February 21, 2010 : Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market. The reports, obtained by “The New York Times”, say that if every diabetic now taking Avandia was instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009. Rosiglitazone should be removed from the market,” a report, by Dr David Graham and Dr Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn. The internal FDA reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” the risk of heart attacks. The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks. Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the FDA to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an FDA oversight board voted eight to seven to accept that advice. Hundreds of thousands still take the medicine, although some top endocrinologists say they have sworn off the drug. Since 2007, more studies have been done. In a December 2009 internal memorandum, Dr Janet Woodcock, director of the FDA’s drug centre, wrote that there are multiple conflicting opinions about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold. I await the recommendations of the advisory committee, the agency’s commissioner, Dr Margaret Hamburg, said on Friday night. Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.” The bipartisan multiyear Senate investigation — whose results are expected to be released publicly on Monday but which were also obtained by The New York Times — sharply criticises GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.