Pubdate: Wed, 02 Jun 1999 Source: Los Angeles Times (CA) Copyright: 1999 Los Angeles Times. Contact: (213) 237-4712 Website: http://www.latimes.com/ Forum: http://www.latimes.com/home/discuss/ Author: Charles R. Babcock INSTEAD OF METH, HE NOW MAKES METABOLIFE The Brains Behind Thepopular Diet Supplement Was Once Busted For Cooking Methamphetamine. The Legal Supplement And The Illegal Drug Aren't All That Different, Critics Say Michael J. Ellis, a 46-year-old San Diego businessman, is the brains behind a weight-loss product advertised as the No 1 herbal dietary supplement in America. Retail sales for his privately held company, Metabolife International, soared from less than $2 million in 1996 to $600 million last year. Ellis has become wealthy selling a product that shares a key ingredient with a drug that got him arrested 10 years ago. He was busted for running a methamphetamine lab in a house not far from his new $2 million home in exclusive Rancho Santa Fe. Back then, Ellis and his friends used ephedrine to make meth, a highly addictive illegal street drug. Today he uses ephedrine to make Metabolife 356, the core of his diet empire. Ten years ago, Ellis was in court fighting the government on his drug case. Today, he threatens to take the government to court if they get in the way of his ephedrine business. He is president of an industry coalition that has so far blocked federal regulators seeking to limit ephedrine products because of safety concerns. Ellis' story illustrates the difficulties federal agencies have in dealing with chemical substances that have many different uses. It also shows how a threatened industry can use a high-powered campaign of lobbying and political giving to stymie government agencies charged with protecting the public from substances that might be unsafe. "It's a Catch-22 for the government," said Don Martin, a Drug Enforcement Administration agent in San Diego. "While ephedrine can be used for absolutely hideous things, like meth, it also can be used for absolutely wonderful things." Legal Speed Ephedrine is a stimulant that is found in nature and can be made synthetically. It has been used in asthma medicines for years, but recently its popularity has soared as entrepreneurs like Ellis have packaged it with caffeine as an energy booster and diet aid. Since the ephedrine in Metabolife 356 comes from the ephedra plant, also known as the Chinese herb ma huang, Ellis can market his product as an all-natural diet supplement. Such supplements are considered "foods" and not "drugs" under a 1994 law and thus do not require FDA approval for safety or efficacy before they are marketed. Instead the law shifted the burden of proving a dietary supplement unsafe to the regulators. Reports of hundreds of adverse reactions and at least 38 deaths -- some overdoses -- associated with ephedrine-based products have alarmed the FDA and regulators in many states. In 1996, the FDA warned that ephedrine "is an amphetamine-like stimulant" that can damage the nervous system and heart. In June 1997, the FDA proposed a rule that would place severe limits on how much ephedrine a supplement could contain and how long it could be used. Ellis said the rule would "virtually eliminate" his business. Last fall, the DEA proposed tighter controls on ephedrine because of concerns that it is being diverted to make methamphetamine. DEA agents have reported finding ephedrine-based diet supplements in raids on meth labs, a claim the industry disputes. Ellis and other members of his coalition charge that the FDA has not properly documented the reported health problems, which they contend are relatively few compared with the billions of servings people take annually. "They're (FDA officials) trying to deal with an issue they can't put in a pigeon hole," Ellis said of the dispute. Some doctors and regulators see the issue as that of a drug that has been allowed to masquerade as a health food. "You can't tell me a horse is a cow," said Frank Wickham, recently retired executive director of the Ohio State Board of Pharmacy. "Ephedrine is a drug regardless of what they say." Ellis and his company have played politics -- at the state and federal levels -- the old-fashioned way. One of the industry's strongest supporters is Ellis' hometown congressman, Rep. Brian Bilbray, R-Calif. Metabolife officials and distributors donated $26,000 to Bilbray's last campaign -- 2 1/2 times more than he received from employees of any other company, according to federal election records analyzed by the Center for Responsive Politics. Ellis and a partner, who also has a methamphetamine conviction, donated $10,000 to Texas Gov. George W. Bush last year at a time when state regulators were rejecting tough proposed restrictions on ephedrine products. Ellis declined to discuss his criminal record, and the records are now sealed. But he is vocal in defending his product as a natural herb that helps millions. "Every herb on the market, the Food and Drug Administration says is dangerous," he said. He said Metabolife has never been sued by a customer and has received no reports of serious health problems from its users. He cites independent studies to back up his claims that Metabolife 356 is safe and effective. But two of the studies were done on animals, just the first step in testing safety for humans. Vanderbilt University Medical Center denounced a Metabolife contractor's use of its name in touting a two-week efficacy study as proof the product was safe. Last month, a summary of a Columbia University study of 48 overweight people over eight weeks found Metabolife effective for weight loss but added a caveat: "Safety for long-term use requires further study." Steven Heymsfield, a Columbia physician who also has studied new prescription-only weight-loss drugs, called his Metabolife study "exploratory" and said Ellis is funding part of a longer-term safety study. Heymsfield said he "wouldn't hesitate" to recommend Metabolife to a patient if he knew the patient didn't suffer from high blood pressure, heart disease or other maladies mentioned on the warning label. Critics, who sometimes