Rosenberg: There have been reports of risks to human
subjects in overseas trials as well as bribes and protocol irregularities. Who
oversees the ethics of outsourced trials and the quality of their data?
Healy: Clinical trials are overseen by private
Institutional Review Boards, which are funded by the organizations they
regulate--
Rosenberg: Like Moody's and Standard & Poor's are
funded by their clients?
Healy: Yes. A recent large trial for the
antipsychotic Abilify demonstrates the danger with outsourced clinical trials.
On the basis of about 28 trials in the US, Abilify did not prophylactically stabilize
mood as the manufacturer wants to claim. But when data from just two trials
from Mexico were mixed in, it did.
Rosenberg: Most of Pharma's power to mislead and harm
comes from such opaque and distorted data, you charge in Pharmageddon.
Healy: Without access to the raw drug data,
medical professionals cannot practice responsible medicine and guidelines
cannot be written. Yet Pharma, with very few exceptions, refuses to publish the
data and share them with practitioners. This result is guidelines that are
fictions and doctors who lack critical information they need to prescribe and
treat.
Rosenberg: Pharma's stonewalling of data and use of
ghostwriters has resulted in articles in major medical journals that made
Vioxx, hormone therapy and
Neurontin look safe when they weren't. Another example you give is a paper in
the Journal of the American Association of Child and Adolescent Psychiatry in which GlaxoSmithKline (GSK) has made
the antidepressant Paxil look safe by hiding raw data. Then editor, Mina
Dulcan, says about the missing data, which hid Paxil's suicidal side effect in
children, "I can't control the authors. No, I don't have regrets."
Healy: If we were getting our drug information
from the New York Times
instead of medical journals, we would all be a lot safer. When the Times reporter Jayson Blair was found to have
fabricated stories, he was history. But the editors and writers involved with
journal fraud still have their jobs and the articles are not even retracted. In
fact, Liz Wager, the chair of the Committee on Publication Ethics (COPE) is
herself Pharma linked.
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