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...victims every year in the U.S. Developed by Merck, the New Jersey-based pharmaceutical giant, in partnership with Chiron, a small (1985 sales: $6 million) biotech firm in Emeryville, Calif., the product is the first genetically engineered vaccine approved for human use. "We're delighted that FDA has expressed such a positive view about the usefulness of recombinant technology for vaccines," said Stephen Sherwin, the director of clinical research in immunology at South San Francisco-based Genentech, a rival biotech company. "It's another example of the technology yielding real benefits," said Dr. Thomas White, vice president for research...
Critics, however, remain unsatisfied. Several consumer groups want detailed nutritional labeling on individual food wrappers, and last year petitioned both the FDA and the Department of Agriculture. "There are important health reasons why it should be right on the label," declares Mitch Zeller of the Washington-based Center for Science in the Public Interest. For example, some people may be allergic to ingredients in fast foods. Stricter labeling, however, is only a small step to better health. As long as people enjoy the taste of big burgers, French fries and milk shakes -- high fat, high salt, high calories...
Despite the clamor, the FDA shows no sign of giving the nod soon. In the past two months, agency officials have scolded Upjohn, charging that a company press release was "overly positive" and contained "misconceptions and false impressions of safety and efficacy." Industry analysts say FDA approval in 1987 seems unlikely...
...question of safety is a major FDA concern. Minoxidil is a potent drug, and taken orally in tablet form it can have serious adverse effects, including disturbing the heart's rhythm. (Minoxidil's ability to grow hair was a side effect, discovered during tests of the oral medication.) Some subjects using the 2% lotion have complained of skin itching, scaling and blistering. Ten subjects enrolled in the hair-growing tests have died, but their deaths, according to Upjohn, were not related to use of the lotion. However, no one knows the consequences of dabbing on the drug for 20 years...
With benefit so slight, the FDA needs to be convinced that the risks are minimal. But the federal agency appears to be almost alone in moving cautiously. Upjohn has already spent nearly $26 million retooling its plant in Kalamazoo. Regaine will not come cheap; a year's treatment with the prescription-only lotion may run around $1,000. But no one doubts there will be plenty of takers. Some resourceful men are creating a moonshine tonic on their own. The key ingredient: mashed hypertension pills, containing--what else?--minoxidil...