Healthy Skepticism Library item: 10392
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Publication type: news
Blum J.
Glaxo's Avandia Fuels Arguments for Tougher Drug Laws
Bloomberg News 2007 Jun 5
http://www.bloomberg.com/apps/news?pid=20601202&sid=aEoQ2_S.ndTY&refer=healthcare
Full text:
Lawmakers are seizing on last month’s study linking GlaxoSmithKline Plc’s diabetes drug Avandia and heart risks to press for new U.S. drug-safety legislation.
The study, released May 21, showed that Avandia, the world’s best-selling diabetes pill, increased the risk of a heart attack 43 percent. Members of Congress are questioning the Food and Drug Administration’s handling of evidence of side effects since the drug won U.S. approval in 1999.
The Avandia report has reignited complaints by Congress that the FDA is too lax in monitoring drug complications after a product is on the market. The agency previously was criticized for failing to act on heart dangers linked to Merck & Co.‘s Vioxx painkiller before it was withdrawn in 2004, and for missing suicide risks linked to antidepressants.
``The American people deserve to know why eight years after FDA approved Avandia, it’s still unclear whether the drug is harmful or helpful,’‘ said Representative Henry Waxman, a California Democrat and longtime critic of the FDA, in a statement.
Waxman, chairman of the House Oversight and Government Reform Committee, summoned top officials of the FDA and Glaxo and the Avandia study researcher to a hearing tomorrow to press for answers related to the drug’s approval and monitoring.
The Senate passed legislation May 9 to give the FDA additional power to regulate drugs after they are approved. Some critics of the agency are pushing the House to go further by creating an independent safety office within the FDA that would have the power to pull products off the market.
Glaxo, FDA Respond
Glaxo says the study, published in the New England Journal of Medicine, was based on incomplete evidence and inconclusive methods. Preliminary results from a company study released today found that Avandia doubled the risk of weakening the heart without increasing the likelihood of heart attack and stroke.
The company’s study is ``very reassuring to doctors and patients,’‘ said Ron Krall, Glaxo’s chief medical officer, on a conference call with reporters.
The FDA is trying to reconcile conflicting results from studies, said agency spokeswoman Julie Zawisza in an e-mail.
``We don’t have the scientific data upon which to make any conclusions or decisions yet,’‘ Zawisza said.
The FDA said today that it will convene a meeting of outside specialists on July 30 to consider the heart risks of Avandia and similar medicines, including Takeda Pharmaceutical Co.‘s Actos.
Share Reaction
Glaxo’s American depositary receipts, each representing two ordinary shares, gained 9 cents to $51.90 at 4 p.m. in New York Stock Exchange composite trading. In London, Glaxo shares fell 10 pence to close at 1281 pence. The stock has declined 13 percent since May 18, the last trading day before the study critical of Avandia was made public.
Witnesses scheduled to testify at Waxman’s hearing include FDA Commissioner Andrew von Eschenbach; Moncef Slaoui, Glaxo’s chairman of research and development; and cardiologist Steven Nissen of the Cleveland Clinic, author of the Avandia study released in May.
In a letter to von Eschenbach, Waxman requested a chronology of the FDA’s actions regarding the heart safety of Avandia and copies of communications between Glaxo and the FDA.
John B. Buse, who wrote the FDA in 2000 to express concern that Avandia may have heart risks, also is scheduled to testify. Buse, a diabetes specialist with the University of North Carolina in Chapel Hill, said in a statement that he expects to tell Waxman’s committee about pressure he received from Glaxo to stop criticizing Avandia. The company later apologized, and ``I hold no ill will toward Glaxo,’‘ Buse said.
The investigative committee ``will focus on whether the agency is properly safeguarding the public and whether changes — in the agency’s authority, resources, or leadership — might be necessary to help it better meet its mission,’‘ Waxman said in the statement.
`Pent-Up Frustration’
Democrats, who gained control of Congress in January, have taken a more aggressive approach in monitoring the FDA than Republicans, holding more hearings and demanding more information from the agency.
``Part of what’s going on, particularly in the House, is caused by years of pent-up frustration that many things that deserved oversight didn’t get them,’‘ said Ira Loss, an analyst at the Washington research firm Washington Analysis.
While Waxman hasn’t proposed legislation, other lawmakers are debating what new drug-safety measures are needed.
Senator Edward Kennedy, the Massachusetts Democrat who heads the Senate health committee, said in a statement that legislation passed by the Senate last month corrects ``major flaws’‘ at the agency that explain why the American public had ``to depend on a group of independent scientists’‘ instead of the FDA to discover risks with Avandia.
New Legislation
The Senate legislation, aimed primarily at renewing fees that drugmakers pay the FDA to speed review of new medicines, would give the agency more power to detect harmful side effects after medications are on the market and to force drugmakers to complete new studies.
Avandia shows the Senate bill doesn’t go far enough, said Senator Charles Grassley, an Iowa Republican. He renewed his call to create an independent safety office within the FDA. Agency safety specialists who track drugs for dangerous side effects after they’re on the market now report to the reviewers who approved the medicines in the first place, according to Grassley.
The FDA didn’t act several months ago when the agency scientists who monitor safety recommended that Avandia’s prescribing information carry the most serious warnings about heart attacks, Grassley said. The FDA has declined to comment on its internal deliberations.
Senate `Dropped the Ball’
``The FDA legislation passed by the Senate two weeks ago dropped the ball on this important reform,’‘ Grassley said in a statement. ``The Avandia case sets it up for the House of Representatives to give real clout to the FDA office that monitors and assesses drugs after they’re on the market and taken by millions of people.’‘
House leaders haven’t yet indicated what they intend to put in their version of the drug legislation or when they will act.
Karl Uhlendorf, a spokesman for the Pharmaceutical Research and Manufacturers of America, a Washington-based trade group for drugmakers, declined to comment on the congressional debate over Avandia. The organization has supported the Senate-passed drug legislation and opposed Grassley’s proposal for a separate safety office.
Glaxo took out advertisements today in about a dozen newspapers, including the New York Times and Washington Post, saying it stands behind Avandia.
To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net .
