Maybe "hate" is too strong a word, but cardiologists certainly seem cynical about the full presentation of Merck's (NYSE:MRK) and Schering-Plough's (NYSE:SGP) SEAS data at the European Society of Cardiology. I guess it's easy to be skeptical of a drug that hasn't been proven to work beyond its ability to lower cholesterol.
The trial was designed to see if Vytorin could help patients with blockage of a heart valve, but instead made a disturbing discovery that Vytorin might be linked to cancer. Subjects taking Vytorin got cancer at a higher rate than those taking the placebo.
At the scientific meeting, much like they had when the initial data was presented, the researchers explained that the small trial size likely contributed to skewed data. Two much larger trials haven't shown evidence that the drug causes cancer.
But a lot of doctors don't seem to be buying it. An editorial in the New England Journal of Medicine said that it's "appropriate to raise a note of caution" and reports out of the conference are littered with quotes from skeptical doctors.
Add to that a congressional and FDA probe into the trial and Merck and Schering-Plough look like they're back in the hot seat.
Personally, I think the idea is bupkis; statistical anomalies can and do happen. That's the reason that the Food and Drug Administration requires companies to run two meaningful clinical trials that meet their primary endpoints -- some fraction of the drugs that pass one clinical trial will have done so because of a statistical fluke.
While I think the chance of Vytorin causing cancer is low, it doesn't really matter what I think. It's the doctors who prescribe the drug that will ultimately decide the direction for sales of Vytorin. If doctors shy away from Vytorin in favor of Pfizer's (NYSE:PFE) Lipitor, AstraZeneca's (NYSE:AZN) Crestor, or Abbott Labs' (NYSE:ABT) Niaspan, Merck and Schering-Plough could be in for some additional lost sales.
Investors should keep an eye on how this story plays out in the media, as many doctors are probably on the fence and may only take concerned patients off the drug. More than ever, Schering-Plough and Merck may be dependent on the media for sales of Vytorin.
