Medical Affairs Focus

Thoughts on Global Medical Affairs

Monthly Archives: December 2012

New To The MA Focus Blog?

Welcome!  My stats say that I have been getting a bunch of new readers and I wanted to welcome you to the MA Focus blog.  My goal with the blog is to discuss issues that are relevant to MA leaders.  I encourage you to add your email to the distribution list (follow this blog link on the right) so you will be notified when there is a new post.  Promise, no spam!

Please take the time to look over some of our archives.  We have discussed a range of topics including MSL proactivity, KOL identification, MedComm/SciComm groups, MA at Product Launch, Global MA and MA’s Relationship with Commercial, just to name a few.

Finally, I really enjoy feedback so please feel free to leave comments or email directly with questions (link on right).

Thanks for your interest.

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Rant: Treatment Guidelines and Biopharma

Have you seen the recent analysis by the Milwaukee Journal Sentinel about biopharma’s influence on treatment guidelines?  If not, you should take a look at it here.

In summary, it reveals the startling fact that physicians who are on treatment writing committees are also often consultants to Biopharma and states that because of this there is a conflict of interest for the physicians.  I find these arguments incredibly frustrating and I think we as a community must push back against them strongly.

On the surface, the conflict of interest argument makes sense but when you scratch the surface a bit it falls apart.  By definition, treatment guidelines not only serve to support patient treatment but they are also used to define standard of care for reimbursement purposes – reimbursement not just for drugs but for all the aspects of treatment.  In general a practicing physician, even one that gets some income from Biopharma consulting, earns most of their income by being reimbursed for treatment they perform.   Some physicians have major financial stakes in treatment reimbursement but no one is (or should) suggesting that a doctor would push for an unnecessary or less effective treatment option just because it would likely be more lucrative to the doctor.  No one is claiming that the largest sources of most of these physicians’ incomes drive a conflict of interest.

But, when it comes to drug treatment, the newspaper story argues that this same ethic goes right out the window and the physicians become pawns to the big bad Biopharma companies.  This is ridiculous.  Physicians who consult to Biopharma generally do so because they are subject matter experts and want the drugs that are developed to most effectively treat their patients.  To imply that by providing that support to Biopharma they suddenly lose their ability to correctly judge what should or should not be in a treatment guideline is insulting to the professionalism of physicians.

As someone who has dedicated a big chunk of my career to helping Biopharma work better with physicians, I know that those physicians are professionals and will do what is best, not lackeys that will do as they are told.

What do you think?  Please leave a comment.

Topic19: MA Impact of the Caronia Ruling

As most of you know, the Caronia Ruling by the Second Circuit Court of Appeals found that a pharma rep was within his 1st Amendment rights to discuss off label use of his company’s drugs, assuming that those discussions were truthful.  This went off like a rifle shot within the pharma world with all sorts of discussions, you can read some of them here, here and here.

It is very likely that this ruling will be appealed to the full Second Circuit, and/or directly to the Supreme Court.  But there are reasons to believe that the Supremes may be open this interpretation given their past rulings on similar subjects.  Regardless, until this is settled it only applies to the Second Circuit so unless you are a pharma company only doing business in the Second Circuit in and around New York, you can’t make much change.

BUT, what if this becomes the new law of the land?  What does it mean for Medical Affairs?  That’s what I want to explore in this blog post.

The most obvious impact it has is on all the current focus we place on “proactivity”.  I have discussed this topic in detail here, here, and here.  I bemoaned the unclear state of the current regs here. Now we are imagining a world where the issue of proactivity has to be seen in a completely different light.  MA avoided proactively discussing off-label data on our products because proactivity implied promotion and it is (or in our scenario was) illegal to promote off label.  Under this scenario that thinking would be wrong.  Replaced, potentially, with a focus on “truthfulness”.

Now, for MA at least, this is an expectation we are more than willing to meet.  In the past MA has typically thought of any peer reviewed study as truthful but some of the commentators are suggesting that the definition might become the same one that they use for the FTC.  The FTC definition id focused on “…competent, reliable scientific evidence supporting the claims you are making…” so it may not require a peer reviewed journal publication.  The one caveat, however, is that if you conduct a test and find that the content being shared is misleading to 20% or more of the targeted consumers, than it is not considered truthful.  In general, then, although peer reviewed journals would not be a requirement, it would represent a fairly safe harbor to avoid the risk of sounding misleading.

So, in the future world we are imagining, our field force of MSLs would be free to go out to HCPs armed with peer reviewed journal articles, and introduce the HCP to that article and then proceed to have a scientific exchange about the results, assuming they stick to findings documented in that or other peer reviewed articles.

Scientifically speaking, this frees MSLs to have very wide ranging discussions with HCPs at their initiation and allows for much greater control over the type of discussions that we have with the HCPs.  It will allow MSLs to show much greater value to the organization by allowing the targeting of discussions that are the most meaningful to our products.  And if you think is hard to hire MSLs today, watch out.  With that increase in value will come greater investment in both MSLs and in Investigator Initiated Studies and P4 studies that will now be seen as more valuable as well.

