Ephedrine: Big Government’s Ban of Free Choice (part 2)
(originally published Dec. 2004 – FreeMarketNews.com)
(continued from Part 1)
ARGUMENTS FOR THE BAN (SORT OF)
Even as an avid supporter of free choice and an outspoken opponent of the ephedrine ban, I will readily admit that there are risks associated with the use of ephedrine, both in its herbal and synthetic forms. But in so doing, as a free-thinking adult I must also acknowledge that at least as dangerous as taking ephedrine-containing products, so too are other products and activities that we engage in every day which are perfectly legal…smoking, drinking alcohol, driving a car, eating at McDonald’s, downhill skiing, and sitting too long in front of a computer writing long-winded essays can all be dangerous to your health when abused. Should they be banned as well? Dumb question, I know, but it needed to be asked.
Okay, the facts:
Ephedrine in all its forms is a stimulant, meaning it causes a rise in cardiac output (heartbeat) and an increase in “thermogenesis” (body heat). Byproducts of this action are the increased burning of fat, a marked rise in energy levels as well as strength and endurance in athletic endeavors, and, in some consumers, mental feelings of well-being or mild euphoria. It also temporarily relieves symptoms of asthma by relaxing the smooth muscle of bronchial passageways.
This being the case, if you swallowed a full bottle of virtually any ephedrine product on the market (medicine or supplement), I personally guarantee that you would likely experience extreme jitteriness, mental irritation and/or anxiety, severe stomach upset, nausea, vomiting, perhaps even heart palpitations. In extreme cases of individuals with existing health problems or in concert with some prescription medications (i.e. people who shouldn’t take the product), you could very well give yourself a seizure, heart attack, or stroke from such a ridiculous and negligent act. Doing so would also be against every label direction ever written (not to mention good-ole common sense).
When not abusing the product, however, the dosages allowed by the FDA are actually quite high and most respectable ephedrine supplements gave maximum daily allowances well below this number. Maximum dosages allowed by FDA ruling held steady at 25mg per dose and 150mg per 24-hour period. Herbal preparations were based upon the content of ephedra alkaloids (the active ingredient) per unit (tablet, capsule, etc.). Due to the quantity of raw herb held within capsules or compacted tablets (and the purity of the given herb blend), dosages ranged from 1 to 4 capsules in a sitting. In my experience, few mainstream products exceeded 20mg of ephedra alkaloids per serving, making them quite a bit safer than their medicinal cousins.
But you’re asking, “what about all the people that supposedly died from using ephedrine?”
The answer is that very few cases can be produced to substantiate such claims. Of those that have been, many are merely “linked” to ephedrine use and little if any direct correlation is ever found. Others, as in the vast majority of claims and lawsuits, have been directly related to misuse of the product. I myself watched a television news program where one individual actually said that he didn’t think he should be held personally responsible for his abuse of the product (and subsequent health problems) because he believed no one should expect him to read the tiny print on the warning label before taking it! So much for personal responsibility.
The media has also been rather quick to jump at every sensationalistic story that happens along that even hints at linking ephedrine use to someone’s death.
Case in point:
23-year-old Baltimore Orioles pitcher Steve Bechler died from heat stroke February 17th, 2003. Virtually every mainstream media organization in the country was quick to jump on the fact that Bechler was taking a popular over-the-counter ephedrine supplement called Xenadrine RFA-1 around the time of his death (it was found in his locker and teammates knew he took it). These same newspapers ran fear campaigns condemning this “known toxin” for its dangerous risk factors weeks before anything conclusive was returned linking Bechler’s death with the supplement.
A forensic investigation conducted by former New York City Medical Examiner Dr. Michael M. Baden concluded that “Xenadrine did not cause or contribute to Mr. Bechler’s death.” Further, Dr. Baden said that Bechler “died of a heat stroke precipitated by his morbid obesity, high blood pressure and heart disease, adverse weather conditions, physical exertion, and inadequate screening, monitoring and medical supervision.”
What’s most interesting about this case is how many articles you find through a casual search on Google that report the incident and the link to ephedrine before the toxicology results and autopsy were ever returned. What’s worse, however, is how few articles are available detailing the results of those tests.
