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Educação e Informação aos Profissionais Prescritores e Usuários como Instrumento para o Uso RacionalPromoting Quality Use of Medicines via Education and Information for Health Professionals and Consumers
Dr Peter R Mansfield
Healthy Skepticismwww.healthyskepticism.org
Brasilia
6 April 2005
2
Topics
1. The current situation in Australia:Information provision
2. How to increase resistance to misleading promotion: Overcoming overconfidence
3. AdWatch website4. Teaching healthy skepticism5. Policy recommendations for education
about drug promotion
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1.The current situation in Australia
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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
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Quality Use of Medicines
• National Prescribing Service– Australian Prescriber– Drug and Therapeutics Information Service
• Educational visiting
• Therapeutic Guidelines
• Australian Medicines Handbook
• Healthy Skepticism
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Providing information works when people know that they don’t know.(doctors often don’t)
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Information for consumers
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• Adverse Medicines Events Line
• Consumer product information
• NPS Telephone Information Service
• Health Insite (www)
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2. How to increase resistance to misleading promotion
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“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.
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“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 Society. Baltimore: John Hopkins Press; 1964.
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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.
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“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
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“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
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“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
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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.
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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.
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• 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.
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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.”
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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.
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4. Teaching healthy skepticism
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“perceived undue manipulative intent of the source of the appeal”
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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?
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Did you plan to tell:
• the truth?
• (without ambiguity)
• the whole truth?
• and nothing but the truth?
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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
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“perceived personal vulnerability to such manipulation”
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“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
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“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
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Shuttle pilots
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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
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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
Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000 Jan 19;283(3):373-80
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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.
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Until we can fix the system the best we can do is avoid all contact with drug companies
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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
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1) Is it ethically acceptable for doctors to receive gifts from drug companies?
1 = Completely acceptable7 = Completely unacceptable median mean rangeBefore 4 3.68 1-6After 6 5.53 2-7Wilcoxon signed-rank test p < 0.001
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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
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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
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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
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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
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5. Policy recommendations
Recommendations for educating health professionals about pharmaceutical promotion. 1 April 2005
Healthy Skepticism
No Free Lunch (www.nofreelunch.org)
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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, USA3. 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, USA5. Jen Edelman, Medical Student, Columbia University, USA6. A/Prof Joel Lexchin, Professor, School of Health Policy & Management, York University,
Canada 7. Dr Luisella Grandori, Coordinator, No grazie pago io, Italy8. Dr David Neely, Director Undergraduate Education, Dept of Medicine, Northwestern
University, USA9. Dr Des Spence, Founder, No Free Lunch (UK), Glasgow, UK10. Dr Jon Jureidini, Chair, Healthy Skepticism Inc / Head, Dept of Psychological Medicine, Women's
and Children's Hospital, South Australia, Australia11. A/Prof Leonore Tiefer, Associate Clinical Professor of Psychiatry, New York University, USA12. Carol Kushner, Health Policy Analyst, Ontario, Canada 13. A/Prof Amy Brodkey, Clinical Associate Professor of Psychiatry, Univ of Pennsylvania, USA14. Dr Mark McConnell, Internal Medicine, LaCrosse, Wisconsin, USA15. Dr. Simon Ahtaridis, Dept of Internal Medicine Cambridge Health Alliance, Massachusetts,USA16. A/Prof Christopher Doecke, Associate Professor of Pharmacy Practice, University of South
Australia, Australia17. Dr Andrew Herxheimer, Emeritus Fellow, UK Cochrane Centre, Oxford, UK18. Prof Dan Mayer, Professor of Emergency Medicine, Albany Medical College, New York, USA19. Dr. Ken Harvey, School of Public Health, La Trobe University, Australia20. A/Prof. David Maxwell, Dept of Family Medicine, Dalhousie University, Canada21. Anne Rochon Ford, Women and Health Protection, Toronto, Canada
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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."
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• 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>
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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>
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• 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.
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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>
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3. Health professionals should be warned that they are vulnerable to pharmaceutical promotionKnowledge 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.
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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 informationHealth professionals should receive education about the availability and strengths and weaknesses of the least biased useful sources of information.
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1. Lomas J, Enkin M, Anderson GM, Hannah WJ, Vayda E, Singer J. Opinion leaders vs audit and feedback to implement practice guidelines. Delivery after previous cesarean section. JAMA. 1991 May 1;265(17):2202-7.1
2. Rogers WA, Mansfield PR, Braunack-Mayer AJ, Jureidini JN. The ethics of pharmaceutical industry relationships with medical students. Med J Aust. 2004 Apr 19;180(8):411-4.
3. Steinbrook R. Commercial support and continuing medical education. N Engl J Med. 2005 Feb 10;352(6):534-5. 4. Schafer A. Biomedical conflicts of interest: a defence of the sequestration 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;15:371-8111. 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.
53
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.
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Healthy Skepticism
Countering misleading drug promotion
www.healthyskepticism.org
