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[Definitie:] "An ergogenic aid is any substance or phenomenon that enhances performance."
(Wilmore and Costill) 
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2 7 - 1 2 - 2 0 0 5 Thanks to '94 law, supplements still poppin'
By MICHAEL O'KEEFFE &
T.J. QUINN
NORCROSS, Ga. — When he was 19, Jared Wheat was convicted of dealing ecstasy. He ended up serving three years in a federal prison after violating his probation with a drunk driving conviction and then driving with a suspended license. With a felony conviction, he couldn't be a banker like his father, couldn't go to law school and become an officer of the court as he had planned. He didn't finish his degree at the University of Alabama-Birmingham, where he studied marketing and management. "I was a kid who made a mistake," Wheat, now 34, says. "I felt with a felony I wouldn't get a fair shot in the business world." Sitting behind his desk earlier this month, a Rolex on his wrist, in an office adorned with photos and models of his black Ferrari 360 Modena (his other car, parked outside, is a Jaguar), Wheat is not beseiged with regret. "I think we'll end up making $40 million this year," he says. "I think we'll make twice that much next year." The banks and the courts are strictly regulated by the U.S. Government. The diet supplement industry is not. From the protein powders he used to sell from the trunk of his car for "date money" in high school, Wheat eventually started Hi-Tech Pharmaceuticals. Now, Wheat, the company's president, has a 4,000-square-foot headquarters in this office park just north of Atlanta. Hi-Tech offers an array of products, including ephedra-based supplements, that promise to improve your sex drive, help you lose weight and gain muscle, and give you an energy boost. All legal without a prescription. The FTC wants Wheat to pay $18 million over what it says are fraudulent claims of efficacy and safety, but he has a team of expensive lawyers battling the agency at every step and he refused an offer to settle for less. "There's a principle here," he says. "I got tired of being picked on by the government." Wheat's success is a product of "DSHEA," the law that deregulated the diet supplement industry in 1994. To Wheat, the Dietary Supplement Health and Education Act allowed him to turn hard work, a line of desirable products and world-class guile into a fortune. To the many critics of the law, Wheat is the perfect example of what is wrong with DSHEA. There is nothing in DSHEA that protects the public from buying the health products of a convicted drug dealer, nothing to assure them that his "natural" supplements are healthy, safe or that they even work. The law says that you don't have to prove natural supplements are safe or effective before you market them; the government has to prove that they aren't after the fact. "The whole notion that you put the burden of proof on the government to prove something isn't safe is of great consequence," says Rep. John Sweeney (R-NY), a critic of DSHEA. "It may not be logical. We may have created monsters in doing that." For all Congress' steps to ban steroid precursors and bully Major League Baseball into adopting a tougher steroid policy, it is lawmakers' refusal to significantly change DSHEA that is most troubling to many in sport and some in Washington. "DSHEA made the marketplace of dietary supplements essentially ungovernable," says U.S. Rep. Henry Waxman (D-Calif.), the ranking minority member of the House Government Reform Committee. "There are certainly illegal steroids masquerading as supplement products out there, but because of DSHEA, the FDA has no tools to keep these products from being marketed in the first place, and limited tools to police them once they are on the market." As long as DSHEA is the law of the land, the dietary supplement industry remains an open frontier. As long as the burden is on the FDA to prove a drug is unsafe, athletes will still be able to use themselves as lab rats anytime a company offers a "natural" product that is supposed to make them faster, stronger, thinner. Fly-by-night companies looking to make a name for themselves can still sell supposedly legal supplements over the Internet that secretly contain illegal steroids, knowing that it is unlikely they will be caught and less likely they will be punished. A revision to the law last year took steroid "precursors" — drugs that turn into steroids once they're ingested — off the market, but experts say there is no way to know how many products still contain illegal steroids. ConsumerLabs.com, which tests and monitors many diet supplements, estimates there are more than 18,000 such products on the market, making it almost impossible to keep track of them. But a Washington Post investigation in October found several that were tainted with steroids that had not been previously detected. The DSHEA law also may have accelerated the methamphetamine crisis that has devastated rural America, making it easier to traffic key ingredients like ephedrine. (The House of Representatives was concerned enough about the use of ephedrine in methamphetamine to pass a bill this month restricting sales of over-the-counter medicines with ephedrine and psuedoephedrine.) "Most people were using ephedrine to make methamphetamine," says Bill Gurley, a professor of pharmacological sciences at the University of Arkansas for Medical Sciences in Little Rock. "I would guess that (ephedra) had a greater impact on meth than we realized. I've had several law enforcement peolple here in Arkansas say they found large amounts of ephedra in labs they busted." And after 11 years, a trusting public still seems unaware of how the law works. "It's amazing how many people still think dietary supplements are regulated by the FDA," Gurley says.
