Ephedrine: Safe Or lethal? Debate on supplement intensifies

Banned in the Olympics.

On sale at nutrition stores, gyms, supermarkets and on the Internet.

Banned in college sports.

Used by millions of Americans who take billions of doses per year.

Available in capsule, drink and chewing gum form.

Mixed messages abound about ephedrine (eh-FEH-drin), a substance extracted from an Asian plant called ephedra and used in an array of products sold as weight-loss aids and energy boosters.

Under a 1994 federal law, they are classified as "dietary supplements." Unlike drugs, they don't require approval from the Food and Drug Administration (FDA) before they go to market. However, the FDA calls ephedrine an "amphetamine-like compound," a stimulant to the heart and nervous system. In supplements, it's usually combined with caffeine.

Last year, ephedrine sales hit $1.05 billion, up from $800 million in 1999, according to the Nutrition Business Journal. But debate continues over whether ephedrine is safe. This year, that debate has escalated in the realm of sports, where athletes from the pros to the scholastic ranks are driven in quest of that extra edge.

Manufacturers protest ephedrine has been wrongly associated, without scientific evidence, to complications and fatalities, including the deaths this year of three football players. They say it's safe when used properly. But a U.S. congressman has called for an FDA investigation of the football deaths, and a consumer group wants the FDA to ban ephedrine.

Meanwhile, athletes have easy access to products such as Ripped Fuel, Xenadrine RFA-1, Hydroxycut and Thermo Speed.

Maybe they're low on energy before an offseason workout or a game. Maybe they want to cut fat, too, for that lean, "ripped" look.

Some give it a try

Albie Lopez, a pitcher for baseball's champion Arizona Diamondbacks, said he used ephedrine for a couple of days in spring training as a pick-me-up and promptly quit.

"My heart was racing," he said. "I felt like I wasn't in control of my body. ... That's what a lot of players say ... and they don't like it."

Lopez decided the caffeine in coffee was enough, but he said he's seen other players use ephedrine. "I think guys think it's a little better than coffee."

In September, the NFL became the first and so far only pro league to ban ephedrine. Commissioner Paul Tagliabue cited "growing evidence" of health risks.

Obafemi Ayanbadejo, a Baltimore Ravens fullback, said he's heeding the ban but calls it "a knee-jerk reaction to the things that happened over the summer."

Ayanbadejo says he used ephedrine off and on for a couple of years before off-season workouts with no problem: "It can be helpful when you're having a day where, 'Hey, I don't feel like doing this.' You take a couple of pills and boom, new energy."

The supplements don't act directly on muscle to boost strength.

"They energize you and pep you up more. People argue that they're used to enhance performance because they enable you to perform longer and harder," said Don Catlin, director of the UCLA Olympic Analytical Laboratory.

"If I mention the word amphetamine, that calls to mind all kinds of things. It's a drug of abuse, it's a stimulant, it's powerful, it's dangerous. When you say ephedrine, it doesn't call up those associations. But the reality is if you take enough ephedrine, it's just like taking amphetamines."

Fuel for debate

Though ephedrine is banned in college sports, an NCAA survey of student-athletes this year reported 3.9% said they'd used it in the last year, up from 3.5% in 1997.

Northwestern University football player Rashidi Wheeler died Aug. 3 after collapsing during a team running drill. The medical examiner ruled Wheeler died from bronchial asthma. Though ephedrine was found in his blood, the examiner said it played no role in his death.

Wheeler's family has sued Northwestern, alleging it failed to provide adequate emergency care. But in an October 9 statement, Northwestern President Henry S. Bienen said experts consulted by the university "have raised significant issues about the precise cause of Rashidi Wheeler's death, including whether dietary supplements containing ephedra played a role."

Bienen said it "appears" that on the day of Wheeler's death, he and some other members of the team used ephedrine. "Indeed, it appears that Rashidi Wheeler took two supplements, Ultimate Punch and Xenadrine, both of which contain this banned substance," he said. Bienen said Northwestern's football staff had "no knowledge" of the use.

