Just say no to drug reps

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Just say no to drug reps
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The Physician-Pharmaceutical Industry Relationship
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Are you drug company dependent?
If you answered yes to 2 or more of the above,
you may be drug company dependent.
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Levels of Interactions

• Clinicians
• gifts
• promotional information
• Researchers
• Professional societies medical journals
• Continuing medical education (CME)

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Case

• It is a busy day in the 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. Knowing your interest in
  golf, he has brought you golf balls emblazoned
  with the letter U, and also 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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Is it appropriate for a medical student to accept
any of the following gifts from a pharmaceutical
company?

• small gifts (e.g. pens, writing pads, golf ball)
• a free meal (e.g. lunch at a departmental journal
  club meeting or at a restaurant)
• a textbook (worth R200)
• a stethoscope (worth R500)
• pharmaceutical samples (drug samples)
• tickets to a Bafana Bafana game (worth R150)
• sponsorship for travel and attendance at a
  conference (worth R3000)
• free shares in the company (worth R1000)

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Consider the following

• Is there any potential for harm for the medical
  student?
• What are the implications of accepting a gift
  from a pharmaceutical company?
• Is there anthing wrong with getting something
  for nothing?
• Why may pharmaceutical companies offer such
  freebies?
• Should medical students response to the
  pharmaceutical industry regarding gifts differ
  from that of their seniors (qualified doctors)?
• Would it be fair to prohibit all industry
  presence in medical schools and training
  hospitals and general practices where students
  are placed?

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Attitudes and Practices
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Are gifts from pharmaceutical companies ethically
problematic? A survey of physicians

• Survey of 42 residents and 52 faculty at a
  university-based IM training program.
• 21 item questionnaire. 4 point Likert scale.
• 0 not problematic
• 3 very problematic
• 90 response rate (105/117 residents).
• 93 of residents, 73 faculty responded.

Arch Intern Med. 20031632213-2218
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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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Of principles and pens 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
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Of principles and pens attitudes and practices
of medicine housestaff toward pharmaceutical
promotions
Am J Med 2001110551
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Of principles and pens attitudes and practices
of medicine housestaff toward pharmaceutical
promotions Practices Among Residents Who
Consider Promotion Appropriate
Am J Med 2001110551
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Of principles and pens attitudes and practices
of medicine housestaff toward pharmaceutical
promotions Practices Among Respondents Who
Consider Activity Inappropriate
Am J Med 2001110551
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Of principles and pens attitudes and practices
of medicine housestaff toward pharmaceutical
promotions Perceived influence of
pharmaceutical reps on Prescribing Practices
You
Other Physicians
Plt.0001
Am J Med 2001110551
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Pharmaceutical branding of Resident Physicians

• Survey of 181 primary care residents 164 (91)
  responded.
• First asked to complete survey, then asked to
  empty pockets of white coats.
• 98 had eaten drug company-sponsored meal within
  the past year.
• 97 of residents were carrying at least one item
  with pharmaceutical insignia.

JAMA 20012861024
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Pharmaceutical Branding of Resident Physicians
JAMA 20012861024
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Pharmaceutical Branding of Resident Physicians
JAMA 20012861024
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Patient Attitudes
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A comparison of physicians and patients
attitudes toward pharmaceutical industry gifts

• Survey of physicians and patients at 2 tertiary
  care medical centers (1 military, 1 civilian).
• 196 patients and 268 physicians completed survey.
• 54 of patients were aware that pharmaceutical
  industry gave gifts to physicians.
• Does your own doctor accept gifts? 27 yes, 20
  no, 53 unsure.

J Gen Int Med 199813151
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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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Professional Guidelines
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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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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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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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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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Pharmaceutical industry Spending on Promotion
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Promotional spending on prescription drugs,
l996-2002
Source NIHCM, 2001
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Promotional spending on prescription drugs, 2002
Total spending 21 billion
Source IMS Health
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Direct to consumer advertising on prescription
drugs, l996-2000
Source NIHCM, 2001
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Direct to consumer advertising spending in the
U.S., 2000
Source NIHCM, 2001
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Comparison of median revenue dedicated to RD,
profits, and marketing/administration, Fortune
500 drug companies, 2000 (n11)
Source Public Citizen, 2001
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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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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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Profitability of drug industry, l993-2000
2.8

• 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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Fortune 500 drug company profitability compared
to all other Fortune 500 companies, 2000
Source Public Citizen, 2001
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Sources of increased drug expenditures, 2000-2001
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Total increase 22.5 billion
Source NIHCM, 2002
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Gifts are just a form of promotion or
advertising, and advertising is a part of our
society, like it or not.
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Gifts

• Cost money (like other advertising).
• Influence behavior (like other advertising).
• Create obligation, need to reciprocate (unlike
  advertising). Conflict of interest
• Create sense of entitlement (unlike advertising).
• Erode professional values demean profession
  (probably unlike advertising).

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Conflict of interest

• Set of conditions in which judgement concerning a
  primary interest tends to be unduly influenced by
  a secondary interest.

NEJM 1993329573-6
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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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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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Should doctors be held to different (higher)
standards?
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The physician-patient relationship is a fiduciary
relationship.
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Characteristics of a Fiduciary

• Has specialized knowledge or expertise
• Holds the trust of others
• Held to high standards of conduct
• Avoids conflicts of interest
• Is accountable or obligated (ethically and
  legally)

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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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Influence
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The Effects of Pharmaceutical Firm Enticements on
Physician Prescribing Patterns

• Pharmacy records reviewed 22 months before and 17
  months after two pharmaceutical company-sponsored
  symposia on two medications
• Drug A New intravenous antibiotic
• Promotion All-expenses-paid trip to luxurious
  resort on West Coast (n10 travelling MDs)
• Drug B New intravenous Cardiac drug
• Promotion All-expense-paid trip to island resort
  in the Caribbean (n10 travelling MDs)

Chest 1992102270
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The Effects of Pharmaceutical Firm Enticements on
Physician Prescribing Patterns
Chest 1992102270
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Physicians' Behavior and their Interaction with
Drug Companies

• Case-control study at a University Hospital
• Cases 40 physicians who had requested formulary
  additions.
• Controls 80 physicians who had made no such
  requests.
• Information regarding interaction with drug
  companies obtained by survey instrument.

JAMA 1994271684
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Physicians' Behavior and their Interaction with
Drug Companies

• Physicians who had requested formulary changes
  were more likely to have accepted money from drug
  companies to attend or speak at symposia.
• (OR5.1, 95CI, 2.0 - 13.2)
• Physicians were more likely to have requested
  additions of drugs made by companies with whose
  reps they had met (OR4.9, 95CI, 3.2 - 7.4).

JAMA 1994271684
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Scientific versus commercial sources of influence

• Telephone questionnaire of 85 randomly selected
  internists in Boston area
• Questioned about two classes of drugs
• Propoxyphene analgesics
• Cerebral and peripheral vasodilators.

Am J Med 19822734
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Scientific versus Commercial Sources of Influence
Am J Med 19822734
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Scientific versus Commercial Sources of Influence
Am J Med 19822734
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Scientific versus Commercial Sources of Influence
on the Prescribing behavior of Physicians

• Were physicians who believed these drugs to be
  effective more likely to rely on commercial than
  scientific sources?
• Vasodilators Yes (p0.006)
• Propoxyphene No

Am J Med 19822734
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A Physician Survey of the Effect of Drug Sample
Availability on Physicians Behavior

• Setting University-based clinics at an academic
  medical center.
• Participants 131 of 154 general medicine and
  family physicians.
• 79 residents, 52 attendings.
• Questionnaire.
• Three hypothetical clinical scenarios Patient
  with uncomplicated urinary tract infection,
  hypertension, depression.

J Gen Int Med 200015478
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A physician survey of the effect of drug sample
availability on physicians behavior

• HTN scenario
• 92 said they would prescribe a diuretic or
  b-blocker as initial therapy.
• When samples were made available, 32 of the 35
  physicians who said they would give a drug sample
  selected a drug that differed from their
  preferred choice.

J Gen Int Med 200015478
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A physician survey of the effect of drug sample
availability on physicians behavior

• HTN follow-up scenario
• Patient now has health insurance, blood
  pressure controlled on drug sample
• 69 said they would write a prescription for the
  sampled medication rather than switch therapy.
• 88 of sample users would have written a
  prescription for a drug that differed from their
  preferred choice.

J Gen Int Med 200015478
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Physicians, Pharmaceutical Sales Representatives,
and the Cost of Prescribing

• Questionnaire on attitudes toward and use of
  information provided by pharmaceutical
  representatives.
• Mailed to all primary care adult medicine
  practitioners in Kentucky (n1603)
• Main outcome measure Relative cost of
  prescribing, based on responses to treatment
  choices for clinical scenarios.
• 36 response 446 questionnaires suitable for
  analysis.

Arch of Fam Med 19965201
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Physicians, Pharmaceutical Sales Representatives,
and the Cost of Prescribing

Arch of Fam Med 19965237
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Physicians, Pharmaceutical Sales Representatives,
and the Cost of Prescribing

• 3 case scenarios acute bronchitis, mild HTN,
  and uncomplicated UTI.
• Positive correlation found between physician
  cost of prescribing and
• perceived credibility of information provided by
  pharmaceutical reps (plt.01).
• Frequency of use of reps as information source
  (plt.001)
• Physician age, years since graduation, hours
  worked per week was not correlated with cost of
  prescribing

Arch of Fam Med 19965237
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Bias in promotional materials
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Pharmaceutical Advertisements in Leading Medical
Journals Experts Assessments

• Peer review of all ads from 10 journals during
  January, 1990.
• 109 advertisements were analyzed by 113
  experienced physician peer reviewers and 54
  clinical pharmacists.
• 71 of reviewers had received money from the drug
  industry within the past 2 years 53 had
  received more than 5000.

Ann Int Med 1992116912
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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.

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

JGIM 200318294-297
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The Quantity and Quality of Scientific Graphs in
Pharmaceutical Advertisements

• 36 of graphs contained numeric distortion.
• 66 of graphs contained chart junk.
• 54 reported intermediate outcomes.

JGIM 200318294-297
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Logical Fallacies in Pharmaceutical
PromotionSample Ads available on request from
No Free Lunch
JGIM, 1994 9563
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Logical Fallacies in Pharmaceutical Promotion

• Argumentum ad populum
• Appeal to popularity

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Logical Fallacies in Pharmaceutical Promotion

• Argumentum ad verecundiam
• Appeal to authority

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Logical Fallacies in Pharmaceutical Promotion

• Argumentum ad celebritam
• Appeal to celebrity

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Logical Fallacies in Pharmaceutical Promotion

• Fallacy of ignoratio elenchi
• (or fallacy of irrelevant conclusions,
• or fallacy of ignoring the issue
• or the non-sequitur)

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Logical Fallacies in Pharmaceutical Promotion

• Appeal to emotion

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Dealing with conflicts of interest

• Prohibition
• Divestiture
• Abstention
• Mediation
• Disclosure

NEJM 1993329573
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Epilogue Do doctors need drug reps?

• Medical Letter (www.medicalletter.com)
• Therapeutics Initiative (Canada)
• (www.ti.ubc.ca)
• Drug and Therapeutics Bulletin (UK)
• (www.which.net/health/dtb)
• Prescrire.org (France)
• etc.

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Conclusion

• The patient-physician relationship is a fiduciary
  relationship.
• Fiduciaries have an obligation to avoid conflicts
  of interest.
• Gifts from the pharmaceutical industry, whether
  large or small, create conflicts of interest.
• Physicians should not accept any gifts from the
  pharmaceutical industry.

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Just say no to drug reps
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