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Ethical Challenges Related to Financial Conflicts of Interest in Research Jeremy Sugarman, MD, MPH, MA Berman Bioethics Institute Johns Hopkins University.

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Presentation on theme: "Ethical Challenges Related to Financial Conflicts of Interest in Research Jeremy Sugarman, MD, MPH, MA Berman Bioethics Institute Johns Hopkins University."— Presentation transcript:

1 Ethical Challenges Related to Financial Conflicts of Interest in Research Jeremy Sugarman, MD, MPH, MA Berman Bioethics Institute Johns Hopkins University Baltimore, Maryland USA

2 At the Newsstand  “Safeguards Get Trampled in Rush for Research Cash”  Chicago Tribune, 9/5/99  “Senators Ask Drug Giant to Explain Grants to Doctors”  New York Times, 7/06/05  “ How Tightly Do Ties Between Doctor and Drug Company Bind ”  New York Times, 7/27/05

3 At the Bookstore  Science in the Private Interest : Has the Lure of Profits Corrupted Biomedical Research?  Krimsky, 2003  The Truth About the Drug Companies: How They Deceive Us and What to Do About It  Angell, 2004  On The Take: How Medicine's Complicity with Big Business Can Endanger Your Health  Kassirer, 2004

4 At the Medical Library  “Handling conflicts of interest between industry and academia”  JAMA 2003;  "Regulating academic-industrial research relationships--solving problems or stifling progress?"  NEJM 2005;  "Reporting Conflicts of Interest, Financial Aspects of Research, and Role of Sponsors in Funded Studies"  JAMA 2005;

5 In the Beltway  Institutional Review Boards: A Time for Reform  OIG, June 1998  Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research  OIG, June 2000

6 Conflict of Interest Timeline 1999  Jesse Gelsinger dies in University of Pennsylvania trial 2000  HHS begins policy review  Human Subject Protection and Financial Conflicts of Interest Conference  HHS issues draft interim guidelines 2001  11 major medical journals require authors to disclose financial role of sponsor  AAU issues report on financial conflicts  AAMC issues guidelines for individual conflicts of interest 2002  NIH releases Review of Financial Conflict of Interest Policies of Grantee Institutions  AAMC guidelines for institutional conflicts of interest 2004  HHS Final Guidance Document released

7 Ethical Foundations  Scandals, codes, regulations and principles  Fiduciary obligations  Reservoir of trust

8 Fiduciary  “a person holding the character of trustee, in respect of the trust and confidence involved in it and scrupulous good faith and candor which it requires.”  a “person having duty, created by his undertaking, to act primarily for another’s benefit in matters connected with such understanding.” Black’s Law Dictionary

9 Fiduciary Obligations  Put aside self-interest  Focus primarily on the interests of the person for whom he or she serves as fiduciary  Act to promote that individual’s interest and so earn the trust of that individual McCullough, et al 1998

10 Reservoir of Trust  Individual physicians and investigators  Specific institutions  The research enterprise as a whole

11 Trust and Trustworthiness “Not all things that thrive when there is trust between people…are things that should be encouraged to thrive…There are immoral as well as moral trust relationships.” Baier A, 1986

12 Spectrum of Conflicts  Initial considerations  Research design  Prospective review  In process Recruitment Informed consent Integrity of the data  Reporting

13 Selected Types of Financial Interests  Per capita payments  Money received outside the study  Investigator holds equity  Institution holds equity

14 Potential Solutions  Divest  Minimize  Disclose

15 Important Empirical Questions Regarding Disclosures of COI  Who, What, When, Where, and How?  How will these data be used?  What are the effects on trust?  What are the effects on the research enterprise?

16 COINS Conflict of Interest Notification Study  Johns Hopkins Jeremy Sugarman  Duke Kevin Weinfurt Rob Califf Kevin Schulman Joelle Friedman Jennifer Allsbrook Michaela Dinan  Wake Forest Mark Hall NHLBI Grant: 1 R01 HL

17 COINS Overview Institutional Policies Officials/ Investigators Potential Research Participants Models for Disclosure Effects of Disclosure

18 Policy Review  Online and written policies of US academic medical centers (AMCs)  February-August, 2004  Identified materials for 98% of 123 AMCs Weinfurt et al, Academic Medicine 2006; 81:

19 Policy Review  Online and written policies of US academic medical centers (AMCs)  February-August, 2004  Identified materials for 98% of 123 AMCs  48% mentioned disclosure to subjects as an option 58% of those contained required or suggested verbatim language  Few suggested more than disclosure of sponsor Weinfurt et al, Academic Medicine 2006; 81:

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23 Interviews With Officials and Investigators  Types of Institutions Sampled Academic Medical Centers Independent Hospitals Independent IRBs Non- Affiliated Research Entities  Participation 23 IRB Chairs 14 COIC Chairs or similar official 7 investigators Weinfurt et al, J Law Med Ethics 2006;

24 Disclose the Amount of the Financial Interest?  “ No! ” according to investigators Complexity of the disclosure Amount “ might detract from what really needs to be decided ”  No consensus among officials PRPs overestimate value and the power to influence  Do not disclose amount Investigators underestimate the power to influence, lay people do not  Do disclose

25 We have not ever asked anyone to express the amount of money involved, really thinking that $1000 may be as bad as $20, IRB Chair

26 Describe Possible Implications of Financial Interest?  No, let them draw their own conclusions.  Yes, warn them like we do on cigarette ads.  Difficult balance

27 I think that that is sort of leading the subject to where they might think that this is what is going to happen. I think that if the relationship between the risk and the study was not clear, you might need to spell that out. But, to some degree I think you are just informing the subject. You are not trying to tell them what they should think about it. --COIC Chair

28 PRP Focus Groups  16 groups (6-8 people each) Healthy adults (6 Groups) Mildly/Chronically ill adults (6 Groups) Severely ill adults (2 Groups) Parents with healthy children (1 Group) Parents of children with illnesses (1 Group)  Stratified by race/ethnicity  Conducted in New York, Chicago, and Durham, NC Weinfurt et al, J Gen Intern Med 2006; 21:

29 PRPs on Disclosure and Trust  Might decrease trust  Might increase trust Transparency Perception that financial interest is good  Need to maintain image of physician

30 Evolution of PRPs ’ Thoughts  Few had considered financial interests and their implications in clinical research  Opportunity to ask questions during consent process Prior to focus group, would not have known what to ask

31 COINS Overview Institutional Policies Officials/ Investigators Potential Research Participants Models for Disclosure Effects of Disclosure

32 Models for Disclosure  Expert Panel Mark Barnes, JD, LLM (Ropes & Gray), Becky Coleman, PharmD (Theravance, Inc.), Joseph DiCesare, MPH, RPh (Novartis Pharmaceuticals Corporation), John M. Falletta, MD (Duke University Medical Center), Robert Gatter, JD, MA (Penn State University), Julie Gottlieb, MA (Johns Hopkins University), Jeffrey Kahn, PhD, MPH (University of Minnesota), Mary Faith Marshall, Ph.D. (University of Minnesota), S. Van McCrary, Ph.D., J.D., M.P.H. (State University of New York at Stony Brook), Erica Rose, JD (GlaxoSmithKline), Michael B. Waitzkin, JD (FoxKiser)  Focus Groups  Cognitive Pre-testing Weinfurt, et al. IRB 2007; 29:1-5

33 COINS Overview Institutional Policies Officials/ Investigators Potential Research Participants Models for Disclosure Effects of Disclosure

34 Assessing Effects of Disclosure  Online survey of 3,520 participants Diabetics and asthmatics  Hypothetical clinical trial  1 of 5 financial interests disclosed Per capita payments Money received outside the study Investigator holds equity Institution holds equity Generic

35 Willingness to Participate

36 Change in Trust Due to Disclosure

37 Self-Rated Understanding of Disclosed Financial Benefit

38 Surprise Over Disclosed Information

39 Perceived Effect on Scientific Quality

40 Does the Type of Interest Matter?  Greater concern over investigator holding equity compared to per capita payment  Other types of financial interest did not differ substantially in their effects on participants

41 Before leaving it up to the PRP to assess risk...  Understanding of implications Some feel financial interest increases chance that investigators are committed, ethical, and confident that the experimental therapy will work  Invitation to ask questions during consent process People might not know what to ask  With greater medical risk, some people may not pay attention to financial disclosure, but it is still important to them.

42 The Process of Disclosure  Study of 300 clinical research coordinators to understand their role in disclosing financial interests in research, and possible barriers to such disclosures  Survey domains Awareness of financial interests in research Experience and comfort with disclosure of such interests Barriers to disclosure

43 Results  Experience 41% reported disclosing financial interests to PRPs 28% reported being asked about financial interests  28% somewhat or not at all comfortable with answering questions about financial interests  Barriers Lack of information PRPs wont understand Investigator privacy

44 Suggestions  More education and training would facilitate the disclosure of financial interests in research to PRPs during the informed consent process  Failure to provide such training could result in discomfort that might discourage the effective communication of financial disclosures in research to PRPs

45 Next Steps  Vignette study with patients with coronary artery disease Provided with a copy of an informed consent document for a hypothetical trial Three disclosure arms (per capita, equity, none) Telephone review to simulate the informed consent process Survey regarding willingness to participate, trust, etc  Conflict of interest management study Determine how and when disclosure is selected as a management strategy

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