|
Recent ephedrine lawsuits beg the question of whether federal and state lawmakers and
regulators are adequately policing the diet industry
as a whole. Federal law forbids regulation of most dietary
supplements unless the FDA proves danger. In 1999, the
FDA tried to enforce dosage requirements for ephedra
supplements like Metabolife, citing death reports,
but industry protests eliminated this FDA proposal.
Bill Gurley, a University of Arkansas pharmacologist,
said in 1999 that he was worried about people taking
ephedra products
and that "if a conventional pharmaceutical company
had this kind of quality control, the FDA would shut
them down in a heartbeat." When Gurley analyzed
about 20 ephedra products he found that there was great
variability in the amount of active ingredient between
products, in addition to within the same brands. Now,
after years of trying to obtain Metabolife reports on
consumer complaints the agency asked the Justice Department
to pursue a criminal investigation on Metabolife. Lester
Crawford, deputy commissioner of the FDA, stated, "we
are greatly disturbed that Metabolife has repeatedly
refused to cooperate with the FDA."
 Michael
Ellis, former Metabolife president, told the FDA in
1998 in a statement that the company had "never
received one notice form a consumer that any serious
adverse health event
has occurred because of the ingestion of Metabolife
356." Information obtained from Metabolife lawsuits
show that Metabolife has received reports of Metabolife
adverse reactions according to a lawyer from the Justice
Department. The Justice Department is trying to obtain
the records for the criminal investigation that had
been protected by judicial gag orders.
September 2001, Public Citizen petitioned that all
ephedrine products be banned, and in June 2002, the
Health and Human Services Secretary Tommy Thompson announced
instead of deciding on that petition the government
had hired Rand Corp. to review all scientific reports
on ephedra's safety. The ephedra report results are
due in the fall of 2002, and the FDA has put off a decision
until at least then. This decision not to ban ephedra
infuriated consumer advocates and doctors who have wanted
ephedra banned due to the high number of adverse
effects. An analysis in the New England Journal
of Medicine in 2000 said at least 54 deaths and about
1,000 reports of complications had been linked to ephedra
since the mid 1990s, and there are currently 100 reported
deaths.
The FDA hired pharmacologist Raymond Woosley in 1995
to analyze the rash of deaths and heart problems in
teenagers that had taken ephedra. After investigating,
Woosley felt there was "no doubt in my mind that
these were being caused by the ephedra
products." Still, no action was taken to restrict,
warn, or ban ephedra use. When Woosley was summoned
in 2000 to review 135 more cases of ephedra use in mostly
young women and athletes, the FDA still failed to act
despite the deaths, heart attacks, and strokes experienced,
and this, in part, according to Woosley was because
the agency was "under pressure from the powerful
ephedra industry". Now, a criminal
investigation is underway to determine if executives
at Metabolife International lied about what they knew
about the safety of Metabolife.
A few hours after news that a federal investigation
on Metabolife was made public, Metabolife announced
they were finally going to give the FDA the 13,000 complaints
it has received since 1997, with 80 of them involving
deaths, seizures, heart attacks, or other serious
events. The number that Metabolife provided caused
even more concern than initially thought, according
to Dr. Lester Crawford, the acting commissioner of the
FDA. Crawford finds that "there is even more concern
than when we started the investigation three weeks ago,
now they have come forward with at least 80 serious
adverse event reports. We still have Americans who are
consuming this product, and allegedly vital information
is being withheld from us, and we are reaching the end
of our tethers". Although Metabolife claims to
be involved in no wrongdoings and has described themselves
as "being totally transparent", Crawford thinks
that Metabolife's last minute attempt to be forthright
is insincere, saying "given their (Metabolife's)
long history of being uncooperative, we view their offer
to make these reports available now to be disingenuous."
The future of Metabolife continues to be investigated,
but already a growing list of organizations has banned
ephedra-based
products. The list of organizations to not allow
Metabolife and other ephedra products includes, the
National Football League,
the International Olympic Committee, and the National
Collegiate Athletic Association. Last year the Canadian
government warned people to not use Metabolife or any
other ephedra
products. A small network of personal injury lawyers
have been pursing litigation against companies that
sell ephedra-containing products that had up to this
point been widely unsuccessful due to the lack of legal
consensus on its safety. The controversy will continue
to grow as long as additional research is not performed
on ephedra, and the number of consumer advocates and
doctors outraged by ephedra's continued availability
on the market keeps growing.
For
more information on ephedrine lawsuit contact us and
learn more about your legal rights.
Ephedrine News -Ephedrine Lawsuit
|