DSHEA took its first hits when a number of young athletes, including Northwestern University football player Rashidi Wheeler, Minnesota Viking Korey Stringer and Baltimore Orioles pitcher Steve Bechler, died after taking ephedra products. There were mitigating circumstances with each of them, but after more than 150 deaths connected to ephedra-based weight-loss supplements, political pressure finally forced the FDA to ban the substance last year. Even before the ban, however, supplement companies began marketing weight-loss products with citrus aurantium, or "bitter orange," a supplement that contains the stimulant synephrine. Now this supposedly safe alternative to ephedra is under fire. Waxman's office met with FDA officials earlier this month to discuss concerns about the supplement, while a University of Arkansas study that has not yet been published has found that synephrine caused "pretty profound effects" in 20% of subjects, especially increased heart rate and high blood pressure, according to Gurley. Major sports leagues do not test for bitter orange and the World Anti-Doping Agency has it only on its "watch list." FDA officials did not respond to requests for the number of "adverse events" that have been reported for bitter orange.
There are plenty of other supplements that concern medical professionals. Weight-lifters and body builders are still "stacking" with dehydroepiandrosterone (DHEA) and a popular new product called tribulus terrestris.
DHEA was that lone precursor left off the government's banned list last year after Sen. Orrin Hatch (R-Utah) and supplement industry leaders insisted it be excluded, as the Daily News first reported in 2004. DHEA converts to androstenedione — the Mark McGwire steroid precursor — in the body, which then converts to testosterone. Research is mixed as to whether it has any real effect on humans. Sen. Charles Grassley (R-Iowa) introduced a bill in May to classify it as a steroid, but the bill hasn't been called for a vote in the Judiciary Committee. Tribulus, taken to boost libido and muscle, is a plant that may have some effect on humans, but the literature about human consumption is scarce. What is known is that sheep grazing on too much tribulus may develop "staggers disease," which causes vision problems, imbalance, sensitivity to light and possible paralysis. "Is it safe? I don't know, maybe it is. Is it pure? Who knows what's going on in the body — is it doing anything?" says NYU associate medical professor Gary Wadler, a board member of the World Anti-Doping Agency. "All we know is if you're a sheep it can be very bad for you. Would you take something based on that?" Many of DSHEA's critics say they support the basic premise behind the law, that consumers should have access to natural products to improve their health. The law also cleaned up a mish-mosh of regulations that classified different substances, although it was so broad that its unintended consequences were predictable, several experts say.
UCLA professor Don Catlin, the man who decoded the stealth steroid THG in 2003 and thus unraveled the BALCO scandal, was consulted 11 years ago when Congress began working on DSHEA. Catlin, who runs the Olympic drug testing lab in Los Angeles, liked some of the thought behind the law. But when he saw how DSHEA would protect some steroids and steroid precursors from government oversight, he was alarmed. "It was very clear to me that DSHEA was created in order to give the supplement manufacturers a huge shield so they could distribute steroids and all kinds of things, which I thought was wrong," Catlin says. The steroid nandrolone, for example, was protected, and Catlin said he warned Hatch that if it were available to the public, manufacturers would start putting it in everything to make their products more effective. Indeed, in 1999, a year before the Sydney Olympics, Catlin was quoted in a newspaper as saying, "I'd stake my life on it. Several of these over-the-counter steroids, as I call them, are straight away metabolites of nandrolone." The sports world is now littered with stories about athletes who tested positive for nandrolone, even though they took supplements that were not supposed to contain it. "We knew we'd find them in Olympic athletes, so we made a big push, myself and others, to try to get Hatch's office to at least get nandrolone off his list," Catlin says. "We weren't even successful at that."
