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More Than 10,000 Settlements Reached in Avandia Lawsuits

Reports have claimed that GlaxoSmithKline has agreed to pay $460 million dollars to settle lawsuits brought by more than 10,000 people affected by the controversial diabetes drug. These reports were leaked to press at the same time as the US Food and Drug Administration (FDA) were meeting to hear evidence in relation to studies that have shown that the drug leads to increased risk of heart attacks. Around 13,000 lawsuits were filed against GlaxoSmithKline alleging that they did not warn about the increased risk of heart problems associated with Avandia. The settlements reportedly range between $46,000 and $70,000.

The drug is used to treat type 2 diabetes and been authorised for use in the EU since 2000. The Irish Medicines Board has commented that at the time of the authorisation, increased risk of heart failure associated with the drug was "already well documented". However it said that a review in February of this year showed no increase in deaths from heart related problems linked to the drug. A scientific advisory group discussed the risk of the drug versus the benefits of its use and concluded that it had a small place in therapy and that there was no further need for restrictions on its use.

A former FDA employee has recently claimed that GlaxoSmithKline knew about the potential side effects as far back 2001 but did not inform the FDA of the findings of their research. As part of a deposition given during the Avandia litigation, Dr. Rosemary Johann-Ling testified that GlaxoSmithKline did not turn over research that showed the risks in relation to heart problems. She also testified that GlaxoSmithKline were given inappropriate access to the FDA's internal decision making process in relation to the safety of the drug. This testimony confirms findings in a US Senate Report that GlaxoSmithKline was aware that the drug could cause heart problems.

Despite this, the FDA advisory panel voted to allow the drug to remain on the market. The advisory committee indicated that the side effects of the drug do increase the risk of heart attack, however a majority still voted to allow the drug to remain on the market. 18 of 33 said that they felt that Avandia appeared to be more dangerous that other diabetes drugs, however only 12 voted in favour of a recall of the product. The FDA's review of Avandia is ongoing and a decision is expected soon on what to do in relation to the medication. The FDA is not bound to follow the decisions of its advisory committees, however they frequently do.

Controversial clinical trials involving Avandia are the subject of scrutiny by the Federal Regulatory Agency which is considering shutting them down. GlaxoSmithKline have come under heavy criticism for using test subjects in the developing world who may not be aware of the dangers associated with the drug. India has recently banned the company from recruiting for subjects in the country.

Some experts feel that the drug is effectively finished anyway, as most doctors will no longer prescribe it due to the potential side effects. Certainly in Ireland, GlaxoSmithKline have advised that the numbers of diabetes patients likely to be using the drug are small, as it is not the main treatment prescribed in this country.

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