Laurie K Mischley, ND PhD MPH

The Next Generation of Parkinson Care

APDA Northwest Chapter2017 Optimism Retreat

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Disclosures❖ Advisory Boards: Brian Grant Foundation, Next Frontier Biosciences

❖ Consulting: Synapse Medical Intelligence

❖ Founder: NeurRx, Social Purpose Company

❖ Owner of PRO-PD Outcome Measure www.PROPD.org (free)

❖ Research Funding: Michael J Fox Foundation, Families with PD (thank you)

❖ Institutional Affiliation: Bastyr University

❖ Practice: Seattle Integrative Medicine

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PD Isn’t What it Used to Be❖ Historically defined by what physician can observe:

❖ Stooped posture

❖ Slowness

❖ Tremor

❖ Impaired balance

❖ Rigidity

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Patient Perspective❖ Most common symptoms:

❖ Fatigue, Impaired Handwriting, Loss of Smell (80-85%)

❖ Memory Impairment, Muscle Pain, Daytime Sleepiness, Slowness, Tremor, Sexual Dysfunction, Balance Impairment, Urinary Dysfunction, Stooped Posture (70-80%)

❖ Lack of Motivation, Insomnia, Depression, Anxiety, Impaired Speech (60-70%).

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Acknowledging [Lack of] Progression

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Quantifying the Burden of Disease

❖ Goal is to shrink the size of the circle.

❖ The ONLY thing that matters is lack of symptom frequency & severity.

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Patients in Charge of Data

❖ Tracking their own symptoms, keeping their own scores, maintaining a record of personal trials.

❖ Patients show me their sleep cycles, show me how treating their SIBO infection improved their PRO-PD score.

❖ Demanding integrative medicine, forcing clinical neurologists to learn about the intestinal microbiome, metabolism, nutrition, Mucuna, etc.

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We finally have a currency for tracking symptoms & progression

PRO-PD www.PROPD.org

FreePatient-centeredMotor & non-motor symptomsRemote accessClinically relevantPermits goal-setting

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Why do some people progress quickly and other so little?

In Search of the Positive Deviants

“Role of Diet and Supplements on Parkinson’s Disease Progression”

Mischley LK, Bennett R, Lau ROx Med Cell Long, Sept 2017

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Patient-Driven Programs❖ AA Example: Physicians and researchers have failed

individuals suffering from addiction. Patients have come together with their own solution. With mechanism of action unknown, it is more effective than any pill or procedure their providers are offering. It’s a PROGRAM. Requires community participation.

❖ Can you skip a step?

❖ Can you go to meetings but not work the steps?

❖ Demonstration of individual efficacy & synergy…

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Programs From Within Community❖ Rock Steady Boxing

❖ Yoga for PD

❖ Cycling

❖ LSVT/ Big & Loud/ Singing

❖ The Parkinson’s Fitness Project

❖ Pickle ball

❖ Support Groups

Plugging into Programs at least as

Essential as Pharmaceuticals

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Dale Bredesen, MD

Reversal of Cognitive Decline

Administered a comprehensive program to 10 patients with memory loss, mild cognitive impairment (MCI), and Alzheimer’s disease (AD).

Followed them for ~ 2 years.

9/10 reversed cognitive loss. Memory improved. Improved ability to work.

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Bringing Medicines to Market❖ Trials that get funded are the ones with greatest return on investment.

❖ Takes ~$1 billion to bring a drug to market

❖ Patent protection ensures the company that makes that kind of investment gets that money back.

❖ Natural products, exercise programs, etc. don’t lend themselves well to patent protection, deterring investors, and stunting research.

❖ Novel molecules are easiest to patent, bias translates to therapeutic development.

❖ Pharmaceutical Social Purpose Corporations (e.g. NeurRx, SPC)

❖ Legally allowed to put people over profit

❖ Straight to generic

❖ Cooperative model— income generated goes toward saving patients money

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N-of-1 Trials❖ Represents only the individual, not the population.

❖ What if a drug helps most people but doesn’t help you?

❖ What if you get benefit from an unstudied therapy?

❖ Large, randomized double-blind placebo-controlled trials can’t answer these questions.

❖ In an n-of-1 trial, the blinded patient is randomized to receive active medicine or placebo. Individual serves as their own control.

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Out with Placebo In with Intention

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Pesky Placebo

❖ Placebo is not what we thought.

❖ A biological and clinical phenomenon in which the body responds in response to community participation, hope, and/or intention.

❖ Measurable improvement created by factors other than the intervention being studied. Why does it matter?

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Why Control for Placebo?

❖ Expensive and dangerous therapies— in order to justify the economic and personal risk, we need to be sure the medicine is effective.

❖ If an intervention is inexpensive, tolerable, safe, and is improving symptoms— why does it matter if the benefit is attributable to the intervention being studied?

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A Study “Ruined” by Enthusiasm

❖ Phase I/IIa Study of Intranasal Glutathione in PD❖ + community enthusiasm❖ + proof of CNS uptake❖ + researcher confidence

❖ Phase IIb Study of Intranasal Glutathione in PD

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Parkinsonism is, in part, a Nutritional Deficiency Syndrome

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Nutritional Deficiencies in Parkinsonism

❖ Glutathione

❖ Coenzyme Q10

❖ Lithium

❖ Vitamin D

❖ Folic acid…

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What Happens When We Look for Metabolic Perturbations?

Fix What We CanUsing the tools we already have at our disposal.

Panel of labs associated with PD outcomes.

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Early Detection is Here

❖ PD can be detected before onset of motor symptoms.

❖ NeurRx, SPC is working on first FDA-approved screening tool.

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Lorem Ipsum Dolor

PREVENTIONEarly screeningIntense exerciseCommunity involvementNutritional Medicine Dietary Modification

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Optimism is Justified❖ Patients taking matters into their own hands.

❖ Finally have a currency for tracking symptoms.

❖ Emergence of efficient, creative study designs provding the answers we’ve been waiting for.

❖ Social stigmas disappearing as PwP redefine disease.

❖ Growing field of neuroplasticity.

❖ If dementia can be reversed, surely PD can be too….

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Thank You!

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