Personalized medicine may mean more legal entanglements rather than fewer

Editorial points to likelihood that personalized medicine may lead to something like personalized justice

Jeffrey Bouley
JUNE 24, 2010—In this month's issue of ddn, we had an editorial by Peter Kissinger on some of the challenges of defining and implementing truly personalized medicine. Despite those challenges, it's clear that some kind of personalized (or at least more personalized) medicine is on the way, thanks to enabling sciences and technology breakthroughs like pharmacogenomics, molecular imaging and biomarkers—but who knew it might lead to more complex legal entanglements with the pharma and healthcare worlds.

Maybe it won't, but a recent editorial in the journal Pharmacogenomics makes a compelling case that such likely will be the case.

To many of us, this might seem counterintuitive. After all, if the pharma and biotech companies can get more personalized, and therapies can be more specifically tailored to those who are most likely to benefit from them and/or experience fewer side effects from them, shouldn't that decrease legal entanglements?

As the authors write in the June 2010 article, "Enabled by pharmacogenomics (PGx), molecular imaging and other molecular biomarkers, personalized medicine (PM) promises to optimize therapy while minimizing side effects. It may also dramatically impact the justice system in ways we are only beginning to understand."

They also note that while personalized medicine has already entered the curricula of well-regarded medical schools such as that of Johns Hopkins University, law schools currently offer nothing comparable.

But the authors write, "Although clinical acceptance of PM has proved slow even with US FDA support, PM's legal ramifications are evident. Recently, for example, the FDA relabeled some drugs with companion PGx, such as warfarin withCYP2C9 and vitamin K epoxide reductase complex 1 to reduce bleeding. If PGx retrospectively reveals that the warfarin patient was at high risk and testing was not initially performed, litigation may follow. Indeed, some lawyers advertise on the internet for cases involving warfarin-related errors. Consequently, PGx may become part of defensive medicine."

As the Future Sciences Group points out in a news release announcing the release of the article, even more fundamental questions could arise from a "personalized justice" perspective, such as issues of whether courts should consider identifiable biological conditions that predispose a person to criminal behavior and might impact on moral culpability.

Although personalized medicine is rapidly taking root among the medical sciences, the authors predict a slower, more begrudging adoption by the legal profession.

"Nevertheless, the law's incredibly rich experience with DNA developments may facilitate acceptance," notes the Future Sciences Group.

The authors do caution that, in establishing personalized justice, a firm foundation should be based on sound legal principles as well as reliable and valid evidence-based studies, not on junk science and unsubstantiated case reports. With sound scientific and legal principles and correct interpretation, they argue that a firm and lasting foundation could support the emerging concept of personalized justice becoming a reality to enhance patient safety and maintain social justice.

"Personalized Justice and Personalized Medicine may also co-exist as an emerging social balance, providing beneficial impetus for advancing molecular medicine," says Steven Wong, a professor of pathology, psychiatry and behavioral medicine at the Medical College of Wisconsin, and toxicology scientific director at the Milwaukee County Medical Examiner's Office, who was lead author of the editorial.
 

Jeffrey Bouley

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