Cholesterol drugs may join FDA over-the-counter trend


Thursday, July 13th 2000, 12:00 am
By: News On 6


WASHINGTON – Millions of Americans with high cholesterol may soon find relief in the same drugstore aisle with aspirin, antacids and antihistamines.
Advisory panels to the Food and Drug Administration will begin hearings Thursday to decide whether to allow the cholesterol-lowering drugs Mevacor and Pravachol to be sold over the counter.

The FDA's discussion pits the consumer self-care movement against traditional doctor-knows-best medicine. FDA approval would signal a willingness to let patients treat some chronic conditions without first seeing a physician.

"It's a huge wave that is going to wash across a lot of other therapy areas," said Steve Francesco, an industry consultant who supports the over-the-counter switch for Mevacor and Pravachol. He is editor and publisher of Switch, a monthly newsletter devoted to over-the-counter drug issues.

Supporters of the switch say consumers should be trusted to consult with a doctor before buying cholesterol-lowering pills and to periodically schedule checkups afterward. In addition, they say that because over-the-counter drugs are typically cheaper than prescription alternatives, the drugs would become available to people who don't have prescription drug coverage or can't schedule doctors' appointments.

Critics of the switch say the government should deny patients unregulated access to drugs that require routine physician monitoring and lab tests.

Numerous studies show that many Americans already don't comply with their doctors' orders. And about 40 percent of patients prescribed cholesterol-lowering drugs stopped taking them within a year.

This week's meetings on Mevacor and Pravachol come amid a broad re-evaluation of the FDA's strategy toward over-the-counter drugs. The agency held hearings last month to consider, among other things:

&149; Whether birth-control pills should be sold over the counter.

&149; Whether medications for osteoporosis, diabetes and bacterial infections should be available without prescriptions.

&149; Whether it can switch drugs to over-the-counter status despite manufacturers' opposition. Blue Cross of California has filed a petition to allow the allergy medication Claritin to be sold over the counter, but maker Schering Plough Corp. opposes it.The FDA has not made a decision on any of these issues.

About 800 drugs are available without prescriptions. Additions in the last few years include Monistat 3 for vaginal yeast infections, Rogaine for hair loss and Nicorette gum for smoking cessation.

An estimated 97 million adults have high cholesterol, and about 38 million of them have levels high enough to warrant medication. High cholesterol can lead to heart disease, which killed 950,000 Americans in 1997, according the American Heart Association.

The approval process

Mr. Francesco predicts that FDA advisory panels won't recommend over-the-counter sales for the two cholesterol-lowering drugs because they rarely approve controversial applications on first review. But Merck & Co., which makes Mevacor, and Bristol-Myers Squibb, maker of Pravachol, can submit more data and request a second consideration, he said.

The final decision rests with the FDA itself, which can overturn its panels' advice but rarely does so.

Both sides of the debate acknowledge that consumers are exercising more control over their health care. Doctors report an increase in the number of patients who have read journal articles about their conditions. And a slew of Web sites give patients access to experts and others suffering from the same ailment.

Even food manufacturers have seized on this voracious appetite for self-care. For example, companies now make dietary supplements, margarine and even salad dressings that promise to lower cholesterol.

Some doctors worry that consumers will rely on these aids to lower their cholesterol without first visiting a physician."Just taking something doesn't mean that you're achieving your goal," said Dr. Henry Punzi, a Carrollton internist, who has participated in clinical studies involving Pravachol. "There may be a false sense of security."

Cholesterol-lowering drugs cause side effects including liver damage and severe muscle aches in a small number of users. And because patients can't feel the effects of high cholesterol, they have no way of knowing whether the drugs are working or if their dosages needs to be changed, Dr. Punzi said.

Officials with Merck and Bristol-Myers say they are working with the FDA to address these concerns.

"We really believe that we have a great product that can benefit millions of Americans who would be eligible," said Gwen Fisher, a Merck spokeswoman.

Protecting market share

Wall Street analysts note that Merck's patent on Mevacor runs out next year and that generic drug makers will begin to produce cheaper replicas. Although Mevacor does not represent a large share of Merck's portfolio, the company wants to keep as much business as it can, the analysts say.

Pravachol has patent protection through 2005, but analysts see Bristol-Myers' request as a competitive move. A company spokeswoman said only that the company is working closely with the FDA.

"This would be another revenue source on a product which they already did development on," said Jeff Chaffkin, a prescription drug analyst with Paine Webber in New York. "As companies try to manage their product life cycles, this is another avenue they will try to pursue."

More than 13 million prescriptions were written in 1999 for Pravachol (also known as pravastatin) and 3.3 million for Mevacor (lovastatin), according to IMS Health, a health-care information company.

Pfizer, which makes the most-popular cholesterol-lowering drug, Lipitor, does not support moving such medications over the counter. The company's patent on Lipitor does not expire until 2009.

"We don't think that patients can really monitor their lipid [cholesterol] levels and then adjust therapy to meet their goal," said Dr. Robert Scott, therapeutic head of Pfizer's cardiovascular and metabolic group.

Fred Nutter, a 57-year-old mechanic with American Airlines, said he has been taking Pravachol since a heart attack last year. As a participant in Dr. Punzi's clinical study, he gets the drug for free. But he doesn't want to see it available over the counter.

"It's a good medication. It's improved my cholesterol quite a bit," he said. "But I still don't think it's something that anyone should be able to take without first consulting a doctor."

Mr. Nutter hasn't experienced any problems with the drugs, and in fact, his cholesterol has gone down. But he blames the FDA for approving drugs that had to be withdrawn because of deadly side effects.

Support for self-care

Mr. Nutter's view isn't shared by the majority of people worried about their cholesterol levels, according to a recent survey by the nonpartisan National Consumers League. In the poll, 65 percent of respondents thought it was a good idea to have a low-dose, nonprescription cholesterol treatment. They cited cost and availability as the top two reasons.

Even if the cholesterol-lowering drugs are moved over the counter, many patients still won't take them, experts said.

"Whenever you're taking a medicine which is not necessarily changing the way you feel, compliance becomes a big problem," said Dr. Sidney Smith, former president of the American Heart Association and chief of cardiology at the University of North Carolina at Chapel Hill. "You may not feel any different other than having the knowledge that you've reduced your risk of having a heart attack."

The key test in approving switches is whether consumers can understand the label and use the drug correctly, said Dr. Bill Soller of Consumer Healthcare Products Association, a trade group representing over-the-counter manufacturers.

This won't be the first time the FDA has considered an over-the-counter switch for a drug that lowers cholesterol. The agency twice rejected Bristol-Myers' request for its drug, Questran, saying that cholesterol-lowering drugs shouldn't be sold without a prescription. But Questran is now widely regarded as a first-generation drug that carries unpleasant side effects and lacks the effectiveness of newer cholesterol-lowering drugs.

If the current debate yields little else, cardiologists hope it raises public awareness about the need to control cholesterol before it's too late.

"This discussion is definitely stirring a pot that needs to be stirred," Dr. Smith said. "Whatever happens should not be done at the expense of people not doing what they need to do otherwise: exercise, eat the right diet and not smoke."