Despite Warnings, Davis Took No Action Against Metabolife

After accepting $150,000 in political contributions from a California weight-loss company two years ago, Gov. Gray Davis decided the state would await federal action and not advise the public of the possible ill effects of the company’s widely marketed herbal diet pills.

Now with the federal government opening a criminal investigation into whether San Diego-based Metabolife International Inc. has covered up thousands of adverse consumer reactions to its product, Davis on Friday said he likely will sign legislation that bans the sale of the products to minors. His administration also sent a letter to federal regulators demanding that they take action to investigate complaints.

“We have given them a couple of years,” Davis said of the federal government. “If they don’t tell us within 30 days that they’re going to do it, we’re going to do it.”

Two years ago, scientists, including some in Davis’ own Department of Health Services, strongly urged that the product be banned, citing concerns that its chief ingredients--herbal ephedrine and caffeine--caused heart attacks, strokes and seizures.

But the governor, who had received three separate donations totaling $150,000 from Metabolife, vetoed legislation--already weakened by the industry’s lobbying--that would have required a warning label on such products marketed in California. In his veto message, Davis declared that regulation of such products should be left to the federal government.

The governor says there is no connection between Metabolife’s political contributions, which have since reached $175,000, and his stance on the legislation. And both he and a spokesman for Metabolife co-founder Michael J. Ellis say the basis of their political relationship is a shared interest in education; they have never discussed Metabolife’s products or the issue of regulation, their spokesmen say.

“All I can say,” the governor noted, “is that there is not a donor to me that has not seen a couple of bills vetoed that he very much wanted signed.”

The decision two years ago to cede power to the federal government was an unusual position for any California governor, particularly Davis, who has often stepped in when the federal government was slow to act. At the time, federal regulatory efforts had stalled.

Davis made no effort to encourage federal action until Friday, when his health director fired off a missive to the U.S. Food and Drug Administration urging that it take “swift action on this important public health issue.”

The legislation Davis is contemplating signing would ban sales to minors, require that marketers of the products in California provide a warning label, and require that companies include an 800 number to the FDA that consumers could call with any adverse health effects.

Sen. Jackie Speier (D-Hillsborough) said she would welcome the governor’s signature on her legislation, SB 1750, calling it “the very least that we should do.” Similar legislation stalled last year, in part, she has said, because the administration did not help push for it.

The FDA has more than 100 reports of deaths possibly associated with ephedra, although experts familiar with the data say records are incomplete and the actual number of attributable deaths could be no more than a dozen. The use of ephedrine compounds made headlines last year when two college football players, Florida State linebacker DeVaughn Darling and Northwestern safety Rashidi Wheeler, died during off-season workouts with the NCAA-banned supplement in their systems.

On Thursday, the U.S. Justice Department disclosed it had opened an investigation into claims by Ellis in a 1998 letter to the FDA that the company “has never received one notice from a consumer that any serious adverse health event has occurred because ingestion of Metabolife 356.”

In response, the company announced it would immediately and voluntarily release records of more than 13,000 health complaints the company has received from customers of the product since 1997.

Industry representatives insist the substance is safe, so long as consumers follow manufacturers’ warnings.

“If we were killing people, we would have been put out of business,” Metabolife lawyer Garry P. Mauro said, adding that obesity is a far more serious public health threat than anything his client sells.

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Metabolife was founded in 1995 by Ellis, then a 42-year-old former police officer and real estate agent, who five years earlier had struck a deal with prosecutors to avoid prison on drug charges.

In 1989, Ellis and longtime friend Michael L. Blevins were indicted on federal charges stemming from an undercover operation against methamphetamine labs in San Diego County. Court papers say Ellis leased a home in the exclusive Rancho Santa Fe area north of San Diego where a meth lab was set up.

The indictment alleged conspiring to manufacture methamphetamine with intent to distribute it. But documents say Ellis cooperated extensively with authorities by making undercover buys from other dealers, and he pleaded guilty in 1990 to a lesser charge of using a telephone to facilitate drug trafficking. He was still on probation in 1992 when he started a dietary-supplement business that grew into Metabolife International.

