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Medicine and Industry: An Ethical Dilemma

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Title: Medicine and Industry: An Ethical Dilemma


1
Medicine and Industry An Ethical Dilemma
Family Medicine Clinical Clerks Discussion 2008
  • Jeff Susman, MD
  • Professor and Chair
  • Department of Family Medicine
  • University of Cincinnati
  • susmanjl_at_uc.edu

Revised, June 2, 2008
2
Case 1
  • It is a busy day in your preceptors office, but
    you have agreed to speak for a minute to a
    pharmaceutical representative who has stopped by
    to drop off some samples of a new quinolone
    antibiotic, called Ubiquinone. He offers you golf
    balls emblazoned with the letter U, and invites
    you to a round of golf at the country club this
    weekend.
  • Would you accept the golf balls?
  • Would you accept the invitation?

From Really difficult Problems in Medical
Ethics
3
Are gifts from pharmaceutical companies ethically
problematic? A survey of physicians
P.08
P.04
P.05
P.88
P.10
P.34
Arch Intern Med. 20031632213-2218
4
Attitudes of residents toward pharmaceutical
promotions
Am J Med 2001110551
5
Attitudes and practices of residents toward
pharmaceutical promotions Perceived influence of
pharmaceutical reps on prescribing practices
You
Other Physicians
Am J Med 2001110551
Plt.0001
6
A comparison of physicians and patients
attitudes toward pharmaceutical industry gifts

J Gen Int Med 199813151
Plt.004 for all except mug, p.24)
7
A comparison of physicians and patients
attitudes toward pharmaceutical industry gifts

J Gen Int Med 199813151
Plt0.0001 for all except trip, p0.0017
8
Conflict of interest?
  • I have never been bought, I cannot be bought. I
    am an icon, and I have a reputation for honesty
    and integrity, and let the chips fall where they
    may. It is true that there are people in my
    situation who could not receive a million-dollar
    grant and stay objective. But I do.

9
Disclosures
  • Editor for JFP, owned by a privately held, for
    profit
  • Medical Co-editor UpToDate
  • STFM Industry Strike Force
  • Medical malpractice work
  • Pharma stock
  • Paid consultant to Pfizer, Forest, Wyeth,
    Neurocrine
  • Ive ghost-written, participated in symposia,
    done paid CME talks, even ate food from a dine
    and dash...
  • Now, do I have your attention?

10
What do Professional Organizations Advise?
11
American Medical Association Council on Ethical
Judicial Affairs
  • Any gifts accepted by physicians individually
    should primarily entail a benefit to patients and
    should not be of substantial value.
  • Subsidies from industry should not be accepted
    directly or indirectly to pay for the costs of
    travel, lodging, or personal expenses of the
    physicians who are attending the conferences and
    meetings . . .
  • No gifts should be accepted if there are strings
    attached.

JAMA 1991261501
12
AMA Opinion E-8.061 (2005) Gifts to
Physicians from Industry
Many gifts given to physicians by companies in
the pharmaceutical, device, and medical
equipment industries serve an important and
socially beneficial function. For example,
companies have long provided funds for
educational seminars and conferences. However,
there has been growing concern about certain
gifts from industry to physicians. Some gifts
that reflect customary practices of industry may
not be consistent with the Principles of Medical
Ethics. To avoid the acceptance of inappropriate
gifts, physicians should observe the following
guidelines .
13
AMA Opinion, 2005
  • No gifts should be accepted if there are strings
    attached. For example, physicians should not
    accept gifts if they are given in relation to the
    physicians prescribing practices.
  • Individual gifts of minimal value are
    permissible as long as the gifts are related to
    the physicians work (e.g. pens and notepads)
  • Revision in June 2008?

