"Yet another drug safety scandal "

NewsTarget Insider Alert (www.NewsTarget.com)
HEALTH WARNINGS / CRITICISM
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Yet another drug safety scandal is emerging over the FDA's reliance
on fraudulent clinical trial data to approve Ketek, an Antibiotic drug.
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From http://www.newstarget.com/019698.html

The FDA has once again been caught red-handed ignoring the dangers of
a widely-prescribed drug and compromising the health of millions.
Internal email messages have now surfaced about how the FDA pushed the
Antibiotic drug Ketek despite urgent warnings from its senior drug
safety scientists. The details of this scandal further highlight the
dubious operations of the Food and Drug Administration, which
consistently places the profits of drug companies as a higher priority
than public health.

Ketek was approved under suspicious circumstances in the first place.
A key clinical trial for the drug, involving 24,000 patients, was
repeatedly found to be fraudulent, according to FDA investigators. One
FDA document concluded that Sanofi-Aventis hid safety dangers from the
FDA -- dangers the FDA later discovered on its own.

One FDA safety scientist, Dr. Cooper, wrote, I tried to argue that
given Aventiss track record in which they have proven themselves to
be nontrustworthy that we have to consider the possibility that they
are intentionally doing a poor job of collecting the postmarketing
data to protect their drug sales.

Dr. David Graham added, For F.D.A. to refer to its being reassured
by postmarketing data from Latin America and Europe as a basis for
declaring Ketek is safe is in my opinion a great abuse of such
surveillance data.

Yet the drug was approved anyway, and the FDA now cites a known
fraudulent study to defend the drug and argue against its withdrawal.

Four FDA safety officials (Dr. Charles Cooper, Dr. David Ross, Dr.
Rosemary Johann-Liang and Dr. David Graham) ultimately sounded the
alarm over Ketek's safety in internal emails. As now seems routine at
the FDA, they were ignored. (See The Rise and Fall of Rezulin to see
another such example.)

Story continues at:
http://www.newstarget.com/019698.html

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