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Drug Giants Cash in on Herbal Therapy


--------Wacky. Untested. Maybe even dangerous.

For years, health food veterans complain, that has been the message from America's pharmaceutical industry regarding herbal and natural supplements.

But a funny thing happened on the way to the ginkgo display. Herbal and natural supplements have become popular -- with as much as $12-billion in annual sales. And they're finding fans far beyond aging hippies and New Agers.

Now some of America's largest drug companies, including SmithKline Beecham, Pfizer and McNeil Consumer Healthcare, the makers of Tylenol, are producing their own earth-tone bottles of energy-boosting ginseng, calming valerian and joint-easing glucosamine.

The move represents a vast departure for the $105-billion U.S. drug industry, which has focused on prescription or over-the-counter medicines such as pain killers and cough syrups, while the natural remedy crowd plugged away on the fringe, largely disparaged by the medical establishment as more than a little nutty.

Pfizer Inc. literature still derides alternative medicine as untested and unethical, even while its consumer products division hawks Stomach Comfort Ginger, Mental Sharpness Gingko Biloba and Valerian Sleep through its Quanterra line.

American Home Products, whose stable includes Robitussin and Dimetapp, last year bought Solgar, the grandfather of natural health care, and its Centrum label recently added saw palmetto, garlic, St. John's wort and three other popular herbs to its line of vitamins. This spring, SmithKline Beecham has launched a national ad campaign to push its new valerian root compound, Alluna Sleep.

"They know that they have to do something," said Bonnie Frost, owner of The Herb Shop in Clearwater. "You go to a doctor, and you've got an enlarged prostate, well nowadays urologists here are prescribing saw palmetto.

"Or if you have arthritis, you've got doctors who are (suggesting) glucosamine sulfate and chondroitin."

U.S. sales of herbs, vitamins and other natural supplements range from $4-billion to $12-billion a year, depending which products you count. Drug companies acknowledge they want a piece of it, and spokesmen smugly say sales of their new herbals are "meeting expectations."

But aside from bullying their way into a lucrative market, drug companies could force far-reaching changes in the makeup of products on the shelves, and in the numbers of people who buy them, experts say. And as major record labels did with bands such as R.E.M. and Nirvana, they also will push the alternative edge further into the mainstream.

In March, SmithKline Beecham began selling its first herbal product, a valerian and hops blend called Alluna Sleep. The company is spending millions to pitch Alluna in a way Natrol or Nature Made never could, airing ads on prime-time TV and in national magazines such as Cooking Light.

The compound has been a staple in health food stores for years, but SmithKline's ad campaign heralds it as "New!" SmithKline says it started with valerian because research showed 60 percent of Americans have trouble sleeping, but many eschew sleeping pills because they fear morning grogginess or addiction.

"Slick. That's good. We produce the drugs, now we're going to tell you about the alternative, too," said a sarcastic Mark Stowe, a Delray Beach health food store owner and president-elect of the National Nutritional Foods Association, which represents stores and natural product manufacturers.

Because of their marketing prowess and marquee names, the pharmaceutical industry can get millions more people thinking about herbs than a firm such as Nature Made can, health store owners say.

And because they're geared for highly regulated, highly processed drugs, they may help improve the standards and quality of natural products on the shelves, pharmacists and physicians say.

Fran Sullivan, spokeswoman for Whitehall-Robins Healthcare, the over-the-counter division of American Home Products, said it was only natural to add herbals to the Centrum line.

"If you look at people's growing interest in herbals and nutritional supplements, and if you look at the fact that the boomer population is starting to get a little older, starting to get a little more interested in natural ways to promote their own health, it did make sense to take a brand name they know and trust and expand it into this herbal category," Sullivan said.

Pharmacologists often complain that the chemical makeup of supplements can vary widely from brand to brand, or even bottle to bottle. The National Nutritional Foods Association has established criteria for purity, manufacturing and labeling, but some companies still don't provide an accurate breakdown of ingredients on their labels.

Some don't even say if an herb comes from the root or the leaves, which can make a big difference with some extracts, like echinacea.

Ann Lumia, the pharmacy manager at St. Joseph's Hospital, said she hopes the pharmaceutical companies will help change that.

"The quality of the products, I would think, would be enhanced, or at least be more reliable," Lumia said. "These companies have the opportunity to provide much-needed information not only to health care providers, but to consumers as well."

Dr. Steven Masley, a family physician for Morton Plant Mease in Clearwater who lectures regularly on herbs in medicine, said pharmaceutical companies also may help doctors feel more at ease with natural products, because they trust them.

"Personally, I'll feel more comfortable buying ginkgo from someone who's a pharmaceutical company than I will from some place in India," he said. "I don't know if that (perception) is true or not, but they've got more at stake to deliver a good product."

So far, the drug companies have stuck to common supplements likely to appeal to the masses, such as gingko biloba, ginger and garlic.

These compounds have been studied extensively in Europe, and in the past few years evidence has mounted that they're safe and can be effective.

Joseph Betz, vice president for scientific and technical affairs for the American Herbal Products Association, which represents herb farmers, producers and distributors, said that makes them appealing to big business.

"These products are all really benign, as compared with pharmaceuticals, so it's almost a license to make money," Betz said. "All they have to do is invest in the manufacturing and the licensing. They don't have to spend $400-million doing research on these products."

Veterans of the health food industry, which often refers to newcomers as "outsiders," haven't quite decided how to take the debut of big pharmaceuticals into their world.

Some question their credibility and expertise, given their focus on synthetic and isolated compounds to create drugs. Many herbalists contend benefits are derived from the whole herb, not just a few key ingredients.

"Every time you break it apart, it becomes a drug rather than a natural substance," said Mary Wardlow, owner of Vita-Ganics Natural Foods in St. Petersburg. "My fear is that they will just use the active ingredient, because that's where they're oriented."

But she and others also acknowledge their marketing power will promote herbs and the good they do, and help validate the healthful claims the supplement industry has been making for years. Stowe and others from his association, whose members include Solgar, Nature's Way and Rexall Sundown, say there appears to be enough business to go around.

But Betz, a former research chemist for the U.S. Food and Drug Administration, doubts the pharmaceutical industry's foray into natural supplements will stop simply with joining the existing market; he thinks the companies eventually will try to push them into the regulatory realm of drugs, where they are most comfortable operating.

The FDA treats herbs and supplements as food, not medicine. The packages don't have to list side effects or drug interactions, although products are required to note that they have not been evaluated by the FDA and are "not intended to diagnose, treat, cure or prevent any disease."

Over-the-counter medicines, such as cough syrups and Tylenol, are regulated as drugs, and manufacturers must prove safety and efficacy. They also must meet higher production standards and list side effects and contraindications.

Putting a natural product such as glucosamine, for instance, into that class would allow the manufacturers to make stronger claims about it. And because doctors and pharmacists are comfortable with regulated drugs, that could greatly expand the market.

For now, drug companies say they're not ready to make that move. But if they do, they would have a head start on most traditional supplement manufacturers.

Already, the pharmaceutical industry is pushing for more FDA regulation of natural products.

"If it did go that way, it would be something that we would have . . . experience in doing," agreed Sullivan, the spokesman for Whitehall-Robins, which makes Centrum. "It wouldn't be something that we would be terribly opposed to. It would tend to kind of formalize things."
  

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