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U.S. Agency Sounds Alarm About 'Miracle' Hormones

Los Angeles Times
Monday, April 28, 1997
by Robert A. Rosenblatt (staff writer)

Health: TV blitz aims to caution consumers about DHEA, melatonin.
Advocates say supplements slow aging.

WASHINGTON--The government is organizing a television blitz to warn Americans who gulp hormone pills to restore their youth and strength that they could be flirting disastrously with high blood pressure, diabetes and cancer.

The heavily promoted "miracle" compounds--melatonin and DHEA--promise to eliminate sleepless nights, stave off the ravages of time and give a 50-year-old couch potato the sexual performance of a 20-year-old. They are touted as weapons to fight the normal declines of aging by improving immunity against illness and restoring lost energy.

But the National Institute on Aging, normally a quiet and staid purveyor of federal dollars to scientific researchers, is sounding a loud alarm about the hormone craze. The agency wants to flood the nation with television commercials--tapes were shipped to 500 broadcast stations this month, and 600 more will be dispatched to cable television outlets in May. It is urging stations to broadcast the commercial, offered in 30- and 60-second versions, as a public service announcement.

In the spot, an anxious, balding middle-aged man whines to "Madame Eterno," a fortune teller, "I'm losing my hair. . . . I've got wrinkles. . . . I've got pains. . . . I seek the fountain of youth . . . the truth about anti-aging miracle drugs." Madame Eterno tells him to call (800) 222-2225 to hear the government's concerns about the potential side effects of the hormone pills.

Callers can have sent to them a four-page fact sheet titled "Pills, Patches and Shots: Can Hormones Prevent Aging?" The gist of the report is that while hormone supplements have been shown to help some people, government officials believe that much more testing is needed to determine their long-range effects.

"Research ultimately may reveal important health benefits from some of the supplements in addition to those already confirmed," the agency says. "But in the meantime, scientists are concerned about the dangerous side effects associated with some of the supplements, and about the possibility of undiscovered health risks."

Government officials believe that millions of people are consuming the compounds, though the exact figure is unknown. The hormones are sold through mainstream grocery chains and drug stores, in nutrition stores and health clubs, through mail-order catalogs and over the Internet without any central tally system.

One of the advocates of the supplements, Ward Dean, a Pensacola, Fla., physician, defends them as safe. "Everybody over the age of 40 should take some DHEA," Dean said. He is also a fan of melatonin from his days as an Army doctor in the early 1980s. He supplied it to members of the elite Delta Force, an anti-terrorist unit, to combat jet lag after long overseas flights. Supplement users are taking melatonin and DHEA without waiting for an official endorsement by the federal experts or the medical profession "because of frustration with government inaction in this area," Dean said.

The government is "more interested in things like determining the optimal distance between bus stops for the elderly, or having a better Meals on Wheels program, than understanding the basic causes of aging and doing something about it," he contended. The public's enthusiasm for hormones frightens the research experts at the institute on aging.

"If you walk into a roomful of people, the odds are good that one or two of them are taking" melatonin or DHEA, said Richard Sprott, head of the agency's biology of aging program. "They are taking risks they just don't know about," because hormones taken in large amounts for a long period of time could help promote high blood pressure, strokes, cancer and diabetes, he said.

DHEA and melatonin are classified as food supplements, available without prescription. Another popular item, which does require a doctor's order, is the testosterone patch, supposedly an aid to strength and restored sexual vigor. The downside is a risk of shrunken gonads, Sprott said.

"What is alarming us is the tremendous amount of hype being put behind this," he said. "There is a lot claimed about the government trying to keep you from taking it, and an anti-government stance is popular these days and becomes a wonderful sales technique."

Advocates and critics agree on one thing: Hormone production drops with age. The body's glands make these natural chemicals to help regulate growth, general well-being and reproduction. DHEA is produced by the adrenal glands and converted into estrogen and testosterone. Melatonin is manufactured by the pineal gland in the brain and helps induce sleep.

The body's natural output of hormones slows after age 30 and goes into steady decline. By age 80, DHEA levels are only 5% of the peak reached by most people between 18 and 30.

The question at the heart of the current dispute is whether restoring the body's hormones to the peak levels can slow down the aging process and perhaps restore some of the vigor and strength of youth. Studies in laboratory rats are encouraging, and some short-term studies in people offer promise.

The claims for the DHEA and melatonin supplements are grandly ambitious: more energy, sound sleeping every night, better muscle tone, an improved immune system and heightened protection against cancer. One book touts melatonin as a "sex-enhancing" hormone.

Government officials say three groups of consumers are gobbling the pills: anxious baby boomers, younger, athletic health-club habitues and weightlifters.

Taking the hormones is "dirt cheap, less than what most people spend at Starbucks" for gourmet coffees, said John Morgenthaler, marketing director of Life Enhancement Products of Petaluma, Calif., which markets a wide variety of hormone products, including melatonin, DHEA and progesterone, sold as a skin cream for women to retard the effects of aging.

"For this small amount, you can slow the aging process and seriously enhance your life," said Morgenthaler, whose firm has Dean as a medical advisor.

But without large-scale trials on human beings, the uncertainties are too great, according to the strongly held views of mainstream medicine and the National Institute on Aging.

Hormones alter the body's physiology, and the changes "are more likely to produce harm than produce good," said Dr. Barry Reisberg, director of the aging and dementia research center at New York University Medical Center. "Before making the alterations, we should have the benefit of controlled studies looking at the risks and benefits."

Without tests of this type, the efficacy and safety of DHEA and melatonin can't be assured, the institute's experts say. DHEA has few reported adverse reactions, but it potentially raises the risk of stimulating enlarged breasts and prostate cancer in men, and breast cancer and endometrial cancer in women, according to a report by Ara Der Marderosian, professor at the Philadelphia College of Pharmacy and Science.

"More research is needed to expand on the potential therapeutic benefits of this hormone," he wrote. "Meanwhile, caution is advised in its use."

Melatonin's side effects include headaches and temporary depression, and in psychiatric patients the compound "aggravated depressive symptoms," Der Marderosian said.

Dan Perry, executive director of the Alliance for Aging Research, a private organization that lobbies Congress on aging-related issues, said the debate over the supplements underlines the need for an expansion of federal spending to research the health issues. Referring to hormone users, he said that "rather than frightening them with warnings, or luring them with unproven appeals, we ought to make it one of the highest priorities to get the answers in the next few years."

Morgenthaler, the hormone marketer, said, "Of course we need the large-scale human trials, but individuals can make a choice now. If you make the choice not to start treating aging as though it is a disease, you are certain to suffer the effects of aging every year until you are dead."

Copyright Los Angeles Times