Here in the United States the FDA has banned supplements that contain ephedrine (most notably the herb sold under the name ephedra), citing various health concerns. Ephedra had 12 million users in the United States since 1999 that were using it for mostly weight loss or to improve athletic performance. This was a relatively new phenomenon as these drugs never gained widespread use for these reasons until companies began promoting them for other reasons than to treat respiratory illnesses. The FDA has been debating this problem for some time now, as postmarket evidence has piled up against ephedrine-containing products and over 12 million citizens were using ephedra. Ephedra is normally regulated under the DSHEA, which puts the burden of proof on the FDA's hands. Oddly enough, ephedrine as a chemically isolated drug is regulated like any other medication would be with clinical trials and restricted access through a physician.
The FDA started its first meeting of the Special Working Group on Foods Containing Ephedra Alkaloids on October 11, 1995 to address the problem of over 300 adverse events mostly involving cardiovascular and central nervous system problems. When the meeting convened in 1996 the amount of adverse reactions had doubled and some members were calling for a ban or further regulations and warnings. A year later, the FDA moved to put dosage restrictions and various warning labels on ephedra, but after getting audited by the General Accounting Office the FDA withdrew that proposal deferring to the GAO's claim of lack of evidence. After this and up until the ban, a string of personal lawsuits, an anti-ephedra petition by Public Citizen and a ban by the NFL have ensued.
The actual evidence is rather complicated. The RAND corporation did a study that plowed through older studies and looked for information on effectiveness and health risks. RAND's study found pure ephedrine and ephedra were effective in short term (less than 6 months for all of the studies) weight loss. No studies have been done to evaluate the long term weight loss benefits of ephedrine or ephedra. In addition, there was insufficient scientific evidence to conclude anything about the short or long term effects on athletic performance. Out of the 50 or so valid scientific studies performed on ephedrine and ephedra, no serious adverse reactions were reported. However, due to sample sizes, these studies could only determine if adverse reactions would occur in 1 out of 1,000 people. The RAND study looked further by retroactively evaluating case studies from the FDA’s Office of Nutritional Products, Labeling, and Dietary Supplements. The study found over a hundred "sentinel events" (reactions that may or may not be related to ephedrine consumption) involving such things as myocardial infarctions and serious psychiatric and neurological effects.
However, things get slightly more complicated when one considers why the FDA banned ephedra. Fatalities due to Tylenol and Benadryl were at 427 and 641 according to the Drug Abuse Warning Network, a government organization that monitors fatalities due to anything from OTCs to illegal drugs. Possible reasons for the FDA's decision include:
- The FDA makes a cost benefit analysis that ephedra failed. The FDA does not consider short-term weight loss or energy boosting worth the possible risks of taking ephedra and has acted accordingly. This would also have an influence over deciding whether to do a study to evaluate severe adverse reactions, as any such study would have to involve a very large sample size and may not be worth it in the FDA's mind.
- Political fervor after the death of Steve Bechler. Bechler was a pitcher for the Baltimore Orioles who died of heat stroke. Ephedra was a factor in his death, although he was in bad health already with high blood pressure, an abnormal liver and being overweight. His parents made an emotional testimony before Congress and his wife has a $600 million dollar lawsuit against Cytodyne Technologies.
- Ephedra can be used to make meth. This is the least likely real reason behind the FDA decision, but also the most likely to give conspiracy theorists a waking wet dream. However, due to various regulations it's more difficult to get ephedra powder in mass and pseudoephedrine substances are more common for your basement chemist.
The relative merits of the government's actions now become a debate in government ethics and politics. Considering the health risks of obesity, should the government ban a weight-loss supplement because of a small amount of adverse reactions? Is it up for the FDA to determine what the public should find useful? Personally, given the large numbers of people taking ephedra and the relatively small amount of risk involved, I would prefer actions like labeling over prohibition. Perhaps ephedra was just the next in line for the War On Some Drugs?
http://www.fda.gov/bbs/topics/NEWS/ephedra/whitepaper.html
http://www.fda.gov/OHRMS/DOCKETS/98fr/95n-0304-bkg0003-ref-07-01-index.htm
http://en.wikipedia.org/wiki/Ephedra
http://www.reason.com/sullum/072503.shtml
http://www.rhodium.ws/chemistry/ephedra.html