Conflict of Interest in Research, Clinical Care

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Conflict of Interest in Research, Clinical Care
Education

• Ross McKinney, Jr, MD
• Duke U School of Medicine

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Increasing Attention

• COI in clinical care hits home to patients
• Many MDs in speakers bureaus, on scientific
  advisory boards
• Consulting payments at times appear to exceed
  fair compensation for effort
• Ghost writing is a problem

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Increasing Attention

• COI in clinical care hits home to patients
• Many MDs in speakers bureaus, on scientific
  advisory boards
• Consulting payments at times appear to exceed
  fair compensation for effort
• Ghost writing is a problem
• OIG just audited NIH COI Management
• OIG local audits expected this year

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OIG Findings

• NIH does not track COI closely enough
• Institutions do not report COI to NIH adequately
• NIH should require detailed reports of how all
  instances of COI are being managed locally NIH
  disagreed resolution pending

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Basic Question

• Is the public more worried about notepads or
  bribes?

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Basic Question

• Is the public more worried about notepads or
  bribes?
• A current example of the public view

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New York TimesFront Page May 10, 2007

• Psychiatrists, Children and Drug Industrys
  Role
• When Anya Bailey developed an eating disorder
  after her 12th birthday, her mother took her to a
  psychiatrist at the University of Minnesota who
  prescribed a powerful antipsychotic drug called
  Risperdal.

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The problem

• Anya gained weight but within two years developed
  a crippling knot in her back. She now receives
  regular injections of Botox to unclench her back
  muscles. She often awakens crying in pain.

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The COI

• In 2003, the year Anya came to his clinic, Dr.
  Realmuto earned 5,000 from Johnson Johnson for
  giving three talks about Concerta.

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The COI

• In 2003, the year Anya came to his clinic, Dr.
  Realmuto earned 5,000 from Johnson Johnson for
  giving three talks about Concerta.
• However, not clever to say
• Academics dont get paid very much. If I was an
  entertainer, I think I would certainly do a lot
  better.

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The COI

• In 2003, the year Anya came to his clinic, Dr.
  Realmuto earned 5,000 from Johnson Johnson for
  giving three talks about Concerta.
• However, not clever to say
• Academics dont get paid very much. If I was an
  entertainer, I think I would certainly do a lot
  better.
• (Dr. Realmutos university salary is 196,310.)

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Senator Charles Grassley September 6, 2007

• Payments to a doctor can be big or small.  They
  can be a simple dinner after work or they can add
  up to tens of thousands and even hundreds of
  thousands of dollars each year.   Thats right
  hundreds of thousands of dollars for one doctor. 
  Its really pretty shocking. 
• Companies wouldnt be paying this money unless it
  had a direct effect on the prescriptions doctors
  write, and the medical devices they use. 
  Patients, of course, are in the dark about
  whether their doctor is receiving this money.

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Kohl-Grassley Physician Payment Sunshine Act

• A federal law requiring public disclosure of
  payments to doctors could be very effective if it
  was carefully monitored and consistently
  applied.
• Bill currently proposed with bi-partisan
  sponsorship

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Kohl-Grassley

• Kohl-Grassley will require that companies report
  all payments, gifts, honoraria, and travel
  awards, given to physicians
• Also the purpose, date, and what was received in
  exchange
• Feds will publish on a publically accessible web
  site
• Already law in MN, with similar laws in VT, DC,
  ME, WV

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Universities Responses

• Several institutions have banned minor gifts,
  travel, meals, and even samples from
  pharmaceutical companies (Yale, Penn, Stanford,
  Pitt, U Mass)
• Several institutions tightly regulate what
  faculty can do in terms of consulting (e.g. Mayo,
  Emory)

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Duke Policy

• Duke School of Medicine COI policies are rooted
  in NIH policy (42 CFR 50, subpart F) and in the
  Duke University COI policy of 1992
• Annual reporting on-line (February each year) for
  previous calendar year and for what is
  anticipated in the current year

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COI Committee

• Duke COI Policy and interpretation involves the
  faculty through a COI Committee that meets
  monthly
• Made up of faculty from Schools of Medicine and
  Nursing
• Includes clinicians, clinical researchers, and
  basic scientists

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Duke Policy - 2

• Currently must report any payments from a company
  that provides an IRS Form 1099, W-2, or K-1
  (except the PDC) Effective threshold is 600
• If lt10,000 in annual payment, institution
  considers this below de minimis and does not
  require action (other than reporting). However,
  disclosure in presentations publications is a
  good idea, and required for CME if payments gt0

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Duke Policy - 3

• Payments between 10,000 and 25,000 mean
  disclosure is required in publications
  presentations.
• Payments gt25,000 mean an individual may not be
  PI on a grant from the company, nor on projects
  that relate to the companys products.
• Public Equity holdings treated by same rule as
  payments

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Duke Policy - 4

• Privately held equity Treat as gt25,000 in most
  cases, since it can be hard to value
• Options (public or privately held company) in
  most cases, treated as gt25,000 since research
  results may effect values.

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Intellectual Property

• Licensed IP with royalties needs to be reported
  and evaluated

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Gifts

• The COI Committee will also evaluate gifts to
  Duke that are deposited into a faculty
  discretionary account to consider whether they
  may represent an attempt to sway a faculty member

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Management of COI

• Most cases of COI can be managed
• Disclosure
• Divestiture
• New PI
• Discussing a Pooled-equity approach for inventors
  
• Voluntary donation of equity into a mutual fund
  in trade for fixed portion of final distribution
  when mutual fund liquidated

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Personal vs. Institutional COI

• Personal COI involves individual faculty members
• Institutional COI involves the institution itself
  and senior officials of the institution
• Duke is developing an Institutional COI policy

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Classical I-COI Situation

• A faculty member invents a technology
• Duke owns the IP and licenses it to a start-up
  company
• Because most start-ups lack capital, Duke
  receives equity in trade
• Since Duke has a stake in the technologys
  success, there can be a public perception it
  doesnt provide oversight thats as careful as it
  should

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Gelsinger Case

• The paradigmatic example of ICOI involved the
  case of Jesse Gelsinger, an 18 year old with OTC
  Deficiency who died in a gene therapy trial at
  Penn
• Although Penn took many steps in regard to ICOI,
  the lead attorney (Alan Milstein) made a
  persuasive public case, and Penn settled
• Currently sets a precedent

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Managing ICOI

• When Duke has ICOI, there is a rebuttable
  presumption human subjects research on the IP
  should not be done here.
• In compelling circumstances, the work may be
  allowed (also true for personal COI)
• COI Committee reviews the circumstances

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Managing ICOI - 2

• If there is a good reason to do the work at Duke,
  we require some external oversight
• DSMB-Plus
• Reviews study design
• Monitors study conduct (esp. for evidence of COI)
• Reviews endpoints
• Monitors and approves publications
• External IRB
• Dukes interest should be disclosed in
  publications

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Annual Reporting Form 2008

• Similar to last years form
• Re-wrote the underlying code so that the separate
  fields are in a database
• Will allow better pre-population next year and
  during updates
• Form Online Location
• coi.duke.edu/coi_form

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Who Must Report?

• All regular rank faculty (University-wide)
• All faculty who participate in research
• Any staff who independently contribute to the
  design, conduct, or reporting of research
• At present, students are generally exempt, unless
  they clearly have an independent role

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Contact Info

• Conflict of Interest Office
• Michelle Evans (michelle.evans_at_duke.edu)
• Susan Brooks (brook003_at_mc.duke.edu)
• 684-6739