Imagine this: - PowerPoint Presentation

Slide1

Imagine this:

lucire@ozemail.com.au

www.Lucire.com.au

Or Google to Lucire Productivity Commission Banks

If you get sued, take the Learned Intermediary defence:

“I was not told.”Slide2

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

Learned professors, all over the world, publish strikingly similar papers to the effect that the prevalence of Glaucoma, and its dire consequences, has both been seriously underestimated.

And that Glaucoma is serious, treatable and affects four percent of the population every month.Slide3

Panopticure and its copycats boom.

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

Drug representatives tout Panopticure for sore eyes, blurred vision, myopia, presbyopia,

or simply to induce clear vision.Slide4

Reports should start appearing in the literature that some users go blind – but they are ignored.

We are repeatedly reassured:

It’s the disease, not the drug, doctor.

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

They find the maker paid off officials of the US Food and Drug Administration and the Office of Drug Safety.Slide5

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

Panopticure paid out millions in compensation as evidence was good and passed Daubert

Hearings

.

The maker knew when Panopticure appeared on the front cover of American Time Magazine after six week trials where two thirds of participants dropped out, where one in 250 became permanently blind and many partially so.Slide6

Ten years after the introduction of Panopticure, the number of persons on blind pensions had increased by 100%.

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

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

Few would believe these to be the intrinsic risks of transiently raised ocular pressure.Slide7

Yet this is the composite tale of the drugs launched by the TEXAS MEDICATION ALGORITHM PROJECT.

Jeb

Bush was Governor

SEROQUEL

, LEXAPRO, (Novartis) CIPRAMIL, (Novartis) ZOLOFT, AVANZA, ZYBAN, SERZONE, EFEXOR (Wyeth) and PROZAC.

These

are called the ‘serotonin drugs’ as all boost serotonin.

RISPERDAL, ZYPREXA, (Eli Lilly)

Their names are the product of market research.

TMAP’s ghost-writers produced RANZCP guidelines to depression, to schizophrenia, are much the same as beyondblue and it subtended GP’s

education

programs

. Slide8

Since the late 1980s, a stream of successful litigation has disclosed the marketing of Serotonin booster drugs

as fraudulent

, marketed as if they had specific actions of on serotonin, along with the fraudulent notion that serotonin was somehow abnormal in depression.

Drugs were hyped in Time and Newsweek.

After 6-10 week

trials

.

Of drugs called antidepressants, which have up to sextupled rates of suicide

and antipsychotics, which have schizophreniform psychosis and hallucinations as a side effect.

On in five hundred had committed suicide in clinical trials, one in seventy attempted.

1 in 145 died in the trials for atypicals

and we were never toldSlide9

All licensed after inaccurately reported and cherry picked clinical trials were presented to the US FDA, itself under investigation,

side effects denied, suicides air-brushed

away

A stream of individual and class action

litigation has resulted in damages being ordered for harm done,

sudden death,

liver failure,

diabetes,

delirium, (which psychiatrists who grew up with these drugs call “schizophrenia”)suicide and homicides, mass homicides, and their aftermath, all caused by these drugs. by good doctors who had not been educated to watch for and warn of the side effects of aggression and suicidality.Who were lied to by professors whose association with the pharmaceutical industry could be checked out by simple google searches

If you get sued, take the Learned Intermediary defence:

“I was not told.”Slide10

And thousands of non-disclosable multi-million dollar payouts to patients and families for wrongful death, professional negligence, failure to warn

In rural NSW, over a third of the admissions to a psychiatric ward in 2002-3 were for those side effects of suicidal and homicidal ideation and acts, (not counting psychosis or mania) presenting in previously normal persons who got serotonergic antidepressants

for the kind of problem that affects 4% of the population every month, anxiety, worrying, grief, stress, work and other.Slide11

The 4% per month figure for treatable depression to be treated comes from the RANZCP Guidelines for the treatment of depression.

This document recommends high dose Efexor, fails to report on any side effects, does not prescribe warnings, but name drops

the names of the

NHMRC, RANZCP, Mental Health Policy

and

so on.Slide12

A score or more of American State Attorneys General are suing TMAP, expecting to recoup costs and damages for states and individuals damaged have now joined the litigation, on the basis that they were all misinformed

of the efficacy and lack of side effects of these drugs.

Montana was the seventh state to sue Eli Lilly directly for Zyprexa fraud.

If you get sued, take the Learned Intermediary defence:

I was not told.

And ask the state to sue on behalf of your patients

Because the States are doing it in United States.Slide13

On a public health level these drugs are a disaster.