14
American College of Physicians Guidelines on
Physician-Industry Relations
  • The acceptance of individual gifts, hospitality,
    trips, and subsidies of all types from industry
    by an individual physician is strongly
    discouraged.
  • The acceptance of even small gifts can affect
    clinical judgment and heighten the perception (as
    well as the reality) of a conflict of interest..
  • The dictates of professionalism require the
    physician to decline any industry gift or service
    that might be perceived to bias their judgment,
    regardless of whether a bias actually
    materializes.
  • Ideally, physicians should not accept any
    promotional gifts or amenities, whatever their
    value or utility, if they have the ability to
    cloud professional judgment and compromise
    patient care.

Annals of Internal Medicine 2002136396-402.
15
American College of Physicians Guidelines on
Physician-Industry Relations
  • Acceptable industry gifts
  • Inexpensive gifts for office use (pens and
    calendars).
  • Low cost gifts of an educational or patient-care
    nature (such as textbooks).
  • Modest refreshment.
  • Annals of Internal Medicine 2002136396-402.

16
American Association of Medical Colleges (AAMC)
  • Gifts should not be accepted
  • Drug samples should be distributed centrally
  • Sales reps only by appointment and outside
    patient care areas
  • No food except at CME events
  • Speakers bureaus should not include faculty
  • Ghost-writing not permitted
  • Travel payment should not be accepted

Report of the AAMC Task Force on Industry Funding
of Medical Education to the AAMC Executive
Council, June 18-19, 2008
17
PhRMA Code on interactions with healthcare
professionals
  • Items primarily for the benefit of patients may
    be offered to healthcare professionals if they
    are not of substantial value (100 or less).
  • Items of minimal value may be offered if they are
    primarily associated with a healthcare
    professionals practice.
  • Items intended for the personal benefit of
    healthcare professionals (CDs, tickets to a
    sporting event) should not be offered.

www.PhRMA.org, April 2002
18
PhRMA Code FAQs
  • Question
  • Under the Code, may golf balls and sports bags
    be provided if they bear a company or product
    name?
  • Answer
  • No.

www.PhRMA.org, April 2002
19
PhRMA Code FAQs
  • Question
  • Under the Code, may healthcare professionals be
    provided with gasoline for their cars if they are
    provided with product information at the same
    time?
  • Answer
  • No.

www.PhRMA.org, April 2002
20
PhRMA Code FAQs
  • Question
  • Under the Code, may items such as stethoscopes
    be offered to healthcare professionals?
  • Answer
  • Yes

www.PhRMA.org, April 2002
21
Case 2
  • You sit in on a discussion at your preceptors
    office about whether to continue to see
    pharmaceutical representatives. Your preceptor
    asks your opinion.
  • You respond by saying
  • A. Let me get back to you on that one.
  • I may not like them, but patients need those free
    drugs
  • No wayits about time medicine banned
    pharmaceutical representatives
  • Everyone needs to make a living...

22
I learn a lot from the drug reps
  • When was the last time a drug rep gave you an
    article unfavorable to their drug?

Lancet 2002 359 1648
23
Typical problems with drug rep info
  • Single, favorable clinical trial vs systematic
    review
  • Disease endpoints vs patient oriented outcomes
  • The review articles and monographs are funded and
    may lack peer review
  • Never, never, NEVER give unfavorable info

24
13 noon-time talks by drug reps
  • 106 statements made by drug reps during their
    presentations
  • 11 were inaccurate all of these inaccurate
    statements were about the reps drug and made it
    look better.
  • All 15 statements about competing drugs were
    accurate, but they were also all negative
  • Only 7 of 27 physicians noted any inaccuracies at
    all

25
What do we know?
  • Physicians deny bias but think their colleagues
    are probably influenced
  • Patients feel same way
  • Studies show that interaction with drug reps and
    other pharma interactions
  • Affect prescribing (for the worse)
  • Increase drug costs
  • Create work for practices
  • Affect formulary decisions
  • Am J Med 2001 110 551
  • J Gen Intern Med 1998 13 151

