Glaxo Subpoenaed by DOJ Over Problems with Avandia

Amid ongoing accusations that the pharmaceutical giant GlaxoSmithKline knew their diabetes drug Avandia increased the risk of heart attacks and tried to suppress that information, the Department of Justice (DOJ) has subpoenaed the drug maker to gain access to clinical data and marketing information. 

The DOJ subpoena has also been accompanied by Civil Investigation Demands issued by several state attorneys general offices. The inquiries were announced in GlaxoSmithKline’s third-quarter earnings statement (pdf), released on Thursday.

Glaxo’s statement indicates that the investigations are at an early stage, and that the company is cooperating. It also noted that new Avandia lawsuits continue to be filed claiming that the company failed to warn patients and doctors of heart risks associated with the drug. 

Earlier this summer, Glaxo announced that it had reached Avandia settlements in about 10,000 cases, out of an estimated 13,000 that had been filed at the time.

Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales plummeted following the concerns about potential Avandia heart risks.

Last month, after a number of studies and internal debate, the FDA determined that only patients who have failed to control their diabetes through every other available medication should be given access to Avandia, and has ordered the company to develop a risk evaluation and mitigation strategy (REMS) to make sure the drug is adequately restricted. The decision came after an FDA advisory committee voted this summer to recommend that the drug stay on the market, but with strict warnings and restrictions.

The government investigations come after three years of contentious debate over the fate of the diabetes drug, which started with a 2007 study in the New England Medical Journal that suggested that Avandia increased the risk of heart attacks by 43%. A number of studies followed with some confirming the first study and others contradicting it.

Earlier this year, a Senate report on Avandia accused GlaxoSmithKline of suppressing the risks of Avandia, and indicated that many within the FDA have been calling for a recall of Avandia. The report claimed the company intimidated scientists and withheld data; accusations that the company denies.

Even the advisory committee hearing on Avandia has been mired in controversy. Some committee members were investigated for failing to disclose conflicts of interest, including one member who voted for no additional restrictions who was once paid to speak on Avandia panels. Some experts, including some FDA drug reviewers, say that the panel was loaded with members sympathetic to the company in order to avoid an Avandia recall.