Avandia: What Did GlaxoSmithKline Know and When Did It Know It?

Forbes put out an article a few days ago about GlaxoSmithKline’s own analysis of its diabetes drug Avandia. It reached essentially the same conclusion as the report in the “New England Journal of Medicine,” which came out earlier this week: Avandia may cause an approximately 43% increase in the risk of heart attack. So why didn’t Glaxo do something when it learned of the potential risk that Avandia posed to the millions of users of the drug?

Glaxo’s defense of Avandia is distrubing. Glaxo says that its does not believe that a 43% increase in risk was definitive of a problem, because the risk may be explained by other drugs or diseases.

This may be so. But what did GlaxoSmithKline do? Did they warn doctors or the millions of uses of Avandia and notify them that at least there may be an increased risk of heart attacks, even though GlaxoSmithKline believed that Avandia was safe? Did they allow doctors and end users the opportunity to decide for themselves if Avandia was safe, or if the benefits outweighed the risk? No, Glaxo chose to risk consumer safety.

The “Forbes” article quoted one drug safety expert, Curt Furberg of Wake Forest University Baptist Medical Center, who feels strongly that Avandia should be taken off the market, because of the increased risk of heart attacks: “Either the company suppressed or the FDA was asleep.” He further said that he believes the question as to whether Avandia should have been taken off the market is a “no-brainer.”

At some point, an Avandia lawyer is going to be asking a jury this same question in closing argument: Was it a “no-brainer” to take Avandia off the market?

A large clinical study Glaxo is conducting to test the risks of Avandia may be in jeopardy as a result of recent reports of the drug’s risks, according Dr. Ronald L. Krall, the medical director for GlaxoSmithKline who said in an interview that some of the 4,450 patients enrolled in the drug trial have dropped out because of safety concerns about Avandia. Now there is concern
about the ability of the study to continue and they are “considering what to do to prevent people from dropping out of the trial,” according to Dr. Krall. I think they should place more concern on the question of whether continuing their trial will lead to more deaths as the result of the use of Avandia.

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