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27/03/2017
Disclosures and Disclaimers
A Science‐Based Look at “Integrative Oncology”
I have no financial or other conflicts of interest to report with respect to this topic.
This presentation was prepared by me in my personal capacity. Any opinions expressed are solely my own, and not the opinions of any organizations I’m employed by, or affiliated with.
Scott Gavura, BScPhm, MBA, RPh, ACPR
Presented at: CAPhO Conference 2017
Image copyright: http://www.mattdawsonillustration.com, used with permission How far we’ve come?
2017: Who offers “Integrative Oncology”?
1983: New England Journal of Medicine editorial:
“Holistic medicine is a pablum of common sense and nonsense offered by cranks and quacks and failed pedants who share an attachment to magic and an animosity toward reason. Too many people seem willing to swallow the rhetoric –
even too many medical doctors – and the results will not be benign”
Glymour C, Stalker D. NEJM 1983; 308: 960‐64
Learning Objectives
In the next 25 minutes…
By attending this presentation, attendees will learn:
• The purported rationale for integrative oncology
• The potential benefits, and possible harms, of integrative oncology practices
• Implications and consequences of integrative oncology
• How pharmacists can effectively advocate for ethical, science‐based patient care
• What are we even talking about?
• What is “complementary and alternative medicine” (CAM)?
• What is “integrative” medicine and “integrative” oncology?
• Challenges with “integrating” CAM into cancer care
• What’s the harm, really?
• Is there anything we can learn from integrative oncology?
• The pharmacist’s role
• Understanding CAM vs. promoting CAM
• Advocating for high standards of cancer care
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The Evolution of CAM and Integrative Medicine
Holistic Medicine / “Unconventional” therapies
What are we even talking about?
Alternative Medicine
Complementary and Alternative Medicine
Integrative Medicine
Functional medicine?
What is “Integrative Medicine”?
CAM and Cancer
• The use of CAM appears to be increasing (Canada/USA)
Integrated Medicine is not Integrative Medicine*
*Not everyone follows this rule
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•
•
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Knowledge related to CAM in cancer is limited
Prevalence probably underestimated
Cancer diagnosis may motivate use of CAM (e.g., supplements) 1
A substantial proportion (29‐91%2,3,4) of cancer patients may be using some form of CAM
• However, CAM definitions in research vary:
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•
•
•
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Spiritualism
Mindfulness, medication
Exercise
Multivitamins
Supplements (herbal remedies, etc).
1Patterson RE et al. Changes in diet, physical activity, and supplement use among adults diagnosed with cancer. J Am Diet Assoc. 2003 Mar;103(3):323‐8.
2See, for example Berretta et al, Oncotarget
L. Kodner D, Spreeuwenberg C. Integrated care: meaning, logic, applications, and implications – a discussion paper. International Journal of Integrated Care. 2002;2:e12.
US National Center for Complementary and Integrative health: Complementary, Alternative, or Integrative Health: What’s In a Name? www.nccih.nih.gov What is “Complementary and Alternative Medicine”?
• National Center for Complementary and Integrative Health1:
• Use of products like herbs, vitamins, minerals, and probiotics, and medical practices (e.g., acupuncture) which are outside of the mainstream Western medicine. • ‘alternative’ when they are used in place of conventional medicine
• ‘complementary’ when they are used together with conventional medicine 3
4
2016, where 48.9% of Italian cancer patients reported CAM use
Boon H et al. Use of Complementary/Alternative Medicine by Breast Cancer Survivors in Ontario: Prevalence and Perceptions. Journal of Clinical Oncology 2000 18:13, 2515‐2521 Tough SC et al. Complementary and alternative medicine use among colorectal cancer patients in Alberta, Canada. Altern Ther Health Med. 2002 Mar‐Apr;8(2):54‐6, 58‐60, 62‐4.
A simpler definition of CAM1
Do you know what they call alternative medicine that’s been proven to work?
• Edzard Ernst2:
• “..diagnosis, treatment and/or prevention which complements mainstream medicine by contributing to a common whole, satisfying a demand not met by orthodoxy, or diversifying the conceptual framework of medicine.”
