Promoting promotion – lessons for the developing world

Nick Broughton

Pharmaceuticalethics.com

To finish off our emerging markets themed month, Nick Broughton discusses the benefits and challenges of medicine promotion within these markets.

Over recent years, the FDA has levied multiple billions worth of punitive fines on a multifarious selection of large pharma companies, principally, for the crime of promoting medicines prior to, or outside, of their licensed indication. One would think therefore that understanding what ‘promotion’ of a medicine actually is would be a good thing so you know when to do it and when not to. Happily research has demonstrated that over 95% of any group you ask are confident they do indeed understand the term. Less happily if you ask any group (and I do mean any – we’ve done this with large groups of medical ABPI Code signatories) whether a particular activity is promotional or non-promotional you get a range of opinion for almost anything you care to mention. Oh dear. Seems when people say they understand the term they understand their own definition of it.

My job here though is not to define the term, as to do anything valuable along those lines takes a seminar of workshops, debate, convincing and cajoling in order to change minds to a single view aligned to voluntary codes and law. Rather this missive aims to promote the notion that ‘promotion’ of medicines (even if loosely defined) is a good and noble thing generally to be encouraged. Strange you may think to spend valuable Word space defending promotion, but frankly I think it needs it.

To me there seems to be developing a flawed logic by which promotion is seen as a lesser form of pharma company activity. The logic goes something like this, promotion in the wrong place can lead to dire consequences (see above), promotion puts us at risk, promotion is risky, let’s do non-promotional stuff instead to reduce our risk, the medical function is non-promotional ergo its activities are non-promotional, let’s have more activities coming out of our medical department, we have now reduced our risk. The consequences of this specious argument are many and varied, but not least amongst them is that risk can go up – to be promoting ill-advisedly is one thing, but to be promoting ill-advisedly whilst pretending (or having convinced yourself) not to be is worse. Members of company medical departments are the worst offenders for thinking their actions can’t be interpreted as promotional simply by virtue of their medical provenance. Twenty-five ‘disease area’ meetings are difficult to defend as unrelated to the promotion of a new drug when they occur in the 6 months up to the launch of that drug whichever arm of the company takes the reins and however ‘scientific’ you make it. It is, to me, delusional to think otherwise, but the problem with emperors clothes is that they look fine to the emperor.

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“Rather this missive aims to promote the notion that ‘promotion’ of medicines (even if loosely defined) is a good and noble thing generally to be encouraged.”

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Subtler consequences of the flawed logic are though no less worrying for the health of our industry. Some marketers have commented quietly that the drift away from promotion has left them feeling their own role is less valuable and that promotion ultimately won’t have a place in the pantheon of our activities. That I contend would be a shame because the art of promoting medicines is a fine one and every bit as important as the science of developing them – one cannot exist without the other.

Good promotion of medicines is, I am here to contend, a powerfully ethical thing to do and we as an industry should be proud to do it. Before I harangue you, the reader, further on the subject there is just one word in the above sentence I should like to re-emphasize, that word is ‘good’. There is no doubt there is lot of bad (in the sense of ethically dodgy) promotion of medicines out there be it misleading, incentivised or outside licence, just as there is bad clinical research and bad regulatory affairs practice in industry and bad medical practice by health professionals. We should take care to discard this historical bathwater though and pay attention to our promotional baby and, particularly in emerging markets, encourage her to concentrate harder than her Western ancestors on being good. A theme I will return to in closing.

One of the worthiest things about good (I’ll stop saying it now entrusting the point to be made) promotion of medicines is that it is innately transparent in showing what the intention of the promoting company is, namely to convince the recipient (usually a prescriber) of the virtues of the medicine in question in order to sell it and make money. The agenda of the promoting company is pretty clear and the prescriber can take that firmly into consideration when making a judgement on the information received. It’s a whole other debate as to the ethics of making money from poorly people but agree with it or not it is at least a clear agenda allowing autonomy of decision making by the prescriber.

