FDA Mulls Easier Access to Cholesterol Drugs

Four years ago, advisory committees of the Food and Drug Administration rejected requests by several companies to turn their prescription cholesterol drugs into over-the-counter medications. Next month, at least one of the drugs will get another chance.

Merck's ( MRK) Mevacor will get a hearing before a joint meeting of two FDA panels on Jan. 13 and Jan. 14. The other drug rejected as an OTC candidate four years ago is Pravachol made by Bristol-Myers Squibb ( BMY).

Both products, which belong to the class of drugs called statins, were rejected because advisory panel members said the companies failed to adequately demonstrate that the OTC drugs could be used safely by consumers. But in July 2004, a joint venture of Merck and Johnson & Johnson ( JNJ) began selling a nonprescription version of Merck's Zocor in the U.K., setting the stage for a renewed effort for OTC statins in the U.S.

A spokesman for Merck, which is collaborating with J&J to make nonprescription Mevacor, declined to comment. Earlier this year, Merck officials said the company would seek OTC status for Mevacor in 2005. A spokesman for Bristol-Myers Squibb declined to comment.

The sales pitch for OTC statins goes like this: The drugs have a long track record of safety; people with moderate risk of heart disease could use these drugs in conjunction with improved behavior such as losing weight and increasing exercise; and converting drugs to OTC status would improve patient access.

The argument against OTC statins goes like this: Even the safest statin can cause side effects such as liver damage and a rare muscle-wasting disease; doctors recommend periodic blood tests and monitoring for signals of liver problems. As for efficacy, critics say the OTC strengths of statins may be too low to be effective. As for cost, critics ask what happens to a consumer whose insurance plan covers prescription drugs but doesn't cover OTC drugs.

"In our view, given patient monitoring and safety issues, it is unclear whether or not any statins will go OTC," said David R. Risinger of Merrill Lynch. Mevacor will be reviewed in January by the adviser panels on nonprescription drugs and on endocrine and metabolic drugs.

Statins will have a tougher time being converted to nonprescription status than heartburn drugs, such as Prilosec, and antihistamines, such as Claritin, Risinger said. These drugs treat "generally benign conditions," and patients can tell when to start taking the drugs and when to stop, he said. But elevated cholesterol doesn't produce obvious signs, requiring physician monitoring and lab tests. Some statin-linked side-effects can be life-threatening, he added, but "such major adverse events are generally not an issue" with the heartburn drugs and antihistamines.

Risinger said doctors view newer statins as superior to older drugs. Even if Mevacor and Pravachol go OTC, "a majority" of physicians will initially write prescriptions for brand-name drugs "and rarely switch to an OTC unless access is limited by an individual's insurer," he said.

A Different Climate

Bringing up the subject of OTC statins comes at an awkward time, given the continuing scrutiny over the FDA's behavior in such matters as Merck's withdrawal of the arthritis drug Vioxx and Chiron's ( CHIR) discovery at literally the last minute that manufacturing problems would kill off its entire supply of flu vaccine for this season.

The agency also has taken criticism for some statins. Baycol was pulled off the market in 2001 by Bayer ( BAY) because the drug was linked to some 31 deaths, according to the FDA. The drug, which entered the U.S. market in 1997, had a high rate of the rare muscle-wasting disease called rhabdomyolysis.

In addition, AstraZeneca's ( AZN) Crestor, approved by the FDA in August 2003, has been criticized by Public Citizen, a U.S. consumer group, and by The Lancet, a leading British medical journal, for what they say are high rates of certain side-effects. Both want the drug withdrawn. AstraZeneca defends Crestor, pointing to clinical trials and comments from top-ranking FDA officials that the drug is safe.

And no drug discussion would be complete without a financial component. Companies have an incentive for seeking OTC status for prescription drugs that are experiencing weakening sales and/or generic competition. This way, companies can use their brand names to capture some sales that would have been lost.

Mevacor's U.S. sales have virtually disappeared due to generic competition. Pravachol, which ranks third in U.S. statin sales, will lose its U.S. patent protection in April 2006.

For the week ended Nov. 12, Pravachol had a U.S. dollar market share of 11.9%, or $39.2 million, according to NDCHealth, a health care information company. The market leader is Pfizer's ( PFE) Lipitor, with a 49% market share, followed by Merck's Zocor, with 25.2%. Zocor, which has lost patent protection in some foreign markets, will be hit by generic competition in mid-2006.

For the week ended Nov. 12, Mevacor had U.S. sales of only $233,314 compared with sales of $13.8 million for generic versions, says NDCHealth. The firm tracks drugs that are dispensed in retail outlets and by mail-order pharmacies. The dollar amounts represent the estimated cost incurred by the wholesaler to purchase product from the drug manufacturer.

Pros And Cons

One way to examine the OTC statin debate is to compare dueling editorials by The Lancet, which opposes nonprescription statins and The American Journal of Cardiology, which says they could provide a benefit.

Shortly before Merck and J&J began selling an OTC version of Zocor in the U.K., The Lancet attacked the British government's decision for becoming the first country to allow a nonprescription statin. It argued that the government failed to require adequate tests on patients who self-medicate and to secure proof that people wouldn't simply "substitute drug use for lifestyle modification," such as losing weight and stopping smoking.

"Will pharmacists have the time to determine the individual's risk of coronary heart disease before selling the drug and also give lifestyle advice?" the editorial asked. "All these are unknowns, which is unfortunate for the U.K. public, who will be the guinea pigs in this large-scale OTC experiment."

The journal said the government hadn't determined "the hazards" of OTC statins and hadn't measured the potential impact of long-term use of low-dose Zocor vs. long-term use of higher doses of statin drugs. "If the U.K. public is to be used in an OTC experiment, then the evidence must be collected and used for the benefit of all," The Lancet said.

For the American Journal of Cardiology, OTC statins could be a valuable therapy because clinical trial data for the cholesterol fighters, excluding Baycol, "indicate a favorable risk-benefit ratio," says an editorial written by a physician who is a consultant for several companies making statins.

An OTC statin "with demonstrated primary-prevention benefits will offer another therapeutic alternative to patients who have intermediate risk and require primary prevention," the editorial said.

The editorial pointed out that OTC statins aren't for everyone. "No argument can be made for self-medication or management without a physician's supervision" for patients with a high risk of coronary heart disease, existing heart disease or other cardiovascular ailments, the journal said. But for patients with an "intermediate risk" for heart disease, low-dose OTC statins "may be a viable approach to decrease risk" as long as the patient also improves diet, increases exercise, loses weight and makes other lifestyle adjustments.

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