the value of whistleblowers and the duty these companies have to act honestly when
seeking taxpayer dollars. n266 B. Neither Qui Tam Statutes nor Bounty Programs are not a Substitute for Whistleblower Protection

The federal

government has recently stepped up its efforts to fight fraud

in a variety of settings by
making it easier for individuals who know of fraud, waste, or abuse of federal funds to receive a substantial financial benefit by coming forward with the

Both link
the whistleblower's recovery directly to the amount recovered by the
government. These programs are successful because they directly address the problem for which they were designed: fraud, waste, and
information. These efforts include [*62] strengthening a very old incentive, qui tam suits, and a newer one focusing on bounties.

abuse against the federal government. The whistleblower provisions in this article, however, are aimed at saving money, they are aimed at saving lives.
Courts have supported the government's recent efforts to characterize actions by pharmaceutical companies to hide dangers as false claims because the
drugs themselves were subsequently purchased through the Medicare or Veterans Health Administration systems. However, neither the availability of a
qui tam suit nor a Bounty program will make it more likely than informant who knows of a danger which does not involve a substantial financial loss to the
federal government.

Statistics show economic decline causes war miscalculation

and diversionary theory
Royal 10 Jedediah Royal, Director of Cooperative Threat Reduction at the U.S.
Department of Defense, 2010, Economic Integration, Economic Signaling and the
Problem of Economic Crises, in Economics of War and Peace: Economic, Legal and
Political Perspectives, ed. Goldsmith and Brauer, p. 213-214
Less intuitive is how periods of

economic decline may increase the likelihood of external

conflict. Political science literature has contributed a moderate degree of attention to the impact of economic decline and the
security and defence behaviour of interdependent states. Research in this vein has been considered at systemic, dyadic and
national levels. Several notable contributions follow. First, on the systemic level, Pollins (2008) advances Modelski and Thompson's

rhythms in the global economy are

associated with the rise and fall of a pre-eminent power and the often
bloody transition from one pre-eminent leader to the next. As such, exogenous
shocks such as economic crises could usher in a redistribution of relative
power (see also Gilpin. 1981) that leads to uncertainty about power balances, increasing the
risk of miscalculation (Feaver, 1995). Alternatively, even a relatively certain
redistribution of power could lead to a permissive environment for conflict
as a rising power may seek to challenge a declining power (Werner. 1999). Separately,
(1996) work on leadership cycle theory, finding that

Pollins (1996) also shows that global economic cycles combined with parallel leadership cycles impact the likelihood of conflict
among major, medium and small powers, although he suggests that the causes and connections between global economic
conditions and security conditions remain unknown. Second, on a dyadic level, Copeland's (1996, 2000) theory of trade expectations

'future expectation of trade' is a significant variable in

understanding economic conditions and security behaviour of states. He argues
suggests that

that interdependent states are likely to gain pacific benefits from trade so long as they have an optimistic view of future trade

if the expectations of future trade decline, particularly for difficult to replace

the likelihood for conflict increases, as states will be
inclined to use force to gain access to those resources. Crises could potentially
be the trigger for decreased trade expectations either on its own or because it triggers protectionist
moves by interdependent states.4 Third, others have considered the link between economic
decline and external armed conflict at a national level. Blomberg and Hess
(2002) find a strong correlation between internal conflict and external
conflict, particularly during periods of economic downturn. They write: The linkages
relations. However,

items such as energy resources,

between internal and external conflict and prosperity are strong and mutually reinforcing. Economic conflict tends to spawn internal
conflict, which in turn returns the favour. Moreover, the

presence of a recession tends to amplify

the extent to which international and external conflicts self-reinforce

each other. (Blomberg & Hess, 2002. p. 89) Economic decline has also been linked with an
increase in the likelihood of terrorism (Blomberg, Hess, & Weerapana, 2004), which has the capacity to
spill across borders and lead to external tensions. Furthermore, crises generally reduce the popularity of a sitting government.

"Diversionary theory" suggests that, when facing unpopularity arising

from economic decline, sitting governments have increased incentives to
fabricate external military conflicts to create a 'rally around the flag'
effect. Wang (1996), DeRouen (1995). and Blomberg, Hess, and Thacker (2006) find supporting evidence showing that
economic decline and use of force are at least indirectly correlated. Gelpi (1997), Miller (1999), and Kisangani and Pickering (2009)

the tendency towards diversionary tactics are greater for

democratic states than autocratic states, due to the fact that democratic leaders are generally more susceptible to
being removed from office due to lack of domestic support. DeRouen (2000) has provided evidence showing that periods of
weak economic performance in the United States, and thus weak
Presidential popularity, are statistically linked to an increase in the use of
force. In summary, recent economic scholarship positively correlates economic integration with an increase in the frequency of
economic crises, whereas political science scholarship links economic decline with
external conflict at systemic, dyadic and national levels.5 This implied connection
suggest that

between integration, crises and armed conflict has not featured prominently in the economic-security debate and deserves more
attention.

Solvency

2AC---Oversight Bad
FDA independence solves and is key to credibility
internationally
Harris 12 (Gardiner- author for the NY Times. White House and the F.D.A. Often at Odds. April 2,
2012. http://www.nytimes.com/2012/04/03/health/policy/white-house-and-fda-at-odds-on-regulatoryissues.html//GH)
Consumer advocates credit the Obama administration with bolstering the F.D.A.s budget and championing
landmark legislation that strengthened the agencys authority to regulate food and tobacco. But they also express

the administration has been overly cautious, sitting on important

regulatory policies regarding foods and medical devices to avoid giving
Republicans fodder for attacks. And some analysts worry that the administrations
concerns that

increased engagement could erode the F.D.A.s reputation for regulatory

thoroughness and integrity. In a globalizing world, where trust is a huge
part of what American manufacturers have to sell, the politicization of the
F.D.A. could hurt not only consumer protection but industry profits as
well, said Daniel Carpenter, an F.D.A. historian at Harvard University. If this trend continues,
one could easily see major government purchasing programs in Europe,
India, China and elsewhere saying, Were not going to follow F.D.A.
recommendations anymore. The tensions between the White House and the F.D.A. are also a
window on Mr. Obamas governing style. The White House is concerned about managing its message, and news
reports or announcements even mundane ones that catch advisers unaware lead to sharp rebukes, according
to health officials across the government. The

White House wants to know everything,

but telling everything takes a huge amount of work, a health official at
the Centers for Disease Control and Prevention said. And in the end, it
cant really be done .

AT: Politics

2AC---No Link
No link---Blame goes to the FDA, not the president
Lasagna and Wardell 75 (Louis and William- MD. The FDA, Politics, and the
Public. http://jama.jamanetwork.com/article.aspx?articleid=336011)
the Food and Drug Administration (FDA) has often been the center
of controversy. Recent scandals in the executive branch of the government have
reminded us that public officials are not above either the law or the public they are
supposed to serve. It is therefore appropriate that the FDA be responsive to public concerns, and
be held accountable when criticism erupts, be it from consumerists, the
medical profession, the drug industry, or the Congress. Still, it is also crucial
that a regulatory agency not become so embroiled in defensive maneuvers
that it loses its ability to serve the public properly. During the last decade, the FDA has
SINCE it was begun in 1907,

been accused both of overregulation and underregulation. Such a situation is not as paradoxical as it might seem.
On the one hand, the FDA might be considered culpable if it fails to police drug manufacturers and allows inferior
brands of digoxin on the market, and on the other hand, it might be held to ac count if it demands so much

the FDA
has been severely chastized for actions that are not only eminently
defensible but reflect a welcome change in agency policy . At hearings in the House
chaired by Mr. Fountain and in the Senate chaired by Mr. Kennedy, FDA officials have been
reprimanded for being "soft" on industry and too ready to approve new drugs. At the August
evidence on new drugs that valuable medicaments are withheld from the American patient. Of late,

Senate hearings, a parade of disgruntled FDA employees and advisors were solicitiously listened to as they voiced
criticisms of the top administrative echelons in the FDA for going against their negative advice, and then,
Commissioner Schmidt was lectured by Senator Ken nedy and warned not to take punitive action against his
malcontent employees.

2AC---GOP Link Turn

Republicans are against FDS surveillance in status quo- aff
reverses that
AP 14 [February 26, 2014 http://www.foxnews.com/politics/2014/02/26/republicans-blast-fda-for-secretlymonitoring-emails-agency-whistleblowers/ Republicans blast FDA for secretly monitoring emails of whistleblowers]
(Vaibhav)

Republican lawmakers blasted the Food and Drug

Administration on Wednesday for secretly monitoring the emails of agency
scientists who went public with allegations that they were pressured to
approve certain medical devices. In a report published in conjunction with a congressional
hearing, two Republicans said that the FDA's computer surveillance may have
overstepped federal laws designed to protect government whistleblowers .
Using software that took rapid-fire screen shots of employees' desktops, the FDA swept up emails
from several whistleblowers to members of Congress and their private
attorneys. Such communications are protected from disclosure by federal
law. The report is the product of a two-year investigation by Rep. Darrell Issa, R-Calif., and Sen. Chuck
Grassley, R-Iowa. Issa acknowledged in his opening statement that federal
workers have no right to privacy when using government computers or
property.
WASHINGTON

2AC---Health Link Turn

Reform popular---21st Century Cures proves
Mukherjee 5/21/2015 (Sy- Associate Editor at Industry Dive, managing and writing
content for BioPharma Dive and occasionally contributing to sister publication Healthcare
Dive. House committee unanimously passes 21st Century Cures FDA overhaul.
http://www.healthcaredive.com/news/house-committee-unanimously-passes-21st-centurycures-fda-overhaul/399631///GH)

The 21st Century Cures initiative is sailing through Congress with notable
bipartisan support . In fact, one committee member noted that Thursday's 510 vote marked the first time in just under three decades that such major
legislation had been passed by the committee without a single detractor .
Given the bill's popularity, it seems extremely likely that it will pass the
full House. What's less clear is its prospects in the Senate, although Sens. Richard Burr (R-NC) and Bill Cassidy
(R-LA) have both indicated the upper chamber will take up the bill by the fall. The goal is to get a final bill to
President Barack Obama's desk by the end of the year.

1AR---Health Link Turn

Plan is popular
Scott 7/28/2015 (Dylan- staff correspondent for National Journal. Upton Wants to Keep
Pressure on Senate to Take Up FDA Reform Bill. http://www.nationaljournal.com/healthcare/upton-wants-to-keep-pressure-on-senate-to-take-up-fda-reform-bill-20150728//GH)

Upton is working to push his much beloved 21st

Century Cures bill over the finish lineand to do it, he'll have to keep the pressure on his
House Energy and Commerce Chairman Fred

colleagues in the upper chamber. So on Tuesday, he is sitting down with Senate health committee chairman Lamar
Alexander and ranking member Patty Murray, Upton said at National Journal's Conversation with the Chair event
sponsored by PG&E. The Cures Act, which Upton has worked on for more than a year, would expedite prescriptiondrug and medical-device approvals by the Food and Drug Administration and inject more research funding into the

It passed the House this month with 344 votes, and

Upton clearly wants to use that big bipartisan vote as a tool in his talks with the Senate.
"As we have learned already, certainly in this Congress, when you can pass
something with 300 votes, the other body is going to take it ," the Michigan
National Institutes of Health.

Republican said. He added that he was going to meet later in the afternoon with Alexander, Murray, and other
senators. "Our

goal is to work with them to get them to do a similar type bill,

go to conference, and really get it done," he said. Alexander had previously been much less
definitive about his committee's plans, telling National Journalin May that they were "taking the time to get it
right." But on Monday at the Bipartisan Policy Center, he said he would work to have a bill ready by the end of the
year, which is likely the soonest that the Senate would have time to bring it up on the floor anyway. " With

the
kind of support it has now, and I expect it to have at the end of the year, I
fully expect it to be the kind of legislation that even could be considered
by the Congress in an election year, something a lot of people can take
pride in," he said.

AT: Disease CP

2AC---No Solvency
The CP cant solve---internal issues
CSIS 10 (Center for Strategic and International Solutions- policy proposal institution
based on coming up with international policies for growing problems. From Conflict to
Pandemics Three Papers from the CSIS Global Health and Security Working Group A Report
of the CSIS Global Health Policy Center.pg 5. May 2010.
http://csis.org/files/publication/100506_Bonventre_FromConflictToPandemics_Web.pdf//GH)

There are several actions DOD could take internally to better reach its
potential for contributing to the national effort to improve global
preparedness. In this report, we have discussed only a few of the many DOD programs that contribute to
global public health surveillance networks either as their primary mission, or as a useful secondary consequence of

just as coordination between agencies is challenging,

coordination of diverse programs within DOD can be complex, requiring
ongoing active dialogue. DODs efforts to contain dangerous pathogens
should be part of a more holistic effort to address biodefense, including global
that mission. However,

laboratory and research cooperation, development of mitigation strategies, stockpiling of countermeasures, and
building surveillance and outbreak response capacities in developing nations. Partners in the GEIS surveillance
network have also contributed to the seasonal influenza vaccine by identifying and providing at least five different
reference or seed virus strains. These successes are highlights of many years of DODs work in health surveillance,
vaccine development, and in strengthening partnerships within the U.S. government and with governments abroad.
12 Indeed, the offices of several senior DOD officials have begun increasing their information sharing and
examining their biosecurity and health programs to identify ways to work together more efficiently where their

Intensifying such collaborative efforts and focusing on

public health capacity building might identify areas of synergy that would
permit each individual program to achieve its primary objectives and still
allow a contribution to global preparedness as a secondary objective.
objectives intersect.13

AT: Corruption CP

2AC---IAAC Bad
The IAAC is unnecessary, ineffective, and trivializes genocide
and war crimes
Shaefer et al 14 (Brett- Senior Research Fellow in International Regulatory Affairs.
Steven Groves- Senior Research Fellow The Margaret Thatcher Center for Freedom. James
Robert- Research Fellow For Economic Freedom and Growth Center for Trade and Economics
(CTE). Why the U.S. Should Oppose the Creation of an International Anti-Corruption Court.
Abstract. http://www.heritage.org/research/reports/2014/10/why-the-us-should-oppose-thecreation-of-an-international-anti-corruption-court//GH)
Advocates believe that grand corruption (extensive, large-scale corruption by high-level government officials)
should be classified as a crime against humanity, subject to jurisdiction under the International Criminal Court or a

Corruption is a real problem, but classifying

it as a crime against humanity subject to international criminal courts
would be impractical, ineffective, and , where it could be pursued, often
unnecessary. Among other problems, it would not address widespread and deeply
entrenched petty corruption, would prove ineffective in cases of true
impunity, and arguably would trivialize genocide and war crimes by
equating them with theft and abuse of power. Long-term, sustainable anticorruption measures cannot be instilled from above via international
treaties and courtsthey must be cultivated domestically from the ground
up. The U.S. should oppose proposals to create an IACC.
new International Anti-Corruption Court (IACC).

