Word: physicians
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Dates: during 1990-1999
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Currently the FDA relies on spontaneous reporting of postmarketing problems by physicians who prescribe the drugs or manufacturers who may receive complaints from doctors. It is a seriously flawed system, says Joe Graedon, author of several consumer-oriented books about prescription drugs. First, says Graedon, if a patient has a problem -- say an upset stomach or itching skin -- he or she may not make the connection to a drug or medical device. Second, even if the patient does make the link, the doctor may dismiss it. Third, a physician simply may not take the time to report a suspicious problem...
Upjohn is meanwhile reassuring physicians that reported problems with Halcion occur only at high doses and if the drug is taken for long periods of time. At the FDA's request, Upjohn revised the drug's package insert to warn patients not to extend its use beyond 10 days without consulting their physician. Last week the firm filed a libel suit against its Scottish accuser, Dr. Ian Oswald, and the British Broadcasting Corporation for televising allegations of fraud. Upjohn is also actively appealing the British Department of Health's decision last fall to ban Halcion...
Despite such regulatory pitfalls, the time is ripe for putting some teeth into the FDA. A profit-driven system cannot be so dependent on trust, particularly when lives hang in the balance. Doctors and their patients also bear some responsibility for using drugs wisely. "All drugs have risk," observes physician-activist Wolfe. "Most of the time the benefits outweigh the risks. But there is abysmal ignorance on the part of the public about side effects." In a culture that has long been addicted to the quick fix, a healthy respect for the power of the pill -- negative as well...
...policy was implemented in 1990, after a faculty physician reportedly exaggerated the results of experiments with a drug produced by a company in which he owned stock...
When possible conflicts arise, a report is issued to the physician's supervisor at the appropriate hospital. Cases which cannot be resolved by the hospitals are then referred to a 10-member standing committee, appointed by Dean of Faculty Affairs Eleanor G. Shore...