Finding money for biomedical research by getting rid of woo

In the wake of President Obama’s election, there was a great deal of hope that he would take science-based medicine seriously and, as he promised in his inaugural speech, “restore science to its rightful place.” Shortly before Obama’s inauguration, in fact, Steve Salzberg proposed that the Obama administration should defund the National Center for Complementary and Alternative Medicine (NCCAM).

NCCAM, as you may recall, is a center in the National Institutes of Health largely dedicated to funding pseudoscience. True, there is some legitimate research mixed in with the pseudoscience, but it’s completely mixed in with the woo, so much so that it’s all too often hard to distinguish between what is science-based and what is not. Part of the reason for this is that so-called “complementary and alternative” medicine advocates have so thoroughly coopted science-based modalities such as nutrition and exercise that they almost automatically fall under the purview of “alternative medicine” in the eyes of many people and even many researchers. Worse, nutrition and exercise represent the Trojan horse that is used to sneak in the hard core, dangerous woo.

And all of it has found a home in NCCAM.

More than two years have passed, and nothing has happened to affect NCCAM’s funding. Despite being a strong supporter of the move to defund NCCAM, I never really expected that Congress would ever do anything to decrease NCCAM’s funding. The reason is quite simple. The legislator who was the driving force behind the creation of NCCAM, Tom Harkin, was critical to President Obama’s effort to overhall the health insurance system in this country. If he wanted to have any chance of getting a bill passed, President Obama could not afford to alienate Tom Harkin. So he didn’t, and the effort to defund NCCAM, although getting a fair amount of press a year ago, went nowhere. In fact, although NCCAM funding didn’t really increase much, supporters of science-based medicine had to fight a rearguard action to keep various provisions requiring government-supported health insurance exchanges to pay for “alternative” medicine and even Christian Science prayer. The final bill wasn’t too bad, at least from the perspective of science-based medicine, but there are still some reasons for concern.

The issue rested quietly for over a year after it fizzled; that is, until now. The man who originated and spearheaded the effort to get NCCAM defunded is back, and he thinks the time is right for a new push for the following reason:

This past week, President Obama called on all federal agencies to voluntarily propose budget cuts of 5%. Well, Mr. President, you might be surprised to learn that there’s a way for you that cut the National Institutes of Health budget without hurting biomedical research. In fact, it will help.

Here’s my proposal: save over $240 million per year in the NIH budget by cutting all funding for the two centers that fund alternative medicine research–the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Cancer Complementary and Alternative Medicine (OCCAM). Both of them exist primarily to promote pseudoscience. For the current year, NCCAM’s budget is $128.8 million, an amount that has rapidly grown from $2 million in 1992, despite the fact that not a single “alternative” therapy supported by NCCAM has proven beneficial to health. OCCAM’s budget was $121 million in 2008 (the latest I could find) and presumably higher in 2010. That’s over $240M, not counting money these programs got from the stimulus package (and yes, they did get some stimulus funding).

Actually, I disagree with Salzberg. No, I don’t disagree that NCCAM and OCCAM should be eliminated, although of the two OCCAM is probably less egregious in its funding of dubious research. What I disagree with is that that funding should go away, particularly given that President Obama has thus far spared the NIH from the budget ax and appears to want to spare it altogether. What I’d propose is to eliminate NCCAM and OCCAM, just as Steve does. After all, neither NCCAM nor OCCAM does any research that couldn’t be done elsewhere in the NIH. Take all the woo, remove its safe and happy home, and make it compete for funding just like everything else in the regular study sections.

In contrast to what Salzberg proposes, I would propose taking the savings from eliminating NCCAM and OCCAM and fold it into the rest of the NIH, rather than taking it as a cut. There’s a fairly good chance that the NIH budget won’t be significantly cut next year, based on my reading, although its budget will likely be flat. Even though NCCAM and OCCAM combined make up less than 1% of the NIH budget, every little bit helps. Of course, where we agree is that, if cuts are inevitable, we’d both want NCAAM and OCCAM to be the first things to be on the chopping block. I’m just more optimistic that cuts to the NIH budget are not inevitable, although I’m under no illusion that there will be any big budget increases.

Steve gives this reason:

These two organizations use our tax dollars – and take money away from real biomedical research – to support some of the most laughable pseudoscience that you can find. To take just one example, NCCAM has spent $3.1 million supporting studies of Reiki, an “energy healing” method. Energy healing is based on the unsupported claim that the human body is surrounded by an energy field, and that Reiki practitioners can manipulate this field to improve someone’s health. Not surprisingly, the $3.1 million has so far failed to produce any evidence that Reiki works. But because there was never any evidence in the first place, we should never have spent precious research dollars looking into it.

