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In 2014, the American Academy of Family Physicians (AAFP) on continuing medical education (CME) credit for all programs related to Functional Medicine (FM) through 2018. The

a lack of accompanying evidence existed to support the practice of Functional Medicine . . . [and the AAFP] identified some treatments as harmful and dangerous.

The AAFP will review its decision in February of 2018. To assist in the review, the AAFP issued a

call to collect peer-reviewed, evidence-based literature that supports claims for the efficacy of Functional Medicine practices and therapeutic modalities.

An was posted for comments through October 6, 2017. Unfortunately, I discovered both the decision to ban FM courses from eligibility for CME credit and the call for comments after the deadline. As might be expected, the Institute for Functional Medicine (IFM) is fully aware of the ban and has provided canned comments for FM practitioners as well as a list of references which presumably, in the IFM’s view, will provide the AAFP with the evidence of efficacy it seeks, as well as allay the AAFP’s fears that its practices are harmful and dangerous. If this is the best IFM can offer, I feel confident the AAFP’s ban will remain in place.

We’ll return to the IFM’s response in a moment. First, we’ll briefly review so-called “Functional Medicine” and take a look at the organization whose courses have come under the AAFP’s scrutiny, as well as the courses themselves.

What is Functional Medicine?

According to the IFM:

The Functional Medicine model is an individualized, patient-centered, science-based approach that empowers patients and practitioners to work together to address the underlying causes of disease and promote optimal wellness. It requires a detailed understanding of each patient’s genetic, biochemical, and lifestyle factors and leverages that data to direct personalized treatment plans that lead to improved patient outcomes. By addressing root cause, rather than symptoms, practitioners become oriented to identifying the complexity of disease. They may find one condition has many different causes and, likewise, one cause may result in many different conditions. As a result, Functional Medicine treatment targets the specific manifestations of disease in each individual.

This is a nice word salad, but it tells us nothing about how FM practitioners go about doing things like promoting optimal wellness, understanding each patient’s genetic, biomedical, and lifestyle factors and addressing root causes rather than symptoms.

Far better minds than mine have raised these same issues and gone looking for answers. Wally Sampson (also here, here, and here), David Gorski (also here, here, and here), Steve Novella and (also ) have all taken a crack at it and have come away wanting for information, although they were able to gather bits and pieces from, for example, published case studies, which they . The medical literature isn’t much help because the proponents of FM have never bothered to set forth their “individualized, patient-centered, science-based approach” in any forum where actual scientists could evaluate it.

From what we’ve been able to gather, it appears that FM includes conventional practices like healthy lifestyles, good nutrition, enough exercise, adequate sleep, and cessation of habits known to be deleterious to health, all of which are rebranded “Functional Medicine,” combined with a whole lot of lab testing – both unvalidated tests and conventional testing that is, in Dr. Gorski’s words, “massively misinterpreted and abused.” From these lab results, said genetic and biochemical “root causes” of disease are divined and “personalized treatment” instituted, which seems to involve a lot of dietary supplements, to the patient , assorted other quackery.

Or, as Dr. Sampson put it nearly a decade ago,

After extensive searching and examination, my answer is still – only the originators of “FM” know. Or, at least one must assume they know, because so far as I can see, I certainly see nothing that distinguishes “FM” from other descriptions of sectarian and “Complementary/Alternative Medicine” practices. A difference may lie in the advocates’ assumptions to have found some “imbalance” of body chemistry or physiology before applying one or more unproved methods or substances. From what I could determine, the “imbalance” or dysfunction is usually either imaginary or at least presumptive. And the general principles are so poorly defined as to allow practitioners vast leeway to apply a host of unproven methods.

Team SBM isn’t the only group both befuddled by FM’s word salads and concerned about the lack of evidence supporting its practices. In response to a “” and accompanying , Medical Director for the Center for Functional Medicine at the Cleveland Clinic, in a 2016 issue of The Permanente Journal, :

We certainly agree that approaching our patients in a holistic and caring manner is always best, but we are unaware of a scientific basis for the “unique operating system” and “personalized therapeutic interventions” suggested in these articles. Perhaps accidentally, Hanaway acknowledges that functional medicine does not have an adequate evidence base and relies on unproven suppositions when he writes, “As we move from Case Reports to randomized controlled trials and population-based trials, Functional Medicine research will offer insight into the best ways to improve the value of the care we offer.”

