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An Ethical Framework for Clinician/Industry Interactions

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Title: An Ethical Framework for Clinician/Industry Interactions


1
An Ethical FrameworkforClinician/Industry
Interactions
  • Mansoor Malik MD
  • Howard University Hospital

2
The CAGE Questionnaire for Drug Company
Dependence
  • Are you Carrying a pen with a drug company logo?
  • Do you get Annoyed by people who complain about
    drug lunches and free gifts?
  • Are you planning to Go to a drug company event
    this week?
  • Do you drink your morning Eye-opener out of a
    coffee mug given to you by a drug rep?
  • If you answered yes to 2 or more of the above,
    you may be drug company-dependent.

3
  • Q1 What percentage of residents surveyed were
    carrying items
  • with a pharmaceutical company logo or product
    brand on
  • them?
  • a) 79
  • b) 88
  • c) 97

4
  • 97 of residents surveyed were carrying items
    with a pharmaceutical company logo or product
    brand on them.
  • 98 of residents surveyed had also eaten at least
    one pharmaceutical company-provided meal sometime
    in the
  • previous 12 months.
  • Chern M-M, Landefeld S. Physicians Behavior and
    Their Interactions With Drug Companies A
  • Controlled Study of Physicians Who Requested
    Additions to a Hospital Drug Formulary. JAMA,
  • 1994, 2710,684-689

5
  • During one six-week period, a medical resident
    reported being offered
  • 12 free breakfasts, 18 lunches, 16 branded pens,
    a branded eyeglasses cleaner, 2 penholder
    necklaces, branded pill holders, post-it pads,
    notepads, a pocket Physicians Desk Reference,
    correction paper rips, a coffee mug, a poster,
    a highlighter, a copy of the DSM-IV, a giant
    clip/fridge magnet, a ruler, a water/oil globe, a
    History of Viagra book, and even a Viagra soap
    dispenser.
  • Silver-Isenstadt J. National Physicians Alliance
    testimony to District of Columbia Health
    Committee (18 October 2007).

6
  • Q What percentage of residents surveyed
    acknowledged that
  • the gifts and meals can influenced prescribing
    patterns?
  • a) 79
  • b) 87
  • c) 91

7
  • 91 of residents surveyed acknowledged that the
    gifts and meals can influence prescribing
    patterns, they decrease objectivity and increase
    the possibility of prescribing being done based
    on decisions other than the best interests of the
    patient.

8
Full Disclosure
  • No financial conflicts

9
Full Disclosure
2010 Gifts and Meals
  • 10 Lunches
  • 12 Detail visits
  • 8 Pens
  • 1 Sticky pad
  • 4 Dinners
  • 2 Toys
  • But no
  • Theater tickets
  • Resort junkets
  • Golf excursions
  • Turkeys or hams

10
Aims and Objectives
  • Review physician-industry interactions
  • Impact
  • Perception
  • Ethics
  • Review Cognitive Dissonance
  • Review Ethical Guidelines
  • Practical Strategies
  • Pedagogical Implication

11
Landscape
  • Increased scrutiny of physician/industry
    relations
  • High profile cases
  • Restrictive laws Vermont and Massachusetts

12
Physician Payment Sunshine Act
  • Passed with Patient Protection Affordable Care
    Act
  • A transfer of anything the value of which is more
    than 10
  • Gift Food Entertainment Travel or trip
    Honoraria Research funding or grant Education
    Research profit distribution consultation/speaki
    ng fees
  • Will be enacted 2013

13
Physician Payment Sunshine Act
  • Name Business address Physician specialty
    National provider identifier Disclosed and made
    available to public
  • Knowingly failing to submit payment information
    will result in a civil money penalty of not less
    than 10,000, but not more than 100,000, for
    each payment.

