For those of you following the Avandia story in the news, you're probably wondering how the patients currently taking Avandia are feeling. Are they flushing the pills down the toilet? What about the patients enrolled in GlaxoSmithKline's current Avandia clinical trial -- are they dropping out like flies? If you are unfamiliar with the Avandia debate, news broke last week that Avandia, a popular diabetes drug, may increase the risk of heart attack. A 43% higher risk.
It may depend on the specialty of your doctor. BusinessWeek has reported endocrinologists tend to be more skeptical of the study, noting its weaknesses compared to original, more rigorous clinical trials. Many cardiologists and drug safety experts give the study more weight, and remain worried about Avandia's potential cardiac danger. Doctors on the frontline are concerned patients may stop taking the drug without medical consultation as many are confused and frightened.
Dr. Nissen, the whistle-blower on Avandia and leader of the fight to withdraw Merck's arthritis drug Vioxx due to safety issues, acknowledges there are real limitations in his analysis, but he points out Glaxo's own data found a 30% increase in the risk of heart attack from Avandia. Nissen was alarmed enough to release his meta-analysis showing a 43% increased risk versus waiting for the results of Glaxo's 4,400-patient, eight-year clinical trial named RECORD, which is specifically measuring cardiovascular outcomes of Avandia.
Critics say Nissen went too far out on a limb this time as a meta-analysis examining 42 Avandia trials with varying research methodologies is not terribly reliable.
How many heart attacks did Nissen's meta-analysis reveal? Among 15,560 Avandia-takers, 86 had a heart attack and 39 died of cardiovascular origin. This compares to 72 heart attacks and 22 deaths from cardiovascular causes of 12,283 diabetics taking drugs other than Avandia. Critics point out Nissen did not include six trials of Avandia that showed zero -- yes, ZERO -- heart attacks. If you wrap those six trials into the mix, critics contend, Nissen's statistical significance is null and void.
Nissen says Avandia's only proven benefit is controlling blood sugar levels and many safer drugs are available. Endrocrinologists want a wide variety of drugs to prescribe in case a patient is resistant to one.
The back-and-forth news on Avandia reminds me of watching a long baseline rally in professional tennis before powerful graphite racquets entered the scene. But this is hardly a recreational moment for diabetics taking Avandia -- it must an unsettling time.
