U.S. BANS DIET PILL EPHEDRA

U.S. BANS DIET PILL EPHEDRA

The federal government will ban the "fat-burning" and muscle-enhancing herb
ephedra within a few months, after more than six years of study and at
least 155 deaths from heart attacks and strokes linked to it.

In the nation's first-ever ban of a dietary supplement, the U.S. Food and
Drug Administration on Tuesday declared ephedra a hazard even for healthy
adults, in light of more than 16,000 reports of adverse reactions from users.

The FDA urged consumers to stop taking ephedra products immediately and
called on manufacturers and marketers to stop selling it. The ban would
take effect 60 days after the new rule is published, expected in the next
few weeks.

"The time to stop taking this product is now," said Tommy Thompson,
secretary of health and human services. "They are just too risky to use."

The amphetamine-like supplement, derived from the herb ma huang used by
Chinese doctors for centuries, has been found to constrict the blood
vessels, speed the heart rate and raise blood pressure. It has been linked
to 155 deaths, including Baltimore Orioles pitcher Steve Bechler, who
suffered heat stroke after taking Xenedrine during spring training in Fort
Lauderdale on Feb. 16.

Ephedra merchants defended the safety of their products and said they
expected the largest producer, Metabolife, to file a lawsuit to challenge
the FDA ban and tie it up in court for months or years. The legal
wranglings would allow ephedra, which brings in $1.5 billion per year, to
continue being sold in stores and on Web sites.

Consumer groups and attorneys for ephedra victims ripped the FDA for taking
so long to act, despite what they called mountains of evidence dating back
to 1997 indicating it is harmful.

"This ban is trying to wash some of the blood off their hands," said Dr.
Sidney Wolfe of the consumer group Public Citizen, which petitioned the FDA
to ban ephedra in 2001.

"The case was already made by their own staff about six years ago, and they
did nothing. They just waited for a high enough body count and waited for
every major manufacturer to take it off the market for liability reasons,"
Wolfe said.

Hundreds of ephedra victims have filed lawsuits. Bechler's family sued
Xenedrine maker Cytodyne Technologies of New Jersey for $600 million in
federal court in Fort Lauderdale; the case is pending.

Miami-Dade County police Maj. Charles Nanney sued two companies in 1995
after suffering a stroke he alleged was linked to taking an ephedra
supplement. Nanney was paralyzed and lost some brain function, although he
has recovered, said his Miami attorney, Ervin Gonzalez. He won a settlement
from General Nutrition Corp. and manufacturer Ultimate Nutrition.

In a similar case, Arthur and Carol Halperin of Boyton Beach last year sued
Cytodyne after a severe reaction to Xenedrine. The case is pending,
although the company has filed for bankruptcy protection.

Wolfe said the delay in banning the herb has allowed the largest supplement
makers to make and market "ephedra-free" diet pills and muscle formulas
that have not been proven safe, Wolfe said.

As part of its ban, the FDA sent letters to 65 companies -- six in South
Florida -- warning of legal action against them if they did not stop making
or selling ephedra pills and sports drinks when the ban takes effect.

"This is far from over," said Jack Owoc, chief executive of VPX Sports in
Davie, which makes and sells the ephedra and caffeine mixture Clenbutrx. A
bottle of about 8 ounces sells for $100. He and others in the industry said
the FDA move was prompted by pharmaceutical companies trying to eliminate
the competition to their diet pills.

"I think [ephedra products] provide a significant health benefit," Owoc
said. "Just look at the number of obese people in this country and how many
have been helped by ephedra. They are not as dangerous as people make them
out to be. You take away the right of the consumer to choose."

Rexall Sundown in Boca Raton stopped making ephedra products in March. Carl
Hymans, a spokesman for Rexall's parent, NBTY Inc., said the ban shows the
FDA has the power to take action without changing the nation's laws over
supplements.

Public Citizen's Wolfe, however, said laws on supplements need an overhaul.
Unlike prescription drugs, which must be proven safe in advance,
supplements can be sold with no studies on safety or effectiveness unless
the FDA can prove they are unsafe.



The Associated Press contributed to this report.

BAN ON EPHEDRA: RUSH TO JUDGEMENT

The beginning of the end for naturally produced ephedra was probably
the death last spring of a baseball player who was overweight, had
liver disease and high blood pressure and was practicing in hot weather.

And, oh yes, reports about all of this tell us, he had taken a dietary
supplement that included ephedra.

It's a fault of democracy that a dramatic incident can be more
compelling to the public mood and political instincts than carefully
weighed scientific data or a rational assessment of comparative risks,
and it is therefore no surprise that the Bush administration has
announced a ban on the product when it is derived from herbs.

Do not suppose, however, that it is thereby a given that public health
will improve. Ephedra products really do help people lose the fat that
diminishes their well-being to the tune of thousands of premature
deaths each year. And, some commentators have pointed out, the
demonstrated dangers of these products are less than the dangers of
any number of other commonly consumed drugs and chemicals, including
aspirin and the caffeine you swallow with your coffee.

Especially if you disregard the directions for use, the stimulation
from ephedra products can contribute to such scary afflictions as strokes.

Care is needed, as is the case with virtually all activities in this
life, and federal requirements for warning labels would have made
great, good sense.

Instead, the government is acting to ban the products within months,
denying people the right to make some judgments on their own.

If consumers had that right, they might note that millions of people
have consumed billions of ephedra-containing pills each year to no ill
effect and, in at least some cases, to beneficial effect.

They might also come to the elementary conclusion that the coincidence
of the taking of the pills with illness or death is no more a proof in
itself of cause and effect than a rooster's crowing can be assumed to
prompt a sunrise.

Perhaps, if challenged in court, the administration will show that it
has more reliable data of unacceptable risk than various publicized
studies have so far put on the table. The suspicion of the moment has
to be, first, that the action is driven more by politically
unacceptable headlines, and, second, that there's not a whole lot of
hand-wringing in the administration about still another failure to
treat Americans as responsible, free adults at least as intelligent as
those who would dictate their choice

The blood is not on the hands of the manufacturers, but on the hands of the FDA, as they forbid to give proper productinformation with these products. It is forbidden to say what many of these products really are: Herbal XTC's. That would be "abuse of products". It is ok, to name them energy supplements or diet supplements and so people start taking Yellow Jackets, etc daily. And so peopledie. Have you ever tried hardcore products like Yellow Jackets? Once the effect comes on it's like a speed rush. No way of standing still. Dance your ass off!


Now; imagine your granny on them. Daily!Or sportfanatics, which are already pushing the limits to the extreme. Ofcourse people are dying. If that's not an "abuse of products" what is? In the Netherlands, where these products have been sold, for over a decade, there has not been one incident, with these products.


And this will not end with the banning of ephedrine containing supplements. It will continue with other herbs, including stay awake pills, containing only high dosage of caffeïne. There will always be legal alternatives to illegal drugs.Why ban less harmfull alternatives to illegal substances? Clearly not from the point of concern over public health.