Conflicts of Interest Who they impact and why

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Conflicts of InterestWho they impact and why?

• Prepared by
• The Office of Research Training Compliance
  (ORTC)
• March 27, 2008
• Director, Jackie Bendall

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Just In Washington Post article

• Tobacco Cash in Lung Study
• Lung scans were proved effective
• Funds provided for research came from ACS, DHHS
• 3.6 Million came from a parent company of
  cigarette maker Liggett Group, Inc.
• Foundation was formed

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Washington Post, cont.

• Cornell Foundation

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What is a COI?

• A COI can occur when there is an actual or
  perceived divergence between a faculty members
  private interests and professional service to the
  University.

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Conflicts Occur When a Faculty Member/PI

• Deprives GW of appropriate (compensated) time and
  effort (conflict of commitment) due to other
  competing demands
• Makes substantial use of GW human or material
  resources for non-University purposes
• Has financial involvements that appear to affect
  his/her academic responsibilities (e.g.,
  invention royalties outside of the University)

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Examples of Actual COIs within Academia

• A Department Chair purchases a computer from
  company run by his son
• A research scientists gives a friend use of a GW
  lab and doesnt disclose to anyone
• A GW researcher invents a new device using GW
  resources and fails to disclose to University
• A faculty member acts as the thesis or
  dissertation advisor to a graduate student for a
  research project, suggested by the faculty
  member, w/ expectation to enhance the value of
  the company in which the faculty has a
  significant interest

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Examples of Actual COIs within Academia(Cont.)

• A faculty member goes against the university
  policy and accepts the sponsors request to
  suppress publication due to undesirable results
  that could significantly affect the sponsors
  financial interests
• Submits proposals in which researcher has
  financial interest in the proposed sponsor,
  subcontractor, vendor, or collaborator
• A faculty member/clinician accepts a fee/vacation
  for the sake of influencing the financial status
  of company and himself/herself (e.g., writing
  prescriptions for a drug).

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What does Perceived mean in this case?

• Exist when an investigators significant
  financial interest could lead an independent
  observer to reasonably question whether the
  design, conduct, or reporting of research might
  be influenced by the possibility of personal
  gain.
• - PI conducts federally or foundation sponsored
  non-clinical research on a product developed by a
  company for which he is a consultant
• - A PI who participates on a scientific advisory
  board conducts non-clinical research sponsored by
  company

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How is significant defined?

• GW policy defines Significant financial interest"
  as
• Stock or ownership interest of the lesser of
  10,000 or 5 ownership
• in the outside entity (excludes mutual funds)
• Receipt, right or expectation of income in any
  form (e.g., consulting),
• salary, allowance, forbearance, forgiveness,
  interest in real or
• personal property, dividend, royalty derived from
  the licensing of
• technology or other processes or products, rent,
  capital gain, real or
• personal property, or any other form of
  compensation or gt 10,000
• per 12 month period
• Serving as PI for or having a management position
  in the outside
• entity

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Corrupted ScienceCorporations view science not
as a generator of truth but as one among many
inputs into production

• Drug Companies carefully choose and pay
  exorbitant fees to influence what is presented
• Ghost Writing (fees paid to Doctors who can be
  cited in journal articles, articles written by
  ghost writers)
• Companies pay scientists fees to submit articles
  to open and peer reviewed journals so that their
  unbiased science could be cited in appeals
• Companies seek to repress publication that affect
  their bottom line and those of their shareholders

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Senator Grassleys Common Themes with the FDA

• Suppression of Scientific Dissent
• Cozy Relationship with Industry
• Pressure to Alter or Exclude Information
• Pressure to Approve Products
• Atmosphere of Fear of Retaliation
• Organizational Challenges
• Lack of Leadership

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Patient Safety and Efficacy of Drugs

• Teaching how to practice has been handed to the
  Pharma companies
• Dangerous side effects are rarely on the
  curriculum
• Half of all continuing medical education courses
  are paid for by drug companies (up 1/3 from a
  decade ago). Promotion of sponsors product?

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Proposed Legislation Senator Grassley Senate
Finance Committee

• Requires drug makers to disclose payments that
  they make to prescribers for services provided,
  including consulting, giving presentations, or
  attendance at seminars.
• Create a federal registry of such payments
  similar to those registries in Maine, Vermont,
  and Minnesota.
• Continuing education provided by Pharma Industry
  should not be accredited.

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Conflicts in Research cannot be avoided in many
cases

• The mere existence of a conflict does not
  necessarily imply wrongdoing on anyones part
• Govt encourages collaboration, therefore
  start-ups are created (STTRs, SBIRs)
• The University encourages engagement and
  collaboration with the outside world

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Prevention Techniques

• Refer to your employers policy regarding COI
• Be wary of publication restrictions and the loss
  of control to publish
• Be wary of gifts, typically there are strings
  attached
• Always, Always, Always, read the fine print
• Always Disclose your relationship

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Reporting of COI

• Report your concerns even if you are not
  completely sure there is a problem
• Speak to your supervisor first
• Provide as many facts as possible
• If you are uncomfortable contacting someone
  directly, contact the Universitys Regulatory
  Compliance Help and Referral Line at
  1-888-508-5275
• Reports will be handled in strict confidence to
  the extent possible or permitted by law.

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THE END, THANK YOU FOR LISTENING!Questions?