Woollahra NSW Australia, 2025 | Phone 93271499 (all appointments) or 93272288 for Dr. Lucire |
Fax 93274555 | Email lucire@ozemail.com.au

Yolande Lucire PhD MB BS DPM FRANZCP.


Withdrawal can often be more dangerous than continuing on a medication.  It is important to withdraw extremely slowly from these drugs, usually over a period of a year or more, under the supervision of a qualified specialist.

If you read this and want get off your medicines, please consult these sites and take the information to your doctor. http://www.mind.org.uk/Information/Booklets/Making+sense/



Please note mainstream citation base. Where secondary sources have been shown in links, the author has checked and re-checked primary sources.

1. The Purpose of the Publication.
This paper seeks to inform Australian health professionals, health administrators, prescribers and citizens that what they have been told the pharmaceutical industry about a whole new generation of 'serotonin' drugs is simply not true. The pharmaceutical industry is a client of the United States Food and Drug Administration, (US FDA) the Therapeutic goods Administration, (TGA). All have been victims of corporate fraud which is coming to light now in the United States as a consequence of litigation by 42 state Attorneys General acting on behalf of the people.


From Wikipedia: In the central nervous system, serotonin is believed to play an important role as a neurotransmitter, in the inhibition of anger, aggression, body temperature, mood, sleep, vomiting, sexuality, and appetite. In addition, serotonin is also a peripheral signal mediator. For instance, serotonin is found extensively in the human gastrointestinal tract (about 90%), and the major storage place is platelets in the blood stream.

Drugs to manage serotonin are prescribed on the assumption that serotonin affects mood and boosts confidence; therefore serotonin must be in deficit in the depressed. This is about as logical as the argument that aspirin cures some headaches so headache must be caused by a deficit of aspirin.

But there is no evidence that serotonin is abnormal in depression, and no scientific basis for the chemical imbalance theory that you will find on each drug manufacturer's website.  We have beyondblue which, until recently promoted Serotonin theory, and provided general practitioners with eduction about identifying and treating depression.

The campaign to prevent depression has been so successful that we currently have a million Australians on antidepressants. And maybe two million who have tried them. That is one in every five Australians, and 32,000,000 Americans.  These drugs make some users fat and somewhere between 6 and 14% diabetic, depending on which trial you believe. 

3. Australia has NO EFFECTIVE system to alert doctors to problems with new drugs as they Arise.
Weekly alerts are available even for Australian doctors from the US FDA and they are free.  Some changes never filter through to Australian doctors and when they do it is because a news program on television has drawn attention to them.

The US FDA was reconsidering its licensing of Chantix, an antismoking remedy which causes violence and suicidality, just as it was being put on the Pharmaceutical benefits scheme in Australia. For example, US doctors get this information:

Audience: Neuropsychiatric and other healthcare professionals, consumers

[Posted 02/01/2008] FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using Chantix therapy for patients.

[February 01, 2008 - Public Health Advisory - FDA]
[February 01, 2008 - Prescribing Information - Pfizer]
[February 01, 2008 - Healthcare Professional Information Sheet - FDA]

No alerts went out to emergency rooms to seek this cause for suicide attempts.

Even after the Sunday program has drawn attention to toxic drugs, the authorities are slow to respond and as with the recent warnings on Stilnox, advisories sent out by Sanofi Aventis were entirely inadequate.

We doctors in Australia are not provided with letters, emails or warnings about interactions. 

There is little demand in Australia for doctors, especially psychiatrists, to get informed consent before prescribing. If there were, it would force doctors to read product information and not to rely on what drug reps tell them or on fatuous advertisements such as Zyprexa's "Have you made the change yet?"

MIMS Annual is not on every doctor's desk, not even in every psychiatric ward.

As some psychiatric drugs, specifically Zyprexa, were licensed on six-week trials, information about what is discovered later just does not filter through. Drugs trialed for six weeks are given for years.

When they are given to bigger populations and or in doctors' surgeries where many drugs are being co-prescribed, providing up to date and frequent alerts is a bare minimum requirement of the licensing authority.

But that requires a measure of political will that seems to be out of reach for relevant bodies. It is hardly surprising that health professionals continue to be misinformed by pharmaceutical companies and receive insufficient scientific advice themselves.

Whereas in the United States, the Food and Drug Administration can force drug makers to send out 'Dear Health Professional' letters to inform of changes in knowledge, our own Therapeutic Goods Administration (TGA) either does not have that power to order it or lacks the will to use it.

We do not have the Physicians Desk Reference (PDR) or its equivalent that the UK and US doctors use, or anything like it. This is what every doctor in the United Kingdom has within reaching distance.

The Physicians' Desk Reference lists the following adverse reactions (side effects) to antidepressants among a host of other physical and neuropsychiatric effects: manic reaction (mania, e.g. kleptomania, pyromania, dipsomania), emotional lability (or instability), abnormal thinking, alcohol abuse, hallucinations, hostility, lack of emotion, paranoid reaction, amnesia, confusion, agitation, delirium, delusions, hysteria, psychosis, sleep disorders, abnormal dreams, and discontinuation (withdrawal) syndrome.

Adverse reactions are especially likely when starting or discontinuing the drug, increasing or lowering the dose or when switching from one SSRI to another SSRI. Adverse reactions are often diagnosed as bipolar disorder when the symptoms could be entirely iatrogenic (treatment induced). Withdrawal, especially abrupt withdrawal, from any of these medications can also cause severe neuropsychiatric and physical symptoms. It is important to withdraw extremely slowly from these drugs, usually over a period of a year or more, under the supervision of a qualified and experienced specialist.

In addition to the adverse reactions listed in the Physicians' Desk Reference, the FDA published a Public Health Advisory on March 22, 2004 which states (in part): "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 psychiatric and nonpsychiatric."

In Australia, instead of accurate and up to date information, we seem to rely, at all levels, on  'opinion leaders' who append their names to information provided by the pharmaceutical industry, without undertaking a great deal of independent research.

It is no secret that incentives offered by pharmaceutical companies can sometimes be hard to resist. The RANZCP at its conference in 2008 faced some discord concerning the influence of the pharmaceutical industry on the behaviours and prescribing habits of psychiatrists, but the industry has prevailed.

A SENIOR member of the Royal Australian and New Zealand College of Psychiatrists resigned as convener of its 2009 congress after his peers unanimously voted down a proposal to dump drug company sponsorship.

The college was forced last week to appoint two co-conveners to replace Malcolm Battersby, a fellow of the college.


Our skilled pharmacists are ignored. A process of epistemic capture is underway.

We are prey to vested interests. The pharmaceutical industry pervades medical education and universities, especially postgraduate eduction, assists with producing treatment guidelines and espouses values that are not the same as the values demanded of the Medical Profession.

4. Doctors: remember our historic duty:  Primum non nocere: Above all, do no harm.

Drug makers are public companies whose primary interest is profit. But the new drugs for schizophrenia do work any better than old ones, some of which have been withdrawn.From New Drugs, New Problems. Yolande Lucire. Australian Journal of Forensic Sciences. 37:1 9-25, 2005.

The FDA trials and 52 subsequent studies evaluated in 2000, by John Geddes of Oxford University demonstrated no clear evidence that atypical antipsychotics were more effective or better tolerated than conventional antipsychotics.i Thirty-six, that being one in every 145 clinical trial subjects for Risperdal, Zyprexa, Seroquel,) and Sertindole died; most by suicide, yet these deaths are never mentioned in scientific literature or prescriber information. These deaths occurred even though two thirds of Zyprexa, nearly half the Risperdal and 80% of Seroquel subjects did not complete the trials because the drugs were poorly tolerated.ii A rate of 27% akathisia in a trial of Zyprexa 10 mg was balanced by an equally high incidence of akathisia on placebo.iii This indicated that Eli Lilly either did not know what they were talking about (as akathisia is always a medication-induced phenomenon), or the participants had not fully recovered from whatever they had been taking before entry to the trial. Serious adverse events affected 84 subjects who took Risperdal.

None of this information appears in promotional material. Indeed 47 serious adverse events in 87,000 users of Zyprexa injectable included eight deaths. We are being assured that the deaths are not related to the Zyprexa but, given the number of suicides and deaths associated with the oral preparation, this seems to be improbable. The FDA issued a ‘black box’ warning about sudden death from the new antipsychotic medications, (including quetiapine and aripiprazole) but only for the elderly, in spite of evidence that all age groups are adversely affected.vi Further warnings are expected to advert to the extreme dangers of mixing them with SSRIs. Nor is it the case, as suggested, that Clozaril protects against suicide when compared with Zyprexa. Zyprexa itself is suicidogenic. This comparison manoeuvre delays their obligation to issue full warnings for all children and adults. The PhaRMAs are stalling again as they did for antidepressants and as Merck did for Vioxx, when they suggested that a high heart attack rate on Vioxx, compared with Naproxen, occurred because the latter was protective. David Healy has pointed out that Zyprexa and Risperdal trials had the highest suicide rates in clinical trial history, but suicide risk does not feature in drug company promotional material. Geodon (ziprasidone) had the same suicide risk as SSRIs, about one in 500.

Only five Zyprexa schizophrenia trials were undertaken, but these generated 234 ghost written articles by prominent “opinion leaders” which were carefully placed in the prestigious journals, dependent for their viability on PhaRMA advertising.vii None of these publications yielded any picture at all of the risk of suicide or suicidal acts on these drugs, let alone sudden death.

“Endorsement Science” had become the means of promotion. The colourful capsules appeared on the cover of Time, in The Washington Times and The New York Times. The “Dopamine Theory of Schizophrenia” was alive and well in these endorsements, although by the time they were published it had no more scientific validity than the serotonin theory of depression. John Merson calls this phenomenon “epistemic capture,” the control of knowledge by vested interests.viii


There is no protection in any mental health legislation in Australian against doctors and Tribunals who order these drugs, which proved intolerable to half of clinical trial subjects even for a short time, to be enforced on community treatment order. Their side effects of akathisia, behavioural dyscontrol, obsessive suicidality and violence are now so common that many mental health units have been required to employ security guards to protect themselves against their own patients. But when so advised, and told by the patients themselves it is my experience that many simply ignore the advice.

These figures should warn that a great number of persons are unable for metabolic reasons to take these drugs.


And increase mortality in those treated for schizophrenia.

5. The Drugs of Concern: New Generation Antidepressants and Antipsychotics
In general terms this group of drugs are called "New Generation" antidepressants and antipsychotics, SSRIs or SNRIs and 'Atypicals'.

The antidepressants of concern have been released serially since 1991.  They are Prozac (fluoxetine) 1991, Zoloft (sertraline) 1994, Aropax (paroxetine) 1994, Luvox (fluvoxamine), Cipramil (citalopram), Lexapro (escitalopram), Zyban (bupropion), Efexor (venlafaxine) and Serzone (nefazodone, which was withdrawn in 2003.  Some have many trade names.

The new antipsychotics, named 'atypicals', include Zyprexa (olanzapine) and Risperdal (risperidone) and Seroquel/quetiapine, Consta/risperidone depot.

I have too little specific knowledge to comment on Ability/aripiprazole and Geodon/ziprasidone, other than that the same metabolic pathways are involved.

The atypical 'antipsychotics' have been promoted for any psychosis, which equates with 'off label' use. The Royal Australian and New Zealand College of Psychiatrists, (RANZCP) has issued guidelines to the treatment of schizophrenia. These guidelines conflate that disorder with first episode psychosis – which may be a drug-induced or medication induced state, or a schizophreniform disorder or a brief reactive psychosis, all of whch are better left alone with minimal symptomatic treatment.  It makes little sense to treat a toxic state with another toxin.

These guidelines suggest proactive treatment for conditions, most of which could get better more quickly if not medicated.

Some of our opinion leaders believe that early intervention can prevent schizophrenia, which by that definition was not there before that early intervention.

Epidemiologists can soon dismiss that claim and have done so.  An early intervention programs in Australia have only increased the numbers of persons needing continuing health care. Some might have got better without intervention. Some have no more then chronic side effects.

In the USA, many doctors believe that some cases of ADHD, a socially constructed checklist diagnosis that describes a lot of kids, are actually cases of juvenile bipolar disorder so they apply its promoted remedies.
Iatrogenic mental disease is common and poorly recognised.  The notion that we have collectively caused harm strikes horror in the minds of many psychiatrists.

I refer to medication induced neurotoxic conditions, which were not present before the vicissitudes of life were treated with drugs that caused profound changes in brain and body.

