This comes for the www.genelex.com website

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.

http://www.healthanddna.com/drugchart.html

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.

http://www.psychotropical.com/1_cyp_introduction.shtml
http://www.healthanddna.com/drugchart.html
http://www.lucire.com.au/documents/Cytochromes-paradigmatic.aspx

Again, from TIME MAGAZINE

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.

http://www.lucire.com.au/documents/pdf/HealyWhitaker.pdf

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.

http://psychrights.org/articles/articles.htm

http://en.epochtimes.com/news/7-4-20/54369.html

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.

http://www.mja.com.au/public/issues/179_11_011203/man10667_fm.html

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.

http://www.pharmalot.com

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

www.theaustralian.news.com.au/story/0,25197,23255729-2702,00.html

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

http://www.abc.net.au/am/content/2008/s2169583.htm

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.


22. THE BACKGROUND: WHAT IS HAPPENING IN MENTAL HEALTH IN NSW, IN AUSTRALIA IN THE EARLY TWENTY-FIRST CENTURY?

MORE PATIENTS, MORE SUICIDES, MORE VIOLENCE AND MORE BEDS

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:

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:

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
http://livesworthyoflife.com/uploads/File/Greenland-Dyingshame.pdf

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.
http://caselaw.lawlink.nsw.gov.au/isysquery/irl2742/1/doc

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.
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0030372

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:

http://www.psychrights.org/Articles/EHPPPsychDrugEpidemic(Whitaker).PDF

24. THE AUSTRALIAN EXPERIENCE: CHEAP MEDICINES AND FREE HEALTHCARE AND NO CONTROLS ON PRESCRIBING

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.
http://www.blackwell-synergy.com/doi/abs/10.1111/j.1440-1614.2004.01484.x

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]:

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

http://www.fda.gov/OHRMS/DOCKETS/AC/06/briefing/2006-4272b1-01-FDA.pdf

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.
http://www.fda.gov/cder/drug/antidepressants/antidepressants_MG_2007.pdf

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 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.
http://amwac.health.nsw.gov.au/pubs/2005/track_trag_06.html

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

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1440-1614.2004.01484.x

http://amwac.health.nsw.gov.au/pubs/2005/track_trag_06.html

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

25. CHILDREN
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

http://www.google.com.au/search?hl=en&q=mental+health+beds+NSW&btnG=Google+Search&meta

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.
http://www.fda.gov/cder/drug/antidepressants/historical.htm

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:
http://parliament.nsw.gov.au/prod/la/latabdoc.nsf/0/9F8D48CCE0DBB525CA25737E003C1E60

Or for former reports
http://www.google.com.au/search?hl=en&q=Tracking+tragedy&btnG=Google+Search&meta

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.
http://psychrights.org/Research/Legal/Evidence/MarisonSSRIsUnderDaubert.htm

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

For the sources of this data:

http://www.ahrp.org/risks/healy/FDA0204.php
http://www.healyprozac.com/EditorsDilemma/Psychotherapy_Psychosomatics.pdf

And is the craze over now?
http://www.guardian.co.uk/society/2008/feb/27/mentalhealth.health1?gusrc=rss&feed=worldnews

26. WHY IS EVIDENCE FROM CLINICAL TRIALS SO IMPORTANT?

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.

27. LITIGATION IN USA – ASK ELI LILLY TMAP
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.

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.
http://www.fda.gov/MedWatch/SAFETY/2004/Paxil_hcp.pdf

And what GSK did not disclose is now available:
http://www.gsk.com/media/paroxetine/adult_hcp_letter.pdf

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.

http://www.newscientist.com/channel/health/mg19726424.600-did-gsk-trial-data-mask-paxil-suicide-risk.html

See Dr. Glenmullen's report at:

http://media.newscientist.com/data/images/ns/av/mg19726424600D1.pdf
http://www.bmj.com/cgi/content/full/333/7558/92

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 purposes^xiii.

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).

28. WHERE DOES FRAUD START?
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. Sincerely, Nancy L Durst, MD Vice President New Products Marketing Michael Dazenski, R.Ph Product Manager New Products Marketing

Marketing Concepts SUGGESTED CLASS NAMES FOR EFFEXOR™ (VENLAFAXINE HCI) 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? a)__________ b)__________ c)_________

29. WHAT DO THESE FINDINGS MEAN?
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:

The complete paper can be accessed at:
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050045#journal-pmed-0050045-g001

http://www.ahrp.org/risks/healy/FDA0204.php

http://www.ahrp.org/risks/healy/FDA0204.php


30. ATYPICAL ANTIPSYCHOTICS

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.
http://www.nisu.flinders.edu.au/pubs/bulletin23/bulletin23-3.html

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.