Answer: MEDICINE 1available at: https:// nccih.nih.gov/health/integrative‐health 2Ernst E, Pittler MH, Wider B, Boddy
K. The desktop guide to complementary and alternative medicine, 2nd edition. Edinburgh: Elsevier Mosby, 2006 1attributed to Tim Minchin
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The integrative continuum
So what is integrative medicine, really?
Science‐based, even “conventional” Many are co‐opted as “integrative”
What it is
What it isn’t
• A brand1
• A strategy
• Marketing
• Profit centre
• Lowering the evidence “bar”
• Choosing Wisely
• Proven to be superior to conventional care
Implausible and/or disproven, often pseudoscience
Diet
Exercise
Acupuncture
Lifestyle changes
Reiki
Some supplements/herbs
Homeopathy
Naturopathy1
Reflexology
Chiropractic
1Can include both evidence‐based and pseudoscientific practices The Unstated Major Premise of Integrative Medicine
• Integrative Medicine/Oncology claims to “integrate” a variety of treatments, treating the “whole person” in a way that is superior to “conventional” medicine.
• It is said to better address “root causes” and deliver superior patient care.
• The unstated premise is that science‐based medicine doesn’t provide patient‐centred care.
• Confuses science with a lack of compassion
• Assumes that “conventional” medicine doesn’t concern itself with the whole person and/or root causes.
• Assumes that providing unproven care is somehow more patient‐centred.
1e.g., http://www.huffingtonpost.com/marc‐stoiber/who‐will‐own‐the‐brand‐of_b_910077.html
Common arguments for IM and CAM
• “Absence of evidence isn’t evidence of absence”
• This is an argument from ignorance
• “Some IM and CAM is backed by good evidence”
• See the Minchin definition
• “Conventional” oncology practice ignores the evidence‐base
• Does any practice change more quickly than oncology, in the face of good evidence?
• We need to study these treatments to see what works
• No rationale to examine outside of current framework
• e.g., herbalism vs. pharmacognosy
Why do institutions offer Integrative Medicine?
• Patient demand
• Argument from popularity
• “Keep the customer satisfied” (USA)
• Manufactured demand
Challenges with “integrating” CAM into cancer care
• Not understanding the (lack of) evidence
• Willing to accept weak evidence
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What are we really integrating?1
The placebo narrative or “thinking makes it so”
Reasonable and/or Evidence Based
Unproven or Proven Ineffective
• Ask patients about CAM
• Provide evidence‐based guidance on CAM
• Acupuncture for pain, xerostomia, N&V, smoking
• Many forms of CAM once thought to have medicinal effects as demonstrated in trials
• Evaluate supplements for interactions
• Mind/body therapies for QOL
• Many of these trials had serious methodological deficiencies
• e.g., acupuncture
• As studies have grown more rigorous, those effects have disappeared
• Proponents now argue these treatments work through the “Power of Placebo”1,2
• Consequently, effectiveness is reliant on provider deception about evidence base
• Meditation, CBT
• “Energy therapies” safe but not encouraged due to lack of evidence
• Refer patients to RDs for dietary advice
• Botanicals as active treatment only in context of clinical trial
• Avoid treatments promoted as “alternatives” to mainstream care
1e.g., Marchant J. A placebo treatment for pain. NY Times 2016 Jan 9; SR5.
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2e.g., Wang SS. Why placebos work wonders. Wall Street Journal 2012 Jan 10.
Journal of the Society for Integrative Oncology 5(2) 2007: 65‐84.
(At least) three major harms from Integrative Oncology
What’s the harm in Integrative Oncology?
Clinical
• Will it improve cancer care? Ethical
• Is it ethically defensible? Economic
• Is providing CAM a good use of limited resources? Harm 1: Clinical
Harm 2: Ethical
• Improvements in survival and QOL have been derived from the increasing application of evidence, not from ignoring the science.
• Given implausibility, is it reasonable to subject patients to treatments that lack any pre‐clinical signs of effectiveness?
• Is there any justification for “integrating” therapies that are not the standard of care into routine cancer care?
• Should unproven therapies be routinely offered outside the context of a clinical trial?
 Many CAM therapies posit implausible or impossible mechanisms of action.
 Before the era of CAM, rare for therapies to proceed to clinical trials based only on laboratory or animal plausibility.
• e.g., acupuncture has no viable mechanism, nor has one been shown.
