Transcript Panopticure - Dr Yolande Lucire

Imagine this:
[email protected]
www.Lucire.com.au
Or Google to Lucire Productivity Commission Banks
If you get sued, take the Learned Intermediary defence:
“I was not told.”
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.
Panopticure and its copycats boom.
And in Australia alone, some ten years later, it is
not 100,000 patients under treatment for
Glaucoma, but a million.
Drug representatives tout Panopticure for sore
eyes, blurred vision, myopia, presbyopia,
or simply to induce clear vision.
Reports should start appearing in the literature that
some users go blind – but they are ignored.
We are repeatedly reassured:
It’s the disease, not the drug, doctor.
In the United States, litigators access drug
company data, and find that clinical trials had
shown 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.
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.
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.
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.
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 told
If you get sued, take the Learned Intermediary defence:
“I was not told.”
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
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.
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.
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.
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.
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.
Efficacy and Effectiveness of
Antidepressants: Current Status of
Research
H. Edmund Pigott a Allan M. Leventhal Gregory S.
Alter, John J. Boren
Psychother Psychosom 2010;79:267–279
Abstract
Background: This paper examines the current status of research
on 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 effectiveness
trial ever conducted.
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 authors 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.
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.
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.
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.
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.
10218—PSYCHIATRIC DRUGS
Mr 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?
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.
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.
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
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.
The greatest satisfaction I have
had in my 38 years as a
psychiatrist has come from
giving livesx back to those who
have suffered from this totally
debilitating and unrecognised
iatrogenic disorder for up to
eight years.
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 told
Small Effects Are Not Trivial From a Public
Health Perspective
by Michael E. Thase, M.D.
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.
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.
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 document
TRACKING TRAGEDY:
Report of the Sentinel Events Committee 2004
Year
All Suicides in NSW No. mental health Pts in care % of
suicides
suicides
1993
676
68
1994
798
72
10%
9%
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%
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.
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
Over the past
Robert Whitaker
Cambridge, MA
years, there has been an astonishing
50
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 .
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.
There are now nearly 6 million Americans
disabled by mental illness, and this number
increases by more than 400 people each day .
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 Coventry
These 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.
Zyprexa Clinical trials
www.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
archives
Prozac
After 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
.
Outcomes of TMAP Publications endorsed
by opinion leaders
Zyprexa
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.”
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
.
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 disorder
•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
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?)
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.
777
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
.
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,
Eli Lilly advertisements for
Zyprexa on the cover of MIMS
(December 2000-January
2001) ask:
Have you made the change?
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.
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.
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 Denning
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 them
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.
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.
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.
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).
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.
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)
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 2003
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.
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”
persons
Mental health services in Australia
2006Р07
Service provision
Ґ General practitioners (GPs) a re often a first contact point for mental health
concerns . In 2007Р08, the BEACH survey estimated that over 11.9 milli on GP
patient encounters invo lved management of a mental health issue. These GP
encount ers increased by an annua l average of 4.4% fr om 2003Р04 to 2007Р
08.
Ґ Medicare provides specific payments for some GP mental health-related
encount ers, such as the preparation or review of GP mental health care plans
These Medicare Benefits Schedule (MBS)-subsidised mental health items
were introduced in November 2006. In 2006Р07 there were nearly 550,000
claims against these i tems and in 2007Р08 there were almost 1.2 m illi on
claims.
Ґ In Nove mber 2006, t he MBS was also extended to cover specific alli ed
mental health services. In 2006Р07 there were approximately 2.6 milli on claims
or subsidised psychiatrist, psycho logist and other a lli ed health professiona
services and in 2007Р08 there were 3.9 million claims.
Ґ Community mental health services and hospital outpatient services also
provide care for mental health consumers, with close to 6 milli on mental health
elated service contacts in 2006Р07, a 5.3% increase from 2005Р
Mental health care is provided to admitted patients in public acute, p ublic
psychiatric and private hospitals. In 2006Р07, there were over 209,000 mental
health-related separations for admitted patients. Over the 5 years to 2006Р07,
the average annual rate of increase for admitted patient mental health-related
separations was 2.2%.
In 2007Р08, there were 20 million mental health-related prescriptions
subsidised by the Pharmaceutical Benefits Scheme (and for vete rans),
accounting for just over one in ten of all prescription claims, costing over $700
million. Prescriptions for antipsychotics (49%) and antidepressants (43%)
accounted for the majority of the spending. Expenditure and resources
Expenditure on state and territory mental health services increased by a n
annual average of 5 .6% (adjusted for inflation) between 2002Р03 and 2006Р
07, to $3 ,040 million. Specialised psychiatric wards in public acute hospitals
and community mental health care services experienced annual average
increases in expenditure of 7.2% and 5.9%, respectively, while stand alone
public psychiatric hospital expend iture remained relatively stable
Psychiatry demands vast resources yet makes no inroads into the numbers of
people getting mental health care
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
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 result
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?
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.
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
population
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.
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?
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.
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.
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).
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.
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 DSM
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 patients
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.
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 their
liability and are seeking to rescind the policies, and Lilly further warns
that, "there is no assurance that we will be able to fully collect from our
insurance carriers on past claims."
This is a manifestation of a certain kind of neuroleptic
toxicity – of psychotropic medication-induced
disorder.
We have an iatrogenic Public Health Disaster.
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.
Whiteford and al found that in 100 countries where
psychiatric services were introduced, the suicide
rate rose.
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.
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%.
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.
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.
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 PloS
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.
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.
NSW WorkCover statistics from annual reports
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
0.7
1999/00
711
866
1,577 17.2
3.0
0.6
2000/01
829
1,087 1,916 20.7 3.6
0.7
2001/02
1,151 1,492 2,643 26.8
4.8
1.0
2002/03
1,396 1,850 3,246 35.4
6.4
1.2
2003/04
1,330 1,896 3,226 33.6
6.3
1.2
2004/05
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.
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.
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.
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.
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?”
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.
Public outrage about the fatal poisoning of fouryear 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-oldrebecca-riley-casualty-of.html
will, hopefully, lead to legislation to break the
stranglehold of the drug
industry's control of child psychiatry.
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