Page 6
The Behrend Beacon
Fight over ephedra safety intensifies
by Linda Marsa
Los Angeles Times
Wes Siegner is trying to save ephedra, the
herbal stimulant that is under attack from a
chorus of critics who say it is dangerous to
your health. Even opponents of the lobby
ist marvel at his victories so far, but it is
looking more and more as if he is fighting a
losing battle.
Siegner's task grew more difficult last
month with news of a federal investigation
of Metabolite International, a leading seller
of ephedra in the United States. The fate of
Metabolite, and of ephedra generally, is
likely to influence the broader debate over
the effectiveness and safety of herbs, sports
drinks, diet pills and hundreds of other prod
ucts for which Americans spend about $4.2
billion annually.
" Siegner's job is to protect the industry,
and thus far he's succeeded," says Dr. Sidney
M. Wolfe, director of Public Citizen's Health
Research Group, a consumer watchdog
group in Washington, D.C., that has called
on the Food and Drug Administration to take
ephedra off the market. "But time is run
ning out.-
The anti-ephedra forces are gaining mo
mentum as government regulators, health
officials, scientists and consumer groups
push for tougher regulation of the herb or
its removal from the market altogether.
These critics, including the influential
American Medical Association, say ephe
dra, the active ingredient in hundreds of
energy boosters and diet products, is a health
hazard. They cite evidence linking it to heart
attacks, strokes, seizures--and more than 100
deaths.
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Seven states already have enacted tough
new rules regarding the sale of ephedra
products. The Canadian government in
January issued a national recall of supple
ments containing ephedra. The National
Football League and the National Collegiate
Athletic Association have outlawed the use
of performance-enhancing supplements that
contain ephedra, partly due to safety con-
The growing number of serious medical
problems linked to the herbal stimulant,
ranging from dizziness, headaches, heart
palpitations and high blood pressure to heart
attacks, seizures, strokes and death, threat
ens not only to derail ephedra hut to engulf
the entire dietary supplement industry.
And then, last month the Justice Depart
ment launched a criminal probe into whether
executives at San Diego-based Metabolife
International made false statements about
the existence of 13,000 consumer com
plaints of serious health problems, at least
80 of which included deaths, seizures, heart
attacks or other medical emergencies.
The FDA has sought unsuccessfully for
years to obtain these reports, which
Metabolife refused to provide until the gov
ernment opened its investigation. In the jar
gon of health regulators, such incidents are
commonly referred to as "adverse events."
Siegner, a lanky man with a plaintive lace,
looks more like the high school biology
teacher he once was than an Ivy League
educated lobbyist whose role is to rebut the
arguments of scientists and politicians alike.
Although he says he has no need to take
ephedra, he would do so "in a heartbeat. -
In conversation, the 50-year-old Buffalo-
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horn lawyer never strays far
from his essential--and, clearly,
well-practiced--message.
"Adverse events don't prove
causality," he says.
"These are a random set of
events that happened to people
who happened to be taking
ephedra
When millions of people use
a product--any product--the law
of averages dictates that a cer
tain percentage of them will
have heart attacks, strokes and
seizures, which may or may not
be linked to use of the product.
Only a rigorous scientific study,
say experts, in which one group
is taking the supplement and an
other is using a placebo or
dummy pill, can prove a direct
connection. Otherwise the evi
dence is circumstantial.
The Metabolite investigation
"makes the situation more dif
ficult,- says Siegner, who con
tends that it diverts attention
from the more important issue
of ephedra safety. Stegner has
led the industry's so-far effec-
live campaign to keep ephedra
products on the market by rais
ing doubts about the link between ephedra
and medical problems, and by challenging
industry critics at every turn. Even though
doctors still aren't sure if ephedra is danger
ous, the supplement makers that Siegner
represents contend that these products are
safe when used as directed on the label.
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Ephedra, a stimulant contained in many weight-loss supplements, is under pressure
to be removed from the market due to adverse side effects in some individuals.
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But critics point to the mounting evidence
of serious side effects. This has prompted
some lawmakers, such as Sen. Richard
Durbin, D-111., to push for stricter regula
tion of dietary supplements, which could
hurt the industry by squeezing out smaller
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companies, driving up prices and curtailing
availability of products.
So far, Siegner and the supplement indus
try have managed to blunt many goveth
ment efforts to restrict the availability of
ephedra, including repeated attempts by the
FDA to regulate the herb over the last five
years. Efforts by Siegner and the Duda
Group, a high-profile Washington, D.C.,
lobbying group, along with nearly $4 mil
lion in contributions to both the Democratic
and Republican parties and to Washington
politicians during the past decade, have so
far largely thwarted attempts at stricter regu
lation.
Siegner, whose specialty is product-liabil
ity cases, was hired in 1997 as a lobbyist
for the American Herbal Products Associa
tion,aitrade group► wlapse members include
such industry heavyweights as Herbalife,
Nature's Way and Weider Nutrition. The
Ephedra Education Council, the industry's
public relations arm, was formed later by a
consortium of ephedra makers, including
Rexall Sundown, General Nutrition Cos.
and Twin Laboratories.
In 1997, when the FDA sought to limit
dosages of ephedra and require warning la
bels on products, Siegner helped persuade
Congress to order a General Accounting Of
fice audit. The GAO concluded that the
FDA's proposed rules were based on only
13 cases of adverse events, and that the data
in those reports were too sketchy to blame
them on ephedra, scuttling any regulatory
action.
Since passage of the Dietary Supplement
Health Education Act in 1994, supplement
makers have not had to prove that their prod
ucts--herbal or otherwise--are safe and ef
fective before they put them on the market.
The law, in effect, mandates that the FDA
assume that supplements are harmless until
proved otherwise, according to Christine L.
Taylor, director of the FDA's Office of Nu
tritional Products, Labeling and Dietary
Supplements in Rockville, Md. To remove
a supplement from the market, the agency
must demonstrate that it is dangerous.
After the release of the GAO report, the
FDA asked University of California, San
Francisco researchers to review 140 ad
verse-event reports received by the agency
between June 1997 and March 1999. In an
article published in the New England Jour
nal of Medicine in December 2000, they
concluded that 87 of the medical problems
reported, including 10 deaths, 17 strokes and
seizures, and 13 cases of permanent impair
ment, were likely caused by supplements
containing ephedra.
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In response, the Ephedra Education Coun
cil gathered its own panel of prominent re
search scientists to look at the product's
safety data. The group concluded that
,the
"available information" did not demonstrate
a causal relationship between ephedra ,and
serious medical emergencies when the barb
was used in the industry's recommended in
dividual dosage of 25 milligrams, and, no
more than 100 milligrams a day.
As debate continues over who's rishl
about ephedra safety, the federal govqm
ment has stepped in to try to clarify rpnt
ters. The U.S. Department of Health rd
Human Services in June asked rese,arctrrs
at Rand Colt.; an influential think tank
based in Santa Monica, Calif., to review
1,300 ephedra-related medical emergencies.
The Rand report is expected to be rele4so
this fall, after which the federal healtki
agency will determine if additional reseach
is needed.