Their side effects include neurotoxicity, neuroleptic toxicity, supersensitivity psychosis, mania, psychosis, personality change, suicide and attempts, violence, homicide, delirium, hallucinations, schizophreniform reaction

Like neurosyphilis, and all other organic mental states, neurotoxicity manifests as any and every possible psychiatric presentation, including violent personality disorder.Slide14

FDA Public Health Advisory March 22, 2004

Subject: WORSENING DEPRESSION AND SUICIDALITY IN PATIENTS BEING TREATED WITH ANTIDEPRESSANT MEDICATIONS

Today the Food and Drug Administration (FDA) asked manufacturers of the following antidepressant drugs to include in their

labeling

a Warning statement that recommends close observation of adult and

pediatric

patients treated with these agents for worsening depression or the emergence of suicidality.

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in adult and

pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.Slide15

Efficacy and Effectiveness ofAntidepressants: Current Status ofResearch

H. Edmund

Pigott

a Allan M.

Leventhal

Gregory S. Alter, John J. Boren

Psychother

Psychosom

2010;79:267–279AbstractBackground: This paper examines the current status of researchon the efficacy and effectiveness of antidepressants.Methods: This paper reviews four meta-analyses of efficacy trials submitted to America’s Food and Drug Administration (FDA) and analyzes STAR * D (Sequenced Treatment Alternatives to Relieve Depression), the largest antidepressant effectivenesstrial ever conducted. Slide16

Results: Meta-analyses of

FDA

trials suggest that antidepressants are only marginally efficacious compared to placebos and document profound publication bias that inflates their apparent efficacy.

These meta-analyses also document a second form of bias in which researchers fail to report the negative results for the pre-specified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure as though it was their primary measure of interest.

The STAR * D analysis found that the

effectiveness of antidepressant therapies was probably even lower than the modest one reported by the study au

thors

with an apparent progressively increasing dropout rate across each study phase. Conclusions: The reviewed findings argue for a reappraisal of the current recommended standard of care of depression.Slide17

Akathisia DSM 333.99

The subjective distress resulting from akathisia is significant and can lead to noncompliance with neuroleptic treatment. Akathisia may be associated with dysphoria, irritability, aggression or suicide attempts.

Worsening of psychotic symptoms or behavioral dyscontrol may lead to an increase in neuroleptic medication dose, which may exacerbate the problem. Akathisia can develop very rapidly after initiating or increasing neuroleptic medication.

The development of akathisia appears to be dose dependent and to be more frequently associated with particular neuroleptic medications. Slide18

Akathisia may be associated with dysphoria, irritability, aggression or suicide attempts.

Worsening of psychotic symptoms or behavioural dyscontrol may lead to an increase in neuroleptic medication dose, which may exacerbate the problem. Slide19

Concern over suicide rate of mental health patients

A new patient safety report has found that a large number of mental patients committed suicide after being released from New South Wales hospitals last year.

There were four suicides in the State's hospitals last year and an additional eight attempts.

There were also 128 patients who committed suicide after they were discharged into the community.

NSW Health Minister Morris Iemma says the figure is higher than in other states, because it includes patients who may have been released some time before they took their own lives.

"It may well be that the health service had no connection, or had absolutely nothing to do with the suicide," he said

.Slide20

Between 1999 and 2008, 79 people, an average of seven or eight annually, while being treated in the NSW Mental Health public sector, committed homicide, killing family members and health care workers.

Between 1993 and 2008, 2344 patients under mental health care in NSW committed suicide.

New South Wales (NSW) Mental Health Sentinel Events Review Committee. Tracking Tragedy: a systemic look at homicide and non-fatal serious injury by mental health patients, and suicide death of mental health inpatients. Fourth Report of the Committee. NSW Mental Health Sentinel Events Review Committee; March 2008. Available at:

http://www.health.nsw.gov.au/pubs/2009/pdf/tracking_tragedy_2008_fourth_report.PDF. Accessed April 12, 2011. Slide21

10218—PSYCHIATRIC DRUGSMr

Daryl Maguire to the Deputy Premier, and Minister for Health—

Has the Minister and her predecessors been warned by individuals that suicides committed by patients and clients under mental health care could be caused by psychiatric drugs:

that affect persons who have a genetically determined inability to

metabolise

them;

that such persons should be

recognised

by their adverse medication responses?

How many persons have committed suicide whilst under mental health care in the years 2003 to 2008? How many have committed homicide? Do these figures represent a deterioration or improvement in the numbers of suicides under mental health care: before 1990; before 2002? Slide22

Answer—I am advised:

NSW Health advises me that there has been correspondence to previous Health Ministers in relation to this issue. I have also received such correspondence. The Chief Psychiatrist in consultation with the NSW Mental Health Clinical Advisory Council is currently considering these issues.

According to the Mental Health Client Incident Information System, there were 937 notifications of suspected suicides of persons under mental health care that were reported to the NSW Health Department between 1 Jan 2003 and 31 Dec 2008.

