Will Avandia Be Pulled from the Market?

The contentious meeting began with what can only be called an understatement from the FDA.

"There are very different opinions on the findings of the cardiovascular risk with Avandia," said Dr. Mary Parks.

Committee members are spending two days listening to more than 20 experts and sorting through 700 pages of data trying to determine whether Avandia causes heart attacks and deaths and should be pulled from the market, reports CBS News medical correspondent Dr. Jon LaPook.

GlaxoSmithKline official Dr. Murray Stewart told the committee their drug is safe "and should remain a treatment option for patients with type 2 Diabetes."

But other experts disagreed vehemently, saying the evidence clearly shows Avandia is dangerous.

The trustworthiness of the company was called into question when Senate investigators released documents Tuesday showing the company knew about problems 11 years ago but didn't make them public.

In 2001, an executive wrote an e-mail saying, "Per Sr Management request, these data should not see the light of day to anyone outside of GSK."

A sales analysis predicted if cardiovascular "safety issue intensifies" than then the company would lose $600 million in sales.

Could Avandia Be Pulled?
Avandia Maker Hid Risks for Years, Probe Finds
Diabetes Drug to Get Second Look

On Tuesday, GlaxoSmithKline released a statement saying that the documents "were taken out of context," accusing the Senate committee of "cherry picking a handful of documents" which "distorts the record and is misleading."

"The company had evidence as early as 1999 that the drug was inferior to their competitor's drug, Actos, the safe drug. And that they concealed it," said Dr. Steven Nissen.

Nissen, of the Cleveland Clinic, published the first study three years ago finding problems with Avandia. He testified Tuesday morning and believes the advisory committee had no choice.

"This drug should be withdrawn from the market as soon as possible" Nissen said. "Every day that goes by more people are hurt."

Wednesday the committee can recommend to withdraw the drug or further limit which patients can take it. The FDA is deeply divided, so whatever the decision, it's sure to be controversial.
  • Jonathan M.D.

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