WHITEHOUSE STATION, N.J. — Some of the world’s biggest drug companies are working behind the scenes to convince regulators to let older cholesterol-lowering drugs be sold without a prescription in low doses, as Britain has just done.
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A decision is months away, but approval by the Food and Drug Administration could significantly affect the nation’s biggest public health problem, heart disease, and greatly expand sales in the top-selling drug category.
By limiting buildup of artery-clogging fat deposits, cholesterol drugs can reduce risk of heart attack by about one-third. The category is dominated by blockbusters Lipitor, made by Pfizer Inc., and Zocor, made by Merck & Co. of Whitehouse Station.
While doctors say the drugs are safe, less than one-half of Americans who could benefit take them, mostly those at highest risk of heart disease, other complications and death, experts say. Most of the 18 million at moderate risk, defined as having a 10 percent to 20 percent risk of such problems over the next decade, are not on medication.
“What we’re proposing with over the counter is, let’s treat that 10 to 20 percent (group),” said Jerry B. Hansen, vice president of marketing for Johnson & Johnson-Merck Consumer Pharmaceuticals Company, a joint venture seeking FDA approval for a low-dose, nonprescription version of Merck’s Mevacor, the first statin drug.
The added publicity also could drive more people at high risk to their doctors.
Lifestyle changes crucial
Hemant Shah, an independent pharmaceutical analyst with HKS & Co. in Warren, N.J., expects it would significantly expand statin use by people at mild to moderate risk without stealing sales from newer cholesterol drugs such as Lipitor, Zocor and AstraZeneca’ Crestor, because they are much more powerful and will be used by higher-risk patients.
But Dr. Sidney Smith, past president of the American Heart Association, worries that some patients won’t see a doctor regularly and address all their risk factors, including high blood pressure, smoking, diabetes, diet, exercise level and weight.
“There’s a possibility that people might assume that by taking a statin they’ve done all they need to do,” Smith said.
Dr. James Cleeman, coordinator of the National Cholesterol Education Program, has similar concerns. Although the program’s 2001 update of treatment guidelines indicates more people than before should take statins, it still stresses a healthier lifestyle.
“The drugs can be potentially life-saving, but the lifestyle changes are crucial,” he said.
Heart disease is the nation’s No. 1 killer, claiming nearly 1 million lives each year. Still, allowing nonprescription sales would be quite a departure for a drug category where periodic follow-up testing is the norm.
British health officials on Wednesday approved the world’s first nonprescription cholesterol drug, saying Zocor can be sold without a prescription at pharmacies later this year. There, however, consumers will ask a pharmacist for the drug and answer questions to determine whether it is appropriate.
Merck and J&J plan to file for FDA approval by year’s end, Ed Hemwall, vice president of global regulatory and scientific affairs for the J&J-Merck operation, told The Associated Press.
Meanwhile, New York-based Bristol-Myers Squibb Co. wants to sell a nonprescription version of Pravachol, its top seller, which loses patent protection in 2006, said spokeswoman Julie Keenan.
Doctor visits encouraged
FDA turned down the joint venture and Bristol-Myers when they tried in 2000, but their chances look better now.
“The FDA has an open mind, as it were, regarding the issue,” said Dr. David Orloff, of the agency’s Center for Drug Evaluation and Research. He noted that FDA rescinded a 2000 statement opposing the idea.
Shah, of HKS, gives approval a 50-50 chance.
In recent years, FDA has approved nonprescription forms of antihistamine Claritin, Prilosec, Pepcid and Tagamet for severe heartburn, and several products for migraine headaches.
Besides compiling evidence of Mevacor’s safety and effectiveness, the venture has worked with nearly 10,000 consumers through surveys, focus groups and tests in mock pharmacies. It’s all aimed at proving to FDA that the average Joe could correctly follow the proposed package information to determine whether he is a good candidate for the nonprescription version or needs a much stronger prescription dose.
“Visits with a doctor are not required but are highly encouraged,” under the application being prepared for FDA, Hemwall said.
The company would encourage people to get follow-up tests of cholesterol levels. Hemwall said it will ask FDA not to require tests of liver function, because early concerns have proven since unwarranted.
Merck says nonprescription Mevacor likely will cost about $1 for a daily dose — more than what many insurance companies would charge for a co-payment on a brand-name prescription drug. Prescription Mevacor currently costs $2.10 per pill.
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