The nation’s leading medical research agency is officially inviting all Americans to contribute to a massive genetic library it says is more inclusive and accessible than any such database built so far.
National Institutes of Health officials announced yesterday that the government’s “All of Us” initiative is open for business, more than three years since they first started working on the ambitious project. Director Francis Collins is inviting people across the country — particularly members of minority communities — to share health records, answer surveys and provide blood and urine samples to be entered into a database with the goal of eventually including 1 million participants.
Recruitment begins Sunday with community events in seven sites across the country, where people will be encouraged to sign up for the mammoth research project, my colleague Lenny Bernstein reports. “Its goal is to supplement and in some cases replace the need to repeatedly recruit human subjects for research by providing a huge database of health and lifestyle information for scientists to plumb,” he writes.
The project is by no means the first time an organization has tried to build a genetic library. Private companies such as 23andMe and Helix have been gathering genetic data for years, giving their customers access to information about their likelihood of contracting certain diseases as well as genealogical insights.
So what’s different about “All of Us?” Leaders of the initiative stressed two top priorities: access and inclusivity.
First, officials are trying to include a wide variety of Americans, especially those from ethnically diverse backgrounds and rural areas. Ideally, they’d like 70 to 75 percent of participants to be from communities typically underrepresented in medical research and clinical trials, said "All of Us" director Eric Dishman.
Dishman said the project would also benefit from many healthy volunteers, as those who typically seek genetic sequencing do so because they have cancer or other serious illnesses. Researchers need to be able to study the genes of healthy people as comparisons and to learn more about preventive medicine.
Building a database with a broad and diverse range of genetic data is a key to the whole project, since researchers will hopefully be using the information years into the future to develop cures targeted specifically to patients’ genetic makeup and their particular form of disease.
Dishman knows the promise of these targeted cures — known as “precision medicine” — all too well. After undergoing nearly two decades of treatment for cancer, he finally went into long-term remission after having his genome sequenced and receiving treatment specifically targeted to his tumor. Now, he wants to help others access these cutting-edge treatments more readily.
“I barely got access to precision medicine, as an educated, wealthy white man,” Dishman told reporters yesterday. “What about everybody else? We need to bring precision medicine to more people with more conditions.”
Private genetics companies don’t necessarily seek out underrepresented populations — they serve customers who come to them and typically have enough resources to invest in exploring their genetic makeup. While the cost of genome sequencing has been rapidly coming down over the past decade, some of the services these companies provide can cost hundreds of dollars.
“Most of the corporate world doesn’t really have that kind of emphasis,” said Rex Chisholm, a cell and molecular biology professor at Northwestern University who has helped advise the "All of Us" project. “Most of the databases are built on people of European ancestry.”
See this Health 202 interview with Collins in January about "All of Us:"
Of course, there are some exceptions. Helix, a three-year-old personal genomics company, is partnering with leading Nevada health-care network Renown Health to sequence the genes of 40,000 Nevadans.
In its initial phase, 10,000 participants donated DNA samples for genotyping. Helix co-founder Justin Kao told me the goal isn’t just to build a database, but also to give patients access to preventive measures and education based on their health risks. The project is particularly aimed at enrolling Hispanic and Native American participants, he said.
Kao said that rather than feeling threatened by NIH’s approach, he thinks the government and private efforts are complementary – and said his company would like to partner with NIH if given the opportunity to share what it has learned about securely transmitting data to patients.
“We need more diversity and I’m thrilled Francis and the team are so focused on that,” Kao said. “Nevada has a lot of Hispanics and Native Americans, and those folks are vastly underserved in the genetics space.”
Another major aim for "All of Us" is to make genetic information readily available to scientists, medical researchers and potentially even lay people. Officials said they plan to launch a portal next year where the data could be widely available to those interested in using it for research purposes, using cloud technology so that it can also be kept secure.
Chisholm, who has served on a committee looking at security and privacy, said the thought is to provide three levels of access. At the first level, researchers could only view data unlikely to lead to the identification of a particular individual. At the second and third levels, they could get more information but would need to go through a registration and verification process.
Assuming the security measures are sufficient, such a broad database would be invaluable to researchers, he told me. Researchers can find genetic data elsewhere — there are some large biobanks in the United Kingdom and Estonia, for example – but it’s not clear that it's as robust as what NIH is aiming to gather, he said.
