Jul 02 2012
I don’t know how I’ve missed this, given that it’s been in existence now for a month and a half, but I have. Regular readers (and even fairly recent readers, given that I write about this topic relatively frequently) know that I’m not a big fan of the National Center for Complementary and Alternative Medicine (NCCAM). (Come to think of it, neither is anyone else writing for this blog.) Just search this blog for “NCCAM” if you don’t believe me. I’ve explained the reasons many times, but the CliffsNotes version is that NCCAM is an enormous waste of taxpayer money, dedicated as it is to the study of modalities that are at best highly implausible and at worst break well-established laws of physics (i.e., “energy healing”). I do concede that, since the latest NCCAM director (Dr. Josephine Briggs) took over, there has been a noticeable attempt to bring more scientific rigor to NCCAM, and to some extent Dr. Briggs has succeeded. At the very least she is a legitimate scientist with an impressive pre-NCCAM track record, and I do fear who will succeed her when she moves on or retires given that there is enormous pressure from the CAM community to appoint one of their own as director.
Unfortunately, as rigorous a scientist as Dr. Briggs was in her former life, since coming to NCCAM she has gradually been assimilated into the culture of the place. Indeed, although it is good that NCCAM has backed away from studying woo like homeopathy and distance healing, the co-optation of science-based modalities such as exercise, diet, and natural products pharmacology has continued apace. Worse, the recently released five year strategic plan for NCCAM admitted that the science funded by NCCAM in the past was crap and, in essence, promised to do some real science for a change. That’s why on occasion I’ve jokingly said that we should take off and nuke NCCAM from orbit. It’s the only way to be sure. On the other hand, no doubt someone would think I seriously mean that we should nuke NCCAM. Of course, I’d never advocate that! NCCAM is located right smack dab in the middle of the NIH campus. The collateral damage would be unacceptable.
What’s in a word?
Like all of the NIH, our mission is to conduct the highest quality biomedical research to improve the health of the Nation. NCCAM’s special charge is to bring rigorous science to the broad array of health practices that have arisen from outside of mainstream medicine. This covers a lot of tough territory! Not surprisingly the conversation about complementary and alternative health practices has often become polarized, with competing views about what makes good sense. I hope to use this blog as a place for a conversation about these challenges.
Sounds like a plan! It’s also one reason why I encourage SBM readers to take part in that conversation, both here and on the NCCAM blog (although you should note that the comments on the NCCAM blog are moderated). I also thank Dr. Briggs for providing me with additional blogging material. In particular, I’d like to join the discussion started in the very first substantive post after her welcome. It’s about the word, “integrative,” which Dr. Briggs discusses in her second blog post, “Integrative” — What Is in a Word? It’s a very good question, although probably not in the way that Dr. Briggs intended it. What is in the word “integrative”? I’ve discussed the use of this word many times before, in particular how “integrative medicine” is a brand rather than a specialty, but before we get to my blather, let’s take a look at Dr. Briggs’ blather. Fair’s fair, after all.
First, Dr. Briggs tries to have it both ways, being a good skeptic but still accepting the CAM framing of science and language:
That seems simple enough but there are a lot of rough edges at the interface between conventional medicine on the one hand and use of complementary/alternative health approaches on the other, and “integrative” can get caught in a highly polarized debate. From one end, “integrative medicine” offers a holistic, gentle, patient-centered approach that will solve many our Nation’s most pressing health care problems. At another end, “integrative care” represents an evasive rebranding of modern equivalents of “snake oil” by practitioners who raise unrealistic hopes and promote approaches that are not sensible, supported by evidence, or proven safe.
This is the classic false equivalency. Notice how Dr. Briggs characterizes “integrative medicine” on the one hand as being all soft and fuzzy, the equivalent of mom and apple pie. Who could argue with “holistic, gentle, patient-centered” approaches? Well, actually, I can, because the word “holistic” is meaningless in this context. A good science-based primary care doctor is “holistic.” You don’t need to buy into woo to be a holistic doctor. Similarly, you don’t need to buy into woo to be patient-centered in your approach. In addition, as I’ve pointed out before, “patient-centered” is a wonderfully flexible term that can mean so many things to so many people, and the woo-meisters have certainly taken advantage of that in order to promote the idea that patient-centered care necessarily involves their favored quackery.