call ephedrine "legal speed," worry that people assume "all-natural" supplements are healthy and take them without a doctor's advice or knowledge. Busted For Drugs In 1988, methamphetamine's popularity as a street drug known as "speed" or "crank" and controlled by outlaw motorcycle gangs gained the attention of Congress and of two California boyhood friends, Michael Ellis and Michael Blevins. That fall, the DEA convinced Congress it needed new powers to control ephedrine and other precursor chemicals used to make meth. Chemically, there is only one atom of difference in the molecular structures of ephedrine and methamphetamine. Around that time, Ellis, a 35-year-old former police officer, joined with Blevins and another man to produce a batch of methamphetamine, for which Ellis received $17,000, according to court documents that The Washington Post obtained before they were removed from public view. Someone tipped off the FBI, and the men were caught up in a DEA sting operation that employed video cameras in a phony chemical-supply house called Triple Neck Scientific. They were among 100 individuals indicted in San Diego in early 1989. Ellis, who had no previous criminal record, pleaded guilty to one count of using a telephone to further a drug deal and was sentenced to five years' probation. Blevins and the other defendant got 5 1/2 years in prison. When Blevins got out of prison in 1996, he got permission to join Ellis at Metabolife. Blevins, who Ellis said has retired from the company, could not be reached for comment. Back In Business His conviction did not prevent Ellis' entry into the diet supplement business. By 1992, he and a partner, W. Robert Bradley, had started a company to market an herbal product as an energy boost for weightlifters. It contained ephedrine and caffeine. Ellis said he developed the formula for his father, who was dying of cancer. In 1995, Ellis started Metabolife International, adapting the earlier formula to make Metabolife 356. This time, he marketed the product primarily for weight loss. Ellis successfully sought an early end to his probation so he could travel freely to build business, court records show. The 1994 diet supplement law that weakened FDA oversight of the herbal industry helped propel the success of Ellis and Metabolife 356. For David Kessler, then head of the FDA, the law had been a bitter defeat in the FDA's fight to regulate diet supplements. The industry had inundated Congress with mail from angry consumers and produced TV commercials of movie star Mel Gibson handcuffed by FDA agents for possessing vitamins. But the 1994 law did not stop the FDA from scrutinizing ephedrine. In early 1995, the FDA followed Texas' lead and warned consumers not to buy the ephedrine-based product Formula One. The FDA also proposed that ephedrine be removed from over-the-counter drugs like Bronkaid and Primatene Mist. It said the stimulant's use to relieve asthma symptoms "can no longer be justified when the drug's potential for illicit use and misuse is considered." The FDA issued another warning in 1996 after a Long Island college student died taking ephedrine pills marketed as a legal high. His family collected a $2.5 million settlement from the product's manufacturer. A week later, a graduate student in Boston died after using an ephedrine energy-boost product. In an effort to tie ephedrine directly to the death, internal FDA documents show, Kessler aides asked the medical examiner to run tests for the stimulant, and the death certificate was revised to cite ephedrine and the brand name of the product. Kessler cited the two deaths in pushing for a tough stance on ephedrine supplements. Lobbying For Survival In June 1997, the FDA issued a proposed rule limiting ephedrine to 8 milligrams a dose and 24 milligrams a day, much lower than the 25- to 100-milligram limits the industry had succeeded in setting in some states. The proposed rule also forbade using ephedrine for more than a week or mixing it with other stimulants such as caffeine. Metabolife and other companies viewed the proposal as a death threat. They set up the Dietary Supplement Safety and Science Coalition to fight back, arguing that the FDA's reports on deaths and adverse reactions were sketchy and flawed. Although an FDA database notes 14 adverse reaction reports and one death involving Metabolife products over the past few years, Ellis said the agency has never provided documentation. The FDA said it has been too busy to respond to Ellis. In early 1998, the coalition hired a Washington lobbying firm, the Dutko Group, at $145,000 a year, according to federal lobbying reports. A Dutko lobbyist prompted Reps. James Sensenbrenner, R-Wis., and George Brown, D-Calif., the top two members of the House Science Committee, to ask the General Accounting Office to review the FDA injury reporting system, a Brown aide said. Rep. Dan Burton, R-Ind., said in a March hearing that he was concerned that the FDA's proposed ephedrine rule is based on "faulty reporting and a long-standing bias in the agency." Burton's committee has scheduled a hearing Thursday on the FDA's adverse reaction reporting system, focusing on ephedrine. New FDA Commissioner Jane Henney promised Burton she will try to develop "a positive" relationship with the supplement industry. Joseph Levitt, her top aide for "foods," said the ephedrine rule is still at the top of his dietary supplement priority list. Ellis said his industry is prepared to sue to block the FDA. "I'm the first one to tell you that if there's an herb out there that, even if properly labeled, is dangerous, it should be off the market." But he noted the FDA has the burden of proof. "It's like America," he said. "You're innocent until proven guilty." Barbara Michal, of Novi, Mich., started an anti-ephedrine group in 1997 after her son died from using an over-the-counter ephedrine product that contained more ephedrine than Metabolife or many other diet supplements. "They have powerful lobbyists. Who do the victims have?" Michal said. "It seems to me that the FDA is not getting the job done." - --- MAP posted-by: manemez j lovitto