[OilsHerbsEtc.] FDA Looking At Chinese Medicine

[Guest guest]

Let me get this right, Chinese Herbal Medicines which have been used

successfully for thousands of years are having a hard time " proving

their effectiveness " to the FDA, the new baby on the block. The FDA

who is the most strict drug watch dog (other then when it comes to

Vioxx, vaccines, genetically modified food and food from clones,

aspertame, etc.) And the FDA would prefer to know the " active

ingredient " (so the powers that be can patent it?) when they still

don't (perhaps willfully) see that is like asking for the most

important letter of the alphabet. Come on, there has to be one

letter that can be used by itself and all the others dumped in the

bin as useless.. And our lives would be so much better, if the

pharmaceuticals got their hands on these herbs than if they are

commonly and easily available in our natural health food stores...

Things that make you go, " huh " ?

Other comments?

Misty L. Trepke

http://health.

 

 

FDA looking at Alternative

 

Dueling Therapies:

Is a Shotgun Better

Than a Silver Bullet?

By NICHOLAS ZAMISKA

March 2, 2007; Page B1

 

HONG KONG -- Chinese doctors have long experimented with

combinations of herbs to cure disease. If a plant extract helped to

fight an infection, why bother trying to figure out which molecule

did the trick? It worked, and that's what counted.

 

By contrast, the U.S. Food and Drug Administration, one of the

world's most stringent drug watchdogs, for decades has looked

askance at most herbal medicines. The focus in Western pharmacology

is finding the single molecule that cures a disease. Pharmaceutical

companies such as Pfizer and Merck spend billions of dollars combing

through huge libraries of compounds to find the elusive blockbuster

therapy.

 

The two approaches boil down to a simple question: Is it better to

attack disease, as the Western world does, with a silver bullet --

the one substance whose potency has been pinpointed? Or should

treatments be administered, as the Chinese method dictates, by

aiming a group of agents at the problem -- the shotgun approach?

 

The FDA has long held botanical drugs to the same standard as other

therapies: Companies applying for regulatory approval had to find

the part that works and prove it. That requirement has relegated

most Chinese medicines and other plant-based, or botanical,

therapies, such as ginkgo and Echinacea, to the dietary-supplement

shelves at supermarkets and kept them out of U.S. pharmacies.

 

But recently, the agency's policy has evolved into one that is more

accommodating to the Chinese approach. In June 2004, the FDA issued

new guidelines making it easier for drug companies to turn herbal

remedies into Western medicines. And late last year, the FDA

approved its first botanical drug under the new system, an ointment

for genital warts called Veregen, made from green-tea leaves. The

treatment was developed by MediGene, a company with headquarters

near Munich, Germany.

 

In the new guidelines, the FDA for the first time spelled out

explicitly how companies could submit for approval botanical

extracts -- emphasizing that further purification wasn't required

and that there was no need to identify a single active ingredient.

Standards for human clinical testing, however, remained the same as

for all drugs.

 

" There were so many stories of potentially new treatments in

alternative medicine ... we needed a different approach than dealing

with a single small molecule, " says Shaw T. Chen, the botanical team

leader at the FDA.

 

This new openness has led to a surge of applications for approvals.

Some 250 botanical drugs have since been cleared to proceed to

clinical trials.

 

The FDA even established a special office to deal with all those

applications. To help run it, the agency hired experts with training

in herbal medicines. Jinhui Dou, for instance, a drug reviewer for

the FDA's newly formed botanical review team, was born in China and

has a degree from the Beijing University of .

 

It's hard to predict how many other traditional remedies from

foreign cultures may someday be presented to the FDA. Chinese

medicine encompasses a vast variety of treatments -- like dried deer

penis pulverized and taken as tea. The FDA says it still is helpful

for applicants to identify active ingredients and how they might

work, because that can help predict dangerous side effects.

 

Proving the effectiveness of these therapies is still a big

challenge for the manufacturers. " Overall progress has been slow, "

Dr. Chen says.

 

One company that is aiming to beat the odds is Phynova, a small

British drug-research concern that has the green light from the FDA

to test a hepatitis botanical drug. The drug is a combination of

four different plants: the roots of the astragalus and the Chinese

salvia plants, the fruit of the schisandra plant, and milk thistle.

The hope is that they will all work synergistically to combat the

symptoms of chronic hepatitis.

 

The number of chemical compounds contained in each of those

distilled extracts could vary from several hundred to more than a

thousand. It may be that many of those are working on a variety of

levels. The advantage of such an assault on multiple targets is that

human bodies, and the pathogens that try to invade them, have many

redundant backup systems -- like a generator that turns on when a

fuse blows.

 

Some proponents of herbal therapies are convinced that the more

shots fired at a disease, the better -- an approach to which the new

FDA guidelines now give more weight.

 

" There's a theoretical possibility that there are multiple active

ingredients in botanicals that act on multiple systems that have

synergistic effects, " says Dr. Chen. " But that remains to be proved. "

 

Write to Nicholas Zamiska at Nicholas.Zamiska@ wsj.com1.