ANTIDEPRESSANTS
For the past decade and a half (since 1990), Baum Hedlund
has represented more than 100 individuals across the country
in suicide and suicide attempt cases involving SSRI antidepressants,
including Paxil, Zoloft and Prozac.
Through litigation,
Baum Hedlund (www.baumhedlundlaw.com) has obtained internal
company documents to which no one else has access, not even
the FDA. Almost all of these documents are labeled confidential
by the drug companies. Generally speaking, the only time
these documents become publicly available is when a case
goes to trial (only 3 have gone to trial). Nevertheless,
short of trial, Baum Hedlund has fought the companies to
get the documents out from under confidentiality seal by
seeking court orders to release the documents or by getting
the companies to concede that the documents should never
have been designated as confidential to begin with.
As a result, a number of documents are now available to
the public (although too many remain hidden and secret). Click
here to read some of internal FDA/drug company documents
that are no longer labeled confidential.
http://www.baumhedlundlaw.com/safety/bhlaw-ssridocs.php
Decide for yourself if they should have been classified
as trade secret and/or confidential for many years.
Below
is excerpts from Baum Hedlund's Submitted Written
Comments to the December 2006 FDA PDAC regarding results
of FDA's ongoing meta-analysis of suicidality date from the
adult antidepressant trials.
INTERNAL DOCUMENTS SHOW THAT GERMAN REGULATORS WOULD NOT
APPROVE PROZAC WITHOUT STRONGER SUICIDE WARNING 20 YEARS
AGO.
All of the Documents referenced in this submission can be
found at:
http://www.baumhedlundlaw.com/safety/bhlaw-ssridocs.php
According to documents obtained in litigation, as early
as 1984, German regulators had expressed concerns about Prozac
and an increased risk of suicidality:
May 25, 1984 internal memorandum from Eli Lilly and Company
(“Lilly,” the maker of Prozac) regarding Lilly’s
efforts to obtain registration of Prozac in Germany: “During
the treatment with the preparation [fluoxetine] 16 suicide
attempts were made, 2 of these with success. As patients
with a risk of suicide were excluded from the studies, it
is probable that this high proportion can be attributed to
an action of the preparation in the sence (sic) of an deterioration
of the clinical condition, which reached its lowest point.”
http://www.baumhedlundlaw.com/01.pdf
June 26, 1984, item # 10: “The BGA [German equivalent
of FDA] suspects fluoxetine [Prozac] to be a stimulating/activating
drug (side-effect profile, suicides, suicide attempts).” Item
# 14 states: “This is a very serious issue in the opinion
of the BGA. It might well be that we will have to recommend
concomitant tranquilizer intake for the first 2 or 3 weeks
in the package literature.”
http://www.baumhedlundlaw.com/02.pdf
January 29, 1985 states: “Two major concerns seem
to be the reason that the registration was not accepted,” “efficacy
questioned” and “suicidal risk.”
http://www.baumhedlundlaw.com/03.pdf
February 26, 1985 states: “The use of the preparations
seems objectionable, as the increase in agitating effect
occurs earlier than the mood elevating effect and therefore
an increased risk of suicide exists.”
http://www.baumhedlundlaw.com/04.pdf
April 1, 1986 memorandum, under a discussion of safety issues: “Still
not resolved is the fact that suicide attempts have been
observed more frequently on fluoxetine as compared to imipramine
. . . . According to the today's knowledge [fluoxetine’s “favourable” side
effect spectrum] is negatively affected by the increased
suicidal risk.”
http://www.baumhedlundlaw.com/05.pdf
August 30, 1989, Additional Feedback Regarding the Fluoxetine
Review by Commission A (an expert working/consultant group
to BGA), Item 3 states: “The counterindication because
of acute suicidality should become a warning whereby the
physicians should be advised that in the absence of sedation,
the risk of higher suicidality should be taken into account.”
http://www.baumhedlundlaw.com/06.pdf
FDA SAFETY OFFICER RECOGNIZED DANGEROUS SIDE EFFECT PROFILE
IN 1985.
