FDA APPROVES PILL FOR MALE BALDNESS.

Byline: Sheryl Gay Stolberg The New York Times

For as long as there has been baldness, it seems, there have been efforts to cure it: oils and creams, toupees and transplants, not to mention what hair stylists gingerly term ``the comb-over.''

But as much as some men may have wanted one, there has never been a baldness pill - until now.

The Food and Drug Administration announced Monday that it had given Merck & Co., the maker of crucial treatments for heart disease, osteoporosis and AIDS, permission to sell a tiny tan octagonal tablet that, experiments show, either promoted the growth of hair or at least stopped hair loss in 83 percent of men who took it.

There are, however, some drawbacks: The pill, which will be marketed as a prescription medicine under the brand name Propecia, can cause birth defects and so is not approved for women. It is useful only for the genetic condition known as male pattern baldness. It must be taken once a day, every day, for the rest of a bald man's life. And it carries a slight risk of impotence, lasting only as long as the pill is taken.

``This is not a panacea,'' said Dr. E. William Frank, a dermatologist at Beth Israel Deaconess Medical Center in Boston who has been following the progress of the drug during testing. ``It's not going to grow hair on the pate of every man who takes it. But the clinical studies which have been done so far are promising.''

Critics, however, say the idea of a prescription drug for baldness is frivolous and complain that no long-term studies have been conducted on the drug.

``It is a cosmetic issue,'' said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, an advocacy organization in Washington. ``What is the risk that we are trading off for a cosmetic benefit?''

And John T. Capps III, founder of Bald-Headed Men of America, a support group for bald men, said no right-thinking bald man would even consider a pill. ``We believe that skin is in,'' he said.

Officials at the FDA, however, said they had become convinced that for some men, hair loss is nothing to laugh about.

An estimated 33 million American men have male pattern baldness, characterized by a receding hair line and hair loss at the vertex, or crown, of the scalp. One survey, published four years ago in a dermatology journal, found that more than 90 percent of men who were growing bald worried about the future of their hair.

``One man's frivolity,'' said Dr. Michael Weintraub, the director of the FDA office that evaluated Propecia, ``is another man's serious problem.''

Merck conducted three clinical trials of Propecia, involving 1,879 men, 1,215 of whom were followed for as long as two years. Although Merck scientists studied men who had a wide range of hair loss, the experiments enrolled only men from the age of 18 to 41. Thus there are no data on how Propecia works in older men.

None of the men in the studies grew back a full head of hair. But when scientists counted the number of hairs in a one-inch-diameter circle on the scalps of the subjects, they found that 83 percent of the men had kept their hair or grown more.

And before-and-after photographs, which Merck submitted to dermatologists for evaluation, showed visible improvements in two-thirds of the men taking the pill, as against 7 percent of men taking a placebo.

Among all the subjects, 30 percent were rated as slightly improved, 31 percent were rated moderately improved, and 5 percent received a greatly improved rating.

The men began seeing results about three months after first taking the drug, said Dr. Vera Price, a dermatologist at the University of California at San Francisco who participated in the Merck studies.

``This is real hair,'' Dr. Price said. ``This is not peach fuzz.''

But in order to sustain the effects, men must continue taking the drug for the rest of their lives.

The only side effects related to sexual function. According to Merck, 1.8 percent of the men taking Propecia experienced decreased libido; 1.3 percent had difficulty achieving an erection, and 1.2 percent reported a decrease in their semen level. The problems went away, however, when the men discontinued use.

The active ingredient in Propecia is one milligram of finasteride, which Merck already sells in a five-milligram dose as Proscar, a treatment for enlarged prostate glands. Finasteride works by inhibiting production of dihydrotestosterone, or DHT, a potent form of the male hormone testosterone that contributes to male pattern baldness.

CAPTION(S):

2 Photos

Photo: (1--Color) ``God made a few perfect heads and the ugly ones he covered them with hair.

- Sion Shabo, 45, Woodland Hills.

(2--Color) ``I'm more confident in myself than how much hair I have. I'm not going to feel bad about myself if I don't have hair.

- Phil Thomas, 43, Calabasas.