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More objections to Avandia suppressed by Glaxo

November 19, 2008 — 11:10am ET | By Anne Zieger
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Mary Money
heart attacks
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Avandia

We haven't heard anything for a while about Avandia, GlaxoSmithKline's diabetes drug that has been linked to a higher risk of heart attacks, but that doesn't mean no one has been paying attention. Actually, there's been an ongoing investigation in the Senate and House over whether GlaxoSmithKline actively suppressed information about the drug's link to heart attacks, and also whether the FDA ignored what evidence it did have.

Now we find out that in the course of the investigation, it has come up that another doctor noticed the link soon after Avandia was released. Dr. Mary Money, an internist in Hagerstown, MD, raised concerns back in 2000, but the company dismissed her concerns and the concerns of her colleague; the FDA was unresponsive.

Further, GlaxoSmithKline (then SmithKline Beecham) then wrote a letter to Dr. Money's hospital asking it to prevent the doctor from discussing the problems with any of her colleagues. This leaves us to wonder how many other doctors may have had their observations suppressed in order to protect GlaxoSmithKline's bottom line.

To learn more about the investigation:
- read this Wall Street Journal piece (reg. req.)

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Avandia controversy sparks FDA criticism

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By Stella Baskomb | Posted 10:52pm | December 5, 2008

Interesting that the WSJ article reported a facet of this situation that Fierce Healthcare omits - perhaps deems unimportant?

The doctors involved also contacted the Food and Drug Administration but FDA was "unresponsive". In fact, the WSJ reports that Dr Money contacted FDA but "received only a form letter in response." The WSJ reporter requested FDA to comment for the article, but "FDA didn't respond".

So the headline is "suppression" by GlaxoSmithKline - but not failure to enforce regulation by FDA?

I wonder if the reason for this differential treatment is differential expectations. That is, physicians expect pharmaceutical companies to respond when their products are challenged. But physicians have far lesser expectations as to helpful or timely responses from government agencies.

In any event, I think the FDA's ho-hum attitude is at least as worrisome as Glaxo's aggressive response. Because. . . who will regulate our national insurance plan when we get it? Ho hum?

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