Yesterday, a study appeared to clear statins of their possible link to cancer. But today, the FDA says it's investigating whether the cholesterol-lowering drug Vytorin can boost the risk of developing that disease. What gives? Well, for one thing, Vytorin isn't just a statin; it combines Zocor with Zetia, a drug that lowers cholesterol via a different mechanism. And the agency is following up on a trial, called SEAS, in which Vytorin-taking patients seemed to have a higher risk of not only developing cancer, but dying from it.
And the FDA is doing so under political pressure, we might add. As soon as Merck/Schering-Plough announced the results of that trial--which, in addition to flagging a possible cancer risk, showed Vytorin didn't affect heart-valve disease any more than placebo did--it trotted out a big cancer expert who concluded that the risk was probably an anomaly. But some experts weren't convinced, and neither were Reps. John Dingell and Bart Stupak, the frequent pharma critics on the House Energy and Commerce Committee. They demanded to look at the cancer data themselves. Yesterday, the Congressmen heard from the FDA about that data, and immediately dispatched letters to Merck and Schering-Plough asking for the cancer expert's analysis. They also asked for proof that the expert was truly independent.
The FDA, for its part, cited two other studies that contradict the SEAS data on cancer risk. And the agency says it will take about nine months to sift through all the avaiable info to determine just what, if any, cancer risk Vytorin carries. Stay tuned.
- see the Washington Post story
- read the Wall Street Journal article