In the same San Francisco Chronicle article I linked concerning UCSF’s promotion of herbal tea to boost the immune system is another tidbit concerning lax FDA standards for research on herbal products. Apparently the FDA thinks it’s OK to study unrefined plants without even knowing the active ingredient. The article reports the FDA position thusly:
“The agency is even allowing researchers to experiment with plant materials in clinical drug trials without first identifying their active ingredients. ‘There's a need to adjust our approach if we want to encourage study of these complex mixtures,’ said Shaw Chen, botanical team leader with the FDA's Center for Drug Evaluation and Research. “ Translated: let’s adopt a double standard.
It's all bass akwards in contrast to legitimate drug development which starts with the search for, discovery and characterization of compounds based on anticipated effects on molecular targets. Then come animal studies followed by preliminary safety and dose finding studies on humans, leading, ultimately and tediously to phase III clinical trials.
And the consequences? If an herbal product fails a clinical study the boosters can just say “Since we don’t know the active ingredient how do we know we studied the right component of the plant, or the right species? Were the climate and soil optimal? What about the dose?” Endless questions and more excuses to pour tax dollars into CAM “research.” It’s all quite convenient for the NCCAM which continues to ride the gravy train despite the fact that no significant medical advances have been made in all its years of existence. No breakthroughs. No debunkings.
A recent example is the story of echinacea. NCCAM’s response to disappointing results of one of its own studies was, in effect, let’s try again; maybe we should focus on the roots; or maybe the flowers, or the seeds; maybe we used the wrong echinacea species---and on it goes.
The double standard for research is becoming pervasive. The NCCAM has adopted it for some time. Now the FDA is on board. It’s going to get worse. As I recently posted, a generation of medical students is being indoctrinated.
Forget the Echinacea (DB’s Med Rants)
NCCAM should be defunded (Quackwatch)