“Disruptive” functional medicine at the Cleveland Clinic: Disrupting medicine by mixing quackery with it [Respectful Insolence]

That the Cleveland Clinic has become one of the leading institutions, if not the leading institution, in embracing quackademic medicine is now indisputable. Indeed, 2017 greeted me with a reminder of just how low the Clinic has gone when the director of its Wellness Institute published a blatantly antivaccine article for a local publication, which led to a firestorm of publicity in the medical blogosphere, social media, and conventional media to the point where the Cleveland Clinic’s CEO Dr. Toby Cosgrove had to respond. Dr. Cosgrove was—shall we say?—not particularly convincing. Indeed, even as he voiced support for vaccines (good), he was clearly in denial that all the pseudoscience and quackery that the Cleveland Clinic has embraced under his leadership facilitated antivaccine views because so much of it included practitioners and belief systems that tend to be antivaccine. As I like to point out in response every time Cosgrove’s becomes all righteously indignant about the criticism the Cleveland Clinic receives for its embrace of pseudoscience and his being shocked—shocked!—that there are antivaccine beliefs in a physician in a leadership position in his Wellness Institute, he hired Dr. Mark Hyman to set up a “functional medicine” (FM) clinic at the the Clinic, the same Dr. Hyman who co-authored with vaccine safety activist antivaccine activist Robert F. Kennedy, Jr. an antivaccine propaganda book, Thimerosal: Let the Science Speak: Mercury Toxicity in Vaccines and the Political, Regulatory, and Media Failures That Continue to Threaten Public Health, a book full of antivaccine fear mongering of the mercury militia variety. I also note every time Dr. Cosgrove gets his knickers in a bunch over this that Hyman and Kennedy published that book the very same year that Cosgrove hired Hyman. Not only that, but RFK Jr. and Hyman appeared on The Dr. Oz Show to promote the book a mere week and a half before the Cleveland Clinic announced Hyman’s hiring.

So it was with some interest that I came across an article praising the Cleveland Clinic’s embrace of pseudoscience as “disruptive innovation.” Yes, it was co-authored by an old “friend” of the blog, Glenn Sabin. We’ve met Sabin multiple times before, most recently earlier this year when I became aware of a book he published about integrative medicine’s latest rebranding of itself. Years before that, he had bragged that integrative medicine is brand, not a specialty, and this was one of the few areas where I actually agreed with Sabin, just not in the way that he meant it. For instance, he liked how “complementary and alternative medicine” (CAM) had been “rebranded as “integrative medicine.” He also thinks integrative medicine is a good thing, whereas I view it—and quite rightfully so, I might add—as “integrating” quackery with real medicine, at least where integrative medicine doesn’t rebrand science-based health interventions like diet and exercise as somehow being “alternative” or “integrative.” So enamored of integrative medicine is Sabin that he also recently wrote a short book on what he considers to be the 125 most important milestones along the path to the acceptance of “integrative medicine,” or, as I refer to them, milestones on the way to normalizing quackery.

In their article, Disruptive Functional Medicine Innovation Drives Value-based Future at Cleveland Clinic, Walsh and Sabin start out quoting Clayton Christensen:

The instinct of every leader is to frame disruption as a threat—even if it constitutes an extraordinary opportunity for growth by reaching more people more affordably. If today’s hospitals set up focused-hospitals to disrupt themselves…the evolution can be profitable rather than painful.

So right from the beginning, you see that they view integrative medicine and FM at the Cleveland Clinic as “disruption” in the service of “innovation”:

Christensen, one of the nation’s leading authorities on disruptive innovation in business, wrote those words at a time after the early forces of healthcare disruption had started coalescing, around 2000.

He would not have recognized them at that time because they were not dependent upon the technological advances he often cites as the basis for successful disruption. Rather they were, and remain, disruptive in how patients can be most beneficially treated. This evolution has often been painful, and it may yet produce profit, if, as we will see, that disruption establishes value based on quality outcomes, reduced costs and patient satisfaction. The Triple Aim by any name.

