Cholesterol Guidelines A Gift For Merck, Pfizer
Matthew Herper, 07.12.04, 4:30 PM ET
Forbes Magazine
http://www.forbes.com/healthcare/20...mh_0712mrk.html

NEW YORK - New guidelines issued by the United States government could increase the number of people who take cholesterol-lowering medicines; already the top-selling medication in the world with $26 billion in annual sales.

The new guidelines were predicted here months ago. (See: "Is Lipitor The New Aspirin?")

Under previously existing guidelines, 36 million people should be taking cholesterol-lowering pills such as Lipitor, Zocor, or Pravachol to prevent heart attacks. In reality, only about 11 million do. Changes issued today by the National Cholesterol Education Program (NCEP), to be published in tomorrow's issue of the journal Circulation, advocate lowering cholesterol in even more patients. Moreover, patients at the highest risk should receive even more aggressive treatment--meaning higher, more expensive doses of these drugs. Now, that figure will increase by millions of people, as the new guidelines suggest treating diabetics and people who at one time would have been considered healthy. Those at high risk, or who have had recent heart attacks, should be treated even more aggressively.

The NCEP did not release an estimate of how many patients should now take cholesterol-lowering drugs, called statins. Christopher P. Cannon, a cardiologist at Brigham & Woman's hospital, says 50 million people should take the drugs. Another cardiologist, Steven E. Nissen of the Cleveland Clinic, said that number looked reasonable, although James I. Cleeman, a researcher at the National Heart Blood and Lung Institute and a co-author of the report said it was "a little high." The cost of treating that many people with even the lowest dose of Pfizer's (nyse: PFE - news - people ) Lipitor could approach $40 billion.

But an even more important facet of the guidelines is that many people would not be on low doses of these drugs. For patients at the highest risk of heart attack, the new guidelines suggest that "bad cholesterol," or low-density lipoprotein (LDL), be reduced to 70 mg per deciliter--although the new guideline is optional. Previous guidelines suggest that LDL of 100 mg was good enough. Many patients will not be able to get to those levels at starting doses of most current drugs. "It may be that reducing cholesterol to levels that are consistent with what used to be found in rural china is where we need to head," says Sydney Smith, a cardiologist at the University of North Carolina, Chapel Hill, and a co-author of the new guidelines.

Even for patients at modest risk of heart attacks--meaning that they have heart disease, diabetes, or a combination of some risk factors--the new guidelines suggest lowering cholesterol at least 30-40%. With weaker statins, such as Pravachol from Bristol-Myers Squibb (nyse: BMY - news - people ) or lovastatin, available as a cheap generic, that requires the second-highest dose. That could encourage doctors to use stronger drugs--a big boost for Lipitor. Crestor, an even more powerful statin from AstraZeneca (nyse: AZN - news - people ) could also benefit, but may be held back because it does not have the same track record of safety as Lipitor.

Another big winner could be Vytorin, a new cholesterol pill from Merck (nyse: MRK - news - people ) and Schering-Plough (nyse: SGP - news - people ) that is expected to hit the market soon. It combines Merck's Zocor with another drug, Zetia, to lower cholesterol even more at lower doses.

Some say the new guidelines do not go far enough. "It's very disappointing to me that NCEP couldn't get it right given the data," says Eric Topol, a cardiologist at the Cleveland Clinic. He points out that two clinical trials have shown that many patients would benefit from more cholesterol lowering. Says Topol: "To make an LDL of 70 an optional strategy is ignoring the trials."