OKLAHOMA CITY --
are scrambling to salvage Vytorin, their new cholesterol-lowering drug, after a recent study raised safety concerns about the once-promising treatment.
In a special conference call held just hours ahead of their earnings reports, the two companies relied on outside medical researchers to break bad news about the recently completed Simvastatin Plus Ezetimibe in Aortic Stenosis (SEAS) study.
Terje Pedersen, a Norwegian doctor who led the SEAS trial, noted that Vytorin failed to work statistically better than placebo in reducing "major cardiovascular events" -- the study's primary endpoint -- and delivered a "disturbing finding" about the safety of the drug as well: That cancer rates among patients taking Vytorin during the SEAS study came in much higher than those among those taking placebo instead.
All told, 93 patients who took Vytorin during the SEAS trial wound up with cancer, and 39 ultimately died of the disease. Those numbers were 43% and 70% higher, respectively, than the numbers reported for patients taking placebo.
Shares of Schering-Plough finished down 11.6% to $18.95. Merck, which relies on Vytorin less for its bottom line, fell 6.2% to $35.33.
To be fair, Pedersen did offer some reason for hope. During the SEAS trial, he noted, Vytorin managed to lower so-called "bad" cholesterol by a whopping 60%. Moreover, he emphasized, the drug achieved a key secondary endpoint by statistically lowering the number of "atherosclerotic disease events" -- such as nonfatal heart attacks, coronary bypass surgeries and cardiovascular deaths -- in patients who face serious risks of such threats.
Sir Richard Peto, an Oxford cancer expert hired to analyze the results before their release to regulators, celebrated that achievement as a "positive result" with "medical relevance" for crowds of high-risk patients. Peto also downplayed the cancer cases that arose in the SEAS study as a likely fluke of chance.
"This isn't the sort of pattern one would expect to see," he declared. However, "when you look at a dozen tests, you're quite likely to get something improbable -- and you have to allow for it."
If Vytorin truly posed a cancer risk, Peto insisted, the drug would likely target a specific area and cause an increase in cases over time. But even in the SEAS trial, he stressed, those patterns never surfaced.
Therefore, Peto is calling for two major studies of Vytorin -- known as SHARP and IMPROVE-IT -- to continue forward as planned. Peto insists that those two large-scale trials will better determine if Vytorin poses a real cancer risk.
Indeed, Peto -- who is personally involved with SHARP -- is trying to shift attention away from SEAS to the other studies already. Time and again, he argued that the ongoing Vytorin trials offer "no credible evidence" of increased cancer risks.
"I think we should not be diverted by fears of cancer," Peto stressed. "It matters that we have drugs that seriously lower cholesterol -- because they will seriously save lives."