Monday, Nov. 23, 1998

Herbal Healing

By John Greenwald

Feeling a little depressed? You could get a prescription for Prozac or try psychotherapy. But 7.5 million Americans in the past year have instead gulped down an extract made from a bright yellow flower called St. John's wort--available without a prescription at the health-food store in the mall or at the local Wal-Mart. Fear the onset of cold and flu season? You could get a flu shot. Or, like 7.3 million Americans, you could swallow a capsule made from echinacea, a purple-petaled daisy native to the Midwest. Worried that your memory is fading? Then write down this name: ginkgo biloba. It's made from the fan-shaped leaf of a tree found from China to South Carolina, and 10.8 million Americans regularly remind themselves to take it.

Whether they seek to brighten their moods, stave off disease, rev up their sex lives or retain their youth, more and more Americans are supplementing and replacing prescription medicines with a profusion of pills and potions that contain various medicinal herbs, vitamins and minerals. Some are proved safe and effective; many are not. Consumers spent more than $12 billion on natural supplements last year--nearly double the amount spent in 1994, and sales continue to grow at better than 10% a year. Shoppers can stock up not only at incense-scented tofu-and-sprouts shops but also at corner pharmacies and supermarkets, and from mail-order houses, websites and Amway distributors who rattle their pillboxes door to door. Preparations made from herbs--from aloe for regularity to valerian for restful sleep--are the hottest of all, with some 60 million Americans now swallowing doses regularly. And for those who crave a tastier fix, there are new so-called functional foods--concoctions such as fruit juice laced with ginseng, or corn chips with kava, the one claiming to perk you up and the other to calm you down.

This blossoming market for all things herbal has attracted growing interest from everyone from Ann Landers (who recommends herbs as an alternative to Viagra) and Larry King (whose radio ads credit ginseng for his youthful, uh, glow) to professors of medicine and Wall Street investors. Just last week the Journal of the American Medical Association (J.A.M.A.) released an issue devoted entirely to studies of herbs and so-called alternative remedies (see accompanying story). Among the eye-opening findings: Americans today make more visits to nontraditional physicians, including naturopaths who claim expertise in herbs and other natural therapies, than to their family doctors. And they spend almost as much out of pocket (not reimbursed by health insurance) on alternative medicine ($27 billion) as on all unreimbursed physician services ($29 billion). Small wonder that analysts from top brokerage houses were earnestly looking forward to meeting and greeting leaders of major nutritional-products companies at a gathering in New York City this week.

The frantic expansion of the market for herbs and other supplements, though, comes at some risk to consumers. These products are not regulated in the U.S. nearly as strictly as over-the-counter drugs or even foods--in sharp contrast to countries like Germany, where the government holds companies to strict standards for ingredients and manufacturing. Experts say that while the top U.S. and European manufacturers pay close attention to the safety, effectiveness and consistency of their products, parts of the industry resemble a Wild West boomtown, where some 800 lightly regulated U.S. companies compete ferociously with fly-by-night hucksters. "When you open a bottle of nutritional supplements, you don't know what's inside," says Jeffrey Delafuente, a pharmacy professor at Virginia Commonwealth University in Richmond. "There may be some ingredients not listed. You do not know how much active ingredient is in each tablet. They can make all kinds of claims that may not be accurate."

What's behind the sudden revival of thousand-year-old remedies? At root, it's the fears and desires of 80 million aging baby boomers who are eager to seize control of their medical destinies. The perceived coldness and remoteness of conventional medicine and red-tape-tangled managed care make readily available herbs and other supplements seem particularly appealing. Consumers value them as preventive measures, as something distinct from potent pharmaceutical drugs that are prescribed only after disease strikes. "Doctors are getting more and more inaccessible," says Leda Jean Van Stedum, 45, a Denver secretary who was shopping in a Vitamin Cottage chain store for preparations of black cohosh and dong quai to head off premenstrual discomfort.

