PC-SPES Court Finding: Implications for herbalists and suppliers?

[Guest guest]

Hi All,

 

Attilio & Sammy (TCM List) flagged the decision of the court case

against Dr. Chen and her associates (and others involved in promoting

PC-SPES).

 

Here are two excerpts from the PSA Rising pages: Dr. Sophie Chen

Pleads No Contest, Company Pays More Than Half Million Dollars For

Lacing Supplements:

 

.... The Chens, Wang and IMR, Inc have been fined a total of $510

thousand. They now face class action and catastrophic personal injury

law suits from prostate cancer patients and others who allege that

BotanicLab's bogus herbal supplements caused death, addiction and

bodily harm.

 

... In yesterday's plea bargain the trio pleaded no contest to a single

felony -- actual knowledge of " serious concealed danger. " After FDA

tests proved that PC-SPES and other BotanicLab products were spiked

with warfarin, Xanax and other prescription drugs, Chen and her

associates knowingly failed to inform public authorities of a hazard

carrying " imminent risk of great bodily harm or death. " Penal Code

section 387 (the California Corporate Criminal Liability Act of 1989)

requires businesses to provide public authorities with prompt notice of

concealed dangers in products so that the public will be made aware.

Companies are required to make this notification within 15 days after the

actual knowledge is acquired, or if there is imminent risk of great bodily

harm or death, immediately. After the Federal Drug Administration

notified BotanicLab on Jan 20, 2002 of dangerous hazards concealed in

their products, the company sat on this information and denied it on their

website. Sophie Chen told PSA Rising July 14 2001 that all her products

were pure herbs and, if not, any " contamination " occurred in China

beyond the reach of her quality control measures. But in January 2002

California health officials found the anti-anxiety drug Xanax (alprazolam)

in SPES, a supplement labeled and sold as a pure herbal mixture. They

found the blood-thinner Coumadin (warfarin) in PC-SPES. Other drugs

hidden in BotanicLab's " herbal " products include the pain killer

Indomethacin and two estrogens, estradiol and DES (diethylstilbestrol),

which is banned in the USA as a cancer-causing agent.

 

For more details see:

http://psa-rising.com/pcspes/pleabargaindec182003.html

 

IMO, the implications for herbalists of this finding, and especially if the

subsequent Class Action case succeeds, are extremely serious.

 

Modern WWW technology allows anyone with basic literacy and a

website to post whatever comments or claims they may have on a

medical Tx, herbal or otherwise. he search engines can locate similar

hits very easil;y, allowing any lawyers who wish to drum up business to

locate patients who may have adverse reactions to a prescribed Tx (say

a herbal product). This will allow class actions in an unprecedented

scale in the future.

 

The Chen case shows the danger of using formulas from sources that

are not 100% above board. Apparently, the adulteration of PC-SPES

was not done in USA, but at the manufacturing end. The Chen's

maintain that they did NOT know that the product was adulterated until

they were informed of that by FDA.

 

 

I am worried about this development because this case is almost certain

to get get high profiling by the opponents of herbal medicine, and

because it must sow doubts in the minds of many herbalists, who must

ask themselves:

 

Can we trust OUR suppliers of herbal formulas to be 100% above board

on their labeling, or are WE sure that what we prescribe is EXACTLY as

it says on the label?