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CFIC AGM Presentation on Misinformation

Progress with a Price Tag attempts to provide a concise summary of evaluating evidence and mitigating biases. It discusses how truth exists in detail rather than on the surface. Evaluating evidence requires considering trial methodology, results, and applicability. Statistical significance does not always mean clinical significance. Applying PICO helps determine if evidence applies. Surrogate outcomes like viral presence may not reflect patient benefits. Overall it emphasizes critically evaluating evidence claims and considering multiple perspectives to find detailed truth.

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Progress with a Price Tag Trying to survive misinformation amidst a pandemic Centre for Inquiry Canada Annual General Meeting – March 11, 2021 Zack Dumont Manager of Clinical Pharmacy Services – SHA Regina Pharmacy Department Clinical Pharmacist – RxFiles Academic Detailing
Acknowledgements • CFIC – for the invitation to present 22 March 2021 2
A poll • Type your answers in the chatbox –The dress is: • A) Black and blue • B) Gold and white • C) Other 22 March 2021 3 Udland M. One year ago, the internet lost its mind over 'The Dress' that might be blue and black or white and gold — And now some people see the colors differently. Business Insider February 2016. Available from: https://www.businessinsider.com/is-the-dress-white-and-gold-black-and-blue-2015-2.
Faculty/Presenter Disclosure Faculty: Zack Dumont • Current or past relationships with commercial interests – Advisory Board/Speakers Bureau: nil – Funding (Grants/Honoraria): nil – Research/Clinical Trials: nil – Speaker/Consulting Fees: nil – Other: nil • Speaking Fees for current program – I have received no speaker’s fee for this learning activity • This presentation has not received financial support from any organization • This presentation has not received in- kind support from any organization 22 March 2021 4
“Your personal experiences make up maybe 0.00000001% of what’s happened in the world but maybe 80% of how you think the world works... We’re all biased to our own personal history.”.” -Morgan Housel 22 March 2021 5
Mitigating Potential Bias • Not applicable – Really? 22 March 2021 6
Disclaimers • I have biases – I am aware of some – I am not aware of others – You will learn some of mine – Do you have any? “We are misled by the ease with which our minds fall into the ruts of one or two experiences.” -Sir William Osler 22 March 2021 7
We all have biases, and… "There are things in medicine that make perfect sense... but are wrong“ -James S. Forrester, MD • Vitamin E to prevent heart disease • Estrogen to prevent heart disease • Raising HDL (torcetrapib) • Taking pills to lower homocysteine • Lowering A1c (rosiglitazone) • Lowering BP (doxazosin) Forrester JS, Shah PK 1997 Lipid lowering versus revascularization. An idea whose time (for testing) has come. Circulation 96:1360–1362 22 March 2021 8
Formulary RN Experience Colleagues Practice Guidelines Pharm Industry Patient Treatment? Practice site Pharmacist CME Influences on a treatment decision 22 March 2021 9 Prescriber
Introducing: COVID-19 • Hydroxychloroquine  rheumatoid arthritis • Remdesivir  Ebola • Colchicine  acute gout treatment • Azithromycin  antibiotic • Ivermectin  anthelmintic (eg, worms, lice, etc) • Tocilizumab  rheumatoid arthritis 22 March 2021 10 • Many interventions have been proposed (samples right) • Theoretical basis proceeds proof – May make history tomorrow – Makes for a headline today – …more on this…
Objectives Learning Objectives • Participants will be able to: – Explain rationale for critical thinking when reviewing literature If you haven’t already guess… one last disclaimer • I’m a pharmacist and not a behavioural psychologist… will do my best to stay in my lane – This will be about drugs  (but I think you can apply it to any intervention) 22 March 2021 11
On “misinformation” What it is • Most common definitions approximating: – “Incorrect and/or misleading information” • Plenty of overlap, yet some definitions differ – Eg, Some suggest an underlying intent to mislead What it is NOT • Truth 22 March 2021 12
On “Truth” • …and perspective 22 March 2021 13 On the Surface In the Detail
In medications and in life: truth is in the detail 22 March 2021 14 • Approximate truth by learning the detail • …then try sharing it with someone who • Is really smart and successful and confident, OR • Is already convinced they see a circle (or a square), OR • Is too busy to look and just wants you to tell them if it there’s a circle (or square) there, OR • Likes to say it’s a square and see if you can convince them it’s not – and… you have minutes, seconds, or less • Facilitating someone’s journey from square/circle  to the truth – As much as this is about truth, it’s about empathy On the Surface In the Detail
