Bill Gurley figured he had made a mistake when he tried to measure the ingredients in a $40 bottle of Exandra Lean, a dietary supplement that claims to provide "some of the most sophisticated natural weight loss technology available." Gurley was testing supplements containing the herb ephedra to see whether the package labels accurately reflected the contents of the pills. His first test of Exandra Lean showed no trace of several compounds listed, so Gurley repeated the experiment. When he kept getting the same results, he concluded that he had purchased, "$40 worth of nothing. And of course I had to buy several bottles to be sure."
Being the personable Southerner that he is, Gurley, a pharmaceutical scientist and analytical chemist at the University of Arkansas for Medical Sciences, called the manufacturer to ask what was what. A spokesman for the Kutting Edge, in Corinth, Miss., readily confirmed Gurley's findings. "They said, 'We know there's nothing in it,'" Gurley says. "They said their supplier had gotten mad and didn't put any ephedra in the pills."
In the weird, sometimes dangerous, world of dietary supplements, there are few controls over what's in a product, and little to tell consumers how much they should take. Half of all Americans report dosing themselves with herbs, vitamins and other supplements. Weight loss aids like Metabolife 356, Diet Phen, Metabomax, Trim Fast and Exandra Lean (where do they get these names?) and other ephedra products make up one of the top-selling categories in the $14 billion-a-year supplement industry.
As it happens, Gurley's $40 bottle of nothing may be a safer bet than an ephedra product that actually contains active ingredients, because for some people the herb can be dangerous, even deadly. Since 1994, the Food and Drug Administration has received reports of more than 40 deaths associated with ephedra supplements, and approximately 900 bad reactions ranging from dizziness and nausea to psychosis, seizures, heart attacks and strokes.
Why is it so easy to walk into a health-food store and buy a potent, potentially harmful weight-loss product -- or any dietary supplement, for that matter? Credit a spineless FDA and a politically savvy, increasingly powerful supplement industry. It successfully lobbied Congress to pass a law six years ago that made it easier to get these products on the market, and more difficult for the FDA to remove them if they proved harmful.
"Dietary supplements don't meet the level of standards that my hair dryer has to meet," says Thomas J. Moore, a health policy analyst at George Washington University, in Washington. "Everywhere [else] you go, everything you touch, from pumping gas to turning on your hair dryer, there is a web of consumer safety."
The makers of ephedra supplements have been especially adept at fighting off federal and state attempts to rein in their products. When the FDA holds yet another round of public hearings on ephedra this summer, the manufacturers will undoubtedly launch another blitz of public relations and lobbying. Just last month, the Ephedra Education Council tried to block publication of Gurley's paper in the American Journal of Health System Pharmacy -- a journal not known for stirring controversy. In a press release, Michael McGuffin, president of the American Herbal Products Association, accused Gurley of expressing opinions that went beyond "his professional expertise."
"That's pretty funny," Gurley says, "since I'm on their board of scientific advisors."
The dietary supplement industry began flexing its muscles in Washington in 1993, when the FDA threatened to tighten controls on its products. Before then, dietary supplements, which include herbal medicines, vitamins, minerals, hormones and homeopathic remedies, fell through the regulatory cracks and a quiet hostility existed between the agency and manufacturers. The FDA kept many supplements off the market with the threat that they would be treated like drugs, which generally require several years of pre-market testing at a cost of several million dollars.
The standoff broke into warfare after 30 people died from l-tryptophan, a "natural" sleep aid. A coalition of manufacturers, the Nutritional Health Alliance, spent $2.5 million on a campaign to stop the FDA from regulating dietary supplements more like drugs. The alliance hired one of Washington's most powerful lobbyists, Tony Podesta, whose brother John would become President Clinton's chief of staff. The coalition published brochures instructing consumers, "Write to Congress today, or kiss your supplements goodbye!" Mel Gibson was featured in a TV commercial, handcuffed by FDA agents for possession of vitamins.
In 1994 Congress passed the Dietary Supplement Health and Education Act. It was cosponsored in the Senate by Orrin Hatch, a Republican from Utah, home of many supplement makers, and Ted Kennedy, D-Mass., an authority on medical issues. The law gave the FDA stronger powers to act quickly if an herbal product posed a clear health threat. But the law placed the burden on the government to prove a particular product is dangerous, rather than requiring manufacturers to demonstrate they are safe.
"You don't need to test herbal products any more than you need to test breakfast cereal," says the American Herbal Products Association's McGuffin.
