THE EPHEDRA EDUCATION COUNCIL�S
RESPONSE TO DATELINE STORY: "HOW SAFE IS EPHEDRINE?"

On April 18, 2000, Dateline aired a story that questioned the safety of dietary supplements that contain ephedrine alkaloids from the herb Ephedra, also known as ma huang. The Ephedra Education Council (the EEC), composed primarily of companies that are members of the Ephedra Committee of the American Herbal Products Association (AHPA), and AHPA itself, worked closely with Dateline to assure that they had the information necessary to air a balanced news story on Ephedra products. Nonetheless, Dateline producers overlooked virtually all of the positive information provided to them on Ephedra products. Dateline�s inaccurate story implied that Ephedra products were harming unsuspecting consumers.

The truth is that millions of American consumers safely use Ephedra products for energy and weight loss. One clinician who has extensively researched the efficacy of Ephedra products on hundreds of dietary supplement consumers looking for safe alternatives to prescription drugs has recently confirmed that these products are among the most safe and useful aids to weight loss available.

Dateline�s own story best illustrates how the producers purposefully left out significant information that did not support their program�s message:

• The story � Dateline began and ended its story with the shocking death from cardiac arrest of a young New Jersey police academy trainee, John Lesemann. Dateline claimed that "two different medical labs linked" ephedrine from an Ephedra product to the young man�s death.

The facts � Dateline did not report that it had provided AHPA with a complete copy of the information concerning Mr. Lesemann�s death and that Dateline had asked AHPA to review and comment on this information. Representatives of the Ephedra Committee of AHPA and the EEC provided the complete file to a professor and national expert in cardiac pathology at the Johns Hopkins University, Dr. Grover Hutchins. A letter was provided to Dateline from Dr. Hutchins stating that, in his opinion as an expert in cardiac pathology, Mr. Lesemann�s death was not caused by an Ephedra product, but "to a reasonable degree of medical certainty, based on the available information, that Mr. Lesemann�s death is ascribable to an arrhythmia arising from myocarditis in the setting of physical exertion."

The Dateline story contained nothing about Dr. Hutchins� review or opinion.

• The story � Dateline reported that the "U.S. Food and Drug Administration says since 1994, it has received reports of 60 deaths linked to ephedrine supplements and close to 1,200 reports of people becoming sick � including dizziness, psychosis and strokes."

The facts � Dateline did not report that FDA widely publicized the reports of deaths and illness, and attempted to use them as the basis for regulations, without ever reviewing the reports to determine if the reports had any connection to the consumption of Ephedra products. Nor did Dateline report that the investigative arm of Congress, the General Accounting Office (GAO), conducted an audit of FDA�s mishandling of the reports on Ephedra products. The GAO found that FDA had inexplicably attempted to use reports of adverse events about Ephedra products in an entirely new and unscientific manner that violated FDA�s own established policies. The GAO confirmed that:

FDA had failed to review the reports before publicizing them;

that the reports were mostly incomplete and irrelevant; and

that there was no scientific basis for FDA�s proposed ban on the use of Ephedra products for weight loss.

Dateline did not report that, embarrassed by the lack of scientific support for the agency�s public accusations, on March 31, 2000, FDA took the highly unusual step of withdrawing most of its proposed restrictions on Ephedra products.

Dateline chose to ignore the science and, instead, publish information that is over three years old and has already been discredited.

• The story � Dateline reported that, according to Bill Gurley, a Ph.D. scientist at the University of Arkansas, some Ephedra products do not contain the labeled amount of ingredients. According to Dr. Gurley, "if a drug company did have such a problem, the FDA would have that company recall that product.

The facts � Dr. Gurley is not a legal expert and he has misstated the law. Products that do not contain the amount of ingredients stated on the label are illegal under federal law, whether they are drugs or dietary supplements, and are subject to essentially the same FDA regulatory actions, including product seizures, injunctions, and even criminal prosecutions.

• The story � Dateline blamed the lack of regulation of supplements on Congress. "Because of a law passed by Congress in 1994, the FDA essentially has no authority to regulate herbal products. . . . [T]here are no federal safety standards or even a requirement [that] a company prove its product works."

The facts � Dateline incorrectly blames Congress�s 1994 passage of the Dietary Supplement Health and Education Act (DSHEA) for the marketing of unsafe and poorly formulated dietary supplements. Contrary to Dateline�s report, DSHEA strengthened federal safety and labeling standards, adding requirements for premarket review of new dietary supplement ingredients and provisions to immediately remove from the market any supplement that poses an imminent hazard to health. DSHEA also provided FDA with specific authority to publish requirements for the manufacture of dietary supplements. Four years have passed and FDA has yet to publish these requirements even as a proposed regulation.

Contrary to Dateline�s report, manufacturers are required to substantiate all claims that they make in advertising for the products that they market, and the Federal Trade Commission has actively enforced its authority in this area, forcing companies that have violated this requirement to pay multi-million dollar fines.

The only explanation for the continued marketing of dietary supplement products that do not contain what the label states, or products that are not safe, is the lack of FDA enforcement, not the lack of authority. Responsible industry has repeatedly urged FDA to take action. FDA has conceded that it has done a poor job of enforcing the law, and has vowed to do better.

Again, Dateline chose not to report the facts.

• The story � Dateline reported that Texas has received over 700 reports of adverse events since 1994, "including at least eight deaths," and that Texas authorities were concerned about the safety of Ephedra products.

The facts � Dateline did not report that virtually all of the 700 reports at issue related to one illegal product, Formula 1, against which Texas, but not FDA, took legal action in 1996. Since that illegal product was removed from the market, Texas has received only three reports of any problems that might be scientifically linked to the consumption of Ephedra products, despite widespread and increasing consumption.

Dateline chose not to report any of the existing scientific analyses of these reports.

• The story � Dateline used Dr. Gurley, who does not claim to be an expert in obesity, weight loss, or even in reviewing clinical efficacy studies, to review the scientific evidence supporting the use of Ephedra products for weight loss. Dr. Gurley reported that, in his view, these products were not very effective for weight loss because consumers who used Ephedra products and dieted over a six month period lost "less than eight pounds" more than people who dieted alone.

The facts � Even if Dr. Gurley were correct, his view that losing an extra eight pounds is not significant runs contrary to what every weight loss expert recognizes. Even the loss of five pounds in overweight individuals can have very significant positive health benefits, including lowering blood pressure, improving cholesterol, triglyceride levels, and reducing the risk for heart disease and stroke. Further, Dr. Gurley did not acknowledge the difficulty that many overweight Americans have in starting a diet without some form of aid, such as Ephedra products, that help curb the appetite and burn calories.

Dateline was given the names of recognized experts who had conducted research into the efficacy of Ephedra products for weight loss. These experts who have a positive view of the usefulness and safety of Ephedra products based on their own research were not interviewed and were not even mentioned in the Dateline story.