What’s an advocate of evidence- and science-based medicine to think about the National Center for Complementary and Alternative Medicine, better known by its abbrevation NCCAM? As I’ve pointed out before, I used to be somewhat of a supporter of NCCAM. I really did, back when I was more naïve and idealistic. Indeed, as I mentioned before, when I first read Wally Sampson’s article Why NCCAM should be defunded, I thought it a bit too strident and even rather close-minded. At the time, I thought that the best way to separate the wheat from the chaff was to apply the scientific method to the various “CAM” modalities and let the chips fall where they may.
Two developments over the last several years have led me to sour on NCCAM and move towards an opinion more like Dr. Sampson’s. First, after its doubling from FY 1998-2003, the NIH budget stopped growing. In fact, adjusting for inflation, the NIH budget is now contracting. NCCAM’s yearly budget remains in the range of $121 million a year, for well over $1 billion spent since its inception as the Office of Alternative Medicine in 1993. Its yearly budget contains enough money to fund around 75 to 100 new five year R01 grants, give or take. In tight budgetary times my view is that it is a grossly irresponsible use of taxpayer money not to prioritize funding for projects that have hypotheses behind them that have a reasonable chance of being true. Scarce NIH funds should not be for projects that have as their basis hypotheses that are outlandishly implausible from a scientific standpoint. Second, I’ve seen over the last few years how NCCAM is not only funding research (most of which is of the sort that wouldn’t stand a chance in a study section from other Institutes or Centers)) but it’s funding training programs. Indeed, that was the core complaint against NCCAM: that it facilitates and promotes the infiltration of nonscience- and nonevidence-based treatments falling under the rubric of so-called “complementary and alternative” or “integrative” medicine into academic medicine. However, NCCAM cannot do otherwise, given its mission:
- Explore complementary and alternative healing practices in the context of rigorous science.
- Train complementary and alternative medicine researchers.
- Disseminate authoritative information to the public and professionals.
If, in fact, NCCAM actually did devote itself solely to “rigorous science” with regard to “alternative” healing practices, I would have much less problem with it than I do. However, it broadly interprets the second and third parts of its mission. For example, it views part of its mission as promotion, rather than study: “Supporting integration of proven CAM therapies. Our research helps the public and health professionals understand which CAM therapies have been proven to be safe and effective.” This would be all well and good if NCCAM had as yet actually proven any CAM therapies to be at least effective, but it has not. Worse, it has not even managed to demonstrate any of them to be ineffective, either, thus leading to endless studies of modalities that either do not work or at the very least would have marginal efficacy.
Still, I thought; All questions of promotion of CAM modalities aside, least there’s the science. Surely, under the auspices of the NIH, NCCAM must be funding some high-quality studies into CAM modalities that couldn’t be done any other way. That thought died when NCCAM announced last week the studies that it had funded during FY 2007.
Before I discuss the studies, it’s useful to explain briefly for the benefit of those not familiar with NIH grant mechanisms (in other words, the vast majority of our readers) just exactly what the alphabet-number soup describing the types of NIH grants means:
- R01. The gold standard of NIH research awards, this mechanism describes investigator-initiated multiyear grants (usually four or five years) to study whatever the investigator wants to study, provided that he or she can convince a study section of the worth of the project and that the project is related to the program interests of one of the NIH Institutes. As such, they generally require a fairly large amount of preliminary data and a well-defined research plan to study a clear and scientifically reasonable and interesting hypothesis.
- R21. These grants are usually one or two year exploratory rewards designed to investigate more risky hypotheses. As such, they require much less, if any, preliminary data.
- P01 and P50. P-series awards are known and program project grants and are intended to fund large, multi-investigator projects (P01), often encompassing more than one institution, or research centers (P50).
- K-awards. These awards are intended to fund the development of junior faculty and are also known as career development awards. The idea is that these awards, which require a mentor to support and guide the applicant, are supposed to be a bridge to independent funding.
- Small Business Research Awards (R41, R42, R43, R44). These are granted to small businesses to fund the development of (usually) biotech and related projects.
- T32. T32 and related grants fund training and fellowship programs. For example, my surgical oncology fellowship was funded by a T32 award, and our cancer institute has a T32 to fund medical oncology fellows who want to spend two years in the lab.
