SSRI
Experts Head To Washington
To Testify Before FDA Panel
By Evelyn Pringle
06 December, 2006
Countercurrents.org
On
December 13, 2006, the FDA’s Psychopharmacologic Drugs Advisory
Committee will hold a public hearing to review the suicidality data
from the adult selective serotonin reuptake inhibitor (SSRI) studies.
And, for what seems like
the umpteenth time, SSRI experts from all over the US, and as far away
as the UK, will travel to Washington to once again testify at yet another
hearing on the suicide risks associated with these drugs.
The committee is expected
to vote on whether the risk of SSRI-induced suicidality in adults should
be included in a Black Box warning on all SSRI labels, including Paxil,
Prozac, Zoloft, Lexapro, and Celexa.
The FDA should begin the
hearing by announcing that suicide rates for adults have not declined
at all in the US even with the massive wide-spread use of SSRIs. According
to a Federal study, by researchers from Harvard Medical School and elsewhere,
in the June 2005, Journal of the American Medical Association, despite
a dramatic increase in treatment with antidepressants in 2001-2003,
when compared to 1990-1992, the rates of suicidal ideation, gestures
and attempts among adults have remained basically unchanged.
There is probably no legal
expert in the US more qualified to testify about SSRIs than Baum Hedlund
attorney, Karen Barth-Menzies, and she will be at the hearing with bells
on. Over the past 10 years, she has represented thousands of clients
against SSRI makers.
By now, the FDA knows that
Ms Menzies makes no secret of the fact that she is outraged about the
over-prescribing of these powerful and dangerous drugs to all age groups
for nothing more than everyday problems.
This will be Ms Menzies'
fourth time up to bat. She has already testified three times at government
hearings. She first spoke at an FDA Psychopharmacologic Drugs and Pediatric
Advisory Committee hearing in February 2004, about the increased risk
of suicide in children and adolescents taking SSRIs.
At that particular hearing,
the famous SSRI litigator concluded her testimony by telling the panel:
"Put me out of business for the right reasons. Warn about these
drugs."
Many of Baum Hedlund's clients
who have suffered tragedies caused by SSRIs will be also be attending
the hearing and some will be speaking. However, a number of clients
who wanted to testify were not selected by the FDA's new "lottery"
system, and will not be permitted to speak. But Ms Menzies says she
plans to speak on their behalf.
She has first-hand knowledge
of how the drug companies hid the evidence about the suicide risks.
The documents that have been unearthed in litigation reveal that the
risk was known in the mid-1980's before the first SSRI, Prozac, was
approved for use in the US.
Because of Baum Hedlund's
work in the Prozac litigation, Ms Menzies has the ability to provide
the committee with the historical background on SSRIs, including internal
company documents that show how and why the SSRI suicide risk with adults
was obfuscated fifteen years ago during the first FDA advisory committee
hearings on the suicide issue.
She will explain exactly
how the clinical trial data was manipulated by SSRI makers to skew the
statistical analyses of suicidality. "Civil lawsuits," she
says, "have uncovered internal company documents to which not even
the FDA has access."
And she maintain that the
drug makers have purposely failed to conduct studies on the risk of
suicidality because they already knew such trials would produce negative
results.
In August 2004, Ms Menzies
testified before the California State Senate and called for better patient
informed consent about the risks associated with SSRIs.
Next, she testified at the
September 2004, FDA Advisory Committee's follow-up hearings and discussed
the lack of efficacy in SSRI treatment of children, as documented in
pediatric clinical trials that had surfaced during litigation.
In between the February and
September 2004 hearings, Ms Menzies met with members of Congress to
discuss SSRI related suicidality and the FDA's failure to alert the
public about the dangers of SSRIs, and provided documentary evidence
to show that the risks posed were real.
She also provided information
to investigators in two separate Congressional investigations that resulted
in two hearings in 2004, at which drug company executives and FDA officials
were interrogated and chastised by members of Congress.
In addition to Ms Menzies,
one of the world's most highly regarded SSRI experts, Dr David Healy,
a professor at North Wales Department of Psychological Medicine, at
Cardiff University, will be flying in from the UK to testify at the
hearing. He too will give a repeat performance.
Dr Healy has authored 12
books including, Let Them Eat Prozac, The Antidepressant Era, and The
Creation of Psychopharmacology, and is known to be outspoken when he
believes it is necessary. During his testimony at this hearing, Dr Healy
says he plans to draw attention to the manipulation of the clinical
trial data on SSRIs.
For over a decade, he has
been trying to raise awareness about the link between SSRIs and suicide.
Back in August 1991, Dr Healy authored the paper, "Antidepressant
Induced Suicidal Ideation," in which he said that the cases of
two patient "suggest that the emergence of suicidal ideation on
antidepressants cannot always be attributed to a lifting of psychomotor
retardation but rather that the ideas may in some instances be produced
by antidepressants."
Three years later in 1994,
he authored the paper, "The Fluoxetine and Suicide Controversy,"
and stated, "In the opinion of this author, the volume of case
reports and other studies is sufficient to demonstrate that antidepressants
and antipsychotics may induce suicidal ideation in certain individuals
under certain conditions."
After the February 2004 advisory
committee hearings, Dr Healy analyzed the data from the pediatric SSRI
trials on suicidality and hostility, including those kept hidden for
years, and sent his analysis to the FDA on February 19, 2004.