Okay, one more example:
27-year-old Minnesota Vikings offensive lineman Korey Stringer died August 1st, 2001 – also of heat stroke and under similar physical health conditions as Steve Bechler while undergoing intensive exercise in conditions of heat and humidity, and also while using an ephedrine-containing product (this one called Ripped Fuel) around the time of his death. Weeks before the results of any medical tests were returned, fans and the press alike equally bemoaned his death at the hands of the dreaded ephedrine demon found in his locker. The results of toxicology screens finding no ephedrine in his system at the time of his death met with similar silence by the mainstream media.
[*Note: to be fair to both sides of the argument, it was later released that toxicology tests run on Stringer’s blood did not test for ephedrine, so a possible link between his death and ephedrine use remains unknown.]
These incidents of media sensationalism played an important role in raising questions and fear in the pubic eye and offering support for a move by the FDA to retake some of the regulatory control over supplements they enjoyed before the passage of the DSHEA in 1994.
ARGUMENTS AGAINST THE BAN
I could certainly write a small novel describing the slighting of our rights of choice by removing ephedrine from our stores, the blow such a ban strikes against personal responsibility, and the increased expansion of government into our personal lives, but I’d rather avoid the rant and stick to the facts. They speak to the truth a lot more directly.
The “truth” I speak of comes from two sources. First, my personal experiences and research as a fitness trainer and nutritional consultant over the past 15 years, and second, the facts supported by the government’s own studies on the issue.
As a child I used Primatene Tablets (ephedrine hydrochloride) to cope with asthma. I can attest that they were lifesavers for the midnight asthma attack that made every breath a grinding effort. As an adult, I mostly outgrew my asthma, but I’ve long since seen (and personally felt) the benefits of ephedrine use. And I’ve tried numerous concoctions and brands of both the herbal and synthetic varieties throughout the years, as have numerous clients of mine. Not once in more than 15 years of fitness training and nutritional consultation have I run across any individual, whether a friend, client or fellow trainer, feeling or observing anything more serious than intense jitteriness or insomnia associated with ephedrine use. Not one! That sampling would include, literally, thousands of individuals.
Finally…(drum roll, please)…the meat and potatoes of the matter. What is the scientific evidence for and against ephedrine use?
Though both sides have produced numerous authenticated studies supporting their version of truth, the most anticipated and debated study was performed by the RAND Institute and co-sponsored by The office of Dietary Supplements (ODS), which is a division of The National Institutes of Health, and The National Center for Complimentary and Alternative Medicine (NCCAM). The study was an evidence-based exhaustive review of existing research on the clinical efficacy and safety of products containing ephedra or synthesized ephedrine alkaloids. The results were released in March 2003 and published in The Journal of the American Medical Association (JAMA).
The Results of the RAND study:
- Out of 52 separate controlled trials, not one “serious adverse event” (heart attack, stroke, seizure, serious psychiatric episode, or death) was found.
- In studies of ephedrine and weight loss, 44 controlled trials were studied and found to show “statistically significant” weight loss using ephedra alone and in concert with caffeine (a popular “stack” among both bodybuilders and casual users alike).
- In studies of athletic performance enhancement, 8 controlled studies using synthetic ephedrine found “modest” increases in short-term athletic strength and endurance.
- In analysis of safety, evidence from trials suggested a 2-3x risk of nausea, vomiting, anxiety/mood change, hyperactivity, and heart palpitations.
- In review of 71 cases reported in medical literature, 241 cases from the FDA, 43 cases from a manufacturer, 1,820 FDA case reports, and more than 18,000 consumer complaints reported to manufacturers, most were deemed too poorly documented and with little cause and effect established between adverse events and the use (or misuse) of ephedra products.
- Total adverse events from the study from all sources that could possibly be attributed at least in part to ephedra use were: 5 deaths, 5 heart attacks, 11 strokes, 4 seizures and 8 psychiatric cases.
Quotes from the ODS summary of findings:
- “Although this analysis raises concerns about the safety of botanical dietary supplements containing ephedra, most of these case reports are not documented sufficiently to support an informed judgment about the relationship between the use of ephedra-containing dietary supplements or ephedrine and the adverse event in question.”
- “According to the RAND report, the number of deaths, myocardial infarctions, cerebrovascular accidents, seizures, and serious psychiatric illnesses in young adults is sufficient to warrant further evaluation of the safety of these products in a controlled manner.”
Notice that nowhere in this study or the summary is anything said about banning the product or that it is intrinsically unsafe or dangerous to human consumption. The study found that there was cause for concern (i.e. risk associated with usage), but not enough evidence to draw a final conclusion, which is what the ban effectively did.