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HPARA CONFERENCE - 26 May 2018

How medication-induced catastrophes were covered


up at the HCCC, Medical Board & NSW Health

Dr Yolande Lucire, MBBS (1964), DPM 1967 (Diploma of


Psychological Medicine),
PhD 1996 (Public Health & Medical Anthropology),
FRANZCP (1971-2011)

A whistle blower's tale of reprisals

1
We need an ICAC enquiry
Into partial (in the sense of biased)
administration concerning an issue of
public health and safety by the Medical
Board of NSW and HCCC.

And much else…

2
Trying to get acknowledgement and apology
• This PowerPoint presentation has one purpose. It is an appeal to the
Medical Council to review its use of “the College” and it’s clinical
practice guidelines as the standard whereby doctors such as myself
have been judged and punished for holding heterodox views, albeit
consistent with the science.
• Since 2016, I have been trying to get an apology from Dr. Kesby, Chair
of the Medical Council which replaced the Board and;
• I want to be acknowledged as the whistleblower who told truth to
power about the medication-induced causes of the “Crisis in Mental
Health,” an explosion in demand for care, and increases in suicides
and homicides committed by patients under mental health care.
• I wrote to the NIOSH Ombudsman who told me to deal directly with the
Council.
• I made two submissions (1) (2) to two Senate enquiries. This incensed
them further.
3
• In late 2017, two manifestly false complaints were put before two
s150 committees, a pseudo-legal procedure that does not accord
fairness or natural justice, and which flies in the face of my human
right to a fair trial.

• False information in many forms (my complaints history and the


notifications I had made which had been ignored) was also put to
these ill-informed committees, whose members had little training or
expertise in judging.

• Both patients were happy with my care and had been damaged by
New South Wales Health.

• I have been again suspended on the personal opinions of people


who cannot read files or understand what I am talking about .

• Bias is obvious, but that is a whole other paper.

4
A Bush Hospital 1997-2005
In 1997, I stopped Prozac in an alcoholic patient when
he developed suicidal thoughts on it.
He murdered his wife six weeks later while taking
amphetamines, alcohol and cannabis
Search for ‘medication-induced suicide homicide’ on
Google, Google scholar, Ovid, or PubMed for more
information):
https://scholar.google.com.au/scholar?hl=en&as_sdt= 0%2C5&q=
antidepressant++induced+suicide+&btnG=
https://scholar.google.com.au/scholar?hl=en&as_sdt=0%2C5&q=
antidepressant-induced+homicide&btnG=
https://scholar.google.com.au/scholar?hl=en&as_sdt=0%2C5&q=+
medication-induced+suicide+homicide&btnG=
5
I wrote to the Commissioner, citing similar
cases in Australia.

There had been a good deal of literature on


the increase in aggression in some persons
taking SSRIs - and with alcohol. Indeed,
there have been quite a number of
homicides committed by people on SSRIs -
so many that it is known as the ‘Prozac
made me do it’ defense.
http://www.healyprozac.com
6
The Perpetrators, whose treatments I notified
• I have called them Doctors A, B, C, and D.

• These 4 psychiatrists were the major perpetrators of these


catastrophes, such as were common in NSW Mental Health, but
I did not know that when I first notified. A hospital admission is a
serious Adverse Drug Event by definition.

• The Sentinel Events Committee which published ‘Tracking


Tragedy 2004 - A systemic look at homicide by mental health
patients and suicide death of patients recently discharged from
mental health inpatient units: Second Report of the
Committee’ was also informed by The RANZCP guidelines.

• In 15 months I notified:

• 1 death;
7
• 5 suicides, (there were actually many more, but I
only reported 5);

• Innumerable (i.e. hundreds) of suicide attempts;

• 1 homicide and 3 homicide attempts and;

• Dozens of inappropriate discharges of suicidal patients


who had to be readmitted. Inadequate diagnoses.

• Poor diagnostic procedures leading to tragedies.

• Unlawful prescribing under PBS regulations: prescribing of


Special Purpose drugs, atypical antipsychotics, for side
effects.

8
• All the patients (including the adolescents) of whose suicide-
inducing treatment I notified had been prescribed massive
doses of antidepressants which had been augmented with one
or both of very large doses of typical and atypical antipsychotic
medication. None was warned of or examined for side effects.
• This prescribing caused the patients to develop toxic states
characterised by aggression, suicidality, toxic psychosis
(hallucinations and delirium), leading to an inability to work due
to toxic brain conditions which produced permanent injury
(DSM-5 substance/medication-induced neurocognitive
disorder, i.e. permanent brain brain injury);
• And all the other Substance/medication-induced conditions
which the treaters did not distinguish from the mental illnesses
they resembled.
• This is iatrogenesis at its worst, as it was avoidable.

9
• These psychiatrists increased or added medication when
toxic side-effects developed;
• because they did not recognise side effects and had not
read the DSM-IV or textbooks.
• This mode of prescribing was recommended by the
RANZCP-endorsed 2003 Summary Guideline.
• Big PharMA via TMAP produced ghost-written drafts of
Clinical Practice Guidelines whose graphics are identical
to those produced by the fraudulent consortium called
TMAP.
• 247 references trailed the RANZCP’s guideline and not
one had any relationship to the text.
10
What is a material risk?
The High Court of Australia has determined:

• “A doctor has a duty to warn a patient of a material


risk inherent in the proposed treatment; a risk is
material if, in the circumstances of the particular case,
a reasonable person in the patient’s position, if warned
of the risk, would be likely to attach significance to it or
if the medical practitioner is or should reasonably be
aware that the particular patient, if warned of the risk,
would be likely to attach significance to it.”
• “Failure to warn” is one head of negligence.
• Rogers and Whitaker {XXX ?}

11
MENTAL ILLNESSES HAVE NO KNOWN CAUSES
• Schizophrenia
• Schizophreniform Disorder
• Delusional Disorder
• Brief Psychotic Disorder
• Manic Episode
• Major Depressive Episode
• Obsessive compulsive disorder
• Generalised and specific anxiety disorders
All mental illnesses listed in the DSM carry a diagnostic
exclusion clause:
The disturbance is not due to the direct physiological
effects of a substance (e.g., a drug of abuse, a medication)
or a general medical condition.
12
SUBSTANCE/MEDICATION-INDUCED DISORDERS IN
DSM-5
SEROTONIN SYNDROME
ANTIDEPRESSANT DISCONTINUATION
SYNDROME Substance-induced addictive disorders
MEDICATION-INDUCED ACUTE Substance/Medication-induced anxiety disorder
AKATHISIA
Substance/Medication-induced bipolar &
Medication-induced Acute dystonia related disorder
MEDICATION-INDUCED DELIRIUM Substance/Medication-induced delirium
Medication-induced Parkinsonism SUBSTANCE/MEDICATION-INDUCED
Medication-induced Postural tremor DEPRESSIVE DISORDER

Medication-induced Tardive akathisia Substance/Medication-induced neurocognitive


disorder
NEUROLEPTIC MALIGNANT SYNDROME
Substance/Medication-induced obsessive-
Other medication-induced movement disorder compulsive & related disorders
Not in DSM but should be:
Substance/Medication-induced psychotic
MEDICATION-INDUCED WITHDRAWAL disorder
AKATHISIA
Substance/Medication-induced sexual
MEDICATION-INDUCED DELAYED POST dysfunction disorder
WITHDRAWAL AKATHISIA
Substance/Medication-induced sleep disorder

*Potentially lethal conditions are in CAPITALS 13


As required by my VMO contract,
I reported serious adverse drug reactions to Dr.
Superintendent, who reported up the line to Dr.
Administrator, Dr. Director, and the perpetrators.
Alongside of my notifications, I reported the scientific
literature, legal decisions, the Spitzer litigation about
adolescent suicidality on paroxetine, clinical trial data,
public health advisories, and proofs of causation of death,
sucidality and violence.
I notified with so much scientific information that I was
threatened with an ICAC inquiry for harassing Dr.
Superintendent.
I said I would welcome that.
14
The Hon. Peter Baume, AO, physician,
epidemiologist, and former Health
Minister and Chancellor of the Australian
National University told me,
“I found similar things when I was Health
Minister. You will find that no matter
what information you put in front of them,
they won’t see it.”
He also told me “If they want to get you
they will go after you until they get you.”

15
The Perpetrators followed recommendations in the
Summary Guideline for the Treatment of Depression, Pete
M. Ellis, Ian B. Hickie and Don A. R. Smith for the
RANZCP:
“Depression is common, serious and treatable. It affects 1 in
25 people in any 1 month.”
What is this depression? Why did I not know about its
treatability in 50 years of experience?
Guidelines contain identical graphics to those produced by a
fraudulent consortium called The Texas Medication
Algorithm Project (TMAP), which was set up by a
consortium of drug companies to promote “new generation”
drugs by ENDORSEMENT, as opposed to science and
literature. TMAP engaged Key Opinion Leaders to give
PharMA-prepared lectures at conferences and CPD events.
16
Sources of information
on what TMAP did
• Fourth amended complain xxx GUIDELINES
GRAPHICS
• Stefan Kruszewski:
http://psychrights.org/articles/articles.htm

• Ghostwritten guidelines:
https://www.ncbi.nlm.nih.gov/pubmed/?
term=Ghostwriting

17
Pete Ellis, one of the guideline signatories knew of this literature, but
did not include it in any guidelines.
Agitation, Restlessness and Suicidal Behaviour with Fluoxetine,
Paroxetine and Zoloft (sertraline)
Prescriber Update 2002, 23(3): 37-38. Website: September 2002. Professor
Pete Ellis, Psychiatrist, Department of Psychological Medicine, Wellington
School of Medicine. http://www.medsafe.govt.nz/profs/PUarticles/SSRI.htm
There have been rare reports of fluoxetine and, more recently,
paroxetine and sertraline being associated with aggressive or suicidal
thoughts and behaviour. Due to similar pharmacological profiles, the
same reactions
may occur with other selective serotonin re-uptake inhibitors (SSRIs).
It is possible that these reactions can be attributed to akathisia
(involuntary severe motor restlessness).
However, the most common reason for self-harm behaviour during
treatment with any antidepressant is worsening depression. The
development of severe agitation or self-harm behaviour is an
indication
that the patient and their antidepressant therapy require prompt
18
review. Patients should be advised to seek medical attention as soon
Ellis continues:

Reports of aggressive and suicidal behaviour with SSRIs


investigated
Soon after the introduction of fluoxetine internationally, it was claimed to
cause suicidal thinking and behaviour.1 This allegation was investigated
by a number of regulatory agencies, including the Food and Drug
Administration in the United States in 1991, and was not
substantiated. More recently, there have been several further case
reports, some given media prominence, and some leading to legal
proceedings, not only in relation to Prozac (fluoxetine) 2,3 but also to
paroxetine and sertraline.4-6
Systematic reviews continue to support the view that selective serotonin
re-uptake inhibitors (SSRIs) are effective and are not associated with
increased suicidality or increased violence.7
However, these reports 1-6 raise questions about whether the small
group of patients experiencing the rare side effect of akathisia are at
increased risk of suicide. 19
Ellis continues:
Behaviour change may be due to SSRI-induced akathisia.
Detailed case reports 1, 4 describe the emergence of marked
restlessness and agitation, followed by suicidal thinking or behaviour, in
patients soon after commencing fluoxetine or other serotonergic agents.
This restlessness and agitation may reflect akathisia (involuntary severe
motor restlessness). Although more commonly associated with
antipsychotics, reflecting dopamine receptor blockade, interactions
between the serotonergic and dopaminergic systems may account for
akathisia also occurring with SSRIs. 8, 10
A putative link between akathisia and suicidal behaviour is less clear,
and not all of the more recent case reports describe preceding
restlessness.1, 4
Older groups of antidepressants have also been associated with
increased suicidal thinking and behaviour, although not related to
increased restlessness.11
20
Ellis continues:
Agitation or harmful behaviour signals need to review both
patient and treatment immediately.

The key issues in treating depression are the selection of an


appropriate treatment in conjunction with the depressed person,
and the use of an adequate dose for an adequate length of
time, along with attention to current stressors. The most
common reason for suicidal ideation or behaviour during
treatment with any antidepressant remains worsening
depression. The development of agitation or self-harm
behaviour (from any cause) indicates the need to increase
support to ensure the patient's safety, as well as a review of
treatment to check that it is optimised for that person.
21
Ellis continues:
Informing patients to seek help may help reduce adverse
outcomes.

