THURSDAY, May 20, 2004 (HealthDayNews) -- Storm clouds are gathering over the British government's decision to make a cholesterol-lowering statin drug available without a prescription in the United Kingdom -- a concept currently being considered by the U.S. Food and Drug Admininstration.
An editorial in the May 22 issue of The Lancet said the move to allow over-the-counter sales of the drug "is unfortunate for the UK public, who will be the guinea pigs in this large-scale OTC experiment." The statin that will hit British store shelves in July is simvastatin (Zocor).
"There are no trials of OTC statins for primary prevention of heart disease," said the unsigned editorial. "There are no data on compliance with OTC statins, which for products that need to be taken daily long-term is a concern."
"Will those who buy simvastatin also stop smoking, lose weight and do more exercise, or will they substitute drug use for lifestyle modifications? Will pharmacists have the time to determine the individual's risk of coronary heart disease before selling the drug and also to give lifestyle advice? All these are unknowns," the editorial stated.
The editorial noted the FDA in 2000 rejected applications for OTC sales of pravastatin (Pravachol) and lovastatin (Mevacor) "because of insufficient evidence that either drug could be used safely and effectively in an OTC setting."
Bristol-Meyers Squibb's application for the OTC sale of Pravachol has not been renewed, said company spokeswoman Julie Keenan, but "we continue to explore the potential of Pravachol as an OTC therapy."
The FDA is considering a new application by Johnson & Johnson-Merck Consumer Pharmaceuticals, a joint venture of the two companies, for OTC sale of a low-dose version of Mevacor, the first statin drug. Its prescription sales have dropped considerably with the appearance of more powerful agents such as Pfizer's best-selling Lipitor.
Johnson & Johnson-Merck did not respond to a request for comment.
The American Heart Association referred questions to Dr. Robert H. Eckel, director of the lipid clinic at the University of Colorado Health Sciences Center and chairman of the association's Council on Nutrition, Physical Activity and Metabolism.
"I agree with the editorial," Eckel said.
Explaining his stand, Eckel said of the British decision, "there is no science behind this recommendation. It looks like it was driven by financial considerations, to transfer responsibility from the National Health Service to the public at large."
The issues involved in OTC sales "relate to how people are going to be monitored in terms of how much cholesterol reduction they need and how the medications will be used in relation to lifestyle measures," he said.
Safety is also an issue, Eckel said. While statins generally are safe, "serious complications, while rare, could occur, with side effects such as muscle pain and liver problems."
Because of referrals made to the lipid clinic by other physicians, "I see a large number of people who have side effects from statins," Eckel said. "Up to 20 percent of the patients referred to me have major problems with statins or other lipid-lowering medications."
"What is now needed is a surveillance system for OTC simvastatin" to gather evidence of benefit and risk, said the Lancet editorial.
"If the UK public is to be used in an OTC experiment, then the evidence must be collected and used for the benefit of all," it said.