Bottom Line in Mind, Doctors Sell EphedraMar 31, 2003
Pressed by rising malpractice insurance premiums and shrinking managed care payments, Dr. Tim Berry was struggling to keep his practice from turning into a high-volume rat race. Some months, he was dipping into his own pocket to pay overhead.
Then, a year ago, Dr. Berry and his wife, Debra, a pediatrician, started a weight loss program, clearing out rooms in their offices in Etowah, Tenn., for exercise equipment and heart monitors. He had few takers until he began selling dietary supplements, some containing the powerful but unregulated stimulant ephedra.
"By the six-week mark, my regular patients couldn't find parking spaces," he said. "It spread by word of mouth: `Dr. Berry has great products that work.' "
To judge by Dr. Berry's practice and others, there is little doubt about ephedra's appeal. Today, he says, he has 200 patients on supplements, a third of them on Biolean, a product made of ephedra and caffeine, and virtually all are shedding pounds.
But safety doubts are another matter. Ephedra, especially in combination with caffeine, has been linked to scores of deaths, including that of Steve Bechler, a 23-year-old minor league baseball player who collapsed while training with the Baltimore Orioles in February. The Food and Drug Administration has banned such combinations in over-the-counter medicines. But the ban holds no sway over supplements, which are not categorized as medicines.
Increasingly, doctors are working with companies that market such products, under various brand names, which can contain differing potencies and chemical combinations. Some doctors have been promoting the products, allowing marketing companies to use their names in endorsements and lobbying efforts.
No reliable statistics exist on how many doctors sell such products, and those who do are breaking no law. Yet for many experts, legality is beside the point.
"You can't exploit the patient for your own financial interest," said Dr. Leonard Morse, chairman of the American Medical Association's council on ethical and judicial affairs. "This is a doctor-patient relationship, and your patient's interest transcends your financial interest."
Dr. Stephen Barrett of Quackwatch, a medical watchdog Web site, put it this way: "I tell people to avoid doctors who sell vitamins. It's a sign of bad judgment; you've made a wrong scientific judgment, in addition to which you're selling to a captive audience at a price that's inflated."
Doctors who sell supplements argue that this stance ignores their increasingly frustrating financial reality.
"Physicians are trying to survive today," Dr. Berry said. "If I can help my patients with the best products out there and customize them to their needs, I should be rewarded for it. I should be paid."
He declines to say how much he makes from supplement sales, but he says it is money that "the insurance companies can't take away from me."
Dr. Berry gets his products from Wellness International Network Ltd., which uses its literature to exploit doctors' anger at incomes pinched by managed care. The doctor is one of at least 100 whom Bob Wagner, a top distributor for Wellness, says he has signed up since the late 90's.
Another company, Unicity Network of Utah, says it counts many doctors among the thousands who sell its dietary supplements, including ephedra products.
Moshe Dekel, a Long Island obstetrician, says in Wellness promotional materials that in one month he made $83,000 selling its products. In a recent interview, Dr. Dekel said his actual yearly income from selling Wellness products was $175,000 or less, which he has still found ample enough to allow him to cut back his practice to just a few hours a week.
Although Wellness, with headquarters in Plano, Tex., is a small player in the $18 billion supplements industry, it is among the top sellers of ephedra, according to the Nutrition Business Journal. And doctors who dispense its ephedra products have taken a leading public role in the effort to stop ephedra regulation.
On Long Island, for example, Dr. Dekel and other Wellness doctors recently fought hard to keep Suffolk County, the site of his practice, from banning ephedra. Although they lost, Dr. Dekel said he did not expect his income to suffer. He plans to keep selling ephedra-based products to doctors outside Suffolk County.
On the national level, backers of ephedra have recently seen cause for concern on several fronts.
After Mr. Bechler's death, minor league baseball joined professional and college football in banning ephedra use by its athletes.
The American Medical Association is seeking to remove ephedra from the market. In early March, a major supplement manufacturer, NBTY Inc., announced that it would stop selling ephedra products. And Health and Human Services Secretary Tommy G. Thompson has said he is considering a ban and will seek warnings on ephedra labels.
In January, more than two dozen Wellness doctors signed a letter to Mr. Thompson, arguing that ephedra was a safe treatment for obesity.
"They have written because of the importance of the continued availability of ephedra products to their patients' health," the letter read. But it did not point out that the doctors made money selling the products.
According to medical ethicists, studies consistently show that when doctors have a financial stake in a product or service, their patients use it more. State and federal laws forbid physicians to refer patients to services, like X-ray equipment, that they own.
Oncologists who sell chemotherapy drugs have recently created contention among insurers who pay the bills, and the A.M.A. has expressed alarm at the growth of selling of products in doctors' offices as managed care has become more prevalent.
But doctors who sell ephedra supplements, including Wellness International's best-selling product, Biolean, contend that they are safe and effective.
"If the product is not good and you just sell it to make money, then obviously that's not good," said Dr. Rajendra Patel, an Albany surgeon, who says that he and his wife, an internist, have made $125,000 selling Wellness products in three years. "I think that if they feel the product is good for the patient, I don't see any problem."
It is true that Biolean's concentration of ephedrine, the main active ingredient in ephedra, and caffeine is smaller than those of some products available in stores (although, like many products sold in such marketing systems, it tends to be more expensive). Its daily dosage of 37.5 milligrams of ephedrine and 12 milligrams of caffeine compares with the daily dosage of 40 milligrams of ephedrine and 400 milligrams of caffeine for Xenadrine RFA, the product found in Mr. Bechler's stomach.
But like other ephedra products, Biolean has caused adverse reactions. Among 700 "adverse events" involving ephedra products made public by the Food and Drug Administration in 1997, 6 involved Biolean, with symptoms like vomiting, chest pain and extreme anxiety. Not one of the Biolean cases was fatal.
Since 1993, the food and drug agency has received 117 reports of deaths among ephedra users, as well as 16,000 reports of other problems, including strokes, seizures, heatstroke, heart disorders and psychotic episodes.
But despite these statistics, no direct causal link has yet been established between the problems and ephedra use.
In proclaiming the safety of their product, Wellness distributors often cite a favorable study in the journal Endocrine Practice conducted by Dr. Bruce Sindler, a Baltimore endocrinologist. But Dr. Sindler himself is a Wellness distributor who says on several Web sites that Wellness paid him more than $500,000 in two years.
Dr. Sindler did not return calls seeking comment.
Dr. Jeffrey Mechanick, associate editor of Endocrine Practice, said Dr. Sindler's substantial financial stake presented a "potential conflict of interest" that should be considered in assessing his science.
Dr. Mechanick said the American Association of Clinical Endocrinologists, whose nutrition task force he leads, does not recommend using ephedra for weight loss.
"In fact," he said, "we recommend that patients who are using it stop it."