Some Bald Facts About Minoxidil

By Anastasia Toufexis

For a product that money can't buy, Upjohn's minoxidil lotion is getting a ! lot of attention. Doonesbury has taken acid note of it, as has the Cathy comic strip, while ABC's Nightline has given it more serious treatment. To millions of men, it may, in fact, be a more promising potion than the elixir of love. Reason: minoxidil, which is otherwise used to treat high blood pressure, apparently can regrow hair on balding heads. When a Washington hospital announced three years ago that it was seeking gleaming pates on which to test the hair restorer, 10,000 eager volunteers called in, jamming the switchboard for three days and forcing the staff to use disaster control lines.

The attention has the Kalamazoo, Mich., pharmaceutical giant chortling happily. But before the product, which the company has named Regaine Topical Solution, can go on the market, it must clear a formidable hurdle: the Food and Drug Administration.

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.

It turns out that minoxidil can indeed grow hair, but it 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 of volunteers' heads. But what truly counts, after all, is what is in the mirror. Only 40% of the subjects felt new hair growth was moderate, and a mere 8% considered it dense. Moreover, test results show that a placebo solution (lacking minoxidil) was at times just as effective as the lotion containing the drug.

The 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 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.

With reporting by Maria Leonhauser/Detroit and Dick Thompson/Washington