According to the Mental Health Client Incident Information System, there were 43 notifications of suspected homicides by persons under mental health care that were reported to the NSW Health Department between 1 Jan 2003 and 31 Dec 2008.

It is not possible to compare the data over this time period due to the fact that different methodology was used to collate this data. Slide23

Akathisia may range in intensity from a mild sense of disquiet or anxiety (which may be easily overlooked) to a total inability to sit still with overwhelming anxiety and severe dysphoria (manifesting as an almost indescribable sense of terror and doom).

In the most severe cases, dysphoria and death wish can be so severe that the patient is literally compelled to take action, leading, possibly, to suicide attempts.

It is not unknown to have patients literally run out of a hospital or emergency room.

Akathisia is often misdiagnosed and can lead the patient to commit suicide in or outside the hospital.Slide24

The development of akathisia is unrelated to the psychiatric diagnosis.

It is

an

organic condition,

caused by toxicity

a

delirium when sufficiently severe.

Superimposed on a condition for which there were no biological markers, depression, schizophrenia

Akathisia often does have biological markers in the CYP enzymes

The metabolic effects of Zyprexa cause delirium before the liver heart and pancreas fail. Remove the cause SLOWLY Slide25

All over the world, clinicians are reviewing all their suicidal patients and finding among them chronic akathisia subjects

behaving like borderlines,

their lives a living hell,

battling a death wish, violent, suicidal, toxic and psychotic, with homicidal impulses, ego-alien outbursts of violence,

unable to articulate internal agitation,

Moving attenuated, but never fully relieved, by co prescribed sedatives

or worse, self -administering alcohol or whatever else is available.Slide26

x

The greatest satisfaction I have had in my 38 years as a psychiatrist has come from giving lives back to those who have suffered from this totally debilitating and unrecognised iatrogenic disorder for up to eight years.Slide27

Antidepressants now taken by one million Australians (200,000 of whom are children).

Their wonders were spruiked by learned professors.

If you get sued, take the Learned Intermediary defence:

I was not toldSlide28

Small Effects Are Not Trivial From a Public Health Perspective

by Michael E. Thase, M.D.Slide29

Beverley Raphael spilt the beans to the Bulletin when she reported on the doubling of numbers of persons being diagnosed with mental illness

and quintrupling of suicides under mental health care.Slide30

The Department of Health in NSW claimed to have no statistics.

A ‘crisis in mental health care’ was announced, and 300 more psychiatric beds were opened.

The excuse was that the Richmond Report had never been properly funded.Slide31

The Sentinel Events Committee chaired by the Hon. Professor Emeritus Peter Baume AO,

charted the rising mental health suicide numbers since 1993.

Dr Bill Barclay AM looked at 9 Homicides by patients under Mental Health

care

The report is called Tracking Tragedy

The DoH response to it is a policy documentSlide32

Year

All Suicides in NSW

No. mental health suicides

Pts in care % of suicides

1993

676

68

10%

9%

1994

798

72

1995

747

100

13%

1996

811

136

17%

1997

946

166

18%

1998

827

143

17%

1999

846

173

20%

2000

738

156

21%

2001

775

159

(156 in 2002)

21%

TRACKING TRAGEDY:

Report of the Sentinel Events Committee 2004Slide33

It was hard to see why some rural areas, which had wonderful residential facilities for chronic schizophrenics, still needed these extra beds.

Ross Kalucy in SA and

Assen

in WA documented this increasing demand.

The Federal Government got support to take over mental health care.

They could fix this problem with a competent Therapeutic Goods Association.

TGA was taken over by cronies in 1996.

Subjected to the Free Trade Agreement . Others documented increased costs.

Other areas of health care are similarly affected by iatrogenic disorders, not only psychiatry

.Slide34

Robert Whitaker published this information in the USA.

Ethical Human

Psychology and Psychiatry, Volume 7, Number I ,

Spring

2005

Anatomy of an Epidemic:

Psychiatric Drugs and the Astonishing

Rise of Mental Illness in America

Robert Whitaker

Cambridge, MAOver the past 50 years, there has been an astonishing increase in severe mental illness in the United States . The percentage of Americans disabled by mental illness has increased fivefold since 1955, when Thorazine-remembered today as psychiatry's first "wonder” drug was introduced into the market . The number of Americans disabled by mental illness has nearly doubled since 1987, when Prozac-the first in a second generation of wonder drugs for mental illness-was introduced . Slide35

A review

of the scientific literature reveals that it is our drug-based paradigm of care that is fuelling this epidemic.

