Educação e Informação aos
Profissionais Prescritores e
Usuários como Instrumento para
o Uso Racional
Promoting Quality Use of
Medicines via Education and
Information for Health
Professionals and Consumers
Brasilia
6 April 2005
Dr Peter R Mansfield
peter.mansfield@adelaide.edu.au
Healthy Skepticism
www.healthyskepticism.org
Topics
1. The current situation in Australia:
Information provision
2. How to increase resistance to misleading
promotion: Overcoming overconfidence
3. AdWatch website
4. Teaching healthy skepticism
5. Policy recommendations for education
about drug promotion
2
1.The current situation in Australia
3
National Medicines Policy
• Quality, Safety and Efficacy
– Therapeutic Goods Administration (TGA)
• Access
– Pharmaceutical Benefits Scheme (PBS)
• Viable pharmaceutical industry
– Dept of Industry ?PBS
• Quality Use of Medicines (no govt dept)
• Missing: Health Professionals, Consumers,
Health
4
Quality Use of Medicines
• National Prescribing Service
– Australian Prescriber
– Drug and Therapeutics Information Service
• Educational visiting
• Therapeutic Guidelines
• Australian Medicines Handbook
• Healthy Skepticism
5
Providing
information
works when
people know
that they
don’t know.
(doctors
often don’t)
6
Information for consumers
7
• Adverse Medicines
Events Line
• Consumer product
information
• NPS Telephone
Information Service
• Health Insite (www)
8
2. How to increase resistance to
misleading promotion
9
“And if, indeed, candor, accuracy,
scientific completeness, and a
permanent ban on cartoons came to be
essential for the successful promotion
of [prescription] drugs, advertising
would have no choice but to comply.”
Garai PR. Advertising and Promotion of Drugs. in: Talalay P. Editor. Drugs in
Our Society. Baltimore: John Hopkins Press; 1964.
10
“The best defense doctors can muster against this
kind of advertising is a healthy skepticism and a
willingness, not always apparent in the past, to do
homework. Doctors must cultivate a flair for
spotting the logical loophole, the invalid clinical
trial, the unreliable or meaningless testimonial, the
unneeded improvement and the unlikely claim.
Above all, doctors must develop greater resistance
to the lure of the fashionable and the new.”
Garai PR. Advertising and Promotion of Drugs. in: Talalay P. Editor. Drugs in Our
11
Society. Baltimore: John Hopkins Press; 1964.
Improving health care decision
making
• Hypothesis 1. Promotion might improve to
match
• Hypothesis 2. Promotion might become
more subtle but stay harmful.
• Even if hypothesis 1 is correct, there is a
limit to how much humans with limited
resources can be expected to improve.
12
“Educated”
“Mr Brindell [corporate affairs manager,
Pfizer Australasia] said doctors, who were
obviously highly educated, could sort the
chaff from the wheat.”
Riggert E. Doctors seduced by drug giants: Drug companies’ tactics spark
rethink by doctors. The Courier Mail. Brisbane 1999;July 26:1-2
13
“Intelligence”
• “Doctors have the intelligence to evaluate
information from a clearly biased source.”
- Dr Rob Walters, ADGP chair
Richards D. Guess who’s coming to dinner. Aust Dr. 2004;23 Jan:19-21
14
“I believe I may have the ability to think for
myself. I know there is a large percentage of
people (esp. in this class) who would easily be
‘sucked in’ as you put it but I am confident this
doesn’t apply to me.”
- 2nd year medical student 2004
The illusion of unique invulnerability
15
The illusion of unique invulnerability
• Many people believe that others may be
vulnerable but not themselves.
• Some doctors believe no doctor is vulnerable.
• Consequently education about misleading
promotional techniques is not applied to the self
and thus not effective.
• Thus the key is to dispel the illusion of unique
invulnerability.
16
Dispel the illusion of invulnerability
“Attempts to confer resistance to appeals
will likely be successful to the extent that
they install 2 conceptual features: perceived
undue manipulative intent of the source of
the appeal and perceived personal
vulnerability to such manipulation.”
