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The Future of Medicine Leslie Levin MD, FRCP (Lon), FRCPC VP Evidence Development and Standards, Health Quality Ontario Chief Scientific Officer MaRS EXCITE Professor of Medicine, University of Toronto Senior Staff Medical Oncologist, Princess Margaret Hospital

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Hydraulic Health System

•  Pressures within the sealed system are variable and dynamic but the amount of fluid (money) is fixed and directed by need (valves) from a reservoir. Relief in one area is redistributed via the reservoir to respond to new needs

•  Can health systems become hydraulic?

•  Evidence is the backbone of the valves in a hydraulic health system

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Never Let a Good Crisis Go to Waste

•  The crisis –  Fiscal constraint –  Demographic realities –  Environmental realities –  Changing public attitudes about health related decision

making

•  The challenge –  Unprecedented opportunity for innovation that drives better

patient outcomes that are less invasive, efficient, cost effective

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Evidence Driving Choice

•  “For hundreds of years medicine was driven by anecdotes and personal beliefs without the least supportive evidence” Kendrick. Examples: –  Colectomies for anxiety, headaches, stomach pain (“toxic

colon) –  Coronary artery bypass – scaremongering and collaterals –  Back to sleep (Spock). Confounding variables

•  Evidence driving choice in Ontario – PET scanning, drug eluting stents

•  What does this mean for innovation now?

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A New Reality - A New World •  Intuitive decision making will become a thing of the past •  The public will demand greater transparency and to be involved

increasingly •  Evaluation of technology aimed mainly at regulatory approval will bleed

investors –  48% rejection post market for licensed devices –  Increasing post market comparative effectiveness –  Recent panel on genetics – change the health system to

accommodate what genetics research will bring –  Drugs and some devices have been pre-market evaluation for >8

years – unsustainable –  The push and pull of evidence is changing e.g ECFA

•  Changing realities

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Societal, Economic and Climate Change •  Climate Change

–  Tropical disease shift –  More COPD universally –  Agricultural changes could lead to malnutrition and poorer choices

•  Societal –  Increasing awareness of choice – public will expect more than marginal

benefits; increased attention to dignity and risk trade offs. “More and newer are best” cannot be assumed to dominate the healthcare debate

–  Increasing public expectation for compassionate care: •  “Health care is more about love than about most other things. If there isn't

at the core of this two human beings who have agreed to be in a relationship where one is trying to relieve the suffering of another, which is love, you can't get the right answer here” DB

•  Aging population will create burden on the young. Could change the conversation regarding end of life care

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Societal, Economic and Climate Change (Cont.)

•  Economic –  Tough choices such as environmental control will decrease spending on

healthcare –  Increasing chronic diseases in developing countries e.g. diabetes, CAD,,

stroke, breast & colon cancer –  Chronic diseases will present a strain on developing country economies

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Genetics 1.  Increasing use of genetic information to stratify risk prospectively:

–  Advantages (treatment) - more selective targeted treatment. •  Unlikely that pharmacogenomics will cost less due to need to

cover developmental costs and for companion testing and need for multimodal. NB treatment related predictive tests (Oncotype)

–  Disadvantages (screening) •  inability to interpret risk •  creation of unwellness •  haphazard tests for those assumed to be at increased risk

2.  As demand for genetic screening increases, disputed value of screening could reduce enthusiasm. E.g., prostate, breast, thyroid ca., diabetes

3. Genetics based research is exciting and holds great promise. Need to

understand the risks and benefits and impact on quality of life and longevity.