Drug Patient No. Suicides Suicidal Acts Risperdal 2607 9 43 Comparator 601 1 5 Placebo 195 0 1 Zyprexa 2500 12 Not disclosed  Comparator 810 1 (2) Not disclosed Placebo 236 0 (1) Not disclosed Seroquel 2523 1 4 Comparator 426 0 2 Placebo 206 0 0 Sertindole 2194 5 20 Comparator 632 0 2 Placebo 290 0 1 Geodon/zisapride 2993 6 Not disclosed Comparator 951 Not disclosed Not disclosed Placebo 424 0 Not disclosed

31. ZYPREXA

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.

http://en.wikipedia.org/wiki/David_Healy_(psychiatrist)

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

http://www.tehachapinews.com/home/Blog/ZyprexaNews/17408

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."
http://www.fda.gov/cder/foi/label/2004/20592se1-019_zyprexa_lbl.pdf

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.

http://www.fda.gov/cder/drug/advisory/antipsychotics.htm

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_917.pdf
zyprexa_summary_978.pdf
zyprexa_summary_980.pdf
zyprexa_summary_982.pdf
zyprexa_summary_1028.pdf
zyprexa_summary_1035a.pdf
zyprexa_summary_1035b.pdf
zyprexa_summary_1729.pdf
zyprexa_summary_1960.pdf
zyprexa_summary_2055.pdf
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.
http://www.nytimes.com/2008/03/26/business/26cnd-zyprexa.html?_r=1&ref=business&oref=slogin 

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.

http://www.helenair.com/extras/complaint.pdf

http://www.furiousseasons.com/legal%20documents/montanavlilly.pdf

http://www.furiousseasons.com/archives/2007/03/
the_zyprexa_chronicles_montana_alleges_kickbacks_and_offlabel_marketing.html

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:

'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:
http://www.furiousseasons.com/zyprexadocs.html

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

http://psychrights.org/index.htm

Also

http://tmap.wordpress.com/2008/02/25/nj-legislator-probe-antipsychotics-kids-medicaid/#more-69


33. THIS IS HOW THE FRAUD WAS PERPETRATED ON PSYCHIATRY:

http://en.wikipedia.org/wiki/Texas_Medication_Algorithm_Project

Perhaps we need to laugh:

http://www.google.com.au/search?hl=en&q=fukitol&btnG=Google+Search&meta

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

And

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.

34. MANY MORE STUDIES CAN BE DOWNLOADED FROM

http://psychrights.org/Research/Dgest/AntiDepressants/AntiDepressants.htm

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:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=193979

http://www.breggin.com/31-49.pdf

http://apt.rcpsych.org/cgi/content/full/12/5/320

http://www.bmj.com/cgi/content/abstract/330/7488/396


35. WHY ARE CLINICAL TRIALS IMPORTANT?

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.

36. WHY ARE PUBLIC HEALTH ADVISORIES SIGNIFICANT?

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

http://www.fda.gov/cder/drug/antidepressants/historical.htm

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

http://www.fda.gov/cder/drug/antidepressants/PI_template.pdf

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.

http://ajp.psychiatryonline.org/cgi/content/full/165/3/300

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.

http://www.breggin.com/31-49.pdf

From DSM IV:

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:

http://www.fda.gov/cder/drug/antidepressants/antidepressantList.htm

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.
http://www.tga.gov.au/adr/aadrb/aadr0508.htm#1

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:
http://www.baumhedlundlaw.com/media/timeline.html

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.

http://www.nytimes.com/2008/01/30/business/30cnd-drug.html?hp

http://www.mindfreedom.org/kb/psych-drug-corp/tmap/Texas-vs-TMAP-drug-fraud/

http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=411

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

http://www.naturalnews.com/021470.html

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:

http://www.healthieryou.com/mhexpert/exp1090202c.html

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.

http://findarticles.com/p/articles/mi_m0ISW/is_245/ai_111496944

http://www.healthanddna.com/drugreactiontest.html

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.

http://www.lawyersandsettlements.com/features/zyprexa-labels.html

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.

http://www.reuters.com/article/rbssHealthcareNews/idUSN1160916520080311?pageNumber=2&virtualBrandChannel=0

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:

View the entire Lilly complaint from Connecticut

http://www.ct.gov/ag/lib/ag/health/elililly-zyprexa.pdf

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

http://www.google.com.au/search?hl=en&q=Tim+Lambert+eli+lilly&btnG=Google+Search&meta

http://www.google.com.au/search?num=100&hl=en&q=Graham+Burrows+Eli+Lilly&btnG=Search&meta

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

Similar litigation about can be found at

http://www.google.com.au/search?num=100&hl=en&q=prozac+death+2000+vickery&btnG=Search&meta

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:

Psychiatric

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

http://www.risperdal.com/risperdal/shared/pi/risperdal.pdf

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.

http://ajp.psychiatryonline.org/cgi/content/full/165/3/300

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.