QUICK ASIDE: Truth? • “Scientific objectivity” – Possible explanations from philosophy • Faithfulness to facts • Absence of normative commitments and the value-free ideal • Freedom from personal biases • A feature of scientific communities and their practices – Enduring philosophical debate • We won’t really solve this today… 22 March 2021 15 Reiss J, Sprenger I. "Scientific Objectivity", The Stanford Encyclopedia of Philosophy (Winter 2020 Edition), Edward N Zalta (ed). Available from: https://plato.stanford.edu/entries/scientific-objectivity/. Truth Possible Observations Truth exists amongst many possible observations
In medications and in life: truth is in the detail 22 March 2021 16 Downden B. ”Fallacies", The Internet Encyclopedia of Philosophy, ISSN 2161-0002. Available from: https://www.iep.utm.edu/. Reiss J, Sprenger I. "Scientific Objectivity", The Stanford Encyclopedia of Philosophy (Winter 2020 Edition), Edward N Zalta (ed). Available from: https://plato.stanford.edu/entries/scientific- objectivity/. • Even if we discover and/or deliver TRUTH, there remain barriers to rational decisions – Rational Choice Theory • If an individual prefers A to B, they value A higher than B – Desires do not have to align with any objective measure of “goodness” – Rationalization • A fallacy in decision-making – “inauthentically offer reasons to support our claim” On the Surface In the Detail
Truth = Evidence? • Globe & Mail – Risk appears increased mainly • In patients with pre-existing risk factors • In more potent or higher doses of statins • Reality – If treating 255 patients for 4 years – 1 more case of diabetes – 5.4 fewer vascular events • Caveat… pooling high risk and low risk – High CV risk  most benefit from statin – Low CV risk  less benefit from statin – Therefore, when CV benefit is low, diabetes risk may supersede » Details… • Details… • Details… 22 March 2021 17 • Evidence: Can it be trusted?
Truth = Evidence? • What do we know? – Interpretation is complex – Not well-served by a headline 22 March 2021 18 • Evidence: Can it be trusted?
Truth = Evidence? 22 March 2021 19 • Evidence: Can it be trusted? – Three over-arching questions: • 1) Quality of trial methodology? – Risk of bias • 2) What are the results? • 3) How do we apply these results to us/our patients?
Truth = Evidence? • Three main considerations – 1) Randomization • How? • Allocation concealment? – 2) Blinding • Who did they blind? – 3) Follow-up • Technical questions – Intention-to-treat? Per protocol? • Questions anyone can ask – Did a lot of people drop-out of the study? – Did they stop the trial early for “benefit”? 22 March 2021 20 • Evidence: Can it be trusted? – Three over-arching questions: • 1) Quality of trial methodology? – Risk of bias • 2) What are the results? • 3) How do we apply these results to us/our patients?
Example: remdesivir • Claim: “clinical improvement was observed in 36 of 53 patients (68%)” • Problem: randomization violation – Did some patients get better in the study while on the medication? • Yes, absolutely – Would they have gotten better without the medication? • We have no idea! Ie, there was no control group 22 March 2021 21 Grein J, Ohmagari N, Shin D. Compassionate Use of Remdesivir for Patients with Severe Covid-19. NEJM April 10, 2020. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2007016.
Truth = Evidence? • Two main considerations – 1) How large or small is the effect? • Statistical significance vs clinical significance • What about benefits relative to harms? – 2) How precise or trustworthy is the effect? • Confidence intervals • Line of no difference 22 March 2021 22 • Evidence: Can it be trusted? – Three over-arching questions: • 1) Quality of trial methodology? – Risk of bias • 2) What are the results? • 3) How do we apply these results to us/our patients?
Example: tocilizumab • Claim: “Improves survival” – 596 (29%) of the 2022 patients allocated tocilizumab died – 694 (33%) of the 2094 patients allocated to usual care died – Relative risk = 86% • 95% confidence interval [CI] 0·77-0·96; p=0·007) – Relative risk reduction = 14% • Problem: statistical significance inflates benefit – Absolute risk reduction = 33% - 29% = 4% • Admittedly, very promising because of the mortality reduction, but will be over-hyped 22 March 2021 23 RECOVERY pre-print. Available from: https://www.medrxiv.org/content/10.1101/2021.02.11.21249258v1
Truth = Evidence? • Use PICO Tool –Patients/Populations – Are these even the patients you see? Were they too healthy? –Intervention – Is this intervention even possible? –Comparator – Did they compare it to the gold standard? Eg, drug, dose, route, interval, duration –Outcomes – Do/should these outcomes even matter to the public? 22 March 2021 24 • Evidence: Can it be trusted? – Three over-arching questions: • 1) Quality of trial methodology? – Risk of bias • 2) What are the results? • 3) How do we apply these results to us/our patients?