14
PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY
  • Healthcare in US is a Two Trillion dollar
    Industry
  • In 2000 Pharma spent 11 billon on promotions
  • 5 billion went to sales representatives
  • An estimated 8000 to 13,000 per year on each
    physician.
  • Wazana, Ashley, JAMA, vol 283 pp 373 380.

15
Economic Issues
  • 2011 Sales of Prescription Drugs
  • Expected to top 880 Billion Globally
  • 7 increase since 2008

Pharmaceutical Research and Manufacturers of
America (PhRMA)
16
PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY
  • Annual marketing budget of US drug industry
    57.5B
  • 61,000 per physician
  • Considerably greater than total budgets of all US
    medical schools and residency programs
  • Gagnon and Lexchin, PLoSMed5(1), 2008

17
PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY
  • With a ratio of 1 industry representative for
    every 4.7 physicians.
  • Average physician sees about 10 pharmaceutical
    sales representatives each month
  • Greene J. AMA Spearheads Gift Education Crusade.
    American Medical News 2001

18
Return on Investment from Marketing Strategies
for each dollar spent in 1999
19
PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY
  • 83.8 of all respondents reported some type of
    relationship with industry during the previous
    year
  • 63.8 received drug samples
  • 70.6 food and beverages
  • 18.3 reimbursements
  • 14.1 payments for professional services
  • Campbell, Arch Intern Med. 2010170(20)1820-1826

20
PHYSICIANS AND THEPHARMACEUTICAL INDUSTRY
  • Industry provides 60 of funding for biomedical
    research which is more than all of the National
    Institutes of Healthfunded research combined.
  • Industry provides more than 50 of funding for
    continuing medical education, which amounts to
    about 3 billion annually.

21
Economic Issues
  • Research and Development Costs 2002
  • 24.2 of total sales are spent on research and
    development

Pharmaceutical Research and Manufacturers of
America (PhRMA)
22
Economic Issues
  • Promotional Costs 2002
  • 12.9 of sales (PhRMA)
  • vs
  • 22 of sales (Nofreelunch.com)

Unrestricted education grants are tax-deductible
charitable contributions, not promotion costs
23
Economic Issues
  • Are Medicines Too Expensive?
  • Research and development costs are high
  • A single lawsuit can be catastrophic
  • Patent protection is time-limited

24
Economic Issues
  • Are Medicines Too Expensive?
  • but
  • Pharmaceutical stocks are considered among the
    most profitable and consistent investments
    available

25
Economic Issues
  • Are Medicines Too Expensive?
  • but
  • High profitability is essential for the
    maintenance of an aggressive research and
    development program

26
Why Do We Do It?
  • Contacts with industry are unavoidable
  • Physician Desk Reference
  • Prescription of proprietary drugs
  • Sponsorship of professional meetings
  • Advertisements in professional journals
  • Response to academic activity

27
Why Do We Do It?
  • Contacts with industry are desirable
  • Sponsorship of educational programs
  • Sponsorship of professional organizations
  • Sponsorship of research
  • Notification of product availability
  • Exposure to proprietary information
  • Academic input into research and marketing

28
But...
Industrys priorities differ from those of
clinical and academic medicine
Is it possible to benefit from industry contacts
without compromising the integrity of clinical
and academic medicine?
29
Competing Goals
Pharmaceutical Industry Profit-making
enterprise Duty is to stockholders
Medicine Advocate for patient interest Duty
is to patients
30
Primary Aims
31
Positive Practices
32
Negative Practices
33
Oversight
34
Major Dangers
  • Clinical compromise
  • Research bias
  • Academic corruption

35
What is Conflict of Interest in the clinical
setting?
  • When interests of the clinician do not align with
    the interests of their patients.