The drugs increase the likelihood that a person will become chronically ill, and induce new and more severe psychiatric symptoms in a significant percentage

of

patients.Slide36

There are now nearly 6 million Americans disabled by mental illness, and this number increases by more than 400 people each day .Slide37

No one told the Therapeutic Goods Association.

Those voices adverting to these matters were silenced.

‘Not in the mainstream.’

I was called “arrogant

and

paranoid”

in 2004, when I first presented this data

“Your

colleagues don’t agree with you

.:“You are unethical, espousing unusual views” Sent to CoventryThese non-mainstream views that are expert evidence in cases for damages such as have not been seen before, run by up to 50 state attorneys. Against makers of fifteen drugs.The history of psychiatry is full of such disasters.Slide38

Zyprexa Clinical trialswww.Lilly trials.com

7.000 started, only 2,500 completed 6 week trials

Akathisia balkanised, but over 27%

Akathisia

at similar rates reported on on placebo

20 died 12 by suicide

Suicide attempts not reported, no data in archivesSlide39

ProzacAfter the clinical trials presented to the US FDA in the late 1980s were re-examined on court orders from a mass homicide case, it was found that

just over

300

patients

had been given Prozac alone to get the drug licensed.

Others had Valium co-prescribed and we were not told.

The only suicide in these trials had occurred on active substance

. Slide40

Outcomes of TMAP Publications endorsed by opinion leadersZyprexa

Adopted

and Promoted in Oz by state and federal departments of health

Drug of choice in RANZCP guidelines to treatments of new entity, ‘first episode psychosis’.

Hyped as wonder drug in Time and Newsweek

Recommended in RANZCP guidelines to treatment of schizophrenia

New entity, ‘first episode psychosis’ invented for this

remedy soon followed by the equally new disease, “treatment refractory schizophrenia.”Slide41

Note there were five schizophrenia trials at this time but only two short six week trials are cited in the document as ‘establishing efficacy” line numbers 112 113. Line numbers as in APPROVED Zyprexa AGREED-UPON LABELLING 1997 2003.

261 Neuroleptic Malignant Syndrome.

264 altered mental status

282 Tardive dyskinesia

321 Seizures occurring in 0.9%

358 Potential for motor an cognitive impairment

378 suicide (which is blamed on the illness)

416 Interference with motor and cognitive function

This comes

from American Prescriber information called APPROVED AGREED-UPON LABELLING 1997 2003.Slide42

COMMENT: THIS IS A SPURIOUS STATISTIC AS TRIALS RAN FOR SIX WEEKS AND 50% DROPPED OUT.

610 denial of discontinuation reaction, See FDA reviewer statements

628-personality disorderSlide43

630 somnolence, dizziness, tremor

638 akathisia, articulation impairment

639 Events reported by at least 2%: agitation, anxiety, apathy, confusion, depression, hallucinations, hostility, nervousness, paranoid reaction, personality disorder, thinking abnormal,

644 COSTART (Non aggressive objectionable behaviour)

650 at more the twice the placebo rate: speech disorder, amnesia,

625 many already listed as well as apathy confusion euphoria

659 at least 2%: emotional lability, abnormal dreams, agitation, hostility,

insomnia, akathisia, anxiety, insomnia, libido up or down, nervousness,

paranoid reaction, personality disorder, sleep disorder, thinking abnormal

(what can this mean here given results for akathisia?)676 akathisia rates are given as percentages: 23% on placebo! 16%, 19% and 27% on Zyprexa, increasing with dose. Using Barnes Akathisia Scale. Note akathisia is a medication-induced condition WHICH CANNOT IN ITS DEFINITION OCCUR IN PLACEBO PATIENTS. Slide44

I list the metabolic disorders as they also have psychiatric manifestations: a delirium that the unwary call as and treat as if it is schizophrenia

763

Metabolic and Nutritional Disorders

—

Infrequent:

acidosis, alkaline phosphatase increased,

764 bilirubinemia, dehydration, hypercholesteremia, hyperglycaemia,

765 hypoglycemia, hypokalemia, hyponatremia, lower extremity edema, and upper extremity edema;

766

Rare: gout, hyperkalemia, hypernatremia, hypoproteinemia, ketosis, and water intoxication. 694 movement disorder (what can this mean? If akathisia is something different?)Slide45

770 Nervous System —

770

Frequent:

abnormal dreams, amnesia, delusions, emotional lability,

771 euphoria, manic reaction, paresthesia, and schizophrenic reaction;

Infrequent:

akinesia, alcohol

772 misuse, antisocial reaction, ataxia, CNS stimulation, cogwheel rigidity, delirium, dementia,

773 depersonalisation, dysarthria, facial paralysis, hypesthesia, hypokinesia, hypotonia,

