Ephedra: boon or bust?
Date: 22-06-2003
Posted by: Anabolic Info TeamUnited States |
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One month after a state law took effect banning the sale of ephedra, Illinois residents still can buy scores of weight-loss products containing the herbal stimulant.
TrimSpa, Metabolife 356, Stacker 2 -- these and a host of other ephedra-laced dietary supplements remain easily available to Illinois residents: over the Internet, by mail order and on Missouri store shelves.
Want a bottle of Stackers 2, whose maker, NVE Pharmaceuticals, made another ephedra-laced product linked to the death last fall of a Lincoln high school football player?
Just drive across the Jefferson Barracks Bridge, to the General Nutrition Center store at the South County shoppingmall. There, a clerk will sell you a 100-tablet bottle of Stackers 2 for $39.99.
Or sit down at your home computer and click on to the www.fitnetusa.com Web site run by professional body-builder Guy Grundy of Los Angeles. Grundy said he sees no problem in selling Stackers 2 a nd other ephedra-based products to Illinois residents.
"We carry every range of the product the companies offer," Grundy said. "If a product has bad play but it continues to sell and the customers want it, then we'll sell it."
Original speed
"Bad play" is a modest way to describe the national outcry that greeted the death of Baltimore Orioles baseball pitcher Steve Bechler, 23, who suffered a fatal stroke in February after consuming two tablets of ephedra-laced Xenedrine RFA-1.
Xenedrine RFA-1, since taken off the market, is one of hundreds of dietary supplements containing ephedra. Ephedrine, its active ingredient, is an amphetamine-like stimulant blamed for strokes, abnormal heart rhythms and heart attacks in thousands of healthy young people nationwide.
The recent bad press engulfing ephedra-based products has laid bare the shadowy, virtually unregulated world of herbal supplements. It is an industry that generated more than $2 billions sales last year, but its biggest players are a handful of private companies that reveal few details about their finances, inner workings and histories.
And for good reason.
The rise of ephedra-based dietary supplements closely parallels the explosive growth of the illegal methamphetamine trade. Ephedrine is a key ingredient used in the making of speed.
Ephedra "is the original speed," said Thomas Tiedt, a pharmacologist who lives near Tampa, Fla.
Indeed, the dangers of ephedra were widely known more than 70 years ago, which is why pharmaceutical companies developed amphetamines -- as a way to drive ephedra off the market, Tiedt said.
Two of the herbal stimulant industry's biggest names -- Metabolife International of San Diego and NVE Pharmaceuticals of Newton, N.J. -- were founded and continue to be led by men convicted of drug felonies.
Robert Occhifinto, 41, the president of NVE, has been convicted of smuggling hashish and laundering money, and admitted supplying methamphetamine makers with three tons of bulk ephedrine hydrochloride powder between March 1990 and January 1991.
Also in the early 1990s, Metabolife founder Michael Ellis, 46, and board of directors member Michael Blevins, 52, were convicted in connection with a methamphetamine factory set up in a Rancho Santa Fe house. Neither Ellis nor Blevins has any day-to-day control over Metabolife's operations, said Jan Strode, a Metabolife spokesman.
Occhifinto, Ellis and Blevins are allowed to remain active in the industry because the Dietary Supplement Health and Education Act, which Congress passed in 1994, exempted dietary supplements, vitamins and minerals from virtually all regulation.
In addition, these companies are not required to prove the safety and effectiveness of their products, nor must they report their customers' negative side effects, such as heart attacks.
The 1994 law that ended up giving such a free ride to the herbal stimulant industry, on paper at least, could be effective if it were enforced properly, Tiedt said.
"But it's being abused by methamphetamine felons," he said.
Dangerous buzz
U.S. Sen. Dick Durbin, D-Springfield, has introduced a bill in Congress to close these loopholes.
And the Illinois law banning ephedra sales stems from the intervention of Durbin, who urged state leaders to take action. He was moved by the campaign against the stimulant waged by the parents of Sean Riggins -- the 16-year-old Lincoln football player who died after consuming an ephedra product he bought at a local gas station and chasing it with a Mountain Dew.
The easy availability of ephedra products today, despite the Illinois ban, "really tells you that in this age of the Internet and this age of drug sales by mail that you really need to have a national policy," Durbin said.
The Illinois law banning ephedra sales will at least keep kids from wandering into stores and buying a dangerous product, Durbin said, "But we need to do more."
Bill Hoskins, the owner of Complete Supplements at 625 E. Main in Belleville, said the wide availability of ephedra makes Illinois' ban "ludicrous."
"That's what's so ludicrous about all this is people can go across the river and get their T-Burn Combo or just order it online," Hoskins said. "There's just really no way to control it."
The ban on the sale of ephedra might actually encourage people to try it on the belief that "it must be good if they're going to outlaw it," said Ron Schaffer, the owner of Belleville Fitness and of American Fitness in Pontoon Beach.
But no one has to convince Dale Radford of ephedra's dangers.
Radford, a former competitive weightlifter, was once a big fan of ephedra-based supplements because of the amphetamine-like "buzz" they gave him.
But Radford's nasty experience on a scorching hot summer day changed his mind.
