ARLINGTON, Va. — Presentations and Q&A sessions at the 1999 AHPA International Ephedra Symposium addressed clinical research, chemistry, regulation, safety, traditional use and supply issues related to the herb. Some highlights include the following:
Gary Huber, M.D., vice president of scientific affairs for the American Nutraceutical Association and senior scientific editor of the Journal of the American Nutraceutical Association, discussed “the obesity epidemic.” He cited data revealing that more than 100,000,000 Americans are overweight or obese. More than 300,000 premature deaths per year are attributed to disease related to obesity, and the cost to the economy is $238 billion per year, according to Huber. “The medical treatment of obesity has historically been and abysmal failure,” Huber said.
Huber also discussed the results of a 6-month randomized clinical trial conducted at the Texas Nutrition Institute. The study examined the effects of three ephedrine-containing dietary supplements on weight loss and quantified both efficacy and risk using 150 study parameters. Results were compared to the same parameters assessed in matched subjects taking physician-prescribed pharmaceutical products, including sibutramine or phentermine. The study made a similar comparison to match subjects who had taken phentermine/fenfluramine (“phen-fen”) for the same duration. The three dietary supplements studied included an encapsulated product containing 24 mg of ephedrine alkaloids, a tableted product containing 12 mg of ephedrine alkaloids, and a tableted product containing 12 mg of ephedrine alkaloids and 33 mg of caffeine. The products’ directions for use resulted in a daily intake of 48 mg, 24 mg and 72 mg of ephedrine alkaloids, respectively. Researchers concluded that all three dietary supplements were efficacious with few or no adverse events or undesired symptoms occurring that were not common to overweight individuals in general.
Michael Scott of the non-profit Academy of Clinical, Environmental, Research and Informational Sciences (ACERIS) discussed the components of a good study protocol. Scott also said that he expects data from safety studies of ephedra currently underway to be available in early January. He said that not much of the data from the 130-subject, multicenter study would be released immediately due to pending papers to be published in two major journals. Upon publication of the results, Scott said that he expects quite a bit of “hoopla.”
Dennis Jones, Ph.D., of Bariatrix International, provided an overview of the history of ephedra and discussed safety and efficacy issues related to weight loss. Jones pointed out that the Canadian label requirement cautioning users not to take ephedra products for more than seven days is often misunderstood. The caution does not imply that the products are unsafe if taken for more than seven days, but rather expressed the attitude of the Canadian government toward self-medication, according to Jones. He explained that this statement means that if an individual uses a self-treatment for seven days and sees no improvement, the individual should go to the doctor. Jones also said that including caffeine as an ingredient with ephedrine alkaloids results in a product with better results and lower side effects than is found with either ephedrine alkaloids or caffeine alone.
Professor Hu Shilin, Ph.D., from the Institute of Chinese Materia Medica in Beijing, discussed the differences between the 17 species of ephedra that grow in China. In addition to the significant differences in chemical profiles between the species, he described the importance of distinguishing between the plant parts of ephedra. According to Shilin, the ephedra root contains alkaloids known as ephedradine A, B and C that have contrary effects to ephedrine alkaloids. He also provided tonnage data for the output of raw ephedra from China.
A panel of four experts on the traditional use of ephedra challenged the modern use of the herb for weight loss. Albert Leung, Ph.D., emphasized that ephedra is not for use as a daily supplement. Zoe Brenner, L.Ac., expressed similar concerns with the use of ephedra as a weight loss product and suggested that long-term studies are needed.
Dan Pearson, Democratic staffer to the Science Committee responsible for the recent Government Accounting Office (GAO) report, discussed the report’s criticism of the FDA’s proposed ephedra regulation. The report criticizes many aspects of the proposed regulation, including the lack of support for the 7-day use limit, the FDA’s “sophomoric” science used in addressing Adverse Event Reports (AERs), and the unusual use of AERs to establish a dosage standard. Pearson explained that the ephedra issue is important for all parties involved in the dietary supplement industry. “The ephedra regulation is the thin edge of the wedge that will decide how your industry is regulated into the future,” he said. Pearson also commented that he believes the industry will, at some time, come under investigation by a congressional committee.
Wes Siegner, an attorney with Hyman, Phelps and McNamara, discussed the short-term and long-term goals of the FDA. He commented that the FDA is using ephedra as a test case, and that the agency’s long-term goal is to obtain the power of pre-market approval of dietary supplements. Siegner suggested that the FDA should withdraw its proposed ephedra regulation to remove the restrictions on agency communication with industry. He also presented data showing exceptional spikes in adverse event reports filed in the days immediately following FDA press releases and media coverage of ephedra.
Raymond Mullady of the law firm Piper, Marbury, Rudnick and Wolfe explained why manufacturers of ephedra products should ready themselves for claims of industry-wide misconduct. He cited several recent lawsuits related to ephedra products and suggested that the industry will likely be the target of an industry-wide approach similar to that seen in the breast implant and tobacco industries. Mullady explained that if this action occurs, evidence can include corporate documents and trade association minutes. He described such an industry-wide legal attack as “inevitable.”
Source: Natural Products Industry Insider archived news article, Jan 1, 2000. [highlighting mine]