Early Critic of Diabetes Drug Says Don’t Panic
TORONTO (Reuters) - 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.
source: ADA