TCS Daily

Substance Abuse,
Science Abuse

By Iain Murray - March 11, 2003 12:00 AM

The death of Baltimore Orioles pitcher Steve Bechler on February 17 has been linked to his consumption of ephedra. Bechler became the second major athlete to die while taking the substance, following Minnesota Vikings player Korey Stringer in 2001. Ephedra is a stimulant herb long used in Chinese medicine, and is also known as ma huang. As a natural dietary supplement it is available without restrictions, yet its use has come under increasing scrutiny as it has been linked to more and more deaths. The problem is that this natural product has been promoted in a most unnatural way by the alternative medicine industry. Moreover, and bizarrely, the pseudoscience behind ephedra's promotion has helped it escape regulation.

Ephedra is an herb whose primary active ingredient is ephedrine, a cousin to amphetamines, that can increase both heart rate and blood pressure. It is this stimulant property that has made it extremely popular among athletes. It is also marketed as an herbal version of ecstasy, itself derived from amphetamines. A review by Cindy Kleiman of the American Council on Science and Health found Internet advertisements for ephedra claiming it to be "the world's first 100% natural, organic, legal and safe alternative to a harmful, illegal recreational chemical" with "positive effects ranging from increased energy to euphoria."

Yet these natural effects can have a profoundly unnatural effect. By increasing the heart rate and constricting blood vessels, the effect on the human body can be drastic. As a Baltimore Orioles team doctor told the New York Times about Bechler's death, "The poor kid cooked from the inside." The effect can be particularly dangerous when combined with other stimulants, such as caffeine, or in certain circumstances, such as in pregnant women. The effect also increases with dosage. The watchdog group Public Citizen, founded by Ralph Nader, has identified over 100 deaths clearly linked to use of the substance. The National Football League added ephedra to its list of banned substances following Stringer's death. It now appears that baseball's doctors were pressing for a ban last winter, but retreated in the face of strong opposition from the players' union (see the February 21 New York Times article, "Baseball Doctors Nearly Took a Stand, but Didn't").

The problem is that ephedra, as a natural substance, is not subject to the same regulatory regime as equivalent pharmaceuticals. It can therefore be marketed without the seemingly endless warnings about contraindications and side effects that, for example, pseudo-ephedrine (the commercial product Sudafed) has to carry.

The main law surrounding the marketing of natural dietary supplements is the Dietary Supplement Health and Education Act (DSHEA) of 1994. It both frees herbal supplements from the regulations that apply to pharmaceutical products and at the same time requires the FDA to prove harm before taking action against them. This is, of course, a reversal of the standard FDA procedure for approving a drug, where the manufacturer is required to prove that the product is generally safe.

The DSHEA was co-written by Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa). Senator Hatch was described to me by one staffer as "the biggest backer of alternative medicine boondoggles in Congress." His efforts to protect ephedra from FDA investigation have been well documented in a recent Los Angeles Times investigation, which also revealed that he and his son have received substantial payments from the supplements industry.

With such powerful protection, and freed from the shackles that slow down their pharmaceutical competition, the supplements industry has been quite happy to market ephedra using good old pseudoscience. The basic premise is that the substance is natural, and so must be safe. Kleiman's survey found the following claims made for it in health food stores:

  • It's one hundred percent herbal...You won't find side effects here, only in drugstores.

  • There are no side effects, because it's natural and not like a drug. Your body needs it anyways.

  • It's not a drug, because it hasn't been taken out of its natural state.

The marketing also promotes ephedra as a dietary supplement. As food, in other words. The clear implication is that it is safe to take on a daily basis. Yet, as Kleiman notes, "Ka Kit Paul Hui, director of the UCLA Center for East-West Medicine and an expert on traditional Chinese medicine, has stated that in China, ephedra is always used as a therapeutic drug, not as a food." Most of the problems with ephedra have come about as a result of overdosing or long-term use.

With such a marketing gimmick, it comes as no surprise that many are taking the substance completely unaware of the risks. In 1994, for instance, British Olympic sprinter Solomon Wariso was shocked to find himself banned from competition for three months because he was found to have taken ephedrine. Wariso appeared at a press conference pleading his innocence. His evidence was the herbal supplement he had been taking, which bore the title "Up your gas." As Daily Telegraph sports writer Gareth Davies put it, "the label itself should have been a clear enough message for the athlete to stay away from it."

Yet even though ephedra has managed to dance its pseudoscientific way around safety regulations, there has been at least one market mechanism that has had an effect on its manufacturers. The insurance industry has not looked kindly on the purveyors of this risky substance. Bloomberg News reported in April last year that product-liability insurance premiums paid by one manufacturer, Herbalife, had increased from $400,000 in 2000 to $2.5 million in 2001. Even if the government could not act, the tort system was beginning to act as a brake on ephedra's unchecked progress.

Now it seems that the federal government is at last willing to stand up against the dietary supplements industry. Health and Human Services Secretary Tommy Thompson told reporters February 28 that a review of over 19,000 cases of people who had experienced serious health defects after taking ephedra had finally suggested that the products "may present a significant and unreasonable risk of illness and injury." Thompson said that he was investigating the possibility of imposing a warning label on the products. Public Citizen, of course, said that the product should be banned outright, although given its occasional legitimate therapeutic use, that might seem a little harsh.

Yet probably the most important thing to come out of the renewed focus on ephedra since Bechler's death is not the long-overdue proposal to regulate ephedra as a dangerous substance, but the realization that the DSHEA gives a free pass to supplements whose claims are based on pseudoscience. Thompson told reporters, "It is surprising to me that drugs have to prove their safety in order to get approved (but) dietary supplements, on the other hand, we have to prove they are unsafe in order to get them off the market." It is a strange world indeed where the scientific is regulated but the unscientific gets to go unregulated.

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