Editor's note: In July 2000, Consumer Health Interactive published a two-part investigative report on ephedra supplements that explored the potentially deadly health risks associated with this supplement, the lack of industry regulation, and the tactics used by some manufacturers to market their products. On Dec. 30, 2003, US Health and Human Services Secretary Tommy G. Thompson announced that the government planned to ban the sale of pills containing ephedra in early 2004, and he urged consumers to stop taking the herbal stimulant immediately. The ban took effect on April 12, 2004. Several years of court battles followed, but ultimately the ban was left intact. Thompson's action to ban ephedra came after years of criticism from consumers and researchers who have documented cases of heart attacks, high blood pressure, and strokes associated with ephedra. While products like the sports drink Extreme Ripped Force no longer contain ephedra, some supplement manufacturers have replaced it with bitter orange, a substance that may carry the same risks as ephedra. Click here to read the full story. The following article, written in 2001, illustrates this supplement's troublesome history.

As professional sports teams compete in hopes of winning championships, some players will tap into an array of supplements to gain an edge. However, one popular supplement commonly used to shed pounds and boost energy during workouts is no longer an option for football players.

That product is ephedra, a stimulant available in supermarkets, drug stores, health stores, and fitness centers across the country. Some baseball officials, including baseball commissioner Bud Selig, are calling for a new policy banning ephedra, which some believe contributed to Bechler's death.

The National Football League has already issued a ban. In a memo issued to 31 teams in September 2001, the league prohibited players from using ephedra, citing health risks such as seizures, strokes, and death. The NFL's move follows a longtime ban by the National Collegiate Athletic Association (NCAA) and by the International Olympic Committee. (In fact, in August 2000, Romanian gymnast Andreea Raducan was stripped of a gold medal after testing positive for pseudoephedrine, an ephedra derivative found in a common cold remedy.)

Ephedra, also listed as ma huang on product labels, is often combined with caffeine to enhance its effects. It's sold in a variety of forms, including pills and sports drinks with names like Extreme Ripped Force and Ephedra White Cross. Because, like all herbal products, ephedra is classified as a dietary supplement and not as a drug, it's relatively free from regulation by the Food and Drug Administration.

John Lombardo, MD, a drug adviser to the NFL and medical director for sports medicine at Ohio State University, says athletes take ephedra to help them perform on the field, but many are unaware of the risks.

"It masks fatigue so they can perform better and longer. Some of them use it as an appetite suppressant to lose weight," he says. Football players "essentially push themselves. ... They do a fair of amount of isometric activities. It puts a lot of stress on the heart. And if you're taking ephedrine, that also puts increased stress on the heart."

Last year, he sent a warning letter to the NFL after seeing some of the reactions personally in his position as head team physician at Ohio State University. Two athletes developed irregular heartbeats while working out, and "both of them passed out. One got shocked back [by medical equipment] to his normal rhythm. The other was taken to the hospital for observation. They both were taking an ephedrine compound.

"Ephedrine has certain risks in people who are NOT exercising," he concluded. "You put the stress of exercise on top of that and there's a potential to increase the risk."

NFL officials have only recently recognized the dangers researchers and government officials have long warned were associated with ephedra. To date, the Food and Drug Administration has logged reports of more than 80 deaths associated with the supplement, and over 1,000 adverse reactions.

Nearly a year ago, a report published in the New England Journal of Medicine underscored the potentially lethal risks of the supplement. Two University of California at San Francisco physicians and researchers, Neal L. Benowitz and Christine A. Haller, reviewed 140 adverse reaction reports filed with the FDA between June 1, 1997 and March 31, 1999. They concluded that nearly a third of the cases -- including three deaths -- were "definitely or probably linked to the use of ephedrine." Another third of the cases may have been caused by products containing ephedra, including seven people who died from a variety of causes.

Among the cases in this study linked to ephedra were reports of chest pain, seizure, severely high blood pressure, five cardiac arrests (two that led to death and three that caused permanent disability), two heart attacks, and four strokes that resulted in permanent disability. In the case of four fatal heart attacks linked to one popular energy pill containing ephedra, the people who died were 15, 22, 38, and 43 years old.

"Our findings arouse concern about the risks of these products, given that they have no scientifically established benefits," wrote Benowitz and Haller, noting that about 12 million people used the supplements every day in 1999. "People who take these products to increase their exercise capacity or to lose weight place themselves at risk without a substantial likelihood of benefit."

Some leading consumer groups and scientists agree. On September 6, 2001, the consumer advocacy organization Public Citizen Health Research Group and pharmacologist Dr. Raymond Woosley, a leading expert on drug interactions based at the University of Arizona, petitioned the FDA to ban ephedra products.

