HHS To Investigate Ephedra Safety, Efficacy 35371

HHS To Investigate Ephedra Safety, Efficacy

WASHINGTON--On June 14, Secretary of Health andHuman Services (HHS) Tommy Thompson reported the department will expand itsresearch efforts on ephedrine alkaloids while aggressively pursuing the illegalmarketing of non-herbal synthetic ephedrine products.

"It is crucial that we have a full understanding of thesedietary supplements," Thompson said. "By increasing our breadth ofknowledge about these supplements, we can give consumers the information theyneed to make informed decisions about these products."

The Food and Drug Administration reportedly advised HHS (www.hhs.gov)that adverse event reports (AERs) would not provide a good enough scientificbasis for assessing the safety of ephedra products, and there is a need forfurther research. HHS announced it recently contracted the RAND Corp., based inSanta Monica, Calif., to conduct a comprehensive review of the existing sciencebehind ephedra, especially in dietary supplements. The meta-analysis is expectedto be completed by early fall, according to HHS, at which point the NationalInstitutes of Health will use this information to expand its research efforts inbetter understanding ephedra.

In mid-May, acting deputy director of the HHS, Yvonne Maddox,submitted an HHS 2002 fiscal budget request to President Bush asking for $232.1million, part of which was earmarked for the Office of Dietary Supplements andother federal centers to conduct an evidence-based review on the safety andefficacy of ephedra. HHS also reported that it planned to nominate ephedra bestudied by the National Toxicology Program at the National Institute ofEnvironmental Health Sciences.

One surprising comment made by HHS was that FDA had begun amajor effort to strengthen its AER system by incorporating existing reportingsystems into a new, unified one to better monitor the safety of all dietarysupplements, including ephedra.

"This is interesting news and the first I've heard aboutit," said Michael McGuffin, president of the American Herbal ProductsAssociation (AHPA) (www.ahpa.org). He addedthat the present system for reporting AERs--the Special Nutritionals AdverseEvent Monitoring System, also known as SN/AEMS--does not work, especially sincethe system allows for nothing more than entering AERs. It does not allowre-entry into the system if the wrong company or even ingredient is attributedto an AER.

In his statement, Thompson not only encouraged FDA to continuewith its plans to improve the current AER system, but also for manufacturers tolabel ephedra products in a way that would better protect consumer health."I urge manufacturers to include FDA's 800-MEDWATCH telephone number ontheir product labels," he advised, adding that this number is anopportunity to support FDA's AER system.

"The general consensus is why should supplements that havea low incidence of AERs compared to drugs receive an 800-number when drugsaren't required to have one?" asked John Cardellina, vice president ofbotanical science and regulatory affairs at the Washington-based Council forResponsible Nutrition (CRN) (www.crnusa.org)."If the government requires them for supplements, shouldn't they alsorequire them for drugs?"

All in all, the move by HHS to better understand ephedrasupplements was seen as a positive action. "Sec. Thompson's statement is... commendable for moving the policy discussion on ephedra's safety to a moreadvanced level," said Wes Siegner, general counsel and spokesperson forWashington's Ephedra Education Council (www.ephedrafacts.com)."For too long, this important public safety issue has been stuck in firstgear and has looked only at the collected AERs."

According to San Diego-based Metabolife, a manufacturer ofweight-loss products containing ephedra, Thompson's words were a positivemessage for the industry. "We are pleased the HHS is conducting additionalscientific research of herbal ephedra-based products ... to add to those studiesthat have been done, showing that when taken as directed, these products aresafe and effective for weight loss."

AHPA commended HHS's announcement as a positive and informedresponse to the current issues surrounding ephedra. "It's satisfying to seethe government is essentially saying that the stand the industry has taken issound," McGuffin said.

However, not everyone was enthused with HHS' plans.Washington-based Public Citizen (www.citizen.org)deemed the HHS announcement as a failure to ban ephedra dietary supplements andalso a failure to seriously warn against the use of these products, and should"result in the firing of all officials in HHS and the FDA who areresponsible for this dangerous cowardice."

Cardellina added, "Advocates for an alternative point ofview are entitled to their opinions. However, ephedra is getting a very thoroughlook at by the government."

According to CRN, the Agency for Healthcare Research and Qualitywill begin circulating the agency's Safety Report on Ephedra on July 1, whichwill have a 30-day technical comment period when industry members such as CRNwill review the report. The final report is slated to be released in September.