Funding reiki is, of course, no different than funding studies of faith healing, because reiki is faith healing that substitutes Eastern mysticism for Christian religious beliefs. Out of curiosity, I decided to look at the RePORT database, which the NIH maintains to list all grants in its portfolio, and search for “reiki.” I wanted to know whether there were still any active, currently funded grants funding reiki from NCCAM. There were two. One was granted to Dr. Joan Fox at The Cleveland Clinic and entitled Effects of reiki on physiological acute consequences of stress. Here is the abstract:

Energy healing therapies such as reiki are becoming popular. reiki is a spiritual practice that involves physical touch and social contact with an empathetic person; unlike many relaxation therapies, reiki requires no participation by the patient. These features make reiki particularly attractive in the hospital setting, where patients are often extremely anxious, depressed, in pain, or sedated. In this setting, stress can be associated with increased pain, cardiovascular reactivity, decreased wound healing, increased susceptibility to infectious disease, increased post-surgical complications, and increased length-of-stay. Although reiki is commonly used in the hospital setting to reduce pain or pre-surgical anxiety, there are few studies demonstrating benefits. Remarkably, no information is available on physiological changes induced during a reiki session. In the absence of such information, it is difficult to make rational predictions concerning situations in which it may be beneficial. Moreover, given the deep state of relaxation often reported by clients, we cannot exclude the possibility that it may have a potential for harm in certain medical situations. Our primary research questions are to determine whether physiological changes are induced during a reiki session and whether a reiki session affects responses to a subsequent acute stressor. Secondary research questions include assessing which benefits result from placebo, empathetic intentions, or unique abilities of “attuned” reiki practitioners and assessing background characteristics associated with acceptance and responsiveness. Based on its use to reduce pain and anxiety, a potential mechanism by which reiki might exert effects is at the level of affecting emotional centers of the brain with resulting decreases in activity of the SNS and other stress pathways. To assess these possibilities, we will perform a randomized, controlled, blinded study with four groups of 80 healthy volunteers. In Specific Aim 1, we will assess changes in physiological markers of sympathetic, parasympathetic, and HPA activation, brain activity, and psychological well-being before and after a 30-min session of reiki, as compared to control groups. In Specific Aim 2, we will assess the ability of reiki to affect psychological, sympathetic, parasympathetic, HPA, immune function, and platelet activation responses to an ensuing 5-min acute laboratory stressor. The use of supine-control, neutral sham, and empathetic sham groups will allow us to gain insights into mechanisms by which reiki effects are mediated. Interactions between baseline characteristics and treatment effects will be assessed. Information obtained from the proposed studies will provide detailed information on physiological pathways affected by reiki. This information is critical if we are to make rational decisions on potential situations in which reiki sessions may provide benefits and those in which there may be the potential for harm. Should reiki decrease stress pathways or reduce physiological responses to stressful situations, it could be a powerful adjunct to traditional medicine and have enormous health and economic impact.

“Supine-control, neutral sham, and empathetic sham groups”? It sounds almost like…science! My best guess is that “supine control” includes people who just lay there; the neutral sham group has someone who doesn’t know any reiki doing the mumbo-jumbo and making the hand motions that reiki masters make; and the “empathetic sham” group receives a nice sympathetic ear. Sadly, the clinical trial associated with this grant is still ongoing.

The second reiki trial currently being funded by NCCAM was granted to the University of Nevada Reno with Dr. Alice Fay Running as the principle investigator. It’s entitled Use of energy biofield therapy for the treatment of cancer and GVHD:

Complementary and alternative therapies are becoming more common in the US for the treatment of a variety of ailments. These include the practices of energy field therapies such as Healing Touch or reiki. However, there is still much controversy if and by which mechanism these therapeutic modalities provide benefit. The mental ability of a being, whether conscious or not, to influence physical parameters especially those linked to stress and inflammatory pathways has become more evident in recent years. Healing Touch therapy is based on the principle that bioenergy channels or fields are blocked in subjects with disease. Clearance or opening of these fields by the Healing Touch practitioner opens these fields resulting in a health promoting state for the subject. However, client acknowledgement of therapy is a prerequisite for treatment. Thus, it is difficult to scientifically assess the contribution of the subject to outcome of the therapy. Through the use of animal models, it is possible to eliminate the variable that clues to the beliefs of the practitioner can be transmitted to the subject. In this proposal, we will test the hypothesis that trained practitioners of Healing Touch can promote beneficial immune responses (anti-tumor) while reducing diseases of immunity (in these experiments we will use Graft versus Host Disease). This hypothesis will be tested in the following specific aims. In the first specific aim, we will determine the limits of Healing Touch to reduce tumor growth and symptoms of graft vs. Host disease in murine models. The effect on immune parameters will also be assessed. We will then determine the amount of treatment that is needed to result in statistically significant differences in outcome. In the second specific aim, we will test the ability of the practitioners vs. trained animal caretakers to make determination of perturbations in health status. This aim will question the ability of the trained Healing Touch practitioners to `sense’ blocked energy fields compared to skilled observation of clinical parameters used to judge animal health. These studies will be used to develop a research and training program for graduate nursing students to learn biomedical and qualitative research techniques, and to develop preliminary data for additional program applications.

That’s right. It’s your tax dollars at work funding a study of therapeutic touch practitioners applying their “skills” to mice with tumors and mice with graft versus host disease. Is that how you want your tax dollars spent? It’s not how I’d want my tax dollars spent, even if the economy were booming and goverment coffers overflowing with tax dollars.

Still, if all NCCAM did was to fund research into “alternative” medicine, I’d have less of a problem with it, its funding of dubious studies notwithstanding. But it’s worse than that. NCCAM funds “education” programs that promote seemingly neutral but in reality skewed information about various “alternative” therapies, as described by Steve Salzberg and Barbara Drescher.

I wish Steve well in his renewed effort to rally support for defunding NCCAM and OCCAM. I’ll be willing to help in any way I can. Unfortunately, now as then I see this as a very uphill battle. I wish it weren’t so, but I doubt this new effort will go any farther than the previous effort. Even so, I don’t advocate giving up. If we want to remove the pseudoscientific blight that is NCCAM from the crown jewel of the biomedical research effort of the United States, the NIH, we have to be in it for the long haul.