SSRIS: DO THEY CAUSE SUICIDE?
Yolande Lucire
PhD, MB BS DPM FRANZCP
School of Rural Health, Albury
NSW
Forensic Psychiatrist. Woollahra
Sydney
Antidepressants form two major groupings:
New SSRIs and older TCAs, which I’ll call
Tricyclics
SSRIs act on Serotonin and have profound effects.
They are capable of changing people profoundly and not
always for the best. Contrary to popular opinion, there is
no scientific evidence that serotonin is abnormal in
depression.
Having more of it floating around makes for a lot
of change.
SSRIs
(the Accused)
TCAs (the
Comparator)
Prozac
Zoloft
Aropax
Efexor
Cipramil
Lexapro
Luvox
Tryptanol
Tofranil
Prothiaden
Sinequan
For the purpose of a 20 minute presentation, I am grouping the
drugs that act on serotonin together and calling them SSRIs,
although some are SSRIs and some are SNRIs and others have
mixed actions.
For the purpose at hand, suicide induction or completed suicide
they all have a similar profile, with the more energising ones
possibly more heavily implicated.
Suicide is the measurable tip of an iceberg of disturbance
violence and disturbance, and may have come about in a variety
of ways.
Similarly the TCA are not only tricyclics but tetracyclics and
some atypical ones, in general not having an action on
serotonin.
Caution:
Do not stop taking an antidepressant
without medical supervision.
Complications occur on starting, stopping and
with irregular dosing. Withdrawal can start up to four
weeks after stopping the drug and can go on for three
months
Complications include agitation, mania, psychosis and
self harm and suicide and violence and homicide.
International Journal of Risk & Safety in Medicine 16 (2003/2004) 31–49
31 IOS Press
Suicidality, violence and mania caused by selective serotonin reuptake
inhibitors (SSRIs): A review and analysis *
Peter R. Breggin
101 East State Street, No. 112, Ithaca, NY 14850, USA
Abstract:
Recognition of these adverse drug reactions and withdrawal from the offending
drugs can prevent misdiagnosis and the worsening of potentially severe
iatrogenic disorders. These findings also have forensic application in criminal,
malpractice, and product liability cases.
Evidence from many sources confirms that selective serotonin reuptake inhibitors
(SSRIs) commonly cause or exacerbate a wide range of abnormal mental and
behavioral conditions. These adverse drug reactions include the following
overlapping clinical phenomena: a stimulant profile that ranges from mild
agitation to manic psychoses, agitated depression, obsessive preoccupations
that are alien.
The possibility that a drug was causing the
effects it was supposed to cure was
unthinkable, especially by clinicians.
But it is accepted: SSRI-induced akathisia is
in the latest Diagnostic and Statistical
Manual, the ever expanding list of mental
disorders. DSM
How common is it?
A 2001: Yale: 8% of patients admitted ‘may
suffer’ from SSRI-induced mania or
psychosis.
Higher levels of prescribing in OZ and
including agitation, suicidal thoughts and
attempts,
its
more like 20%.
Preda A, MacLean RW, Mazure CM, Bowers MB (2001). Antidepressant associated
mania and psychosis resulting in psychiatric admission. J Clinical Psychiatry 62, 30-33
I will give you Daubert competent science.
Science that has passes 6 Daubert Hearings.
Scientific (as opposed to opinion) evidence is the
only kind of expert evidence admissible in
American and Australian courts
Scientific evidence that SSRIs cause:
Suicidal thinking
Suicidal acts
Completed suicide.
The 1993 US Supreme Court Decision in Daubert v. Merrell Dow
Pharmaceuticals altered the criteria by which scientific testimony
is admitted as evidence in court.
The unanimous ruling states that the criterion of the scientific
status of a theory is that it can be tested, refuted and falsified.
Scientific method is based on generating a null hypothesis, a
conjecture that something does not exist, and testing it to see if it
you can prove the contrary.
