By Arlene Weintraub and John Carey
In 2000, California Governor Gray Davis accepted $150,000 in political contributions from Metabolife International Inc., the privately held San Diego maker of herbal supplements. That same year, Davis vetoed a bill aimed at restricting the sale of the very herb-based products that Metabolife makes. Davis is just one of several leading politicians to accept donations from Metabolife and its execs; his Republican challenger, William Simon Jr., also accepted $10,000.
They may be wishing they hadn't. That's because Metabolife's diet pills contain the natural stimulant ephedra, blamed for a rash of heart attacks, strokes, and seizures. Says California State Senator Jackie Speier, sponsor of a new bill to regulate herbal products: "This billion-dollar industry is muzzling legislators' ability to come out with important regulations."
Indeed, Metabolife contributions shed light on how herbal-supplement makers keep their products in stores. Even though ephedra is a key ingredient in products ranging from health drinks to weight-lifting tonics, the U.S. Food & Drug Administration lacks the power to substantially regulate them because herbs are not classified as drugs. Efforts to change that have been beaten down by deep-pocketed industry lobbying. Metabolife, with estimated annual sales of $500 million, has contributed $1.6 million to national politicians since 1999, including Senator Orrin G. Hatch (R-Utah) and Representative Patrick J. Kennedy (D-R.I.), according to the Center for Responsive Politics.
Mounting evidence of ephedra's dangers may stifle Metabolife's ability to buy favors. More than 85 consumer lawsuits are now pending against the company. On Aug. 15, in response to criticism from the consumer-advocacy group Public Citizen, Metabolife released records of 13,000 calls it has received since 1997. More than 80 reported heart attacks, strokes, and seizures in customers claiming to have taken Metabolife weight-loss pills. Three of them died. The FDA and the U.S. Justice Dept., which has launched a criminal probe, had been requesting the records for years. Metabolife attorney Lanny J. Davis (no relation to California's governor) says the company was preparing to release them.
These days Metabolife is trying hard to show that it's on the side of safety--but it may be a losing battle. While lawyer Davis says Metabolife would support legislation limiting dosages and banning the sale of ephedra to minors, many experts say it should be outlawed altogether. Like synthetic amphetamines, ephedra elevates heart rate and blood pressure, especially when combined with caffeine--as it is in some Metabolife products. A chemical derivative of ephedra, phenylpropanolamine (PPA), was banned by the FDA in 2000 after it was linked to several cases of stroke. "Ephedra is converted in the body to PPA," says Dr. Raymond L. Woosley, dean of the University of Arizona College of Medicine. "It is a chemical cousin of speed. There is no safe dose."
Problem is, there's no formal system to prove ephedra isn't safe. Manufacturers like Metabolife don't have to conduct safety studies. Nor are they required to report complaints. And whenever the FDA has requested additional funding to beef up its own system for tracking complaints, Congress has said no. The FDA has been trying for years to obtain safety information on Metabolife, only to be told by members of Congress to back off. "This is a company that has a lot of friends," reports a FDA official.
Ephedra opponents are hopeful the newly released customer complaints will spur some of those friends to finally take action against Metabolife and other companies pushing ephedra. Governor Davis says he plans to sign Speier's herbal-supplement bill, which will ban the sale of ephedra to minors in California and require more cautionary warning on labels.
Those who have witnessed the dangers of ephedra firsthand hope federal legislators will consider even more drastic measures. "It should be banned immediately," says Kimberly Case, a commercial assistant at a bank in Denver. Her husband, Doug, is still recovering from a brain hemorrhage and stroke he suffered in 2000. Experts blame Metabolife. "Lawmakers have a great responsibility to protect the public," says Case. That's no less true when they're accepting handouts from the very companies that are putting the public at risk.
Weintraub covers the drug industry in Los Angeles, and Carey writes about the FDA in Washington.