With nandrolone and other steroids on the open market, chemists such as Patrick Arnold, the man who created THG, were able to find ways to "tweak" molecules to create new drugs, Catlin says. Arnold rose to fame in the industry when he took a steroidal nasal spray and turned it into the pill form of "andro" that eventually was found in McGwire's locker. Andro was legal in the United States when McGwire was taking it, but most international and Olympic sports federations had banned it. It was reclassified as a controlled substance in last year's revision to DSHEA. Arnold was prominent enough in the supplement industry that he was with a group that lobbied Hatch in his Washington office in 2001, hoping Congress would ignore the IOC's demand to reclassify some drugs as steroids. Less than two years later, Arnold fiddled with another steroid, gestrinone, and altered it to create THG. He went into business with BALCO founder Victor Conte and is now under federal indictment for conspiring to distribute steroids and misbranding drugs. Arnold, like Wheat, is not the only supplement success story with feet in both the legitimate and criminal worlds. Hi-Tech's vice president, Tom Holda, was convicted of trafficking anabolic steroids in 1996, and was sent to a federal prison last month for firearms possession. Robert Occhifinto, the owner of the now-bankrupt NVE Pharmaceuticals in New Jersey, did 18 months in prison for laundering $350,000 in profits after selling ephedrine to a methamphetamine dealer. His company was the target of 114 lawsuits over its ephedra products. Wheat describes Occhifinto as one of his closest friends. Conte, currently serving four months in a federal prison for trafficking steroids, has made millions off the legal diet supplement ZMA, a zinc-magnesium compound that is popular among weight lifters and bodybuilders. Former Metabolife International owners Michael Ellis and Michael Blevins were convicted of manufacturing methamphetamine in the late 1980s. What galls Catlin is how easy it was to predict all that followed DSHEA's passage. "I knew who Patrick Arnold was. I was tracking Conte way back in 2000, maybe even earlier. Their heads come up above my radar," Catlin says. The brightest red flag came during the Sydney Olympics when shotputter C.J. Hunter, then the husband of sprinter Marion Jones, tested positive for nandrolone and Conte addressed the press on Hunter's behalf, saying Hunter was the victim of a tainted supplement Conte had given him. With Conte's proximity to a discredited athlete, his creation of the supplement ZMA and his association with Arnold, Conte seemed destined to dabble with designer steroids. "I knew it was a matter of time," Catlin says. Hatch's office puts most of the blame for those problems on the FDA, and says most of them could have been avoided. "Much of the criticism of DSHEA is a result of the law not being fully implemented or enforced," Hatch senior staffer Maureen Knightly said in an E-mail. "For years, Senators Hatch and Harkin have urged the agency to step up enforcement, and they have worked through the appropriations process to obtain more money for enforcement." Catlin agrees that the FDA has been lax, but William Obermeyer, ConsumerLab's vice president for research and a former chemist in the FDA's Division of Natural Products says that while he was at the FDA, it just didn't have the funds to go after supplement companies when it was busy busting companies that offered fake cancer cures. Senate critics say that the FDA's failure to go after bad companies doesn't explain why Hatch and Harkin were so unwilling to address the proliferation of precursors. Once they did agree, with the support of the industry's larger, legitimate companies, it was on the condition that DHEA be exempted from the law. "It was like a kabuki dance to get the (2004) steroid bill passed without upsetting Hatch or Harkin," a veteran Senate staff member says. "From their point of view, they are cleaning up the industry. They are trying to take away the mud you can sling at DSHEA. They don't want it to be known as that stupid bill that allows kids to buy ephedra. To their credit, they say the FDA should be enforcing a lot of things the FDA doesn't really enforce." While DSHEA allows the government to remove products from the market, very few have been, and only ephedra has been removed under the law's "unreasonable risk" provision. Ephedra has been a particularly frustrating case to critics of the law. When DSHEA went into effect in 1994, adverse event reports about ephedra started trickling in almost immediately, says Obermeyer. Many at the FDA thought it would be banned in short order, and at the time the FDA wasn't even aware of the more than 14,000 adverse events that Metabolife had failed to report. "It was kind of daunting that it took so long. It took about 14 years to prove it was unsafe," Obermeyer