According to FDA’s March 1985 Safety Review of Prozac,
conducted by Dr. Richard Kapit: “It is fluoxetine’s
particular profile of side effects which may perhaps, in
the future, give rise to the greatest clinical liabilities
in the use of this medication to treat depression.”
http://www.baumhedlundlaw.com/07.pdf
Under “Catastrophic and Serious Events,” Dr.
Kapit noted: “... 52 cases were [] subjected to review
of case reports on microfiche. Certain additional adverse
events, not reported by the Company, which were revealed
on microfiche, are also included in this tabulation. In most
cases, these adverse events involved the onset of an unreported
psychotic episode.”
http://www.baumhedlundlaw.com/08.pdf
Dr. Kapit explained: “[F]luoxetine’s profile
of adverse effects more closely resembles that of a stimulant
drug than one that causes sedation and gain of weight,” therefore, “fluoxetine
treatment might, at least temporarily, make their illness
worse.”
http://www.baumhedlundlaw.com/09.pdf
1991 – FDA’S FAILURE TO TAKE ACTION.
Notwithstanding the German government’s recognition
in the mid-1980's of an increased risk of suicidality and
Dr. Kapit’s concern over Prozac’s side effect
profile, the public concern over the risk of antidepressant-induced
suicidality did not emerge until 1990 when two prominent
Harvard psychiatrists, Drs. Martin Teicher and Jonathan Cole,
published a study entitled "Emergence of Intense Suicidal
Preoccupation During Fluoxetine [Prozac] Treatment.” From
their personal observations of patients taking Prozac, Drs.
Teicher and Cole, after first noting that four of the six
patients referenced in their study experienced akathisia
(a condition marked by profound inner restlessness and agitation),
found that “persistent, obsessive, and violent suicidal
thoughts emerged in a small minority of patients treated
with fluoxetine.”
http://www.baumhedlundlaw.com/10.pdf
The FDA thereafter assembled a group of psychiatrists to
serve on its PDAC to discuss the issue. The advisory committee
meeting took place on September 20, 1991.
Lilly assigned Dr. Gary Tollefson to testify at the September
1991PDAC. According to his November 16, 1994 testimony in
the Prozac case, Fentress v. Shea et al., Case No. 90-CI-06033,
he did not disclose to the FDA the fact that the issue had
been raised by the German government in 1984/1985. Dr. Tollefson
testified:
Q. . . . Doctor [Tollefson], to back
up a little bit, earlier you said . . . that the first time
the issue of using Prozac and the incidence of suicide was
raised [was] in 1990 by Doctor Teicher's article; correct?
A. It was the first time that I was aware
of the issue having arisen at that time.
Q. Okay. So let's make sure we're clear
on this. That issue was raised by the German government back
in 1984; correct?
A. I have heard that indication, yes.
* * *
Q. Were you aware in 1991, when you testified
before the PDAC, that Lilly had in fact hired experts back
in 1985 and 1986 to look at [the suicide] issue with regards
to the German government?
A. I had heard that there were some individuals
that have consulted previously with Lilly on those issues
but did not know specifically whether it was related to the
BGA or the issue in general.
Q. Okay. Did you tell the PDAC in 1991,
that Lilly had previously - and I'm talking about prior to
Doctor Teicher raising the issue, that Lilly had previously
hired experts to look at the issue of increased suicide and
the use of Prozac?
A. I think as part of the presentation
it was made clear that a very thorough and comprehensive
analysis of the worldwide data on suicide and Prozac had
been made.
* * *
Q. Let's try it one more time. Specifically,
did you tell the PDAC that prior to 1990, when the German
government raised this issue, that Lilly hired experts to
investigate the issue of increased suicide and the use of
Prozac, yes or no?
A. That was not a question I was asked
by the PDAC, so I did not answer that question.
Q. Did you volunteer it?
A. No.
* * *
Q. Did you inform the committee that
there was a package insert in use in Germany, on the day
of the advisory committee, that recommended the use of sedatives
in people who were suicidal or agitated on Prozac? . . .
A. That was not one of the points of
discussion.
Q. The answer is you didn't; right?
A. Again, I did not feel there would
be any reason.