After the Senate Inquiry into Mental Health (and others) had found a huge increase in mental health presentations as and in suicide of patients under mental health care, a spokesman for the Department of Human Services in Victoria that any ‘apparent increase in suicide among persons under mental health care has to be offset against the rising numbers using the service.’ I have has similar reasoning put to me in NSW as well. However the increase in persons using services and the suicides have a common cause, which is the new drugs which have suicide induction, akathisia and psychosis among their listed and well reported side effects. Each completed suicide represents 10 to 20 unsuccessful attempts, all of which increase pressure on beds.

6. Prescribing by Australian psychiatrists
'Off label' prescribing is done with the best of intentions. Off label marketing is good for the PHaRMAs bottom line.  Becausemarketed as 'antipsychotics' not as 'major tranquillisers' as were older drugs, doctors assume that they are so called because that is what they do.

But they induce organic psychosis, (confusion, delirium) in some users, and supersensitivity psychosis on withdrawal in some not previously psychotic users.  Many so affected are genetically polymorphic.  It is a matter of textbook psychiatry that 8% of the population cannot be treated with antipsychotic medication and some of them have mental illness.  That is about the same number as are poor metabolisers of drugs requiring CYP450 450 2D6. This small population gets worse on them, hallucinates, commits suicide or violence. If the diagnosis is of schizophrenic or bipolar is certain, this group of 8% of 1-2% of the population is a small number.  But if toxic states (drugs) and manic shifts (from antidepressants carelessly prescribed for stress) are misdiagnosed as serious mental illness and this treatment is enforced on people who have already reacted badly to a drug or substance, we soon have a public health problem.

7. Names that hijack reasonING
Bipolar mania is rarely psychotic. However since atypicals were licensed for it, the high incidence of psychotic side effects has become obvious.

In drug company terms, 'frequent' means they affect more than 10% of users. The following effects are listed in 2007 Zyprexa Product Information (PI). (Zyprexa is licensed for bipolar disorder)

Nervous System — Frequent: abnormal dreams, amnesia, delusions, emotional lability, euphoria, manic reaction, paresthesia, and schizophrenic reaction;

Infrequent: akinesia, alcohol misuse, antisocial reaction, ataxia, CNS stimulation, cogwheel rigidity, delirium, dementia, depersonalisation, dysarthria, facial paralysis, hypesthesia, hypokinesia, hypotonia, incoordination, libido decreased, libido increased, obsessive compulsive symptoms, phobias, somatization, stimulant misuse, stupor, stuttering, tardive dyskinesia, vertigo, and withdrawal syndrome; Rare: circumoral paresthesia, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid haemorrhage, and tobacco misuse.

The guidelines are silent on side effects and what doctors should do.

8. children
It is particularly pernicious that these drugs are given to children when they have confusion, delirium and dementia among their listed side effects.  Their long-term effects have never been properly researched. They were licensed after 6-week trials and used for decades, without regard for long-term consequences of changes in serotonin levels.

9. CoNsequences on public health
The public health consequences include the need for more beds for this new population of children diagnosed with bipolar illness, which was very rare before kids were dosed with antidepressants, antipsychotics and various ADHD drugs, Ritalin, Adderall and amphetamines.

The resulting disturbances attracts misdiagnoses of bipolar illness and schizophrenia, as these conditions are promoted in various ways by those who have interests in selling remedies or increasing their power and funding.

This is the subject of major inquiries in the United States but ignored in Australia.


The terms pharmacogenomics and pharmacogenetics tend to be used interchangeably. Pharmacogenetics is generally regarded as the study or clinical testing of genetic variation that gives rise to differing response to drugs, while pharmacogenomics is the broader application of genomic technologies to new drug discovery and further characterization of older drugs.

Pharmacogenetics considers genes of interest, while pharmacogenomics considers the entire genome. (Wikipedia) Much of current clinical interest is at the level of pharmacogenetics, involving variation in genes involved in drug metabolism with a particular emphasis on improving drug safety.

Responses to any medication are governed by three genetically determined systems: transporters, receptors and cytochromes. There is also drug sensitivity, just like allergy to penicillin, and CYP450 metabolism might be normal in those cases.

We know nothing that can as yet be clinically applied about the first two, but genetic testing is available for CYP450 polymorphism.

Charts are available to predict reactions to and interactions between drugs that are metabolised by CYP450. These charts go a long way to elucidate adverse drug events, which are clinically visible but universally unacknowledged and unrecognised in Australia.

Note that the use of one drug, such as Aropax (and other "SSRIs") can turn a rapid metaboliser into a poor metaboliser by inhibiting cytochrome P2D6 needed both to metabolise itself and often more so for the second drug.  That is one of the reasons that polypharmacy is a pernicious practice.  There is even a nursery rhyme that could be about it.

There was an old lady who swallowed a cow.
I don't know how she swallowed a cow!
She swallowed the cow to catch the goat...
She swallowed the goat to catch the dog...
She swallowed the dog to catch the cat...
She swallowed the cat to catch the bird ...
She swallowed the bird to catch the spider
That wriggled and jiggled and wiggled inside her.
She swallowed the spider to catch the fly.
But I don't know why she swallowed that fly Perhaps she'll die.

There was an old lady who swallowed a horse -
She's dead, of course.


If you give drugs that target the brain, you must expect psychiatric side effects: not always those you want.

Neuroleptic toxicity (neuroleptic – called the 'neuroleptics' or drugs that act on neurones i.e. the brain) has many faces: restlessness, feeling terrible, wanting to tear oneself apart, blind panic, a feeling of impending doom, insomnia, bizarre (sexual and violent) dreams, impaired psychomotor activity, schizophrenia-like symptoms, hallucinations, even confused beliefs and mood changes, evidence of delirium, toxic confusion, sleepwalking, and bizarre changes in behaviour and personality.

These reactions all occur in some patients undergoing treatment with some psychotropic drugs. The patient gets worse, and more confused when another psychiatric drug is added.  Neuroleptic toxicity is too frequently mistaken for the mental illness its myriad manifestations suggest or mimic.

12. Citing my own publication, New Drugs New Problems
Other than in rare neurological disorders or in the aftermath of epidemics of encephalitis lethargica, akathisia is drug induced, and always iatrogenic (caused by or resulting from medical treatment).xi

Acute akathisia may emerge after only two or three doses of an SSRI. It is called tardive akathisia when it develops late in treatment. Withdrawal akathisia is clinically identical and may develop up to three months after stopping the medication.

It may be associated with a manic shift as well as rebound depression. It does not get better unless akathisia-inducing medications are ceased, and even then, it might take time to recede, and sometimes it becomes chronic.

All phases cause serious distress, may compromise the psychiatric status of the patient, may lead to impulsive actions including aggression or self-harm, and may become chronic and resistant to treatment. Reports ascribe to it cases of homicide and suicide.

Robert Whitaker wrote about “the madman of our nightmares” who is not a schizophrenic but an akathisiac, having just taken, or taken himself off, prescribed medication. Akathisia is a manifestation of brain toxicity or altered structure. Once akathisia has set in the patient cannot recover from whatever was there before that adverse reaction took over.

At its extreme, akathisia can be the most painful mental state known to humans. It was induced to torture Soviet dissidents before the 1970s and is still used on Falung Gong in China.

(Cite source for above facts)

13. A well known Self-disclosed person: Rebekah beddoE

I take this opportunity to thank Rebekah Beddoe for her generosity and her continuing assistance to sufferers. Her book, Dying For a Cure Random House 2006 should be compulsory reading for all doctors and patients.

Rebekah Beddoe didn't like the idea of going on drugs and decided not to take them. She checked in to the mother-and-baby unit of a private hospital, where staff helped her to settle Jemima. There, after another brief consultation, a psychiatrist diagnosed Beddoe with postnatal depression and suggested she start on Zoloft right away.

This time, she relented.

A week later, she was in hospital, waiting in good spirits for a group-therapy session, when something happened.

She suddenly couldn't breathe and her heart was pounding. The walls seemed to be closing in. She thought she was having a heart attack, but a nurse took one look at her, disappeared for a few moments, then returned with a paper bag that she placed over Beddoe's mouth. When Beddoe calmed down, the nurse told her she'd had a panic attack but not to worry - they were common in people with depression.

Beddoe's plunge into madness had begun. When a neighbour revved his motorcycle within earshot of a sleeping Jemima, Beddoe flew into a rage, chasing him and screaming profanities.

That night, preparing dinner, she used a knife to make shallow cuts in her left forearm, just to see how it felt.

14. Akathisia again
Since 1994, serotonin drug induced akathisia has been in the psychiatrists' bible, the Diagnostic and Statistical Manual (DSM) of the American Psychiatric Association. The current edition DSM IV TR: 333.99 contains the following information:

The subjective distress resulting from akathisia is significant and can lead to non-compliance 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.

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%).

The following was all known twenty-eight years ago about all psychiatric drugs. All has since been largely forgotten.  Why does a whole generation of psychiatrists not know about it? From Comprehensive Textbook of Psychiatry III (1980, eds. Kaplan, Freedman & Sadock), p. 2284:

The term “behavioural toxicity” has been applied to adverse behavioural change produced by a psychotropic drug.

It is often difficult to evaluate such a change in seriously ill schizophrenic patients, since it would be necessary to clearly separate non drug-related worsening of the schizophrenic state from drug-induced toxicity.

Symptoms such as insomnia, bizarre dreams, impaired psychomotor activity, aggravation of schizophrenic symptoms, toxic confusional states and somnambulism do occur in patients undergoing treatment with psychotropic drugs.

In addition, patients differ in their rate of metabolism of a specific drug, and slow metabolizers may build up psychotoxic levels of drugs or metabolites.

In 1980 it was textbook psychiatry that individuals metabolised drugs differently.

Most of the drugs used in psychiatry, and some other medicines (and this is very general) are metabolised in the liver by an enzyme system called cytochrome P450.

The undergraduate, short version of DSM III(1980) aplan and Sadock contained this information:

Akathisia is a subjective desire to be in constant motion. A manifestation of drug sensitivity, it may be confused with psychotic agitation and incorrectly treated by increasing the dose of the offending medication.

The symptom subsides promptly when the offending medication is discontinued and replaced by another one better tolerated by the patient.

If acute akathisia is unrecognised it becomes chronic, and recurs again and again in the course of treatment. Beddoe's story continues, in Time Magazine.

Over time, her psychiatrist added tranquilizers, an extra antidepressant, lithium and eventually an antipsychotic to Beddoe's diet of drugs. There was also a course of electroconvulsive therapy.

But her condition worsened. In 2000 she tried to end her life by overdosing on sleeping pills, the first of four such attempts.

At her mother's urging she switched psychiatrists, but after stripping back her regimen to a single drug, Prozac, the new doctor gradually built it up again. Beddoe developed akathisia, which she describes "as a horrible energy that fills you with angst and dread and propels you to move about constantly."  Akathisia can be a manifestation of SSRI sensitivity, and "it's psychiatry's dirty little secret, "says skeptic Lucire."

But Beddoe's psychiatrist saw it as just another symptom of his patient's illness. Beddoe's behaviour is a typical acute akathisia response such as occurs not only in response to Zoloft but to any antidepressant or antipsychotic to which the user is sensitive. Its elements are intense dysphoria (meaning the patient feels awful) panic, violence in thought and deed directed at self or others, substance-induced delirium (in this case induced by medication), complicating or mimicking a mental illness, and behavioural toxicity.

17. Akathisia in wikipedia
The definition of akathisia in wikipedia is among the best for the polymorphic condition with many faces.

Akathisia (or "acathisia") is an often extremely unpleasant subjective sensation of "inner" restlessness that manifests itself with an inability to sit still or remain motionless, hence the origin of its name: Greek a (without) + kathisis (sitting). It is a common side effect of certain drugs, notably typical or atypical antipsychotics (also called major tranquillisers), such as haloperidol (Haldol®) and droperidol, olanzapine (Zyprexa®); SSRIs, such as paroxetine (Paxil®); tricyclic antidepressants, certain antihistamines, such as promethazine and diphenhydramine (Benadryl®); and certain anti-emetic drugs, particularly the dopamine blockers (e.g. metoclopramide (Reglan®) and prochlorperazine (Compazine®)).

Akathisia may range in intensity from a mild sense of disquiet or anxiety (which may be easily overlooked) to a total inability to sit still, with overwhelming anxiety and severe dysphoria (manifesting as an almost indescribable sense of terror and doom). In the most severe cases, dysphoria can be so severe that the patient is literally compelled to take action, leading, possibly, to suicide attempts. It is not unknown to have patients literally run out of a hospital or emergency room.

Akathisia is often misdiagnosed and can lead the patient to commit suicide in or outside the hospital.


