Running head: REGULATORY ISSUES IN CAM

Regulatory Issues in CAM Team B Survey of Alternative Medicine 201 March 18, 2013 Jeanette Plodek

REGULATORY ISSUES IN CAM

Regulatory Issues in CAM The use of CAM (complimentary alternative medicine) is well known not just in the United States but all around the world. The popularity level with the use of CAM is increasing tremendously. Nearly 40 percent of adults are having reported to use complimentary alternative medicine. Even the doctors are taking into consideration the use CAM therapies and combining with mainstream medical therapies for greater results. Individuals are in search of a good health and wellbeing; the use of CAM is bringing just that. The Current Regulations and Oversights in the US The United States has no standard system for credentialing CAM practitioners. Each states credentialing process varies widely depending on the state and the type of CAM practice. Certain CAM professions like chiropractic care are licensed in most states. However, training, testing, and continuing education vary from state to state (National Institute of Health [NIH], 2013). Many alternative practitioners belong to national organizations that are familiar with the process for licensing, certification, or state laws for that specific CAM therapy (Fontaine, 2011). However, the current system is flawed as there is no uniform practice for evaluating all CAM therapies and practices. The U.S. Food and Drug Administration (FDA) provide regulations for dietary supplements. However, these regulations are much less strict than for prescriptions or over-thecounter medications. The manufacturer does not have to prove the supplements to be safe and effective prior to release, but the FDA does monitor safety once supplements are released to the public. The FDA also monitors the supplements claims to be accurate. Additionally, advertising is monitored by the Federal Trade Commission (NIH, 2013).

REGULATORY ISSUES IN CAM

Back Flower Remedies The Bach flower remedies developed by Dr. Edward Bach have been recommended for many psychological and emotional conditions such as stress or anxiety. A compound of five flowers called Rescue Remedy was found to be useful in emergency situations, such as trauma. These remedies are often used as alcohol-based preparations but can also be used as topical treatments. There are numerous anecdotes about successful treatment with Bach flower remedies, although how effective and safe they are has not been investigated scientifically. They are not listed on the U.S. Food and Drug Administration's (FDA) Generally Recognized as Safe (GRAS) list, however the essential oils extracted from the plants may be listed ("Natural Standard", 2013). The current regulatory oversight is not sufficient and presents significant public safety and health risks. According to Ventola (2010), The Dietary Supplement Health and Education Act (DSHEA) in 1994 classified dietary supplements as foods, thereby preventing the FDA from regulating them as strictly as drugs with respect to their efficacy, safety, or marketing claims. While believed to be safe by many patients they could still be potentially harmful. Manufactures are not mandated to submit clinical efficacy and safety data for their products to the FDA prior to market approval and therefore lack of information. This communication gap can cause these potential adverse outcomes (Ventola, 2010). Biofeedback Biofeedback therapy helps a person to read their own body and understand how the body works instead of relying on a doctor. Various ailments depend on the biofeedback where the training and therapies play a big role in understanding how it works. Doctors rely on biofeedback machines to help them understand and know what the person is feeling. Some examples include

REGULATORY ISSUES IN CAM

heart rate machines, blood sugar machines, and machines used to see the bones. Every person has also used biofeedback machines such as a scale and thermometer. Biofeedback provides a report back to the person and helps to train the person to understand what has been received. An important issue regarding the purchase of an instrument is making sure that it is safe and effective. These instruments need to have FDA approval and practitioners have the responsibility to maintain the equipment after the purchase. Another area of concern is to make sure that clients are aware of the risks in taking an equipment home. This is the practitioners responsibility to provide the necessary training. According to the Food and Drug Administration (FDA) (Striefel, 2002, and Sherman, 1994), biofeedback equipment is classified as a Class II Medical Device. These medical devices have certain levels of risks and benefits that the regulation depends on the level of control that considers necessary in ensuring the safety and effectiveness. Polarity Polarity Therapy involves the practiced application of body work skills to promote pleasant life functions. It addresses a physical, mental, emotional and spiritual wellbeing. It can be applied to a wide range of health and healing systems. The organization that provides the oversight is The National Institute of Health (SZENT-GYORGYI, 2011). They are currently funding seven studies on Polarity Therapy. According to their studies, Polarity practitioners believe that the body, mind, emotions, and spirit are interdependent. They believe that individuals are responsible for their own health and even the most minor steps can improve and maintain a healthy level of wellness. Considering that Polarity Therapy is still going through a process of study, it has potential deficits of the current regulatory oversight. Currently, it is not recognized by the

