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FDA advisers say baldness pill works for some menFriday, November 14, 1997By LAURAN NEERGAARD The Associated Press BETHESDA, Md. -- 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: slathering 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 postmenopausal 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 one-inch circle on top of the head than did placebo patients. For receding hairlines, the improvement was a more modest 60 hairs. Propecia didn't help every man, but Merck argued that many who didn't grow new hair at least stopped losing what they had left. The FDA's advisers weren't sure that was proved, but Merck did note that when men stopped taking Propecia, their new hair fell out. But Dr. Michael Weintraub, FDA dermatologic drug chief, 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 -- to shrink enlarged prostates. Merck says the 1-milligram Propecia dose is safe for the merely hair-impaired. The main side effect, 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. Ultimately, the FDA panel said Propecia works for male pattern baldness, the most common type. But they added a wrinkle: Merck made patients use the same shampoo to ensure hair care didn't alter the studies, and consequently the panel insisted that Propecia be labeled as effective when used with this Neutrogena T-Gel. Merck scientists argued they have extra safety assurance from studies of men born with a rare disease that depletes their DHT for life. Not only do these men never go bald, they also don't get enlarged prostates or prostate cancer, suggesting a possible protective effect. Copyright © 1997 Bergen Record Corp. |
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