NIH officials also stressed a third goal — to make sure all the volunteers can access their own genomic data if they want. They said the project needs to be a two-way street in which participants contribute to the database but in return get potentially helpful insights into their own health status.
Dishman said he and other NIH officials have drawn from knowledge amassed by private industry, mentioning the UK Biobank as a particular influence. Going forward, it’s “incumbent” on the commercial sector and the government to work together on promoting precision medicine research, he said.
“There will still be lots of scientific questions the power of 1 million can’t answer,” Dishman said. “I see it as the more cohorts, the better.”
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AHH: President Trump's longtime personal doctor Harold Bornstein claims Trump's bodyguard, a Trump Organization lawyer and a third man conducted a “raid” of his office and took decades of medical records two days after he told the New York Times he'd prescribed Trump hair-growth medicine. Bornstein told NBC News he felt “raped, frightened and sad” when on the morning of Feb. 3, 2017, the three men came to collect 35 years of Trump’s medical records.
This might be the “craziest White House story you’ll read this week,” our colleague Aaron Blake writes. The big question here is whether any laws were broken with the seizure of the documents. The New York doctor says he was not provided with a Health Insurance Portability and Accountability Act release signed by Trump, the patient, which would be a violation of the law.
Yet it's not. Bornstein told CNN that the glowing health assessment he signed when Trump was a candidate? That was fake news. CNN’s Alex Marquardt and Lawrence Crook III have the story: “When [Bornstein] described in hyperbolic prose [Trump's] health in 2015, the language he used was eerily similar to the style preferred by his patient. It turns out the patient himself wrote it, according to Bornstein. ‘He dictated that whole letter. I didn't write that letter,’ Bornstein [said]. ‘I just made it up as I went along.’ The admission is an about face from his answer more than two years when the letter was released …'His physical strength and stamina are extraordinary,' [Bornstein] crowed in the letter, which was released by Trump's campaign in December 2015. 'If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency.' ... ‘That's black humor, that letter. That's my sense of humor,’ he said. ‘It's like the movie 'Fargo': It takes the truth and moves it in a different direction.’”
The parallel universe on Twitter was aflutter:
.@KaciSokoloff just spoke w Dr. Harold Bornstein, who refused an interview but said that NBC's piece was "a pretty good story." Bornstein also said that he spoke to the NBC reporter “in the bathroom” of his office. He signed off with: "Sweetheart, this is watergate, goodbye!"— Jacqueline Alemany (@JaxAlemany) May 1, 2018
For real, the public does have some right to know the health of their presidential candidates before voting on them. It’s no small matter. And Trump deprived voters of that right. It’s pretty astonishing— Sam Stein (@samstein) May 2, 2018
The former Democratic congressman:
So the leader of the free world hasn’t been to a real doctor in a decade but I have to go to mine damn near every other day?— John Dingell (@JohnDingell) May 2, 2018
Yesterday, White House Press Secretary Sarah Huckabee Sanders defended the possession of the medical records and disputed Bornstein's description of how they were obtained.
"As is standard operating procedure for a new president, the White House Medical Unit took possession of the president's medical records," Sanders told reporters at the White House briefing.
From PBS Newshour's Yamiche Alcindor:
Reminder: Sarah Sanders just said this was "standard procedure." https://t.co/Ft87xdwhWl— Yamiche Alcindor (@Yamiche) May 1, 2018
OOF: Synthetic opioids -- specifically illicit fentanyl -- led to more overdose deaths in the United States in 2016 than prescription opioids.
A new analysis published yesterday in JAMA Psychiatry found synthetic opioids contributed to 19,413 deaths in 2016 -- 2,000 more deaths than were linked with prescription opioids. It’s the first time in this decade that synthetic opioid drugs were linked to more fatal overdoses than prescriptions, Stat News’s Lev Facher reports. The study also found about 80 percent of people who died from synthetic opioid-related overdoses in 2016 had another drug or alcohol in their system. Since 2010, the rate of opioid-related deaths involving synthetic versions of the drugs also jumped to 46 percent from 14 percent.