774 incoordination, libido decreased, libido increased, obsessive compulsive symptoms, phobias, 775 somatization, stimulant misuse, stupor, stuttering, tardive dyskinesia, vertigo, and withdrawal 776 syndrome; Rare: circumoral paresthesia, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid haemorrhage, and tobacco misuse. 777Slide46

GIVEN THE PROPENSITY, KNOWN TO ELI LILLY, as disclosed by FDA reviewers TO CAUSE SUPERSENSITIVITY PSYCHOSIS ON DOSE CHANGE, THIS IS FRANKLY DISINGENUOUS

Supersensitivity psychosis is withdrawal akathisia

810 or physical dependence. While the clinical trials did not reveal any tendency for any drug-

seeking

behavior

, these observations were not systematic, and it is not possible to predict 811 on the basis of 812 this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or

.Slide47

FDA Briefing document on Zyprexa 2001

Akathisia is a problematic and uncomfortable side effect of antipsychotics that involves persistent motor restlessness and muscle tightness.

It may be misdiagnosed as a psychotic decompensation (Janicak et al. 1997) and often contributes to patients’ reluctance to take antipsychotics.

Severe manifestations of akathisia can lead to homicide or suicide (Drake and Ehrlich 1985; Van Putten and Marder 1987).

3. Many antipsychotics cause ECG abnormalities,Slide48

Eli Lilly advertisements for Zyprexa on the cover of MIMS (December 2000-January 2001) ask:

Have you made the change?Slide49

Kaplan and Sadock III (1980) (and all editions since) state:

Akathisia is a subjective desire to be in constant motion. A manifestation of drug sensitivity, it may be confused with psychotic agitation and incorrectly treated by increasing the dose of the offending medication. The symptom subsides promptly when the offending medication is discontinued and replaced by another one better tolerated by the patient.Slide50

Whether or not one develops akthisia is determined by boiology, not psychology

.

by genetic polymorphism the prepolymorphism or limited availability of certain CYP 450 enzymes,

or the stress put on this metabolism by addition or removal of co-prescribed medications demanding the CYP450 system.

Cannabis inhibits some and causes metabolic chaos.Slide51

It is organic,

a delirium and

crimes committed in this condition attract an absolute defence of involuntary intoxication.

NOT GUILTY

Automatism

see Falconer and Lord DenningSlide52

Akathisia Homicides (even mass homicides) and other bizarre are committed by the most unlikely perpetrators

3600

are reported on

www.ssristories.com

.

Akathisia inducers include SSRIs, most psychiatric drugs speed channel blockers Maxolon Stemetil and statins such as Lipitor and other antidepressants.

You need pharmacy records to assess themSlide53

My research was criticised: not mainstream psychiatry.

But consistent with DSM, Kaplan and

Sadock

, Textbook of American Psychiatry, Sachdev’s

Akathisia and Restless Legs

, Prescriber Information, MIMS ANNUAL,

suicide data,

600 papers on Medline,

6 Daubert Hearings,

Prescriber Information in the USA, legal data bases in coronial, negligence and criminal proceedings. Slide54

Australasian Psychiatry• Vol 11, No 1 •March 2003

RANZCP CLINICALPRACTICE GUIDELINES 4

Summary of guideline for the treatment of depression

Pete M. Ellis, Ian B. Hickie and Don A. R. SmithPete M. Ellis, Ian B. Hickie and Don A. R. Smith for the RANZCP

Clinical Practice Guideline Team for Depression

Practice guidelines, secondary care.

Depression is common, serious and treatable. It affects 1 in 25

people in any 1 month.

Slide55

When the US FDA issued a Public Health Advisory in March 2004 on increasing depression and suicidality, the College representative immediately responded.

We are not convinced. Slide56

The College has not retracted that, has not done any research nor checked the literature nor read the trials. Yet it purports to issue guidelines to double guess the data rich FDA.

(Nor are they convinced by evidence and science).Slide57

The guidelines that the RANZCP should be promoting,

Med-Psych Drug-Drug Interactions Update

Clinical Guidelines for Psychiatrists for the Use of

Pharmacogenetic Testing for CYP450 2D6 and CYP450 2C19

JOSE DE LEON, M.D.

SCOTT C. ARMSTRONG, M.D.

KELLY L. COZZA, M.D.Slide58

I told the Therapeutic Goods Association of these problems.

The TGA, told me that on the whole, these drugs did more harm than good.

Professor Hickie has yet to tell me how drugs which increase suicide rates on clinical trials, can decrease a national suicide rate.

(there is a way)Slide59

The Federal Government and the Medical Journal of Australia published that the suicide rate in Australia decreased.

But the suicide rate actually rose (in some sectors) by 2% after Prozac was introduced, with 90% of the increased numbers being taken up by suicides under mental health care.

Persons in mental health care did not suicide so much before 1992.

