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FDA: REJECTING ADVICE AND RISKING LIVES
Hundreds of new drugs have been approved for OTC status since 1993, when the Food and Drug Administration changed its policies to speed the approval process. The changes came in response to activists seeking fast approval of experimental drugs that offered at least a ray of hope to AIDS patients who were otherwise facing certain death.
Of the hundreds of drugs approved since 1993, seven have been withdrawn after reports of deaths and severe side effects. Examples of drugs that have been placed on the pharmacy shelves as a result of the FDA\'s more lenient approach, but have yielded fatal results, include Redux and Lotronex. Redux, the diet pill approved in 1996 despite an advisory committee\'s vote against it, was taken off the shelves in 1997 after heart-valve damage was detected in patients taking the drug. Lotronex, a drug for treating irritable bowel syndrome, was approved despite warnings. It has now been linked to five deaths, the removal of a patient\'s colon, and other bowel surgeries.
Lotronex was pulled from the market after being available for only 10 months.
Reports of adverse drug reactions made to the Food and Drug Administration are considered by public health officials to be the most reliable early warning that a product may be dangerous. The reports are filed to the FDA by health professionals, consumers, and drug manufacturers. More than 250,000 side effects linked to prescription drugs, including injuries and deaths, are reported by doctors and others each year. These \"adverse-event\" reports are filed voluntarily. Experts, including Dr. Brian L. Strom, chair of epidemiology at the University of Pennsylvania, believe the reports represent as few as 1 percent to 10 percent of all such events. \"There is no incentive at all for a physician to report [an adverse drug reaction],\" said Strom, who had documented the process. \"The underreporting is vast.\"
Even when deaths are reported, records and interviews show that companies consistently dispute that their product has caused a given death by pointing to other factors, including pre-existing disease or use of another medicine. To be sure, a chain of events does affect safe use of a prescription drug. A lapse at any link could prove fatal. The chain includes these steps:
• The companies\' conduct of clinical studies
• The FDA\'s regulatory actions
• The doctor\'s decision to prescribe
• The pharmacist\'s filling of a handwritten prescription
• The patient\'s ability to take the drug as directed
When serious side effects emerge, FDA officials have championed using package labeling to warn of potential risks as a way to, in their words, \"manage\" risks. Yet the agency typically has no way to know if the labeling precautions - dense, lengthy, and in tiny print - are read or followed by doctors and their patients. The FDA often addresses unresolved safety questions by asking companies to conduct studies after the product is approved. However, this research frequently has not been performed.
To address this lack of follow-through, the inspector general of the Department of Health and Human Services issued a statement in 1996, stating, \"FDA can move to withdraw drugs from the market if the post-marketing studies are not completed with due diligence.\" Since that statement was issued, the FDA has not withdrawn any drug because of a company\'s failure to complete a post-approval safety study.
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GENERAL HEALTH
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