5/10/2013 Dr. J.W. Scott ’ ’ ’ ’ s parabola Disclosures and the medical-industrial • Consultant Trimed Co • AO Foundation complex • Stock OHK Co • Research AO foundation • Reviewer Elsevier;Springer; Walter Klower • Editor Walter Klower • Committess AAHS;ASSH;AAOS • All images in presentation are my own I certify that, to the best of my knowledge, no aspect of my current personal or profession situation might reasonably be expected to affect significantly my views on the subject on which I am presenting. Jesse B Jupiter MD Hansjorg Wyss/AO Professor Harvard Med Scott ’ s Parabola The rise and fall of a new surgical technique Standard treatment Doubts creep in General Damaging survey reported Strong media introduction pressure Publicised medico-legal cases Condemned by several Widespread authorities Encouraging enthusiasm reports Ancient surgeons Promising amaze their juniors Operating staff ponder uses idea for large quantities of expensive with rollicking Possible value obsolete equipment as research tool stories of the old days Scott, J W BMJ 2001;323:1477 1
5/10/2013 Dr. J.W. Scott ’ ’ ’ ’ s parabola AO/ASIF Hand Study Group and the medical-industrial Distal Radius Plate complex Jesse B. Jupiter, MD Ueli Buchler, MD Jurg Brennauld, MD Hill Hastings, MD Scott ’ s Parabola The rise and fall of a new surgical technique Solution in the 1990’s • Precontoured but flexible design • Option of butttress pins anchored into plate • Recessed screw Encouraging holes reports Promising • Self tapping idea screws Possible value as research tool Scott, J W BMJ 2001;323:1477 2
5/10/2013 10 Scott ’ s Parabola Scott ’ s Parabola The rise and fall of a new surgical technique The rise and fall of a new surgical technique Standard Standard treatment treatment Doubts creep in General General Damaging survey reported Strong media introduction Strong media introduction pressure pressure Widespread Widespread Encouraging enthusiasm Encouraging enthusiasm reports reports Promising Promising idea idea Possible value Possible value as research tool as research tool Scott, J W BMJ 2001;323:1477 Scott, J W BMJ 2001;323:1477 3
5/10/2013 π Plate--problems • Design ?? • Metallurgy ?? Scott ’ s Parabola “ Emerging ” “ ” Orthopaedic Technologies “ “ ” ” The rise and fall of a new surgical technique Chymopapain disc injections Standard treatment • 7000 US surgeons “ • Pioneered by Dr. Lyman Smith “ trained ” “ “ ” ” ” Doubts creep in General Damaging survey reported • Complications – paraplegia, stroke Strong media introduction pressure Publicised medico-legal cases Condemned by several Widespread authorities Encouraging enthusiasm reports Ancient surgeons Promising amaze their juniors Operating staff ponder uses idea for large quantities of expensive with rollicking Possible value obsolete equipment as research tool stories of the old days Chymopapain 1986 Chymopapain 1984 Scott, J W BMJ 2001;323:1477 4
5/10/2013 “ original industry-sponsored trials “ “ “ OBJECTIVES …were remarkable for the complete clinical adverse events… ” absence of reported rhBMP-2–related • Examine existing problems with our “ …most cursory review shows that scientific studies drugs used in an off-label manner… ” ” ” ” this was all about devices and • Bring into focus the “medical-industrial “ …some clinical researchers in the complex” on health care ‘‘ market environment ’’ ‘‘ ‘‘ ‘‘ ’’ cannot be ’’ ’’ • Evaluate perspectives on our current relationships with industry and trusted to resist enormous financial reporting… ” ” ” ” forces that encourage biased research “ …our patients remain our number one “ “ “ priority.We need to fulfill their trust. ’’ ’’ ’’ ’’ OBJECTIVES Musculoskeletal Research System • Examine existing problems with our • Rewards positive results scientific studies • Little motivation to perform negative • Bring into focus the “medical-industrial studies or those that duplicate prior complex” on health care published results • Evaluate perspectives on our • “Positive” trials and “negative” trials relationships with industry and take the same amount of time to research conduct but “negative” trials take 2-4 years longer to be published 5
