THE PROGNOSIS

Starting this spring, Americans across the country will be invited to contribute to a massive new pool of genomic information being assembled by the government, a project that represents the most ambitious effort yet to capitalize on the promising new frontier of gene-based medicine.

Three years after the National Institutes of Health first announced its Precision Medicine Initiative — subsequently redubbed “All of Us” — the agency’s director, Francis Collins, says the large-scale project is ready to expand beyond its initial testing stages. In early spring, on a date yet to be announced, NIH is planning a nationwide launch to start enrolling what it hopes will eventually be as many as 1 million participants.

“It will be a big deal. You’ll hear a lot about it,” Collins told The Health 202 in an interview last week at NIH headquarters in Bethesda, Md. “We want the world of American folks to know about this and have a chance to sign up.”

Collins and I discussed that project and a range of topics, including the directives by President Trump to address the opioid abuse crisis and the agency’s finances, which after several tough years Congress has been closely guarding despite deep cuts proposed last year by the White House.

'All of Us'

I was most excited to hear from Collins about the Precision Medicine Initiative, an effort that has been happening mostly behind the scenes for the past several years. It’s an idea Collins first wrote about in the early 2000s -- and private companies such as 23andMe and AncestryDNA have already genotyped more than 2 million people. But the effort only recently grew more realistic for NIH as the cost of genome sequencing has dropped and electronic-health records are being more widely used.

First rolled out under President Barack Obama, the program's aim is to essentially compile the world’s largest genetic library intended to be widely available to scientists and researchers. This rich collection of DNA information is designed to assist scientists and researchers exploring the genetic basis for all sorts of health conditions -- and those working to develop targeted therapies calibrated to an individual’s genetic makeup instead of the traditional one-size-fits-all approach.

The ultimate goal is faster advances in the cutting-edge field of what’s known as precision medicine. But the tall, wiry and ever-enthusiastic Collins emphasizes that the aim is also to give participants a deeper knowledge of their own health and health risks. Volunteers won’t be study subjects; they’ll be partners, he stresses. He has found that to be one of the strongest arguments in attracting participants.

“People want information about themselves — that’s a big part of why you’d want to sign up,” Collins told me. “For the most part, in these kinds of studies, we haven’t done that in the past.”

Collins, who Trump notably retained as NIH director last year even as he replaced most other Obama appointees, said progress with the initiative in 2015 and 2016 was somewhat slow as the agency grappled with questions about how to recruit a diverse pool of volunteers, sources of funding and, most importantly, how to collect and securely store so much private genetic information.

Private companies that offer genetic screening have already been grappling with such problems for years. The company 23andMe has been sued over claims that certain tests could help consumers prevent or mitigate serious diseases such as diabetes or breast cancer. It has also faced pointed criticism over its handling of consumers' genetic information, which it provides to other private companies for genetic research if the consumer has consented.

“Of course, we can’t guarantee anybody that privacy is going to be absolutely protected no matter what, because we’ve all seen situations where hacking can happen,” Collins said.

But Collins said he can promise this: There will be end-to-end encryption and all identifiable information gathered from participants will be removed before data is consolidated in one place.

“We will continue to do — as we have been — all the hackathons, penetration tests, all the things you need to do to figure out if you have any vulnerabilities in your system,” he said. “So far, I think we are top of the line here in terms of our security system.”

Another big piece of the puzzle was finding the right person to lead the project. In April 2016, NIH brought on Intel’s Eric Dishman, who fought a rare form of kidney cancer for 23 years and went into remission only after genome sequencing revealed his cancer had more in common with pancreatic disease than renal cancer, allowing his doctors to much better target Dishman’s treatment plan.

Later that year, the project got a messaging makeover when NIH renamed it “All of Us” to better portray its aims to the many Americans who may not understand exactly what precision medicine is (three years ago when the project was first announced, I was certainly among these folks).

“I think ‘precision medicine initiative’ didn’t exactly light up a lot of people’s excitement,” Collins told me with a grin.

Collins said he wanted an inclusive-sounding name because one of his key goals is a diverse range of participants. In fact, he’s aiming for groups typically underrepresented in medical research — including racial minorities and lower-income Americans — to comprise at least half of the 1 million-person pool. Toward that end, NIH is working with federally qualified community health centers to find volunteers and is publishing all materials in Spanish, too.

