The PhysicianPharmaceutical Company Relationship

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The Physician-Pharmaceutical Company Relationship

• Slide presentation adapted from
• No Free Lunch

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Pharmaceutical promotion in clinical practice

• Ethics
• Medical education
• Good medical practice
• Costs

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The Hidden Curriculum

• Pharmaceutical Industry
• Data Collected by Dr. Fitz

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of contacts with Drug Reps?
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Have you received gifts?
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Should students receive gifts?
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Should Docs Receive Gifts?
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Your Thoughts? OK or Not OKA Yes B
No

• Pens/Mugs with logos
• Calipers, Stethoscope IDs
• (Small) References (i.e., Sanford, Washington
  Manual)
• (Big) Texts
• Fogo de Chao
  plus SO?
• Golf
• Sporting Event Tickets
• Travel to a Conference

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But other businesses take gifts.

• However, in the market place
• If the gift increases costs..
• the company wont remain competitive
• If the gift decreases quality ditto
• And, in areas of public trust
• Can you say Kick Back, Bribe, Big House

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With doctors its different

• If we take gifts, the patient and/or public pays.
• We have no risk
• Unless you count integrity, professionalism, etc

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Goals

• Review policy statements governing
  physician-pharmaceutical interactions.
• Understand the staggering dollar amounts spent in
  marketing medications.
• Appreciate who is at risk who needs to be
  protected.
• Leave more informed and prepared to make your own
  personal decision regarding the role of drug reps
  in your life.

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Goals

• Review policy statements governing
  physician-pharmaceutical interactions.
• AMA
• ACP-ASIM
• Royal College of Surgeons
• Canadian Medical Association
• All give similar recommendations

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American College of PhysiciansPhysicians and the
Pharmaceutical IndustryPosition Statement

• Gifts..ought not to be accepted
• if acceptance might influence or appear to others
  to influence the objectivity of clinical
  judgement.
• A useful criterion is
• Would you be willing to have these arrangements
  generally known?

Ann Int Med April 1990
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American Medical AssociationCouncil on Ethical
Judicial Affairs

• Any gifts should primarily entail a benefit to
  patients and should not be of substantial value.
• Subsidies should not be accepted to pay for
  travel, lodging, or personal expenses. . .
• No gifts should be accepted if there are strings
  attached.

JAMA 1991261501
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ACP-ASIM Position PaperPhysician-Industry
Relations

• Physicians have an obligation to themselves,
  their profession, and society to evaluate,
  correct for, and eliminate potential bias in
  medical information from all sources."

Ann Int Med 2002136000
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ACP-ASIM Position PaperPhysician-Industry
Relations

• A perception that a physician is dispensing
  medical advice on the basis of commercial
  influence is likely to undermine a patient's
  trust not only in the physician's competence but
  also in the physician's pledge to put patients'
  welfare ahead of self-interest.

Ann Int Med 2002136000
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ACP-ASIM Position PaperPhysician-Industry
Relations

• Physicians frequently do not recognize that
  their decisions have been affected by commercial
  gifts and services and in fact deny industry's
  influence.

Ann Int Med 2002136000
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No Strings Attached

• Physicians should not accept gifts if
• they are given in relation to the physicians
  prescribing practices.
• In addition, when companies underwrite medical
  conferences
• responsibility for the selection of content,
  faculty, educational methods, and materials
  should belong to the organizers.

Ann Int Med 2002136000
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ACP-ASIM Position Paper 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.

Ann Int Med 2002136396
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PhRMA Code on interactions with healthcare
professionals

• Who is PhRMA?
• Pharmaceutical Research and Manufacturers of
  America
• PhRMA Mission?
• devoted to inventing medicines that allow
  patients to live longer, healthier, and more
  productive lives

www.PhRMA.org, April 2002
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PhRMA Code on interactions with healthcare
professionals

• Items primarily for the benefit of patients may
  be offered if
• they are not of substantial value (100 or less).
• 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 PhRMA code, may golf balls and/or
  sports bags be given bearing a company logo?

www.PhRMA.org
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PhRMA Code FAQs

• Question
• Under the PhRMA code, may golf balls and/or
  sports bags be given bearing a company logo?
• Answer
• No

www.PhRMA.org
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PhRMA Code FAQs

• Question
• Under the PhRMA code, stethoscopes be given?

www.PhRMA.org
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PhRMA Code FAQs

• Question
• Under the PhRMA code, stethoscopes be given?
• Answer
• Yes

www.PhRMA.org
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Goals

• Review policy statements governing
  physician-pharmaceutical interactions.
• Understand the staggering dollar amounts spent in
  marketing medications.

