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The Physician-Pharmaceutical Industry Relationship
The CAGE Questionnaire for Drug Company Dependence
• Have you ever prescribed CelebrexTM?
• Do you get Annoyed by people who complain about drug lunches and free gifts?
• Is there a medication loGo on the pen you're using right now?
• Do you drink your morning Eye-opener out of a LipitorTM coffee mug?
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”)
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.
• 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
Arch Intern Med. 2003;163:2213-2218
Resident and faculty responses
0 1 2 3 4
Happy Hour -rep
Happy Hour +rep
Free Lunch -rep
Free Lunch +rep
$40 golf balls
$40 textbook
Residents
faculty
P=.08
P=.04
P=.05
P=.88
P=.10
P=.34
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
0
20
40
60
80
100
abxguide
conf.lunch
dinnerlect.
article pen social text CME luggage
Very appropriateSomewhat appropriate
Am J Med 2001;110:551
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
0102030405060708090
100
abxguide
conf.lunch
dinnerlect.
article pen social text CME luggage
Am J Med 2001;110:551
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
0102030405060708090
100
abxguide
conf.lunch
dinnerlect.
article pen social text CME luggage
Am J Med 2001;110:551
Of principles and pens: attitudes and practices of medicine
housestaff toward pharmaceutical promotions
Perceived influence of pharmaceutical reps on Prescribing Practices
Am J Med 2001;110:551
A little38%
A lot1%
None61%
A Lot33%
A Little51%
None16%
P<.0001“You” “Other Physicians”
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
JAMA 2001;286:1024
Frequency of items found in residents' white coats
58
2841
95 93 98
51
0
20
40
60
80
100
% o
f re
sid
ents
car
ryin
g it
em
Pharmaceutical Branding of Resident Physicians
JAMA 2001;286:1024
Frequency of items found in residents' white coats
14
85
31
55
9079
45
0
20
40
60
80
100
% o
f res
iden
ts c
arry
ing
item
wit
h ph
arm
aceu
tica
l bra
nd
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
J Gen Int Med 1998;13:151
Percentage that considered gift inappropriate
01020304050607080
Pen Mug Lunch Dinner Trip
PatientsPhysicians
P<.004 for all except mug, p=.24)
A comparison of physicians’ and patients’ attitudes toward pharmaceutical industry gifts
J Gen Int Med 1998;13:151
Percentage that considered gift influential
31 31 29
48
56
8 812
24
42
0
10
20
30
40
50
60
Pen Mug Lunch Dinner Trip
Patients
Physicians
P<0.0001 for all except trip, p=0.0017
Professional Guidelines
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 1991;261:501
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 2002;136:396-402.
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 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 ($100 or less).
• Items of minimal value may be offered if they are primarily associated with a healthcare professional’s practice.
• Items intended for the personal benefit of healthcare professionals (CDs, tickets to a sporting event) should not be offered.
www.PhRMA.org, April 2002
PhRMA Code FAQs
Question:
Under the Code, may golf balls and sports bags be provided if they bear a company or product name?
Answer:
No.
www.PhRMA.org, April 2002
PhRMA Code FAQs
Question:
Under the Code, may healthcare professionals be provided with gasoline for their cars if they are provided with product information at the same time?
Answer:
No.
www.PhRMA.org, April 2002
PhRMA Code FAQs
Question:
Under the Code, may items such as stethoscopes be offered to healthcare professionals?
Answer:
Yes
www.PhRMA.org, April 2002
“That stuff doesn’t influence me at all. I don’t even know what drug is on my pen. I just go for the food.”
--Fill in your name here?
Pharmaceutical industry Spending on Promotion
17.8
21
15.713.9
12.511
9
0
5
10
15
20
25
1996 1997 1998 1999 2000 2001 2002
Pro
mot
iona
l exp
endi
ture
s ($
bil
lion
s)
Promotional spending on prescription drugs, l996-2002
Source: NIHCM, 2001
DTC ads 12.5%$2.63billion
Samples 56.1%$11.78 billion
Detailing to doctors 25.3%$5.3 billion
Journal ads 2%$480 million
Hospital detailing 4.1%$861 million
Promotional spending on prescription drugs, 2002
Total spending: $21 billionSource: IMS Health
2.5
1.85
1.321.07
0.791
0
0.5
1
1.5
2
2.5
3
1996 1997 1998 1999 2000
Pro
mot
iona
l exp
endi
ture
s ($
bill
ions
)Direct to consumer advertising on prescription drugs,l996-2000
Source: NIHCM, 2001
Direct to consumer advertising spending in the U.S., 2000
Source: NIHCM, 2001
125
146161
169
0
20
40
60
80
100
120
140
160
180
Pepsi Budweiser Vioxx GM Saturn
Spen
ding
($
mil
lion
s)
Comparison of median revenue dedicated to R&D, profits, and marketing/administration, Fortune 500 drug companies, 2000 (n=11)
Source: Public Citizen, 2001
12%17%
30%
0%
10%
20%
30%
40%
50%
60%
R&D as % of revenue Profits as % ofrevenue
Marketing &administration as %
of revenue
Main task of drug company employees, 2000
Distribution, Other
2%
Production,Quality Control
26%
R&D22%
Marketing39%
Administration11%
Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar
Drug company jobs in marketing and research, 1995-2000
55,348
87,810
49,409 48,527
0
20,000
40,000
60,000
80,000
100,000
1995 1996 1997 1998 1999 2000
Marketing
Research
Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar
# Jobs
18.7%
11%
5%
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%P
rofi
t a
s %
rev
enu
e
drug industry median profit as % revenueother industry median profit as % revenue
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).