*typical or atypical antipsychotics (also called major tranquillisers), such as haloperidol (Haldol®) and droperidol, olanzapine (Zyprexa®);

*SSRIs, such as paroxetine (Paxil®);

*Tricyclic antidepressants, certain antihistamines, such as promethazine and diphenhydramine (Benadryl®); and certain anti-emetic drugs, particularly the dopamine blockers (e.g. metoclopramide (Reglan®)(Maxolon) and prochlorperazine (Compazine®)).

Treatment includes discontinuation or reduction of dose of the causative agent, and the use of typical or atypical antipsychotics (also called major tranquillisers) to reduce the agitation and anxiety. Unfortunately, these neuroleptics are often the cause of the condition and are known to cause irreversible akathisia in some cases. While the administration of these drugs may temporarily ameliorate the symptoms, there is a serious risk of worsening the condition over the long term.

Most of the clinical cases of akathisia can be prevented by not administering the drugs that cause the condition.

Adverse drug reactions (ADRs), usually called side effects, are a long-standing and largely neglected major medical problem.

These are not medical errors. They occur within the US Food and Drug Administration (FDA) approved dosage and labelling recommendations. The recently reported problems with antidepressant-induced teen suicides, the recalls of Vioxx and Baycol and the upgrading of Accutane monitoring by the FDA are the tip of the iceberg.


This comes for the www.genelex.com website

ADRs are the fourth to sixth greatest killer in the US, with more than 100,000 deaths per year; and 2.2 million serious adverse reactions per year according to a 1998 Journal of the American Medical Association report (JAMA 279:1200 1998). This study is a meta-analysis of 39 research reports published from 1966 to 1996.

21.3% of the 548 most recently FDA approved medications were subsequently withdrawn from the market or given a black box warning. (JAMA 287:2215 2002)

The Government Accountability Office reports that 51% of new drugs have serious, undetected adverse effects at the time of approval.

Of the best selling prescription drugs, 148 can cause depression, 133 hallucinations or psychoses, 105 constipation, 76 dementia, 27 insomnia and 36 parkinsonism. (Worst Pills Best Pills: A Consumers Guide to Avoiding Drug-Induced Death or Illness, 3rd ed., 1999)

$1.77 billion in added health care costs per year (Journal of the American Pharmaceutical Association 41:192 2001)
Health maintenance organisations spend more treating ADRs than on drugs.

Attention: Medical Benefits Funds in Australia. You can stop insurance money being wasted.

Adverse Drug Reactions are the cost leader for malpractice payouts.
Up to one third of drug prescriptions are not needed and therefore wasted.

http://www.fda.gov/c der/aers/default.htm
Has anyone talked to Medical Benefits funds?

Has anyone noticed Workcover statistics? Psychological injury is increasing annually. And suicides in WorkCover claimants. Why? They were fully functional workers with industrial problems before they were medicalised.

NSW WorkCover Mental disorder cases by gender, 1992/3 to 2004/5





% of all diseases

% of all claims

Incidence rate

































































































6.4 3


Note females have overtaken males as they nearly have in suicide data.  Different metabolism in females, slower perhaps, as with Zyprexa?

My own series indicates that most got antidepressants and side effects and stayed sick, sometimes catastrophically so.


There are genetic, biological differences between individuals, some of whom do not produce certain cytochromes at all. Many patients do not respond to drugs and/or experience adverse drug reactions. 25% of the most commonly prescribed drugs, antidepressants, antipsychotics and antiepileptics, are metabolised by CYP2D6 and 2C19, and 2C9.

In practice this means that somewhere between 7% and 14% of Caucasians who are born with no 2D6, or very little of it, cannot metabolise certain drugs, for example, SSRIs, at all or they do it slowly. 2D6 is one of several cytochromes that are different in different people. They have responses like Beddoe's.




Even doctors who swear by SSRIs and newer variants concede that 1–2% of patients have a severe negative reaction to these drugs. That's a small percentage. But it's a small percentage of a very large number. Intractable misery is rife, it seems: in Australia last year, 12 million prescriptions for antidepressants were dispensed through the federal government's Pharmaceutical Benefits Scheme (up from 8.2 million in 1998), a figure equating to more than a million users. Do the math, says Sydney forensic psychiatrist Yolande Lucire: if only 1% of users suffer terrible side effects that aren't recognized for what they are, that's more than 10,000 Australians who've recently been disabled by a drug that was supposed to help them. "That would be enough to fill the beds in every mental hospital in the country."

1–2% is a very conservative estimate. Clinical trials have shown that it is more like 27% and one in ten, at a minimum, becomes suicidal.
One in 500 died of suicide in those clinical trials that had been published before 2003, as analysed by David Healy in this paper.

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-de-challenge and rechallenge basis between SSRIs and both agitation and suicidality. Meta-analyses of RCTs conducted around this time indicated that SSRIs might 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.


We now know that the trials where the drug did not do well were never revealed.

At a minimum, the rate that such adverse reactions will occur is consistent with the number of poor metabolisers, 7–14% of 2D6.  When one adds in poor metabolisers for other CYP450 isoenzymes, it can be 50%. Antidepressants inhibit 2D6 and make it difficult for any but ultrarapid metabolisers to take more than a single dose and to tolerate more then one drug that demand 2D6 for its metabolism. 

About 8% of Caucasians cannot metabolise these drugs at all.  They simply lack one essential enzyme, 2D6, some completely and some are very short of it and it cannot be induced.  About half the population has difficulties taking a high dose or being on more than one drug. Cannabis renders normal metabolisers effectively polymorphic by inducing 1A2.

Those who cannot metabolise antidepressants and antipsychotics develop serious adverse side effects – including sudden death. Some commit suicide or homicide after only a few doses as their blood levels rapidly become elevated and the brain and body become toxic.

Most people stop taking the drug immediately they feel awful on it, as did clinical trail subjects, but in hospital they are not permitted to do so and on treatment orders they are forbidden to do so. They may develop vomiting and diarrhoea, as 95% of the serotonin is in the body, and only a small amount in the brain. Sometimes the body's rejection of the drug is treated with Stemetil of Maxolon, (both akathisia inducers) with disastrous results. Most fail to recognise effects in themselves because of their organically impaired condition.

Breggin has previously proposed the brain-disabling principle of psychiatric treatment that all somatic psychiatric treatments impair the function of the brain and mind. Intoxication anosognosia (medication spellbinding) is an expression of this drug-induced mental disability.

Intoxication anosognosia causes the victim to underestimate the degree of drug-induced mental impairment, to deny the harmful role that the drug plays in the person's altered state, and in many cases compel the individual to mistakenly believe that he or she is functioning better.

In the extreme, the individual displays out of character compulsively destructive behaviours, including violence toward self and others.




Drug interactions are not the subject of black box warnings in Australia, and there is no system for teaching doctors in the community about them.


Adverse drug reactions and interactions are rarely a subject of continuing medical education, most of which is conducted at drug-company funded conferences and seminars.


Subject: Drug promotion disguised as "independent" medical seminars:


Also an interview for Radio National. A transcript is available at:


Drug interactions can be found by consulting prescribing manuals and combining the known effects. But there is a shortcut: Google on the Internet will disclose most of them, in a fraction of a second. Some understanding is needed of metabolic pathways, which deal with these drugs in the body.



In June of 2003, Professor Beverley Raphael, Director of the NSW Centre for Mental Health, told The Bulletin that the numbers of people requiring psychiatric treatment fronting at hospital emergency departments had doubled in the past decade.

Nobody asked why, or whether this was real or apparent, or what this new seriously mentally ill population was really suffering from. The incidence of schizophrenia, biological depression and bipolar disorder (diagnosed according to international criteria) has been constant over the last century and across cultures. Yet NSW appeared to have twice as many persons with mental illness serious enough to present at emergency departments than were presenting before 1992.

The new population demanding mental health services was also more suicidal and more violent. The Bulletin went on to describe changes:

About 400 mentally ill patients throughout Australia – most of them aged in their 20s and 30s – will commit suicide this year because the places that once treated them have been closed or diminished. They are being turned away and sent to their deaths.

Increasing resources and bed numbers has done little for the problem, as exemplified by a rural unit, described later.

The Bulletin article written by Hall Greenland, in August 2003, continued:

When a cluster of nine homicides by recently discharged psychiatric patients occurred in NSW in 2001, the NSW Centre for Mental Health sent for (Dr. Bill Barclay, a very senior forensic psychiatrist.... Violent and suicidal, Hossam Attia tried to kill himself by driving his car into a wall. After being admitted to hospital, he was assessed by two psychiatrists as being at high risk of doing harm to himself and his family, and was recommended for hospital treatment. Two days later, another two psychiatrists (without consultation with Hossam’s wife or their colleagues) gave him a prescription for anti-depressants and let him loose. He went home and shot his wife, then himself. Their three children were in the house at the time. Asked later by the coroner why they discharged him, the doctors replied: “Risks of suicide and harm to others were considered high. However, community management was considered the least restrictive option.”

By 2003, the connection between antidepressants and suicide/homicide was well established internationally, and few of us have not seen this problem in our patients, colleagues, friends and neighbours. The Wesbecker/Forsyth case (see below) had been written up in the national newspaper The Australian in 1996. Such reports appear daily in the international press. But the fact that the perpetrators of massacres were on psychiatric drugs, which drugs they were on or were in withdrawal from, is not reported in Australian newspapers.|

The Bulletin report can be accessed at

The case of the 72-year-old Mr Hawkins, who killed his wife after having Zoloft prescribed (for little more than feeling out of sorts), was decided in the NSW Supreme Court in 2000.

Dr Healy’s views as to the effects of Zoloft have particular weight since his doctoral thesis was based on research on the serotonin transporter system and the role of serotonin in depression and suicide. In this regard it should be noted that Zoloft is a serotonin re-uptake inhibiter. His interest in serotonin re-uptake inhibitors has been ongoing. Furthermore, he has carried out research and clinical work on existing and novel psycho-pharmacological drugs and is an author in the field of psychopharmacology. His opinion is also supported by an assessment of suicidal acts of patients on sertraline prepared in response to an inquiry from the Irish Medicines’ Board in 1999, and by a study in healthy volunteers conducted in the College of Medicine in the University of Wales using a dose of only 50 mgs of Zoloft. Two subjects with no prior history of mental or psychiatric problems and no current problems became suicidal and aggressive on such a dose of Zoloft. This was said by Dr Healy to be:

 “Significant in that it demonstrates that such problems can occur in an entirely normal individual.”

Psychiatrists were in denial, or not reading the newspapers.

Over 2,000 more such tragic cases of homicides, family homicides, senseless and often multiple homicides, suicides, weird crimes and serious adverse drug events and some of their legal defences are documented from media reports around the world at www.ssristories.com And more at http://ssri-uksupport.com/files/homicidesSSRISandADHDmedications.pdf

D, Herxheimer A, Menkes DB (2006). "Antidepressants and violence: problems at the interface of medicine and law". PLoS Med. 3 (9): e372. Several cases have been extensively analysed.

Also link to Let Them Eat Prozac – The Trials

The original group of litigated mass 'SSRI' homicides and suicides complete with Daubert Hearings, court transcripts and experts' depositions (evidence) can be seen on the website of Professor David Healy with the following link: http://www.healyprozac.com/Trials/default.htm


The problem is not only Australian. Robert Whitaker writes:

Over the past 50 years, there has been an astonishing increase in severe mental illness in the United States.

The percentage of Americans disabled by mental illness has increased fivefold since 1955, when Thorazine, remembered today as psychiatry's first "wonder" drug was introduced into the market.

The number of Americans disabled by mental illness has nearly doubled since 1987, when Prozac – the first in a second generation of wonder drugs for mental illness – was introduced. There are now nearly 6 million Americans disabled by mental illness, and this number increases by more than 400 people each day.

A review of the scientific literature reveals that it is our drug-based paradigm of care that is fuelling this epidemic. The drugs increase the likelihood that a person will become chronically ill, and induce new and more severe psychiatric symptoms in a significant percentage of patients.



From my own practice, I have reported on homicides, attempted homicides, scores of suicide attempts, completed suicides and assaults, as well as peculiar crimes, various manias, dipsomania, kleptomania, erotomania, gambling mania, as well as sexual crimes by improbable offenders, in a serried of cases involving over 500 hospital admissions for akathisia, suicidality, homicidal thinking and violence, in over 400 individuals, some of whom were admitted thirty or more times. Cases treated in private practice or reported to courts are rarely reported in the press.

Medical confidentiality is a fine thing in itself, but it may be an impediment to progress if one is not permitted to write up information generated in the public sector. No personal details are required to do this, only medications and responses.