Now here’s the false equivalency. Dr. Briggs equates the above wonderfully Orwellian verbal prestidigitation that describes CAM (or “integrative medicine” or whatever you want to call it) as the path to holistic care with skeptics who point out that integrating quackery with real medicine makes no sense. As Mark Crislip so famously put it, “If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.”
And if you “integrate” pseudoscience with science, it does not make the science more rigorous. If you mix quackery with real medicine, you do not make the real medicine better—or even more “holistic.” Much of “integrative medicine” represents, more than anything else, a return to pre-scientific beliefs, such as vitalism, miasmas, and illnesses being caused and cured by, in essence spirits or gods or magic. After all, reiki is nothing more than a form of faith healing, and most energy medicine is nothing more than magic, the belief that if you wish for something really, really hard, you can bend the universe to do your bidding and provide you with that thing, in this case, healing.
Dr. Briggs then asserts three “very well documented facts.” Unfortunately, none of these facts are unequivocally true—or even that particularly well documented. I’ll show you what I mean.
Here’s “fact” one:
Individuals, their health care providers, and their health care systems are all, on a large scale, incorporating various practices which have origins outside of mainstream medicine into multi-pronged treatment and health promotion approaches.
Well, yes and no. First the no. As I’ve explained many times, the evidence for this assertion is weak at best. Most surveys of CAM use include spirituality and prayer, which artificially inflates the numbers. It also includes exercise and meditation, both of which are arguably not from “outside the mainstream.” As I’ve pointed out before, when you look at the hardcore woo, such as homeopathy and the like, the numbers of people who use them are actually quite small and haven’t changed that much over the last decade. Now the yes. It is true that quackademic medicine has infiltrated medical schools and that many hospitals whose leaders should know better have embraced it.
Now here’s “fact” two:
This “integrative” trend among providers and health care systems is growing. Driving factors include perceived benefit in health or well-being, emerging evidence in at least some cases that perceived benefits of integrative are real and/or meaningful (e.g., management of chronic pain), and marketing of “integrative care” by health care providers to consumers.
OK, I’ll give Dr. Briggs this one—partially, anyway. The reason, however, is because Dr. Briggs cleverly worded it. Note how she refers to “perceived” benefit rather than actual benefits. She’s also right that the marketing of “integrative care” plays a large role in its current popularity. As I’ve pointed out before as well, “integrative medicine” is a marketing term, not a term that describes anything real. It’s more about keeping the customer satisfied rather than actually helping the patient. It’s a sham. It’s also quite arguable whether in the case of the management of chronic pain the perceived benefits of “integrative care” are real or meaningful. Indeed, some “integrative” modalities touted as effective are in fact science-based treatments, such as exercise and lifestyle interventions.
This leads to “fact” three:
With few exceptions, data to guide evidence-based decision making about safety and efficacy are at best preliminary.
No, no, no, no. With few, if any exceptions, data to guide science-based decision making about CAM or “integrative medicine” are negative. They do not work, by and large. As Kimball Atwood so famously described CAM modalities:
A spectrum of implausible beliefs and claims about health and disease. These range from the untestable and absurd to the possible but not very intriguing. In all cases the enthusiasm of advocates vastly exceeds the scientific promise.
Unfortunately, Dr. Briggs remains inordinately impressed with the concept of “integrative” medicine, calling it “simple” and “pragmatic” while declaring it a “very useful construct” that “focuses on major trends in 21st century health care.” In actuality, most CAM modalities focus on major trends in 17th or 18th century health care or even earlier. They are modalities steeped in prescientific beliefs because they have their origins in a time before we understood enough about how the body works and how health and disease occur not to attribute disease and health to mystical concepts. That is the reality of what CAM “integrates” with science-based medicine.
