Conflict of Interest: 200708 Fellow seminars abbreviated for SPCAP

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Conflict of Interest 2007-08 Fellow seminars
abbreviated for SPCAP

• Carl Feinstein, M.D.
• Professor of Psychiatry and Behavioral Sciences
• Stanford University School of Medicine

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Bioethics

• The subfield of ethics that concerns the ethical
  issues arising in medicine and from advances in
  biological sciences.

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Three Central Topics of Bioethics

• Ethical issues that arise in relations between
  health care professionals and patients.
• Broader issues of social justice in health care
• Ethical issues raised by new biological knowledge
  or technology.

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The Six Principles of Medical Bioethics

• 1. Beneficence The duty to do good
• The duty to do right by your patients.
• 2. Autonomy Respect for persons.
• The right of the patient to full, voluntary,
  informed consent for all treatments (or
  research).
• 3. Nonmaleficence First, do no harm.

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The Six Principles of Medical Bioethics

• 4. Justice An equitable distribution of medical
  treatment resources .
• Quality of and access to care and research should
  be equal.
• 5. Veracity The obligation to tell patients
  (and the public) the truth and to not deceive
  through omission (withholding the full truth).
• 6. Fidelity Serving patients faithfully.
• Serving patients beneficently ahead of other
  possible objectives or interests.
• NOTE This principle is the cornerstone of an
  ethical rule system for regulating conflict of
  interest.

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CONFLICT OF INTEREST
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Definition of Conflict of Interests Thompson,
D., 1993, NEJM. V.329573-576, 1993

• A conflict of interest is a set of conditions in
  which professional judgment concerning a primary
  interest (such as a patients welfare or the
  validity of research) tends to be unduly
  influenced by a secondary interest such as
  financial gain or fame).
• Conflict of interest rules, informal and formal,
  regulate the disclosure and avoidance of these
  conditions.

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Primary Interests

• The primary interest is determined by the
  professional duties of a physician, scholar, or
  teacher.
• In their most general form, the primary interests
  are
• The health of patients.
• The integrity of research.
• The education of students.

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Secondary InterestsProblematic only when they
comprise primary interests

• Secondary interests might include
• Gifts or payments for prescribing or promoting
  particular products.
• Access to luxuries (expensive restaurants, free
  lunches, tickets to sporting events, sponsored
  trips to meetings or resort-based cme events.
• Prestige, fame, or increased referrals. (being
  designated a thought leader).
• To gain greater academic prominence through
  sponsored professional speaking opportunities,
  including industry-supported grand rounds.
• Indirect financial support through your
  institution for academic career advancement or
  professionally-related travel expenses
• To fund all or part of a research laboratory.
• Free ride to professional meetings (travel,
  hotels, etc) for you or your students.
• To obtain incidental for computers, equipment,
  etc.

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Purpose of Conflict of Interest Rules

• To maintain the integrity of professional
  judgment.
• The rules seek to minimize the influence of
  secondary interests that should be irrelevant to
  the merits of decisions about primary interests.
• To maintain confidence in professional judgment.
• The aim is to minimize conditions that would
  cause reasonable persons to believe that
  professional judgment has been unduly influenced
  by secondary interests, whether or not it has
  (appearances and credibility.)
• Since the actions of individual researchers can
  affect public confidence in the whole profession,
  each researcher has an obligation, both to the
  public and to the profession, to make sure
  his/her own conduct does not impair colleagues
  capacity to conduct research or practice
  medicine.

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Economic forces and professional ethics(Wall
Street Journal 6/13/03)

• American expenditures for prescription drugs in
  2002 were 161 billion (increased 14 in one
  year).
• 2.76 billion spent on consumer drug ads.
• 2 billion spent on pharmaceutical sales force.
• Currently more than 90,000 drug reps.
• Medical practitioners, especially those with high
  volume practices are literally besieged by drug
  company reps.

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Intrinsic Ethical Issues in Current Child
Psychiatric PracticeFirst Do No Harm
(Beneficence)

• Many drugs in child pharmacotherapy lack clear
  efficacy or safety data.
• Off-label use is heavily promoted (Neurontin,
  Zyprexa, etc.)
• Many thought-leaders routinely suggest various
  off-label uses in the Q A portions of CME
  presentations.
• Why dont you try XXXX
• XXXX has worked with some patients for me
• Children seen in psychiatric practices very
  commonly have more than one co-occurring
  diagnosis.
• Frequent use of medications for each diagnosis.
• There is almost no safety or efficacy data for
  the use of multiple medications.

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Common Conflict of Interest IssuesSeen in
Current Child Psychiatric Practice(Non-Maleficenc
e and Fidelity)

• Increasing trend towards med management only
  professional practice (brief and infrequent
  visits).
• A practice based on short visits with many
  patients per unit of time is financially more
  lucrative, with less hassle from managed care
  companies.
• Pressure to add medicines or increase doses to
  provide something of value for the visit.
• The prescription pad as the only tool of the
  practitioner.
• Gifts, indirect financial support, and kickbacks
  from pharmaceutical companies and device makers
  are widespread.

