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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. Kevin Riggins
Honorable Representatives, my name is Kevin Riggins. My wife and I live in Lincoln, Illinois. On September 3, 2002, we lived every parent's worst nightmare when our only child, Sean Riggins, died from a heart attack. Sean was a gifted athlete, excelling in football, wrestling and Tae Kwon Do. He had no congenital heart problems and he was in the peak of health. He had just passed his athletic physical examination in order to start football. As we were to find out later, the heart attack had been brought on by the usage of a dietary supplement called ephedra. My wife and I were not familiar with this particular substance; in fact, we had no idea that Sean had been taking it. As we were to discover later through investigation and conversations with Sean's teammates, numerous teenagers, including athletes, and young people trying to lose weight, were using these products. The teens could buy these pills at the corner gas stations with pocket change. The little packages, which promote weight loss, performance and energy enhancement, were being sold right next to the Twinkies and candy bars, in fact, the use of these products was so casual, none of the kids believed that they were taking a drug. With the marketing style and the ease in which they could be obtained, the teens thought nothing of it. "They sell these things in the stores, they are not illegal, so they must be okay". This was a quote from one of my sons friends. As it turns out, the vast majority of the American public believes this as well. As Americans, we believe that our regulatory organizations, in this case the F.D.A., are protecting our interests by not allowing dangerous products to be sold, especially in regards to what we put in our bodies. In the case of ephedra, we could not be more wrong. As you well know, The Dietary Supplement Health and Education Act of 1994, allows dietary supplement companies to operate with virtually no federal oversight. A company does not need a license to produce these products nor are there any no pre-market approval requirements. There have never been any Good Manufacturing Practice guidelines developed for these companies and they have a voluntary adverse event reporting system. When a supplement poses a risk of serious injury or death, the burden of proof falls to the Government to prove cause and effect. This is the exact opposite of the rules and regulations set up for drug companies. It is no surprise that the supplement industry wants no changes to be effected in the federal requirements. This is an 18 billion dollar per year industry which does not seem to care that it is producing products that kill. According to the FDA and several medical organizations including the American Heart Association and the American Medical association, ephedra has killed at least 117 persons and accounts for almost 20, 000 serious adverse events. Please bear in mind that these are reported adverse events. The supplement companies do not divulge these facts readily or willingly, therefore, we truly do not know how many citizens have been affected by these products. The Poison Control Center recently published a study showing that ephedra is the most dangerous dietary supplement on the market. They used adverse event reports, from the industry, to come to this conclusion. The Ephedra Education Council immediately labeled the study as "garbage". They claimed that utilizing adverse event reports was not a valid way of conducting studies such as this. Conversely, they have touted the Rand Corporations study of ephedra's safety and efficacy as bearing out what they have said all along; that ephedra is safe if used as directed. This, of course, is not true. The Rand study was inconclusive. Ironically, the Rand Corporation utilized the available adverse event reports in conducting the study. It seems that the industry only agrees with a study if it agrees with there agenda. The industry claims that there are 55 studies that show the safety and efficacy of ephedra. They bring out physicians, pathologists and other scientists to bolster their claims that ephedra is safe and effective. What they do not say, is that the large portion of these studies are commissioned, financed, supervised and published by the supplement companies, many times using their own people to conduct the studies. The ephedra industry has, unfortunately, become a collection of rogue corporations that care for nothing but the bottom line. Look at the criminal records of some of the CEO's of these companies, and you will see a pattern of criminal activities and corruption. These are the facts, not innuendo, not speculation. Ephedra is a dangerous drug that is being sold as an innocuous weight loss aid and stimulant. Here in Illinois, our general assembly recognized that fact. In November, 2002, I began a campaign to educate our state lawmakers on the dangers of ephedra, and to encourage them to take action. On May 28, 2003, those efforts came to fruition, when after a unanimous yea vote in both house, Gov. Rod Blagojevich signed the Ephedra Prohibition Act making Illinois the first state in the nation to ban ephedra products. Now there are several other states taking up the initiative as well, however, I believe that you, our national leaders, need to take up the cause at the federal level and protect our citizens from this dangerous substance. Labeling requirements are not enough, as we have seen studies that show dosage variations of up to 154% between pills in the same bottle. This makes the dosage requirements listed on the label of no use. Age limitations are not enough; less than ten percent of the adverse events associated with ephedra were attributed to persons under the age of eighteen. The only logical course of action is to remove ephedra from the market completely, and impose stricter regulations on dietary supplement companies to ensure the purity and safety of their products. This is not an issue of trying to stifle business or over-regulating legitimate companies, this is an issue of protecting the American consumers and ensuring the public health. No other family should have to suffer the loss of a child, be that child 16 or 46. My wife and I will never get over the loss of our son, but we can try to make sure that it does not happen again, and to do that, I need your help. Look past the industry rhetoric and all of the misdirection and obfuscation. Help us get ephedra off of the market. The industry will survive and so will our American brothers and sisters. Thank you.
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