As with many medicines, rare serious side effects may emerge


during treatment and patients should be aware of these and what
action to take. It is recommended that all patients taking SSRIs
should be advised that if they become particularly agitated or
restless, they should seek medical advice and stop their
antidepressant in the interim. In addition, any serious worsening of
their symptoms, particularly in relation to suicidal thoughts, should
be reported urgently to their treating doctor (or on-call
colleague). Severe agitation, severe restlessness/akathisia, and/or
increased suicidality with SSRIs have been added as adverse
reactions of current concern.
22
Professor Pete Ellis
• Has competing interests (author): the author is
supervising a PhD student whose research has been
funded by Eli Lilly.
• He has accepted invitations from pharmaceutical
companies to speak at several meetings relating to
prescribing in general, as well as other topics.
• He has a beneficial interest in shares of certain
pharmaceutical companies, including some who
manufacture antidepressants, including SSRIs.
• Correspondence to Professor Pete Ellis, Department
of Psychological Medicine, Wellington School of
Medicine, PO Box 7343, Wellington South.
• E-mail: ellis@wnmeds.ac.nz
23
References to Ellis, a Guidelines signatory
1. Teicher MH, Glod C, Cole JO. Emergence of intense suicidal preoccupation during
fluoxetine treatment. Am J Psychiatry 1990;147: 207-210.
2. Leon AC, Keller MB, Warshaw MG, et al. Prospective study of fluoxetine treatment and
suicidal behavior in affectively ill subjects. Am J Psychiatry 1999;156: 195-201.
3. Healy D, Langmaak C, Savage M. Suicide in the course of treatment of depression. J
Psychopharmacology 1999;13: 94-99.
4. Healy D. Emergence of antidepressant induced suicidality. Primary Care Psychiatry,
2000;6: 23-28.
5. Jackson A. Two years' jail for anti-depressant killer. Sydney Morning Herald, 24 May 2001
www.smh.com.au/news/0105/24/update/news108.html
6. Bosely S. Murder, suicide. A bitter aftertaste for the 'wonder' depression drug. Guardian 11
June 2001 www.guardian.co.uk/Archive?article?0,4273,4201752,00.html
7. Walsh M-T, Dinan TG. Selective serotonin reuptake inhibitors and violence: a review of the
available evidence. Acta Psychiatr Scand 2001; 104: 84-91.
8. Teicher MH, Glod C, Cole JO. Antidepressant drugs and the emergence of suicidal
tendencies. Drug Safety 1993;8: 186-212.
9. Power AC, Cowen PJ. Fluoxetine and suicidal behaviour. Some clinical and theoretical aspects
of a controversy. Br J Psychiatry 1992;161: 735-741.
10. Tueth MJ. Revisiting fluoxetine (Prozac) and suicidal preoccupations. J Emergency Med
1994;12: 685-687.
11. Macleod AD. Paradoxical responses to antidepressant medications. Ann Clin Psychiatry 1991;3:
239-242.
24
This information did not find its way into guidelines
Inter alia, Ellis et al., Summary of Guideline, which was
published in a medical magazine of the kind left in the
waiting room, recommends prescribing Effexor
(venlafaxine) and increasing the dose and augmenting with
antipsychotics or Lithium, which produces a quagmire of
drug-drug interactions.

An algorithm is an obscenity in a population whose ability to


metabolize these drugs varies 1000-fold.

TMAP has been successfully sued for fraud.

Summary guideline xxx


25
This information did not reach guidelines either
Doctors including Borison and Diamond (who went to jail for research
fraud) and two Australian Key opinion leaders have seeded the
literature with eulogistic descriptions of new drugs.
A Time Magazine cover story anticipated the approval of wonder
drugs, Zyprexa and Risperdal.
Olanzapine had been the most suicidogenic drug in the history of
clinical trials, with risperidone not far behind.
Both had a 50% dropout rate and near 1% mortality in trials presented
for licensing, and about half the deaths were suicides.
The deaths were written off by the FDA psychiatrist Leber, who
believed that this mortality rate did not did not matter, as schizophrenia
had a high mortality rate.
Indeed schizophrenia did have a high mortality rate from tuberculosis
before antibiotics and now has a high mortality rate from medication.
26
Two of these psychiatrists practiced together in Sydney,
with a third who was put on a tribunal I appeared before,
and a fourth who used to advise police.
Two sister hospitals were involved. Let’s call them A and
B.
Dr A was the Director at Hospital A and advisor to Medical
Board.
He replaced a 12-bed open ward with a 50-bed secure
unit (opened October 2013) which he needed to
accommodate the iatrogenic epidemic of akathisia and
sub-lethal and catastrophic side effects that his team was
producing and refusing to recognize.
Dr B also advised Medical Board. Both enjoy stellar
careers.
27
Drs C and D worked alongside me at hospital B.
At Hospital B, Dr. C was producing 2 or 3 suicide
attempts a week by prescribing massive doses of
suicide-inducing incompatible medications.
These doctors were refusing to recognise the causes of
akathisia and associated suicidality even when
information was put in front of them.
The RANZCP was and remains in denial about
medication-induced suicide, violence and homicide.
And refuses to enter FDA mandated warnings about
worsening depression and suicidality into Australian
and New Zealand clinical practice guidelines for the
treatment of depression. xxx
Not even for kids.
28
The Diagnostic and Statistical Manual of Mental and Behavioural
Disorders, of the American Psychiatric Association, known as
DSM-IV IS THE MOST BASIC OF PSYCHIATRIC TEXTBOOKS.
Neuroleptic-Induced Acute Akathisia (DSM 333.99) is no longer in
DSM-5: Why?
Diagnostic Features
The essential features of Neuroleptic-Induced Acute Akathisia are
subjective complaints of restlessness and at least one of the
following observed movements: fidgety movements or swinging of the
legs while seated, rocking from foot to foot or "walking on the spot"
while standing, pacing to relieve the restlessness, or a inability to sit or
stand still for at least several minutes. In its most severe form, the
individual may be unable to maintain any position for more than a few
seconds.
The subjective complaints include a sense of inner
restlessness, most often in the legs; a compulsion to move one's
legs; distress if one is asked not to move one's legs; and dysphoria
and anxiety.
DSM 333.99 Neuroleptic-Induced Acute Akathisia
You might not see akathisia in the office as it might be
fluctuating, so you have to ask about it.
• The symptoms typically occur within 4 weeks of
initiating or increasing the dose of a neuroleptic
medication and can occasionally follow the reduction
of medication used to treat or prevent acute
extrapyramidal symptoms (e.g., anticholinergic
agents).
• The symptoms are not better accounted for by a mental
disorder (e.g., Schizophrenia, Substance Withdrawal,
agitation from a Major Depressive or Manic Episode,
hyperactivity in Attention-Deficit/Hyperactivity
Disorder) and are not due to a non neuroleptic
substance or to a neurological or other general medical
condition (e.g., Parkinson's disease, iron-deficiency, 30
DSM 333.99 Neuroleptic-Induced Acute Akathisia
The subjective distress resulting from akathisia is
significant and can lead to noncompliance with
neuroleptic treatment. Akathisia may be associated
with dysphoria, irritability, aggression or suicide
attempts. Worsening of psychotic symptoms or
behavioural dyscontrol may lead to an increase in
neuroleptic medication dose, which may exacerbate the
problem.
Akathisia can develop very rapidly after initiating or
increasing neuroleptic medication. The development of
akathisia appears to be dose dependent and to be more
frequently associated with particular neuroleptic
medications. 31
DSM-IV Continued:

• Acute akathisia tends to persist for as long as


neuroleptic medications are continued, although the
intensity may fluctuate over time. The reported prevalence
of akathisia among individuals receiving neuroleptic
medication has varied widely (20%-75%).

• Variations in reported prevalence may be due to a lack of


consistency in the definition of caseness, neuroleptic
prescribing practices, study design, and the
demographics
of the population being studied.

32
DSM 333.99 Neuroleptic-Induced Acute Akathisia
continued:
Differential Diagnosis
• Neuroleptic-Induced Acute Akathisia may be clinically
indistinguishable from syndromes of restlessness due
to certain neurological or other general medical
conditions, to non neuroleptic substances, and to
agitation presenting as part of a mental disorder (e.g., a
Manic Episode).
• The akathisia of Parkinson's disease and iron-
deficiency anemia are phenomenologically similar to
Neuroleptic- Induced Acute Akathisia.
• The frequently abrupt appearance of restlessness soon
after initiation or increase in neuroleptic medication
usually distinguishes Neuroleptic-Induced Acute 33
DSM-IV continued: Serotonin-specific reuptake
inhibitor antidepressant medications may produce
akathisia that appears to be identical in
phenomenology and treatment.
Response to Neuroleptic-Induced Acute Akathisia.
Akathisia, a condition that affects 25-75% of a treated
population was not recognized or acknowledged by Drs
A, B and C, (or by any of the “peers” called in, or by any
psychiatrist sitting on a committee or a tribunal in cases
where akathisia and the literature linking it to suicide was
extensive and basic textbook psychiatry was at issue.
https://www.ncbi.nlm.nih.gov/pubmed/?term=akathisia+su
icide
34
‘Neuroleptic and SSRI-induced Acute Akathisia’ (DSM
333.99) caused sucidality and homicidal ideation and was
responsible for over one third of admissions.
I documented 192 patients who were admitted suicidal and/or
homicidal to hospital B (many of whom were Hospital A patients) in
2003-4.
These patients had been prescribed mostly paroxetine, venlafaxine
and olanzapine by GPs.
I reported to Dr. Superintendent, who passed it on, to Dr.
Administrator and Drs A and B.
I also made serious adverse drug reaction reports to ADRAC
(Adverse Drug Reactions Advisory Committee) (1) (2), and to the
Medical Board.
Everything I sent in, wrote and reported was ignored.
I have the patients’ birthdates and file numbers and wonder how
many are still alive.
35
The Second Reading Speech
setting up the HCCC
The HCCC (Health Care Complaints Commission) was set up in
the wake of The Chelmsford Royal Commission to ensure that
whistleblowers who tried to draw attention to 26 inpatient
medication-related deaths and 42 outpatient medication–related
suicides in Chelmsford Hospital were never again ignored.
See Second Reading Speech for parliament’s intentions in
setting up the HCCC.
The Health Care Complaints Commission is supposed to identify
a trend in complaints and report the trend of complaints to
the health minister.
But the traffic goes the other way.
I sent 60 de-identified reports of previously normal persons who
had become suicidal and/or homicidal on psychiatric medication to
a health minister, but New South Wales Health sent them straight
to the then-Medical Board, which made no comment.
36
The Second Reading Speech continued
However, the HCCC just covered up poor prescribing, and
now rates of death and suicide all over Australia are similar
to those in Chelmsford, with ever-more suicidogenic drugs
being prescribed (see Maris Daubert).
The Medical Council follows suit and takes no notice. It
does not respond to correspondence, except to tell me to
stop writing and sending them information. They have told
me that it is not their concern, and that the RANZCP (Royal
Australian and New Zealand College of Psychiatrists) is the
expert. However, the RANZCP’s Clinical Practice
Guidelines for the Treatment of Depression suggest
massive doses and dangerous drug combinations, leaving
patients and prescribers in a potentially dangerous
predicament.
This situation demands a Royal Commission.
37
USE OF SSRI ANTIDEPRESSANTS IN
CHILDREN & ADOLESCENTS
A statement by ADRAC, 15 October 2004
• The Australian Adverse Drug Reactions Advisory Committee
(ADRAC) has reviewed data on the safety and efficacy of SSRIs* in
the treatment of major depressive disorder (MDD) and other
psychiatric disorders in children and adolescents. The data reviewed
has included the US FDA analysis in collaboration with a group at
Columbia University.† ADRAC has also consulted again with the
Royal Australian and New Zealand College of Psychiatrists and the
Royal Australasian College of Physicians.
• None of the SSRIs, and indeed no antidepressant, is currently
approved in Australia for the treatment of MDD in children and
adolescents (persons aged less than 18 years). Fluoxetine, but none
of the other SSRIs, is approved in the US for MDD in young people
without a specified lower age limit. Two of the SSRIs, fluvoxamine
and sertraline, are approved in Australia for children and adolescents
with obsessive compulsive disorder (OCD).
38
ADRAC of the TGA, statement continued:
• Assessment of the published and unpublished data available
for SSRI use in children and adolescents indicates that there
is evidence of an increased risk of suicidality, including
suicidal ideation, suicide attempts and self-harm events,
associated with each of the SSRIs.1 The strongest
association has been found with paroxetine and venlafaxine,
but sertraline, citalopram and fluoxetine have also been
implicated, with fluoxetine possibly having the smallest risk.1,2
There are very few data for fluvoxamine.
• Increases in suicidal ideation and behaviour during the early
stages of antidepressant treatment are well-known clinical
phenomena in adults. It is clear that these events can occur
in children and adolescents as well. While the size of the
increase compared to placebo is small, around 2 to 3
patients per 100, the effect is stronger with some SSRIs than
others in young people.
39
Australian Adverse Drug Reactions Bulletin
Volume 24, Number 4, August 2005.
* Suicidality with SSRIs: adults and children

In 2004, ADRAC published a statement on the use of


SSRI antidepressants in children and adolescents, in
view of evidence that the use of these agents in these
age groups was associated with an increased risk of
suicidality, including suicidal ideation, suicide attempts
and self-harm events.1

SSRIs are not registered for the treatment of


depression in those less than 18 years of age, and
neither are any other antidepressants.

