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(Ivanhoe Newswire) -- In the U.S., it is legal for doctors to prescribe drugs for off-label use -- prescribing it for a condition or disease that it was not approved to treat. It is, however, illegal for drug manufacturers to promote off-label use, but two physician researchers say the companies are using covert techniques to illegally promote off-label use.
Adriane Fugh-Berman of the Georgetown University Medical Center and Douglas Melnick, a preventative medicine physician working in North Hollywood, Calif., say off-label drug use is sometimes unavoidable and in fact is sometimes demonstrably beneficial. But it has also been linked with serious side effects, the doctors say.
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In an article, Fugh-Berman and Melnick write drug companies have an incentive to promote off-label use because increased off-label use means larger revenues from larger user populations, especially for products with narrow indications.
The doctors said drug companies use several methods to push off-label use, including seeking approval for new drugs for narrow indications, even if the drugs makers believe there will be extensive off-label use. This helps speed the drug to the market, Fugh-Berman and Melnick said.
They said the companies also use drug representatives to promote off-label uses to doctors, even though that practice is not permitted in the U.S.
The authors said stiff penalties and increased scrutiny by regulatory agencies are the only ways to stop the unmonitored, potentially dangerous use of drugs.
SOURCE: PLoS Medicine, October 27, 2008
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