To distinguish the difference
between suicide possibly caused by SSRIs verses suicide caused by an
underlying illness of depression, Dr Healy broke down the studies into
a group of children being treated for depression and a group of anxious
children who were being treated for obsessive compulsive disorder or
social phobia.
From a pool of 931 depressed
patients taking SSRIs versus 811 depressed patients taking placebo,
Dr Healy determined that there were 52 suicidal acts by patients on
SSRI versus 18 in the placebo group.
In a pool of 638 anxious
patients taking SSRIs versus 562 anxious patients taking a placebo,
there were 10 suicidal acts in the SSRI group versus 1 in the placebo
group.
When these data sets were
combined, in the 1569 patients on SSRIs there were 62 episodes of suicidality
versus only 19 episodes in 1373 patients on a placebo.
This analysis clearly shows
that SSRIs can cause some children who were not depressed to begin with
to become suicidal.
Dr Healy believes the FDA
should do more about the industry's practice of paying medical professionals
to publish fraudulent research papers ghostwritten by PR firms. "While
it is not FDA's brief to regulate the academic literature," he
states, "the possibilities of a close to fraudulent representation
of data and of extensive ghostwriting does set up an argument that these
apparently scientific articles are in fact infomercials rather than
the real thing."
"If these articles are
essentially advertisements," Dr Healy says, "it is much less
clear that FDA can throw their hands up and plead an inability to do
anything about the production of such materials."
Former Federal fraud investigator,
Allen Jones, will also be testifying at the hearing and he too has testified
before about the over-promotion and marketing of psychiatric drugs.
"The pervasive manipulation
of clinical trials, the non-reporting of negative trials and the cover-up
of debilitating and deadly side effects," Mr Jones says, "makes
it impossible to prescribe, or take, these drugs with any level of meaningful
informed consent."
"Doctors and patients
alike," he states, "have been betrayed by the governmental
entities and officials who are supposed to protect them."
During an investigation in
Pennsylvania, Mr Jones learned all about Big Pharma's methods promoting
the sale of psychiatric drugs by corrupting public officials and says,
"conflicts of interest permeate the testing, approval and marketing
of drugs in America."
"Academic researchers
with industry ties," he explains, "put favorable spin on dubious
clinical trial results and then the embellished results are presented
to FDA Advisory Boards peopled with Pharma consultants, grantees and
advisors."
"These results,"
he reports, "are further embellished in medical journals by still
more academics on drug company payrolls."
From there, he says, this
body of misleading research becomes institutionalized by "expert
panels" in treatment guidelines generated by additional academics
and researchers with financial ties to the industry.
As a fraud investigator,
he discovered a hidden account in Pennsylvania where drug companies
were funneling money to the state employees who were in charge of deciding
which psychiatric drugs could be included in the treatment guidelines
for the official list of drugs covered by public health plans like Medicaid
and prescribed to people in all state institutions and programs.
According to Mr Jones, the
employees "were given unrestricted educational grants that were
deposited into an off-the-books account, unregistered, unmonitored,
literally operated out of a drawer."
Mr Jones also found that the drug makers were paying these same state
employees honorariums of up to $2,000 to speak at industry events and
giving them perks such as lavish meals and trips.
After the SSRIs and atypical
antipsychotics were successfully added to the state formulary list,
Mr Jones reports, Pennsylvania spent a combined total of $139 million
in 2003, for those 2 classes of drugs alone.
Last month, the former Pennsylvania
Chief Pharmacist, identified as being on the take by Mr Jones during
his investigation, was indicted on felony and misdemeanor conflicts
of interest charges involving accepting money from drug companies while
a state employee with great influence over the drugs that would added
to the state formularies to be prescribed to patients in Pennsylvania.
"I predict we will be
seeing many more prosecutions of this type," Mr Jones says, "as
the extent of drug company corruption of government officials becomes
known."
Another prominent SSRI expert
making a return visit to testify once again is Dr Joe Glenmullen, a
psychiatrist and clinical instructor in psychiatry at Harvard Medical
School, and the author of the book, "Prozac Backlash," which
describes his experiences of watching patients become suicidal while
taking SSRIs.
He has testified previously
about a specific side effect of SSRIs called akathisia, that he and
many other experts say, can make some patients so agitated that they
feel death would be a welcome relief.
"This side effect is
so well established," Dr Glenmullen told a previous panel, "that
it is clearly described with SSRIs in the Diagnostic and Statistical
Manual, the DSM, the American Psychiatric Association's official diagnostic
manual."
"If you look at the
transcript of the FDA hearing on this very side effect 10 years ago,"
he stated, "you will see the FDA saying repeatedly we don't know
what to do, we need more research."
"It is a tragedy,"
he added, "to be here 10 years later and hear the FDA saying the
same thing."
"The industry's response
to this side effect," he continued, "has been to blame the
underlying psychiatric conditions of patients, to dismiss legitimate
medical case reports as anecdotes, and to scare the media away from
the subject, claiming that it would frighten patients away from treatment."
"Well, I prescribe SSRIs
and I warn patients," he told the panel, "and they are not
frightened away from treatment."
In conclusion, Dr Glenmullen
clearly stated that the suicidality in SSRI patients was not caused
by an underlying psychiatric condition, that it was caused by akathisia.
"Let's stop blaming
the victims," he said, "and deal with this very real side
effect."
(Evelyn Pringle is a columnist for OpEd News and an investigative journalist
focused on exposing corruption in government and corporate America [email protected])
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