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BETTER THAN A BIOPSY The FDA has approved a handheld imaging device that can help doctors decide whether to perform a biopsy when the results of a mammogram are ambiguous. The device, called T-Scan 2000, sends a tiny jolt of electricity to suspicious breast tissue; potentially malignant cells conduct electricity differently than normal cells do. T-Scan is not meant to replace a mammogram, but it may prevent some 200,000 unnecessary biopsies a year...
Sources--Good News: FDA; American Association of Endodontists annual meeting. Bad News: Wall Street Journal (4/20/99), Circulation (4/20/99...
...disturbing data is drawn from the FDA's adverse events database, which routinely collects information about patient experiences with drugs from doctors, pharmacists and the drug companies themselves. As such, the reports are merely "observations that certain patients took the drug and then something happened," Gorman explains. But until the incidents are investigated, it is impossible to say whether a given reaction was caused by the drug or by other factors. The complications may have been precipitated, for example, by a patient's other medicines, illnesses or conditions, and may have nothing to do with the drug. In the case...
...industries in America. It turns out that bottled water, according to the group, is hardly any better than tap water--in fact, 17 percent of the samples tested by the group flunked the water industry's own purity standards. The group accompanied the report with a call for tighter FDA regulations on bottled water and Sen. Frank Lautenberg (D-N.J) said last Tuesday he would introduce a bill that would require bottled water to at least meet the same purity standards as tap water. Tighter regulation might be the least of the industry's problems, though: a separate California...
...that clearly wasn't enough. Though the panel decided to keep Rezulin on the market, its thumbs-up came with a warning to the FDA to limit the drug's use to patients who are failing other treatments. And the ruling made it clear, implicitly at least, that without adequate follow-up, the agency's streamlined approval process could be a fast track to disaster...