These by no means encompass all of the funding mechanisms of the NIH, but they are the most common and ubiquitous across Centers and Institutes. Now, let’s look at the breakdown for NCCAM:
|Award Mechanism||Number of NCCAM grants funded in FY2007|
|K- and F-series||
|Misc. (F-, R-series)||
It should also be noted that the NIH funds its grants by the fiscal year. Consequently, a five year grant is, in reality, made up of five one-year awards. The difference is that investigators do not have to compete for the renewal of their grants during the years encompassed by them. Rather, they simply have to submit progress reports, and, if reasonable progress is being made, the NIH will usually rubberstamp the renewal of the grants. These are called “noncompetitive renewals,” appropriately enough. The suffixes (-01, -02, -03, etc.) tell us which year of the grant is represented. At the end of the grant period, for R01 and other mechanism, (but not, for example, R21 grants, which are meant to be followed up by other mechanisms), the investigator can either submit a competitive renewal for a continuation of the grant or let the grant lapse.
We see from the above chart that NCCAM funded two new and nine ongoing P01 grants and 14 new and 47 ongoing R01 grants, but a more illuminating analysis comes when we look at the breakdown of general topics being covered in the P01, R01, R21, and training grants. I’m going to take the liberty of concentrating on studies of herbal remedies or dietary supplements or manipulations (mainly because these are the grants that could easily be funded by one of several other NIH Institutes), other modalities that are considered “alternative” for unclear reasons (such as studies of various light therapies on different diseases), studies of CAM usage (many of which seem designed to promote CAM usage), true “alternative therapies” (homeopathy, chiropractice, etc.), and then funding for training programs. A caveat is that not everyone will agree with which studies I chose for each group, but the relative numbers are such that minor quibbles on a few studies will not change the overall trend. Finally, I’m going to concentrate mainly on the R01, P01, and training mechanisms:
|NCCAM grant topic||Number of grants awarded|
|Herbs, supplements, dietary interventions||
|Modalities considered “CAM” for unclear reasons||
|CAM usage/promotion (not counting fellowships)||
|True “CAM” (chiropractic, craniosacral, prolotherapy, homeopathy, etc.)||
|Centers and fellowship programs||
What we can see from this is that by far the largest category of NCCAM grants for research not related to small businesses is a topic that could just as easily be funded by numerous other Institutes or Centers within the NIH: the study of herbal remedies, which, when you come right down to it is nothing more than the study natural products, and studies of dietary manipulations to treat disease and improve health. If you peruse the list, you’ll see numerous studies of chromium supplementation, gingko bilova, saw palmetto, various dietary manipulations, and similar studies. Since when did the study of natural products and diet become “alternative”? There is no good reason why these sorts of proposals need a special “CAM” Center to fund them or why they could not be evaluated by the appropriate study sections in the appropriate disease-specific Institute of the NIH.
Then there are a number of other studies (you may disagree with me about the specific studies chosen) that examine physical treatments that are considered “alternative” for unclear reasons, studies such as near infrared therapy or the effects of blue light on alertness. There’s no reason why such these studies need to be under the rubric of “alternative” or “complementary” medicine, either. These are the same sorts of studies that “conventional” physicians have been doing for decades. Indeed, when it comes to natural products and herbal remedies, I suspect some pharmacologists, dieticians, and medicinal chemists probably look at NCCAM as easy money (or, in this disastrously tight NIH funding environment, at least less torture to get) if they just slap together a project to study the most popular herb du jour. Finally, there are the 28 grants funding either fellowships or large collaborative CAM centers or projects and 13 funding studies that either examine CAM usage or seem custom-made to promote CAM usage, such as this study of the effect of increased coverage of CAM therapies by insurance companies.
That just leaves approximately 61 P01- , R01, or R21-level grants that seem to look at therapies that might truly be called “CAM” (at least by NCCAM’s definition). These are, not surprisingly, weighted towards acupuncture or accupressure (17 grants), mind-body interactions (15, with a huge emphasis on “mindfulness,” a distinctly religious concept), and then assorted miscellaneous CAM therapies that constitute a grab-bag of mostly unrelated modalities. There are also some rather disturbing grants here, a few of which look as though they couldn’t get through an Institutional Review Board (IRB) review. For example, there is actually a grant to fund the study of acupuncture for acute spinal cord injury. I wish I were joking. It even pulls the usual acupuncture trick of including electrical stimulation (which, by the way, is not acupuncture, but rather transcutaneous electric nerve stimulation, a decidedly conventional therapy that has been well-studied to treat chronic pain) as part of it.
