Avandia's Fate to be Decided by Today by FDA Advisory PanelJul 30, 2007 | Parker Waichman LLP
Avandia, the widely-used diabetes drug manufactured by GlaxoSmithKline Plc. that has been linked to increased risk of heart attacks in diabetes patients, could be removed from the market by the federal Food and Drug Administration (FDA) after a meeting held today that will review contrasting studies about its risks, according to Steven Nissen, chairmen of cardiovascular medicine at the Cleveland Clinic.
Nissen, the author of a study that showed diabetics taking Avandia had a 43-percent higher risk of heart attack than those taking competing drugs, told CBS’s The Early Show that he thought the FDA could take one of three courses at today’s meeting: take no action at all, remove Avandia from the market completely, or require the world’s best selling diabetes drug to come with a strong warning label. Wall Street analysts following GlaxoSmithKline agreed there was a chance that Avandia could be removed from distribution, according to the Associated Press.
Nissen was also among the six medical doctors who received “conflict of interest” waivers from the FDA earlier this month, granting them permission to participate in the July 30 review of health risks associated with Avandia despite their financial ties to the drug industry. Doctors Curt Furberg, Thomas Pickering, David Schade, Morris Schambelan, and John Peerlink also received waivers from the agency, which concluded that the need for their unique expertise regarding the Avandia discussion outweighed the conflicts associated with their financial interests. Consulting fees, grants, compensation for service on advisory committees, and stock or mutual fund holdings were among the doctors’ financial ties to GlaxoSmithKline and its direct competitors that could have precluded their participation in the meeting.
Pickering, Schade, and Schambelan will be “voting members” of the FDA Endocrinologic and Metabolic Drugs Advisory Committee at the meeting, which is a joint review between that committee and the agency’s Drug Safety and Risk Management Advisory Committee. Nissen, Furber, and Peerlink will offer expertise but will not have a say in the joint committee’s decision.
GlaxoSmithKline has countered Nissen’s data with long-term studies of its own that show Avandia does not have a higher heart-attack risk compared to other oral drugs that can be used to reduce blood sugar in diabetics, Reuters reported on Thursday. “We feel the cardiovascular profile is very reassuring for Avandia,” Dr. Anne Phillips, GlaxoSmithKline vice president of clinical development, told the news agency.
Voting members at the today’s hearing will address data compiled by the FDA as well as GlaxoSmithKline before deciding whether Avandia carries an elevated risk of heart attack and whether that risk is higher relative to other competing medications, according to an FDA memorandum.
In February, FDA staff recommended a black box label on Avandia that warned against an increased risk of heart attack associated with the drug, according to a report from Reuters. GlaxoSmithKline had previously proposed more watered-down language that mentioned the data regarding elevated heart attack rates while saying that their relationship to Avandia itself was “not clear.”
Avandia sales accounted for $3 billion in revenue for GlaxoSmithKline in 2006. Financial results released by the company this past week showed sales of Avandia were down 22 percent during the second quarter of 2007.