What do you think?  Do you think it we will see the end of proactivity restrictions in the next three years?  Leave your comments above.

QuickNote: Off Label Promotion Ruled OK by US District Court

In a ruling with huge potential impact on MA as well as commercial functions, the Court of Appeals for the Second Circuit in Manhattan has overturned a conviction of a salesperson who was promoting the off-label use of a product! This 2-1 ruling goes against years of court rulings stating that pharma does not have the right to promote off-label.  In fact,  in the past month GSK has been fined $3 billion for off-label promotion and J&J fined $181 million for off label promotion.

Clearly, new legal ground is being broken here.  BUT, if urge caution.  This is one ruling that contradicts years of previous rulings.  It may serve as grounds for kicking this up to the Supreme Court, but until clear legal direction is given I would not be changing any policies.

Take a look at the article here and the actual ruling here.

Topic 19 – EU Considering Major Change in P4 Trials

A new position paper has been floated by the European Commission Health and Consumer Directorate-General that may have HUGE impacts on the way P4 trails are conducted in the EU (and the rest of the world).  My take on it is below:

Stemming from the new EU regulations around pharmacovigilance, the EU is also considering the role of post-marketing efficacy studies (PAES).  In a position paper seeking feedback, found here, the EU lays out its perspective that the new PV legislation also refers to the possibility of requiring the market authorization holder to develop PAES to complement the efficacy data used to grant marketing authority.  That power is granted where “concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed.”

Regulatory Purpose

The position paper goes on to lay out the regulatory purpose of PAES and suggest that after the results of a required PAES were provided to the regulatory agencies, they would be free revisit the authorization decision and determine if “…the marketing authorization should be maintained as granted, varied or even withdrawn on the basis of the new data resulting from the study.”

While regulatory agencies have always been free to revisit their decisions, this approach seems to imply that they are obligated to reconsider their decision after the required PAES.  This makes thoroughly changes the role of the non-PV focused P4 trial from today’s approach to a much more high-stake trial.  Under this approach, these types of P4 trials would have much higher risk and would likely need to be treated much more like we treat P3 studies.  This means a likely significant increase in cost for these trials.

Efficacy vs. Effectiveness

The next section of the position paper focuses on the question of efficacy vs. effectiveness.  The paper comes down clearly on the side of efficacy.  Again, this could be a major change for P4 trials, many of which are focused on developing real-world effectiveness data to provide support for reimbursement decision makers.  This change may also force a significant revisiting of the P4 approach followed today.  Additional P4 trials may be needed if the mandated trials focus on efficacy and cannot be tasked with also considering effectiveness.  This will have a significant impact on time and budget as well.

Situations Where PAES May Be Required

The paper then proposes a set of 7 situations where PAES may be required.  They are:

Situation Where PAES May Be Required Comment
1.   Studies aimed at determining clinical outcome following initial assessment based on surrogate endpoints This type seems very logical.  If surrogate end points were used to get authorization, then a study may be required investigating the underlying endpoint sought.  But, this may significantly add to the cost of using surrogate endpoints for approval, since surrogates are sometimes used because of the time (and cost) of gathering data on the underlying endpoints.
2.   Studies on combinations with other medicinal products Acknowledging that testing for authorization can only cover a limited range of combinations, P4 trials may be required to test additional combinations.
3.   Studies in sub-populations Given the limitations on the number of sub-populations, additional sub-populations may be required to be tested.
4.   Studies in the context of the European standard of care If the trial uses subjects primarily from outside of the EU, the EU may request additional information from patients treated within the EU.  This would negate any cost savings a company might hope to garner by working in other markets.
5.   Studies linked to a change in the understanding of the standard of care for the disease and/or the pharmacology of the medicinal product This is a scary one.  It proposes that if the standard of care for a disease had changed, the authorization holder may be required to develop new efficacy data addressing the new standard of care.  This could result in a never-ending need for new efficacy trials – a major change in way we think of authorized products.
6.   Studies aimed at determining the long-term efficacy of a medicinal product This is one of the “traditional” reasons for P4 is long-term analysis.  Difference is focus on efficacy instead of effectiveness.
7.   Studies in everyday medical practice The proposals suggests that these would be required when “…there is clear evidence that the benefits of the medicinal product underdiscussion as shown by randomised controlled clinical trials might be significantly affected by

the real-life conditions of use.”  This seems to open the door for any misgivings or concerns by the regulatory authorities to result in the requirements for a trial – and when they get results they will be obliged to revisit the approval.

Final Thoughts

While this is still in proposal stage, the direction is clear.  PAES is going to become a new tool for regulators who have efficacy concerns about both new approved and legacy products to address their concerns.  It is likely to have a significant impact on the cost, risk and structure of Medical Affairs if it comes into effect.

I urge you if you have comments to follow the process found in the document to express them.  I will be doing so.

What are your thoughts?  Am I overreacting? Please leave a comment.

h/t PharmExecBlog