AT: Biotech Turn

2AC---No Biotech Bubble

No biotech bubble---industry is set for long-term growth
Chang 3/27 (Sue, Markets Reporter, MarketWatch, 3/17/15, Biotech bubble may
just be an optical illusion, http://www.marketwatch.com/story/biotech-bubble-mayjust-be-an-optical-illusion-2015-03-27, Accessed 7/25/15)//LD
SAN FRANCISCO (MarketWatch)The

stellar performance of biotechnology stocks in the

past few years has predictably sparked fears of an impending crash . But for
all the talk of a bubble, biotechs are far from being overbought , according to
analysts at Credit Suisse. There are optics suggesting that we are in a biotech bubble, wrote Ravi Mehrotra at Credit Suisse in a
note to investors on Friday. Biotech was the best-performing sector between 2011 to 2014 and the NYSE Arca Biotechnology Index
BTK, -3.46% rose 204% since January 2011 versus the S&P 500s SPX, -1.07% 64%. The combined market cap of the top five biotech

a multiyear rally does not a bubble

make, according to Mehrotra. Yes, we are in unprecedented times with regards to
performance, interest levels, valuations of SMID caps but we are also
seeing unprecedented success in the sectorsuccess that is fundamental
and long-lasting, he said. At the core of Mehrotras analysis is that the biotech industry business
model has changed and evolved over the past three years from Biotech
1.0 to Biotech 2.0. Biotech 1.0 is the Hopes And Dreams Model make great drugs for unmet medical needs and sell
them thus creating a unique infrastructure. Biotech 2.0 is the Nirvana Model where
companies develop next-generation blockbuster drugs that bring with it
record growth and profitability. Biotech 2.0 not only delivered exceptional top-line growth that was further
leveraged to even higher bottom line growth but a massive improvement in operating margins, he said. Biogen Inc.
BIIB, -22.08% Gilead Sciences Inc. GILD, -4.11% and Celgene Corp. CELG,
-2.96% are prime examples of companies that successfully adopted the
Biotech 2.0 model, he said. Aside from a fundamental shift in the industry, he also claims the
cool factor of gene therapy, stem cells, and cell engineeringalong with
new scientific discoveries make these technologies drug-able--will fuel
greater investors interest in biotech stocks. Mehrotra said he believes biotechs must
dominate in their chosen fields to sustain the upward trajectory. We view
domain domination as the best pathway for yielding the highest chances
of post 2020 growth. Among large caps, Biogen and Celgene are almost on the
verge of domain domination while small-cap names that bear watching are Celladon Corp. CLDN, -1.98%
companies is $513 billion, quadrupling from $128 billion in 2011. But

Ironwood Pharmaceuticals Inc. IRWD, -6.13% Ovascience Inc. OVAS, +0.76% Esperion Therapeutics Inc. ESPR, -20.71% PTC
Therapeutics Inc. PTCT, -2.94% and Amana Takaful PLC ATLN, +7.69%

1AR---Ext. No Biotech Bubble

No biotech bubble---innovation, aging population, full
pipelines, visible growth
Greenberg 4/6 (Gregg, staff reporter, The Street, M.B.A. from Cornell
University's Johnson School of Business, and a B.A. in history from Amherst College,
4/6/15, Biotech Stocks Still Feeling Healthy Despite Bubble Talk,
http://www.thestreet.com/story/13102754/1/biotech-stocks-still-feeling-healthydespite-bubble-talk.html, Accessed 7/26/15)//LD
Shareholders feeling a touch of vertigo following the
steep run-up in health care and biotech stocks need not reach for the medicine
cabinet -- or the exit -- just yet, said Marshall Gordon, senior research analyst
at ClearBridge Investments. "You really have some powerful long-term
tailwinds including innovation and the aging of the population which can
continue to drive the stocks higher," says Gordon. The health care sector, as represented
NEW YORK (TheStreet) --

by the Health Care Select Sector SPDR ETF (XLV), climbed 6% in the first quarter of 2015 compared to a flat S&P
500 index. Nearly a quarter of the XLV is comprised by pharmaceutical giants Johnson & Johnson (JNJ) (10%), Pfizer
(PFE) (8%) and Merck (MRK) (6%). As for which major drug companies will fare best in the coming months, Gordon

the winners will be those companies that repeatedly deliver

encouraging clinical results, as well as solid drug launches. He cites the Food and
said

Drug Administration's early approval last month of Bristol-Myers Squibb's (BMY - Get Report) advanced lung cancer
drug Opdivo as an example of how a clinical success can generate momentum for a pharma giant's shares. Bristol's
stock spiked 6% on the approval and have risen over 28% in the past 12 months. Must Read: 10 Stocks Carl Icahn Is

Gordon also dismissed the idea that investors may want to avoid U.S.
drug companies due to the strengthening dollar and bet on European players instead.
Buying

"Currencies can make a difference in the short term but long-term success depends on bringing new drugs to

Gordon is even more bullish on the biotech sector,

despite growing worries that the space is piercing bubble territory . The sector,
market," said Gordon. Meanwhile,

as widely tracked by the iShares Nasdaq Biotechnology ETF (IBB), spiked 12% in the first three months of 2015 as a
result of merger deals that included AbbVie's (ABBV) $21 billion acquisition of Pharmacyclics to gain access to its
Imbruvica blood cancer treatment. "Certainly

valuations are toward the higher end of

historical ranges, but I don't see it as overvalued," said Gordon. "The bigcap biotechs have very full pipelines and visible earnings growth for the next
few years, so they remain attractive." Among Gordon's top biotech picks are Biogen Idec (BIIB - Get Report) and
BioMarin Pharmaceutical (BMRN - Get Report).

2AC---Credibility Turn
Only increased FDA cred can save the biotech bubble from
bursting
Baghda 7 (Ramsey, Regulation Policy Market Access, September, Vol. 2, No. 9,
Avandia and the Commercial Impact of FDAs Credibility Gap,
www.consumersunion.org/pdf/RPMreport0907.pdf)
The last thing industry needs right now is more damage to FDA s already battered
cred ibility. But that is precisely what happened in the Avandia review. The Whipsaw Effect: The Cost of FDAs
Loss of Credibility If you dont think a weak FDA can hurt the drug industry, think
again. The cost may be impossible to quantifyor it may be surprisingly easy. How about $13
billion? That is how much value GSK lost from Wall Streets initial reaction to the Avandia safety signal. On
May 21, a meta-analysis showing a 43% increased risk of heart attack for
Avandia patients compared to control was published in an electronic version of the
New England Journal of Medicine. The analyis was conducted by Cleveland Clinic cardiologist Steve Nissen and his
colleague Kathy Wolski.

That same day, GSK lost 8% of its market cap, or $13

billion . The stock market was in no mood to wait for FDA to speak on the issue. The market sees, for all
practical purposes, that drug safety determinations have been ceded to outside
figures with the reputation and ability to generate headlines . Would GSK
have lost billions if the investment community trusted FDA as the final
word on drug safety? Theres little doubt Glaxos stock price would have taken a hit, but a $13 billion hit
in one day? No , I think [the hit] would have been less, MedImmune Inc. CEO David Mott says.
Mott isnt alone. If there was a stronger FDA, then people wouldnt have been
as quick to judge Avandia based on what may not be a thorough analysis, agrees Sam Colella,
cofounder and managing director of the hedge fund Versant Ventures.

1AR---Ext. Credibility Turn

Only FDA cred can save the biotech bubble
LaMattina 14 (John, Forbes pharma contributor, How Did A 30 Year Big Pharma
Veteran Become An FDA Apologist?,
http://www.forbes.com/sites/johnlamattina/2014/04/01/how-did-a-30-year-bigpharma-veteran-become-an-fda-apologist/)
a strong,
independent FDA is crucial to the success of any company doing drug R&D. The
primary role of the FDA is to protect Americans from unsafe drugs and poorly
So, how did a big pharma guy become an FDA apologist? Basically, it stems from the fact that

effective agents. Patients and physicians need to be assured that the medicine being prescribed has undergone
vigorous and thorough testing. FDA credibility makes moot the accusations of pharma critics like
Ben Goldacre that: Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly
small numbers of weird, unrepresented patients, and analyzed using techniques that are flawed by design, in such a
way that they exaggerate the benefits of treatment. Anyone who has worked with the FDA knows that the FDA
reviews all clinical trials and would never allow a key clinical trial to proceed if it was poorly designed or was to
include weird, unrepresented patients, or analyzed with flawed techniques. Such comments are absurd. Yet,

unless we have a strong and well respected FDA, such challenges are
accepted as fact. The same can be said about the side effects of new drugs. Some critics charge that the
industry hides adverse events of their experimental medicines. Few realize, however, that a company is
legally bound to report every adverse drug event within 15 days of its
occurrence. Furthermore, when a company files a New Drug Application for FDA approval, every shred of data
ever accumulated by the company is included. Thus, the credibility of the biopharmaceutical
industry is directly connected with the credibility of the FDA . Should the public
believe that the FDA is inadequately doing its job, then they will be concerned that the medicines they are being

pharmas reputation is directly tied

to the strength of the FDA. Given that I believe that pharmas biggest
challenge is improving its poor reputation, you can see why I believe that
the FDAs role is important for so many reasons.
prescribed are not what they are made out to be. In effect,

1AR---AT: ABR Impact

No antibiotic resistance impact
Jesse Pines 10, Professor, Emergency Medicine and Health Policy, George
Washington University, Should We Be Afraid of the Superbug? FOREIGN POLICY,
9/3,
www.foreignpolicy.com/articles/2010/09/03/should_we_be_afraid_of_the_superbug,
accessed 9-14-14.
For a few days this August, much of the news media in the West became convinced that we were headed back to
the 1800s, medically speaking. A study in the September 2010 issue of British medical journal the Lancet argued
that bacteria carrying genes for NDM-1, a gene that imparts resistance to a key family of antibiotics, had made their
way through India and Pakistan into Britain and were now threatening to derail medical treatment across the
developed world. Linked with the always shady-sounding concept of "medical tourism" -- the practice of traveling to
other countries for budget surgery -- the so-called "superbug," able to breed vicious and deadly infections, became
an instant media panic during a slow news month. The Drudge Report and Andrew Breitbart's news website both
featured it. A Guardian science columnist wrote, "Now, the post-antibiotic apocalypse is in sight." Er, not so much.

the reality of superbugs is a bit more complex than the

media has portrayed it. Yes, antibiotic-resistant bacteria are a threat, as this week's news of an outbreak
As with most August stories,

among premature infants in London reminds us. But no one yet knows how bad NDM-1-related infections could be.
Not only is it far too early to say we're headed for apocalypse , we've also got a lot to
learn from superbugs -- namely, how our own over-use of antibiotics is making it more likely that a superbug of the
future could live up to this summer's hype. Alexander Fleming discovered the first antibiotic by accident in 1928,
when he left out a bacterial culture for a month while on vacation and came back to find that some of the bacteria
had been killed by a fungus named Penicillium. By the early 1940s, a commercial product, penicillin, was massproduced to cure bacterial infections in humans, and medical practice hasn't been the same since. These days,
antibiotics are a major weapon in medicine's war on disease, used to treat everything from life-threatening
infections like meningitis to more run-of-the-mill ear infections. For more advanced medical technologies, like
chemotherapy or organ transplantation, antibiotics are needed to prevent and treat infections while patients heal.
Neither treatment would be possible without antibiotics. At this point, in fact, antibiotics are suffering from their
own success. They are so engrained in the medical and social culture that over-prescription is a major problem.
Recent surveys have found that 70 to 80 percent of doctors' visits for sinus infections result in an antibiotic
prescription. But most sinus infections are caused by viruses, and antibiotics don't cure viral infections. The
medical sin of antibiotic overuse goes beyond mere ineffectiveness -- it actually can be harmful. Here's how it
works: Bacteria are everywhere on our bodies, even when we are not sick. When we take antibiotics for a bacterial
infection, they only kill certain bacteria (usually the ones making us sick). Then, as the body gets better, the
surviving bacteria multiply and take over. Now and then a few remaining bacteria carry special resistance to
antibiotics -- which is what kept them alive in the first place. With the other bacteria out of the way, the resistant
bacteria (i.e., the superbug) can multiply and sometimes cause problems. For example, if one of those superbugs
causes an infection, some antibiotics won't work anymore, and then you have an infection that is more difficult to
treat. One of the prototypical superbugs caused by antibiotic use (and overuse) is Methicillin-Resistant
Staphylococcus aureus (MRSA). MRSA is resistant to many antibiotics, including penicillin, and causes a variety of
problems in humans: mostly skin infections, but also more invasive diseases like pneumonia and bloodstream
infections. Another superbug that's been around for a while but has also taken a recent media tour is Clostridium
difficile (C. diff), which can be spread when antibiotics wipe out normal intestinal bacteria that keep C. diff in check.
A recent study found C. diff infection occurred in 13 out of every 1,000 hospitalizations. C. diff causes diarrhea, and
in some cases a particularly severe and sometimes lethal infection of the colon. Looking at bacteria carrying the
NDM-1 gene, C. diff, and MRSA, it's not surprising that people would panic over the possibility of these or other,
even more resistant, bugs of the future making our advances in antibiotics worthless. And it's a legitimate fear.
Although there are antibiotics and other treatments that work against all known superbugs, bacteria will continue to
evolve, developing stronger antibiotic resistance in the future. It is conceivable that bacteria will someday outsmart

it is unlikely that it will happen any time soon. One reason is

that there are many different classes of antibiotics , so while some don't work
against superbugs, there are usually others that do. Antibiotics that have been
shelved for years might even be re-introduced to fight superbugs, though obviously this
our best medical technologies. But

would be less than ideal because of higher risk of side effects. A better and more likely solution is for drug
companies and other

incentives

scientists to discover new classes of antibiotics. The financial

would be huge --

for heading off a true superbug-led medical catastrophe

something that always drives medical innovation quite nicely, as it did with treatments
for HIV in the 1990s.

NEG

T-Privacy

1NC---Violation
Whistleblowers dont have an expectation of privacy
Issa 14 (Chairman Darrel Issa- committee on oversight and government reform. HEARING BEFORE
THE COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE
HUNDRED THIRTEENTH CONGRESS SECOND SESSION. February 26, 2014. Pg 3.
http://www.gpo.gov/fdsys/pkg/CHRG-113hhrg87176/pdf/CHRG-113hhrg87176.pdf//GH)

Federal employees know that every communication they

do on government property, on government time, or using government
assets, or doing government business is subject to the Federal
Government looking at it. There is no expectation of privacy.
I am here to say that the

Politics

1NC---Dems Link
House democrats defend status quo surveillance
AP 14 [February 26, 2014 http://www.foxnews.com/politics/2014/02/26/republicans-blast-fda-for-secretlymonitoring-emails-agency-whistleblowers/ Republicans blast FDA for secretly monitoring emails of whistleblowers]
(Vaibhav)

House Democrats defended the surveillance, in part, pointing to the

findings of the inspector general that oversees the FDA . In a report released just
ahead of the hearing, the inspector general concludes that the surveillance had a
"reasonable basis" because the employees were leaking confidential
information to the press about devices under review . The report also concluded that
the surveillance was not targeted to capture communications with Congress
or any other specific parties. While finding justification for the monitoring, the report also faults the
agency for having no system to ensure that "their investigations were conducted in
accordance with laws and regulations." As a result, the program "had significant
negative consequences for FDA."

1NC---Health Link
Reform is unpopular---partisan posturing
Mukherjee 1/28/2015 (Sy- Associate Editor at Industry Dive, managing and writing
content for BioPharma Dive and occasionally contributing to sister publication Healthcare
Dive. 4 things you need to know about the sweeping FDA reform bill Congress just
proposed. http://www.biopharmadive.com/news/4-things-you-need-to-know-about-thesweeping-fda-reform-bill-congress-just/357481///GH)

There's bound to be controversy and partisan sniping when it comes to

crafting reform of this magnitude. And the stakes are even higher
considering that the legislation would directly affect the health and safety
of millions of Americans, including some of the most sick and vulnerable people in the country.
However, 21st Century Cures (or at least many of its major provisions) is the rare initiative that has enjoyed
bipartisan support in an ever-gridlocked Congress. As the draft summary takes pains to note, the reforms proposed
in the bill come from top Democrats and Republicans alike, including Sens. Michael Bennett (D-CO) and Orrin Hatch
(R-UT), Rep. Joe Pitts (R-PA), Rep. Marsha Blackburn (R-TN), Rep. Diana DeGette (D-CO), and even the White House.

an ambitious mishmash of ideas, bipartisan or not, does little to ensure

comity or final passage in today's tumultuous legislative landscape. Last
minute hang-ups over controversial provisions, or the specifics of the bill's
funding mechanisms, could easily derail the whole effort (see: every year that
Congress has failed to pass a permanent "doc fix"). And then there's the fact that Congress is, for the first
time during Barack Obama's presidency, now fully controlled by Republicans. That
means that Senate health committee leadership has flipped from
Democrats to the GOP, and Republican staffers are the ones who get to
write the actual language of the bill. This could lead to some chestthumping and scuffles over turf (not to mention legislative minutiae ).
But

2NC---AT: No Link
The FDA is tied to the executive and politically controversial
Cook 1 (Kate- Harvard paper. The Presidential FDA: Politics Meet Science. Pgs 89. http://dash.harvard.edu/handle/1/8852216//GH)
In spite of the FDAs long history, the agency was not recognized in Congressional legislation until 1988.27
Moreover, until 1988 the head of the agency the Commissioner of Food and Drugs was appointed by the

the FDA Commissioner must be

appointed by the president with the advice and consent of the Senate.28 Because of the
Secretary of Health and Human Services. Since 1988 however,

public interest in food and drug regulations the FDA is a highly visible
administrative agency . The potential sensitivity of its decisions always
have given the Commissioner a direct line to the Secretary of HHS and, sometimes the
White House as well.29 Formally placing the responsibility of appointing the
Commissioner of the FDA in the hands of president rather than the Secretary makes
explicit the importance of the job, exposes the inherently political nature
of the job , and suggests that indeed the executive is properly located in
the executive branch of government. That is, the FDA does not have the same independence of
presidential control that independent agencies enjoy. Indeed, the Commissioner can be removed from her position
at the will of the president for any or no reason.30 Supreme Court doctrine has construed the president has the
power to remove an employee (as designated by Congress) as evidence of whether or not the executive has
authority to control the policies of the agency in question.31 Interestingly, prior to the statutory grant that the
Commissioner shall be appointed by the president back when the Health and Human Services Secretary appointed
this head few administrative transitions resulted in a high level of resignations or reassignments among the
agencys middle and upper-level managers.32 Thus, many observers have noted that unlike some of its peer

multiple
political organizations pull the FDA in different directions (sometimes
agencies, the FDA has historically operated without substantial political influence.33 Nonetheless,

contradictory): Congress, the president, the consumer protection lobby, the pharmaceutical lobby, and the
bureaucracy in general. To fully expose and compare the relative influence and strength of these political bodies is
beyond the scope of this paper; suffice it to say however, that

every decision the FDA faces will

create political results effecting given constituencies and harming others.

