FDA Official Wants Ketek Support Withdrawn

At least one U.S. drug safety official wants Ketek taken off the shelves. The New York Times has reported that Dr. David Graham, a U.S. drug safety official with the Food and Drug Administration believes that the FDA's 2004 approval of the drug Ketek -- manufactured by Sanofi-Aventis for the treatment of acute upper respiratory tract diseases -- was a mistake.

Last month, Dr. Graham wrote in an e-mail to another official, "It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin [Ketek] is concerned." He went on, "We don't really know if the drug works; no one is claiming it works better than other, safer drugs; and we're flying blind as far as safety goes, except for our own A.D.R. data that suggests telithromycin is uniquely more toxic than most other drugs."

Additionally, FDA safety evaluators discovered 23 cases where patients suffered serious liver injuries after taking Ketek. According to an internal agency memo, that number, when considered in proportion to the number of prescriptions filled for Ketek, exceeds the number of serious liver injuries in similar antibiotics. Officials in the Office of Drug Safety estimate that acute liver failure occurs four times more often in patients taking Ketek than patients taking similar antibiotics.

In response to the safety concerns, Sanofi-Aventis announced June 29, 2006 it was adding a warning to the drug's label. The antibiotic will now carry a bold-type warning that the drug could cause severe liver injury, liver failure, or even death. Additional information will also be made available to doctors and patients. However, the drug makers have no plans to pull their product from the shelves in the near future, arguing that the benefits of Ketek outweigh the risks.

In addition to the serious injuries caused by taking Ketek, it has come to light that Sanofi-Aventis fraudulently reported results from the clinical trials of the antibiotic. According to a report issued by The Union of Concerned Scientists July 20, 2006, "Doctors received $400 for each patient they signed up, signatures and patient data were forged, and ninety percent of the participants at one study site did not even receive the drug." The U.S. Senate Finance Committee is investigating these allegations of fraud.

Dr. Graham was not the only FDA official to find fault with Sanofi-Aventis. Dr. Charles 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." At least two other FDA officials also expressed concern in internal emails about the agency's decision to approve Ketek for sale.

Dr. Graham wants the FDA to withdraw its support of Ketek because it is at least as toxic to the liver as other drugs that have been pulled by the FDA and because the FDA's original approval of the drug was based on a safety study that FDA officials knew was fraudulent.

Apparently, not everyone in the FDA believes the benefits of Ketek outweigh the risks. Whether or not FDA support is pulled remains to be seen. What is apparent is that the controversy surrounding Ketek will not disappear any time soon.

Ketek, a telithromycin, was approved for use in the United States in 2004. Since then, more than five million prescriptions have been written for its use. Side effects of Ketek include loss of consciousness, blurred vision, liver injury, or liver failure. In at least four cases that liver failure has resulted in death.