Testimony of Dr. Gary Tollefson, transcript, p. 111:9-25;
114:10-115:15; 118:2-119:2:
http://www.baumhedlundlaw.com/11.pdf
FDA OFFICIALS TREAT 1991 PDAC AND SUICIDE RISK AS A "PUBLIC
RELATIONS PROBLEM".
Through documents obtained in litigation, we learned that
the FDA never took this issue seriously. According to a GlaxoSmithKline
(GSK) memorandum dated October 3, 1990, the FDA believed
the public controversy that had erupted concerning the potential
for antidepressants to increase the risk of suicide in adults
was, to the FDA, not “a real issue, but rather "a
public relations problem.” The FDA’s Dr. Martin
Brecher indicated to GSK that the FDA “does not think
it is an issue, but it needs to be addressed.” (http://www.baumhedlundlaw.com/12.pdf)
1991 PDAC Conclusion: “More research and data is needed”
Although the committee members ultimately voted that there
was insufficient data to conclude that Prozac caused suicide
(the question posed was: “Is there credible evidence
to support a conclusion that antidepressant drugs cause the
emergence and/or intensification of suicidality and/or other
violent behaviors?”), the FDA stated that it did “not
dismiss the possibility that antidepressants in general or
fluoxetine in particular may have the capacity to cause untoward
injurious behaviors and acts, and/or to intensify them.” The
FDA concluded that “more research is needed” and “asked
[Lilly] to develop plans to conduct new studies, including
clinical trials and epidemiological studies, studies that
could provide more direct answers to the questions that have
been raised” in the advisory committee meeting. See
the September 1991 PDAC Transcript at 128:18-24:
http://www.baumhedlundlaw.com/13.pdf
The FDA advisory committee only saw data from the Prozac
clinical trials. Had the committee seen the data from the
Paxil clinical trials, things might have ended quite differently.
After the FDA asked GSK to submit an analysis of its clinical
trial data in order to respond to the public’s concerns
about the risk of suicidality, GSK responded by inappropriately
adding suicide events that occurred in the placebo run-in/wash-out
period, thus masking Paxil’s suicidality risk. When
the placebo run-in/wash-outs are removed, Paxil users were
over 8 times more likely to have engaged in suicidal behavior
than those on placebo. At the time, had GSK properly reported
this to FDA and had FDA actually noticed the actual Paxil
suicidality risk, this would have had a devastating impact
on Paxil’s capacity to compete with Prozac, an SSRI
with an already established market, and, under proper FDA
supervision, may have even impacted Paxil’s ability
to have obtained FDA approval. Moreover, it would likely
have had a substantial impact upon the PDAC’s conclusions
and the whole history of the hidden risk of SSRI-induced
suicidality.
POST 1991 - NONE OF THE DRUG COMPANIES CONDUCTED FOLLOWUP
RESEARCH, NOR DID THE FDA PUSH THEM TO DO SO.
Despite the PDAC’s mandate that further research be
conducted, no such studies were ever conducted by Lilly or
any other SSRI producing company.
In fact, Lilly proposed a protocol for a “rechallenge” study
of patients who developed suicidal ideation while under Prozac
treatment, but never performed the study. In addition, a
more sensitive scale for detecting treatment emergent suicidality
was developed that could have been utilized in ongoing and
future clinical trials, however, the scale was never implemented.
According to Lilly’s answers to Interrogatories submitted
under oath in the lawsuit Biffle v. Eli Lilly: “Discussions
were had between Lilly and the FDA regarding possible data
analyses or clinical trial designs which would test whether
the Teicher assertions are in fact real. The FDA did not
request or require any action from Lilly nor suggest a particular
analytical of study approach. The discussions and question
as to whether additional studies be done were mooted by the
findings of the FDA Psychopharmacological Drug Advisory Committee
on September 20, 1991. No additional studies were conducted.”
http://www.baumhedlundlaw.com/14.pdf
This statement is demonstrably false. According to a letter
the FDA sent to Public Citizen in June 1992: “There
was a consensus [amongst the PDAC above] that more research
is needed to further explore the relationship between suicidality
and the use of not only Prozac, but other antidepressants
as well.” The FDA further stated that it would “continue
our careful evaluation of data in our spontaneous reporting
system and encourage additional research on this matter.”
http://www.baumhedlundlaw.com/15.pdf
None of the antidepressant manufacturers at the time nor
since then, has conducted a single safety oriented study
to examine the risk nor have they utilized more sensitive
measures to detect treatment-emergent suicidality.
