JAMA: A willing accomplice to co-opting “nonpharmacologic” treatments for pain as being “alternative” or “complementary”

That I’m not a fan of the National Center for Complementary and Integrative Health (NCCIH, formerly known as the National Center for Complementary and Alternative Medicine, or NCCAM) should come as no surprise to anyone. Basically, from its very inception as the Office of Alternative Medicine in the early 1990s to its growth to large center with a yearly budget of $120+ million, NCCIH has served one purpose: The promotion and attempted legitimization of quackery and magical thinking in medicine, the better to “integrate” pseudoscientific medicine with science-based medicine. Certainly, the leadership and supporters of NCCIH will deny to high heaven that that’s true, but the history of NCCIH makes such a conclusion inescapable, and when NCCIH can’t “integrate” quackery like acupuncture and naturopathy into medicine, it co-opts science-based modalities like diet and exercise as somehow being “alternative” or not part of mainstream medicine, to claim them for itself because, unlike the pseudoscience, these methods can work.

One of the more amusing yet disturbing aspects of NCCIH over the last five years or so is that its leadership seems to be coming to the realization that the “interesting” forms of “complementary and alternative medicine” (CAM), the far out ones that first attracted its mandated attention (or, more correctly, attracted the attention of NCCIH’s original Congressional patron Senator Tom Harkin) have been a failure. Despite over $1 billion expended over the last 20 years or so, NCCIH has failed to validate homeopathy, acupuncture, naturopathy, reflexology, chelation therapy, or the Gonzalez protocol for cancer. All that leaves are exercise, diet, and lifestyle changes. Undeterred, however, the NCCIH, led by Dr. Josephine Briggs, has continued to charge boldly onward by taking full example of the opioid addiction crisis in this country to represent CAM as “nonpharmacological” approaches to chronic pain. Indeed, a couple of months ago, NCCIH even published a rather poor quality systematic review that purported to show that some forms of CAM were effective against chronic pain and represented nonpharmacological alternatives to opioids.

It’s bad enough when the NCCIH produces a document that was widely derided as not showing what the NCCIH claims it shows; e.g., by Steve Novella and Edzard Ernst. It’s also bad when NCCIH apologists like John Weeks compare such criticism to Donald Trump. Ironically, the comparison to Donald Trump reminds me that the problem with NCCIH presents to medicine is the same problem Donald Trump poses to the body politic. As Trump normalizes misogyny, racism, borderline fascism, and utter cluelessness, NCCIH normalizes pseudoscience and quackery, seeking to “integrate” them as part of medicine. Of course, CAM itself does the same thing, but, just as Trump has become the face of the forces he’s unleashed, the NCCIH is the face of CAM, at least in academia.

It’s continuing to have an effect, too. For example, just this week JAMA, normally viewed as one of the top tier medical journals, published a Medical News & Perspectives article by Jennifer Abbasi entitled As Opioid Epidemic Rages, Complementary Health Approaches to Pain Gain Traction. It’s basically a story about the NCCIH’s systematic review that lacks—shall we say?–adequate skepticism. The first part of the article basically reports the findings of the systematic review; so I won’t comment much on it. If you want to know why the conclusions of the systematic analysis do not flow from the data presented, read the contemporaneous discussions by Steve Novella, Edzard Ernst, and myself.

What’s irritating to me comes in the second part of the article:

Nahin noted that the clinical trials that met the bar for his review tended to be small and participants were limited primarily to older white women. “The review identified a lot of gaps in the data,” he said, adding that “there’s still a lot of research that needs to be done to see whether these data can be generalized to the larger US demographic population.” Nahin also acknowledged that the analysis was somewhat subjective: “As a narrative review geared to busy primary care providers, our conclusions are our qualitative assessments of the literature and are not based on a hard quantitative analysis such as a meta-analysis or meta-regression,” he said.

No, what busy clinicians need is not “qualitative assessments.” What they need are the very “hard quantitative analyses” that Richard Nahin seems to be dismissing as unnecessary or not useful to “busy clinicians.” In fact, it just occurred to me that I missed a part earlier in the study that shows you just how misguided the NCCIH review was:

Unlike a typical systematic review that assigns quality values to the studies, the investigators conducted a narrative review, in which they simply looked at the number of positive and negative trials. “If there were more positives than negatives then we generally felt the approach had some value,” Nahin explained. “If there were more negatives, we generally felt the approach had less value.” Trials that were conducted outside of the United States were excluded from the review.

