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The medical-marketing interface and how to bridge the gap

Published on 18/05/09 at 11:53am

Drug companies are not charities and are accountable to their shareholders, as we all know. Products have to be sold by the commercial arm but at the same time are still subject to scientific and ethical constraints.

This tension between the commercial imperatives and the legal and medical restrictions continues to be controversial - not only in the public perception of pharma but also internally between medical and marketing departments.

Can't we just give the facts?

I began my career in sales, and I remember one example of practices that seemed perfectly reasonable at the time but now raise doubts in my mind. I had very good sales training, and one technique I learned was to minimise a product's disadvantage. A customer might pick on a real problem, such as the poor tolerability of a non-steroidal anti-inflammatory, so what should the salesperson do? The accepted ploy was to play it down, such as by comparing it with a competitor with a worse tolerability profile. At the time we salespeople were convinced we had the best product, so there was no ethical dilemma raised by doing this. Today, I look back with the benefit of hindsight, and can see this approach raises serious ethical questions.

After a few years in sales, I moved into clinical research and have now spent the best part of three decades in R&D. This means I tend to set more store by scientific evidence than marketing objectives. Why can't the salespeople just tell the customers the facts? There are those who would say that if we did that, we would not need salespeople. One product I was charged with selling was quite frankly pretty mediocre, and was called by many in the company a 'salesman's product': it wasn't good enough to sell itself, but a good salesman could do well with it. Without salespeople, it would never have achieved any market share.

Using key opinion leaders

So let's take a step back and look at the standard model for the drug development and marketing pathway. I think a key feature of this is that marketing is ideally involved very early on, with the definition of a target product profile. Thereafter, R&D is engaged in generating evidence to support that profile, which usually means it gets modified. In reality, in most cases the profile is not supported by the data and the product dies. But if the drug makes it to phase III, it is much less likely to fail and at this stage marketing becomes much more interested. Here is where a lot of conflicts can arise. One of these is in the selection of investigators. Marketing will insist on key opinion leaders (KOLs) being recruited, and clinical research will argue that these thought leaders very rarely contribute much to patient recruitment. The KOL model has become so embedded that it is widely recognised and criticised outside the industry, and KOLs are expected to declare the consultancy fees they receive in any publications to which they put their names. But let me raise a question. Do we really need opinions, or do we need facts?

The other day I learned something interesting from a lawyer. When judges listen to expert witnesses, they call that an opinion. Even if the expert cites solid evidence, the judge still considers this is open to interpretation, so it's still an opinion. Much the same seems to apply to KOLs. What it boils down to is the need for critical thinking by those listening, but the dilemma is that to be really critical they need to be experts themselves.

The use of KOLs in clinical trials was justified in the past by the need to get them experienced in using the drug - an element of 'seeding', although overt seeding trials were proscribed decades ago. In my experience this isn't always effective, because of their poor patient recruitment record. I would, however, have no problem with engaging KOLs as consultants per se, as long as the arrangements were open and ethical. Again, it isn't easy to work out what you want from a KOL, and quite often it hasn't been fully thought through. But pharma's relations with KOLs must now be far more ethical and transparent than before. Back in the 1980s, I was aware of a company that put a leading professor on an annual retainer of £10,000 without any real definition of what he was to provide in return. That was big money in those days. Around the same time I was asked to launder an overseas speaker's fees and expenses via another speaker's institution, a request that was politely declined. I'm sure most of you can cite similar cases if you have been around long enough.

Defining the medical/marketing interface

Although there is a voluntary UK pharmaceutical industry code of practice that covers these activities, the interface between R&D and marketing is not clearly defined. But in talking to consultants who advise on compliance with the code, I have learned that adverse publicity is a far bigger consideration. A lot of ordinary people are becoming sceptical about the trustworthiness of trials sponsored by pharmaceutical companies, and a newspaper articles alleging underhand marketing tactics regularly reinforce this impression. Yet it happens. Of course, there is nothing wrong with marketing managers visiting potential prescribers, who are also clinical investigators, in the pre-launch period. They have a business to run after all. But what if they start a discussion about patient recruitment? This is very clearly the domain of the clinical research associate, and is always a checklist item on monitoring visit reports. One problem is that anyone having such discussions automatically comes under the jurisdiction of prevailing legislation.