The group's petition draws on several different studies, including the New England Journal report, and on updated reports of adverse reactions from both the FDA and the American Association of Poison Control Centers.

While the FDA hasn't yet banned ephedra, in February 2003, the secretary of health and human services announced that the FDA would be formulating new warning labels for the supplement. The warnings will likely caution against the following: combining ephedra with caffeine or other stimulants, taking ephedra if you are pregnant or nursing, and taking it after strenuous exercise. People under the age 18 will probably also be cautioned against taking ephedra.

The supplement industry says ephedra's risks have been exaggerated. When the NFL issued its ban, supplement manufacturers rushed to defend their product -- and its safety.

"One disagreement we have with the NFL is that they indirectly tried to tie ephedra in to recent tragic football-related deaths," says Wes Siegner Jr., a lawyer representing the Ephedra Education Council (EEC), a Washington, D.C.-based trade group that represents ephedra manufacturers.

In August 2001, Rashidi Wheeler, a Northwestern University football player, collapsed and died during a workout. The county coroner found ephedrine in Wheeler's system but said it had nothing to do with his death.

"You can't assess risk or safety from individual adverse reports... the answer is to look at the clinical data," says Siegner, citing studies that suggest ephedra is safe and effective for weight control and that the reports of adverse reactions are exaggerated. Manufacturers "are fully supportive of sports leagues that want to keep stimulants out because they're known to increase performance in certain circumstances," he adds.

Metabolife International, a manufacturer of Metabolife 356, which contains ephedra, says it doesn't market its product for athletic performance. But company officials criticized the NFL's move because it implies that ephedra is unsafe for all uses.

Manufacturers contend that their bottles are clearly marked with warning labels that caution certain people against using the drug. Bottles containing ephedra warn, for example, that pregnant women or people with high blood pressure shouldn't take the supplement and that it should not be used recreationally.

Still, in lawsuits involving ephedra, consumers have recently won several major victories against supplement makers. In February 2001, Rosalie Talbert -- an Alaskan woman who suffered a major stroke after taking the weight-loss product AMP II Pro in drop form -- won a $13.3 million lawsuit against the supplement's manufacturer, E'OLA International.

Meanwhile, it appears that federal agencies are stepping up their vigilance over ephedra. On June 14, 2001 the Federal Trade Commission, which focuses on consumer protection, entered the fray, citing the Aaron Co. of Palm Bay, Florida, for failing to warn customers of the dangers of ephedra in their Ultimate Energizer product.

And on October 31, 2001, the FDA requested that United States Marshals seize 140,000 bottles of AMP II Pro because it contained synthetic ephedrine HCl -- a drug ingredient prohibited in dietary supplements -- and because E'OLA International was marketing the product as a treatment for obesity, a disease. (By law, dietary supplements cannot be marketed to treat diseases.) In addition, the FDA criticized E'OLA for failing to adequately label the product.

But according to Woosley, such actions are far from enough. "I think the FDA is taking action where the law allows, but the law in this case is pretty restrictive. Anything containing any form of ephedra -- whether from natural or chemical sources -- is dangerous. I hope the agency will act very aggressively to protect the public by banning all of these substances."

However, ephedra products remain easily accessible. Millions of Americans are still unaware of the dangers and are taking ephedra supplements (three billion doses were sold in 1999), primarily for weight loss or energy boosts during exercise. In some cases, people are even using ephedra as a recreational stimulant. Sales of pills, fruit drinks, and snack bars with ephedra have skyrocketed, and ephedra has appeared for consumption in newer forms. American Body Building recently introduced Speed Stack Gum with this promotion: "THIS AIN'T NO CANDY STORE BUBBLE GUM!... Chew just one great tasting serving of advanced Speed Stack Gum with ATR Technology (Advanced Thermo Release) and you'll know why we say, 'It's not just gum, it's flipping awesome!'"

This and other marketing tactics are part of the reason Woosley feels that despite developments over the last year, people aren't getting the message.

"The only way to protect the public from ephedra products is to take them off the market. I still see these products on TV and in the grocery stores making medical claims," Woosley says. "And given the way they're marketed, I don't think the public understands, for example, that ma huang is ephedra, and that ephedra can cause harm."

-- Benj Vardigan is a senior editor for Consumer Health Interactive and the winner of an Outstanding Young Journalist award from the Northern California chapter of the Society of Professional Journalists.

References

First published November 7, 2001
Last updated February 14, 2008
Copyright © 2001 Consumer Health Interactive