• On February 26, Florida State University football player Devaughn Darling died after a workout. The autopsy provided no conclusive cause of death but mentioned sickle cell trait, a blood condition, as a possible factor. On April 19, in a Florida State report on the case, team physician Tom Haney said "cardiac arrhythmia" was the most likely cause.

  The autopsy said ephedrine was in Darling's system. But, according to published reports, Darling had taken cold medicine. Some cold medicines contain a synthetic form of ephedrine. Attorney Michael Lewis, who represents the family, said the ephedrine trace "was not something anybody thought carried any weight whatsoever." Lewis has notified Florida State he intends to file a negligence suit against the school.

   

• Curt Jones, 35, of Orem, Utah, died August 5 in Las Vegas after playing an indoor game in the United States Inside Football League. The coroner's report said Jones, a father of four, died of heart problems. But his widow, Daria Jones, said she believes ephedrine contributed.

  She says that two years earlier, Jones had used Hydroxycut for three months. After that, she said, he had used ephedrine drinks at the gym on occasion. She said she had obtained a copy of the coroner's report and that it quoted teammates as saying her husband had used an ephedrine product the day of the game. "I don't think he had any clue how much danger is in ephedrine," she said.

  U.S. Rep. Henry Waxman, D-Calif., has written the FDA asking it to investigate whether the football deaths are ephedrine related. In September, the Public Citizen Health Research Group, co-founded by Ralph Nader, asked the FDA to ban production and sale of the supplement.

  The petition cited data collected since 1993 via the FDA's "adverse event" monitoring program. Individuals and health-care providers can make submissions. The FDA decides whether to list them. It said about 1,400 adverse events, including 80 deaths, have been "associated" with ephedrine. Other events included heart attacks, strokes and seizures.

  The industry's Council for Responsible Nutrition said it commissioned a review of the FDA data, which found that none of the cases could be directly linked to ephedrine.

  Last December in the New England Journal of Medicine, two researchers reported their study of 140 of the FDA's cases. They concluded 31% were definitely or probably related to the supplement and 31% were possibly related. The review was requested by the FDA.

  Industry protest

  Media reports mentioning ephedrine in relation to this year's football deaths and the FDA's overall data have drawn industry protest.

  "We are dealing with a lot of misperception here," said Wes Siegner, legal counsel for the Ephedra Education Council. "It doesn't help for the FDA to be saying ephedra is associated with 80 deaths when they know in virtually all those cases there's no possible way there is any causal association."

  A leading manufacturer, Metabolife International, said it markets Metabolife 356 as a weight-loss aid, not a sports supplement. It says the supplement is "safe and effective ... when used at recommended doses by appropriate individuals."

  In a letter to the NFL commissioner, Metabolife general counsel Garry Pay wrote that as a former NFL player he understood why a pro league would ban a "performance enhancement" substance. But Pay wrote he was "very concerned" that media accounts of the ban had suggested the NFL decision was based on the notion that "ephedrine-containing supplements are unsafe for all uses, regardless of the dosage or the health of the individual using them."

  Pay wrote that was "flatly untrue." He cited studies showing ephedrine as safe and effective. Pay said that connecting ephedrine to deaths via the FDA data reminded him "of the famous logical fallacy: 'The rooster crows ... the sun rises ... and, therefore, the rooster causes the sun to rise."

  In announcing its ban, the NFL did not cite this year's football deaths. It did cite health concerns.

  "The purpose is to protect our players, who are operating in a unique environment," NFL spokesman Greg Aiello says. "The issue is this substance when it's being used by highly conditioned athletes in stressful situations, and there's certainly enough evidence to indicate that it has risk. ... We know the IOC has banned it, the NCAA has banned it. We have our own doctors. We talk about this. So it's based on that."

  The ban was made in concert with the NFL Players Association. "All we're saying is we're concerned about it enough to look at it and pull it," said Gene Upshaw, NFLPA executive director.

  Baltimore tight end Shannon Sharpe also disapproves of the NFL ban. He, too, calls it a "knee-jerk reaction to what transpired this summer."

