From conflict to confluence. Is it time for change?
05.11.15
This is a good thing: in any field, in any career, in any situation, experience helps. Unless of course you are in involved in the process of researching, developing, regulating or prescribing medicines. All too often, in this context, our perspective on experience dissolves when someone sounds the conflict of interest alarm.
A conflict of interest is essentially a situation in which a person has a duty to more than one person or organisation, but cannot do justice to the actual or potentially adverse interests of both parties. The assumption is often that the conflict – and ultimately the collaboration – that led to it must result in flawed decision-making and bias. In this scenario, the reputation of the investigator, the sponsor, the congress attendee is called into question and we are left trying to negotiate a paralysing maze of guidance and regulations designed to help clinicians, researchers, journals and industry us navigate the murky waters of conflict.
Whatever the intent, this cannot be the best approach to encourage innovation, collaboration and really ensure that we deliver the best for patients. Don’t get me wrong; in the context of my own healthcare, I am pretty enthusiastic about the notion that my interests are everyone’s primary concern. But it is not the absence of conflicts of interest I am looking for, its uncompromised clinical decision making, experience, expertise and transparency.
Increasingly, the research and development model relies on collaboration, between companies large and small, with academia, with patients, health systems and individual researchers and health professionals. Beyond the research and development of a medicine, we see increasing use and analysis of real world evidence and new ways to share outcomes data and best clinical practice. All these elements require increased collaboration.
So, for me, trying to minimise conflicts of interest, or creating such a layer of bureaucracy around them that collaboration becomes untenable, is just not an option: quite the reverse. If we are to address some of the challenges facing our healthcare systems I am pretty sure no one group has all the answers, not industry, not health professionals, not patient organisations, not regulators, scientists nor governments. If more collaboration is part of the solution it means more conflicts of interest so we need to get smarter about how we manage this.
We have spent decades building an infrastructure to manage conflicts of interest. So as collaboration becomes both more common and more vital, how do we effect change?
Changing the Language
Language is important; it shapes not only how we describe a situation, but also how we feel about it. The whole phraseology around conflicts of interest – in its current guise – creates an artificial barrier to greater collaboration and, ultimately, the innovation that it brings. This was touched upon in the recent JAMA article “Confluence not conflict of interest: name change necessary” (Anne R. Cappola, MD, ScM, Garret A. FitzGerald, MD, FRS, The Journal of the American Medical Association, 24-09-2015).
Rather than conflicts, their focus was on the objectivity of decision-making, based on a confluence of interest implying an alignment of primary and secondary interests. If objectivity, based on broad, collaborative experience, could replace conflict, we would take a collective step forward.
Increasing transparency
Transparency can play a key role too. Collaboration between industry and health professionals benefits patients. It is a relationship that has delivered numerous innovative medicines and changed the way many diseases impact on our lives. But we must understand that society has increasingly high expectations for transparency, none more so than in healthcare. We want to ensure that we meet those expectations going forward.
That is why across Europe, by quarter two 2016, companies will begin disclosing payments made to health professionals, such as sponsorship to attend meetings, speaker fees, consultancy and advisory boards. Bringing greater transparency to this, already well-regulated, vital relationship can strengthen the basis for collaboration in the future. It is a proactive move by industry; based on our commitment to this relationship, which I hope will help to shift the focus from conflict to collaboration.
Operating with integrity
Finally, and perhaps most importantly is integrity. No matter how we describe relationships or how transparent they are, all collaborators in any relationship are judged by their actions.
Perhaps one of the most influential roles in the introduction and regulation of new medicines is the FDA Commissioner. Dr Rob Calliff’s recent nomination for the role has been met with widespread support yet his list of declaration of interest is as long as it is distinguished. It is likely that the positive reaction to his appointment is based as much on how he operates, as it is on his experience as one of the world’s top 10-cited medical authors and leaders in translational research.
Changing perspectives and attitudes takes time. To move away from the negativity and bureaucracy that surrounds conflicts of interest to fostering greater collaboration, celebrating experience and the confluence of interests based on transparency and integrity, requires all stakeholders to buy into the change.
If we look at the future of research, regulation and healthcare, it’s a change worth making.
