Time to take conflict of interest seriously

Chris Stevenson

PER Group

There are few phrases in our industry that create such a closed mind as ‘Conflict of Interest’ (COI). Ask many people involved in working with medical professionals about the phrase and they will quickly tell you that COI is for the medical professionals to deal with.

Of course, it is true that medical professionals do need to be concerned about COI. Indeed, many medical organisations, publishers and medical schools are reviewing their COI policies to ensure they are clear and reflect the contemporary views of the organisation. As an example, Harvard Medical School recently published a revision to its COI Policy 2010 (more on this later).

However, it is important to recognise that COI is an issue for many people and organisations active in the medical education and medical communications fields including the pharmaceutical companies, medical education companies, medical communication companies, advertising and PR agencies. Many of us have COI that we experience on a very regular basis. Below are a few simple examples. In a brief article such as this it is clearly not possible to elucidate on all the possibilities. However, the table below should convince us that COI is a common occurrence.

Isn’t it obvious, what’s the problem?

The above simple examples may be obvious, but others are much more subtle and far less obvious. The point isn’t whether COI is obvious or not. It is whether you, a party that recognises a COI, are transparent about the COI and about the way in which you reduce it or remove it altogether.

Problems can occur when the audience is misled, whether intentionally or not. This can lead to the audience thinking publications, comments or presentations are independent when they are biased or, of course, vice versa. A misinterpretation of the information could lead to the inappropriate use of information in prescribing and other patient-centred decisions. Global experience shows that the more open and clear we can be, the better it is for all stakeholders.

It’s not about guilt

The most important word in the examples above is ‘may’. The recognition of a COI is not an acceptance that something is wrong, has been wrong or is about to be wrong. In fact, the contrary is true. Transparency about COI allows potential issues to be discussed and dealt with openly and publicly and, importantly, it allows organisations and individuals to explain how they have dealt with a COI. An undisclosed COI is often a problem simply because it is not disclosed.

Professionals in our industry should recognise that declaring a COI is not an admission of guilt, it is in fact the first step in avoiding future guilt, and it is a highly ethical and professional thing to do. Furthermore, we need to tell the other stakeholders so that we can raise awareness and raise the standard of disclosure.

"Professionals in our industry should recognise that declaring a COI is not an admission of guilt..."

Back to Harvard

The recent review of the COI Policy at Harvard Medical School (HMS) places some burdensome commitments on their staff. Some examples are rules on disclosure in the following categories that equal or exceed USD$5000,

• Consulting arrangements, including legal consulting as an expert witness

• Membership on advisory boards

• Service on boards of directors of pharma, device, software and biotech companies

• Equity in privately held companies

• Equity in publicly traded companies

• Honoraria from various organisations including med ed companies, marketing firms etc

In the revised Policy HMS wants to ‘...ensure transparency and continued public confidence in the integrity...’ of the relationship between HMS and industry. Clearly, HMS takes the potential for issues and problems very seriously and wants to be open and clear to avoid misunderstandings and misperceptions of the intentions and actions of its staff. There has been a significant amount of time and effort expended to revise the policy, all in a drive for openness and clarity.

We may want to question some of the requirements HMS has laid down. However, that is not the reason for this article. For our purposes it is sufficient to recognise that a leading organisation (and many others) takes the issue of COI, transparency and disclosure very seriously.

Please note that HMS neither suggests that anything inappropriate has happened or will happen. Shouldn’t other organisations that have similar issues in their internal operations and dealings with external parties want to have the same standards of disclosure of COI?

Disclose what?

We must encourage members of the healthcare professions to disclose COI and we must work to explain to them why it is important. We should start by reminding them that we all have COI and that disclosure is not an admittance of guilt.

"We must encourage members of the healthcare professions to disclose COI and we must work to explain to them why it is important."

In addition we should disclose our own COI. What about the medical communications company that provides marketing services (such as symposia etc.) to a client and also provides medical writing services for publications to the same client. Shouldn’t the medical communications agency disclose the significant financial relationship as a COI? There is a multitude of other examples we could use.

Furthermore, in this example, shouldn’t the medical communications agency also explain how it has dealt with the COI, perhaps by using firewalls, separate teams, separate offices or other appropriate means? Without the disclosure of COI and the explanation of how it is resolved the potential for influence/bias is hidden from the audience and there is no incentive to deal with the COI.

Disclosure is not enough

It’s clear that the disclosure of COI is only the first step in developing a robust system that provides the transparency and confidence that HMS strives to maintain. Having achieved disclosure it is important to assess COI and decide whether it needs resolution, a solution needs to be put in place or whether the COI is so strong that it is irreconcilable.

If the COI is irreconcilable clearly the relationship needs to stop. It is not in the scope of this article to define irreconcilable COI, and it is probably easier to understand it when you see it than it is to define it.

Resolution of a COI, if needed, may be more straightforward. For example, a contributor to an independent education item may have a COI because they have received payment from the organisation developing the programme for other non-independent work or from one of the sponsor companies supporting the independent programme directly for, say, a recent advisory board. Once this COI is recognised it may be that it needs to be resolved. This may be as simple as asking another expert in the field to review the work of the contributor to assert that it is free of bias. However one approaches it, resolution of COI is often an important step in creating the transparency and confidence, and the lack of ambiguity about our motives that we all strive for.

A way forward

In the modern world, where COI is seen around most corners, and where transparency, disclosure and resolution are seen as important standards to achieve, our industry needs to raise its game and accept that we need to be more open about relationships and accept that openness will lead to more, not less, trust.

"…our industry needs to raise its game and accept that we need to be more open about relationships..."

We need a set of working standards that recognise the inherent (as in many industries) COIs that exist in the work we do and the relationships we have. We need to recognise that COI is something we all have, not something that healthcare professionals alone ‘suffer’ from. We need to be prepared to disclose relationships in the interests of integrity and confidence and to avoid misleading (either intentionally or not) the audience. Leadership on these topics needs to come from within the medical education and communications industry. It is not sufficient for our profession to defend itself by claiming what we do is ‘not against the rules’.

If we wait for regulators to impose the rules we will already have lost the confidence of our clients and stakeholders. As a professional industry we need to address the issue of COI because it will be better for healthcare professionals and, ultimately, their patients. There is no better reason.

About the author:

Chris Stevenson has worked in the pharmaceutical, medical communications and medical education markets for over 20 years. He can be contacted on chris.stevenson101@live.com.

How can pharma better manage conflict of interest?