Australia seems to be behind the UK and USA in recognising and dealing with this public health problem. It seems to be a problem in the United States as well, where disability from psychiatric causes has increased. Three years ago, the identification and retrieval of these patients was occupying the Royal College of Psychiatrists.

Also going up and up from 1992 were numbers and rates of hospitalised suicide attempts, as documented in the Annual Report of the New South Wales Chief Health Officer. These increased from 55 per 100,000 to 155 per 100,000. This information can be accessed by the link: http://www.health.nsw.gov.au/public-health/chorep/men/men_suihos.htm

In that report note the numbers of young females. Females, particularly young ones, metabolise Zyprexa/olanzapine and perhaps other medicines poorly. Females now figure too prominently in suicide numbers, where they were formerly outnumbered four to one by men. Suicides on antidepressants involve equal numbers of men and women, whereas in national statistics, men outnumber women in a ratio of 4:1.

It is interesting to note that there are recorded instances where the introduction of psychiatric services to a developing country that previously did not have such services, in fact increases its suicide rate. The study concludes that it is of concern that most mental health initiatives are associated with an increase in suicide rates.

The authors try to find an explanation for this phenomenon, one that avoids blaming psychiatry and its remedies. Following is a statement from a textbook of psychiatry published over 40 years ago. It refers to observations in patients during initial treatment with tricyclic antidepressants [Clinical Psychiatry, by Mayer-Gross, Slater, and Roth, 1960, p. 231]:

With beginning convalescence (following initiation of treatment with tricyclic antidepressants), the risk of suicide once more becomes serious as retardation fades.

This British textbook, my undergraduate book, was cited in the recent FDA review of antidepressant suicidality.


We would now call this condition and its energised or 'manic suicidal' state 'acute akathisia', but we knew nothing about akathisia in the 1950s, only that some patient treated for depression killed themselves very suddenly and without warning, the drugs in use were tri and tetracyclics.  (TCAs)

The inherent risk that a patient will experience this phenomenon provides a reason to limit any anti-depressant treatment to a small, well focused, high risk group of biologically depressed persons and to increase the dose slowly, to watch and warn and supervise carefully. As suicide epidemiologist Ronald Maris has shown, new antidepressants are up to six times more likely to cause suicide than old ones, which are not innocent either.

Akathisia is but one of several mechanisms that have been proposed to explain the clinical observation that some patients being treated with antidepressants, particularly early in treatment, may have an increase in suicidality. This FDA study of 372 clinical trials, which looked at suicides on active substance and not in withdrawal reports:

This has been a major effort, involving 372 placebo-controlled antidepressant trials and almost 100,000 patients. The purpose of the December 13th 2006 meeting is to update the committee with our findings from this meta-analysis. We will present our findings and our interpretations of the data, and we will generally discuss our plans for labelling modifications based on these findings

This review does not look at suicides in the withdrawal phase, so one can halve the numbers on 'placebo’; and double the suicide numbers responding to or on antidepressants. Nonetheless the figures associated with venlafaxine and paroxetine, even without relocating some placebo suicides as medication-withdrawal phase suicides, carry serious implications but are consistent with the peer-reviewed literature.

But in 2008, we have yet to hear something from the Australian equivalent of the US FDA, the Therapeutic Goods Administration (TGA) or get updated advisories or letters from drug companies to tell us of the massive paradigm shift. Australians are being taken for suckers.

Dr Jean Lennane told The Bulletin that 20-30 was the number of annual suicides under mental health care before 1992. This number has increased hugely since that time, peaking in 1997 after the introduction of several new medicines. Psychiatric services are the equivalent of giving drugs.

Extract: Reported suicide deaths of patients in contact with mental health services, and all suicide deaths in NSW 1993-2001



Extract: Reported suicide deaths of patients in contact with mental health services, and all suicide deaths in NSW 1993-2001


Suicides in NSW

Suicides in mental
Health care

Percentage of all







































159 and 156 in 2002


NSW has built approximately 500 new mental health beds since 1992. The increasing demand for mental health beds is described by an audit accessed at



NSW has a further 1100 beds on the drawing boards, some of which are for adolescents.

Adolescents are badly affected by antidepressants and antipsychotics – this is subject of many Advisories and Black Box Warnings. Only Prozac is licensed for children, but 'off label' prescribing of all antidepressants and of antipsychotics not licensed for kids is rife in Australia, to the extent that new mental health units for adolescents have had to be built.

Further information about the rising numbers of suicides and homicides by people under mental health care can be accessed by examining Tracking Tragedy: the annuals Reports of the Sentinel Events Committee 2003, 2004, 2005. The Sentinel Events Committee looked at all factors other than recent and current medication. The link is:

Or for former reports

The relative risk of suicide against placebo by these drugs was reported by Maris in 2002, and can be accessed by the link below. This much was known in 2002.

This information has been published in peer-reviewed journals by David Healy.

Table 1: Incidence of Suicides and Suicide Attempts in Antidepressant Trials Submitted to FDA

Investigational Drug Patient No Suicide No Suicide Attempt No Suicides and Attempts as a % of Patient Numbers
Sertraline Active comparator Placebo Placebo Washout 2,053 595
Paroxetine Active comparator Placebo Placebo Washout 2,963 1151 554 5
Nefazodone Active comparator Placebo 3,496 958
Mirtazapine Active comparator Placebo 2,425 977
Bupropion Placebo 1,942 370 3
---- ----  
Citalopram Placebo 4,168 691 8
Fluoxetine Placebo Placebo Washout 1,427 370 1
Venlafaxine Placebo 3082 739 7
All new drugs All SSRIs Total Placebo 21,556 13,693 4,879 43

For the sources of this data:


And is the craze over now?


Clinical trials are important because they are designed to tell us how a drug will perform when it is it is released into the community. If placebos do better then the drug it will cause problems.

In practice, it will actually not do as well as it appeared to do in the trials.

Many more start the trials than finish them, so a lot of people who cannot tolerate the drug simply drop out.

We are told only of those who stayed in until the end.  We are told only of the best trials. Where the drug did not do well is simply not disclosed.

In clinical trials, subjects see a rater each week. The rater knows what side effects are and pulls out subjects who exhibit them. We are not told of the dropouts, so we do not have a proper idea of how the drug is tolerated by a random population.

In clinical trials only one drug is being taken.

In the clinical setting, patients are often taking more than one drug, but in the clinical setting side effects are often not recognised as such. The patient who becomes hallucinated on an antidepressant will get an antipsychotic requiring the same metabolic pathway and making her condition even worse.

The patient who develops diarrhoea or vomiting (serotonergic side effects) might get an antiemetic.

The patient with antidepressant-induced hypertension is treated with an antihypertensive. Instead of withdrawal of the culprit drug, each complicating symptom might get its own remedy, and it all gets worse.

Such polypharmacy (use of multiple medications) is almost inevitable in hospitals.

Congressional hearings in the USA have revealed the disparity between the knowledge held by (pharmaceutical companies) and the information they disclose in their advertising.

New York’s former Attorney General, Eliot Spitzer, now Governor, won a settlement of $US 430 million against Warner Lambert, a subsidiary of Pfizer Inc., for illegal and deceptive promotions of one of its blockbuster drugs, Neurontin.

A score of US State attorneys have followed suit, expecting windfall income for state coffers to recoup some of the healthcare costs generated by the indiscriminate use of these drugs.

“It is critically important that physicians and their patients receive fair, balanced and accurate information about prescription drugs and the conditions these medications are approved to treat,” Spitzer said. “Marketing strategies that deceptively and illegally promote drugs for unapproved purposes in order to increase a pharmaceutical company's bottom line will be aggressively investigated.” xii

Spitzer conducted the first successful litigation against GlaxoSmithKline (GSK) for non-disclosure of risk, specifically in the case of Aropax. He obtained an undertaking by pharmaceutical companies to place details of clinical trials, even those previously undisclosed, on the Internet. Most have failed to comply, but Eli Lilly information or at least summaries of it are is available on www.lillytrials.com and it took four more years before GSK disclosed the suicide rates in clinical trials for Aropax in adults.

An Area Health Service can counter-sue pharmaceutical companies.

For example, GSK failed to disclose relevant information about suicide caused by Seroxat/Paxil/Aropax/paroxetine in persons under 30, while denying that this happened in older persons. There were six suicides in the clinical trails conducted by GSK in young persons being treated with Aropax for social anxiety disorder (psychobabble for shyness), see below and none among those on placebo.

This is more than a six-fold increase: 6 suicides to none is infinitely more than sixfold. Shy people do not commit suicide.  See below a link to a ‘Dear Doctor’ letter from GSK. I for one am still waiting to receive such a letter from an Australian regulator.

And what GSK did not disclose is now available:

In February 2008 it was uncovered that, again, GSK criminally and catastrophically failed to reveal an eightfold increase in suicide in clinical trials for adults.

An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data, demonstrating an eightfold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it's "virtually impossible" that GSK simply misunderstood the data – a claim the company describes as "absolutely false."


See Dr. Glenmullen's report at:


These postings on the FDA website have forensic utility to show the extent to which the advertising differs from what was found in clinical trials presented for licensing purposesxiii.

However the FDA is not well regarded in the USA. It is beholden to clients, the pharmaceutical industry and riddled with conflicts of interest. The TGA was similar placed into a client relationship with drug companies and Mr Tony Abbott, the federal Health minister, announced that at a post budget presentation in 2005 at a function at the Sydney Opera House funded by Pfizer.

An excellent overview of FDA's failure to function as a public interest watchdog -as is its legal mission- appears in the current issue of The Readers Digest (below).

 "Lurching from one disaster to another, the 102-year-old agency learns of dangers too late and then moves too slowly to remedy them. Instead of depending on the FDA, Americans are doubting it -- and for good reason."

The greatest concern is drug safety. FDA's financial dependence on pharmaceutical company user fees has led FDA leadership to regard industry-rather than the public--as the agency's "clients." The consequences of this mindset can be measured in hundreds of thousands of preventable tragedies, including deaths. From veracare@ahrp.org, ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability

Reader's Digest

Strong Medicine: What's Ailing the FDA

http://www.ahrp.org and http://ahrp.blogspot.com


Professor Edward Shorter, a historian of medicine, often shows the following documents in slides, demonstrating that the names of these drugs were no more than marketing ploys, and did not reflect their actions.

I can’t refrain from pointing out that the terms SSRI and SNRI, which I have just used as though they were scientific terms, are in fact marketing concepts.


Dear Doctor,

March 19, 1993

Thank you very much for participating in the EffexorTM (venlafaxine HCI) Consultants Meeting. We hope you enjoyed all the presentations and corresponding programs.

As a brief follow-up to the meeting we would very much appreciate your help with some additional reactions regarding a potential class name or category description for Effexor.

We would like to develop a class name that effectively communicates to the average clinician that venlafaxine is distinct and different from the tricyclic antidepressants (TCA), and the selective serotonin reuptake inhibitors (SSRI). The class name we select should possess the following characteristics:

accurate and descriptive of the product’s actions

easy to pronounce

simple to remember

Please review the list of potential names on the following page, and then answer the few short questions that follow. When finished, just drop your answers in the enclosed pre-addressed postage-paid envelope and mail.

Thank you very much for all your cooperation.


Nancy L Durst, MD

Vice President

New Products Marketing

Michael Dazenski, R.Ph

Product Manager

New Products Marketing

Marketing Concepts


A) NESRI  Norepinephrine Serotonin Reuptake Inhibitor

B) NSRI   Norepinephrine Serotonin Reuptake Inhibitor

C) SCRI   Selective Combined Reuptake Inhibitor

D) SMRI   Selective Multi Reuptake Inhibitor

1) Given our objective of creating a new class name which of the alternate class names do you feel is most appropriate?

Insert letter from above _______

2) Why you prefer this class name the most?

3) Is there anything about the class name that you do not like

4) What class name is your 2nd choice?

Insert letter of 2nd choice __________

5) Do you have any new suggestions for a class name category description?




Examined in combination, clinical trials have also provided evidence of the dubious effectiveness of ‘new generation’ antidepressants.

In 2008 Irving Kirsch and co-authors published in the public access journal,  PloS Medicine a study entitled ‘Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration’. The journal editor’s summary of the findings of Kirsch et al. tells the story:

These findings suggest that, compared with placebo, the new-generation antidepressants do not produce clinically significant improvements in depression in patients who initially have moderate or even very severe depression, but show significant effects only in the most severely depressed patients.