The project got its biggest boost last May, when NIH started enrolling people as part of a pilot phase with the help of eight major health providers operating in several dozen cities across the United States. Collins said that as of last week, about 10,780 people are enrolled in the pool — more enrollees than he’d initially imagined in this early phase.

“The beta test now is really going great guns,” Collins said. He’d initially cited 2019 as the goal for reaching 1 million participants but has since said he’s aiming for 2022 — and he’s sticking with that year for now, he told me.

“I’m still saying 2022 because I don’t want to overpromise,” he said. “The beta test has been interesting … as with most things, you have a bit of a slow start as people are trying to figure out how to make all the pieces work.”

The agency has created a website — AllOfUs.NIH.gov — where all the information on the project will be housed, once the agency opens enrollment more broadly within the next few months. Exactly what does participation involve? It’s pretty simple: A participant submits blood and urine samples and basic measurements such as their height and weight, and fills out a questionnaire about family and health history.

Once an individual's data has been stored at the biobank at the Mayo Clinic in Rochester, Minn., he or she could request to have their complete DNA sequenced. Or they could could get a pared-down analysis called SNP genotyping, showing only the key places in their genetic code associated with health risks or benefits.

In the perfect world, every participant would get a full genome sequencing — and that might eventually be possible as the costs of such a procedure have been coming down rapidly. But a full sequence still comes with a price tag of about $800, compared to just $30 for partial genotyping, probably making it too expensive a goal for NIH at the moment.

NIH’s budget

Collins worked under Obama for most of his two terms after he was appointed to NIH in 2009. I asked whether he feels supported in the agency's endeavors by his new boss, Trump, who last year asked for a nearly 20 percent budget cut to his agency as part of his budget proposal to Congress. Collins shrugged off the request as a move by a young administration.

“I think that was very early in the administration, coming in and needing to have a budget shortly after arrival,” Collins said. “I think a lot of talk and conversation in a very productive way has gone on over the past year since that original budget.”

Collins is used to making the case for more medical research funding; after all, he spent nearly a decade pleading with Congress to infuse NIH with more dollars as year after year the agency’s budget either remained flat or even shrank under sequester cuts.

Over the past three years, Republicans in Congress have appeared more enthusiastic about supporting the agency, growing its budget by $2 billion annually. Yet NIH’s approximately $34 billion budget is still 19.3 percent down from 2003 when adjusted for inflation.

The government funds about 23 percent of medical research and development in the United States, its lowest share since World War II. But Collins insists he’s focusing on the recent positive indicators from lawmakers that bipartisan support for medical research is strong and growing.

“Sure, we have not made up the lost ground that happened between 2003 and 2015,” he said. “But at least we’re on this upward trajectory, which gives a lot of encouragement to a community that had gotten to feel pretty oppressed and pretty discouraged.”

What Trump wants

Obama and then Vice President Joe Biden were vocal supporters of medical research, frequently cheerleading Collins as he rolled out not just the Precision Medicine Initiative but also projects to advance cancer research (dubbed the “cancer moonshot”) and better understand the human brain.

So, what excites our current president, I asked Collins? He had a prompt and ready response: combating the opioid abuse epidemic. Collins recalled an Oval Office meeting last March, where he and Trump discussed research opportunities.

“We quickly settled into the direction of opioids as the thing he wanted to be sure every possible effort was being made,” Collins said.

At that meeting, the president asked Collins to both channel NIH’s resources in that direction and work with private industry on developing better ways to treat addiction. Over the past 10 months, the agency has partnered with more than 30 companies to work on addiction treatments and alternatives to opioid painkillers that can be used by patients with chronic pain, Collins said.

A few other agencies are also taking steps to addressing opioid abuse, which kills more than 60,000 Americans every year. The FDA recently approved a new 30-day injectable treatment, while the CDC has launched a campaign to raise awareness about the dangers of addiction.

But the White House has come under criticism for talking about opioid abuse without actually doing that much to address it. Trump declared opioid abuse a public health emergency last fall, but the declaration expires Jan. 23 unless the administration extends it. No new funding has been provided, and the Department of Health and Human Services has provided few details about what new steps — if any — have recently been taken to target the problem.

There’s also a disconnect between how Trump and some of his appointees talk about opioid abuse versus how Collins and other medical professionals believe it should be tackled. Attorney General Jeff Sessions frequently uses the “just say no” terminology to argue that drug addiction is a personal failing people can prevent.

“People should say no to drug use,” Sessions said in October at the Heritage Foundation. “They have got to protect themselves first.”