2NC---FDA Link
The plan is unpopular---business lobbies
Smith 10 (Douglas- Senior Lecturer in Residence at Loyola University Chicago School of
Law. The criminalization of Business. 6/16/2010.
http://spectator.org/articles/39409/criminalization-business//GH)

the Obama administration has exhibited a disturbing tendency

to criminalize business. Recently the administration announced that it was opening a criminal
Under the radar,

investigation into the activities of Goldman Sachs in selling securities backed by subprime mortgage loans. Now

the Food and Drug Administration is considering imposing

criminal penalties against Johnson & Johnson's McNeil Consumer
Healthcare unit for a "pattern of non-compliance" with rules governing the manufacture of pharmaceutical
products. This criminalization of business represents a dramatic expansion of
government power that is unwarranted . In the case of McNeil, the FDA's action is prompted
comes word that

by a series of recalls of contaminated over-the-counter children's medicines. While this is a potentially serious

FDA official Joshua Sharfstein recently acknowledged in

congressional testimony that "the risk for any child in the United States
was remote" and that "[s]o far, FDA has no cases with evidence that a product quality issue contributed to a
significant adverse health outcome." Moreover, Mr. Sharfstein's testimony makes clear that the FDA was
long aware of potential problems at McNeil's facilities. As he acknowledged, "Before
matter,

2009, FDA investigators identified several problems with cGMP compliance at facilities run by McNeil." Nonetheless,

only now has the FDA suggested that criminal penalties are warranted .
Moreover, recent comments by FDA officials indicate that this latest action may be part of a
wider program to make its regulatory program more "visible " by, among other
things, "strengtheningcriminal enforcement of FDA's laws."

FDA reform is unpopular---economy

Smith ND (Fred- founder of the competitive enterprise institute. Pg 1. Expectations for
a New Congress The Triumph of Hope over Experience?. https://cei.org/pdf/5705.pdf//GH)
**I cant find a specific date but it was written in the context of the 110 Congres so its from
this decade I promise
Speaker Pelosi has suggested revising some of the more burdensome aspects of the Sarbanes-Oxley Act; we hope
to work with her and others on this issue. We hope to share with the new Congress our ideas on how to jump-start
the stalled economic liberalization processhampered by botched, partial deregulations in electricity,
telecommunications, airlines, and other network industries .

We also hope to work with the new

Congress on Food and Drug Administration (FDA) reform, to speed the process of bringing new lifesaving drugs to market. With major change comes major risks. As a Louisianan well aware of
the something-for-nothing allure of populism, I see worrisome traces of it in the current
political climate. Mistakes made in the name of helping the little guy
can hurt everybody in the long run, by creating long-lasting damage to the
American economy. Proposals for one-size-fits-all mandates in areas like
wages and prescription drugs threaten to undermine many of the new
Democrats recognition of the marketplace as the best means of allocating resources. We will happily
work with lawmakers of both parties to help stop bad bills such as these.

Disease CP

1NC---Disease CP
Text: The Department of Defense should build the military
public health capacity of countries with weak civilian
emergency response and engage multilateral forces to
undertake broader disease response efforts.
DOD solves disease best---global connections
CSIS 10 (Center for Strategic and International Solutions- policy proposal institution
based on coming up with international policies for growing problems. From Conflict to
Pandemics Three Papers from the CSIS Global Health and Security Working Group A Report
of the CSIS Global Health Policy Center. Pg 3-4. May 2010.
http://csis.org/files/publication/100506_Bonventre_FromConflictToPandemics_Web.pdf//GH)

DODs geographic combatant commands build and maintain relationships

with militaries across the globe through disaster responses, civic assistance missions, training
exercises, and formal security cooperation programs . This network of connections to foreign
militaries gives DOD access to senior decisionmakers across the globe . In countries
with weak civilian emergency response capacity, governments often turn to their militaries for emergency

Focusing a portion of military-to-military activities on building the

military public health capacity of these countries could fill important gaps
responses.

in global disease detection and response . DOD also has an opportunity to

engage multilateral forces such as UN peacekeeping operations, NATO, the
African Union, or other regional military forces to undertake broader
disease surveillance and response efforts. Using the World Health Organization (WHO) or
other neutral international organizations as an independent interlocutor can facilitate the building of trust and
strengthen partnerships between military and civilian health agencies and result in a fuller DOD engagement with a

For example, officials from NATO, WHO, and DODs Global Emerging
met with Russian counterparts in 2003
to discuss pandemic preparedness. A follow-on event on emerging disease surveillance,
greater legitimacy.8

Infections Surveillance and Response System (GEIS)

communication with civilian counterparts, and compliance with the legally binding and internationally agreed upon
International Health Regulations (IHRs) is being planned for fall 2010 under the aegis of WHO and the International

There is an
opportunity to leverage these expanding global networks of military
medical policymakers, some of whom command more health capacity than
their civilian health ministries.
Congress of Military Medicine, a consortium of military surgeons general from 104 nations.

2NC---Solvency
Empirics prove the DOD is the most effective
CSIS 10 (Center for Strategic and International Solutions- policy proposal institution
based on coming up with international policies for growing problems. From Conflict to
Pandemics Three Papers from the CSIS Global Health and Security Working Group A Report
of the CSIS Global Health Policy Center. Pg 4-5. May 2010.
http://csis.org/files/publication/100506_Bonventre_FromConflictToPandemics_Web.pdf//GH)

DODs domestic and overseas military laboratory network has a long and rich
heritage, having contributed over the years to many important developments in
preventive medicine that not only benefit uniformed personnel, but also contribute to improving overall
global public health. The Centers for Disease Control and Prevention (CDC), for example, evolved out
of a wartime agency established to reduce malaria around military training bases in the southern United
States These laboratories were originally established for the explicit purpose of researching and developing
products (e.g., yellow fever vaccine, antimalarial drugs) that would preserve and protect the health of our

these efforts continue to this day through the Military

Infectious Diseases Research Program. Although geographic locations of the laboratories have
uniformed personnel;

changed over time, their current sites are in Peru, Thailand, Southeast Asia, Egypt, and Kenya, assuring broad

after Presidential Decision Directive 7 stated

that DODs role should be expanded to include support of global
surveillance, training, research, and response to emerging infectious
disease threats, the DOD Global Emerging Infections Surveillance and Response System (GEIS)
was established to implement this directive. The GEIS program brought
much needed flexibility to DODs laboratories by facilitating outbreak
investigations, disease surveillance, capacity building, and training that
directly benefits host nation civilian populations while simultaneously
improving collaborative military-to-military relationships and providing
baseline disease-specific data to help frame future DOD research
priorities.
visibility to global health risks. In 1996,

Corruption CP

1NC---Corruption CP
Text: The United States Federal Government should create the
International Anti-Corruption Court as proposed by Mark L.
Wolf.
Solves the corruption advantage and doesnt link to politics--wide domestic support
Biron 14 (Carey- Washington correspondent for IPS. Proposal for International AntiCorruption Court Seeing Significant Momentum. 11/21/2014.
http://www.ipsnews.net/2014/11/proposal-for-international-anti-corruption-court-seeingsignificant-momentum///GH)

The key U.S. advocate of a proposal to create a multilateral body

mandated to investigate allegations of political corruption says the idea is
receiving significant interest from civil society, politicians and major business leaders. Mark L.
Wolf, a U.S. federal judge, first proposed the idea of an International AntiCorruption Court (IACC) in two articles this summer (available here and here). Since that time, Wolf told a recent
briefing at the U.S. Congress, the proposal has seen remarkable progress. There
are, of course, challenges to refining the concept of an IACC, Wolf told a House of
Representatives committee last week. However, since July 2014 significant support has developed for
meeting these challenges. Wolf reported ongoing meetings with U.S.
officials and the World Bank, and reported that the new United Nations
high commissioner for human rights, Zeid Raad Hussein, has made the
IACC proposal a personal priority. Hussein was a key force in the creation of the International Criminal
Court, a potential model for the IACC. This week, Wolf is addressing representatives of major global companies. American
companies generally want to behave ethically and, in addition, are significantly deterred by the threat of prosecution, Wolf
stated. They know they would benefit from the more level playing field an IACC
would provide. Indeed, many say the speed with which the congressional
committee moved to hold last weeks briefing is remarkable. It
underscores a uniquely broad consensus, both domestically and
internationally, around the need to crack down on what is referred to as
grand corruption the abuse of political office for personal gain. Increasingly, this issue is being seen as less one of
theft than of basic human rights. Todays briefing seeks to foster an understanding that
human rights and anti-corruption efforts are inseparable , James McGovern, the member
of Congress who chaired the committees discussions, stated in opening remarks. Currently, there is a lack of reference to human
rights in international anti-corruption commitments and, conversely, the lack of reference to corruption in international human rights
instruments. 140,000 children a year Grand corruption is today thought to eat up more than five percent of global gross domestic
product. According to estimates cited by Judge Wolf, illicit financial flows out of developing countries are 10 times larger than the
foreign assistance those countries receive losses that have direct human consequences. In the developed world we can make the
mistake of seeing corruption as merely stealing money, but in fact political corruption kills more people than war and famine put
together 140,000 children a year, by our estimates, Akaash Maharaj, the executive director of the Global Organization of
Parliamentarians Against Corruption (GOPAC), told IPS. If a political actor were to kill that many people, there would be very few
people who wouldnt say that we have to deal with this problem. But those who bring about human suffering through political

GOPAC, which includes legislators from almost every

country, has been mobilising around the need for concerted international
action against corruption for the past three years. Maharaj says that his organizations
membership has lost faith in the ability of many countries to deal with political corruption at the national level. While there
are international mechanisms that threaten penalties for egregious human
corruption are no less guilty.

rights abuse, for the most part corruption continues to fall into a nebulous
zone of national responsibility. Existing multilateral agreements, including the United Nations Convention
Against Corruption, which came into effect in 2003, lack substantive enforcement mechanisms. Yet while anti-corruption legislation
exists in almost every country, advocates note that many of the most corrupt officials are often able to use their wealth and power
to subvert these laws. These figures are typically the least likely to face domestic justice, and thus can come to expect impunity.
There

are certain crimes so beyond the pale and beyond state capacity to
prosecute that it becomes appropriate for the international community
and for international law to become engaged. Certainly the harm grand corruption causes in
many developing countries is enormous, Zorka Milin, a legal adviser with Global Witness, a watchdog group, told IPS. An
international court would be a good mechanism for trying to translate that
momentum into meaningful accountability, which we havent really seen
so far. Its important to frame the discussion in terms of ending impunity ,
and this court would be one piece of that, together with other legal anticorruption tools at the domestic level. Under Wolfs
proposal, an IACC would be mandated to investigate and prosecute officials from countries that are unable or unwilling to undertake
such actions on their own. He suggests making acceptance of the proposed courts jurisdiction a pre-condition for membership
under the Convention Against Corruption or at the World Trade Organisation, or for obtaining loans from multilateral banks.
Inevitable, unclear action The global discussion today is increasingly conducive to some sort of concerted global action against
political corruption. In part, this trend is driven by strengthened concern around the effects that tax evasion is having on public
coffers in both developed and developing countries. Unquestionably,

there is today more

momentum and awareness on the issue of grand corruption, and thats
the major reason these issues are rising on the international agenda, Milin
says. GOPACs Maharaj agrees. Im struck by the extraordinary level of consensus across the world, he says. This is absolutely
inevitable. Its not a matter of if, but when. Exactly what should be done about the issue, however, remains highly contentious.
There are multiple potential options, after all, with an international court being just one. Others include expanding the purview of the
International Criminal Court or other regional human rights courts. Likewise, the jurisdiction of national judicial systems could be
enlarged to be able to deal with allegations of corruption in other countries. Another possibility could be to coordinate national
legislation and priority in developed countries, aimed at seizing the assets of or denying visas to corrupt officials. While this
would not result in jail time, it would make it harder to spend ill-gotten wealth while simultaneously emphasising international
disapproval. Importantly, some countries have become increasingly aggressive in this regard in recent years, particularly the United
States and Switzerland. Watchdog groups say these nascent initiatives are important and already having impact. Over

the
last eight years theres been growing official action against kleptocracy in
the U.S. and elsewhere, Arvind Ganesan, the head of the business and human rights programme at Human
Rights Watch, told IPS. Strengthening those efforts now meaning fully resourcing
and expanding them, and pushing other countries to put in place similar
policies will build momentum towards an International Anti-Corruption
Court.

2NC---Solvency
IAAC solves corruption
Wolf 14 (Mark L- senior united states district judge. The Case for an International AntiCorruption Court. July 23, 2014. Pg 1.
http://www.brookings.edu/research/papers/2014/07/international-anti-corruption-courtwolf//GH)
International efforts to combat grand corruption have been inadequate and ineffective. Similar circumstances
concerning genocide and other egregious abuses of human rights led to the creation of the International Criminal

An International Anti-Corruption Court (IACC), similar to

the ICC or as part of it, should now be established to provide a forum for
the criminal enforcement of the laws prohibiting grand corruption that
exist in virtually every country, and the undertakings that are requirements of various treaties and
international organizations. Staffed by elite investigators and prosecutors as well as
impartial judges, an IACC would have the potential to erode the
Court (ICC) in 2002.

widespread culture of impunity , contribute to creating conditions

conducive to the democratic election of honest officials in countries which
have long histories of grand corruption, and honor the courageous efforts
of the many people, particularly young people, who are increasingly exposing and opposing corruption at
great personal peril.

Biotech Turn

1NC---Biotech Turn
Biotech is in a bubble now because of FDA approvals---plan
bursts it
Zuckerman 3/26 (Gregory, Wall Street Journal, 3/26/15, Biotech stocks inflate
fears of Nasdaq bubble, http://www.theaustralian.com.au/business/wall-streetjournal/biotech-stocks-inflate-fears-of-nasdaq-bubble/story-fnay3ubk1227278542038, Accessed 7/26/15)//LD
Nasdaq bubble fears are back. But this time around, the biggest dangers
may not involve technology stocks. Instead, some investors are looking askance at biotech stocks, a
sector that wasnt nearly as developed when the Nasdaq Composite Index set its record close in 2000 of 5048.62.

The Nasdaq Biotech Index is up about 240 per cent since the beginning of
2012. That dwarfs the 82 per cent gain logged by the Nasdaq-100 tech index of the largest technology
companies listed on the exchange operated by Nasdaq OMX Group. Giant biotech firms have
surged in value: both Gilead Sciences, valued at $US152 billion ($192bn), and Amgen,
at $US127bn, have risen 40 per cent over the past year. Biogen, valued at
$US108bn, has climbed 47 per cent. Celgene, valued at $US99bn, is up 75
per cent. If any part of the market reminds me of the go-go tech years,
its biotech, said Jack Ablin, chief investment officer at BMO Private Bank. Its
an expensive sector. Companies developing biotech drugs often upstarts that can be
acquisition targets for larger pharmaceutical companies comprise 13 per cent of the Nasdaq
Composite Index by market value but have accounted for 27 per cent of
the indexs gain over the past year, according to Birinyi Associates. Biotech firms generally seek
to develop medicines using living cells rather than chemicals. Nasdaq biotech shares have advanced 27.4 per cent
over the past six months and roughly 17 per cent so far this year, compared with gains of 7.3 per cent for Nasdaq-

Behind the surge

are heady earnings growth, more approvals from the Food and Drug
100 Technology Sector Index shares over the past six months and 1.4 per cent this year.

Administration and investor enthusiasm for a range of new biotech drugs

and potential treatments. However, biotech stocks often are viewed as a gamble for investors: highrisk and high-reward propositions that can drop like a rock if a drug trial fails or funding runs out. Biotech
shares have been hammered en masse several times, notably in 1990,
1993 and 2000. To us, shares of biotech companies find themselves entering
bubble territory, said Darren Pollock, portfolio manager at Cheviot Value Management. We think
investors are applying too high a success rate on biotech molecules. For all
the sectors recent successes, some see recent excitement for biotech shares as the
latest sign that low interest rates are encouraging investor to take
excessive risks. If the economy slows, or rates start climbing, investors could turn more conservative and
shy away from these companies, which often offer little in the way of earnings. A burst of IPOs of biotech companies
over the past few years raises other concerns that these companies and selling insiders may be cashing in on
investor excitement at the expense of public shareholders. That is why some investors are becoming wary.

Biotech shares in the Nasdaq now trade at almost 50 times their earnings
over the past year, compared with a price/earnings ratio of 27.5 for the
overall Nasdaq Composite. Nasdaq biotech shares trade at 31.5 times their expected earnings over
the next 12 months, above the 21 ratio for the overall Nasdaq market, according to FactSet.

