Healthy Skepticism Library item: 10717

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Dixon K.
Glaxo's Avandia stirs debate at diabetes meeting
Reuters 2007 Jun 26
http://uk.reuters.com/article/healthNews/idUKN2522984320070626?pageNumber=3

Full text:

CHICAGO (Reuters) – Controversy over popular diabetes pill Avandia took centre stage on Monday at a meeting of the world’s experts on the disease, where researchers debated findings that the drug could boost heart-attack risk.

The GlaxoSmithKline Plc drug has been under a cloud since an analysis published in the New England Journal of Medicine last month found taking Avandia led to a 43 percent boost in heart attack risk and a 64 percent rise in risk of heart death.

Study author Steven Nissen, cardiology chief at the Cleveland Clinic, defended his analysis to a packed audience of diabetes experts and other doctors, in a session added at the last minute at the American Diabetes Association’s annual meeting in Chicago.

“What was the alternative? Not to know?” Nissen said, addressing concerns that his findings have caused alarm among patients. “The alternative was unacceptable: to keep the scientific community in the dark.”

Some 60 million prescriptions have been written for Avandia, which generates about $3 billion in annual sales for Glaxo. Sales have dropped sharply since the report.

Nissen’s analysis of the drug, known generically as rosiglitazone, sparked debate because it is based on the pooled data of 42 trials involving nearly 28,000 patients.

“If you take a study not designed to look at heart attacks, can you make a conclusion?” said John Buse, chief of endocrinology at the University of Chapel Hill, North Carolina, and president-elect of the diabetes group.

Nissen headlined on Monday at the diabetes meeting, attended by about 13,000 doctors and researchers.

One audience member called the publication of the study irresponsible, in light of an ongoing randomized clinical trial looking at heart effects of the drug. That elicited applause from the audience; but Nissen’s response that he had an ethical obligation to publish his findings also drew applause.

“FDA RUSHED TO APPROVE”

Nissen said early data on links between Avandia and cardiac events were ignored, including those presented at the FDA advisory meeting prior to Avandia’s approval.

“The FDA rushed to approve this new (drug),” he said. “In my view that was a regulatory mistake. A strong safety signal of excess (cardiovascular events) was ignored.”

Diabetes is a chronic disease in which the pancreas cannot produce enough insulin or properly use the hormone, which regulates blood sugar. The drug treats type II diabetes — the most common form, afflicting some 180 million people globally.

Philip Home, professor of diabetes medicine at Britain’s Newcastle University, made a presentation at the panel. He is a lead investigator on a separate, ongoing 4,400-patient clinical trial of the drug.

The Nissen study “doesn’t answer a question, it asks a question,” said Home, who supported the release of Nissen’s analysis but criticized the New England Journal of Medicine for not including more context and rebuttal when it was published.

Home said the study he is working on, funded by GlaxoSmithKline, suggests Avandia should have a role in the “glucose-lowering armoury,” but that a clinically significant rise in heart attacks not causing death “cannot be ruled out.”

U.S. regulators have recently asked for stiffer warnings on Avandia and a similar drug called Actos, for another heart condition, congestive heart failure. An advisory panel of the U.S. Food and Drug Administration is due to study the issue of Avandia’s safety at a meeting on July 30.

Avandia and Actos, sold by Japan’s Takeda Pharmaceutical Co., are part of a class of drugs known as thiazolidinediones, or glitazones. The first drug in the class, Rezulin, was pulled from the market in 2000 after more than 60 people died from acute liver failure.

Glaxo has disagreed with Nissen’s findings and said there was compelling data from other trials showing Avandia was just as safe as other diabetes medicines.

Dr. Joel Zonszein, the head of the Clinical Diabetes Center at New York’s Montefiore Medical Center who is on an advisory board at Takeda, said Nissen’s study and the media attention were premature because the findings have not been confirmed by randomized prospective trials.

“It is very difficult to prescribe a drug when you turn on the TV and the lawyers are already soliciting,” he said. “One thing is what the science shows and the other thing is what is happening in real life.”

(Additional reporting by Julie Steenhuysen)