Patient Advocates in Research

1
Patient Advocates in Research

• Rebecca Dresser, JD
• Washington University in St. Louis

2
Advocates Activities

• AIDS Activists Expanded Access to
  Investigational Drugs Faster Drug Approval
  Process
• Participation in Study Planning, Implementation,
  and Merit Review for Funding

3
Advocates Activities, contd

• Lobbying for Funds, e.g., Mother Teresas
  Waiting Room
• Political Pressure on Public Officials and
  Researchers

4
Worries

• Devalue Basic Research?
• Unrealistic Demand for Investigational Drugs?
• Damage to Clinical Trial System?
• Competition for Scarce Research Resources among
  Advocacy Groups?

5
Mixed Possibilities

• Produce Research Enterprise That Better Reflects
  Interests of People Affected by Disease?
• Improve Public Understanding of Research?
• Can Advocates and Researchers Work Together in
  Meaningful Way?
• Window-Dressing?
• Advocates as Lobbyists

6
Therapeutic Misconception

• Advocates May Fail to Distinguish Between
  Investigational Intervention Proven Therapy
• Advocates May Promote Exaggerated Expectations
  about Likelihood Speed of Clinical Benefits
  from Research

7
Evaluating Research Merit

• Focus on Patient Needs and Benefits
• Research Should Be Designed to Respond to Most
  Serious Health Needs
• Biomedical Science Has Value Only If It Is
  Relevant to Public Health Needs

8
Potential Problems

• Do Advocate Lobbyists Overemphasize Applied vs.
  Basic Science?
• Does Demand for Access to Investigational
  Interventions Threaten Trial Enrollment?

9
Advocates as Constituent Representatives

• Personal Knowledge Alone, or Constituency Views?
• Financial Conflicts of Interest?
• Who Are Constituents?
• Diversity of Constituent Interests

10
Fairness in Advocacy

• Unequal Participation in Research Policy
  Activities
• Disparities Among Organizations in Wealth
  Access to Policymakers Researchers
• When Not All Can Participate, How Should Choices
  Be Made?
• Real vs. Sham Participation

11
Advocates and Ethicists

• Common Objectives But Also Differences
• Advocates Emphasize Benefits From Research,
  While Ethicists Stress Risks, Uncertainties, Need
  for Human Subject Protection
• Cooperation Could Improve Research Ethics

12
An Example

• Patient Response to Disappointing Results in
  Clinical Trial
• Anger That Those Who Performed Procedure Failed
  to Notify Her
• Wish for Sign That Team Recognized Impact on
  Individuals
• Means to Express Basic Ethical Principle of
  Respect for Persons in Research

13
Ethics for Advocates

• Accuracy Honesty About Research Prospects
• Recognize Constituent Diversity
• Reject Parochialism in Policy Work

14
HIV/AIDS Activism as Model?

• Yes
• -Becoming Lay Experts
• -Close Ties to Grassroots
• No
• -Focus on Speedy Cure
• -Embracing Untested Alternatives

15
Industry Influence

• Alert Constituents to Role of Financial Interests
  in Research
• Dont Compromise on Ethical Standards for Human
  Research Participation
• Dont Be Co-Opted

16
Novel Research Areas

• Challenging Science to Learn
• Patients Interests May Conflict with Religious,
  Moral Concerns (e.g., Embryonic Stem Cells) or
  Public Health Concerns (e.g., Xenotransplants)
• Develop Effective, Responsible Responses to Such
  Concerns