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Bloomberg BNA – The Emperor of All Maladies' New Clothes?

Bloomberg BNA – The Emperor of All Maladies' New Clothes?

Troy Cox says “The Emperor of All Maladies”—Siddhartha Mukherjee’s Pulitzer Prize-winning “biography” of cancer—is the best and most difficult book he’s ever read.


The sequel should be an easier read—according to Cox, we’re living through a major plot point (to the extent a nonfiction book has a plot).


“When ‘The Emperor of All Maladies 2.0’ is written 100 years from now, there’s no question in my mind that they’ll point to this period right now,” says Cox, chief executive officer of Foundation Medicine Inc., a company that promotes genomic testing as part of a cancer patient’s treatment.


Cox was one of numerous precision medicine advocates who turned out in Washington recently to discuss what’s next for the promising approach to disease treatment and prevention. Precision medicine is tailored to patients’ unique attributes, especially their genetic makeup.


With advances in genomic testing, such as Next Generation Sequence (NGS) tests, hopes are high that precision medicine soon will transform treatment and prevention of a variety of diseases, most notably cancer (“Make it manageable like diabetes,” Cox says), but also other conditions with a genetic component, such as cystic fibrosis and heart disease.


“We’re moving from what now is kind of a crude population-based modality, where you’re really almost operating with a chainsaw or some other crude instrument, to really the microsurgery techniques of precision medicine,” says Carrie Wolinetz, the National Institutes of Health’s associate director for science policy, who spoke at a Sept. 18 forum sponsored by Arent Fox LLP.


“Maladies 2.0” might include a chapter on how regulators, researchers, and insurers figured out how to remove some obstacles getting in the way of this shift.


At its own event Sept. 13, Friends of Cancer Research and its partner Alexandria Real Estate Equities released a draft white paper, “Charting the Course for Precision Medicine,” emphasizing the need for NGS tests to be subject to a common set of standards and exempt from the traditional FDA premarket approval process when test modifications are appropriate.


And both events touched on the all-important question of reimbursement for genetic testing costs.


My colleague and office next-door-neighbor Jeannie Baumann has extensively covered precision medicine developments, including funding, legislative efforts and NIH’s massive All of Us Research Program. (Much more of her work and others’ is available to Bloomberg BNA subscribers.)