On December 13, 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 widespread 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
By now, the FDA
knows that Ms. Menzies makes no secret of the fact that she is outraged about
the overprescribing 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
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 firsthand
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-1980s before the first SSRI, Prozac, was approved for use in
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 15 years ago during the first FDA advisory committee hearings on the
She will explain
exactly how the clinical trial data were 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
And she maintains
that the drugmakers have purposely failed to conduct studies on the risk of
suicidality because they already knew such trials would produce negative
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 patients "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 1,569 patients on SSRIs there were 62 episodes of
suicidality versus only 19 episodes in 1,373 patients on a placebo.
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."
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."
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
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."
patients alike," he states, "have been betrayed by the governmental
entities and officials who are supposed to protect them."
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."
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
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 drugmakers 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 two 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
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, which he and
many other experts say can make some patients so agitated that they feel death
would be a welcome relief.
effect is so well established," Dr. Glenmullen told a previous panel,
"that it is clearly described with SSRIs in the Diagnostic and Statistical
Manual (DSM), the American Psychiatric Association's official diagnostic
"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."
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."
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.
blaming the victims," he said, "and deal with this very real side
Evelyn Pringle is a
columnist for OpEd News and an investigative journalist focusing on exposing corruption in government. She can be reached at: firstname.lastname@example.org.