Word: label
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...label prescribing so common? Chiefly because pharmaceutical companies are reluctant to invest the time and expense to get FDA clearance on new uses for an established drug--especially when the drug's safety has already been proved. Says Dr. Martin Raber, physician in chief of the M.D. Anderson Cancer Center in Houston: "It is accepted practice that once a drug is FDA-approved it can be freely used." But the FDA gets nervous when a drug's unapproved uses overshadow its original purpose. Retin-A cream, for example, was approved by the FDA for the treatment of acne...
This shadowland of medical practice didn't start to attract public scrutiny until off-label prescribing became the treatment of choice for people suffering from AIDS or advanced cancers. "When it comes to treating cancer, things are much more liberal than in other areas of medicine," says Dr. Thierry Jahan, an oncologist at the University of California at San Francisco. "There's an element of desperation. So you try a lot of combinations of drugs that are already on the market while waiting for new drugs to become available...
Deciding who pays for unapproved uses is, in fact, a growing problem. For years insurers have recognized the importance of off-label prescribing and have agreed to reimburse patients for their prescriptions. Now many cost-conscious managed-care firms have started to clamp down on off-label reimbursements--especially if the medication is particularly expensive. "A physician and patient can argue with the insurer," says Dr. Howard Ozer, director of the Winship Cancer Center at Emory University in Atlanta. "But if it goes on for too long and the patient can't pay for the drug...
Trusting someone to do what's right can be hazardous. But doctors have traditionally been given a lot of latitude when it comes to deciding what drugs to prescribe, and in the gray area of off-label medicine, the benefits of letting them continue to use their best judgment is probably worth the risk...
Coltrane discoveries are continuing. The newly revived Impulse! label--which has already rereleased such late Coltrane albums as A Love Supreme--will release two more albums in October: the complete Africa/Brass sessions, in which Coltrane experiments with tribal rhythms, and Stellar Regions, mostly unreleased songs recorded with his pianist wife Alice only months before his death. The latest trove: 30 hours of raw tape found earlier this year, rescued as they were about to be trashed. Impulse! is negotiating to release these recordings starting next year. Dorn calls it "possibly one of the great musical discoveries of all time...