FDA Should Ban Dangerous Diet DrugSep 26, 2002 | The Battalion Online Texas A&M's News Source Three years ago, U.S. Army pilot Capt. Michael McDonald was having the time of his life. At 35 years old, McDonald was happily married, the "picture of health" and living out a dream he had since he was a kid. Life was perfect, until his world came crashing down around him faster than his plane could have. Today, Michael McDonald "can't recall his own wedding day, and sometimes can't remember from one minute to the next."
And his dream of flying? It flew out the window the day he collapsed during routine physical training. This may have been because he took Ripped Fuel, one of many popular dietary supplements containing the herb ephedra. His is the story of many, and partly why the watchdog group Public Citizen is demanding the Federal Drug Administration (FDA) ban the drug. As the FDA contemplates its decision, anticipated to come this fall, it must open its eyes to the facts and prohibit the use of ephedra as an over-the-counter dietary aid.
Ephedra, a chemical cousin to speed, is used to enhance athletic performance and endurance and to suppress appetite. The ads for dietary supplements containing ephedra proudly proclaim its effects: "I lost over 50 lbs. while eating all the pizza and ice cream I wanted! And I never exercised once!"
The U.S. Department of Agriculture (USDA) reports 2,900 adverse events resulting from use of herbs and supplements, including 104 deaths. At the top of this list of supplements is ephedra. The Space Coast Medical Associates cites ephedra as the cause of 70 percent of FDA-reported deaths. In another study, the New England Journal of Medicine reported 1,000 instances of complications, primarily strokes, seizures and heart attacks, linked to the herb since the mid-1990s. If this isn't conclusive enough, the USDA estimates only one percent of events are reported.
Many products claiming to aid in weight loss and enhance body-building list ephedra, in combination with caffeine, as the number one ingredient. These include Hydroxycut, The Original Formula One, and Thermogenic. Perhaps the most widely known and used ephedra product is Metabolife-356. The public has heard for years about the drug's benefits, and was promised in 1998 by then-Metabolife President Michael Ellis that his company had "never received one notice from a consumer that any serious adverse health event has occurred because of the injection of Metabolife-356." However, Fox News reported on Aug. 15 that the Justice Department announced it is conducting a criminal investigation into Metabolife International. At the heart of the controversy is the company's recent offer to turn over 13,000 consumer health complaints associated with its product. The FDA has long sought these suspected records but were repeatedly lied to about their existence in statements from company representatives. In fact, Fox News claimed that court records from private lawsuits prove Metabolife had received reports of serious illnesses among its users before Ellis' assertion. "Metabolife has refused and resisted us every step of the way," FDA Acting Commissioner Lester Crawford said. "News that so many reports exist greatly heightens our concern."
The big problem is that ephedra products are available over-the-counter to anybody who wants them. Kids of all ages can purchase these products and consume them incorrectly in a futile attempt to mirror the bodies of their favorite celebrities or athletes. This is particularly alarming to Raymond Woosley, a pharmacologist hired by the FDA in 1995 to analyze numerous deaths and heart problems in teenagers who had taken a form of the drug. "There's no doubt in my mind that these were being caused by the ephedra products," he said. Since then, Woosley conducted a new study in 2000 of primarily young women and athletes. The results were the same.
Ephedra has not been banned because herbal supplements are officially classified as food, not drugs. This, however, is not a valid excuse for keeping ephedra on the market in light of the problems associated with it. In fact, CBS News reported on Aug. 13 that the proof required to force ephedra products off the market is much greater than what is necessary to ban a dangerous drug. Hence, the FDA's impending decision must follow the example of Canada, the International Olympic Committee, the National Collegiate Athletic Association and the National Football League, which have all banned the drug.