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.