Company spokeswoman Jan Strode described the crime as a “mistake by Mr. Ellis many years ago,” and called it “totally irrelevant.”

Blevins helped prosecutors too but received stiffer penalties. Federal authorities, believing Blevins had been dealing drugs since the 1970s, won court orders to seize $1.3 million in assets. He served 4 1/2 years in federal prison, then received a judge’s permission in 1995 to join Ellis in the dietary supplement venture.

Ephedra, which is the herbal twin of a synthetic compound used to make illegal methamphetamine, has been wildly successful for the company--and for Ellis. In a 1999 court document, Ellis’ ex-wife estimated his income at $250,000 a month. She said he paid cash for a 200-acre ranch near Julian, as well as a home with five baths, a pool and a four-car garage in the Fairbanks Ranch enclave, not far from the Rancho Santa Fe house that he leased in the late 1980s and that was a target of the meth sting.

As a privately held company, Metabolife’s sales figures aren’t public, but it touts itself as the leader in a niche of the industry that the Legislature says has annual sales of $200 million in California alone.

As its fortunes grew, Metabolife began donating to charities--more than $1 million a year by 1999, mostly to causes benefiting children in the San Diego area, where the company is headquartered. Through his personal foundation, Ellis has donated $1 million to his hometown Chula Vista schools, according to a local superintendent’s estimate, and he has guaranteed that all students in the graduating class of 2006 who have the grades but not the money can attend San Diego State University.

“Mike is visionary,” said Sweetwater Union High School District Supt. Edward Brand. “He sees that unless we fix the gap between the haves and have-nots, the country is going to be in for some rough times. He believes that education is the key to doing that.”

The company and its executives also donate to political candidates. Records compiled by the Center for Responsive Politics in Washington show Metabolife and people affiliated with it contributed $1.41 million to federal campaigns between 1999 and 2001.

Metabolife gives to Democrats and Republicans. It has helped state candidates and federal candidates around the country, frequently those with some connection to the government’s regulatory machinery.

It was against this backdrop of growing political influence that Metabolife first heard from Davis.

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In early 2000, one of Davis’ paid campaign fund-raisers telephoned Mauro, the Metabolife lawyer and Democratic political consultant, and solicited a contribution.

As Mauro recalls it, he advised Ellis to donate. “I don’t know any business we’ve got in Sacramento,” he remembers telling his client, “but you might someday.”

Ellis was eager to meet the governor, Mauro said. So Metabolife hosted a fund-raiser for Davis in February 2000 at the Four Seasons Hotel in Austin, Texas. The company contributed $50,000 then, followed by another $50,000 in March.

As he generally does at such events, Davis met privately with the sponsors--Ellis and other Metabolife executives. And as he often does, recalls Mauro, the governor talked about public schools.

“I don’t think we mentioned herbal supplements,” Mauro said. “I can tell you they talked about education, education and more education.”

In Mauro’s view, however, such conversations do not need to be directly on-point to be effective.

“In my mind,” he said, “politics and business are a lot alike. Who do you do business with? People you have personal relationships with. Who do you do politics with? People you have personal relationships with. So the time to become friends with a politician is not when you need to ask him for something.”

That “someday” that Mauro cautioned Ellis to consider arrived the same week as the fund-raiser. Then-Assemblywoman Susan Davis, a San Diego Democrat who is no relation to the governor, introduced legislation to toughen warning levels on Metabolife 356 and other ephedrine products.

“Exceeding recommended serving may cause serious adverse health effects, including heart attack and stroke,” the proposed label said. The legislation also required that labels include a toll-free number, so consumers suffering ill effects could report them to the California Department of Health Services.

Her effort was the latest round in several years of government attempts to regulate the substance.