Radford was training for the bench-press competition at the Prairie State Games in June 1997. As he had done for eight years, Radford started off his work-out with an ephedra-based product called Ultimate Orange.
Suddenly he began feeling agitated, irritable and terribly overheated.
"I just felt like I was having one of the worst days of my life," said Radford, the manager of Kings Point Fitness Club in Belleville.
Radford felt so wired he still couldn't get to sleep even by 11 p.m. that night, he recalled.
"I've never touched the product since then," Radford said, "That's how bad it was."
Unregulated industry
The Rand Corp., a nonprofit California think tank, released a report in February on the safety and efficacy of products containing ephedra and ephedrine.
The study, commissioned by the U.S. Food and Drug Administration, included a review of more than 1,500 "adverse event" reports linked to ephedra use that were voluntarily reported to the FDA, as well as 125 reports related to products containing ephedrine.
Ephedra use carries risks of heart palpitations, psychiatric disorders and gastro-intestinal problems, as well as tremors and insomnia, especially when taken with caffeine and other stimulants, the study's authors concluded.
Rand called the nearly 15,000 adverse health reports submitted by Metabolife International a year ago "sentinel events." That's because they might signal a safety problem, but do not prove that ephedra caused the adverse event. The review also found evidence that ephedra helps in short-term weight loss, but hardly any evidence that it boosts athletic performance.
Because of the recent negative publicity -- as well as dozens of lawsuits and soaring liability insurance premiums -- ephedra sales have fallen by as much as 40 percent from a year ago, according to published reports.
General Nutrition Centers Inc. (GNC) plans to pull all ephedra-based products from the shelves of its 5,300 stores nationwide by June 30.
GNC is following the lead of the 7-Eleven convenience store chain, which pulled ephedra-based products off its shelves several months ago. And a year ago, the U.S. Department of Defense pulled ephedra products from all retail outlets on military bases around the world. In January, Canada banned ephedra products nationwide.
In response, the major makers of ephedra-based supplements -- TrimSpa Inc., Metabolife International and NVE Pharmaceuticals -- have started selling ephedra-free versions of their products.
But that isn't mollifying industry critics such as Tiedt, the pharmacologist.
That's because many of the ingredients being used to replace ephedra, such as "citrus aurantium," consist of untested blends of stimulants. They include synepherine -- a near identical twin of ephedrine -- and hordenine, a stimulant banned in the horse racing industry but legal to give to humans, Tiedt said.
"They're adding a cocktail of drugs and a bunch of stimulants in totally unheard of, unprecedented combinations," Tiedt said.
Metabolife International is by far the biggest player in the herbal stimulant industry. With sales of more than $1 billion, it has attracted many of the personal injury lawsuits filed against makers of ephedra-based products.
The first such lawsuit that will be heard in U.S. District Court in East St. Louis against Metabolife was filed June 10 by Elizabeth and Robert Wigginton of Troy.
In May 2001, Elizabeth Wigginton discovered she had developed serious and permanent problems with her heart and cardiovascular systems as a result of consuming Metabolife, which failed to warn her of dangerous side effects, according to the complaint.
TrimSpa, Metabolife and NVE Pharmaceuticals have voluntarily quit selling directly to Illinois customers.
But companies that distribute these companies' products see no problem in shipping to Illinois.
The Metabolife Store, of Overland Park, Kan., will mail Illinois residents a 200-tablet jar of ephedra Metabolife 356 for $44.95, plus shipping and handling, operator Kathy Westerbeck said.
Attilio D'Agostino, the owner of seven Attilio's Discount Supplement stores in Missouri, as well as two in the metro-east, said his Missouri stores will continue to carry ephedra-based products, including the T-Burn Combo.
The ephedra products sold at Attilio's are safe and effective if taken correctly, and their quality is guaranteed, D'Agostino said.
D'Agostino dismissed the criticism of ephedra as "sensationalist hype" promoted by the pharmaceutical industry. D'Agostino acknowledged some risks connected to the herb, but the debate over its use is overlooking the greater dangers posed by the epidemic of obesity sweeping America, he said.
"We have seen people with the T-Burn Combo and many other products with ephedra find a weight loss solution that was the first thing that ever helped them," D'Agostino said. "And it changed their lives."
Looking to Congress
Not even the most diligent consumers can ensure they are taking ephedra-based products correctly because of the lack of consistent standards, said Joe Shoemaker, a spokesman for Durbin.
For example, dietary supplement makers are not required to ensure each tablet of their products contains a uniform dosage. The ephedra in the tablets remaining in the bottle of Xenedrine found in Bechler's Florida motel room ranged in strength from 5 milligrams to 55 milligrams, Shoemaker said.
"That's the crazy part," he said. "That's the part that is so out of whack here."
Durbin's bill would require makers of these supplements to prove they are safe and effective before bringing them to market. He acknowledged his bill could be headed for rough waters. Its chief opponents are U.S. Sen. Orrin Hatch, R-Hatch -- the chief sponsor of the 1994 exemption -- and U.S. Rep. Dan Burton, R-Ind., another vocal champion of the dietary supplement industry.
But passage of a national law regulating dietary supplements, and soon, is crucial, Durbin said.
"Too many bad actors in this industry are destroying the credibility of a very important source of healthy nutritional supplements for Americans," he said.
