August 2016, Vol. 5, No. 6

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The President and Personalized Medicine

Edward Abrahams, PhD

The Last Word

abrahams-Stroke“As science and technology have advanced,” President Obama wrote in an op-ed he titled ‘Medicine’s Next Step’ in the Boston Globe for July 7, “it’s become possible to make it personalized as well, giving us the tools to better understand, prevent, and treat everyone’s individual health needs.”

No one has laid out a clearer vision for personalized medicine. Praising progress already made with targeted therapies in leukemia, breast cancer, cardiology, and cystic fibrosis, the president anticipates a future in which precision medicine—knowing in advance what works and for whom it works—replaces one-size-fits-all/trial-and-error medicine, allowing us, in his words, to “keep ourselves, our families, and our nation healthier for generations to come.”

As the author of the Genomics and Personalized Medicine Act, a bill he introduced in 2007 and which would have sought to create a friendlier landscape for the development of personalized medicine, his is not a late entry to the field. The president understands that, in addition to research, public policy makes a difference. Whereas the Affordable Care Act eclipsed attention devoted to personalized medicine, President Obama never lost sight of its ability to transform patient care and find cures to unmet medical needs. As his presidency nears its conclusion, he wants to define his legacy in healthcare, writing that after extending insurance to 20 million Americans, “we’re working to ensure more people will also have access to the information that makes their healthcare more effective.”

In addition to publishing his op-ed, on July 7 the Obama administration also announced 3 steps to provide the foundation for his Precision Medicine Initiative (PMI). Those steps include $55 million in National Institutes of Health funding to recruit 1 million research participants into the PMI Cohort Program; a proposal to “streamline” the FDA’s oversight of next-generation sequencing; and the development of tools and technology to make data accessible to researchers and patients.

These measures—building a cohort for future research and preparing the FDA to evaluate new technologies to analyze data—while necessary and important, are nonetheless insufficient. If President Obama is serious about introducing a new order of medicine, a daunting exercise to say the least, he needs to organize all of the government’s resources to support his vision.

He should focus on 3 areas of ongoing concern that, paradoxically, require little new financial investment, although they do require considerable political capital. The administration should, first, incentivize investment in personalized medicine diagnostics by creating a transparent, stable, and predictable regulatory environment for personalized medicine products that is flexible enough to respond to emerging science and opportunities to improve patient care. As part of that effort, the FDA, along with Congress, should work with all stakeholders to fashion a workable solution to the regulation of laboratory-developed tests that fosters innovation and ensures accuracy and reliability. Second, he should instruct the Centers for Medicare & Medicaid Services, while moving away from the traditional fee-for-service model, to support—that is, pay for—innovative diagnostics and therapies that facilitate his vision for customizing care. If recent proposals, including several that would cut payments for sophisticated diagnostics and put in place crude health technology assessment tools that eschew an appreciation of individual variation, are any indication, the administration is moving in the wrong direction and thereby chilling investment in discovery and innovation, the exact opposite of where it says it wants to go. And, third, and perhaps most importantly, the administration should encourage public-private partnerships that demonstrate the value of personalized medicine to both patients and the health system.

Until we disarm the skeptics by demonstrating conclusively that one-size-fits-all medicine is outdated and put in place policies that truly support “medicine’s next step,” progress will be much slower than he and patients hope.

ASCO - August 5, 2016

AML Vaccine Induces Immunologic Responses in Phase 2 Study

Serial vaccination with galinpepimut-S (GPS) induces immunologic responses in patients with acute myeloid leukemia (AML) who are in remission. Both disease-free survival (DFS) and overall survival (OS) appear to be improved in AML patients with an immune response to GPS, according to data from a phase 2 trial of GPS. [ Read More ]

ASCO - August 5, 2016

Phase 3 Evidence for New Standard in Elderly Glioblastoma Patients

Short-course (hypofractionated) radiotherapy (RT) and temozolomide (TMZ) followed by TMZ significantly prolonged survival versus short-course RT alone in newly diagnosed elderly patients with glioblastoma. These results of a global cooperative group phase 3 trial were 1 of 4 talks selected for the plenary session at the 2016 ASCO Annual Meeting. [ Read More ]