In the UK we have three statutory instruments that implement the European Union Directives on Clinical Trials and on Good Clinical Practice (GCP). This is not voluntary regulation, it's the law, and it says that anyone involved in the conduct of clinical trials for medicines must be qualified by education, training and experience to do the job. They have to write visit reports and put them in the Trial Master File (so they will have to be very careful what they say). They will need training in GCP, but that could well involve telling them what they can't do more than what they can do, i.e. ring-fencing their jobs.

Companies have to be extremely careful about defining how the commercial and R&D areas interact, because if not, it can get very messy and generate a huge amount of unnecessary work. Of course, the two groups must work together to bring the product to market with maximum value, but this is an internal activity. Perception weighs heavily in the world today, and how it looks to the outside world is what everyone should always be considering.

Interpreting research results: avoiding bias

I have an enduring admiration for the rigour, dedication and sheer hard work of most people involved in clinical research and reporting of trials. If the general public had any idea of the effort required to get trials set up, conducted, closed down and reported, the industry's reputation would be a lot higher. It's not a perfect system by any means, and errors, abuses and wishful thinking all happen from time to time, but in general people know that things have to be right.

Now marketers work hard as well, so many of the conflicts stem from the different perspectives and demands placed on the two camps. Many clinical researchers probably feel that marketers have little understanding of regulatory and scientific constraints, and marketers may well feel that researchers are too reticent to sing the praises of the latest flagship drug. Nowhere is this more prominent than in health economics. It is not uncommon for cost-effectiveness studies to be handled by the marketing department, as they are often the people who negotiate with healthcare providers. Health economics is a far from standardised discipline - methodologies are variable and hotly debated, so that substantially different conclusions might be drawn for the same treatment. Thus the temptation to select the methodology that portrays your drug in the best light is very strong. I say this from a personal standpoint, having worked closely with the commercial arm on perimarketing studies.

Well, of course no company can operate without a commercial function, because products do not sell themselves. It is, I suppose, theoretically possible to operate without R&D if all products are bought in fully developed, but I don't know of a company that does this, even those in the generics market. So the key role of sales/marketing is very clear, but because of this the potential for bias in the messages it puts out is considerable. The gatekeeper is supposed to be the process of medical sign-off of promotional materials, but if this were fully effective we would not have the level of criticism we do suffer. For example, a medical director will check that a promotional claim is backed up by a published reference, which is fine, but what if there are three or four relevant studies and only one of them supports the claim? I am ducking right now to avoid the brickbats from all the rigorous medics who check all the studies, but the potential for 'cherry picking' does exist.

I want to round up with a consideration of the way we regulate all this. A few months ago I re-read the ABPI code of practice, specifically regarding the involvement of commercial personnel with clinical trials. I could not find any clause which addressed this clearly. I think the intention of the code is to separate R&D from sales and marketing, but the specific words are not there.

Even a direct approach to the ABPI yielded no further clarity. So we are thrown back to basic scientific principles to guide us in these matters. Enthusiasm for one's products, and commitment to one's employer, are laudable and indeed essential attributes, but they necessarily introduce bias. Thus a key question for sales and marketing professionals is: "If I worked for another company, would I believe this?" The controlled experiment, of which the randomised clinical trial is a specific version, arose because scientists accepted that bias is embedded in human observations. We have to do all we can to eliminate it.

EFFECTIVE MEDICAL/MARKETING TEAM WORKING

* What do we want from Key Opinion Leaders?

* Are we happy for KOL remuneration and other benefits to be published? They will have to be if KOLs author papers in journals.

* As well as clinical research associates, who else is visiting investigators? Do they have clearly defined terms of reference?

* Are we including all the clinical evidence in promotional materials and not just that which suits our messages?

Les Rose is a freelance writer and clinical science consultant with Pharmavision Consulting. For more information e-mail: lesrose@ntlworld.com

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