The findings also show that the effect for these patients seems to be due to decreased responsiveness to placebo, rather than increased responsiveness to medication. Given these results, the researchers conclude that there is little reason to prescribe new-generation antidepressant medications to any but the most severely depressed patients unless alternative treatments have been ineffective. In addition, the finding that extremely depressed patients are less responsive to placebo than less severely depressed patients but have similar responses to antidepressants is a potentially important insight into how patients with depression respond to antidepressants and placebos that should be investigated further.

The complete paper can be accessed at:




Following the introduction of the 'atypicals' in 1997, suicide numbers and rates rose by about 9% from 1996 to 1997, a large increase although less than the 14% increase in the number of suicide registrations. Hanging suddenly became the dominant means for suicide. Hanging suddenly became the most popular means of suicide in akathisia.

The trials of new generation or atypical antipsychotics that were presented to the US FDA to get the 'atypicals' licensed yielded the following outcomes: Zyprexa and Risperdal were twice as suicidogenic as the antidepressants.


Patient No.


Suicidal Acts
















Not disclosed 



1 (2)

Not disclosed



0 (1)

Not disclosed




























Not disclosed



Not disclosed

Not disclosed




Not disclosed


This was published by David Healy, after court-ordered access to Eli Lilly's archives. No documentation of suicide attempts exists. We know only of 67 Zyprexa overdoses, and we know of those only if we read US Product Information.


These problems are documented in ZYPREXA PRODUCT INFORMATION (the US version below). Reports of these overdoses, which are probably only some of the suicide attempts, do not appear in Australian product information nor in any information given to prescribers and patients, nor, it seems, to those who write guidelines for the treatment of schizophrenia.

Full prescribing information, including a boxed warning, is available at http://pi.lilly.com/us/zyprexa-pi.pdf

Experts say it would be highly unlikely that a competent psychiatrist could misdiagnosis this condition because the symptoms are so extreme and distinct.

Once a drug is approved to treat one condition, it is legal for doctors to prescribe the drug for other uses. These unapproved uses are referred to as "off-label," and can mean prescribing a drug for a longer duration than specified, at a different dose, in combination with other drugs, or with a different patient population than listed on the label.


In reality, the atypicals entered the market with significant warnings and are evolving a side effect profile that includes serious and life threatening conditions in an alarming number of patients. In fact, the FDA data established that one in every 145 persons enrolled in clinical trials for these drugs died as a result of adverse reactions to the drugs.

Independent researcher Dr. David Healy studied FDA raw data on the atypical schizophrenia drug Zyprexa and concluded that it was among “the deadliest drugs ever to gain FDA approval."

The FDA has issued an advisory about an increase of 70% in sudden death in the demented elderly, and about a 70% increase in death in persons over 60 on atypical antipsychotics.


The Food and Drug Administration has determined that the treatment of behavioural disorders in elderly patients with dementia with atypical (second generation) antipsychotic medications is associated with increased mortality. Of a total of seventeen placebo controlled trials performed with olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), or quetiapine (Seroquel) in elderly demented patients with behavioural disorders, fifteen showed numerical increases in mortality in the drug-treated group compared to the placebo-treated patients. These studies enrolled a total of 5106 patients, and several analyses have demonstrated an approximately 1.6-1.7 fold increase in mortality in these studies. Examination of the specific causes of these deaths revealed that most were either due to heart related events (e.g., heart failure, sudden death) or infections (mostly pneumonia). Date created: April 11 2005.


The US FDA was already aware of the death rates in clinical trials where 1 in every 145 clinical trial subjects died.

# In the face of Eli Lilly failing to record suicide attempts, US Zyprexa Product Information discloses that 67 persons out of 3,100 took overdoses of Zyprexa and only one died. Eli Lilly argues the drug is safe, because it is safe in overdose. Only 1 in 67 died. A toxicologist's view would be appreciated here.

3100 was number of subjects left in five trials presented to the US FDA after two thirds had dropped out in less than six weeks, for reasons that were never disclosed. One of the trials left was declared useless by the US FDA, but it is used by Eli Lilly to produce information about the 20 deaths See www.lillytrials.com

zyprexa _summary_2551.pdf

These original clinical trials which got Zyprexa licensed have now been merged with hundreds of others on the Eli Lilly website.

This product information does not disclose the causes of the overdosing, so they could represent suicide attempts, akathisia or delirious confusion.

For Dr. Grace Jackson's summary of these trials, dropouts, suicides, FDA reviewer comments (but not eight undisclosed deaths) see http://psychrights.org/states/Alaska/CaseOne/30-Day/ExhibitD-Olanzapine.htm

And a second current case in Alaska was settled in March 2008.

While it seems to be about diabetes, it is fluctuations in blood sugar that contribute to delirium and cause exacerbations of hallucinosis and 'schizophrenic reactions'. http://psychrights.org/States/Massachusetts/071006PsychRightsMassStrategyMemo.pdf

Fluctuating blood sugar levels cause untoward behaviours. Perhaps more so when combined with metabolites of Zyprexa and most if the drug in not able to be metabolised so causes high blood levels, for genetic reasons, all unrecognised.

The Montana case, alleging various forms of fraud in the clinical trials that got the drug licensed and in its later promotion, has been now joined by nine State Attorneys General.




Concerns about safety and side effects are available at this infrequently accessed site: http://www.fda.gov/medwatch/SAFETY/2004/zyprexa_PI.pdf

Zyprexa product information contains this:

Body as a Whole — Frequent: dental pain and flu syndrome; Infrequent: abdomen enlarged, chills, face edema, intentional injury, malaise, moniliasis, neck pain, neck rigidity, pelvic pain, photosensitivity reaction, and suicide attempt;

Rare: chills and fever, hangover effect, and sudden death.

'Frequent' in drug company trial jargon is 1 in 10.

'Infrequent' lies somewhere between 1 in 10 and 1 in 500

Suicide attempt is described as 'infrequent but none were ever disclosed. According to David Healy, this data simply does not exist. (Personal communication from Healy, who has examined the archive.)

'Rare' is 1 in 500. Suicide is 'rare,' but catastrophic! Twelve persons out of the remaining 2500 committed suicide (after two thirds of subjects had dropped out). This is 1 in 208.

Sudden death is also described as 'rare' but there were eight deaths in about 7500 starters.

It would be well nigh impossible to get informed consent for a drug with that profile if safer alternatives were available.

5000 Zyprexa whistleblower documents about what Eli Lilly knew about diabetes and other matters and what they did not disclose are now available at:

Allan Jones, the whistleblower whose testimony underpins litigation by US State Attorneys General, against the Texas Medication Algorithm Project (TMAP) a consortium that produced endorsements, protocols and guidelines, writes:

In reality, the 'atypicals' entered the market with significant warnings and are evolving a side effect profile that includes serious and life threatening conditions in an alarming number of patients. In fact, the Food and Drug Administration (FDA) data established that one of every 145 persons enrolled in clinical trials for these drugs died as a result of adverse reactions to the drugs. See this link





Only five Zyprexa schizophrenia trials were undertaken, but these generated 234 ghost-written articles by prominent “opinion leaders," which were carefully placed in the prestigious journals, dependent for their viability on pharmaceutical Industry advertising. The ghostwritten articles and some algorithms for treatment emerged from the Texas Medication Algorithm Project (TMAP), and their graphics bear a striking resemblance to those on the TMAP website.

None of these publications yielded any picture at all of the risk of suicide or suicidal acts on these drugs, let alone sudden death.

“Endorsement science” has become the means of promotion.

The colourful capsules appeared on the cover of Time, in The Washington Times and The New York Times. The earlier drug company invention, the “Dopamine Theory of Schizophrenia” was alive and well in these endorsements, although by the time they were published it had no more scientific validity than the serotonin theory of depression.


Perhaps we need to laugh:


Did anyone licensing this drug consider how side effects at this rate might play out in the community? Placebo beats it every time.


What these unrecognised side effects would cost the public purse? That is an overdose rate of 2160 per 100,000, which is an awful lot of overdoses given how many persons take olanzapine for the drug to gross to Eli Lilly six billion dollars annually.

But overdose is not the preferred mode of suicide in akathisia, where suicides tend to be violent.



In my study on an admission ward in 2003 and 2004, 161 persons came in suicidal and a further with 40 diagnosed with akathisia and aggression; 44 came in suicidal, with akathisia and/or homicidal on olanzapine but not olanzapine alone. That is a lot of pressure on beds. This is similar to the situation in patients seen for other jurisdictions.

If these drugs behave in the community as they did in clinical trials, a public health problem is the inevitable outcome.

More information is accessed by the following links:





The clinical trials presented to the US FDA were a harbinger of what might be expected if these drugs were released into the community.

In the community no raters familiar with side effects are employed, and drugs are co-prescribed and compete for metabolic pathways, causing a logjam at the liver as toxic metabolites recirculate and cause symptoms.


Public Health Advisories have been published by the US FDA regularly since 2003. These can be accessed by the link:


On March 22, 2004, after a great deal of research, the FDA issued its first Public Health Advisory about antidepressants for adults.

Adults being treated with antidepressant medications, particularly those being treated for depression should be watched closely for worsening of depression and for increased suicidal thinking or behaviour. Close watching may be especially important early in treatment, or when the dose is changed, either increased or decreased. Adults whose symptoms worsen while being treated with antidepressant drugs, including an increase in suicidal thinking or behaviour, should be evaluated by their health care professional.

The agency is also advising that these patients be observed for certain behaviours that are known to be associated with these drugs, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania and mania, and that physicians be particularly vigilant in patients who may have bipolar disorder.


This is not bipolar disorder. Manic shift occurs in persons using antidepressants up to 30 times more often than could in bipolar illness by chance.  It remits when the drug is withdrawn. Manic shift caused by antidepressant or other medication does not respond to remedies for real, endogenous bipolar illness. Unstable moods characterised by brief periods of energy followed by fatigue that ‘ropes you to the bed’, get worse and more and more drugs are co-prescribed to deal with each side effect as if it was the condition it suggested or mimicked.


This condition, legitimated by DSM, appears to be new and iatrogenic.

In psychiatry, organic brain syndrome mimics every disorder, just as neurosyphilis imitated all of them.   

However, a group of antidepressants that have worsening depression and suicidality among their side effects may well explain the need for scores of mood disorder specialists.  If the first three antidepressants tried by the GP did not work, then the fourth to the eighth can be tried then 'augmented' with lithium, atypicals or thyroid supplements, none of which has been shown to be effective.


Moreover one cannot diagnose a ‘manic episode’ within criteria set by DSM or the International Classification of Diseases if the symptoms are not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication, or other treatment) or a general medical condition (e.g. hyperthyroidism).

From DSM IV:

Note: Manic-like episodes that are clearly caused by somatic antidepressant treatment (e.g., medication, electroconvulsive therapy, light therapy) should not count toward a diagnosis of bipolar disorder.

So psychiatry invents a new category, Bipolar 11 for an iatrogenic disorder, a toxic psychosis, and this leads to its treatment by more medicines. 

A list of drugs to be included in updated Public Heath Advisories can be found at:


The problem in Australia is that the Adverse Drug Reactions Advisory Committee (ADRAC) issued a belated and watered down advisory on August 4, 2005, only on its website, but it has not enforced its circulation by the manufacturers to doctors.

The matter of the drug companies failing to disclose lethal side effects may be a matter for the Commonwealth Attorney General. For example, what Eli Lilly knew from 1978 but failed to disclose about its antidepressant Prozac is well documented and can be accessed by the link:

It may be the case that fraud has been committed on the Commonwealth of Australia as it has been on people and prescribers of the United States. Here are some links to that information.




The UK Healthcare Commission, faced with similar problems, called in more relevant experts, pharmacists, who found that 70% of drugs given to mental health patients had been poorly prescribed.

The Commission's report found that when pharmacists reviewed patients' medications, 70 percent of cases resulted in a change in the patient's medication, while 46 percent of patients whose medication was reviewed were found to be taking their doses improperly.

The link to the news item is


It is likely that biology accounts for massive dropout rates in clinical trials for both SSRIs and atypicals.

Up to 75% do not complete the trials. Others have Valium co-prescribed and the public is not told. Statistics about those who could not tolerate drugs do not appear in product information. 

If people cannot metabolise the drug, its level in the rises and adverse events follow. Some people do not get nausea, a useful early warning, but quickly develop akathisia and psychosis. Such people might reject their medication at home, but in hospital, one finds nurses and doctors who urge patients to keep taking medicines – which, they should realise, are making the patient sick.

Not all cytochromes can be induced. Some can be induced, but it does not happen overnight.