Example: molnupiravir • Claim: “Stops COVID in its tracks” – Eg, “By day 3, 28% of patients in the placebo arm had SARS-CoV-2 in their nasopharynx, compared to 20.4% of patients receiving any dose of molnupiravir.” • Problem: Surrogate outcomes! – Should we really care about viral presence? • It’s not irrelevant, but we demand proof of benefit to patients! 22 March 2021 25 Boerner H. Five-Day Course of Oral Antiviral Appears to Stop SARS-CoV-2 in Its Tracks. March 08, 2021. Available from: https://www.medscape.com/viewarticle/947061?src=WNL_dne_210310_mscpedit&uac=102683EX&impID=3239028&faf=1#vp_1.
Conclusions 22 March 2021 26
• Just because we have biases doesn’t mean we can be complacent about them “I was taught that the way of progress was neither swift nor easy.” -Marie Curie 22 March 2021 27
Conclusions Progress with a price tag • Scientific progress like we’ve never seen – Some interventions will stick • Masks • Tocilizumab? • Sickness, suffering, and death like we’ve never seen Trying to survive misinformation amidst a pandemic • Evidence: Can it be trusted? – Three over-arching questions: • 1) Quality of trial methodology? – Risk of bias • 2) What are the results? • 3) How do we apply these results to us/our patients? 22 March 2021 28
“It is the mark of an educated mind to be able to entertain a thought without accepting it.” -Aristotle 22 March 2021 29
Objectives Learning Objectives • Participants will be able to: – Explain rationale for critical thinking when reviewing literature If you haven’t already guess… one last disclaimer • I’m a pharmacist and not a behavioural psychologist… will do my best to stay in my lane – This will be about drugs  22 March 2021 30
References • Udland M. One year ago, the internet lost its mind over 'The Dress' that might be blue and black or white and gold — And now some people see the colors differently. Business Insider February 2016. Available from: https://www.businessinsider.com/is-the-dress-white-and-gold-black-and-blue-2015-2. • Lau A. “Implementation,” The First and Most Important Concept You Should Know in Implementation Science. Active Aging Research Team @ UBC November 2019. Available from: https://medium.com/@activeaging_research/implementation-the-first-and-most-important-concept-you-should-know-in-implementation-science-3d15ee2ace8d. • Balas EA, Boren SA. (2000). Managing clinical knowledge for health care improvement. In: Bemmel J, McCray AT, editors. Yearbook of Medical Informatics 2000: Patient-Centered Systems. Stuttgart, Germany: Schattauer Verlagsgesellschaft mbH; 2000:65-70. • Kennedy AG, Regier L, Fischer M. Educating community clinicians using principles of academic detailing in an evolving landscape. American Journal of Health-System Pharmacy November 2020. Available from: https://doi.org/10.1093/ajhp/zxaa351. • Reiss J, Sprenger I. "Scientific Objectivity", The Stanford Encyclopedia of Philosophy (Winter 2020 Edition), Edward N Zalta (ed). Available from: https://plato.stanford.edu/entries/scientific-objectivity/. • Guyatt, Gordon; Guyatt, Gordon. Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice, 3E (Users Guides to the Medical Literature) (p. 72). McGraw-Hill Education. • Downden B. ”Fallacies", The Internet Encyclopedia of Philosophy, ISSN 2161-0002. Available from: https://www.iep.utm.edu/. • Reasons J. Human error: models and management. BMJ March 2000. Volume 320, pages 768-770. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1117770/. • Elliott MH, Skydel JJ, Dhruva SS, Ross JS, Wallach JD. Characteristics and Reporting of Number Needed to Treat, Number Needed to Harm, and Absolute Risk Reduction in Controlled Clinical Trials, 2001-2019. JAMA Internal Medicine November 2020. E1-E3. • Mostofsky E, Dunn JA, Hernández-Díaz S, Mittleman MA. Patient and Physician Preferences for Reporting Research Findings. Fam Med June 2019; 51(6):502-508. Available from: https://journals.stfm.org/familymedicine/2019/june/mostofsky-2018-0384/. • Minkow D. The Evidence-Based Medicine Pyramid! Students 4 Best Evidence April 2014. Available from: https://s4be.cochrane.org/blog/2014/04/29/the-evidence-based-medicine- pyramid/. • Grein J, Ohmagari N, Shin D. Compassionate Use of Remdesivir for Patients with Severe Covid-19. NEJM April 10, 2020. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2007016. • RECOVERY pre-print. Available from: https://www.medrxiv.org/content/10.1101/2021.02.11.21249258v1 • Boerner H. Five-Day Course of Oral Antiviral Appears to Stop SARS-CoV-2 in Its Tracks. March 08, 2021. Available from: https://www.medscape.com/viewarticle/947061?src=WNL_dne_210310_mscpedit&uac=102683EX&impID=3239028&faf=1#vp_1. 22 March 2021 31
Questions? Now • Please share any – Questions – Comments – Musings Later • Contact me – Email: zackdumont@me.com – Twitter: @ZackDumontYQR – LinkedIn: /ZackDumont 22 March 2021 32