40
ADRAC Advisory
Note two adolescents were misdiagnosed after taking paroxetine
prescribed by Drs A and B. The doctors ignored the following
information, which was in Product Information:
Recently, ADRAC conducted a review of the evidence of suicidal
thoughts and behaviour associated with the use of SSRIs in
adults.
The Committee concluded that, in most adult patients, SSRIs in
the treatment of depression are beneficial or cause no harm.
However,
it was noted that individual case reports, including some
describing dechallenge and rechallenge, support an association
between SSRI use and new onset suicidality. 2, 3
When this syndrome occurred it tended to develop soon after the
introduction of an SSRI, or an increase in the dose, and to be
associated with akathisia, agitation, nervousness, and anxiety. The
effect often persisted with continuing treatment. Similar symptoms
can follow withdrawal of the SSRI. 41
Practicing Medicine Responsibly
The ADRAC Committee noted that the drugs
used in the treatment of depression “in most
adult patients” was either beneficial or
harmless.
Are we not responsible for the wellbeing of all
patients, including those who cannot
metabolize SSRIs?
Penicillin helps most people too, but some
people are allergic to it, and they are also our
responsibility.
42
The admissions followed visits of marketing agents to the town.
Those I examined had been normal, but worried people,
experiencing stressful life events.
I was able to effect a cure by slow safe withdrawal in many
cases.
They had been made suicidal and/or homicidal on venlafaxine
and paroxetine, augmented by olanzapine and risperidone
following blitzes of drug reps and big dinners in this country
town.
I saw only one third of them, and my treatment was often
contradicted by others.
See suicide on the ward case of Dr. D.
See list of 192 admissions of whom at least eight had died
before I left.

43
Hospital B: SSRI-induced admissions

In the 3 months from 24 December 2003 to


March 2005, I recorded 192 persons who were
admitted with suicidal or homicidal thoughts or
actions.
My pleas to the Administration for attention to
this problem were dismissed and are still being
dismissed by the Medical Council.
This was a list of Serious Adverse SSRI Drug
Events, serious, because each was a hospital
admission.
44
This list of patients represent sixteen months of admissions to
Nolan House. I counted only those who came in with suicidal
ideation or acts, homicidal ideation or acts, and violent acts for
which some were charged and of which some left victims.
These coded ‘SA suicidal act or attempts’ should have been
reported to the Department of Health, as they were
hospitalised suicide attempts.
I did not count those who had come in psychotic or after a
manic shift, as I would have needed their previous medical
records, which I did not have access to.
In 1991, Preda et al. found that 8.1% of admissions were for
psychosis and manic switch caused by SSRIs.
These admissions are only one manifestation of a public
health problem.
45
I repeatedly asked that the patients discharged on
antidepressants by Dr. C after being admitted suicidal
and/or homicidal be recalled and re-examined for continuing
akathisia, which affected those I saw and treated
successfully with withdrawal.
I have charted information from discharge summaries alone
in most cases.
Their files would have provided more detail, but I did not
have access to them. These patients include three deaths,
and many needed intensive care.
I provided the list to Dr. Superintendent, who refused me
secretarial assistance to give details to ADRAC, however he
told me he passed them up the line.

46
No proper procedures had been followed. Not one root cause
analysis was done, and no relatives or patients had been notified of
reasons or drug sensitivity so they would not recur in that patient.
However, Dr. A told Judge Foster that the proper procedures had
been followed and that I did not know what I was talking about.
Dr. A also gave false information to Judge Foster that peer
reviewer, Dr. Cockram, thought I was dangerous, even though I had
correctly diagnosed 8 cases of SSRI-induced side effects in a row
and had dealt with them appropriately. However, this was untrue;
(unless it was a private conversation) she had not said that in her
report.
Dr. Superintendent farewelled me saying he was sorry to see me
go, but it was “The System”.
This was all iatrogenic illness, as this population did not exist before
Prozac and the atypicals, and I have 50 years of experience in
psychiatry to say that.
47
However no one took any notice of what I had
identified as their preventable causes.

An inquiry is needed such as that conducted in


New Zealand when a doctor failed to follow up
on his carcinoma in situ patients, who did not
know that they had a potentially fatal condition.

By 2003, the TGA had 10,000 reports of serious


adverse drug reactions from these drugs and I
can provide the details.

48
Dr. D might still not know why his patient, who’d had no problems
until he was prescribed antidepressants after a workplace injury,
had multiple admissions on different antidepressants for suicide
attempts.
I had brought him in for a slow, safe, withdrawal and education,
and while I was absent (as I had been sent to a credentials
committee to be censured), another doctor saw him, did not read
the file and prescribed venlafaxine together with electroconvulsive
therapy.
He left the ward and hanged himself when put back on on 300
mg/day Effexor.
His family was not told, and the Coroner did nothing.
The reason for his suicide is documented in his medical records..I
was not given an opportunity to speak of it.
The administration, and doctors A, B, and C just redoubled their
attacks on me. 49
I had released one of the patients, an adolescent who had
been prescribed paroxetine by Dr. A seven days after a suicidal
overdose of paroxetine and amphetamines, as I had no
grounds to hold him. He had returned to pick up his belongings
five days later in a normal state.
He was captured and treated with incompatible polypharmacy
at unbelievably high levels until he knifed a man.
His medication was increased and he again attempted
homicide, so they changed his diagnosis from “bipolar
disorder” to “antisocial” and sent him to jail.
I was accused of dangerousness when when no harm came
from my action. I told told Dr. B that this patient’s disordered
behaviour came from doctor A’s and B’s prescribing.
De-identified details are here.
50
Dr. Administrator blamed me for discharging such
a dangerous patient, but this patient was only
dangerous when on amphetamines or medication
which have an identical side effect, Akathisia, in
the young or genetically vulnerable.

Dr. A. arranged for Dr. Administrator to be his


proxy, and report me to the HCCC. However, this
was an ‘Own Notification,’ that is, one which
emerges from the Commission itself. These
notifications do not need to be based on patient
complaints.

51
From 1994 MIMS Annual: Page 3-229-10
Side effects of Aropax (paroxetine)
Use in children: the use of paroxetine in children is not recommended
as safety and efficacy have not been established in this population (p.
3-229).
Adverse effects
Nervous system: Akinesia, alcohol abuse, amnesia, ataxia, convulsion,
depersonalization, hallucinations, hypotonia, hypotonia,
incoordination, lack of emotion, manic reaction, paranoid reaction,
abnormal thinking.
Later in PI:
Nervous system: Abnormal electroencephalogram, abnormal gait,
antisocial reaction, choreoathetosis, circumoral paraesthesia, delirium,
delusions, diplopia, drug dependence, dysarthria, dyskinesia, dystonia,
euphoria, fasciculation's, grand mal convulsions, hostility, hyperalgesia,
hypokinesia, hysteria, increase libido, manic depressive reaction,
meningitis, myelitis, neuralgia, neuropathy, nystagmus, psychosis,
psychotic depression, increase reflexes, stupor withdrawal
52
syndrome.
From 1994 MIMS Annual: Page 3-230
Psychiatric side effects of paroxetine
Somnolence, insomnia, dizziness, tremor, nervousness,
anxiety, paraesthesia, decreased libido, agitation, drugged
feeling, myoclonus, CNS stimulation, confusion, impaired
concentration, depression, emotional lability, vertigo.
Less common: abnormal electroencephalogram, abnormal
gait, antisocial reaction, choreoathetosis, circumoral
paraesthesia, delirium, delusions, diplopia, drug
dependence, dysarthria, dyskinesia, dystonia, euphoria,
fasciculations, grand mal convulsions, hostility,
Note: emotional lability is drug company code for suicidal
ideation. Hostility is drug company code for homicidal
ideation.

53
Further psychiatric adverse reactions, rarer events in post
marketing from paediatric clinical trials include:

In paediatric clinical trials, the following adverse events were


reported at a frequency of at least 2% of patients and occurred at
a rate at least twice that of placebo:
Decreased appetite, tremors sweating hyper only show, hostility,
agitation, emotionally ability, including crying mood fluctuations,
self-harm suicidal thoughts and attempted suicide. Suicidal
thoughts and suicide attempts were mainly observed in
clinical trials of adolescents with major depressive disorder.
In studies that used the tapering regimen, symptoms reported
during the taper phase on discontinuation of paroxetine at a
frequency of at least 2% of patients and occurred at a rate at
least twice that of placebo were nervousness, dizziness, nausea,
emotional lability and abdominal pain.

54
Dr Lucire comment:
Note this is totally untrue.
Study329.org revealed that approximately 11 young people became
suicidal on the drug, and only one on placebo. Similar results were
found in clinical trials for adults. There were several like this which
came to light during the Spitzer litigation in New York.
Adverse drug reactions occur in the body and are unrelated to a
diagnosis of mental disorder which occurs in the mind. However the
drugs affect the brain and in turn affect the mind. That is, adverse
drug reactions will occur whether the patient is being treated for
major depression or menopause.
Adverse drug reactions are due to toxicity: too-high a dose, sudden
changes of dose up or down, co-prescribed cytochrome inhibitors,
removal of inducers, the patient's age, their general liver health, and
the condition being treated. For example, inflammation is an inducer
of CYP activity.
55
Drs A and B both prescribed paroxetine to two adolescents.

From TGA Advisory published in 2003:

2. The choice of an SSRI for children or adolescents with


MDD should be made only after taking into account the
recent evaluations of clinical trial data and the Product
Information. Note that the current Australian Product
Information for paroxetine and venlafaxine recommends
against their use in children and adolescents.
3. Children and adolescents who are currently being treated
for MDD with an SSRI should not have their medication
ceased abruptly.

See venlafaxine cases I reported in both adults and adolescents.

56
Use of SSRI antidepressants in children & adolescents
Adverse Drug Reactions Advisory Committee
11 March 2004

The Australian Adverse Drug Reactions Advisory


Committee (ADRAC) has considered the safety and
efficacy of the Selective Serotonin Reuptake Inhibitor
(SSRI) antidepressants in children and adolescents.

There is international concern about a possibility of


increased suicidal ideation and self harm behaviour
provoked by the use of these drugs for the treatment of
major depressive disorder (MDD).

57
Dr C (who was Dr A’s best friend) was installed in Hospital B to
displace me, and he bullied me dreadfully, taking over my patients,
cutting back my hours and suggesting I leave.
I was greeted weekly with, “Administration is gunning for you
because so and so has committed or attempted suicide or tried
to kill someone.”
But I was never the one who had prescribed medication that
caused the problem, yet they held me responsible in public.
They knew about root cause analysis, because when an
alcoholic man whom I had taken off Effexor successfully (after
three years of repeated suicide attempts and treatment by my
colleagues) refused further assistance and went home, drank a
bottle of vodka, aspirated and died, Dr. Administrator called a root
cause analysis.
Although the police said it was a natural death, a root cause
analysis was undertaken because Dr. Administrator wanted to hold
me responsible.
58
Dr. C’s prescribing of antidepressants (venlafaxine,
fluoxetine, and escitalopram), always at least 4 to 6
times the standard dose, and combining them with huge
doses of risperidone and olanzapine, was
causing two or three suicide attempts each week.
Dr. A issued an edict to the effect that I was not to
see any patient that came from Hospital A or from
Dr. C.
I refused to see anyone who had anything to do with
him for several months, because it was tearing me
apart, but when our excellent registrar left, I had to
see his patients again, as I was the only psychiatrist
there on Mondays.
59
For three months, authorities took no notice of my
notifications and supporting literature, did not
respond to further internal notifications, complained
to the HCCC about my disruptive behaviour, and
ignored the academic literature on SSRI and
neuroleptic-induced suicide (see DSM-IV) and
warnings in Product Information about the dangers
of using paroxetine in kids.

