Bush's Diet-Drug Problem

By MICHAEL WEISSKOPF

Not long after Governor George W. Bush named him Texas health commissioner in September 1997, William ("Reyn") Archer decided to restrict sales of dietary supplements containing ephedrine. It was a bold but logical move for the head of a nationally applauded state agency. An amphetamine-like stimulant derived from a Chinese herb, ephedrine was widely used for weight loss, but it seemed to pose serious health risks. Products with ephedrine had in the previous five years been linked to eight deaths and more than 1,400 health problems in Texas alone.

A few months after Archer's decision to crack down on ephedrine, something curious happened. Archer abruptly changed course. He called in large manufacturers and let them negotiate looser rules for marketing their ephedrine products. A physician and son of powerful House Ways and Means Committee chairman Bill Archer, Reyn Archer had gone from taking the actions of a crusading regulator to taking those of an industry ally.

Why the flip? Archer reversed himself because of the ephedrine industry's strong opposition and its threats of litigation, his spokesman said. But records and interviews obtained by TIME suggest another plausible reason: the office of Governor Bush encouraged, if not inspired, Archer's about-face after lawyers close to Bush began work for a leading manufacturer. Those same lawyers funneled $40,000 to Bush's re-election drive about the time of a key industry meeting with Archer. The rise and fall of ephedrine regulation offers a case study of politics, policy and money in George W. Bush's Texas.

Archer wasn't the first Texas health commissioner to tackle ephedrine. Since 1995, Texas' health department had been trying to ban over-the-counter sales of most ephedrine items. Marketed under such brand names as BioLean and Ripped Fuel, the substance had been linked to heart attacks, strokes and seizures. Leaders of what has become a $1 billion industry nationwide responded that their products were safe if taken as directed, and they launched a lobbying blitz against Archer's proposal to require a doctor's prescription for most products containing ephedrine.

To press its case, the herbal industry turned to Bush allies. Metabolife International--which makes Metabolife 356, the best-selling herbal diet product in America--hired a San Antonio law firm headed by some of Bush's closest political associates, including Jeff Wentworth, a powerful state senator. (In Texas it is legal for a sitting state senator to represent clients before a state agency.) Wentworth arranged a July 2, 1998, meeting between Metabolife president Michael Ellis and Archer. Ellis says he called for a "dialogue" with his industry in place of the tough regulatory stand--a position being quietly urged on Archer by the Governor's office, report two sources involved in the issue. Just days after Ellis' plea, Archer brought in an outside lawyer to help him and the state's board of health to negotiate a settlement with ephedrine producers.

What, exactly, was the role of aides to Bush in all this? The Governor's health-care adviser, Ron Lindsey, tells TIME he does not recall pressing Archer to abandon his initial tough-on-ephedrine proposal--although Lindsey allows that he strongly supported Archer's move to negotiate with ephedrine producers. Lindsey's 1998 calendar (a copy of which was obtained by TIME) shows that starting in May, he met with industry officials--including Ralph Oats, owner of Wellness International Network, who, along with his wife, contributed almost $90,000 to the G.O.P. and national candidates in the mid-1990s. Lindsey says another Metabolife lawyer, James Jonas III, paid him a visit, apparently to "get leverage" on the issue. But while Bush and his chief of staff, Joe Allbaugh, were kept informed, Lindsey insists "there was no pressure from the top [other than to] just work this thing out if you can." Allbaugh, who has since become Bush's presidential campaign manager, says Metabolife lawyers did not discuss the issue with him or the Governor.

Archer's negotiations with the industry were a closed-door affair. When he began the sessions on Aug. 11, officials from Metabolife and seven other companies flanked both sides of the U-shaped mahogany conference table in the department's boardroom. No outside doctors or consumer advocates were invited--unusual if Archer hoped to find common ground. Also missing were Archer's staff experts who favored strong regulation of ephedrine.

After the doors reopened, the industry seemed to get much of what it wanted. Archer accepted several industry positions, including ephedrine-dosage limits of 25 mg a serving and 100 mg a day--much higher than the limits favored by Archer's specialists, who cite evidence of ill health effects at significantly lower doses. Participants also agreed to let a smaller task force, including lawyers from an industry coalition headed by Ellis, work with Archer to tackle the remaining issues. According to notes obtained by TIME, they decided on what can only be called a rather unbalanced division of labor. Archer's general counsel, Susan Steeg, wrote, "Industry will draft rules." Pointing to her notes, Steeg claims she merely meant that the industry would shape the language, not the substance of the rules.

In mid-September 1998, Archer appeared to get a bit tougher on the industry. Urged by his staff to press for stricter limits, he told the industry task force that he wanted to allow no more than 10 mg a serving and 40 mg a day. The industry said those restrictions would wipe its products off the market. The task force asked for an audience with Archer. On Oct. 2, Ellis, Wentworth and Jonas contributed a total of $10,000 to Bush's re-election campaign, followed three days later by $5,000 from another Metabolife official, Michael Blevins. According to Ellis' spokesman, Jonas sought the money as co-chairman of a fund raiser for Bush.

Archer held a meeting with the task force Oct. 20 and once more backed off the stricter limits. On the same day, Tom Loeffler, a former Texas Congressman hired as a Washington lobbyist for Metabolife, contributed $25,000 to the Bush gubernatorial campaign. Loeffler, a mentor for Bush, has given $141,000 to his gubernatorial races and raised at least $100,000 for his presidential bid. He did not return phone calls seeking comment. Nor did his partner Jonas. For his part, Wentworth told TIME, "I'm not aware of any coordinating of contributions to get a meeting with Dr. Archer." (Months later, after news reports that Ellis and Blevins had been convicted years earlier of drug-related offenses totally unconnected to their work in the herbal industry, the Bush campaign returned their donations.)

Where was Bush during these negotiations? According to copies of his calendar, he met with Archer in mid-July and mid-September--key junctures in the ephedrine negotiations. He twice saw Wentworth at political events during this period. But a spokesman in the Governor's office said Bush did not get involved in Archer's deliberations and had no discussions with Metabolife's lawyers about ephedrine. Wentworth says he never raised the issue with Bush.

As the package was prepared for formal presentation in November 1998, Texas' chief of food and drug safety under Archer was worried. The chief, Dennis Baker, called the softer proposals "quite disturbing" in comments e-mailed to Archer. "The rules as currently written," he wrote, "would only serve to facilitate marketing of ephedrine products at the expense of public health." By the time regulations were approved in May 1999, Archer decided to take no position on dosage limits. Such limits would imply that ephedrine products were safe at certain levels. But he did allow the industry to carry a label that warned about "exceeding" the recommended dosage, as if staying below it would not cause any problems to consumers. In fact, as Archer's aides pointed out in memos, 90% of the health problems reported in Texas have occurred after the consumer took the directed amount of product--or less.

Archer would not comment on the ephedrine regulatory regimen. But his agency spokesman, Doug McBride, says Archer describes the rules as a "starting point. We have something where nothing existed before." While industry seemed to dominate the rulemaking, McBride notes that a doctor and a consumer representative sit on Archer's board, which gave final approval to the rules. And he contends there was no connection between Archer's actions and industry contributions to Bush's campaigns. Perhaps it is instructive, though, that when Bush posted a list of Pioneers, those who raised at least $100,000 in 1999 for his White House quest, a new name came up: Craig Keeland, president of Youngevity Inc. of Dallas. Youngevity was not among the companies lobbying in 1998, but its products include Fat Metabolizer 2001+, which contains ephedrine.