Those early disruptive forces in care first stirred in the U.S. in the 1980’s, initially in the form of formal recognition of complementary and alternative medicine (CAM) modalities by the U.S. healthcare system. The subsequent growth of clinical businesses and their patient populations (to shocking levels by 1991²) was completely driven by patient preferences and out-of-pocket spending that was not reimbursable.

There are two interesting, perhaps unintentional, admissions in just this brief passage. First, a whole lot of “integrative medicine” is not reimbursable by insurance companies because they don’t cover it. Why don’t they cover it? The reason is simple: It’s not science- and evidence-based. Once you get away from the interventions that integrative medicine has rebranded, such as diet, exercise, lifestyle, and a handful of others, such as a very few herbal medicines, you’re left with acupuncture, reiki, homeopathy (and, yes, homeopathy is still used because naturopathy is popular in integrative medicine, and you can’t have naturopathy without homeopathy), reflexology, chiropractic, and a large number of other pseudoscientific modalities. That’s what’s being integrated into medicine.

The second admission is that this integration has been driven by patient preferences. Now, I don’t agree that it’s been “completely” driven by patient preferences. There are plenty of physicians who have, for whatever reason, fallen into pseudoscience and offer these services to patients. Sure, many of them are responding to what they see as a marketing opportunity, but there are a lot of docs who have gone into “integrative medicine” because they’ve become true believers as well. Be that as it may, the National Center for Complementary and Integrative Health (NCCIH) doesn’t exist because scientists and physicians clamored for it. The NCCIH exists because a woo-friendly politician aligned with quacks who sold laetrile and other nonsense foisted it on the NIH. Similarly it wasn’t physicians who clamored for these programs Walsh and Sabin describe:

• In the establishment of many Centers of Integrative Medicine at U.S. medical schools, growing from eight at its 1999 inception to more than 70 today, and leading to the formation of The Academic Consortium for Integrative Medicine & Health, ACIMH.
• The growth of integrative health and medicine in the U.S. Military Health System and especially the VA that began in the wake of the wars in the Middle East, that now influences the approaches to care and healing in these and other major institutions.
• The investment in integrative medicine and health units at academic and non-academic regional and national hospital systems such as Mayo, Allina, Medstar, Sutter Health, Meridian Health and Beaumont Health (many, including the VA, are now members of ACIMH).

Yes, over the years I’ve discussed these developments, such as the infiltration of quackery into medical school education and academic medical centers and the VA, as well as the proliferation integrative medicine centers like the Cleveland Clinic’s Wellness Institute:

If there is a model of disruptive innovation in healthcare that Christensen might recognize today it is probably located at the Cleveland Clinic, where its Center for Functional Medicine (CC-CFM) is as close to a ‘focused-hospital’ bent on deliberate self-disruption as we are likely to find.

Established in 2014 after CEO Delos (Toby) Cosgrove, MD and Mark Hyman, MD, current chairman of the Institute for Functional Medicine, agreed to bring to the Cleveland Clinic functional approaches to identifying root causes of illness and to treating conditions in collaborative fashion.

Behind this decision was the intention to create a sustainable business model based on value that would scale in such a way as to establish new relationships with insurers and make the functional approach a norm in healthcare.

In presentations at the Personalized Lifestyle Medicine Institute (PLMI) conference “Harnessing the Genomic Revolution: Breakthroughs in Personalized Precision Health Care” in October of 2016, Dr. Hyman, now Director of CC-CFM, and Patrick Hanaway, MD, its Medical Director, described the careful, intentional efforts being made to establish this business model grounded in the precepts of the Triple Aim: reduced costs, better outcomes and greater patient satisfaction.

Let’s step back and remember what FM really is. Basically, FM represents itself at getting at the “root cause” of illness and attacking it directly. In reality, FM is more like “making it up as you go along” the same way that so many other alternative medicine practitioners do. Basically, FM involves the worst of both worlds, alternative medicine and conventional medicine. Like the worst aspects of conventional medicine, FM involves massive overtesting, with FM doctors sometimes testing dozens or scores of lab values. They claim they know what these values mean and how to treat them based on evidence, but seldom do. So, like alternative medicine practitioners, they make it up as they go along. Of course, when you test so many different lab values, inevitably by random chance alone one or more of them will be abnormal, because normal lab values are usually set so that their ranges encompass 95% of normal people. So you get things like hormone panels, thyroid panels, metabolic panels, micronutrient testing, and many, many more. You get bogus tests like provoked urine heavy metal testing, in which a patient is given a dose of a chelating agent and then a urine test for heavy metals is carried out. Inevitably the values are high, and FM docs use them to justify chelation therapy.