5/10/2013 Famous People ’ s Hip Musculoskeletal Research “Evidence-based Triad” vs “Orthopaedic Triad” Dr Freddie Fu • Combining best • Famous surgeon available evidence with • Famous athlete • Clinical expertise of Jimmy Jack the physician • Untested treatment • And the expectation and value of the patient Mary Lou Floyd Dr John P. Ioannidis Douglas Jackson MD Stanford’s Prevention Reseach Center Orthopaedics today, June 2012 • “ Reproducibility of published work is only occasionally challenged by knowledgable scientists and clinicians who work in the same field or by industry when it tries to duplicate results before proceding with product development” “ In contrast, successful venture capitalists will be more inclined to reproduce results by ‘In many different ways, much of what biomedical researchers independent observers before committing to conclude is misleading, early funding” exaggerated, and at times wrong’ 6
5/10/2013 Dr. John P. Ioannidis Dr. John P. Ioannidis Stanford David Freedman Lies, Damned Lies, and Medical Science The Atlantic 2012 • 2005 landmark paper in PLoS Medicine, demonstrated convincingly in # studies in • In randomized controlled trials, he found different fields of medical research it was easy to manipulate results at every step a) 80% of non-randomized turn out to be in room to distort results • error • make a stronger claim b) 25% randomized controlled trials also flawed • or select what is going to be concluded c) 10% of “platinum” large clinical trials flawed “Intellectual conflict of interest” Dr. John P. Ioannidis Dr. John P. Ioannidis Stanford Stanford randomized controlled trials-- range of errors David Freedman Lies, Damned Lies, and Medical Science JAMA 2005 The Atlantic 2012 • Studied 49 of most highly regarded research • What questions researchers asked findings in medicine over prior 13 yrs • How they set up the study • 45 claimed to have uncovered effective • Which patients were included interventions • Which measurements used • 34 had been retested with 14 or 41% shown to • How data analyzed be wrong or substantially exaggerated results • How results presented • How studies came to be published 7
5/10/2013 Dr. John P. Ioannidis OBJECTIVES Stanford • Examine existing problems with our David Freedman The Atlantic 2012 scientific studies • Notes that much of the wrongness problem could be • Bring into focus the “medical-industrial solved if the world simply stopped expecting scientists to be right. But as long as careers remain contingent on complex” on health care producing a stream of research that is dressed up to • Evaluate perspectives on our seem more right than it is, scientists will keep delivering exactly that relationships with industry and • “Science is a noble endeavor, but it is also a low-yield research endeavor. I’m not sure that more than a very small % of medical research is ever likely to lead to major improvements in clinical outcomes and quality of life. We should be very comfortable with that fact” The Medical Industrial Complex: Understanding the Business of Medicine The American Health Enterprise: Michael R. Mills, MD, MPH Power, Profits, and Politics February 2012 Graph 1: Escalation of healthcare costs as a percentage of GDP Barbara Ehrenreich • Among the first to introduce the term “medical-industrial complex” 8
5/10/2013 P resident Dwight D. Eisenhower P resident Dwight D. Eisenhower Farewell Address Jan 17, 1961 Farewell Address Jan 17, 1961 • Warned the nation of the risks of an emerging “military-industrial complex” • Growing dependence of universities and research labs for federal funds • Potentials to compromise researchers in their search for truth as well as reduce the “scholar” to an “obedient servant” Dr Michael Mills The Social Transformation of American Medicine Medical-Industrial Complex Paul Starr 1982 • Landmark study of the social and • 3 Trillion dollar economic development of medicine in industry America • One of fastest • Final chapter “The Coming of the growing business in Corporation” USA describes the new corporate • Interaction of MDs, transformation of the United States other providers, health care system and its growing hospitals, nursing Graph 2: Distribution of healthcare homes, insurance co., threat to the sovereignty of physicians pharma et al. expenditures in the UnitedStates, 2008 9
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