2.8%
Fortune 500 drug company profitability compared to all other Fortune 500 companies, 2000
Source: Public Citizen, 2001
19% 18%
29%
15.8%
3.9%4.9%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
Profits as %of revenues
Profits as %of assets
Profits as %of equity
Drug industrymedian
All Fortune 500industriesmedian
Sources of increased drug expenditures, 2000-2001
Increased number of
RxsShift to more expensive
drugs
Increased cost of drugs
Source: NIHCM, 2002 Total increase: $22.5 billion
24%
39%
37%
“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
Drug "A" Usage
050
100150200250300350400450
Un
its
Index Institution Major Medical Centers
Chest 1992;102:270
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
Scientific versus Commercial Sources of Influence
Am J Med 1982;273:4
62%
4%4%
68%
0%10%20%30%40%50%60%70%80%90%
100%
Scientific papers Drug ads
% P
hysi
cian
s
Very important Minimally important
Scientific versus Commercial Sources of Influence
Am J Med 1982;273:4
71%
32%
49%
0%
20%
40%
60%
80%
100%
Impaired cerebralblood flow majorcause of dementia
Vasodilators usefulin managing
"confused geriatricpatients"
Propoxyphene morepotent than aspirin
% P
hysi
cian
s ag
reei
ng
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 -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
Arch of Fam Med 1996;5:237
% of physicians that used information provided by reps in their clinical practice
Yearly14%
Weekly31%
Daily5%
Never1%
Monthly49%
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
Ann Int Med 1992;116:912
3044
57
92
0102030405060708090
100
Disagreedwith DOC
claim
Ad wouldlead toproper
prescribing
Little or noeducational
value
Not incompliancewith 1 or
more FDAcriteria
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
The Academic-Industry Relationship
Scope and Impact of Financial Conflicts of
Interest in Biomedical Research
• Systematic review of studies on relationships between investigators and industry.
• 144 studies identified in Medline and other sources.
• 37 studies met inclusion criteria.
JAMA 2003;289:454
Scope and Impact of Financial Conflicts of
Interest in Biomedical Research
JAMA 2003;289:454
Pharmaceutical industry sponsorship and research outcome and quality: systematic review • Systematic review of studies that compared
pharmaceutical company-sponsored research to non-industry-sponsored research.
• Searched Medline, Embase, Cochrane register; contacted experts.
• 30 studies were included in analysis.
BMJ 2003;326:1167-1170
Pharmaceutical industry sponsorship and research outcome and quality: systematic review • Drug company-sponsored research was less likely to be
published than research sponsored by other sources.• Drug company sponsored Pharmacoeconomic studies were
more likely to report results favoring the sponsor's product
than studies with other sponsors.
• 13 of 16 studies found that clinical trials and meta-analyses sponsored by drug companies favored the sponsor’s product.
• Methodological quality of industry-sponsored studies was as good as or better than non-industry sponsored studies.
BMJ 2003;326:1167-1170
Association between competing interests andauthors' conclusions
• Randomized clinical trials published in the BMJ from January 1997 to June 2001. 159 trials.
• Gathered data on authors' conclusions, competing interests, methodological quality, sample size, type of intervention, and type of control.
• Competing interest: “Anything that may influence professional judgment.”
BMJ, 2002:325:249
Association between competing interests andauthors' conclusions
159 trials:• 65 trials competing interests declared:
– 27 funding by for profit organizations.– 19 funding by both for profit and non-profits.– 19 “Other.”
BMJ, 2002:325:249
BMJ, 2002:325:249
Relationships between authors of clinical practice guidelines and the pharmaceutical industry
• Authors of CPGs endorsed by North American and European societies on common adult diseases published between 1991-99.
• Identified through MEDLINE search, reference lists, interviews with experts.
• 44 CPGs with 192 authors were included.
• Survey instrument evaluated interactions with pharmaceutical industry.
• 100 (52%) authors participated.
JAMA 2002;287:612
Relationships between authors of clinical practice guidelines and the pharmaceutical industry
JAMA 2002;287:612
87
64
53
38
6
0
20
40
60
80
100
Any rela
tionsh
ip
Speakin
g Hon
orar
ium
Trave
l fundin
g
Employ
ee/C
onsu
ltant
Equity
% a
utho
rs
Relationships between authors of clinical practice guidelines and the pharmaceutical industry
JAMA 2002;287:612
Do relationships influence treatment recommendations?
7
19
0
10
20
30
40
50
60
70
Personal Recommendations Colleague Recommendations
% a
uth
ors
Relationships between authors of clinical practice guidelines and the pharmaceutical industry
JAMA 2002;287:612
Declarations contained within guidelines regarding authors' interactions (n=44)
42
1 10
10
20
30
40
50
No declaration Declared nosponsorship
Declaredindustrysupportreceived
# of
gui
deli
nes
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