REGULATORY ISSUES IN CAM

legislative arena to provide a greater degree of accommodation for access to and practice Polarity Therapy. This therapy is considered to be a less known complimentary modality. It has not been established nor are there licensed practitioners. Polarity concentrates on the health of an individual and it is understood that nutrition plays a large role in the level of wellness of an individual. Some potential adverse outcomes that may occur with the current system are that unlicensed practitioners cannot perform this therapy that may possibly heal individuals who believe in it. The therapy is a positive way of life style. It is nothing you eat, drink or may harm your body. It should be determined on the individual if they are healthy enough to follow as exercise and a healthy diet is not known to harm you with supervision and advice. Reiki Reiki Therapy is a form of spiritual healing developed in Japan, but is not associated with any specific religion (Cleveland Clinic). There is no special background or credentials required for Reiki training, which is obtained from experienced Reiki practitioners. Although there are many Reiki practitioners who have opened private practices, or perform Reiki in hospitals and other health care settings, there is no true oversight board (University of Minnesota). The Reiki License Commission, which is affiliated with the Federation of Spiritual Healer License Boards, claims on its website that it is a volunteer organization of license qualified Reike healers and masters (Reiki License Commission). However, neither organization defines what license qualified means. The Federation of Spiritual Healer License Boards website simply discusses its work in legally defending the rights of spiritual healers to practice. This complete lack of oversight is an obstacle to potential practitioners who have no way of researching the qualifications of teachers, to ensure they are being taught properly. Similarly,

REGULATORY ISSUES IN CAM

with no defined scope of practice, patients could fall victim to practitioners providing services they are not properly trained to perform. Proposal and Rationale for Regulatory Process Although many states have different standards to regulating Complementary and Alternative Medicines (CAM) there needs to be a national process. The rationale for this is quite simple the public needs to be informed on what is out there. This information needs to come from a trusted source and the public has to know what is safe and what works. This is also important for doctors to know and trust what they may prescribe. The process should entail gathering conventional medical doctors, practitioners of alternative medicine, and clinicians to a conference. Everyone should have an input on what needs to be relegated and how to do it. There are many studies out there that show either the non-effectiveness or the effectiveness of different CAMs. If there are enough people to agree on the validity then they can discuss. If there is no validity, then they can discuss possible tests to prove the strength of the medicines. All the participants must go into the conference with an open mind. Once a CAM is approved all practitioners should have a process where they receive a license to administer the CAM. The public could feel much safer and better served if they know there is an oversight committee governing and handing out licenses for all medications. Analysis of the Improved Consumer Protection: There are some health professionals that either disagree with CAM or just do not educate their patients. Some feel threaten by this therapy because patients will stop taking prescription pills and use other medication that is more natural. The National Center of Complementary and Alternative Medicine (NCCAM) provides funding and has the right to limit who can be on

