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Metabolife International Under Criminal Investigation
The Justice Department has opened a criminal investigation
to determine if Metabolife International lied when telling
the FDA they had not received any reports of adverse
health effects caused by Metabolife weight loss
pill. Metabolife is the nation's number one maker of
ephedra supplements. Since Metabolife is derived from
ephedra, a plant, any product containing it can be marketed
as an all-natural food supplement and is not regulated
except in cases where the FDA can prove the products
are dangerous.
 Michael
Ellis, former president of Metabolife told the FDA in
1998 that, "Metabolife has never received one notice
from a consumer that any serious
adverse health event has occurred because of the
ingestion of Metabolife 356". When the FDA's news
for their request for the Justice Department's criminal
investigation got out, Metabolife lawyer's released
their records of more than 13,000 health complaints
they had received since 1997 from Metabolife consumers.
This move by Metabolife was considered "disingenuous"
by the FDA after the agency's attempts since 1997 to
obtain this information unsuccessfully due to Metabolife's
repeated refusal and resistance.
In 1997, Metabolife had started a toll-free number
that was included on their product label informing customers
to call with questions regarding weight loss. In a five
year time period, the Metabolife number received over
400,000 calls, but for the first year the company did
not have a system of tracking the questions or complaints.
Metabolife responded that "of those calls, between
1997 - September 2001, approximately 13,000 reported
certain health-related issues and of those, based upon
the expert reports explained below, only approximately
80 reports even mention the primary categories of potential
concern that FDA has identified," including seizure,
stroke, heart attack, or death. Metabolife did not explain
what the other 387,000 calls involved.
There had been 120 more calls that were referred to
hospitalization. Metabolife never reported any information
to the FDA, nor did the company follow up with the customers,
although the company was not required by any law to
do so. The FDA had been receiving reports of heart attacks,
seizures, strokes, and other health
problems from Metabolife users, in addition to other
ephedra products
users. The FDA has now collected over 100 reports of
ephedra related deaths since 1994.
The Public Citizen, who had petitioned the FDA September
5, 2001 for the ban of ephedra
containing products like Metabolife, noted in a
letter to HHS Secretary Tom Thompson of Michael Ellis'
criminal record. Ellis was convicted in 1990 on a drug-related
charge for the illegal manufacture and sale of methamphetamine
and pleaded guilty to a felony charge. Methamphetamine
can be produced from ephedra.
In addition, Metabolife has had a considerable involvement
with political influence. Metabolife was ranked seventh
among all pharmaceutical companies nationwide for donating
$638,000 to federal campaigns by October 1, 2000. The
Texas state health department had been trying to more
tightly regulate dietary supplements and had been battling
with ephedra makers, and Metabolife had spent over $4
million between 1998 and 2000 to lobby against the state
regulations. The San Diego based company also ranked
fourth in California for "soft money" contributions
with $493,000 in 2000 and a $100,000 donation to Governor
Gray Davis' campaign. Governor Davis announced, in an
unusual veto message, that he agreed with virtually
all the major arguments for Metabolife regulation. The
governor's office announced on August 16, 2002, that
California would regulate ephedra-based dietary supplements,
such as Metabolife, unless the federal government takes
swift action.
The future of Metabolife is still uncertain because
under law the FDA cannot check the safety or effectiveness
of herbal products and may not require herbal makers
to disclose health hazards they find. Public Citizen
concluded their August 15, 2002 letter to Secretary
Thompson saying, "Any failure by your department
to: a) agree to aggressively pursue a criminal investigation
against Metabolife President Michael Ellis for apparently
lying to the government; b) to pursue the acquisition
of now-sealed court documents concerning serious adverse
effects of Metabolife, many likely not to have been
reported to the FDA because there is no requirement
to do so; and c) to order a ban on the production and
distribution of ephedra products will ultimately bring
disgrace to you and your department."
For
more information on the metabolife investigation contact
us and learn more about your legal rights.
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