Thursday, December 31, 2015

Uncertain Health in an Insecure World – 70

“So What?”

Throughout 2015, a Microsoft Cloud ad touted the world-wide connectivity of some 450 million fanatics to Real Madrid football, positing that “It is not the device that is mobile… It is You!

So what?” is the Real question.

On the threshold of 2016, an idea remains pervasive that good health is a gift of better healthcare. In truth “It’s not the system of care that brings health… It is You!

So what?” is it that keeps humankind trapped in the era of imprecision medicine.

Despite technology triumphs and access upgrades, most patients still fly blind through a flawed healthcare system. This is partly because the experience dis-empowers patients and dis-intermediates physicians.

 “So what?” can be done to connect purported innovations with perceived needs.

Modern medicine’s current whack-a-mole approach to disease detection is wasteful. For example, the cost of false-positive mammograms performed on American women exceeds >US$4B per year!! Could this have anything to do with the huge number of imaging sites offering this basic diagnostic service?

Generalist physicians often function like epidemiologists. Their point-of-care clinical decisions can be enhanced by simply adding one or two data points. For example, public health information about the local prevalence of beta-hemolytic strep cultures and antibiotic prescribing patterns could reduce defensive medicine’s sore throat over-treatment bias, and the rise in drug resistance.

Specialist physicians frequently apply aggregated randomized clinical trial (RCT) and registry data to patient care. Unfortunately, many patients just don’t respond. Despite statistically significant data showing a cohort treatment’s benefit, averaged RCT responses are not a great predictor of individual patient responses.

So what?” can be done. Views vary…

Enter two experts.

Michael Porter and Thomas Lee have proposed a new strategy to “fix” struggling healthcare systems around the world (Harvard Business Review, October 2013). They suggest a laser-like focus on the needs of the patient, and more rational service delivery in the right locations. They warn that there are no “magic bullet” solutions to the systemic problems and entrenched forces negatively impacting healthcare value for patients.

The lack of precision in the maintenance of wellness is even more shocking.

Enter one visionary.

Leroy (Lee) Hood founded the Institute for Systems Biology in 2000, when he and others at the University of Washington became convinced that RCT’s alone could not reflect the complexity of individual disease biology. Their novel P4 paradigm – Predictive, Preventive, Personalized and Participatory – aggregates billions of human data points in the Cloud, reflecting the genomic and environmental factors characterizing illness and wellness at the organismic level.

Of note, the genetic risk of illness is not a disease state.

But if early-onset Alzheimer’s risk can be identified before the transition from organismic illness into clinical disease, an intervention to delay the onset could be very useful. For example, in early prion brain disease, arachidonic acid metabolic and calcium signaling changes in the glutamate receptor ionotropic N-methyl D-aspartate 1 (GRIN 1) protein superfamily (below) might offer interventional targets.

A new age registry study – the 100K Person Wellness Project – has been underway in Seattle Washington since 2014. So far, one hundred and seven “well pioneers” have had their genomes sequenced, and their gut microbiome, clinical, proteomic, metabolomic, and Fitbit gyroscopic little data moved to the Cloud. Up there, 107 ‘N=1’ dense data experiments have yielded >35,000 correlations designed to establish each individual’s genetic risk for sixty diseases. Resulting high- or low-risk genetic probability markers have revealed several actionable possibilities. Wellness coaching opportunities to encourage personal behavior changes were available for 70% of this cohort. For example, when hemochromatosis homozygous subjects with arthritis proactively pursued weekly blood drawing, they were restored back to normal health (i.e., wellness).

That’s “So what!” These well pioneers actually took back control of their individual health!

In order to more widely apply P4 approaches, new technologies are needed. These include 3rd generation DNA sequencing (cheaper, faster), peptide protein capture agents (for ELISA assays on micro-sized blood samples), dynamic personalized data (individualized Clouds), selected reaction monitoring (SRM) assays for targeting blood proteins (reflecting specific cellular network perturbations in lung cancer, PTSD, etc.), and single instrument multiplex diagnostics for micro RNA’s and RNA sequencing (based on existing scientific evidence).  
Some companion diagnostics are now available for home use. But patients still have to go to the doctor for treatment.

So what?”, then, is the value of all this testing… to You?

Real value lies in information collected and modeled being actionable at an individual level.

We in the Square begin 2016 full of hope, but with many unresolved “So what?” questions. 

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