I reported 4 of Dr. C’s medication-induced suicidality


and violence cases to the HCCC, together with two
lever arch folders of supporting academic
information.

60
I provided this Level 1* evidence on the meta analysis
of trials to the HCCC:
Antidepressants and suicide: risk–benefit conundrums
David Healy, MD; Chris Whitaker
MSc J Psychiatry Neurosci 2003; 28(5): 331-37.
ABSTRACT
There has been a long-standing controversy about the possibility that
selective serotonin reuptake inhibitor (SSRI) antidepressants might
induce suicidality in some patients. To shed light on this issue, this
paper reviews available randomized controlled trials (RCTs), meta-
analyses of clinical trials and epidemiological studies that have been
undertaken to investigate the issue further. The original clinical
studies raising concerns about SSRIs and suicide induction produced
evidence of a dose-dependent link on a challenge-dechallenge and
rechallenge basis between SSRIs and both agitation and suicidality.
*Level 1 is evidence obtained from at least one properly designed randomized
controlled trial.
61
Antidepressants and suicide - continued

Meta-analyses of RCTs conducted around this time indicated


that SSRIs may reduce suicidal ideation in some patients.
These same RCTs, however, revealed an excess of suicidal
acts on active treatments compared with placebo, with an
odds ratio of 2.4 (95% confidence interval 1.6–3.7). This
excess of suicidal acts also appears in epidemiological
studies.
The data reviewed here make it difficult to sustain a null
hypothesis that SSRIs do not cause problems in some
individuals.
Further studies or further access to data are indicated to
establish the magnitude of any risk and the characteristics of
patients who may be most at risk.
62
A month after I notified these four near-fatal ADRs to Tim
Rochford of HCCC, Dr C returned, claiming to have been
“exonerated.”
His prescribing did not change, and on advice of the RANZCP
(Dr. Lyndon), he ignored the literature I had provided.
He immediately discharged a very young woman initially
treated at Hospital A, who had been hospitalised suicidal for
several months at Hospital B on 80 mg/day of Prozac (4 times
the maximum dose) and he added Risperdal 3mg/day. She
fetched up at Hospital A, even more suicidal.
A caller asked me to take her back to Dr. Superintendent. I
referred the caller to him, but he did not return the call.
The caller released her, and I was blamed for the resulting
near-lethal suicide attempt.
63
The Black Box Warning for worsening depression and suicidality in
adolescents taking antidepressants extends to the age of 25. Twenty-five is
the age at which 2D6 is thought to be mature at the cortex.
This warning is only found on antidepressants in the USA, however there
were also general warnings about antidepressants for adolescents on the
FDA and TGA websites.
This patient was well under 25, and Prozac (fluoxetine) is metabolized by
cytochrome P450 2D6, and inhibits it strongly. Risperdal (risperidone) is
metabolized by cytochrome P450 2D6.
Each drug carries a warning to the effect that they should not be prescribed
together, as there is a serious adverse reaction between them. It is warned
of in both Risperdal and Prozac Product Information.
Many years later, this combination was given to a girl who committed a
double homicide, and I got blamed. She developed chronic, homicidal
akathisia and killed when her GP gave her another drug metabolized by
cytochrome P450 2D6.
But no one read the product information.
64
The week he returned, exonerated, Dr. C
treated an itinerant Aboriginal alcoholic, whose
liver was damaged by drinking methylated
spirits, with 225 mg/day Efexor (6X standard
dose) and 3 mg risperidone (6X standard dose).
The patient became agitated and absconded
from the ward, and died three days later from
internal bleeding. The relative risk (RR) of
bleeding on Efexor is 3.8.
The Coroner suggested further inquiry, but
nothing was done.

65
Dr C discharged a young woman who’d had six
admissions for antidepressant-induced suicidality
on a huge dose of Lexapro (4x standard dose)
augmented, and she committed suicide on
polypharmacy by jumping from a high building
after 58 days, 2 scripts, later.
The coroner suggested getting further advice, but
nothing was done.
The HCCC did not investigate any of my notifications.
Nor did their peer read Product Information for the
drugs in use, and nor did they heed any of the Level 1
Evidence that I provided.

66
32 NOTIFICATIONS WERE IGNORED
By the time I was sacked in January 2005, I had reported the following
ADRS caused by three doctors:
1. 30 patients becoming suicidal on antidepressants and/or
having causes of suicidality mismanaged (Drs A, B & C).
2. 1 bleeding death of an itinerant alcoholic on a huge dose
of Risperdal and Efexor (Dr. C).
3. 5 completed suicides on antidepressants (Efexor, Prozac, and
Lexapro) co-prescribed in huge doses and augmented with
olanzapine and risperidone. There were more in the following year,
with various doctors responsible.
4. Innumerable serious and some nearly successful suicide attempts.
5. Two whose treatment I reported as making them suicidal went on
to kill themselves.
6. 1 Prozac-induced homicide.
7. 1 venlafaxine suicide on the ward (Dr. D).
67
Notifications continued:

8. 3 attempted homicides on polypharmacy (multiple medications


including antidepressants and atypical antipsychotics) who were
re-diagnosed as antisocial and 1 was jailed (Drs. A and B).
9. Half a dozen inappropriate discharges of patients who had to be
brought back.
10. Stressed teacher: 11 suicidal admissions on paroxetine and 2
attempts to kill self and children on venlafaxine (Dr. A and team).
11. Failure to diagnose and treat schizophrenia after I told the the
diagnosis twice. Angry about being refused treatment, the patient
knifed people in the hospital waiting room and caused litigation
against the hospital (Dr. A).
12. Pehm told the patient’s mother that “the diagnosis of
schizophrenia is a matter of opinion.” This view was consistent
with Dr. A’s practice. Schizophrenia is a condition needs to be
diagnosed to strict criteria.
68
In the middle of these 32 reports (some
analysed in detail later), the United
States Food and Drug Administration
(FDA) issued a much anticipated warning
based on a massive literature on
antidepressant-induced suicidality going
back to the 1950s, and my
undergraduate textbook.

69
FDA Public Health Advisory March 22, 2004
Subject: WORSENING DEPRESSION AND SUICIDALITY IN
PATIENTS BEING TREATED WITH ANTIDEPRESSANT
MEDICATIONS
Today the Food and Drug Administration (FDA) asked
manufacturers of the following antidepressant drugs to include in
their labeling a Warning statement that recommends close
observation of adult and pediatric patients treated with these
agents for worsening depression or the emergence of
suicidality.
Anxiety, agitation, panic attacks, insomnia, irritability,
hostility (Pharma term for homicidal behaviours), impulsivity,
akathisia (severe restlessness), hypomania, and mania have
been reported in adult and pediatric patients being treated with
antidepressants for major depressive disorder as well as for other
indications, both psychiatric and nonpsychiatric.
Adverse effects are consequences the direct action of the
drug on the brain and have no relationship to the condition 70
Public health advisory continued:
Warning Information
Health care providers should carefully monitor patients receiving
antidepressants for possible worsening of depression or
suicidality, especially at the beginning of therapy or when the
dose either increases or decreases.
Heath care providers should carefully evaluate patients in whom
depression persistently worsens, or emergent suicidality is
severe, abrupt in onset, or was not part of the presenting
symptoms, to determine what intervention, including discontinuing
or modifying the current drug therapy, is indicated.
Anxiety, agitation, panic attacks, insomnia, irritability,
hostility, impulsivity, akathisia (severe restlessness),
hypomania, and mania have been reported in adult and
pediatric patients being treated with antidepressants for major
depressive disorder as well as for other indications, both
71
psychiatric and nonpsychiatric
Public health advisory continued:

Health care providers should instruct


patients, their families and their
caregivers to be alert for the emergence
of agitation, irritability, and the other
symptoms described above, as well as
the emergence of suicidality and
worsening depression, and to report
such symptoms immediately to their
health care provider. 72
I thought the FDA advisory (Suicide Warning for Prozac March 25,
2004) would persuade them TO CONSIDER THE DANGERS OF
PSYCHIATRIC DRUGS. I was wrong…

RANZCP TO THE RESCUE!


“Dr. Bill Lyndon, chair of the psychotropic drugs committee
of the Royal Australian and New Zealand College of
Psychiatrists, said he welcomed any move that raised
awareness about SSRIs and encouraged caution.
"I'm aware of a link between SSRIs and suicidal thoughts in
adults, as well as adolescents, but the evidence is not
conclusive," Dr Lyndon said.”
Dr. Lyndon so advised Dr. C in writing. Doctors C, A, B, and Mr.
Pehm all hid behind this grandiose dismissal of the science that
was behind the US FDA’s Public Health Advisory.
73
Background/Elsewhere in NSW
Three out of these four doctors regularly prescribed as recommended
by the RANZCP’s Clinical Practice Guidelines, no differently to others
educated by the pharmaceutical industry and drug reps.
Normalising tragedy
But not all doctors prescribed this way.
Not all prescribed huge doses, augmented with other drugs.
Some of us recognised akathisia and examined for it.
Not all doctors refused to see adverse drug reactions.
Not all ignored the literature.
This public health disaster was being produced in NSW.
Report of the New South Wales Chief Health Officer (2005)
Mental Health Suicide Attempt Admissions
• 1989 55.4/100,000
• 2005 155/100,000
74
SUICIDE BY PATIENTS BEING TREATED BY
NSW HEALTH MENTAL HEALTH
• In the 10 years, 1993 to 2002, counted within 28 days of contact:
– 1290 persons treated in NSW public mental health care
committed suicide: Average 129 a year.
In 2002 NSW Health changed the mode of counting but the numbers
got worse.*

In the 6 years, 2003 to 2008, counted only within 7 days of contact:


– 937 persons treated in NSW public mental health care committed
suicide: Average 156 a year.
• 2227 persons committed suicide between 1993 and 2008, in 16
years under NSW care mental health care where these drugs
were being prescribed or changed.
* NSW Parliament Question asked on 13 May 2010 (session 54-1) and
published in Questions
75
1993-2002 - Suicides committed within 28 days of
contact with NSW Mental Health Services
Suicides in mental % of all
Year Suicides in NSW
health care NSW suicides
1993 676 68 10%

1994 798 72 9%

1995 747 (748) 100 13%

1996 811 (817) 136 17%

1997 946 (950) 166 18%

1998 827 (832) 143 17%

1999 846 (854) 173 20%

2000 738 156 21%

2001 775 (789) 159 21%

2002 643 117 ?


76
HOMICIDE BY PATIENTS BEING TREATED
BY NSW MENTAL HEALTH
• In the 10 years, 1993 to 2002, counted within 28 days of
contact:
– 36 patients being treated in the New South Wales Mental
Health public sector committed homicide, 3.6 a year.
NSW changed the mode of counting# but numbers got worse.
In the 6 years, 2003 to 2008, counted within 7 days of contact:
– 43 patients being treated in the New South Wales Mental
Health public sector committed homicide. * 7 a yea.r
79 committed homicide in 16 years, an average of 5 a year,
killing friends, family members, nurses and health care
workers.
# Sentinel Events Committee report 2003) *NSW Parliament Question
asked on 13 May 2010 (session 54-1) and published in Questions
77
The Royal Commission into Institutional Responses to Child
Sexual Abuse pointed out that CSA was a crime that should
be investigated by police.
The situation with medication-induced fatalities is no
different. Rather than turn over medication-induced fatalities
to police and have prescribers investigated for involuntary
manslaughter in proper courts with rules of evidence, the
Commissioner ignored the science and FDA advisories.
This was how the problem’s causes were covered up.
The HCCC pursued me with at least 10 manifestly false
complaints turned into “Own notifications.”
Neither their “peer reviewers” reviewers nor their committee
or tribunal members wanted to know what I was talking
about.

