OLIS is the reality many of my clients face when their legal group begins to tie itself in knots over the practical implications of the fact that MA must talk about the science involved with its products, and some of that science may ultimately be compelling enough that the HCP decides that our product is something that they should use. OLIS drives them to wonder “How can we not be promotional if the results of our permissible scientific exchange is that the HCP decides to use our products?”
See our thoughts below:
1) Can we allow Internal Journal Clubs?
- We already agree that field staff can have permissible scientific exchanges with physicians
- In order to have scientific exchanges they need to know the latest science which is represented by what is being published in peer reviewed journals
- Although our team is good, no one member of the field force has all the knowledge necessary to understand the huge range of potential scientific articles or the time to cover the huge range of journals
- As a group, however, they do posses both the knowledge and the time
- Therefore, they should be allowed to review the new scientific information as a group and share with the members the information they need
2) What if the conclusions reached in the internal discussions of the articles are biased?
- So what? – we are not going out to the HCPs to present our conclusions but to have a scientific dialog – to listen and answer scientific questions
- Any perspective we have is already perceived to be biased – we work for a major pharmaceutical company and everyone knows it
- The issue is not bias – which is not against the law – the issue is promotion
3) What if our perspective is deemed to be promotional?
- There is absolutely nothing new about a concern that our scientific dialogs run the risk of being promotional
- BUT, we already have standards and training in place to ensure our staff does not promote during scientific exchange – regardless of whether that exchange is about a new article in a journal or an existing safety issue, etc. etc.
4) What if the conclusions of the author of the journal article are promotional in and of themselves?
- First, we need to agree that facts, even facts that are favorable to our products, are neither promotional nor non-promotional – facts are facts
- Conclusions drawn from the facts can be promotional
- So if the study finds that patients using our drug have better results than patients using a competitive drug, that fact is NOT promotional UNLESS our field staff says something like:
i. “I don’t see how anyone can read this and not put all their patients on our drug”
ii. “Clearly our drug is the more effective and it wouldn’t be ethical to put your patients on any other treatment”
- If the author of the article draws their own conclusion “…and in the opinion of the authors you would be a fool to treat with anything but X.” then we are back to the points in number 3 above, meaning our team needs to know a promotional statement when it sees it and avoid repeating it
- In this scenario, the internal journal club is actually of value to the company because it allows the group to identify this potentially promotional author conclusions and agree on strategies to engage in this topic without endorsing the author’s conclusions
- Bottom line – these “promotional conclusions” drawn by independent 3rd parties and published in peer reviewed journals are out in the public sphere and keeping our field team from understanding the article and agreeing on an approach to addressing it without a promotional bias will not stop HCPs from asking them about it and forcing some kind of reply
What has been your experience with OLIS? What about internal journal clubs? Leave a comment.
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