Mental health care is now a risk factor for suicide.

NSW Mental Health Sentinel Events Review Committee

Tracking Tragedy

A systemic look at suicides and homicides amongst

mental health inpatients

First Report of the Committee

December 2003Slide60

From 1990 to 2002, antidepressant use increased by 352%, to reach 51.5 DDDs/1000/day

In this same period, 1990 and 2002, Suicides of persons under Mental Health Care (in NSW alone) increased from under between 36 and 56 say 46 to over 155.

Just about 350%

Hanging became the method of choice with hanging deaths increasing from 6 to 12 per 100,000 suicides.

Every akathisiac with suicidal ideation with whom I have spoken thinks of hanging him or herself.

Other violent means are also contemplated, but seeking peace is always the motivation.

This becomes an empirical question for coroners who will have toxicological results from these deaths. But will not pick up withdrawal suicides without further information.Slide61

The death rate in treated schizophrenia rose by 40%.

Mania rose – its incidence has risen from 0.1% to 5%.

Psychiatry’s institutions and researchers did not ask what was fuelling this epidemic of mental illness

.

Just asked for more money.

From governments and Big

PhaRMA

Psychiatry is not making any inroads.

These

statistics are newly diagnosed “mentally ill” personsSlide62
Slide63
Slide64

The New York Times suggested that psychiatry was in denial.

The American Psychiatric Association declared that it was in a partnership with the Pharmaceutical Industry.

The

APA’s

President agreed with Tom Cruise

http://pn.psychiatryonline.org/cgi/content/full/40/16/3

Psychiatric News,

August 19, 2005 page 3

Big PhaRMA and American Psychiatry: The Good, the Bad, and the Ugly

by Steven S. Sharfstein, M.D. 2005 President, American Psychiatric Association Slide65

Do antidepressants work?

What do they do?

All of morphine, heroin, cocaine, alcohol, bromides, barbiturates, amphetamines, sedatives, meprobamate and benzodiazepines ‘work’ in the sense that some people feel different on them, and some people like that.

4.7% of the Australian population is taking antidepressants at a cost of over, now $500,000 for the drug alone.

One has to ask if the conditions for which they do are legitimately medical conditions, and should be ‘treated’ by a doctor wearing a metaphorical white coat.

They are now being provided for menopause and stress incontinence and suicides still resultSlide66

On May 6 2006, GSK published a review of all its clinical trials for Aropax. Six persons had committed committed suicide on active substance and none on placebo. Relative risk of 6 or more

Efexor is worse in some trials

This is biological not psychological and unrelated to diagnosis

And this passes for an ‘antidepressant ‘

And what disturbance causes these suicides

?Slide67

In 1993, Martin Teicher postulated nine clinical mechanisms have been proposed through which suicide may occur.

These are:

(a) energizing depressed patients to act on pre-existing suicidal ideation;

(b) paradoxically worsening depression;

(c) inducing akathisia with associated self-destructive or aggressive impulses;

(d) inducing panic attacks;

(e) switching patients into manic or mixed states;

(f) producing severe insomnia or interfering with sleep architecture;

(g) inducing an organic obsessional state;

(h) producing an organic personality disorder with borderline features; and (i) exacerbating or inducing electroencephalogram (EEG) or other neurological disturbances. Slide68

Where better to hide lethal psychiatric side effects than among a ‘psychiatric’ population?

One in twenty Australians is now a psychiatric patient

increasing to 80% of the prison populationSlide69

On May 5, 2006, GlaxoSmithKline admitted on its website that the relative risk of suicide on Paroxetine (

v

placebo) was six, and they always knew.

I should like Professor Ian Hickie to explain to me exactly how a drug that sextuples the rate of suicide in those who use it could possibly reduce national suicide rates if it is given mostly by non specialists to a million people.

TCAs have an RR of suicide of well over one but careful use on a biologically depressed population, watching and warning did halve suicides in that high risk group.Slide70

No ‘Dear Doctor’ letters to any of us in Australia.

The US FDA complained

on December 16 when it released its data

This has been a major effort, involving 372

placebo-controlled antidepressant trials and almost100,000 patients.

Outcome

Suicides were doubled or more on active substance and Efexor nearly quintupled,

without looking at withdrawal suicides which could double these figures again as those coded placebo are recoded withdrawal.

Why did it not do these studies before and why are we not being told? Slide71

Aropax users were social anxiety patients ,

Not suffering from biological depression which alone carries significant suicide risk.

I notified the TGA and the College: no action was taken, no warning form and no Dear Doctor letter for Australian prescribers like our American counterparts received.Slide72

On 5 June 2005, the US FDA issued a further Advisory admitting a causal link between suicide and serotonin boosters.