36
Industry Interactions with Physicians
  • Marketing Contacts
  • Physician detailing
  • Lunch/dinner meetings and presentations
  • Advertisements

37
Industry Interactions with Physicians
  • Educational Programs
  • Unrestricted education/research grants
  • Industry-sponsored symposia
  • Patient education materials
  • Journal sponsorship

38
Industry Interactions with Physicians
  • Contract Services
  • Scientific advisory boards
  • Marketing advisory boards
  • Speakers bureaus
  • Research design, participation, and publication

39
  • An industry representative invites you and a
    guest
  • to dinner and a lecture at an upscale restaurant
    at
  • The Mall. Following dinner, you also receive a
    gift certificate for shopping at The Mall.
  • Should you accept this offer?

40
Non-Maleficence and Beneficence
  • When developing new products, industry is
    required to demonstrate that a new product
  • is safe
  • provides a benefit to patients

41
Respect for Autonomy
  • Protection from Intrusion into the
    Physician-Patient Relationship
  • MD influenced to prescribe certain product
  • Patient should know of any relationship between
    MD and company whose product is being recommended

42
Distributive Justice
  • Fair or just distribution of rights and
    responsibilities, such as
  • to each an equal share
  • to each according to need
  • to each according to merit

43
Fiduciary Relationships
  • Fiduciary is often used to describe the
    patient-physician relationship because
  • A) patients place their trust and well-being
    in the hands of physicians
  • B) physicians are responsible for the
    welfare of patients
  • C) physicians respond to patients actual
    (vs. perceived)needs
  • D) physicians are responsible for controlling
    patient/third party
  • payer expenses for medications and other
    medical services

44
Physicians and Conflicts of Interest
  • Because of the fiduciary nature of the
    patient/physician relationship, it is generally
    expected that physicians should avoid conflicts
    of interest that may undermine patient care.
  • For actual or perceived conflicts that cannot be
    avoided, disclosure may function as the primary
    mechanism to reduce the effect of the conflict.

45
  • What do physicians think of this

46
Attitudes and practices of medicine housestaff
toward pharmaceutical promotions
  • Survey of 117 1st and 2nd year residents at a
    university-based IM training program.
  • Attitudes towards 9 types of promotion assessed.
  • 90 response rate (105/117 residents).

Am J Med 2001110551
47
Attitudes and practices of medicine housestaff
toward pharmaceutical promotions
Am J Med 2001110551
48
It is Just Free Lunch?
  • 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

-Steinman MA, 2001Arch Intern Med.
20031632213-2218
49
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
50
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
51
  • How do you account for the discrepancy ?
  • Cognitive Dissonance

52
Festingers Theory of Cognitive Dissonance
  • When Prophecy Fails 1957
  • Festinger, Riecken, Schacter

53
Cognitive Dissonance
  • Subjects are paid varying amounts of money (e.g.
    1 or 100) for writing essays expressing
    opinions contrary to their own
  • Those in the 1 group rated them more positively
    than those in the 100 group
  • Less external justification and forced to
    internalize the attitude they initially opposed

54
Prophecy from planet Clarion flee the flood
  • House wife in Chicago Dorothy Martin, (Sister
    Thedra ), received messages in the form of
    automatic writing from alien from planet Clarion
  • Believed that world would end in a great flood
    before dawn on December 21, 1954
  • Group gave away everything and waited for the
    flying saucer

55
Failure of Prophecy from planet Clarion
  • The group begins an urgent campaign to spread its
    message to as broad an audience as possible.
  • Reversal of its previous distaste for publicity
  • Merged into Dianetics and Scientology ?

56
Dissonance Model
Motivation to reduce dissonance
Two inconsistent cogntions (e.g., an attitude
and a counter- attitudinal behavior)
State of dissonance
Attitude change
57
Dissonance Model
Motivation to reduce dissonance
Two inconsistent cogntions (e.g., an attitude
and a counter- attitudinal behavior)
State of dissonance
Attitude change
Justification for counter- attitudinal behavior
UNLESS
58
Dissonance Model
Motivation to reduce dissonance
Two inconsistent cogntions (e.g., an attitude
and a counter- attitudinal behavior)
State of dissonance
Attitude change
Justification for counter- attitudinal behavior
UNLESS
59
Cognitive Dissonance
  • Subjects are paid varying amounts of money (e.g.
    1 or 100) for writing essays expressing
    opinions contrary to their own
  • Those in the 1 group rated them more positively
    than those in the 100 group
  • Less external justification and forced to
    internalize the attitude they initially opposed

