Wednesday, February 10, 2021

The Ephedra Debate

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One of the primary roles of government in the marketplace is to protect the end user. This can become difficult at times in our free market society as consumers create a demand for a product that, overall, may not be in their best interest to use. But where there is demand, supply will surely emerge. With our capitalistic form of government, declaring a product unsuitable for sale is a complicated matter, especially when Republicans are calling the shots.


One recent development that has brought this issue up for debate is the death of Baltimore Orioles pitcher Steve Bechler, a -year-old who had been taking Xenadrine RFA-1 during spring training to help him shed the ten pounds he needed to lose to get to his playing weight. During a workout on a warm mid-February day in Florida, Bechler's body temperature shot up to 108 degrees and he fell victim to heatstroke.


An ingredient in Xenadrine is the herb ephedra, which contains ephedrine. Since ephedra is an herb, it is allowed to circumvent FDA rules and fall under the more lenient Dietary Supplement Health and Education Act (DSHEA), which was pushed through Congress by powerful Senator Orrin Hatch. Hatch represents Utah, where approximately 0% of the nation's supplements are made.


The DSHEA puts the burden of proof on the FDA and requires that agency to prove ephedra is a dangerous product. This is despite the fact it contains ephedrine, which has been classified as a drug and is thus "held to the FDA's more stringent drug standard when it is extracted and sold as medicine." (Wolff) While there had already been roughly 1,500 reports of complications deriving from ephedra use and about 100 deaths, it wasn't until Bechler's passing that this issue has drawn any notable attention from the media.


So should the government continue to allow the sale of potentially hazardous products such as those containing ephedra? Shouldn't it at least be classified as a drug since one of its key components is a drug? A utilitarian approach is necessary to answer these questions. Labeling ephedra as a drug would certainly protect consumers but it would also have a negative economic impact on an industry that generates approximately $ billion in sales each year.


Consumers need protection from big business. Scandals such as those that erupted at Enron and WorldCom show companies are fully capable of making profits a higher priority than people. How many more fatalities would have occurred by now if auto safety regulations allowed Ford to continue producing cars such as the Pinto? What are the chances R.J. Reynolds would voluntarily set off on an advertising campaign that discourages smoking if it hadn't been mandated to do so in a settlement with the Attorneys General from several states?


But consumers also can't expect the government to hold their hand through every buying decision. Ephedra certainly isn't alone in its being an item available for consumption on the marketplace that could cause bodily harm under certain conditions if the directions on the bottle aren't followed. While they may require more time to inflict their damage, smoking and excessive drinking are just as dangerous and are addictive as well. I don't recall seeing a warning label on the Big Mac I had at McDonald's the other day. It would be difficult to imagine the total damage to our economy if compensatory justice was doled out whenever a buyer was slighted in the least. Consumers have the right to government protection but the line must be drawn somewhere.


I would recommend Congress close the loophole in the DSHEA that allows drugs to be used as ingredients in herbs and thus avoid the watchful eye of the FDA (the results of a Rand study on ephedra, commissioned by the Bush Administration, are due within weeks). This would allow ephedra to stay on the market but make it a little more difficult to obtain. While a doctor could have seen Bechler's high blood pressure as reason not to prescribe it, that same doctor would have had no control over the fact Bechler took more pills than clearly permitted in the directions on the package. In the end, it's nice to have our government around as a safety buffer but each of us must take at least some responsibility for our own decisions.


Despite the controversy, this was not a major story in any of the magazines I reviewed for this paper. Most did a good job of presenting the basic facts but they did this story no justice by not allocating enough print to allow an in-depth analysis of the issue. It doesn't reflect well on our society that a good portion of my sources came from sports pages and these sources provided the best coverage.


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