Redefining the Role of the Pharmaceutical Industry in Medical Education: One Medical Schools Experie

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Redefining the Role of the Pharmaceutical
Industry in Medical Education One Medical
Schools Experience

• February 5, 2007
• David L. Coleman, M.D.

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Relationship between Pharma and Physicians Focus
on Discovery

• Collaborations in basic and clinical research
  vital to improving the health of the public
• Movement of faculty to pharmaceutical industry
  and vice versa
• Examples of research collaborations such as the
  Pfizer Alliance at Yale

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Relationship between Pharma and Physicians Focus
on Marketing

• Pharmaceutical industry largest source of funding
  for CME in U.S.
• Several examples of potential and actual bias in
  educational activities funded by industry
• Significant financial conflicts of interest may
  arise for academic physicians
• Legal challenges to relationship
• Public surveys reveal strong consensus for
  transparent relationships between MDs and
  commercial entities that eliminate or minimize
  potential bias

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Major Legislation with Impact on Pharmaceutical
Industry

• 1980 Bayh-Dole Act enabled Universities and small
  businesses to patent their discoveries from
  research funded by NIH
• 1984 Hatch-Waxman Act increased patent life and
  reduced preclinical testing requirements for
  generics
• 1997 FDA authorized Direct to Consumer Advertising

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Economics of the Pharmaceutical Industry

• Pharmaceutical Industry sales estimated at 200
  billion/year in the U.S.
• Medication costs are the fastest growing portion
  of the healthcare bill (10-12)

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Research in the Pharmaceutical Industry

• Pharmaceutical industry most research intensive
  of all industries that fund R/D privately
• Spend 18 of sales on R/D
• Industry cites average cost of 802 m per
  approved drug

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Industry Spending on Research and Promotion
Billions
GAO Oct 2002
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Forms of Marketing

• Sales Representatives
• Medical Meetings
• Medical Education
• Journals
• Some forms of Clinical Research
• Direct to Consumer
• Media

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Pharmaceutical Sales Representatives

• 80,000 pharmaceutical representatives
• 300,000 events for physicians sponsored each year
  by the Pharmaceutical Industry
• 80-95 of Physicians regularly meet with
  pharmaceutical representatives

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Accuracy of Information from Sales Representatives

• 106 assertions in 13 presentations analyzed for
  accuracy (Ziegler, et al JAMA 2731296, 1995)
• 11 statements inaccurate
• All inaccurate statements favored the
  representatives drug
• Survey of Physicians who attended
• 74 could not recall any false statements
• 37 said the information influenced the way they
  prescribed the sponsors drug
• More frequent visits from pharmaceutical industry
  representatives associated with lower quality of
  prescribing as determined by compliance with
  general practice guidelines in Netherlands
  (Family Practice 22624, 2005)

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Pharmaceutical Print Advertising.Can it Mislead?

• FDA issued 88 letters accusing Pharmaceutical
  companies of misleading advertising (8/97-8/02)
• Wilkes et al reviewed 109 Full Page Ads from 10
  journals (Ann Int Med 116912, 1992)
• 20 of assertions without citation
• 1/3 cases, specialists disagreed with assertion
  that advertised drug was drug of choice
• 28 of ads should not have been published and
  major revisions required in another third

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Citation of Clinical Trials in Pharmaceutical
Advertising

• Villanueva et al studied 102 clinical trials
  cited in promotional statements by Pharmaceutical
  company (Lancet 36127, 2003)
• 44 of statements not supported by citation
• Most common incorrect statement-cited benefit to
  a patient group other than that studied in the
  reference
• Lankinen et al studied 1036 ads in 4 Finnish
  medical journals (Pharmacoepidemiology Drug
  Safety 12789, 2004)
• 38 of claims were referenced
• 21 of the references irrelevant to the claim
• 9 of claims were unambiguous, none supported by
  evidence

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Does Pharmaceutical Advertising Influence
Prescribing Practices?

• Survey of 29 studies on the influence of Meetings
  with Sales Reps and Industry-Sponsored CME on
  MDs (Wazana JAMA 283373, 2000)
• Associated with subsequent requests to add drugs
  to formulary
• Drug company sponsored CME preferentially
  highlighted the sponsors drugs
• Attending sponsored CME events associated with
  increased prescription rates of sponsors
  medications

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Effect of Direct to Consumer Advertising

• 3.1 billion spent on direct advertising to
  consumers in 2003 (PhRMA)
• Average American saw 9 Ads/day for drugs in 1999
  (BMJ 2002)- heightens awareness of disease and
  medications
• Patients who saw DTCA significantly more likely
  to request the drug and 16 times more likely to
  receive the drug (Quality Safety in Healthcare
  14246, 2005) similar findings using
  standardized patients making specific, general,
  or no requests (JAMA, 2942436, 2005)
• No studies on patient satisfaction with care or
  the impact of DTCA on health outcomes or economic
  costs of altered prescribing

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Distribution of Free Samples of Medications

• 16.3 b annually (retail value according to
  PhRMA)
• Sales Representatives (Can Fam Physician 411363,
  1995)
• 59 provided Rx drugs to persons other than MDs
• MDs
• 51/53 MDs, RNs, residents, office staff
  reported some use of drug samples (JAMA 278141,
  1997)
• 20 of encounters used free samples
  (J.Fam.Practice 49817, 2000)

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Distribution of Free Samples of Medications