Of course, breakfast cereal doesn't raise your blood pressure the way ephedra can. The principal active ingredient in the ephedra plant is ephedrine, the synthetic form of which is found in prescription asthma medications and on "crash carts," those rolling trays of drugs and devices used to revive patients whose hearts have stopped. Like its chemical cousins the amphetamines -- speed -- ephedrine is a stimulant. It curbs appetite, constricts blood vessels and raises blood pressure, even when it comes from its natural source, the ephedra plant. This can have serious consequences for some people
Ephedra products have been linked to irregular heartbeat, strokes and cardiac arrest. There have been several reports of ephedra-induced psychosis, including agitation, paranoia, depression and hallucinations. A recent case reported in the British Medical Journal involved a 34-year-old man who jumped out a second-story window to escape imagined attackers. In the emergency room, doctors determined that the patient, who had no history of mental illness, had been taking ephedra for 10 days. His symptoms disappeared once he went off the pills.
Doctors have recently begun seeing ephedra users in their 20s who have developed kidney stones made of the crystallized form of compounds in the plant.
Many consumers willingly accept some risk in order to lose weight. But there is only sketchy evidence that ephedra is useful. The industry likes to point to Danish studies that it says demonstrate the effectiveness of the combination of ephedra and caffeine. Over six months, people who dieted and took the herbal mixture lost about eight pounds more than those who tried dieting alone. In the next six months, the difference narrowed: the ephedra users lost an extra three pounds compared with the diet-only group.
That's not surprising. Even the most powerful prescription diet drugs work only so long. Redux, or fen-phen, which was recalled by the FDA in 1999 because of evidence it damages the heart, stopped helping dieters after about a year. After dieters go off drugs, the weight typically returns, in part because the body's metabolism dips below what it was before the drug was used.
"It's a classic drug rebound effect," says David Levitsky, a Cornell University psychologist who studies obesity. His research suggests that almost anything, even a sugar pill, can help people lose weight, as long as they believe it works.
Millions of consumers apparently believe in ephedra. Metabolife 356, Ripped Fuel and Up Your Gas are just a few of the 200 herbal diet aids, body-building potions and energy boosters on the market. Sales of Metabolife 356 alone hit close to $1 billion last year, according to the company, putting it in the same category as blockbuster prescription drugs like Zantac and Prozac. (For the record, Metabolife 356 contains precisely what its label says, according to Gurley's analysis.)
The story of Metabolife, the San Diego company that makes the drug, will one day be taught in business schools. Michael J. Ellis, the 48-year-old founder, developed Metabolife 356 in the early 1990s to help his father fight fatigue from cancer treatment. Ellis has worked as a cop, a private investigator, a chauffeur, a real estate agent and, allegedly, an illegal drug maker. In 1990, according to reports in the Washington Post and San Diego Union-Tribune, he pleaded guilty to charges linking him to a San Diego lab producing methamphetamine, an illegal street drug that is chemically similar to ephedrine.
Ellis was on probation when he began marketing his herbal product as a body-building supplement in 1992. Sales didn't take off until 1995, when he switched to selling Metabolife 356 as a diet aid and hit upon a marketing plan that allowed customers to become independent dealers. They hawk the stuff on the Internet, mall kiosks and hand-printed signs tacked to telephone posts in neighborhoods coast to coast. Last year the company was projecting sales of around 20 million bottles of Metabolife 356, or about 225,000 pills every hour.
Maybe it's a coincidence that sales of Metabolife 356 and other ephedra diet aids skyrocketed after the FDA yanked fen-phen from the market. That recall came after the agency received about 100 reports of heart-valve damage linked to the prescription drug. It makes you wonder what the agency is waiting for with ephedra.
By 1996, David Kessler, FDA commissioner at the time, was growing alarmed about ephedra. The agency had received nearly 400 reports of "adverse reactions" to ephedra products, including 15 deaths. Then, Peter Schlendorf, a 20-year-old college junior from New York, died in a motel room in Panama City, Fla., after taking an ephedra street drug knockoff. The FDA issued a consumer alert, warning people to avoid ephedrine-based stimulants. Kessler called them "street drugs masquerading as dietary supplements," and proclaimed that "inaction was unacceptable."
A week later, George Korizis, a master's candidate in mechanical engineering at Tufts University, was found dead in his room after taking Ripped Fuel, an ephedra product marketed to body builders to lose fat and build muscle. A health-food nut who did not smoke cigarettes and rarely drank alcohol, Korizis had been taking the product before his workouts for six months. At autopsy, the young man's heart was riddled with bits of dead tissue, a potential side effect of stimulants, according to Boston lawyer Jim Eisdale, who represents the Korizis family in a suit filed last summer against the manufacturer. (Gurley's analysis found that different lots of that product varied by as much as 1,000 percent in the amount of at least one stimulant, and 260 percent of another.) The company, Twin Labs, in Hauppauge, N.Y., denies responsibility for the death, but refused requests for further comment.