The unicorn does not exist. The prisoner is not guilty. These are
respectively good science and good law
Disproving the negative differentiates science from other
forms of inquiry
William Daubert, et ux., etc., et al., Petitioners v. Merrell Dow Pharmaceuticals,
The null hypothesis is:
SSRIs DO NOT CAUSE SUICIDE
We need to watch two numbers
RELATIVE RISK RR
SUICIDE RATE /100,000
And the range, which is the CONFIDENCE
INTERVAL CI indicating reliability
A Relative Risk, RR, is how many more
times SUICIDE and its precursors
THINKING OF SUICIDE AND
SUICIDAL ATTEMPTS
occur in SSRI-TREATED PATIENTS
over and above
those treated with a Tricyclic
or not treated at all.
If a medicine saves some depressed patients
from committing suicide, the RR between that
medicine and no treatment should be less than 1.
Tricyclics generally had an RR of 0.5 against no
treatment, in “hospital” depressions, in which
suicides were a known risk.
Tricyclics halved the number of suicides in a
seriously depressed population.
Tricyclics were known to cause suicide by
energising the depressed, but RR was still
favourable.
If the relative risk equals 1.0, the risk in treated
individuals is the same as the risk in untreated
ones.
If the relative risk is more than 1.0, the risk in
treated is greater than in untreated.
As we are trying to prevent suicide, an RR of 1
would be ominous.
Eli Lilly (Prozac) Pfizer (Zoloft) and GSK (Aropax)
proposed in 1999, the cut off point of
SIGNIFICANCE, Relative Risk, RR, be 2.0.
Ridiculously HIGH by any standard.
Corporate chutzpah.
Exposure to asbestos
is deemed contributory to cancer if the RR is only
1.2 which is 20% higher.
Asbestos was never expected to PREVENT
cancer.
AN RR OF 2 IS FIVE TIMES THAT.
The evidence for suicide induction can be found in many
areas of research
1.
2.
3.
4.
CLINICAL PSYCHIATRY
Observations and mechanisms
Challenge-Dechallenge-Rechallenge experiments
Studies of NEW suicidal ideation, (Fava)
SUICIDE EPIDEMIOLOGY
SUICIDES BY PRESCRIBED DRUG
JICK, UK
DSRU
DONOVAN
POPULATION STUDIES , PRIMARY CARE
HEALY AND BOARDMAN
HEALTHY VOLUNTEER STUDIES
RANDOM CONTROL TRIALS (RCTs)
The evidence from all these sources is overwhelmingly supports a relative risk of
CLINICAL PSYCHIATRY 1990
American Journal of Psychiatry. 147(2):207-10, 1990 Feb.
Six developed intense, violent suicidal
preoccupation after 2-7 weeks of Prozac which persisted 3
days to 3 months after Prozac was stopped.
Abstract Teicher Glod and Cole.
None had ever experienced a similar state .
Drug companies called this ‘anecdotal’ and said
“It’s the disease not the drug, doctor”
Now scores of such reports,
patients treated for anxiety, eating disorders,OCD and
menstrual problems and children
CLINICAL PSYCHIATRY
Teicher and Cole (1993) delineate 9 “clinical
mechanisms” by which SSRIs can induce or
exacerbate suicidal tendencies by:
(1) energizing depressed patients,
(2) paradoxically worsening their depression ,
(3) inducing akathisia,
(4) inducing panic attacks,
(5) switching patients to mania or hypomania,
(6) causing insomnia or interfering with sleep
architecture (esp. with REM sleep),
(7) inducing an organic obsessional state,
(8) promoting personality disorder with borderline traits,
(9) producing EEG or other neurological disturbances.
Those at risk of suicide are agitated,in
turmoil, nervous, sleepless, pacing,
energized, almost manic, and they reject
their obsessive suicidal thoughts as
‘strange’, ‘weird,’‘not me’.
This can go on for weeks or
can turn into suicide unpredictably in a matter of
minutes.