Bu once addicted, people generally don’t have the capabilities to just quit, Collins warned. “Let nobody imagine that once you get to the point where your brain has been rewired with opioids that you can just decide to stop,” he said.

That’s a message Collins said he has been able to present to executive branch officials on occasion, and he believes it has been well received.

“I’ve had many occasions to make that case and provide the data that backs that up,” Collins said. “That has generally been well received by the White House when that’s been presented.”

AHH, OOF and OUCH

AHH: Last week, the FDA cleared the first treatment for patients with advanced breast cancer caused by BRCA mutations, which are genetic defects that raise the risk of malignancies, The Post's Laurie McGinley reports.

"Lynparza belongs to a class of drugs called PARP inhibitors that block an enzyme involved in repairing damaged DNA," Laurie writes. "By blocking the enzyme, the DNA in cancer cells may be less likely to be fixed, leading to the death of those cells and potentially a slowdown or halt in tumor growth...The agency said its approval was based on a randomized clinical trial of more than 300 advanced breast cancer patients with BRCA 1 or BRCA 2 mutations. The trial found that the length of time during which the tumors did not grow significantly...was a median of 7 months for patients treated with Lynparza compared to 4.2 months for patients receiving chemotherapy only."

In an interview Friday, Mark Robson, an oncologist at Memorial Sloan Kettering Cancer Center who led a multisite trial on the drug, called it an “exciting new option” for patients with BRCA-caused cancer. “It's a building block,” he told Laurie, adding researchers now need to determine whether results can be improved by using it in combination with other treatments.

The National Cancer Institute estimates about 253,000 women will be diagnosed with breast cancer this year and more than 40,000 will die of the disease. About 5 percent to 10 percent of patients with breast cancer have a BRCA mutation.

OOF: The Post's Juliet Eilperin and I scooped Friday night that Teresa Manning -- the staunchly antiabortion head of family planning programs for the HHS -- has left her job. Although some sources said Manning was let go, HHS said she resigned -- either way, an agency official said Manning was escorted from the building by security officials after she'd turned in her badge.

Manning will be replaced by Valerie Huber, a prominent abstinence education advocate who has been named acting deputy assistant secretary for the Office of Population Affairs, the office in HHS overseeing the Title X program that provides contraception to low-income women. Like Manning -- who once suggested that contraception doesn't work -- Huber has a record of skepticism about birth control.

Huber managed Ohio’s abstinence program from 2004 to 2007 and subsequently led Ascend, a group initially founded as the National Abstinence Education Association. She says she prefers to use the term “sexual risk avoidance,” telling Focus on the Family’s Citizen magazine that Ascend’s mission is broader than telling teens not to have sex.

“I bristle at the terminology ‘abstinence only,’ because our programs are so holistic,” Huber said. “They contextualize a whole battery of different topics that surround a young person’s decision whether to have sex or not. Rather than someone telling a young person, ‘Do this, don’t do that,’ it’s casting a vision for a young person’s future.”

OUCH: Now that Republicans have repealed the Affordable Care Act’s individual mandate, what’s next? The New York Times’s Robert Pear reports the party’s next target could be the employer mandate, which requires mid- and large-size employers to offer health benefits.

There may be momentum behind gutting the requirement. Republican Reps. Devin Nunes (Calif.) and Mike Kelly (Pa.) have introduced a bill to suspend the employer mandate and halt any penalties that would be issued from 2015 to 2018. James Klein, president of the American Benefits Council, told Robert it's “inequitable to leave the employer mandate in place when its purpose — to support the individual mandate — no longer exists.”

“Opposition to the employer mandate could increase as more employers are fined for not offering coverage or for not meeting federal standards for adequate, affordable coverage,” Robert writes. “Since October, the Internal Revenue Service has notified thousands of businesses that they owe money because they failed to offer coverage in 2015, when the mandate took effect…The Congressional Budget Office has estimated that employers will pay $12 billion in penalties this year and a total of more than $200 billion in the coming decade."

What’s the argument against repealing the employer mandate? For one, people would lose coverage from their employers, which could leave fewer people insured overall. The shift would cost the federal government, too. As people lose coverage from their employers, more people purchasing plans through the public ACA marketplace would quality for subsidized coverage. Republicans charge the mandate encourages employers to reduce employees and hours, and slows job creation, but Democrats argue it hasn't harmed employment, hours of work or wages ever since the ACA was passed in 2010.

