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Do Vytorin’s Risks Outweigh Its Benefits?
July 22, 2008 04:56 PM
A new study reveals more flaws with cholesterol-lowering drug Vytorin. Besides failing to improve certain cardiovascular conditions, the drug may raise the risk of cancer.
30-Second Summary
The new study showed that the cholesterol drug Vytorin, created by pharmaceutical company Merck, failed to improve a heart valve condition called aortic stenosis, which, left untreated, can lead to serious heart problems.
Perhaps more importantly, the study showed the drug may increase rates of cancer. In a study of more than 1,800 people, 93 people who took Vytorin developed cancer, compared with 65 in a control group, “a statistically significant difference,” according to Forbes.
However, some researchers were quick to say the cancer finding was most likely an anomaly. Richard Peto, a statistician at Oxford University, said the idea that Vytorin could cause cancer was “a bizarre hypothesis.”
Although the link between Vytorin and cancer remains uncertain, the study contributes to the debate over brand-name drugs versus generic, with some patients questioning whether they should pay more when the brand name drug does not meet expectations.
According to NPR, the study showed that Vytorin doesn’t reduce the need for heart valve surgery as scientists predicted it did, although it does provide some benefits, such as reducing the chances that coronary bypass surgery might be needed.
Shares of Schering-Plough, which makes the drug Zetia (Vytorin is a combination of Zetia and older drug Zocor) and Merck stock fell 11 and 6 percent respectively July 21, following the study’s release.
Perhaps more importantly, the study showed the drug may increase rates of cancer. In a study of more than 1,800 people, 93 people who took Vytorin developed cancer, compared with 65 in a control group, “a statistically significant difference,” according to Forbes.
However, some researchers were quick to say the cancer finding was most likely an anomaly. Richard Peto, a statistician at Oxford University, said the idea that Vytorin could cause cancer was “a bizarre hypothesis.”
Although the link between Vytorin and cancer remains uncertain, the study contributes to the debate over brand-name drugs versus generic, with some patients questioning whether they should pay more when the brand name drug does not meet expectations.
According to NPR, the study showed that Vytorin doesn’t reduce the need for heart valve surgery as scientists predicted it did, although it does provide some benefits, such as reducing the chances that coronary bypass surgery might be needed.
Shares of Schering-Plough, which makes the drug Zetia (Vytorin is a combination of Zetia and older drug Zocor) and Merck stock fell 11 and 6 percent respectively July 21, following the study’s release.
Headline Links: Study links Vytorin to cancer; pharmaceutical stocks fall
“If you do enough significance tests, you’re going to see some things that are statistically significant,” said Peto, who believes the cancer finding is a “fluke,” according to Forbes. The study, called the SEAS study, was released Monday.
Source: Forbes
“Vytorin and a related drug called Zetia generate sales of four and a half billion dollars a year,” reported Jim Zarroli of NPR. Stocks for Schering-Plough and Merck, the companies that created the drugs, dropped Monday.
Source: NPR
Related Topics: Generic vs. brand-name; FDA pushes new drug rules
The Los Angeles Times questions whether generic drugs are “just as good” as their brand-name counterparts. According to the story, generics cost less than one-third of the corresponding brand names and the FDA ensures generic drugs are equal to brand name drugs, with the “same dose of the same active ingredient, delivered in the same way, and manufactured according to the same standards of quality.”
Source: Los Angeles Times (free registration may be required)
The Food and Drug Administration is researching whether moving away from measuring traditional benchmarks—like lowering blood sugar and bad cholesterol—may make drugs more effective overall. Currently, companies need to prove only that diabetes drugs regulate blood sugar levels. But two major recent studies show that even aggressively lowering patients’ blood sugar levels doesn’t prevent them from having heart attacks.
Source: findingDulcinea
Background: Study shows Vytorin no better than older drugs
Researchers predicted that a study conducted in January would show that Vytorin, a combination of Zetia and Zocor, would clear plaque from arteries better than Zocor alone. However, the study, which consisted of 720 patients and lasted for two years, found that Vytorin is not more effective than Zocor.
Source: findingDulcinea
Reference: Aortic valve stenosis
According to the Mayo Clinic, “Aortic valve stenosis — or aortic stenosis — is a condition in which the heart's aortic valve narrows. This narrowing prevents the valve from opening fully, obstructing blood flow from your heart into your aorta and onward to the rest of your body.” The condition can lead to serious heart problems.
Source: The Mayo Clinic
© 2009 Dulcinea Media, Inc.
