Despite widespread public outcry following the death of a Baltimore Orioles pitcher last month, the nation’s largest producers of ephedra are nearing a major regulatory victory in Washington that would allow them to seize a larger share of the billion-dollar market for controversial dietary supplements.
After a four-year fight on Capitol Hill and within the executive branch of the federal government, San Diego-based Metabolife International Inc. and a handful of other major industry players are poised to prevail in an important federal proceeding that would slap strict new regulations on the industry.
Ironically, the new rules expected to be imposed by the Food and Drug Administration later this month would be a boon to large ephedra producers such as Metabolife by effectively weeding out scores of smaller, fly-by-night companies.
“Clearly we would prefer to have very strong regulation of these products,” said Wes Siegner, a lobbyist for a coalition of large ephedra producers
called the Ephedra Education Council. “We’ve gotten what we’ve asked for from the FDA.”
The new federal restrictions, added a lobbyist for industry leader Metabolife, will “regulate all but the largest companies out of the industry.”
The maneuvering by the ephedra industry — and its poster child, Metabolife — illustrates how an industry ostracized by the public and press can employ a savvy lobbying operation in Washington to transform a public relations disaster into financial gain.
At issue is the dietary supplement ephedra, a naturally produced substance — often dubbed “legal speed” — that boosts heart rate, blood pressure and metabolism. Dieters use it to lose weight. Truck drivers say it helps them stay awake. Athletes utilize it to improve their stamina.
Ephedra is sold at convenience stores, truck stops and health-food stores across the country under names ranging from “Ripped Fuel” to “Gut Cutter.” While the health effects of the drug are unproven, scores of Americans have died after popping the pill and hundreds of others have suffered heart attacks, strokes and seizures.
Ephedra is “as insidious and harmful and dangerous as a lot of drugs on the street that we’re warning kids to ‘Just say no,’” said Sen. Dick Durbin (D-Ill.), who became interested after a pair of football players died in his home state after taking the drug.
Still, Congress has done little to curtail the industry — even voting in the mid-1990s to exempt ephedra and other dietary supplements from FDA regulation.
But after ephedra was blamed for a series of deaths among athletes — including Minnesota Vikings football player Kory Stringer in 2001 — Durbin and Rep. Henry Waxman (D-Calif.) launched a pair of probes into the industry.
“We need to remove these products from the market so [families] don’t see their loved ones’ lives cut short for the sake of an energy buzz or the loss of a few pounds,” Durbin demanded at a Governmental Affairs subcommittee hearing he held last fall.
Waxman, the top Democrat on the Government Reform panel, charged that Metabolife executives hid hundreds of files documenting heart attacks, seizures and strokes among its customers.
As the Democrats ramped up their attacks, Metabolife launched a massive public relations campaign on Capitol Hill.
Since 1999, Metabolife has contributed $1.7 million in soft money to the national political parties, most of which went to Democrats. The company also juiced up its lobbying operation, tapping former Rep. Tom Loeffler (R-Texas) and his well-connected shop to keep an eye on the GOP-controlled Congress.
After Sen. Jim Jeffords (I-Vt.) left the GOP and handed control of the Senate to Democrats in May 2001, Metabolife hired Democratic lobbyist Lanny Davis of Patton Boggs to assist the effort.
Metabolife believed that Davis, a counsel to former President Bill Clinton, would help warm relations with Durbin because the two worked closely together during the Senate’s investigation into campaign finance abuses in the Clinton administration.
They were wrong. Durbin says Davis is “a bit much” — and raked him over the coals when the lobbyist presented Metabolife’s case before the Senate subcommittee last October. Nevertheless, Davis and his allies have been scoring victories on the Hill.
In addition to Davis, Metabolife’s other chief lobbyist is Gary Mauro, a Democrat who lost to then-Gov. George W. Bush in the 1998 Texas gubernatorial campaign.
Though Mauro has worked the Hill for years for Metabolife, he filled out a lobbying disclosure form for the first time last week.
Overall, the new hires boosted the company’s lobbying fees tenfold, from just $40,000 in 2000 to $440,000 in 2001. Metabolife spent another $450,000 on lobbyists in the first six months of last year, according to PoliticalMoneyLine.com.
Meanwhile, two of the industry’s trade groups have padded their lobbying rosters with Republicans close to Sen. Orrin Hatch (R-Utah), who champions the industry on Capitol Hill.
In the past several years, the industry has paid more than $1 million to retain lobbyists Jack Martin, a longtime Hatch aide, and Scott Hatch, the Senator’s son.
Martin and Scott Hatch, now with Walker Martin & Hatch, represent the National Foods Association and Twin Laboratories, a producer that exited the market last fall.
Metabolife and the industry have worked Capitol Hill aggressively for several years. But they flew into action last month after Baltimore Orioles pitcher Steve Belcher collapsed and died during spring training.
A bottle of ephedra was spotted near Belcher’s locker after his death, and medical examiners said the drug was a major factor in his death. A final autopsy report is due Thursday.
Since Belcher’s death, industry lobbyists have cautioned policymakers against jumping to conclusions.
“We see a huge amount of coverage of this baseball player’s death, and we still don’t know if he took ephedra,” said Siegner of the ephedra trade group. Siegner said the media blamed ephedra for the death of Northwestern University football player Rashidi Wheeler, though a medical examiner later found his body free of the supposed performance-enhancing drug.
“Heart attack, seizure and death are all things that are going to happen whether you take ephedra or not,” Siegner said. “So how do you tell if this one was the result of ephedra?”
Added Metabolife lobbyist Mauro: “Yes, there are some adverse affects from time to time. But given the population that takes the products, the health effects are very similar to what happens to people who take aspirin or Tylenol.”
Last month, ephedra lobbyists gave key lawmakers a 6-inch-thick binder with 53 scientific studies and articles challenging the belief that ephedra is dangerous.
Nevertheless, Durbin and a group of lawmakers continue to pressure the FDA to ban ephedra. Durbin will begin to circulate his latest bill this week.
To counter the ban, Metabolife has asked Congress and federal regulators to impose a tough regulatory regime on the industry. In testimony before Durbin and comments to the FDA, Metabolife officials said the government should ban sale of ephedra to minors and prohibit companies from marketing the drug as a performance enhancer. They also want the government to require stiff warning labels.
On Feb. 28 — less than two weeks after Belcher’s death — Health and Human Services Secretary Tommy Thompson proposed rules for the industry that track Metabolife’s request.
One rule, for example, would require a stern warning label: “Contains ephedra alcolate. Heart attacks, stroke, seizure and death have been reported after consumption.”
The new regulations, which could take effect later this month after a 30-day comment period, represent a major regulatory triumph for Metabolife and the other large players in the industry.
Not only did they persuade federal regulators to back away from a complete ban of ephedra, but the established producers already comply with most of the rules.
With few exemptions, Metabolife and other major players include warning labels on their products and market ephedra as a diet pill, not a performance-enhancing drug.
“Metabolife has been urging policy makers for years to establish strong public health protections governing the use of ephedra-based supplements,” said Metabolife lobbyist Davis. “Metabolife supports a ban on sale to minors, a ban on marketing for athletic enhancement, and the type of strong warning label proposed by the FDA.”
In another victory for Metabolife, Thompson charged more than two dozen smaller ephedra makers with violating the FDA’s regulations on marketing ephedra products.
Metabolife praise the ban. “There have been some bad actors out there,” said Mauro, the Metabolife lobbyist.
A Democrat working to ban ephedra was more blunt: “HHS just knocked the competition out. Metabolife has been in a pretty good position for a long time. Now they have a corner on the market.”