Ephedra sinica and The Fear and Death Administration

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Ephedra sinica and The Fear and Death Administration

JoAnn Guest

Sep 19, 2004 19:26 PDT

 

Ephedra sinica and The Fear and Death Administration

Toj-@a...

 

I send this in case any of you do not understand the far reaching

significance of FDA's decision to ban Ephedra.

 

They obviously do not worry about 110,000 annual deaths from in

hospital use of approved drugs, but really want to control the

dietary supplement industry.

 

There are at most 2-3 deaths that appear to have a significant

relationship, and in those cases,

abuse of recommended dosages was a major contributor to the outcome.

 

So to " protect " the public they would make EVERY dietary supplement

go through MAJOR toxicity studies to drive the cost out of sight!

 

If they really cared to " protect the public " , they would check a

real

percentage of all cattle for mad cow disease.

 

But it is important to understand that sometimes you LOSE if you

fight too hard about saving ephedra - this is NOT simple.

 

Garry F. Gordon MD, DO, MD(H)

President, Gordon Research Institute

www.gordonresearch.com

 

 

In my opinion, allowing this latest ruling by the FDA to go

unchallenged will open the industry to attack on almost any basis.

 

The industry should oppose the ruling if for no other reason than it

sets a precedent for one of the most obvious double standards in my

recollection.

 

The following are a few points of interest that should not be

ignored.

 

Ephedra contains ephedrine.

It stands to reason that an isolated, purified form of the active is

potentially more hazardous than a plant containing lower levels.

 

If Ephedra is considered so hazardous, why are a majority of

allergy/decongestant medications

being sold over the counter " contaminated " with ephedrine HCL or

Ephedrine Sulfate?

 

Why are 75mg dosages of Ephedrine HCL administered to elementary

children for ADD?

 

How likely is it that other stimulants are completely avoided in all

of these instances?

 

Clearly Ephedra is one supplement that competes with a burgeoning

pharmaceutical market niche.

 

If you believe that the FDA would not participate in such a

political market showdown, consider the following.

 

I attended a seminar (Focus on the Future) where an FDA employee

stated that any supplement that acts like a drug and has

physiological activity should be regulated as a drug.

(His fist was closed and softly pounding on the table for added

emphasis.)

 

This was not in regards to Ephedra, but SAW PALMETTO! Incidentally,

I know of no adverse events even remotely attributed to this

supplement.

 

However, I am aware that within a period of five years,

Saw Palmetto stole nearly 50% of the pharmaceutical market for

Proscar.

 

I could go on, but perhaps the best defense of my position comes

from a matter of public record.

 

A quotation from the FDA Dietary Supplement Task Force Report, page

2, June 15, 1993, deserves careful reading.

 

" The [FDA] Task Force considered various issues in its

deliberations;

including ... what steps are necessary to ensure that the existence

of dietary supplements on the market does not act as a disincentive

for drug development. "

 

I rest my case.

 

David Parish

President

Designed Nutritional Products

 

DSHEA permits FDA to declare an ingredient or product to be

declared " adulterated " if it presents a significant or unreasonable

risk under conditions of use described in labeling (paraphrase).

 

The term " unreasonable risk " is not defined, but must logically be

definable and was clearly intended by the framers of the law to have

some meaningful impact.

 

We have not yet seen FDA's rationale for

the action they plan to take, and the details will be important. I

don't believe we can reject out of hand the potential for developing

a reasonable rationale and definition of the term.

As for the argument that this opens the door to a wholesale attack

on

other ingredients, that assumes a level of potential risk or even

physiological activity for those other ingredients that I for one am

not aware of.

 

Let us be thoughtful about this issue, because it is

huge. By its advance notice, FDA has created an opportunity for

frenzy to build, as everyone speculates about worst-case scenarios,

in the absence of solid information about the agency's actual

arguments.

 

I know this useful dialogue within the industry will

continue and will raise valuable points to be considered, but I hope

we won't let the momentum push us into assuming we " must " oppose any

and all efforts to define and implement the " unreasonable risk "

provision of DSHEA.

 

As Senator Hatch has pointed out, the fact that FDA is choosing to

act by implementing DSHEA is a potentially powerful demonstration

that the law works when FDA decides to make it work.

 

Annette Dickinson, Ph.D.

President

Council for Responsible Nutrition

1828 L Street, N.W., Suite 900

Washington, D.C. 20036

202 776 7951 direct line

202 776 7929 CRN main line

202 204 7980 FAX

anne-@c...

_________________

 

JoAnn Guest

mrsjo-

DietaryTi-

http://www.geocities.com/mrsjoguest/Beans.html