Parsing Clinical Trial Data in an Era of Personalized Medicine

  • by: |
  • 10/26/2007
Matt Herper and Robert Langreth have a good column about Lilly's hurry up and wait approach to releasing the results of a dosing study about prasugrel, which would not compete with but be an alternative to people who do not respond well to Plavix or aspirin.

Again, it's not the data so much as how it is presented to investors and the clinical community. The rules of the road have changed. People demand more data. And the genetic underpinnings that cause differences in drug response and dose response -- which is what at issue here -- are pretty much like open source software or operating systems.

I don't think anything nefarious is going on. If the science types have control of the process -- and Steve Paul who runs RD at Lilly is a straight shooter -- they are probably retooling and re-examining the data to see which dose works for which groups.

But that is not the end of the matter. Matt and Robert should know that Lilly is likely trying to figure how all this tailored treatment info pans out and whether or not -- in the safety uber alles environment -- even a drug that has diagnostic or gene-specific dosing limits ala warfarin could even get through the FDA these days.

Maybe Lilly is compiling a list of drug safety vigilantes it needs to hire as consultants to ensure they don't trash the drug to the trial attorneys and the media. Drug safety? More like a protection racket.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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