From

http://medicine.plosjournals.org/perlserv?request=get-document&doi=10.1371/journal.pmed.0030185

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

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.

http://psychrights.org/Drugs/DrJacksonUCELecture(UK)09.06.04.pdf

http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Search&Term=NIDS%20neuroleptic&itool=QuerySuggestion


40. WHAT IS AKATHISIA AND HOW DOES IT DIFFER FROM SCHIZOPHRENIA?

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.

http://www.breggin.com/31-49.pdf

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'.

http://www.psychotropical.com/

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.

http://www.psychrights.org/Articles/EHPPPsychDrugEpidemic(Whitaker).PDF

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.

http://en.wikipedia.org/wiki/Akathisia

http://www.antidepressantsfacts.com/Akathisia%20as%20Violence.htm

http://www.antidepressantsfacts.com/akathisia-mania.htm

http://www.lawyersandsettlements.com/features/ssri-suicide-akathisia.html

http://www.jeffmann.net/NeuroGuidemaps/akathisia.html

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:

http://www.austlii.edu.au/cgi-bin/sinodisp/au/cases/nsw/NSWSC/2001/420.html?query=akathisia

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:

http://theeffexoractivist.org/forum/viewtopic.php?t=891&sid=9a4ed8c52d980799e5cdc8026c02884a

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

http://www.google.com/search?q=akathisia+(law+OR+legal+OR+legislation+OR+regulation+OR+judgment+OR+treaty)

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:

http://www.time.com/time/pacific/mag...0228-1,00.html

http://www.time.com/time/magazine/article/0,9171,503051121-1130228-1,00.html

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

These guidelines can be accessed at the link below:

http://www.ranzcp.org/pdffiles/cpgs/Depression%20Clinican%20Full.pdf

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:

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

http://www.bmj.com/cgi/content/abstract/334/7587/242

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

http://www.medsafe.govt.nz/Profs/PUarticles/SSRI.htm

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.

http://en.wikipedia.org/wiki/Allen_Jones_%28whistleblower%29


41. HOW MANY BEDS DO SUCH PATIENTS OCCUPY?

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.

http://www.bmj.com/cgi/content/abstract/334/7587/242

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.

http://psychrights.org/Articles/SwedishSuicides.htm

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:

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.

The Ghostwriters are (this information comes from David Healy)

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

Whose remit is

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

http://www.fda.gov/CDER/Drug/antidepressants/AntidepressanstPHA.htm

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

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.

http://www.fda.gov/cder/drug/advisory/SSRI200507.htm

http://www.socialaudit.org.uk/58090-DH.htm

http://psychrights.org/expertestimony.htm

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.

http://www.lucire.com.au/documents/Maris_Daubert-Competent_Scientist.aspx

http://www.healyprozac.com/EditorsDilemma/Psychotherapy_Psychosomatics.pdf

http://www.abc.net.au/worldtoday/content/2004/s1073736.htm

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

The ADRAC Advisory of August 4, 2005, states

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.

http://www.bmj.com/cgi/content/full/326/7397/1008

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:

http://www.bmj.com/cgi/eletters/326/7397/1008


42. PROFESSOR IAN HICKIE, PSYCHIATRIST, ON CHANNEL 9 PROGRAMME SUNDAY 9TH MARCH, 2008

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.

http://www.bmj.com/cgi/content/full/324/7342/886

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.

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:

http://www.lucire.com.au/documents/Links.aspx

And for fun and good measure, this one:

http://carlatpsychiatry.blogspot.com/2008/02/counter-detailing-for-kevin-md.html

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

http://en.epochtimes.com/tools/printer.asp?id=64187


43. HOW WE WERE ALL SNOWED BY BIG PHARMA.

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

See reviews

http://www.nybooks.com/articles/20851

I commend the Semmelweiss Organization.

http://www.semmelweis.org/Acrobat/article_uoworks_peer_review.pdf

Diamond and Kabul's insight that:

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. 

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

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
www.lucire.com.au
lucire@ozemail.com.au

[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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