Comparative Effectiveness Comparatively Speaking

J0403705 Just what is comparative effectiveness research (CER)?  It seems that as many opinions exist as there are people to express them.  This past month, there has been a good deal written about comparative effectiveness, particularly as President Obama included $.1 billion dollars in funding for comparative effectiveness research in his stimulus package and the National Institutes of Health is gearing up to get the research going as evidenced in this typo-laden communication from NIH.  However, it has a nice summation of what comparative effectiveness research is when it says – "CER studies typically focus on comparing the impact of different options on comprehensive health outcomes…."   

The part of that statement that is worrisome to me is the term "comprehensive health outcomes" – what does that mean?  Is it the drug that best addresses what will cure the ails of the majority of people?  Or is it looking at medicine comprehensively as to what makes the best outcomes for individuals in a comprehensive manner?  I want to believe the latter, but if that is the case, is it really possible on a (dare I say it?) measly $1.1 billion dollars?  

I mean I want CER to compare outcomes for me and what my body will best utilize in terms of medicine to help me fight cancer or HIV, but I don't want what is generally best for everybody.  That raises the question, does CER undermine personalized medicine – a point raised this week in The New England Journal of Medicine.   Because make no mistake about it, if CER determines that drug A is better than drug B for most people, than payer C is going to want to only pay for drug A and people who don't respond to it may have to pay for drug B themselves.  As mentioned in a previous post, hypertension drugs and anti-depressants as individual drugs simply don't work for all people and often need to be taken in combination for some individuals in order to be effective. Will CER put those individuals at risk, or does "comprehensive health outcomes" include the health outcomes for the minority of outliers as well as the majority who respond to a medication?  And what role will genomics play in helping guide CER effectively.  If genomics is included as an integral part of CER, it may be less scary, but is it?  

Moreover, will CER lead to a situation in the United States that looks like the British National Institute of Clinical Effectiveness (NICE) system where drugs are evaluated for their reimbursement status dependent on meta-analyses? the system is often not-so nice for people suffering from fatal illnesses.

It is especially true in cancer.

One recent posting in EuroPharma Today reports on a recent presentation by a senior member of the law firm Sidley Austin where it was suggested that the value proposition may be at least as important in the U.S. CER as the effectiveness portion of the equation.  CER is primarily research, NICE looks at secondary research.  Will the U.S. policy be a hybrid?

There is undoubtedly good reason for CER and many excellent benefits.  The investment of $1.1 billion however, is a drop in the bucket compared to what will ultimately be needed to combine CER with humane policy development that also considers individual outlier needs.  The policy, like the science, should not be developed piecemeal.  What we will end up with is a horrible public debate that hinges on ad campaigns like Harry and Louise (in fact, this is what Harry and Louise were afraid of – government telling us what should be in our medicine chest….) that mis-characterize policy proposals to the detriment of better health policy.  

I'm all for CER.  I'm also all for knowing what we are getting into.  What is the ultimate policy goal here – is it cost containment or is it better drugs?  And if it is some hybrid of the two, what are the best tools to get us there and what is the game plan?  Moreover, how much will it cost and is the cost worth the benefit.  CER raises a lot of questions – I'm not sure where the answers lie.  

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