TRUMP TEMPERATURE

--The doctor who examined Trump last week is expected to provide more details about the president's health and answer reporters' questions at a White House briefing today. Dr. Ronny Jackson, who also served as a White House physician under Obama, declared Trump in “excellent health” Friday after giving the president his first checkup at Walter Reed military hospital.

Jackson said the examination “went exceptionally well," in a statement released by the White House. "The president is in excellent health and I look forward to briefing some of the details on Tuesday," he added, per the Associated Press. During the exam, Trump's blood pressure, cholesterol, blood sugar, heart rate and weight were taken, but the White House did not provide specific results of those tests.

--How did Taylor Weyeneth -- a 24-year-old whose only professional experience after college and before becoming an appointee was working on Trump’s presidential campaign -- nab a prime appointment helping lead the government's drug policy office? A Washington Post investigative reporter Robert O'Harrow Jr. takes a look at Weyeneth, his vault through the executive ranks and how it reflects the troubled state of the White House's Office of National Drug Control Policy.

Less than a year after receiving an undergraduate degree, Weyeneth was a political appointee and rising star at the ONDCP, which is responsible for supporting the president's efforts to curb the opioid epidemic. Weyeneth would soon become the office's deputy chief of staff, a role recently occupied by a lawyer and veteran government official, yet his only professional experience after college and before joining the administration was working on Trump’s presidential campaign.

"Weyeneth’s ascent from a low-level post to deputy chief of staff is the result, in large part, of staff turnover and vacancies," Robert writes. "The story of his appointment and remarkable rise provides insight into the Trump administration’s political appointments and the troubled state of the drug policy office."

Trump has pledged to marshal government resources to address the opioid crisis, but nearly a year after his inauguration the drug policy office lacks a permanent director. At least seven of his administration’s appointees have departed, among them the general counsel and acting chief of staff, some of whose duties were assumed by Weyeneth, according to a memo obtained by The Post.

“ONDCP leadership recognizes that we have lost a few talented staff members and that the organization would benefit from an infusion of new expert staff,” said the Jan. 3 memo from acting director Richard Baum, a civil servant. “The functions of the Chief of Staff will be picked up by me and the Deputy Chief of Staff.”

Current and former ONDCP officials who have served under Democratic and Republican presidents said in interviews that the turmoil, including the elevation of Weyeneth, hinders efforts to rally the government at a time when the nation is going through the worst opioid crisis in its history.

“It sends a terrible message,” said Gil Kerlikowske, a former Seattle police chief who ran the office during the Obama administration. “It’s a message that we’re not taking this drug issue seriously.”

HEALTH ON THE HILL

--Tomorrow, the Senate Finance Committee will meet in executive session to vote on Alex Azar, Trump’s pick to lead HHS. Committee chairman Sen. Orrin Hatch (R-Utah) announced yesterday Azar would be considered during a hearing on United States Trade Representative nominees. 

The Health 202 noted last week Democrats generally view Azar as a better pick than his predecessor, Tom Price. Two Democrats so far have announced their support: Sens. Heidi Heitkamp (D-N.D.) and Joe Manchin (D-W.Va.).

--A government shutdown is growing more likely. Concluding yesterday they would be unable to reach a long-term spending accord by the Friday deadline, GOP leaders are now turning to a short-term funding measure in hopes of keeping agencies open while talks continue, but Democratic leaders say they are unlikely to support any deal that does not protect young illegal immigrants, The Post's Mike DeBonis, Ed O'Keefe and Sean Sullivan report.

Republicans are trying to leverage long-term funding for the Children's Health Insurance Program, which technically runs out of funds at the end of March although some states will run short sooner. "One option Republicans are strongly considering to win over Democrats...is attaching a long-term renewal of CHIP to the stopgap," my colleagues write. "Republicans believe that many Democrats — especially senators seeking reelection this year — will have a tough time voting against the program, which they have called a top priority."

STATE SCAN

--Kentucky is the first state granted permission by the Trump administration to institute work requirements for Medicaid enrollees after the Centers for Medicare and Medicare Services approved the state's waiver request Friday. The approval came on the heels of a Thursday announcement by the administration that states will be allowed to institute work requirements for non-disabled recipients of the health insurance program for the poor.