Perhaps a third of Americans have tried an herbal remedy, and that number is expected to grow sharply now that giant pharmaceutical companies with huge ad budgets and vast distribution channels are charging into the field. Trusted brands like Bayer's One-A-Day and well-known companies such as Warner-Lambert (Sudafed, Benadryl and Listerine) and the Whitehall-Robins Healthcare unit of American Home Products (Centrum, Advil, Robitussin) all launched brightly packaged lines of herbal remedies this fall. SmithKline Beecham (Tagamet HB, Contac, NicoDerm CQ) test marketed herbs in four U.S. cities last summer. The entry of these brands and the growing body of serious research on herbal remedies are lifting some of the stigma attached to these products--and cutting through some of the claptrap one can still hear about mystical recoveries in many a juice bar or organic grocery.

America's rediscovery of the healing power of plants marks a return to an ancient form of medicine that was medicine for thousands of years--and that remains so for 80% of the world's people. Herbal remedies are common throughout Asia and Europe, particularly in Germany, France and Italy. Poppy extract was used to quiet crying children in the time of the pharaohs, eons before the medical use of opiates. Ephedra, the main ingredient of some over-the-counter asthma treatments, has relieved breathing problems in China for 5,000 years. An estimated 25% of all modern pharmaceutical drugs are derived from herbs, including aspirin (from white willow bark); the heart medication digitalis (foxglove); and the cancer treatment Taxol (Pacific yew tree). There might have been no sexual revolution without the birth-control pill, derived from a Mexican yam.

U.S. doctors more commonly prescribed medicinal herbs before World War II and before the advent of wonder drugs like penicillin. But the connection between plants and healing has never been lost. Today pharmaceutical companies send Indiana Jones-style researchers into rain forests around the world to cajole tribal medicine men out of their secrets and scout out new plants that might be proved as remedies and profitably mass marketed. Such teams have turned up some of the most important compounds used in chemotherapy for cancer.

Yet while there is little clear historic division between herbal and pharmaceutical remedies, the two are as distinct as cats and dogs to the U.S. Food and Drug Administration. Drugs, whether sold by prescription or over the counter, must meet rigid FDA standards for safety and effectiveness. And companies that package food must demonstrate its purity. But ever since Republican Senator Orrin Hatch of Utah rammed through the 1994 Dietary Supplement Health and Education Act--with the enthusiastic support of a supplement industry largely based in his state--herbs and other supplements have been all but exempt from federal oversight. "The FDA still doesn't like us," says Loren Israelsen, executive director of the Utah Natural Products Alliance, whose companies grind out preparations with a retail value of $4 billion a year. "They ask, 'Who are these guys--food or drug?' We just don't fit the model. That's the nature of our products. And we've been willing to fight."

In this chaotic marketplace, herbal enthusiasts like Theo Pappas choose their brands with care. Pappas, 58, a graphics artist in New York City, takes ginkgo biloba for mental alertness and goldenseal and echinacea to boost her immune system. She tosses in multivitamins and the mineral selenium, plus a pair of preparations to lower her cholesterol. She tops it all off with primrose oil and a soy extract, two botanicals she believes help prevent a recurrence of the breast cancer that forced her to undergo a mastectomy four years ago. Pappas chose her regimen over the prescription drug Tamoxifen, a powerful remedy that can suppress breast tumors but has also been linked to an increased risk of uterine cancer. "This is working better than any weird prescription medicine," Pappas says of her supplements. "I definitely feel healthier. I have more energy."

Pappas gets advice from Lisa Cosman, 60, a self-described nutritionist with no formal training or certification (only 23 states require licensing of dietitians and nutritionists) who relies on news accounts to keep abreast of new research. Cosman warns her clients to visit a doctor before taking herbs and fears that too many are searching for magic bullets. "My concern is that they are overhyping herbs," she says, "and missing the central idea that you must eat healthy."

