Avandia (Rosiglitazone Maleate): New Hazard or Hoax?

I have been nothing short of astonished about the hype over the New England Journal of Medicine (NEJM) article published yesterday (actually published on-line prior to it’s scheduled hard-copy release on June 14) on the possible dangers of a widely-used drug for people with type 2 diabetes. In summary, the article, written by Stephen Nissen and colleagues at the Cleveland Clinic, reviewed 44 previously published reports on the use of Avandia and concluded there was a 43% increased risk (relative risk 1.4) of heart attack in people taking the drug compared to those taking placebo or a different diabetes drug. Thus, here we have a meta-analysis- a study that combines the results of actual clinical studies and analyses the data as if they came from a single large study. This is a well-established statistical tool but one with many pitfalls.

How this all unfolded

First, those of us who subscribe to the NEJM, received an e-mail on May 21 with the article. Apparently, the press release was not to take place until after the stock market closed on the 21st. But, earlier in the day of May 21, the report was released by several news services and chaos ensued. The maker of the drug, GlaxoSmithKline had a 7% drop in their stock by the close of the market on the 21st. They, of course, issued a statement defending the drug’s safety. The FDA issued an “alert,” warning patients taking the drug to check with their doctors.

There is more!

In an article today in the New York Times, the interesting course of events and the economic impact of the NEJM report are detailed nicely. The article, written by Stephanie Saul made the front page of the business section and was entitled “Heart Risk Seen in Drug For Diabetes.” The new report summarized the NEJM report and the economics of diabetes drugs (big bucks). In addition, Ms. Saul tells us that as far back as last August, the FDA had data showing increased risk of heart disease in patients taking the drug.

Why so much excitment over this study?

I am amazed at the hype over this report and it does not say much good about the news media, the FDA, medical journals, and doctors. This morning, the news of the dangers of Avandia were everywhere- I just couldn’t hide from it: I even heard about it on CNN when I was waiting to pick up my car (a hybrid) which was getting an oil change.

This is not the way for important medical information to be disseminated. First, I would question how important the news is. Remember, all of the studies that the Nissen article had already been published and those of us “in the field” already knew there were concerns about the cardiocascular side effects of Avandia. The increased risks of heart failure with the drug and with other “glitazones” is well known already. Even worse, along with the Nissen article, there was an editorial and an editor comment that the results should be considered preliminary and interpreted with caution. Give me a break- the NEJM rushes this report to publication, hypes it big time, and asks us to interpret the results with caution. Don’t get me wrong, I LOVE the NEJM and have subscribed to it since 1965, but this was done poorly.

I almost forgot- what should people with diabetes do?

First, I wouldn’t start any patients on Avandia or any of the other glitazones at this time. There are many other drugs (those manufacturers are smiling today). In fact, most of my colleagues who are “expert” in the management in patients with type 2 diabetes, rarely if ever use the glitazones because of their known side effects: I find the vast majority of physicians who prescribe the glitazones and the newer drugs for the treatment of type 2 diabetes, are primary care physicians who learned about these drugs at a drug-company sponsored lecture or from their drug company rep, who provided samples (forgive me if I generalize to excess).

Where do we get our medical information?

One last thing- I am concerned that, increasingly, we (health-care professionals and the lay public) get most of our medical information from the media- TV ads and news reports. The news reports are of particular concern to me. I would be willing to bet that 90% of medical news reported in the media (including the New York Times) comes from only a few out of thousands of medical journals- The Journal of the American Medical Assoication, the NEJM, and Nature. Is it marketing by these journals or is it that the science/medical news journalists rely most heavily on these few journals? I don’t know, but it’s not healthy for any of us.

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