Tuesday, July 19, 2016

A quarter century ago a controversial clinical idea burst onto the scene in the form of published research. University of California, San Francisco (UCSF) researcher Dean Ornish, MD applied a lifestyle-oriented integrative health protocol involving a low-fat diet, group support, mind-body techniques, and exercise that he claimed reversed atherosclerosis. For many in that exceedingly polarized era—before “alternative” morphed into “integrative”—the assertion seemed utterly implausible. Most now accept that such an effect can come from the concerted use of an integrative, whole-person, natural health intervention. The Ornish program has gained coverage through Medicare.

A study claiming the reversal of another major and costly chronic disease that has also seemed intractable is now in our scopes again. In June 2016, Aging included an article entitled Reversal of Cognitive Decline in Alzheimer’s Disease. The article was essentially an update on outcomes from this 2014 paper by the same group. Science Alert immediately published a review of the Aging piece. They echoed the headline: “Small trial shows memory loss from Alzheimer’s disease can be reversed.”

How many of us who are watching the years mount, our own recollections falter, or are witnessing the memory troubles in those around us, read those surprising headlines as life-lines from a far shore?

Dale BredesonThe study came from a team led by Dale Bredeson, MD (pictured) that was based in another part of the “left coast” of medical exploration, University of California, Los Angeles (UCLA). The team calls their approach the MEND protocol—Metabolic Enhancement for NeuroDegeneration. Perhaps as remarkable as the study itself was the announcement a week prior that 3,000 miles away on medicine’s more conservative coast a group at George Washington University School of Medicine has adopted the MEND protocol and is already delivering it to patients. The director, Mikhail Kogan, MD, expects other medical delivery organizations will follow.

So what is going on here? First, as Aging indicates, this was not a large trial. The two studies report ongoing interventions on a small group. The 10 patients have either “well-defined mild cognitive impairment, subjective cognitive impairment, or frank Alzheimer’s disease diagnosis” prior to beginning the program. Nine improved. The Aging paper includes brief case reports on each of the 10. Some got back to work. Others regained significant memory-related functionality. Skills in adding digits came back. Reading recall returned. Improvement in 90% is good. Return to work and life as a functional and valued participant has potentially huge personal and economic ramifications. The team called for a larger trial.

Of what does this promising approach consist? The MEND protocol has in common with the work of Ornish that it features a whole person, multi-modality, integrative clinical strategy. Yet if the complexity of Ornish’s approach would provoke grave consternation in a single agent trialist, Bredesen’s would certainly propel them through the roof. The 2014 paper includes a chart with over two dozen modalities. Among the most significant, in Bredesen’s view, are detoxification and a requirement to fast at least three hours before sleep and at least 12 hours between evening and morning meals. Also recommended are a gluten-free diet, yoga or another form of mindfulness, and a number of natural agents including curcumin, fish oil, Vitamin D, and others, are also included.

Mikhail KoganI called up Kogan (pictured), who directs the George Washington University (GWU) Center for Integrative Medicine, to gain his perspective on the work and to learn why his program had adopted the protocol. Kogan is an integrative geriatrics specialist. He shared that he had “developed a similar program five years ago with similar results.” He said that he “had some cures” then added: “If I hadn’t met [Bredesen] two years ago I would have been developing a program of my own.”

As he learned, Bredesen’s group created an agreement with Muses Labs to roll out MEND’s proprietary program for managing the protocol to medical practices and delivery organizations across the nation. Kogan recounts that he “decided to jump onto the bandwagon since [Muses Labs] already had the structure to support patients and families in the program.” The firm, for which Kogan serves as an advisor, provides the software platform for what Kogan shares are the large amounts of data that are maintained and managed for each patient. Included are fields related to “genome, bio-specimen data, medical history, demographics, medications, patient lifestyle and cognitive ability.” The firm can also link patients to health coaches to manage that part of the family and patient relationship. Kogan notes that his center has their own coaches who GWU uses for their onsite patients. The Muses platform also includes ongoing data collection and outcomes research.

The MEND integrative clinical strategy is what may be called the integrative “kitchen sink” approach. This is the stuff of many integrative medicine, functional medicine, and naturopathic medicine practices that—while under the radar of most published science—are delivering care across the country daily to tens of thousands of people with multiple chronic conditions. Explore all of the possible agents and approaches that may in some measure remove the obstacles to health, then support the patient’s movement toward well-being. Then throw all that the patient can withstand at them. The clinical theory is of creating multiple synergistic effects. Bredesen’s group notes that the ability of individuals to adopt the protocol varies significantly per patient.  But if a given patient can also swallow the kitchen sink, offer that too.

It is clear that an N of 10 is small. Just as clear is that the complexity of the program, and the level of personal involvement and social support required, will not be for everyone. What is also clear is that this functionality oriented, personalized, speculative, ambiguous, outcomes approach to reporting research results is likely to be greeted with the same kind of finger-wagging from the reductively-minded research community that Ornish’s protocol met a quarter-century ago. Fact is, we wouldn’t have these data if we left our research priorities up to that kind of thinking. Anyone want to take bets on whether Medicare will one day be reimbursing some iteration of an Alzheimer’s treatment like this?


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