Makers of Anti-Cholesterol Drugs Want Over-the-Counter Status

Jan. 13–CHICAGO — The makers of the most popular prescription medications in the United States — anti-cholesterol drugs — want permission to sell their products on grocery and drugstore shelves, like cough syrup or aspirin.

During the next two days, a Food and Drug Administration advisory panel will consider pharmaceutical giant Merck & Co.’s petition to market its cholesterol-lowering drug Mevacor over the counter, without a doctor’s order.

The proposal has generated heated debate in the medical community. On the positive side, consumers could have more access to anti-cholesterol drugs and pay less under Merck’s plan. Given the potential of anti-cholesterol drugs to reduce the burden of heart disease, some physicians say, the benefits could be substantial.

Others worry that consumers will start popping pills to prevent heart problems instead of dieting, exercising and getting advice from their physicians. This could lead some people to take drugs unnecessarily and others to forgo treatments they really need, these critics maintain.

“Once you make a medication like this over-the-counter, there is no guarantee that people will take it properly or that they will be supervised adequately by their physicians,” said Dr. Ivan Pacold, director of preventive cardiology at Loyola Univ. Health System. “I don’t think it’s a good idea.”

Statins, the class of medications to which Mevacor and Pravachol belong, are the best-selling drugs in the United States. In 2003, the last full year for which data is available, doctors wrote 126 million prescriptions for these drugs while sales soared to nearly $14 billion.

The drugs slow the body’s production of cholesterol, helping to prevent plaque from accumulating in blood vessels and lowering the risk of heart problems.

Merck is the first company to ask for a change in status for an anti-cholesterol drug, but Bristol-Myers Squibb Co. has a similar application for its cholesterol-buster Pravachol waiting in the wings. Other companies are expected to follow in the years ahead if the FDA grants approval.

Drug makers are lured by an enormous potential market of people at moderate risk of developing heart disease who want the convenience of an on-the-shelf product. By some estimates, more than 20 million people fall in this category.

Merck has especially pressing reasons to search for new Mevacor customers: The former blockbuster lost patent protection in Dec. 2001 and generic copycat competitors have gobbled up sales since then. There is little precedent, however, for the direction in which the drug industry wants to move.

Similar proposals for Mevacor and Pravachol failed to gain FDA approval four years ago. At the time, the agency’s advisory committee said it wasn’t convinced consumers would take the medications appropriately or that the drugs would yield significant benefits at the doses than being suggested.

An even larger issue loomed in the background, then and now.

“Over-the-counter medications are intended to help people treat self-diagnosed, short-term, symptomatic conditions like stomach aches or colds,” said Dr. Michael Davison, director of preventive cardiology at Rush University Medical Center. “But high cholesterol is associated with a chronic condition which is, for the most part, asymptomatic, and people who take these (anti-cholesterol) drugs stay on them for years and years.

“Selling these drugs over-the-counter would be a paradigm shift.”

The American Heart Association isn’t convinced the change is warranted. In a statement, the organization said it “does not believe that we have sufficient data available to us at the present time to make a final decision.”

For its part, Merck promises it will conduct extensive consumer education, encourage people to get their cholesterol levels tested, and set up a toll-free hotline to answer questions.

“We’re not just going to be selling a pill in a box,” said Tony Plohoros, a company spokesman. He noted that over-the-counter Mevacor would probably cost “about $1 a pill,” compared with a cost of “more than $2 a pill” for prescriptions.

Ironically, consumers could end up paying more even though the medication costs less because insurance plans typically won’t pay for over-the-counter drugs.

The company also says it has conducted new research that should allay FDA concerns.

“What we’ve found is most people will use Mevacor appropriately, the majority of people will seek advice from health-care professionals, and most achieve their (cholesterol lowering) goals,” said Plohoros, citing a Merck-sponsored study published in the Nov. 15 issue of the American Journal of Cardiology.

That report, which modeled consumer behavior by setting up 14 faux storefronts selling Mevacor over-the-counter, raises some significant questions, however.

Of the 1,044 people in the study who decided to buy and use the drug, one-third didn’t follow the label’s instructions for who should take the medication. Similarly, one-third of this group hadn’t talked to their physician about cholesterol in the previous two years.

That prospect disturbs Dr. Stephen Fortmann, a professor of medicine at Stanford University. Preventing or treating heart disease doesn’t depend exclusively on controlling cholesterol, he notes. “You have to take into account someone’s blood pressure, their weight, their blood sugar status, their family history,” he said.

If people don’t see their doctors, he and other physicians ask, how are they going to figure out what their treatment goals are or whether this therapy makes sense for them?

Dr. Bruce Psaty, professor of medicine at the University of Washington, worries about potential side effects associated with the statins, such as muscle aches, nausea, and a rare but life-threatening form of muscle breakdown.

Other over-the-counter drugs have side effects that can be equally serious, experts note.

Weighing the potential positives against the potential negatives, Dr. Lori Mosca, director of preventive cardiology at New York-Presbyterian Hospital said she’s leaning toward favoring over-the-counter status.

“I think there’s great potential to improve public health” because physicians are currently doing a “sub-optimal job managing cholesterol,” she said. But there’s also potential for abuse, she noted, if low-risk consumers medicate themselves and patients aren’t adequately monitored.

Mosca suggested that if the FDA approves the switch, it needs to aggressively educate consumers and monitor the impact “within at least six months.” Labels should indicate that consumers should only take the drugs “under the guidance of physicians or other health-care professionals,” she said.

That’s the model being followed in England, which last summer became the first country to give the go-ahead for over-the-counter sales of an anti-cholesterol drug, Zocor, also made by Merck.

In that country, consumers can only get Zocor from a pharmacist, who keeps packages behind the counter and who presumably will dispense advice along with the medication. No similar mechanism exists for controlling the sale of over-the-counter products in the United States.

England’s move prompted the distinguished medical journal The Lancet to warn in an editorial that “the UK public … will be the guinea pigs in this large-scale OTC experiment.”

“Let’s face the facts,” the journal opined. “There are no trials of OTC (over-the-counter) statins for primary prevention of heart disease. There are no data on compliance with OTC statins, which for products that need to be taken daily long-term is a concern.”

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