The Vytorin Question

Every day millions of people swallow Zetia and Vytorin in the hopes of reducing their risk of heart attacks and strokes, generating $5 billion a year in sales for Merck and Schering-Plough, which produce them.

Despite millions of prescriptions, no study has ever shown that these $3-a-day pills prevent heart attacks, strokes or deaths any better than just taking older drugs like Pfizer's

news - people ) off-patent Zocor, even though they're proven cholesterol fighters. That's why a two-year delay in a 720-person study aimed at clarifying the issue has cardiologists expressing skepticism and spinning conspiracy theories. If the news were good, the companies would rush it out, the thinking goes. Delay doesn't bode well.

"It starts to raise suspicion," says Allen J. Taylor, head of cardiology at Walter Reed Army Medical Center. "The more time it takes, the more you start to naturally wonder what is wrong."

Roger Blumenthal, a director of the Ciccarone Cardiology Center at Johns Hopkins, says he currently suspects the trial may not show a benefit for Vytorin. "I think anyone would have to think that," he says. He blames the study's design, not problems with the drug itself.

The study, called ENHANCE, began in 2002 to answer the question of whether Zetia increases the effectiveness of Zocor at preventing heart attack by keeping plaque from building up in the arteries. Vytorin is a combo pill of Zetia and Zocor.

Well,...answers today...perhaps....

Merck, Schering Drug Comes Up Short
Carl Gutierrez, 01.14.08, 4:27 PM ET

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Merck and Schering-Plough's Vytorin couldn't best Zocor.

Shares of drugmakers Merck (nyse: MRK - news - people ) and Schering-Plough (nyse: SGP - news - people ) dropped 1.3%, or 77 cents, to $59.78, and 8.0%, or $2.21, to $25.52, respectively, on Monday, after a long-delayed study found that high cholesterol patients fared no better taking Vytorin over the generic form of Zocor (See "Long-Delayed Vytorin Study Fails").

Miller Tabak analyst Les Funtleyder said Schering-Plough fell further than Merck Vytorin was proportionally more important to the company.

“Merck has six or seven potential blockbusters,” Funtleyder said, “and until further notice, Schering’s existing product offering is not as strong.”

Forbes.com had previously reported that the study, Enhance, had been delayed for eighteen months, raising expectations among some cardiologists of a negative result. (See "The Vytorin Question") The House Committee on Energy and Commerce has started an investigation into the delay.

Vytorin Study Shows No Benefit
Matthew Herper, 01.14.08, 1:37 PM ET

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In a potentially damaging result, a long-delayed study showed Merck and Schering-Plough's expensive Vytorin had no benefit on the buildup of artery plaque over the older drug Zocor, even though Vytorin cut bad cholesterol 40% more.

The results could hardly be worse for the companies. Vytorin and its sister pill Zetia generate $5 billion in sales annually for Merck (nyse: MRK - news - people ) and Schering (nyse: SGP - news - people ). (Vytorin is a combo pill of Zetia and Zocor.) The medicines are taken by millions of people; Vytorin lowers low-density lipoprotein (LDL) more than any other single pill. But the study raises questions about whether it has the same benefits as other cholesterol drugs such as Lipitor, from Pfizer (nyse: PFE - news - people ), and Crestor, from AstraZeneca (nyse: AZN - news - people ).

"Physicians should only use ezetimibe or Vytorin as a last resort," Steven Nissen, head of cardiology at the Cleveland Clinic, said Monday. "It should not be used as a routine therapy for high cholesterol unless we see some additional evidence of benefit."

ENHANCE, as the study is known, had been delayed for 18 months, raising expectations among some cardiologists of a negative result. There was scant disclosure of the delay until Forbes reported it last November, leading to a raft of criticism from experts about the way the study has been handled. The House of Representatives' Committee on Energy and Commerce has started an investigation into the delay. (See "The Vytorin Question.")

Responding to Nissen, Skip Irvine, a spokesman for Merck/Schering-Plough, said patients should always consult their physicians before starting or stopping any medicine and should discuss with their doctor the risks and benefits of doing so. He added that the big drop in LDL, or "bad" cholesterol, seen in the study is consistent with previous evidence for Zetia and Vytorin, and that a wealth of clinical data going back decades links lowering LDL to preventing heart attacks, deaths and other heart problems.

"That still remains the foundation of therapy," Irvine said.

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