Confessions of a Quackbuster

This blog deals with healthcare consumer protection, and is therefore about quackery, healthfraud, chiropractic, and other forms of so-Called "Alternative" Medicine (sCAM).

Tuesday, July 12, 2005

Ephedra Death Case Settled for Almost $1 Million by Nutraquest Inc. and Four Other Companies

Ephedra Death Case Settled for Almost $1 Million by Nutraquest Inc. and Four Other Companies

Date Published: July 12, 2005
Source: Newsinferno.com News Staff

On February 17, 2003, 23-year-old Baltimore Oriole pitcher Steve Bechler
died of multiple organ failure secondary to heatstroke while at spring
training. He was 6’2” tall and 239 pounds. At the time, he had been
using Xenadrine RFA-1, an ephedra-based weight loss product.

Bechler was working out in extremely hot weather with heavy clothing in
an attempt to lose weight. He also had a number of risk factors which
should have discouraged him from using the product. A medical examiner
found ephedra contributed to the deadly heatstroke where Bechler’s body
temperature soared to 108 degrees.

Bechler’s wife instituted a $600 million dollar lawsuit against the
product manufacturer Nutraquest Inc. (formerly known as Cytodyne
Technologies), which filed for bankruptcy in October 2003. Several
lawsuits against the company are in mediation discussions.

Now, according to Newsday.com, a settlement has been announced wherein
Nutraquest, its owner, and three related companies have agreed to pay
almost $1 million and refrain from making unsubstantiated claims in
their advertising.

Nutraquest states that it stopped selling ephedra-based products in 2003
because they were no longer profitable. Although the company claims 10
clinical studies have proven their products are safe and effective when
used as directed, it settled the case “to avoid the uncertainty and cost
of litigation.”

Ephedra is a stimulant containing ephedrine, an herbal “remedy” often
used for weight loss, increased energy, and to relieve the symptoms
associated with asthma, congestion, hay fever and allergies, and the
common cold. (Ephedrine-containing products may list any of the
following ingredients on their labels: ma huang, Chinese Ephedra, ma
huang extract, Ephedra, Ephedra Sinica, Ephedra extract, Ephedra herb
powder, Sida Cordifolia, or epitonin.)

Ephedra is a shrub-like plant that is found in desert regions in central
Asia and other parts of the world. The main active ingredients in
ephedra are the alkaloids ephedrine and pseudoephedrine.

Ephedra, which is or has been used in a wide array of products, has been
accused of causing adverse reactions including heart attack, stroke,
tachycardia, paranoid psychosis, depression, convulsions, coma, fever,
vomiting, neuropathy (nerve damage), myopathy (muscle injury),
palpitations (rapid heart rate), hypertension (elevated blood pressure),
memory loss, insomnia, nervousness, tremors, seizures, respiratory
depression, and even death.

While most of the products containing ephedra include only the
recommended or otherwise permissible amounts of the supplement, some of
the products, such as those designed for weight-loss and body building,
often contain unsafe amounts of the substance, are used in unsafe
concentrations, are used under conditions which greatly increase the
risk of injury, or are taken by people who have one or more risk factors
which made the use of Ephedra extremely dangerous.

The likelihood of suffering serious health problems increases as the
exposure to ephedra-containing products increases. However, even
short-term use at increased levels, or under adverse conditions, or by
those with known risk factors, may prove to be even more dangerous.
Sudden “jolts” of ephedra in high dosages may result in heart attack,
stroke, seizure, or death.

As a result of the efforts of Health Canada to stop the improper use of
ephedra, the sale of Ephedra products was banned completely in Canada in
January 2002.

In October 2002, the FDA announced that it was stopping imports of
“Yellow Jackets,” an herbal amphetamine product which contains ephedra
among other stimulants.

This action was likely a response to the death of a teenager who died
after taking Yellow Jackets. The FDA claimed that there did not seem to
be any legitimate use for this product and that it was being marketed to
consumers as an alternative to cocaine and other “street drugs”.

In February 2003, the Department of Health and Human Services (HHS),
working in conjunction with the FDA, announced that they were finally
going to take action to protect Americans from potentially serious risks
associated with products containing ephedra. HHS and the FDA stated that
they would make information concerning the health risks associated with
Ephedra more readily available to the public in order to support new
restrictions on Ephedra-containing products.

In addition, they demanded that new warning labels, which accurately
explain the risks associated with ephedra use, appear on any products
which continue to be marketed. They also sought to eliminate false or
misleading advertising associated with the substance (as in the case of
Yellow Jackets and energy-boosting products which promise enhanced
athletic performance).

The results of a RAND Corporation study were perhaps responsible for
this change in FDA and HHS policy as these results illustrated just how
harmful ephedra can be when used both properly and improperly.

The results of the study listed about 16,000 adverse side effect reports
including two deaths, four heart attacks, nine strokes, one seizure, and
five psychiatric cases. The report also concluded that while
ephedra-products make up less than one percent of all dietary
supplements sales, these products account for 64% of adverse events
associated with dietary supplements.

As a result of these findings, the FDA sent warning letters to more than
two dozen firms marketing dietary supplements that contain ephedrine.
The FDA also proposed a new warning label which illustrates the serious
health risks associated with ephedra and the heightened risk of these
health conditions when the supplement is taken in unsafe dosages, with
strenuous exercise, and with other stimulants such as caffeine.

Notwithstanding efforts to restrict the sale of ephedra-based products
and to prohibit unsubstantiated advertising claims, young people and
athletes often risk serious injury or death by taking unsafe amounts of
the supplement without proper medical monitoring.

As discussed above, on February 17, 2003, Steve Belcher died of multiple
organ failure secondary to severe heatstroke while using an ephedra
based weight loss product in an inappropriate way and probably in unsafe
amounts.

On November 21, 2002, Johnny Perry, a 30-year-old strongman (6’5” and
375 pounds) died shortly after finishing among the top qualifiers in the
World’s Strongest Man competition. Perry, who also used steroids, was
known to “get wired” before a competition by taking 5 or 6 capsules of
Ephedra.

In May of 2003, following the death of a 16-year-old boy in Illinois who
ingested Ephedra in order to help him make the football team, a
nationwide class action lawsuit against Metabolife and other
manufacturers of Ephedra-containing products was commenced. As a result
of this lawsuit, Illinois completely banned the sale of Ephedra.

Many sports organizations such as the NCAA, the NFL, and the
International Olympic Committee have already banned Ephedra while others
are considering similar bans.

In addition, General Nutrition Centers (GNC) announced that it will no
longer sell Ephedra-containing products due to the overwhelming reports
of adverse health events. Many of the manufacturers of products which
had included Ephedra or one of its derivatives or associated compounds
have reformulated theirproducts to exclude those substances. Their
advertising campaigns clearly announce their products are now "Ephedra
free.”

Although Ephedra was finally banned by the FDA in April 2004, the ban
was lifted by a federal judge.

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