Litigation in California, targeting Paroxetine, Citalopram and Venlafaxine has 100% successful outcomes.Slide73

The FDA kept its promise and had all drug trials examined. They found that only the best ones which had been cherry-picked for presentation to the FDA and TGA for purposes of getting a licence for the drug

.

On February 5, 2005,

Fergussen

and Healey published in the British Medical Journal that the relative risk of suicide by serotonin boosters was, on the average, 2 (in clinical trials). Slide74

Or how many persons have been treated for voice hallucinations, psychosis or mania induced by SSRIs have been then treated with Zyprexa

after that for “uncovered schizophrenia”

and ‘bipolar disorder.’

That serotonin boosting antidepressants induced akathisia has been in DSM since 1994.

Slide75

The psychosis in akathisia is a medication-induced problem.

Akathisia

is one of the neuroleptic toxicity syndromes along with dyskinesia, Parkinson’s disease, Psychoactive substance induced disorder.

Psychoactive

substance induced disorder is well classified in ICD10 but poorly in DSMSlide76

As well as suicide attempts, death wish, aggression, homicide and behavioural dyscontrol – which Teicher calls ‘induced borderline personality disorder,’ often of very, very late onset.

Eli Lilly updated its Prescriber Information in August to tell us that Zyprexa causes hallucinations.

It was also the most death

dealing and most suicidogenic

drug in clinical trial history,

22

deaths in 2,500.

12 suicides in 2,500 patientsSlide77

After 7,000 did not complete six-week trials and we were not told of the two thirds drop out rates, or deaths or suicides.

It

is not uncommon to see Zyprexa enforced in NSW.Slide78

Eli Lilly has told so many lies that it cannot get indemnity cover for

Zyprexa.

In filings with the SEC, Lilly admits that it is having problems and that

the company may end up having to pay its own Zyprexa costs, but blames it on

the insurance industry stating: "We have experienced difficulties in

obtaining product liability insurance due to a very restrictive insurance

market and therefore will be largely self-insured for future product

liability losses."

As for the insurance that Lilly does have to cover past and future Zyprexa

lawsuits, the filing reports that carriers have raised defences to theirliability and are seeking to rescind the policies, and Lilly further warnsthat, "there is no assurance that we will be able to fully collect from ourinsurance carriers on past claims."Slide79

This is a manifestation of a certain kind of neuroleptic toxicity – of psychotropic medication-induced disorder.

We have an iatrogenic Public Health Disaster.Slide80

A generation of psychiatrists who have never learnt about akathisia, (and its still not in the 5 CD ROMs that will get them past the RANZCP examinations).

A medical profession entirely educated by the pharmaceutical industry.

An incompetent TGA.

No Office of Drug Safety.

No

one has

responsibility.

An HCCC whose criterion of satisfactory practice is that they can find a peer who thinks that inducing a litany of suicide, attempts, homicide, violence and akathisia is

standard psychiatric practice

. An HCCC that does not recognise a Public Health problem because, by its own law, it would have to investigate.Slide81

Whiteford and al found that in 100 countries where psychiatric services were introduced, the suicide rate rose.Slide82

Following Lilly’s licence to treat and prevent Bipolar with Zyprexa advertisements and websites appeared to promote mood watching

.

With the exception of Lithium to treat acute mania, there is precious little theoretical justification, and virtually no research support for the notion that Bipolar can be prevented by long-term medications including Li or anticonvulsants.Slide83

Bipolar entered DSM in 1980, and at least one hospitalisation for mania was a criterion, Other causes for mania and depression were

exclusions

.

Bipolar II, Bipolar NOS and cyclothymia then emerged for chemical remediation by a rapacious pharmaceutical industry – and the prevalence rose from 0.1% for 1% (Bipolar 1) to 5%.Slide84

A massive use in the diagnosis in children, as young as 4 years, followed the description of a nine year old bipolar on the cover of Time in August 2002.

Time had similarly launched Prozac and Zyprexa.Slide85

In North Wales 100 years ago, before the advent of modern pharmacotherapy, patients with bipolar 1 disorder, meeting today’s DSM criteria, had 4 admissions every ten years. Slide86

The incidence of Bipolar 1 remained constant.

In the face of dramatic improvements, service provision, in modern times, Bipolar 1 patients show a 4-fold increase in the prevalence of admissions, despite being treated with the most latest psychotropic medications.

The Latest Mania: Selling Bipolar Disorder

PloSSlide87

Do new drugs work?

Yes – but so do speed and coke. Mood

boosters

all.

But there is a price in brittleness of

personality

and aggression.

Just like speed and coke

The question is ‘Do they cure depression?’

No: not on a public health level, not if you look at disability.Days lost from depression have increased.Medical retirement for psychiatric reasons has increased. Work stress claims have increased as has failure to recover.Slide88

Admissions have increased by 7%.