Teicher and Cole, 1993 Healy, Langmaak, and Savage, 1999;
’
•
The traditional suicidogenic triumvirate of psychotropic drug
reactions are
1) akathisia,
(2) emotional blunting, also called psychic numbing “I cannot
feel anything, do not care” and/or
(3) psychotic decompensation
Akathisia is turmoil, feeling numb as if nothing matters, and feeling
one is going mad.
It can happen over weeks or days, or very very quickly, in a matter
of minutes.
Teicher and Cole, 1993
Healy, Langmaak, and Savage, 1999;
CLINICAL PSYCHIATRY
1991: Suicidal thinking (out of the blue)
Fava and Rosenbaum found suicidal
thinking developed in patients who had
never been suicidal before, more on Prozac
than on other drugs.
Prozac v TCAs = RR = 2.7
Scores of reports
Fava, M. & Rosenbaum, J. 1991. Suicide and 3 fluoxetine. Journal of Clinical
Psychiatry, 52-5.
CLINICAL PSYCHIATRY
SUICIDAL ACTS
2 of 26 depressed patients overdosed in
the first 2 weeks when Prozac was
increased quickly.
7.6% is an extremely high rate.
M. Muijen, et al., A Comparative Clinical Trial of Fluoxetine, Mianserin, and
Placebo in Depressed Outpatients, Acta Psychiatrica Scandinavica, Vol. 78
(1988), pgs. 384-390).
CLINICAL PSYCHIATRY
Challenge-Dechallenge-Rechallenge CDR
There are many Challenge-DechallengeRechallenge studies.
Suicidality starts on drug,
clears up when it is stopped
and
Reappears on re-exposure, even to another SSRI.
SUICIDE EPIDEMIOLOGY: JICK
Against concerns that Britain’s most popular TCA
antidepressant, Prothiaden, dangerously toxic in
overdose
and being labeled as a ‘dirty drug by SSRI mfrs.
Jick examined
172,598 persons and 1.2 million scripts for 10
antidepressants,
old and new,
general practice patients
143 had committed suicide.
Jick S, Dean AD, Jick H (1995). Antidepressants and suicide. British Medical
Journal 310: 215-218
SUICIDE EPIDEMIOLOGY : JICK
Prothiaden turned out to be the safest as only 14%
of suicides involved antidepressant overdose.
RR of SUICIDE
Prozac v all TCAs
Prozac v Tofranil
Prozac v Amitriptyline
Prozac v Prothiaden
Prozac v Lofepramine
RR =
RR =
RR =
RR =
RR =
6.6
1.9
4.0
2.1
4.04
SSRI overdoses are not fatal. SSRI suicides tend to be violent: hanging,
drowning, shooting, jumping, stabbing or cutting, dying on a railway,
burning, electrocution, or deliberate road accidents.
Jick Relative risks compared with
Dru g
Dothiepin
con trol s
N= 823
Adj RR an d C I
doth i epi n
ami tryptali n
C l omiprami n
C as e
s N=
76
37
15
4
308
223
51
1.0
0.5 (0.3-1.0)
0.7 (0.2 to 2.0)
Imiprami ne
Flu pe n th i xol
Lofe pram in e
Mi an se rin
4
6
1
5
56
49
36
41
0.5
0.9
0.2
1.1
Fluoxetine
3
18
2.1 (0.6 to 7.9)
Doxepi n
Traz odon e
1
0
19
12
0.5 (0.1 to 3.7)
(0.2 to 1.5)
(0.4 to 2.4)
(<0.1 to 1.7)
(0.4 to 3.2)
SUICIDE EPIDEMIOLOGY: JICK
Jick was embarrassed and suggested that ‘selected’
patients may have been given Prozac, which had a high
suicide rate attached.
SUICIDE EPIDEMIOLOGY : DRUG SAFETY
RESEARCH UNIT UK (50,000 pop.)
The DSRU follows up drugs in the community
it looked at completed suicides and
what medicines they had been prescribed.
Suicide rate on SSRIs = 219/100,000.
Prozac
244/100,000
Aropax
269/100,000
Luvox
183/100,000
SUICIDE EPIDEMIOLOGY
Table 8:
Drug
Drug Safety Research Unit Studies of SSRIs & Mirtazapine in Primary
Care in the United Kingdom.
