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Prepared Witness Testimony The House Committee on Energy and Commerce
Issues Relating to Ephedra-containing Dietary Supplements.
Subcommittee on Oversight and Investigations
Mr. Eugene Orza
Mr. Chairman and Members of the Committee: My name is Gene Orza, and I serve as Associate General Counsel of the Major League Baseball Players Association. The Association is, as you know, the exclusive collective bargaining representative of all major league baseball players, and I am pleased to appear on their behalf today in response to the Subcommittees' invitation to testify. The MLBPA understands and appreciates the Subcommittees' interest and concern about the use of dietary supplement products containing ephedra. As indicated in our submission to the full House Commerce Committee on April 15, 2003, we have for some time believed that an overall legislative and regulatory reexamination of all dietary supplements, to include their composition, their marketing and labeling, and their safety, has been appropriate. Baseball players, just like the overwhelming majority of their fellow citizens, look to the federal government as the ultimate arbiter of the degree, if any, to which ingestible substances require regulation. Consistent with our view of the federal government's role in the determination of what is safe and not safe, we would, therefore, wholeheartedly support and embrace a decision by Congress, the Food and Drug Administration, or by any other arm of the federal government in the business of determining what is safe and not safe, to more strictly regulate or even ban any specific dietary supplement that the available science suggests to the Congress should be more strictly regulated or banned. The position of the Players Association has long been that players should not be prohibited from using any substances that the United States government has effectively determined are not unsafe for consumption by other American consumers. As I am sure you know, the issue of how best to regulate ephedra-based products is not new to this Committee, the Congress as a whole, or the FDA. In fact, I believe the debate actually predates Congressional consideration and passage of the Dietary Supplement Health and Education Act in 1994. Over the ensuing decade, the government's decision to refrain from taking any significant action relating to ephedra appears to be based, at least to some degree, on the inability to forge an appropriate consensus on exactly what the science shows, with those who advocate stricter control unable to change the governmental order of things when it comes to dietary supplements. The task has only been more complicated by the passage of time, which has produced large numbers of people who have at least come to believe that it was their safe use of ephedra that enabled them to control or reduce their weight. The MLBPA and Major League Baseball have a four-person Health Policy Advisory Committee, staffed by a medical and legal representative of the Players and Clubs. The duties of the Committee are wide-ranging, and include the review of medical literature pertinent to players. Among other things, the Committee, and principally its medical representatives, has reviewed on an ongoing basis scientific literature related to the health effects of a number of dietary supplements, not just ephedra. In fact, it was on HPAC's recommendation that the Players Association and the Clubs jointly funded a study of androstenedione, conducted by two distinguished scientists at Massachusetts General Hospital, that represents a major contribution to the scientific literature on the substance and for which contribution, frankly, the players and clubs deserve commendation. I believe the committee has been provided with a copy of the study. For the past three Spring Trainings, dating from 2001, HPAC has caused to be distributed to players a pamphlet, which HPAC authored, concerning nutritional supplements. The very first paragraph of that document is instructive of the Committee's approach to this matter. It reads: No pamphlet . . . can serve as a substitute for personalized professional consultation. Consequently, no player should take any substances reported or claimed to improve training capacity, to increase strength and endurance, or to improve performance without first consulting his personal physician or a physician knowledgeable in these areas. The pamphlet contains a specific section on "Ephedrine", and includes the following language: There have been a number of severe side effects reported related to the drug, including high blood pressure, rapid heart rate, seizures, strokes, heart attacks, and death. Ephedrine is also associated with psychological side effects such as increased irritability, anxiety, tremors, paranoia and, in rare instances, a complete break with reality. The psychological effects of the drug often severely impair performance. With the onset of litigation involving the death of Steve Bechler, it is perhaps best that not too much be said about it at this time. All of us in baseball, players and clubs alike, were and remain deeply saddened at Steve's passing. We can say this much. Shortly after Steve's death, we sent a memorandum to all players, notifying them that we were monitoring the situation, and advising the players that the Department of Health and Human Services had taken action to alert possible users of ephedra to risks potentially associated with use of the product. We passed along the Department's warning to athletes and others who engage in strenuous physical