Healthy Skepticism Library item: 13329

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Publication type: news

Cortez MF, Pettypiece S.
Merck, Schering-Plough Appeal to Doctors to Boost Vytorin Sales
Bloomberg News 2008 Mar 27
http://www.bloomberg.com/apps/news?pid=20601202&sid=a9Fmg_Q9eeX4&refer=healthcare

Full text:

Merck & Co. and Schering-Plough Corp. are telling physicians to ignore research showing their jointly marketed cholesterol-drug Vytorin failed to halt progression of artery disease. It’s unlikely they will listen.

Preliminary findings of the study, called Enhance and released in January, drove Vytorin prescriptions down 18 percent and slashed $49 billion from the drugmakers’ market value. In an effort to retain the pill’s $2.8 billion in annual sales, Merck and Schering-Plough are doing the unprecedented: discrediting research they funded and helped design.

The trial, intended to show Vytorin can reduce artery clogging, was created to help the drug compete against Pfizer Inc.‘s Lipitor for a share of the $35 billion worldwide cholesterol market. The failure of Vytorin to outperform an older drug means doctors have little reason to use it. The final report, to be presented Sunday at the American College of Cardiology meeting in Chicago, won’t help, researchers say.

``The study results aren’t going to influence practice much,’‘ said Randy Thomas, a cardiologist at the Mayo Clinic in Rochester, Minnesota. ``The question we’re asking is does it lower heart attack risk. We won’t know that from Enhance.’‘

Sekar Kathiresan, director of preventive cardiology at Boston’s Massachusetts General Hospital, says research may eventually show that Vytorin and Zetia, one of the two medicines that make up Vytorin, will prevent heart attacks, strokes and death. Until studies prove that, he plans to rely on older so- called statins like Lipitor and simvastatin, a generic version of Merck’s Zocor, the other component in Vytorin.

Statins Standard

``Statins should be first, second and third line agents, and the combination of Zetia and simvastatin should be relegated to the patient who has a very hard time with statins or has very high cholesterol,’‘ Kathiresan said in a telephone interview. ``That’s not going to be the common patient.’‘

Schering-Plough, based in Kenilworth, New Jersey, has fallen 28 percent in New York Stock Exchange composite trading since the findings were released. Merck, based in Whitehouse Station, New Jersey, has declined 29 percent in the same period.

Vytorin sales will fall 15 percent in 2007 if the Enhance data presented March 30 at the cardiology meeting doesn’t show better results than the findings released in January, says David Risinger, an analyst with Merrill Lynch & Co. in New York. He previously expected sales to increase 8 percent this year.

Tried and True

``People were hopeful that maybe the full data set might not be quite so bad,’‘ said Jon Paul LeCroy, an analyst at Natixis Bleichroeder in New York. ``If we see worse data, I think it could create another round of down side, especially if we see a big push from cardiology leaders to stick with the tried and true statins.’‘

The data will include information about the impact Vytorin has on several locations in the arteries, giving doctors a broader picture of the pill’s overall effect. Schering-Plough Chief Executive Officer Fred Hassan said doctors should wait for the presentation before making decisions about how to use Vytorin since the results have been taken out of context by the media.

``The companies are eager to disclose the data,’‘ said Michael Krensavage, an analyst at Raymond James & Associates in a telephone interview from New York. ``I think they want to get their side of the story out there.’‘

Merck and Schering-Plough want doctors to focus on Vytorin’s ability to lower LDL, or ``bad’‘ cholesterol, in the blood more than simvastatin can accomplish alone. They also said the results shouldn’t be applied to the mainstream population because the study only looked at patients with a rare genetic condition that causes them to produce excess cholesterol.

Preventing Plaque

LDL cholesterol can build up on vessel walls, causing a thick plaque to form and creating a blockage. A main tenet of cardiovascular care is that lowering bad cholesterol in the blood will translate into less plaque on the artery walls and fewer heart attacks and strokes.

Statins, such as simvastatin, Lipitor, and AstraZeneca Plc’s Crestor work by blocking an enzyme in the liver needed to make cholesterol. Zetia works differently, by absorbing cholesterol in the digestive tract, an approach that hasn’t been proven yet to prevent strokes and heart attacks, doctors say.

The Vytorin combination pill, costing about $100 a month, is five times more expensive than generic simvastatin. The Enhance study was designed to persuade doctors and insurers that Vytorin is worth the extra expense. The study’s failure may be used by insurers to encourage the use of simvastatin instead.

``It is important that the scientific process be respected and we discuss these things in a proper forum rather than running with a very narrow set of assumptions,’‘ Hassan said at a March 18 meeting with analysts. ``We are really looking forward to ACC in the sense that a much fuller discussion will occur around the data.’‘

Showcase Session

John Kastelein, a professor at the Academic Medical Center in Amsterdam and the study’s director, will present the findings at a ``showcase’‘ session Sunday morning. A panel of cardiologists, from Yale University in New Haven, Connecticut, the Mayo Clinic in Rochester, Minnesota, Brigham and Women’s Hospital in Boston, and Rush University Medical Center in Chicago, will review it.

``The goal that we’ve given to the panel members is to, at the end of the discussion, come up with a recommendation for how they would treat patients when they go home on Wednesday after the meeting,’‘ said Marc Shelton, chair of the ACC scientific session and a cardiologist at Prairie Cardiovascular Consultants in Springfield Illinois.