LILLY'S ANALYSIS OF PROZAC CLINICAL TRIAL DATA CRITICIZED
BY OTHER DRUG COMPANIES AND FDA.
Lilly published its meta-analysis of Prozac clinical trial
data in 1991, which meta-analysis was hotly criticized. As
one scientist explained it, “the term meta-analysis
sounds rather grand, but it is worth no more than the quality
of the original data collection... What was needed was a
critical assessment, independent of the manufacturers, that
included assessment of the quality of data collection–and
not Eli Lilly’s employees deciding which clinical comments
should be ‘eliminated.’” Oswald, “Fluoxetine
and suicide” BMJ 1991 Oct 26;303(6809):1058-9. He concluded: “A
negative result of research, a failure to find something,
can arise from lack of sensitive research techniques.” Id.
According to an internal Pfizer memorandum obtained in litigation
and written by Pfizer’s top scientist at the time: “I
do not think fluoxetine are ‘out of the woods’ as
regards their association with violence/ suicidality. The
recent meta-analysis of controlled clinical trials (Beasley
et al, BMJ 303: 685-692, 1991) was initially followed by
favorable comment but skeptical voices remain. A recent re-analysis
of the data from this study using Monte-Carlo simulations
demonstrates the conclusions of the Beasley paper to be invalid
as this original meta-analysis had low power (LiWan PoA.
Pharmacoepidemiology and Drug Safety 2: 78-84, 1994).” January
20, 1994 memo from Roger Lane to Giller regarding Use of
Zoloft in Impulsive/ Aggressive Behaviour.
http://www.baumhedlundlaw.com/16.pdf
FDA epidemiologist, Dr. David Graham, also criticized Lilly’s
meta-analysis, which had been submitted to FDA in September
1990. In a document obtained from the FDA through the Freedom
of Information Act, Dr. Graham stated:
Suicidality. The firm [Lilly] reviewed data from NDA studies,
prefacing it with the acknowledgment that these trials were
not designed for the prospective evaluation of suicidality.
In these trials patients with current suicidal ideation were
excluded. Suicidal ideation was studied in two ways. The
first involved analysis of clinical comments ascertained
through non-probing, open-ended questions during the trial.
Also, at the beginning and end of the study, patients completed
a self-administered questionnaire, the Hamilton Rating Scale
for Depression, which included one question on suicide. This
question, referred to as HAMD-3, rated suicidal ideation
on an ordinal scale from 0 (absent) to 4 (severe ideation,
usually with an attempt). The capacity of these trials to
identify and describe the quality and intensity of suicidality
was low.
Dr. Graham made a number of other important points:
1.
Dr. Graham criticized Lilly’s “meta-analysis,” which
was being touted by Lilly as showing that there was no relationship
between Prozac and suicidality. ("In the meta-analysis
of suicidality from the IND trials, 76 fluoxetine cases were
excluded from analysis because the patients were in studies
or other trials lacking comparative controls.") (Graham
memo p. 4: http://www.baumhedlundlaw.com/17.pdf;
2.
Dr. Graham questioned Lilly's reliance
on an abstract by Fava & Rosenbaum which Lilly asserted
showed "no statistically significant differences among
rates of treatment-emergent suicidal ideation associated
with five classes of antidepressant therapy." (When
Dr. Graham re-analyzed Fava & Rosenbaum's data he found
that "Treatment-emergent suicidality was more frequent
among 'fluoxetine alone' than 'tricyclics with or without
lithium' patients. The relative risk of suicidality was 3.3.
(95% CL 0.9, 12.2), p-0.07.") (Graham memo p. 4);
3.
Dr. Graham validated the report
by Teicher, et al., which first discussed the relationship
between Prozac and suicide ("Interestingly, the proportion
of patients with treatment-emergent suicidality on fluoxetine
in this study was similar to that reported by Teicher et
al.") (p. 6).
