Meeting short take #6: Terra Sigillata comments on the recent saw palmetto trial so I don't have to
Anyone associated with drug discovery and development whether in academia or industry will tell you how extreme the guidelines are for chemical composition and purity of any drug product intended for clinical trials. Yet, NCCAM continues to fund expensive clinical trials of botanical therapies even when the chemicals purported to be responsible for biological activity(ies) are unknown. In the rush to show clinical utility, this funding agency has taken shortcuts on the basic science studies necessary to precede any clinical trial, perhaps hoping that one day they will get a positive result. Instead, they are racking up a series of high-profile failures that cast a broad shadow across all natural products research and creating public relations challenges for otherwise well-meaning herbal education and trade groups.
Only now has NCCAM revealed that they probably should fund investigations of basic science, mechanisms of action, and, be-still-my-heart, phase I pharmacokinetic trials.
Since its inception in 1992 as the NIH Office of Alternative Medicine, NCCAM has been a lightning rod for criticism of how the scientific method has been abandoned in favor of trying to show that ideological therapies work. Basic scientists in pharmacognosy and natural products chemistry were enthusiastic initially that a new funding source would be available to support their work. However, NCCAM was charged with reviewing all types of alternative therapies, from the more legitimate realm of herbal medicine to the implausible, homeopathy, for example. Review panels were stocked with individuals who had never held an NIH grant, much less with experience reviewing grant applications. An unusually high percentage of dietary supplement industry and trade group panelists infiltrated the peer-review system. In 2002, Quackwatch.com reported that just ten individual investigators held more than 20% of the NCCAM budget. I'd encourage Dr. Sampson to conduct another assessment today.