No. Patients
No. Suicides
Fluoxetine
Se rtraline
Se roxat/Paxil
Fluvoxamine
12692
12734
13741
10983
31
22
37
20
Suicides/
100,000 Patients
244 (C.I. 168 – 340)
173 (C.I. 110 – 255)
269 (C.I. 192 – 365)
183 (C.I. 114 – 274)
Total SSRIs
50150
110
219/100,000
Mirtaz apine
13,554
13
96 (C.I. 53 – 158)
The suicide rate in UK primary care on these antidepressants is of the order of
200/100,000patients.
Boardman and Healy investigated
475,000 over 5 years
counting all the mood disorders in
all the private practices and
suicide rates for these disorders
SUICIDE EPIDEMIOLOGY Boardman &Healy
North
Staffs
467,000
X 5 Years
Number of
Suicides
Primary
Care
Any
Any
Primary
Disorder Affective Affective Primary
Disorder Disorder Affective
Disorder
212
180
115
41
Rate of
Suicide
9/
100,000
7.6/
100,000
4.7/
100,000
1.7/
100,000
Suicide
30/
68/
48/
27/
Prevalence
100,000 100,000 100,000 100,000
SUICIDE EPIDEMIOLOGY: Boardman &Healy
PRIMARY CARE SUICIDE RATES
All mental disorders
< 27-67/100,000.
Fits in with other primary care mood
disorders suicide statistics
Holland
Sweden
Antedating SSRIs Simon, von Korff
Highest UK rate
30/100,000
0/100,000
30/100,000
68/100,000
Boardman AP, Healy D. Madeley suicide risk in primary care primary affective disorders. European
Psychiatry. 2001; 16: 400-405.
SUICIDE EPIDEMIOLOGY: DONOVAN
again sought to establish the safety of SSRIs against TCAs which
were toxic in overdose.
Examined 222 COMPLETED SUICIDES,
and the medicines they had been taking,
and found
SSRIs v TCA
RR= 2
Donovan S, Kelleher MJ, Lambourn J, Foster R. The occurrence of suicide
following the prescription of antidepressant drugs. Arch Suic Res. 1999; 5:
181-192.
SUICIDAL ACTS: DONOVAN
At the same time, DONOVAN looked at 2776 acts
of DELIBERATE SELF HARM in 1954 persons
presenting to emergency and what they were taking
Aropax v Tryptanol (TCA)
Prozac v Tryptanol (TCA)
Zoloft v Tryptanol (TCA)
Aropax v Tofranil (TCA)
All SSRI v Tofranil (TCA)
RR = 4.0
RR = 6.6
RR = 4.9
RR = 1.9
RR = 5.5
Donovan S, Clayton A, Beeharry M, Jones S, Kirk C, Waters K, Gardner D, Faulding J,
Madely R. Deliberate self-harm and antidepressant drugs. Investigation of a possible
link. Brit J Psychiatry. 2000; 177: 551-556
HEALTHY VOLUNTEERS
Healy: 2 of 20 healthy volunteers suicidal on Zoloft.
Healthy Volunteer Studies
DRUG
PUBLISHED
DONE
PROZAC
12
of
53
AROPAX
14
of
35
ZOLOFT
7
of
35
1 healthy volunteer suicide in an Aropax trial was not reported
2 healthy volunteers have suicided:
19 year old Traci Johnston, a healthy
volunteer,
suicided February 7th 2004 in a trial of Eli
Lilly's new Serotonin drug - duloxetine, for
incontinence
aborting the trial
Reported in Sydney Morning Herald
Lilly had been doing clinical trials in
Australia
Result:
You cannot set up a trial to see how many
people kill themselves as a consequence of
the drug you are testing
It would be impossible to get insurance
or ethics approval.
Or informed consent?
Have to make do with information we have.
Emergence of antidepressant suicidality, published in 2000 in Primary Care
Psychiatry (Vol. 6, No. 1).