Sagarin, B. J.; Cialdini, R. B.; Rice, W. E., and Serna, S. B. Dispelling the
illusion of invulnerability: the motivations and mechanisms of resistance to
persuasion. J Pers Soc Psychol. 2002 Sep; 83(3):526-41.
17
18
• Fascinating way to learn.
• www.healthyskepticism.org/adwatch.php
• Illuminates the logical, psychological and
pharmacological techniques in drug ads.
• Evidence based recommendations.
• Feedback for the AdWatch team, the company
and regulatory agencies.
19
Feedback to AdWatch and to the
company
• To AdWatch re Nexium: “Unfortunately had
me sucked in for a period but no longer.”
• To the company re Micardis Plus: “You
have misled me into a false understanding
of the response to telmisartan + Hcl.”
20
When people
know that they
don’t know or
know they are
vulnerable to
being misled
then they will
want to use more
reliable
information
sources.
21
4. Teaching healthy skepticism
22
“perceived undue manipulative
intent of the source of the appeal”
23
Put yourself in their shoes
• You are responsible for promotion of a new
drug that is no better than the old ones but
will be sold at a higher price.
• If you do not succeed you will lose your
job. Because you will not be able to get
such a well paid job elsewhere you and your
family will loose your house.
• What promotional methods will you use?
24
Did you plan to tell:
• the truth?
• (without ambiguity)
• the whole truth?
• and nothing but the truth?
25
Drug companies know how to
manipulate our main motivations
Burnt out Dodo
Caring Bunny
Conservative Sheep
Entrepreneurial Wolf
Branthwaite A, Downing T.
Marketing to doctors – the
human factor. Scrip Magazine
1995 March;32-5
26
27
“perceived personal vulnerability to
such manipulation”
28
“Educated”
“Mr Brindell [corporate affairs manager,
Pfizer Australasia] said doctors, who were
obviously highly educated, could sort the
chaff from the wheat.”
Riggert E. Doctors seduced by drug giants: Drug companies’ tactics spark
rethink by doctors. The Courier Mail. Brisbane 1999;July 26:1-2
29
“Intelligence”
• “Doctors have the intelligence to evaluate
information from a clearly biased source.”
- Dr Rob Walters, ADGP chair
Richards D. Guess who’s coming to dinner. Aust Dr. 2004;23 Jan:19-21
30
Shuttle pilots
31
Your ability to cope with potentially
misleading promotion depends on your
understanding of:
• Medicine
– Pharmacology, Epidemiology, Public Health, Evidence Based
Medicine, Drug Evaluation, Pharmacovigilance
• Social sciences
– Psychology, Semiotics, Economics, Sociology, Anthropology,
Management, History, Politics, Communication Studies,
• Humanities
– Logic, Rhetoric, Epistemology, Linguistics, Literature, Art
• Marketing
– Product Management, Advertising Account Planning, Public
Relations
• Statistics
32
Studies of influence of promotion on
prescribing find more harm than good.
Becker MH, Stolley PD, Lasagna L, McEvilla JD, Sloane LM. Differential education concerning therapeutics and
resultant physician prescribing patterns. J Med Educ 1972;47:118-27.
Linn LS, Davis MS. Physicians’ orientation toward the legitimacy of drug use and their preferred source of new drug
information. Soc Sci Med 1972;6:199-203.
Mapes R. Aspects of British general practitioners’ prescribing. Med Care 1977;15:371-81
Haayer F. Rational prescribing and sources of information. Soc Sci Med 1982;16:2017-23.
Ferry ME, Lamy PP, Becker LA. Physicians’ knowledge of prescribing for the elderly: a study of primary care
physicians in Pennsylvania. J Am Geriatr Soc 1985; 33:616-21.
Blondeel L, Cannoodt L, DeMeyeere M, Proesmans H. Prescription behaviour of 358 Flemish general practitioners.
Paper presented at the International Society of General Medicine meeting, Prague, Spring 1987.
