Word: upjohn
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Indeed, several birth-control methods are available abroad but not in the U.S. Depo-Provera, an injectable contraceptive that prevents pregnancy for three months, is used in 86 countries. Ironically, it was created by the U.S.'s Upjohn Co., but it has repeatedly failed to win the approval of the Food and Drug Administration because of concern about side effects. Norplant, which releases a hormone for five years, is available in five nations. The implant was developed by scientists of the New York City-based Population Council and will be submitted to the FDA next year. But even if Norplant...
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...
...rarely produces a robust crop. It works best on the scalps of men who are just beginning to go bald, especially those in their early 20s. Only a fraction of the nation's millions of balding men meet those criteria. This limited efficacy is borne out by Upjohn-sponsored tests at 27 centers around the country. According to the company, 76% of the men using a solution that was 2% minoxidil showed evidence of new hair growth after a year. That was the assessment of researchers who regularly counted the strands within a 1-in.-diameter circle at the peak...
...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 or more--a realistic prospect, since hair stops growing when application stops...
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...