REGULATORY ISSUES IN CAM

CAM. CAM practice as safe or meaningfully effective for treating any illness or condition [6]. Nor is there any reason to believe that the teaching envisioned by the committee will provide science-based information to its recipients (Quackwatch.org). If more patients were willing to speak with their doctors about CAM I believe it will become a popular therapy that many patients would like to try. Another thing that would kind of interfere in communication with CAM is not letting enough people know about it and how it can better ones health. To add insult to injury, state law generally gives the Boards governing these practices exclusive authority to regulate their professions. This has resulted in rules which incorporate even more pseudoscientific nonsense into the scope of practice. In Florida, for example, a Board of Acupuncture rule allows aromatherapy, electric moxibustion, color therapy, homeopathy, ion pumping cords, iridology, Kirlian photography, magnet therapy, photonic stimulation and sonopuncture (Science-Based Medicine.org). Once more patients are aware of CAM and what it can do for them it will become a new form of medication that is more natural than others. Potential Obstacles: Implementing a new plan for CAM regulation would definitely have some advantages but it would also present obstacles as well. In a case like this implementation of new regulatory issues will provide connection with many physicians with different point of views and levels of professional and academic skills. Thus making it challenging to set rules for them to agree on, and creating obstacles that will need to be resolved immediately. Some may not agree with the morals and ethics of the CAM regulations. According to source, Issues raised include access to qualified CAM practitioners, state regulation of CAM practitioners, integration of CAM and conventional health care, collaboration between CAM and conventional practitioners, and the cost of CAM services. There are so many different views when it comes to CAM that it makes

REGULATORY ISSUES IN CAM

regulating a lot more difficult to uniform, which makes it safe to say that one of the biggest challenges would be to change the mindset of practitioners who have been a part of a particular form of alternative medicine for numerous years. Conclusion The ever-changing of the human body brings the many changes in medication. Individuals are learning and requiring medication which can be more natural with the least amount of side effects. The ever growing need of complementary and alternative medicine is based not just on a single type of medication but many practices that center on a philosophy and perhaps that is why there is an increase in this medication. Individuals are looking for a change and different ways to get better faster and with all the different ways offer by CAM, the need of the medication will only continue to increase with time.

REGULATORY ISSUES IN CAM

References Biofeedback Therapy. (2007). Retrieved from http://www.biofeedbacktherapy.net/ Cleveland Clinic . Integrative Therapy: Reiki Therapy. Retrieved March 16, 2013 from: http://my.clevelandclinic.org/departments/integrativemedicine/reiki_therapy.aspx Federation of Spiritual Healer Licensing Boards. Retrieved March 16, 2013 from: http://www.fshlb.com/about.html Fontaine, K. L. (2011). Complementary and alternative therapies for nursing practice (3rd ed.). [Adobe Digital Editions version]. Retrieved from http:ecampus.phoenix.edu/content/eBookLibrary2/content Jann Bellamy, The CAM Consumer: Misled and Abused, Science-Based Medicine.org, copyright May 2012, retrieved from http://www.sciencebasedmedicine.org/index .php/the-cam-consumer-misled-and-abused/ National Institute of Health. (2013). What is complementary and alternative medicine. Retrieved from http://nccam.nih/health/whatiscam Natural Standard. (2013). Retrieved from http://naturalstandard.com/index-abstract.asp?create abstract=patient-bachflowerremedies.asp&title=Bach%20flower%20remedies Reiki License Commission. Retrieved March 16, 2013 from: http://reikilicense.com/about.html Stephen Barrett, M.D., Institute of Medicine Committee Issues Irresponsible "CAM" Report, Quackwatch.org, copyright January 2005, retrieved from http://www. quackwatch.org/07PoliticalActivities/iomreport.html Striefel, S. (2011). Potential FDA Regulation of Feedback. Retrieved from

REGULATORY ISSUES IN CAM

10

http://www.aapb.org/i4a/pages/index.cfm?pageID=3339 SZENT-GYORGYI, A. (2011). Combined Physical and Biofield Therapies. In K. L. Fontaine, Complementary &Alternative Therapies for Nursing Practice, Third Edition. Prentice Hall. University of Minnesota (June 4, 2012). Taking Charge of Your Health: How Can I Find a Qualified Reiki Practitioner. Retrieved March 16, 2013 from: http://takingcharge.csh. umn.edu/explore-healing-practices/reiki/how-can-i-find-qualified-reiki-practitioner Ventola, C.L. (2010, September). Current Issues Regarding Complementary and Alternative Medicine (CAM) in the United States. Pharmacy and Therapeutics (P&T), 35(9), 514 522. White House Commission on Complementary and Alternative Medicine. Retrieved from http://www.chiro.org/alt_med_abstracts/CAM/Rosner.shtml