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Survey of physician-industry financial relations

• A National Survey of Physician-Industry
  Relationships. (2007) Eric G. Campbell, Ph.D.,
  Russell L. Gruen, M.D., Ph.D., James Mountford,
  M.D., Lawrence G. Miller, M.D., Paul D. Cleary,
  Ph.D., and David Blumenthal, M.D., M.P.P. NEJM,
  Vol 356, 17, 1742-1750
• Survey of 3167 physicians in six specialties
  (anesthesiology, cardiology, family practice,
  general surgery, internal medicine, and
  pediatrics) in late 2003 and early 2004.
• Raw response rate 52, weighted response rate
  58.

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Review a case study where industry/physician
interactions could well have been in play

• Intense industry promotion of medications to
  physicians and the public during period when
  negative safety or efficacy data is emerging.
• Examples that have attracted enormous media,
  public, and legislator attention.
• Cox-2 inhibitors, off-label Neurontin, Zyprexa
  (off-label or suppression of side effect data)
• Current example of failed , but very profitable
  anti-cholesterol knock-offs (Vytorin).
• Industry promotion of newer, profitable
  look-alike meds when older, equally/more
  effective meds in the same class are off-patent
  (SSRIs).
• Controversial case studies of meds where safety
  data was minimized in publication of
  industry-academic randomized trial approaches.
• Re-reading the now-famous Paxil paper in JAACAP.

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Questions for Discussion

• Why do pharmaceutical companies give gifts or
  financial support to doctors?
• Why do pharmaceutical companies provide financial
  resources to medical specialty organizations?
• Why do pharmaceutical companies provide free
  samples to doctors?
• Does being designated a thought leaderby a
  pharmaceutical company etc. influence the
  behavior of the thought leader?
• Does the liberal sprinkling of doctors offices
  with drug company-branded notepads, mugs,
  mousepads, pens, etc. have any effect on
  patients?
• Does the decision not to report negative findings
  from a clinical trial have an adverse effect on
  medical practice?

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Why do so many doctors believe that their
prescribing practices are not influenced by
pharma gifts?

• Narcissism? (I, personally, am incorruptible, so
  why not?)
• Even despite widespread awareness that other
  MDs behaviors are influenced..
• Everybody else is doing it?
• Free lunches, pens, and pads are fun? (And whats
  the harm?)
• We deserve to share the bounty?
• For all my hard work and the long years of
  training, I deserve it.
• Special attention from really nice pharmaceutical
  representatives?
• Opportunity to feel virtuous giving some free
  samples to patients?

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New England Journal of Medicine EditorialMay
18, 2000

• Is Academic Medicine for sale?
• Describes psychiatrist author in current journal
  with ties to drug companies producing
  antidepressants that are so long that the Journal
  could not provide sufficient space to disclose
  them all.
• Journal complains of great difficulty finding
  editorialists in Psychiatry (but also in some
  other specialties) who were not disqualified by
  conflicts of interest.
• Can we really believe that clinical researchers
  are more immune to self-interests than other
  people?

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The Academic Psychiatrist Confronts Reality

• Conversation with a graduate of our program now
  in private practice in the midwest for 5 years.
  Setting following town hall meeting at AACAP
  meeting on physician-industry interactions Fall,
  07
• Carl Well, what did you think?
• Former Fellow Well, I thought it was pretty
  silly. I think the people who organized this
  must be on another planet. I agree that gifts and
  pharm-reps are a big influence on practice, but
  this meeting isnt going to help.
• Carl (incredulous) Why? If its a problem,
  shouldnt we be discussing it?
• Former Fellow You have to realize that out of
  the 10-15 child psychiatrists who are really
  active in my region, Im the only one who is even
  attending this meeting. My colleagues think its
  silly to pay to come to a meeting for cme when
  the reps pay for us to go to dinners and vacation
  resorts for cme.

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Current Professional Climate Surrounding Conflict
of Interest

• Most researchers find conflict of interest
  disclosure rules annoying and even insulting.
• (for example, disclosure at the beginning of
  every lecture ).
• In surveys, most physicians (including academics,
  including psychiatrists) report that they,
  personally, are incorruptible , even though they
  might be receiving payments, honoraria, or gifts.
• However, they consistently report that other
  physicians might be corrupted.

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The Public - MD Disconnect

• Many physicians resent being told they cannot
  accept gifts.
• Many physicians who give donated free samples
  to patients feel virtuous Most deny that free
  samples influence the patterns of their
  prescriptions.
• Even in academic centers where they are
  prohibited, many physicians stash supplies of
  free samples in their desks and dispense them
  anyhow.
• However, a massive amount of research shows that
  free samples have a major influence on
  prescribing practices.
• Media, public interest groups,legislators, and an
  increasing large segment of the public are
  cynical and mistrustful regarding the
  corruptibility of doctors and medical
  researchers.
• There is a disconnect between medical researchers
  and an increasingly skeptical public.

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The Self Image Of Academic Child
Psychiatrists(Marie Curie)
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Self Image of Practitioners(Sir Galahad The
Chaste Knight)
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American College of PhysiciansGuidelines for
Industry Payments to Physicians

• Physicians should ask themselves
• What would my patients think about this
  arrangement?
• What would the public think?
• How would I feel if the relationship were
  disclosed through the media?