A Judge Overturns A Dangerous Substance…Heed The Warning Signs

By Gregory Moore
Updated: April 15, 2005

Pretty soon, Ephedra could reappear on your nearest retail store in the diet supplement aisles of your favorite store. Should the manufacturers err on the side of caution despite an overturned ban from a U.S. District Court judge?

SAN ANTONIO – Ephedra is a nasty little substance that has killed athletes and non-athletes alike yet a U.S. District Judge overturned the ban saying the FDA lacked the evidence needed to say what was a safe arbitrary dosage. Judge Tena Campbell ruled, “A negative inference is different from the affirmative proof required. There is not sufficient evidence in the administrative record to establish that the risks identified by the FDA are associated with the intake of low dose EDS,” Campbell said in her opinion.

The Associated Press quoted Neutraceutical president Bruce Hough as saying the decision is about “protecting the public’s access to safe and effective dietary supplements.”

Well that may be all well and good but let’s look at the stone cold facts. This is a dietary supplement that has killed individuals and even if it were one life, I would think that Mr. Hough would want to err on the side of caution. I say that because I am still haunted by the death of Northwestern starting safety Rashidi Wheeler. If you don’t remember this case, Wheeler collapsed after ‘voluntary’ workouts during the 2001 off-season. Wheeler’s family eventually dropped the makers of the dietary supplements that Wheeler was taking but those supplements contained Ephedra derivatives. Wheeler also was an asthmatic and it the diet supplement may have played a part in the role of his collapse.

While doing some research on this article, I came across one media story written in 2003 in which the writer was making the argument of the dangers of Ephedra. Quoting from ABC7’s Rob Johnson’s piece “Evidence on Ephedra”, I want to pull a quote that Mr. Johnson received from Northwestern Memorial Hospital’s Dr. Robert Bonow: “The anecdotal evidence continues to accumulate and we do see examples, unfortunate examples of people having heart attacks in and around the time they were taking the substance.” Am I trying use scare tactics at a time when a U.S. District Judge is asking for a review of this supplement? Yes I am. I’m doing so because while Neutraceutical and other Ephedra manufacturers may be saying, ‘We have a chance to put our product back on the market”, our society deserves to be saved from something that even the manufacturers may not have a full understanding. The evidence folks is truly out there on just how dangerous this substance can be. You can go to Mr. Johnson’s article at http://abclocal.go.com/wls/news/specialsegments_Nov02/051103_ss_ephedra.html to read about the dangers the Dr. Bonow speaks of and you can go to various websites that will have information on this substance. As a sports writer I am very worried about anything an athlete may take where manufacturers may not truly have a full understanding as to what the effects on the human body. Athletes at all levels train hard and are always looking for an edge to give them a leg up on their competition, so when I read that a dietary supplement can cause the heart to go into a cardiac arrest or be the cause of triggering something else that has to do with the respiratory functions of the body, I am very skeptical of its safety.

Now I realize that many proponents may believe I am jumping the gun here but when it comes to public safety, there should always be a reason to err on the side of caution over profits. I know that many manufacturers will say that their products were safe AND are safe now if the user takes the proper dosage. Yet my question is this: what is the proper dosage. More importantly how are these manufacturers testing their products to ensure that the FDA can say, “we approve of this drug and it is safe”. I think any manufacturer would be hard pressed to say that they could get a federal agency to go along with this program. Where are these manufacturers doing the testing and who are the test subjects? Reese’s monkeys? Baboons? Rats? Human patients? If these companies are doing testing, as part of the buying public I should know who and what are the test subjects for these products and if there is no such testing, then I cannot see how anyone would think the Federal Drug Administration is going to endorse such a product.

I know that in this country we believe in free enterprise and capitalism is what makes this economy grow. However I also believe that there are reasons why agencies like the Federal Drug Administration have a task in halting dangerous products from being put on the retail shelves. The product makers who want to have Ephedra and its derivatives put back on the shelves should be willing to at least help the FDA come up with some guidelines and warnings on the usage of these products. I know that profits may mean everything to these companies but as for this writer I don’t want to see another Rashidi Wheeler make the headlines. I’m all for a capitalist society but more importantly I’m for a society that is safe in their consumption of health products as well.

WRITER’S NOTES: Portions of this editorial’s content came from ABC7 of Chicago and from www.healthnews.com. The quotes attributed to Dr. Bonow were published in May of 2003 by ABC7 and are from the special series, “Evidence on Ephedra”, reported by ABC7’s Rob Johnson.