Worst of all, there are two grants to study arguably the most scientifically implausible of all CAM modalities, homeopathy. For instance, there is an R21 grant funding a study called Polysomnography in Homeopathic Remedy Effects. Yes, you have it right. Your tax dollars are going to fund at least a study this year on homeopathic remedies (a.k.a. water). But it’s even worse than that. There was actually awarded an R21 grant to study homeopathic dilution and succussion and how they affect the dose-response curve of homepathic remedies. This latter grant actually proposes to study whether succussion (the vigorous shaking done with each homeopathic dilution) that, claim homeopaths, is necessary to “potentize” their remedies affects the dose-response characteristics of homeopathic remedies up to 30C dilution (30 times 100-fold, or a dilution factor of 1 x 10-60). This is a dilution factor many orders of magnitude larger than Avagaddro’s number, which is makes a 30C homeopathic remedy nothing but water. Period. In fact, the investigators are actually going to compare stirring with succussion to see whether succussion, as homepaths claim, improves the dose-response curve. It beggars the imagination that such a project was actually seriously considered and then scored highly by a study section. There can also be found grants studying seriously dubious modalities such as craniosacral therapy, prolotherapy, and even qi gong for treating cocaine addicition. Truly, it’s like studying whether eye of newt or pixie dust is more efficacious in curing cancer!
Here’s another thing to consider: An NIH-funded grant is the pinnacle of external funding mechanisms to universities, largely because the government gives the universities additional “indirect costs” of around 50 cents on the dollar to administer the grants and maintain their infrastructure. In the eyes of universities (and probably the public) it doesn’t matter whether that grant came from NCCAM, the NCI, NHLBI, NIAA, NIDDK, or whatever. Universities will be just as happy if investigators get grants from NCCAM as from any other agency within the NIH. More insidious still are the grants to fund fellowship and training programs. It’s easy enough to laugh at grants being offered to study whether homeopathic succussion does anything other than aerate the solution, but when I see how much NCCAM is laying out for the promotion of non-evidence-based medicine through “education” grants, I find it truly disturbing. There are grants to fund fellowships in CAM at the University of North Carolina Chapel Hill, the Weill Medical College of Cornell University, the University of Virginia, Harvard University, the University of Arizona, Oregon Health and Science University, UCSF, and a naturopathic college (Bastyr University). Most of these centers are not there to look at CAM from a truly scientific or skeptical viewpoint. Most are run by believers, and their NIH-funded existence lends a patina of undeserved scientific credibility to the enterprises, particularly since most of them are housed in academic medical centers.
As two of my co-bloggers Wally Sampson and Kimball Atwood IV have pointed out, NCCAM was created not because of any groundswell of support from the scientific community. Rather, it was CAM-friendly legislators who foisted it upon the NIH and made sure that its budget skyrocketed–at least until the recent flattening and decline of the NIH budget put the brakes on. It doesn’t seem to matter if a bona fide scientist is placed in charge, either. For example, Dr. Stephen Strauss was the Director of NCCAM from 1999 to just last year, and he was a hardcore scientist who promised to “explore CAM healing practices in the context of rigorous science, to educate and train CAM researchers and to disseminate authoritative information about CAM to the public.” Yet that is not what has happened. Recently, it was announced that Dr. Strauss’ replacement would be Josephine Briggs, MD, another accomplished researcher with a strong CV making similar promises. Can she deliver on them?
It’s highly unlikely.
Here’s why. First, she has only minimal control over who is appointed to the two councils charged with advising the Director on matters related to research funding and clinical trials, and, in any case, the Council is mandated to be constituted as follows:
Of the 18 appointed members, 12 shall be selected from among the leading representatives of the health and scientific disciplines (including not less that 2 individuals who are leaders in the fields of public health and the behavioral or social sciences) relevant to the activities of the NCCAM, particularly representatives of the health and scientific disciplines in the area of complementary and alternative medicine. Nine of the members shall be practitioners licensed in one or more of the major systems with which the Center is involved.
