Fwd: HOT CONTROVERSIES – EPHEDRA, FROM RFD, MARCH 9, 2003

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Sun, 9 Mar 2003 15:41:05 -0800

HOT CONTROVERSIES – EPHEDRA, FROM RFD, MARCH 9, 2003

 

 

MARCH 8, 2003

RFD’S HOT CONTROVERSIESEPHEDRA — SORTING OUT HYPE FROM WHAT IS KNOWN

The safety and effectiveness of ephedra continues to be a highly volatile

controversy. The FDA wants ephedra product labels to warn that these

formulations commonly used for weight loss, energy boosting and athletic

performance can cause heart attacks or strokes and even kill. The agency has

indicated that it intends to further investigate its regulatory options.

 

The Public Citizen Health Research Group has referred to this warning label

approach as " cowardly. " The Washington-based consumer group wants a ban on all

ephedra products and it is threatening to sue the FDA and the Department of

Health and Human Services to force a ban.

 

One industry group, the Ephedra Education Council, claims that ephedra products

help millions lose weight safely. One key point, the council makes is that

" Ephedra is as safe and effective as other food and over-the-counter products

when used as directed, according to clinical research. "

 

(Ephedra’s active ingredient is a chemical called ephedrine. Ephedra includes

" ephedrine alkaloids " which are naturally occurring compounds found in plants.

Ephedra dietary supplements generally contain standardized extracts that have 6

to 8 per cent ephedrine alkaloids.)

 

Based on our review, there is much that is extremely murky on both sides of the

debate. Much better scientific data will be required before this controversy

blows over, one way or the other. To date, the science has been generally weak,

the FDA review process has been unimpressive and distorted, and the industry

continues to spin science in its favor and is being rather disingenuous in the

manner in which it interprets the available research on ephedra..

 

Ephedra is now a more political issue than a scientific one. Both sides have

blurred the distinction between soap-box pronouncements and honest assessment of

what the available science actually states.

 

Ephedra is being vastly overused and, in fact, its real promise, as revealed by

thousands of years of Chinese medicine, is being ignored and circumvented by the

profit motives of the U.S. dietary supplement industry. In short, ephedra, in

its present use, constitutes a threat to genuine herbal medicine, as it is

practiced by many as part of holistic medicine. The ephedra sales boom is just

another example of what happens to genuine alternative health intentions when

industry grabs onto something that it can exploit: in this case, obesity and

athletic performance anxiety. The excessive marketing, as well as the bad apples

in the barrel, make it more difficult for herbal medicine to be taken seriously.

The shameless marketing of ephedra products as " highs " (just one example of

outrageous abuse) is just the kind of activity that unfortunately casts a shadow

on the use of herbs in general.

 

It is important to keep in mind that the Chinese have used the herb, also known

as ma huang, for over 5,000 years, particularly to treat asthma and reduce upper

respiratory infections. Excessive marketing and greed, particularly in the U.S.,

which sometimes rivals the Big Pharma approach to health, in this case, may well

lead to a total ban. If that is what it will take to stop the free-for-all

marketing going on, along with deceptive arguments about the science, then so be

it. But for those herbal health practitioners who genuinely are interested in

using formulations that include ephedra, this would yet be another blow to

progress in incorporating important alternative concepts into the health care

mix.

 

If ephedra is now deemed so disproportionately important for weight loss, then

there should be strong evidence that it does the job safely and effectively. In

other words, the benefits should certainly exceed the risks. The Ephedra

Education Council cites studies that prove ephedra’s effectiveness for weight

loss. Yes, there are some studies that do just that, but they are altogether not

very impressive, at least in relation to the huge dollars spent by millions of

people. The council states in one of its press releases that " RAND review

Supports Weight Loss Benefits…. " But the fact is, RAND makes it very clear that

" dietary supplements containing ephedra, the drug ephedrine and ephedrine plus

caffeine promoted modest short-term weight loss, averaging about two pounds per

month more than among people taking a placebo. However, none of the studies

reviewed followed participants for longer than six months, less than the 12

months accepted as necessary to establish a drug’s value as a weight-loss aid. "

 

RAND also makes clear that there is NO evidence that ephedra, and scant evidence

that ephedrine, enhance physical performance. Ask yourself this: Who is

responsible for pushing the idea that ephedra products can enhance performance?

 

RAND also had this to report about safety:

 

" The available evidence is sufficient to conclude that these products are

related to a two-or three-fold increase in side effects such as nausea,

vomiting, jitteriness, and palpitations….Furthermore, the evidence suggests a

link between these products and catastrophic events such as sudden death, heart

attack or stroke. "

 

The FDA, which has a deep-rooted in-house cultural prejudice against dietary

supplements, has made such a mess of reviewing VOLUNTARY reports about ephedra

side-effects that the " link " to " catastrophic events, to the degree that critics

of ephedra suggest, is still very much scientifically at issue.

 

Taken as a whole, the RAND report also concludes that " more analyses of existing

data are unlikely to settle the issue and that new data are needed. " The think

tank then goes on to suggest ways that ephedra might be studied.

 

Whether this research now gets done is anyone’s guess. It may well be at this

point that the hucksterism on the ephedra front may be too deeply engrained for

any significant turnaround toward a sensible and science-based ephedra policy.

This is another example of the kind of debacle that occurs when both industry

and the FDA engage in superficial action and reaction.

RESOURCES

RFD has put together the following online reading list that will help our

members access a wide-scale view of the current controversy:

 

RAND STUDY OVERVIEW

 

THE ALLEGED ROLE OF EPHEDRA IN THE DEATH OF A PROFESSIONAL BASEBALL PLAYER

 

THE PERSPECTIVE OF THE EPHEDRA EDUCATION COUNCIL

 

THE EPHEDRA COUNCIL’S CONSUMER INFORMATION ON EPHEDRA

 

THE EPHEDRA COUNCIL’S SUMMARY OF THE FDA’S ACTIONS (INACTIONS) ON EPHEDRA.

 

STATEMENT FROM THE HEALTH RESEARCH GROUP

 

THE HEALTH RESEARCH GROUP’S VIEWPOINTS ON EPHEDRA

 

STATEMENT OF THE AMERICAN MEDICAL ASSOCIATION

 

 

Gettingwell- / Vitamins, Herbs, Aminos, etc.

 

To , e-mail to: Gettingwell-

Or, go to our group site: Gettingwell

 

 

 

 

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