Supping with the devil? The dangers of liaisons between pharma and our profession

Pharmacological interventions are pivotal in the treatment of many psychiatric disorders and in reality we rely on the pharmaceutical industry (informally referred to as pharma) for the development and promotion of new drugs with the aim of improving the outcomes for patients. While there are concerns regarding the efficacy of antidepressant medications (Young, 2012), with clinical trials showing ever-diminishing differences in outcome between drug and placebo that suggest they offer little additional benefit, we know that in clinical practice antidepressants are often effective in severely depressed patients. There is no doubt that pharma needs to work with the profession in conducting clinical trials, disseminating information about the efficacy and effectiveness of medications that they produce, and obtaining advice as regards the positioning of pharmacotherapy in treatment regimes. On the surface this seems to be a straightforward relationship, but in recent times it has become increasingly acrimonious, with allegations of impropriety being made against those in the profession who have links to pharma.

In this issue of the ANZJP we have four invited perspectives on aspects of the relationship between the profession and pharma (Jureidini, 2012; Kerridge, 2012; Ryan, 2012; Smith, 2012). These articles follow in the wake of a series of letters published earlier this year in The Lancet (Barbui and Cipriani, 2012; Carroll, 2012; Howland, 2012; Jureidini and Raven, 2012; Lloret-Linares et al., 2012; Serfaty and Raven, 2012) that raised concerns about the perceived relationship between the authors of a review paper, and the media discussion that ensued. These initial letters raised important issues about aspects of the relationship between the pharmaceutical industry and the profession that warrant thoughtful debate (see ‘Declaration of interest’).

It is therefore time we all give serious consideration to our links to pharma, and it is hoped that our College (Royal Australian and New Zealand College of Psychiatrists, RANZCP) will play a central role in this discussion. All too often, when calls for this to happen arise, such as the recent proposal for no pharma involvement at the annual College congress, the problem appears insurmountable and eventually little changes. As a profession, we need to have a clear understanding of our position in relation to interactions with pharma, and work towards developing a comprehensive statement as to what is ‘appropriate involvement’, how this should be disclosed and what are the boundaries of any such involvement. Our current state of ambiguity and ignorance is simply not acceptable.

Unfortunately, discussions around this topic often culminate in reinforcing polarised views that do not usefully advance debate or our search for a solution. In such discussions, pharma is often demonised and those involved with them are usually viewed dichotomously either as naïve and innocent victims or unscrupulous scoundrels only interested in feathering their own nests. Such demonisation occurs because of a number of reasons. First, the marketing of new generations of drugs has been particularly aggressive in recent years. Excesses in ‘wining and dining’ psychiatrists (and our colleagues from other specialties) that came to light via the general media created a very negative image of the medical profession as a whole. Thankfully, lavish and indeed sometimes outlandish entertainment has been wound back and pharma are now bound, in Australia at least, by a code of conduct (Medicines Australia, 2010). Second, the merits of new drugs were often exaggerated and overstated, with key opinion leaders (Jureidini, 2012; Moynihan, 2008) being used to promote the sales of drugs. Third, there have been a series of high-profile failures to disclose pecuniary interests from both recipients and their providers. Finally, the failure of pharma to be forthcoming in a timely manner about the known negative impact of medications has heightened the suspicion with which they are viewed (Smith, 2012).

Considering these points in the current context of possible inappropriate prescribing, for sometimes questionable diagnoses (Angell, 2011), and uncertainty as to why DSM-5 is further broadening the definition of many disorders, it is no surprise there is a perception that the devil is at work.

The reality remains, however, that despite all these concerns, we still require pharma to develop new drugs and conduct clinical trials to test their efficacy because the costs of conducting randomised clinical trials are enormous (Angell, 2004) and these simply cannot be met by funding from government agencies alone such as the National Health and Medical Research Council. Efficacy trials are necessary in order for medications to be registered and appropriately licensed; ultimately, pharma requires clinicians to advise and indeed execute these clinical trials in their patients. Thus, pharma cannot function independently of clinicians and at the same time we clearly need their resources to develop new treatments.

What does this then mean for our role as doctors? As doctors we need to be able to fulfil our professional role as scholars and, in so doing, critically appraise the outcomes of clinical trials so that we can determine whether the claims made by the investigators are accurate. When doing this, we need to be aware of who has funded a particular study or piece of research, and what potential conflicts there may be between the investigators and the relevant pharmaceutical company.

In addition to drug development, pharma is also a major provider of continuing medical education (CME) activities, in which opinion leaders often give presentations about new products in the market (Jureidini, 2012; Moynihan, 2008). It is important that we are informed about new medications as they may lead to improvement in our practice and provide help for our patients but, equally, we should not be passive recipients of such information. Instead, we need to be circumspect and carefully appraise any evidence presented to us. Again, we should also be mindful of what potential conflicts there may be between those delivering these messages and their pharma sponsors, and be able to determine whether they are potentially compromised (Kerridge, 2012).

Professionally, full disclosure is expected from psychiatrists and stated in our code of ethics ‘Psychiatrists shall declare any dualities of interest when presenting or publishing research results’ (RANZCP, 2010) (principal 7.13). Many journals and academic institutions require such statements of potential conflict and the disclosure of funding received from pharma. Whether this is sufficient to manage this sophisticated relationship remains to be seen because although these declarations address our concerns in part, they fail to capture the more difficult issues surrounding the role and extent of sponsorship, and support for CME and research meetings.

In any debate that examines this relationship we need to take into account the essential aspects of how we, as a profession, need to deal with pharma and ensure that the interactions are necessarily moral and free from corruption and, equally importantly, are perceived as such. Ultimately, we have to be confident that we can assure the public that we conduct our clinical practice independently and are not unduly influenced by marketing or economic agendas. This is a complex issue and one that is not going to go away. It is therefore imperative both for our sakes and for that of our patients that we formally and systematically examine this issue. However, whilst consensus can be readily achieved with respect to our overall goals that capture our good intentions, it is important to note that if we are to develop meaningful detailed guidelines, we need to negotiate the devil within the detail.