78
THE DRUGS whose ADRs I reported: Paroxetine
In 1998 GSK advised staff to withhold data about SSRI use
in children.
The data indicated that the antidepressant, paroxetine, had
no beneficial effect in treating adolescents.
Paroxetine is 1 of 6 SSRI drugs that Britain has banned for
pediatric use because of increased risk of suicide.
GSK paid a $3 billion fine to the Department of Justice for
fraud, and paid $1 million in 2004 to the State of New York
for fraudulent promotion to children.
Fraud on the Commonwealth remains unprosecuted.
No one does anything in Australia.
79
THE DRUGS: Zyprexa, Risperdal,
Seroquel and Geodon
• By 2003, US Food and Drug Administration (FDA)
data established that:
• One of every 145 persons enrolled in clinical trials for
Zyprexa, Risperdal, Seroquel and Geodon died as a
result of adverse drug reactions
• Most were suicides
• Drug companies did not put deaths and dropouts into
product information, so if the patient cannot tolerate
the drug, it gets enforced anyway, because
prescribers are not aware of the risks and side
effects.
Fraud on the Commonwealth remains unprosecuted.80
In the Zyprexa trials presented
to the US FDA for licensing:

There were 7,500 starters, and 5,000 dropped out.


Stage 2 trials:
• Of 2607 remaining subjects,
• 20 died, and 12 were suicides;
• (One on comparator and none on placebo).
• The death rate in these (best) clinical trials was:
1 in 103 clinical trial subjects died; most by
suicide.
Fraud on the Commonwealth remains unprosecuted.
81
Risperdal trials presented to
US FDA for licensing
Safety Review on FDA website:
• Of 2067 subjects, near half withdrawn or dropped
out;
• Of remainder, 24 died, of which 9 were suicides.
• (One on comparator and none on placebo).
The Commonwealth, prescribers and patients were
never told of trial drop-outs, suicides or deaths & the
information is not in Prescriber Information in
Australia.
Fraud on the Commonwealth remains unprosecuted.
82
Lexapro in Australian and USA
Product Information
• Does list it XXX
• Side effects Psychiatric Disorders:
• Uncommon: suicide attempt,

83
Venlafaxine in USA Product Information

Body as a whole –
Infrequent: (1 in 100), intentional injury,
suicide attempt … withdrawal syndrome;
psychosis, homicidal ideation.
None of this information is in Australian
Product Information.

84
I did not agree with Doctor A and B’s diagnoses of
“schizophrenia” and “bipolar” in two substance-
abusing adolescents for whom Dr. A had
prescribed paroxetine and who had become
suicidal on it.
Paroxetine had never been approved for children.
‘Suicide attempt’ and ‘hallucinations’ are listed as
side-effects in local Product Information.
At the time, lawsuits were ongoing in the UK and
New York, and damages were being paid.

85
Dr. A complained to Dr. Administrator about my peculiar diagnosis
(not schizophrenia, but side effects) after he had prescribed
paroxetine, and on second admission, venlafaxine, to a 16-year-old
substance abusing girl.
Dr. Administrator made a false notification to the HCCC. Mr Pehm’s
January 22 2005 letter to me referred to the false complaint about
me, not about the complaint I had made about these teenagers’
treatment.
The complaint really came from Dr A, who was unhappy about being
pulled up for dangerous prescribing and failure to recognise side
effects, mistaking them for schizophrenia.
It came from the HCCC, where Dr. A was an advisor.
If GSK and Dr. Lucire are right, their two their young patients were
seriously misdiagnosed, and could have sued them.
Dr. A complained to Dr. Aministrator that I was disruptive and caused
me problems to deflect from his ignorance.
Doctors A B and C did not review their diagnoses
86
The “peer reviewers” of these manifestly false allegation against me
could not even spell akathisia, the very dangerous side effect of
restlessness associated in textbooks and the DSM with suicide and
homicide.
They called me “arrogant” for disagreeing with good doctors.
Dr. Administrator had allowed Dr. A to “peer review’ complaints
against himself, his bestie and his team.
The HCC Commissioner accepted his five line opinions as “peer
reviews’
It was no surprise that Dr. A and the Commissioner found nothing
wrong with the prescribing. It was just like his own, with weekly
suicidal and violence crises at Hospital A reported to me by patients
coming to Hospital B from Hospital A, which was always overflowing
and ended up needing a new secure, 50-bed ward built.
I complained that Dr. Administrator had provided false and
misleading information. After being so informed in detail, Dr.
Administrator swore to the truth of the complaint. I again complained.
I was told: “The HCCC does not deal with administrators.”

87
On January 22, 2005,
Mr. Pehm wrote an extraordinary letter. He
believed that he had seen the science and had
formed an opinion, and that what I was telling him
was not yet psychiatric orthodoxy, but one day
might be.
On the basis of this decision, and on advice from
Dr. A that the literature was nonsense, the HCCC
did not investigate a single one of my complaints.
Instead he sent me to the professional standards
committee on the complaints that the treaters had
made about me.
88
89
I had sent a great deal of scientific information, but Mr Pehm
did not seem to understand that this was a major public health
problem to which I was attributing causation. He simply
abused his untrammeled power to ignore correspondence and
evidence.
Pehm wrote:
“It is clear from your letter and other dealings between
you and the Commission that you are extremely
concerned about the dangers of SSRI antidepressants. I
have no doubts as to the sincerity of your
convictions on this issue and it may eventually turn
out that your views become more widely accepted
and may even become psychiatric orthodoxy, that is
not the case, however, at present, although I note
more recent studies suggesting SSRIs may increase
suicidal ideation in juveniles.”
90
Alleging that he was in no position to determine if I was
right or not, he decided I was not right and prosecuted me
while ignoring notifications:

“The Commission is in no position to determine whether


you are right about SSRls or not. Section 92 of the
Health Care Complaints Act 1993 ("the Act") provides
that "nothing in this Act gives the Commission power to
determine or recommend general standards of clinical
practice.” There are good reasons for this statutory bar -
the Commission does not have the expertise to
determine complex medical issues or clinical standards
where there are disputes between practitioners. These
are matters that must be settled, if they are ever to be
settled, by research and the consensus of scientific and
medical opinion.”
91
Of course, Pehm could have called in an expert as his legislation
demanded.
These was no shortage of experts, including hundreds of medication review
trained pharmacists, psychiatrists of my vintage, or those trained overseas
who knew what I knew, and who read prescriber information, having been
educated properly before Big PharMA took over psychiatric education and
policy…
…And took control of the regulators.
The TGA called experts and published the following expert report:
• Therapeutic Goods Administration REPORT OF THE PSYCHIATRIC
DRUG SAFETY EXPERT ADVISORY PANEL 2009
https://www.tga.gov.au/alert/release-report-psychiatric-drug-safety-
expert-advisory-panel
https://www.tga.gov.au/book/update-tga-response-recommendations-
made-psychiatric-drug-safety-expert-advisory-panel

This was another opportunity for Pehm to reverse his


judgement, but he did not do so.
92
Pehm continued:
“Commission investigations rely on expert or peer opinion to assist in
determining whether there has been a departure from the standards
generally applicable for medical practitioners. I appreciate the strength of
your views that the experts or peers used by the Commission in your
matters are wrong and note the material cited in your letter in support of
your view.”
“I accept that, in areas where there is significant dispute as to applicable
standards, one or two expert or peer opinions may not be a sufficient
basis on which to assess whether there has been a departure. Where
medical opinion is divided and/or contested, the Commission also
has regard to material published by the Colleges.”
Here, Pehm is admitting that the Medical Council believes RANZCP is the
expert; the RANZCP, whose position is that antidepressants do not have
side effects worth mentioning, and have no relationship to suicidality and
violence. The results of this decision are plain to see in the community, and
are tabled in the Australian Bureau of Statistic’s 2017 study: 4329.0.00.006 -
Mortality of People Using Mental Health Services and Prescription
Medications, Analysis of 2011 data
93
Pehm protected Hospital A and the perpetrators,
who were the same doctors that had advised him.
I was told that “they” at Hospital A were very
relieved that “it” has been fixed at the HCCC.
I’d had no suicide attempts in my patients in six
years, however my contract was not renewed.
Pehm protected the perpetrators who were his
advisors, Dr. A and Dr. B and, thereby, Dr C.
Pehm was not interested in Dr. D’s two fatalities.
Doctors A, B, and C stayed on at Hospital A.

94
It was Pehm's unsupported opinion that antidepressant suicide
was “not yet psychiatric orthodoxy” that allowed him to ignore 42
reports from me and hundreds from others.
However I have it on good authority that ignoring notifications
against NSW Health was his habit.
His role was to assist the medical board in their only
responsibility: to protect the public and to protect the public
He ignored 192 suicidal and homicidal admissions.
Pehm refused to look or comprehend the 142 papers I sent in on
antidepressant-induced akathisia-related suicidality.
Pehm contadicted text book psychiatry, the huge amount of
knowledge and scientific literature that underpinned the US FDA
Public Health Advisories on worsening depression and suicidality
and the contents of each drug’s own prescriber information

95
The ill informed opinions of Drs A,B and C were
taken for “psychiatric orthodoxy,”
The spokesman for the Royal Australian and New
Zealand College of Psychiatrists, Dr. Bill Lyndon,
rejected the FDA Advisory before s he even saw it let
alone had time to investigate the huge number of
submissions that went to the United States Food and
Drug Administration to force it to issue this advisory.
He did not have access to 373 failed clinical trials in
most of which suicides were excessive on
antidepressants and in withdrawal
The RANZCP refused to put suicide warnings into its
clinical practice guidelines for depression
while the American Psychiatric Association
immediately added suicide warnings to Clinical
practice guidelines

96
What is a peer? Someone who was what everyone does the
same as everyone else and is prepared to say “We all do it.
This is STANDARD PRACTICE”
What is an expert? A person who has special skill or
knowledge in some particular field; specialist; authority.
What is a Peer Expert? And expert in what peers do or a
contradiction in terms
A college, as association of doctors whose publications are not
same as an expert.
An expert has to be a person with skills and knowledge.
Clinical Practice guidelines guidelines were drafted by the
pharmaceutical industry, specifically the fraudulent TEXAS
Medication Algoriththm Project which provided graphics and
suggestions
CPGs look like they have118 references following but 247
references trailing
not one reference has any relationship to the text,
This is drug company FRAUD
97
A second chance
• Mr. Pehm got another chance to look at
the science when I answered the peer in
SS
• He did not take this opportunity to review
his opinion but sent me a profession
standards committee
• for being so disruptive

98
I had sent into Dr. Superintendent, knowing that it reached Dr.
and to Kieran Pehm much all the information that he was given
and decided was not yet psychiatric orthodoxy.
I re sent it with Dear Mr. Randell response to the peer reviewer
in SS. attached
The mother of SS had complained about Dr. C’s treatment
with polypharmacy that caused him to attempt suicide and he
nearly died from suicide attempt but the HCCC ignored her
complaint and turned on me.
I sent the Dear Mr. Randall letter (attached) on 6 January 2006
and I know it was received because the it was found in my
medical board file but it was never sent to the professional
standards committee.

99
100
• Can the Medical coundcil or HCCC knowing
all this science backing the FDA advisory
• accept the validity of the Clinical Practice
Guidelines? Or advicde form the
acknoweldged Expert “The College” this is no
os not ocnclusiove?
• Or doubt the validity and academic
underpinnings of the US FDA public health
advisory,
• Is the evidence “not conclusive?”
• Shoud the HCCC accepte the opinion of the
HCCC and RANZCP and Dr. A?
• Or with the Science good?

101
In this letter, I provided 32 sources of
information about medication –induced suicide
including textbooks going back to the 1960s.

I also provided 143 papers about


antidepressant/akathisia induced suicide and
any rational person would see that if this
information was “not yet psychiatric orthodoxy”
was not familiar with it
Here is what I had sent before, deed to be
nonsense by Dr. A

102
Randell letter

Jan 6 2006, Dear Mr Randell, MBNSW Response to peer reviewer in SS


and withheld from PSC and ignored by Kieran Pehm Attached in full

• I am not at all sure what the ‘… generally


accepted knowledge base of the profession
…’ is, but my knowledge is consistent with
textbooks, prescriber information, MIMS and
the medical literature.
• At the HCCC, I have had my complaints
rejected on the spurious assertion by the
accused doctors and their peers that my
views are personal and, on one occasion,
idiosyncratic. This is not the case at all.

