Sunday, August 06, 2006


Ketek drug scandal reveals pattern of scientific fraud at the FDA

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 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.”
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.)
A drug that can killMore than five million prescriptions have been written for Ketek since its approval in the United States. Ketek can cause loss of consciousness, blurred vision, and in rare circumstances, even death. It has so far been linked to liver failure in fourteen adults, four of which have died. Twenty-three more suffered serious liver injury. Given that the reporting of drug side effects remains voluntary in the United States, it is possible that the actual number of people harmed by Ketek is ten to twenty times larger.
Related articleFDA admits children's antibiotic could cause liver failure, but allows its sale anyway

Related articleFDA accused of suppressing drug safety information (commentary)
The FDA's power is based on censorship and intimidation, not education and empowerment. On numerous occasions, the agency has attempted to censor and / or intimidate its own scientists, including Dr. David Graham who was nearly silenced before he could testify to Congress about the dangers of Vioxx.
The greatest threat to our safety isn't terrorismAs I have stated many times, I believe the Food and Drug Administration is currently the greatest threat to the health and safety of the American people, far outweighing the threat of terrorism or violent crime. Over one hundred thousand Americans are killed each year by FDA-approved prescription drugs, and well over two million are harmed. Each year, FDA-approved drugs kill more Americans than died in the Vietnam War plus the 9/11 terrorism events combined.
The Ketek fiasco
is merely the latest in a long history of FDA negligence and fraud that makes the agency a genuine threat to the health and safety of the American people.

Stumble Upon Toolbar

No comments: