The FDA expanded approval process for toxic
drugs is unaffected by evidence uncovered by the US Justice Department
showing the studies to be flawed, if not fraudulent.
NEWS BLAZE
April 16,2009
By Martha Rosenberg Op-Ed Contributor
Is the FDA Bipolar?
In February the Justice Department charged Forest Laboratories with
illegally marketing antidepressants Celexa and Lexapro to younger
patients and burying a study that showed suicidal side effects in
children. But the next month the FDA approved Lexapro for depression in
adolescents 12 to 17.
In March the Justice Department charged AstraZeneca with knowing and
hiding the diabetes side effects of Seroquel. But this month the FDA
considers expanding the antipsychotic's approvals to depression and
anxiety.
And in January, Eli Lilly pled guilty to promoting its antipsychotic
Zyprexa for unapproved and dangerous uses in a $1.4 billion
settlement. But in March the FDA approved Lilly's Zyprexa/Prozac combo,
Symbyax for treatment resistant depression (TRD). What do you get when
you cross Zyprexa with Prozac? Someone who gains 100 pounds and feels
great about it!
"TRD" is such a new pharma invention it googles as Toyota Racing
Development and Teacher Recruitment Days. But it will soon move 'script
like GAD (general anxiety disorder), MDD (major depressive disorder) ADD
(attention deficit disorder) RLS (restless legs syndrome) GERD (gastroesophageal
reflux disease) and PMDD (Premenstrual dysphoric disorder)-and for the
same reasons.
Of course FDA drug approvals are only as good as the studies.
Which is the problem.
Forest paid Massachusetts General Hospital's Jeffrey Bostic, MD
$750,000 to chat up Celexa and Lexapro according to US District
Court in Boston filings. AstraZeneca paid University of Minnesota
Charles Schulz, MD $112,000 to push Seroquel according to US
District Court in Orlando filings. And a decade of pain "studies"
conducted by Baystate Medical Center's Scott S. Reuben, MD on Vioxx,
Lyrica, Celebrex and Effexor were completely fabricated-including the
patients say published reports.
And speaking of "made up, Coast IRB, an institutional review board which
oversees some 300 clinical trials and 3,000 researchers agreed last year
to approve a human trial for "Adhesiabloc," a surgical gel which
Congress and the Government Accountability Office completely made up in
a sting operation. Oops.
And let's not forget Joseph your-child-is-bipolar Biederman, MD at
Harvard who assured benefactor Johnson & Johnson his studies would have
pro Risperdal results according to the New York Times-in advance of
doing them. (Why leave things up to science?)
And Charles "Paxil" Nemeroff, MD who was forced to step down in December
as psychiatry chairman at Emory University thanks to unreported
GlaxoSmithKline income of up to $800,000.
And the pharma funded studies continue!
Last May a pro Lexapro article, "Escitalopram and Problem-Solving
Therapy for Prevention of Poststroke Depression," ran in JAMA, the
Journal of the American Medical Association, with no mention of
financial ties author Robert G. Robinson, MD has to Forest.
Why was, "a researcher with a history of being funded by SSRI
makers...given a forum in the national media to tell the general public
that anyone who has had a stroke, whether or not they have been
diagnosed with depression, should start a prophylactic regimen of
Lexapro...even though non-medical approaches perform just as well,"
wrote Jonathan Leo, PhD, Associate Professor of Neuroanatomy at Lincoln
Memorial University in the British Medical Journal in March.
And then there's AstraZeneca's "studies."
Seroquel is linked to high blood sugar, weight gain, diabetes,
cholesterol and triglycerides abnormalities, sudden cardiac death,
suicide, Iraq war veteran deaths and the tardive dyskinesia it is
supposed to prevent.
But its "safety" was established by a different kind of chemistry.
Research director for Seroquel, Wayne MacFadden, was having affairs with
two women responsible for Seroquel studies say court documents: a
researcher at the Institute of Psychiatry in London and a ghostwriter at
Waltham, MA-based medical communications firm Parexel.
The studies upon which the FDA approved Seroquel for bipolar
disorder-called "Bolder" I and II-were written by a ghostwriter,
possibly accelerated by a motel room. And seated on the FDA's
Psychopharmacologic Drugs Advisory Committee at the time was Jorge
Armenteros, MD, who has been a paid AstraZeneca speaker for five years
according to the Philadelphia Inquirer.
He now heads the committee as the FDA considers expanding Seroquel
approvals to include depression and anxiety this month-and to children
in June.
Hopefully FDA will keep some Seroquel for itself.
Martha Rosenberg is a columnist and cartoonist, who writes about public
health
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