Vytorin is a “best-selling” and heavily promoted cholesterol lowering drug. It is a composite of two drugs ezetimibe and simvastatin, which work by inhibiting an LDL-cholesterol raising enzyme in the body, and it is usually taken in combination with statin medication.

However, studies conducted in July by Terje Pedersen of Ulleval University Hospital in Oslo, following a 2000-patient study called SEAS, which was supposed to assess Vytorin’s efficacy in preventing heart-valve disease, not only showed it was less-than-effective, but also showed a “disturbing” result: it apparently doubled the risk of cancer among patients who took it. The SEAS study showed that, of the patients who took Vytorin, 101 developed cancer, as opposed to the 65 in the control group. Further, of these 101 patients, 39 died of cancer, while only 23 died in the control group.

In January, to verify the SEAS study, Sir Richard Peto of Oxford University started two continuing 10,000 patient ezetimibe studies titled SHARP and IMPROVE-IT. His findings report no link between cancer and Vytorin, as differences in cancer rates and deaths resulting from cancer between his test and control groups were statistically negligible.

In a press conference held today at the European Society for Cardiology, Peto and Pedersen reported their findings. Pedersen, following Peto’s study, is now convinced the study results were a fluke, however editors of the New England Journal of Medicine report the link cannot be completely ruled out, and indeed report odds as low as 0.7% that the increase in cancer deaths was mere chance.

The debate remains open until the conclusion of the full 12,000 patient IMPROVE-IT trials in 2012. Nevertheless, both researchers agree on one fact: Vytorin’s efficacy in reducing cardiovascular disease in patients taking it was close to naught, and they have recommended that that the drug be taken only by those patients who cannot take other cholesterol-lowering drugs.