The impact is economic collapse pharma supports resilience

Sullivan 11 (Thomas Sullivan, founder of Rockpointe Inc., former political
consultant, Study Shows Importance of Biopharmaceutical Jobs For US Economy,
Policy and Medicine, July 12, 2011, http://www.policymed.com/2011/07/study-showsimportance-of-biopharmaceutical-jobs-for-us-economy-for-every-20-billion-loss-inrevenue.html)
pharmaceutical research companies produce the highest-value jobs, the types of jobs Americans
the kinds of jobs that can drive future economic growth.
No other sector has the ability to drive innovation , create high-quality jobs and provide new lifeBio

want in the 21st century economy,

saving medicines for patients. According to a recent report from the Battelle Technology Partnership Practice (TPP), nationwide, the

pharmaceutical sector supported a total of 4 million jobs in 2009, including nearly 675,000 direct jobs. Battelle is the worlds largest
nonprofit independent research and development organization, providing innovative solutions to the worlds
most pressing needs through its four global businesses . TPP has an established reputation in
bio

statebystate assessment of the biopharmaceutical sector, and has recently undertaken major impact assessment projects for the Human Genome
Project, the nations biotechnology sector, and major bioscience organizations such as Mayo Clinic. TPP has also been active in provision of analysis to
industry organizations, including the Council for American Medical Innovation, PhRMA and BIOthe Biotechnology Industry Organization. Each job in a
biopharmaceutical research company supported almost 6 additional jobs in other sectors, ranging from manufacturing jobs to construction and other
building service jobs to contract researchers and child care providers. Together, this biopharmaceutical sectorrelated workforce received $258 billion in
wages and benefits in 2009. Battelle also found that across all occupations involved in the biopharmaceutical sector, the average wage is higher than
across all other private sector industries, due to the sectors role as a high value-added sector. Specifically, the annual average personal income of a

the
biopharmaceutical sectors total economic output (including direct, indirect and induced impacts)
was $918 billion in 2009. The sector generated an estimated $85 billion tax revenues in 2009$33 billion in state and local and more
biopharmaceutical worker was $118,690 in 2009 as compared to $64,278 in the overall economy. Additionally,

than $52 billion in federal. This impact comprises $382 billion in direct impact of biopharmaceutical businesses and $535 billion in indirect and induced
impacts (an output multiplier of 2.4meaning that every $1 dollar in output generated by the biopharmaceutical sector generates another $1.4 in output
in other sectors of the economy). To put this export volume into perspective, 2010s total biopharmaceutical exports of $46.7 billion compares favorably to
other major U.S. exports including: automobiles ($38.4 billion in 2010 exports); plastics and rubber products ($25.9 billion); communications equipment
($27 billion) and computers ($12.5 billion). In addition, the U.S. Congressional Budget Office noted that, the pharmaceutical industry is one of the most
researchintensive industries in the United States and that pharmaceutical firms invest as much as five times more in research and development, relative
to their sales, than the average U.S. manufacturing firm. At over $105,000 in biopharmaceutical R&D per employee, the sector is way ahead of the
average across all U.S. manufacturing which stands at about $10,000 per employeeand is far ahead of the second and third ranked sectors of
communications equipment and semiconductors, which respectively spend $63,000 and $40,000 per employee in R&D annually. PhRMA Statement on
Battelle Report Consequently, Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani issued a statement

pharmaceutical research sectors impact on jobs and

the American economy. Castellani asserted that, at a time when the U.S. is facing a jobs crisis, evidenced by the terrible
employment numbers from last Friday, it is critical that our policymakers embrace dynamic and innovative
business sectors such as the biopharmaceutical research sector and
refrain from stifling job growth through shortsighted proposals such as government-mandated price controls in Medicare
discussing the results from this report and the bio

Part D. Specifically, the PhRMA CEO pointed to a new paper from the Battelle Technology Partnership Practice, which underscored the pharmaceutical
sectors tremendous contribution to Americas economy. Castellani recognized that, startling potential job losses would result from undermining the
business foundations of biopharmaceutical companies. He noted that the Battelle report estimated that a $20 billion per year reduction in
biopharmaceutical sector revenue would result in 260,000 job losses across the U.S. economy and a $59 billion reduction in U.S. economic activity. As a
result, Castellani recognized that, as the President and Congressional leaders negotiate an important agreement on the debt ceiling and the future of the
nations economy, it is critical that the jobs crisis is not exacerbated. For example, Castellani noted how the President and some in Congress have
proposed including government-mandated rebates in Medicare Part D as part of a debt ceiling agreement. However, he recognized that such a provision
would have a dramatic negative effect on the economy and patients, and could undermine the success of the Part D program, which has very high
beneficiary satisfaction and has cost far less than original government projections. He pointed to the Battelle numbers, which clearly demonstrated that
reducing the biopharmaceutical sectors annual revenue by $20 billion would be a serious blow to employment. Castellani added that, while the research
is not specific to any one policy or event, proposals being considered, such as government-mandated Part D rebates, would be expected to have revenue
impact of this magnitude. Moreover, he noted that, Part D is an unparalleled success, providing unprecedented access to life-saving medicines for
seniors. Accordingly, Castellani asserted that PhRMA does not believe policies that discourage R&D and cutting-edge science and that will inevitably
slow the development of needed new medicines are fair for seniors waiting for new treatments against our most challenging and costly diseases. Battelle
Report The Battelle Report quantifies the economic impact of the biopharmaceutical sector on the U.S. economy and jobs using input/output analysis,
measures the direct and indirect impacts of the biopharmaceutical sector, and quantifies the economic impacts that would occur if biopharmaceutical
revenues increase or decrease from significant changes in the business operating environment. The report also highlights some of the functional impacts

pharmaceutical sectors contributions to enhancing

human health, improving life spans and sustaining the high qualityoflife that Americans enjoyand assesses the
contributions of the biopharmaceutical sector to key areas of importance to our
economy innovation, product exports and quality of jobs produced. The Battelle Report
of the sectorthe wideranging benefits provided through the bio

starts by recognizing that the biopharmaceutical sector has all of the characteristics for an ideal industry for economic growth and sustainability in the

the biopharmaceutical sector: Grows in output and employment even in tough economic times Provides high wage,
good quality jobs Is innovative and deploys hightechnology to generate comparative advantage for U.S. companies
U.S. Specifically,

boost the U.S. economy

Generates significant exports that

Has a strong supply chain that drives further economic growth across
the economy through multiplier effects Builds on Americas longstanding strengths and investment in fundamental and applied research

Encourages capital flows to sustain growth, and is profitable to provide

funds for reinvestment into the research and development (R&D) cycle; Generates federal, state and local
taxes and other economic contributions that support public services Is sustainable and not a major drain on global resources Is geographically dispersed,
providing opportunities for job creation and economic growth across many areas of the nation, not just a few selected places Produces a product of value

Improved
productivity resulting from prevention and effective management of
disease and chronic conditions; and Reductions in unnecessary hospitalizations resulting in potential costoffsets elsewhere in
the health care system. Fundamental to major progress in human longevity, reducing the marginalization of individuals from
to society, something that improves the quality of life for humankind, including Improved life spans (personal longevity)

disease and disability, and generally improving our qualityoflife, biopharmaceuticals are a unique contributor to societal and individual wellbeing.
Moreover, the output of the biopharmaceutical sector is highly valued by society because the sector develops and manufactures a broadrange of unique
products to treat disorders and diseases that, were they to go untreated, can ruin individual quality of life, personal abilities and productivity. In many

pharmaceuticals are central to helping to prevent and treat a range of

public health issues, address pandemic risk and thereby support national economic
security. For example, innovation in the biopharmaceutical sector, combined with the diagnostic and treatment skills of U.S. healthcare
instances, bio

professionals, has contributed to a lengthening of the average life span of Americans. In 1900, the expected life span of an American at birth was just 47.3
years. With the advent of more modern medicines and advanced medical knowledge, life expectancy at birth has seen a steady increase rising to 69.7
years in 1960, and 77.9 years in 2007. In fact, the National Bureau of Economic Research reports that there is a highly statistically significant relationship
between the number of new molecular entities [drugs] approved by the FDA and increased longevity. Furthermore, Lichtenberg found in a study of FDA
data that "approval of priorityreview drugsthose considered by the FDA to offer significant improvements in the treatment, diagnosis, or prevention of a
diseasehas a significant positive impact on longevity. Additionally, the American Hospital Association (AHA) notes that advances in medicine
contribute to national economic growth by helping Americans recover more quickly from injury and illness, avoid lost or ineffective work time due to flare

Without effective medicines and treatments for

illnesses, injuries, pain and chronic conditions, the productivity of the U.S. economy would clearly
be greatly impaired. Biopharmaceuticals are a key contributor to a more
productive and healthy America and U.S. economy. Beyond direct employment in biopharmaceutical companies, the
ups of chronic conditions, and live longer with higher quality of life.

biopharmaceutical sector is the foundation upon which one of the United States most dynamic innovation and business ecosystems is built. A large part of
the modern biomedical economy is built upon a robust foundation of biopharmaceutical companies that perform and support advanced biomedical and
technological R&D, and act as the funnel and distribution engine for getting lifesaving and qualityoflifesustaining therapeutics to the marketplace.
Providing R&D impetus and funding, capital resources, technology licensing opportunities, and a sophisticated market access and distribution system, the
biopharmaceutical sector is of central importance to the much broader biomedical and life sciences economy. Fueled by private investment capital,
venture capital investments, and public/private collaborations, and enabled by the U.S. open market system, the nation has been able to advance
biomedical innovation, which in turn has led to new startup companies, business growth and exports across the world. Conclusion Despite the
tremendous success in the biopharmaceutical industry, emerging infectious diseases continue to present new challenges and a substantial volume of long
standing diseases such as cancer, diabetes, neurodegenerative diseases, psychiatric diseases, immunological diseases, etc. continue to demand novel

The
need for ongoing biopharmaceutical research and development is simply enormous. The
treatments and improved therapeutics. There are millions of people suffering from diseases and disorders for which a therapy has yet to be found.

only way the U.S. economy can stay ahead of international competition is
by using advanced R&D and innovation to drive the growth of high valueadded industries. By leveraging
investment in federal lab, university and industry R&D, our nation is able to produce highvalue, typically technologically advanced products that the rest
of the world values highly. In recent decades, life sciences have come to the fore as a leading driver of U.S. technological innovation and competitive
advantage, and the biopharmaceutical sector is a key foundation of the life sciences innovation ecosystem. The Unites States biopharmaceutical industry
produces products that save, sustain and improve lives, and the sector has a large and significant economic impact, affecting many other key areas of the

Gains or losses in biopharmaceutical sector revenues will be

reflected in gains and losses across a broad range of additionally
important U.S. economic sectors that have robust supply chain
relationships with the biopharmaceutical sector.
U.S. economy.

Econ decline causes nuclear war

Hutchinson 14 (Martin, Business and Economics Editor at United Press
International, MBA from Harvard Business School, former international merchant
banker, 1-3-14, The chilling echoes of 1914, a century on Wall Street Journal)
http://online.wsj.com/articles/william-galston-secular-stagnation-may-be-for-real1409095263,

The years before 1914 saw the formation of trade blocs separated by high tariff
barriers. Back then, the world was dominated by several roughly equivalent powers, albeit with different strengths
and weaknesses. Today, the world is similarly multi-polar. The United States is in a position of clear leadership, but
China is coming up fast. Europe is weaker than it was, but is still a force to be reckoned with. Japan, Russia, Brazil,
India are also too powerful to ignore. A hundred years ago, big international infrastructure projects such as the
Berlin-Baghdad Railway, and before it the Suez Canal, were built to protect favored trading. Todays equivalent may
be the bilateral mining partnerships forged between, for instance, China and mineral-rich African states. Today, the
World Trade Organization offers some defence against tariffs. But protectionism could be become entrenched if
prolonged economic stagnation leads countries to pursue their own narrow interests. Germany, Austria, Russia and
France lost between 20 and 35 percent of national output between 1913 and 1918, according to Angus Maddisons
data used in Stephen Broadberrys The Economics of World War One: A Comparative Analysis. British GDP
declined in 1914 and 1915, but grew 15 percent over the four years, as did the U.S. economy. The 37 million

if history were to repeat itself,

the global conflict could be both more universal and more destructive. Nuclear weapons
proliferate. Warped diplomatic anger could lead to the deployment of chemical
and biological devices. Electromagnetic pulses could wipe out our fragile
electronic networks. Like the assassination of Archduke Ferdinand that sparked World War One, the catalyst for
military and civilian casualties may tell a more accurate story but

cataclysm might be something quite surprising. A global run on bank and other investment assets or an outbreak of
hyperinflation, maybe? These threats get more serious the more policymakers pump up equity, bond, property and

If global wealth evaporates, or is proven to be an illusion, todays largely

cordial global entente could be smashed with precipitous speed.
banking bubbles.

2NC---Ext. Yes Biotech Bubble

Yes biotech bubble---stock prices have risen 88%
Sarich 7/18 (Christina, Collective Evolution, 7/18/15, Biotech Stock Bubble
About To Pop & Heres Why, http://www.collectiveevolution.com/2015/07/18/biotech-stock-bubble-about-to-pop/, Accessed
7/26/15)//LD
Remember the dot.com bubble? How about the housing bubble? If you are old
enough you can probably even remember gas rationing. In the increasingly more transparent
manipulation of markets, the biotech bubble is now set to pop. The dot.com bubble may
not have affected you, but if you made it through that one unscathed, then you may have been bruised and battered by the housing
bubble even if you werent part of the mortgage scam, which mainly targeted the poor but affected the entire nation, since bank
bailouts were largely funded with the idea of peoples inability to pay used as a scapegoat, though big bank fraud was really to
blame. Pump and Dump These scams can be hard to keep track of, let alone understand, but they are all based on a single premise

An industry is inflated as the next best thing and puffed up to

such a degree, even the most level headed among us think were missing out if we dont invest, also called the
pump. Then prices are manipulated, the one percent that run the entire world push a few buttons,
and everything is devalued thats the dump. If you havent noticed, the biotech
industry has been heavily pumped lately. Weve been inundated with press about genetically
pump and dump.

modified this, and gene-edited that. From GM wheat trials that fail to the tune of several million dollars, to GM corn being refused by

the writing has been on the wall that the biotechnology dump is just
around the corner. In fact, the Zero Hedge website pointed out many months
ago that one of the sectors which was substantially stretched in this
country was biotech: Nevertheless, valuation metrics in some sectors do appear substantially stretchedparticularly
China,

those for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms
early in the year Equity valuations of smaller firms as well as social media and biotechnology firms appear to be stretched, with

Even with this news, however,

biotech stock prices have skyrocketed over 88 percent . Matt Taibbi, one of my favorite
ratios of prices to forward earnings remaining high relative to historical norms.

journalists for Rolling Stone, talks about this phenomenon with great acumen in an article titled, The Great American Bubble
Machine. As he so eloquently points out, Goldman Sachs is everywhere. He continues: The worlds most
powerful investment bank is a great vampire squid wrapped around the face of humanity, relentlessly jamming its blood funnel into
anything that smells like money. In fact, the history of the recent financial crisis, which doubles as a history of the rapid decline and

Though the
banks did it with another type of investment, biotech companies take
advantage of the same strategy. They sell GM food and the chemicals
required to grow them to farmers throughout the world, causing them to
become dependant upon patented seed and proprietary chemical
cocktails. Since many farmers initially bought the propaganda that they were helping to feed
the world and could increase yields or fight weeds, they bought in. They put their investment in GM goods. We all
bought in, and when I say we, I mean the world in general, though some of us did it kicking and screaming. Then, the stock
prices start to go up this is the bubble. Though hes talking about mortgages, he could be talking
about anything from barrels of oil to GM soy. Taibbi explains: The formula is relatively simple: Goldman positions
itself in the middle of a speculative bubble, selling investments they know
are crap. Then they hoover up vast sums from the middle and lower floors
of society with the aid of a crippled and corrupt state that allows it to
rewrite the rules in exchange for the relative pennies the bank throws at
political patronage. Finally, when it all goes bust, leaving millions of ordinary citizens broke and starving, they begin
fall of the suddenly swindled dry American empire, reads like a Whos Who of Goldman Sachs graduates.

the entire process over again, riding in to rescue us all by lending us back our own money at interest, selling themselves as men
above greed, just a bunch of really smart guys keeping the wheels greased. Check out the evidence: MonsantoDow

Monsanto stock prices in the past five years have gone up, despite

grassroots efforts to promote divestment. So have the stock prices of

Syngenta, Dow, and Bayer. Overvalued? Thats an understatement.
SyngentaBayer These companies have single handedly caused super weeds, super bugs, and farmer suicides in India. The WHO just
called one of Monsantos biggest selling chemicals probably carcinogenic. Thats the same chemical that their inaugural crops
were developed for thus the name, Round Up Ready. There is no evidence that GM seed yields more crops, and a large part of the
world, including Russia, wont even allow their import any longer.
pop like gum gone rancid.

The biotech bubble is ripe, and its about to

Biotech is a bubble---collapse in the pharma industry will cause

a burst
Nisen 15 (Max, Quartz, Forget the tech bubble. Its the biotech bubble you
should worry about, 2-19-15, http://qz.com/324939/biotech-valuation-bubble/, ava)
CAR T-cell therapy, for example, genetically engineers the bodys own immune cells to attack tumors. It has shown
the potential to rapidly eliminate some cancers. But the problembesides the fact that it could cost $300,000 or
more per patient for a one time treatmentis preventing the cells from attacking healthy tissues, or releasing
dangerous chemicals into the bloodstream. And the research has yet to yield a commercially available treatment.
But none of that has stopped the market going nuts on small bits of news about the therapy. In January, Intrexon,
Ziopharm and MD Andersen Cancer Center announced a licensing agreement for this kind of technology at J.P.
Morgans biotech conference. Intrexons stock almost immediately jumped $10 per share, adding a billion dollars to

Big Pharma is
suffering a science stagnation Momentum and market optimism have a lot
to do with these surging biotech valuations. But a more basic reason is that major
pharmaceutical companies, the ones worth hundreds of billions of dollars, badly need new
its market capitalization, while Ziopharms stock price nearly doubled. The cause:

drugs . A wave of patents on blockbuster drugs have expired in the past

few years, hitting the industrys profitsthe phenomenon known as the
patent cliff. But bringing new drugs to market has gotten more expensive .
According to a 2012 study, pharmaceutical firms spend an average of $4 billion in R&D for each drug that gets
approval. For some companies its as much as $12 billion. (Research sponsored by the industry puts the figure at
$2.6 billion per drug, but such estimates, according to the 2012 study, dont sufficiently account for high failure
rates.) A key reason is that its become harder to find promising substances .
Pharmas traditional expertise, known as small molecule discovery (paywall)screening large numbers of relatively

Years of investment in
attempting to streamline, speed up, and automate discovery havent
panned out (pdf). A newer class of medicines called biologics (paywall)made up of giant molecules that
simple chemicals to find effective onesis seeing rapidly diminishing returns.

adapt or exploit processes that already occur in the bodyare more promising, but need a lot more investment.
Moreover, if companies try to research a broad portfolio of potential drugswhich might seem like a prudent way to
ensure a few successesthey risk ending up with spiraling costs and low returns, according to a recent report from
Deloitte (pdf, p.4). The internal rate of return on research and development (R&D) has fallen over the past few
years, according to Deloittes analysis, which covers the 12 biggest R&D spenders (see chart below). On some other
measures,

R&D productivity has been declining for more than a decade .

