Friday, August 1, 2008

Vytorin: Using medical reports for media hype and political attention

If you are a reader of this blog, you will know that I am no fan of Vytorin. Despite their massive marketing campaign, Merk-Schering has failed to prove why treating the "two sources of cholesterol" has any benefit to just treating patients with a statin. Both the ENHANCE study and SEAS studies (the only outcomes studies thusfar) failed to show any benefit of Vytorin , and thus there is really no need to use it.

However, the Vytorin saga seems to have struck and chord with the public, and so folks are piling on.

It was not surprising that many of the media outlets like Forbes, MSNBC, ABC news and others reported on the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) trial. As I have mentioned in a previous post, SEAS compared Vytorin to placebo in about 1800 patients with aortic stenosis, and showed no difference in the primary endpoint of both aortic valve events combined ischemic events (nonfatal MI, coronary, CABG, etc.). It was also not surprising to see that the media reported on an unexpected finding in the study, double the risk of cancer for those patients taking Vytorin.

However, apparently congress is now asking for a cancer investigation. According to the Wall Street Journal:

In a letter to the FDA, Rep. John Dingell (D., Mich.) said that based on the study's finding, "Vytorin may not be safe. Its potential for cancer and cancer deaths may be a significant cause for concern among physicians and patients."

And of course, this brings more media attention to the issue. The problem is that this is a non-issue. The SEAS study was not a Merk-Schering study. Cancer rates in the SEAS study were doubled, (106 in the Vytroin group versus 67 in the controls) but absolute difference was about 7% and did not reach (though it came close) statistical significance. Moreover, there is really no biologically plausible reason for Vytorin to cause cancer . In addition, as a result of these findings, analysis of large ongoing Vytorin studies (IMPROVE-IT and SHARP) showed fever cancers in the Vytorin group (313) then in patients not taking Vytorin. In other words, Vytorin very likely does not cause cancer.

On the one hand, I am in favor of further reasons for physicians not to prescribe/patients not to take Vytorin. On the other hand, I am annoyed that congressmen are using media-hyped anti-pharma fear to try to earn political clout. I would be the first to say that further scientific investigation on the issue of Vytorin and cancer is probably warranted. However, let's leave this to the scientists and the FDA. Why does congress need to get involved? Aren't there better things for them to worry about, like say 47 million Americans without health insurance?


Anonymous said...

Well said!

Anonymous said...

okay, I have been on vytorin since my heart attack in 2002. I have had three types of cancer since then Lyphoma, lung, and colon. About a month ago my doctor took me off vytorin because my ankles, legs and feet were swelling, I couldn't walk more then half a mile, I was constantly in pain from my waist down. Now since I have been off of it my body is back to normal and the pain is gone. My cholesteral level was pretty good while I was on it. So I really don't know if vytorin is the cause of cancer, but I have heard stranger things. Thanks