Introducing New Techniques and New Technologies: Role of the BOA Code of Ethics

1
Introducing New Techniques and New
TechnologiesRole of the BOA Code of Ethics

• Gordon Bannister
• Professor of Orthopaedic Surgery
• University of Bristol

2
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

3
New Techniques and TechnologiesNarrow Window of
OpportunityHeavy 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• 3M Capital hip and ASR withdrawn

4
Revision after Hip Replacement
5

Can you really do better?
Charnley 22.25 mm LFA
12 revision at 15 years
6
Innovation in THR

• 62 THR systems
• 19 companies
• Published outcomes on 30
• Murray and Bulstrode 1995

7
Innovation in THR

• gt600 combinations of hip prostheses
• Bristol Arthroplasty Register 2010

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Ethics of Innovation in THR

• Clear unmet patient need
• Rigorous appraisal of hypothesis
• Impeccable trial design

9
Background of Innovation

• 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

10
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

11
Background of Payments in USA

• Payments not all for bona fide research

12
Background of Payments in USA

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

13
Background of Payments in Europe

• Greece
• 2009 Former Vice President of De Puy convicted

14
Action in USA

• Deferred prosecutions of companies
• Settlements of 310,000,000 by industry
• Sunshine Act 2009

15
Industry Payments in USA

• 2007 207,000,000 to 1693 surgeons
• 2008 105,000,000 to 628 surgeons
• List of recipients published

16

• Guide to
• Professionalism and
• Ethics in the Practice of
• Orthopaedic Surgery
• 2011
• 161 pages

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Examples of unethical conduct
Knowingly negotiating for more funding than is
appropriate to support the project and related
institutional and departmental overhead costs
A researchers selling or purchasing stock in a
company whose orthopaedic device is being tested
by that orthopaedic surgeon-researcher A
researchers receiving financial incentives to
alter data A researchers receiving excessive
remuneration by the funding corporation
for evaluating that corporations products A
failure to disclose research or consulting
arrangements with the funding corporation when
reporting about research on devices manufactured
by that corporation.
18
BOA Code of Ethics

• Follows on the Bribery Act 2011
• Draws heavily on AAOS Guide

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BOA Code of EthicsGovernance gt Innovation

• Conflict of Interest
• Consultancy Agreements
• Royalties
• Disclosure
• Education
• Meetings organised by Industry
• Presentation /Publication
• Research

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Conflict of Interest

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

21
Consultancy Agreements and Royalties

• Compensation appropriate for work done
• Payment not related to personal use of device

22
Disclosure

• Remote from hospital purchasing decisions
• Disclosure when ordering company devices

23
Education

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

24
Meetings organised by Industry

• No funding unless approved by base hospital

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Research

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

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Strengths of BOA Code of Practice

• Ethos of Transparency
• Defines acceptable commercial practice

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Potential for Greater Strength

• Ensuring compliance
• Informed Ethical Review
• Advice on hypothesis and study design

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Role of the BOA Code of EthicsConclusion

• Good initial framework
• Compliance needs to be encouraged
• Primum non nocere
• Ethic of innovation is good quality research