Ephedra - Overview
Overview
The Chinese herbal remedy ephedra, also called ma huang, has generated a whirlwind of debate since the mid-1990s, when some of its users became seriously ill. Reports of adverse events, or negative side effects, related to ephedra use raised considerable concern among physicians and legislators. Until it was banned by the U.S. Food and Drug Administration (FDA) in 2004, ephedra was most often taken by young and middle-aged adults for weight loss, increased energy, and bodybuilding. Chinese herbalists argue that ephedra should not be used for these purposes.
The earliest known use of ephedra was in ancient China, where it was used as an herbal remedy to treat a variety of ailments. In the 1920s, Dr. K. K. Chen studied ephedra and isolated its active ingredient—ephedrine. An active ingredient is the chemical or substance in a compound known or believed to have a therapeutic, or healing, effect.
Ephedrine alkaloidsA nitrogen-containing substance found in plants. act as powerful stimulants on the heart, causing an increase in heart rate and a rise in blood pressure. (Stimulants are substances that increase the activity of a living organism or one of its parts.) Ephedrine also helps dilate, or open up, the breathing passages in the lungs.
Soon after the discovery of ephedrine alkaloids, physicians in the United States began prescribing ephedra as a decongestant for stuffy noses. It was also used as a bronchodilator—a drug that relaxes
breathing muscles, allowing air to flow more easily through the tubes that lead to the lungs.
Serious side effects associated with ephedra include high blood pressure, irregular heart rate, seizures, heart attacks, and strokes. Extensive research and analysis have linked the use of this herbal stimulant to 155 deaths. One tragedy involved a healthy sixteen-year-old high school student from Lincoln, Illinois. In September of 2002, Lincoln Community High School football player Sean Riggins died of heat strokeA condition resulting from longtime exposure to high temperatures; symptoms include an inability to sweat, a very high body temperature, and, eventually, passing out. after taking a strength-boosting ephedra supplement he had purchased at a gas station. As of early 2005, the controversy surrounding ephedra—and its ban—raged on.
Bulking Up and Slimming Down
Before ephedra was banned by the FDA in 2004, products containing the herb were used primarily for weight reduction. Health food stores, supermarkets, drugstores, convenience stores, and even gas stations sold products containing ephedrine alkaloids. These included products with names such as Easy Trim, Diet Max, Xtreme Lean, Metabolife 356, Xenadrine RFA-1, Ultimate Orange, Yellow Jacket, Quick Shot, Stacker 2, and Ripped Fuel. The products' labels promised they would fight fat, build lean muscle mass, curb the appetite, boost energy, and help users lose weight.
Under the U.S. Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994, herbs are treated as foods rather than drugs. The act allowed dozens of brands of supplements containing ephedrine alkaloids to flood the market without being tested for safety. As a rule, herbal supplements do not have to undergo the extensive testing required for over-the-counter (OTC) medications and prescription drugs. In fact, it is up to the FDA to show that an herbal supplement is unsafe. As Snigdha Prakash explained in a National Public Radio (NPR) story on ephedra, "the FDA must prove that problems associated with ephedra supplements are caused by them."
As far back as April of 1996, the FDA issued a consumer warning about ephedra. The government agency noted that ephedra may have been connected with a dozen deaths and several hundred complaints of adverse reactions. From that point on, the reports of complications linked to ephedra use kept climbing. In an article published in the Virginian Pilot in 2000, Dr. Neal L. Benowitz of the University of California at San Francisco noted that heart attacks, strokes, seizures, and deaths were occurring in "otherwise healthy young people" who had taken the herbal stimulant. He and fellow researcher Dr. Christine Haller concluded: "Dietary supplements that contain ephedra alkaloids pose a serious health risk to some users."
The Ephedra Education Council, a group backed and supported by the herbal products industry and supplement manufacturers, has always insisted that ephedra is completely safe when taken as directed. They blame adverse reactions to ephedra on: 1) improper dosing; 2) preexisting health problems among users; and 3) the combined effects of caffeine or other drugs taken along with the herbal supplement.
Tragedy on the Ball Field
On February 16, 2003, the ephedra controversy became front-page news when twenty-three-year-old Steve Bechler, a pitcher with the Baltimore Orioles, collapsed during a preseason workout in Florida. He died the next day.
Bechler was trying to lose about ten pounds that he had put on between seasons. He had not eaten regular meals for several days and was reportedly taking a weight-loss supplement that contained ephedra and caffeine. By speeding up body processes, ephedra and ephedrine alkaloids create more heat within the body. The substances also act to constrict, or narrow, the blood vessels, making it harder for the body to release the pent-up heat through the skin in the form of sweat. In addition, experts note that the energy-enhancing effect of ephedra may prompt users to exercise longer and harder than they normally would or should.
Aside from being overweight, Bechler had other health problems, including an enlarged heart, higher blood pressure than he should have had, and trouble with his liver. On the day of his fatal spring training workout, he is said to have taken three ephedra-containing supplement pills—one pill more than the recommended dosage. Bechler later collapsed on the field from severe heat stroke. His organs simply stopped working. According to a New York Times article by George Vecsey, "conditions in Florida on Sunday were 81 degrees" with "74 percent humidity, far below the danger level" for heat stroke. Still, Bechler's body temperature rose to 108.4 degrees Fahrenheit before his death.
