Ethical Interactions with Industry: Avoiding the Siren Song

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Ethical Interactions with Industry Avoiding the
Siren Song

• K. Christopher McMains, MD
• Assistant Professor
• Associate Program Director
• Department of Otolaryngology
• UTHSC-San Antonio
• March 11, 2008

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Dr. McMains Real and Perceived Conflicts of
Interest

• Stryker- Consultant, Instrument Development
• Olympus- Consultant Endoscopy Development,
  Speaker
• Medtronic- Consultant, Biofilm studies
• Daichi-Sankyo- Speakers Bureau

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Why are we talking about this?

• Retail spending on prescriptions has more than
  doubled between 1995 and 2000 from 64.7 billion
  to 132 billion (www.nihcm.org/innovations.pdf)
• Marketing accounts for over 30 of revenues in
  the pharmaceutical industry
• Approximately 90 of the 21 billion marketing
  budget continues to be directed toward physicians
  (Kerber, 2004)

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By the numbers

• Industry spends twice the amount on marketing
  than it does on R D (Relman, Angell, 2002)
• One pharmaceutical representative for every 4.7
  office-based physicians
• Approximately 60 million physician visits made in
  2000 (PhRMA, 2001)
• Over 60 of the 1.2 billion costs of CME are
  underwritten by industry (Relman, 2001)

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Scenario

• While rotating on the Otolaryngology service as a
  medical student, you encounter a pharmaceutical
  representative who offers you a copy of a recent
  article on the drug that he details.
• What issues are involved in this interaction?

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Pharmaceutical Research and Manufacturers of
America (PhRMA) Code of Conduct

• Interactions between company representatives and
  physicians should primarily benefit patients and
  enhance the practice of medicine. (2002)

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Competing Goals
Pharmaceutical Industry Profit-making
enterprise Duty is to stockholders
Medicine Advocate for patient interest Duty
is to patients
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What is Conflict of Interest in the clinical
setting?

• When interests of the clinician do not align with
  the interests of their patients.

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Therapeutic Role of Trust

• Trust has been called a basic building block for
  healing doctor/patient interactions. (Rogers DE,
  1994)
• Outcomes may be related to patient ratings of
  their doctors. (Franks P, et al, 2005)

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What do patients think?

• Patients surveyed thought it is not alright for
  physicians to accept
• Dinner at a restaurant 48.4
• Baby formula 44.2
• Coffee Maker 40.7
• Ballpoint pens 17.5
• Medical books 16.9
• Drug Samples 6.9

-Blake RL, Early EK, 1995
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What do patients think?

• Patients thought gifts more influential and less
  appropriate than physicians.
• Half of patients were unaware of gifts to doctors
  from industry.
• Of those who were previously unaware, 24 had an
  altered perception of the medical profession.

-Gibbons RV, et al, 1998
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Wonder Drug Inspires Deep, Unwavering Love Of
Pharmaceutical CompaniesMarch 6, 2006
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Scenario 1.1

• The same representative has left medication
  samples, lunch and pens in the ENT clinic.
• What are the issues here?

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Governing Policies
UTHSCSA Guidelines for Interactions between
Clinicians and Industry, UTHSCSA Handbook of
Operating Procedures, Chapter 7, Section 7.7,
Policy 7.7.3. AMA policies http//www.ama-assn.o
rg/ama/pub/category/5689.html
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Samples are for the good of needy patients, right?

• Int. Med residents prescribing patterns of 5
  drug class pairs were studied
• Decreased use of unadvertised drugs
• Decreased use of OTC drugs
• Trend towards a decrease in use of less expensive
  drugs

-Adair RF, Holmgren LR, 2005
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Are Medical Students insulated?

• Survey of Finnish medical students
• 44 attended industry sponsored presentations gt2
  times per month
• Importance attached to industry-supplied
  information and intensity of interaction
  increased through training

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Or is it?

• Survey of 105 residents at an Internal Medicine
  residency program
• Judged appropriateness based on cost
• All who viewed lunches/pens as inappropriate had
  accepted them
• 61 believed that industry contact did NOT affect
  their own prescribing
• 16 believed that others in their program were
  unaffected

SELF-SERVING BIAS
-Steinman MA, 2001
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Residents

• Pharmaceutical marketers know that lasting habits
  and attitudes are formed early in physicians
  training (e.g., Wazana, 2000)
• Residents are more readily to attest to the
  possible impact on their peers (Keim, et al.,
  1993)

SELF-SERVING BIAS
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Attitudes of Practicing Physicians

• Strongly disagree that their prescribing
  behavior could be influenced
• Slightly disagree that taking gifts was
  inappropriate
• Slightly averse to having relationships made
  public

• SELF-SERVING BIAS

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Self-Serving Bias

• Individuals are not aware of their bias even when
  taught about it. So, training wont work.
• Bias is strong even in studies with small stakes.
  So, limiting gift size wont work.
• Disclosure can only be effective if those
  informed can rationally update their beliefs in
  light of the disclosure. So, disclosure wont
  work.

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Harm to trainees
Norm of reciprocity Trainees must either accept
the obligation to reciprocate, becoming
consciously or unconsciously indebted and paving
the way for future access and influence, or they
may feel they have gotten something for
nothing, and have successfully exploited
industry, leading to an unwarranted sense of
entitlement that impedes their moral development
as physicians. (Brodkey, 2005)
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What now?

• Limiting gift size, educational incentives, and
  mandatory disclosure are unlikely to eliminate
  bias because they rely on a faulty model of human
  behavior (Dana Loewenstein, 2003).
• Movement towards zero tolerance threshold
  (Krimsky S, 2003)

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World's Scientists Admit They Just Don't Like
Mice
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Scenario 1.2

• You are offered a stipend to attend a meeting
  being held in scenic and lovely Del Rio at which
  data on his companys new drug will be discussed.
  No CME is offered for this event.
• What are the issues here?

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Industry and CME

• Study of GPs in Scotland
• ½ of meetings/conferences were funded by industry
• 1/3 of meetings would not have been attended
  without industry funding
• 40 thought industry funding created COI
• 86 denied that industry involvement affected
  their drug selection.

-Rutledge P, 2003
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Industry and Research Funding

• Industry-funded studies are more likely to report
  positive outcome.
• Involvement of drug company employee has a much
  greater effect on outcome than financial
  sponsorship

FDA Approves Sale Of Prescription
Placebo SEPTEMBER 17, 2003
-Tungaraza T, 2007
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Industry and Research Funding

• Study of NEJM and JAMA articles (2001)
• 16.6-32.6 of articles had one or more authors
  with COI
• 38.7 of drug studies had authors with COI
• Strong association between authors with COI and
  positive reported finding.

-Friedman LS, 2004
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Summary

• Relationships with industry can create conscious
  and unconscious conflicts of interest.
• If is morally and therapeutically vital that we
  uphold our patients trust in our interactions
  with industry.

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Final Thoughts

• You are in this profession as a calling, not as
  a business as a calling which exacts from you at
  every turn self-sacrifice, devotion, love, and
  tenderness to your fellow-men. Once you get down
  to the purely business level, your influence is
  gone and the true light of your life is dimmed.
  You must work in the missionary spirit, with
  abreadth of charity that raises you far above the
  petty jealousies of life.

-Sir William Osler