FDA, Congress Investigating Vytorin Cancer Link

August 22, 2008

As previously discussed on Gooznews (see here, here, and here), the recently announced results of the SEAS trial showed an increase in cancer cases and deaths in the group that received Vytorin, a drug that combines ezetimibe (Zetia) and a statin. Because statins are not thought to promote cancer, suspicion has centered on ezetimibe.

Yesterday, the FDA announced that it was investigating the cancer incidence and deaths in SEAS. The FDA stated that its investigation would take approximately nine months and that “to date, [the cancer data] in the SEAS trial plus the interim data from ongoing trials should not prompt patients to stop taking Vytorin or any other cholesterol lowering drug.”

In July, the House Energy and Commerce Committee sent a letter to the FDA asking for the results of a statistical analysis of SEAS and other Vytorin trials by Richard Peto, an epidemiologist at Oxford University. As reported by Dow Jones, the FDA responded to the committee yesterday, but deferred questions on the content of its response to the committee. Yesterday, the committee sent letters to Merck and Schering-Plough demanding that they turn over details on the cancer cases and deaths in SEAS and the two ongoing Vytorin trials, as well as information relating to payments, contracts and communications between Richard Peto or his Oxford University Clinical Trials Service Unit and the companies.

In the letter, Congressmen Dingell and Stupak stated that “[w]e are concerned that the analysis of Vytorin data conducted by Sir Richard Peto may not be as ‘independent’ as expected, given that his Clinical Trials Service Unit is conducting the Study of Heart and Renal Protection (SHARP) trial of Vytorin, also funded by Merck, Schering-Plough, and/or the joint venture.”

As discussed in this recent Gooznews post, a theory worth investigating is the possibility that ezetimibe causes or promotes cancer by blocking the absorption of dietary plant sterols. Yesterday, Steven Nissen, the Cleveland Clinic cardiologist, explained that, “There’s a body [of] medical literature that says those very plant sterols can inhibit the growth of cancer.”

While I appreciate the FDA’s need to evaluate all the evidence before making a recommendation, I do not agree that patients can safely stay on Vytorin until all the evidence is in. Given the substantial questions as to ezetimibe’s safety and effectiveness, I believe it would be reasonable and prudent for patients who are on Vytorin or Zetia to discuss with their doctors the advisability of switching to a statin.

– PM

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