introducing new techniques and new technologies: role of the boa code of ethics gordon bannister...
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Introducing New Techniques Introducing New Techniques and New Technologies:and New Technologies:
Role of the BOA Code of Role of the BOA Code of EthicsEthics
Gordon BannisterGordon Bannister
Professor of Orthopaedic SurgeryProfessor of Orthopaedic Surgery
University of BristolUniversity of Bristol
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Need for New Techniques and Need for New Techniques and Technologies in Joint ReplacementTechnologies in Joint Replacement
Patient eg cup wear and fixation in young THRPatient eg cup wear and fixation in young THRCompany extends portfolioCompany extends portfolio
Surgeon wishes to develop conceptSurgeon wishes to develop concept
Most innovations no better than predecessors:Most innovations no better than predecessors:Some much worseSome much worse
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New Techniques and New Techniques and TechnologiesTechnologies
Narrow Window of Opportunity:Narrow Window of Opportunity:Heavy Price for failureHeavy Price for failure
Total knee replacements are very similarTotal knee replacements are very similar
Cemented THR better than uncementedCemented THR better than uncemented
Exeter stemExeter stem better than modern Charnley better than modern Charnley
Cemented Charnley cup bestCemented Charnley cup best
Takes 15 years to establish true outcomeTakes 15 years to establish true outcome
3M Capital hip and ASR withdrawn3M Capital hip and ASR withdrawn
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Revision after Hip ReplacementRevision after Hip Replacement
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Can you really do better?Can you really do better?
Charnley 22.25 mm Charnley 22.25 mm LFALFA
12% revision at 15 years
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Innovation in THRInnovation in THR
62 THR systems62 THR systems
19 companies19 companies
Published outcomes on 30% Published outcomes on 30%
Murray and Bulstrode 1995Murray and Bulstrode 1995
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Innovation in THRInnovation in THR
>600 combinations of hip prostheses>600 combinations of hip prostheses
Bristol Arthroplasty Register 2010Bristol Arthroplasty Register 2010
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Ethics of Innovation in THREthics of Innovation in THR
Clear unmet patient needClear unmet patient need
Rigorous appraisal of hypothesisRigorous appraisal of hypothesis
Impeccable trial designImpeccable trial design
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Background of Innovation Background of Innovation
Before 2005Before 2005
Central research funding restricted in surgeryCentral research funding restricted in surgery
Surgeons and Companies cooperatedSurgeons and Companies cooperated
Companies paid surgeons in cash or kindCompanies paid surgeons in cash or kind
Kind = Materials, labs, staff, Fellows, Kind = Materials, labs, staff, Fellows, educationeducation
29.5% AAOS revenue from industry29.5% AAOS revenue from industry
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Background of PaymentBackground of Payment
2005 Christopher Christie, Attorney New Jersey2005 Christopher Christie, Attorney New Jersey
alleged alleged
‘‘many orthopaedic surgeons … choose which many orthopaedic surgeons … choose which device to implant by going to the highest bidder’device to implant by going to the highest bidder’
New York Times 19/9/2010New York Times 19/9/2010
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Background of Payments in Background of Payments in USAUSA
Payments not all for bona fide researchPayments not all for bona fide research
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Background of Payments in Background of Payments in USAUSA
Consultancy agreements for questionable workConsultancy agreements for questionable work
Royalties without transfer of intellectual Royalties without transfer of intellectual propertyproperty
Trips to luxury resortsTrips to luxury resorts
Payments for using specific implantsPayments for using specific implants
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Background of Payments in Background of Payments in EuropeEurope
GreeceGreece
2009 Former Vice President of De Puy 2009 Former Vice President of De Puy convictedconvicted
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Action in USAAction in USA
Deferred prosecutions of companiesDeferred prosecutions of companies
Settlements of $310,000,000 by Settlements of $310,000,000 by industryindustry
Sunshine Act 2009Sunshine Act 2009
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Industry Payments in USAIndustry Payments in USA
2007 $207,000,000 to 1693 2007 $207,000,000 to 1693 surgeons surgeons
2008 $105,000,000 to 628 surgeons2008 $105,000,000 to 628 surgeons
List of recipients publishedList of recipients published
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Guide toGuide toProfessionalism andProfessionalism and
Ethics in the Practice ofEthics in the Practice ofOrthopaedic SurgeryOrthopaedic Surgery
20112011161 pages161 pages
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Knowingly negotiating for more funding than is appropriate to support the projectand related institutional and departmental overhead costs;• A researcher’s selling or purchasing stock in a company whose orthopaedicdevice 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 forevaluating that corporation’s products;• A failure to disclose research or consulting arrangements with the fundingcorporation when reporting about research on devices manufactured by thatcorporation.
Examples of unethical Examples of unethical conduct:conduct:
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BOA Code of EthicsBOA Code of Ethics
Follows on the Bribery Act 2011Follows on the Bribery Act 2011
Draws heavily on AAOS GuideDraws heavily on AAOS Guide
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BOA Code of Ethics:BOA Code of Ethics:Governance > InnovationGovernance > Innovation
Conflict of InterestConflict of Interest
Consultancy AgreementsConsultancy Agreements
RoyaltiesRoyalties
DisclosureDisclosure
EducationEducation
Meetings organised by IndustryMeetings organised by Industry
Presentation /PublicationPresentation /Publication
ResearchResearch
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Conflict of InterestConflict of Interest
Must be declared to patientsMust be declared to patients
Reasonable alternatives must be offeredReasonable alternatives must be offered
22ndnd opinion of clinician without Conflict opinion of clinician without Conflict
Financial interest must be declared Financial interest must be declared
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Consultancy Agreements and Consultancy Agreements and RoyaltiesRoyalties
Compensation appropriate for work doneCompensation appropriate for work done
Payment not related to personal use of Payment not related to personal use of devicedevice
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DisclosureDisclosure
Remote from hospital purchasing Remote from hospital purchasing decisionsdecisions
Disclosure when ordering company Disclosure when ordering company devices devices
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EducationEducation
No funding for CME accredited events No funding for CME accredited events unless part of fellowship or bursary unless part of fellowship or bursary
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Meetings organised by Meetings organised by IndustryIndustry
No funding unless approved by base No funding unless approved by base hospitalhospital
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ResearchResearch
Finders fees not permittedFinders fees not permitted
All projects to be reviewed by Ethics All projects to be reviewed by Ethics committeecommittee
Declaration of Interest on presentation Declaration of Interest on presentation
Declaration of Interest on publicationDeclaration of Interest on publication
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Strengths of BOA Code of Strengths of BOA Code of PracticePractice
Ethos of TransparencyEthos of Transparency
Defines acceptable commercial Defines acceptable commercial practicepractice
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Potential for Greater Potential for Greater Strength Strength
Ensuring complianceEnsuring compliance
Informed Ethical ReviewInformed Ethical Review
Advice on hypothesis and study designAdvice on hypothesis and study design
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Role of the BOA Code of Role of the BOA Code of Ethics:Ethics:
ConclusionConclusion
Good initial frameworkGood initial framework
Compliance needs to be encouragedCompliance needs to be encouraged
Primum non nocerePrimum non nocere
Ethic of innovation is good quality Ethic of innovation is good quality researchresearch