And, addressing the case report:

The patient in the case was assessed with a Comprehensive Digestive Stool Analysis 2.0 (CDSA 2.0) and a Nutritional Evaluation (NutrEval) by Genova Diagnostics. [The authors] claim that these tests offer insight into the patient’s functional status with regard to several of the proposed core pathways comprising functional medicine. . . . Although the case report documents improvement in patient-reported outcomes scores across three scales . . . attributing this improvement to the multitude of interventions presented in Table 3 of the article, “Stool and urine metabolic testing results and therapeutic interventions,” is dubious. Association is not necessarily causation.

Finally:

In Hanaway’s editorial, we noted with interest that randomized controlled trials comparing functional medicine with current standard care are underway at the Cleveland Clinic. But unless and until such clinical trials demonstrate efficacy of the functional medicine approach, we believe TPJ should not encourage Permanente physicians to incorporate functional medicine into clinical practice as it has done implicitly by publishing this case study and editorial.

Actually, Hanaway misrepresented the nature of the clinical trials at the Cleveland Clinic. They do not compare functional medicine with current standard of care. standard of care alone with standard of care functional medicine, and one of them is a . As and Mark Crislip have pointed out, this type of trial almost guarantees that the results will favor the addition of functional medicine.

Uncovering the secrets of Functional Medicine, for a mere $15 grand

The only place you can learn the all of secrets of Functional Medicine practice appears to be the Institute for Functional Medicine’s , the very ones the AAFP refuses to recognize for CME credit. They aren’t cheap either, costing from about $1,500 to over $3,000 per course. It comes as no surprise that companies offering dubious lab tests and dietary supplement sellers are and of these courses (see also and ).

Completing seven of these courses (Applying Functional Medicine in Clinical Practice, GI, Detox, Energy, Hormone, Cardiometabolic, and Immune), presentation of one case report ($800 fee) and passing a test (another $800 fee), makes one eligible for a certificate that allows one to claim he or she is an “IFM Certified Practitioner.” Altogether, the of becoming certified at $12,000 – $15,000.

The IFM takes a to awarding IFM Certification. It is available on equal terms to MDs, DOs, dentists, naturopathic doctors, chiropractors, acupuncturists, nurses and nurse practitioners, registered dietitians, and pharmacists. IFM does not explain how it came to determine that chiropractors, naturopaths, and acupuncturists have sufficient education and training in endocrinology, gastroenterology, immunology and cardiology to pass their courses in, and knowledgeably practice in, those areas.

Unlike the AAFP, the Accreditation Council for Continuing Medical Education, which is more tolerant of pseudoscience, has accredited the IFM as a CME provider. This means that MDs can get state-required CME credit for IFM courses, if not AAFP credit. Because PAs and nurses also allow AACME-accredited organizations to provide CME, those professions can get credit for IFM courses as well.

Whatever shortcomings the AAFP has observed, it doesn’t seem to have affected the IFM’s bottom line. Because it is a tax-exempt organization, it must file a Form 990 income tax return, available on the . According to the latest available return, its educational courses brought in revenue of almost $9 million in 2015.

Functional Medicine guru Mark Hyman, whose mangling of medical science and anti-vaccination sympathies have been called out before on SBM (also here) and by (also and ) is . (No surprise there either.)

Also on the Board is naturopath Joe Pizzorno, a founder and former president of Bastyr, the premier naturopathic “medical school,” and instrumental in establishing a separate accrediting agency for naturopathic schools, which shields them from effective oversight of their pseudoscience-filled curricula. Pizzorno is co-editor of the naturopathic masterwork, The Encyclopedia of Natural Medicine, which tells us that 25% of the US population suffers from heavy metal poisoning. Pizzorno has given talks on “assessing body burden” and “detoxification” to the American Academy of Integrative Health & Medicine, . Keep this in mind when we get to a discussion of IFM’s coursework.