60
Moral of the Story
  • No gift is too small

61
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
62
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
63
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
64
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
65
Ghostwriting
  • JAMA study defined a ghostwriter as any unnamed
    individual who made substantive
  • intellectual contributions or writing other than
  • copy-editing
  • 7.9 in JAMA
  • 4.9 in the Annals of Internal Medicine
  • 10.9 rate NEJM
  • 7.6 in The Lancet
  • Flanagin at el JAMA, July 15, 1998Vol 280, No.
    3

66
How reliable are marketing brochures
  • Only 6 of the brochures contained statements
    that were scientifically supported by
    identifiable literature
  • Tufts, A BMJ 2004 328 485

67
How reliable are marketing brochures
  • Only 40 were compared to another treatment
    regimen
  • 15 of the promotional marketing brochures
    presented data that was different from what was
    in the original published study
  • Only 5 presented a relative risk reduction
    while only 1 brochure presented an absolute risk
    reduction
  • Cardarelli et al, BMC Fam Pract. 2006 7 13

68
How reliable are marketing brochures
  • 122 GP in Pakistan
  • Promotional materials covering 182 drugs
  • One quarter (21), false claims , no evidence
    to support
  • exaggerated (32), ambiguous (26), and
    controversial (21).
  • Rohra et al, J Pharm Pharm Sci. 20069(1)50-9

69
  • Health knowledge of both physicians and patients
    systematically distorted by views and models of
    disease that sell the most drugs

70
False Claims Act Settlements
  • AstraZeneca pays 520 million to resolve
    allegations that Seroquel was promoted for uses
    not FDA approved
  • Alpharma Inc. pays 42.5 million to resolve False
    Claims Act allegations in connection with the
    marketing of the morphine-based drug Kadian
  • WarnerLambert paid more than 430 million to
    settle illegal marketing charges for Neurontin

71
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)

72
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)

73
FDA Guidelines
  • All marketing materials must be FDA approved, and
    information shared during marketing contacts may
    not exceed the boundaries of approved packaging
    information
  • Sponsored speakers may answer questions, but may
    not initiate or perpetuate discussion of
    off-label drug uses

74
FDA Guidelines
  • Sponsored speakers may only discuss information
    derived from accepted research methods or
    recognized expert consensus opinion
  • Research studies involving a competitors drug
    must follow packaging guidelines for the drug

75
ACCME Guidelines forCME Programs
  • Potential or perceived conflicts of interest
    regarding the topic of the presentation must be
    disclosed
  • Presentations must include specific learning
    objectives
  • The speakers qualifications must be appropriate
    to the topic covered

76
AMA Ethical Guidelines
  • Any gift should benefit patients
  • Gifts should be of minimal value and related to
    the physicians work
  • No gifts should be accepted with strings attached

77
AMA Ethical Guidelines
  • Support for legitimate conferences or meetings
    (including faculty honoraria) is permissible
  • Subsidies for individual physicians to attend
    meetings are not permissible
  • Scholarships for residents and fellows must be
    assigned by the training program

78
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 a
    breadth of charity that raises you far above the
    petty jealousies of life.

-Sir William Osler
79
Readings
  • Lexchin J. Interactions between physicians and
    the pharmaceutical industry What does the
    literature say? Can Med Assoc J 1491401-07
    1993
  • Rosner F. Pharmaceutical industry support for
    continuing medical education programs A review
    of current ethical guidelines. Mt. Sinai J Med
    62427-63 1995
  • Wazana A. Physicians and the Pharmaceutical
    Industry Is a gift ever just a gift? JAMA
    283373-80 2000
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