In Chicago, marathoner Tom Smithburg works out daily and, in place of morning coffee, downs a megadose of ginseng: 1,000 mg, vs. the recommended maximum of 600 mg. "Coffee is a drug," says Smithburg, a public relations representative of the Chicago Bulls. "I hear more people complaining that they have headaches over the weekend from not getting their caffeine."

That herbal preparations seem--and are marketed as--"natural," as distinct from synthetic pharmaceutical drugs, adds to their appeal. "A lot of people feel comforted by taking something they regard as a natural substance," says Dr. Sidney Bogardus, who directs Yale's Geriatric Assessment Clinic. "Of course, the substances in an herb are chemicals just as they are in medicine made by pharmaceutical companies. But it seems more gentle and safe, and people are reassured by that."

Some unwary consumers, though, have been getting hurt. Geoffrey Bove, a pain researcher at Boston's Beth Israel Deaconess hospital, recalls a woman whose skin became hypersensitive when she stepped into sunlight. Even a mild breeze triggered a painful reaction. Bove traced the cause to the St. John's wort that the woman was taking to combat mild depression. When she switched to a prescription drug, the painful burning vanished.

The woman's distress points up the danger of taking herbs without considering the side effects or gauging other risks. Yet many physicians have received little training in nutrition or herbal medicine. In Los Angeles, neuropsychiatrist Dr. Ronald Lawrence runs the Council on Natural Nutrition and teaches at UCLA, where he is deluged by questions from doctors seeking information about herbs. "I can't keep up with the phone calls," he says.

With consumer interest rapidly spreading, the medical profession is gradually and sometimes grudgingly learning the benefits and pitfalls of nutritional supplements. More than 50% of U.S. medical schools now offer courses in unconventional medicine such as homeopathy (a system that uses highly diluted remedies) and acupuncture. Says Dr. Woodson Merrell, who has taught nutrition and herbal medicine to practicing physicians at Columbia University: "The point is that this is not alternative but complementary medicine."

Which herbs work, and which ones don't? Recent scientific research--and fresh attention to practical evidence that sometimes stretches back millenniums--is beginning to give guidance. In Germany, where the government has supervised studies of 279 herbs approved for sale in the country's strictly regulated pharmacies, remedies that enjoy the greatest popularity (including ginkgo, kava and St. John's wort) are generally those that have been the most thoroughly investigated.

The German findings are collected in a 685-page tome called The Complete German Commission E Monographs, which the American Botanical Council in Austin, Texas, recently published in English. It tells which herbs have proved safe and beneficial but warns against side effects and other risks. It advises pregnant and nursing women not to take kava, for example, and notes that some people may become sensitive to sunlight when using St. John's wort. It approves standardized doses of ginkgo extract but rejects nonstandard preparations made from whole leaves as untested and potentially hazardous. At the same time, it turns thumbs down on folk remedies like nutmeg for upset stomachs, noting scant evidence that it works and warning that large doses can cause hallucinations.

Similarly, last week the Archives of Family Medicine, a sister publication of J.A.M.A., reported a study suggesting that echinacea was no better at preventing colds than a placebo (a pill with no active ingredients). But the researchers conceded that their sample size, 302 volunteers, may have been too small to detect modest differences and concluded that more study was needed. The researchers didn't test whether echinacea alleviates colds already in progress.

In considering the effectiveness of any medicine, conventional or herbal, it's important to consider that the placebo effect, or the patient's desire to believe in a cure, can have a powerful influence. Recent studies show, for instance, that while 86% of men taking a baldness remedy reported that it worked, so did 42% of men taking a placebo.

The history of diet supplements is rife with fads that fizzled or proved dangerous to health. Melatonin, a hormone used to prevent insomnia, became a craze a few years ago, when, on the basis of studies with mice and rats, some researchers hailed it as a miracle cure for aging. But when later reports cast doubt on the findings, sales of melatonin went back to sleep. Last year a tea made from the Chinese kombucha mushroom that was promoted as a remedy for cancer caused four people to be hospitalized for conditions ranging from jaundice to headaches and nausea.

