Information on Metabolife
Metabolife Consumer Information
PUBLIC CITIZEN'S
METABOLIFE BATTLE . . .
Public Citizen Health Research Group has been successful
in their efforts to petition the FDA regarding consumer safety, but
after petitioning the FDA September 5, 2001, the watchdog group has
yet to be satisfied. Public Citizen has continually made their concern
for consumer safety when using Metabolife and other ephedra products
known by issuing letters and statements for government action.
If you have taken, or are still taking Metabolife or any
other ephedra-based products, please contact
us to confer with a Metabolife lawyer.
August 15, 2002
Public Citizen issued a letter to the Department of Health and Human
Service’s Secretary Thompson to urge him to direct the FDA to open
a criminal investigation of Metabolife. The letter noted Metabolife
President and co-founder, Michael Ellis’ 1990 conviction on a drug-related
charge that involved the illegal manufacture and sale of methamphetamine
that can be produced by ephedra. Ellis pleaded guilty to a felony charge.
In addition, Public Citizen noted the Washington Post article from December
25, 2000, finding Metabolife had donated $638,000 to federal campaigns,
ranking seventh among all pharmaceutical companies nationwide by October
1, 2000.
Metabolife spent more than $4 million between 1998-2000
to lobby against state regulations in Texas that were trying to regulate
dietary supplements more tightly. Metabolife ranked fourth in California
state “soft money” contributions with $493,000 in 2000 and
a $100,000 donation to Governor Gray Davis’ campaign who vetoed
state legislation imposing restrictions on ephedra use. Public Citizen
aggressively wrote that “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 youand your department.”
June 14 2002
Public Citizen’s Sidney Wolfe made a statement on June 14, 2002,
regarding the HHS’s failure to ban ephedra (including Metabolife)
or to issue adequate warnings. The group had issued a petition to the
FDA September 5, 2001 for the ban of Metabolife and other ephedra products,
and the failure to do so had resulted in well over 100 deaths reported
to the FDA, in addition to more reports of death, stroke, arrhythmia,
heart attacks, chest pain, seizures, and hypertension than for all other
dietary supplements combined. The statement ended with Wolfe summarizing
“it should not require further deaths or strokes in soldiers or
anyone else in this country for the FDAand HHS to abandon their cowardly
position and ban ephedra alkaloids.” Wolfe continued saying, “If
officials in those agencies do not believe that these products ‘present
a significant or unreasonable risk of illness or injury’ (the legal
standard for banning a dietary supplement when there is evidence of
harm at the recommended dose), they are dangerously misinformed, medically
and legally.”
(Public Citizen)
October 11, 2001
On October 11, 2001, Sidney Wolfe, the Director of Public Citizen’s
Health Research Group, made a statement before the National Academy
of Sciences on the Framework for Evaluating the Safety of Dietary Supplements,
a policy that preventedthe FDA to obtain information from Metabolife.
Wolfe’s statement included:
| “The goal of this committee must be to
delineate a scientific evidence-based decision-making process for
setting priorities, but a Catch-22 exists because of the lack of
data on the safety and efficacy for most of these drug supplements.
Priorities for safety review should ideally be based on pre-existing
knowledge of safety problems but the Dietary Supplement Health and
Education Act (DSHEA) prevents the FDA from requiring such data.
Similarly, since the benefit-risk balancing that should precede
a patient’s decision to use drug supplements needs to include
a consideration of effectiveness or benefit in order to ascertain
whether the benefits outweigh the risks--the kind of logic which
eventually led to the 1962 drug efficacy requirement being added
to the earlier 1938 drug safety requirement--DSHEA’s failure
to allow the FDA to require efficacy data is also a serious hindrance.
Safety evaluation is further handicapped by the failure of DSHEA
to require manufacturers to submit adverse reaction reports on their
products. In summary, unlike the regulation of other drugs or even
food additives, wherein the burden of proof lies with the manufacturer
to document safety prior to approval, the burden is on the FDA to
demonstrate harm for these drug supplements despite these disabling
features of DSHEA.”
Read More… |
Wolfe continued to discuss a short-term strategy for the
safety evaluation framework. This statement followed the group’s
previous month’s petition for the FDA ban of Metabolife and other
ephedra products.
(Public Citizen)
Read More Related Ephedra Articles:
»
Reports Continue to Show Ephedra Dangers
»
Public Citizen Requests Ephedra Ban for Second Time
»
Ephedra Linked to High Number of Marine Illnesses
»
Ephedra Class Action Lawsuit Makes Closing Arguments