Now look at what they’re doing at the Functional Medicine Center:

• Dr. Hanaway’s presentation described the programs and clinical systems, analytical tools, team-building and research programs being put in place to create this paradigm of value. These include:
• Conducting a select group of small RCTs.
• Working with the Institute for Functional Medicine to standardize clinical protocols.
• Collecting and integrating quality, outcome and cost data (often for the first time ever).
• Collecting patient case studies that illustrate the patient experience.

[Note: Dr. Hanaway’s full presentation (40 min.) is available here on the PLMI web site (requires free registration). Click on the “Day 2” tab.]
In reviewing these efforts in some detail, Hanaway noted, “We’re in a learning process of ‘How do we put these tools together?’ We look at quality, we look at cost, and work toward value.”

Let’s see: Do a few small RCTs? That’s a perfect recipe for either a bunch of negative results because the trials are underpowered or for spurious results. Collect case studies? That’s the lowest form of clinical evidence, not even a case series! Then there’s this:

Another measure, using the NIH’s PROMIS-10 tool to compare the results of “clinically significant improvement” from CC-CFM treatments to those of the Clinic’s family medicine unit (CC-FM) (already among the nation’s best for patient clinical improvement), demonstrates the following improvement scores:

• CC-CFM: + 38.7%
• CC-FM: + 27.4%

In part this nearly 40% difference reflects what Hanaway reports as the CC-CFM’s success in encouraging patients to actively embrace activities that support their health (through ‘patient activation measures’). Indicative of this were results from comparisons of patients being treated for fatigue, mood, and autoimmune conditions.

And here’s where the rebranding comes in. Remember, the Center for Functional Medicine claims that its greater success is due to its ability to get patients to “embrace activities that support their health.” Whenever I discuss FM, I’m forced to conceded that there is a grain of good there. There are some things that FM gets right. The problem is that these things tend to be no different than the sorts of things every good primary care doctor should be getting right anyway, such as emphasizing healthy lifestyles, good nutrition, enough exercise, adequate sleep, cessation of habits known to be deleterious to health (e.g., smoking). How do they do it? One advantage FM doctors have over primary care doctors practicing science-based medicine (SBM) is that, because insurance often won’t cover much of what they offer, FM doctors tend to spend more time with patients, which is something that primary care doctors have a harder time doing these days. They emphasize prevention, which is a good thing but again something that good primary care doctors do anyway. Unfortunately, the FM version of “prevention” isn’t always in line with the SBM version of prevention. Where FM doctors go so very wrong is in what Grant Ritchey described as a major unstated premise. That premise is that FM really does address the root causes of disease better than conventional medicine. FM also encompasses a lot of quackery, such as acupuncture, chiropractic adjustments, and especially “detoxification” programs. It’s little wonder that many naturopaths are very enthusiastic about FM.

So here’s the problem. Whatever benefit there is from FM almost certainly derives from the things that primary care physicians do right, such as getting patients to improve their diet and exercise more, which FM docs could well be more successful at because they can spend more time with each patient. There’s nothing magical about that. Also notice how the RCTs that are being done are not testing individual FM interventions, but rather the whole package. If the improvements seen are driven primarily by lifestyle interventions, they’ll never know that the overtesting and the woo that FM slathers over the few good things it does had nothing to do with the patient improvements reported. Maybe that’s the point. After all, the main purpose of the “research” Hyman is doing at the Center for Functional Medicine seems to be to show that FM saves money, in order to persuade insurance companies to reimburse for FM services.

Same as it ever was. The only “disruption” going on at the Cleveland Clinic involves finding a way to extract more cash out of offering pseudoscientific medicine in the form of “functional” medicine, traditional Chinese medicine, and all manner of quackery.