FDA looking at Alternative Chinese Medicine

[Guest guest]

According to the Wall Street Journal, the FDA is taking a new look at

/herbs. I can't help but wonder if this is the next

step towards regulating herbs.

 

Dede

 

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.