Unregulated ephedrine shows that 'natural' doesn't mean safe Health: Deaths in the United States from "natural" ephedrine now at 15, but herbal drug cannot be yanked from market or even regulated.

April 30, 1996|By Gina Kolata | Gina Kolata,NEW YORK TIMES NEWS SERVICE

Some people assume that what is natural is good for you, or at least harmless. That assumption, as it turns out, is a great marketing ploy but a dangerous motto for living.

So far, at least 15 people have died in the United States after taking herbal products containing ephedrine, also known as ephedra or ma huang. And yet, this herbal drug is still on the market along with other untested herbs and so-called food supplements, including vitamins, amino acids, melatonin and "natural" birth control pills made from yams.

Dr. Richard Friedman, a psychiatrist who directs the Psychopharmacology Clinic at New York Hospital-Cornell Medical Center, wanted to test the limits on what kinds of herbs could be sold without approval from the Food and Drug Administration.

So he called the FDA. Suppose, he asked, he wanted to sell hemlock tea, the deadly poison that Socrates drank. Would there be any way for the FDA to stop him before his tea was on the shelves in health food stores and groceries across the nation? The answer was no.

The FDA, he learned, "couldn't stop me from selling hemlock tea until the bodies piled up."

Why? There is a law that prevents the FDA from regulating herbs and other food supplements. Less than three years ago, tens of thousands of Americans, responding to an intense lobbying campaign by the food supplement industry, wrote, faxed and telephoned members of Congress, urging them to deregulate the industry.

Mitchell Zeller, the deputy associate commissioner for policy at the FDA, who was, at the time, a congressional staffer, said that Congress received more mail in 1993 urging it to deregulate supplements than it received on any other issue that year, including health care reform or the North American Free Trade Agreement.

And Congress responded. In 1994, it passed the Dietary Supplement Health and Education Act.

As a consequence, makers of supplements no longer have to demonstrate that their products are safe before marketing them.

The burden is on the FDA to show they are unsafe -- after they have been marketed. The law also enables the companies to make unrestrained and unjustified health claims.

While some cities have banned the sale of stimulant herbs containing ephedrine, an amphetamine-like stimulant, others are still selling these herbs, with names like Cloud 9 (not to be confused with the health-food candy bar of the same name), Ultimate Xphoria and Herbal Ecstacy.

Stores are marketing the herb as a "natural" substance to promote euphoria or increase energy. Under other names, the herb is sold to promote weight loss or as an aid for body builders.

One product marketed to body builders combined ephedrine with kola nut, Mr. Zeller said. "It was a combination of nature's version of speed and nature's version of caffeine," he said.

And some people who took it had strokes, heart attacks and psychotic episodes. Some even died.

One of the recent ephedrine deaths was that of 20-year-old Long Island, N.Y., man, Peter Schlendorf, who died shortly after taking eight Ultimate Xphoria pills while he was on spring break in Florida in March.

When the ephedrine casualty reports surfaced this month, the FDA decided to set up a toll-free telephone number to solicit information on adverse reactions to the herbs.

The first day, the agency received 1,200 calls.

Although some of the callers simply wanted more information about the herbs, many were alarmed by what had happened to them or to their friends.

The widespread shock about these deaths reflects two popular misconceptions of herbal products, experts said. First, said Dr. Friedman, there is the conviction that anything that is "natural" is also safe.

"There is a suspension of any critical disbelief," he said. By contrast, he added, many people view the pharmaceutical industry with great suspicion and search out supplements to replace prescription drugs.

At the same time, many Americans are unaware that the FDA has no power to regulate food supplements.

"Everyone alive today has come to expect that the products they buy are at least safe," said Dr. William Jarvis, director of the National Council Against Health Fraud. "They believe there is this powerful regulation going on. People are always talking about how the FDA is a such a hard-nosed Gestapo organization. They feel we're overprotected."

But, he added, "of course, that's not true when it comes to health care products."

Not all dietary supplements are dangerous. In many cases, the worst that happens is that people waste their money.

Dr. David Eisenberg, director of the Center for Alternative Medicine Research at Beth Israel Hospital in Boston, said, "I think that by and large the evidence is that many herbal products are safe.

"All have the potential to be dangerous," he said but added that "the same is true for conventional medicines and drugs."

The difference is that the risks of conventional drugs must be established before they are marketed.

And their benefits must be shown to exceed their risks.

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