If a person does not have the cytochromes to break down drugs, its metabolites build up, and recirculate and produce a traffic jam at the liver. 

That’s why, when prescribing an SSRI or one of the many other drugs, which are similarly metabolised, you ‘start low – go slow’. Then ‘tolerance’ has a chance to develop and the drug is better tolerated, and it might be more usefully used with impunity. Toxins slowly ‘induce’ the enzymes that metabolise them, and in time the liver is able to deal with higher doses. See the detailed answer that has been provided to the question “Are there any antidepressive medications that can be used by a poor metabolizer of the P-450 drugs?” (Link below). For example, it’s stated:

There is no reason why antidepressants can't be used in slow metabolizers – you just have to be very, very careful. Beginning with very small doses and measuring blood levels of the drug in question is appropriate. It is also important to avoid co-administration of other drugs metabolised by the same CYP enzyme. 


Many non-metabolisers can be identified through taking a good medication history, starting low, adjusting the dose slowly, watching and warning and, if necessary, not giving the same or similarly metabolised drugs again.



Litigation on the basis of being a non-metaboliser would be settled by the drug company, as all of them have failed to warn of this vulnerable population. As Eli Lilly failed to disclose information they had about Zyprexa/olanzapine.


6 US states have sued Janssen regarding Risperdal: Arkansas, Louisiana, Montana, South Carolina, Texas and Pennsylvania.

3 US states have sued Austrazeneca regarding Seroquel: Montana, Pennsylvania, South Carolina

At least 8 US states have sued TMAP over anti-depressants and antipsychotics and some ADHD medications.

Nine US States have sued Eli Lilly regarding Zyprexa - Alaska, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah and West Virginia.

The State of Connecticut has filed a detailed statement of claim against Eli Lilly for various forms of fraud in relation to the promotion of Zyprexa.


According to the Connecticut complaint and in my own knowledge and experience in Australia as well as in the United States, Eli Lilly's illegal marketing enterprises and schemes included the following:

PEER-SELLING ENTERPRISE: Lilly compensated medical marketing firms and several physicians who routinely promoted Zyprexa to peer physicians in venues nationwide. Physicians who attended "educational" events were deceived into thinking that the events were independent of Eli Lilly. Conspiring physicians concealed information about the efficacy of Zyprexa in off-label uses and dangerous side effects, as well as the doctors' financial ties with Eli Lilly.


PUBLICATION ENTERPRISE: Eli Lilly created a "Publication Enterprise" that hired writers to create articles, and then paid specialists to "author" the articles. The articles only included favorable results of Eli Lilly's own internal trials, and suppressed unfavorable results, including a clinical trial that failed to show Zyprexa's efficacy for bipolar disorder.

PUBLIC PAYER ENTERPRISE: Eli Lilly targeted those who oversaw treatment for people with serious mental illness, including patients in mental hospitals and clinics who are on Medicaid - among the largest users of antipsychotic drugs. Lilly also influenced prescribing physicians to over-medicate senior citizens in nursing homes and adolescents in detention centers with antipsychotic.

View the entire Lilly complaint from Connecticut


And see how Lilly promoted in Australia and by whom and for a general idea of the level of support given to various researchers. 



The drug companies get away with it in Australia and psychiatrists (through peer reviews) help them.

Similar litigation about can be found at



Many drugs cross into the brain and have psychiatric effects, which are often undesirable ones. One undesirable outcome might occur in the treatment of genuine mental illness, when the patient becomes toxic on medication, the doctor fails to recognise.

Genuine mental illness, such as bipolar disorder, biological depression or schizophrenia, might have been present in the patient before taking the medication. But that medication might have had hallucinations, mania, delusions or schizophreniform reaction among its side effects. And in the case of risperidone, 6 manic reactions on placebo and 8 on active substance.  And this drug is licensed to treat mania?  It increases the risk of it. See old Risperdal Product information:

Table 2. Incidence of Treatment-Emergent Adverse Events in a 3-Week, Placebo-Controlled Trial - Monotherapy in Bipolar Mania Body System/ RISPERDAL® Placebo Preferred Term (N=134) (N=125)

Central & peripheral nervous system


























Manic reaction






Concentration impaired



This information has been eliminated from the latest PI.  Akathisia is eliminated altogether in the latest version.


It is necessary to investigate the original diagnosis and question whether these disorders were not present before medication was started. If the disorders weren’t present, then the patient is very likely to be misdiagnosed and that patient may well be part of the new, second 50% of the treatment-seeking population.


There must be causes for an epidemic of mental illness to come about. First the drugs do not work in a lot of people, and second their side effects are being misdiagnosed as mental illness and they are given more drugs that do not work. This problem has a number of starting points.

    1. A hallucination has been caused by a street drug: strong cannabis, speed or another.
    2. The initial 'psychiatric' symptom is a side effect of a non-psychiatric medication such as an anti-emetic, calcium channel blocker, antimalarial, antihistamine, conjugated oestrogen, triptan, Tramadol, or any one of five hundred drugs listed as causing psychiatric side effects or Serotonin Syndrome in some people.  Serotonin Syndrome causes confusion, delirium with hallucinations, mania, depression or an organic schizophreniform disorder.
    3. These might not be recognised as side effects and so they are treated with an atypical antipsychotic or an antidepressant that has the same psychiatric symptoms among its reported side effects. 
    4. New generation or 'SSRI' antidepressants prescribed for stress, grief, girlfriend trouble, menopause and anxiety, any human events, boyfriend trouble, and they cause some people to become suicidal, hallucinated and aggressive. This side effect is mistaken for depression, mania, schizophrenia, or if it persists, for borderline personalty disorder.
    5. A patient on antidepressants or atypical antipsychotics becomes manic and is then gets diagnosed as bipolar. But as this is neurotoxic, it does not respond to the remedies for true bipolar, so they do not recover.
    6. A depressed patient gets worse, hallucinated or suicidal, so is prescribed more medication.
    7. Patients with schizotypal personality disorder (which affects 3% of the population) are at risk of being misdiagnosed as schizophrenic. They may then be medicated with drugs that induce schizophreniform symptoms, delusions and hallucinations and they then are sometimes forcibly medicated with more psychiatric medication. They are given new schizophrenia medicines, one or more of Zyprexa, Risperdal or Seroquel, in series or in parallel, and no one improves. This is because one is treating not schizophrenia but a toxic mimic of schizophrenia and treating a side effect with another similar toxin, which cannot be easily metabolised.
    8. Then more medications are added, different ones in each case.
    9. Drugs marketed as 'mood stabilisers' that have no such effect, more antidepressants, more antipsychotics, sleeping pills, sedatives, benzodiazepines as well as antiemetics for nausea, remedies for diarrhoea and antihypertensives for high blood pressure. Mood stabilisers are added to mood de-stabilisers and new disorders emerge from that.
    10. A list of drugs that inhibit CYP450 2D6 includes amphetamines.  Poor tolerance of amphetamines suggests that a person might be a poor or intermediate metaboliser and is at risk of responding adversely to other meds that require 2D6 and even more adversely when they are drugs (or are combined with drugs) that inhibit 2D6 because they effectively turn intermediated metabolisers into poor metabolisers.  Similarly if a person had already responded poorly to drugs that require 2D6, it seems not to be a good idea to give them other drugs that require the same metabolic pathway, singly or in combination. 2D6 is a non-inducible enzyme, which is virtually absent in 8% of Caucasian and there is a 100% variance between individuals in the same population, in that some are ultrarapid metabolisers.  This is all in MIMS ANNUAL but not in what drug reps pass out.  So it is not the doctors' fault and patient in USA sue the drug company successfully for failing to reveal this information, which they had in their possession forever. They fail to reveal it for commercial reasons and these problems are now coming home to roost in the form of litigation by state attorneys and individuals as well as class actions.   

As the rate of bipolar rose in USA and Australia, the DSM invented more catef gories to deal with this new epidemic without losing patients.

A century ago, rapid-cycling bipolar disorder was not observed. Either classic nosologists, such as Kraepelin, simply missed it or it did not exist. The term was first coined in the 1970s to identify lithium nonresponders in randomized clinical trials; thereafter, rapid cycling became the subject of decades of further research, which has confirmed that rapid cycling is a factor in poor prognosis. Rapid-cycling patients do worse in follow-up than patients without rapid cycling, and they are also less likely to respond to treatment. The erroneous impression then arose that anticonvulsants, such as carbamazepine or divalproex, were more effective than lithium in treating rapid cycling. The error came from comparing studies using lithium alone against studies using anticonvulsants alone, without a direct comparison of the two treatments. Such comparisons need to be made head to head, in randomized studies. When these comparisons are performed with proper methods, anticonvulsants are seen to be about equivalent to lithium (i.e., ineffective) in treating rapid cycling (1, 2).


In bipolar disorder, one often has to wonder if it is medication-induced bipolar that is causing the problems, because the condition simply does not get better.

But aside from these hazards, there are also grounds to question whether the treatment effects that some think have been demonstrated in bipolar disorder trials translate into therapeutic efficacy.

If use of these agents based on demonstrated effects leads on to efficacy, admissions for bipolar disorder might be expected to fall, but the evidence for this is difficult to find.

In North Wales before the advent of modern pharmacotherapy, patients with bipolar I disorder had on average four admissions every ten years. In contrast, against a background of a constant incidence of bipolar I disorder, and dramatic improvements in service provision, bipolar I patients show a 4-fold increase in the prevalence of admissions despite being treated with the very latest psychotropic medications. This is not ordinarily what happens when treatments “work,” but quite often is what happens when treatments have effects.




Sedatives, benzodiazepines may be added to the mix, as well as sleeping pills, in the face of product information that antidepressants enhance and prolong their sedative and confusional effects

Benzodiazepines. The half-life of concurrently administered diazepam may be prolonged in some patients ...Co-administration of alprazolam and fluoxetine has resulted in increased alprazolam plasma concentrations and in further psychomotor performance decrement due to increased alprazolam levels.

Then second and third 'antipsychotics' are administered, so by the time they come into hospital they are taking between one and five drugs.

By then they're also on medications for nausea and diarrhoea, Stemetil and Losec, both of which have interactions with what is already present.

Each drug was prescribed as an antidote to a side effect. All put stress on the CYP450 metabolic pathways. This is all in MIMS Annual, but not honoured in the observance. A first-rate tutorial and charts can be found at www.genelex.com

Good history taking will reveal whaUsing 'patient exposure years' and combining suicides in withdrawal from drugs in use, Khan reported a rate 752 per 100,000 persons for those treated with atypical antipsychotics--risperidone, olanzapine, and quetiapine; Among 10,118 participating patients, in antipsychotic trials presented to the US FDA 26 committed suicide and 51 attempted suicide.

Using similar criteria he examined Food and Drug Administration (FDA) summary reports of the controlled clinical trials for nine modern FDA-approved antidepressants provided data for comparing rates of suicide and found that of 48,277 depressed patients participating in the trials, 77 committed suicide.

This was a rate 718 per 100, 000 persons for those treated with selective serotonin reuptake inhibitors;

Khan also reported a suicide attempt rate of 4% in clinical trial subjects of antidepressants after 10-week trials.  He noted that suicidal persons and those carrying suicide risk had not been allowed to become clinical trial subjects.  These drugs were targeted at lesser 'ills,' stress, unhappiness and social anxiety and clinical trial subjects had those conditions and had become suicidal on use and after use, in withdrawal and in the year following. 

This is 4000 per 1000,000, an enormous rate, with enormous public health consequences.

Some are left with neuroleptic-induced deficit syndrome (NIDS) and may be permanently damaged.




Completed suicide is the measurable tip of poorly recognised psychotropic side effects, which have been systematically and deliberately discounted as ‘the patients’ problems’. Pharmaceutical companies lose no opportunity to belittle David Healy, who was able through court orders to prise clinical trial statistics out of the FDA, and Peter Breggin, who was the first to bring to public notice the risks of new antidepressants and other medicines used for psychiatric purposes.

Breggin defined a stimulant continuum beginning with lesser degrees of insomnia, nervousness, anxiety, hyperactivity and irritability, which progresses toward more severe agitation, restlessness, aggression and varying degrees of mania. Mania or manic-like symptoms include disinhibition, grandiosity; sleep disturbances and out-of-control aggressive behaviour. The patients cycle into depression and suicidality. They can produce a combined state of stimulation and depression, an agitated depression, with a high risk of suicide and violence. Panic and anxiety are common.


Obsessive preoccupations with aggression, against self or others, are often accompanied by a worsening of any pre-existing depression. Depression and suicidality may appear in persons treated for anxiety or other disorders. A state similar to personality disorder with borderline traits may appear in mature, formerly stable persons. Its extreme results from a combination with alcohol and substance abuse, in what seems to be an attempt to relieve the ‘living hell’ that the worst and most dangerous side effect, akathisia, creates.

