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.)
Senior FDA drug safety scientist Dr. David Graham -- best known for blowing the whistle on Vioxx -- is now recommending that the agency pull Ketek from shelves. The drug, Dr. Graham explains, is at least as toxic to the liver as three other drugs that have been pulled by the FDA. Furthermore, the FDA's original approval of the drug was based on a safety study that FDA officials knew was fraudulent.
The FDA's approval of Ketek, Dr. Graham wrote in a June 16 email, was a mistake. “It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin [Ketek] is concerned,” he wrote. “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." He concluded by recommending the drug be withdrawn.
In response, Aventis, the company that manufactures Ketek, announced it was adding a warning to the drug's label. It's the standard response of drug companies and FDA officials to any dangerous drug: Slap a warning label on the drug and call it "safe enough." Warning labels, however, don't make drugs any safer. They only provide a justification for the continued promotion of drugs that even some of the FDA's own scientists believe should be withdrawn from the marketplace.
“It’s no surprise to learn that the F.D.A. didn’t listen to Dr. Graham on the dangers of Ketek,” said Sen. Charles Grassley. “The F.D.A. has made it their business to discredit Dr. Graham and others who aren’t willing to cater to the drug companies.”
Sen. Grassley is a frequent observer and critic of FDA activity, and has worked on legislation to reform the agency.
The FDA not only routinely approves and defends dangerous prescription drugs (much to the delight of drug companies), it also goes out of its way to discredit and outlaw nutritional supplements, herbal medicine and anything tied to alternative medicine (also much to the delight of drug companies). Rather than regulating Big Pharma, the FDA has now become its greatest promoter.
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.
Yet astonishingly, the FDA believes that too much information about the dangers of drugs is being communicated to the public by drug safety officials like Dr. David Graham. If the FDA had its way, all such information would be permanently censored, the public would never be warned about drug dangers, and, in fact, the public would be denied the right to sue drug companies for harm caused by FDA-approved prescription drugs.
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.