Food & Drug Administration in a constant conflict of interest | Searcy Law

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John Hopkins

Meridia–Can the Food & Drug Administration Continue In Constant Conflicts of Interest?

» Written by // October 12, 2010 // , ,


Like it or not, the Food & Drug Administration is in a constant conflict of interest.

The FDA “supervises” a multi-billion dollar drug industry; an industry which is also the largest source of the agencies’ funding.

So, for FDA employees (including the people who ultimately approve or withdraw drugs), they are putting bread on their families’ tables by trying to control the companies putting bread on their families’ tables.

It is a perverted system in many ways. Can it continue to work? I think this is the only way it is going to work; certainly for the foreseeable future. It simply does not make sense to dedicate government funding to the FDA that will make up for the industry funding – at least not in these economic times.

Essentially, drug manufacturers perform clinical studies under the approval process of the FDA. The manufacturers report the results of the clinical studies to the FDA. The FDA tries to make sure the results reported comport to the data they have received and approve or disapprove the drug.

The system works if the drug manufacturer reports honest data generated by informed and honest laboratory testing and clinical trials. So, the fox may not be guarding the hen house, but the fox certainly gets to hang out there.

The FDA has recently announced that Abbott Labs “withdrew” its drug, Meridia. Meridia is a weight loss drug that did not really impact weight loss all that much, but its increased risk of cardiac and stroke finally got the attention of the FDA.

It was 2004 when Dr. David Graham, a reviewer at the FDA and the man who sounded the alarm about the dangers of Vioxx, went public to warn about the risks of Meridia and five other drugs — the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne drug Accutane.

When Dr. Graham sounded the alarm, he faced staunch criticism, even from his own colleagues:

“Dr. Steven Galson, the director of the F.D.A.’s center for drug evaluation and research and one of the agency’s top civil servants, later said that Dr. Graham’s new numbers “constitute junk science” and were “irresponsible.” Dr. Graham, with more than 20 years of service with the Food and Drug Administration, cited the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne drug Accutane. Makers of each drug defended the medicines as safe.”

“Dr. Sandra Kweder, deputy director of the F.D.A.’s office of new drugs, told the panel that Dr. Graham was not describing “the F.D.A. that I know” and that she did not see the five drugs he cited as “more concerning than any others.”

Since FDA officials made their 2004 pronouncements, we have gone through Vioxx, Serevent, Accutane and now Meridia that have been demonstrated to have unreasonably increased risks to patients.

So can drug regulation work in its current form? It can if the people inside the FDA are more concerned about public safety (think Dr. Graham) and less concerned about drug makers’ profits (think the colleagues). It requires an administration that is not dedicated to being the handmaidens of corporate America. And, it requires hiring more “Dr. Grahams”.


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