Healthy Skepticism International News
August 2006
Introduction to Healthy Skepticism Inc, our reform agenda and methods
By: Peter R Mansfield
Mansfield PR. Introduction to Healthy Skepticism Inc, our reform agenda and methods. Healthy Skepticism International News. 2006 Aug;24(8)
Healthy Skepticism Inc is an international non-profit organisation for health professionals and everyone else who has an interest in improving health care. Our main aim is to improve health by reducing harm from misleading drug promotion. Our philosophy of healthy skepticism involves selectively resisting claims that are not justified by good evidence or argument, while accepting those that are, regardless of whether the claims fit well with our self interest and previous beliefs.
Healthy Skepticism commenced in 1983 with the name: Medical Lobby for Appropriate Marketing (MaLAM). For the first 18 years MaLAM focused on misleading promotion in developing countries. MaLAM was modelled on Amnesty International and wrote open letters to the international headquarters of pharmaceutical companies questioning them about specific advertisements in developing countries. MaLAM letters were signed by many people around the world and contributed to many improvements in drug marketing. [1] MaLAM also questioned drug advertisements in Australia during 1993 to 1997.
In 2001 we changed our name to Healthy Skepticism and widened our scope to include research, education and advocacy about misleading drug promotion in all countries. [2] Our core funding is from subscriptions. We have also provided services under contract with a range of organisations including Consumers International, Health Action International and the Royal Australasian College of Physicians.
Health Skepticism Inc is an international incorporated association based Australia with members and subscribers in 46 countries. Anyone who is interested in improving health care is welcome to become a registered guest, subscriber or member of Healthy Skepticism. As of 29 July 2006 688 people were registered to gain free access to more of the website and monthly email Supporters Updates. On that date we had 288 subscribers and 144 members. We have a range of subscription fees depending on income. Students and retired people can become subscribers for free. Members are subscribers who state their support for our aims; they can access more information on our website and can vote in elections to select our management group.
Healthy Skepticism’s reform agenda
Rather than on blaming individuals, or companies the Healthy Skepticism reform agenda is based on understanding that inappropriate marketing and inappropriate treatment decision making results from system problems. [3] When drug companies produce misleading promotion they are rewarded by doctors prescribing more drugs. When doctors over prescribe that gives companies more money to spend on giving doctors “education”, research funding, samples, visits from attractive ego-boosting sales staff, branded stationary, equipment and toys. This can occur with both doctors and drug companies genuinely believing that they are doing their best for patients as result of groupthink. [4] This vicious cycle of ‘bad’ promotion and ‘bad’ decision making can be compounded by deliberate unethical behaviour. However the problem of unintended bias is more common and thus causes more harm. [5]
The Healthy Skepticism reform agenda includes three main components:
1. Improve regulation of drug promotion
2. Improve health care decision making
3. Redesign the incentive systems for all involved in drug use.
All three components are needed to work in synergy. Major reforms are desirable but even small changes in the right direction may be beneficial. Changes could be implemented quickly or gradually.
Improve regulation of drug promotion
Drug promotion currently does more harm than good. Consequently, ideally, all types of drug promotion should be banned. However if the reforms outlined below improved promotion to the point that it did more good than harm then a ban would not be justified. [6] Even if that is achieved, regulation would still be required to minimize harm.
Healthy Skepticism recommends improving regulation by using sociologist John Braithwaite’s responsive regulation approach. [7] This includes frequent use of notifications and light sanctions with all involved understanding that if problems are not resolved there will be an inevitable progressive escalation to heavier sanctions. These should include sanctions that are heavy enough and frequent enough to make harmful practices unprofitable. If all else fails to prevent harmful practices, regulators should incapacitate or completely remove individuals and/or companies from the market. We also recommend that non-government non-profit organisations be given a role in regulation to reduce regulatory capture (the tendency for regulators to act in the interests of those they are supposed to regulate). [8]
Improve health care decision making
Health care decision making can be improved with education about insights from many relevant fields of study including: logic, psychology, economics, sociology, statistics, ethics, communication studies and business studies. [9] However knowledge and skills alone are not enough to protect people from being misled by promotion. People are normally vulnerable to misleading promotion regardless of how intelligent or well educated they are. It is also normal for people to believe that only other people are vulnerable to being misled. As long as they maintain this illusion of unique invulnerability they will be too overconfident to use what skills they have to protect themselves. Consequently, the key to increasing resistance to misleading drug promotion is to help people accept that they are personally vulnerable. [10, 11]
Redesign the incentive systems for all involved in drug use
Healthy Skepticism recommends redesigning the incentives so that health professionals, drug, device, advertising, public relations and media company staff, regulators, and consumers and their organisations are not rewarded for harmful practices and so that good performance is rewarded cost effectively.
