The Struggle to Build a Massive ‘Biobank’ of Patient Data

however All of Us can be the only one of which attempts to capture a huge sample of which can be representative of the United States population. “of which will be transformative,” said Dr. Francis Collins, director of the National Institutes of Health.

of which will also be expensive.

In 2017 alone, the budget for All of Us was $230 million, of which $40 million came coming from the 21st Century Cures Act. Congress has authorized an astounding $1.455 billion over 10 years for the project.

While supporters say the results will be well worth the money in addition to effort, others have begun to question whether All of Us can be just too ambitious, too loaded with cumbersome bureaucracy — in addition to too duplicative of smaller programs of which are moving much more quickly.

inside the three years since the All of Us program was announced, not 1 person’s DNA has been sequenced. Instead, project leaders have signed up more than 17,000 volunteers as “beta testers” in a pilot phase of the program. They supplied blood in addition to urine samples, had measurements taken, in addition to filled out surveys.

Dr. George D. Yancopoulos, the president in addition to chief scientific officer of the biotech company Regeneron, said the N.I.H. did not have much to show for three years of planning. Regeneron has been deeply involved in similar public in addition to private efforts, sequencing the DNA of more than 300,000 participants.

The beta testers constitute just 1.7 percent of the program’s target, Dr. Yancopoulos noted, in addition to the investigators have collected only the simplest data, not genetic sequences.

“At of which rate, when will they complete their one million-person target?” he wondered. “in addition to at what taxpayer cost?”

“I think someone needs to ask tough questions about whether of which can be the best use of precious N.I.H. resources,” he added. “Should the funding instead go to individual researchers who are doing truly basic in addition to innovative science?”

Two large health providers — Geisinger in addition to Kaiser Permanente — both backed away coming from grants to participate in All of Us.

David Ledbetter, executive vice president in addition to chief scientific officer of Geisinger, said of which the program’s complexity made of which too time-consuming: conference calls upon conference calls, meetings upon meetings, without much progress.

“We decided of which was not the right expenditure of our time,” he said. Geisinger gave back its award of which was potentially worth $50 million over 5 years.

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Dr. Francis Collins, director of the National Institutes of Health, testifying before the Senate in 2010. All of Us “will be transformative,” he said.

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Chip Somodevilla/Getty Images

Geisinger has enrolled more than 180,000 participants in a biobank of its own, in addition to the health system already has years of their medical records. Regeneron can be sequencing the participants’ DNA in addition to has completed more than 100,000.

Dr. Ledbetter said the N.I.H. program could be “very valuable someday.” however Geisinger, he said, did not want to wait.

“Someday can be today,” he said.

Kaiser Permanente, too, can be right now far ahead in developing its own biobank. Originally, the company expected of which the federal project could profit coming from Kaiser’s experience with recruiting in addition to data analysis, said Elizabeth McGlynn, vice president of Kaiser Permanente Research.

“We were not able to engage as a scientific partner,” Dr. McGlynn said. “We felt increasingly of which we were just being asked to give access to our members.”

DeCode Genetics, a subsidiary of Amgen, a biotech company, can be working having a biobank of 0,000 people coming from Iceland. Dr. Sean E. Harper, Amgen’s executive vice president for research in addition to development, says of which can be hard to imagine the complexity of analyzing the data.

“of which took about 20 years in addition to over a billion dollars of investment to get to the point where we are able to routinely extract coming from the data the necessary information to validate or invalidate drug targets,” he said. Sequencing the DNA can be the easy part, he said. “The hard part can be to get all these medical records in addition to lab tests curated in a computer system where they are query-able in addition to to perfect the analytics.”

Despite these concerns, All of Us has contracted with scientists at just about every leading university, as well as with companies like Verily, a subsidiary of Alphabet, parent company of Google.

“We will have an unprecedented amount of data at a scale never done before,” said Eric Dishman, director of the program.

Investigators have grand plans for all of which data once of which becomes available.

Dr. Atul Butte, director of the Institute for Computational Health Sciences at the University of California, San Francisco, hopes to find the earliest signs of disease, especially of Type 2 diabetes.

“Do you go back in addition to forth coming from diabetes for a while?” he asks. “can be of which preventable?”

