What do people understand about the issues that influence their judgment and decision making? What point is served by declarations of interest? There are a wide range of people with different interests, ranging from professionals, patient organisations, medical students and the public. How much information is needed and what needs to be done beyond the ‘declaration’ to manage the interests?
Contacts with industry are vast and multidirectional (i.e. clinicians and researchers approach industry as much as industry approaches clinicians and researchers). There is much less data in Australia about the extent of interactions between the health sector and the pharmaceutical industry than in the USA. A US study showed that:
- 85% of professional organisations are sponsored by, or receive advertising revenue from, the pharmaceutical industry.
- More than 80% of patient/consumer groups receive support from the pharmaceutical industry.
- Many medical students have accepted gifts from industry and had extensive contact with industry-sponsored education, promotional materials and data before graduation.
- The public also engage with industry through direct-to-consumer activity – despite this being prohibited in Australia.
In 2009 an American Medical Student Association PharmFree Scorecard survey asked US universities if they had conflict of interest policies. The domains of interest included gifts, consulting relationships, industry-funded speaking relationships, disclosure, on-site educational activities, medical school curriculum, and compensation for attendance at meetings. One-third of the universities refused to answer the question. The American Medical Student Association gave permission for their methodology to be used to assess conflict of interest policies in Australian medical schools. The results were published in 20111 and showed that the majority of Australian universities, as with those in the USA, scored very poorly.
Another recent study looked more broadly. The Australian University Conflict of Interest Survey2 showed that nearly 30% (n=12) of universities declined to provide any information. Of those that did provide information, most (n=27) had policies on staff’s competing interests:
- 15 universities did not require regular declarations from staff and only four required annual declarations
- Only eight universities maintained a central register of staff declarations
- Only six universities had some mechanism in place that allowed members of the public to access information from their register
- None required that staff place their declarations on their website profiles and none had policies that indicated staff should declare conflicts when making public comment. These can be recovered through Freedom of Information processes, but it is hard work.
Recent National Health and Medical Research Council-funded studies (NHMRC 457497 and 141772) have been conducted to seek more detail on the relationships and interactions between industry and Australian specialists. The study involved 1500 clinicians and showed that:
- 96% had accepted gifts (the value of gifts was higher if the physician was in an active research relationship with that company or was on the advisory panel of that company)
- 84% had attended a sponsored symposium or product launch (as distinct from a conference)
- 52% had accepted travel sponsorship and 30% had accepted travel support for their partner
- 23% had been a member of an industry advisory panel
- 7% owned shares in pharmaceutical companies that produced drugs that they prescribed
- 6% had acted as a paid consultant.
The study also investigated the concerns of respondents about industry-funded research. These concerns, by percentage of respondents, included:
- premature termination of trials (most of these appeared justifiable e.g. adverse events) – 14% (114)
- first draft of paper written by sponsor or ghostwritten – 12% (100)
- unreasonable delay in publication – 6.7% (55)
- failure to publish negative findings – 5.2% (41)
- draft of paper editing to make the drug look better – 2.7% (22)
- concealment of results – 2.2% (18)
- inappropriate alteration of data – 0.9% (7).
The potential adverse consequences of pharmaceutical-industry sponsorship of research have been extensively described. They include:
- increased costs of care
- distortion of care, erosion of rational prescribing and quality use of medicines
- distortion of research agenda (creation of the ‘90/10 divide’ whereby 90% of research is conducted in diseases that affect 10% of the world’s population – those able to afford pharmacotherapies)
- distortion of evidence (with the results of sponsored studies consistently being more often favourable towards the sponsored therapy under investigation)
- distortion of research question (reduction in ‘head-to-head’ studies, particularly of competitor drugs)
- distortion of research methods (move from superiority to non-inferiority trials)
- selective reporting of data favourable to product
- loss of researchers’ independence and integrity
- creation of multiple ties and conflicts of interest
- creation of gift relationships
- increase in secrecy in medicine and research
- delay or non-publication of key findings for commercial reasons (such as has been documented with studies of COX-2 inhibitors and selective serotonin reuptake inhibitors)
- erosion of public trust in research, medicine and health professionals.
While these harms work in different ways in different contexts, ultimately they all have the capacity to subvert the (proper) goals of medicine, health education and biomedical research.
This level of systematic bias in medicine is a challenge for all those engaged in health, but it is a particular problem for evidence-based practice, which emphasises and relies on published evidence. If the data on which evidence-based practice is founded are corrupted, then so is practice itself.
Concern about this level of pharmaceutical industry involvement in research, education and clinical care is not limited to liberal critics of medicine, but is shared by many of those who have an interest in the quality of medicine and biomedical science. It is noteworthy that past and present editors of many of the world’s major medical journals have noted the adverse impact that industry sponsorship has had (and continues to have) on the scientific record and on the integrity of the profession.