4.
In conclusion, Dr. Graham stated: “The
firm’s analysis of suicidality does not resolve the
issue. The firm acknowledged that its clinical trials were
not designed to study this and specificity of data to be
gleaned from these trials to address suicidality were poor.
. . . Because of apparent largescale underrreporting, the
firm’s analysis cannot be considered as proving that
fluoxetine and violent behavior are unrelated.”
Clinical Trials are not designed to adequately test for
side effect of suicidality
The hypothesis of whether antidepressants cause suicidality
has never been prospectively studied. Clinical trials are
useful to prove that a drug has an intended effect, however,
they were not designed to determine questions such as whether
a drug is causing suicidality.
1. Clinical trial data is not a good measure to test rare
events.
Suicidality, particularly completed suicides, are rare events.
Patients who are suicidal are excluded from most clinical
trials, and a significant percentage of patients quit clinical
trials due to side effects.
*
Epidemiologists Gunnell and Ashby
(1995 BMJ article) wrote:
“Suicide is
rare, even among people with depression. [Cite omitted.]
Thus, most clinical trials have insufficient power to provide
clear evidence on the effect of antidepressants on suicide.”
* As the editor of the New England Journal
of Medicine thoughtfully explained:
First “a drug is
approved because it is more effective than placebo.” Then, “worries
emerge about its safety.” However, “few or no
adequately powered controlled trials [conducted by drug companies]
are conducted to address these issues.” Thus, “The
health care system has a hard time performing drug safety
analyses, in large part because it relies on the pharmaceutical
industry to conduct most research on the risks and benefits
of medications. It is naive to expect companies to voluntarily
fund studies that could sink lucrative products” and
further complicating matters is the fact that “the
FDA lacks regulatory clout to require them.” (N N Engl
J Med. 2006 Nov 23;355(21):2169-71)
http://www.baumhedlundlaw.com/18.pdf
* Epidemiologists Gunnell and Ashby (1995
BMJ article) wrote:“
Suicide is rare,
even among people with depression. [Cite omitted.] Thus,
most clinical trials have insufficient power to provide clear
evidence on the effect of antidepressants on suicide.”
Despite the unlikelihood that a statistically significant
increased risk will be found from clinical trials conducted
by drug companies to obtain FDA approval, meta-analyses of
both child/adolescent and adult clinical trials have revealed
a risk.
*
Dr. Thomas Newman, an epidemiologist
from the University of San Francisco and an advisor to the
FDA on the issue of child/adolescent suicidality (following
recommendations that antidepressants carry black box warnings)
noted that, the fact that higher rates of suicidality in
those taking antidepressants have emerged from the clinical
trials is “striking” and “such a dramatic
result would be expected to occur by chance only 1 time in
20,000.”
*
Dr. Newman observed that “some
FDA staff and committee members expressed reservations about
the data used for this analysis,” but as he explained, “these
concerns only made the results more compelling.” He
further stated: “The fact that an association emerged
from the meta-analysis ... for an outcome that the sponsors
of the trials were not looking for, and presumably did not
wish to find, was quite convincing.”
http://www.baumhedlundlaw.com/20.pdf
The fact that a risk has been detected in clinical trials
not intended to answer this question for an event that is
rare, even in depressed patients, makes the evidence even
stronger.
2. HAMD an insensitive measure of treatment-emergent suicidality
Rather than legitimately studying the link between their
drugs and suicidality, SSRI manufacturers have conducted
analyses of their clinical trial databases using a scale
called the “Hamilton Depression Scale” (HAMD),
a scale used to assess changes in the degree of depression
of patients enrolled in the clinical trials. The HAMD contains
one question concerning suicidality. It is an insensitive
measure of treatment-emergent suicidality. Nevertheless,
these analyses, inaccurately described as “thorough,” have
been used by the manufacturers to claim their drugs have
been “exonerated” against claims of increased
suicidality.
