ethics, business, innovation - advamed · 2016-08-11 · title: australian orthopaedic association...
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Ethics, Business, Innovation
Andreas Loefler Adrian Cosenza
Australia
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Collective Aims • Promote innovation
– New drugs – New devices
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Collective Aims • Promote innovation
– New drugs – New devices
• Patient safety – Provide a benefit – Do no harm
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Collective Aims • Promote innovation
– New drugs – New devices
• Patient safety – Provide a benefit – Do no harm
• Keep the trust – of patients – of community
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Specific Objectives • Companies
– Need profits – Answerable to shareholders – Need clinical outcomes – Need doctors to prescribe
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Specific Objectives • Companies
– Need profits – Answerable to shareholders – Need clinical outcomes – Need doctors to prescribe
• Doctors – Need patients – Want good outcomes
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Specific Objectives • Companies
– Need profits – Answerable to shareholders – Need clinical outcomes – Need doctors to prescribe
• Doctors – Need patients – Want good outcomes – Want good incomes
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Specific Objectives • Governments
– Provide health care – Encourage business – Regulate industry
• Safety • Transparency
– Control costs
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Company Perspective • New product • Needs safety
– Preclinical testing – Regulatory approval
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Company Perspective • New product • Needs safety
– Preclinical testing – Regulatory approval – Clinical trials – Clinical papers
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Company Perspective • New product • Needs safety
– Preclinical testing – Regulatory approval – Clinical trials – Clinical papers
• Need sales
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Company Perspective • New product • Needs safety
– Preclinical testing – Regulatory approval – Clinical trials – Clinical papers
• Need sales • Target doctors
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Doctors’ Perspective • Well trained and skeptical • Treat patients • Enjoy trust in the community • Believes in the New
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Doctors’ Perspective • Well trained and skeptical • Treat patients • Enjoy trust in the community • Believes in the New (Techno Optimism)
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Doctors’ Perspective • Well trained and skeptical • Treat patients • Enjoy trust in the community • Believes in the New (Techno Optimism)
– Better – Quicker – Safer
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Doctors’ Perspective • Well trained and skeptical • Treat patients • Enjoy trust in the community • Believes in the New (Techno Optimism)
– Better – Quicker – Safer – But unproven
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Incentives • Direct payments • Royalties and consultancies • Educational support • Overseas trips • Wining and dining • Tickets to rugby games
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Three Parties • Unusual business model
– Company markets the product – Doctors choose the product – Governments pay for the product
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Three Parties • Unusual business model
– Company markets the product – Doctors choose the product – Governments pay for the product
• Educated players – Sophisticated industry – Highly trained doctors – Specialized government departments
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Ethical Problems • Drugs or devices untested • Informed consent with hope • Payments undisclosed • Cost of the New is usually high • Advertisements overstated
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Ethical Problems • Drugs or devices untested • Informed consent with hope • Payments undisclosed • Cost of the New is usually high • Advertisements overstated Lack Science Use Testimonials
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Better Way • Company approaches institution • No direct payments to doctors • Randomized Controlled Trial • Minimum 2 year follow up • Independent assessment • Peer reviewed publication
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Registries • AOA National Joint Replacement Registry
– Captures all hip and knee replacements – Cooperation of surgeons, hospitals, industry – Government funded – Surgeon owned – Post market surveillance – Long term outcomes
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Registries • Other registries
– Anterior Cruciate Ligament – Cardiac stents – Breast implants, etc.
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Codes of Conduct • Australian Orthopaedic Association
– Position Statement on Interaction with Medical Industry
• Royal Australasian College of Surgeons • Australian Medical Association • Medical Board of Australia • Medical Technology Association Australia • State and National Legislation
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Interaction with Industry • AOA Position Statement spells out
– To act in the patients best interest – To avoid commercial persuasion – To disclose financial interests – To acknowledge sponsorship – To refuse gifts
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Interaction with Industry • MTAA Code stipulates
– What companies can and cannot do – How to interact with surgeons
• AOA requires MTAA compliance • Regular discussion and cooperation • Arms length funding of projects
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Legislation • Illegal under Medical Board
– To create unrealistic expectation – To use testimonials
• Corporations Act – Directors to act honestly
• Crimes Act – Offence to bribe a public official
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Legislation • Illegal under Medical Board
– To create unrealistic expectation – To use testimonials
• Corporations Act – Directors to act honestly
• Crimes Act – Offence to bribe a public official
(The Brown Paper Bag)
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International Code • Global trade
– Same pathology – Converging medical practice
• Companies – Multinationals have legal departments – Smaller companies need help
• Governments – Lobby for business
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International Code • Global trade
– Same pathology – Converging medical practice
• Companies – Multinationals have legal departments – Smaller companies need help
• Governments – Lobby for business – Lobby for patients and for ethical practice
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Thank you.