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- The Origins of Modern Clinical Research
Green SA, Clin. Orthop. 405:311-319, 2002
- Orthopaedic Surgeons: Inheritors of Tradition
Green SA, Clin. Orthop. 363:258-263, 1999
- The Evolution of Medical Technology
Green SA, Clin. Orthop. 385:260-266, 2001
The Placebo Value of Ritual Green SA, Clin. Orthop. 450:249-256, 2006
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SLIDE 4 The Evolution of Medical Technology: Lessons from the Burgess Shale
- Clin. Orthop. 385:260-6, 2001
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S.J.Gould
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Profit motive
Short follow-up
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Developer Enthusiasm
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Developer Enthusiasm Distortion of Preliminary Data
SLIDE 27 Developer Enthusiasm Distortion of Preliminary Data
- Eliminate earliest cases (“learning curve”)
SLIDE 28 Developer Enthusiasm Distortion of Preliminary Data
- Eliminate earliest cases (“learning curve”)
- Use subjective outcome criteria
SLIDE 29 Developer Enthusiasm Distortion of Preliminary Data
- Eliminate earliest cases (“learning curve”)
- Use subjective outcome criteria
- Short follow-up
SLIDE 30 Developer Enthusiasm Distortion of Preliminary Data
- Eliminate earliest cases (“learning curve”)
- Use subjective outcome criteria
- Short follow-up
- Bad outcomes are “lost to follow-up”
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SLIDE 33 Number of Articles 10 20 30 40 50 60 68-70 71-73 74-76 77-79 80-82 83-85 86-88 89-91 92-94 95-97
SLIDE 34 “…we can expect all the earliest reports of a new design to be glowing and written by the designers and champions. When the longer-term empiric outcomes are less-than- rosy, the next wave of reports is written by individuals who are more objective because they are not directly linked to the design.”
Engh, CA: Pioneering in the First Century of Hip Replacement: Experiences of a Surgeon-Designer. Clin Orthop, 407, 35-49, 2003
“Because surgeons sell to other surgeons best, companies need surgeon champions who truly believe in the features of their products.”
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NONE
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How did the U. S. Government get involved in regulating medical devices?
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Hypothesis 1: Government regulatory involvement is usually scandal driven.
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Hypothesis 2: Magnitude of government regulations is directly proportional to the scandalʼs volume.
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Hypothesis 3: The scandalʼs volume is directly proportional to the body count.
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1862 scandal: Civil War dead from malnutrition & starvation Bureau of Chemistry within Department of Agriculture. Body Count = 10,000s
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Scandal: Tainted Armour canned meat to U.S. Army during Spanish American War (1898-99) Body Count: Dozens
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Body Count = 108
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Body Count = 20,000
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United States vs ...Bacto-Unidisk
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1969: Environmental Protection Agency 1972: Occupational Safety and Health Administration 1972: Consumer Product Safety Commission
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1976: Medical Device Amendments Body Count = 2,100,000
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SLIDE 53 Body Count = 17,000
Congressman Henry Waxman, 1989
Civil penalties for underreporting adverse events during trials
“The American device industry cannot be trusted” Congressman Waxman
Piggybacked
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Body Count = 24,000
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The FDA and the Medical Device Marketplace
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SLIDE 73 *Annuloplasty Ring *Automatic Implantable Cardioverter Defibrillator *Cardiovascular Permanent Pacemaker Electrode (Lead) *Coronary Vascular Stent *Implantable Pacemaker Pulse Generator *Implanted Diaphragmatic/Phrenic Nerve Stimulator *Replacement Heart Valve *Total Artificial Heart *Tracheal Prosthesis *Vascular Graft Prosthesis (any diameter) *Ventricular Assist Device - Implant
SLIDE 74 *Glenoid Fossa Prosthesis *Implantable Infusion Pumps *Implanted Cerebellar Stimulators *Interarticular Disc Prosthesis (Interpositional Implant) *Mandibular Condyle Prosthesis *Total Temporomandibular Joint Prosthesis
SLIDE 75 Effective, February 19, 1998, manufacturers will no longer be automatically required to conduct postmarket surveillance studies... Rather, FDA may order such studies...for any device: *the failure of which would be reasonably likely to have serious adverse health consequences; or *which is intended to be implanted in the human body for more than one year
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SLIDE 77 Developer Enthusiasm Distortion of Preliminary Data
- Eliminate earliest cases (“learning curve”)
- Use subjective outcome criteria
- Short follow-up
- Bad outcomes are “lost to follow-up”
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71 patients
75% satisfactory results (25% unsatisfactory results) 32% Lost to follow-up
25% + 32% 57% unsatisfactory results
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SLIDE 82 This product is new; it has been tested according to FDA procedures and determined to be safe & effective. Unforeseen problems may become apparent with the passage of time that may limit the productʼs value or cause unexpected complications.
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- Dr. Thomas Bond
- Dr. Benjamin Franklin
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“I suspect there is more valuable knowledge
in Physic to be learnt from the honest candid Observations of an old Practitioner, who is past all desire of more Business, having made his Fortune…
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THE END