Bower AD, Burkett GL. Family physicians and generic drugs: a study of recognition, information sources, prescribing
attitudes, and practices. J Fam Pract 1987;24:612-6.
Cormack MA, Howells E. Factors linked to the prescribing of benzodiazepines by general practice principals and
trainees. Family Practice 1992;9:466-71.
Berings D, Blondeel L, Habraken H. The effect of industry-independent drug information on the prescribing of
benzodiazepines in general practice. Eur J Clin Pharmacol 1994;46:501-505.
Caudill TS, Johnson MS, Rich EC, McKinney WP. Physicians, pharmaceutical sales representatives, and the cost of
prescribing. Arch Fam Med 1996;5:201-6.
Powers R. Time with drug reps affects prescribing. Paper presented at the Society of General Internal Medicine meeting,
1998
33
Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000 Jan 19;283(3):373-80
Benzodiazepine prescribing in
Flanders
• Years since graduation + positive views
about commercial information + seeing
more reps accounted for 26% of the
variation in prescribing.
Berings D, Blondeel L, Habraken H. The effect of industry-independent drug
information on the prescribing of benzodiazepines in general practice. Eur J
Clin Pharmacol 1994;46:501-505.
34
Until we
can fix the
system the
best we
can do is
avoid all
contact
with drug
companies
35
Results
• A 90 minute session with 19 General
Practice registrars on 25 February 2005.
• 5 questions asked before and after the
session about beliefs and plans
• Answers on 1 to 7 Likert like scales
36
1) Is it ethically acceptable for
doctors to receive gifts from drug
companies?
1 = Completely acceptable
7 = Completely unacceptable
median mean range
Before 4
3.68 1-6
After 6
5.53 2-7
Wilcoxon signed-rank test p < 0.001
37
2) Will you accept visits from drug
company representatives?
1=Never
7=At every opportunity
median mean range
Before 5
4.37 1-7
After 3
3.26 1-7
Wilcoxon signed-rank test p = 0.0119
38
3) Will you accept gifts from drug
companies?
1= Never
7 = At every opportunity
median mean range
Before 5
5
2-7
After 4
3.74 1-7
Wilcoxon signed-rank test p = 0.0034
39
4) How often is information
from drug companies reliable?
1 = Never reliable
7 = Always reliable
median mean range
Before 4
3.68 2-5
After 2
2.47 1-5
Wilcoxon signed-rank test p = 0.0006
40
5) Will you be vulnerable to
being misled by drug companies?
1 = Completely vulnerable
7 = Completely invulnerable
median mean range
Before 4
3.79 2-6
After 3
3.42 1-7
Wilcoxon signed-rank test p = 0.2377
41
5. Policy recommendations
Recommendations for
educating health professionals
about pharmaceutical promotion.
1 April 2005
Healthy Skepticism
No Free Lunch (www.nofreelunch.org)
42
1. Dr Peter R Mansfield, Founder, Healthy Skepticism Inc / Research Fellow, Dept of General
Practice, University of Adelaide, Australia
2. Dr Bob Goodman, Founder, No Free Lunch, New York, USA
3. Prof Allen F. Shaughnessy, Professor of Family Medicine, Tufts University, USA
4. Prof Jerome Hoffman, Professor of Medicine and Emergency Medicine, University of
California Los Angeles, USA
5. Jen Edelman, Medical Student, Columbia University, USA
6. A/Prof Joel Lexchin, Professor, School of Health Policy & Management, York University,
Canada
7. Dr Luisella Grandori, Coordinator, No grazie pago io, Italy
8. Dr David Neely, Director Undergraduate Education, Dept of Medicine, Northwestern
University, USA
9. Dr Des Spence, Founder, No Free Lunch (UK), Glasgow, UK
10. Dr Jon Jureidini, Chair, Healthy Skepticism Inc / Head, Dept of Psychological Medicine, Women's
and Children's Hospital, South Australia, Australia
11. A/Prof Leonore Tiefer, Associate Clinical Professor of Psychiatry, New York University, USA
12. Carol Kushner, Health Policy Analyst, Ontario, Canada
13. A/Prof Amy Brodkey, Clinical Associate Professor of Psychiatry, Univ of Pennsylvania, USA
14. Dr Mark McConnell, Internal Medicine, LaCrosse, Wisconsin, USA
15. Dr. Simon Ahtaridis, Dept of Internal Medicine Cambridge Health Alliance, Massachusetts,USA
16. A/Prof Christopher Doecke, Associate Professor of Pharmacy Practice, University of South
Australia, Australia
17. Dr Andrew Herxheimer, Emeritus Fellow, UK Cochrane Centre, Oxford, UK
18. Prof Dan Mayer, Professor of Emergency Medicine, Albany Medical College, New York, USA
19. Dr. Ken Harvey, School of Public Health, La Trobe University, Australia
20. A/Prof. David Maxwell, Dept of Family Medicine, Dalhousie University, Canada
21. Anne Rochon Ford, Women and Health Protection, Toronto, Canada
43
44
The role of drug promotion in the heavy death
toll from COX2 selective drugs illustrates the
reality that misleading drug promotion is a
major health threat.
