Ephedrine/Caffeine Combo: New Study Says “NOT GUILTY”
I n this fast-paced world, where printed news media is losing audience because it is too slow in reporting when compared to television outlets, and absolutely stagnant in comparison to instantaneous release on the Web, headline- grabbing controversies appear and disappear in days, even hours. The urgency of more current problems tends to displace yesterday’s crises in the minds of the public (and programming of the media). Thus, it is of little surprise that people have forgotten the prominence of ephedrine/caffeine-based weight-loss products and the hotly debated allegations of harm that preceded the ban on ephedrine, pseudoephedrine and ephedra (ma huang) from the market. The following is a somewhat brief and superficial review of the events that defined that time, acknowledging that a few sentences do not adequately convey the entirety of related issues. Ephedrine-based, over-the-counter (OTC) products including herbal ephedra-based products were being purchased in record amounts, as weight-conscious consumers found the products to be effective in curbing appetite, boosting energy and burning calories. Numerous peer-reviewed studies and reviews confirmed the efficacy of the ephedrine/caffeine combination in causing weight loss, increasing resting energy expenditure (metabolism) and reducing appetite.The beta-adrenergic-stimulating natüre of the products also provided a performance boost to athletes, increasing its appeal and expanding its market to normal- weight, active individuals. Unfortunately, the stimulating effect also appealed to young adults and adolescents for fighting fatigue and as a party drug. Sales of ephedrine-containing products established the ingredient as the keystone of the top-selling products in the highly lucrative weight loss category. Estimates of use are inherently inaccurate, but it is not unreasonable to accept that 33 percent of young adults had some exposure to such products, given that overweight and obesity was affecting more than 50 percent of the nation at that time. However, obesity was just being identified as a significant condition poised to dramatically affect public health and the financial welfare of the nation; certain companies were violating the spirit of DSHEA (Dietary Supplement Health and Education Act) by adulterating supplements with pharmaceutical drugs; unscrupulous advertising was tainting the industry’s reputation; and certain companies were marketing ephedra-based products as a party drug to high-risk youth and young adults. Ephedrine was already a regulated drug within sports organizations, being placed on the banned substance list by the NCAA in 1997 and prior to that by the IOC/ WADA (1994) for its stimulant-based ergogenic properties. Though relatively few well-known athletes were sanctioned, a small number were banned from competition. It was during this time that the topic of adulteration (intentional or unintentional) in OTC and supplement production was raised as an element in the athletes’ (largely unsuccessful) appeals of the bans.
As ephedrine and ephedra use became increasingly prevalent, and its use/abuse was associated with mood, behavior and health problems, watch groups became rightfully anxious about its presence as an unregulated stimulant accessible to minors. Further, the potential threat of cardiovascular harm or death was raised by concerned individuals and health professionals. Beta-adrenergic stimulants are capable of inducing dangerous elevations in blood pressure or irregular heart rhythms in sensitive individuals or when dosed/consumed in excess of the therapeutic range. As often happens, once public awareness was raised, numerous reports were registered in the media and public forums. Public health watch agencies released statements calling for a ban of ephedrine-containing products in the interest of the public’s welfare.The well-publicized deaths of users of ephedra-containing products, fortified public support for withdrawing the products from retail shelves. The level of attention and implied risk in ephedracontaining products, along with the punitive damages awarded in civil litigation, caused insurers to raise premiums such that scrupulous manufacturers withdrew ephedra-containing products from their product line prior to the formal ban handed down from the U.S. Food & Drug Administration (FDA) in 2004. In close up statement, available on their website, are two quotes that would be contested by many who followed the research and reports of ephedrine-related weight-loss products. “There is strong scientific evidence of harm associated with the use of ephedra products” and, “The agency found that supplements containing ephedra show little evidence of effectiveness, except for short-term weight loss.” A following comment, “These reactions have been linked to serious health problems, including heart ailments and strokes,” serves as the primary reason for the passage of the 2004 rule that removed ephedra-containing products from the retail market. Finally, “This final rule will protect consumers by ensuring that these dangerous products are removed from the market and never sold,” says FDA Commissioner Mark B. McClellan, MD, PhD. Clearly, the FDA is certain that ephedrine and ephedra-alkaloids are inherently dangerous chemicals that should not be placed within reach of consumers. Of course, this does not take into account ephedrine and pseudoephedrine contained within over-the-counter medicines that treat asthma, nasal congestion and minor eye irritation. However, as those products are regulated in most states to be dispensed only from “behind the pharmacy counter” and only in amounts less than a defined threshold, the risk of adulteration or abuse are lessened considerably. Thus, the existence of ephedrine-containing and pseudoephedrine- containing weight-loss products were relegated to history. Previously (2001), phenylpropanolamine (PPA) experienced a similarly rapid and controversial withdrawal from the market, despite the long-standing success of Dexatrim and like products. A study published in The New England Journal of Medicine concluded that PPA was associated with an increased risk of hemorrhagic stroke in women, causing the FDA to recommend the withdrawal of all PPA-containing products from the retail market.This move was vigorously debated, as many scientific experts contested the conclusion and study design of this and a related PPA review. Interestingly, the same issue of the NEJM contained a preliminary report of 140 cases of adverse events related to ephedrine.
Numerous peer-reviewed studies and reviews confirmed the efficacy of the ephedrine/caffeine combination in causing weight loss, increasing resting energy expenditure (metabolism) and reducing appetite.
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