Just to keep you up on the latest news; there was a long article in the New York Times today written by Stephanie Saul and Gatrdiner Harris, entitled “Years Ago, Agency Was Warned of a Drug’s Risks,” (Section C, page 1). The gist of the article was that several years ago the FDA was warned by at least one physician, Dr. John Buse, that rosiglitazone (Avandia) might pose cardiovascular risks for patients with diabetes. Dr. Buse is soon to be the president of the American Diabetes Association. It is interesting that he has done studies for Eli Lilly on a competing drug, Actos. I like Dr. Buse but deep down might there be some bias or conflict of interest in his current criticisms? Maybe not?
Enter the cool-headed British
Most interesting to me was an editorial published yesterday on-line in the distinguished British medical journal, The Lancet. The editorial (I couldn’t find out who wrote the piece), which appeared in my e-mail today courtesy of the Lawson Wilkins Pediatric Endocrine Society, summarized the Avandia “press” over the past 2 days. The author, like me, was surprised at the incredible uproar over the Nissen paper in the New England Journal of Medicine (see my last entry for the details) and the FDA warnings.
The Lancet editorial pleaded for calm and reason; there were already considerable data showing increased cardiovascular risks for patients with type 2 diabetes who took Avandia. The author suggested we might wait until more data are available from large prospective studies that might allow us to sort things out better (just to remind you, the paper by Nissen and colleagues was a meta-analysis of ALREADY PUBLISHED data. Oh, what are the British to think of us?
What does the Avandia story tell us?
Clearly, the way we in American medicine and our patients get information about drugs and other therapies that are commonly used needs rethinking. The Avandia “the sky is falling” story should be embarrassing to us all. Pharmaceutical companies, physicians, the medical journals, and the FDA need to do a much better job in sorting out the risks and benefits of this or that therapy; every treatment, drug or otherwise, has a risk/benefit ratio- sometimes the risks are unknown, but it’s worth knowing that.
I believe most physicians who prescribe this or that drug are very shaky regarding the risk side of things; if physicians do not know the risks of the drugs they prescribe, patients will not get the chance to “weigh in” on whether the recommended therapies are right for them. All physicians, including yours truly, are guilty of not always sharing enough information with patients about a recommended therapy, even if we do know the risks involved. I wonder how many physicians who have prescribed Avandia were even aware of the data suggesting increased risks of heart disease? Don’t get me wrong, even if a drug or other therapeutic approach has risks, it may be well worth the risk for the potential benefits, and that may be the case with Avandia. Who knows?
- Avandia (Rosiglitazone Maleate): New Hazard or Hoax?
- TV And Blood Sugar Control In Children With Type 1 Diabetes