Complex ethics

During a discussion with a product manager recently, I discovered I'm old enough to be her father — easily, in fact, even by Home Counties standards. Pensive, I reflected on the years I've spent in pharma in clinical research, regulatory, commercial and medical affairs roles. Two thoughts came through the memories. Firstly, I love working in pharma, and particularly at that medical-marketing interface where campaigns and projects are developed and nurtured to implementation. The second thought is more troubling: why, at that medical-marketing interface, am I still dealing with so many of the same problems I was 14 years ago?

I'm still reviewing material that should never get close to a job-bag, stuff that should be dismissed before ever being committed to Word and briefs that blow the ethical justification for an activity clean out of the water even as they are describing it. The frustration is not just that it wastes so much energy and accrues risk, it's more that it is all so unnecessary.

People in pharma are every bit as ethical as those in the NHS (I could write at length on this matter, having seen both sides) and the projects they plan and deliver are in the main wholly appropriately implemented. The only problem is that we waste so much time getting there.

Wasting time
At meetings we as a company hold with medical, commercial and managing directors there is much agreement on this point. At a very practical level we frequently hear a view expressed that agencies who consistently deliver ethically sound material will prosper over those that don't, if only because it reduces cost and time to delivery. The question (which I'm not going to answer) is: does anyone differentiate themselves on this score at the moment?

Now before we get much further and in order to maintain the goodwill of you, the reader of a pharmaceutical marketing publication, let's be clear that this article is not a polemic on the ills of marketing. Indeed, if anything, it is a rallying call to the medical side of the business to up its game in the education of pharmaceutical promotional ethics, to ensure businesses are better equipped to meet the challenges of what is a radically different selling model from the one I first knew.

Working in the new model
In the new world we have whole new customer groups, whole new customer facing roles, whole new offerings and whole new means with which to communicate with the world at large. The number, complexity and types of interactions between healthcare, the public and pharma have all increased exponentially and there is no sign this rate will slow down.

The bottom line is that, in such an environment, those looking for clear ethical solutions for all situations in a code of practice book are going to be dreadfully disappointed. It is, quite simply, already fundamentally impossible to write such a code.

So what do we do? Sit on our hands, look nervously over our shoulders at our competitors and petition the Code of Practice Authority for as many rules as they can manage? Or should we just make up the rules as we go along? Well, bizarrely perhaps, it's the latter I'm going to propose we do a little more of. Let me explain.

Making it up as we go along
The vast majority of people, in general, act ethically in their day-to-day lives. Most people aren't burglars, embezzlers or crooks not otherwise specified. The worst that could be said of most of us is a tendency to white lying when it suits us.

In pharma I'd guess that criminality is even less the norm than in the wider population. People who are attracted to this profession are, in general, pretty good eggs who make ethically appropriate decisions every day of the week and hold opinions on hugely complex ethical dilemmas without reference to any third party.

The mystery to me then is why, when confronted with complex ethical questions about promotion for which there is no 'Code precedent', so many of those same people are happy to surrender the decision to medical, legal or compliance 'experts'. The situation would be understandable if those experts all invariably arrived at the same nailed-on ethical conclusion to any given situation, but the problem is that very often they don't. The outcome is that a commercial lead for a project can be pointed in several different directions at once, with the resultant oft-repeated complaint that 'the medics never agree'.

The real question is not 'Why do the medics never agree?' but instead 'Why should they agree?' In very complex ethical questions about company activity, there is no more reason for everyone to agree than for everyone to agree about the rights and wrongs of abortion, capital punishment or the suitability of John Terry as England captain.

A single conclusion
From my perspective, the fault of the promotional compliance community (of which I consider myself a member) is not that it doesn't come to a single ethical conclusion in a difficult situation but rather that it has given the impression there always is a single ethical conclusion. In fact when looking at the myriad of interactions now possible between pharma, the public and health professionals, whether to carry out an activity is less important ethically than the thinking that led up to the decision.

Let me draw an analogy. I may think euthanasia is right, you may disagree. If I thought euthanasia was right because it saved money on all those expensive terminal care services you'd be appalled and rightly so. If I believed euthanasia right because it protected the dignity and rights of the individual you may not agree but you'd probably have some understanding of my decision and are more likely to respect it.

My plea then, in the more complex environment in which we find ourselves, is this: drive and crystallise the ethical justification for your activities as hard as the commercial one. The ethical reasoning for why something is done is too often lost in corridor conversations, e-mail debates and meeting minutes. If external eyes disagree with a course of action they may be sceptical as to motives if they have no evidence of a thought process to the contrary.

Ethical justification is the responsibility of everyone, not simply those who make the compliance decisions. With complex matters, a written justification of the actions taken is critical not only to show that fundamental ethical principles have been considered but also to ensure consistency and speed of action across large teams.

In trying to define what those fundamental principles are, one trick is to forget the Code for a few minutes and think like the ethical person you are. The most important consideration in any activity undertaken by a pharmaceutical company is the protection of the unknown individual from harm. Activities and drugs can be justifiable if the risk of harm can be offset by (the expectation of) much larger benefits to individuals. For most promotional activities, however, the benefits are mainly to the company, so risk of harm is barely (if at all) tolerated.

The principles of promotion
And so to promotion: be honest, is the primary intention of what you are doing mainly to influence opinion for the benefit of a product?

There's a lot of confusion out there about what promotion is. At presentations to larger audiences I put a series of activities on a slide and I ask the audience to vote on whether these activities are promotional or non-promotional — for some fairly bog-standard activities what results from asking this question is a complete split of opinion displayed very graphically.

A definition of promotion needs to be established to allow some fairly fundamental decisions about what is ethical to be made. Promotion can only be effective through force of argument; attach benefits to it and it becomes bribery. (A note for anyone out there thinking 'everything we do is promotional' — it isn't. Not if you want a definition that's of any use to take you forward. Everything we do is for our business and the patients and health professionals that to varying degrees rely on us, but it's not all promotion.)

Another fundamental, again very familiar to us in everyday life, is that of transparency. If I'm buying life insurance from someone, it makes a difference to my assessment of his advice if I know that he's getting a big commission on the particular policy he's recommended. It doesn't mean the advice is bad but I've a right to know it in making my decision. There is no stock transparency phrase for me that can describe all the interactions we have and the things we support as an industry — whatever is being done needs to be described as accurately and fully as possible and (let's face it) it should be with a certain amount of pride that many of the things industry supports would not happen without that support.

The Code of Practice
Just about everything in the UK Code of Practice can be traced back to sound fundamental principles, most particularly to protect patients from harm. All pharmaceutical codes are built on this very solid base but they can never be exhaustive unless we as an industry restrict ourselves to a limited tick list of activities that can easily be delineated. That would be in the interest of no-one, least of all patients and healthcare.

A more fundamental approach to ethical thinking across teams and roles in pharma has the power both to liberate and to protect the pharmaceutical industry in a shifting environment. Ultimately the great paradox here is that to deal with the great complexity of this pharmaceutical age we should perhaps return to a simpler, more fundamental, approach to our ethical thinking; only then will we be able to take the spirit of the Code into the places that its text and precedent have not yet travelled.

The Author
Nick Broughton is managing director of pharmaceuticalethics.com
His email address is nick.broughton@pharmaceuticalethics.com

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