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Conflict of Interest in Academic Research

Presented by: Julie Gottlieb, Johns Hopkins University School of Medicine. Conflict of Interest in Academic Research . Presentation to the University of New Mexico Health Sciences Center. Conflict of interest . When a secondary interest competes with a primary objective or responsibility. vs.

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Conflict of Interest in Academic Research

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  1. Presented by: Julie Gottlieb, Johns Hopkins University School of Medicine Conflict of Interest in Academic Research Presentation to the University of New Mexico Health Sciences Center

  2. Conflict of interest When a secondary interest competes with a primary objective or responsibility vs. http://www.childrenscancer.org/images/uploaded_ images/6810/6811/2-1_what_we_fund_left.jpg http://www.oralchelation.net/heartdisease/images/money.jpg

  3. The Objective of COI Policy Balance the mission of transferring knowledge and commercializing technology with the imperative of protecting the safety, integrity, and reputation of biomedical research COI policy and process must be credible and effective

  4. Purpose of the COI Process • Implementation of University’s COI policy • Adherence to PHS regulations • Support ethical conduct of research • Ensure credibility of institution’s and investigators’ research

  5. Contents • Overview: history and regulatory environment • Analyzing risks of COI in research • Case studies

  6. Conflict of Interest Policy:A Brief History (1) • 1980 – Congress passed Bayh-Dole Act allowing universities to retain ownership of inventions made with federal funds • Growth of university (especially medical school) technology licensing, startups, consulting, industry sponsored research • Development of biotech industry: 1994-2004 revenues increased 410% and R&D expenditures increased 283%* *BIO Biotechnology Industry Organization; http://www.bio.org/speeches/pubs/er/statistics.asp

  7. Significant Interactions between Industry and Academia • Technology licensing (fees, royalty, stock) • FY07: 5,109 licenses and options* • Research Sponsorship • FY07: $48.8 bn (total), $3.4 bn (industry) * • Consulting (cash, stock) • Collaborations (cash, material) *AUTM U.S. Licensing Survey FY2007

  8. COI Regulation, Guidance • 1995 – PHS/NSF COI regulations • 1998 – FDA COI regulations • Gelsinger death at UPenn • 2000 – NIH Summit on COI in Human Subject Research (HSR) • 2001- 2002 – AAMC recommendations on COI in human subject research (expanded 2008) • 2004 – HHS final guidance on COI in human subject research

  9. Recent Developments • 2004 - 61% of AMCs (voluntarily) adopted “presumptive prohibition”* • 2005-6 – NIH prohibits COIs for intramural scientists, staff • 2008-9 – Sen. Charles Grassley investigating (unreported) COIs • 2008-9 – Required (orthopedic firms) and voluntary disclosure of industry payments to physicians, investigators • 2009 – NIH expected to revise, strengthen COI regulations • *U.S. Medical School Policies on Individual Financial Conflicts of Interest: • Results of an AAMC Survey 2004

  10. PHS, NSF Regulations onCOI in Research • PHS (NIH, etc.), NSF • Grantees must identify and manage, reduce or eliminate COIs and report to awarding agency before spending award $ (or within 60 days of being notified of COI in active project) • > $10K/year, > 5% stock, royalties other than from grantee, etc. • Prospective review

  11. FDA Regulations on COIin Research • FDA • Applicants for marketing approval (e.g., companies) for drugs, devices, biologicals, must disclose financial interests of investigators in “covered” studies • Personal payments, > $50K stock, > $25K payments for research separate from costs of clinical study, etc. • Retrospective

  12. COI and Public Trust in Biomedical Research • Sentinel events • Death of Jesse Gelsinger at U. Penn (1999) • Deaths in Protocol 126 at Hutch • Other events • Seattle Times series on COIs in Protocol 126 • Wall St. Journal series on COIs at Cleveland Clinic (2005) • COIs of NIH intramural staff exposed (2005-6) • Dr. Charles Nemeroff resigns editorship of Neuropsychopharmacology after failing to disclose (2006) • Cleveland Clinic revokes physician’s appointment for failure to disclose (2006) Harvard researcher investigated • NIH freezes Emory grant over Nemeroff’s COIs (2008)

  13. Benefits of Relationships with Industry • Funds and material for research (clinical trials) • Access to information about drug and device development • Ability to influence commercial strategy and move inventions “from bench to bedside” • Ability to place graduates in industry jobs

  14. Potential Costs of Academic-Industry Relationships • Risks to safety human research subjects • Bias in research (more pro-industry results)* • Impact on students and trainees • Impact on use of university resources Biased research may lead to poor decisions in research, product approval, and clinical care * Associations between pro-industry research results and authors with COIs have been reported in several articles. One such article is Stelfox, et al., “Conflict of Interest in the debate over calcium-channel antagonists.” New England Journal of Medicine, 1998; 338 (2): 101-06.

