MUNICH (Reuters) - Experts clashed over the safety of Merck & Co and Schering-Plough's cholesterol drug Vytorin on Tuesday as full results from a controversial study were presented at Europe's biggest medical congress.
Researchers involved in the so-called SEAS study -- highlights of which were first released in July -- said there was no credible evidence linking Vytorin to cancer and that the higher number of cases seen in the trial was simply a fluke.
But an editorial in the influential New England Medical Journal, which published the full data from the Vytorin study online, said the safety of the drug was now in doubt, and several leading doctors also expressed concerns.
Researchers involved in the so-called SEAS study -- highlights of which were first released in July -- said there was no credible evidence linking Vytorin to cancer and that the higher number of cases seen in the trial was simply a fluke.
But an editorial in the influential New England Medical Journal, which published the full data from the Vytorin study online, said the safety of the drug was now in doubt, and several leading doctors also expressed concerns.
The full report on the trial, involving 1,873 patients, showed a total of 105 cancer cases among Vytorin patients compared with 70 taking a placebo. That was an upward revision from the totals of 93 and 65 reported in July.
Lead investigator Terje Pedersen of Ulleval University Hospital in Oslo, however, said cross-checks with cancer rates in two much larger, ongoing trials simply did not support the idea that Vytorin was linked to cancer.
Other leading cardiologists were not so sure.
"I am quite concerned," Heinz Drexel, professor of medicine at the University of Innsbruck in Austria told Reuters.
"At the moment, I would not take ezetimibe myself," Drexel said, although he urged patients not to stop treatment without consulting their doctor.
Ezetimibe is one of the two ingredients in Vytorin, alongside the established statin drug simvastatin.
Pedersen presented data on the drug at the annual European Society of Cardiology congress in Munich. His trial had aimed to see whether Vytorin could help prevent heart valve problems but concluded it was no better than a placebo, or dummy, pill.
U.S. lawmakers have already announced a probe into the possible Vytorin cancer link, and shares in both the drug's makers have fallen since July. The U.S. Food and Drug Administration expects to give its verdict in about nine months.
Merck and Schering-Plough shares were both flat in early trade in a sharply higher New York market.
UNCERTAINTY
The key for the firms -- both of which say the finding is simply a statistical anomaly -- will be doctors' reaction to the furore.
The New England Journal of Medicine added to the skepticism.
"Physicians and patients are unfortunately left for now with uncertainty about the efficacy and safety of the drug," it said in an editorial.
It noted that ezetimibe interfered with the gastrointestinal absorption not only of cholesterol but also other molecules that could conceivably affect the growth of cancer cells.
Pedersen said there was absolutely no evidence for such a cancer-causing mechanism -- echoing the conclusions of Richard Peto, a cancer epidemiologist at Oxford University.
Lead investigator Terje Pedersen of Ulleval University Hospital in Oslo, however, said cross-checks with cancer rates in two much larger, ongoing trials simply did not support the idea that Vytorin was linked to cancer.
Other leading cardiologists were not so sure.
"I am quite concerned," Heinz Drexel, professor of medicine at the University of Innsbruck in Austria told Reuters.
"At the moment, I would not take ezetimibe myself," Drexel said, although he urged patients not to stop treatment without consulting their doctor.
Ezetimibe is one of the two ingredients in Vytorin, alongside the established statin drug simvastatin.
Pedersen presented data on the drug at the annual European Society of Cardiology congress in Munich. His trial had aimed to see whether Vytorin could help prevent heart valve problems but concluded it was no better than a placebo, or dummy, pill.
U.S. lawmakers have already announced a probe into the possible Vytorin cancer link, and shares in both the drug's makers have fallen since July. The U.S. Food and Drug Administration expects to give its verdict in about nine months.
Merck and Schering-Plough shares were both flat in early trade in a sharply higher New York market.
UNCERTAINTY
The key for the firms -- both of which say the finding is simply a statistical anomaly -- will be doctors' reaction to the furore.
The New England Journal of Medicine added to the skepticism.
"Physicians and patients are unfortunately left for now with uncertainty about the efficacy and safety of the drug," it said in an editorial.
It noted that ezetimibe interfered with the gastrointestinal absorption not only of cholesterol but also other molecules that could conceivably affect the growth of cancer cells.
Pedersen said there was absolutely no evidence for such a cancer-causing mechanism -- echoing the conclusions of Richard Peto, a cancer epidemiologist at Oxford University.
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