Transcript Patients, Products and Public Trust Deborah Zucker, MD, PhD, Tufts

Ethics & Academic Technology Transfer:
Patients, Products and Public Trust
Deborah Zucker, MD, PhD,
Tufts Medical Center
D.Zucker
Draft-EB09
Research to Improve Health
Research
Knowledge
Products
Interventions
Patient Care
Public Health
Who does what?
Missions, Goals and Participants in the Research Enterprise
D.Zucker
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Historically: University Industry Relations-•Closer ties in Physical Sciences– Government Labs, Defense
•Bayh-Dole Act and the rise of Biotechnology
•Increase in Commercialization by Faculty
•Increased University–Industry Ties - in Biological Sciences
and Medicine
•Reduced NIH Funding—Need for funding
•The rise of Managed Care
•Increased focus on Health Services Research
D.Zucker
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Research to Improve Health
Who’s doing what?
Research
Knowledge
Acad
Indus
Product
Development
+
+
Product
Testing
+
+
Patient Care
Public Health
+
+
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What’s the concern with increasing
-University – Industry Interactions?
-Institutional/Investigator Focus on
Commercialization?
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Drug X is Effective in Treating ConditionA.
Dr. Researcher*, BioMed PeerReview 1:1-10
What do you think when you also read:
*Corresponding author:
Dr. Researcher, TheCompany (manufacturer of DrugX)
OR
•Corresponding author:
Dr. Researcher, Academic University;
This work was funded by TheCompany (manufacturer of DrugX)
OR
*Dr. Researcher, Academic University;
“Patent pending”
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What are your concerns?
Bias - Research Integrity
Financial/Non-Financial Conflicts of Interest
Consider the Real / Perceived Impacts on:
1. What we research
2. How we research
3. How we interpret results
4. How and What we disseminate
5. What and How things are put into practice
6. How and what outcomes are assessed
Consider Missions- Goals– Processes –
Where do they overlap?
Where do they differ?
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Mission – Goals
ACADEMIC INSTITUTIONS:
Colleges—Education, Developing Knowledge
Universities – Broader Missions—
e.g., Provide Quality Patient Care, from primary care to
the most advanced available technologies;
Advance Economic Development
Encourage responses to healthcare needs
Preserve and optimize human life
Research to improve basic understanding of the causes,
mechanisms, treatment and prevention of disease,
and the social interactions related to human health;
Education & service programs to serve the community
….
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Missions – Goals
GOVERNMENT AGENCIES:
NIH:
NIH is the steward of medical and behavioral research for the
Nation. Its mission is science in pursuit of fundamental
knowledge about the nature and behavior of living systems and
the application of that knowledge to extend healthy life and
reduce the burdens of illness and disability.
NSF:
Mission and purpose: To promote the progress of science;
to advance the national health, prosperity, and welfare; to secure
the national defense....
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Missions – Goals
COMPANIES:
Pfizer: Mission - We will become the world's most valued
company to patients, customers, colleagues, investors,
business partners and the communities where we
work and live. Purpose - We dedicate ourselves to
humanity's quest for longer, healthier, happier lives
through innovation in pharmaceutical and consumer
health products.
Genentech: Mission..to be the leading biotechnology company,
using human genetic information to discover, develop, manufacture and
commercialize biotherapeutics that address significant unmet
medical needs. We commit ourselves to high standards of integrity
in contributing to the best interests of patients, the medical profession,
our employees and our communities, and to seeking significant returns
to our stockholders based on the continual pursuit of scientific and
operational excellence.
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Potential Risks and Benefits with increasing
-University – Industry Interactions?
-Institutional/Investigator Focus on
Commercialization?
For:
1. Researchers/ Clinician Researchers
2. Institutions
3. Companies
4. Insurers (Private and Public)
5. Government
6. PATIENTS -PARTICIPANTS
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Potential Risks and Benefits for:
Researchers/Faculty
• Academic Freedom –
measuring success?
• Can I talk about my work
with colleagues?
• Financing your work
•Access to new interventions
for evaluation
• Funding for Research
• Expertise in production,
Clinical Trials and Marketing
• My patients and my
research- “double agents”
Institutions• Autonomy and financial
viability
• Funding for Research for
Faculty
• Oversight- Biting the hands
that feed you
• Return on Investments in
Research (Royalties)
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Companies
• Proprietary considerations
•Access to Patients
•“Academic” connection
Insurers (Private & Government)
• What data can we trust?
•Unbiased evaluations
Government
• Public Funding --Public
Benefit?
Patients
• In whose best interest?
•
•Translation of Research into
interventions
• Access to potentially effective
new medications
Trust – Easy to lose …Very
hard (impossible?) to win back!
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Conflicts of Interest always exist—
How can they be minimized and managed?
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