• Internal medicine residents (29) randomly
  assigned to use free samples of drugs or not in
  an urban primary care clinic (AJM 118881, 2005)
• 390 treatment decisions over 6 month period
• Users of free samples
• Less likely to prescribe unadvertised drugs
• Less likely to choose OTC drugs
• Trend toward less use of inexpensive drugs

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Medical Students Exposure to Pharmaceutical
Marketing

• University of Minnesota Medical Students
• 114 preclinical students
• 107 clinical students
• Results
• Nearly all students had at least one exposure to
  pharma advertising.
• 68 had not discussed pharma advertising with a
  faculty member
• 72 of clinical and 33 of preclinical recalled
  20 pharma encounters
• Acad Medicine 791041, 2004

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Predictors of Internal Medicine Residency Board
(ABIM) Program Pass Rates (3 year running
average)

• Inversely Related
• Financial support from drug companies
• Clinical duties of residency director (less time
  for residents)

• Positively Related
• Number of faculty

Acad Med 20027750
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What Does the Public Want? (BMJ Poll 6/03 -1479
Respondents)

• MDs to stop seeing Drug Reps
  79
• MDs to stop receiving Gifts 84
• MD education from independent
• sources 84
• MD ties to Pharmaceutical
• Industry should be transparent
  96

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Why Develop Guidelines for Relationship between
Pharma and Academic Physicians?

• Academic medicine sets standard for the quality
  of medical education including the lifelong
  learning habits of trainees
• Professionalism about doctors not pharma!
• Legal risk
• Academic medical centers and academic physicians
  viewed as vital societal resource
• Affirmation and clarification of ethical
  standards
• Cost issues, particularly for AMCs

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Overview of Guidelines/Requirements

• No gifts
• No meals
• No free medications for personal use
• Resolution of COI through peer review or
  elimination of SFI (e.g., AACME compliant)
• Educational stipends only through Departments or
  Sections
• No sponsorship of educational activities on
  campus
• Recommendations for participation in
  pharma-sponsored educational events off campus

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Steps in Formulating and Approving the Guidelines

• Issue raised before clinical chairs
• A proposal distributed to chairs and universitys
  general counsel
• Comment period
• Guidelines released to faculty for review and
  comment
• Proposal sent to Pharmaceutical companies
• Guidelines reviewed with YNHH
• Guidelines reviewed by Yale Medical Group Board
  of Governors
• Approved by YMG Board (May 2005)
• Distributed to faculty and pharmaceutical
  companies

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Lessons Learned from Developing the Guidelines
The Good

• Consensus among faculty for insuring objectivity
  of clinical and educational programs
• Iterative and inclusive process improved clarity
  and content
• The debate was constructive for the Chairs
• Identified potential legal risks for faculty
• Important to unlink pharma support for research
  from that for support of education
• Importance of input from General Counsel and from
  Pharmaceutical industry
• Importance of core faculty working group
• Constructive efforts of YMG and YNHH

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Lessons Learned from Developing the
GuidelinesThe Bad

• Process slow (11 months) and tedious - came to a
  vote before Board three times before being passed
• Objections not consistently stated openly
• Concerns among some faculty and pharma regarding
  pharma bashing
• Compromises in content
• Difficulty in developing enforcement provisions

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Impact of the GuidelinesThe Good

• Brought clarity to the rules
• Positive for image of YMG-YSM
• Stimulated dialogue with industry
• Sets standards for broadening to relationships
  with other commercial entities
• Helped University-Medical School relationship?
• Financial impact less than anticipated

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Impact of the Guidelines The Bad

• Has increased food budget of the
  Department/Sections (80,000 at BUSM)
• Some negative feelings among pharmaceutical
  representatives
• Has reduced support for CME and travel for
  trainees

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Impact After One YearQuery of the Clinical Chairs

• 1. Are the guidelines being followed?
• 2. Whats been the financial impact of the
  guidelines?
• 3. Would you change any aspect of the guidelines?

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Impact After One Year

• Chair 1 The guidelines have not had a dramatic
  effect on our department except that the house
  staff are getting thinnerAs you know, I dont
  agree with some aspects of the guidelines, but
  there is no point in going over all that again.
• Chair 2 They (guidelines) are being followed
  to the letter of the law at YNHH, the medical
  school and YPB. We have allowed XXX to continue
  to provide lunches off site. He is a XXX rep who
  is much loved by many generations of Yale XXX and
  is retiring in the Fall-I didnt have the heart
  to blow him off. No financial impact, we have
  continued to seek unrestricted support for
  interns attendance at the XXX meeting

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Impact After One Year

• Chair 3 Im not aware of any direct effect.
  Our interactions with Pharma, however have been
  limited.
• Chair 4 Weve stopped all drug company support
  of sub-specialty lunches on site (for example,
  about 10 months ago, a drug company provided a
  lunch in GI clinic, complete with chef in
  uniform!). Drug companies have never underwritten
  our house staff lunches, parties, etc, so this
  did not present a problem. Theres been no
  financial impact. Wouldnt change a thing.

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Conclusions

• Process for developing guidelines can affirm
  institutional and professional values
• Guidelines for relationships between faculty in
  AMCs and commercial entities have important
  benefits for academic institutions and
  individuals
• Quality of Education
• Legal
• Professionalism
• Image
• Role of AMCs
• Adverse impact of more stringent guidelines for
  interactions between pharma and faculty have been
  minimal