ethics

[Guest guest]

I've been preparing a talk for AHVMA on clinical research and have a little

to add to this. There are a couple of sides to the issue of 'alternative

medicine' research.

 

First, the most groundbreaking and useful research has always occurred in

clinics, with practitioners. While all kinds of alt.med., including TCM, is

gaining acceptance among conventional practitioners like MDs, some see it

as a moral imperative that we as practitioners continue the tradition of

clinical research. This is both to confirm what we think we know (there

are whole papers on how we don't really know what we think we know

regarding our methods), and to bring our successful methods to more

patients in need once the positive results are published.

 

There is some evidence that human patients actually want to be involved in

clinical research if they are suffering from chronic problems. These

patients sign informed consent, and know that placebo treatment is a

possibility for them, which obviates our aversion to placebo treatments in

clinical practice. Some do it for the advancement of science, and some do

it for some extra cash. The smallest percentage do it to receive better

medical care, on the assumption that the best doctors are involved with

research and have more state of the art knowledge, drugs and equipment.

(1999/2000 CenterWatch survey of 1,050 study volunteers

(http://www.researchpractice.com/archive/race_bottom_files/frame.htm)

 

A cost/benefit analysis must be accomplished on each study participant, and

includes these questions:

 

a) risk is small in comparison with that already incurred by patient as

consequence of disease;

b) serious disease;

c) knowledge gained of great practical benefit;

d) no other means of obtaining the knowledge;

e) the patient gives fully informed consent.

 

Pharmaceutical companies are seeking the quickest, most efficient settings

to conduct their clinical trials. Increasingly, they are shifting out of

the academic medical centers (AMCs). Approximately 50 % of

industry-sponsored trials are conducted in AMCs now, compared with 80 % 5

years ago.

 

Unfortunately, all of these ideas are based on the pharmaceutical model,

where lots of money is thrown at the doctors running the trials as well as

the participants. Our herb companies don't have that kind of money, but the

increasing pressure from the FDA, as well as pressure to do the research

RIGHT, as opposed to academics in medical schools who don't understand TCM

practice, may have to change that.

 

Experts who act as consultants to these companies have only recently begun

to take some money for their knowledge, after volunteering their time for

years to get these companies going. The companies may have only recently

begun making real money. But *I* believe that all the nutraceutical and

herb companies need to be budgeting for research on their products and I

try to insist on it for companies I work with. If we are the voice for

properly done clinical research, we may end up with clinically important

answers in a few years, as opposed to more useless in vitro and animal

studies.

 

 

 

Susan G. Wynn DVM

Marietta, GA

s.wynn

 

" Unanswered questions are far less dangerous than unquestioned answers. "