103
• None of my 42 notifications of suicidality violence and neuroleptic brain injury
was never sent to an expert
• Only to a peer reviewer, as a complaint about me

• A Peer reviewer is useless because he knows only what his peers do.

• Medical Council insists THE COLLEGE IS THE EXPERT!

• An Expert: Professional who has acquired knowledge and skills


through study and practice over the years, in a particular field to the
extent that opinion may be helpful in fact finding, problem solving, or
understanding of a situation.

• I also sent in 192 reports of people with serious ADRS admitted in


2003-4 to the bush hospital (Hospital B). At least 8 were dead by 2005

• And the Expert Report commissioned by the TGA on 90 of my workers


compensation patients who had become suicidal and homicidal on
antidepressants. EXPERTS agreed with the science and with me. 104
1 death of an alcoholic investigation discontinued
5 completed suicides on antidepressants always augmented not
investigated
Over 20 reports involving hundreds of suicide attempts not
investigated,
Two who went on to kill themselves after I reported disregarded, no
interest
Innumerable serious and some nearly successful suicide attempts
none investigated
one medication induced homicide No interest (SUPREME COURT
ACCEPTED MY EVIDENCE)
3 attempted homicides on multiple medications including
antidepressants and atypical antipsychotics not investigated
Failure to diagnose and treat schizophrenia after being told twice told
resulting in patient attacking others and litigation against the
hospital “Referred to Ombudsman” and negligence paid but Dr A
was not criticised
half a dozen inappropriate discharges of patients who had to be
brought back Not investigated 105
His mother’s notifcation was ignored,
A complaint against Dr. Lucire emerged from the HCCC itself instead.
My Medico legal r[port was sent o peer reviewer a psyhoanysit in
queensland who had never done a section 32 report and did not know
the difference between it and an independent medical examination.
I am attaching the peer review and my response
In my response, which I attach in full, I provided 32 sources of evidence
about medication induced suicidality and 143 papers that have been
published in peer-reviewed journals from the 1950s to the present time.
Mr Pehm ignored all the science.
Instead Dr Lucire was prosecuted for telling his mother that her son had
akathisia not schizophrenia (FULL AND FRANK DISCLOSURE)
Dr A had told Dr. Administrator that he had akathisia but told his mother
that he had schizophrenia.
3 psychiatrists at both bush hospitals had agreed the he had akathisia
not schizophrenia

SS has had had no symptom or sign of schizophrenia before or since


this iatrogenic episode

106
Response to Peer criticism of SS case Medical Board
January 6 2006 in my MB file and not produced for PSC
hearing

• I am not at all sure what the ‘… generally


accepted knowledge base of the profession
…’ is, but my knowledge is consistent with
textbooks, prescriber information, MIMS and
the medical literature.
• At the HCCC, I have had my complaints
rejected on the spurious assertion by the
accused doctors and their peers that my
views are personal and, on one occasion,
idiosyncratic. This is not the case at all.

107
SS Prosecuted at Professional standards committee

32 REPORTS) mostly Dr. C’s


He had provided an incompetent court report
and made an incompetent diagnosis that had
sent SS to jail
and his massive polypharmacy see SS affidavit
his affidavit caused a near fatal suicide attempt
on “5 drug polypharmacy” including fluvoxamine,
clopixol and olanzapine
His mother (a Lawyer) wanted treatment by Dr C
that had caused a near fatal suicide attempt
investigated.
Her and his notifications were ignored,
108
SS I have never had a mental problem before I had
this medication, I haven’t had one since. I am
working three jobs. I have been more or less
unemployed for 20 years and I blame that on my
family.
I now have a criminal record and also a mental
illness record. I was sent to jail with a diagnosis of
schizophrenia.
I remember driving in a car thinking, ‘I want to get
out of here’. I could not. If I got into someone else’s
car, it was a panic.
When I was asleep, it was the only respite I got. I’d
go down into the garage, walk up and down
smoking, screaming, for nine months inside my
head. I enjoyed no warm thoughts at the time.
I remember you were an angel.

109
He had just attempted suicide after worsening depression and constant
suicidal ideation, and intolerable akathisia.
He described his akathisia as
I just couldn’t stand still. I was in hell every day, every minute of
every day for nine months. I was just in hell.
I had no homicidal thoughts. I can think of worse things than killing
them (his treaters). I want to see them burn in hell. (This is a violent
homicidal thought).
Oh my God all day, I couldn’t sit down, I couldn’t stand up. I couldn’t
watch TV, I couldn’t laugh or think happy thoughts. It was as if I was
trapped in the boot of a car. I had no energy. I lived on the couch. I
knew there was nothing wrong with me mentally.
I had terrible fatigue. I could not sleep. It took me four or five hours to
get to sleep every night. I was up fifty times a night. I did not have
any dreams. I had no respite from panic attacks. It made me into a
smoker. I had hardly smoked before. My memory for this period is
poor.
It was like a panic attack. I tried to read a book. I had no enjoyment of
anything.
I had to see the doctor because I was in trouble for smashing windows at my
former friend’s house. He said ‘What is your side of the story?’
He did not agree with anything I told him. He said, ‘You are a
schizophrenic’. I was telling him about the ‘dickheads’.
110
I now have SS’s CYP 450 profile. He had ‘diminished’
capacity to metabolize all these drugs. Co-prescribing
Luvox and Zyprexa is
contraindicated in Product Information.
I would have been negligent had I failed to warn his
mother (a care-giver) of this problem as further exposure
to drugs requiring the same pathways would again cause a
repeat of this problem.
I enclose also my answer to the HCCC. I was found to
have ‘inappropriately destroyed his faith’ in treaters who
diagnosed him with schizophrenia having caused him to
develop akathisia.
Yours sincerely,
Dr Yolande Lucire
Consultant Psychiatrist

111
• I listed 32 sources of information see attached letter.
Textbooks back to 1950s DSM ICD legal decisions
• Then I provided 143 references in scientific peer
reviewed journals to Akathisia antidepressant and
neuroleptic- induced suicial and homicde and its
relationship to suicidl and violence.
• This literature is is evidence at the SUPREME
COURT)
• Calling it “nonsense” as did Dr. A is not admissible
evidence
• They had already decided that I was to be himiliated
by being sent to professional standard committee.

112
FIRST HCCC prosecuted me at a Professional
Standards Committee on three of their false “own
notifications”
• For notifying treaters of paroxetine suicide/homicide in
adolescents so treated by Dr. A and Dr. B.
• for telling mother of SS to ask for a change of doctor as Dr C
did not believe in medication-caused akathisia suicide and he
was till at risk for his prescribing
• For disagreeing with good doctors’ diagnosis even when their
care had resulted in tehse serious listed adverse drug
• making strange diagnoses like “toxic hallucinosis”
• not talking to treating team when it was documented I had
done so
• For not speaking to psychiatrists and that (with which I had
not been charged was a figment of the PSC’s imagination.

113
SS Letter to GP
Re: SS
SS completed a university degree in the face of a history of brain
injury at birth and measles encephalitis at age 20. He was mostly
unemployed. Two years earlier he had developed an attachment
for a young woman and was thought to be stalking her by leaving
several notes on her car believing that she was interested in him.
He was interviewed.
In late 2003 or early 2004, SS was deemed to be schizophrenic in
a brief
interview to which he alone can do justice and in due course
olanzapine, 30 mg daily, fluvoxamine 100-150 mg daily and
Clopixol were prescribed.
He was sent to jail where he developed intense akathisia, could not
sit down.
When I saw him in September of 2004, following yet another
breach of AVO, he was on olanzapine 30 mg (a dose which is
above the level ever tested by Eli Lilly with only that one drug in
play), Clopixol 200 mg fortnightly and fluvoxamine 100 mg daily.

114
PSC
• made counterfactual factual findings
• Board circulated the PSC report extensively
although it was marked “not for publication”
• ordered me to see a colleague to be re- educated.
• Colleague agreed with my knowledge and twice
refused to re-educate
• Said that it was “all over Sydney” that Dr. Lucire
was being investigated by the medical board.
• So they defamed me in the press

115
Pehm writes:

It is clear from your letter and other dealings between


you and the Commission that you are extremely
concerned about the dangers of SSRI
antidepressants.
I have no doubts as to the sincerity of your
convictions on this issue and it may eventually
turn out that your views become more widely
accepted and may even become psychiatric
orthodoxy,
That is not the case, however, at present,
although I note more recent studies suggesting
SSRIs may increase suicidal ideation in juveniles.
116
Pehm Continues:
Commission investigations rely on expert or peer
opinion to assist in determining whether there has
been a departure from the standards generally
applicable for medical practitioners.

I appreciate the strength of your views that the


experts or peers used by the Commission in
your matters are wrong and note the material
cited in your letter in support of your view.

Where medical opinion is divided and/or


contested, the Commission also has regard to
material published by the Colleges.

117
RANZCP was declared to be “the expert”
and guidelines were “material published by
the College”
Dr. Lyndon RANZCP had declared on the
day after the FDA advisory was published
that the evidence was “inconclusive.”
What information Pehm was shown and
what he discarded and on whose advice is
a matter for Royal Commission or lCAC

118
• I did not agree with the diagnoses made by Dr. A
and Dr. B, “schizophrenia” and “bipolar” in 2
substance abusing adolescents for whom Dr. A
had prescribed paroxetine and who became
suicidal on it.
• Paroxetine had never been approved for children
“suicide attempt” there and “hallucinations” were
listed as side-effects in local PI until 2005 when
specific advice was replaced by FDA mandated
text
• Lawsuits were ongoing in UK and New York,
Damages were being paid
• The complaint about my peculiar diagnosis (not
schizophrenia, but side effects) was sent to HCCC
by the proxy of Dr. Administrator and it was false
every sentence.
119
Summary
• Because Pehm opined that medication-
induced suicide was not yet psychiatric
orthodoxy and a psychiatrist on an RANZCP
committee opined tht “the evidence” that led
to the FDA public Health Advisory was
“inconclusive.”
• HCCC did not investigate a single one of 32,
now 43 similar notifications including fatalities
or anyone else’s complaints
• “We all do it so its OK” says a peer
120
Nies' Law: The energy expended by a
bureaucracy in minimizing any error is directly
proportional to the magnitude of the error.
I had in 2003-4 sent a huge amount of information about
SSRI suicide, all ignored by Drs A, B and C and Mr.
Pehm.
A peer reviewer criticized my s32 report without knowing
what it was. I faced an ill informed PSC
I responded with enclosed Dear Mr. Randell YL to Pehm
but Pehm still prosecuted me at PSC
I provided 32 sources of information about medication
induced suicide and a list 143 publications in journal that
he les to the FDA advisorey. Pehm ignored it all and put
me to a PSC on the peers ill informed views
I attach the letters in full as well as David Healy’s
summary of SSRI SUICIDE Mr. Randell.

121
None of my 42 notifications of suicidality violence and
neuroleptic brain injury was ever sent to an expert
Only to a peer reviewer, and only as a complaint about me
A Peer is useless because he knows only what his peers do.
Medical Council still insists THE COLLEGE IS THE EXPERT!
An Expert has to be a person: Professional who has
acquired knowledge and skills through study and to the extent
that opinion may be helpful in fact finding, problem solving, or
understanding of a situation.

122
I also sent to Andrew Dix registrar of medical
board 192 reports of people admitted to hospital
B in 2003-4, homicidal and suicidal with file
numbers, drugs and doses.
• At least 8 were dead by 2005, no doubt more
now.
• An Expert Report commissioned by the TGA
on 90 of my workers compensation patients
who had become suicidal and homicidal on
antidepressants agreed with the science and
with me. But MED BOARD took no notice
• If TGA found experts why did Mr Pehm find
them?
123
• After seeing a Prozac + Risperdal akathisia homicide
which I failed to prevent when GP prescribed as he
had been told not to, in writing, and mother did not tell
me (admitted that in evidence) and patient lied
• I faced a Tribunal on which sat Dr. C’s business
partner (yes, same practice and friendship network)
• I was permitted to treat anyone whom another doctor
thought was psychotic
• I was allowed to do medico legal reports but not to
discuss side-effects with any patient. (WAS this their
primatyt motive? To cover them up?
• You can imagine the conflict and problems that this
generated and how I hated hearing years later the
patients whom I could have informed and saved were
still in the state in which I have seen them.