Journals have evolved into laundering operations for the pharmaceutical industry. - Richard Horton, Lancet
Journals have been co-opted by industry. - Marcia Angell, New England Journal of Medicine
Medical journals are an extension of the pharmaceutical industry. - Richard Smith, British Medical Journal
There is a cycle of dependency between journals and the pharmaceutical industry. - PLoS Editors
Assessing and managing interests in medicine
There is now a huge amount written about conflicts of interest. Many professional bodies, colleges, universities, research institutes and industry organisations and networks now have codes of ethics and conflict of interest policies, although these are of variable quality and most remain in the private rather than the public sphere.
Three of my own experiences illustrate both the importance of having some means for thinking through conflicts of interest and the difficulties associated with assessing and managing them.
Development of embryonic stem cells and human cloning legislation
In 2005 to 2006 I was involved in the Lockhardt Committee, a Legislative Review Committee established by the Commonwealth Government to review the Acts relating to human cloning and embryo research. One of our tasks was to draw up a view regarding progress or reform in this area that was consistent with ‘community values’. It became clear that, on this issue (and undoubtedly on others), there was no single community or single community view or values. Instead, there were many communities and many values and interests, and these were often diverse and sometimes incommensurable. Also, there was not a single person in the community who was not concurrently a member of many different ‘communities’, each of which had its own norms, values and language. A person was simultaneously a research scientist, a doctor, a mother, a Catholic and a friend of someone with a disease that may, in the future, be helped by stem cell research. The task for us as a committee, and also for every person when deciding how they should act or behave or vote, was to reflect on the multiplicity of values and to identify what these interests are, how salient they are, where upon a continuum of interests they lie, and how they should be managed – particularly when they appear to be incommensurable.
The lesson here is that one always has multiple interests simply by virtue of having different social roles, and sometimes these are problematic and sometimes they are not. The task for guideline developers is to identify the interests at play and then to consider, through open and transparent debate, whether or not these interests create a conflict or put at risk the integrity or rigour of the guideline.
In recent times I have had cause to think about the relevance of faith to medicine and health policy. Faith is important to people, their lives and families. It comes with a set of values, rituals, authorised dogma and hierarchies of decision making that influence the way people of faith may approach any issue or situation. Faith, in and of itself, does not represent a conflict of interest or necessitate exclusion from discussions about health policy. Indeed, ethics committees are required to include representatives from pastoral care or faith in their membership. And faith undoubtedly contributes to thinking about values or beliefs or the impacts of health policy. However, while there is a tendency to privilege faith – to suggest that it is never appropriate to exclude people of faith from policy-making on the grounds that they have a conflict of interest – this seems not to be true. Surely a Jehovah’s Witness has an unavoidable conflict when it comes to blood policy, a Scientologist has an unavoidable conflict when it comes to mental health policy, and a Catholic priest has an unavoidable conflict when it comes to determining policy on access to reproductive technology or third-trimester termination of pregnancy?
While one would not seek to exclude people of faith or be deaf to their values, for those charged with developing guidelines, the question is where relevant expertise (including representatives from industry or researchers with extensive ties to industry) should sit. Should the person have a role in the development of expert guidelines, or should they be kept distant but be invited to give an expert perspective – an interested perspective – via submission or review?
Interests and expertise: The ubiquitous nature of competing interest in contemporary healthcare and research
This year I was invited to write a commentary on the issues surrounding a well-publicised public and professional debate about conflict of interest. In 2011 the well-known psychiatrist, mental health advocate and public intellectual Professor Ian Hickie co-authored a narrative review of melatonin-based therapies (agomelatine) for depression in the Lancet.3 In the paper both authors disclosed ties (financial and professional) with the manufacturer, Servier. This paper provoked a firestorm of criticism in the Lancet, lay press, and social media about the disclosure of interests. The criticism included both empirical claims – that the authors misreported the tolerability/efficacy of agomelatine – as well as moral claims – that the authors were conflicted or biased or that they, or Servier, may have benefited from publication.
Hickie and Rodgers penned a spirited response4 defending their findings, their professional ethics and their compliance with the Lancet’s disclosure policies.