2NC---ABR Impact
Antibiotic resistance causes extinction---new drugs are key
Davies 8 (Julian, British Columbia Microbiology and Immunology professor
Resistance redux: Infectious disease, antibiotic resistance and the future of
mankind, EMBO Rep. Jul 2008; 9(Suppl 1): S18S21)
antibiotic-resistant pathogens have been recognized as one of
the main threats to human survival, as some experts predict a return to the pre-antibiotic era.
So far, national efforts to exert strict control over the use of antibiotics have had
limited success and it is not yet possible to achieve worldwide concerted action to reduce the growing
For many years,

threat of multi-resistant pathogens: there are too many parties involved. Furthermore, the problem has not yet
really arrived on the radar screen of many physicians and clinicians, as antimicrobials still work most of the time
apart from the occasional news headline that yet another nasty superbug has emerged in the local hospital.
Legislating the use of antibiotics for non-therapeutic applications and curtailing general public access to them is

In order to meet the

growing problem of antibiotic resistance among pathogens, the discovery
and development of new antibiotics and alternative treatments for
infectious diseases, together with tools for rapid diagnosis that will ensure effective and appropriate use
of existing antibiotics, are imperative. How the health services, pharmaceutical industry and
academia respond in the coming years will determine the future of
treating infectious diseases. This challenge is not to be underestimated: microbes are
formidable adversaries and, despite our best efforts, continue to exact a toll on the
human race.
conceivable, but legislating the medical profession is an entirely different matter.

Pharma Advantage Answers

1NC---Big Pharma Down

Big pharma down now---strong dollar and patent losses
Kinahan 7/27 (JJ, 26-year trading veteran, regular CNBC guest, frequently quoted in the Wall Street
Journal, Financial Times and Reuters News, 7/27/15, Big Pharma's Pfizer And Merck To Feel Pinch Of Strong Dollar,
Patent Loss, http://www.forbes.com/sites/jjkinahan/2015/07/27/big-pharmas-pfizer-and-merck-to-feel-pinch-ofstrong-dollar-patent-loss/, Accessed 7/28/15)//LD

Strong dollar headwinds are likely to smack pharmaceutical giants Pfizer

Inc. (PFE) and Merck & Co. (MRK) when they report earnings Tuesday ahead of the
markets opening. Both big pharma firms have a heavy international
presencemore than half of their revenues and like other multinationals
are likely to feel the ravaging financial impact of foreign currency
translations. Ahead of earnings, these stocks tend to trade in similar fashion
with volatility on both measuring in a relatively low 20th percentile range. Pfizer
Lost Celebrex, Lipitor Kingpin Pfizer (PFE), which has a 61% forex exposure, is
expected to turn in earnings of $0.52 a share on revenue of $11.42 billion,
according to Thomson Reuters. Thats below the year-ago results of $0.58 per
share and $12.7 billion on the top line as the company grapples with patent
losses on blockbuster treatments including arthritis drug Celebrex and
cholesterol drug Lipitor, the best-selling drug of all time.

2NC---Ext. Big Pharma Down

Big pharma is on a decline---3 warrants:
1. New pricing models undercut profits
Campbell 7/18 (Todd, E.B. Capital Markets, 7/18/15, The 3 Biggest Threats to
Big Pharma, http://www.fool.com/investing/general/2015/07/18/the-3-biggestthreats-to-big-pharma.aspx, Accessed 7/28/15)//LD
Todd Campbell: According to the Memorial Sloan Kettering Cancer Center,
drugmakers slapped prices of nearly $10,000, or more, on eight of nine
cancer drugs approved by the FDA since 2014, and last year a new generation
of hepatitis C medicines hit the market with $1,000 per pill price tags. Harvoni
SOURCE: GILEAD The soaring cost of newly approved therapies like these has
payers incredibly nervous and that's leading many of them to investigate
new pricing models that could threaten Big Pharma's payday. For example,
Express Scripts has floated the idea of a pay-for-performance model that
would pay drugmakers more when their drug succeeds in a patient and less -- or
nothing -- if their drug fails. Insurers are right to be looking at new payment
models given that they're likely to remain under considerable pressure
from governments to keep premiums affordable. Last month, California's
health-insurance exchange capped copays for people paying for highpriced medicine, forcing insurers to make up the difference. This suggests that at
some point the current trend in pricing will become untenable. After all,
insurers are already operating on single-digit margins, so there's not a lot
of fat for them to cut.

2. Stiff competition from generic pharma companies

Speights 7/18 (Keith, The Motley Fool, 7/18/15, The 3 Biggest Threats to Big
Pharma, http://www.fool.com/investing/general/2015/07/18/the-3-biggest-threatsto-big-pharma.aspx, Accessed 7/28/15)//LD
Keith Speights: Stiff competition ranks as another huge challenge facing
many Big Pharma companies. And the biggest threats are coming from
outside the ranks of the major drugmakers. Generic pharmaceutical
companies and "Little Pharma" -- the smaller up-and-coming players -- could
make life much tougher for Big Pharma in the years ahead. Lyrica SOURCE:
PFIZER For example, look at Pfizer's top-selling drug, Lyrica. Pfizer made over
$5.1 billion last year from the drug, which is used to treat several conditions,
including fibromyalgia. But the company lost patent exclusivity for Lyrica in
several key European markets in July 2014. An assortment of generic
drugmakers are chomping at the bit to create their own versions of the
drug. While Pfizer won a legal battle that holds off U.S. generic competition for
Lyrica until 2018, the threat from generics is significant. Meanwhile, smaller
pharmaceutical companies are hoping to dethrone Lyrica with new drugs.
Theravance BioPharma is in midstage clinical trials with TD-9855 targeting

treatment of fibromyalgia, and the company thinks this drug could wind up
being "more compelling" than existing treatment options. What are Big
Pharma companies like Pfizer doing to remain competitive? Spending a lot of money.
They are investing in developing new drugs. And, in some cases, they'll buy some of
those Little Pharma rivals to cover their flanks and gain access to more new
products. Those Big Pharma companies that don't spend their money wisely
could find themselves to ultimately be big losers.

3. Overestimated revenues and earnings

Budwell 7/18 (George, writing about healthcare and biotechnology companies
since 2013, 7/18/15, The 3 Biggest Threats to Big Pharma,
http://www.fool.com/investing/general/2015/07/18/the-3-biggest-threats-to-bigpharma.aspx, Accessed 7/28/15)//LD
George Budwell:

Big Pharma's resurgence following the patent cliff has been

closely tied to the advent of multiple new classes of game-changing
products, such as cancer immunotherapies and potent cholesterol-lowering drugs known as PCSK9 inhibitors.
As these groundbreaking drugs make their way to the market , though, we're
learning that their initial peak sales estimates might have been grossly
overestimated for a variety of reasons. As Keith noted, fierce competition is one factor that
could cut deeply into the sales of any one new product. Last month, for example, an advisory panel for the U.S.
Food and Drug Administration recommended the approval of two PCSK9 inhibitors, Repatha and Praluent, from
Amgen and Sanofi/Regeneron, respectively, meaning that they'll now probably hit the market around the same
time. And not to be left out, Pfizer is planning on filing for regulatory approval for its own PCSK9 inhibitor within the

When the Street originally pegged Praluent's peak sales at over

$6 billion, however, the prevailing wisdom was that the drug would enjoy a
somewhat lengthy first-mover advantage -- a competitive advantage that
has since evaporated with the rapid development of Amgen's Repatha .
Lymphoma SOURCE: WIKIMEDIA And then there is the problem of how widely some of
these new drug classes will be used in the real world . The cancer immunotherapy
next two years.

craze had analysts suggesting that drugs based on the PD-1 and related PD-L1 proteins could generate sales in the
stratosphere of $35 billion by 2020. The clinical data, though, hints at a far leaner estimate. The basic issue is that

patients who respond to these treatments tend to do so within three to

four months, and their responses are often extremely durable. In short, there's
little reason to continue treatment beyond the four-month benchmark in
most cases, and this issue wasn't fully appreciated by the Street at first . All
told, Big Pharma's revenues and earnings are likely to continue to rise as
these innovative new drugs barrel toward the market, but they probably
won't touch the sky-high peak estimates the Street was floating only a few
months ago.

**TPP Scenario**

1NC---Generic Drugs Bad

Generic drugs bad---dont work as well and appearance
changes cause confusion
Kamerow 11 (Douglas, chief scientist, RTI International, and associate editor,
BMJ, 7/20/11, "The pros and cons of generic drugs", BMJ, Vol. 343, Accessed
7/26/15)//LD
the financial incentives to use generics are not as
dramatic as the cost differences would indicate. Patients who have insurance see only the
Not necessarily. Firstly, in the United States

difference in copayments between generic and brand drugs, which is usually tens rather than hundreds of dollars per prescription.

all this makes sense only if the generics are truly clinically
equivalent to brand name drugs. As Robin Ferner and colleagues point out in a recent review,5 there
are lots of reasons to expect that generic drugs may not work as well, or at
least the same, as what the drug industry likes to call the innovator products. Some generics use a
different chemical version of the drug, such as another salt. They may use
different excipients to stabilise or flavour the drug, which can lead to
different absorption properties or adverse reactions . Although US generics must be proved
to be bioequivalent to gain approval for sale by the Food and Drug Administration, bioequivalence is required
only within 90% confidence intervals. This may be fine for most drugs, but some conditions may
require drug levels with smaller variations. Full clinical trials are not
required to approve genericsthats why they are so inexpensive, after allso true clinical
equivalence is never tested. There are lots of examples of patients taking
drugs requiring careful titration and close tolerancesanticonvulsants, antifungals, thyroid replacement, and others who
have had therapeutic failures when they switch to generics. Because pharmacies
constantly change which generic version they purchase, depending on where they can get the best price, it is common
for different generic versions to be dispensed each time the prescription is
refilled. Ive seen these changes myself with my generic prescriptions for a statin and a sleeping tablet. Thirdly, and perhaps
more widespread and serious than the occasional clinical equivalence problem, is the confusion that may arise in
many patients when they find that their dependably yellow round pill is
now a green oblong one after a generic is introduced or changed. Patients, especially
elderly patients, use colour to identify their pills,6 and they report great concern
when the appearance, packaging, and labelling change.7 This may lead to a
paradoxical decrease in adherence with generics that could be equal to or greater than the
increased compliance seen because of lower prices. To decrease this confusion Jeremy
Secondly,

Greene and Aaron Kesselman have proposed that the FDA allow manufacturers of generic drugs to adopt the trade dress
(appearance) of the innovator drug.8

2NC---Ext. Generic Drugs Bad

Big pharma solves disease better
Chris Lo 14, Progressive Media Reporter, "Drug prices: profits before patients?"
Progressive Media, 6-9, Lexis
A new UCL report questioning the use of off-label drugs to save money has been criticised for propping up an unfair status quo in

Pharma companies charge high premiums for patented

medications to recover costs, maximise profits and help fund new R&D, but is
there another way of funding high-risk research while avoiding budget-busting prices at the other end of the pipeline? The
pharmaceutical industry has been responsible for a host of medical
the pharma industry.

miracles over the past century, from disease-eradicating vaccines to

revolutionary new treatments for a wide range of cancers and long-term
chronic conditions like diabetes. Research undertaken by private
pharmaceutical companies and bio-tech firms, alongside public research institutions, has improved
the length and quality of millions of lives. In light of the industry's achievements, it's natural to
think of it as something of a sacred cow, a special case that should, to a certain extent, be given extra leeway to ensure it can
continue bankrolling life-saving medical innovations. That status also makes it easy to forget the price tag that comes with many of
these innovations - a price tag that has been rising steadily over time. In the US, for example, annual cancer care costs are expected
to rise from $104bn in 2006 to $173bn in 2020, according to the American Society of Clinical Oncology. A major component of that
increase is the rising number of cancer diagnoses along with other factors, but with data from the Memorial Sloan Kettering Cancer
Center showing that 15 cancer treatments launched in the last five years cost more than $10,000 a month, and many existing drugs
getting pricier every year, the fact remains that the cost of innovative, patent-protected drugs is becoming increasingly difficult for
patients and cash-strapped health systems to cover.

Pharmaceutical profits are key to innovation against emerging

disease threats
Engelhardt 8 (PhD, MD, Professor of Philosophy @ Rice (Hugo, Innovation and
the Pharmaceutical Industry: Critical Reflections on the Virtues of Profit, EBrary)
Many are suspicious of, or indeed jealous of, the good fortune of others. Even when profit is gained in the market
without fraud and with the consent of all buying and selling goods and services, there is a sense on the part of
some that something is wrong if considerable profit is secured. There is even a sense that good fortune in the
market, especially if it is very good fortune, is unfair. One might think of such rhetorically disparaging terms as
"wind-fall profits". There is also a suspicion of the pursuit of profit because it is often embraced not just because of
the material benefits it sought, but because of the hierarchical satisfaction of being more affluent than others.

The pursuit of profit in the pharmaceutical and medical-device industries is

tor many in particular morally dubious because it is acquired from those
who have the bad fortune to be diseased or disabled. Although the suspicion of profit is not
well-founded, this suspicion is a major moral and public-policy challenge. Profit in the market for the
pharmaceutical and medical-device industries is to be celebrated. This is the case, in that if
one is of the view (1) that the presence of additional resources for
research and development spurs innovation in the development of pharmaceuticals
and med-ical devices (i.e., if one is of the view that the allure of profit is one of the most effective ways not only to
acquire resources but productively to direct human energies in their use), (2) that given the limits of altruism and of

the possibility of profits is necessary to secure

such resources, (3) that the allure of profits also tends to enhance the
creative use of available resources in the pursuit of pharmaceutical and medicaldevice innovation, and (4) if one judges it to be the case that such innovation is both
the willingness of persons to be taxed,

necessary to maintain the human species in an ever-changing and always

dangerous environment in which new microbial and other threats may at any
time emerge to threaten human well-being, if not survival (i.e., that such innovation is necessary to
prevent increases in morbidity and mortality risks), as well as (5) in order generally to decrease morbidity and

one should be concerned regarding any

policies that decrease the amount of resources and energies available to
encourage such innovation. One should indeed be of the view that the possibilities for profit, all
mortality risks in the future, it then follows (6) that

things being equal, should be highest in the pharmaceutical and medical-device industries. Yet, there is a suspicion
regarding the pursuit of profit in medicine and especially in the pharmaceutical and medical-device industries.

Generics dont solve---inactive ingredients can trigger allergies

Wax 7 (Naomi, New York-based journalist and the editor of PillGirlReport.com,
12/17/7, Generic drugs' hidden downside,
http://articles.latimes.com/2007/dec/17/news/OE-WAX17/2, Accessed 7/26/15)//LD
true insanity lies in the way many medical professionals , convinced by the FDA,
keep pushing the myth that "generic drugs are identical to their brandname counterparts." Assurances of total sameness "in dosage form, safety, strength, route of administration, quality,
Yet the

performance and intended use" pop up all over the FDA's website and are dutifully reprinted on the sites of health insurers, drug

Health insurers, for instance, save so much on

generics that a number of them actually offer incentives to doctors and
pharmacists to switch their patients off brand-name drugs; earlier this year, Blue Care
makers, pharmacies and others whose interests it serves.

