Personalized Medicine and the Regulators, Lititgators, etc.

  • by: |
  • 04/10/2006

Why is this week different from all other weeks? Well, it’s Passover for one thing but moreover BIO is meeting in Chicago where plenary sessions are discussion some very critical questions about whether, when personalized medicine matures, government regulators, trial attorneys, and the pols won’t suffocate in pursuit of their own agendas. Cases in point:

The Agency for Health Care Quality and Research — under orders from Congress — is supposed to compare the cost-effectiveness of certain drugs and treatments. (This is a Hillary Clinton pet project.) Bad enough that every day more and more research comes in for specific subgroups that AHQR isn’t looking at. Medical knowledge is not just doubling it is transforming as molecular diagnostics will help tailor preventive strategies for care to the individual or specific pathway. And what if reimbursement decisions are made based on these head to head studies while ignoring genetic variations? I can see a system where people are dying or sicker than they should be under Hillarycare’s new manifestation because it’s cheaper to simply rule on the old data and ignore the new.

What about a federal prosecutor or HHS that makes it a crime to tell patients about novel uses for medicines that are apparent at the molecular or biomarker level but not aproved by the FDA? Does that make sense? Where is the safe harbor for companies? The fact is, docs and researches and patients are already way ahead of the bureaucrats and lawyers in the effort to match targeted treatments to high responders. BUt will the threat of litigation and the refusal to pay for these treatments slow down progress?

Finally, the Critical Path opportunities list has been launched. We need a new commissioner to drive change through the agency and to create momentum for change throughout the regulatory system. The agency needs more resources to retain and hire talented and dedicated scientists to bring about this change and it needs to be involved in the development of the scientific consensus required for such an effort. Technological and societal change requires leadership. Requlations that stifle it will will not fall without such efforts.


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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