Friday, October 19, 2012

Topic16: Greater Clinical Trial Transparency and Medical Affairs Rapid Response

GSK announced this week that it would open up its clinical trial data sets to researches who receive approval from a GSK review board.  Next year, the EMA intends to open up access to all new clinical data files that are part of a product registration filing.

I believe this is a trend that will not stop – the increasing openness of biopharma with its clinical trial data.  What does this mean for medical affairs?  I have some initial thoughts below but I would be curious to hear your perspective.

As this data becomes more open, other scientists, some perhaps not fully qualified to understand the data set, are going to review it and draw conclusions.  Since our culture has incentives for publicity in academia, expect that at least some of the scientists are going to spin the data into the scariest sounding headline they can.

The result is, I predict, a sharp rise in news stories highlighting safety risks of products, often blown out of proportion.  Nevertheless, it will ultimately fall to MA to deal with this misinformation on the scientific side.   While this can happen today, it is still fairly rare.  I believe it is going to be common place.

In order to be ahead of this, MA leaders are going to need to set up a Rapid Scientific Response capability (if they don’t already have one):

  • Identify Potential Areas Requiring Responses  –  First step is determining what potential areas require rapid scientific responses.  Start with a brainstorming exercise and prioritize to get to the top 5 to 10 topics.

  • Determine Leader of Response – For each topic area, identify who from the MA or other functions team should take the lead on coordinating the rapid scientific response

  • Identify Internal Experts and Voices – Search through the organization and determine who else has the scientific expertise and other skill sets needed to support the rapid scientific response – PR and Legal should be a part of each team

  • Develop Rapid Response Plan – Create a plan for assessing the situation, determining the outline of the response, assigning elements to team members, pulling it together, getting it reviewed and getting the message out  

The entire goal of develop the Rapid Scientific Response capability is to be able to move quickly when the event occurs and produce an accurate and complete response in as little time as possible.  Without this advanced planning, when issues hit no one is clear who should be taking the lead and how.

Do you have a plan for Rapid Scientific Response?  What other impacts do you think the increasing openness of clinical trial data will bring to MA?  Leave your thoughts in the comments section.

Monday, October 1, 2012

Topic15: OLIS and Journal Clubs and Journal Articles

I was talking with a friend and client about internal journal clubs in particular and discussing journal articles with HCPs in general. This discussion may be germane to a number of you because it really stems from what I think of as “Overactive Legal Imagination Syndrome.”

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.