Tell the FDA not to embrace quackery: Write to oppose its proposal on acupuncture and chiropractic for chronic pain

Last week, I wrote about acupuncture, specifically how acupuncturists are unhappy that the UK National Institute for Health and Care Excellence (NICE), which provides guidelines for recommended treatments for diseases and conditions, does not recommend acupuncture for the treatment of knee osteoarthritis but does recommend arthroscopic washouts and debridement, for which the evidence is weak. My retort was simple: If this is true, the answer is not for NICE to start recommending quackery like acupuncture, but rather for it to stop recommending conventional medical and surgical treatments with very little evidence for efficacy. Unfortunately, I recently learned that on my side of the pond our FDA appears poised to go in the opposite direction, as an article in STAT News, FDA proposes that doctors learn about acupuncture for pain management:

Chiropractors and acupuncturists who have lobbied for a bigger role in treating pain have won a preliminary endorsement from federal health officials.

The Food and Drug Administration released proposed changes Wednesday to its blueprint on educating health care providers about treating pain. The guidelines now recommend that doctors get information about chiropractic care and acupuncture as therapies that might help patients avoid prescription opioids.

“[Health care providers] should be knowledgeable about the range of available therapies, when they may be helpful, and when they should be used as part of a multidisciplinary approach to pain management,” the agency wrote in the proposal.

The suggested changes come as chiropractors and other alternative medicine providers have stepped up lobbying Congress and state legislatures to elevate their role in treating chronic pain. They’ve scored several big victories in recent years.

The draft document is entitled FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain (May 2017), and it is the culmination of an effort on the part of alternative medicine practitioners to use the opioid epidemic as a rationale to promote their pseudoscience as "nonpharmacologic treatments" for pain. I'll give Megan Thielking credit for a sharp eye, as the relevant passage in the FDA document doesn't dwell on acupuncture or chiropractic, but only mentions each once. Once is enough, however. First, the stage is set early on, as the FDA discusses pain management and the various strategies that might be used to control chronic pain:

Possible constituents of the treatment plan – The HCP [health care provider] should be knowledgeable about which therapies can be used to manage pain and how these should be implemented.

• Nonpharmacologic therapies – includes psychological, physical rehabilitative, surgical approaches; and complementary therapies
• Pharmacologic therapies – non-opioid, opioid, and adjuvant medications

Which leads to this:

A number of nonpharmacologic therapies are available that can play an important role in managing pain, particularly musculoskeletal pain and chronic pain.

• Psychological approaches – e.g., cognitive behavioral therapy
• Physical rehabilitative approaches – e.g., physical therapy, occupational therapy
• Surgical approaches
• Complementary therapies – e.g., acupuncture, chiropracty

HCPs should be knowledgeable about the range of available therapies, when they may be helpful, and when they should be used as part of a multidisciplinary approach to pain management.

Notice how the FDA lists "complementary therapies," like acupuncture and chiropractic, as, in essence, co-equals with conventional medical nonpharmacologic therapies for treating pain. This is profoundly misleading, given that acupuncture is nothing more than a theatrical placebo. As I like to put it, it doesn't matter where you place the needles or even if you place the needles. The effect is the same, and consistent with placebo effects.

How did we get to this point?

"Integrative" medicine and rebranding

It's no secret that the US is in the midsts of an opioid addiction epidemic. Opioid overuse and abuse are major problems, and government at all levels has started to take notice. A recent article in The Economist provides some perspective on the scope of the problem:

THEY have America in a deadly grip. In 2015, the most recent year for which full statistics are available, 33,091 Americans died from opioid overdoses, according to the Centres for Disease Control—almost three times the number who perished in 2002. Nearly as many Americans were killed by opioids in 2015 as were killed by guns (36,132) or in car crashes (35,092). In the state of Maryland, which releases more timely figures, drug-overdose deaths were 62% higher in the first nine months of 2016 than a year earlier.

The opioid epidemic is quite unlike past drug plagues. Deaths are highest in the Midwest and north-east, among middle-aged men, and among whites. Some of the worst-affected counties are rural. In 2013 a 40-year-old woman walked into a chemist’s shop in the tiny settlement of Pineville, West Virginia, pulled out a gun, and demanded pills. Don Cook, a captain in the local sheriff’s department, says he continues to nab many people for illegally trading prescription painkillers.

I first noted proponents of "integrative medicine" (or, as I like to refer to it, the "integration" of quackery into real medicine) using the opioid epidemic as a rationale to promote their preferred brand unscientific medicine about a year ago, when the National Center for Complementary and Integrative Health (NCCIH) released its strategic plan for 2016-2021. In that plan, the "nonpharmacologic management of pain" and difficult-to-control symptoms leapt front and center to become a major scientific priority, explicitly invoking the opioid crisis as the external problem that its leaders believed that "integrative medicine" could make some headway with.