Arrrgh! That’s exactly the same raationale that antivaccine activists use. They ignore the quality of the evidence and simply count positive and negative trials. Since in the antivaccine world there are always a lot of crappy “positive” trials while the negative trials that fail to find a link between vaccines and autism or other serious health problems tend to be much larger and more rigorous, just counting positive and negative trials isn’t helpful. In fairness, the NCCIH review didn’t actually ignore the quality of trials. The included trials had to reach minimal quality standards, but within the groups of trials there were trials that didn’t use sham controls along with trials that did. (Guess which ones were negative and which ones were “positive.”)

It’s worse than that, though. NCCIH argues to go “beyond the randomized clinical trial” or “beyond the RCT.” What does that mean? Longtime readers might be able to predict what’s coming next. Certainly I could. Yes, we’re talking “pragmatic trials”:

A next step for the NCCIH, Shurtleff said, is to conduct “pragmatic” studies that look at the effectiveness of complementary health strategies for pain outside of the strict inclusion/exclusion criteria of RCTs. “We’re looking to see how this works in real time in the real world, with all the warts and things that go along with that,” he said.

“At the end of the day, if an approach is successful you’ll be able to generalize it more to everyone with the disease, versus a very small cohort of individuals,” Nahin added.

Such pragmatic studies may begin next year in collaboration with the Veterans Administration and the Department of Defense. These agencies are looking toward complementary health approaches for returning service members, who experience both high levels of chronic pain and other comorbid conditions such as posttraumatic stress disorder and substance abuse, Shurtleff said.

What are pragmatic trials? They’re pretty much as described above. The reason they’re inappropriate for CAM, though, is because pragmatic trials of CAM put the cart before the horse. Pragmatic trials are useful and can provide data that can be very helpful in determining which treatments work in the “real world.” However, they are only useful to test interventions that have already proven themselves to be efficacious and safe in RCTs. RCTs have very strict inclusion and exclusion criteria, and, not infrequently, once an intervention is validated in RCTs and released “in the wild,” so to speak, patients selected for them don’t fit the strict criteria used in the RCTs and the interventions might not be done just as they were in the RCTs. In other words, the real world intrudes. Here’s where pragmatic trials come in. They actually do give a better idea how well an intervention works in “the real world.” Not surprisingly the most common outcome is that treatments that worked well in RCTs don’t work as well in the real world.

For treatments in which the outcome is subjective, however, such as CAM treatments for pain, the results are often the opposite. Pragmatic studies give a false impression of effectiveness. The reason, of course, is that most pragmatic trials don’t include a placebo or sham intervention control; so what is measured tends to be placebo effects more than anything else. That’s why I describe pragmatic trials as putting the cart before the horse. So why is NCCIH doing this if it’s bad science? Do you even need to ask. It’s all about the money:

Madhu K. Singh, MD, a physical medicine and rehabilitation orthopedic physician at Midwest Orthopaedics at Rush in Chicago, praised the NCCIH review as “an excellent overview of the more rigorous RCTs that have been performed” for several common complementary therapies. However, Singh—who emphasizes nonsurgical spine management in her practice—pointed out that many of the approaches aren’t feasible for patients because insurance companies by and large don’t cover them. Because of this, “physicians are often backed into a corner when dealing with a patient’s pain,” she said, referring to the tendency to default to medications.

The IOM report, which emphasized a model of “integrated, interdisciplinary pain assessment and treatment” that includes complementary and alternative medicine (CAM), recommended that reimbursement policies should be revised to accommodate this approach.

Out-of-pocket spending on complementary health treatments for adults and children in the United States added up to $30.2 billion in 2012, according to National Health Interview Survey data. But not every patient can afford to foot the bill themselves, Singh said: “We need to create better access to CAM therapies. By reducing the cost burden on the patient, these therapies become far more accessible.”

Basically, pragmatic trials are being used to generate data to convince third party payers to reimburse for CAM treatments. It’s not good data, but it might be enough.

That’s where NCCIH is doing its real harm.

Categories

More like this

I’ve been critical of the National Center for Complementary and Integrative Health (NCCIH), which was until relatively recently known as the National Center for Complementary and Alternative Medicine (NCCAM) ever since I first discovered that it existed, lo, these many years ago. When I first…
John Weeks has long been an activist for alternative medicine—excuse me, “complementary and alternative medicine” (CAM) or, as it’s more commonly referred to these days, “integrative medicine.” Despite his having zero background in scientific research or the design and execution of experiments and…
It's no secret that I'm not particularly fond of the National Center for Complementary and Integrative Health (NCCIH). Formerly known as the National Center for Complementary and Alternative Medicine (NCCAM) and before that the Office of Alternative Medicine, NCCIH has been the foremost government…
It's been a while since I've written about Brian Berman. We first met him when he somehow managed to insinuate a "case report" of chronic low back pain into The New England Journal of Medicine in which he recommended acupuncture for this patient. Dr. Berman also happens to be a founder of…

What would be required to shut down NCIIH? If the political will were there, what would need to happen?

