Inside the World of Medical Evidence

1. Inside the World of Medical Evidence Joan Young

2. Inside the World of Medical Evidence Agenda • My Background • What is medical evidence and why does it matter • Five-part process, illustrated • Future of medical evidence • Take-home questions

3. Inside the World of Medical Evidence Background • Co-investigator of a clinical survey • Participated in medical research projects leading to 3 journal articles • Part of a team that developed medical practice guidelines • Testified at an FDA drug hearing • Wrote two journal articles based on my experiences • Wrote a chapter for a medical textbook • Became a member of the American Society of Hematology • Associate editor of the International Journal of User-Driven Healthcare • Reviewed research protocols for the National Institutes of Health • Reviewed and wrote hundreds of medical research articles for the public • Worked for several pharmaceutical companies

4. Inside the World of Medical Evidence One Definition “…the use of mathematical estimates of the risk of benefit and harm, derived from high-quality research on population samples, to inform clinical decision-making in the diagnosis, investigation or management of individual patients." Greenhalgh, Trisha. How To Read a Paper: The Basics of Evidence-Based Medicine. Wiley-Blackwell, fourth edition, 2010, p. 1.

5. Inside the World of Medical Evidence Why do we care? • FDA approvals are based on medical evidence • Practice guidelines are based on medical evidence • Medical recommendations are based on medical evidence • Medical evidence is used to justify medical opinions • Evidence-based medicine is the gold standard for classically trained physicians

6. Inside the World of Medical Evidence Levels of Evidence http://www.emeraldinsight.com/content_images/fig/2400370406003.png

7. Inside the World of Medical Evidence Process Researchers • Decide and do research • Write an article about the research • Publish the research Physicians/Patients • Find the research • Apply the research

8. Inside the World of Medical Evidence Researchers - Decide and do research • Grant opportunities • Promotion opportunities • Professional visibility/acceptance • Faculty/Academic direction • Industry directive/incentive • Personal interest

9. Inside the World of Medical Evidence Researchers - Decide and do research “In fact, the four labs that tested Tritan [plastic containing BPA] for the peer-reviewed paper in the Elsevier journal received funding from Eastman that was not publicly disclosed. Also not reported by Eastman's marketing materials or the paper: The lead author of the study, who analyzed the data from the four labs, was paid by Eastman for that work.” Begley S. “Insight: Science for hire - Trial over plastic exposes disclosure deficit.” Reuters. Jul 18, 2013 http://www.reuters.com/article/2013/07/18/us-science-eastmanchemical-insight-idUSBRE96H05020130718

10. Inside the World of Medical Evidence Researchers - Decide and do research My experience

11. Inside the World of Medical Evidence Researchers – Write an article about the research “An analysis of nearly 600 registered clinical trials published online October 29 in BMJ has shown that 29% remained unpublished 5 years after completion, that no results were available in ClinicalTrials.gov for three fourths of those unpublished trials, and that industry-funded trials were nearly twice as likely to go unreported as studies that had not received industry funding.” Kelly JC. “Randomized Clinical Trials: 1 in 3 Not Reported.: Medscape Medical News. Oct 29, 2013 http://www.medscape.com/viewarticle/813447

12. Inside the World of Medical Evidence Researchers - Write an article about the research My experience

13. Inside the World of Medical Evidence Researchers – Publish the research “…emphasizing that research is considered especially important if it is published in one of a few historically influential journals — Cell, Nature, Science— could be a laudable attempt to get scientists to think ambitiously about their research goals. But it can also result in excessive pressure to publish big claims, leading to problems of irreproducibility, for example.” “The maze of impact metrics.” Nature. Oct 21 2013 http://www.nature.com/news/the-maze-of-impact-metrics-1.13952?WT.ec_id=NATURE-20131017

14. Inside the World of Medical Evidence Researchers – Publish the research My experience

15. Inside the World of Medical Evidence Physician/patients – Find the research Pubmed - www.pubmed.com Medscape - www.medscape.com Green Med Info - www.greenmedinfo.com NEJM Journal Watch - www.jwatch.org Clinical Trials - www.clinicaltrials.gov Government agencies – FDA/NIEHS/NIH institutes Medical Journal Indexes

16. Inside the World of Medical Evidence Physician/patients – Find the research My experience

17. Inside the World of Medical Evidence Physicians/Patients- Apply the research “Among 357 recommendations in 17 guidelines issued between 2005 and 2011, 121 (34%) combined a strong recommendation with low-quality evidence…the authors found 33 instances in which no compelling justification for a strong-recommendation/low-evidence guideline existed. In a second study, researchers reviewed 169 guidelines on prostate, lung, breast, and colorectal cancer published between 2005 and 2010…On average, guidelines fulfilled only 2.75 of the 8 standards.” Brett AS. “Clinical Practice Guidelines Require Scrutiny for Quality.” Journal Watch. Sep 26 2013. http://www.jwatch.org/na32275/2013/09/26/clinical-practice-guidelines-require-scrutiny-quality

18. Inside the World of Medical Evidence Physician/patients – Apply the research “Scientists reviewed each issue of The New England Journal of Medicine from 2001 through 2010 and found 363 studies examining an established clinical practice. In 146 of them, the currently used drug or procedure was found to be either no better, or even worse, than the one previously used…More than 40 percent of established practices studied were found to be ineffective or harmful, 38 percent beneficial, and the remaining 22 percent unknown.” Bakalar N. “Medical Procedures May Be Useless, or Worse.” New York Times. 2013 jul26 http://well.blogs.nytimes.com/2013/07/26/medical-procedures-may-be-useless-or-worse/ Vinay Prasad, MD et al. “A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices.” Mayo Clin Proc. 2013 August;88(8):790-798. http://download.journals.elsevierhealth.com/pdfs/journals/0025-196/PIIS0025619613004059.pdf

19. Inside the World of Medical Evidence Physicians/patients – Apply the research “This demand for evidence to draw conclusions and inferences is often a trap that many of us fall into. Not always. Don't we know of so [many examples of medical evidence] that are sitting on the shelf and yet have not led to or been implemented in the form of progressive changes in policy? The road from generating evidence through research to improving human situation in the form of reducing injustice or inequity is so long. “ MD in India

20. Inside the World of Medical Evidence Physician/patients– Apply the research My experience

21. Inside the World of Medical Evidence Future of Medical Evidence • Comparative effectiveness • Personalized medicine • Publish all results • Open access publishing • More targeted clinical trials • Sunshine laws • Patient education

22. Inside the World of Medical Evidence Take-home Questions What kind of study is it? Who funded the study? Who wrote it? What are the other studies on the subject, including those in the past? Do the authors have a financial incentive/disincentive? What does the package insert say? Does the informed consent include everything? Did you get a second opinion?

23. Inside the World of Medical Evidence Medical Evidence Crusaders Dr. John Ioannidis Freedman D. “Lies, Damned Lies, and Medical Science.” Atlantic Magazine. Nov. 2010. http://www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medical-science/8269/ Bob Goldacre (UK) Book: Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients www.badscience.net http://www.ted.com/talks/ben_goldacre_battling_bad_science.html

24. Inside the World of Medical Evidence Book - Wish by Spirit : A journey of recovery and healing from an autoimmune blood disease Web - www.JoanYoungWrites.com Facebook - JoanYoungWrites