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SmithKline Hid Data on Avandia Heart Risks

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According to a New York Times report, SmithKline Beecham knew over a decade ago knew that Avandia increased risk of heart problems in patients but concealed key data from the public.

*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

  • In patients already being treated with these medicines
  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

What’s the problem?

July 13, 2010 – In 1999, SmithKline Beecham began conducting tests to see how its diabetes drug Avandia compared to a similar pill Actos, which is manufactured by Takeda. According to the Times report, the results showed signs that Avandia posed a significant heart risk, but instead of publishing the results, the company spent the next 11 years trying to cover them up.

“This was done for the U.S. business, way under the radar,” Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that were obtained by the Times. “Per Sr. Mgmt. request, these data should not see the light of day to anyone outside of GSK,” the corporate successor to SmithKline.

Avandia is now under investigation by the U.S. Food & Drug Administration (FDA). Beginning today, the FDA is holding a special two-day meeting to help decide what course of action to take on the matter. A panel of independent physicians will consider issues including adding more warning levels, limiting which doctors can prescribe the drug, and possibly pulling the drug from the market altogether.

Although the heart risks from Avandia first became public in 2007, documents demonstrate that GSK knew about the drug’s risks almost as soon as it was introduced in 1999, and sought to keep those risks from becoming public. In one document, the company sought to quantify the lost sales that would result if Avandia’s cardiovascular safety risk “intensifies.” The cost: $600 million from 2002 to 2004 alone, the document stated.

But GSK has done more than merely hiding trial data. An FDA reviewer who closely examined a landmark Avandia clinical trial called “Record,” found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial’s tally of adverse events, mistakes that further obscured Avandia’s heart risks.

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