Avandia being regarded as a potential death risk
Last year, the Food and Drug Administration issued a warning about a possible elevation in heart attacks among patients who took the diabetes drug Avandia. This happened after its maker, GlaxoSmithKline, posted a study along with many others on a remote company website.
The study indicated that Avandia caused patients’ chances of having a heart attack to go up 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, in 2005.
Even so, neither the company nor the agency took further steps to warn the public until a study (involving more than 27,000 patients) published in the New England Journal of Medicine spurred the FDA to issue a safety alert that warned of a potentially severe risk of heart attack and heart-related deaths.
The FDA acted in response to a study that linked Avandia to a 43% increase in the risk of heart attack and a 64% increase in the risk of death from all forms of heart disease. The data came primarily from GSK, culled from 65 studies of varying sizes, many of which had been posted on the company’s website.
Dr. Steven Nissen of the Cleveland Clinic, lead author of the NEJM study, says, “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.”
According to IMS Health, American doctors wrote 13 million prescriptions for Avandia in 2006 as it generated more than $2 billion in sales.
Dr. Ronald Krall, medical director at GSK, sought to defend his company and its diabetes blockbuster by criticizing Dr. Nissen and his research methodology. He claimed that it mingles data from many different studies that were never meant to be lumped together, but this is the nature of meta-analysis. Dr. Krall reaffirmed his company’s faith in Avandia in the treatment of type 2 diabetes.