To help consumers stay informed I'm posting an article form the the New York Times dated January 14, 2008.
A clinical trial of Zetia, a cholesterol-lowering drug prescribed to about 1
million people a week, failed to show that the drug has any medical benefits, Merck
and Schering-Plough said on Monday.
The results will add to the growing concern over Zetia and Vytorin, a drug
that combines Zetia with another cholesterol medicine in a single pill. About
70 percent of patients who take Zetia do so in the form of Vytorin, which
combines Zetia with the cholesterol drug Zocor.
While Zetia lowers cholesterol by 15 to 20 percent in most patients, no
trial has ever shown that it can reduce heart attacks and strokes — or even
that it reduces the growth of the fatty plaques in arteries that can cause
heart problems.
This trial was designed to show that Zetia could reduce the growth of those
plaques. Instead, the plaques actually grew somewhat faster in patients taking
Zetia along with Zocor than in those taking Zocor alone. Patients in the trial
who took the combination of Zetia and Zocor were receiving it in the form of
Vytorin pills.
Dr. Steven Nissen, the chairman of cardiology at the Cleveland Clinic, said
the results were “shocking.” Patients should not be prescribed Zetia unless all
other cholesterol drugs have failed, he said.
“This is as bad a result for the drug as anybody could have feared,” Dr.
Nissen said. Millions of patients may be taking a drug that has no benefits for
them, raising their risk of heart attacks and exposing them to potential side
effects, he said.
Both companies’ stocks were down in mid-day trading in New York on Monday, with Merck’s share price
off by 2.4 percent and Schering-Plough’s down nearly 6 percent.
The results will also add to the controversy surrounding a long delay in
releasing the results of the trial, which was known as Enhance. Merck and
Schering-Plough completed the trial in April 2006 and had initially planned to
release the findings no later than March 2007. But the companies then missed
several self-imposed deadlines, blaming the complexity of the data analysis
from the study and saying they did not know when or if the data would be ready
for publication.
Last month, after several news articles highlighted the delay, they finally
agreed to release the results soon.
For Merck and Schering-Plough, which jointly market Zetia and Vytorin and
share profits from the drugs, the trial’s results are a serious setback. Zetia
and Vytorin are important contributors to both companies’ profits, especially
to Schering, which is smaller and less profitable than Merck.
Analysts estimate that about 70 percent of Schering's earnings depend on the drugs. The controversy over the trial is also a problem for Merck, which is trying to repair its reputation after withdrawing the painkiller Vioxx from the market in September 2004.
Jason - a Lumen