More recently, the NCCIH made its intent even more explicit when it held a Twitter chat on Pain and Complementary Health Approaches under the hashtag #TalkPain, after having released a review article on complementary approaches for five painful conditions. The review was widely touted as demonstrating the following "positive" results for pain:

• Acupuncture and yoga for back pain
• Acupuncture and tai chi for osteoarthritis of the knee
• Massage therapy for neck pain—with adequate doses and for short-term benefit
• Relaxation techniques for severe headaches and migraine.

As I pointed out at the time, the methodology used to construct the review was quite weak, and even the positive conclusions listed above were quite suspect. Yet in the press coverage, never (or almost never) was heard a discouraging word regarding these treatments. The NCCIH spin on its own questionable review was pretty much parroted without skepticism, other than in a few skeptic blogs.

It just goes to show that the new preferred framing of "integrative medicine" (or "complementary and alternative medicine," i.e., CAM) is working. That framing flows from a common device that has been used by CAM advocates since the 1990s at least. It's a devilishly simple and plausible-sounding frame, too. In this frame, potentially science-based interventions based on lifestyle changes, such as dietary interventions and exercise, have been co-opted as being somehow "complementary" or "integrative," even though there is nothing “alternative” about them. I realize I use this example fairly frequently, but that's becasue it's a good one, especially if there are any newbies to SBM reading. Think about it this way: What is the first science- and evidence-based intervention for type II diabetes? It’s to alter diet, lose weight, and to start to exercise, with the hope of losing enough weight to reverse the disease, or at least to prevent the need to begin pharmacological management with metformin. There's another example I like to use from my own personal life, too: Hypertension. I remember when I was first diagnosed with hypertension several years ago, partially likely thanks to the curse of genetics but also influenced by my sedentary lifestyle. My doctor insisted on at least three visits to see if I could bring my blood pressure down without drugs through dietary changes and exercise, even though I myself thought my blood pressure was probably too high for that. I couldn’t; so I ended up on an antihypertensive. I realize this is just one anecdote, but it does suggest that a lot of primary care doctors don’t go straight to the prescription pad, contrary to the stereotype promoted by CAM advocates.

What's happening with the opioid crisis as a pretext for promoting the embrace of quackery is different from the "rebranding" I described above, but it's also related. In CAM, the "rebranding" of science-based treatments based on lifestyle, diet, and exercise is not enough. Rather, it serves to give cover to the quackery that is also labeled CAM or "integrative medicine," such as acupuncture, naturopathy, and so many other pseudoscientific or prescientific modalities. If CAM and "integrative medicine" only "integrated" these forms of quackery into medicine, it would be much harder to gain traction. However, if CAM practitioners can somehow convince patients and their fellow physicians that there's something somehow "complementary" about diet, exercise, and healthy lifestyle modification and claim them as CAM, then they add plausibility to at least some of their treatments.

So we come to the rebranding of various CAM modalities as "nonpharmacological." Basically, after co-opting sensible and potentially science-based lifestyle interventions as being “complementary” or “integrative,” CAM advocates divide interventions into two categories, “pharmacological” and “non-pharmacological.” Naturally, CAM claims all the non-pharmacological interventions for its own, furthering the stereotype that science- and evidence-based medicine is about nothing more than drug therapy, while they are about the "whole" patient.

Quacks see an opening in the opioid crisis to seek legitimization

In her article on the FDA, Thielking doesn't go into much depth about how aggressively CAM practitioners have used the opioid crisis as a convenient pretext to persuade desperate legislators that they offer a solution (or at least a major part of the solution). However, back in April she did a story on just that basically confirming what I've been saying all along about integrative medicine advocates using the opioid epidemic to brand their specialty as legitimate "nonpharmacologic treatments" for pain. Chief among them are naturopaths (nearly all of whom offer some forms of traditional Chinese medicine, like acupuncture) and, of course, chiropractors:

Seizing on the opioid epidemic as a chance to expand their reach, naturopaths and chiropractors are aggressively lobbying Congress and state governments to elevate the role of alternative therapies in treating chronic pain. They’ve scored several victories in recent months, and hope the Trump administration will give them a further boost.

Their most powerful argument: We don’t prescribe addictive pain pills.

Shunning pharmaceuticals, they treat pain with everything from acupuncture to massage to castor oil ointments. They offer herbal supplements and homeopathic pills.

Yes, it's true that naturopaths, acupuncturists, and chiropractors don't prescribe addictive pain pills. They do, however, frequently prescribe boatloads of supplements and use treatments with little basis in evidence. With the new administration, coupled with a bipartisan consensus that something needs to be done to combat opioid addiction, CAM practitioners see an opening that they hope to drive a Mack truck full of acupuncture needles and chiropractic tables through:

Hoping to make even more inroads, both naturopaths and chiropractors are lobbying Congress to push the Veterans Affairs health system to hire alternative providers. Chiropractors are also pushing for a role in the National Health Service Corps, which puts providers to work in community health centers, often in rural areas.

