Drug maker GlaxoSmithKline intentionally hid the risks of its diabetes drug Avandia and promoted it despite its potential to increase incidents of heart attack, a U.S. Senate committee says in a report to the U.S. Food and Drug Administration.
The FDA is holding a special two-day meeting today and Wednesday with a panel of independent expert physicians to help decide what to do with the drug. The FDA isn't obligated to act on the panel's advice, although it often does.
Diabetes is a condition that occurs when your blood sugar level is too high and your body doesn't regulate its level with the chemical hormone insulin. If your body doesn't make enough insulin, or the insulin doesn't work the way it should, the blood sugar -- called glucose -- stays in your blood instead of providing fuel to your body's cells, says the U.S. National Institutes of Health. People with diabetes have an increased risk of heart attacks, stroke, kidney and eye problems.
A U.S. Senate Finance Committee probing Avandia sent a report to the FDA Monday in advance of the expert panel's meeting, claiming GlaxoSmithKline knew about the health risks for more than a decade, yet still promoted it over a competing, less risky drug.
"In an internal email sent on Oct. 23, 2000, a GSK executive sought to downplay the fact that Avandia gave a worse lipid profile [tests to determine heart disease risk] than the competitor, Actos," says a Senate committee letter to the FDA. "In that email, a GSK executive wrote, 'This was done for the U.S. business, way under the radar ... these data should not see the light of day to anyone outside of GSK.'"
In a statement released today, GlaxoSmithKline called the Senate committee's reference to the e-mails "misleading."
"Cherry-picking a handful of documents from more than 14 million pages of documents distorts the record and is misleading," the company said in the statement, adding the study the e-mails reference "did not contribute any significant new information."
Actos, a product of the Japanese drug company Takeda, brought in $3.4 billion in U.S. sales in 2009, says industry research group IMS Health Inc. in a ranking of the top 15 prescription drugs sold in this country. Avandia didn't make that list, but another IMS Health report shows it brought in $2.43 billion globally for Great Britain's GlaxoSmithKline in 2007.
The Journal of the American Medical Association also published in June the results of a study that looked at the risk of heart attack and stroke in elderly Medicare patients treated with rosiglitazone (Avandia) or pioglitazone (Actos). That study showed rosiglitazone did increase risk of stroke, heart failure and death when compared to the other drug. However, the study said it didn't have a group of people free of either drug to use as a reference point. Therefore it couldn't determine if one or the other drug had a higher overall risk.
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