Abstract
It is not because things are difficult that we do not dare, it is because we do not dare that they are difficult. Seneca (5 BC-65 AD)
The partnership between doctors and the pharmaceutical industry that Singh et al. describe and have set out to achieve is as ambitious as it is sophisticated. Recently the relationship between doctors and drug companies, and how ‘entanglement’ in various ways may influence medical practice, has been the subject of considerable debate, as highlighted by a series of thought-provoking articles published in the British Medical Journal.1–3 The commentary in these articles depicts two contrasting viewpoints that abstract many of the arguments.
One view is that doctors are best advised to remain as distanced as possible from drug companies and that they should minimize interaction, especially as regards their own education and clinical practice. The contrary view suggests that in modern medical practice a substantive relationship between doctors and the pharmaceutical industry is necessary and indeed often beneficial, and that any influence mediated via this relationship is minimal and does not risk significantly compromising patient management.
At first pass, the Lilly Melbourne Academic Psychiatry (MAP) Initiative, as described by Singh et al., can be easily criticised despite the many safeguards designed to address the concerns of the academics involved. For instance, the fact that the collaboration is so substantive in monetary terms and involves a single academic department would surely suggest some degree of bias. Furthermore, the requirement for manuscripts to be reviewed by Lilly, albeit for patent protection, and the retention of intellectual property rights with the host company for their products also raises some concerns as regards academic freedom. However, a cursory examination of the 12 projects that have been funded thus far reveals a somewhat different picture. More than half the studies are mainly education- and training-orientated, with only a handful actually involving medications. Within those that do, there is a predominant neuroscientific focus and the use of medications can be justified. At the very least it is clear that these are not simply ‘treatment trials’. However, the Initiative is still in its infancy and many would argue, quite correctly, that ultimately industry views medicine as a business and that drug companies are simply commercial enterprises that are in the business of marketing products. Furthermore, in order to achieve their financial goals, pharmaceutical companies are variably reliant on doctors, and therefore, in practice, wherever there is a ‘prescription choice’, companies will necessarily compete to enhance the appeal of their particular product. Hence purists argue that by the very nature of this ‘interdependence’ it is inevitable that doctors are susceptible to marketing, be it in the form of seemingly innocent freebies such as pens or more substantive amounts including educational grants, travel subsidies and research funding. Briefly examining the latter, it is evident, as Singh et al. point out, that mental health research, especially in Australia, is poorly funded and that in reality the majority of academics do not have a choice. In order to survive, they have to have additional sources of funding.
The key question, then, relates to the long-term cost of a relationship with industry and how researchers in academic medicine that are financially hamstrung can continue to be productive and at the same time remain true to the ‘primary purpose of medical research’, namely improving prophylactic, diagnostic and therapeutic procedures.[4] After all, it is this objectivity and independence that contributes significantly to our professionalism, and any potential erosion or threat needs to be scrutinized carefully. In practical terms, such questions often seem too complex to tackle, largely because of the subtle complexities of real-life situations within which they have application. However, this in itself should not dissuade us from trying.
So, to what extent does collaboration with industry, a seemingly effective means of gaining access to resources, actually constrain medical practice, education and research? In the first instance, it is reasonable to assume that association does to some extent translate into influence. Indeed, this is fundamental to all relationships and to argue otherwise, thereby imputing that doctors have unique immunity, would be futile. However, the extent of such influence and its management are a very different matter. If it is autonomy and independence that we seek, as doctors in clinical practice, research or acadaemia, then surely we should be the most adequately equipped to achieve this? After all, doctors already successfully negotiate many exacting relationships. For instance, doctors practising in public hospitals are constantly drawn in different directions by hospital administration and the needs of patients. In this setting, doctors usually favour patients, asking for more resources such as beds and staff. However, cynics suggest that doctors are largely motivated by helping themselves and that their primary or underlying concern within these actions is for their own livelihood. Such criticism is particularly poignant when the argument is carried over into private practice. Here the potential for developing a conflict of interest is perhaps much greater or at least more obvious. Hence, generally doctors are quite vulnerable and yet we negotiate these difficulties quite successfully. Perhaps one reason for this is that doctors are trained to be ethically minded and that therefore they are more acutely cognizant of such issues. Furthermore, it is routine practice for clinicians to partition personal opinion from clinical action and in doing so build and maintain doctor—patient confidence.
It is therefore imperative that doctors are involved not only in the marketing aspects of industry but also in the decision-making forums. In this way doctors can perhaps hope to reach and influence the higher echelons that govern industry and industry objectives. This is absolutely necessary, because the simple truth is that modern-day drug development is far too expensive and sophisticated to be undertaken by organizations other than large multinational pharmaceutical companies, and governments are certainly not interested in undertaking such risky ventures. Withdrawing altogether is a myopic view, which sets up confrontation and cuts us out of the discussion. Only with dialogue can we hope to play a part in setting the agenda, finding common goals and developing educational and research initiatives.
The reality is that doctors are already involved in many roles that impact upon industry, and the latter can facilitate the majority of these. Singh et al. have articulated a model in which they have endeavoured to embrace academic sponsorship with the ultimate aim of ‘quality care and industry success through academic excellence’. By design, this positions aca demic excellence first, a natural corollary of which is an improvement in quality of care. Theoretically, industry success can be modelled as a useful by-product that acts both as a catalyst and substrate, furthering the efforts of those involved. If this is the ultimate aim of the Lilly MAP Initiative, then it is a bold venture that is presently undoubtedly flawed by virtue of being the first experiment of its kind in Australia. Finding the requisite correct balance will take time and perhaps umpteen attempts. This Darwinian process will no doubt have many failures but also some successes. In that time, any such collaborations will draw attention and spawn criticism, some of which will likely be well founded. However, the proponents should at least be given the benefit of the doubt and judged ultimately on outcomes.
With respect to Australian academic psychiatry, the Lilly MAP Initiative is akin to a song being jointly improvised by the researchers in Melbourne and the Company itself. So far, it seems to be in harmony. However, only time will tell whether Singh et al. can remain in tune and last the distance or whether ‘the fat lady’ will be the last to sing.