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“There is no doubt there is lot of bad (in the sense of ethically dodgy) promotion of medicines out there be it misleading, incentivised or outside licence…”

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Payers, on the other hand, who promote prescribing of particular medicines in their formularies and guidelines often have an agenda, which is far from crystal to the patient. Typically payer decisions to promote particular medicines are based on a trade-off between what is best for the individual and what is best for the population. It is not immoral to promote sub-optimal treatment of an individual (say using a generic rather than a marginally better branded medicine) in order that more people can be treated with the same amount of money. It is however questionable to hide this motivation from the patient particularly if done in collusion between payers and prescribers so that the patient is not informed of choices that would be better for them as an individual. Worse, decisions to promote certain treatment for cost saving reasons are sometimes justified using evidence that would be pilloried if it were used by a pharma company for the same ends.

This brings us to a second noble feature of the promotion of medicines by pharma companies, namely that it is (unlike that of the payers above) closely regulated and framed within certain rules. God knows I’ve argued long and hard elsewhere that rules are not enough to ensure ethical promotion but, notwithstanding that, some rules are vital. That there are rules and that competitors monitor each other to enforce them encourages fair play and equality as well as guaranteeing a quality to the promotion for its target audience.

Promotion of medicines benefits patients in both the long and short term. In the longer term the only effective model we have for developing new medicines is a profit based one. No promotion of medicines, no profits, no industry, no new medicines. Humanity will survive, as it would without doctors, but it would be a lesser world if we didn’t seek to improve the quality of the human experience. In the short term, patients also benefit from acts of promotion (as distinct from what is being promoted). Clinical knowledge does not move rapidly, particularly in primary care where everything subject has to be catered for. To have a small army of people visiting doctors, with the sole purpose of having discussion and debate about a medicine in a diseases area, is bound to make some clinicians think about things they haven’t done in a long time, whether or not they accept the promotional argument. Allied to this in the wake of any promotional campaign comes a raft of medical education in palatable forms that is dispensed freely and enthusiastically. Gainsayers would point towards bias in such education, but that is for the recipient to judge unless we consider health professionals irretrievably dim, requiring of protection and unworthy of autonomous choice in deciding from where they will take information.

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“Poor promotion of a medicine deserves to fail under challenge, but so do poor excuses for not using a medicine.”

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It cannot be thought, however, that promotion is only good for primary care and its patients. Specialists too gain from the challenge promotion brings to accepted routines and the forums it creates for presentation and debate both locally and at international congresses. Is there anyone to step into the educational breach should pharma remove its promotional forces around which a melee of valuable scientific discussion takes place?

Poor promotion of a medicine deserves to fail under challenge, but so do poor excuses for not using a medicine. The people who create medicines must have the right to make their case and not leave that case in the ponderous hands of self-appointed experts whose biases are no less real simply because they are unclear. There are lessons to be learnt however and I return to the ‘good’ motif. There has been too much poor promotion that has sullied the ‘brands’ it has sought to create. The value of the ‘Western’ representative was sacrificed a while back on the altar of coverage and frequency such that numbers are now declining heavily in mature markets just as they are taking off in the developing world. Please God we protect the value of the representative in that world with a long-term view that recognises the ethical merits of promotion and works hard to keep it good.

European-CME-Forum-15-16-November-2012

About the author:

Dr Nick Broughton is Managing Director at Pharmaceuticalethics.com.

Nick Broughton qualified at Nottingham University Medical School and worked in hospital medicine and primary care for a period of seven years before joining the pharmaceutical industry.

His first role was as a clinical research manager in phase II and III at studies Sanofi Winthrop before moving into a medical adviser role at MSD UK.

The majority of his pharmaceutical career has been at AstraZeneca where he was UK Medical Affairs Manager before becoming UK Head of Medical Affairs. He then gained over 2 years international experience as European Director of Regulatory Affairs.

Nick is co-founder of Pharmaceuticalethics.com, a company that provides ethics and compliance audit, education and consultancy services to pharma and allied agencies.

How can we improve promotion of medicines?