Akathisia may present as a diffuse psychomotor restlessness, which affects the patient’s entire body, an increased tenseness, insomnia and a feeling of being very uncomfortable, frequently verbalised, as "I don’t feel like myself, weird, strange, not me." Patients feel they are going mad, in turmoil, and numb as if nothing matters. Embarrassed, they do not confess their impulses. Eliciting them needs careful questioning. These experiences can go on for hours or years, or can be acted on very quickly, in a matter of minutes.

I repeat:

Acute akathisia is a psychiatric emergency. Recurrent episodes of hallucinatory delirium along violent or sexual themes with colourful visual, voice and tactile hallucinations may be misdiagnosed as a schizophrenic illness. Sexual craving has been reported.

Akathisia has a strong association with violence, self-harm, suicide and homicide. It is an inner restlessness or jitteriness, accompanied by a subjective as well as objective compulsion to move, abscond, pace or run, or drive long distances in a somewhat dissociated state. Akathisia can lead to suicide because it is intolerable. Intense and involuntary preoccupation with unwelcome, obsessively violent thoughts is pathognomonic.

A pathognomonic sign or symptoms is a particular sign whose presence means, beyond any doubt, that a particular disease is present. It is derived from the Greek páthos (πάθος, disease) and gnōmon (γνώμον, "judge"). Labelling a sign or symptom "pathognomonic" represents a marked intensification of a "diagnostic" sign or symptom.

First recognised in users of reserpine for high blood pressure, akathisia and suicide became prominent in the forensic literature of the 1970s and 1980s as an effect of haloperidol and, later, of flupenthixol.

The above syndromes often appear in combination with each other. They may recede within days of stopping the medication or persist, requiring hospitalisation and additional treatment over subsequent weeks or months. They occur in individuals with no prior history of violence, suicidality, psychomotor agitation or manic-like symptoms. Some patients cannot easily stop taking these medicines without going into a state of withdrawal. They are, technically, addicted.

No single word describes the problem. Dr. Ken Gillman proposes 'toxidrome'.


My preference is for ‘neurotoxicity spectrum disorder’ to describe the manifestations of intoxication with medications said to have serotonergic and/or dopaminergic properties.

Professor Perminder Sachdev has proposed a classification of one of these, akathisia.


Since 1994, SSRI-induced akathisia has been recognised in the Diagnostic and Statistical Manual (DSM IV TR), where it is coded as a movement disorder, but it fits equally well into drug-induced psychotic states or with organic brain syndromes.

A useful concept is the “akathisia-prone patient”: one who is likely to develop akathisia on tricyclics, lithium, SSRIs, Zyprexa, Risperdal, Solian and Seroquel (quetiapine) as well as a variety of other medications (often Lipitor and conjugated oestrogens, antihistamines, antiemetics and calcium channel blockers). Akathisia accompanies the taking of the medication but it can also occur if a drug is stopped suddenly rather than slowly. Many suicides and homicides are committed in withdrawal, which can go on for three months in some circumstances.

It should not surprise anyone to find that psychotropic drugs have psychiatric side effects, but they are poorly recognised as such, even by psychiatrists, because they occur in the context of treatment for ‘psychiatric’ conditions. Sublethal side effects place heavy demands on mental health resources. It is rare to see a person who has been on these medicines for some time who is not also taking co-prescribed tranquillisers of one kind or another.

Suicide is an indicator of how neurotoxic a medication is. In February 2008, the FDA undertook to pay attention to suicidality in future clinical trials of all medicines, and not before time.

Descriptions of akathisia abound in medical and legal literature.






In Australian a legal case of akathisia in its acute form (homicidal and suicidal) is well described in R v Hawkins Supreme Court of NSW 2001. The link is:


Akathisia in its chronic form (also homicidal and suicidal) is well described in R v B Supreme Court of WA 2004, in the sentencing judgement in R v B SCWA 67 of 2004.

Richard Guilliatt reported on "B" in the Sydney Morning Herald’s Good Weekend on May 19, 2004:


A search for akathisia through Austlii, (the legal database) repeated using ‘law’ through Google, throws up literally hundreds of well-described cases through the links below


Rebekah Beddoe’s story as told in her book ‘Dying for a Cure’ has already been detailed.  Ms Beddoe discovered on the Internet how to slowly withdraw herself from the medicines and she did so. She had endured many hospitalisations and had developed diabetes on Zyprexa/olanzapine, a Special Purpose medication licensed for schizophrenia alone.

She did not have schizophrenia at all. She had side effects, which disappeared when she stopped the antidepressant and all that had been prescribed with it.

TIME MAGAZINE published her story. That article is reproduced in full on one of the many patient chat rooms, which brought the drug companies to their knees:



If Rebekh Beddoe's response to Zoloft only happened in 1-3% of users, then SSRI side effects are already presenting the taxpayer with a serious economic problem. In some studies, suicidal thinking and behaviours on "SSRIs" have been noted at a rate of 27%.

In common among the many patients who comprise the increased numbers of those seeking mental health care since 1992 is that they did not have mental illness before they were given medication, which caused side effects including suicidality, akathisia, aggression and hallucinations.

The Royal Australian and New Zealand College of Psychiatrists (RANZCP) Clinical Practice Guidelines advocate the use of Efexor/venlafaxine, stating

'Depression is common. In the Australian Mental Health Survey, 4% of adults had a depressive disorder in the past month.'

These guidelines can be accessed at the link below:


The RANZCP recommend the use of Efexor/venlafaxine for such conditions. People taking venlafaxine committed suicide at six times the rate of those taking a placebo in the same trials. Each completed suicide represents 20-40 attempts, some of which require hospital admission. Efexor is as toxic as older antidepressants in overdose. This study suggests that these drugs do more harm than good. The RANZCP should arrange urgently for a pharmacologist and pharmacogeneticist to look over its recommendations for treatment, as the epidemic spread and intractability of depression demonstrates that there is something wrong.

Product information, from the United States. on Effexor contains the following side effects:

Nervous system - Frequent: amnesia, confusion, depersonalization, hypesthesia, thinking abnormal, trismus, vertigo;

Infrequent: akathisia, apathy, ataxia, circumoral paresthesia, CNS stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, manic reaction, myoclonus, neuralgia, neuropathy, psychosis, seizure, abnormal speech, stupor, suicidal ideation;

Rare: abnormal/changed behavior, adjustment disorder, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, feeling drunk, loss of consciousness, delusions, dementia, dystonia, energy increased, facial paralysis, abnormal gait, Guillain-Barre Syndrome, homicidal ideation, hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, libido increased, motion sickness, neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes decreased, reflexes increased, torticollis.

And if you examine for them you will find them.  Hence many homicides and mass homicides have occurred on Efexor.


When challenged after the Hawkins case was decided (see earlier), this is what Professor Ellis wrote:

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 review. Patients should be advised to seek medical attention as soon as possible if they develop agitation or restlessness, or if their depression worsens.

Reports of aggressive and suicidal behaviour with SSRIs investigated. Behaviour change may be due to SSRI-induced akathisia. Agitation or harmful behaviour signals need to review both patient and treatment immediately.

Informing patients to seek help may help reduce adverse outcomes.


Those who attract pharmacological treatment under these guidelines would mostly be ordinary people suffering normal human emotions that have been relabelled as ‘depression'.

Campaigns to treat depression have been so successful that there are now nearly a million Australians, 200,000 of them children, taking antidepressants, and many others have tried them. When the guidelines were criticised, Professor Hickie told us: 'The guideline for the treatment of depression makes sound recommendations, in agreement with comparable guidelines from the US and the UK.'

All had a common source, the Texas Medication Algorithm Project, TMAP, now subject to fraud litigation, where drug companies had taken over creating and writing guidelines.



I made 190 reports to the Adverse Drug Reactions Committee (ADRAC) from one inpatient unit and from 12 related (through treaters) medicolegal reports during 2003 and 2004. I have since made a further 300 approximately from my compensation and criminal jurisdiction practice.

65 of the patients were taking Efexor/venlafaxine, which has suicidal thinking and acts as well as homicidal ideation among its listed side effects. Other drugs which were not available before 1992 were also well represented. A surprise was the number of times that an older injectable drug, Clopixol, which was not ever used on its own, caused homicidal ideation and violence. However this number is meaningless without knowing how many persons in that community were getting it.

The Department of Health refused to acknowledge that a public health problem existed.


26 patients on various new drugs had made homicidal attacks. There are now five suicides in this series. I warned in writing of dangerous prescribing in 17 cases, and my warnings were inevitably followed by 'SSRI events', suicide attempts or violence.

Sweden acknowledges, investigates and reports this problem.


Australian coroners use toxicologists as experts and most lack the education and training to identify and investigate the issue of suicide induction so the Minister is simply not told how bad the problem is in Australia.

In many cases, an "SSRI" generation antidepressant had been prescribed and the patient had become suicidal, hallucinated and aggressive. The patient’s condition was then mistakenly diagnosed as schizophrenia. All were given new schizophrenia medicines, one or more of Zyprexa, Risperdal or Seroquel, in series or in parallel, and not one improved. Then more medications were added, different ones in each case: ‘mood stabilisers', sedatives, sleeping pills and second and third antipsychotics

Sometimes this march into chronic psychiatric invalidity had started with a hallucination caused by a non-psychiatric medication or street drug, which was treated with another toxic atypical antipsychotic.

Such patients made up about a third of admissions in one region, but at least half of the workload, as they presented many times before being recognised, one more than 30 times. They recovered when the causal medicines were withdrawn, but some did eventually commit suicide.

Some worked it out for themselves and stopped taking pills. Many were discharged on the same medicines as had caused their admissions, and some on increased doses with disastrous results.

Imagine this:

Panopticure is launched, a new drug for Glaucoma, a serious eye condition which, untreated, causes blindness.

Learned professors, all over the world, publish strikingly similar papers to the effect that the prevalence of Glaucoma, and its dire consequences, has all been seriously underestimated. And that Glaucoma is serious, treatable and affects four percent of the population every month.

Panopticure and its copycats boom.

And in Australia alone, some ten years later, it is not 100,000 patients under treatment for Glaucoma, but a million.

Drug representatives tout Panopticure for sore eyes, blurred vision, myopia, presbyopia, or simply to induce clear vision.

Reports should start appearing in the literature that some users go blind – but they are ignored. We are repeatedly reassured: It’s the disease, not the drug, doctor.

In the United States, litigators access drug company data, and find that clinical trials had shown that some people being treated for sore eyes went blind on Panopticure.

They find the maker paid off officials of the US Food and Drug Administration and the Office of Drug Safety did not examine clinical trial data that had not been put in front of them.

The Bush Administration stifled Federal investigations into how this had occurred.

Panopticure paid out millions in compensation as evidence was good and passed 6 Daubert hearings. The maker knew that in clinical trials one in 250 became permanently blind and many partially so. And this was after six week trials from which two thirds of participants dropped out. They did not tell us why they could not take the drops for six weeks. Panopticure appeared on the front cover of American TIME MAGAZINE.

Ten years after the introduction of Panopticure, the Department of health told us that the number of persons on blind pensions had increased by 100%.

And by a further 25% in the next four years.

You would think that there would be an outcry – and that ophthalmologists collectively would be angry at being duped.

But psychiatrists do not seem to have the same concern or remain unaware of why they need more resources.

Few would believe these to be the intrinsic risks of transiently raised ocular pressure.

That 4% of us experience in each month.

Yet this is the composite tale of the drugs launched by the TEXAS MEDICATION ALGORITHM PROJECT. George Bush was Governor of Texas.

RISPERDAL, ZYPREXA, (Eli Lilly) SEROQUEL, LEXAPRO, (Novartis) CIPRAMIL, (Novartis) ZOLOFT, AVANZA, ZYBAN, SERZONE, EFEXOR (Wyeth) and PROZAC. These are called the ‘serotonin drugs’ as all boost serotonin.

Their names are the product of market research. TMAP’s ghostwriters influenced RANZCP guidelines to depression, to schizophrenia, which are much the same those used in beyondblue and its subtended GP eduction programs. These guidelines tell us how to treat depression with new miracle drugs. And how to treat their side effects, their complications with atypical antipsychotics.