It took the FDA two more years to propose regulations for ephedra. By then, Kessler had stepped down as commissioner. The proposed regulations would have required labels on ephedra products recommending no more than 25 milligrams of ephedrine per day for no longer than a week. That's a quarter of the dose most herbal diet pill makers suggest, and a lot shorter than the three months they tell consumers to stay on the products. (Of course, who knows how much ephedrine is in the bottles?) The FDA also wanted to ban combining ephedra with caffeine, a popular addition to herbal diet pills.
When the proposed rules went to Congress, the industry went on the warpath. It whipped up another consumer letter-writing campaign, which delivered mail by the pound to the FDA and Capitol Hill. The American Herbal Products Association paid the Dutko Group, a well-connected lobbying firm, $195,000 in 1998 and $245,000 in 1999, according to federal lobbying reports. Dutko president Mark Irion's strategy was to discredit the adverse reaction reports on which the FDA based its proposed regulations.
The industry also gave generously to members of Congress. Metabolife executives sent Rep. Brian Bilbray, R-Calif., checks totaling $12,000 in 1997 and 1998, according to federal election reports at the Center for Responsive Politics. Metabolife distributors and consultants sent Bilbray at least $20,750 more. Bilbray, whose district encompasses the company's headquarters, pushed his colleagues on Capitol Hill to write administration officials about the FDA's rules. He also urged the co-chairs of the powerful House science subcommittee to commission a government study, which found the FDA had based its proposed rules on insufficient data.
The industry and its supporters in Congress have used that report to great effect. Rep. Dan Burton, R-Ind., who has a long history of supporting unorthodox treatments (as a state legislator he promoted the now-discredited cancer "cure" laetrile), has held several hearings attacking the FDA for various reasons, including its proposed rules for ephedra. Metabolife brass gave Burton $8,000 last year, his second biggest contribution from a single company. According to health policy analyst Tom Moore, the FDA has been thoroughly demoralized. The agency didn't even bother sending a representative to testify at one of Burton's bash fests.
To hear the industry and its supporters tell it, the FDA is filled with jackbooted bureaucrats. At a 1998 hearing, Burton accused the agency of "harboring a culture of intimidation and sometimes harassment against ... alternative cures." The FDA, which has all of 20 people overseeing the entire dietary supplement market, tells a different story. "The law was passed without Congress providing resources to do the job," says Joseph Levitt, director of the FDA's Center for Food Safety and Applied Nutrition.
The agency can't even seem to enforce good chemistry practices, not to mention truthful labeling. In his tests of 20 ephedra products, Gurley found that some pills had one-and-a-half times the amount of active ingredients listed on the label. Several supplements contained only ephedrine, not the mix of related compounds usually found in the ephedra plant, suggesting the pills were spiked with synthetic drugs. One bottle he tested had high levels of methylephedrine, a compound found in the herb at low levels that can produce amphetamine-like effects when combined with caffeine.
When Gurley called folks at the Kutting Edge to ask why Exandra Lean had no ephedra, they blamed their supplier. Trey King, president of the Kutting Edge, explained to Salon that his company did not manufacture the supplement, but simply sold it. The company has since discontinued the product, King said.
The FDA, it seems, is getting ready to do something about ephedra, though it's not clear what. The agency withdrew its doomed proposed rules earlier this spring. In April, it issued a new set of adverse event reports, including additional cases and more information about incidents that the industry had effectively challenged. FDA spokesman Brad Stone says a public hearing to discuss the new cases is scheduled for this summer. "This time," he added, "we want everybody to see the data first."
Another public hearing. What's really needed is another Kessler, who took on the tobacco industry, and who had just begun to go after ephedra when he stepped down. The current commissioner, Jane Henney, has shown little inclination to rein in the dietary supplement industry or take on its buddies in Congress. Last year she told Congress that the FDA was committed to "developing a positive relationship with the industry."
At the very least, dietary supplements like ephedra should carry stiff warnings on their labels, and companies should be required to follow good manufacturing standards. Better yet, Congress should give the FDA the authority to compel supplement makers to prove their products are safe and effective, and at what dose. In the meantime, the best thing consumers can do is exercise caution and read the labels. For whatever that's worth.