Janus Face Or Jaundiced Eye?

Ephedra continues to fight an uphill battle.

ByAnthony L. Almada, B.Sc., M. Sc.

Ephedra is the natural products industry’s aspartame. But before ephedra captured a bullseye position on the walls of both media and excoriating medical re­searchers, aspartame was central in the cross hairs of the processed food detractors and the food add­itive subtractors. Over 10,000 adverse event re­ports have been reported to FDA in re­gards to as­partame and the Department of Health and Human Services has identified at least 91 aspartame-associated symptoms, such as headaches, temporary blindness, diz­ziness and mood changes. The in­creasing rate of brain tumors has been ascribed to the increased disappearance rates of aspartame (J Neuropathol Exp Neurol, 1996). However, the majority of the “challenge” studies (wherein subjects with presumed aspartame hypersensitivity reactions are assigned to receive either a placebo or aspartame) show no greater adverse events than with placebo. Did, and do, national media subject aspartame to the intensive investigative journalism and muckraking that is emblematic of ephe­dra?

The aspartame curse must have worn off, as Met-Rx® (a Nutricia USA/Royal Numico brand) has introduced a product (Thin FX™) that calls out aspartame (identified by its chemical text­book name) as an active in­gredient on both the front and Supplement Facts panels.

It appears as if the media and regulators can fluently engage in double-speak. Excoriation of those who sell and market ephe­dra-containing products, citing research articles dissecting temporal relationships between ephedra ingestion and cardiovascular and cerebrovascular medical events, and even deaths (see Mayo Clin Proc, 2002), is the norm. Typically these ignore or discount the abundance of safety data with synthetic ephedrine + caffeine (E + C) combinations and the small number of studies with botanical E + C. As of last February, the number of adverse event reports submitted to the FDA since January 1993 numbered slightly less than one-tenth of those associated with aspartame. Caveat one: 81 of those reports involved deaths. Caveat two: Botanical-derived ephedrine could be more prone to producing cardiovascular adverse events rel­a­tive to an equal amount of synthetic race­mic ephedrine. Mantra: Dietary supplements are unsafe, despite the data.

Given the surfeit of anecdotes and the paucity of adverse event report reviews for aspartame, like that seen with ephedra (e.g. N Engl J Med, 2000 and Mayo Clin Proc, 2002), one wonders why. Consumer groups, mothers, unconventional-minded health professionals and even some university researchers have vociferously fought against aspartame, one internist/lay author calling it the “molecular Auschwitz.” What defamatory comments has Consumer Reports made about aspartame? Did they ignore the comments of a respected university sports nutrition researcher regarding their piece last year on sports nutrition pro­ducts (including a treatment of ephedra)? Yes. Who did they cite as an expert to render an opinion about safety? Someone with NO sports nutrition product research ex­pertise whatsoever. Caveat: No un­equi­vocal body of evidence supports a causal relationship between aspartame ingestion and adverse events. Mantra: Food additives are safe despite adverse event reports.

Could soy and its phytoestrogenic iso­flavones be the next target, walking a du­plicitous path of being approved for foods (as isoflavone-rich protein concentrates) and allowed for dietary supplements? Given the emerging body of animal evidence, derived from the same experimental model that gave birth to the anti-breast cancer drug tamoxifen, one could argue YES. Several NIH-funded studies from the University of Illinois, Urbana-Champaign have shown that the isoflavones genistein and genistin promote the growth of human breast cancers implanted in the tamoxifen mouse model (Cancer Res, 1998; Carcinogenesis, 2001; J Nutr, 2001). Take the isoflavones away and the tumors shrink.

These data suggest that for the post­meno­pausal women (with low blood estrogens) and an elevated risk of breast cancer genis­tein ingestion may be a risky proposition. A soon to be published animal study will cast an additional unfavorable light upon genistein and its antagonistic interaction with a widely used breast cancer drug. How will the media treat this Trojan horse? Food or dietary supplement as target practice?NW