May 23, 2007Diabetes drug Avandia seen as potential death risk
In 2006, the Food and Drug Administration warned that patients taking the diabetes drug Avandia were at an elevated risk of heart attacks. This came after Avandia’s maker, GlaxoSmithKline, posted a study on a remote company website.The study indicated that Avandia caused patients’ chances of having a heart attack to increase by 30%. The FDA was informed, but that was not the first time GSK warned the agency about its drug. It had happened at least one other time.
Nevertheless, neither the agency nor the company acted to warn the public until the recent publication of a study (involving nearly 28,000 patients) in the New England Journal of Medicine. It led the FDA to issue a safety alert warning of a potentially severe risk of heart attack and heart-related deaths.
The FDA was acting in response to a study that links Avandia to a 43% increase in heart attacks and a 64% increase in death from all cardiovascular disease. GSK provided the data, in 65 widely varying studies. Many of them had been posted on the company’s website.
“This is important because cardiovascular disease is the leading cause of death in diabetics and is responsible for between 65% and 80% of all deaths in diabetics,” says Dr. Steven Nissen, lead author of the NEJM study.
In 2006, some 13 million prescriptions were written in the United States for Avandia, which generated more than $2 billion in sales.
GSK’s medical director, Dr. Ronald Krall, defended his company and its money-making diabetes drug by seeking to refute Dr. Nissen’s methodology and interpretations. He says that mingling data from many different studies has led to bogus conclusions.