Network of Michigan was paying $100 per case. Even more widespread: insurers' practice of charging lower co-pays for generics.
Many insurers won't cover brand-name drugs at all if there's a generic available. To be sure, consumers benefit financially as well.
With an average price of $102 to fill a brand-name prescription -- compared to $29 for a generic one -- generic drugs make

how advantageous is it to save $70 a month if

taking a generic makes you feel like crap? I wrestled with this question a few months ago when my
medication vastly more affordable. But

doctor prescribed Sertraline, a Zoloft generic, to treat my depression. I'd done well on Zoloft in the past and had seemed to do all
right when I was switched to a generic, but I'd only taken it for a few months before I went off the medication entirely. This time,
after a month, Sertraline hadn't made a dent in my symptoms. My generics-happy insurer wouldn't cover Zoloft, so I contemplated
paying the additional cost myself. And I did some research. It turns out that hundreds of former Wellbutrin XL 300 users were facing
a similar dilemma -- although under far graver conditions. The FDA-approved generic, Budeprion XL 300, had arrived on the market
last December, and in the weeks and months that followed, complaints began to appear all over Internet health boards. Users who'd
been successfully treated with Wellbutrin for years said that they'd been switched to Budeprion by their doctor or pharmacist, often
without being informed, and had suffered such consequences as a return of depression (sometimes more severe than ever), suicidal
thoughts, panic attacks, mood swings, anxiety, nausea and insomnia. Those who then went back on the brand-name medication
reported that their symptoms disappeared. Veteran syndicated health columnists Joe Graedon, who holds a master's degree in
pharmacology, and his wife, Terry, who earned her doctorate in medical anthropology, were so alarmed by the unprecedented
volume of reader response on their website, peoplespharmacy.com, that they notified the FDA. The FDA, in October, confirmed that
it was investigating but has yet to issue a comment or findings. The Graedons also contacted ConsumerLab.com, an independent
testing organization. Budeprion users probably found bittersweet consolation in the lab's analysis of the little yellow pills. It
discovered that "generic bupropion XL released its ingredient at a very different rate than Wellbutrin XL." While the extendedrelease feature is meant to keep a steady supply of medication flowing to the bloodstream throughout the day, the generic pill
released 34% of its ingredients in the first two hours, compared to the brand-name's 8%. Although both pills started out with equal
amounts of active ingredient (bupropion), according to the ConsumerLab report, the large upfront dose from the generic could
account for the anxiety, irritability and nausea -- all known side effects of too high a dose of bupropion. The FDA finds it acceptable

Although the rate and

extent of absorption must be similar enough to be deemed "medically
insignificant," lab data and/or test results from a small group (typically 24 to 36 people) of healthy volunteers (typically
male) -- provided by the manufacturer -- are considered sufficient to demonstrate this. Clinical testing -- multiphase
studies done on thousands of patients to determine safety and effectiveness, which brand-name drugs undergo -- is not
required for generics. The assumption is that the innovator drug was already thoroughly tested on humans, so if the
generic can be shown to perform "in the same manner" in the lab, then it will perform similarly in patients. Yet, although
for generics to use different time-release technology than their brand-name counterparts.

generics must have the same active ingredients as the brand-name

product, they can include any number of different inactive ingredients
(colorings, flavorings, binders, diluents, fillers, etc.) that can cause differences in how well a
particular patient absorbs and tolerates a particular medication -especially patients with allergies, sensitivities or gastrointestinal disease .
Formulas also vary from one generic manufacturer to the next. So someone who has success with, say, Company X's Zoloft generic
may have trouble if his or her pharmacist refills a prescription with Company Y's version. Which is what happened to me. Once I'd
made the rounds of neighborhood pharmacies and found one that carried my old generic brand, my symptoms improved.

1NC---No Disease !
No impact to disease they either burn out or dont spread
Posner 5 Senior Lecturer at University of Chicago (Richard A, Catastrophe: the dozen most
significant catastrophic risks and what we can do about them., Winter,
http://findarticles.com/p/articles/mi_kmske/is_3_11/ai_n29167514/pg_2?tag=content;col1)

the fact that Homo sapiens has managed to survive every disease to
assail it in the 200,000 years or so of its existence is a source of genuine
comfort, at least if the focus is on extinction events. There have been
enormously destructive plagues, such as the Black Death, smallpox, and
now AIDS, but none has come close to destroying the entire human race.
There is a biological reason. Natural selection favors germs of limited
lethality; they are fitter in an evolutionary sense because their genes are
more likely to be spread if the germs do not kill their hosts too quickly . The
Yet

AIDS virus is an example of a lethal virus, wholly natural, that by lying dormant yet infectious in its host for years

The likelihood of
a natural pandemic that would cause the extinction of the human race is
probably even less today than in the past (except in prehistoric times, when people lived in
small, scattered bands, which would have limited the spread of disease), despite wider human
contacts that make it more difficult to localize an infectious disease . The
reason is improvements in medical science. But the comfort is a small one. Pandemics can
maximizes its spread. Yet there is no danger that AIDS will destroy the entire human race.

still impose enormous losses and resist prevention and cure: the lesson of the AIDS pandemic. And there is always a
lust time.

2NC---Ext. No Disease !
Burnout and variation check
Ian York 14, head of the Influenza Molecular Virology and Vaccines team in the
Immunology and Pathogenesis Branch of the Influenza Division at the CDC, PhD in
Molecular Virology and Immunology from McMaster University, M.Sc. in Veterinary
Microbiology and Immunology from the University of Guelph, former Assistant Prof
of Microbiology & Molecular Genetics at Michigan State, Why Don't Diseases
Completely Wipe Out Species? 6/4/2014, http://www.quora.com/Why-dontdiseases-completely-wipe-out-species
diseases don't drive species extinct. There are several reasons
For one, the most dangerous diseases are those that spread from one
individual to another. If the disease is highly lethal , then the population
But mostly

for that.

drops, and it becomes less likely that individuals will contact each other
Highly contagious diseases tend to burn themselves out that way.
Probably the main reason is variation. Within the host and the pathogen population there will be a wide range
of variants. Some hosts may be naturally resistant. Some pathogens will be
during the infectious phase.

less virulent . And either alone or in combination, you end up with infected individuals who
survive . We see this in HIV, for example. There is a small fraction of humans who are naturally resistant or altogether
immune to HIV, either because of their CCR5 allele or their MHC Class I type. And there are a handful of people who were infected
with defective versions of HIV that didn't progress to disease. We can see indications of this sort of thing happening in the past,
because our genomes contain

many instances of pathogen resistance genes

that

have spread

through the whole population. Those all started off as rare mutations that conferred a
strong selection advantage to the carriers,

meaning that the specific infectious diseases were

serious threats to the species.

Infectious diseases cant cause extinction population density

mitigates virulence through resistance
Wynne Parry 11, 2/2/11, Live Science Staff Writer, Article: Theory About
Mammals and Fungus Explains Bat Plague, <http://www.livescience.com/11705theory-mammals-fungus-explains-bat-plague.html>
Even highly virulent infectious disease does not cause extinctions
because as population density decreases, so does transmission, and the
remaining individuals are more resistant. In addition, at the end of the Cretaceous,
dinosaurs weren't the only ones to be decimated. Marine animals were affected, as were many species of
flowering plant, according to Douglas Robertson, of the Cooperative Institute for Research in Environmental
Sciences at the University of Colorado.

"It is not even vaguely plausible that

all these

extinctions , let alone just the various dinosaur species extinctions, were all caused by some
pathogen," Robertson wrote in an e-mail.

Government responses solve

Zakaria 9 - Editor of Newsweek, BA from Yale, PhD in pol sci, Harvard (Fareed,
The Sky Isnt Falling, 5/16/9, Newsweek,
http://www.newsweek.com/id/197922)//WL
It certainly looks like another example of crying wolf. After bracing ourselves for a global pandemic, we've suffered
something more like the usual seasonal influenza. Three weeks ago the World Health Organization declared a health
emergency, warning countries to "prepare for a pandemic" and said that the only question was the extent of
worldwide damage. Senior officials prophesied that millions could be infected by the disease. But as of last week,
the WHO had confirmed only 4,800 cases of swine flu, with 61 people having died of it. Obviously, these low
numbers are a pleasant surprise, but it does make one wonder, what did we get wrong? Why did the predictions of
a pandemic turn out to be so exaggerated? Some people blame an overheated media, but it would have been
difficult to ignore major international health organizations and governments when they were warning of

there is a broader mistake in the way we look at the world. Once

we see a problem, we can describe it in great detail, extrapolating all its possible consequences. But we can
rarely anticipate the human response to that crisis. Take swine flu. The
virus had crucial characteristics that led researchers to worry that it could
spread far and fast. They describedand the media reportedwhat would happen if
it went unchecked. But it did not go unchecked. In fact, swine flu was met
by an extremely vigorous response at its epicenter, Mexico. The Mexican
government reacted quickly and massively, quarantining the infected
population, testing others, providing medication to those who needed it.
catastrophe. I think

The noted expert on this subject, Laurie Garrett, says, "We should all stand up and scream, 'Gracias, Mexico!'
because the Mexican people and the Mexican government have sacrificed on a level that I'm not sure as Americans

They shut down their schools.

They shut down businesses, restaurants, churches, sporting events. They
we would be prepared to do in the exact same circumstances.

basically paralyzed their own economy. They've suffered billions of dollars in financial losses still being tallied up,

Every time one of these viruses is

detected, writers and officials bring up the Spanish influenza epidemic of
1918 in which millions of people died. Indeed, during the last pandemic scare, in 2005,
and thereby really brought transmission to a halt."

President George W. Bush claimed that he had been reading a history of the Spanish flu to help him understand how

But the world we live in today looks nothing like 1918. Public
health-care systems are far better and more widespread than anything
that existed during the First World War. Even Mexico, a developing
country, has a first-rate public-health systemfar better than anything
Britain or France had in the early 20th century.
to respond.

**India Scenario**

1NC---Indian Pharma Resilient

Indian medical industry is successfully resisting US big pharma
push---court rulings prove
Smedley 13 (Tim, The Guardian, 5/14/13, Patent wars: has India taken on Big
Pharma and won?, http://www.theguardian.com/sustainable-business/patent-warsindia-takes-on-big-pharma, Accessed 7/28/15)//LD
Two recent court cases in India may have changed
the rules of the game. On 1 April, pharma giant Novartis lost a six-year legal
battle after the Indian supreme court ruled that small changes to its
leukaemia drug Glivec did not deserve a new patent. Campaigners had long
highlighted this as a clear case of "evergreening" making minor
alterations to existing drugs in order to secure a new patent, and so extend its
monopoly (Glivec costs patients $2,600 (1,670) a month). And only one month before, India
upheld a compulsory licence of Bayer's cancer drug Nexavar, effectively
allowing generics firms to copy a patented drug, reportedly bringing the price down from
more than $5,500 (3,540) per month to $175 (112). Both rulings are landmark cases,
vehemently criticised by both Big Pharma and major drugs-producing
countries. Crucially, India broke no rules. Its verdicts are allowable under
TRIPS it's just that no country had previously dared try it. "You could say," says Dr
India's trailblazing patents decision

Ken Shadlen, reader at LSE and co-editor of Intellectual Property, Pharmaceuticals and Public Health, "that the
health activist community for the past five or six years has been calling Novartis all the names under the sun for
pursuing this case, but right now they are probably thanking them." Similarly, says Colin McCall, a leading
pharmaceutical patent lawyer with Taylor Wessing LLP, "I think [India] felt a little bit miffed that having entered into
the WTO and taking on this obligation to allow product patents, that these pharmaceuticals were no longer

[India] is blazing a trail by granting compulsory

licences where products aren't sold cheap enough and they are willing to
say no to [evergreening] outright."
available at a publicly affordable price. So

2NC---Ext. Indian Pharma Resilient

Court rulings block big pharma from evergreening
McCauley 14 (Lauren, staff writer, Common Dreams, 12/13/14, Crippling
Dominance of Big Pharma, Indian Judge Blocks Bayer's Drug Monopoly Bid,
http://www.commondreams.org/news/2014/12/13/crippling-dominance-big-pharmaindian-judge-blocks-bayers-drug-monopoly-bid, Accessed 7/28/15)//LD
In a move that advocates are saying is a "momentous" win for public
health, an Indian court on Friday rejected a bid from multinational
pharmaceutical giant Bayer to block a local generic drug company from
mimicking their costly cancer drug. Bayer had attempted to appeal a 2012
decision by India's patent controller, who had argued the monthly $5,500-perperson cost charged by Bayer for the liver and kidney drug Nexevar was too costly
for most Indians. The Hyderabad-based Natco Pharma's version of the drug
costs roughly 97% less. Friday's court's decision highlights India's "critical
role" in "balancing intellectual property and public health," Leena
Menghaney, South Asia regional head of Medicins San Frontieres (MSF)/ Doctor's
Without Borders' regional access campaign, told AFP. Observers are saying that
the decision may have far-reaching impact on the drug market because of
India's dominance in the pharmaceutical industry. AFP reports: India'a
Lawyers' Collective, another rights group, said the "momentous"
judgement held wide-ranging implications for access to other medicines.

Novartis case sets a precedent for judicial protection of

generics in India
Mahr 13 (Krista, Time, 4/1/13, The Novartis Decision: Is the Big Win for Indian
Pharma Bad News for Investment?, http://world.time.com/2013/04/01/the-novartisdecision-is-the-big-win-for-indian-pharma-bad-news-for-investment/, Accessed
7/28/15)//LD
In a decisive victory for Indias pharmaceutical industry, Indias Supreme
Court rejected Novartis patent application for the cancer drug Glivec on
Monday, ending a seven-year battle by the Swiss drugmaker to get a patent in India on its powerful leukemia
drug. The medication, which was approved for use in the U.S. back in 2001, has been produced generically by

The Indian drug industrys

victory, however, is being described as a stunning defeat for intellectualproperty rights and may have repercussions on Indias attempts to attract foreign investment.
Nevertheless, health activists have called the top courts decision a win for
patients seeking cheaper treatment and against evergreening, the alleged
Indian pharmaceuticals for years at a fraction of the Swiss drugs cost.

practice of making minor tweaks to an existing drug to prolong a companys hold on a patent and protect it from

The ruling was

met with enthusiasm by Indian drug manufacturers, which produce a
generic version of Glivec, or Gleevec, as it is called in the U.S. market. Patients-rights groups, who
being produced by other firms as a cheaper generic version once the patent has expired.

advocate for cheaper drugs to be available in countries like India where few can afford costly medication, also
applauded the move.

Advocates were concerned that a ruling in favor of Novartis

could set a precedent that would ultimately cut off Indias vast supply of
cheap generic drugs for diseases like HIV. Such medicines are exported to other developing
markets. Millions of poor patients rely on them.

1NC---Indian SoPo High

Indian soft power high and resilient now---spiritualism, culture,
principles, democracy
Ramachandran 5/29 (Sudha, The Diplomat, 5/29/15, Indias Soft Power
Potential, http://thediplomat.com/2015/05/indias-soft-power-potential/, Accessed
7/26/15)//LD
Yoga is among the themes that figured during the recent visit of Indias Prime Minister Narendra Modi to China,

Clearly, India is dipping into its ample soft power

resources in its diplomatic engagements abroad. But first, what is soft power and why are
Mongolia, and South Korea.

countries looking to it in their conduct of diplomacy? According to Harvard political scientist, who coined the term,

soft power is the ability of a country to persuade others to do what it

wants without resorting to force or coercion. Soft power, he said, lies in a countrys
attractiveness and comes from three resources: its culture (in places where it is attractive to others), its political
values (when it lives up to them at home and abroad), and its foreign policies (when they are seen as legitimate
and having moral authority). Though slower to yield results, soft power is a less expensive means than military

India boasts an amazing variety

and wealth of soft power resources. Its spiritualism , yoga, movies and
force or economic inducements to get others to do what we want.

television soaps, classical and popular dance and music , its principles of
non-violence , democratic institutions , plural society, and cuisine have all
attracted people across the world. Indian foreign policy analyst C Raja Mohan observed that
India holds strong cards in the arena of soft power to further its foreign
policy goals. It is only over the past decade or so that India has begun to
play its soft power cards more systematically. Besides setting up a public
diplomacy division within the Ministry of External Affairs in 2006 and
expanding the Indian Council for Cultural Relations (ICCR) worldwide , it has
roped in the Ministry of Tourism, which is behind the Incredible India campaign, and the
Ministry for Overseas Indians to showcase its social, political, and
cultural assets abroad, Rohan Mukherjee, a research scholar at the Department of Politics in
Princeton University told The Diplomat. These government actors are working to leverage
Indias soft power by using it to support larger foreign policy initiatives
such as the Look East Policy (now Act East), the Connect Central Asia policy, and
developing strategic aid and trade partnerships in Africa, he said, adding that in
each of these initiatives, official diplomacy has been buttressed by cultural
exchange and efforts at increasing public knowledge and appreciation of
India in foreign countries.

1NC---No Indian SoPo !

No impact to Indian soft power---overestimation, lack of hard
power, unresolved identity
Mukherjee 14 (Rohan, Princeton University, 2014, The False Promise of Indias
Soft Power, Geopolitics, History, and International Relations, Vol. 6(1), 2014, pp.
4662, Accessed 7/27/15)//LD
Since the early 2000s, in keeping with Indias rise on the world stage, the scholarly
and policy communities in India and abroad have witnessed a steady
increase in writing on Indias soft power. Many of these assessments are
optimistic, placing faith in Indias potential as a civilizational great power
with considerable resources arising from its culture, domestic ideology and
diplomacy. However, in terms of impact, Indian soft power has fallen far
short of expectations . Significant sections of public opinion in the West and
in Asia are still not favorable toward India. Moreover, one is hard pressed to
identify a significant role played by soft power in Indias diplomatic gains
since the early 1990s. This paper argues that Indias inability to capitalize on
its soft power resources is the result of three factors. First, the
overestimation of these resources by analysts. Second, the lack of
sufficient hard power to undergird Indias soft power ambitions. And finally,
unresolved elements of Indias identity that tend to undermine its efforts at
soft power projection through public diplomacy.

2NC---Ext. No Indian SoPo !

