Posted by I just had a chance to check in on a triad of posts by Prof Janet Stemwedel at Adventures in Ethics and Science (1, 2, 3) on the ethical issues of the conduct of studies, particularly clinical trials, supported by the US NIH’s National Center for Complementary and Alternative Medicine (NCCAM).
For background, NCCAM was originally established for political, not scientific reasons, as the NIH Office of Alternative Medicine in October 1991. It received a token budget of $2 million at the time. They still only get $120-ish million; modest by NIH standards as compared, say, with the 2007 NCI budget of about $4.8 billion. But that $120-125 million is pretty significant in that it could fund about 60 independent researchers and their laboratory groups for five full years.
How was alternative medicine defined then? Primarily as folk and cultural modalities not incorporated into conventional Western medicine but used and promoted for disease treatment or prevention without statistically-defined efficacy and safety. The net was cast very wide, from “energy therapies” that defy the basic tenets of physics to herbal medicines that have given rise to 25% of prescription medicines.
Hence, CAM is not one modality. It is a term used to describe a wide spectrum of health-promoting approaches that have not been evaluated previously under rigorous, controlled basic or clinical science standards.
CAM is a terrible term. It is NOT medicine. Modalities proven to work are medicine. Modalities that don’t work are not medicine. There is no complement to medicine. Medicine is medicine. There is no integrative medicine, either. Medicine already takes advantage of all modalities: surgical, pharmacological, radiological, physical, psychological, nutritional – if a clear benefit can be offered to a patient that outweighs the risk.
So-called integrative medicine gurus have adopted proven, preventive medicine techniques – diet, exercise, meditation, yoga – and have used them 1) to justify that “CAM” works and 2) that the efficacy of these approaches justifies study and implementation of approaches that have absolutely no scientific basis.
Oh yeah, often with substantive personal financial benefit.
I must admit to having a dog in this fight. I have spent 23 years investigating the molecular action of chemicals derived from plants, fungi, and bacteria for their anticancer or cancer preventive activity. Some of these agents came from folk remedies, others came from pure compounds isolated from random plant sources because of the recognized chemical diversity of secondary metabolites produced by plants. Yet what I do is not of interest to NCCAM. I think it is, and well should be, but I have had no success convincing reviewers that what my lab and collaborators do will be informative to those studying the natural products side of untested herbal medicines.
Yet our nation’s health agency separates the evaluation of biomedical research proposals across over more than 110 topical areas. NCCAM instead is charged with evaluating research proposal investigating dozens of potential therapies across dozens of therapeutic settings. And that’s without even getting into the basic science foundations that might underlie the mechanism(s) of any potentially useful therapies. One could find an NCCAM grant application reviewed on reiki therapy for depression followed immediately by an application, say, studying a naturally-occurring plant product that inhibits the function of the hypoxia-induced transcription factor, HIF-1α, in cancer.
I must also make another disclosure: my laboratory has never received funding from NCCAM, although my collaborators and I have attempted repeatedly. Rather than write off NCCAM, though, I have offered instead to serve as a NCCAM grant reviewer and resolved to be part of the solution rather than whine about the problem (Review panel rosters are a matter of public record on the NIH website; while one can never be sure which reviewers were assigned one’s grant, an investigator is provided with the roster of all those assembled at the meeting).
NCCAM is, sadly, still a political entity and if my colleagues and I don’t agree to serve as scientific reviewers, we are likely to be substituted by individuals with lesser rigor and credentials. So, while it is in existence, I will continue to be part of it when called upon. Not telling tales out of school, I have provided strongly positive evaluations of a very small number grant applications for investigators and their projects that have been fantastic successes and published in top-tier peer-reviewed journals. Not many folks talk about this, but like some study section members I have followed the careers of basic and clinical investigators to whom I have given excellent scores to their research proposals. I am incredibly proud that I have served the scientific community by rigorously evaluating research proposals submitted to NCCAM.
However, these projects represent less than 5% of the projects I have reviewed for the agency. (No surprise since only 10-19% of NIH extramural projects are being funded these days.).
As a scientist, I share the proposal set forth others that NCCAM is really not necessary as an NIH entity. Untested therapies, and the basic science underlying their potential therapeutic efficacy, might be better evaluated by institutes or centers (ICs) of NIH dedicated to specific pathophysiological areas.
As far as I know, NCI is the only IC that has established an alternative medicine evaluation center that focuses on untested modalities for the broad area of cancer. The NCI Office of Cancer Complementary and Alternative Medicine (OCCAM) has a budget to support some intramural and extramural projects on therapies that may be of benefit to cancer patients.
In my very first blog post, I tried to note the diversity of rationale and application of so-called complementary therapies while invoking two of my science blogging mentors: Orac and the former-Dr Free-Ride, now Prof Janet Stemwedel. I have had the honor of knowing them both personally and respect both of their views in this area of the ethical and medical issues surrounding federal support of scientifically-valid, conceptually-possible, and absolutely implausible so-called alternative therapies. (A lively discussion currently ensues between them on studies supported by NCCAM.).
From 15 December 2005 at the old blog:
The polarizing quality of alternative medicine among academic health and life scientists is exemplified by the other extreme in the blogosphere: hucksters using blogs to sell supplements, services, books, etc. with dubious and often irrational claims of cures while feeding the conspiracy theorists with the idea that cures are out there that “they” don’t want you to know.
There are few folks in the middle ground. Orac Knows at Respectful Insolence and Doctor Free-Ride at Adventures in Ethics and Science often take on alternative medical claims in a thoughtful, balanced, respectful manner that is based in fact. But what I see missing in many blog threads, however, is 1) a distinction between the relative validity of each of the alternative modalities and 2) an honest appreciation for what the natural world has lent to modern medicine, healthcare and wellness.
I have to admit: it’s fun to look back at what one wrote more than three years ago.
Janet is correct to question how we evaluate therapies outside the realm of conventional belief; Orac is correct to criticize the existence of a political entity dedicated to prove things that are unlikely to be useful (based upon current basic science tenets).
The common thread here is that the discussion between Orac and Janet is being conducted by people trained in the scientific method: Orac is a MD, PhD, and Janet holds two PhDs, one of which is in physical chemistry. Neither is a finanically-driven woo-peddler or an anti-natural product person (as a breast oncologist, 55% of the drugs Orac’s patients are given are naturally-derived).
Where I worry is when such discussions are held amongst patients and those trying to make a buck out of their misery and uncertainty.
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