By Eva von Schaper and Michelle Cortez
Sept. 2 (Bloomberg) -- Schering-Plough Corp. and Merck & Co. may see sales of their cholesterol drug Vytorin drop even further after it was linked to cancer deaths in a three-study analysis intended to reassure patients.
The review found that more patients getting Vytorin died from cancer, although overall rates of the disease weren't higher, according to a publication of the results in the New England Journal of Medicine. Doctors representing U.S. and European cardiologists said they wouldn't recommend the medicine for a majority of heart patients.
``This can't help'' the drug's sales, said Gordon Tomaselli, a spokesman for the American Heart Association and a cardiologist at Johns Hopkins University School of Medicine in Baltimore, in an interview today at the European Society of Cardiology conference in Munich.
Tim Gardner, president of the American Heart Association, said he wouldn't recommend taking the treatment to lower high cholesterol because the cancer link hasn't been completely refuted. Patients who can't otherwise get their blood lipids low enough, and those currently enrolled in a trial, should stay on the drug, both doctors said.
``We are moderately reassured, but we are not completely reassured,'' Gardner said in an interview.
Prescriptions Fell
New Vytorin prescriptions fell to 65,461 for the week ending Aug. 22 from 73,408 in the week ending July 18, the last week before preliminary cancer data were announced. More than 23,000 patients taking the drug stopped it in this time period, according to Bloomberg data.
Total prescriptions first dropped after the company released data in January showing Vytorin reduced artery-clogging plaque no better than a generic form of Zocor, a drug that is combined with Schering-Plough's Zetia to make Vytorin.
Schering-Plough reported a 19 percent drop in second-quarter profit as Vytorin sales fell 9 percent to $1.2 billion. Merck, which posted a 5 percent increase in quarterly profit on rising sales of its diabetes pill Januvia, said it wouldn't reaffirm its 2008 earnings forecast because of the Vytorin study.
Merck, which has lost 40 percent of its value this year, fell 84 cents, or 2.4 percent, to $34.83 at 4:01 p.m. in New York Stock Exchange composite trading. Schering fell 31 cents, or 1.6 percent, to $19.09. Its shares have dropped 28 percent this year.
Chance Link?
The cancer fear was first raised in July, when a study dubbed Seas found patients taking Vytorin were more likely to develop cancer than those getting a placebo. To determine whether that was a real or chance finding, researchers examined data from two larger studies already underway. The three studies taken together didn't find more cases of cancer, the researchers said.
The analysis did find that more patients taking Vytorin actually died from cancer. Those results raise additional questions about the drug's safety and shouldn't be immediately dismissed, according to an editorial in the New England Journal.
The authors of the original study and the three-trial review said they believe neither Vytorin nor Zetia, also know as ezetimibe, boosts the risk of developing or dying from cancer.
``The available results from these three trials do not provide credible evidence of any adverse effect of ezetimibe on rates of cancer,'' said the researchers, led by Richard Peto from the Clinical Trial Service Unit at Oxford University.
Lawmakers' Questions
Representative John Dingell, who heads the U.S. House Committee on Energy and Commerce, and Representative Bart Stupak, chairman of the panel's Oversight and Investigations Subcommittee, asked the chief executive officers of Schering- Plough and Merck today to provide them with more information for an ongoing Vytorin investigation.
Dingell and Stupak, both Michigan Democrats, questioned whether a five-page analysis they received from Oxford's Peto was the complete report sent to the Food and Drug Administration and asked if the companies reviewed or edited the work before it was submitted. The findings didn't go much beyond what was presented at a press conference in July, raising concern that there may be ``a secret report to FDA,'' they said.
Most doctors recommend Vytorin as a fallback therapy for those who don't benefit enough from other treatments, said Heinz Drexel, a European Society of Cardiology spokesperson and a cardiologist at Feldkirch hospital in Austria. Some cardiologists give Vytorin right away because of its blood fat-lowering properties, and because side effects linked to cholesterol drugs known as statins, such as Pfizer Inc.'s Lipitor, were troublesome for patients, he said.
Drexel said he won't take patients off Vytorin, though he won't recommend it for new cases. The patients he would prescribe the drug for make up about 10 percent of all high cholesterol cases, he said.
Doctors should stick to current guidelines, Douglas Weaver, the president of the American College of Cardiology said. ``Use statins first,'' Weaver said in an interview before the release. Vytorin ``is not a first-line therapy.''
To contact the reporters on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net
Last Updated: September 2, 2008 16:06 EDT
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