Audience Q&A • Zack’s answer – Well, where to begin? He received/took quite a few medications throughout this pandemic (eg, hydroxychloroquine). If speaking specifically about his hospitalization, however, we might be able to pin it down to a couple/several: dexamethasone, remdesivir, and REGN-COV2 monoclonal antibody. – Dexamethasone is a corticosteroid that’s been around for quite some time. It’s not magic, but of all the interventions, it’ll probably be one sticks. It’s quite effective at knocking out inflammation. Why doesn’t it get much attention? It’s been around long enough that it’s been genericized and, therefore, there aren’t shareholders standing to make much gain. – Remdesivir, or Veklury®, is the anti-malarial that was re-purposed to supposedly work for COVID. It’s showed a bit of benefit in studies, but also some neutral and negative findings. Why this can happen with studies: the drug probably doesn’t do much, if anything, but if you study it enough times it will on occasion – due purely to random chance – show a benefit in one study. One study might be all you need to market your medication. – The REGN-COV2 monoclonal antibody (Regeneron®) will probably stick around, too. It’s not quite this simple, but one possible explanation of how it works: while a vaccine is given to trick your body into thinking an infective agent is present and then developing endogenous (from within) antibodies, this medication is a short-cut and just gives you the antibodies (usually copied from someone who’s had COVID) 22 March 2021 33 • Question – What drug was given to Trump?
Audience Q&A • Zack’s answer – My gut instinct says ‘no’, but I don’t like relying on my “feelings”, so if it was (created in a lab) all I can say is that there could be massive implications. But, from a politically agnostic perspective, it doesn’t matter. Pardon my curtness. It doesn’t matter if it did or not because this could have happened – and eventually would have happened – naturally. In addition, the idea shares characteristics with conspiracy theories, which are almost always untrue purely because they would be too difficult to orchestrate. 22 March 2021 34 • Question – What is your view on the potential that COVID came from a lab?
Audience Q&A • Zack’s answer – Great question. In short, I think it’s a net problem. But there are pros and cons. Most formularies are responsible for a particular geographical area or population; so, a formulary can be a bit more nimble and responsive to a specific population. An overly simplistic example: in an area where there’s a higher elderly population, they might dedicate more resources to covering medications for seniors. The threat that probably immediately comes to mind is that transferability is immediately compromised; so, as soon as someone moves to another jurisdiction without coverage then they’re scrambling to change therapies. At the same time, a big single formulary is possible, and just needs to be developed with higher levels of detail. It should be sought-after over the long-term. We’re fortunate in Canada to have CADTH (the Canadian Agency for Drugs and Technology in Health) to help coordinate the many formularies. Patience is required, no doubt. It’s been around for a few decades and the ecosystem it works within is still very very far away from realizing the power and economy of scale from having a single formulary. 22 March 2021 35 • Question – How much of a problem is it having so many formularies?
Audience Q&A • Zack’s answer – You’ve probably heard (Spider-Man’s) Uncle Ben’s saying: with great power comes great responsibility? Well… that doesn’t fit here… at all. Instead, this situation is probably best quoted with something like: with low expectations comes low exertion. Bottom-line is that research doesn’t have to be conducted well because it has nearly the same impact independent of its rigour. A study can and will be marketed easily, even if poorly-conducted. A study can and will face change intolerance, even if well-conducted. It’s such a paradox; everything changes, yet everything stays the same. For every person that adopts drugs too early and based on poor research, there’s nearly one-to-one someone who refuses to budge even if the research is great. So, there’s perhaps not much impetus. – The second, and perhaps more charitable reason: good intentions (you can probably think of a saying about good intentions, too ;) ). But, to be fair, educated people are under intense pressure from patients and society to fix things. To fix everything… and to fix it yesterday. This causes interventions to progress through the research stages too quickly: a theory is tested in a lab, and before it even gets a chance to get outside, someone learns about the theory and starts trialing it in certain patients, and before it gets a chance to prove whether or not it works in patients, someone finds out about it and is writing it into a guidelines, maybe simply because they know an expert who believes it… and so on, and so on. – There is a number of other reasons that we just can’t get into: publication quotas for academics, decentralized study conduct, uncoordinated endeavours, competing interests, politics, stigma, etc, etc, etc 22 March 2021 36 • Question – How do so many poor studies get run, despite that researchers should be educated in proper study design?

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CFIC AGM Presentation on Misinformation

  • 1.