Indian soft power fails---empirics prove
Mukherjee 14 (Rohan, Princeton University, 2014, The False Promise of Indias
Soft Power, Geopolitics, History, and International Relations, Vol. 6(1), 2014, pp.
4662, Accessed 7/27/15)//LD
As the Cold War wore on, Nehru was succeeded eventually by his daughter
Indira Gandhi, who continued to speak the language of non-alignment and antiimperialism but pursued policies that were far more realist in substance.
This had the effect of undermining some of Indias international legitimacy,
especially when India concluded a defense pact with the Soviet Union in
1971. The following two decades were also marked by increasing Indian
interventionism in the affairs of neighboring countries, especially Sri Lanka,
Nepal, and the Maldives. The end of the Cold War, according to one scholar, marked
a transition from realpolitik back to softer forms of diplomatic in- 53 tercourse for
India, largely due to the realization that hard power had failed to achieve beneficial
objectives in the preceding two decades (Wagner 2005). While this might be true in
terms of grand strategy, it was certainly not the case that any of the foreign
policy gains made by India after 1990 were due to its use of soft power.
Increases in investment from and trade with developed economies,
rapprochement with the US in the mid-2000s, and improvements in bilateral
relations with other South Asian states (including Pakistan, despite setbacks)
can all be traced back to the end of the Cold War and Indias economic
liberalization and rapid growth since 1991. Soft power has been a very minor
aspect if at all of Indian foreign policy during this period.

No impact to Indian soft power---3 warrants:

1. India has no international influence
Mukherjee 14 (Rohan, Princeton University, 2014, The False Promise of Indias
Soft Power, Geopolitics, History, and International Relations, Vol. 6(1), 2014, pp.
4662, Accessed 7/27/15)//LD
shortcomings on this front are due to three factors. First, its soft power
resources are not as abundant as proponents of the idea might suggest .
Indias cultural influence abroad, while significant, pales in comparison to the cultures of the
West already in circulation around the globe, and increasingly in comparison to Chinese
culture in circulation in Asia and beyond. Official and semi-official Indian modes of cultural
dissemination are also relatively few. For many decades, organizations such as the Peace Corps,
Indias

Alliance Francaise, the British Council, the Goethe Institut and the Japan Foundation have been promulgating the respective cultures
of the great powers around the world. They have most recently been joined by Chinas Confucius Institutes, which numbered 322 in

the Indian Council for Cultural Relations (ICCR) has been around since
of January 2013 it did
not have more than 35 centers in foreign countries (ICCR 2013). Moreover, it was
only in 2004 that India established its Ministry of Overseas Indian Affairs to
better leverage the presence of millions of Indians abroad, and only in 2006 that Indias Ministry of
2011 (Na 2012). Although

1950 with the aim of conducting activities similar to the organizations already mentioned, a s

External Affairs established a division dedicated to public diplomacy (Suri

2011). In the realm of non-governmental cultural dissemination, Bollywood has been a major force and yet
despite producing more films than Hollywood annually, the size of the
former remains considerably smaller than that of the latter: Hollywoods 2010
worldwide box office receipts alone were estimated at $US 31.8 billion (Verrier 2011), whereas Bollywoods entire industry size in

Bollywoods international diffusion

is not as strong as many analysts argue in 2011, overseas theatrical sales
constituted only eight percent of total industry revenue (Fig. 6 in Appendix). Although
2010 was estimated at $US 1.8 billion (FICCI-KPMG 2011). Moreover,

Indian culture, which is based largely on universalist and assimilationist Hindu principles, is a potent source of attraction,

Indias domestic institutions and foreign policy have mitigated this effect
on the perceptions of outsiders. In the domestic realm, India has done a much poorer
job of lifting its population out of poverty when compared to China . Although 54
growth has been impressive, Indias per capita income leaves it in the ranks of
countries such as Sudan, Ghana, the Solomon Islands, and Nigeria . Although the
government has made major strides in liberalizing the economy, many sectors remain highly regulated .
Indias public institutions are rife with corruption, inefficiency, patronage and
nepotism. In Transparency Internationals 2012 Corruption Perceptions Index, India ranked 94 out of 174 countries, tied with
Benin, Colombia, Greece, Moldova, Mongolia, and Senegal (China ranked 80). In the words of one analyst (Malone 2011, p. 38),
no

amount of cultural promotion can undo the damage internationally

caused by spectacular corruption scandals of the sort that India has recently been witness to,
and that have given rise to an anti-state social movement that made
international front page news in 2011. In the international realm, India has not
pursued the types of cooperative and conciliatory policies required to
garner soft power resources. Particularly in the realm of global governance, India has been
accused of being a spoiler on issues as diverse as trade, nuclear
nonproliferation, and humanitarian intervention . On trade, India was held
responsible to a great extent for blocking the efforts of the great powers
to rescue the Doha Round in 2009 (Blustein 2009). On nuclear non-proliferation and testing, India
continues to be a non-signatory to the Non-Proliferation Treaty (NPT) and
the Comprehensive Test Ban Treaty (CTBT), despite having received official recognition as a nuclear
power via the 2008 agreement with the US on civilian nuclear cooperation. On humanitarian intervention, Indias
approach to crises in Libya and Syria during its recent term on the UN
Security Council invited much criticism from the West (Kelemen 2011). As with China
which itself is struggling to increase its stock of soft power Western observers are frequently heard asking if India can be a

All these factors point to major

obstacles in the way of Indias soft power ambitions , obstacles that might have been
responsible stakeholder in the international system (Dormandy 2007).
irrelevant had India been more powerful.

2. Soft power is useless without sufficient hard power

Mukherjee 14 (Rohan, Princeton University, 2014, The False Promise of Indias
Soft Power, Geopolitics, History, and International Relations, Vol. 6(1), 2014, pp.
4662, Accessed 7/27/15)//LD
India is not sufficiently far along in terms of hard
power resources for its soft power to make a difference in its foreign
policy. Although in earlier periods India had relied on soft power as a substitute for hard power, Indias
Which leads to the second reason:

attractiveness following the end of the Cold War grew precisely because of
its hard power resources, specifically economic growth, which made India a desirable international
partner. It is no coincidence that references to Indias soft power grew in
frequency only after its economic gains were consolidated and the world could be
optimistic about Indias fortunes. In this sense, Indias trajectory corroborates the
argument of various analysts that soft power is most effective when
backed by hard power (Tharoor 2008, Lee 2010, Blarel 2012). Soft power is therefore not
only generated by hard power (all else being equal, other countries are drawn to success), it
also facilitates the smoother exercise of hard power by influencing the preferences of
those who are the targets of a states foreign 55 policy. India, however, is not at the point yet
where the precepts of Joseph Nye which were meant largely for an American audience
might apply. Instead, India remains in a transitory phase where its hard
power is yet to become preponderant even regionally to the point where it can
meaningfully project its soft power in order to create a political environment conducive to its
international goals. Although India is not in the position of China, which wields considerable hard power but lacks
the required domestic legitimacy to successfully wield soft power, it does lack many of the
ingredients that make soft power a useful tool for states such as the US and Western
European countries that can rely on an astute mix of hard and soft power to effect outcomes in world politics.
Indeed, as one scholar has argued (Hanson 2012, p. 13), Indias primary challenge lies in gaining the attention,
status, and recognition of a global power, rather than in battling any negative perceptions that its rise may have

recognition is likely to come only when

India addresses its internal problems and devises a more cooperative
foreign policy within the existing global order.
created in other states (as is the case with China). This

3. No coherent, consistent policy strategy

Mukherjee 14 (Rohan, Princeton University, 2014, The False Promise of Indias
Soft Power, Geopolitics, History, and International Relations, Vol. 6(1), 2014, pp.
4662, Accessed 7/27/15)//LD
The third and final cause of Indias underperformance with regard to soft
power is the contested nature of Indias own identity . Indias ruling elites
have yet to determine what kind of power their nation will be as it
continues to rise, and this indecision contributes to a sense of incoherence
in the portrayal of Indias image to the world. On the one hand, India is the secondlargest contributor to the US-led UN Democracy Fund for the promotion of democracy around the world; on the

continually reiterates its unwillingness to become an exporter of

democracy, i.e. to externalize its domestic political values. Consequently, states
and peoples that look to India for leadership on democratization such as Myanmar
are frequently frustrated by Indias unwillingness to commit to a coherent
policy on democracy promotion. In a similar vein, on the one hand, India is increasingly a
other, it

member of small groups of powerful states that determine the course of international bargaining over global issues

clings to its identity as a

developing and non-aligned country, remaining an active member of the Non-Aligned
Movement and frequently arguing for special privileges due to its developingnation status (e.g. on climate change). Consequently, poorer countries in international
organizations such as the African nations and small island states in the climate change negotiations are
often frustrated by what they perceive to be Indias pursuit of self-interest
such as trade, climate change, and international security; on the other, it

over the interests of developing nations, and rich countries decry Indias
unwillingness to compromise on issues that might cede some ground to
the developed world (e.g. in trade negotiations). At a more basic level, Indias multiple social
and political identities Hindu, Islamic, economically liberal, protectionist, conscientious objector to
nuclear treaties, responsible nuclear power, staunch supporter of human rights, opponent of humanitarian

continue to conflict with each other both within 56 Indian

policymaking and in the messages and images that India portrays to the
world. The end result is confusion at the receiving end, unpredictable
policy shifts, and general distrust among Indias interlocutors, none of
which is conducive to the effective exercise of soft power.
intervention

**Africa Scenario**

1NC---SQ Solves African Health

Status quo solves local African pharma production
UNAIDS 14 (Press Release, 3/29/14, Cooperation for the local manufacturing of
pharmaceuticals in Africa intensifies,
http://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2
014/march/20140329ecapharmaceuticals, Accessed 7/28/15)//LD
GENEVA/ABUJA, 29 March 2014African

leaders and key multilateral organizations

are strengthening and broadening support for the local production of
essential medicines on the continent. This was one of the key outcomes of the Seventh Joint
African Union (AU) Conference of Ministers of Economy and Finance and the Economic Commission for Africa (ECA)
Conference of African Ministers of Finance, Planning and Economic Development held in Abuja, Nigeria, from 25 to

the AU, UNAIDS, UNECA and UNIDO

held a high-level meeting, Local Manufacture of Pharmaceuticals: an
Untapped Opportunity for Inclusive and Sustainable Industrial
Development in Africa, with African ministers of finance and economic planning. The event
highlighted the opportunities for developing a high-quality pharmaceutical
industry in Africa, which will bring important health and economic development benefits. African Union
30 March. On the sidelines of the annual conferences,

Commission Deputy Chairperson, Erastus Mwencha stressed the benefits of the local production of medicines.
Local

production of generic medicines promises affordability and

availability of needed drugs, employment opportunities and overall public
health benefits, including shortened supply chains, hence helping to reduce stock outs, as well as
enhancing the capacity of local regulatory authorities to oversee the quality standards of essential medicines for
their countries. The Pharmaceutical Manufacturing Plan for Africa business plan, the Action Plan for the Accelerated
Industrial Development of Africa and the AU Roadmap on Shared Responsibility and Global Solidarity for AIDS, TB
and Malaria Response in Africa have been endorsed by African Heads of State and Government as strategic
continental frameworks for developing the pharmaceutical sector from both the public health and industrial
development perspectives. UNAIDS Executive Director Michel Sidib welcomed the broader support from financial
and industrial leaders for the local manufacture of medicines. The time for Africa to break its dependency on

The local manufacture of pharmaceuticals in Africa is an

opportunity to develop a broader manufacturing and knowledge-based
economy, he said.
foreign imports is now.

1NC---No Africa War !

No risk of great power conflict over Africa
Barrett 5 (Robert Barrett, PhD student Centre for Military and Strategic Studies,
University of Calgary, June 1, 2005,
http://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID726162_code327511.pdf?
abstractid=726162&mirid=1)
Westerners eager to promote democracy must be wary of African politicians who promise democratic reform
without sincere commitment to the process. Offering money to corrupt leaders in exchange for their taking small
steps away from autocracy may in fact be a way of pushing countries into anocracy. As such, world financial lenders
and interventionists who wield leverage and influence must take responsibility in considering the ramifications of
African nations who adopt democracy in order to maintain elite political privileges. The obvious reason for this,
aside from the potential costs in human life should conflict arise from hastily constructed democratic reforms, is the
fact that Western donors, in the face of intrastate war would then be faced with channeling funds and resources
away from democratization efforts and toward conflict intervention based on issues of human security. This is a
problem, as Western nations may be increasingly wary of intervening in Africa hotspots after experiencing firsthand
the unpredictable and unforgiving nature of societal warfare in both Somalia and Rwanda. On a costbenefit basis,

the West continues to be somewhat reluctant to get to get involved in

Africas dirty wars, evidenced by its political hesitation when discussing ongoing sanguinary grassroots
conflicts in Africa. Even as the world apologizes for bearing witness to the Rwandan genocide without having

the United States, recently using the label genocide in the context of the Sudanese conflict
(in September of 2004), has only proclaimed sanctions against Sudan, while
dismissing any suggestions at actual intervention (Giry, 2005). Part of the problem is
that traditional military and diplomatic approaches at separating
combatants and enforcing ceasefires have yielded little in Africa. No
powerful nations want to get embroiled in conflicts they cannot win
especially those conflicts in which the intervening nation has very little
interest.
intervened,

2NC---No Africa War !

No US involvement their ev is all hype
OHanlon 2/16/14 [Michael OHanlon, senior fellow with the Center for 21st
Century Security and Intelligence and director of research for the Foreign Policy
program at the Brookings Institution, where he specializes in U.S. defense strategy,
the use of military force, and American foreign policy, February 16, 2014, U.S.
military intervention, done right, could boost African stability,
http://articles.latimes.com/2014/feb/16/opinion/la-oe-ohanlon-troops-to-africa20140216]
For decades, one golden rule has guided America's military involvement in
Africa: Stay out . Generally speaking, the reason was a sense that the
strategic stakes did not justify the risk. When we deviated from this rule,
we often learned lessons the hard way that seemed to reinforce its
validity, as in Somalia in 1993. And while presidents often profess a
stronger interest in Africa than their actions would imply, they tend to say
such things when not in the White House witness Bill Clinton calling the
nonintervention in Rwanda's 1994 genocide his greatest regret as president, or Sen.
Barack Obama calling for more assertiveness in the Democratic Republic of Congo,
or DRC, and Sudan six to eight years ago.

Empirics dozens of conflicts disprove

Docking 7 (Tim Docking, African Affairs Specialist with the United States Institute
of Peace, 2007, Taking Sides Clashing Views on African Issues, p. 372)
Nowhere was the scope and intensity of violence during the 1990s as
great as in Africa. While the general trend of armed conflict in Europe, Asia, the Americas, and the Middle
East fell during the 1989-99 period, the 1990s witnessed an increase in the number of conflicts on the African
continent. During this period, 16 UN peacekeeping missions were sent to Africa. (Three countries-Somalia, Sierra

this period saw

internal and interstate violence in a total of 30 sub-Saharan states. In
1999 alone, the continent was plagued by 16 armed conflicts , seven of which were
Leone, and Angola-were visited by multiple missions during this time.) Furthermore,

wars with more than 1,000 battle-related deaths (Journal of Peace Research, 37:5, 2000, p. 638). In 2000, the
situation continued to deteriorate: renewed heavy fighting between Eritrea and Ethiopia claimed tens of thousands
of lives in the lead-up to a June ceasefire and ultimately the signing of a peace accord in December; continued

Sierra Leone, Burundi, Angola, Sudan,

Uganda, and Nigeria as well as the outbreak of new violence between
Guinea and Liberia, in Zimbabwe, and in the Ivory Coast have brought new hardship
violence in the Democratic Republic of Congo (DRC),

and bloodshed to the continent.

No escalation doesnt spill over enough

Stremlau 2k professor and the head of the Department of International Relations at
the University of the Witwatersrand in Johannesburg, South Africa (John J., Ending Africa's
Wars, Council on Foreign Relations, July/August 2000,
<http://www.foreignaffairs.com/articles/56245/john-j-stremlau/ending-africas-wars>)//SS

Following last year's military interventions in defense of human rights in Kosovo and East Timor, Western leaders
proclaimed a new determination to stand up to similar abuses whenever they occur. On one continent, however,

Renewed clashes in Sierra

Leone and on the Ethiopian-Eritrean border are two recent examples of
deadly African conflicts that have killed and displaced millions of people. Yet despite
occasional bursts of aid and attention, the United States and Europe have
remained largely disengaged. The reasons for their lack of involvement in conflict prevention and
peacekeeping there are fairly obvious. War in Africa seems to pose no clear and present
danger to U.S. interests. Furthermore, most African conflicts are fought
within, not between, states. The international norms, institutions, and
political will to intervene in such hard-to-solve conflicts remain
inadequate. So do Washington's defense doctrine, bureaucracy, and budgets, all of which are still dedicated
warfare still rages unchecked, and far too little is being done about it.

to preventing or settling traditional conflicts between states.

Whistleblowing Advantage Answers

1NC---Cred Turn
Whistleblowing destroys cred
Bard 12 (Jennifer S, Visiting Professor, Drake University Law School; Alvin R.
Allison Professor of Law, Texas Tech University School of Law and Director, What to
Do When You Can't Hear the Whistleblowing: A Proposal to Protect the Public's
Health by Providing Whistleblower Protection for Medical Researchers, 2011 / 2012,
lexis)//ghs-VA
Stricter laws protecting whistleblowers in the United States might also backfire by
encouraging the already prevalent practice of exporting medical research
overseas . It is therefore important that any proposed legislation close this loophole
by requiring the FDA to monitor companies seeking to market drugs , vaccines
or medical devices in the United States to make sure they have a documented program
for protecting scientists conducting basic research .