124
I was a known entity at the Supreme Court which
exonerated me.
SCNSW had accepted my evidence in Dr. D’s Prozac
Homicide case
Professor Healy’s evidence in R v Hawkins Zoloft homicide,
SCNSW2001
Professor Healy’s evidence R V B (SCWA 2004) both of
which were mentioned in Dr. Mr Randell letter and well all
All together I got costs against HCCC three times but had
to pay for their corrupt prosecutions which failed to deliver
natural justice to me or patients or the Australian
community

On gardening leave for a couple of years so I researched


pharmacogenomics and I published

125
Dr. Jill Reddan

Their “peer reviewer” in the Homicide Tribunal


advised the Medical Board

that this publication, in a discipline not known to her

in the top peer-reviewed journal, Pharmacogenetics


and Personalized Medicine was

nonsense.
126
Subject: medical board February 2008
>
Hi Dr Lucire

I am a health reporter at the Sun-Herald newspaper.

It has been bought to my attention that you


have been reprimanded by the NSW Medical
Board and ordered to seek psychiatric
treatment.

I am in the process of writing a story about this for


Sunday's newspaper. I was wondering if you would like the
opportunity to comment on the order.
Also, I understand you have particular opinions on
SSRIs and suicide, and ADHD medication. I was
hoping to discuss these with you further. 127
Hall ignored my denials and published

• Prominent psychiatrist ordered to seek help


Louise Hall Health Reporter
• January 27, 2008
• A PSYCHIATRIST known as a "hired gun" in court cases
ordered into treatment by
has been
medical authorities after being
accused of a dubious diagnosis.
• Yolande Lucire has been reprimanded by the NSW Medical
Board after its professional standards committee disagreed
with a diagnosis she made in a medico-legal case and
questioned her professionalism.

128
I wrote to Medical Board Registrar, Andrew Dix
who had received all my 32 notifications of medication
induced suicidality
Had attended a presentation by way Andrew DIX did
not know
He pretended he did not know
Had received 192 suicidal/homicidal admissions to
Hospital B charted with meds
Mr Dix admitted that Louise Hall had telephoned the
Medical Board and had been referred to
The Care Complaints Commission
He wrote
“The journalist must have got it wrong.”
And did nothing
129
Strategic lawsuits against public
participation
my correspondence was never answered

Nothing I submitted to Medical board and HCCC was ever believed or


acknoweldged

THE HCCC went after me ten or more times in a series of SLAPP writs

SLAPP writs are Strategic lawsuits against public participation

Intended to censor, intimidate, and silence critics by burdening them


with the cost of a legal defence until they abandon their criticism or
opposition. ...
The typical SLAPP plaintiff does not normally expect to win the lawsuit.
But they won some because tribunal members and their peer-reviewers
had no idea what I was talking about and sensing that I was dangerous
to their interests, decided I needed to be silenced and humiliated
anyway.
130
HCCC pursued me through committees and a tribunal with
at least 10 manifestly false allegations turned into “Own
notifications”

• Neither their “peer reviewers) reviewers


nor their committee or tribunal members
had a clue of what I was talking about.

• but they also did not want to know and


The HCCC created its “own notifications”
• The complaints I had made were
somehow made irrelevant
• Putting costs and blame on me
131
HCCC repeatedly invistigated me for breach of
conditions

Pehm had put incorrect conditions on the website of


HCCC. His excuse was The HCCC is “dysfunctional”

Because he refused to answer any correspondence


from my lawyers it cost $90,000 in legal bills to bring
Kieran Pehmto a negotiating table to force him to put
the correct information about me on the website.

(70% was returned and I got an apology in “The


Australian.”
132
• I was repeatedly pursued and brought to committees
and Tribunals
• For my unusual ideas, for committing perjury when
the notifier (a board member) was mistaken, for doing
research without ethics approval (I did not need it) for
taking a buccal swab, for doing a normal interview,
• For having a different diagnosis to the treaters, for
provoidong a report that was not “evidence based (i.e.
in Pharmacogentics)
• for disagreeing with the diagnoses making
notifications of suicides and violence which they
inevitably ignored, all 42 of them
• The latest allegations are that I am somehow impaired
and must have been to do what I was doing
• I am unlikely to be impaired as I published seven
papers since 2011 2016 in a discipline they had never
heard of

133
• I was brought to committees and Tribunals always on
“own notifications” based on false reports using peer
reviewers and committee members who had no idea
what I was talking about. The most recent today was that
I breached confidentiality by sensing information about
patient in the Medical council. I di not as I had permission
or changed their names.
• I was held responsible for my lawyer’s not answering
correspondence and found guilty of “unprofessional
conduct for not responding to a letter that the
professional standards committee was well aware I had
not received as they had written to my lawyer not to me
and I was advised not to be in direct communication. This
was the worst advice I repeatedly receivbed
• From that time I started to hold the PSC procedures in
contempt
134
• HCCC put l Dr. C’s business partner and landlady to
Dr. A on a tribunal where a patient whom I had
diagnosed as akathisia and at risk, committed
homicide on her GPs prescription
• Having developed (like KW see below) chronic
homicidal akathisia on Prozac and Risperdal which
had been enforced for several months
• Her GP prescribed a drug that was contraindicated in
my report to that practice but he ignored it..
• HCCC withheld crucial information about this case,
refused to do a swab test genotype
• HCCC pursued me right up to the Supreme Court of
Appeal for my ideas
• And HCCC lost that one and I was awarded costs.
• The Supreme Court of New South Wales knew that
there was evidence for what I had done

135
My medical board file revealed
That Dr A was their chief adviser and had been
permitted to peer-review complaints about himself
and his team and his best friend.
that he thought that medication induced suicide was
nonsense
That his five line “peer reviews” were done without
reference to clinical notes, doses or medications or
Product Information
That his five line “peer reviews” were passed on to
the Health Care Complaints Commissioner who
seemed to take his word for it.

136
Lobbied
• I wrote ten letters and provided science
based information to the Chair of the
Medical Board Dr. Peter Procopis, a
neurologist who would have known what I
was talking about
• but he ignored me.

137
Medical Council of NSW wrote
Dear Dr Lucire

Re: Allegation of fraudulently promoted drugs and unmonitored


prescribing

I refer to previous correspondence dated 6 August 2012

On 11 September 2012 the Conduct Committee considered the


information provided by you and resolved that the Medical
Council of New South Wales is not the appropriate forum for
the issues you have raised therefore no further action will be
taken

Yours faithfully

Dominica Azad legal officer


138
From my list of Complaints. This response
demonstrated Dr. A’s knowledge base to be the
adviser to the Medical Board and HCCC.

From HCC document:


COMPLAINT: (about Dr. A)
That patient (Subject 9) had chronic akathisia.
Allegation that this was not diagnosed and
there was a failure to recognise symptoms
when it's recurred after taking Tramadol. KW
was not informed that the drugs were addictive
or had side effects.
Matter discontinued- unsuitable for
Conciliation/investigation
I have her consent to post this
139
Subject 9 was a teacher in her fifties suffering from work stress;
Dr. A treated her for a long time with paroxetine, an SSRI that
was well known to me as one of the worst suicide drugs.
During that period she had 11 admissions for suicidality. Her
condition was not recognised. See vignette below published
about her treatment in a top peer reviewed journal
Pharmacogenomics and Personalised Medicine. She was later
switched to venlafaxine and on this drug she twice went to kill
herself and her children by jumping off a silo. This was covered
up in her next admission.
I saw her for a S32 Report because she had d forgotten to take
venlafaxine, had gone into a withdrawal delirium and trepssed

I was on the phone dealing with a crisis at hospital B. She walked


in walked around the room and sat down and did it again and
shhalf a dozen times.
My opening question to her was” You have akathisia. What are
you taking?”

300 mg/day of venlafaxine.


140
I then asked the questions on my pro forma to diagnose the DSM-
listed associated features of akathisia.
Do you have suicidal thoughts?
She told me of the 11 suicidal admissions.
Have you ever thought of killing someone?
Yes. Twice I tried to kill myself and my children.

She later told me what a relief it had been to meet someone who
knew what she was talking about.
She went to the Internet and took herself slowly of venlafaxine
and made some recovery but, when put on oestrogens and
Tramadol, she had a relapse. Dr. Administrator refused to me see
her records,
She now has chronic substance/medication induced
neurocognitive disorder and has not been able to work again.
On last last contact she has been unable to leave her bed for
some three years. This is the condition that used to be known as
NIDS neuroleptic end-use deficit syndrome

141
Subject 9 “standard psychiatric practice
was the HCCC response
• Subject 9, (52 year old female, genotypes CYP2D6 *4/*4,
CYP2C9 *1/*1 and CYP2C19 *1/*1) a teacher, was
prescribed a series of antidepressants following
harassment at work. After three years on a series of
antidepressants, always superimposed on polypharmacy
containing CYP450 substrates and inhibitors and drugs
with similar side effects and causative of
pharmacodynamic interactions, she tried to kill her two
children while taking venlafaxine XR with other
medicines. She suffered from mild chronic bilirubinaemia,
which may have been Gilbert's Syndrome.

142
Subject 9 contd
• She was initially given paroxetine for her work-
related stress and increased to 60 mg/day.
Paroxetine is metabolized by CYP2D6 and she
had no CYP2D6 activity, with two null alleles
(*4/*4), and after paroxetine had occasioned a
hospital admission, she was switched to
citalopram and this was titrated up to 60 mg/day
which was three times the standard dose, and
restlessness, aggression and suicidality
continued. Citalopram is metabolized by 2C19,
2D6, 3A4. Its major metabolic pathway, 2C19
was inhibited by her treatment for menopause,
conjugated estrogens, which also inhibit 3A4 and
2C9, as do naturally occurring estrogens.
143
Citalopram was replaced by venlafaxine, 300 mg/day.
Venlafaxine is metabolized by 2D6, 2C9 and 2C19, and inhibits
2D6 mildly but it was prescribed at 300 mg/day. Her total body pain
diagnosed as "atypical somatoform disorder" and this occasioned
the use of tramadol, metabolized by 2D6, and celecoxib, which is
metabolised by 2C9 and inhibits 2D6. Her hypertension was
treated with irbesartin metabolized by 2C9. Her elevated
cholesterol was treated with atorvastatin, metabolized by 3A4 and
inhibits 2C9 and 3A4, and this drug might have caused painful
muscle deterioration. Tramadol and celecoxib interact adversely.
Irregular doses of both tramadol which causes serotonin syndrome
and metoclopramide, both metabolized by 2D6 and both causing
akathisia made it impossible for her to recall exactly which of the
co-prescribed intermittently used akathisia inducers
(metoclopramide or tramadol) she had taken before she tried to kill
her children and herself first by gas and then by jumping with them
from a great height, an impulse she resisted at the last minute.

144
Subject 9 cont.
She had been hospitalised 11 times over three years for suicidal
behaviours and for the homicide attempts however she no longer
needed attention after she stopped taking psychiatric medicines.
She came to the author's attention a year after the homicide
attempts as she had been charged with "entering enclosed
lands" while delirious after missing doses of venlafaxine, which
were left at home over a holiday weekend.
She returned to work briefly after following withdrawal protocols
from the Internet, but further prescriptions of lovastatin, tramadol
and estrogens all induced further bouts of akathisia and she lost
her job. She was never "herself" again or able to work, but
hypertension did resolve. She reported this:

145
own words
• I’m more depressed than I’ve ever been in my life. I
throw things when someone comes into my room. I
had surges of rage with everyone, with the medical
people who could not fix me. It was strange to feel like
that, with violent thoughts all the time. I drove all day
to find a silo I was going to jump. I took the children on
a holiday and gassed us all to kill them and myself. I
was not charged. The thoughts of suicide are there all
the time. I’ve now started a suicide book. The
psychiatrist doesn’t understand me. I fidget, cannot
keep my legs still, I am apprehensive, irritable,
uncomfortable with unstable mood. I’ve got a hit list in
my head. It’s listed, one, two, three. I think how to get
access to these people. I feel violent. Before all this, I
was a big reader. I can’t focus.