    Progress with aPrice Tag Trying to survive misinformation amidst a pandemic Centre for Inquiry Canada Annual General Meeting – March 11, 2021 Zack Dumont Manager of Clinical Pharmacy Services – SHA Regina Pharmacy Department Clinical Pharmacist – RxFiles Academic Detailing
  • 2.
    Acknowledgements • CFIC –for the invitation to present 22 March 2021 2
  • 3.
    A poll • Typeyour answers in the chatbox –The dress is: • A) Black and blue • B) Gold and white • C) Other 22 March 2021 3 Udland M. One year ago, the internet lost its mind over 'The Dress' that might be blue and black or white and gold — And now some people see the colors differently. Business Insider February 2016. Available from: https://www.businessinsider.com/is-the-dress-white-and-gold-black-and-blue-2015-2.
  • 4.
    Faculty/Presenter Disclosure Faculty: ZackDumont • Current or past relationships with commercial interests – Advisory Board/Speakers Bureau: nil – Funding (Grants/Honoraria): nil – Research/Clinical Trials: nil – Speaker/Consulting Fees: nil – Other: nil • Speaking Fees for current program – I have received no speaker’s fee for this learning activity • This presentation has not received financial support from any organization • This presentation has not received in- kind support from any organization 22 March 2021 4
  • 5.
    “Your personal experiencesmake up maybe 0.00000001% of what’s happened in the world but maybe 80% of how you think the world works... We’re all biased to our own personal history.”.” -Morgan Housel 22 March 2021 5
  • 6.
    Mitigating Potential Bias •Not applicable – Really? 22 March 2021 6
  • 7.
    Disclaimers • I havebiases – I am aware of some – I am not aware of others – You will learn some of mine – Do you have any? “We are misled by the ease with which our minds fall into the ruts of one or two experiences.” -Sir William Osler 22 March 2021 7
  • 8.
    We all havebiases, and… "There are things in medicine that make perfect sense... but are wrong“ -James S. Forrester, MD • Vitamin E to prevent heart disease • Estrogen to prevent heart disease • Raising HDL (torcetrapib) • Taking pills to lower homocysteine • Lowering A1c (rosiglitazone) • Lowering BP (doxazosin) Forrester JS, Shah PK 1997 Lipid lowering versus revascularization. An idea whose time (for testing) has come. Circulation 96:1360–1362 22 March 2021 8
  • 9.
    Formulary RN Experience Colleagues Practice Guidelines Pharm Industry Patient Treatment? Practicesite Pharmacist CME Influences on a treatment decision 22 March 2021 9 Prescriber
  • 10.
    Introducing: COVID-19 • Hydroxychloroquine rheumatoid arthritis • Remdesivir  Ebola • Colchicine  acute gout treatment • Azithromycin  antibiotic • Ivermectin  anthelmintic (eg, worms, lice, etc) • Tocilizumab  rheumatoid arthritis 22 March 2021 10 • Many interventions have been proposed (samples right) • Theoretical basis proceeds proof – May make history tomorrow – Makes for a headline today – …more on this…
  • 11.
    Objectives Learning Objectives • Participantswill be able to: – Explain rationale for critical thinking when reviewing literature If you haven’t already guess… one last disclaimer • I’m a pharmacist and not a behavioural psychologist… will do my best to stay in my lane – This will be about drugs  (but I think you can apply it to any intervention) 22 March 2021 11
  • 12.
    On “misinformation” What itis • Most common definitions approximating: – “Incorrect and/or misleading information” • Plenty of overlap, yet some definitions differ – Eg, Some suggest an underlying intent to mislead What it is NOT • Truth 22 March 2021 12
  • 13.
    On “Truth” • …andperspective 22 March 2021 13 On the Surface In the Detail
  • 14.
    In medications andin life: truth is in the detail 22 March 2021 14 • Approximate truth by learning the detail • …then try sharing it with someone who • Is really smart and successful and confident, OR • Is already convinced they see a circle (or a square), OR • Is too busy to look and just wants you to tell them if it there’s a circle (or square) there, OR • Likes to say it’s a square and see if you can convince them it’s not – and… you have minutes, seconds, or less • Facilitating someone’s journey from square/circle  to the truth – As much as this is about truth, it’s about empathy On the Surface In the Detail
  • 15.
    QUICK ASIDE: Truth? •“Scientific objectivity” – Possible explanations from philosophy • Faithfulness to facts • Absence of normative commitments and the value-free ideal • Freedom from personal biases • A feature of scientific communities and their practices – Enduring philosophical debate • We won’t really solve this today… 22 March 2021 15 Reiss J, Sprenger I. "Scientific Objectivity", The Stanford Encyclopedia of Philosophy (Winter 2020 Edition), Edward N Zalta (ed). Available from: https://plato.stanford.edu/entries/scientific-objectivity/. Truth Possible Observations Truth exists amongst many possible observations
  • 16.