The Veterans Affairs Department began building a similar biobank, called the Million Veteran Program, in 2011 having a very lean budget: just $250 million over the past seven years.

The agency has recruited 650,000 vets so far in addition to has years of their medical records, including prescription data. Investigators expect to sequence the DNA of 100,000 participants inside the next two years, at a cost of $70 for each person’s entire genome. The data will be public.

The British program, called the U.K. Biobank, has half a million participants with complete medical records in addition to additional data for some, including body in addition to brain scans.

Regeneron has committed to sequencing the DNA of all of the participants by the end of 2019. After a six to 12 month period of exclusivity, the company will make of which data public.

however what All of Us can be attempting to do can be much more complex, said Dr. Dishman. The U.K. project in addition to the program at Geisinger lack a representative range of racial in addition to ethnic groups; the V.A.’s biobank has relatively few women.

All of Us will be built to reflect the United States population. The San Francisco General Hospital Foundation, for instance, was given a grant to recruit lesbian, bisexual, gay in addition to transgender participants.

“I think what the U.S. project adds can be of which of which reflects the diversity of the U.S.,” said Dr. Sekar Kathiresan, a geneticist at the Broad Institute in addition to an investigator with the N.I.H. program.

of which’s partly why planning for the project has dragged on. in addition to the diversity of participants makes the daunting task of retrieving medical records even more difficult.

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President Obama signing the 21st Century Cures Act into law in 2016. The act authorized $1.455 billion for the All of Us program over 10 years.

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Al Drago/The brand new York Times

Americans tend to have medical records stored slapdash all over the place, in addition to they change insurers in addition to medical plans frequently. There can be little uniformity inside the country’s electronic health systems.

Even the most straightforward part of the project — DNA sequencing — can be formidable.

“There are not enough sequencing machines inside the U.S. to just focus on our project,” Dr. Dishman acknowledged. All of Us will depend on prices falling for sequencing — in addition to more sequencers being built.

For participants, there will be a reward, Dr. Collins noted. The program will give them genetic information in addition to health data, in addition to tell them how they compare to others inside the population.

To do of which, All of Us plans to enlist genetic counselors. Yet right right now, there are not nearly enough counselors to handle the task.

The counseling issue also bothered Kaiser, Dr. McGlynn said, in addition to of which was a factor inside the decision to return the grant money.

“Genetic counselors are in terribly short supply,” she said. “We wanted to be sure we were well organized to deliver results in a way of which was ethical in addition to not scary to members.”

The accumulation of tremendous caches of medical data can be raising troubling questions about what participants should be told. The U.K. Biobank, for instance, considered returning results to participants, however decided against of which after an experiment.

of which involved participants getting whole body scans for the program. For some subjects, a radiologist systematically assessed the scans to see if anything seemed abnormal. If of which did, the patient in addition to the patient’s doctor were informed.

As of which turned out, 20 percent of the participants had abnormalities. They often went on to have additional tests, some of which were invasive in addition to involved major surgery, like removal of a lobe of the lung.

Yet inside the end, only one in eight with abnormal scans actually had a medical problem, in addition to even then there was nothing they could do about of which most of the time, said Dr. Rory Collins, chief executive of the U.K. project.

“What we are trying to do can be not provide care to individuals, however to generate a resource of which can provide health information,” Dr. Collins said. “Feedback can cause more harm than not bad.”

additional experts disagree with the British approach. At Geisinger, participants are told if they have a genetic variant of which might affect their disease risk.

They are offered genetic counseling if they want of which — in addition to so far, about two-thirds do. The medical system has sufficient counselors to handle the demand, said Adam H. Buchanan, co-director of the counseling program.

Given the substantial obstacles, will the N.I.H. project, which has not even actually begun, be worth the immense expense in addition to effort?

Dr. Collins, an adviser to All of Us, thinks of which will. Huge amounts of data will be needed to actually understand interactions between genetics, environment in addition to lifestyle.

“Half a million people isn’t enough. Even a million isn’t enough,” he said.

Dr. Ledbetter was more circumspect. “I think the idea can be great,” he said. “of which can be ambitious. of which can be expensive. of which will take a while.”

“I wish the N.I.H. well.”

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