This is not the first time that psychiatry has featured in discussions around the links between the pharmaceutical industry and the medical profession. Over the past two decades there have been innumerable occasions where concerns have been raised about the links between psychiatry and industry (likely a consequence of the nature and prevalence of mental illness and the vagaries surrounding psychiatric diagnosis). In recent times, for example, concerns have been raised about the impact of commercial interest on the revisions to the DSM-5. These concerns have included questions over the definition and diagnosis of illness, issues of overdiagnosis, overt drug promotion and non-disclosure of pecuniary conflicts of interest. For the Working Groups revising DSM-5, 67% of the Mood Disorders Work Group, 83% of the Psychotic Disorders Work Group, and 100% of the Sleep–Wake Disorders Work Group had ties to manufacturers of medications used to treat these disorders.5
There is no doubt that Professor Hickie is entangled in a web of interests, but in this regard he is likely no different to any other major researcher or director of a research institute. As an academic researcher, well-respected clinical psychiatrist, public advocate and director of a research centre he is expected to create and sustain links with industry, forge public–private partnerships, and develop research that inevitably engages with industry.
The lesson here is that each social role carries with it a series of moral, social and professional imperatives that one assumes when one adopts that role, and these are often difficult to balance. While most of the time each of us can balance these different roles easily, in some situations conflicts may emerge – conflicts that may or may not have very serious implications for science and practice.
‘Interests’ involve a commitment, goal or value arising out of a particular social role or practice. There is nothing wrong with interests per se. So rather than speaking of conflicts of interest we should speak of multiplicities of interests and accept that just as people have many roles they also have many interests – none of which has obviously greater a priori importance or weight.
At any one time a person has a range of interests. For example, I am a clinician, teacher, director, colleague, collaborator, father and partner – all these roles have different demands and expectations attached to them and sometimes these interests collide.
The task for guideline developers and clinicians is to establish whether any one of these divergent interests constitutes a genuine conflict of interest (such that one's primary commitment at that time or in a particular context – e.g. research or design of guidelines/policy – is subverted or distorted) and to consider what should be done. This may be a function of the importance of the task and the necessity to separate interests. While this must be a matter for personal reflection and humble introspection, it must also be a public matter for discussion and discourse with relevant stakeholders.
In guideline development processes it is clear that it is not sufficient to simply disclose an interest and rely on that disclosure to resolve ethical concerns. Disclosure may obfuscate or provide moral licence and does not reduce the prevalence or impact of competing interests. Disclosure and transparency are, of course, important, but the idea that disclosure is sufficient to expunge the possibility of bias, or that responsibility for assessment lies with the public, readers and users, is naïve and morally inadequate. We need to go beyond this, and this requires that we develop a more sophisticated view of interests and that we ‘de-psychopathologise’ conflict of interest and remove blame or ignominy from declarations.
We must also openly establish 'interests' as a conversation and establish rigorous, transparent and professionally accepted processes for discussing, assessing and managing competing interests. These conversations will only happen, of course, if the relevant communities (be they industry, scientific or research communities) have a culture that respects discourse on these issues, and are prepared to establish guidance regarding what sort of disclosure and management of the interests is required. This guidance will need to make clear not only when and how interests should be declared and how relevant interests should be assessed, but what relationships may or may not be acceptable and how competing interests should be managed – by declaration alone, consultation, collaboration, abstention, delegation, divestment or separation.
Importantly, guidance on assessing and managing competing interests should attend both to pecuniary and non-pecuniary interests. While we have made some progress in thinking about financial conflicts of interest, much less is known about non-pecuniary interests and how we should manage them. In my view it is very likely that non-pecuniary interests (which include political influences, publication, status, professional recognition, academic progression, and belonging to a professional or academic community) are much more important ‘drivers’ than financial interests and rewards.
There are no clear solutions, but it is clear that we need to think differently about interests, we need to think more rigorously about interests and make the discussion about facts and values rather than personal failings or psychopathology. We also need to have these discussions in public spheres rather than purely private ones.
Acknowledgments: Professor Ross Upshur, Dr Wendy Lipworth, Professor Paul Komesaroff, Emeritus Professor Miles Little and Dr Chris Jordens
Professor Kerridge provided a detailed declaration of his interests (see Appendix 2 for details)
- Mason PR, Tattersall MH. Conflicts of interest: a review of institutional policy in Australian medical schools. Med J Aust 2011;194:121-5.
- Chapman S, Morrell B, Forsyth R, Kerridge I, Stewart C. Policies and practices on competing interests of academic staff in Australian universities. Med J Aust 2012;196:452-6.
- Hickie IB, Rogers NL. Novel melatonin-based therapies: potential advances in the treatment of major depression. Lancet 2011;378:621-31.
- Serfaty M, Raven PW. Novel melatonin-based treatments for major depression [letter]. Lancet 2012;379:217-9.
- Cosgrove L, Krimsky S. A comparison of DSM-IV and DSM-5 panel members’ financial associations with industry: a pernicious problem persists. PLoS Med 2012;9:e1001190.