    In medications andin life: truth is in the detail 22 March 2021 16 Downden B. ”Fallacies", The Internet Encyclopedia of Philosophy, ISSN 2161-0002. Available from: https://www.iep.utm.edu/. Reiss J, Sprenger I. "Scientific Objectivity", The Stanford Encyclopedia of Philosophy (Winter 2020 Edition), Edward N Zalta (ed). Available from: https://plato.stanford.edu/entries/scientific- objectivity/. • Even if we discover and/or deliver TRUTH, there remain barriers to rational decisions – Rational Choice Theory • If an individual prefers A to B, they value A higher than B – Desires do not have to align with any objective measure of “goodness” – Rationalization • A fallacy in decision-making – “inauthentically offer reasons to support our claim” On the Surface In the Detail
  • 17.
    Truth = Evidence?• Globe & Mail – Risk appears increased mainly • In patients with pre-existing risk factors • In more potent or higher doses of statins • Reality – If treating 255 patients for 4 years – 1 more case of diabetes – 5.4 fewer vascular events • Caveat… pooling high risk and low risk – High CV risk  most benefit from statin – Low CV risk  less benefit from statin – Therefore, when CV benefit is low, diabetes risk may supersede » Details… • Details… • Details… 22 March 2021 17 • Evidence: Can it be trusted?
  • 18.
    Truth = Evidence? •What do we know? – Interpretation is complex – Not well-served by a headline 22 March 2021 18 • Evidence: Can it be trusted?
  • 19.
    Truth = Evidence? 22March 2021 19 • Evidence: Can it be trusted? – Three over-arching questions: • 1) Quality of trial methodology? – Risk of bias • 2) What are the results? • 3) How do we apply these results to us/our patients?
  • 20.
    Truth = Evidence? •Three main considerations – 1) Randomization • How? • Allocation concealment? – 2) Blinding • Who did they blind? – 3) Follow-up • Technical questions – Intention-to-treat? Per protocol? • Questions anyone can ask – Did a lot of people drop-out of the study? – Did they stop the trial early for “benefit”? 22 March 2021 20 • Evidence: Can it be trusted? – Three over-arching questions: • 1) Quality of trial methodology? – Risk of bias • 2) What are the results? • 3) How do we apply these results to us/our patients?
  • 21.
    Example: remdesivir • Claim:“clinical improvement was observed in 36 of 53 patients (68%)” • Problem: randomization violation – Did some patients get better in the study while on the medication? • Yes, absolutely – Would they have gotten better without the medication? • We have no idea! Ie, there was no control group 22 March 2021 21 Grein J, Ohmagari N, Shin D. Compassionate Use of Remdesivir for Patients with Severe Covid-19. NEJM April 10, 2020. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2007016.
  • 22.
    Truth = Evidence? •Two main considerations – 1) How large or small is the effect? • Statistical significance vs clinical significance • What about benefits relative to harms? – 2) How precise or trustworthy is the effect? • Confidence intervals • Line of no difference 22 March 2021 22 • Evidence: Can it be trusted? – Three over-arching questions: • 1) Quality of trial methodology? – Risk of bias • 2) What are the results? • 3) How do we apply these results to us/our patients?
  • 23.
    Example: tocilizumab • Claim:“Improves survival” – 596 (29%) of the 2022 patients allocated tocilizumab died – 694 (33%) of the 2094 patients allocated to usual care died – Relative risk = 86% • 95% confidence interval [CI] 0·77-0·96; p=0·007) – Relative risk reduction = 14% • Problem: statistical significance inflates benefit – Absolute risk reduction = 33% - 29% = 4% • Admittedly, very promising because of the mortality reduction, but will be over-hyped 22 March 2021 23 RECOVERY pre-print. Available from: https://www.medrxiv.org/content/10.1101/2021.02.11.21249258v1
  • 24.
    Truth = Evidence? •Use PICO Tool –Patients/Populations – Are these even the patients you see? Were they too healthy? –Intervention – Is this intervention even possible? –Comparator – Did they compare it to the gold standard? Eg, drug, dose, route, interval, duration –Outcomes – Do/should these outcomes even matter to the public? 22 March 2021 24 • Evidence: Can it be trusted? – Three over-arching questions: • 1) Quality of trial methodology? – Risk of bias • 2) What are the results? • 3) How do we apply these results to us/our patients?
  • 25.
