was do a search/now quality control

[Guest guest]

, mshort@z... wrote:

> If the FDA decides to crack down on suppliers, then it will be up to the

> suppliers to show that they are selling to licensed practitioners.

>

> But licensed professionals have license numbers which is a way of tracking

> identification, so there is a system in place for companies to create a

> paper trail or interface with state or national databases.

 

the logistics are pretty straightforward. it is already done for drugs. I

think we

should set up our own adverse event reporting infrastructure, but not support

government imposition. The bush admin supports development of voluntary

controls

in every other industry, so why not us. Because we have dropped the ball while

we

rode the gravy train of supplement sales during the past decade. BTW, any grand

regulatory overhaul of supplement regulation that creates a category of chinese

medicinals for rx by licensed healthcare providers only is gonna have some

strings

attached. We should se this crisis as a great opportunity to settle this matter

once

and for all.

 

One issue I have long predicted we would have to face is herb quality control.

It is

one thing to allow dietary supplements to sold willy-nilly with regard to

dosage.

Items that have been reserved for professional use must meet a much more

stringent

standard. No one is going to care how much antioxidants are in your broccoli,

but

you bettter darn well know how much ephedrine is in your ma huang that you

prescribe for asthma. Merely saying that has been done safely for thousands of

years

won't cut it with this crowd. One merely vhas to point to the AA debacle to

identify a

safety issue that was not known traditionally. While we can claim this issue is

overblown, it remains the standard by which other TCM incidents will be judged

for

some time to come.

 

There is a reason that Taiwan and Japan's state healthcare systems only

reimburse for

granules and not raw herbs - standardization. When one goes looking for models

of

herb regulation worldwide that protect consumers while not restricting licensed

practitioners, the issue of standardization is always central. Same in germany,

for

example. We can argue that this has never been necessary in ancient china, but

then

do we really know how many people needlessly died from using bogus herbs. People

have this mystique of the ancient herbalist at one with nature, but I suggest

the

reality is more likely one of illiterate, undereducated folks trying to get by

in a hostile

world. Lot of mistakes were probably made. And today's herbalist has even less

experience with the actual plants since most people only take pills.

 

So people can talk all they want about things like sensory evaluation of herbs

based

upon models from the food industry. No one would even consider applying such a

model to drugs and this is the comparison that will be made if want to have our

own

prescriptive category. Think how ludicrous it would sound to go to the FDA and

say

that we are going to regulate ourselves, but we have decided our standard of

safety

and potency will be based upon smell and taste of herbs, rather than biochemical

analysis. foods may be OK to rate this way, but consider that even substances

that

are rated by the senses for quality, such as wine, still must be measured for

alcohol

content using scientific means to be sold legally. the take home message is that

we

can't have our cake and eat it, too.

 

If we want to practice medicine and we want our medicinals recognized as

effective

and physiologically active, we must be willing to submit to standards even

imposed

upon bioactive foods like alcohol. It does not matter that we do not prescribe

ma

haung based upon ephedrine content. We better know what consitutes a dangerous

does of ephedrine and be able to insiure that noone ever receives such a dose.

This

can never be accomplished satisfactorily with raw herbs or products assessed

purely

by sensory means. The possibility of human error is much more grave in medicine

than in winemaking. So while I would never argue that biochem analysis is

enough to

determine the best herbs, it is necessary to determine the baseline and upper

safety

levels in a way that will satisfy the feds. And to be honest, unless you handle

raw

herbs every day, I don't think it serves the social good to do anything less.