In March of 2003, reports from the medical examiner in Broward County, Florida, stated that ephedra "played a significant role" in Bechler's death. This tragedy followed earlier reports of ephedra-related fatalities among young athletes. One and a half years earlier, twenty-two-year-old Northwestern University cornerback Rashidi Wheeler died during a workout. The cause of death was listed as an asthma attack, but Wheeler had been taking a powdered performance-enhancing dietary supplement containing ephedra and caffeine. The company that manufactured the supplement had discontinued the product and all other ephedra supplements shortly before Wheeler died.
Athletic Associations Take Action
In September 2001, just one month after Wheeler's death, the National Football League (NFL) joined the National Collegiate Athletic Association (NCAA) and the International Olympic Committee (IOC) in banning its players from using ephedrine. The ephedrine ban allows for the random testing of NFL players for ephedrine use.
Mounting Evidence of Health Risks
Authorities in Canada were equally concerned about the safety of ephedra. Health Canada, the agency that regulates Canadian health care, requested a voluntary recall of products containing ephedra or ephedrine in 2002. The agency's Web site posted an advisory stating: "A risk assessment concluded that these products pose a serious risk to health." Health Canada received sixty reports of adverse events and a report of one death related to ephedra use. The agency noted that it would "continue to monitor reports of adverse events" and "take further action if necessary."
By January of 2003, 7-Eleven stores announced that they would stop selling ephedra-containing products such as Metabolife. The General Nutrition Centers (GNC) retail chain followed suit in May. Meanwhile, the makers of Metabolife announced the release of a new formula of their supplement—one that did not contain ephedra. At the time, Metabolife International, the San Diego-based maker of Metabolife, was being investigated by the U.S. government following claims that the company had lied about the safety of its ephedra product.
At the end of 2003—six years after the safety of the herbal supplement was first called into question by the U.S. government—the administration of President George W. Bush took steps to ban ephedra. This decision was based on an in-depth investigation of the situation by RAND, a nonprofit research institute. An expert panel of researchers from RAND was hired by the government to analyze the data surrounding the ephedra controversy. The group examined the results of 20 clinical trials and 284 case reports of adverse events. RAND researchers admitted that they did not have much data to work with but stated they were able to compile "enough evidence to reach fairly confident conclusions." The results of the study were released in March of 2003. Highlights include findings that:
- Ephedrine-containing supplements increased the average weight loss of dieters in the short term by 0.4 to 2.2 pounds per month
- The athletic benefit from supplements containing ephedrine and caffeine was limited to a "20-30 percent increase in short-term performance" only
- "There may be a causal relationship between taking the substances and suffering rare serious adverse events. Catastrophic effects of ephedra, including death, cannot be ruled out."
Research from the University of California at San Francisco supports these findings. Dr. Stephen Bent and his colleagues set out to compare the health risks of ephedra with the dangers of other herbal products. The results of their study were published in the Annals of Internal Medicine in March of 2003. The researchers found that even though ephedra products amounted
to less than 1 percent of herbal supplement sales in the United States, more than 64 percent of all adverse reactions to herbal supplements were linked to their use. Bent and his colleagues concluded: "Ephedra use is associated with a greatly increased risk for adverse reactions compared with other herbs, and its use should be restricted."
FDA Bans Ephedra in 2004
In February of 2004, the FDA prohibited the sale of ephedra supplements. The agency issued a consumer advisory that stated, in part: "After a careful review of the available evidence about the risks and benefits of ephedra in supplements, the FDA found that these supplements present an unreasonable risk of illness or injury to consumers." The ban went into effect on April 12, 2004. During the weeks leading up to that date, diehard users were "reportedly stocking up" on their favorite ephedra supplements, commented Mary Duenwald in the New York Times. In some cases, users bought a large enough supply to last one to two years.
With ephedra gone from the shelves, dieters and athletes began looking for a product to take its place. "Critics … remained concerned because so little was known about the other herbal ingredients being used as substitutes," reported Christopher Drew and Ford Fessenden in the New York Times. One such substance is an ephedrine-like stimulant called synephrine (sih-NEH-frinn), also known as the bitter Seville orange (Citrus aurantium) or simply bitter orange. The substance is supposed to be safer than ephedra but has not undergone studies to prove that claim. According to the New York Daily News, bitter orange "has been linked to seven deaths."
Back in the News in 2005
The Utah-based supplement company Nutraceutical International was the first in the industry to be successful in challenging the FDA's ban on ephedra. In the spring of 2005, federal judge Tena Campbell ruled in favor of Nutraceutical, saying the FDA had failed to prove that the company's product "posed a significant health risk," wrote Penni Crabtree. The judge's ruling applies only to so-called "low-dose" supplements such as the one produced by Nutraceutical. A "low dose" supplement contains 10 or fewer milligrams of ephedrine alkaloids per daily dose.
The Utah ruling made it hard to predict the future legal status of ephedra. Under Judge Campbell's order, the FDA cannot stop Nutraceutical from selling its ephedra supplement. In addition, the FDA must determine what constitutes a "safe level" of ephedrine.
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