Oh, the pain, the pain…
One notes that Dr. Briggs emphasizes multiple times “nonpharmacological approaches” to pain management. No doubt this is because pain management is where placebo effects are most common. Be that as it may, she’s already produced one post on pain management. She begins by exulting about the science presented NIH Pain Consortium 7th Annual Symposium on Advances in Pain Research, which she attended, mentioning various targets and promising new pharmacological therapies. What impressed her inordinately (much as the word “integrative” appears to do) were the potential nonpharmacological approaches that, of course, fall under the rubric of complementary and alternative medicine (CAM). The reason she uses to justify this promise is recent data that find a serious problem with the abuse of prescription pain medications. This is indeed a serious problem, although one notes that in fields such as mine (cancer) there is considerable evidence that many patients are undermedicated for their pain as well. Be that as it may, this is how Dr. Briggs views the landscape:
Clearly, drugs are, and will remain, critically important in managing pain, but drugs alone are not enough. There is another important piece to pain management—patients also need strategies for self-care and ways to harness the huge impact that context, attention, emotional state, and reassurance can have on pain. NCCAM is bringing a special contribution to pain research by pursuing promising, nonpharmacological approaches to pain management; about 30 percent of our total research budget is focused on pain. Our research is built on evidence, still incomplete, that various mind and body approaches, such as meditation, guided imagery, yoga, tai chi, massage, and spinal manipulation, may have value as adjuncts in pain management. Some of these techniques are being integrated into pain management in health care facilities around the country. And, while there is a growing evidence base for their value, and a number of “real world” testimonials, there are still many areas of uncertainty. It’s my belief that NCCAM, by funding the kind of research that builds a critical, rigorous evidence base, can truly have an impact on pain management.
I find it rather revealing that NCCAM spends one-third of its budget on pain research. After all, pain is one symptom where placebo effects play a huge role. Consequently, if there’s an area where CAM modalities would be most expected to appear to show an effect, it would be in treating pain. Of course, if there’s one research area where it’s really hard to separate placebo effects from real effects it’s in pain research as well. Without really rigorous research design, any clinical study looking at the effect of a CAM modality on pain, particularly chronic pain, will be prone to many confounders, such as recall bias, regression to the mean, placebo effects, various biases that can creep into the design of clinical trials, and the like. Note how Dr. Briggs points out how there are a “number of ‘real world’ testimonials” supporting the efficacy of CAM modalities. No doubt there are. There always have been. Unfortunately, as we’ve documented time and time again for CAM modalities, in particular acupuncture, when CAM modalities are tested under truly rigorous conditions with appropriate controls the result is nearly always that they are indistinguishable from placebo.
There’s another consideration, and it goes to the heart of why NCCAM should even exist. Once again, there is nothing inherent in pain research that requires a separate institute dedicated to CAM, or “integrative medicine,” or whatever you want to call it. NCCAM is completely unnecessary for this sort of research; worse, it’s counterproductive. The reason is that it overlays woo on what should be rigorous scientific research. Worse, if the next blog post is any indication, NCCAM doesn’t even really want to do truly rigorous research.
Reversing the progression
If the pain research carried out at or funded by NCCAM were indeed highly rigorous, then I wouldn’t have much problem with it. I’d still argue that NCCAM as a center is completely superfluous, but I’d be more willing to accept its continued existence. Unfortunately, if the most recent post on the NCCAM blog is any indication, Dr. Briggs’ promise of building a “critical, rigorous evidence base” is a lot of hot air. This post was not written by Dr. Briggs, but rather by Richard Nahin, Ph.D., M.P.H., who is Senior Advisor for Scientific Coordination and Outreach at NCCAM and is entitled Observational Studies and Secondary Data Analyses To Assess Outcomes in Complementary and Integrative Health Care. I’m guessing that from the title alone you’ll be able to tell where this is going. You won’t be wrong. Dr. Nahin wants to encourage “pragmatic” trials of CAM modalities. It’s rather sad to see his rationale because he describes well the problems with observational trials and then concludes that they’re useful anyway:
Although observational studies cannot provide definitive evidence of safety, efficacy, or effectiveness, they can: 1) provide information on “real world” use and practice; 2) detect signals about the benefits and risks of complementary therapies use in the general population; 3) help formulate hypotheses to be tested in subsequent experiments; 4) provide part of the community-level data needed to design more informative pragmatic clinical trials; and 5) inform clinical practice.
