Making it Personal

In remarks prepared for this year's Biotechnology Industry Organization conference, US Department of Health and Human Services Secretary Mike Leavitt predicted that, "The next ten years will be seen as a signal point of transition in healthcare. Medicine will be transformed from an instinctive art of alleviating symptoms to a science of personalized healthcare." Within hours, press releases and news stories flooded my e-mail inbox with bold visions of personalized medicine and the future of healthcare as we know it.

Kaylynn Chiarello-Ebner

The basic premise behind personalized medicine is to tailor disease diagnostics and treatments according to a patient's precise medical condition and genetic makeup. As intriguing as it sounds, reactions to personalized medicine are a mixed bag with privacy issues topping the list of concerns. To determine predictive patterns based on pharmacogenomic data, researchers in and out of industry must collect huge databases of individual genetic and medical information. Patients may not be willing to donate tissue and blood samples or disclose their medical histories for fear that the information will be misused.

Public concerns aside, is industry ready for this revolution? We don't yet have a framework for regulating and validating personalized medicine and the requisite testing. Testing labs currently are certified by the Joint Commission on the Accreditation of Healthcare Organizations, with only slight attention from FDA. If lab tests are treated as an integral element of drug therapy, can they stand the financial strain and regulatory scrutiny?

The burden of making the public comfortable with disclosing genetic information and the even bigger task of financing and regulating personalized medicine might be topped by the challenge of changing how we develop new drugs. Clinical trials will need to be shortened dramatically, and blockbuster drugs may become things of the past. But industry can't let these challenges discourage it from trying to make personalized medicine a reality. We can't enter places of discovery without venturing into unknown territory.

Kaylynn Chiarello-Ebner is the managing editor of Pharmaceutical Technology, kchiarello@advanstar.com