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We are witnessing the unraveling of a system that was intended to ensure
that marketed drugs met high safety standards; that physicians were
informed about potential, serious adverse drug effects - so that they
would prescribe judiciously; and that the integrity of the scientific
literature was preserved. But that system has been hijacked by the drug
industry - which has infected medical practice and medical research
with detail men and informercials that make false claims while manipulating
partial data to conceal adverse drug effects.
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
www.ahrp.org
***PRESS STATEMENT***
Re:
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The FDA & Concealment of Suicide-Related Risks of Antidepressants
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Date:
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September 14, 2004
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Contact:
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Vera Hassner Sharav, President
ahrp.org
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We are witnessing the unraveling of a system that was intended to ensure
that marketed drugs met high safety standards; that physicians were
informed about potential, serious adverse drug effects - so that they
would prescribe judiciously; and that the integrity of the scientific
literature was preserved. But that system has been hijacked by the drug
industry - which has infected medical practice and medical research
with detail men and informercials that make false claims while manipulating
partial data to conceal adverse drug effects.
The issue in the US was propelled by the irresponsible promotion of
SSRI antidepressants for children with tragic, but foreseeable consequence.
The issue has been brought to a head by recently surfaced company documents
that shatter the credibility of company-controlled data. However that
data has seeped into the scientific literature. The FDA's complicity
in the concealment of evidence showing failed test results with emergent
suicide-related behavior has outraged parents and bewildered physicians.
Two congressional committees have charged the FDA with stonewalling,
intimidation of its employees, and concealment of evidence. This agency
cannot, under its current leadership, lead the way toward resolving
the current credibility crisis in medicine.
The real problem confounding the integrity of clinical trial findings
and the significance of the adverse incidence reports would largely
be resolved if drug manufacturers did not have quasi-total control over
trial design and subject selection, and total proprietary possession
of the data and over its release. Understandably, public trust in medicine
has been eroded.
It is no coincidence that those invited to make presentations continue
to conceal evidence of adverse drug effects, apparently with FDA's blessing.
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