Risk seen in diabetes drug

Study links GSK pill to heart attacks

The Food and Drug Administration on Monday alerted physicians and patients about safety concerns for the diabetes drug Avandia after a study linked the GlaxoSmithKline best-seller to a greater risk of heart attack.

The research, published by the New England Journal of Medicine, isn't the first time Avandia has been linked to heart attacks. An accompanying editorial argued that Avandia represents "a major failure of the drug-use and drug-approval process in the United States." Members of Congress quickly echoed the criticism.

The FDA isn't asking GSK to add warnings to packaging or withdraw the drug. Instead, it is asking physicians to make treatment decisions on a patient-by-patient basis. About 1 million Americans take Avandia to control blood sugar; worldwide at least 6 million patients have used the drug since it was approved in 1999.

The FDA is reviewing the study along with studies from GSK that present conflicting findings, said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. The agency is not ruling out future action.

GSK strongly disagreed with the study's conclusions and in a statement said: "The suggestion that GlaxoSmithKline has placed patients at risk and attempted to silence independent investigation of data is absolutely false."

The British drugmaker, which has a U.S. headquarters in Research Triangle Park and employs about 6,000 in the area, said the new study was based on incomplete evidence and a methodology that the author of the analysis admits has limitations.

However, Dr. Ronald Krall, GSK's chief medical officer, acknowledged in a conference call that the company came across increased cardiovascular risks in its own 2004 analysis. GSK posted the findings on its online trial registry, which lists hundreds of study results for dozens of drugs. The company also submitted them to the FDA in August and has been talking with regulators since then, Krall said.

Krall said GSK will not voluntarily withdraw Avandia.

"We are confident in the benefit-risk profile of Avandia," he said. "It is an important treatment for patients with Type 2 diabetes."

U.S. lawmakers criticized regulators for withholding the GSK findings. Rep. Henry Waxman, D-Calif., chairman of the House Oversight Committee, called a hearing for June 6 to examine the FDA's role in evaluating Avandia's safety.

"The FDA is on notice that we have reached the end of our rope," Rep. Bart Stupak, D-Mich., said in a statement. "Like Vioxx, Avandia may have unnecessarily risked the lives of tens of thousands of Americans."

U.S. drug maker Merck pulled Vioxx, an arthritis drug, from the market in 2004 after a study found it doubled the risk of heart attacks and strokes. The withdrawal spawned Congressional hearings about regulatory oversight and led to dozens of lawsuits.

About Avandia

Avandia is GSK's second largest-selling drug, accounting for $3 billion in worldwide sales last year. GSK also has been testing Avandia as a diabetes preventative. In separate studies, it was studying the drug's effectiveness in preventing Alzheimer's disease. It was unclear how the new study would affect those efforts but analysts said they expected Avandia sales to drop. And GSK's stock price reflected the news, with shares closing at $53.18 Monday, down $4.53 or 7.8 percent.

In treating Type 2 diabetes, Avandia lowers blood sugar levels. Type 2 diabetes is linked to obesity, physical inactivity, older age and a family history of the disease. It afflicts some 20 million Americans, according to the American Diabetes Association. Rising obesity rates add about 1.5 million cases annually.