Incentives for health professionals
Health professionals should not receive rewards that are associated with suboptimal decision making. Consequently all gifts for health professionals from other players with vested interests should be banned. Possible designs for rewarding health professionals for good performance deserve research.
Incentives for consumers’ organisations
Consumers’ organisations should not accept funding from bodies that have vested interests that may be very contrary to the interests of the organisations’ constituents. Because there are always problems about receiving money from drug companies it is essential that consumer’s organisations have access to adequate funding from other sources without inappropriate conditions.
Incentives for drug companies
Pharmaceutical companies currently have four main functions: manufacturing, research, promotion, and education. Performance of those functions is currently distorted by incentive systems that reward only activities that increase sales of more expensive drugs regardless of the impact on health care. We recommend that the four functions be paid for separately by government agencies via competitive tender. This would allow the relevant divisions and subcontractors of pharmaceutical companies to compete with universities and non-profit non-governmental organisations for funding to provide each function separately. Incentives can then to be aligned to reward quality performance at each function separately. If a company performed poorly-for example, through research fraud or misleading promotion-then it would not get funding for that function in the next tender round. Drug prices would no longer include a premium for research, promotion, and education. Consequently, drug companies would no longer fund those functions from drug sales. Lower prices would make drugs more cost effective for larger numbers of people.
Healthy Skepticism’s methods
Examples of our education, research and advocacy work during 2003-2006 are listed below.
Education
We are developing an interactive website providing an “Update on Treatment Decision Making” for the Royal Australasian College of Physicians. We are also contributing to the World Health Organisation – Health Action International “Guide to understanding and responding to drug promotion”. This guide is intended for use in medical and pharmacy schools around the world.
Research
We published a systematic review with critical appraisal of trials of antidepressants for children and adolescents in the British Medical Journal. We are currently doing a systematic review of the relationship between exposure to promotion and the quality of prescribing.
Advocacy
Our main advocacy methods are listed below:
Our website
Our website (www.healthyskepticism.org) had an average of 2,328 visitors per day during July 2006. Popular sections of our website include:
Adwatch (www.healthyskepticism.org/adwatch.php) illuminates the techniques used in drug advertisements
The library (www.healthyskepticism.org/library.php) has over 6,000 references relevant to drug promotion many with full text. More are added at least twice a week.
What’s new in the news media (www.healthyskepticism.org/newmedia.php) lists reports relevant to drug promotion published in the news media in the past 90 days with introductory comments.
Healthy Skepticism International News (www.healthyskepticism.org/news.php) is our journal.
The Healthy Skepticism Fora (www.healthyskepticism.org/fora/index.php) enable discussion and are the best way to keep up with what Healthy Skepticism is doing. More information is added most days.
Medical journal articles
During January 2003 to July 2006 members of the Healthy Skepticism management group were authors of 50 publications in medical journals. The best of these were articles about: relationships between health professionals and drug companies, [12, 13, 14] direct to consumer advertising of prescription drugs, [15] antidepressants for children and adolescents, [16] the system failures that allowed the Vioxx and similar drugs disaster, [17] evaluations of drug promotion, [18-22] AdWatch, [23] Healthy Skepticism’s reform agenda [24] and drug company control of research [25, 26] and influence on medical journals. [27]
News media appearances
We are interviewed by journalists at least once a week.
Submissions
We have made submissions to many inquiries and consultations including the UK parliamentary inquiry into the influence of the pharmaceutical industry, the Australasian College of Physicians consultation about their guidelines for ethical relationships between physicians and industry.
Presentations
During 2003-2006 members of our management group have given or will give presentations relevant to drug promotion in Australia, Brazil, Canada, Finland, Germany, India, Ireland, New Zealand, Spain, Sweden, Thailand, The Netherlands, the UK and the USA.
Reports
We wrote a report on drug promotion in developing companies commissioned by Consumers International. [28] We also contributed to a World Health Organisation report on drug promotion. [29]
The future
Everyone in every country is invited to join Healthy Skepticism. If you like our work, please tell others. If you think our work could be improved, please tell us or help us.
