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New Government Cholesterol Standards Would Triple Number of Prescriptions

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New Government Cholesterol Standards Would Triple Number of Prescriptions

By THOMAS M. BURTON and CHRIS ADAMS
Staff Reporters of THE WALL STREET JOURNAL
 

Rarely have so few doctors recommended so many drugs for so many people -- virtually overnight.

For the first time in eight years, the federal government has published new cholesterol standards. If the more rigorous guidelines are widely followed, doctors could end up writing a stack of prescriptions that would nearly triple -- to 36 million people -- the number of Americans on cholesterol-lowering drugs.

The recommendations would put fully 18% of American adults on "statin" drugs like Pfizer Inc.'s Lipitor, Merck & Co.'s Zocor and Bristol-Myers Squibb Co.'s Pravachol. And the new guidelines could theoretically triple U.S. sales of these medicines to nearly $30 billion a year.

The standards come from the National Cholesterol Education Program's expert committee on cholesterol, and they are published in this week's Journal of the American Medical Association. The quasigovernmental group was appointed by the National Heart, Lung and Blood Institute, which is part of the National Institutes of Health.

Under the guidelines, anyone who already has coronary artery disease and whose LDL, or "bad," cholesterol is above 130 generally should be on drug therapy. "We used to say to try lowering it with diet first, but now we say that if your LDL is above 130 and you have coronary disease, you should be on drug therapy," says the committee's chairman, Scott M. Grundy, director of the center for human nutrition of the University of Texas Southwestern Medical Center at Dallas.

The new standard is similar for anyone with symptomatic peripheral or carotid artery disease, or with diabetes: Anyone with those conditions, and with LDL cholesterol above 130, should get drug therapy, the guidelines say. And even if the LDL cholesterol of these people is between 100 and 130, says Dr. Grundy, "we think the evidence justifies the majority of these people going on drugs." Also, people with multiple risk factors like smoking and high blood pressure should try dietary changes but then be on statin drugs if their LDL cholesterol remains above 130, the panel says.

The new standards don't change the overall guidelines for total cholesterol: Above 240 is still considered high, 200 to 239 borderline high and below 200 desirable. But the latest guidelines focus more on components of cholesterol, and on groups of people with certain health risks.

For instance, HDL, or "good," cholesterol below 35 was previously considered too low. Now, below 40 is considered too low. Previously, people with coronary disease, symptomatic peripheral or carotid artery disease or diabetes were considered in good shape if their LDL cholesterol was below 130. Now that target is below 100.

For people who are otherwise healthy, the recommendations are complex. But the panel says that anyone with LDL cholesterol over 190 should generally be on drug therapy regardless.

To calculate their need for dietary or drug therapy, people can go to the Web site of the National Heart, Lung and Blood Institute (www.nhlbi.nih.gov¹). For instance, a nonsmoking 50-year-old man with relatively high total cholesterol of 230 -- but with high HDL cholesterol of 85 and normal blood pressure of 120 -- has about a 3% chance of getting a heart attack in the next decade. He probably wouldn't be a drug candidate. But people whose 10-year chance of a heart attack is 20% or more and whose LDL is above 130 should automatically be on drugs, the guidelines say. The cholesterol-lowering drugs will decrease a person's risk by about one-third, says Dr. Grundy.

Some say the recommendations are too complex. "The average doctor is going to have a lot of trouble making sense of these recommendations," says Lee Newcomer, medical director of a health-insurance consulting company and former medical director of insurer UnitedHealth Group.

While the new guidelines also urge dietary changes, some doctors think these don't go far enough. Dean Ornish, an internist at the University of California at San Francisco who generally urges very low-fat diets before prescribing drugs, says, "It's so easy to write a prescription for a statin drug. Most people don't even know they have a choice because most doctors assume people can't change diet and lifestyle."

Dr. Grundy responds that, in the case of a person with coronary disease and LDL above 130, the vast majority won't drop below LDL of 100. "But," he adds, "we certainly hope that people don't ignore the dietary approach."

Some doctors suggest the financial ties of some committee members may have played a role in the emphasis on drug therapy. Five of the 14 panel members were consultants to -- or received honorariums from -- Pfizer, Merck, Bristol-Myers or other companies, including AstraZeneca PLC, maker of the experimental drug Crestor, which may be the most powerful cholesterol drug yet. "This whole program has the flavor of a drug industry/NIH cabal," says Sidney Wolfe, director of the Health Research Group of Public Citizen, a Washington-based consumer advocacy group. "The fundamental principles are correct, but it seems like they are pushing too hard toward drug therapy."

Acknowledging that most of the experts in the field do have ties to statin-drug makers, Dr. Grundy says, "You can have the experts involved, or you could have people who are purists and impartial judges, but you don't have the expertise."

In any case, managed-care and insurance executives generally endorsed the recommendations. "These guidelines are catching up to standards of practice that have evolved in recent years," says Raulo S. Frear, vice president of clinical services at pharmacy-benefits company Express Scripts Inc. "We have already forecast a tripling of cholesterol-lowering drug expense over the next four years."

But will people follow the recommendations? Research has shown that a fairly low percentage of people who are theoretically candidates for cholesterol drug treatment actually undergo it. And many who do start it don't stick with it longer than a year. "There are many, many, many people who are eligible for treatment who are not getting it," says James McKenney, a professor emeritus of pharmacy at Virginia Commonwealth University and a member of the NIH panel. "So we're coming up with new guidelines when we haven't gotten the old ones right yet."

Of course, drug companies will try to correct that. "The pharmaceutical industry will promote them widely," says Dr. McKenney about the new recommendations. "If you were in the business of selling drugs and you were told your population tripled, you would be doggone happy."

"This brings in a lot of people who are priority targets who now need to be treated," agrees Rob Scott, a Pfizer official who oversees the company's cardiovascular portfolio, including sales of Lipitor, the top-selling cholesterol-reducing drug. "Obviously, we're not unhappy about that."

Write to Thomas M. Burton at tom.burton@wsj.com² and Chris Adams at chris.adams@wsj.com³

URL for this Article:
http://interactive.wsj.com/archive/retrieve.cgi?id=SB989937801155630059.djm

Hyperlinks in this Article:
(1) http://www.nhlbi.nih.gov/index.htm 
(2) mailto:tom.burton@wsj.com 
(3) mailto:chris.adams@wsj.com 
 

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