Source: New York Times
Date: 17 February 2004
Despite F.D.A. Ban, Ephedra Won’t Go Away
By MARY DUENWALD
By April 12, ephedra will disappear from stores and Web sites that sell dietary supplements, by order of the Food and Drug Administration. But that does not mean the herb will entirely drop out of sight.
The agency’s ban on ephedra specifically excludes uses of the herb in traditional Asian medicine. Acupuncturists, herbalists and other practitioners of Oriental medicine routinely dispense teas, pills and powders containing ma huang, the type of ephedra grown in China, to treat colds, asthma, persistent cough, headache, water retention and other maladies.
The ban on dietary supplements containing ephedra, announced in December, was published by the agency on Wednesday and will take effect 60 days later. It targets the ephedra supplements that have been advertised for weight loss, muscle building and athletic performance.
The supplements have been linked to heart attack, stroke and sudden death because of their ability to raise blood pressure, increase heart rate and speed up brain activity.
The F.D.A.’s ban states that herbal medicine preparations “are beyond the scope of this rule because they are not marketed as dietary supplements.”
California and New York, which had already banned the sale of ephedra supplements, made similar exceptions for herbal medicine. Illinois, in its ephedra ban, did not.
Herbal medicine practitioners say they are relieved that their profession has not been included in the F.D.A. ban because ma huang is so useful.
“Ephedra is the first herb taught in a Chinese medicine course,” said David Molony, an acupuncturist in Catasauqua, Pa., who is a vice president of the American Association of Oriental Medicine. “It’s traditionally been used as one of the top herbs for one of the top complaints of humanity: colds.”
Yet ma huang is becoming increasingly difficult for herbalists to obtain, because of insurance costs. Ephedra’s dangerous side effects have led to lawsuits against supplement makers. And those, in turn, have caused insurers to raise the premiums for companies that deal in ephedra, even for use in herbal medicine.
“This started even before the baseball player died,” said Subhuti Dharmananda, an herbal medicine supplier, referring to the death last year of Steve Bechler, a 23-year-old pitcher for the Baltimore Orioles, who had been taking ephedra supplements. “If we have one product with ma huang in it, then the insurance company raises our product liability insurance rate for everything by a factor of three,” Mr. Dharmananda said.
As a result, his company, the Institute for Traditional Medicine, in Portland, Ore., has not used ma huang in any of his products since 2001. “We have reformulated all the products that had ma huang,” Mr. Dharmananda said.
Some other herbal medicine distributors have also discontinued ma huang, but some continue to sell it.
“We decided to pay higher insurance rates to keep those formulas available,” said Dr. John Scott, an Oriental medicine practitioner and owner of Golden Flower Chinese Herbs, an herbal medicine distributor in Albuquerque. But Dr. Scott said he was disturbed by the rising insurance rates and by the negative news surrounding ephedra.
The active ingredient in ephedra is ephedrine, a stimulant. Dietary supplements have contained concentrated amounts of ephedra, sometimes combined with caffeine, another stimulant. Herbalists say they are not surprised that some consumers suffered side effects.
“Chinese medicine practitioners have known for years that you could get too much of this,” said Dr. Robert Schulman, a physician who practices acupuncture in Manhattan.
They even recommend a specific herbal antidote, known as white tiger decoction, to be given to people who are overstimulated by ma huang, he said.
Dr. Schulman and other practitioners of Oriental medicine say they would not dispense ephedra in concentrations as strong as those found in dietary supplements, they would not dispense it for weight loss or muscle building, and they would not dispense it for more than a week or two.
Because ma huang relaxes the air passages in the lungs, Mr. Molony said, it is used to treat asthma and cough. It also promotes sweating, so it can help a person recover from a minor cold, he said. And it is said to promote urination and thus relieve edema.
But ma huang is never dispensed by itself, practitioners say. It is used in combination with various other herbs. “Part of what makes herbal medicines safer is that they have a complex array of constituents,” Dr. Scott said.
Ma huang can be found in dozens of different formulations, but only a few are commonly used. One of these combines ma huang with cinnamon twig, apricot seed and licorice.
These ingredients can be boiled together to create a rather viscous tea. Or they can be boiled and then dried to make powders or tablets.
The cinnamon twig is meant to help promote sweating; the apricot seed, to suppress cough and stop wheezing; and the licorice, to moisten the lungs and “harmonize” the other ingredients, Mr. Molony said.
“I’ve gotten a lot of mileage out of this formulation for a chronic cough,” said Dr. Schulman, “one that just doesn’t go away.”
Herbal medicine practitioners caution against giving ma huang formulations to people who have high blood pressure or a fever or to women who are pregnant.
Though herbalists universally claim that their use of ma huang is safe, there have been no efforts to monitor harmful effects in patients receiving herbal treatments, the F.D.A. reports.
What if someone asked an herbalist to dispense ephedra for weight loss? The F.D.A.’s new rule does not specifically prohibit that.
Herbalists said in interviews that they and their colleagues would not do that.
“I would tell them there are a lot better ways to lose weight than using stimulants,” Mr. Molony said.
Mr. Dharmananda said, “For those of us involved in natural healing, the idea of popping pills for weight loss doesn’t work.”
Andrew Gaeddert, an herbalist at the Get Well Clinic in Oakland, Calif., said: “I can’t think of one herbalist who would use ephedra or ma huang as a weight loss alternative. When people get herbal training, they get the idea drummed into them that this is a strong herb and we use it only for a short time.”
Dr. Stephen Bent, a physician at the University of California at San Francisco who has studied the health risks of ephedra, said, “The traditional Chinese medicine loophole is probably not a great danger.”
A bigger danger, he said, is that consumers may turn to F.D.A.-approved over-the-counter asthma medications that contain ephedrine. “It seems strange to me that the F.D.A. is banning ephedra because it contains ephedrine but not over-the-counter products containing ephedrine, which obviously could be used for a long period of time,” Dr. Bent said. “It raises the question of how often these approvals are reviewed for their appropriateness.”