Medicine and Industry: An Ethical Dilemma

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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
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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
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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
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Attitudes of residents toward pharmaceutical
promotions
Am J Med 2001110551
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Attitudes and practices of residents toward
pharmaceutical promotionsPerceived influence of
pharmaceutical reps on prescribing practices
You
Other Physicians
Am J Med 2001110551
Plt.0001
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A comparison of physicians and patients
attitudes toward pharmaceutical industry gifts

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

J Gen Int Med 199813151
Plt0.0001 for all except trip, p0.0017
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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.

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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?

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What do Professional Organizations Advise?
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American Medical AssociationCouncil 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
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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 .
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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?

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American College of PhysiciansGuidelines 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.
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American College of PhysiciansGuidelines 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.

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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
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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
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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
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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
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PhRMA Code FAQs

• Question
• Under the Code, may items such as stethoscopes
  be offered to healthcare professionals?
• Answer
• Yes

www.PhRMA.org, April 2002
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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...

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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
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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

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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

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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

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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

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Patient cost
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Societal cost - 1320/year
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Your pharmaceutical rep?
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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

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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.

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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

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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

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What do you think of the COM Policy?
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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
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Scope of Pharmaceutical Industry Support
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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
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Promotional spending on prescription drugs, 2002
Total spending 21 billion
Source IMS Health
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Our Journals Pure and Unadulterated?
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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

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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
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Drug company jobs in marketing and research,
1995-2000
Jobs
Source PhRMA Industry Profile 2000 percentages
calculated by Sager and Socolar
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Physicians Link Journals to Advertising
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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
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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

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Physicians View Journals as Important Sources of
Information
76.3 of physicians rated journals as most
important source of information
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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
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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

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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
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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
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How Can We Do Better?
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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

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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)
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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