says. "There were so many adverse events associated with it that it didn't seem like it was going to be so difficult." Just when ephedra opponents thought they had won, however, a federal judge in Utah ruled that the FDA had overstepped its bounds by banning ephedra outright. The FDA has appealed the case and it is pending. The big companies, like TwinLab and Nutraceutical, which filed the lawsuit against the FDA, did not resume production of ephedra products after a federal judge in Utah said in April that the FDA had overstepped its bounds. But some smaller companies, including Wheat's Hi-Tech, felt free to get back in the game. American Generic Labs of Cheyenne, Wyo., also recently announced several new ephedra products. But the company does not list its officers in public records filed with the Wyoming Secretary of State's office, and a spokesman, Frank Huerta (who was the subject of a resolved 1986 FTC false claims complaint), declined to identify them when asked. "They prefer to have it stay that way," he says. "They're not spokespeople, they're not used to speaking to the media and they've asked me to speak on their behalf." Huerta says he is not an officer of the company. Some lawyers read the judge's ruling to mean that anything up to 10 milligrams per serving was acceptable, as American Generic did. Wheat says Hi-Tech's legal team felt the decision completely overturned the ban, and thus they believe they are protected in selling ephedra at 25 mg. "We looked at what the law was — ran it past, conservatively, seven attorneys and they ran it by two former judges to make sure that we were on solid ground," Wheat says. They weren't worried about insurance, he says, because "plaintiffs attorneys" aren't going to go after smaller companies like his. And he certainly wasn't worried about public relations. "Our demand has probably quadrupled," he says. As for the larger question about whether it's safe to sell a substance that has been linked to so many deaths, Wheat echoes industry complaints that many of ephedra's adverse events were the result of misuse, despite warning labels telling consumers to stick to recommended doses. FDA spokeswoman Kim Rawlings would not comment on the handful of companies that are selling ephedra again, other than to say the agency is aware of them. But the Justice Department, acting at the FDA's request, sent U.S. marshals into Texas and Oregon earlier this month to seize ephedra that was being sold in excess of 10 mg per serving. The action was civil and no criminal charges were filed. Wheat says he isn't worried about being raided and that the FDA has inspected his labs. He likes to push the limits of the law as far as his lawyers will allow him. Wheat, for example, sells a supplement that contains DHEA and tribulus, and he calls it Dianabol. If you know steroids, you know that Dianabol was a popular anabolic agent, a brand name for methandrostenolone. It's a controlled steroid that is illegal without a doctor's prescription. Wheat has kept an eye on trademarked names, however, and he saw that the company that owned Dianabol, Ciba-Geigy, let the trademark expire. So Wheat bought the trademark and now uses the name for a supplement that is perfectly legal. When asked whether he is trying to make consumers think they are buying a powerful anabolic steroid, he says no, "We don't say it's a steroid." Wheat is aware that his criminal record is fodder for DSHEA critics. If he were on the outside looking in, his record "would probably get me to raise an eyebrow before I trusted someone in that company or even our business." But Wheat believes in the market. People will come to products because they work, he says. They will buy ephedra because it is an effective weight-loss supplement, and it's up to them to use it properly. "If someone's going to take a product and abuse it, I can't help that. What about the alcohol industry?" he says. "I like (DSHEA) in the way that it puts the burden of proof on the government. (But) I have no problem with the government being able, if they find there's a problem, to do something about it. I'd like to see them beef that up. "I play," he says, "by whatever set of rules I'm given." Lobby Holds Sway on Capitol Hill