In other words, they must be CAM practitioners and “leaders” in the field. It’s unlikely that such a group will support rigorous science that might threaten their livelihood, and indeed they don’t. In fact, its stated mission notwithstanding, NCCAM was never originally intended as a means of rigorously investigating CAM therapies but was rather as a government agency to give these therapies the patina of credibility and respectability that they can’t earn through the science. Dr. Strauss may have tried to do what he said he would do during his tenure, but it clearly just didn’t work. He couldn’t change NCCAM. Moreover, no matter what he did, he couldn’t win either way. On the one hand, he was criticized by scientists and physicians who support science- and evidence-based medicine (like me) for allowing highly dubious studies to be funded, while on the other hand he was castigated for being too scientifically rigorous and not being a CAM practitioner because CAM advocates didn’t like his emphasis on determining whether their therapies worked or not. The same thing appears to be true of Dr. Briggs. Indeed, I found an open letter to Dr. Briggs from a CAM supporter that is most revealing, from which I draw a key excerpt:
Your predecessor, Stephen Straus, MD, also had no experience in complementary and alternative medicine. He told the New York Times during his tenure that he had no plans to experiment. I always thought that an odd waste of human imagination. This is not cancer, or renal failure we’re typically talking about. These are therapies and approaches which many view as particularly valuable for creating health and vitality – often altering the course of disease, or a person’s experience of disease, in doing so. Why spend 7 years as an “investigator” and never personally investigate?
Now, a decade later, the NIH has done it again. Director Zerhouni appointed you, despite the fact that you too have no visible professional experience in the field that you were selected to lead. Of your 125 publications, none appear to touch on the kinds of interventions which will be on your desk at your new job.
The writer of this letter, John Weeks, then tries to give Dr. Briggs some advice, most importantly to “go get yourself some experience of complementary, alternative and integrative practices.” He then goes on a rant against NCCAM for, in essence, not being friendly enough to the CAM practices he supports because it does not spend as much as he would like on “whole systems” and “whole practice” approaches. Even worse, from his perspective, NCCAM actually is out of compliance with the mandate that 50% of NACCAM members be licensed in the specialties studied by NCCAM in that only 25% are so licensed. (Actually, if true, this was the only heartening information I found during my research). Mr. Weeks goes on:
I spoke with a conventional academic medicine colleague and researcher yesterday who is a close NCCAM watcher. He said he was “flabbergasted – not in a positive way” by your appointment. His gut feeling was that “the appointment makes it very clear that the NIH wants to bury NCCAM.” He wondered why you took the job, given your career path. Did you just want to be on the NIH director’s Council? Is it, for you, merely a step in dirty water, a post in Siberia on a career path which you hope will veer back into other zones more prestigious in your view – a plum position in Moscow? – as soon as possible?
My colleague told me he believes that, with all of the momentum in recent years, and the increased interest among employers and consumers, the field of integrative medicine is going to keep growing. The question on the table, he believes, is “whether NCCAM will provide leadership or become irrelevant.”
What this letter encapsulates to me is the attitude of CAM advocates towards NCCAM. They don’t want truly rigorous scientific studies to determine if these therapies work. They want studies that assume that these therapies work and then simply look at utilization and cost-effectiveness. They want funding of fellowships in CAM (taught, of course, by true believers). In brief, they want CAM promotion.
This is why we can only hope that the NIH really is trying to bury NCCAM. There’s nothing that NCCAM does, other than its advocacy for CAM therapies in academic medicine, that couldn’t be done as well or much better by other Institutes and Centers of the NIH appropriate to each question. This is particularly true for the study of herbal remedies and dietary interventions, neither of which are “alternative” except when claims are made that diet or herbs can, for example, cure cancer. Unfortunately, as protected as it is by powerful legislators, the best we can hope for is a career scientist like Dr. Briggs trying to slow NCCAM’s descent into pseudoscience. It can’t last forever, though. Sooner or later a true believer will be appointed Director at NCCAM. It’s virtually inevitable. The only thing keeping that from happening, I’d guess, is that the most prominent CAM practitioners (like Andrew Weil, for instance) make far too much money to be easily willing to take a huge pay cut to work for NCCAM. When that day comes, any pretense of rigorous science taking into account scientific plausibility will fly out the window.