The U.S. Food and Drug Administration had tried without success to restrict ephedrine-based products since 1997, when it proposed cutting the allowable dose of herbal ephedrine in dietary supplements to eight milligrams per pill, one-third of the amount in many products. That same year, the Food and Drug Branch of the California Department of Health urged the FDA to go even further. California scientists advocated allowing no more than one milligram of ephedra per pill.

The state also called for a prohibition on spiking the products with caffeine, as Metabolife 356 does, and it proposed a warning label with direct language: “Taking more than the recommended serving may cause heart attack, stroke, seizure or death.”

Ellis and a representative of a dietary-supplement trade association traveled to Sacramento in October 1997 to confer with Food and Drug Branch scientists. According to a memo prepared by scientists after the meeting, Ellis’ associate advocated for the right to sell pills containing up to 30 milligrams of ephedra--nearly four times the federal proposal and 30 times the state’s recommendation--with a daily maximum of 150 milligrams.

The following April, Rosanna Porras, a 15-year-old girl from Fillmore, in Ventura County, took two to four pills of an energy booster containing ephedrine (but not manufactured by Metabolife) and collapsed while playing soccer. She died three days later. Her death was blamed on a congenital heart defect. Still, there was intense interest in the possible connection between her death and ephedrine, both publicly and within the Department of Health Services.

“Isn’t it time for the [Food and Drug Branch] to do something?” department toxicologist Susan Loscutoff wrote to her colleagues in an April 21, 1998, e-mail obtained by The Times under the California Public Records Act. “If not [as an] unapproved food additive,” she continued, “then [as an] adulterated or controlled substance?”

Jim Waddell, head of the Food and Drug Branch, replied: “I agree with Susan. Perhaps action is needed.”

No action was taken, however, and by the time Assemblywoman Davis introduced her warning-label legislation in February 2000, some of the early momentum had stalled.

Metabolife’s lobbyist attended hearings and meetings on the bill, but the trade group, the American Herbal Products Assn., of which Metabolife is a member, took the lead in lobbying against it. By August, the legislation had been weakened considerably.

The proposed warning no longer mentioned heart attack or stroke. And rather than require a phone number linked to the Department of Health Services, the bill said the toll-free number would be linked to the industry--and companies could omit the identities of consumers in any adverse-effect reports they turned over to the state.

By the time the Legislature approved the final bill, in August 2000, the industry no longer opposed it. On Sept. 29, 2000, Davis vetoed the watered-down warning label legislation.

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The veto came as a relief to some health experts. One said the final version was worse than nothing. But the governor’s reasoning also troubled them.

“While regulation and labeling of dietary supplements containing ephedrine would seem prudent and in the interest of public safety,” Davis said, “this is a matter of interstate commerce, and clearly the responsibility of Congress to regulate, which they have thus far neglected to do.”

By concluding that the issue was the federal government’s responsibility, said those who want to regulate ephedrine, Davis seemed to be declaring that California would assert no jurisdiction over dietary supplements out of deference to federal authority. It was a curious position, given Davis’ past.

Under Davis and his predecessors, California has used state law to regulate substances it deems dangerous. Earlier this year, state health scientists concluded an “herbal” prostate cancer remedy was unsafe. The Department of Health Services issued a public warning and persuaded the manufacturer to recall it. Last month, Davis signed first-in-the-nation legislation to limit greenhouse gas emissions from automobiles.

Past administrations have similarly asserted the state’s autonomy. Republican Gov. Wilson signed legislation banning smoking in restaurants. And using its own authority, Wilson’s Department of Health Services in 1997 placed warnings unique to California on dieters’ tea after the product was linked to 11 deaths and 67 illnesses nationwide.

In light of that record, some people said Davis’ inaction on ephedrine was inexcusable.

“It’s a cop-out,” said James P. Frantz, a San Diego attorney who has sued marketers of herbal ephedrine on behalf of consumers who have suffered or died after taking the products. “The state of California, if it wanted to do something to protect the consumer, would. The state doesn’t need the federal government to step in.”