If you have a cure for something like small pox or blocked coronary arteries.

Demand for treatment soon goes down, as do cases.

Look at

workcover

. How long since you have seen some one on stress claim not on SSRIs?

90% of those I see have debilitating side effects, it is not depression that causes much disability but treated depression.

Several had over twelve admissions for suicidality and violence on work stress claims, and none after I intervened.

Admissions have increased by 7%

.If you have a cure for something like small pox or blocked coronary arteries.Demand for treatment soon goes down, as do cases. Look at workcover. How long since you have seen some one on stress claim not on SSRIs? 90% of those I see have debilitating side effects, it is not depression that causes much disability but treated depression. Several had over twelve admissions for suicidality and violence on work stress claims, and none after I intervened.Slide89

Table 4.3.2a: Number of mental disorder cases by gender, 1992/3 to2004/5

Year Males Females Total % of all diseases % of all claims Incidence rate

1991/92 299 174 473 4.8 0.9 0.2

1992/93 366 278 644 5.4 1.3 0.3

1993/94 597 512 1,109 6.9 1.9 0.5

1994/95 784 804 1,588 9.4 2.5 0.7

1995/96 752 986 1,738 10.7 2.8 0.8

1996/97 720 867 1,587 13.9 2.6 0.7

1997/98 875 1,033 1,908 18.8 3.3 0.8

1998/99 736 946 1,682 17.6 3.0 0.71999/00 711 866 1,577 17.2 3.0 0.62000/01 829 1,087 1,916 20.7 3.6 0.72001/02 1,151 1,492 2,643 26.8 4.8 1.02002/03 1,396 1,850 3,246 35.4 6.4 1.22003/04 1,330 1,896 3,226 33.6 6.3 1.22004/05 1,259 1,943 3,202 ????? 6.4 1.2 3 The consequence of medicalising work stress have been disastrous. It is now a big, big disease. No doubt covering the 18% of Australians who suffer from a mental disorder.NSW WorkCover statistics from annual reportsSlide90

What is indisputable however is that the careful use of tricyclics in biological depression reduces the suicide rate by 50%.

Tricyclics have a relative risk of suicide, a fair bit greater than 1, not as high as serotonin boosters or Zyprexa and Risperdal.

Careful use can prevent suicide.

Giving antidepressants willy nilly to persons with no risk factors increases suicide.

Remember it is not the psychology that determines a medication response but biology.Slide91

I argue that these drugs should be in the hands of persons who know how to use them, when to use them (in biological not major depression)

We

should not support the PHaRMAs desire to have 20% of the population psychiatric and medicated.

That the use of neuroleptics be restricted to those who sign a document to the effect that they are familiar with side effects.

And to patients who have been given relevant and sufficient information to make an informed choice.Slide92

That patients have to give informed consent for all emergency treatment that we stop pretending we can prevent relapse when the WHO is telling us that outcomes are better in Nigeria where they cannot afford drugs. Slide93

When Major Gross was emptying England’s psychiatric units of persons like Evelyn Waugh’s Gilbert Pinfold, delusional, delirious with bromide psychosis, I have little doubt that his colleagues bleated:

“If we don’t have bromides, how will I treat nerves?” Slide94

Medicines that have mania as a side effect include all antidepressants, old and new.

Zyprexa, Risperidone, Quetiapine but on use and on withdrawal.

Akathisia can mimic mania, and ‘manic suicidal’ is an apt description.

All psychiatric drugs cause akathisia in the vulnerable except

benzos

.

So do Maxolon

,Stemetil

channel blockers conjugated oestrogens and

statins and ICE, speed and all combinations.I have seen all of those diagnosed as mania.Slide95

Public outrage about the fatal poisoning of four-year old Rebecca Riley,

who, since the age of 28 months had been prescribed a toxic drug combination

by a board certified child psychiatrist, (Feb. 15)

http://ahrp.blogspot.com/2007/02/4-year-old-rebecca-riley-casualty-of.html

will

, hopefully, lead to legislation to break the stranglehold of the drug

industry's control of child psychiatry.Slide96

Eli Lilly was having

trouble obtaining and retaining insurance coverage for Zyprexa litigation because apparently insurance companies are no longer willing to buy its wide eyed innocence routine when it comes to the company's fraudulent off-label marketing schemes.

Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa

$515 Million Criminal Fine Is Largest Individual Corporate Criminal Fine in History; Civil Settlement up to $800 Million.

January 30, 2009

PHARMACEUTICAL COMPANY ELI LILLY PLEADS GUILTY TO MISBRANDING DRUG

and many others

Connecticut Alaska, check out the US department of Justice site for details of settlements