INSTEAD OF METH, HE NOW MAKES METABOLIFE

The Brains Behind Thepopular Diet Supplement Was Once Busted For Cooking
Methamphetamine. The Legal Supplement And The Illegal Drug Aren't All That
Different, Critics Say

Michael J. Ellis, a 46-year-old San Diego businessman, is the brains
behind a weight-loss product advertised as the No 1 herbal dietary
supplement in America. Retail sales for his privately held company,
Metabolife International, soared from less than $2 million in 1996 to
$600 million last year.

Ellis has become wealthy selling a product that shares a key
ingredient with a drug that got him arrested 10 years ago. He was
busted for running a methamphetamine lab in a house not far from his
new $2 million home in exclusive Rancho Santa Fe. Back then, Ellis and
his friends used ephedrine to make meth, a highly addictive illegal
street drug. Today he uses ephedrine to make Metabolife 356, the core
of his diet empire.

Ten years ago, Ellis was in court fighting the government on his drug
case. Today, he threatens to take the government to court if they get
in the way of his ephedrine business. He is president of an industry
coalition that has so far blocked federal regulators seeking to limit
ephedrine products because of safety concerns.

Ellis' story illustrates the difficulties federal agencies have in
dealing with chemical substances that have many different uses. It
also shows how a threatened industry can use a high-powered campaign
of lobbying and political giving to stymie government agencies charged
with protecting the public from substances that might be unsafe.

"It's a Catch-22 for the government," said Don Martin, a Drug
Enforcement Administration agent in San Diego. "While ephedrine can be
used for absolutely hideous things, like meth, it also can be used for
absolutely wonderful things."

Legal Speed

Ephedrine is a stimulant that is found in nature and can be made
synthetically. It has been used in asthma medicines for years, but
recently its popularity has soared as entrepreneurs like Ellis have
packaged it with caffeine as an energy booster and diet aid.

Since the ephedrine in Metabolife 356 comes from the ephedra plant,
also known as the Chinese herb ma huang, Ellis can market his product
as an all-natural diet supplement. Such supplements are considered
"foods" and not "drugs" under a 1994 law and thus do not require FDA
approval for safety or efficacy before they are marketed. Instead the
law shifted the burden of proving a dietary supplement unsafe to the
regulators.

Reports of hundreds of adverse reactions and at least 38 deaths --
some overdoses -- associated with ephedrine-based products have
alarmed the FDA and regulators in many states. In 1996, the FDA warned
that ephedrine "is an amphetamine-like stimulant" that can damage the
nervous system and heart. In June 1997, the FDA proposed a rule that
would place severe limits on how much ephedrine a supplement could
contain and how long it could be used. Ellis said the rule would
"virtually eliminate" his business.

Last fall, the DEA proposed tighter controls on ephedrine because of
concerns that it is being diverted to make methamphetamine. DEA agents
have reported finding ephedrine-based diet supplements in raids on
meth labs, a claim the industry disputes.

Ellis and other members of his coalition charge that the FDA has not
properly documented the reported health problems, which they contend
are relatively few compared with the billions of servings people take
annually.

"They're (FDA officials) trying to deal with an issue they can't put
in a pigeon hole," Ellis said of the dispute.

Some doctors and regulators see the issue as that of a drug that has
been allowed to masquerade as a health food.

"You can't tell me a horse is a cow," said Frank Wickham, recently
retired executive director of the Ohio State Board of Pharmacy.
"Ephedrine is a drug regardless of what they say."

Ellis and his company have played politics -- at the state and federal
levels -- the old-fashioned way. One of the industry's strongest
supporters is Ellis' hometown congressman, Rep. Brian Bilbray,
R-Calif. Metabolife officials and distributors donated $26,000 to
Bilbray's last campaign -- 2 1/2 times more than he received from
employees of any other company, according to federal election records
analyzed by the Center for Responsive Politics. Ellis and a partner,
who also has a methamphetamine conviction, donated $10,000 to Texas
Gov. George W. Bush last year at a time when state regulators were
rejecting tough proposed restrictions on ephedrine products.

Ellis declined to discuss his criminal record, and the records are now
sealed. But he is vocal in defending his product as a natural herb
that helps millions. "Every herb on the market, the Food and Drug
Administration says is dangerous," he said.

He said Metabolife has never been sued by a customer and has received
no reports of serious health problems from its users. He cites
independent studies to back up his claims that Metabolife 356 is safe
and effective.

But two of the studies were done on animals, just the first step in
testing safety for humans. Vanderbilt University Medical Center
denounced a Metabolife contractor's use of its name in touting a
two-week efficacy study as proof the product was safe. Last month, a
summary of a Columbia University study of 48 overweight people over
eight weeks found Metabolife effective for weight loss but added a
caveat: "Safety for long-term use requires further study."

Steven Heymsfield, a Columbia physician who also has studied new
prescription-only weight-loss drugs, called his Metabolife study
"exploratory" and said Ellis is funding part of a longer-term safety
study. Heymsfield said he "wouldn't hesitate" to recommend Metabolife
to a patient if he knew the patient didn't suffer from high blood
pressure, heart disease or other maladies mentioned on the warning
label.

Critics, who sometimes call ephedrine "legal speed," worry that people
assume "all-natural" supplements are healthy and take them without a
doctor's advice or knowledge.