2NC---Ext. Cred Turn

Revelations cause the FDA to lose credibility
Ting 8 (Michael, Department of Political Science and SIPA, Columbia University,
WHISTLEBLOWING, May 12, 2008,
http://www.columbia.edu/~mmt2033/whistleblowing.pdf)//ghs-VA
Whistleblowers have historically played key roles in passing crucial information
from lower levels of organizations to higher-level officials. A casual survey of American organizations in recent years
amply demonstrates that this trend has not abated. In 2002, Federal Bureau of Investigation (FBI) staff attorney
Coleen Rowley went public over the bureaus investigation of the alleged 9/11 co-conspirator Zacarias Moussaoui.
Her account of how FBI headquarters stifled attempts to investigate his activities built support for the

In 2004, Food and Drug Administration (FDA) researcher

Graham testified before a Senate committee that the agency had ignored
warnings about the heart disease risks posed by Vioxx prior to its approval. These
revelations caused serious damage to the FDAs credibility , and
generated demand for both stricter drug approval procedures and improved
post-approval monitoring. Such episodes have not been confined to the public sector. In 2002,
reorganization of its anti-terrorism efforts.
David

Sherron Watkins of Enron and Cynthia Cooper of WorldCom both gained acclaim for their roles in uncovering
managerial irregularities in their respective corporations.

1NC---G20 Fails
G20 Policies are useless and ineffective more than half of the
time.
ITUC 14 (International Trade Union Confederate, 12/12/14, New Survey: Half of
G20 Policies Rated as Ineffective, http://www.ituc-csi.org/new-survey-half-of-g20policies?lang=en, Accessed 7/28/15)
More than half of G20 policies have failed to have a positive impact on
working people with weak action on issues that could have had an impact
on workers lives such as jobs, decent wages and social protection , said Sharan
Burrow, General Secretary, International Trade Union Confederation, on the eve of the annual Labour 20 (L20)
Summit in Brisbane, Australia. More than 200 million people were unemployed in 2013, an increase of five million
compared with the year before according to the International Labour Organisation. Governments

are
prioritising policies which support the interests of big business and not
tackling the inequality of wages and rising unemployment, said Ms Burrow. In Brisbane, the G20
needs to agree on a plan for jobs and growth, putting in place comprehensive measures to support aggregate
demand, reduce inequality and spur investments. This must be backed up by national job creation targets, and
followed up in consultation with social partners, said John Evans, General Secretary of the Trade Union Advisory
Committee to the OECD (TUAC). Economic modelling prepared for the L20 shows that a co-ordinated mix of wage
and investment policies in G20 countries could halve the global jobs gap and create up to 5.84 percentage points
more growth in G20 countries, compared to business as usual. Labour 20 Chair and Australian Council of Trade
Unions President Ged Kearney said that effectively tackling unemployment must be a priority for the G20 Leaders
Summit. With Australias unemployment at a twelve year high of 6.2%, and youth unemployment more than
double that at 14%, the Abbott Government must shelve its spin and set out a jobs plan, Ms Kearney said. Prime
Minister Abbott needs to understand that empty rhetoric wont cut it. He needs to spell out concrete
policies and initiatives for job creation based on decent wages, conditions and investment in skills. The ITUC Global
Poll 2014 of G20 countries found that 68 per cent of people say their government is bad at tackling
unemployment; 79 per cent of people believe the economic system favours the wealthy, rather than being fair to

62 per cent of people want their governments to do more to

tame corporate power. The results of the G20 tracking survey will be presented at the Labour 20
most people; and

Summit in Brisbane 14 -15th November 2014.

2NC---Ext. G20 Fails

G-20 does not solve for all it claims.
Foley 9 (Stephen, The Independent, 9/27/9, G20 promises: 'Overhyped and
ineffective', http://www.independent.co.uk/news/business/news/g20-promisesoverhyped-and-ineffective-1793731.html , Accessed 7/28/15)
Promises of a new era of international co-operation to end economic
imbalances, monitored by the G20 and the International Monetary Fund,
were overhyped by the leaders of the industrialised nations, according to the Nobel
prize-winning economist Joseph Stiglitz. The G20 pledged this weekend to work towards a stronger and more balanced global
economy, after years when US policymakers have blamed China for saving rather than spending the fruits of its export boom,

The post-summit
communiqu described itself as "a compact that commits us to work
together to assess how our policies fit together, to evaluate whether they
are collectively consistent with more sustainable and balanced growth,
and to act as necessary to meet our common objectives". And it promised a
new role for a reformed International Monetary Fund, which would help conduct a "candid, even-handed, and balanced
analysis of our policies". But Professor Stiglitz said hopes that this might mean the Chinese agreeing to
leaving the American consumer to borrow and spend to keep the global economy moving.

international oversight of their economy were far-fetched. "It has been accepted because at least some of the people who have
signed up to it believe it won't be effective," he said. Substantial further concessions will be required from Western nations,
Professor Stiglitz said, but he welcomed the agreement to scrap the G8 as the main body of international economic co-operation in
favour of the G20, which includes more emerging nations. The move is the first step in what will be "very slow progress towards a
new financial architecture", he said. "At the G8, China and others were treated like second-class citizens, allowed only to come to
the dinner after the communiqu was issued. "So China is beginning to assert itself, and to take its rightful place. The post-colonial
world order, 60 years on, is beginning to fall apart." The G20 pledged that there will be reform of the IMF to increase the voting
power of newly powerful economies, including China, but the balance of power will shift by just 5 per cent. Bigger moves were
blocked by France and the UK, which face losing seats. Professor Stiglitz said: "There is quibbling over the details, but the bigger
picture is that the US is not giving up its veto power and, until it does, the IMF as an institution cannot serve in the role of
international arbiter." John Lonski, a senior economist at Moody's Investors Service, said the economic imbalances will erode in the
face of reality not because of any international communiqu. "Even without an accord, you would still find that countries such as
the US will move away from consumption and towards production. "That's what the weaker dollar implies, and an ageing US
population means it cannot be the juggernaut of global growth any more. It behoves other countries to step up and stimulate
demand of their own."

Empirics prove transparency fails and G-20 utility is hype

Davis 13 (Alan, DevEx, 9/4/13, Why the G20 anti-corruption drive is failing in the
Philippines, https://www.devex.com/news/why-the-g20-anti-corruption-drive-isfailing-in-the-philippines-81736, Accesed 7/28/15)//LD
The irony of Russia making growth through trust and transparency one
of three overarching priorities during its presidency of the G-20 is
unlikely to be appreciated by those civil society groups currently being
targeted by the Kremlin. Nor is it likely to be missed by those leaders of countries
which score poorly in global transparency and corruption rankings who may take
comfort in the ongoing gap between rhetoric and reality in the West and thus see
little need or pressure to undertake real reform at home. Despite some clear
gains in the G-20s anti-corruption action plan in the areas of combating
bribery and money laundering, perhaps too much claimed progress is
based on governments own assessments of their performance and too
little emphasis given to external and more objective monitoring and
engagement by ordinary citizens. A similar criticism might also be made of the

Open Government Partnership, the global initiative established in 2011 to promote

greater public transparency and accountability where membership, more open than
the G-20, is offered to all states which promise to do better for their people.

1NC---No Econ Nationalism !

No impact to economic nationalism or protectionism--institutional checks
Dadush et al 11 [Uri, senior associate and director in Carnegies new International Economics Program,
currently focuses on trends in the global economy and the global financial crisis, previously served as the World
Banks director of international trade and before that as director of economic policy. He also served as the director
of the Banks world economy group, leading the preparation of the Banks flagship reports on the international
economy, Shimelse Ali, economist, Carnegies International Economics Program, Rachel Esplin Odell, junior fellow in
Carnegies Asia Program, Carnegie Endowment for International Peace, Is Protectionism Dying?, May,
http://www.carnegieendowment.org/files/is_protectionism_dying.pdf]

Despite a

increase in the incidence of protectionist measures during the

recent financial and economic crisis, the effects on global trade appear smallthe world,
remarkably, did not resort to protectionism . In addition to the concerted stimulus
measures, financial rescues, and the strengthening of lender-of-last-resort
facilities that restricted the duration and depth of the economic downturn,
the World Trade Organizations disciplines, enforceable through its dispute settlement
mechanism, no doubt played an important role in staving off trade protection . But
this is only one part of the story. The increased resistance to protectionism is the result
of a complex, mutually reinforcing set of legal and structural changes in
the world economy that have made a return to protection more costly and
disruptive and have established new vested interests in open markets. These changes include:
National disciplines: Along with autonomous liberalization and a generally robust rule of law in the
largest trading countrieswhich improve the confidence of importers and exporters national trade
tribunals help prevent protectionism by providing a mechanism whereby
individual firms can contest protectionist measures that impact their company. Many
limited

national governments have also developed explicit or implicit mechanisms for countering protectionism and

Regional and bilateral agreements: In

addition to codifying further tariff reductions, regional trade agreements
now covering over half of world tradecontain provisions establishing
dispute settlement mechanisms that parties can use to contest violations of the agreement and
thereby defend against protectionism. Furthermore, such agreements have often established
regular high-level dialogues on trade disputes, treaty implementation, and further
liberalization, providing a mechanism for resolving serious violations of the
agreement even if its formal juridical mechanisms are not utilized . Facts on
the ground: The political resistance to backsliding on liberalization is stronger
because trade has become more prevalent and inextricably woven into
production and consumption patterns. The change in the political economy of protectionism is
ensuring that trade policy reflects the general interest.

manifested in the increased interest of retailers and consumers in imports, the internationalization of production,
and the rise of intrafirm trade. Limiting trade in any one sector not only hurts those consumers, retailers, and firms
that depend on imports for inputs, but also has repercussions for firms that operate both vertically (within a sector)
and horizontally (across sectors) that depend on complex global production chains.

2NC---Ext. No Econ Nationalism !

Protectionism is not relevant to war -- other factors outweigh
Hulsman et al 3 [John, PhD, Research fellow in European affairs at the Heritage
Foundatiions Davis Institute, Joshua Bridwell and Eric Hamilton, The Myth of
Interdependence, August 20, http://nationalinterest.org/article/the-myth-ofinterdependence-2412]
As realization of this phenomenon increases, it is disturbingly common for analysts to develop false conclusions
based upon a superficial understanding of globalization. Perhaps the most prevalent and beguiling mirage of all is

Implicit in the arguments of

interdependence proponents is the premise that interdependence affects
all nations to roughly the same extent --that it acts as a blanket phenomenon, restraining all
the notion of a universal "interdependence."

that are involved to the same degree. Clearly this is not true.

Consider this hypothetical. Would Australian foreign

Would Canberra have

been likely to abrogate the ANZUS treaty because of its people's
opposition to the Iraq war? Hardly, as Australia undoubtedly benefits from
the American military alliance serving as life insurance in the volatile Asian region.
policy have been affected if it had strenuously opposed America's efforts in Iraq?

Would it be likely to impose an embargo on the U.S.? Nonsense, as it greatly benefits from trade with America. In
fact the opposite is true: it has long been a goal of Australian foreign policy to secure a free trade agreement (FTA)
with Washington --Iraq war or no. Would Australia refuse to continue closely sharing intelligence with America?
Impossible, as the Bali bombing illustrated that Canberra is a major target of Al-Qaeda, along with the United
States. Or would certain Australian diplomats simply snub Americans at cocktail parties? For in the end, that is what

While interdependence does mean that

there is always mutual vulnerability, in the case of the U.S. and Australia
(and indeed in every case), this is not the salient feature of the
relationship. Rather, Australia's far greater dependence on the U.S.
conditions foreign policy decision-making at the highest levels --but not
necessarily the other way around. The Wilsonian habit of misunderstanding the nature of
"disapproval" with America often amounts to.

interdependence is far from an esoteric error. For despite what many foreign policy practitioners believe, policy

By overrating the universal

impact of interdependence theory, Wilsonians naturally see the present
order as fundamentally multipolar, and devise policies to fit this reality.'
Unfortunately, the real world does not correspond to their assessment,
thus dooming their policy initiatives to failure. In the turbulence of a
changing world order, one particular paradigm has been almost totally neglected. Ironically, we
have abandoned realism-the one doctrine that can best navigate our role
in the uni-multipolar world we find ourselves in. For, if we hold that the attempt to
remake our global history of conflict and chaos into a hopeful future of peaceful order is but an illusion, then we
must accept the anarchic nature of our world and attempt to live in it as
best we can. Specifically, we must create policies that recognize and place our national interest above all
outputs flow naturally from first principle intellectual assumptions.

other priorities. This reality is largely reinforced by the current nature of interdependence. The Wilsonian view
suggests it binds all states with equivalent strength, while the realist outlook allows that interdependence in the
economic arena is very much part and parcel of the modern world, but does not in fact affect all states equally. As

Countries
that possess the preponderance of power are able to significantly
influence the policy outcomes of weaker states (assuming such states do
not perceive overriding security/geopolitical concerns). Such will it ever
be.
illustrated by the U.S.-Australia hypothetical, a power hierarchy characterizes interdependence.

Solvency Answers

1NC---Oversight Key
Oversight is key to agency effectiveness
Oleszek 10 (Water J- Senior Specialist in American National Government. Congressional
Oversight: An Overview. February 22, 2010. http://fas.org/sgp/crs/misc/R41079.pdf//GH)

Oversight is an implicit constitutional obligation of the Congress . According to

Historian Arthur Schlesinger, Jr., the framers believed it was not necessary to make specific reference to oversight
in the Constitution. [I]t was not considered necessary to make an explicit grant of such authority, wrote
Schlesinger. The

power to make laws implied the power to see whether they

were faithfully executed.15 The Constitution also granted Congress an array of formal powersthe
purse strings, lawmaking, impeachment, among othersto hold the president and the administration accountable
for their actions or inactions. In short,

oversight plays a key role in our system of checks

and balances. There is a large number of overlapping purposes associated with oversight. This array can be
divided into three basic types: programmatic, political, and institutional. Programmatic purposes
include such objectives as making sure agencies and programs are working in a
cost-effective and efficient manner; ensuring executive compliance with
legislative intent; evaluating program performance; improving the
economy of governmental performance; investigating waste, fraud, and
abuse in governmental programs; reviewing the agency rulemaking
process; acquiring information useful in future policymaking; or
determining whether agencies or programs are fulfilling their statutory
mission. There are also political purposes associated with oversight, such as generating favorable publicity for
lawmakers, winning the electoral support of constituents and outside groups, or rebutting criticisms of favorite
programs or agencies. After all, oversight occurs in an ever-present political context in which Congresss
relationship with administrative entities can range from cooperation to conflict. There are, moreover, inherent
constitutional and political tensions between Congress and the President even during periods of unified government
(one party in charge of the House, Senate, and White House). Partisan and inter-branch conflicts are not uncommon

there are institutional oversight

purposes that merit special mention, because they serve to protect
congressional prerogatives and strengthen the American publics ability to
evaluate and reevaluate executive activities and actions. Three institutional
in the conduct of the legislative review function. In addition,

purposes include checking the power of the executive branch; investigating how a law is being administered; and
informing Congress and the public.

2NC---Ext. Oversight Key

Oversight is key to FDA credibility---turns their adv
Markey 7 (Edward J- representative from Mass. The Adequacy of FDA to assure the safety of the
nations drug supply Pg51.https://books.google.com/books?
id=s6cBQmWJbm8C&pg=PA51&lpg=PA51&dq=FDA+whistleblowers+AND+legislative+oversight&sour
ce=bl&ots=gzO4GSXmHl&sig=06myUJ5CuVgEXvPSDNvf1yQUeoY&hl=en&sa=X&ved=0CEoQ6AEwB2o
VChMI1pLX_9P5xgIVg5aICh0acQ2z#v=onepage&q=FDA%20whistleblowers%20AND%20legislative
%20oversight&f=false//GH)
Chairman Stupak, thank you for allowing me to participate in today's hearing.

The FDA is clearly in

desperate need of oversight and reform. Like Senator Grassley, I have been working on FDA
reform with whistleblowers for several years and asking the FDA questions about Ketek since May, 2006. The FDA

It appears that the FDA has finally

responded to congressional oversight. It is not a coincidence that FDA
finally took action to protect the public from Ketek by making changes to
the label the day before this hearing. But the FDA's long overdue actions on Ketek do not
refused to answer my requests for information.

eliminate the threat to the American people. Although the FDA has acted to warn the public about Ketek, we have
no idea exactly how many dangerous products like Ketek the FDA has allowed on the market and put our families at
risk every day. The FDA's problems are systemic and it is in dire need of reform. Today we will hear about the truly
frightening problems at the FDA including: a culture of suppression and intimidation; a lack of transparency into
the review process; the inaction of FDA management in response to serious drug risks; and a lack of scientific
freedom and the inability of FDA Reviewers to have their concerns heard by senior management, FDA advisory

the FDA is a deeply troubled

agency that has failed to act in the best interest of the public. We need the FDA
to be a watchdog for public health, not a lapdog for the industry. We need to bring transparency,
accountability and scientific integrity back to the FDA through a
committees and the public. It is clear from the testimony that

combination of increased oversight and legislative reform . Today we

begin the oversight and later this week I will reintroduce my bill, the Swift Approval, Full Evaluation
(SAFE) Drug Act to address many of these problems. We need to act now--not only to protect
the public health but also to restore the public's confidence in the FDA . A
Harris Poll conducted last year found that 80 percent of adults say they are concerned about the FDA's ability to

We
need to turn this agency around now and I look forward to working with
my colleagues on this committee to make the changes necessary to ensure
that the FDA can protect the public health.
make independent decisions that will ensure that patients have access to safe and effective medicines.