    Example: molnupiravir • Claim:“Stops COVID in its tracks” – Eg, “By day 3, 28% of patients in the placebo arm had SARS-CoV-2 in their nasopharynx, compared to 20.4% of patients receiving any dose of molnupiravir.” • Problem: Surrogate outcomes! – Should we really care about viral presence? • It’s not irrelevant, but we demand proof of benefit to patients! 22 March 2021 25 Boerner H. Five-Day Course of Oral Antiviral Appears to Stop SARS-CoV-2 in Its Tracks. March 08, 2021. Available from: https://www.medscape.com/viewarticle/947061?src=WNL_dne_210310_mscpedit&uac=102683EX&impID=3239028&faf=1#vp_1.
  • 26.
  • 27.
    • Just becausewe have biases doesn’t mean we can be complacent about them “I was taught that the way of progress was neither swift nor easy.” -Marie Curie 22 March 2021 27
  • 28.
    Conclusions Progress with aprice tag • Scientific progress like we’ve never seen – Some interventions will stick • Masks • Tocilizumab? • Sickness, suffering, and death like we’ve never seen Trying to survive misinformation amidst a pandemic • Evidence: Can it be trusted? – Three over-arching questions: • 1) Quality of trial methodology? – Risk of bias • 2) What are the results? • 3) How do we apply these results to us/our patients? 22 March 2021 28
  • 29.
    “It is themark of an educated mind to be able to entertain a thought without accepting it.” -Aristotle 22 March 2021 29
  • 30.
    Objectives Learning Objectives • Participantswill be able to: – Explain rationale for critical thinking when reviewing literature If you haven’t already guess… one last disclaimer • I’m a pharmacist and not a behavioural psychologist… will do my best to stay in my lane – This will be about drugs  22 March 2021 30
  • 31.
    References • Udland M.One year ago, the internet lost its mind over 'The Dress' that might be blue and black or white and gold — And now some people see the colors differently. Business Insider February 2016. Available from: https://www.businessinsider.com/is-the-dress-white-and-gold-black-and-blue-2015-2. • Lau A. “Implementation,” The First and Most Important Concept You Should Know in Implementation Science. Active Aging Research Team @ UBC November 2019. Available from: https://medium.com/@activeaging_research/implementation-the-first-and-most-important-concept-you-should-know-in-implementation-science-3d15ee2ace8d. • Balas EA, Boren SA. (2000). Managing clinical knowledge for health care improvement. In: Bemmel J, McCray AT, editors. Yearbook of Medical Informatics 2000: Patient-Centered Systems. Stuttgart, Germany: Schattauer Verlagsgesellschaft mbH; 2000:65-70. • Kennedy AG, Regier L, Fischer M. Educating community clinicians using principles of academic detailing in an evolving landscape. American Journal of Health-System Pharmacy November 2020. Available from: https://doi.org/10.1093/ajhp/zxaa351. • Reiss J, Sprenger I. "Scientific Objectivity", The Stanford Encyclopedia of Philosophy (Winter 2020 Edition), Edward N Zalta (ed). Available from: https://plato.stanford.edu/entries/scientific-objectivity/. • Guyatt, Gordon; Guyatt, Gordon. Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice, 3E (Users Guides to the Medical Literature) (p. 72). McGraw-Hill Education. • Downden B. ”Fallacies", The Internet Encyclopedia of Philosophy, ISSN 2161-0002. Available from: https://www.iep.utm.edu/. • Reasons J. Human error: models and management. BMJ March 2000. Volume 320, pages 768-770. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1117770/. • Elliott MH, Skydel JJ, Dhruva SS, Ross JS, Wallach JD. Characteristics and Reporting of Number Needed to Treat, Number Needed to Harm, and Absolute Risk Reduction in Controlled Clinical Trials, 2001-2019. JAMA Internal Medicine November 2020. E1-E3. • Mostofsky E, Dunn JA, Hernández-Díaz S, Mittleman MA. Patient and Physician Preferences for Reporting Research Findings. Fam Med June 2019; 51(6):502-508. Available from: https://journals.stfm.org/familymedicine/2019/june/mostofsky-2018-0384/. • Minkow D. The Evidence-Based Medicine Pyramid! Students 4 Best Evidence April 2014. Available from: https://s4be.cochrane.org/blog/2014/04/29/the-evidence-based-medicine- pyramid/. • Grein J, Ohmagari N, Shin D. Compassionate Use of Remdesivir for Patients with Severe Covid-19. NEJM April 10, 2020. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa2007016. • RECOVERY pre-print. Available from: https://www.medrxiv.org/content/10.1101/2021.02.11.21249258v1 • Boerner H. Five-Day Course of Oral Antiviral Appears to Stop SARS-CoV-2 in Its Tracks. March 08, 2021. Available from: https://www.medscape.com/viewarticle/947061?src=WNL_dne_210310_mscpedit&uac=102683EX&impID=3239028&faf=1#vp_1. 22 March 2021 31
  • 32.