146
TRAMADOL

• Oh and by the way, tramadol is a prodrug


which requires CYP2D6 to metabolise into
an analgesic so she had no benefit from it.
It is also an SNRI like venlafaxine,
• In addition, it inhibits the reuptake of
noradrenaline and serotonin.
• Dr. A or the HCCC might have taken a look
at this information on the website of the
Therapeutic Goods Administration:

147
AUSTRALIAN ADVERSE DRUG REACTIONS BULLETIN VOLUME 20,
NUMBER 4, DECEMBER 2001. TRAMADOL AND SEROTONIN
SYNDROMETRAMADOL (2001) TGA webs willite

Tramadol hydrochloride (Tramal) is a centrally acting analgesic, which although


chemically unrelated to the opioids, binds to and stimulates opioid receptors.
In addition, it inhibits the reuptake of noradrenaline and
serotonin. Since its marketing in Australia in late 1998, ADRAC has received
171 reports of suspected adverse reactions. Six of these reports describe the
serotonin syndrome. The commonly accepted diagnostic criteria for the
serotonin syndrome were developed by Sternbach.
The diagnosis requires the development of at least three of ten clinical features
(see box) coincident with the addition of a new serotonergic agent to an
established medication regimen or an increase in the dose of a serotonergic
agent.1

148
TRAMADOL cont (2001) TGA WEBSITE
Four reports to ADRAC described the use of tramadol in patients who were
taking antidepressants known to increase the concentration of brain serotonin.
These included the selective serotonin reuptake inhibitors sertraline and
citalopram, the selective monoamine oxidase inhibitor moclobemide (which
releases serotonin), and a combination of the tricyclic antidepressants
amitriptyline and clomipramine (serotonin reuptake inhibitors).
Another report involved a patient who was taking St John’s wort which is also
believed to increase serotonin concentrations. The other report described the
use of a relatively high daily dose (400 mg) of tramadol in an elderly male. Four
of the six patients recovered after treatment while one patient required
intensive care admission and had not recovered at the time the report was
submitted. The outcome is unknown in another patient. ADRAC advises that
caution should be taken with the use of high doses of tramadol and with
tramadol in patients taking medications known to increase brain concentrations
of serotonin.
Reference:
1. Sternbach H. The serotonin syndrome. Am J Psychiatry 1991; 148: 705-13.
Clinical Features of Serotonin Syndrome
- mental status changes (confusion, hypomania) – agitation – myoclonus149 –
Medical Board’s response
• Matter discontinued – unsuitable for
conciliation/investigation
• Her GP was briefly Director of Clinical Services at
Hospital A He was prevented from answering my
letters to him adverting attention to this near fatal
problem. He was threatened by administration to the
effect that they would do to him what they were doing
to me if he answered my correspondence. He sold his
farm and went interstate
• This is one of the notifications I made that is listed on
S 150 statements as
• “Dr. Lucire made many complaints and she was put
under observation.”

150
Dr A's level of knowledge; 5. Complaint received by the
Board on 13 September 2005 – HCCC file number 050294
Matter discontinued.

5. Complaint received by the Board on 13


September 2005 – HCCC file number 0502940
Complaint refers to information presented to Dr.
A on new antidepressants, which he regarded
as nonsense issues were also raised
regarding lack of knowledge on
cytochromes, drug interactions and genetic
polymorphisms. And Dr A and his colleagues
were combining them unlawfully with Zyprexa.

151
• Denial still evident and inability to read or research
Information that I sent and is in this slide set.
• But like the RANZCP Dr. A still disputes the validity of
FDA advisories and advice on the TGA website and
mandated contents of every antidepressant Product
information.
• There is a $5000 fine for prescribing off label. I
contacted the PBS and they said that it was a matter
for the Health Care Complaints Commission.
• This prescribing is a flagrant breach of the PBS
Legislation and I reported it as advised by authorities at
the PBS Pharmaceutical Benefits Scheme.
• Dr. A shows disregard for the law.

152
• Whether or not information about side effects
use by the pharmaceutical industry and
underpinning US FDA public health
advisories shoule be called “nonsense” is a
matter for judgement, I hope by a ROYAL
• five minutes on the internet would contradict
that.
• I ma aware that Dr. B influenced the HCCC
to refuse to do a $100 swab gene test after a
young woman developed chronic homicidal
akathisia on enforced fluoxetine and
risperidone depot for being very religious
from the age of four and talking to Jesus.
• I would be very interested to know if he
influenced that case.
153
• Dr B certainly did influence that prosecution
and he brags about it to my clients.
• If Dr. A were to read Product information in
MIMS he would know about cytochrome
enzymes, genetic polymorphisms and drug
interactions. However the evidence that this
point is that he has not ever read it or he
would not sanction Dr. C’s co prescribing of
Risperdal with other drugs metabolised by
CYP450 2D6, such as Prozac or Aropax
• subject 9.
• Dr. A really should read product information,
Board or HCCC that it is nonsense.

154
Lets have a whole page abot Zyprexa d frad
Zyprexa was the most suicidogenic a drug in the history of
clinical trials. It is also a special purpose drug for
schizophrenia. It is not permitted to be prescribed on the
pharmaceutical benefits scheme for any purpose other than
schizophrenia or acute phase of manic depressive illness. The
people to whom ZYPREXA was prescribed were not
schizophrenic before they got their antidepressants.
Schizophrenia any cannot be diagnosed if the symptoms are
caused by a substance or a medication.
In many of the cases I saw, both Dr A’s and Dr B's, Zyprexa
was an add-on when antidepressants had not been effective.
Zyprexa is fraudulently promoted in Australia: these are the
differences between American and Australian product
information on Zyprexa which I also brought to his attention,
repeatedly.
155
Although marketed as an antipsychotic, Zyprexa has serotonin syndrome
among its listed side-effects so it is technically a serotonin booster.
So giving it on top of a serotonin boosting antidepressant is usually
catastrophic
Original data about suicide and deaths in the clinical trials submitted for
its approval is in these documents. See also attached PowerPoint on
failure of regulators for the fraud that will was involved in approving the
atypicals.
Putting these wrods into the Internet will find the original data.

Andreason, Paul. Review and Evaluation of Clinical Data, NDA 20-592,


Reviewer Completion Date: July 29, 1996, pp 1-108, Appendices 7.2.1-
7.2.4, Appendix 8.

Andreason, Paul. Statistical Review and Evaluation, NDA 20-592,


February 14, 1996.

Otherwise for a summary, Google to Grace Jackson's evidence on


the analysis of these clinical trials or access it through my website
along with other fraud settlements
https://www.drlucire.com/law.html

156
• ZYPREXA
• Zyprexa is licensed for the treatment of schizophrenia
and bipolar illness. It is not licensed for the treatment of
drug-induced or medication-induced side effects.
• In Australian PI only
• Nervous system – Very common ( 10%): somnolence.
Common ( 1% and < 10%): dizziness; akathisia.
Uncommon (≥ 0.1% and < 1%): amnesia

• .

157
Zyprexa has the following as listed psychiatric side effects (not in the
body, but mental) in American PI. (APPROVED AGREED-UPON
LABELLING)

USA PI FOR Zyprexa Note death and suicide attemp t


• Abnormal dreams, aggressiveness, agitation, akathisia 27% rate on 1
mg/day, akinesia, alcohol misuse, altered mental status tardive dyskinesia,
amnesia, antisocial reaction, anxiety, apathy, articulation impairment, ataxia,
choreoathetosis, coma, confusion, COSTART (Non aggressive

objectionable behaviour), death, delirium, delusions, dementia,


depersonalization, depression, dizziness, dreams, emotional lability, ,
encephalopathy, euphoria, extrapyramidal symptoms, hallucinations,
hostility, hyperkinesia, incoordination, insomnia, intentional injury, libido
decreased, libido increased, manic reaction, motor and cognitive
impairment, nervousness, neuroleptic malignant syndrome, obsessive
compulsive, paranoid reaction, personality disorder, phobias, reduced level
of consciousness ranging from sedation to coma, schizophrenic reaction,
seizures, sleep disorder, somatization, speech disorder, stimulant misuse,

suicide attempt
stupor, stuttering, , tardive dyskinesia,
thinking abnormal, tobacco misuse, tremor, vertigo and withdrawal reaction.
158
USA PI states: In premarketing trials involving more
than 3100 patients and/or normal subjects,
accidental or intentional acute over dosage of
olanzapine was identified in 67 patients.
That is an overdose rate of 2161/100,000, and this
causes a privatized profit and socialized cost model
of health care delivery.
Prescribers in neither USA or Australia are not told
the 50% of clincial trial subjects did not compete 4
weeks and out of the r remaining 2607, 20 died and
12 died by suicide,
This makes death and one in 108 occurrence and
not a rare.

159
Complaint 6
By Dr. Lucire Complaints received by the Board on 18 October 2005
– HCC file No. 05/02940
it is alleged that Dr A failed to recognize SSRI induced suicidal ideation
and acts in DC and MC (his mother) and still denies the existence of
this problem
Matter discontinued.

Both mother and child sucidal on


effexor

160
22 September 2005
Mr. A Dix
Registrar
New South Wales Medical Board
DX 22808
GLADESVILLE

Dear Mr. Dix


Re: 1. DC
2. MC
Similar case evidence concerning Dr. A
One of the reasons my complaints were rejected by the inquiry by Mr.
Foster, was that there were so many of them. It is hard to get one’s mind
around the magnitude of this problem. I had no idea how much of this
there was in 2002, I saw a lot but just fixed them as I went along then Dr.
A complained that I was ‘idiosyncratic’ etc. in JS and SL.

161
Neither olanzapine or risperidone
were approved for kids
Diagnosis & Opinion S 32 DC cCont
DC is an adolescent who has been put on SSRI medication, Zoloft, in 2001 which was subject
to Public Health Advisories and ADRAC Advisories in childhood in 2002. This has been
combined with unlawfully prescribed Risperidone. Jansen did not tell the truth about
Risperidone and suicide-induction but that is another story.
He has had every side effect reported with these drugs. He has been more depressed, indeed
depressed de novo, as he was ‘hyperactive’ before, not violent, suicidal, homicidal and he has
a changed personality.
He will need to come off his Prozac slowly. He will need support. He may need Valium from
time to time. He needs to be enrolled in his own management.
It is essential he comes off fluoxetine slowly (Prozac, Lovan) He should never have been put
on any such medication.
He was not depressed before. The indication was spurious, that he was simply overactive.
He became depressed on Zoloft and it was downhill from there.

Link Lilly letter

162
Professor Alan Fels
Chair Of National Mental Health Commission

• I lobbied everyone, all organizations of


relevance, Ass/professor Procopis
• Inter alia, I wrote to Professor Fels.
• A pro forma letter from the Commission told
me were I could go.
• So I re-addressed my bundle of scientific
and clinical trial data and sent it to his
university
• September 2017, the Australian Bureau of
Statistics published the following study.

163
ABS 4329.0.00.006 - Mortality of People Using Mental
Health Services and Prescription Medications, Analysis of
2011 data
• At the instigation of the National Mental Health Commission,
the Australian Bureau of Statistics in September 2017
published that,

• In 2012, 14.8% of the population had accessed mental health


services and

• Had been dispensed one or more of the five groups of mental


health drugs on the Pharmaceutical Benefits Scheme

• Antidepressants, antipsychotics benzodiazepine sedatives like


Valium, non-benzodiazepine sedatives like Zolpidem, and
psychostimulants for ADHD, all of which increase mortality in
using populations

• Usually in polypharmacy mixes


164
14.8 % OF THE POPULATION IN 2012 accounted for
 49.6% of the deaths (n=153,451) in age range 15-75.

 52% of the suicides (n= 2,295).

 That is, 75,000 deaths and 1145 suicides were associated with
mental health drugs

 all groups that are known to increase deaths in popiltions of


users

 Three times as many ex-servicemen have committed suicide


since coming home than died in Afghanistan. On
antidepressants. They also have been told, but take no notice

EPIDEMICS ARE EITHER INFECTIOUS OR IATROGENIC, i.e.


CAUSED BY TREATMENT

And we have a suicide epidemic whi


165
• The absolute number of suicides in Australia
increased by 732 between 2012 and 2016,
well in excess of the population increase
bringing total to 3025
• Australia had the highest rate of prescribing in
antidepressant and one of the highest suicide
rates in

• Huffington Post 8/09/2016 1:27 PM AEST

• Australia's Suicide Crisis Has Peaked To A


Terrifying New Height. One person takes
their own life every three hours.
166

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