Perspectives on the President's Precision Medicine Initiative

30 March 2015 Personalized Medicine Bulletin Blog

President Obama’s “precision medicine initiative” earmarked over $200 million from his proposed 2016 budget to “bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”[1] The National Institutes of Health (“NIH”) and the National Cancer Institute (“NCI”) will be the major benefactors if the proposed budget for this initiative is approved. A recent article co-authored by Drs. Francis S. Collins and Harold Varmus, directors of the NIH and NCI, respectively, identifies precision medicine’s critical needs and discusses how the President’s initiative will help “accelerate progress toward a new era of precision medicine.”[2]

A Research Program with Reach and Depth

In their article published in the February 26, 2015 issue of The New England Journal of Medicine[3] Drs. Collins and Varmus contend that personalized medicine needs a broad research program to encourage and test creative approaches to precision or personalized medicine, and to build needed evidence to guide clinical practice.

A Cancer Knowledge Network

In the near term, the initiative will focus on cancers while the longer term goal is to generate knowledge applicable to the treatment and prevention of other diseases. Cancer is identified as the “clear choice”[4] as a near term goal because cancers are common diseases and their incidence is increasing as the population ages. In addition, initial research into the genetic basis for disease focused on cancer, and discoveries to date have begun to influence risk assessment, diagnostic categories, and therapeutic strategies. While this progress is promising, there is a realization that to achieve a deeper understanding of cancer, more data is needed from the analysis of additional patient genomes and clinical trials. A “cancer knowledge network” will be built “to store the resulting molecular and medical data in digital form and to deliver them, in comprehensive ways, to scientists, health care workers, and patients.”[5] This initial work in cancer will then be leveraged toward the adoption of precision medicine in other spheres, notably inherited genetic disorders and infectious disease.

A Million Patient Cohort

The authors note that current methodologies to identify actionable interventions may be not be enough to understand disease sufficiently to implement precision medicine. The President’s initiative thus is designed to support and encourage the next generation of scientists to develop new approaches for “detecting, measuring, and analyzing a wide range of biomedical information – including molecular genomic, cellular, clinical, behavioral, physiological, and environmental parameters.”[6] To achieve this objective, more information from a large patient population is needed. Thus, the second component of the initiative is to assemble a “cohort” of 1 million or more Americans volunteers, who will provide biologic specimens and personal information to enable observational studies to better understand disease and potential therapies. Unlike prior studies, it will allow patients to access their own health information and information about research using their data.

A New Regulatory Framework

In President Obama’s January 2015 address, he also noted that the nation’s process for approving new drugs and devices may require new procedures to allow patients and individuals to participate in research. Thus, the NIH is working with the Department of Health and Human Services to create procedures that allow patients to become active partners in modern science. The Food and Drug Administration also will work to advance the careful use of genomic technology in the drug approval process.

Near Term and Long Term Benefits

It is not expected that the President’s precision medicine initiative will yield immediate benefits. Much of the early research will lay the foundation for future discoveries and therapies. However, Drs. Collins and Varmus believe that even these initial studies may provide early insights into treatment of other common diseases. And with many ambitious research endeavors, there will be benefits that cannot be imagined or anticipated to the end of providing “everyone the best chance at good health.”[7]

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

[1] Collins and Varmus (2015) A New Initiative on Precision Medicine, N Engl. J Med, Vol.372, No. 9:793-95, at page 793, quoting President Barack Obama, State of the Union Address, January 20, 2015. See also our prior posts of January 25, 2015 and February 2, 2015 discussing the President’s Precision Medicine Initiative.

[2] Collins and Varmus (2015) A New Initiative on Precision Medicine, N Engl. J Med, Vol.372, No. 9:793-795, at page 793.

[3] Id.

[4] Id.

[5] Id. at 794.

[6] Id.

[7] Id. at 795.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services