The World Health Assembly resolution 52.19
urges member states to:
"integrate the rational use of drugs and
information on commercial marketing
strategies into training for health practitioners
at all levels."
45
• Healthy Skepticism Inc and No Free Lunch
recommend the following 4 objectives for
education about pharmaceutical promotion for
health professionals at all levels of training and
practice.
• Pharmaceutical promotion includes any activity
that can increase pharmaceutical sales.
• Education should use methods that are effective
for changing behavior, such as involvement of
influential peers.<1>
• Education for health professionals should never be
funded by vested interests.<2-7>
46
1. Health Professionals should avoid
pharmaceutical promotion
Exposure to pharmaceutical promotion correlates with
harmful and wasteful use of pharmaceuticals.<8-19>
There are no proven methods for enabling health
professionals to gain more benefit than harm from
exposure to drug promotion.
Consequently, education for health professionals
should increase the understanding that all health
professionals have a professional fiduciary
responsibility to patients to take all practical steps to
avoid pharmaceutical promotion.<20-21>
47
• This responsibility includes refusing to accept gifts
and one to one visits from drug company
representatives both at the personal and
organisational levels.
• Meetings of groups of doctors with drug company
representatives may be less harmful than one to one
meetings but it is highly unlikely that this type of
activity will be found to do more good than harm
compared to no such meetings.
48
2. Health Professionals should be educated
about decision making
Education for health professionals should include
teaching the psychology and illogic of misleading
arguments and appeals with the aim of improving
the quality of medical decision making in response
to evidence.<22-25>
49
3. Health professionals should be warned that
they are vulnerable to pharmaceutical
promotion
Knowledge of misleading arguments and appeals
does not reliably protect people from being misled
by promotional techniques.<26,27>
The key to reducing vulnerability to being misled
by promotion is helping people move from
overconfidence in their abilities to understanding
that they are vulnerable.<26,27>
Consequently, education for health professionals
should explain that whilst knowledge of
misleading promotional techniques may increase
their resistance to being mislead, it is unlikely to
enable them to reach a level of resistance where
they would gain more benefit than harm from
exposure to drug promotion.
50
An effective way to reduce dangerous
overconfidence is to expose participants to
misleading promotion, allow them to express
incorrect beliefs and then debunk those beliefs and
explain the misleading techniques used so that
participants can understand that they are personally
vulnerable.<24-27>
4. Health professionals should be educated about
more reliable sources of information
Health professionals should receive education about
the availability and strengths and weaknesses of the
least biased useful sources of information.
51
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2. Rogers WA, Mansfield PR, Braunack-Mayer AJ, Jureidini JN. The ethics of pharmaceutical
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3. Steinbrook R. Commercial support and continuing medical education. N Engl J Med. 2005 Feb
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thesis-learning from the cases of Nancy Olivieri and David Healy. J Med Ethics. 2004
Feb;30(1):8-24.
5. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA
2003; 290: 252-255.
6. Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of
pharmaceutical industry gift giving. Am J Bioethics 2003; 3: 39-46.
7. Katz D, Mansfield P, Goodman R, Tiefer L, Merz J. Psychological aspects of gifts from drug
companies. JAMA. 2003 Nov 12;290(18):2404-5
8. Becker MH, Stolley PD, Lasagna L, McEvilla JD, Sloane LM. Differential education concerning
therapeutics and resultant physician prescribing patterns. J Med Educ 1972;47:118-27.
9. Linn LS, Davis MS. Physicians' orientation toward the legitimacy of drug use and their preferred
source of new drug information. Soc Sci Med 1972;6:199-203.
10. Mapes R. Aspects of British general practitioners' prescribing. Med Care 1977;15:371-81
11. Haayer F. Rational prescribing and sources of information. Soc Sci Med 1982;16:2017-23.
12. Ferry ME, Lamy PP, Becker LA. Physicians' knowledge of prescribing for the elderly: a study of
primary care physicians in Pennsylvania. J Am Geriatr Soc 1985; 33:616-21.
13. Bower AD, Burkett GL. Family physicians and generic drugs: a study of recognition, information
sources, prescribing attitudes, and practices. J Fam Pract 1987;24:612-6.
14. Cormack MA, Howells E. Factors linked to the prescribing of benzodiazepines by general
practice principals and trainees. Family Practice 1992;9:466-71.
52
15. Berings D, Blondeel L, Habraken H. The effect of industry-independent drug information on the
prescribing of benzodiazepines in general practice. Eur J Clin Pharmacol 1994;46:501-505.
16. Caudill TS, Johnson MS, Rich EC, McKinney WP. Physicians, pharmaceutical sales
representatives, and the cost of prescribing. Arch Fam Med 1996;5:201-6.
17. Mansfield PR, Lexchin J. Scepticism and beliefs about new drugs. Healthy Skepticism
International News 2001;19:1-6
18. Caamano, F.; Figueiras, A., and Gestal-Otero, J. J. Influence of commercial information on
prescription quantity in primary care. Eur J Public Health. 2002 Sep; 12(3):187-91.
19. Watkins, C. Harvey, I. Carthy, P. Moore, L. Robinson, E. Brawn, R. Attitudes and behaviour of
general practitioners and their prescribing costs a national cross sectional survey. Qual Saf Health
Care. 2003 Feb; 12(1)29-34.
20. Mansfield PR, Henry D. Misleading drug promotion-no sign of improvements.
Pharmacoepidemiol Drug Saf 2004 Nov;13(11):797-9.
21. Brody H. The company we keep: why physicians should refuse to see pharmaceutical
representatives. Ann Fam Med. 2005 Jan-Feb;3(1):82-5.
22. Scott DK, Ferner RE. "The strategy of desire" and rational prescribing.Br J Clin Pharmacol
1994;37: 217-9.
23. Shaughnessy AF, Slawson DC, Bennett JH. Separating the wheat from the chaff: identifying
fallacies in pharmaceutical promotion. J Gen Intern Med. 1994 Oct;9(10):563-8.
24. Mansfield PR. Healthy Skepticism's new AdWatch: understanding drug promotion. Med J Aust.
2003 Dec 1-15;179(11-12):644-5.
25. Sagarin BJ, Cialdini RB, Rice WE, Serna SB. Dispelling the illusion of invulnerability: the
motivations and mechanisms of resistance to persuasion. J Pers Soc Psychol 2002;83: 526-41.
26. Mansfield P. Accepting what we can learn from advertising's mirror of desire. BMJ. 2004 Dec
18;329(7480):1487-8.
27. Wilkes MS, Hoffman JR. An innovative approach to educating medical students about
pharmaceutical promotion. Acad Med 2001; 76: 1271-1277.
53
Healthy Skepticism
Countering misleading
drug promotion
www.healthyskepticism.org
54