Controversy Heats Up Again
Wyn Snow, Managing Editor
is the main ingredient in several popular weight-loss products.
Also known as ma huang, ephedra has appeared in almost a
thousand reports (as noted in the federal Food and Drug Administration's
"Adverse Events" database) of serious adverse effects ranging from
disabilities to death.
claims ephedra causes injuries and death
1997, after receiving reports of hundreds of adverse events, the
FDA proposed to limit ephedra's use in weight management. However,
it withdrew this proposed rule after the industry and congressional
investigators challenged it, saying that the FDA did not have sound
scientific evidence to support their position.
on even more reports of adverse events in the past three years,
the FDA has begun a new investigation into the safety of ephedra.
It held a two-day public meeting on this subject on August 8-9,
and continues to welcome public comment through September 30th.
evidence not reliable
FDA's adverse event reporting system for dietary supplements is
both voluntary and anonymous, making it vulnerable to two very different
kinds of errors. Real adverse events can be underreported -- entirely
missing from the database. False reports can be included -- thereby
creating erroneous information in the database.
an adverse event report that is associated with a product might
be caused by some other health condition or product or interaction
with other products or ingredients -- thereby creating a false impression
of the cause of the adverse event.
believe ephedra is safe at reasonable dosage
McGuffin, a leading herbalist and president of the American Herbal
Products Association, stated in a live interview with Ted Koppel
on Nightline that he does not believe people have died as a direct
result of taking ephedrine. However, McGuffin does "recognize that
ephedra is an herb that needs to be treated with respect."
herbal industry has created dosage limit guidelines and specific
labeling cautions for all ephedra products. [See ephedra
label/dosage guidelines.] McGuffin says they have shared these
guidelines with the FDA and asked them to adopt a similar regulatory
evidence for safety
to the Ephedra Education Council, more than 3 billion doses of ephedra
were consumed in 1999. If those doses were consumed by 1 million
people (300 doses or approximately 3-5 months of use), then approximately
0.0075 percent of those people (75) have appeared in the FDA's adverse
event reports for the year.
this is a significant number, it is modest in relation to the wide-spread
use of the product and in relative terms is no greater than the
number of adverse events associated with many prescriptive drugs.
Also, millions of people safely consume over-the-counter cold and
asthma remedies containing synthetically produced versions of the
same alkaloids present in ephedra.
evidence for risk
contains two alkaloids that are powerful stimulants: ephedrine and
pseudoephedrine. Ephedrine causes blood vessels to constrict and
the heart to beat faster and stronger. Pseudoephedrine opens up
air passages in the lungs and decreases nasal congestion.
of these actions, ephedra has been compared to adrenaline and amphetamine,
both of which are also powerful stimulants to the central nervous
system. Critics have said that ephedra is "nothing more than legal
is causing these adverse events?
Some of the reports of adverse events contain details that are
biologically impossible, strongly suggesting that they are false
reports, but it's unlikely that all of them are. Given that some
of these reports probably reflect real problems, what kind of fire
is causing all this smoke?