Ephedrine/Caffeine Combo: New Study Says “NOT GUILTY”
No “Substantially Increased Risk” Continued…!
A maxim used in criminal investigation is cui bono (who benefits). Who would benefit from removing a safe and effective weight-loss product from the market? It is certainly not the overweight individual seeking to lose weight without the expense, inconvenience and risk (as has been shown with fen-phen, rimonabant and other pharmaceutical drugs) of needing to visit a physician’s clinic and obtain a prescription. It is certainly not the athlete (not competing in an organization that bans ephedrine) looking for a (assumably) safe and effective ergogenic. It is certainly not society who bears the financial burden of treating obesity and obesity-related conditions.
Who then? Accusing fingers point at big pharma. The pharmaceutical industry takes the brunt of much of America’s ire…necessary drug therapy is often prohibitively expensive, especially for noninsured people; quality-of-life drugs are not developed or are restricted either by legislation or physician resistance; allegations of bribes, inappropriate
influence with the FDA, and numerous FDA-approved drugs causing harm or death have eroded public confidence in the pharmaceutical industry. Yet, it is clear that any pharmaceutical company that could produce a cost-effective weight-management drug or drug combination would make billions of dollars. The only barrier to herding the American obese to questionably effective and marginally tolerated drugs such as alli® was the presence of the blockbuster brand Dexatrim® (PPA) and the many ephedrine/caffeine products which were providing consumers with subjective benefit and measurable weight loss. When ephedrine and PPA were removed from the market, the marketing potential for any effective OTC weight-loss product or prescription product escalated dramatically. Sadly, such a product has not been introduced since that time.
Another possibility spoken of more quietly in nonscien tific circles is a serious social issue. Methamphetamine is a stimulant-class drug. Historically, it was trafficked by biker gangs and other elements that operate on the fringe of society.
Though similar in effect to cocaine, it was much cheaper and referred to as “trailer park coke,” in addition to other slang terms (meth, crystal, crank, etc.), as most users were white and lower income. However, as enforcement against cocaine gained some degree of success, drug-seeking individuals discovered methamphetamine whose supplies were initially unhampered. As the numbers of methamphetamine users rose and its effects touched “middle-class America,” enforcement turned its eye on that problem. It was quickly discovered that methamphetamine distribution was going to be more difficult to control, as it could be synthesized in crude “bathtub” labs and the intermediate used in production was easily obtained at the local health store, truck stop, pharmacy or over the Internet. That intermediate is ephedrine (pseudoephedrine can also be used).It is suggested that the real danger involving OTC ephedrine had little to do with ephedrine-based drug reactions, but rather with its use in the cottage-industry meth labs hidden in garages, sheds, trailers and basements throughout America. Unfortunately, the easy answer for enforcement agencies appears to have been to close Access (legitimate and illegitimate) to ephedrine.23,24 However, as people living in rural areas know, methamphetamine use continues to be a problem; much of the ephedrine used by larger, better organized gangs in production crosses the border illegally from Mexico.
The Danish study uncovers new evidence that demands an appeal of the status of ephedrine/caffeine for weight loss. The need for an affordable, convenient, safe and effective weight-loss product remains as the current options are all lacking. Perhaps the Danish model would be best, to make a Letigen-like drug, available only by prescription to minimize the risks of diversion to methamphetamine production, abuse and use by people with clinically evident contraindications. Further, educating the consumer to be aware of signs of toxicity or adverse effects, particularly during the first month of use, is critical to minimize the potential for harm.
Ephedrine/caffeine has been tried and found guilty of harm by a zealous FDA in the court of public opinion. One very important comment from the Danish study deserves to be boldly acknowledged. As suggested by the Danish authors in their published study, most “evidence” of adverse effects associated with ephedrine/caffeine use appears to be based on spontaneous reports, and does not withstand scientific scrutiny. Much like eyewitness testimony that condemns an innocent man, whose innocence is later proven through DNA analysis of the evidence, this study calls for a re-assessment of ephedrine/caffeine for weight management. Case reports involving hundreds, even thousands of ephedrine users are statistically (not emotionally) meaningless due to the huge number of users in the U.S. and abroad. The new evidence uncovered by a “Dream Team” of scientists, and data in the country of Denmark, suggests that an innocent sits on death row. Hopefully, some avenue of appeal will be made available to reevaluate this case.
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