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MAY 20, 2004
By Amy Tsao Statins in Aisle 7? Following Britain's lead, the FDA could soon approve the popular cholesterol-lowering medicines as over-the-counter remedies In early May, the health department in Britain made an unprecedented move: Starting this summer, it will be the first country to sell a low-dose cholesterol-cutting drug without a prescription, much like aspirin or other pain relievers. The decision immediately got the wheels turning: Could America be next? It's a strong possibility, considering the preoccupation with lowering cholesterol over the last decade. Nowadays, cutting LDL, or "bad" cholesterol, with drugs called statins is widely accepted as a primary means of fending off heart disease –- America's No. 1 killer. Statins have generally been prescribed with a preventive aim, and their use has lately been expanded to include younger people who have less troublesome levels of cholesterol. At the same time, the drugs have become more potent, and the bar on what's deemed a high-risk LDL level has continued to come down. And the U.S. Food & Drug Administration has recently signaled that it's considering the over-the-counter (OTC) possibility. EARLY TREATMENT. Some 12 million to 15 million Americans already take statins of some kind, though that's well below half of the total number who could benefit from the drugs, according to current estimates. Among the blockbuster brands are Pfizer's (PFE ) Lipitor, Merck's (MRK ) Zocor, Bristol-Myers Squibb's (BMY ) Pravachol, and Astra-Zeneca's (AZN ) Crestor. The belief among British health authorities and proponents here is that if low-dose statins were made available OTC, more folks with only a moderate risk would start therapy. This could result in considerable cost-savings down the road in prevented heart problems. Certainly, such a transition in the U.S. would have plenty of obstacles. America is generally more cautious than Europe on shifting prescription drugs to open shelves. The FDA has taken a neutral stance on the possibility of cholesterol-cutting drugs being sold OTC, but as recently as 1997 the agency decided that these drugs were unsuitable as a class for OTC status. In 2000, Merck and Bristol-Myers applied to have their statins approved for OTC use, but the FDA turned them down. This time, however, the agency backed off its negative sentiment. Statins have proven safe and effective as prescription drugs, says Mary Parks, deputy director of the FDA's division of metabolic and endocrine drug products. "If data were presented to support [safety in an OTC setting, approval] certainly could happen," she adds. Parks says the agency wants to see data that show consumers can figure out how to use statins correctly without a doctor's supervision. "VASTLY UNDERSERVED." In part, the FDA's mood shift stems from former Commissioner Mark McClellan, who was credited with making health economics a bigger part of the decision-making process. McClellan recently left to run the Centers for Medicaid & Medicare Services, but observers say the FDA has adopted much of his thinking. "Its mission is safety and efficacy, but the agency also has to take into account costs," says Joshua Cohen, senior research fellow at the Tufts Center for the Study of Drug Development. Cohen expects that eventually the FDA will actually force switches to OTC status in certain cases. Both Merck and Bristol-Myers are planning a fresh attempt to get FDA clearance to sell Mevacor and Pravachol OTC. A low-dose version of Merck's Mevacor, a now-generic statin, would serve a "target population that's being vastly undeserved," says Edwin Hemwall, director of regulatory affairs for the Merck-Johnson & Johnson (JNJ ) joint venture set up to secure OTC status for prescription drugs. With regard to the FDA's concerns, Hemwall says Merck has conducted a study measuring consumers' understanding of how to use statins in a simulated retail setting. It will unveil the results this summer. SERIOUS SIDE EFFECTS. Other drugmakers are also campaigning hard. Securing OTC status for treatments that are about to lose their patent protection is one way to fend off losses to generic copycats. Take Schering-Plough (SGP ). When its legal battles to hold on to patent protection for allergy treatment Claritin failed, it announced plans to apply for OTC status. "Companies are thinking that if they can make the switch, they'll be able to capitalize on the brand and undercut generic competitors," says Cohen. In Merck's case, it hopes that an OTC version of Mevacor, which has been exhaustively tested, could pave the way for OTC Zocor, which will lose its U.S. patent protection in 2006. But OTC statins will pose unique challenges because they can have serious side effects, including liver inflammation and muscle toxicity, though these are rare. Doctors now use blood tests to scan for possible problems. Hemwall says both side effects are uncommon in patients on low doses of the drugs, but he concedes that the FDA will ultimately have to "weigh in on that." SELF-DIAGNOSIS? Some physicians worry that OTC availability of statins might be too successful. Lowering cholesterol levels is an important goal, says Robert Bono, former president of the American Heart Assn. and chief of cardiology at Northwestern, but oversight of some kind is essential. He fears that people who need statin therapy may take the wrong dose without knowing it, and others who don't need treatment might expose themselves unnecessarily to potential side effects. The risk is low, Bono notes, "but when you start applying it to an enormous population, that becomes a concern." Experts don't dispute the benefit of starting statin treatment earlier, but many physicians are skeptical that the potential vetting processes imposed by regulators will be enough to make the drugs viable without a prescription. For one thing, many patients might not know the drugs could help them: High cholesterol isn't like hayfever or heartburn, which cause unmistakable symptoms. Before patients can even start on statins, they should find out their cholesterol level with a blood test. Plus, unlike most other drugs that have made the OTC switch, statins are a long-term therapy. Pharmacists in Britain are expected to play a key role in determining who can take an OTC statin. If cleared in the U.S., Bono expects American pharmacists also to be the gatekeepers, and perhaps even be responsible for keeping a register of patients. And patients may be required to provide evidence –- from a doctor, most likely -– of their cholesterol level or submit to tests made available at the drugstore. Over the next year, the experience across the Atlantic will help determine if and when selling cholesterol-reducing drugs off the shelves will become common practice in the U.S. Federal regulators and the medical Establishment will be watching closely.  Tsao covers biotechnology issues for BusinessWeek Online. Follow her Biotech Beat column only on BusinessWeek Online Edited by Douglas Harbrecht
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