In fact, the IFM is very naturopathy-friendly. , are naturopaths, as are the Assistant Director of Medical Education and the Medical Education Program Coordinator.

IFM “Detox Advanced Practice Module”

That one of the seven courses required to become an IFM Certified Practitioner is called “” should be a big red flag for the AAFP. As we have explained many times here on SBM (also here), it is a fundamental tenet of alternative medicine that we are all infested with vaguely defined “toxins” which our natural “detoxification” systems (basically, the kidneys and liver) can’t get rid of. Thus, these “toxins” must be removed from our bodies with various “detoxification” interventions, lest we become ill. Dubious lab tests are sometimes employed to assist the practitioner in uncovering these “toxins.” IFM’s “Detox Advanced Practice Module” is Functional Medicine’s version of this medical fantasy.

According to the faculty,

we are what we absorb and fail to eliminate.

So, “patterns of clinical presentations with possible connections to toxic exposures” and “routine laboratory findings linked to toxicity” as well as “functional and genomic assays” will “aid in the assessment and treatment of toxicity cases.” Participants learn of the “detoxification-promoting Detox Care Food Plan . . . tailored to optimize your patient’s metabolic detoxification processes.” As well, they learn “which nutrients [i.e., dietary supplements] are involved in detoxification and biotransformation pathways . . . [and] address oxidative stress, along with cytochrome P450 enzymes and the conjugative pathways of phase 2. A “Functional Dentistry” expert helps participants “identify and address toxicity with a dental component.”

And so on. Sounds .

Faculty include an MD who is the and a autism, ADD, ADHD and developmental delays with “dietary plans, nutritional supplementation and detoxification strategies” which, of course, “essential laboratory testing . . . review of pertinent laboratory findings [and] customized dietary and nutritional supplementation,” as well as “testing for nutrient deficiency and chemical / metal toxic overload, nutritional needs based upon genetic profile.” Lest one think this sort of thing is beyond the capability of a chiropractor, not to worry. He is an IFM Certified Practitioner. Other quackery in his practice includes applied kinesiology testing, “Digital Meridian Imaging to diagnose the acupuncture imbalanced energy channels,” something called the “ – unlike any other cranial procedure to remove nerve interference throughout the whole body,” as well as the and “.” The teaching “functional dentistry,” also an IFM Certified Practitioner, is a member of the , which engages in fear mongering about fluoridation and urges the removal of amalgam fillings.

The IFM’s response to the AAFP

As noted, the AAFP has issued a call for peer-reviewed, evidence-based literature that supports claims for the efficacy of Functional Medicine practices and therapeutic modalities. The IFM has suggested proponents that make the same sort of vague, uninformative statements that have stumped others trying to figure out just what they are up to. Such as:

A major premise of Functional Medicine is that, with science, clinical wisdom, and a deep empathy for the patient, many of the underlying causes of chronic disease can be identified and interventions to remediate those causes can be addressed earlier and more effectively.

OK, but how? Show your work.

They also say:

The modalities taught in Functional Medicine are all focused on safety and efficacy with a deep underpinning in the peer-reviewed literature.

The Detox Advanced Planning Module has a “deep-underpinning in the peer-reviewed literature?” Where?

When pressed to come up with actual studies backing up FM’s claims, Hanaway, as noted by his critics, has pretty much admitted there aren’t any. What the IFM does offer in its response to the AAFP is a , but without any explanation as to how they support the practices of functional medicine. I have to assume that if there were a cogent justification for Functional Medicine supported by citations to the medical literature, the IFM would have come up with one. They didn’t and that speaks volumes. The burden is on them to do so, not on the AAFP to try to figure it out from a list of journal articles and obfuscatory language. That, as I said, gives me confidence the AAFP will come to the right decision and make its moratorium on Functional Medicine courses permanent. If I am wrong, the have no meaning.

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Posted by Jann Bellamy

Jann J. Bellamy is a Florida attorney and lives in Tallahassee. She is one of the founders and Board members of the  (SfSBM) dedicated to providing accurate information about CAM and advocating for state and federal laws that incorporate a science-based standard for all health care practitioners. She that would allow pseudoscience in health care for the SfSBM website.  Her posts are archived .