RANDOM CONTROLLED TRIALS (RCTs)
SUICIDES AND SUICIDAL ACTS
2003, Khan et al. looked at
BLIND CLINICAL TRIALS from 1986-90
Presented to the US Federal Drug Administration,
to get SSRIs licensed.
FOR
9 Serotonin ANTIDEPRESSANTS
against
comparators and placebos.
Kahn found NO DIFFERENCE
in suicides and suicidal acts between
those on SSRIs
or on COMPARATOR DRUGS
or PLACEBOS
48,277 depressed patients participated in the trials,and
77 committed suicide. That’s a lot.
Am J Psychiatry. 2003 Apr;160(4):790-2.
RANDOM CONTROLLED TRIALS
SSRIs had failed to demonstrate usefulness in hospital
depressions. (We still give as much ECT as we ever did)
so ‘hospital patients’ carrying suicide risk were
not recruited into these trials.
SSRIs were aimed at general practice.
‘Samples of convenience’
patients under stress, with minor disorders,
The Valium using population of the 1970s
With suicidal patients filtered out.
In September of 2003, Healy and Whittaker re-evaluated
the same, original FDA studies.
They published a watershed paper in September 2003.
Antidepressants and suicide:
risk–benefit conundrums
David Healy, MD; Chris Whitaker,
MSc
Healy — Department of Psychological Medicine, University of
Wales College of Medicine, Hergest Unit; Whitaker —
Department of Informatics, University of Wales Bangor, Bangor, United Kingdom.
J Psychiatry Neurosci 2003;28(5):331-7
Whereas Kahn had coded as ‘placebo suicides’
those within 2 weeks of stopping an SSRI
Healy and Whittaker
recognised these 5 SUICIDES
and MANY SUICIDAL ACTS
AS
‘SSRI WITHDRAWAL SUICIDES’.
Khan had counted
suicides per number of patient
years exposed to the drug, PEYs.
Healy counted
suicides per number of patients
treated
Healy argued that the risks of SSRIs
resembled the risks of space travel which,
mile for mile, was the safest form of
transport available.
But going up and coming down are the
danger periods for both.
But landing and re-entry occurs each time a
dose is forgotten, not absorbed, taken with
alcohol or if a co-prescribed medicine is
added or removed.
Incidence of Suicides and Attempts in Trials From FDA Medical Reviews
Inve s t igational Dr ug
ZOLOFT
Active comparator
Placebo
Placebo Washout
AROPAX
Active comparator
Placebo
Placebo Washout
SERZONE
Active comparator
Placebo
AVANZA
Active comparator
Placebo
CIPRAMIL
Placebo
PROZAC
Placebo
Placebo Washout
EFFEXOR
Placebo
Patie nt
No
Suicide
No
Suicidal
Act No
2
0
0
0
5
3
0
2
9
0
0
7
1
2
3
0.44%
0.17%
0.25%
40
12
3
2
1.52%
1.30%
0.54%
12
6
1
2,425
977
494
8
2
0
29
5
3
4,168
691
8
1
1
0
1
7
1
91
10
0.60%
0.63%
0.11%
1.53%
0.72%
0.61%
2.38%
1.59%
0.91%
0.00%
2,053
595
786
2,963
1151
554
3,496
958
875
1,427
370
3082
739
12
0
0
36
2
Suicide s &
Acts as a % of
Patie nt No
1.40%
0.41%
Summary: Incidence of Suicides
and
Suicide Attempts (combined) in
Antidepressant Trials From FDA Medical Reviews
DRUG
Suicides
S/Acts
Suicide
Number
Suicide Rate/
100,000
Suicide and
Acts %
All Inve s tigational
dr ugs
21,556
43
232/100,000
1.28%
All SSRIs
13,693
23
186/100,000
1.53%
Active com par ator
3,681
5
24/100,000
0.79%
Total Placebo
4,879
2
21/100,000
0.47%
SSRI Trial Place bo
3,140
2
16/100,000
0.57%
Healy D, Whitaker CJ (2003). Antidepressants and suicide; Risk-Benefit Conundrums. J
Psychiatry & Neuroscience 28 (5) 331-339, with response by Y Lapierre 340-349.
