Merck May Sell Anti-Alcohol Drug in U.S.

Merck Unit Ponders Selling 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


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

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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