Collaboration with drug industry won’t affect clinical decisions, says new guideBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e2489 (Published 02 April 2012) Cite this as: BMJ 2012;344:e2489
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Guidance on collaboration with pharmaceutical industry offers little in the way of ethics or transparency
Your legal correspondent recently reported1 uncritically on the Ethical Standards in Health and Life Sciences Group’s “Guidance on collaboration between healthcare professionals and the pharmaceutical industry.”2 The Guidance comes with eighteen endorsements from government, professional colleges, an academic journal and others, so we might expect a thoughtful and rigorous assessment of the issues and some measured guidance. Instead, the Guidance offers an uncritical and glowing endorsement of relationships between the pharmaceutical industry and healthcare professionals.
Despite carrying a banner proclaiming “Ethics, transparency, partnership”, it takes some searching to find out that the Ethical Standards in Health and Life Sciences Group is a multi-stakeholder group whose role is to “evolve the relationship between healthcare professionals and commercial life science organisations … by promoting positive, collaborative behaviours and addressing areas of reputational vulnerability to health professionals and commercial organisations.” 3 This information appears on the website of the Association of the British Pharmaceutical Industry (ABPI), thus suggesting that the Group is part of or supported by ABPI. Neither the Group’s membership nor its funding is declared either in the Guidance itself or the ABPI website. So much for transparency.
The Guidance purports to be based upon three ‘core principles’ all of which are in fact unsubstantiated empirical claims about the potential benefits of collaboration and the ability of healthcare and industry professionals to manage their relationships without compromising clinical decision making. The second claim runs counter to a large body of evidence,4 though not to the beliefs of many health professionals.5 The third ‘core principle’ is the only one that addresses ethics and principles of collaboration between industry and healthcare professionals, but it is merely a statement of faith that a supposedly robust set of currently existing regulations, including UK law and various codes, “ensure professional and ethical standards are upheld”. With the exception of glib injunctions to "declare all relevant conflicts of interests", to not "tolerate unacceptable practice" and to "be transparent", the Guidance is silent on the ethical principles underpinning collaboration between industry and healthcare professionals. There is no indication that the authors understand the complexity and seriousness of conflicts of interest. 6
The Guidance comprises a list of facts followed by 10 things “you should know” and lists of “DOs and DON'Ts” for healthcare professionals and the pharmaceutical industry. Although there have been some "great collaborations" between healthcare professionals and the pharmaceutical industry, they cannot be found “everywhere”. It is certain that there have been collaborations that have led to significant harms to patients.7 Given the importance of the claim, it seems odd that no references at all are provided. Such unsubstantiated claims would be in breach of the industry’s own Code of Practice if referring to pharmaceutical products under clause 7.2, which states that information “must be based on an up-to-date evaluation of all the evidence and reflect that evidence clearly.” 8
There are many other elements of the Guidance that warrant critical examination and refutation, such as the claim that industry plays a valid and important role in the provision of medical education - a claim worryingly endorsed by the Medical Schools Council. This is a particularly disheartening endorsement given that we would expect and hope that future generations of doctors would have the chance of an industry-free education.
This Guidance refuses to take seriously the challenging issue of conflicts of interest and does nothing to improve ethics or transparency. It is deeply disappointing.
Wendy Rogers, Professor of Clinical Ethics, Macquarie University, Sydney, Australia
Tamara Zutlevics, Visiting Scholar, Flinders University, South Australia
Melissa Raven, Adjunct lecturer, Flinders University, South Australia
Jon Jureidini, Discipline of Psychiatry, University of Adelaide
1. Dyer C. Collaboration with drug industry won’t affect clinical decisions, says new guide. BMJ 2012;344:e2489
2. Ethical Standards in Health and Life Sciences Group. Guidance on collaboration between healthcare professionals and the pharmaceutical industry. 2012 - [cited 2012 Apr 16]. Available from: bit.ly/H9Y3eo
3. Association of the British Pharmaceutical Industry. Healthcare community agree on principles for working together to improve patient health. 2012 - [cited 2012 Apr 16]. Available from: http://www.abpi.org.uk/media-centre/newsreleases/2012/Pages/290312.aspx
4. See for example, De Laat, E., Windmeijer, F., & Douven, R. How does pharmaceutical marketing influence doctors' prescribing behaviour? The Hague: Centraal Planbureau Netherlands Bureau for Economic Policy Analysis; 2002 - [cited 2012 Apr 16]. Available from: http://www.centraalplanbureau.nl/sites/default/files/publicaties/downloa... Cegedim Strategic Data. How pharma promotion influences physician prescribing behavior. Irvine CA: SK&A; 2011 Jun. 2012 - [cited 2012 Apr 16]. Available from: http://www.skainfo.com/health_care_market_reports/Pharma%20promotional%2...
5. Rutledge P, Crookes D, McKinstry B, Maxwell SR. Do doctors rely on pharmaceutical industry funding to attend conferences and do they perceive that this creates a bias in their drug selection? Results from a questionnaire survey. Pharmacoepidemiol Drug Saf. 2003 Dec;12(8):663-7; Halperin EC, Hutchison P, Barrier RC Jr. A population-based study of the prevalence and influence of gifts to radiation oncologists from pharmaceutical companies and medical equipment manufacturers. Int J Radiat Oncol Biol Physics. 2004 Aug 1;59(5):1477-83; Mansfield PR. Is it insulting to suggest that health professionals are influenced by drug promotion? Healthy Skepticism International News. 2007 May. 2012 - [cited 2012 Apr 16]. Available from: http://www.healthyskepticism.org/global/news/int/hsin2007-05
6. Lo B, Field MJ, editors. Conflict of interest in medical research, education and practice, Washington DC: National Academies Press; 2009 - [cited 2012 Apr 16]. Available from: http://www.nap.edu/catalog.php?record_id=12598
7. Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 2008;299(15):1800-1812; Dieppe P. Complicity theory: an explanation for the 'coxib problem'? J R Soc Med. 2006 Jun;99(6):273-4 2009 - [cited 2012 Apr 16]. Available from: http://www.jrsm.org/cgi/content/full/99/6/273; Spielmans GI, Parry PI. From evidence-based medicine to marketing-based medicine: Evidence from internal industry documents. Journal of Bioethical Inquiry. 2010;7(1):13-29.
8. Association of the British Pharmaceutical Industry. Code of Practice for the Pharmaceutical Industry 2012. 2012 - [cited 2012 Apr 16]. Available from: http://www.abpi.org.uk/our-work/library/guidelines/Pages/code-2012.aspx
Competing interests: No competing interests