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The debate over Vytorin’s cancer risk
continues as results of a controversial Vytorin study, called SEAS, and the
analysis conducted by Oxford
University’s Richard
Peto, one of the world’s top statisticians are presented at the annual congress
of the European Society of Cardiology. The opinions about the results differ.
An editorial published in the New England
Medical Journal, which contained the full data from the SEAS study questions the
drug safety and effectiveness. The full data from the Vytorin study showed a
total of 105 cancer cases among patients taking Vytorin compared with 70 cancer
cases among patients taking a placebo. Several prominent cardiologists also
expressed concern about the safety of the drug.
The Food and Drug Administration approved
the new type of cholesterol-lowering drug in 2002.
On the other hand, according to Peto’s
analysis, “There is no credible evidence of any side effect.” Peto also says that
few drugs could survive in a world where they are constantly tested against any
possible risk.
The cholesterol-lowering pill produced by Schering-Plough
Corp. and Merck & Co. was prescribed 20 million times last year. But there
is still no strong evidence that Vytorin helps patients live longer or avoid
heart attacks. More than that, studies are conducted to see if the cholesterol
drug causes cancer. The companies which make Vytorin and Zetia say that Zetia
showed no cancer risk in animal trials and claimed that cancer finding is
probably the result of chance. Douglas Weaver, a cardiologist at Henry Ford Hospital in Detroit
and president of the American
College of Cardiology
says he is almost certain the increase in cancer deaths is due to chance.
Previous studies compared Vytorin with an
older cholesterol drug. The difference between the two drugs is that Zetia, the
component found in Vytorin, prevents cholesterol from being absorbed from food,
while older cholesterol drugs prevent cholesterol from being made in the liver.
Studies found that Vytorin does not work better than older cholesterol drugs,
which are sold for a fifth of Vytorin’s price.
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