  Sharpe says he's used ephedrine: "Do I take it now? No."

  However, he has an endorsement deal with EAS, a Colorado-based firm that markets supplements, including ephedrine.

  In announcing its ban, the NFL said it would not approve players' endorsements involving companies that make or sell a substance that is on the league's banned list.

  What effect will that have on players who already had endorsements in place? "We would have to work that out," Aiello said.

  Sharpe said he hasn't heard from the NFL and makes his case by noting: "We're not allowed to endorse beer products, but probably two of the biggest sponsors of NFL football are Budweiser and Coors Light. So what kind of message are you sending? You can make money but players can't?"

  Meanwhile, Sharpe said he continues to use other EAS supplements. In an interview this year with EAS' Muscle Media magazine, he listed his favorite supplements, products with names like Phospagen HP, HMB and Myoplex.

  "I like to think ... being a professional, that I understand what I'm taking, and I know how to take it," Sharpe said.

  He draws an analogy with aspirin. He says that if you take two, and they clear your headache in an hour, does it make sense to think that if you take 100 it will cure you in a minute? "No," Sharpe said, "it will probably kill you. ... If you're taking more than the dosage of pretty much anything, it can kill you."

  Ayanbadejo, his Baltimore teammate, said he also uses assorted supplements, from multi-vitamins to liver supplements: "I don't like liver, so I just take pills."

  His philosophy: "I study everything I put in my body. I don't want to just put anything in my body because someone said it works. I want to find out why it works and what's the purpose of it."

  He knows people in the supplements and training business who help him with questions.

  "A lot of people don't have the resources," he said. "They don't know where to go."

  Education stressed

  David Page, strength and conditioning coach for the Diamondbacks, said he tries to educate the players about the history of ephedrine use: "There are guys in our clubhouse that I battle with every day, trying to discourage that."

  How many use it? "I don't have a guess," Page said. "It's all populations. It's older guys and younger guys."

  Educating young athletes is the goal of Blue Cross and Blue Shield's Healthy Competition Foundation. Its Web site, www.healthycompetition.org, has information about supplements, including brand names and health warnings.

  The foundation says that in a survey it did this year, 3.5% of young people between the ages of 12 and 17 said they'd tried ephedrine or knew someone who had.

  Iris Shaffer, foundation executive director, applauded the NFL stand: "For most kids, their role models are not Olympic athletes. They are professional athletes. They should be part of this education process. They need to come forward, and they need to say this is wrong."

  John Cordaro, president of the industry's Council for Responsible Nutrition, agrees ephedrine isn't for young athletes. "If we teach our young athletes ... that there's a quick fix or a shortcut, I think we send them the wrong signals in life," Cordaro said.

  He said those under age 18, "perhaps even under age 21," should not use ephedrine. "It's not just a question of the industry being responsible," Cordaro said. "We have to build responsibility into the gatekeepers, the coaches, parents and guardians."

  On January 8-9 in Bethesda, Md., Cordaro's group, in conjunction with the government's National Institutes of Health, will hold a conference on the "Science and Policy of Performance-Enhancing Products." Physicians, coaches and trainers will attend.

  Catlin, director of the Olympic lab at UCLA, also stresses education. But, he added, "We know it doesn't work all that well. There's been a lot of education. ... One of the best educational pieces, sad as it is, is what you (the media) do when you write about a player that falls over and has ephedrine in his system. We don't know whether ephedrine contributed or not, but when you write about it, people put two and two together. That's tough education, but it's out there."

  The industry says that's false education. So the debate continues.

  Amid all the questions, all the medical and legal complexities, it may come down to self-regulation by athletes themselves, a matter of trial and error.

  Jonathan Katz, a New York sports clinical psychologist, said athletes push the envelope to gain an extra edge, driven by the growth in the rewards, the hype and popularity of sports.

  "The nature of all this," he said, "is the envelope has to be pushed far enough that something bad happens that helps people swing the pendulum back. ... When there are more injuries, even deaths, they pull back."