OT: FDA caught red handed in scientific FRAUD

[Guest guest]

Yet another drug safety scandal is emerging over the FDA's reliance

on fraudulent clinical trial data to approve Ketek, an antibiotic drug.

...

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. , wrote, “I tried to argue that

given Aventis’s 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.â€

Dr. 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.â€

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. , Dr. Ross, Dr.

Rosemary Johann-Liang and Dr. 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