FDA TRIALS SUMMARY 26,000 subjects
SUICIDE RATES
ALL DRUGS SUICIDE
SSRI SUICIDE
PLACEBO SUICIDE
=
=
=
232/100,000
186/100,000
64/100,000
RELATIVE RISK FDA TRIALS
SUICIDE ON SSRI
RR = 2.4 (CI 0.6-10.2)
SUICIDAL ACT ON SSRIS
RR = 2.2 (CI 1.4-3.5)
S/ ACTS ON NEW ANTIDEPRESSANTS
RR = 4.3 (CI 1.1-17.8)
SUICIDE RATES
DRUG SAFETY RESEARCH UNIT
SSRI SUICIDE
=
212/100,000
JICK
PROZAC in first 30 days of treatment
274/100,000 PEYs
PROZAC
93/100,000
SUICIDE EPIDEMIOLOGY: Boardman & Healy
and many others
Antedating SSRIs
PRIMARY CARE SUICIDE RATES < 27-68/100,000
MAXIMUM ANY POPULATION STUDY
68/100,000
Boardman AP, Healy D. Madeley suicide risk in primary care primary affective disorders. European
Psychiatry. 2001; 16: 400-405.
Healy and Whittaker’s conclusion was modest:
It is no longer possible to support the null
hypothesis that SSRIs do not cause suicide
The null hypothesis has been falsified.
Any way you look at available information,
clinical settings,emergency rooms,
morgues, clinical trials,
SSRIs as a general cause of suicide would
pass the scientific standard of proof.
The BMJ issued warnings on February 5 2004.
FDA on March 23
Most manufacturers put on Websites on May 3, 2004.
Only in USA.
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 patients treated with these agents for
worsening depression or the emergence of suicidality. The
drugs that are the focus of this new Warning are: Prozac (fluoxetine);
Zoloft (Sertraline); Paxil (paroxetine); Luvox (fluovoxamine); Celexa
(citalopram); Lexapro (escitalopram); Wellbutrin (bupropion); Effexor
(venlafaxine); Serzone (nefazodone);
WARNING MAY 3 2004
… patients being treated with
antidepressants should be
observed closely for clinical
worsening and suicidality,
especially at the beginning of a
course of drug therapy, or at the
time of dose changes, either
increases or decreases.
WARNING MAY 3 2004 Families and
caregivers of patients being treated with
antidepressants for major depressive
disorder or other indications, both
psychiatric and non-psychiatric, should
be alerted about the need to monitor
patients for the emergence of agitation,
irritability, as well as the emergence of
suicidality, and to report such symptoms
immediately to health care providers
Unlike smallpox, depression has not been
disappeared since a cure became available
Potentially fatal complications of any treatment
might be acceptable if the treated population
were small, dangerously ill, at high risk
the availability of a remedy
has increased the diagnosis of depression a
thousandfold.
and lethal side effects have increased by the
same multiplier.
The drug manufacturers promote the
medicalization of stress
subsidize psychiatrists, journals, conferences.
Encourage moral entrepreneurs of health who
talk about cases undiagnosed, and so untreated
John Merson calls this phenomenon ‘epistemic
capture’: the control of knowledge by vested
interests.
200/100,000 represents 1 death in 500
people treated with SSRIs in primary care.
68/100,000 v 200/100,000
A least 100 suicides per 100,000 over
treatment with other drugs or non treatment.
By 2003, over 28 million people had started
Prozac since its launch in 1988.
6,664,960 prescriptions for SSRI
written 2003 by Australian doctors.
Twelve times the annual number studied by
Donovan
40% of first prescriptions remain unfinished,
because of side effects.
PBS spends $160 million a year on SSRIs.
Cui Bono?
I in 500
too rare for clinicians to see.
They need advice from suicide epidemiologists and
statisticians.
