Heavy Meddling

If you were worried about the safety of Metabolife 356, perhaps you'd do what Flora Hickman did: you'd call the authoritative-looking 800 number printed on the bottom of each bottle. Hickman, 38, of Los Angeles, started taking the herbal supplement earlier this year, and after a shaky start--"the first three days I was a little jittery, like I had too much coffee"--she was doing swimmingly: 15 pounds gone in just three months. Then six months ago she saw a cautionary TV report questioning the safety of Metabolife. The news program was enough to give Hickman pause. Dialing the health-information number on the bottle, she reached one of 11 full-time health-care practitioners hired by Metabolife to field such calls. "They told me that the levels [of the herbal stimulant ephedra] are so low it's not enough to get alarmed about." Her fears were assuaged. She continued on the supplement, and recently became a distributor. For the makers of Metabolife, one battle won.

The five-year-old company has won millions of these battles. Even for the get-rich-quick economy of the late 1990s, Metabolife International Inc. has gotten very rich, very quickly. Started by an ex-cop with no formal medical training, the company has tapped a voracious appetite for easy weight-loss fixes. As our collective waistband expands, Americans pop 225,000 capsules of Metabolife every hour. Retail revenues this year, according to company founder and CEO Michael Ellis, are expected to reach $900 million. In our national and often irrational war against fat, Metabolife is becoming, for millions, the weapon of choice.

In his cramped San Diego headquarters last week, Ellis was fighting a different sort of battle, not over flab but over the lean sinew of information. On Sept. 9 he had given an interview to the ABC news-magazine show "20/20," to air later this fall. It was contentious. For 70 minutes, reporter Arnold Diaz confronted Ellis with a litany of charges about both his personal history (in 1990, Ellis pleaded guilty to charges linking him to an illegal methamphetamine lab) and his product. Though the company has cited studies from two prestigious universities as evidence that Metabolife 356 is safe and effective for weight loss, researchers on both studies cautioned their findings are not conclusive (box). Most of these disclosures had been previously reported in various outlets, including NEWSWEEK. But the high visibility of "20/20," and the tone of the interview, set Ellis off. "I believe in open, honest debate," he told NEWSWEEK, "but this was more like a deposition."

Together with his publicist, Michael Sitrick, known for his aggressive damage control on behalf of clients like Kelsey Grammer and Food Lion supermarkets, Ellis went on the offensive. Before "20/20" could air its report, Metabolife pre-emptively loaded its own, unedited tape of the interview onto the Internet (www.newsinterview.com), and committed $1.5 million to advertise the site in newspapers and on radio stations around the country. In print interviews, Sitrick and Ellis accused "20/20" of seeking revenge against Metabolife because the company had recently brought suit against an ABC affiliate over an unrelated report. ABC, surprised by the maneuver, denied the charge and accused the company of acting in bad faith. "It's clear that Metabolife is trying to intimidate us or change our editorial process," said network spokeswoman Eileen Murphy. "The piece will air, exactly as it would have before all this happened, in the next couple of weeks." Ellis, in response, renewed the war of words. "If their report is fair," he told NEWSWEEK, "they have nothing to worry about. I just want to put it all out there." In its first 15 hours, claims Sitrick, more than 1 million users registered to use the Web site.

The charges against Metabolife, taken in or out of context, are serious. Though herbal supplements are not subject to regulation, the FDA has warned that in high dosages ephedra can lead to "cardiac arrhythmia and death"--a health hazard not listed anywhere in the company's voluminous literature, nor volunteered on the health-information 800 line. Instead, Metabolife advises users to consult their physicians. The company cites the product's history of safety. For all its widespread use, often among the morbidly obese, Metabolife has been associated with very few "adverse events" and only one personal-injury lawsuit, which Sitrick dismisses as unfounded.

In the high-volume, big-money diet biz, however, health claims can be monumental, as the pharmaceutical company American Home Products, maker of the prescription cocktail Fen-Phen, found last week. Two years after pulling the highly touted treatment from the market, the company agreed to a $3.75 billion settlement of claims that the product caused heart-valve problems.

To bolster its claims of efficacy and safety, Metabolife touts a body of ephedra research, including several animal studies and two performed on humans: one at Vanderbilt University and the other at Columbia University. But contacted independently by NEWSWEEK in August, researchers from both studies said that neither was comprehensive enough to support any conclusions about long-term usage of the product. While neither study found the supplement unsafe, both were short term and small. Dr. Harry Gwirtsman, who led the Vanderbilt team, says his aim was to measure metabolic effects over a 24-hour period, rather than assess long-term safety or efficacy. Dr. Steven Heymsfield of the Columbia team says that while he "wouldn't completely negate the use of" Metabolife, he noted an increase in jitteriness, insomnia and heart palpitations among some subjects taking the supplement. (Heymsfield is also a trustee for the rival Slim-Fast.) Vanderbilt insisted that its name be removed from Metabolife's promotional materials; the company complied. Metabolife's Ellis and Sitrick say the Columbia and Vanderbilt studies were just part of a body of research that, when taken together, indicates that the product is safe when used as directed. Referring to an as-yet-unpublished paper from the ongoing Columbia study, Sitrick said "it showed the product to be effective for weight loss, and that none of the participants were at health risk."

In the battle against ABC and "20/20," Metabolife has scored first. And it is perhaps fitting that this fiercest battle is not over health issues but over information. Medical news that used to come almost entirely from physicians or a neutral source like the FDA now flows at the public from every direction: from magazines, doctors and the even woollier, unregulated world of the Internet. For consumers like Flora Hickman, the challenge isn't getting information. It's figuring out which source to trust.