BY MICHAEL O'KEEFFE There is growing concern on Capitol Hill that the Dietary Supplement Health and Education Act (DSHEA) has unleashed a flood of unregulated, sometimes ineffective, often dangerous performance-enhancing products — but congressional insiders tell the Daily News there is virtually no political will to revise or overturn the 1994 law. That's because although the dietary supplement industry is a relative lightweight when it comes to campaign contributions, it spends its money wisely: The industry counts powerful friends in Congress — Sen. Orrin Hatch, Sen. Tom Harkin, Rep. Dan Burton — and it is supported by a substantial grass-roots base that moves quickly to inflict maximum pain on critics and foes. "A lot of guys who were around in ‘94 who voted for DSHEA don't want to go on record as changing thier position," says Rep. John Sweeney (R-NY). "The other thing is, don't underestimate the dietary supplement industry lobby." But if Sweeney has his way, DSHEA will be a hot topic in the halls of Congress in 2006: The upstate Republican plans to propose a congressional review of the 11 years since the supplement law was passed. "I want to look at the effects and consequences of DSHEA," says Sweeney. Sweeney was one of the earliest and loudest congressional critics of Major League Baseball's steroid policy, and he believes the supplement industry can be persuaded to police itself just as Congress convinced Bud Selig and Don Fehr to beef up their drug program. Congress has to tell the responsible members of the industry to figure out a way to get rid of the fly-by-night companies, or the federal government will do it for them. There will be other piecemeal attempts to reign in DSHEA's biggest loopholes next year, congressional staffers say. Bills that would force supplement companies to follow good manufacturing practices and report consumer complaints to the Food and Drug Adminstration will be reintroduced after Congress returns from the holiday break next month. Still, Sweeney faces a daunting challenge. The industry has donated almost $5.9 million to federal candidates since 1990, according to OpenSecrets.org, a pittance compared to lawyers and law firms ($679 million since 1990), insurance ($242 million), oil and gas ($185 million) and other heavy hitters. But the industry' biggest recipient is a Senate alpha dog: Hatch, a Utah Republican whose home state is the center of the supplement industry, is one of the most powerful men on Capitol Hill. When a lawmaker makes noise about supplement regulation, industry Web sites and literature distributed at supplement stores report that the feds are working to make vitamins available by prescription only. The result is a flood of angry E-mails, hostile phone calls and nasty letters. When the FDA announced two years ago that it was going to ban ephedra, commissioner Mark McClellan received death threats. "In 1994 the industry used lies and distortions to scare millions of Americans into thinking their vitamins were going to be taken away," says Rep. Henry Waxman, D-Calif., a longtime DSHEA critic and frequent target of supplement activists. "Those panicked consumers then bombarded congressional offices with phone calls and demands that legislation be passed. Unfortunately, the industry continues to use those same tactics to fight reasonable regulation of some potentially dangerous products." 2 6 - 0 2 - 2 0 0 6 Feds seize dietary supplements from Norcross company
Andria Simmons LAWRENCEVILLE — Federal agents seized about $3 million worth of dietary supplements and ingredients containing ephedrine this week from a Norcross-based pharmaceutical company. The U.S. Food and Drug Administration determined that “Lipodrene,” “Stimerex-ES,” and “Betadrene” — dietary supplements manufactured, marketed and distributed by Hi-Tech Pharmaceuticals Inc. — contain too much ephedrine. Ephedrine has been found to cause serious health problems, according to a press release issued Friday by the U.S. Attorney’s Office in Atlanta. The U.S. Marshal’s Service on Thursday began seizing products from Hi-Tech facilities on Jimmy Carter Boulevard in Norcross. It quarantined more than 200 cases of finished product, more than 200 boxes of bulk tablets and nine 25-kilo drums of ephedrine alkaloid raw material. Ephedrine is an adrenaline-like stimulant that can have potentially dangerous effects on the heart, raising blood pressure and stressing the circulatory system, the press release said. In February 2004, the FDA declared that they present an unreasonable risk of illness or injury. Jared Wheat, president of Hi-Tech Pharmaceuticals, disputes the FDA’s claims and stands behind his product. He claimed the agency has been wishy-washy about the effects of the plant ephedra and the alkaloids derived from it. It allows ephedrine in some over-the-counter medications but prohibits it in dietary supplements, Wheat said. “In my opinion they’re talking out both sides of their mouth,” Wheat said. Wheat said his company sued the FDA in federal court six months ago seeking to prevent the agency from enforcing the ban on ephedrine. The seizure of Hi-Tech Pharmaceutical’s products is costing the company about $100,000 a day, he estimated. “We are filing a temporary restraining order on Monday asking the judge to lift the embargo and keep the FDA from taking any future action until the lawsuit is settled,” Wheat said. “We stand behind the safety and the efficacy of our product, and we look forward to our day in court.” |
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