Financial Conflicts of Financial Conflicts of Interest in Biomedical Interest in Biomedical

ResearchResearchProject FindingsProject Findings

Josephine JohnstonJosephine JohnstonThe Hastings CenterThe Hastings CenterGarrison, New YorkGarrison, New York

Project PurposeProject Purpose

• Review nature and extent of Review nature and extent of financial conflicts of interestfinancial conflicts of interest

• Consider existing rules and Consider existing rules and guidelinesguidelines

• Compare with other Compare with other professionsprofessions

• Isolate areas of concern in Isolate areas of concern in present managementpresent management

• Recommend changesRecommend changes

PrevalencePrevalence

Financial interests are Financial interests are pervasivepervasive

• Individual researchersIndividual researchers– 1/3 have ties to industry

• Research Institutions Research Institutions – Equity in companies

sponsoring research

Benefits of Financial Benefits of Financial InterestsInterests

• Benefits – knowledge Benefits – knowledge transfer, additional transfer, additional finances. finances.

We focused on the risksWe focused on the risks• Financial interests can Financial interests can

conflict with other conflict with other interests or dutiesinterests or duties

Conflicting Conflicting InterestsInterests

• Conflict of primary and Conflict of primary and secondary interests – secondary interests – actual or apparentactual or apparent

• Term = description of Term = description of situationsituation

≠ ≠ moral judgmentmoral judgment• ““Yellow flag”Yellow flag”

Risks Risks

““Human nature” creates risks:Human nature” creates risks:• BiasBias• Carelessness Carelessness • SecrecySecrecy• Delay in publicationDelay in publication• Loss of public interest Loss of public interest

scientistsscientists• Loss of public trustLoss of public trust

QuestionsQuestions

• What do about these What do about these situations?situations?

• What must be preserved What must be preserved and protected?and protected?

• Which mechanisms Which mechanisms already work well?already work well?

• What new measures are What new measures are necessary?necessary?

Existing Rules and Existing Rules and GuidelinesGuidelines

• Institutions, professional Institutions, professional societies, federal societies, federal regulations, journals. regulations, journals.

• Complex, variable, Complex, variable, misunderstood, misunderstood, resented, avoided, resented, avoided, relaxed, not enforced.relaxed, not enforced.

• Over-reliance on Over-reliance on disclosure.disclosure.

RecommendationRecommendation

Changes to existing rulesChanges to existing rules• SimplificationSimplification• UnificationUnification• Education Education • EnforcementEnforcement

Existing CultureExisting Culture

• Lack of understanding of Lack of understanding of risks of financial risks of financial interestsinterests

• Lack of support for rulesLack of support for rules• ResentmentResentment• Comparison with other Comparison with other

professionsprofessions

RecommendationRecommendation

Promote recognition of thePromote recognition of the

problem through:problem through:• EducationEducation• Professional discussionProfessional discussion

Aim for:Aim for:• ““Buy in”Buy in”• Culture of embarrassmentCulture of embarrassment

Other Other RecommendationsRecommendations

• Firewalls to separate research Firewalls to separate research and finance.and finance.

• Support public clinical trials Support public clinical trials registry.registry.

• Presumption against conflicted Presumption against conflicted investigators in human subject investigators in human subject research (AAMC).research (AAMC).

• Reduce reliance on disclosure.Reduce reliance on disclosure.• Publicize best practices.Publicize best practices.• Continue public discussion.Continue public discussion.