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Congresswoman Calls for Avandia Recall

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Calls for an Avandia recall are increasing. The latest has come from Rep. Rosa DeLauro (D., Conn.), the chairwoman of the House appropriations panel that controls the FDA’s budget, is the latest to call on the agency to do so.

According to The Wall Street Journal, DeLauro said yesterday that it is “reprehensible that many people might have suffered heart attacks or heart failure as a result of taking this drug, especially if a safer alternative exists.”

As we reported over the weekend, a two-year investigation of Avandia by the Senate Finance Committee found that in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. According to the report, two of the FDA’s own doctors wrote in an October 2008 memo that Avandia should be removed from the market because it poses serious heart-related dangers to patients. The report included emails from GlaxoSmithKline officials and drew on interviews with Glaxo and FDA officials and anonymous whistleblowers.

The controversy has prompted the FDA to take another look at Avandia. According a notice posted on the FDA’s Web site, the agency is reviewing the primary data from a large, long-term clinical study, RECORD, on possible cardiovascular risks with Avandia.

According to a report in The Wall Street Journal, Glaxo released the results of RECORD last June, and said it showed there is no serious risk of heart attack or death from Avandia. The Senate report released over the weekend said Glaxo was aware since at least 2004 that RECORD was statistically inadequate, or “underpowered.” Some doctors have also questioned whether RECORD was adequate enough to draw conclusions, The Wall Street Journal said.

In a conference call arranged Monday for health-care groups, FDA drug division leader Dr. Janet Woodcock acknowledged that the results of RECORD were “at odds” with other studies that associated Avandia with heart attacks.

In addition to RECORD, the FDA said yesterday it has also been reviewing a number of observational studies of the cardiovascular safety of Avandia that have been published. The results of the review will be discussed at a public meeting in July, the FDA said.

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