Once Again, The FDA Abandons It’s Duty – The Danger of Ketek

Once Again, The FDA Abandons It’s Duty – The Danger of Ketek

The Federal Drug Administration is only a shadow of it’s original power as a regulatory watchdog over the pharmaceutical industry. Weakened by the hand picked Bush administration appointees and Drugs corrupted by the lobbying of the industry the FDA has become the lap dog of the pharmaceutical companies rather then the watchdog it is supposed to be for Americans. I’ve pointed out their failure to do their job before. (See 11/23/06 and 12/5/06 postings) Now the New England Journal of Medicine discloses another serious failure by the FDA to monitor the sale of a drug causing serious harm to users as well as cover up in it’s April 19, 2005 issue (Vol 356:1601). The New England Journal of Medicine is regarded among the medical community as one of the oldest and most prestigious peer review medical journals in America. For it to publish such a report is an indication of the seriousness of the situation with the FDA.

Dr. David Ross M.D. reports that three years ago the FDA approved the drug Ketek (telithromycin). This is a drug intended to be used to correct the problem of antibiotic resistance in respiratory tract infection cases. But, Dr. Davis says, since its approval it has been linked to dozens of cases of severe liver damage. As a result, Congressional investigations have and are taking place as to why the FDA approved the drug in light of what turned out to be fraudulent safety data and falsified reports.

The first time the drug was studied the medical reviewers had substantial safety concerns. As a result, a federal advisory committee told the manufacturer, Sanofi-Aventis, to do additional safety studies. The repeat study concluded Ketek was safe. But a routine inspection uncovered fraud including complete fabrication of evidence as well as other violations of trial procedures in the study. Despite this, the FDA presented the corrupted study to the advisory committee, but failed to disclose the facts about the fraudulent and false evidence it was based upon. So, the committee, unaware of these facts, approved the drug.

Even after approval, however, the manufacturer was asked to conduct another study, apparently to have accurate studies supporting approval already given. But, when this data was received, the FDA criminal investigators found evidence of "systematic fraud" by the manufacturer in obtaining approval and recommended FDA investigation. So what did the FDA do? The FDA did nothing. It buried the recommendation and ignored it letting the drug to continue to be sold and without any investigation. This, even though the FDA was aware the manufacturer knew about fraudulent and false information, but, provided it to the FDA to get approval anyway. On top of that, it turns out the FDA put pressure on the medical reviewers to alter their negative reviews about the safety of the drug.

As sales of the drug continued, reports of acute liver failure and serious toxic effects began to surface. So, did the FDA step in and issue warnings or suspend sale of the drug? No, the FDA issued a public announcement that it considered the drug safe. To compound it’s complicity in the sale of the drug, the FDA warned the medical reviewers not to talk about the issue outside the FDA.

But, as the FDA continued to sit on it’s hands and conceal the facts, some 23 cases of acute liver injury and 12 cases of acute liver failure, with four of them fatal, were reported. Still the FDA waited until the day before the Congressional hearing was to take place before it did anything. When it did act, it only withdrew approval for two obscure potential uses of the drug, but allowed continued use for its primary purpose which was causing harm to patients. Congress is now looking into the actions of the FDA. As Dr. Ross says:

"If the case of Ketek leads to important reforms, then the drug may have done some good after all."

It is frightening when the agency which is responsible to protect Americans from dangerous drugs is in the pocket of the pharmaceutical industry. It is the fox watching the hen house. That’s because of the Bush administration’s deliberate corruption of the FDA through its political appointees. It is also thanks to the Republican Congress giving the industry a green light in exchange for the millions spent by the industry in political contributions favoring the Bush administration & Republican majority. It is likely that it will be business as usual until a new administration takes over and this Congress acts to correct the corruption of this agency.

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