By Daniel Rajala (not verified) on 04 Nov 2016 #permalink

It seems the pain industry is all the rage these days. NCCIH is big into supplements, are they not?

Daniel Fabricant, Ph.D. is Executive Director and CEO of the Natural Products Association (NPA), the nation’s largest and oldest trade organization representing the natural products industry, including dietary supplements, ... He is responsible for implementing board policy for the advancement and protection of the natural products industry, while overseeing every aspect of the association’s programs and activities. Most recently, Dr. Fabricant served as the Director of the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA), where he directed agency policy, public affairs and regulatory action regarding regulation of the dietary supplement industry for more than three years...

Prior to the FDA, Dr. Fabricant was vice president, global government and scientific affairs, for NPA, responsible for establishing and leading industry coalitions dealing with a range of legislative, regulatory and scientific matters.

http://www.npainfo.org/NPA/AboutNPA/Leadership.aspx

It is just another revolving door. It is interesting to note that Dr. Fabricant's last act at FDA was to issue an import alert and start seizure of shipments of a certain natural pain killer -- The very natural pain killer that NDA was lobbying to have banned.

http://www.accessdata.fda.gov/cms_ia/importalert_1137.html

When I consider their "treatments", suffice it to say, if anyone suggests such a course of treatment for my disabled wife or myself, I fully reserve the right to revive an ancient practice.
Hung, drawn and quartered. I'll bring the knives and charcoal.

Arrgh! I don't know if anyone has seen the Last Week Tonight (John Oliver) piece on opioids, but one of the things that the doctors mentioned is that you can't prescribe someone physical therapy if their insurance won't cover it, and the nearest PT is 50 miles away.

So how about let's spend less money on ridiculous nonsense like supplements and riki, and more on making science-based non-pharmacological pain treatments more widely available?

By JustaTech (not verified) on 04 Nov 2016 #permalink

I can't take opioids (severe nausea), but if I could, I would, because there are few days that I have pain at a level 3. Most of the time, it's much higher unless I'm sitting perfectly still and in exactly the right position. If anyone came to me suggesting these "treatments," they would feel what I like to call The Wrath Of Cane. That would go for suggestions of weed, also.

#4 I had the inverse problem a decade ago: PCP would prescribe physical therapy, insurance would approve, the PT would fix me right up, and insurance would deny payments (beyond the rather generous copays they demanded).

Which, to my eyes, made insurance nothing more or less than a buyer's club with a gatekeeper function that reserved the right to deny medical treatment on arbitrary grounds.

By Robert L Bell (not verified) on 04 Nov 2016 #permalink

Ellie, have you tried cannabis?

By sullenbode (not verified) on 04 Nov 2016 #permalink

( oops! )

Which points to the larger issue, one that (I am afraid) is not just limited to medicine. The enthusiasts are quite admirably persistent in pushing for The Cause to be accepted into reputable journals and reputable organizations.

Not so that they can demonstrate that their pet idea actually works, but that there is sufficient popular support for the pet idea that mandatory payments/reimbursements/support can be demanded through the political process.

We all believe in Democracy (I hope) but Democracy presupposes an informed citizenry that is capable of discerning its own best interests. Debauching the education system and tainting the stock of reliable knowledge: two tactics that are as effective as they are dangerous.

By Robert L Bell (not verified) on 04 Nov 2016 #permalink

I won't say much for NCCIH, I haven't noticed many useful papers about supplements from them.

Dramatic, reliable single component applications are less common, e.g acute antivirial IV vitamin C, which I'm still waiting to see honest attempts to test in maimstream medicine.

Even with my limited range and experience base, however, you folks are all wet about pain and supplements. As usual, you folks seem to have no idea at all about "what works".

Some people need large amounts of vitamin D to have normal, healthy blood levels, say 10,000-20,000 iu per day for 30-45 ng/ml. Without supplements they will suffer terrible arthritic pains and health problems, previously decades without redress. Even today, with raised awareness and better blood assays, support on this is spotty, especially the related nutrients like magnesium and vitamin K, or items that interfere.

