If Merck's hopes bear fruit, Mevacor may soon be available off the drug store. That is, is the US FDA gives a clearance to its cholesterol -lowering prescription drug .

On Wednesday and Thursday( January 13 and 14) officials from Merck conducted a two-day presentation before the US Food and Drug Authority to push for making its cholesterol-lowering drug Mevacor from the prescription category to over the counter category. OTC drugs can be bought from the chemist wthout a doctors prescription, whereas prescription drugs, as hr name suggests requires a doctor's sanction.

The drug Mevacor, which has been in the market for quite a while, will make a move to the drug stores' OTC shelf, if the FDA gives its go-ahead. The FDA ove is keenly watched. Last time, four years back the FDA had rejected a siilar presentation by Merck to free up Mevacor. Mevacor is the brand name for Lovastatin.

Mevacor is used, along with diet, to lower cholesterol levels in people with primary hypercholesterolemia (too much cholesterol in the bloodstream). High cholesterol levels foster the buildup of artery-clogging plaque, which can be especially dangerous when it collects in the vessels serving the muscles of the heart. Mevacor is prescribed to prevent this problem--called coronary heart disease--or to slow its advance if the arteries are already clogging up.

Merck says, quoting a study invlving about 1000 users, that customers made the right choice, in purchasing the drug and often, did them with doctors advice. But many consumer and health activists are worried that this may be seen as a on-size-suits all drug and may create unwanted results.

This opinion gains support in the background of Merck recently withdrawing Vioxx, a cardiac drug. Immediately, several Indian drug makers who make generic copies of the same drug also withdrew ther variants. This will be raw in the minds of the FDA panelists when they take up the Mevacor case. After the Viox saga, there were several allegations that Merck knew the dangers of Vioxx since 2000. Activists are sure to point out the Vioxx history.

Once Mevacor goes OTC, customers will buy the proudct, Merck says, based on individual risk factors and their cholesterol levels.

According to Jerome Cohen of the St. Louis University Health Sciences Center, who helped conduct the study, "there's good evidence that consumers can manage their cholesterol medication over time and obtain a benefit," said.

Merck's proposed OTC labeling for Mevacor also encourages consultation with a doctor, Cohen added, noting that three out of four consumers in the study who had high risk factors consulted a physician about their use of the OTC drug.

If Mevacor OTC becomes a reality, he said, four to five million consumers at moderate risk for heart problems will consult a physician as a result of the OTC Mevacor program and one to two million high risk consumers will see a doctor.

Some FDA panel members are concerned that insurance companies might drop prescription Mevacor from their payment plans if Mevacor goes OTC. Merck officials say that managed care companies view cholesterol therapy differently from drugs that treat heartburn and allergy and would retain coverage for the prescription drug.

If Mevacor goes OTC, it will become the first statin to hit pharmacy shelves.

Mevacor and other lipid-lowering medicines have been linked to liver toxicity and muscle weakness before. Besides, pregnant and nursing women are not recommended this drug since the drug may get into the infant's system. It has been found that the drug, when it intercsts with other chemicals inside the human body, creates reaction that lead to muscular toxicity and weakness. Wheter customers witout a doctor's prescription are smar enough to by Mevacor OTC will be question FDA has to tackle.

Mevacor is usually prescribed only if diet, exercise, and weight-loss fail to bring cholesterol levels under control.

BY OUR HEALTH CORRESPONDENT