U.S. in
Criminal Inquiry on Metabolife Product
By PHILIP
J. HILTS
 he
Justice Department said yesterday that it was conducting a criminal
investigation into Metabolife International, a leading manufacturer
of the herbal stimulant ephedra, to determine whether executives
lied about what they knew about the safety of the substance.
Lester M. Crawford, the deputy commissioner of the Food and Drug
Administration, said in a statement yesterday that the agency had
asked the Justice Department to pursue the investigation because
after years of seeking company reports on consumer complaints, "we
are greatly disturbed that Metabolife has repeatedly refused to
cooperate with the F.D.A." The Justice Department confirmed that
there is an investigation into the company, whose main ephedra
product is Metabolife 356.
In 1998, the president of the company at the time, Michael Ellis,
said in a statement to the F.D.A. that the company had "never
received one notice from a consumer that any serious adverse health
event has occurred because of the ingestion of Metabolife 356."
A company spokeswoman, Jan Strode, said yesterday that "Michael
Ellis has not made any false statements to the F.D.A."
But court records from lawsuits have since shown that the company
received many reports of bad reactions to the product, according to
Eugene Thirolf, a Justice Department lawyer. He said in a letter to
the F.D.A. that staff members at the department were ready to try to
obtain those records and pursue an investigation of the company.
In a surprise move, Metabolife, a closely held company based in
San Diego, said yesterday that it would release its record of
consumer complaints about the product.
The company said that it had about 13,000 complaints, including
some dated before Mr. Ellis's statement. About 80 mentioned serious
injury or death, and 100 to 200 involved hospitalization, the
company said. Mr. Crawford of the F.D.A. said that "given their long
history of being uncooperative, we view their offer to make these
reports available now to be disingenuous."
But company officials said that just the reporting of an injury
or death did not mean that the product was the cause of the problem,
and so the company maintains that it was and is truthful to say that
ephedra has not been shown to cause adverse health effects.
"The F.D.A. has a right to ask for an investigation, but we are
confident that there is no wrongdoing here," said Lanny Davis, a
lawyer for Metabolife, according to Bloomberg News. "We are being
totally transparent."
In a statement, Metabolife also said that it wanted the
supplement industry to submit to mandatory reporting of adverse
effects from herbal products, and it asked that the F.D.A. be given
the power to carry that out. The company also offered to finance a
campaign to warn consumers of the dangers of the "abuses of ephedra
products."
Ephedra is an amphetamine-like stimulant that is widely used for
weight loss and, more recently, to enhance the performance of
athletes.
Mark Blumenthal of the American Botanical Council, a nonprofit
group that monitors herbal supplements, said that figures showed a
very large increase in the use of ephedra since herbal supplements
were deregulated in 1994, from about 425 million "servings," or
doses, sold in 1995 to 3 billion sold in 1999.
Under law, the F.D.A. cannot check the safety or effectiveness of
herbal products and may not require herbal makers to disclose health
hazards they find.
The Public Citizen Health Research Group has petitioned the F.D.A.
to try to pull ephedra off the market. The director of the group,
Dr. Sidney M. Wolfe, said yesterday that "ephedra causes more deaths
and injuries by itself than all the other herbals put together, and
it is time to get it off the market."
The number of deaths and injuries from the substance is not
known. More than 100 deaths have been reported over the last decade,
Dr. Wolfe said. But it is unclear whether they could be attributed
to use of the product or to some other condition in the patients at
the same time.
The F.D.A. has struggled with herbal manufacturers over ephedra
since deregulation. The F.D.A. has tried to collect data on the
number of deaths and injuries attributed to the product. But the
agency does not have a system to do anything other than receive
reports from patients and doctors, and manufacturers have not
cooperated with the agency.
The F.D.A.'s attempts to collect the data have been criticized by
the General Accounting Office and the herbal industry as incomplete
and therefore not a sufficient basis to say how many injuries had
been caused and what kind of regulation was needed.
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