FDA and practitioners of Chinese medicine

April 15, 2004

I agree with Andy. this is the only long term solution

On Thursday, April 15, 2004, at 09:33 AM, Andrew Ellis wrote:

To the list of companies and people concerned with the herb ban:

I will here put into writing a thoughts I have expressed to a few of

you over the last few years.

I have felt for some time that practitioners of Chinese and related

medicine (i.e. those using herbs that come mostly from China in a

system developed initially by the Chinese) need a separate category in

which they are regulated. They are not drugs, they are not food (though

some certainly are), they are not dietary supplements. These items are

traditional remedies that have been in use for centuries in Asian

countries.

The unique aspects of these items are:

1. Practitioners are trained in their use and follow the progress of

their patients - including appropriate record keeping.

2. They are intended to treat imbalances in the body.

3. They have been used safely by practitioners in the West for at least

30 years.

4. They have been used in Asia for more than 2000 years.

If a separate category is defined for these practitioners there will be

several advantages:

1. Herbs that the FDA might deem dangerous to the general public may

not be considered that way if prescribed by qualified practitioners.

Adverse effect records could be kept for this category separate from

those for dietary supplements. The advantage of this is obvious. It is

doubtful that any substantial amount of adverse effects of Ma Huang

have been reported from practitioner-prescribed formulas. We could then

argue as a group (separate form dietary supplement manufacturers) about

the safety of each new herb that comes under scrutiny. In addition, a

simple testing procedure for practitioners could assure the FDA that

all persons prescribing these herbs are appropriately trained (NCCAOM

exam could easily be fitted to this need).

2. Labeling requirements could be designed to fit this category that

would not be as irrelevant to patients as the current requirements for

dietary supplements. The fat content of an herb formula is not

important to the patient, but other information regarding the product's

use may be.

3. This separation of herbs prescribed only by practitioners from

dietary supplements will give a status to practitioners of Chinese

medicine that they do not presently have. It may well encourage them to

act as a group to preserve the right to use the herbs which they have

been trained to prescribe.

I believe that this separation would help the FDA to do its job of

protecting the public better as they would have a group of

manufacturers and practitioners with whom to communicate and would not

need to throw the baby out with the bath water when they make a ruling.

The more than 10,000 (at least) practitioners in the US need to

distinguish themselves as uniquely trained to prescribe these herbs if

the medicine is going to continue to exist in the US in a form that

will be useful for patients.

Any substance can be dangerous to the general public if misused (think

Ma Huang for weight loss). Practitioners should not pay for the

excesses of the dietary supplement industry. That is the reason we have

come to this point.

It would require an initiative from the practitioner organizations, the

NCCAOM, and the manufacturers to bring such a category into existence.

The test is whether these diverse groups can work together to bring

about this change.

Andy Ellis

Chinese Herbs

FAX:

April 15, 2004

, wrote:

> I agree with Andy. this is the only long term solution

>

While what Andy wrote looks like a good solution, it expresses a

possibly naive point of view - that we (CM) are the baby in the

bathwater and that the FDA does not want to throw us out.

The other way of looking at the current situation is that the FDA is

killing 2 birds with one stone.

It would be great if the FDA was willing to work with us and if our

prescribing ability carried some weight.

Brian C. Allen

April 15, 2004

I also agree wholeheartedly. Especially the part I've excerpted below.

Why should our profession pay the price for the indiscretions of the

supplement industry?

On Apr 15, 2004, at 10:16 AM, wrote:

> I agree with Andy. this is the only long term solution

>

> On Thursday, April 15, 2004, at 09:33 AM, Andrew Ellis wrote:

>

> To the list of companies and people concerned with the herb ban:

>

> I will here put into writing a thoughts I have expressed to a few of

> you over the last few years.

>

> Practitioners should not pay for the

> excesses of the dietary supplement industry. That is the reason we have

> come to this point.

>

> It would require an initiative from the practitioner organizations, the

> NCCAOM, and the manufacturers to bring such a category into existence.

> The test is whether these diverse groups can work together to bring

> about this change.

>

> Andy Ellis

>

> Chinese Herbs

>

> FAX:

>

April 16, 2004

Oh! the irony. Oh! the hypocrisy!

New York Times excerpt:

Top Food and Drug Administration officials admitted yesterday that they barred

the

agency's top expert from testifying at a public hearing about his conclusion

that

antidepressants cause children to become suicidal because they viewed his

findings

as alarmist and premature.

" It would have been entirely inappropriate to present as an F.D.A. conclusion

an

analysis of data that were not ripe, " Dr. Robert Temple, the Food and Drug

Administration's associate director of medical policy, said in an interview.

" This is a

very serious matter. If you get it wrong and over-discourage the use of these

medicines, people could die. "

April 16, 2004

This is eloquent and brilliantly written. I whole-heartedly agree.

< wrote: