Transcript No Slide Title

Just say no
to drug reps
The Physician-Pharmaceutical Industry Relationship
Are you drug
company
dependent?
If you answered yes
to 2 or more of the
above, you may be
drug company
dependent.
Levels of Interactions:
• Clinicians
– gifts
– promotional information
• Researchers
• Professional societies; medical journals
• Continuing medical education (CME)
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”)
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)
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?
Attitudes and Practices
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. 2003;163:2213-2218
Are gifts from pharmaceutical companies
ethically problematic? A survey of physicians
Resident and faculty responses
$40 textbook
P=.08
$40 golf balls
P=.04
Free Lunch +rep
P=.05
Free Lunch -rep
P=.88
Happy Hour +rep
P=.10
Happy Hour -rep
P=.34
0
1
2
3
Arch Intern Med. 2003;163:2213-2218
Residents
faculty
4
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 2001;110:551
Of principles and pens: attitudes and practices of
medicine housestaff toward pharmaceutical promotions
Percent Who Consider Appropriate
Very appropriate
Somewhat appropriate
100
80
60
40
20
0
abx
guide
conf.
lunch
dinner
lect.
Am J Med 2001;110:551
article
pen
social
text
CME luggage
Of principles and pens: attitudes and practices of
medicine housestaff toward pharmaceutical promotions
Practices Among Residents Who Consider Promotion Appropriate
Percent who did or would have participated
100
90
80
70
60
50
40
30
20
10
0
abx
guide
conf.
lunch
Am J Med 2001;110:551
dinner
lect.
article
pen
social
text
CME
luggage
Of principles and pens: attitudes and practices of
medicine housestaff toward pharmaceutical promotions
Practices Among Respondents Who Consider Activity Inappropriate
Percent who did or would have participated
100
90
80
70
60
50
40
30
20
10
0
abx
guide
conf.
lunch
dinner
lect.
Am J Med 2001;110:551
article
pen
social
text
CME
luggage
Of principles and pens: attitudes and practices of medicine
housestaff toward pharmaceutical promotions
Perceived influence of pharmaceutical reps on Prescribing Practices
A Lot
33%
A lot
1%
A little
38%
None
16%
None
61%
A Little
51%
“You”
Am J Med 2001;110:551
“Other Physicians”
P<.0001
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 2001;286:1024
Pharmaceutical Branding of Resident Physicians
95
100
80
60
98
93
58
51
41
40
20
28
JAMA 2001;286:1024
nl
ig
ht
Pe
n
Pe
C
al
ip
R
er
ef
s
le
x
ha
m
m
St
er
et
ho
sc
op
e
R
ta
ef
g
er
en
ce
bo
ok
or
0
C
al
cu
la
t
% of residents carrying item
Frequency of items found in residents' white coats
Pharmaceutical Branding of Resident Physicians
100
90
85
79
80
55
60
45
31
40
14
20
JAMA 2001;286:1024
nl
ig
ht
Pe
n
Pe
C
al
ip
R
er
ef
s
le
x
ha
m
St
m
er
et
ho
sc
op
e
R
ta
ef
g
er
en
ce
bo
ok
or
0
C
al
cu
la
t
% of residents carrying item with
pharmaceutical brand
Frequency of items found in residents' white coats
Patient Attitudes
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 1998;13:151
A comparison of physicians’ and patients’
attitudes toward pharmaceutical industry gifts
Percentage that considered gift inappropriate
80
70
60
50
40
30
20
10
0
Patients
Physicians
Pen
Mug
Lunch
J Gen Int Med 1998;13:151
Dinner
Trip
P<.004 for all except mug, p=.24)
A comparison of physicians’ and patients’
attitudes toward pharmaceutical industry gifts
Percentage that considered gift influential
56
60
48
50
40
42
31
31
24
20
10
Patients
Physicians
29
30
8
8
Pen
Mug
12
0
Lunch
J Gen Int Med 1998;13:151
Dinner
Trip
P<0.0001 for all except trip, p=0.0017
Professional Guidelines
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 1991;261:501
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 2002;136:396-402.
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 2002;136:396-402.
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 ($100 or less).
• Items of minimal value may be offered if they are
primarily associated with a healthcare professional’s
practice.
• Items intended for the personal benefit of healthcare
professionals (CDs, tickets to a sporting event) should
not be offered.
www.PhRMA.org, April 2002
PhRMA Code FAQs
Question:
Under the Code, may golf balls and sports bags be provided if
they bear a company or product name?
Answer:
No.
www.PhRMA.org, April 2002
PhRMA Code FAQs
Question:
Under the Code, may healthcare professionals be provided
with gasoline for their cars if they are provided with product
information at the same time?
Answer:
No.
www.PhRMA.org, April 2002
PhRMA Code FAQs
Question:
Under the Code, may items such as stethoscopes be offered to
healthcare professionals?
Answer:
Yes
www.PhRMA.org, April 2002
“That stuff doesn’t influence me at all.
I don’t even know what drug is on my
pen. I just go for the food.”
--Fill in your name here?
Pharmaceutical industry
Spending on Promotion
Promotional spending on prescription drugs,
l996-2002
Promotional expenditures ($ billions)
25
21
20
17.8
15.7
13.9
15
12.5
11
10
9
5
0
1996
Source: NIHCM, 2001
1997
1998
1999
2000
2001
2002
Promotional spending on prescription drugs, 2002
Hospital detailing
4.1%
$861 million
Journal ads 2%
$480 million
Detailing to
doctors 25.3%
$5.3 billion
Samples 56.1%
$11.78 billion
DTC ads 12.5%
$2.63billion
Source: IMS Health
Total spending: $21 billion
Direct to consumer advertising on prescription
drugs, l996-2000
Promotional expenditures ($billions)
3
2.5
2.5
1.85
2
1.5
1.32
1.07
1
0.791
0.5
0
1996
Source: NIHCM, 2001
1997
1998
1999
2000
Direct to consumer advertising spending in
the U.S., 2000
180
161
Spending ($ millions)
160
140
169
146
125
120
100
80
60
40
20
0
Pepsi
Budweiser
Vioxx
GM Saturn
Comparison of median revenue dedicated to R&D,
profits, and marketing/administration, Fortune 500
drug companies, 2000 (n=11)
60%
50%
40%
30%
30%
17%
20%
12%
10%
0%
R&D as % of revenue
Profits as % of
revenue
Marketing &
administration as %
of revenue
Main task of drug company employees, 2000
Distribution,
Other
Administration
2%
11%
Production,
Quality Control
26%
R&D
22%
Marketing
39%
Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar
Drug company jobs in marketing and research, 1995-2000
100,000
87,810
Marketing
80,000
60,000
Research
55,348
48,527
49,409
# Jobs
40,000
20,000
0
1995
1996
1997
1998
1999
2000
Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar
20%
18%
16%
14%
12%
10%
8%
6%
4%
2%
0%
18.7%
11%
5%
2.8%
19
92
19
93
19
94
19
95
19
96
19
97
19
98
19
99
20
00
Profit as % revenue
Profitability of drug industry, l993-2000
drug industry median profit as % revenue
other industry median profit as % revenue
•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).
Fortune 500 drug company profitability compared
to all other Fortune 500 companies, 2000
50%
45%
40%
35%
29%
30%
Drug industry
median
25%
20%
19%
18%
15.8%
15%
10%
5%
4.9%
3.9%
Profits as %
of revenues
Profits as %
of assets
0%
Profits as %
of equity
All Fortune 500
industries
median
Sources of increased drug expenditures, 2000-2001
Increased
cost of drugs
37%
39%
Shift to more
expensive
drugs
Source: NIHCM, 2002
24%
Increased
number of
Rxs
Total increase: $22.5 billion
“Gifts are just a form of promotion
or advertising, and advertising is a
part of our society, like it or not.”
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).
Conflict of interest
Set of conditions in which judgement concerning
a primary interest tends to be unduly influenced
by a secondary interest.
NEJM 1993;329:573-6
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.”
“That stuff doesn’t influence me at all.
I don’t even know what drug is on my
pen. I just go for the food.”
--Fill in your name here?
Should doctors be held to different
(higher) standards?
The physician-patient relationship
is a fiduciary relationship.
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)
“That stuff doesn’t influence me at all.
I don’t even know what drug is on my
pen. I just go for the food.”
--Fill in your name here?
Influence
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” (n=10 travelling MDs)
Drug B: New intravenous Cardiac drug
Promotion: All-expense-paid trip to island resort in
the Caribbean (n=10 travelling MDs)
Chest 1992;102:270
The Effects of Pharmaceutical Firm Enticements
on Physician Prescribing Patterns
Index Institution
Chest 1992;102:270
Ju
l
Se
pt
N
ov
Ja
n
M
ar
M
ay
Ju
l
Se
pt
N
ov
450
400
350
300
250
200
150
100
50
0
Ja
n
M
ar
M
ay
Units
Drug "A" Usage
Major Medical Centers
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 1994;271:684
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.
(OR=5.1, 95%CI, 2.0 - 13.2)
• Physicians were more likely to have requested additions
of drugs made by companies with whose reps they had
met (OR=4.9, 95%CI, 3.2 - 7.4).
JAMA 1994;271:684
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 1982;273:4
% Physicians
Scientific versus Commercial Sources of Influence
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
68%
62%
4%
Scientific papers
Very important
Am J Med 1982;273:4
4%
Drug ads
Minimally important
% Physicians agreeing
Scientific versus Commercial Sources of Influence
100%
80%
71%
60%
49%
32%
40%
20%
0%
Impaired cerebral
blood flow major
cause of dementia
Am J Med 1982;273:4
Vasodilators useful Propoxyphene more
in managing
potent than aspirin
"confused geriatric
patients"
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 (p=0.006)
• Propoxyphene: No
Am J Med 1982;273:4
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 2000;15:478
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 2000;15:478
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 2000;15:478
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 (n=1603)
• 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 1996;5:201
Physicians, Pharmaceutical Sales Representatives,
and the Cost of Prescribing
% of physicians that used information provided
by reps in their clinical practice
Never
1%
Yearly
14%
Daily
5%
Weekly
31%
Arch of Fam Med 1996;5:237
Monthly
49%
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 (p<.01).
–Frequency of use of reps as information source (p<.001)
•Physician age, years since graduation, hours worked per week
was not correlated with cost of prescribing
Arch of Fam Med 1996;5:237
Bias in promotional materials
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 1992;116:912
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 1992;116:912
Pharmaceutical Advertisements in Leading Medical
Journals: Experts’ Assessments
100
90
80
70
60
50
40
30
20
10
0
92
57
44
30
Disagreed
with DOC
claim
Ad would Little or no
Not in
lead to
educational compliance
proper
value
with 1 or
prescribing
more FDA
criteria
Ann Int Med 1992;116:912
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 2003;18:294-297
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 2003;18:294-297
Logical Fallacies in Pharmaceutical Promotion
[Sample Ads available on request from No Free Lunch]
JGIM, 1994; 9:563
Logical Fallacies in Pharmaceutical Promotion
Argumentum ad populum
Appeal to popularity
Logical Fallacies in Pharmaceutical Promotion
Argumentum ad verecundiam
Appeal to authority
Logical Fallacies in Pharmaceutical Promotion
Argumentum ad celebritam
Appeal to celebrity
Logical Fallacies in Pharmaceutical Promotion
Fallacy of ignoratio elenchi
(or fallacy of irrelevant conclusions,
or fallacy of ignoring the issue
or the non-sequitur)
Logical Fallacies in Pharmaceutical Promotion
Appeal to emotion
Dealing with conflicts of interest
•
•
•
•
•
Prohibition
Divestiture
Abstention
Mediation
Disclosure
NEJM 1993;329:573
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.
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.
Just say no
to drug reps