And this month, naturopaths will descend on Washington, D.C., for a meeting all about chronic pain. “Naturopathic doctors are poised to be the leaders in combating the opioid epidemic,” the promotional materials claim.

The pain workshops will be followed by a three-day conference to set a lobbying agenda and teach naturopaths organizing techniques.

The American Association of Naturopathic Physicians clearly sees an opening to make gains: The arrival of the Trump administration and a new, Republican-controlled Congress “opens up new opportunities for AANP to push for insurance non-discrimination, to have [naturopaths] included in the VA, and to emphasize that naturopathic care is a much-needed alternative to opioids for the treatment of chronic pain,” the AANP website declares.

Unfortunately, the Veterans Administration (VA) medical system has been heavily infiltrated by advocates of subjecting our veterans, to whom we owe so much, to quackery. Naturopaths have been lobbying to be hired as practitioners at the VA for at least two years. Indeed, in 2015, the American Veterans (AMVETS) teamed up with the American Association of Naturopathic Physicians (AANP, which unfortunately shares an abbreviation with the American Association of Nurse Practitioners and must be distinguished from such a respectable organization) to lobby Congress to pass a bill that would pay for "natural, non-pharmacological approaches to treating veterans suffering from chronic pain." The argument was basically a classic quack talking point: Opiate pain relievers, as effective as they are, have a downside, including dependence, addiction, and overdosing. Because of these problems, a common problem with opioids is that physicians are often overly cautious prescribing opioids, resulting in undertreatment of chronic pain. What “non-pharmacologic” treatments of chronic pain would help? The AMVETS press release didn't say.

I've written before about "battlefield acupuncture," a form of ear acupuncture that has actually been foisted upon our injured soldiers. As I like to say, as goes the military, so goes the VA. Indeed, the VA, led by Dr. Tracy Gaudet, director of the VHA’s Office of Patient Centered Care and Cultural Transformation, is a big fan of CAM, including naturopathy, acupuncture, and chiropractic. Indeed, Dr. Gaudet spoke at the AANP legislative initiative mentioned in Thielking's story, characterizing naturopathy as “a huge answer for the country, for practice, for patients” that is available “at a pivotal transformational moment” in health care and referring to them as “pioneers” who have been practicing integrative medicine “all along.” One notes that, before being hired by the VHA, Dr. Gaudet was a very high profile promoter of “integrative medicine,” having served as the director of Duke Integrative Medicine, a “pioneer” institution in quackademic medicine, as well as, before that, the founding director of the University of Arizona Program in Integrative Medicine with Dr. Andrew Weil.

Basically, the bottom line is that, as in the NCCIH and medical academia, advocates of unscientific and vitalistic treatments like acupuncture, chiropractic, and naturopathy are in ascendance. The might not always win, but they always come back again and again and again until they do.

But what about the FDA?

Will the FDA give its blessing to chiropractic and acupuncture for pain?

The law mandates that new drugs and devices must be shown through rigorous clinical evidence to be safe and effective for the indication for which they are intended. Over the last few years, there has been a push by free market fundamentalists, who have co-opted the narrative by falsely claiming that the caution and slow bureaucratic pace of FDA approval is keeping the free market from unleashing a flood of cures to the people. Indeed, a couple of truly scary men, one of whom believes that the FDA should require evidence only of safety, not efficacy, before approval (because, you know, the free market will sort efficacy out), the other of whom thinks that online rating systems (as in a Yelp or Über for drugs) can replace rigorous science for drug approval. So bad were these two Peter Thiel associates that it was actually a relief that we got the pharma shill, Scott Gottlieb, as FDA director. Gottlieb will likely champion "streamlining" and deregulation, but not beyond the pale of what we would see in any Republican administration.

The FDA doesn't move that rapidly when it comes to draft policies; so most likely this recently released draft has been under development since before the election. Be that as it may, the FDA has a bit of a strange relationship with CAM modalities, such as acupuncture. For instance, the FDA does regulate acupuncture needles as Class II medical devices, which means that the needles are regarded as safe and effective when used appropriately by a licensed practitioner. Manufacturers must include on the label the statement "for single use only" and provide information about device material sterility and compatibility with the body, and the needles must also bear a prescription label restricting use to qualified practitioners as determined by individual states.