We are keen to have a local group in your area and a special interest group focusing on whatever interests you most about drug promotion.
We are also keen to collaborate with any governments, companies, universities, or organisations for health professionals or consumers who are interested in improving health. [30]
 
1. Mansfield PR. MaLAM, a medical lobby for appropriate marketing of pharmaceuticals. Med J Aust 1997 Dec 1-15;167(11-12):590-2
2. Mansfield PR. Healthy Skepticism’s new AdWatch: understanding drug promotion. Med J Aust 2003 Dec 1-15;179(11-12):644-5
3. Sweet M. Doctors and drug companies are locked in ‘vicious circle’. BMJ 2004 Oct 30;329(7473):998
4. Goleman D. Vital lies, simple truths: The psychology of self-deception. London: Bloomsbury; 1985
5. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA 2003 Jul 9;290(2):252-5
6. Mansfield PR. Banning all drug promotion is the best option pending major reforms. J Bioethical Inquiry 2005;2(2):16-22
7. Braithwaite J. Restorative Justice and Responsive Regulation. Oxford: Oxford University Press 2002
8. Ayres I, Braithwaite J. Responsive regulation: Transcending the deregulation debate. Oxford: Oxford University Press 1992
9. Mansfield PR, Lexchin J, Wen LS, Grandori L, McCoy CP, Hoffman JR, Ramos J, Jureidini JN. Educating Health Professionals about Drug and Device Promotion: Advocates’ Recommendations. PLOS Medicine [Accepted for Publication]
10. 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.
11. Mansfield P. Accepting what we can learn from advertising’s mirror of desire. BMJ. 2004 Dec 18;329(7480):1487-8.
12. 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
13. Raven M, Rogers W, Jureidini J. Partnerships between academic psychiatry and the pharmaceutical industry. Australas Psychiatry 2005 Mar;13(1):83-4
14. 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
15. Mansfield PR, Mintzes B, Richards D, Toop L. Direct to consumer advertising. BMJ 2005 Jan 1;330(7481):5-6
16. Jureidini JN, Doecke CJ, Mansfield PR, Haby MM, Menkes DB, Tonkin AL. Efficacy and safety of antidepressants for children and adolescents. BMJ 2004 Apr 10;328(7444):879-83
17. Vitry A, Lexchin J, Mansfield PR. Is Australia’s National Medicines Policy failing? The case of COX-2 inhibitors. Int J Health Serv [In Press]
18. Mansfield P. Accepting what we can learn from advertising’s mirror of desire. BMJ 2004 Dec 18;329(7480):1487-8
19. Harvey KJ, Vitry AI., Aroni R, Ballenden N, Faggotter R. Pharmaceutical advertisements in prescribing software: an analysis. MJA 2005 Jul 18;183(2):75-79
20. Mansfield PR, Henry D. Misleading drug promotion—no sign of improvements. Pharmacoepidemiol Drug Saf 2004 Nov;13(11):797-9
21. Svensson S, Mansfield PR. Escitalopram: superior to citalopram or a chiral chimera? Psychother Psychosom 2004 Jan-Feb;73(1):10-6
22. Mansfield P, Henry D, Tonkin A. Single-enantiomer drugs: elegant science, disappointing effects. Clin Pharmacokinet 2004;43(5):287-90
23. Mansfield PR. Healthy Skepticism’s new AdWatch: understanding drug promotion. Med J Aust 2003 Dec 1-15;179(11-12):644-5
24. Mansfield PR. Another way to tame the monster.BMJ 2006 Jul 22;333(7560):202
25. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003 May 31;326(7400):1167-70
26. Lexchin JR. Implications of pharmaceutical industry funding on clinical research. Ann Pharmacother 2005 Jan;39(1):194-7
27. Lexchin J, Light DW. Commercial influence and the content of medical journals. BMJ 2006 Jun 17;332(7555):1444-7
28. Mansfield PR, Layton MR, Ramos J. Drug promotion - Social responsibility or complications? Rapid systematic review of data and opinion in developing countries. Consumers International [In Press]
29. Norris P, Herxheimer A, Lexchin J, Mansfield P. Drug Promotion: What we know, what we have yet to learn. Geneva: World Health Organisation and Health Action International 2005
30. Mansfield PR, Lexchin J, Vitry A, Doecke CJ, Svensson S. Drug advertising in medical journals. Lancet 2003 Mar 8;361(9360):879
 
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