The main difficulty with causal inference in such observational studies has to do with the fact that participants or their providers choose which therapies the participants receive. Invariably, this “choice” means that participants choosing one therapy may not have the same characteristics as participants choosing another therapy; one or more of these differences may be the true cause of any observed effects rather than the use of one therapy or another. This is, of course, very different than a well-designed randomized clinical trial of sufficient size, where the same process that randomly assigns participants to one treatment or another also helps to balance the characteristics of individuals in each group.
Here’s the problem. Nahin is putting the cart before the horse, as so many CAM apologists do. Pragmatic “real world” trials can be useful, particularly in terms of comparative effectiveness research, which will be more and more important in the coming years. There’s a caveat, though. It’s only useful to do pragmatic or observational trials after treatments have already had their efficacy and safety demonstrated in well-designed randomized clinical trials. In other words, for comparative effectiveness studies, there’s no point in comparing the “real world effectiveness” of two studies that haven’t yet been shown to be efficacious in randomized clinical trials. “Pragmatic studies,” which try to examine the “real world” effectiveness of a treatment are pointless if the treatment under study hasn’t actually been demonstrated to be efficacious yet in rigorous randomized clinical trials. And observational studies are right out, as we say, when randomized clinical trials of a modality have already failed to demonstrate efficacy, as is the case for the vast majority of CAM treatments that have been subjected to randomized clinical trials.
None of this deters Nahin. He proposes a number of methods to try to control for treatment self-selection, such as regression modeling or employing propensity scores or instrumental variables to match samples. Don’t get me wrong; I have nothing against these methods when they are appropriately used. However, they are utterly unnecessary for the sorts of questions that Nahin apparently wants to ask. They could just do randomized clinical trials, which would be less prone to the biases and shortcomings that necessitate all that statistical prestidigitation in the first place.
Steve Novella has made an excellent point multiple times on this blog and on his own about the normal progression of clinical trials. Usually, what happens is that clinical observations are made (or something is discovered in the laboratory and tested in preclinical models). Next come small pilot trials in humans. If those are promising, then larger, rigorous clinical trials are performed. These are the classic randomized clinical trials, either with placebo control or comparing the new therapy to standard of care therapy. Once large randomized clinical trials demonstrate efficacy, then, and only then, are “pragmatic” trials indicated in order to examine “real world” effectiveness. Indeed, frequently, as we have found out, treatments are less effective in the “real world” than they are under the idealized conditions under which randomized clinical trials are carried out. CAM advocates, however, tend to flip the order. Basically, when more rigorous randomized clinical trials fail to demonstrate efficacy, they tend to start advocating things like “pragmatic” trials because such trials are far more likely to be confounded by placebo effects and the various biases that randomized, double-blinded trials are designed to try to avoid. That appears to be exactly what Nahin is doing here.
In a way, I’m rather happy that NCCAM has a blog now, and it’s not just because it provides me with extra blogging material. The reason is that, even after just four posts, this blog demonstrates the very problems with “integrative” medicine (or CAM) in general and how NCCAM does research in particular. Despite Dr. Briggs’ attempts to portray NCCAM as doing only the most rigorous research and even though to some extent Dr. Briggs does appear to have succeeded in tightening up the scientific rigor of the center, in this blog we still see that NCCAM is steeped in the pseudoscientific attitudes that underlie so much of CAM. Dr. Briggs buys into the language of CAM, which is one of the most potent tools CAMsters have to make it seem as though they are not quacks, and the scientific leadership clearly buys into the idea that it’s acceptable to put the cart before the horse and do pragmatic trials and “real world” observational studies before they’ve actually demonstrated that CAM modalities can actually do anything above and beyond placebo.
All of this is why, more than ever, NCCAM should be dismantled, defunded, and its personnel absorbed into the rest of the NIH, where they could do some good.
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