Glaxo Says Avandia Is Victim of Politics

[JohnMack]

Source: Wall Street Journal

Glaxo Says Diabetes Drug
Has Become Political Victim
By JEANNE WHALEN
June 15, 2007 6:41 p.m.

A senior GlaxoSmithKline PLC official said the company's diabetes drug Avandia has gotten unfairly caught in a political battle, with congressional Democrats exaggerating safety concerns about the drug in order to chastise President Bush and the Food and Drug Administration.

Chris Viehbacher, president of London-based Glaxo's pharmaceuticals business in the U.S., said in an interview he thought the political tone was obvious during a congressional hearing about Avandia safety on June 6. The House Oversight and Government Reform Committee called the hearing after a study in the New England Journal of Medicine linked Avandia to possible heart attack risks.

"You've clearly got a major political battle in the middle of this, with Congress trying to paint the Bush administration yet again as having in some way failed, and Avandia is kind of the latest club to beat the administration with," Mr. Viehbacher said during an interview at Glaxo offices in Research Triangle Park, N.C. "It's pretty much Democrats beating up on us," he said, adding that he felt Congress was undermining the FDA.

During the hearing, Republican members of the committee also accused Democrats of politicizing the discussion. Rep. Henry Waxman, a Democrat from California and chairman of the committee that held the hearing, questioned whether the FDA should have acted more forcefully earlier about the possible risks of heart attack. Mr. Waxman's office didn't return phone calls seeking comment Friday.

The FDA has scheduled a hearing of outside medical advisers for July 30 to discuss the safety of Avandia and similar diabetes drugs. Mr. Viehbacher said he expects a more scientific discussion at that hearing. "In the end science will win," he said.

Glaxo maintains that the bulk of scientific evidence shows that Avandia is as safe for the heart as other diabetes drugs.

The total number of Avandia prescriptions written by physicians has fallen by 20% since safety concerns about the drug surfaced last month, Mr. Viehbacher said. The number of Avandia prescriptions doctors are writing for new patients has fallen by 40% over that same period, he added. Avandia was Glaxo's second biggest selling drug last year, with global sales of £1.6 billion ($3.2 billion).

The NEJM paper that sparked the concerns was written by Steven Nissen, a cardiologist at the Cleveland Clinic. Dr. Nissen analyzed 42 previous trials of Avandia and concluded that the drug was associated with a higher risk of heart attacks than comparator treatments, although the absolute number of heart attacks in both groups was low.

Write to Jeanne Whalen at jeanne.whalen@wsj.com