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Healthy Skepticism Library item: 11844

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Mathews AW.
FDA Says Aventis Failed To Act on Ketek Drug Fears
The Wall Street Journal 2007 Oct 25A20
http://online.wsj.com/article/SB119328145497070973.html?mod=yahoo_hs&ru=yahoo


Full text:

The Food and Drug Administration said drug maker Aventis failed to act on reports of serious problems with a safety study on its antibiotic Ketek and didn’t properly oversee the trial’s conduct.

The FDA detailed its concerns in a letter posted yesterday on its Web site and sent to Sanofi-Aventis SA, the successor company after a merger. Ketek, which has been linked to a risk of liver damage, was approved by the FDA in 2004, though the agency has said it didn’t rely on the questionable safety study in approving the drug.

The doctor who ran the site that enrolled the most patients in the study ultimately pleaded guilty to fraud. The study was supposed to answer questions about whether the drug was tied to side effects including liver damage.

In yesterday’s letter, the FDA said visits from an Aventis contractor and the drug maker’s own audits documented “serious protocol violations and regulatory noncompliance by multiple clinical investigators.” The agency said it was “unable to find evidence” that the company either fixed the problems or threw the problematic doctors out of the study and told the FDA. The FDA also faulted Aventis for failing to make sure the study was properly conducted and for allowing unqualified investigators to participate in the trial.

Ketek and the safety study have been the subject of investigations by Congress. Rep. John Dingell (D., Mich.) said the letter “confirms that the company was aware the data in its study was compromised.” Sen. Charles Grassley (R., Iowa) said the letter “starts to hold the drug maker accountable.”

Sanofi-Aventis said it acted in good faith in conducting the study and intends to provide a detailed response to the FDA’s letter, including steps it has taken to prevent similar problems. Last year, Sanofi-Aventis added a warning to Ketek’s label about the potential for liver risk.

Write to Anna Wilde Mathews at anna.mathews@wsj.com

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909