DUIMerck May Sell Anti-Alcohol Drug in U.S.
Health-care experts split on medication available in Europe
Published Friday, July 31, 1998, in the San Jose Mercury News
BY DAVID J. MORROW
New York Times
A drug widely available in Europe that may reduce the urge to drink is being tested in the United States, which has an estimated 13.7 million alcoholics. The French maker of the drug hopes to have it on the U.S. market in 2000.
Many experts on dependency say the drug -- acamprosate, which would be sold in the United States as Campral -- is badly needed. Only two other medications can treat alcoholism and both can have unpleasant or potentially dangerous side effects.
Doctors say they can prescribe acamprosate to help alcoholics remain sober, possibly saving thousands of people from painful relapses while reducing the cost of rehabilitation, which was $5 billion last year.
Acamprosate's expected arrival, though, has ignited a controversy in the health-care community, pitting specialists who argue that alcoholics should be treated with counseling alone against doctors who insist that drugs are crucial tools.
The debate has become rousing at times, with acamprosate's champions deriding opponents for their "medieval" outlook. Advocates of drug-free treatments say their approach has worked for decades; why take chances?
Acamprosate's maker, Lipha SA, a subsidiary of the German drug maker Merck KGaA, is undeterred. It plans to take on a U.S. marketing partner and stress acamprosate's success rate.
In 11 clinical trials with 3,338 alcohol-dependent patients in Europe, 50 percent of those patients using acamprosate abstained for three months -- the period when alcoholics are most likely to regress -- compared with 39 percent of those using a placebo.
A U.S. trial, with 600 alcohol-dependent patients at 21 sites nationwide, should be completed early next year. Lipha officials are so excited about acamprosate's benefits that they hope it will eventually be available over the counter.
"Acamprosate has been shown to help prevent relapse," said Dr. Karl Mann, a professor of medicine at the University of Tubingen, who conducted the trial in Germany. "Once patients give up alcohol and go on with their lives, they see it, smell it, dream about it. Acamprosate helps them get through all that."
Doctors hope acamprosate will become popular because it is cheap and simple to take. In France, the average cost is $1.94 a pill, about the same as a red wine at the local bistro. Patients take two 500-milligram pills in the morning and two more at night; the main side effect is mild diarrhea, which usually goes away after several days.
By contrast, American Home Products' Antabuse, introduced in 1951, can be toxic if the patient drinks enough alcohol, while naltrexone, made by DuPont Merck Pharmaceutical, can cause liver damage if prescribed in too high a dose.
The drug is no substitute for detoxification. A patient's alcoholism must be treated before it can do any good. But moderate drinkers might also turn to it to try to control their drinking.
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