DATE: Friday, November 14, 1997             TAG: 9711140608

SECTION: FRONT                   PAGE: A8   EDITION: FINAL 

SOURCE: ASSOCIATED PRESS 

DATELINE: BETHESDA, MD.                     LENGTH:   62 lines

HAIR-GROWTH DRUG GETS CAUTIOUS PRAISE; FDA WEIGHS HORMONE'S EFFECT ON YOUNG

The balding man's dream of a pill to grow hair took a step toward reality Thursday, as government scientists declared Merck & Co.'s Propecia a viable way for some men to fight shiny pates.

But the experts expressed concerns over whether taking a pill that affects hormones could have long-term side effects.

The Food and Drug Administration still must give the final verdict.

The FDA's scientific advisers said Propecia seems to treat bald spots on top of men's heads but may not promise as much help for a receding hairline.

``I've been very impressed'' by studies on Propecia, said panelist Dr. James Kilpatrick Jr. of the Medical College of Virginia.

Propecia is not a miracle pill - nobody grew a full head of hair and not everybody was helped. But before-and-after photographs showed Propecia helping bald spots shrink, some by very small amounts but a few by enough that just a quarter-sized spot of scalp still showed.

The nation's 40 million balding men who want to grow hair today have one option: applying non-prescription Rogaine on their scalps. It helps about 25 percent of users grow varying amounts of hair, but stop using it and the hair falls out. So thousands of men spend $15 to $30 every month hoping for help.

Merck wants to sell Propecia by prescription only - and, unlike Rogaine, to men only. Women should not use Propecia because it can cause birth defects, Merck warned. Although Merck has begun testing in post-menopausal women who don't have that concern, no one knows if their different hormones will allow Propecia to work.

But for men, one Merck study where dermatologists analyzed before and after photographs concluded 30 percent of Propecia patients grew slight amounts of hair in a year, and an additional 18 percent grew moderate to heavy amounts.

When Merck actually counted hairs, Propecia patients averaged 106 more new hairs within a 1-inch circle on top of the head than did placebo patients. For receding hairlines, the improvement was a more modest 60 hairs.

But FDA dermatologic drug chief Dr. Michael Weintraub said his main concern is whether it's safe for young men to take a pill that affects hormones for years merely to fight hair loss. Merck studied balding men ages 18 to 40.

Propecia blocks an enzyme that converts testosterone into the related hormone dihydrotestosterone, or DHT, that shrinks hair follicles.

Merck argues that any serious side effects already would have emerged in the millions of older men who take doses five times higher - under the brand name Proscar - to shrink enlarged prostates.

Merck says the 1-milligram Propecia dose is safe for the merely hair-impaired. The main side effects, experienced by 2 percent of men, are decreased libido and impotence.

But FDA officials wondered whether long-term use would affect male fertility, because of some evidence that users' ejaculate fluid was diminished. In addition, some advisers worried that Propecia might hide early signs of prostate cancer. ILLUSTRATION: KRT Graphic

Baldness Pill

What it is

How it works

How effective?

For men only

Side effects

For complete copy, see microfilm

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