    Questions? Now • Please shareany – Questions – Comments – Musings Later • Contact me – Email: zackdumont@me.com – Twitter: @ZackDumontYQR – LinkedIn: /ZackDumont 22 March 2021 32
  • 33.
    Audience Q&A • Zack’sanswer – Well, where to begin? He received/took quite a few medications throughout this pandemic (eg, hydroxychloroquine). If speaking specifically about his hospitalization, however, we might be able to pin it down to a couple/several: dexamethasone, remdesivir, and REGN-COV2 monoclonal antibody. – Dexamethasone is a corticosteroid that’s been around for quite some time. It’s not magic, but of all the interventions, it’ll probably be one sticks. It’s quite effective at knocking out inflammation. Why doesn’t it get much attention? It’s been around long enough that it’s been genericized and, therefore, there aren’t shareholders standing to make much gain. – Remdesivir, or Veklury®, is the anti-malarial that was re-purposed to supposedly work for COVID. It’s showed a bit of benefit in studies, but also some neutral and negative findings. Why this can happen with studies: the drug probably doesn’t do much, if anything, but if you study it enough times it will on occasion – due purely to random chance – show a benefit in one study. One study might be all you need to market your medication. – The REGN-COV2 monoclonal antibody (Regeneron®) will probably stick around, too. It’s not quite this simple, but one possible explanation of how it works: while a vaccine is given to trick your body into thinking an infective agent is present and then developing endogenous (from within) antibodies, this medication is a short-cut and just gives you the antibodies (usually copied from someone who’s had COVID) 22 March 2021 33 • Question – What drug was given to Trump?
  • 34.
    Audience Q&A • Zack’sanswer – My gut instinct says ‘no’, but I don’t like relying on my “feelings”, so if it was (created in a lab) all I can say is that there could be massive implications. But, from a politically agnostic perspective, it doesn’t matter. Pardon my curtness. It doesn’t matter if it did or not because this could have happened – and eventually would have happened – naturally. In addition, the idea shares characteristics with conspiracy theories, which are almost always untrue purely because they would be too difficult to orchestrate. 22 March 2021 34 • Question – What is your view on the potential that COVID came from a lab?
  • 35.
    Audience Q&A • Zack’sanswer – Great question. In short, I think it’s a net problem. But there are pros and cons. Most formularies are responsible for a particular geographical area or population; so, a formulary can be a bit more nimble and responsive to a specific population. An overly simplistic example: in an area where there’s a higher elderly population, they might dedicate more resources to covering medications for seniors. The threat that probably immediately comes to mind is that transferability is immediately compromised; so, as soon as someone moves to another jurisdiction without coverage then they’re scrambling to change therapies. At the same time, a big single formulary is possible, and just needs to be developed with higher levels of detail. It should be sought-after over the long-term. We’re fortunate in Canada to have CADTH (the Canadian Agency for Drugs and Technology in Health) to help coordinate the many formularies. Patience is required, no doubt. It’s been around for a few decades and the ecosystem it works within is still very very far away from realizing the power and economy of scale from having a single formulary. 22 March 2021 35 • Question – How much of a problem is it having so many formularies?
  • 36.
    Audience Q&A • Zack’sanswer – You’ve probably heard (Spider-Man’s) Uncle Ben’s saying: with great power comes great responsibility? Well… that doesn’t fit here… at all. Instead, this situation is probably best quoted with something like: with low expectations comes low exertion. Bottom-line is that research doesn’t have to be conducted well because it has nearly the same impact independent of its rigour. A study can and will be marketed easily, even if poorly-conducted. A study can and will face change intolerance, even if well-conducted. It’s such a paradox; everything changes, yet everything stays the same. For every person that adopts drugs too early and based on poor research, there’s nearly one-to-one someone who refuses to budge even if the research is great. So, there’s perhaps not much impetus. – The second, and perhaps more charitable reason: good intentions (you can probably think of a saying about good intentions, too ;) ). But, to be fair, educated people are under intense pressure from patients and society to fix things. To fix everything… and to fix it yesterday. This causes interventions to progress through the research stages too quickly: a theory is tested in a lab, and before it even gets a chance to get outside, someone learns about the theory and starts trialing it in certain patients, and before it gets a chance to prove whether or not it works in patients, someone finds out about it and is writing it into a guidelines, maybe simply because they know an expert who believes it… and so on, and so on. – There is a number of other reasons that we just can’t get into: publication quotas for academics, decentralized study conduct, uncoordinated endeavours, competing interests, politics, stigma, etc, etc, etc 22 March 2021 36 • Question – How do so many poor studies get run, despite that researchers should be educated in proper study design?