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Information Technology IT will be increasingly scrutinized for effectiveness in improving patient outcomes and in intelligence seeking regarding patient risk profiles and treatment strategies. NB Based on associations rather than causality""Investments by health systems into IT will be based on comparisons with other technologies using existing evidence based methodologies"

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1.  Increasing emphasis on relevant, disruptive technologies 2.  Increasing alignment between innovators, payers, academia and end users in

defining the pre market pipeline. Industry will become a true partner with decreased need for post market policing. EXCITE

3.  International harmonization of regulatory approval for health technologies will likely not materialize but there will be increasing harmonization re- regulatory and reimbursement processes - e.g. FDA and CMS parallel review, EXCITE

4.  Increasingly rationalized health care. May lead to rationed health care. "There is going to have to be a very difficult democratic conversation that takes place. The decision is not whether or not we will have to ration care. The decision is whether we will ration with our eyes open" (Donald Berwick)

5.  Health systems will define their basket of services based on transparent criteria. These decisions must be evidence based and represent the larger public interest

6.  Health systems will continuously monitor services for obsolescence. $1 trillion dollars wasted care out of a $2.7 trillion dollar health system in the US. In Ontario, increased spending in healthcare is currently 2% per year compared to 7% increase per year over the past 5 years.

How Will Health Systems Respond to Changing Realities

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Inevitable Change on the Way 1.  Hospitals will increasingly become short stay high tech institutions with a critical

mass of highly specialized professionals.

2.  Specialties will change. Decreased demand for invasive procedures and need for continuous re-training to cope with less invasive technologies. Likely to create disruptive environment with changing and shared roles. Examples: •  coil embolistation •  draining intra abdominal abscesses, bleeding control etc. •  endocardial ablation •  replacing aortic and mitral valves •  removing renal calculus with ultrasound •  nanotechnology? Increasing role for specialised nursing & interdisciplinary care in the community

3. Non drug technologies will increasingly replace drugs and will be used as front ended treatment strategies e.g. bariatric surgery for diabetes, renal nerve ablation, RTMS and deep brain stimulation for depression. There will be increase in novel ways to deliver drugs with devices such as nanotechnology and spinal infusion of analgesics

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From: http://nano.cancer.gov/resource_center/cancer_nanotechnology_brochure.pdf

Nanotechnology – Multifunctional Dendrimer

From Pill-Popping to Bionic Man

Condition Example Drugs Used Non-drug technologies as adjunct or replacement to drugs

Ventricular arrhythmias

Amiodorone Implantable cardiac defibrillator

Atrial fibrillation Digoxin, coumadin, ca+ channel blockers

Endocardial ablation

Obesity Lipase inhibitors, appetite suppressants

Bariatric surgery

Depression Antidepressants Deep brain stimulation/ RTCMS

Parkinsons L-Dopa Deep brain stimulation

Acute MI Thrombolysins Coronary stents

Heart failure Inotropic drugs Ventricular assist devices

Acute respirotary failure

Mechanical ventilation Extracorporeal life support

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4.  Surgical treatments will continue to become less invasive e.g. artificial valves, aortic aneurysm, cholecystectomy, lithotripsy

5.  Community based health care will assume better control of chronic diseases. Community based care will be tracked more closely. More surgical procedures will be performed in private not for profit community clinics

6.  Tracking data will increase but our ability to translate to information and knowledge to shape policy and patient outcomes will be a constant challenge

Inevitable Change on the Way (2)

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What Does the Future Hold for Innovation?

•  Huge opportunities for innovations that aim to reduce costs and/or improve benefits for chronic disease and changing patterns of disease attributed to e.g. climate change

•  Pharmacogenomics and other genetic targeted therapies will make large contributions but will increase in complexity and probably cost in the treatment of cancer

•  Research into decision making will become increasingly important and especially how to involve the public. Need and relevance must be re-defined from a societal perspective (e.g. absolute risk reduction)

•  The technology pipeline will be aligned to innovators, health systems, public, climate and environmental change research, clinical trials methodologists, epidemiologists and health economists.

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What Does the Future Hold for Innovation?

•  A matrix approach that responds to changes and prioritization will expand the research agenda. This will change the nature of clinical research and methodologies

•  Genetics research will be needed to better understand risk stratification and KT so that results become an asset to health outcomes

•  IT will need to undertake outcomes based research based on proven platforms. IT platforms alone will not provide a rationale for funding

•  Big data will grow but will need to go beyond capacity to cross link large amounts of data. Could provide new approaches to clinical trials design through prospectively collected patient outcomes

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