Busted For Drugs

In 1988, methamphetamine's popularity as a street drug known as
"speed" or "crank" and controlled by outlaw motorcycle gangs gained
the attention of Congress and of two California boyhood friends,
Michael Ellis and Michael Blevins. That fall, the DEA convinced
Congress it needed new powers to control ephedrine and other precursor
chemicals used to make meth. Chemically, there is only one atom of
difference in the molecular structures of ephedrine and
methamphetamine.

Around that time, Ellis, a 35-year-old former police officer, joined
with Blevins and another man to produce a batch of methamphetamine,
for which Ellis received $17,000, according to court documents that
The Washington Post obtained before they were removed from public
view. Someone tipped off the FBI, and the men were caught up in a DEA
sting operation that employed video cameras in a phony chemical-supply
house called Triple Neck Scientific.

They were among 100 individuals indicted in San Diego in early 1989.
Ellis, who had no previous criminal record, pleaded guilty to one
count of using a telephone to further a drug deal and was sentenced to
five years' probation. Blevins and the other defendant got 5 1/2 years
in prison.

When Blevins got out of prison in 1996, he got permission to join
Ellis at Metabolife. Blevins, who Ellis said has retired from the
company, could not be reached for comment.

Back In Business

His conviction did not prevent Ellis' entry into the diet supplement
business. By 1992, he and a partner, W. Robert Bradley, had started a
company to market an herbal product as an energy boost for
weightlifters. It contained ephedrine and caffeine. Ellis said he
developed the formula for his father, who was dying of cancer.

In 1995, Ellis started Metabolife International, adapting the earlier
formula to make Metabolife 356. This time, he marketed the product
primarily for weight loss. Ellis successfully sought an early end to
his probation so he could travel freely to build business, court
records show.

The 1994 diet supplement law that weakened FDA oversight of the herbal
industry helped propel the success of Ellis and Metabolife 356. For
David Kessler, then head of the FDA, the law had been a bitter defeat
in the FDA's fight to regulate diet supplements. The industry had
inundated Congress with mail from angry consumers and produced TV
commercials of movie star Mel Gibson handcuffed by FDA agents for
possessing vitamins.

But the 1994 law did not stop the FDA from scrutinizing
ephedrine.

In early 1995, the FDA followed Texas' lead and warned consumers not
to buy the ephedrine-based product Formula One. The FDA also proposed
that ephedrine be removed from over-the-counter drugs like Bronkaid
and Primatene Mist. It said the stimulant's use to relieve asthma
symptoms "can no longer be justified when the drug's potential for
illicit use and misuse is considered."

The FDA issued another warning in 1996 after a Long Island college
student died taking ephedrine pills marketed as a legal high. His
family collected a $2.5 million settlement from the product's
manufacturer. A week later, a graduate student in Boston died after
using an ephedrine energy-boost product.

In an effort to tie ephedrine directly to the death, internal FDA
documents show, Kessler aides asked the medical examiner to run tests
for the stimulant, and the death certificate was revised to cite
ephedrine and the brand name of the product. Kessler cited the two
deaths in pushing for a tough stance on ephedrine supplements.

Lobbying For Survival

In June 1997, the FDA issued a proposed rule limiting ephedrine to 8
milligrams a dose and 24 milligrams a day, much lower than the 25- to
100-milligram limits the industry had succeeded in setting in some
states. The proposed rule also forbade using ephedrine for more than a
week or mixing it with other stimulants such as caffeine.

Metabolife and other companies viewed the proposal as a death threat.
They set up the Dietary Supplement Safety and Science Coalition to
fight back, arguing that the FDA's reports on deaths and adverse
reactions were sketchy and flawed. Although an FDA database notes 14
adverse reaction reports and one death involving Metabolife products
over the past few years, Ellis said the agency has never provided
documentation. The FDA said it has been too busy to respond to Ellis.

In early 1998, the coalition hired a Washington lobbying firm, the
Dutko Group, at $145,000 a year, according to federal lobbying
reports. A Dutko lobbyist prompted Reps. James Sensenbrenner, R-Wis.,
and George Brown, D-Calif., the top two members of the House Science
Committee, to ask the General Accounting Office to review the FDA
injury reporting system, a Brown aide said.

Rep. Dan Burton, R-Ind., said in a March hearing that he was concerned
that the FDA's proposed ephedrine rule is based on "faulty reporting
and a long-standing bias in the agency." Burton's committee has
scheduled a hearing Thursday on the FDA's adverse reaction reporting
system, focusing on ephedrine.

New FDA Commissioner Jane Henney promised Burton she will try to
develop "a positive" relationship with the supplement industry. Joseph
Levitt, her top aide for "foods," said the ephedrine rule is still at
the top of his dietary supplement priority list.

Ellis said his industry is prepared to sue to block the FDA. "I'm the
first one to tell you that if there's an herb out there that, even if
properly labeled, is dangerous, it should be off the market." But he
noted the FDA has the burden of proof. "It's like America," he said.
"You're innocent until proven guilty."

Barbara Michal, of Novi, Mich., started an anti-ephedrine group in
1997 after her son died from using an over-the-counter ephedrine
product that contained more ephedrine than Metabolife or many other
diet supplements.

"They have powerful lobbyists. Who do the victims have?" Michal said.
"It seems to me that the FDA is not getting the job done."