Opinion evidence is not admissible. ‘We are not
convinced’ and ad hominem arguments do not get
admitted as evidence.
1 in 500
is well above Rogers and Whittaker’s,
1 in 14,000
and demands a duty to warn of a catastrophic side
effect.
Someone has that duty.
Who will tell the prescribing doctor? The manufacturers
have not done so in Austrlalia.
The Therapeutic Goods Administration has not issued
warnings.
The Federal Drug Administration in USA argues that its
role is licensing drugs, not protecting the public.
Psychiatrists, all clinicians, are ‘not convinced’.
Some more alarming informataion has emerged from
David Healy's re evaluation of the clinical trials of
antipsychotic drugs presented to the FDA.
It concerns commonly prescribed antipsychotic drugs
The regulator, the FDA, just did not notice in the late
1980s that one in 208 or 12 in 2,500 clinical trial subjects
committed suicide while Zyprexa was being trialled and
only one on placebo and one on a comparator, most
likely haloperidol did that.
SUICIDAL ACTS IN ANTIPSYCHOTIC TRIALS
DRUG
PATIENT NO
SUICIDES
SUICIDAL ACTS
Risperdal
2607
9
43
Comparator
601
1
5
Placebo
195
0
1
Zyprexa
2500
12
??
Comparator
810
1
(2)
??
Placebo
236
0
(1)
??
Seroquel
2523
1
4
Comparator
426
0
2
Placebo
206
0
0
2194
5
20
Comparator
632
0
2
Placebo
290
0
1
Geodon
2993
6
??
Comparator
951
1
??
Sertindole
Placebo
The subject numbers are so small that relative risk
cannot be calculated, but Zyprexa (Olanzepine) trials
had the highest rate of suicide in clinical trial history.
Suicidal Acts have not been reported
Risperdal was not far behind Zyprexa.
The mechanism is thought to be similar,through causing
akathisia and doing these drugs synergistically with
SSRIs.
Doctors have not been warned.
All Truth passes through Three Stages:
First, it is Ridiculed...
Second, it is Violently Opposed...
Third, it is Accepted as being SelfEvident.
Arthur Schopenhauer (1778-1860)
In Friedson’s account, moral entrepreneurs in
medicine are commonly part-time practitioners
who
crusade
in
health
matters.
The thrust of their activity is towards political
power as they seek to implement measures
designed to improve what they see as public
health.
They give press interviews and try to give
testimony in court.
They are often responsible for legislation. They want to
place jurisdiction for their concerns in the hands of
health professionals rather than leave them with
society.
Freidson identified lay interest groups, sometimes led
by, and always including, prominent physicians, whom
he described as ‘the most flamboyant moral
entrepreneurs of health, untrammelled by professional
dignity, crusading against the menace of a specially
chosen disease, impairment or disease-producing
agent’
Such moral entrepreneurs, essential players in
any
moral
panic,
are
ubiquitous.
Professional entrepreneurs are creating panics
about the consequences of child sexual abuse,
others about failing to have professionals attend
immediately on persons involved in traumatic
events and about depression which had
become the greatest scourge of modern
society.
They advert to cases of undiagnosed and
untreated post-traumatic stress disorder and
depression, which medication would surely
cure.
They attribute to these evils a status of being
important causes of personal failure and
society’s
epidemic
ills.
Physician moral entrepreneurs are likely to see the
environment as more dangerous to health than does the
layman, and to emphasise the seriousness of the health
problem preoccupying them by estimating the cases
probably undiagnosed and therefore untreated.
They are disposed to see mental illness where
the layman sees nervousness, to see illness
where the layman sees variations within the
broad range of normality, to see a serious
problem where the layman sees only a minor
one. They are biased towards the creation of
sick roles and press their licence as physicians
to manage the newly defined sick within their
relevant
speciality
frameworks.
In
brief,
the
medical
profession is more prone to
see illness and the need for
treatment than it is to see
health and normality. This
selective perception is both
self-confirming
and
selfsustaining.