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The Dollars

• The cost of developing a new drug is now
  estimated at close to 1 billion.
• Spending on drugs in the U.S. has risen by double
  digits in the past few years.

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Physicians and the Pharmaceutical Industry Is a
Gift Ever Just a Gift?Ashley Wazana, MD

• The pharmaceutical industry spends an estimated
  10,000 per year on each physician in marketing
  its products.
• .1 drug rep per 11 physicians

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Pharmaceutical companies spend over 10
billion/year on drug promotion in the U.S.

• This is
• More than is spent on RD
• More than is spent on the raw materials for their
  products
• More than is spent on medical school and
  residency training combined.

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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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Main task of drug company employees, 2000
Source PhRMA Industry Profile 2000 percentages
calculated by Sager and Socolar
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Profitability of drug industry, l993-2000 .

• Source Public Citizen update of Stephen W.
  Schondelmeyer calculation, Competition and
  Pricing Issues in the Pharmaceutical Market,
  PRIME Institute, University of Minnesota based on
  data found in Fortune magazine, 1958 to 1999
  Fortune magazine, April 2000, Fortune 500
  (www.fortune.com).

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Goals

• Review policy statements governing
  physician-pharmaceutical interactions.
• Understand the staggering dollar amounts spent in
  marketing medications.
• Appreciate who is at risk who needs to be
  protected.

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That stuff doesnt influence me at all. I dont
even know what drug is on my pen. I just go for
the food. --Fill in your name here?
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Whats the Evidence?
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Interactions with the pharmaceutical industry
experiences and attitudes of residents, interns,
and clerks.

• Survey of 105 residents, interns, and clerks
  rotating through 7 teaching hospitals in Toronto,
  Canada
• whats in the pockets?
• Findings
• The number of promotional items correlated with
  the belief that discussions with reps have no
  impact on prescribing behavior.

CMAJ 1995153553
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Interactions with the pharmaceutical industry
experiences and attitudes of residents, interns,
and clerks.

• 66 believed that discussions with reps DO impact
  physicians prescribing practices .
• However only 44 said their own prescribing was
  affected.
• (Only) 42 disagreed with the statement I would
  maintain the same degree of contact with reps if
  no gifts were distributed.
• Would 58 truly interact with drug reps just as
  much?

CMAJ 1995153553
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It may affect others.but not me!
p Am J Med 2001110551
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The role of commercial sources in the adoption of
a new drug

• Physicians who cited the literature as their
  1st source of information were more likely to
  prefer alternatives
• i.e., less expensive, equally effective meds.
• Doctors who had received a sample were more
  likely to prescribe the sample med than those who
  hadnt.

Soc Sci Med, 1988261183
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Physicians, Pharmaceutical Sales Representatives,
and the Cost of Prescribing

• 3 case scenarios acute bronchitis, mild HTN, and
  uncomplicated UTI.
• .found a direct correlation between the cost of
  the prescribed medicine and
• Perceived credibility of information provided by
  pharmaceutical reps (p
• Frequency of drug rep contact (p

Arch of Fam Med 19965237
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ACP-ASIM Position PaperPhysician-Industry
Relations

• Physicians must keep in mind that
  industry-supplied medical information, although
  neutrally packaged, is in fact promotional.

Ann Int Med 2002136000
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Pharmaceutical Advertisements in Leading Medical
Journals Experts Assessments

• FDA regulations specify that ads are false,
  lacking in fair balance, or otherwise misleading
  if
• They make claims about relative safety and
  efficacy or about the populations in which the
  drug is useful that are not supported by the
  current literature.
• Use literature or references inappropriately to
  support claims in the advertisement.
• Use statistics erroneously.
• Use headlines, sub-headlines, or pictorial or
  other graphic material in way that is misleading.
• Dont Believe Everything You Read.