  15. Voluntary disclosure increasing • AMCs • Cleveland Clinic, (forthcoming:) U. Penn, Emory • Industry • Pfizer, Merck, Lilly • 5 orthopedic device manufacturers as result of DOJ settlement • Professional Societies • Spine surgeons

  16. Analyzing risks of COI inResearch 3-part process • Reporting • Review • Determination

  17. Reporting • Administrative system for obtaining reports of investigators’ financial interests in research • Integration, communication between grants/contracts office, IRB, COI office, etc. • Educate faculty and staff

  18. Review (1) COI committee must define and address risks Are the risks different in human subject research?

  19. Review (2) • Understand the research project • In what ways is it susceptible to conscious or unconscious bias? • Understand the financial interests and relationships • How large are they? Are they fixed or contingent? How closely do they relate to the research?

  20. Review (3) • Study design – may skew to show desired outcome • (HSR) Subject recruitment – may “stretch” inclusion criteria • (HSR) Consent process – may understate risks of participation • (HSR) Intervention • Data analysis – may be shaded to favor desired outcome, esp. if endpoints are subjective • Publication/Presentation – may overstate results or omit unfavorable data • Use of resources/grant – may redirect resources to projects with personal gain

  21. Case 1a: Dr. Apple • Dr. Apple conducts NIH-funded lab research in genetics. He consults for Genlabs on assay development and earns $10,000/year. Genlabs is developing diagnostic kits to detect inherited molecular markers that have been identified in colon cancer. Dr. Apple does not use Genlabs’ assays in his research. Is there a COI? http://www.eurekainc.com/services/files/ADCCassays.jpg

  22. Case 1b and 1c: Dr. Apple • 1b: Same as 1a, except Dr. Apple earns $30,000/year as a consultant. • 1c: Same as 1a, except Dr. Apple invented the assay used in Genlabs’ diagnostic kit and receives royalties.

  23. Case 1d: Dr. Apple • 1d: Same as 1c, except the diagnostic kit is not on the market, so no royalties are flowing yet. Dr. Apple proposes to test the efficacy of the assay he invented in a clinical study. He is a co-investigator on the IRB protocol, but has no contact with patients. Clinicians will take blood samples and, using the assay in his lab, Dr. Apple will run the samples. His findings will be correlated with clinical information at 1 and 3 years. Can he participate in the study? If it’s a pilot study? If it’s a definitive study?

  24. Case 2: Dr. Giannini • 2a: Dr. Giannini, a psychiatrist, is an expert in anxiety and depression in adolescents. She is PI of a 3-center, Phase II, NIH-sponsored trial comparing MegaPharm’s antidepressant to cognitive therapy in adolescents with anxiety. The drug has been approved for adults but not for pediatric use. • Dr. Giannini’s father died and left $200,000 worth of MegaPharm stock to her 6-year old son. The stock is worth much less than when her father bought it. Can she conduct the study while her son owns MegaPharm stock?

  25. Case 2b: Dr. Giannini • 2b: Dr. Giannini’s son does not own MegaPharm stock. However, Dr. Giannini was a frequent speaker for MegaPharm in the year before the study was proposed, and she earned $40,000. She stopped speaking for the company when her institution banned speaking for industry. Can she be PI of the study?

  26. Case 2c: Dr. Giannini • 2c: Dr. Giannini and her family own no MegaPharm stock and she never served as a speaker for the company. However, MegaPharm is in discussions with her department chair to endow an institute for the study of adolescent mental health, and she would be a member of the institute. Can she be PI of the study?

  27. Determination (1) • The COI management arsenal • Disclosure – to research subjects, colleagues, in publications, presentations • Reduce or eliminate financial interest, place stock in escrow • Limit role of the conflicted investigator • Oversight of research by disinterested expert(s) • Establish “safe haven” for subordinates, students • (for institutional leaders) evaluate decision-making

  28. Determination (2) • Enforce compliance with management decisions • Do spot audits • Specify sanctions

  29. In closing… • Strive for culture of integrity: “do the right thing” • Questions?

  30. Contact Information Julie Gottlieb Assistant Dean, Policy Coordination Johns Hopkins University School of Medicine http://www.hopkinsmedicine.org/Research/OPC/ jgottlie@jhmi.edu 410-516-5560

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