Becoming the first-in-the-nation state to move forward with work requirements is a victory for Kentucky's Gov. Matt Bevin (R), who during his campaign had promised to roll back the ACA's Medicaid expansion but then allowed the program to stand with extra strings attached, The Post's Amy Goldstein reports. At a news conference Friday, Bevin said state agencies will phase in the “community engagement and employment initiative” in different parts of the state from July to November.

“Why should a working-age person not be expected to do something in exchange for what they are provided?” Bevin said.

About half of 350,000 able-bodied, working-age Medicaid recipients subject to the “community engagement” requirement meet its terms to work at least 80 hours per month, volunteer or be in job training, per Bevin aides. Under the new rules, individuals will need to send documentation to prove their compliance.

"Those who do not will receive a notice after a month, then be given one more month," Amy writes. "After that, their benefits will cease until they prove they have begun following the rules. ... The requirement is among several changes that the CMS is allowing Kentucky to adopt. They include a system that will require some people in the program to make small monthly premium payments, incentives to adopt healthy behaviors and different benefits provided to certain groups."

The Hill’s Rachel Roubein and Peter Sullivan report on the legal obstacles already brewing over the Medicaid policy shift. As soon as Kentucky was granted approval, the National Health Law Program (NHeLP) released a statement threatening litigation. "Advocacy groups are gearing up to sue the administration, arguing that it doesn’t have the power to allow work requirements and other rules for Medicaid without action from Congress,” Rachel and Peter write.

“It’s not that work creates health. It’s that creating health allows people to work,” said Leonardo Cuello, NHeLP’s health policy director. “They have taken two things that are correlated — work and health — and made up a false causation, and they're trying to use that to justify what is really a square peg they are trying to fit into a round hole.”

Eliot Fishman, a former Medicaid officer in the Obama administration who now works for liberal advocacy group Families USA, warned the policy shift would lead to people losing coverage, which he called “antithetical to the objectives of the Medicaid program.” 

--A few more good reads from The Post and beyond:

House Speaker Paul Ryan acknowledged Friday that entitlement reform isn't likely to happen in 2018. "I don't see us tackling it this year," Ryan said at an event in Wisconsin. 
The Hill
MEDICAL MISSIVES
To Your Health
The session originally planned had drawn intense interest given escalating tensions between President Trump and North Korean leader Kim Jong Un.
Lena H. Sun
To Your Health
Flu season is in full swing across the United States, with more people going to the hospital.
Lena H. Sun
Local
“If we were alone, we might have gotten discouraged.”
Justin Wm. Moyer
To Your Health
Teens are biting into the liquid laundry detergent pods, or cooking them and chewing them before spitting them out.
Lindsey Bever
INDUSTRY RX
CareFirst, a large Blue Cross Blue Shield insurer with 3.2 million members around Maryland, Virginia and D.C., ended its membership with America's Health Insurance Plans at the end of 2017.
Axios
DAYBOOK

Today

  • The House Committee on Rules holds a hearing on the Born-Alive Abortion Survivors Protection Act.

Coming Up

  • The Senate Homeland Security and Governmental Affairs Committee holds a hearing on “Unintended Consequences: Medicaid and the Opioid Epidemic” on Wednesday.
  • The Senate Judiciary Subcommittee on Crime and Terrorism holds a hearing on the “long-term care needs of first responders injured in the line of duty” on Wednesday.
  • The Senate Health, Education Labor and Pensions Committee holds a hearing on “Facing 21st Century Public Health Threats: Our Nation’s Preparedness and Response Capabilities, Part I” on Wednesday.
  • The House Ways and Means Oversight Subcommittee holds a hearing on the opioid crisis on Wednesday.
  • The Bipartisan Policy Center holds an event on “Reinventing Rural Health Care” on Wednesday.
  • The Bipartisan Policy Center holds a discussion on “Reinventing Rural Health Care: A Case Study of Seven Upper Midwest States” on Wednesday.
  • The House Veterans’ Affairs Subcommittees on Health and on Economic Opportunity hold a joint hearing on addressing veteran homelessness on Thursday.
  • The Cato Institute Policy Perspectives 2018, including a keynote address on “Misdiagnosing the Opioid Crisis”, takes place on Thursday.
  • Kaiser Health News holds an event on what’s in store for health care in 2018 on Thursday.
SUGAR RUSH

Here's a history of physical fitness in the Oval Office: 

Here's a brief history of presidents using profanity: 

When asked about his remarks about Haiti, El Salvador and African nations, President Trump declared: "I am not a racist:" 

Watch a car in Santa Ana hit a median and fly into the second story of a building: