skip navigation nih record
Vol. LXVII, No. 21
October 9, 2015
cover

previous story

next story


Briggs Named Interim Director
Collins Welcomes Working Group’s PMI Plan

On the front page...

NIH director Dr. Francis Collins has enthusiastically embraced the summer-long efforts of an advisory committee to the NIH director working group on the President’s Precision Medicine Initiative (PMI). The PMI workgroup presented him on Sept. 17 with a report outlining how to enroll a cohort of more than 1 million Americans by 2020 in an effort to, as HHS Secretary Sylvia Burwell has explained, “tailor disease prevention and treatment to individuals based on genetics, environment and lifestyle.”

“This is an excellent report,” Collins told reporters during an hour-long media telebriefing that afternoon, “an excellent framework…The stars are aligning.”

He cautioned that PMI “is not just a genomic project. We are taking a much broader view…This is an inflection point of a very significant sort.”

Continued...

NCI acting director Dr. Douglas Lowy explains his institute’s component of PMI at a stakeholders’ briefing in Wilson Hall.
NCI acting director Dr. Douglas Lowy explains his institute’s component of PMI at a stakeholders’ briefing in Wilson Hall.
Collins announced that while a nationwide search for a PMI director will begin soon, the effort will be led in the interim by Dr. Josephine Briggs, director of the National Center for Complementary and Integrative Health. The first task is to prepare a research infrastructure and to begin enrolling, in January 2016, a cohort that reflects the diversity of the U.S. population with respect to age, gender, race and ethnicity.

“But this is all contingent upon congressional appropriations,” noted Collins, just days before the end of fiscal year 2015; PMI is budgeted at $215 million in FY 2016—$130 million for the large-scale cohort and the balance for an NCI component.

Collins said PMI is “a long-term endeavor,” scheduled to last at least 10 years. “I hope to see it go much longer,” he said, calling it a complex and ambitious initiative that could rival the Framingham Heart Study, ongoing since 1948, as a producer of useful medical knowledge.

In response to questions from reporters, Dr. Kathy Hudson, NIH deputy director for science, outreach and policy, said there are “two doorways to enter the study”—via health care provider organizations such as Kaiser Permanente, which have already established electronic health records (EHRs), or by “anyone, anywhere, simply signing up as a direct volunteer.”

Hudson said, “Motivations to participate are multiple…there is a strong thread of altruism that we hope to tap into…People are interested in getting [medical] information back about themselves. Our surveys have shown that people find it attractive.”

Collins said NIH is “very much aware of opportunities” offered by already-existing cohorts, which, in addition to KP, include Geisinger Health System, Intermountain Healthcare, Mayo Clinic, Marshfield Clinic and others.

“It will be very valuable to build upon [these cohorts],” he said. “We very much want to engage with them.” Collins said both arms of enrollment—volunteer and legacy cohorts—“are going to be pursued avidly…The value of a cohort gains over time.”

PMI workgroup cochair Dr. Richard Lifton of Yale University, who also participated in the telebriefing, predicts that some cohort enrollees might find themselves invited to participate in future clinical trials, based on a spectrum of personal characteristics.

Participating in a PMI briefing for stakeholders on Sept. 25 at NIH are (from l) Dr. Kathy Hudson, NIH deputy director for science, outreach and policy, NIH director Dr. Francis Collins, and Lowy.

Participating in a PMI briefing for stakeholders on Sept. 25 at NIH are (from l) Dr. Kathy Hudson, NIH deputy director for science, outreach and policy, NIH director Dr. Francis Collins, and Lowy.

Photos: Bill Branson

Collins added that EHR technology itself will likely be revamped and upgraded as PMI progresses. “Perhaps we can move the needle in improving the way EHRs function overall,” he said.

One reporter wondered what NIH would do if 3 million people wanted in on the study. “That’s a potentially serious possibility,” said Collins. “There’s been a lot of increase in the public’s interest in participating in research. When you open the door to the nation, you don’t know how many will respond. But it’s a great problem to have. Maybe we’ll have to say, ‘Going fast! Only a few tickets left!’”

PMI will rely heavily on mHealth, or mobile health, with enrollees using smartphones and personal devices such as Fitbits and Jawbones to collect and monitor health data, said Dr. Josh Denny, associate professor of biomedical informatics and medicine at Vanderbilt University, another PMI advisor.

Collins imagines that some cohort enrollees could be fitted with wearable on how where we live contributes to health or disease.

Asked to sum up PMI’s value, Lifton concluded, “This is a meritorious thing to do, a really extraordinary and unprecedented opportunity to determine personal disease cause and risk…It also offers open access to all investigators, offering novel analytic capability.”

Collins emphasized that cohort participants “are partners in all we do.”

“We’ve been welcomed to the table,” said PMI cochair Bray Patrick-Lake of Duke University, a disease advocacy activist who admitted to having been skeptical about PMI at the outset. “PMI is committed to doing what’s right, not what’s easy.”

“I think we’re on a pathway that can be quite transformative,” said Collins. “It’s going to teach us a lot about health…We are thrilled to be given this charge by the President.”


back to top of page