Ditto a number of other nutrients for back pain that the combinations are often totally inadequate for complete coverage both by molecular entity and by dose. Early in the onset or injury is fastest. I hesitate to mention what ranges reported or observed, because of the cacophony of bias here. Some doses may well represent various malabsorption problems unaddressed in clinical GI land.

I have great sympathy for anyone who has experienced unredressed crippling joint or back pains, acute or chronic. I can only wonder what they tried and did not try, before more drastic treatments.

@ Robert L Bell
"two tactics that are as effective as they are dangerous". This is a conspiracy theory. What I actually see is a collapse of the knowledge industry, due to greed, conflict of interest, bureaucracy and uncontrolled demography.

By Daniel Corcos (not verified) on 04 Nov 2016 #permalink

"Basically, pragmatic trials are being used to generate data to convince third party payers to reimburse for CAM treatments. It’s not good data, but it might be enough.

That’s where NCCIH is doing its real harm."

I couldn't agree more. Much to the pleasure of the dietary supplement industry, to say nothing of naturopaths, John Weeks began championing full reimbursement for CAM by insurers in the U.S. well over a decade ago.

On the subject of treatments for pain, either ignorant of the law or acting in deliberate disregard, dietary supplement companies are marketing one thing and another, whether proven safe and effective in humans or not. After a quick search online I found so many that I had wonder if the FDA had changed the law. Despite their lack of enforcement to protect the public, here's what they state:

"Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs, not dietary supplements."

http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm109760.htm

By Lighthorse (not verified) on 04 Nov 2016 #permalink

I have worked for a large drugstore for years and have been the point person to bring people to the pharmacy for immunizations every shift I work. I have sales background and really believe in what I am "soft selling" to all generations of customers/patients that come to us for scripts or OTC or even passport photos (let's ask the pharmacist if your immunizations are current for your travel plans...) I volunteer to work on senior day so I can talk up the flu and shingles, pneumonia immunizations in a very soft sell way. I overcome objections calmly and if you will, close the deal. What gets me angry is we have homeopathic remedies side by side with OTC and we have it all over the freaking store, even on "clipstrips" you know, those things that stick out that hang off an arm that is supposed to be located near another item you may need (like tissues, cough drops) so you will buy it as an afterthought. Isn't there any way a person like myself can start up a fuss with the government to forbid the marketing of homeopathic remedies side by side with OTC? If you know of a way I can, trust me I will.

By Drugstore employee (not verified) on 06 Nov 2016 #permalink

I guess this is what we get with a low-comment post: got to bring out your pet theories again.

@Gilbert: I have no interest in discussing your plant of the week and haven't since the last time you brought it up (yesterday). Look, I get it, you like this plant, you think it's a good thing and you're mad at the FDA/DEA. Point made.

@prn: Do you own a giant orange orchard somewhere? Is that it? And I'm sorry but I don't see how having the right vitamin D levels is going to address the pain of a compound femur fracture. (My point being that not all pain can be prevented.)

By JustaTech (not verified) on 07 Nov 2016 #permalink

@JustaTech, I have a few favorite plants as well. Most bear fruits or leaves that are phenomenally tasty, some, actually do have somewhat variable, but well observed pharmacological results. The problem is variable. :/

Meanwhile, my wife has been vitamin D deficient, badly so, with advanced osteoporosis, which is impacted by it, but it's not primary to. Something about menopause and all, plus PCOS.
Vitamin D supplementation, after blood testing showed severe deficiency has helped slightly with that deficiency and its symptoms, osteoporosis remains, of course.

As for an orange orchard, anyone owning one and wanting to whore it for vitamin C, screw that, just get those oranges to me fresh.
I don't care so much about the vitamin, but fresh oranges are wonderful, considering our distribution system and fresh orange juice is exceptionally tasty in the extreme, after having it a few times. :)
I can even get a few dining establishments that'll go for fresh oranges. Something about acquiring stars or something... ;)

By Wzrd1 (not verified) on 07 Nov 2016 #permalink

In reply to by JustaTech (not verified)

@14 Of course, you're right. I take vitamin D every day and have exactly the right levels according to two of my doctors. I will continue to take it, but it does diddly squat for my chronic arthritic pain.

Isn’t there any way a person like myself can start up a fuss with the government to forbid the marketing of homeopathic remedies side by side with OTC?

In practical terms, you've missed the boat.

Ellie@16 (and JustaTech):

@lll. I take vitamin D every day and have exactly the right levels according to two of my doctors. I will continue to take it, but it does diddly squat for my chronic arthritic pain.

Ellie, I did not say arthritis was universally solved by vitamin D3, but rather D deficiency could also be one correctable cause with severe pain.