26
I need the samples to help my patients
  • Nexium (esomeprazole) 40 mg samples vs omeprazole
    40 mg prescription
  • Nexium 40 mg copay 30, actual cost 140/month
  • Omeprazole 40 mg copay 10, actual cost
    30/month

27
Patient cost
28
Societal cost - 1320/year
29
Your pharmaceutical rep?
30
Case 3, Continued
  • After a lengthy debate about pharmaceutical reps,
    your preceptor asks, does the University have a
    policy in place?
  • Your respond by
  • Getting another helping of pizza
  • Paging yourself
  • Mumbling something about a H and P that needs
    completed
  • Yes, Im glad you asked that question

31
Health Alliance Policy
  • It is mandatory that representatives schedule
    appointments...
  • Loitering or wandering to spontaneously deliver
    product information is not deemed appropriate.
  • Food may be only be provided if scheduled in
    advance... in
  • conjunction with an informational presentation.
    Take-out meals
  • and meals to be eaten without the company of the
    representative
  • being present (e.g. Dine and dash programs) do
    not facilitate
  • the transfer of quality information and as such
    are prohibited
  • in the Health Alliance.

32
University COM Policy
  • Comprehensive addressing research and scholarly
    activity clinical training and patient care and
    consulting, collateral employment and
    entrepreneurial affairs/technology transfer
  • Incorporates external standards (e.g.,
    International Committee of Medical Journal
    Editors ACCME Standards for Commercial Support
    University Rules
  • Site Access controlled
  • Gifts or Compensation
  • Anything of value provided by or on behalf of
    Industry, including but not limited to food,
    beverages, pharmaceutical or device samples, or
    travel related expenses

33
University COM Policy (II)
  • Unacceptable Gifts and Compensation
  • Incentives for prescribing or for changing a
    patient's prescription to a specific medication
  • Incentives for recommending or utilizing a
    specific diagnostic or therapeutic device
  • It is expected that no form of Gift or
    Compensation from Industry will be accepted by
    Personnel of the University of Cincinnati College
    of Medicine under any circumstances, except as
    reasonable compensation for bona fide services.
  • Other training sites policies are honored if
    they are more restrictive than those in the COM
    Policy
  • Industry Interactions Committee established
  • Training opportunities for faculty, staff and
    students

34
What do you think of the COM Policy?
35
Its a National Issue State Legislative
Initiatives
1993 Minnesota 2002 West Virginia 2002 Vermont 200
3 Maine, District of Columbia 2004 California 2006
Florida, New Hampshire, South Carolina
36
Scope of Pharmaceutical Industry Support
37
Scope of Pharmaceutical Industry Support
  • Commercial CME 600 million, 2001
  • 1500 per doc, in 2003 70 of all CME
  • 24 of top 26 corporate partners for AAFP/F are
    from pharma
  • Rapid growth of CME intermediaries, PriMed, etc
  • Funding of 80 of clinical trials in 2002
  • Even partnerships to fund residencies

On the Take, J Kassirer, New York Oxford, 106
2005
38
Promotional spending on prescription drugs, 2002
Total spending 21 billion
Source IMS Health
39
Our Journals Pure and Unadulterated?
40
Case 4
  • You are reading a new study in the NEJM on the
    effectiveness of a new antibiotic that concludes
    cefakilital is more effective than high dose
    amoxicillin for the treatment of otitis media.
    You...
  • Begin prescribing cefakilital for all your
    patients with otitis
  • Prescribe cefakilital only for patients who fail
    amoxicillin
  • Treat otitis media with antibiotics?
  • Buy stock in the firm publishing the study

41
How Much for Journals?
  • Top 10 US pharma companies spent 31 on marketing
    and administration in 2002
  • PhARMA says 19.1 billion
  • 380 million for journal ads
  • 2.7 billion for DTC
  • 10.5 billion for samples
  • 5.5 billion for doctor visits
  • Angell contents another 35 billion on marketing
    masquerading as education
  • Ads approximately 500 million and 100 million
    for supplements in 2006, but shrinking (1-2 of
    industry funding)