The Ghostwriters are (this information comes from David Healy)

Current Medical Directions http://www.cmdny.com

Whose remit is

“to deliver scientifically accurate information strategically developed for specific target audiences”

CMD writes up studies, review articles, abstracts, journal supplements, product monographs, expert commentaries and textbook chapters.  It conducts meta-analyses, and organizes journal supplements, satellite symposia, and consensus conferences as well as advisory boards for its clients

 [CMD] “strives to exceed the expectations of our clients and to assist them in achieving their strategic objectives”.

Australia is lagging behind the rest of the world in addressing a problem first reported in the 1980s.

This is because (unlike its counterparts in Canada, the UK and the USA) the various instrumentalities of the NSW Department of Health (Area Health Services, the Health Care Complaints Commission) rely on peers and collective opinion (consensus gentium, i.e of the people) of the RANZCP rather than on research and cutting edge information when they issue guidance and advisories to practitioners.

The NSW Department of Health relied on the collective opinion of the Royal Australian and New Zealand College of Psychiatrists and did not pass on the FDA Public Health Advisory: Worsening Depression and Suicidality in Patients Being Treated With Antidepressants. March 22, 2004


The College spokesman, Dr. Bill Lyndon, responded to US FDA advisories in The Australian on 24 March 2004, saying

'We are not convinced.'

And later

But we also need to be careful not to throw out very important drugs that save a lot of lives on the basis of as yet unsubstantiated claims or unproven claims.

The claims that new antidepressants caused suicides at least double placebo were very well substantiated by March 24, 2004. In June 2005, the US FDA conceded legal causation.




October 4, 2002, Ronald W. M. MARIS PhD, Distinguished Professor Emeritus, Maris@sc.edu, 803-777-6870, www.suicideexpert.com

ABSTRACT: This paper critically examines several methodological issues growing largely out of Daubert, pertinent to the question of whether or not SSRI medications can be said scientifically to cause suicide ideation, suicide attempts, and/or completed suicide.


Background: There has been a long-standing controversy about the possibility that selective serotonin reuptake inhibitor (SSRI) antidepressants might induce suicidality in some patients.

Methods: Starting from the clinical studies that gave rise to this issue, this paper reviews an unselected cohort of randomised clinical trials (RCTs), a series of meta-analyses undertaken to investigate aspects of the problem, studies in recurrent brief depressive disorders, epidemiological studies and healthy volunteer studies using SSRIs to shed light on this issue.

Results: The original clinical studies produced evidence of a dose-dependent link, present on a challenge, de-challenge and rechallenge basis, between SSRIs and both agitation and suicidality. Meta-analyses of RCTs conducted around this time indicate that SSRIs may reduce suicidal ideation in some patients. These same RCTs, however, yield an excess of suicides and suicide attempts on active treatments compared with placebos. This excess also appears in the best-controlled epidemiological studies. Finally, healthy volunteer studies give indications that SSRIs may induce agitation and suicidality in some individuals.

Conclusions: The data reviewed here, which indicate a possible doubling of the relative risk of both suicides and suicide attempts on SSRIs compared with older antidepressants or non-treatment, make it difficult to sustain a null hypothesis, i.e. that SSRIs do not cause problems in some individuals to whom they are given. 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.



There is no evidence that antidepressants save lives or reduce suicide in users.

The ADRAC Advisory of August 4, 2005, states

Increased prescribing of antidepressants in Australia during 1991-2000 was associated with decreasing suicide rates, with the trend being most apparent in older age groups.

ADRAC cites Hall WD, Mant A, Mitchell PB, Rendle VA, Hickie IB, McManus P. Association between antidepressant prescribing and suicide in Australia, 1991-2000: trend analysis. BMJ 2003;326:1008-1.


However, the cited paper does not contain any such suggestion.

Suicide rates in older age groups had been falling for some years, with improved social services. Professor Hickie has often repeated what ADRAC reported. The conclusion of the paper actually states:

Results: While overall national rates of suicide did not fall significantly, incidence decreased in older men and women and increased in younger adults.



“I would like to be quite blunt about it.  From the large evidence base that we have there is not systematic evidence of over-prescribing in Australia.  There is also clear cut evidence that increased treatments for depression in Australia has resulted in decreased suicides in Australia. So, more people treated, medicine, psychological counselling, support – less dead people.”

Older antidepressants saved lives only in a small high-risk population of persons with melancholic 'hospital' or 'biological' depression where the antidepressants could be carefully administered and monitored.

The pharmaceutical industry rewards opinion leaders who promote their drugs, as described by Roy Moynihan in his acclaimed book, Selling Sickness.


The pharmaceutical industry is allowed to help with mental heath planning. Persons with benefits from the industry advise on mental health policy.

The NSW Health Care Complaints Commission is the only body available in the state to consider treatment complaints, and it similarly relies on peers of the prescribers, who are likely have the same knowledge deficits as those who are the subject of treatment complaints.

The HCCC was set up in 1993, in the wake of the Chelmsford Royal Commission (1988-90) to ensure that malpractice of such magnitude could not recur. 26 deaths and suicides were occasioned by the pharmacological treatment delivered by the late Dr Harry Bailey, Director from 1963 to 1979 of the Neuropsychiatric Institute and later the Chelmsford Private Hospital, a private psychiatric institution in Sydney.

It is somewhat ironic that reports of more preventable deaths and suicides than Bailey ever caused in the same time frame have been investigated and dismissed in a cavalier fashion by the Medical Board of NSW. Its anonymous 'peer reviewers' find nothing suspicious about a similar series of events, suicide attempts and suicide deaths, a bleeding death when my tragic and alarming series was reported.

The cause, with Bailey's Chelmsford patients as well as those in the present time, was medication-induced akathisia.

Today's medicines produce more akathisia, (Zyprexa 27%) more have more side effects and are given to more people than ever took psychotropic medication in the 1970s. More reports were lodged at the US FDA  about Prozac than about any other drug

http://www.oism.info/en/psychiatric_drugs/harm/fda_report_prozac_side_effects.htm drug in the history of the US FDA.

Further useful links can be found here:


And for fun and good measure, this one:


Think of your own kids when you see how medications are being promoted for other kids.



The following books were reviewed by Quentin Crews in the New York Review of Books

The Loss of Sadness: How Psychiatry Transformed Normal Sorrow into Depressive Disorder by Allan V. Horwitz and Jerome C. Wakefield, Oxford University Press, 287 pp., $29.95

Shyness: How Normal Behavior Became a Sickness by Christopher Lane, Yale University Press, 263 pp., $27.50

Let Them Eat Prozac: The Unhealthy Relationship Between the Pharmaceutical Industry and Depression by David Healy, New York University Press, 351 pp., $18.95 (paper)

See reviews


I commend the Semmelweiss Organization.


Diamond and Kabul's insight that:

“When the evidence conflicts with our judgment we tend to resist it, but when the evidence is consistent with our judgment we tend to embrace it”

This phenomenon is well known to psychologists as confirmation bias.

It was also known to the ancients:

"When a man finds a conclusion agreeable, he accepts it without argument, but when he finds it disagreeable, he will bring against it all the forces of logic and reason." Thucydides

The opposite is accepting good evidence or argument whether it suits us or not i.e. healthy scepticism.

I thank David Healy for coming to Australia in September of 2003.  I listened to him speak about Let them Eat Prozac.

In those two hours, all the organic, peculiar and undiagnosable psychiatric presentations I had been seeing since recommencing work in the public sector in 1997 after a three year break, suddenly made sense.

I had one question to ask. 

"David, has this passed any Daubert Hearings?"* 

Professor Healy told me, "Yes six."

This told me that the causal relationship of antidepressants to suicide was scientifically sound, and that I needed to follow it up. And look at the sublethal side effects all that led to suicide, psychosis, hallucinations death wish, suicidal thinking, akathisia

* The 1993 United States Supreme Court decision in Daubert v. Merrell Dow Pharmaceuticals changed the criteria by which the views of experts are to be admitted as scientific testimony in court.xvi

Daubert was one of a thousand actions, on behalf of infants with abnormalities, against the manufacturer of Bendectin, known in Australia as Debendox, a common morning sickness remedy. The judges allowed evidence from epidemiologists who had found no excess of foetal abnormalities among the progeny of users of the drug. The judges barred from giving evidence to a jury those experts who only pointed out that it was impossible to prove that no causal relationship existed when Bendectin use and foetal abnormality coincided.xvii

The unanimous ruling states that the criterion of the scientific status of a proposition is that is can be tested, particularly by way of a logical process called ‘falsification’. That is, it must be possible to specify a set of circumstances, the occurrence of which, would demonstrate that the proposition is false.

In effect, Daubert replaces the Frye and Bolam tests of ‘expert opinion’, being that which is ‘generally accepted’ by a significant number of authorities in the field, with Karl Popper’s notion of science as ‘knowledge’ which has withstood rigorous testing. This sometimes entails a preliminary assessment, a Daubert Hearing, to decide if the reasoning or methodology underlying the testimony is scientifically valid.

Daubert has not been adopted in Australia where simple plausibility of expertise has held sway, with Adamcikxviii and Abalosxix setting the standard. In each case, the High Court lost an opportunity to comment on the difference between expert evidence within the relevant body of scientific knowledge, and the unsupported opinions of persons who held the status of being, professionally trained, hence  experts. The High Court, on each occasion, confirmed that the judge or jury could choose whichever opinion they preferred.

Scientific method includes putting up a proposition couched in the negative, a null hypothesis, and testing it to see if it can be knocked down. Examples of the null hypothesis are that the prisoner is not guilty and that the unicorn does not exist. In junk science, the null hypothesis is replaced by a positive assertion, one which cannot be proved to be untrue even if it is untrue. One can never prove that a unicorn does not exist, as it might always be just out of sight, so a proposition asserting that a unicorn exists is not a suitable one for a scientific investigation. The presumption of innocence is a null hypothesis, a hallmark of good law as well as good science.

Although I was warned, by persons with experience, of what would happen to me personally if I became involved in this issue, nothing, nothing could prepare me for the Semmelweiss phenomenon, for bland denial by a vast number of my psychiatric colleagues.

Yolande Lucire

[i] Geddes J: Atypical antipsychotics in the treatment of Schizophrenia: a Systematic Overview and Meta-Regression Analysis BMJ.321 (2000)1371-1376

[ii] WhittakerRobert: Mad In America Perseus Publishing 2002.

[iii] Lillytrials.com

[iv] Harris G: Popular Drugs for Dementia Tied to Deaths. The New York Times, April 12, 2005

[v] FDA Public Health Advisory: Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances: http://www.fda.gov/cder/drug/advisory/antipsychotics.htm

[vi] Meltzer HY et al.: Clozapine treatment for suicidality in schizophrenia: International Suicide Prevention Trial [see comment][erratum appears in Arch Gen Psychiatry.2003 Jul;60(7):735]. Archives of General Psychiatry, 2003. 60(1): p. 82-91.

[vii] Details from Professor C. Adams of the Cochrane Centre for Schizophrenia, Leeds, October 2004. Cited by David Healy.

[viii] Merson J: Epistemic Capture: The Science and Politics of Stress-related Illness. PhD thesis UNSW 2004.

[ix] Sachdev, P: Akathisia and Restless Legs. Cambridge University Press. 1996.

[x] Whittaker Robert: Mad In America. Perseus Publishing 2002.

[xi] Philip Burgess, Jane Parkas, Damien Jolly, Harvey Whiteford, Shekhar Sabena (2004) Do nations’ mental health policies, programs and legislation influence their suicide rates? An ecological study of 100 countries 
Australian and New Zealand Journal of Psychiatry 38 (11-12), 933–939 doi:10.1111/j.1440-1614.2004.01484.x

[xii] Press Release: Office of Elliot Spitzer May 13, 2004 http://www.oag.state.ny.us/press/2004/may/may13b_04.html            http://www.centerwatch.com/patient/nmtresults/index.html

[xiii] http://www.fda.gov/cder/approval/index.htm

[xiv] Schulte J: Homicide and suicide associated with akathisia and haloperidol. American Journal of Forensic Psychiatry, 6:3-7, 1985.

[xv] Shear MK: Suicide Associated with Akathisia and Depot Fluphenazine Treatment. Journal of Clinical Psychopharmacology, 1983. 3: p. 235-236.

[xvi] Daubert v. Merrell Dow Pharmaceuticals Inc. 113 Supreme Court of the USA, 2786, June 28, 1993.

[xvii] Foster K.R. & Huber P.W: Judging Science: Scientific Knowledge and the Federal Courts, Cambridge Massachusetts: The MIT Press, 1997.

[xviii] Commissioner for Government Transport v. Adamcik (1961) 106 CLR 292.

[xix] Abalos v. Australian Postal Commission (1990) 171 CLR 167 F.C. 90/44.


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