• Evidence suggests that acupuncture’s overall effects are indistinguishable from placebo1.
• Possible, but unlikely, exception: chemotherapy‐induced N&V2.
• Not clear that all forms of CAM can be used without risk of harm.
 E.g. herbal remedies are effectively impure, unstandardized drugs.
 Little evidence Canadian supplements have meaningful quality control3
1 Colquhoun D, Novella SP. Acupuncture is theatrical placebo. Anesth Analg. 2013 Jun;116(6):1360‐3
2 Garcia MK et al. Systematic review of acupuncture in cancer care: a synthesis of the evidence. J Clin Oncol. 2013 Mar 1;31(7):952‐60. 3 See, for example, Erland LAE and Saxena PK. Melatonin Natural Health Products and Supplements: Presence of Serotonin and Significant Variability of Melatonin Content, J Sleep Medicine 2017;13 (3).
 Integrative centres routinely offer homeopathy, reiki, acupuncture, etc.
• Pharmacists (and other HCPs) selling CAM violate ethical principles1
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Macdonald C, Gavura S. Alternative medicine and the ethics of commerce. Bioethics 2016; 30(2): 77‐84.
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Harm 3: Economic
• Ever dollar spent on unproven therapy results in time and money spent on interventions that have not been demonstrated to improve QOL or survival.
• Integrative oncology wastes the resources of patients (time and often money), providers, and system administrators.
Is there anything we can learn from integrative oncology?
• Integrative oncology reflects, in part, consumer enthusiasm for CAM
• Understand the evidence to support candid discussions with patients and HCPs
• Much of the good in integrative oncology is what we should already been offering to our patients:
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•
•
•
•
Promoting prevention, where possible
Healthy lifestyle & discontinuing actions known to be harmful
Proper nutrition
Exercise (it doesn’t have to be yoga!)
Adequate sleep
• Understand patient values and preferences
None of this is “alternative” or “integrative.” It’s just good patient care.
The Pharmacist’s Role The pharmacist’s role
“Patients trust that as healthcare professionals we will respect and protect their vulnerability and maintain professional boundaries within the healthcare professional/patient relationship as we use our knowledge, skills and abilities to make decisions that enhance their health and well‐being” ‐ Ontario College of Pharmacists – Code of Ethics (Dec 2015) Pharmacist’s Role
• Understanding CAM approaches and perspectives are critical.
• Pharmacists are the drug therapy experts.
• Assessing CAM therapies like herbalism or homeopathy is not outside the expertise of pharmacists
• If a CAM therapy works, it works according to scientific principles, not alternative ones
Conclusion
• Don’t relinquish that role (and responsibility)
• The profession must maintain a clear identity grounded in evidence and science, not one willing to ignore science on the basis of “alternative” ideas.
• Popularity shouldn’t drive what we offer, evidence should.
Image copyright: http://www.mattdawsonillustration.com, used with permission 5
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Beware the Trojan Horse
Readings and References
• Good patient care isn’t “alternative” or “integrative”
• Ensure our colleagues and organizations understand that integrative oncology introduces unproven treatments and lowers the evidence bar.
• Gorski DH. Integrative oncology: really the best of both worlds? Nat Rev Cancer. 2014 Oct;14(10).
• Ross C et al. Medicine with a side of mysticism: Top hospitals promote unproven therapies. STAT News 2017 March 7. Available at: • Don’t patients want (and expect) not to be sold false hope, or to be misled?
• Should public institutions offer unproven therapies, given limited resources?
• Understand motivations for integrative oncology, and address root issues
• Promote good patient care, not “integrative” care
• We have a responsibility as health professionals to offer patients the best care, without misleading them.
• Providers (like pharmacists) need to continue to demand that institutions offer ethical, science‐based care.
• Scarce resources = apply evidence.
• The patients we serve deserve it.
https://www.statnews.com/2017/03/07/alternative‐medicine‐hospitals‐promote/
• Born K et al. Integrative cancer care in Canada: curiosity and cautions. Healthy Debate 2014 May 15. Available at: http://healthydebate.ca/2014/05/topic/health‐promotion‐disease‐prevention/integrative‐cancer‐care‐
canada‐cautions‐curiosity
• Science‐Based Medicine Blog: www.sciencebasedmedicine.org/tag/integrative‐medicine/
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