Can the Information Age Deliver Medical Marvels? Congress Just Bet $200 Million It Can.

Doctors can get more information than ever about their patients. Now they’re hoping to put it to work.

President Obama tours an oncology laboratory at the National Institute of Health in Bethesda, Maryland in 2009, along with (from left) Dr. Marston Linehan, NIH Director Francis Collins, and then-Health and Human Services Secretary Kathleen Sebelius. (AP Photo/Gerald Herbert)

Wrist­bands that track your daily activ­ity. Kits that can pur­portedly ana­lyze your ge­net­ics. Smart­phone apps that track your daily in­take of pro­tein, sug­ar, and carbs.

It’s the age of “pre­ci­sion medi­cine,” as doc­tors and pa­tients look to lever­age vast amounts of in­di­vidu­al­ized in­form­a­tion avail­able to fight dis­eases in a way they’ve nev­er been able to be­fore—with treat­ments that take in­to ac­count en­vir­on­ment, life­style, and even genes.

At least, that’s what the ap­proach’s pro­ponents have said they could de­liv­er with the re­search sup­port of the fed­er­al gov­ern­ment.

The more than $1.1 tril­lion budget deal gave full fund­ing to the Na­tion­al In­sti­tutes of Health for Pres­id­ent Obama’s Pre­ci­sion Medi­cine Ini­ti­at­ive. Con­gress ap­pro­pri­ated $200 mil­lion for NIH ($70 mil­lion for the Na­tion­al Can­cer In­sti­tute and $130 mil­lion to build a re­search co­hort pro­gram).

A core part of the program involves recruiting volunteers to submit genetic data, biological samples, and information about their diet and lifestyle over the course of many years with the overall goal of expanding precision medicine to many diseases.

The fund­ing comes after a year of un­cer­tainty, start­ing on Jan. 20, when Obama an­nounced his Pre­ci­sion Medi­cine Ini­ti­at­ive in the State of the Uni­on in just a few sen­tences:

“I want the coun­try that elim­in­ated polio and mapped the hu­man gen­ome to lead a new era of medi­cine—one that de­liv­ers the right treat­ment at the right time,” Obama said. “In some pa­tients with cyst­ic fibrosis, this ap­proach has re­versed a dis­ease once thought un­stop­pable. So to­night, I’m launch­ing a new Pre­ci­sion Medi­cine Ini­ti­at­ive 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.”

Even be­fore the State of the Uni­on, Rep. Tom Cole—the newly ap­poin­ted head of the sub­com­mit­tee over­see­ing NIH’s budget—was gear­ing up for a tour of the NIH fa­cil­ity. Cole says he ar­rived be­fore oth­er mem­bers for a quick brief­ing with NIH Dir­ect­or Fran­cis Collins on the soon-to-be-un­veiled ini­ti­at­ive.

It wasn’t hard to get on board with pre­ci­sion medi­cine, the Ok­lahoma Re­pub­lic­an said in an in­ter­view. Among many pro­posed ad­vance­ments, the ini­ti­at­ive aims to help chron­ic­ally ill Amer­ic­ans in a way that of­fi­cials say they hope could re­duce med­ic­al costs. This is something Cole says his party can sup­port, as evid­enced in the re­cently passed spend­ing bill, which ended al­most a year of re­l­at­ive un­cer­tainty for the ini­ti­at­ive’s fu­ture and gave NIH the money needed to rev the pro­gram in­to high gear in 2016.

(NIH con­firmed Cole’s vis­it on the day of the State of the Uni­on, and said that while the con­ver­sa­tion between Collins and Cole was con­fid­en­tial, NIH aims to give the Hill a heads-up on up­com­ing is­sues.)

The new ap­pro­pri­ation comes as a re­lief for Collins. The ini­ti­at­ive has two ma­jor parts: The Na­tion­al Can­cer In­sti­tute (a part of NIH) will ac­cel­er­ate Amer­ica’s know­ledge of can­cer ge­n­om­ics, and NIH will es­tab­lish a co­hort of a mil­lion or more people to sub­mit their health in­form­a­tion and par­ti­cip­ate in a na­tion­al study of health. By the end of 2016, NIH hopes to have about 75,000 Amer­ic­ans signed up for the Pre­ci­sion Medi­cine Ini­ti­at­ive Co­hort Pro­gram, Collins said in an in­ter­view. (The over­all goal of at least 1 mil­lion vo­lun­teers will likely take three or four years.)

Obama’s fiscal 2016 budget made clear what this would cost: $200 million would go to the NIH, $10 million to the Food and Drug Administration, and $5 million to the Office of the National Coordinator for Health Information Technology.

Ini­tially, both the House and Sen­ate seemed on board with fund­ing the ini­ti­at­ive, but when budget talks stalled, it ap­peared pos­sible that Con­gress would opt for a con­tinu­ing res­ol­u­tion—one that would provide no ad­di­tion­al fund­ing for pre­ci­sion medi­cine.

Mean­while, NIH pro­ceeded with plan­ning, work­ing to have the pro­gram ready to kick off in 2016 if Con­gress came through with the cash for it. Had NIH waited, Collins said, the co­hort pro­gram wouldn’t have been ready in 2016.

“We’ve kind of been hold­ing our breath but go­ing full-speed ahead un­der the as­sump­tion that the dol­lars would be there,” Collins said in an in­ter­view.

At a Sen­ate Ap­pro­pri­ations sub­com­mit­tee hear­ing in Oc­to­ber, Collins voiced his con­cerns about what would hap­pen if a new spend­ing bill wasn’t passed: “A year­long CR … would be simply dev­ast­at­ing,” he said. “The Pre­ci­sion Medi­cine Ini­ti­at­ive, for in­stance, would ba­sic­ally have to go in­to the freez­er or on moth­balls or whatever the ap­pro­pri­ate dis­cour­aging meta­phor would be. We would just be at the point of start­ing this ef­fort to en­roll a mil­lion Amer­ic­ans in this un­pre­ced­en­ted study and carry out ex­cit­ing new stud­ies in can­cer ge­n­om­ics, and those would ba­sic­ally have to go on hold, and that would be enorm­ously dis­ap­point­ing.”

But in the end, Con­gress reached its deal, and now NIH will con­tin­ue to pre­pare for the launch of the co­hort pro­gram. By late sum­mer, en­roll­ment is ex­pec­ted to be­gin. And by the end of 2016, that’s when Collins hopes to have about 75,000 Amer­ic­ans signed up.

Bey­ond fiscal 2016, Cole said he hopes this year’s in­crease to NIH is the start of more to come. The con­gress­man wants to give the agency a sense of sta­bil­ity, to know that Con­gress is in­ves­ted in NIH’s work. “Pre­ci­sion medi­cine is one of the areas that we think is really prom­ising in terms of be­ing able to de­liv­er tre­mend­ous med­ic­al break­throughs,” he said.

The White House is already tout­ing how pre­ci­sion medi­cine has be­nefited a se­lect num­ber of Amer­ic­ans, of­fer­ing a glimpse of what could hap­pen if these cases of us­ing ad­vanced ge­net­ic in­form­a­tion be­came the norm for treat­ing all ill­nesses.

Beatrice Rienhoff’s father, a clinical geneticist, helped identify a variant responsible for the weakness of his daughter’s leg muscles and the fact that she couldn’t gain weight. Melanie Nix’s doctors found a gene mutation that led to the discovery that she had an aggressive form of breast cancer and that a bilateral mastectomy was her best option. And at 6 years old, according to the White House’s website, Emily Whitehead became leukemia-free after enrolling in an immunotherapy trial that collected and reengineered her own T cells.