Ann Int Med 1992116912
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Characteristics of Materials Distributed by Drug
Companies An Evaluation of Appropriateness

• Setting Academic internal medicine residency
  program, an HMO, and a private internists
  office.
• All materials left behind by drug reps or mailed
  to offices over a 7-month period. 482 items
  analzyed.
• Determined if items met FDA requirements for
• Fair balance
• Adequate instructions for use
• Discussion of approved uses only

JGIM 199611575
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Characteristics of Materials Distributed by Drug
Companies

• 42 of the drug rep materials failed to comply
  with at least one FDA requirement

JGIM 199611575
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Pharmaceutical Advertisements in Leading Medical
Journals Experts Assessments

• Question
• If this advertisement were subject to the same
  review criteria as a scientific article, would
  your suggestion be to accept in present form,
  accept with minor revisions, accept with major
  revisions, or reject the advertisement?

Ann Int Med 1992116912
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Pharmaceutical Advertisements in Leading Medical
Journals Experts Assessments
Ann Int Med 1992116912
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The Quantity and Quality of Scientific Graphs in
Pharmaceutical Advertisements

• Review of all pharmaceutical ads in from 10
  leading American journals in 1999.
• 498 unique advertisements (3,185 total).
• 74 unique graphs
• 36 of graphs contained numeric distortion.

JGIM 200318294-297
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ACP-ASIM Position Paper Physician-Industry
Relations

• Physicians frequently do not recognize that
  their decisions have been affected by commercial
  gifts and services and in fact deny industry's
  influence.
• Research, however, shows a strong correlation
  between receiving industry benefits and favoring
  their products.

Ann Int Med 2002136000
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The pharmaceutical industrys influence on chief
medical residents. Adler, L, Muller D, Bao P,
Lan J, Haddow S. JGIM. 1999 14supplement 2128.

• National survey of 84 chief medical residents.
• 100 reported that their programs participated in
  pharmaceutical company-sponsored theatre or
  sporting events
• 67 had personally participated in such events.
• Thirty percent said that the reps were more
  likely to get access to the housestaff if they
  left gifts
• 27 asked for gifts.

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Goals

• Review policy statements governing
  physician-pharmaceutical interactions.
• Understand the staggering dollar amounts spent in
  marketing medications.
• Appreciate who is at risk who needs to be
  protected.

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Senior Citizens

• 31 lack coverage for prescription drugs.
• Average 21 prescriptions a year.
• About 45 have incomes at 200 or less of the
  poverty line.
• That's 16,000 to 18,000 a year before taxes.
• The average senior citizen today has 2 to 2 ½
  chronic conditions
• A drug just for one chronic condition can cost
  between 500 and 3,000 a year.

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To Repeat

• The Research-based pharmaceutical industry
  spends more on marketing and administration than
  it does on research and development.
• U.S. Drug spending increased 17.1 to 154.5
  billion dollars in 2001. One-quarter of this
  increase was due to a shift to the use of more
  expensive drugs. 
• Pharmaceutical industry profits were 18.5 of
  revenue in 2001. For the remainder of Fortune 500
  companies, median profits were 3.5

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Gifts

• Create relationship, obligation.
• Cost money -- patients pay.
• Erode professional values, damage image of
  profession.
• Influence behavior.

JAMA 19892623448
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What About Residency Program Policies?
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Benchmarks of support in internal medicine
residency training programs

• Survey of U.S. internal medicine residency
  program directors to identify characteristics of
  support of programs.
• Results were correlated with 3 year running
  average of ABIM exam pass rates
• 73 response rate

Acad Med 20027750
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Benchmarks of support in internal medicine
residency training programs

• 3 independent predictors of program pass rates
• Positively related
• Number of faculty
• Negatively related
• Clinical responsibilities of program director
• Financial support from pharmaceutical companies

Acad Med 20027750
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EpilogueDo doctors need drug reps?

• MedicalLetter.com
• Micromedex.com
• MDConsult.com
• Uptodate.com
• etc.

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A comparison of physicians and patients
attitudes toward pharmaceutical industry gifts

J Gen Int Med 199813151
P
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A comparison of physicians and patients
attitudes toward pharmaceutical industry gifts

J Gen Int Med 199813151
P
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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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Our Residency

• Unrestricted Donations to Educational Fund
• We pick topic and speaker
• No physical presence
• Recognize support via flyer
• No gadgets/gizmos
• Post-CPCs
• Attending donatations
• Tuesdays/Friday
• DOM (i.e. attendings collections)
• 7th Floor Support Office
• Leave flyers
• Appointment Only
• Your time is your time
• Secretaries wont distribute flyers/email, etc

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Just say no to drug reps