Research on many herbs is generally at the stage where studies of vitamins and minerals were a decade ago. Vitamins, though, are easier to investigate because the active ingredients in plant remedies can take years to identify. Vitamin C has been shown to protect against infection and bruises, while vitamin E improves circulation and helps lower blood pressure. But megadoses of many nutrients can have dangerous side effects. Overuse of vitamin D, a substance that promotes the growth of bone and teeth in children, can be particularly toxic, as can overuse of the mineral iron by older adults.

Research on herbs has lagged in the U.S. because companies have little incentive to spend $500 million on 10 to 15 years of tests--as pharmaceutical firms typically do to check out new medications. Unlike drugs, most herbal preparations cannot be patented, so the testing company would not be rewarded for its efforts. The FDA, meanwhile, would have to prove that a supplement is unsafe before yanking it off the market, yet it has no authority to test nutritional supplements. "The result is that there are a lot of products on the market that little is known about," says FDA deputy commissioner for policy William Schultz.

Of course, few users of supplements want the agency to tell them what they can and can't take. "I would be horrified if this little bit of autonomy were taken away," says Teresa Tudury, 48, who has been taking vitamins and other diet aids since a 1986 bout with Epstein-Barr virus left her with "unbearable fatigue."

The absence of tight oversight has allowed makers of herbal products to flourish, particularly in Utah, where the dry desert air helps keeps raw materials and pills and capsules fresh, and where land and skilled labor have been relatively inexpensive. Utah's free-enterprise culture has nurtured characters like Tom Murdock, an Arizona entrepreneur who in 1969 started what is now Murdock Madaus Schwabe, whose Nature's Way line is the top-selling herbal brand in health-food stores. Murdock founded the company to market the chaparral herb, which he had used to treat his cancer-stricken wife.

Today closely held Murdock Madaus Schwabe crushes and packages herbs in a factory the size of several football fields. Farther up I-15, near Salt Lake City, neighboring Nature's Herbs is in the midst of its third expansion in four years--this one aimed at tripling production to 2 million capsules an hour. That kind of growth enabled Nature's Herbs, a unit of Twinlab of Ronkonkoma, N.Y., to boost its sales 50% last year.

With the invasion of pharmaceutical companies, the entire supplements industry is braced for a shake-out. In the long run, the new arrivals could bring more testing and standardization to the market. But in the interim, their presence may prompt more corner cutting by companies that are pressured on price and that may respond by diluting potency and quality. The new arrivals "are bringing marketing dollars and something very important to the industry--consumer awareness and legitimacy," says Matthew Patsky, managing director of the investment bank Adams, Harkness and Hill. "What you're going to see is a dramatic increase in consumer awareness of what these products are for."

That will happen naturally as the newcomers slug it out with big-bucks ad campaigns. Bayer and Whitehall-Robins are spending a total of $75 million between them to launch their herbal brands. Bayer, sensing the public's confusion about such products, decided not to cite herbs in the names of its new One-A-Day preparations but to use tags like Cold Season and Memory and Concentration instead. Says brand manager Michaela Griggs: "We found that consumers don't fully understand what herbs do."

Such rival brands are emphasizing their quality to health seekers like Shirley Palmer, 66, a Los Angeles writer who pops ginkgo and ginseng and a handful of vitamins on the say-so of friends and news reports. "I have no evidence that these things really work," Palmer says. "I take them on faith." But they keep her away from the doctor, she says, and that's good because "I don't have time to sit around waiting in doctors' offices." Like Palmer, millions of Americans are using ancient remedies to broaden the range of modern health-care choices. And these flowering gifts from the past can be powerful medicine--but handle with care.

--Reported by Ann Blackman/Washington, William Dowell and Aixa M. Pascual/New York, Richard Woodbury/Salt Lake City and other bureaus

With reporting by Ann Blackman/Washington, William Dowell and Aixa M. Pascual/New York, Richard Woodbury/Salt Lake City and other bureaus