The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: CER

Biotech Trends Update: A Personalized Critique of Comparative Effectiveness Misses the Mark

As the U.S. and Canada move to invest and rely more on comparative effectiveness research (CER), lack of personalization has been the loudest and most frequent objection.  That is why we have been following the interaction between comparative effectiveness and personalized medicine as a key industry trend.

Yesterday, an opinion piece in the WSJ by Leonard Zwelling, a professor of medicine and pharmacology at M.D. Anderson, came out strongly in opposition to CER.  Zwelling takes a number of swipes at CER, but most of the time he is focused on the inability of CER to personalize treatment – for a patient’s genes, age or preferences – in identifying a “best” treatment.  For example:

“If decisions based on CER inhibit the progress of personalized medicine—or in any way interfere with a meaningful interaction between doctor and patient to individually tailor the most appropriate therapy—no one is helped.”

Zwelling’s argument sets up more than a few straw men — that CER uses only retrospective data, that it will ignore qualify of life, and that treatment options change too quickly for CER to provide timely advice — but the main problem is that he assumes that CER and personalization are incompatible.

As this blog has noted on many occasions, CER is at its best when coupled with personalized medicine.  This post about KRAS genotyping is a great example.  This point is not lost on the Obama administration, which is aware of and sensitive to the need to account for personalized treatment in CER.  Zwelling himself opens with a quote from relevant legislation that says the current CER funding is supposed to find out

“what works best for which patient under what circumstances.”

The clause “for which patient” is a built-in acknowledgement of the importance of personalized approaches to CER. 

My bottom line: Both comparative effectiveness and personalized medicine are critical to medically effective and financially sustainable medical care and drug development.

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