Ethical Issues in Patent Law Biotechnology and Research Ethics Clinical Research: Conflicts and Controversies

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Ethical Issues in Patent LawBiotechnology and
Research EthicsClinical Research Conflicts
and Controversies

• Patricia C. Kuszler, M.D., J.D.
• University of Washington School of Law

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Issues Arising in the Context of Clinical
Research

• Numerous Media Exposes
• The Rights of the Human Subject
• The Interests of the Researcher and Study Sponsor

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Questions

• When should financial conflicts be disclosed?
• When should non-financial conflicts be disclosed?
  Are they so insidious that disclosure is not
  possible?
• Who is a vulnerable subject and how should the
  law protect them?
• Who cares and Why?

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Who Cares and Why?

• Patients/Human Subjects
• Funders of Research
• Beneficiaries of Successful Research
• Society and Future Generations

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Research Ethics Human Subjects

• Ethical Principles
• Respect for Autonomy
• Beneficence/Non-maleficence
• Justice
• Medical Standards of Care Professionally Driven
• Informed Consent Legal Ramifications
• Federal Law Protections for Subjects

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Funders of Clinical Research

• Federal Agencies costs of the study, data
  collection and analysis, salary for the
  researchers, and subject costs
• Private Industry Sponsors costs of the study,
  subject costs the drug, device or biological
  that is being researched
• Medicare routine patient care costs, costs of
  complications -- by National Coverage Decision
  issued 6/7/00
• Private third party Payers routine patient
  care costs, costs of complications -- by policy
  or default

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Downstream Gains Future Products, Patents and
Profits

• Stevenson-Wydler Technology Act (1980)
  cooperative model for technology transfer
• Bayh-Dole Act (1980) retention of ownership,
  patenting and licensing of discoveries
• Federal Technology Transfer Act (1986) joint
  venture Cooperative Research and Development
  Agreements (CRADA)

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Financial Technology Transfer Benefits

• Research University Benefits
• Ongoing revenue source in face of decreasing
  government subsidy patents, royalties,
  licensing
• Often tax-free
• Transformation into research networks
• Individual Researcher Benefits
• Equity, royalty income
• Lucrative financial connections to sponsors
• New, less encumbered, sources for research
  sponsorship

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Non-financial Benefits of Clinical Research

• Emotional and Professional Satisfaction
• Academic Prestige and Scientist Stardom
• Increased Publications
• Peer Respect
• Improved Posture for Future Funding

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Our Duty to Society and Future Generations

• The Legacy of Eugenics and the Tuskegee Study
• Products Liability
• Downstream Harms to Populations and Species
• Societal Backlash and Destruction of the
  Integrity and Image of Altruism in Science

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Law and Policy Addressing Conflicts of Interest
in Research

• FDA PHS Regulations
• Focus on Disclosure
• Institutional Policies
• Focus on Management
• Generally Disclosure
• Increasingly Zero Tolerance

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• Conflicts of Interest are ubiquitous and
  inevitable in ...all professional life
• David Korn, MD
• JAMA, Nov. 1, 2000
• Conflicts of interest are of concern because of
  their potential effect on the quality, outcome
  and dissemination of research, as well as their
  effects on the publics perception of and trust
  in researchers and universities
• Mildred K. Cho, et al.
• JAMA, Nov. 1, 2000

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Challenges in Conflict of Interest

• Institutional conflict of interest academic and
  research medical centers equally corruptible
• The Power Differential Problem Researcher
  vis-à-vis the vulnerable subject
• The Question of Currency dollars vs. prestige,
  fame ego