M Angell, The Truth about the Drug Companies,
New York, Random House, 135-155, 2004
42
Drug company jobs in marketing and research,
1995-2000
Jobs
Source PhRMA Industry Profile 2000 percentages
calculated by Sager and Socolar
43
Physicians Link Journals to Advertising
44
Ways Industry Provides Support
  • Advertising
  • Annals, 1992
  • 44 of drug ads would have led doctors to
    improperly prescribe
  • 92 ads in violation of FDA rule
  • Backlash by industry
  • Norvasc most advertised drug in NEJM, 1996, but
    no ads for diuretics
  • Impact of ALLHAT

J Abramson, Overdosed America, New York Harpers
Collins, 113, 2004
45
Further Industry Support
  • Direct sponsorship of publications
  • Lipid Letter
  • National Initiative in Sepsis Education
  • Reprints
  • Supplements, monographs, symposia and other print
    materials
  • Multimedia, meetings and other joint ventures

46
Physicians View Journals as Important Sources of
Information
76.3 of physicians rated journals as most
important source of information
47
Is this Trust Well Placed?
  • Evaluated 70 articles on calcium channel blockers
  • Association of positive stance on safety with
    financial support by manufacturers making these
    drugs (96) if neutral, 67 if negative, 37

As reported by, On the Take, J Kassirer, New
York Oxford, 79 2005 Stelfox et al, NEJM 1998
48
Bias?
  • Suppression of research
  • Immune Response Corporation, Remune
  • Ineffective vaccine, but tried to prevent PI from
    publishing
  • JAMA publication
  • Law suit by IRC (lost)
  • CEO of IRC I spent over 30 million. I would
    think I have certain rights

49
Bias?
  • Vytorin
  • Pravachol and stroke
  • Misleading articles in NEJM and JAMA?
  • The Vioxx story
  • CLASS, VIGOR and DECEPTION?
  • Odds are 3.6 to 4x greater that commercially
    sponsored studies favor a product than those
    without commercial funding

J Abramson, Overdosed America, New York Harpers
Collins, 2004
50
And More Bias?
  • Ghost-writing
  • Case of Dr Richard Atkinson and obesity drugs
    (Xenical, Redux)
  • I think Ive been pretty honest and uncorrupted
    by the money. But who knows, maybe its so
    insidious that I dont notice it
  • The Neurontin story
  • Off label use for pain
  • Avandia

On the Take, J Kassirer, New York Oxford, 33-5
2005
51
How Can We Do Better?
52
How Can We Do Better?
  • See less reps, more patients and fund low cost
    formulary
  • Buy your own pens
  • Full accessibility of primary data and
    registration of clinical trials
  • Editors, editorial boards, and reviewers with no
    financial ties?
  • IOM study
  • Foundation model
  • Professional societies self supporting
  • Free is not cheap enough for a doctor
  • Physicians pay for journals and CME
  • Federal support for publication, CME

53
(No Transcript)
54
(No Transcript)
55
The Unprepared Drug Rep. (Haiku)
Imagine my shock when the rep asked to borrow my
pen. Ironic.
Metkus TS. Ann. Int. Med. 147(11) 818 (December
4, 2007)
56
Selected Resources
  • J Kassirer, On the Take, New York Oxford 2005
  • M Goozner, The 800 Million Pill, Berkeley, CA
    U California Press, 2004
  • J Abramson, Overdosed America, New York Harpers
    Collins, 2004
  • M Angell, The Truth about the Drug Companies, New
    York, Random House, 2004
  • J Avorn, Powerful Medicines, New York Knopf,
    2004
  • G Critser, Generation Rx, Boston Houghton
    Mifflin, 2005
  • British Medical Journal, articles on industry
    sponsorship and bias, www.bmj.org
  • The Association of Medical Publications,
    http//www.amponline.org
  • PhARMA, www.PhARMA.org
  • No Free Lunch http//www.nofreelunch.org
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