|Government Trial Balloon
he ban on ephedra, strategically announced on the eve of the new year in a press conference by the heads of the federal health care bureaucracy, found the fourth estate lined up like a bunch of drooling hooligans eager to participate in a gangbang.
Filling their newspapers and airtime with articles feigning factuality, the press spewed forth unsubstantiated information about Ephedra sinica (aka ma huang), a plant that was the official court drink in ancient China 5000 years ago, when written language was birthed, and where it may very well have instigated that Great Leap Forward.
But the press conference was a leap backward for the millions of consumers who, despite governmental warnings, have continued to partake of what is undoubtedly the most safe and effective substance ever used for weight loss, when used correctly.
Thus it is surprising that Tommy Thompson, the head of the Department of Health and Human Services, announced at the press conference, as his strategy for removing ephedra from the marketplace, the idea that products containing it are “adulterated,” meaning that “[ephedra] presents a significant or unreasonable risk when it’s used as labeled.” This is not the meaning of adulterated as it is commonly understood, but it apparently suits the purposes of the regulators. Also, if this is their strategy to remove ephedra from the market, what about those products that do not have “adulterated” labels, those whose labels are truthful and not misleading because they specify correct use and are formulated to be metabolized slowly and safely?
All the criticism of ephedra, as well as the announced ban, depends on reports of its doing harm. But what is the truth of this, and where is the evidence? Several years ago, the General Accounting Office reviewed the FDA’s evidence and, finding it seriously lacking in quality and quantity, dismissed it. So why is anything any different today, despite a flawed report from the RAND Corporation and the improperly attributed death of a baseball player from the use of ephedra? (A report by Baylor University researchers claimed that ephedra had little to do with the ballplayer’s demise.) It’s an election year!
Additionally, a report published recently in Forensic Science International, which examined autopsies in the Medical Examiner’s jurisdiction of San Francisco from 1994 to 2001 in which ephedrine or any of its isomers were detected, concluded:
What is most surprising about the results of this study is that, of the cases where only ephedrine alkaloids were detected, only one possible case of ephedrine toxicity occurred in San Francisco from 1994 to mid-1999. This data contradicts [emphasis added] the recent well-publicized case reports suggesting that large numbers of ephedrine-related deaths were occurring, and that only a fraction are being reported to the FDA.
There’s something more to this press conference. Despite claims by both Thompson and FDA Commissioner Mark McClellan that they want to obey the law, they are flying a trial balloon to overturn the Dietary Supplement Health and Education Act by trying to set a significant legal precedent. In the words of Secretary Thompson, “I would like to see the law changed” and “. . . we’re going to change the culture in America.” Now that’s an ominous statement. In this atmosphere, none of our supplements are safe. It’s time to let Congress know that we will not put up with this.
- Blechman KM, Karch SB, Stephens BG. Demographic, pathologic, and toxicological profiles of 127 decedents testing positive for ephedrine alkaloids. Forensic Sci Int 2004 Jan 6;139(1):61-9.