* Drs. Healy and Creaney criticized Lilly’s
analysis in 1991 and Lilly’s use of HAMD Item 3 to
analyze the risk (1991 British Medical Journal article):
Lilly’s “analysis
of whether there is an association between fluoxetine and
suicidality does not entirely settle the question raised
by Teicher/Cole of whether treatment with fluoxetine may
in certain instances lead to suicidal ideation.” There
were several reasons for this, the first being that “item
3 of the Hamilton scale for depression, ratings on which
provide the data for the analysis, is an insensitive measure
of suicidality ... the capacity of these trials to identify
and describe the quality and intensity of suicidality was
low.”
* Senior FDA epidemiologist, Dr. David
Graham was likewise skeptical of Lilly’s use of the
HAMD Item 3 measure:
Lilly’s “analysis
of suicidality does not resolve the issue.” (See
p. 4)
http://www.baumhedlundlaw.com/17.pdf
3. FDA finally acknowledge the inadequacy of its review
of SSRI suicide data
Unfortunately, it took FDA officials over a decade to figure
this out. Senior FDA officials recently acknowledged at the
Congressional hearings and the Advisory Committee hearings
in 2004 that its analysis of the SSRI-induced suicidality
was inadequate.
*
In testimony before Congress resulting
from investigations of the FDA’s failure to protect
consumers related to the antidepressant suicidality issue,
the FDA’s Dr. Robert Temple defended the agency’s
failure, stating that although the FDA “had been systematically
looking at the adult data for almost that entire decade” and
had “not seen a signal in that data,” Dr. Temple
admitted that the FDA’s analyses could have been far “better,
more structured, [and] more careful, ... but we didn’t
know to do that.” (See p. 100)
http://www.baumhedlundlaw.com/21.pdf
*
At the February 2, 2004, FDA advisory
committee meeting concerning the risk of suicidality in children
and adolescents taking antidepressants, the FDA’s Dr.
Thomas Laughren similarly explained: “Just one follow
up on a suggestion that has come up from several committee
members now about looking at items from the rating scales.
That was actually done here, and it turned out not to be
very helpful. Now, this was a similar analysis that had been
done with the adult data years ago. ... ” He explained
that this method “did not detect a signal in these
trials ... ” and admitted that the method was “was
not particularly productive.”
(http://www.baumhedlundlaw.com/22.pdf,
pp. 342-343.)
GSK’s May 2006 Analysis of Paxil Clinical Trials Confirms
Risk in Adults
For its meta-analysis of suicidality data from the adult
clinical trials, the FDA asked companies to submit data only
from short term depression studies up to 17 weeks, which
had at least 30 patients in the study. GSK decided to do
its own blinded analysis of its adult clinical trial data.
The results of the new analysis showed: “In adults
with MDD (all ages), there is a statistically significant
increase in the frequency of suicidal behavior in patients
treated with paroxetine compared with placebo.”
http://www.baumhedlundlaw.com/23.pdf
The masking of this risk in previous analyses was the result
of a contamination of the data-set from inappropriately included
anomalous studies. Once these studies were excluded due to
FDA’s criteria, the increased risk of suicidality in
adult patients taking Paxil, which had been evident from
GSK’s initial submission, reappeared. The odds ratio
is 6.7.
As a result of GSK’s recent analysis, GSK strengthened
Paxil’s label to include this new information and sent
a “Dear Doctor” letter to every doctor in the
United States including this information. Id.
THE QUESTION OF ANTIDEPRESSAENT EFFICIACY IS RAISED.
Doctors must weigh the benefits of drug treatment versus
the risks. In order to do a proper risk benefit analysis,
a doctor must be aware of the degree of effectiveness of
the drug – not just drug company hype. Is the drug
extremely effective or only marginally effective? Doctors
know the drug was approved by the FDA, but do they know the
FDA’s standards for approving a drug as effective?
In an analysis of efficacy data submitted to the FDA between
1987 and 1999 for six of the most popular selective serotonin
reuptake inhibitor (SSRI) antidepressants, 75 to 80% of the
response to medication was duplicated in placebo groups.
(Kirsch and Moore, "The Emperor’s New Drugs: An
Analysis of Antidepressant Medication Data Submitted to the
U.S. Food and Drug Administration," Prevention & Treatment,
Volume 5, Article 23, July 15, 2002.) These data were the
basis on which the medications were approved by the FDA.
