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

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

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3M Capital hip and ASR withdrawn3M Capital hip and ASR withdrawn

Revision after Hip ReplacementRevision after Hip Replacement

Can you really do better?Can you really do better?

Charnley 22.25 mm Charnley 22.25 mm LFALFA

12% revision at 15 years

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

Innovation in THRInnovation in THR

>600 combinations of hip prostheses>600 combinations of hip prostheses

Bristol Arthroplasty Register 2010Bristol Arthroplasty Register 2010

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

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

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

Background of Payments in Background of Payments in USAUSA

Payments not all for bona fide researchPayments not all for bona fide research

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

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

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

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

Guide toGuide toProfessionalism andProfessionalism and

Ethics in the Practice ofEthics in the Practice ofOrthopaedic SurgeryOrthopaedic Surgery

20112011161 pages161 pages

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:

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

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

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

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

DisclosureDisclosure

Remote from hospital purchasing Remote from hospital purchasing decisionsdecisions

Disclosure when ordering company Disclosure when ordering company devices devices

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

Meetings organised by Meetings organised by IndustryIndustry

No funding unless approved by base No funding unless approved by base hospitalhospital

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

Strengths of BOA Code of Strengths of BOA Code of PracticePractice

Ethos of TransparencyEthos of Transparency

Defines acceptable commercial Defines acceptable commercial practicepractice

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

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