Avandia Prescriptions Are Getting Anemic
Wednesday, June 06, 2007SUSIE GHARIB: There is word tonight that new prescriptions for GlaxoSmithKline's diabetes, Avandia, are down 40 percent, falling sharply after a report May 21st that the drug may increase the risks of heart attack. Avandia came under scrutiny today at a U.S. House hearing on how the Food and Drug Administration evaluates drug safety. Darren Gersh reports.
DARREN GERSH, NIGHTLY BUSINESS REPORT CORRESPONDENT: The head of the Food and Drug Administration told Congress he wants to put a stronger, so-called "black box" warning on the anti-diabetes drugs Avandia and Actos, informing patients of an increased risk of congestive heart failure.
But Andrew Von Eschenbach also told Congress the evidence these drugs also increase the risk of heart attacks was, quote, "inconsistent," and the agency would look to a panel of outside experts for guidance.
ANDREW VON ESCHENBACH, FDA COMMISSIONER: We are assessing that as we speak, and we are taking that to an advisory committee at the end of July.
GERSH: It now appears the controversy over Avandia began the year it was approved by the FDA. In 1999, after researcher John Buse raised concerns Avandia might increase the risk of cardiovascular problems, he says an employee at SmithKline Beecham, now part of GlaxoSmithKline, called to say the findings had hurt the company's stock.
JOHN BUSE, PRESIDENT-ELECT, AMERICAN DIABETES ASSN.: He mentioned that there was a notion that the market capitalization of the company had decreased by approximately $4 billion, and that company -- there were people in the company that felt that I might be liable for that.
GERSH: GlaxoSmithKline executives say the company would never try to stifle medical debate, and the employee who spoke to Dr. Buse has left the company. Glaxo also complains its critics are politicizing the science on Avandia.
Moncef Slaoui, Glaxo's head of research and development, cites clinical studies of more than 4,400 patients that found Avandia did not increase the risk of heart attacks when compared to other anti-diabetes drugs.
MONCEF SLAOUI, CHMN., RESEARCH & DEVELOPMENT, GLAXOSMITHKLINE: The complete body of evidence available to date clearly supports our conviction that the cardiovascular safety of Avandia is comparable to that of the two most-widely used oral anti-diabetes medicines.
GERSH: The stakes in this medical debate are high. Millions of people take Avandia, earning Glaxo more than $3 billion last year. So far, Chris Viehbacher, president of U.S. pharmaceuticals for GlaxoSmithKline, says most doctors are staying with Avandia.
CHRIS VIEHBACHER, PRES., U.S. PHARMACEUTICALS, GLAXOSMITHKLINE: Physicians are able to understand the difference between a meta analysis and a clinical study. And physicians have had eight years of prescribing this and they have the confidence in the product.
GERSH: Henry Waxman, the chairman of the House Oversight Committee who called today's hearing, says the Avandia controversy is a classic example of why the FDA needs more authority. Waxman says the FDA should be able to force pharmaceutical companies to conduct safety studies after their drugs are on the market. He hopes Congress will give the agency that power later this year. Darren Gersh, NIGHTLY BUSINESS REPORT, Washington.