If you want to get an idea of how...complicated...the FDA's relationship with CAM products is, it's worth perusing Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Guidance for Industry. The document quite reasonably points out that botanical products and probiotics might, depending upon what they are and what they are used for, be subject to FDA regulation. However, when the FDA starts discussing "energy medicine," things get weird. First, the FDA distinguishes between veritable energy fields (which can be measured and use either mechanical vibrations or electromagnetic forces, including visible light, magnetism, monochromatic radiation, and other light rays) from putative energy fields (have defied measurement to date by reproducible methods and include things like the "human energy field" in therapeutic touch). Then it says:

In a sense, "conventional" medicine already uses various forms of "energy" medicine. For example, a magnetic resonance imaging (MRI) device uses electromagnetic waves to create images of internal body organs and tissues. As another example, an ultrasound machine uses sound waves to create images of body organs, tissues, and fetuses. Given their intended uses, we regulate these products as medical devices under the Act.

CAM products that use veritable energy fields in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in man or animals or to affect the structure or any function of the body of man or animals may be medical devices under the Act.10 Additionally, if the product is electronic and emits radiation, it may be subject to additional requirements to ensure that there is no unnecessary exposure of people to radiation.

CAM products that use putative energy fields in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or animals may be medical devices under the Act. For example, we regulate acupuncture needles as "class II" medical devices.

Talk about asking how many angels can dance on the head of a pin!

Manipulative therapies, such as chiropractic, are more straightforward:

To the extent that manipulative and body-based practices involve practitioners physically manipulating a patient's body, without using tools or machines, we do not believe that such practices are subject to regulation under the Act or the PHS Act. If, however, the manipulative and body-based practices involve the use of equipment (such as massage devices) or the application of a product (such as a lotion, cream, or oil) to the skin or other parts of the body, those products may be subject to regulation under the Act, depending on the nature of the product and its intended use.

So basically, the FDA has tried to thread the needle, stating that the equipment used to do acupuncture and chiropractic can be regulated but saying nothing about the efficacy of acupuncture or chiropractic themselves. That's part of the reason why this new FDA draft policy is disturbing. It goes from an approach that is (mostly) nonjudgmental about the treatments themselves and concentrates only on regulating the equipment, which is definitely suboptimal, to one that is even worse, recommending that physicians know about acupuncture and chiropractic for pain and consider them as valid treatments on par with the real medical treatments.

One can't help but wonder how the FDA interpreted existing evidence to come to this conclusion. As Steve Novella notes, whenever acupuncture is compared with sham acupuncture, there is no detectable difference and usually both sham and "real" acupuncture produce modest improvement in pain completely consistent with placebo effects. Yes, there is a large meta-analysis that found otherwise for knee osteoarthritis, but we've discussed it before. Its flaws render its results highly questionable, particularly given that the actual magnitude of the clinical benefit reported was less than the “minimally clinically important difference” (MCID). In any case, the vast preponderance of evidence is consistent with acupuncture having no specific effect for any condition and for all its claimed "effects" being due to placebo.

The evidence for chiropractic is a little more complex, but, boiled down to its essence, not that much. I like to refer to chiropractors as undertrained physical therapists with delusions of grandeur. What I mean by that is that chiropractors claim to be able to treat a lot of diseases and conditions not related to the spine or musculoskeletal system through spinal manipulation, such as allergies, hence the delusions of grandeur. Whatever benefit might derive from chiropractic is likely limited to the effect of spinal manipulation on back pain, which could well be nonexistent.

So, basically, in this draft FDA education blueprint for healthcare providers on managing chronic pain, the FDA is about to put its imprimatur on chiropractic, which makes no sense given that physical therapy does everything that chiropractic does, minus the woo and plus modalities other than spinal manipulation. It goes beyond no sense to do the same for acupuncture, an ancient, prescientific treatment that originated as bloodletting and was retconned by Chairman Mao Zedong into having always been practiced in its present form, a treatment that is nothing more than a theatrical placebo. To add the proverbial insult to injury, the FDA lists these forms of quackery alongside evidence-based treatments, as though they were on close to equal footing.

It's not too late to stop this

Fortunately, the FDA being a federal government regulatory agency and all, this revised draft guideline is not final, and there is a period for public comment:

The FDA’s draft blueprint isn’t final — and drug makers, doctors, and alternative medicine providers will all have a chance to weigh in. The FDA will take public comments through July 10.

The blueprint released this week is part of a strategy the FDA rolled out in 2011 to address a crisis of prescription drug abuse. The FDA required opioid manufacturers to provide education for health providers who prescribe their pain medications — but didn’t mention chiropractic care or acupuncture in its initial blueprint for what that education ought to look like.

Interesting. I wonder how that one line recommending acupuncture and chiropractic found its way into the revised draft guidelines.

However it happened, you know what to do. The FDA needs to hear from supporters of science-based medicine. The opioid epidemic is a serious problem, and it needs science-based medical solutions, not the liberal application of fairy dust, if we are to dramatically reduce the toll taken by opioid addiction.