The researchers explained that the “small difference
between the drug response and the placebo response has been
a ‘dirty little secret’ known to researchers
who conduct clinical trials, FDA reviewers, and a small group
of critics who analyzed the published data …” Kirsch,
Moore et al., "Antidepressants and Placebos: Secrets,
Revelations, and Unanswered Questions," Prevention & Treatment,
Volume 5, Article 33, posted July 15, 2002 http://www.baumhedlundlaw.com/24.pdf
and Moncrieff and Kirsch, "Efficacy of antidepressants
in adults" BMJ July 2005.
http://www.baumhedlundlaw.com/25.pdf
FDA approval of these drugs implies that the data were strong
enough and reliable enough to warrant approval, however,
as one FDA memorandum written by Dr. Paul Leber on December
24, 1991 illustrates, the FDA’s standards for approving
antidepressants as effective are not robust: “Approval
[of the antidepressant] may … come under attack by
constituencies that do not believe the agency is as demanding
as it ought to be in regard to its standards for establishing
the efficacy of antidepressant drug products.”
http://www.baumhedlundlaw.com/26.pdf
NO SCIENTIFICALLY RELIABLE EVIDENCE THAT DECLINING
SUICIDE RATES ARE THE RESULT OF INCREASED PRESCRIPTIONS
OF ANTIDEPRESSANTS
On the issue of national suicide rates going down and, in
particular, on the possible impact of antidepressants on
these rates, as one renowned expert has noted: “This
argument is like saying that, because there has been an increase
in storks seen recently and a coincidental increase in births,
babies are therefore brought by storks.” (Declaration
of Dr. David Healy, Tucker v. GSK.)
In fact, according to Gunnel et al. 1, "Antidepressants
and suicide: what is the balance of benefit and harm," British
Medical Journal (BMJ), 2004; 329:34-38 (3 July):
Surprisingly, direct evidence that antidepressants
prevent suicide is hard to find. ... In the most comprehensive
synthesis of data from randomised trials, Khan and colleagues
found no evidence of a beneficial effect of antidepressants
on suicide.
Gunnell, citing Khan A, Khan S, Kolts R, Brown WA. “Suicide
rates in clinical trials of SSRIs, other antidepressants,
and placebo: analysis of FDA reports,” Am J Psychiatry
2003;160: 790-2
The authors also pointed out that “Suicide is rare,
even among people with depression. [Cite omitted.] Thus,
most clinical trials have insufficient power to provide clear
evidence on the effect of antidepressants on suicide.” Gunnell
citing Jick SS, Dean AD, Jick H. Antidepressants and suicide.
BMJ 1995;310: 215-8.
According to a study by Herman Van Praag published recently
in World Journal of Biological Psychiatry titled “A
Stubborn Behaviour: the Failure of Antidepressants to Reduce
Suicide Rates,” despite the increased use of antidepressants “completed
suicide has remained quite stable” and “suicide
attempts even seem[] to have increased.”
CONCLUSION
For over a decade and a half, SSRI manufacturers
have enjoyed enormous financial benefits from the flawed
results of their defective analyses and their manipulations
of the clinical trial data. They have been further shielded
by their own failure to legitimately study and examine this
serious risk. Instead, they have relied on studies that were
not designed to detect a risk and conducted illegitimate
analyses from them. Like an ostrich, they stuck their heads
in the sand and pretended that no such risk could possibly
exist, so why look? They have blamed patients, arguing that
it’s “the
disease, not the drug.” The FDA, likewise, has been
derelict in its duties in protecting the public health on
this issue. While it appears that the FDA has finally taken
the issue more seriously, it is 20 years and thousands of
lives too late. Through [our] representation of the more
than 100 families who have lost loved ones to suicide or
who have attempted suicide themselves while under the influence
of an antidepressant, [we are] touched by a tremendous sense
of duty to prevent this terrible tragedy from continuing
to happen to others. [We are] motivated by our clients to
seek out and expose the truth so their loved ones’ deaths
will not be in vain.
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