Introducing New Techniques and New Technologies: Role of the BOA Code of Ethics Gordon Bannister Professor of Orthopaedic Surgery University of Bristol

Need for New Techniques and Technologies in Joint Replacement Patient eg cup wear and fixation in young THR Company extends portfolio Surgeon wishes to develop concept Most innovations no better than predecessors: Some much worse

New Techniques and Technologies Narrow Window of Opportunity: Heavy Price for failure Total knee replacements are very similar Cemented THR better than uncemented Exeter stem better than modern Charnley Cemented Charnley cup best Takes 15 years to establish true outcome 3M Capital hip and ASR withdrawn

Revision after Hip Replacement

Can you really do better? Charnley mm LFA 12% revision at 15 years

Innovation in THR 62 THR systems 19 companies Published outcomes on 30% Murray and Bulstrode 1995

Innovation in THR >600 combinations of hip prostheses Bristol Arthroplasty Register 2010

Ethics of Innovation in THR Clear unmet patient need Rigorous appraisal of hypothesis Impeccable trial design

Background of Innovation Background of Innovation Before 2005 Before 2005 Central research funding restricted in surgery Surgeons and Companies cooperated Companies paid surgeons in cash or kind Kind = Materials, labs, staff, Fellows, education 29.5% AAOS revenue from industry

Background of Payment Background of Payment 2005 Christopher Christie, Attorney New Jersey alleged ‘many orthopaedic surgeons … choose which device to implant by going to the highest bidder’ New York Times 19/9/2010

Background of Payments in USA Background of Payments in USA Payments not all for bona fide research

Background of Payments in USA Background of Payments in USA Consultancy agreements for questionable work Royalties without transfer of intellectual property Royalties without transfer of intellectual property Trips to luxury resorts Payments for using specific implants

Background of Payments in Europe Background of Payments in Europe Greece 2009 Former Vice President of De Puy convicted

Action in USA Deferred prosecutions of companies Settlements of $310,000,000 by industry Sunshine Act 2009

Industry Payments in USA 2007 $207,000,000 to 1693 surgeons 2007 $207,000,000 to 1693 surgeons 2008 $105,000,000 to 628 surgeons List of recipients published

Guide to Professionalism and Ethics in the Practice of Orthopaedic Surgery pages

Knowingly negotiating for more funding than is appropriate to support the project and related institutional and departmental overhead costs; A researcher’s selling or purchasing stock in a company whose orthopaedic device is being tested by that orthopaedic surgeon-researcher; A researcher’s receiving financial incentives to alter data; A researcher’s receiving excessive remuneration by the funding corporation for evaluating that corporation’s products; A failure to disclose research or consulting arrangements with the funding corporation when reporting about research on devices manufactured by that corporation. Examples of unethical conduct:

BOA Code of Ethics Follows on the Bribery Act 2011 Draws heavily on AAOS Guide

BOA Code of Ethics: Governance > Innovation Conflict of Interest Consultancy Agreements RoyaltiesDisclosureEducation Meetings organised by Industry Presentation /Publication Research

Conflict of Interest Must be declared to patients Reasonable alternatives must be offered 2 nd opinion of clinician without Conflict Financial interest must be declared

Consultancy Agreements and Royalties Compensation appropriate for work done Payment not related to personal use of device

Disclosure Remote from hospital purchasing decisions Disclosure when ordering company devices

Education No funding for CME accredited events unless part of fellowship or bursary

Meetings organised by Industry No funding unless approved by base hospital

Research Finders fees not permitted All projects to be reviewed by Ethics committee Declaration of Interest on presentation Declaration of Interest on publication

Strengths of BOA Code of Practice Ethos of Transparency Defines acceptable commercial practice

Potential for Greater Strength Ensuring compliance Informed Ethical Review Advice on hypothesis and study design

Role of the BOA Code of Ethics: Conclusion Good initial framework Compliance needs to be encouraged Primum non nocere Ethic of innovation is good quality research