Early Critic Of Diabetes Drug Says Dont Panic

Patients should not haphazardly stop taking the controversial diabetes drug Avandia, even though it has been linked to heart risks.

Patients should not haphazardly stop taking the controversial diabetes drug Avandia, even though it has been linked to heart risks, an early critic of the drug said on Sunday.

Dr. John Buse, chief of endocrinology at the University of North Carolina at Chapel Hill and incoming president of the American Diabetes Association, was one of the first experts to query the safety of GlaxoSmithKline's blockbuster drug.

He raised questions about the drug's heart safety in 2000.

But Buse told the Endocrine Society's annual meeting in Toronto that he does not believe patients should stop taking the popular pill just yet.

"We'll have additional data in the near future and that would be the appropriate time to consider making judgments over Avandia's safety," Buse told Reuters in an interview.

Buse also said he would tell the U.S. Congress this week about how GlaxoSmithKline may have tried to pressure him about his early criticism of the drug's safety.

A clamor about Avandia, taken by millions of people, arose from consumer groups, heart experts and Congress last month after Cleveland Clinic cardiologist Dr. Steven Nissen's pooled analysis was published in the New England Journal of Medicine.

Nissen's study linked the diabetes drug to a 43 percent increased risk of heart attack and a 64 percent higher risk of any heart-related death.

The U.S. House of Representatives Oversight and Government Reform Committee has scheduled a hearing for Wednesday on the U.S. Food and Drug Administration's handling of the drug, approved in 1999.

Buse said he would testify at that hearing.

TROUBLING QUESTIONS

The New York Times quoted University of Michigan diabetes expert Dr. Charles Burant as saying that Buse had been troubled by pressure he had received from Glaxo about his questions over the drug.

It quoted Burant as saying Glaxo had contacted University of North Carolina medical school.

Buse declined to give any more details of what happened, saying he would wait for the hearing. He characterized the issue as "ancient history."

"If I am asked a question about it, I'll answer it. I don't have anything to hide," he told Reuters.

Glaxo said it did have discussions with Buse. "We regret if, at any time, Dr. Buse felt the conduct of any GSK employee was contrary to the spirit of open, scientific debate regarding his views on Avandia," the company said in a statement.

Glaxo has disagreed with the study findings and says Avandia is safe.

"If there is a safety problem with Avandia it needs to be taken off the market. There is no doubt about that," Buse said.

"I still have concerns but I don't think Dr. Nissen's analysis has changed the landscape dramatically," he added.

"Dr. Nissen's study is adequate to raise the question. It's just not adequate to provide the answer."

Dr. Hertzel Gerstein, director of the division of endocrinology and metabolism at McMaster University in Ontario, Canada, agreed.

"My big concern of summarizing this type of data is that none of the trials that were summarized were designed to answer the question of whether the drug increases or reduces the risk of heart attack," Gerstein said in an interview.

"For patients, this creates a lot of anxiety," he added.