activities, and we reiterated our discouragement of the use of ephedra-based products. Then, on March 14, 2003, we sent another memorandum to the players following the release of the autopsy report on Steve. We advised the players that while the report concluded that Steve's use of Xenadrine was not the sole cause of his death, it also concluded it was a contributing cause of it, and players therefore should be extremely reluctant to use ephedra-based products. In addition, Don Fehr, the Association's Executive Director, annually undertakes a tour of all spring training camps. In 2003, he made sure that a portion of these meetings - - which are intended to encompass the vast sweep of issues that continually confront the union - - was devoted to ephedra. He emphasized, during his meetings, that under the framework of the Dietary Supplement Health and Education Act, the legality of a dietary supplement should not be construed to be the equivalent of a governmental determination of its safety; that the law was designed to block the sale of products found to be unsafe after their sale, and not to allow the sale of products only if prior to sale they were determined by the FDA to be safe; that the Association has always felt that any supplement product should only be taken after consultation with a physician; and, that every player should make sure they read supplement labels and, if they found the label confusing, to talk to someone who could explain it. Don actually read to all the players parts of the warning label on Xenadrine, including the admonition to "consult a physician or licensed health professional before using" the product; not to use the product if taking any other drugs containing ephedrine or pseudoephedrine, or other weight control products; and, importantly, its warning that recommended dosages should not be exceeded, and that doing so "may cause serious adverse health effects, including heart attack and stroke." Don concluded his remarks, in the meetings I and others observed, by encouraging the players once again to refrain from using ephedra-based supplements pending such additional scientific evidence as might come out of the ongoing governmental review. And finally, just a couple of weeks ago, at a meeting of HPAC, the Association and Clubs agreed that they would recast and reemphasize the warnings given in its pamphlet on supplements, and to urge the players, and indeed everyone in the baseball community, to be extremely cautious about ephedra-based products in the face of that same ongoing governmental review of the adequacy of the science that makes ephedra- based products as freely saleable as they are. The MLBPA has been encouraging the Congress and the federal government to reexamine both the safety and adequacy of the current federal regulatory structure for dietary supplements, and the sufficiency of existing law, well before Steve Bechler's tragic passing. We have long thought that there is a compelling argument that while the law may be appropriate for the vast majority of vitamins, minerals and herbal-based products, there are some substances, and their number seems to increase weekly, which are not naturally or traditionally part of most diets and are taken more for their presumed and artfully touted pharmacological benefit than for any nutritional value they may indeed have. Perhaps consideration should be given to treating these sorts of products different from, for example, the way the regulatory scheme should treat Vitamin C or folic acid. In the end, however, we believe that scientific determinations about the safety and efficacy of ingestible ingredients, whether they are nutritional supplements or other types of food, are not only best left to the appropriate federal regulatory agencies, but are entrusted to them by the American people, who look to the government and rely on the government for the neutral, unbiased science they need and deserve. Viewed from the broad historical perspective, neutral government agencies - - whose vision is not colored by the profit motive - - have shown a commendable capacity to make findings based on the totality of the evidence, medical information and research, and to ensure that conclusions are based on fact and not self-interest. In a phrase, the Players -- just like me and everyone I know -- look to the federal government, and not advertisers, interest groups, or newspapers, to tell the country what should and should not be regulated, controlled, or banned. Finally, let me address an issue that is always raised in this context -- what message is our decision to rely upon the federal government's determination of what is and is not freely available as a consumable sending to young people who are playing baseball or any other sport and may be dreaming of a career in the big leagues? Frankly, it is the same message we send to today's Players. Play to the best of your ability, but not at the price of your health. Products that have not withstood the test of time and are accompanied by clarion calls of "a new and improved you" should be viewed skeptically -- even if the government allows them to be freely sold. And remember just as there is a difference in all players, so that the efficacy of a product for one person might not be beneficial for another, there is also a profound difference between the use of any product and its misuse. Mr. Chairman, and members of the Committee, thank you again for the opportunity to share some of our views about ephedra, and I would be happy to try to answer any questions that you may have.
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