“The study corresponds to an increased focus within the public health community on fentanyl, the powerful synthetic opioid sometimes used as an anesthetic in hospitals and to treat chronic pain," Lev writes. "Increasingly, however, drug dealers sell opioids laced with fentanyl — often cheaper than other forms of illicit opioids — to purchasers either unaware that they are getting the synthetic drug or unable to predict its increased potency."
OUCH: Illnesses from mosquito, tick and flea bites more than tripled in the United States from 2004 to 2016, according to a new CDC report, The Post's Lena H. Sun reports. Reported cases of these diseases — which include Lyme disease, Rocky Mountain spotted fever, West Nile and Zika — jumped from 27,388 cases in 2004 to more than 96,000 cases in 2016.
“Officials say the actual number of people who have become sick is much higher, in part because many infections are not reported or recognized,” Lena writes. “Some patients may experience mild symptoms and not seek medical attention, and not all diseases were reported for the full 13-year analysis period or from all states and territories.”
The increase in cases is the result of many factors, Lena explains. “Mosquitoes and ticks and the germs they spread are increasing in number and moving into new areas. West Nile virus, for example, was introduced to New York City in 1999 and then spread across the country. As a result of these increases, more people are at risk for infection. Overseas travel and commerce are also increasingly common, and someone infected with a mosquito-borne disease such as Zika in one country can unknowingly transport it home.”
— Yesterday, former HHS secretary Tom Price said he's not a fan of Congress's decision to repeal the Affordable Care Act’s individual mandate, a remark that breaks with many Republicans and the Trump administration that pushed to include the repeal in last year’s tax overhaul. In remarks delivered at the World Health Care Congress in Washington, Price said repealing the mandate (which forced Americans to have health insurance or pay a penalty) means people buying insurance through the government-run marketplaces will pay higher prices.
“There are many, and I’m one of them, who believe that that actually will harm the pool in the exchange market, because you’ll likely have individuals who are younger and healthier not participating in that market, and consequently that drives up the cost for other folks within that market,” he said.
Before he resigned from HHS last September following uproar over his use of pricey chartered flights, Price insisted the mandate wasn't working. “The individual mandate is one of those things that is actually driving up the cost for the American people in terms of coverage,” he said on ABC’s “This Week” last summer. “So, what we’re trying to do is make it so that Obamacare is no longer harming the patients of this land — no longer driving up costs, no longer making it so that they’ve got coverage but no care.”
Bloomberg News's Steven Dennis noted how Price has changed his tune on the mandate:
Tom Price before/after shot/chaser: pic.twitter.com/jzY5Y9TKYT— Steven Dennis (@StevenTDennis) May 1, 2018
Former acting CMS administrator Andy Slavitt:
BREAKING: Former HHS Sec said in a speech today he KNEW premiums would rise with a Republican actions. They did it any way.— Andy Slavitt (@ASlavitt) May 1, 2018
Current Admin official spoke afterwards and denied the sabotage EVERYONE sees.
Looking for a job brings out the truth.https://t.co/JzyDxul5Cg
But with his comments Tuesday, Price was affirming predictions of the Congressional Budget Office, which in November projected 13 million fewer Americans would have health insurance by 2027 without the mandate, our colleague Jeff Stein notes.
Democrats quickly responded to Price’s unexpected admission. “I’m glad to see former Secretary Price admit the truth, which is that families’ premiums are going up because President Trump and Republicans in Congress have spiked prices with their relentless, partisan health care sabotage,” Sen. Patty Murray (D-Wash.) said in a statement. The office of Senate Minority Leader Chuck Schumer had this comment: “We couldn’t have said it any better ourselves.”
Andrew Bates, a spokesman for Democratic super PAC American Bridge called it a “shocking admission.” “Tom Price just broke with Trump and congressional Republicans while confirming what nonpartisan experts and Democrats warned of all along: that by undermining the ACA, the Republican tax giveaway to the rich will cost Americans their health-care coverage and raise out-of-pocket costs even more,” Bates said.
Sen. Chris Coons (D-Del.):
Even former Trump Administration officials are now admitting that their attempts to gut the Affordable Care Act will make health care more expensive for Americans: https://t.co/zTyRhGW4Vh— Senator Chris Coons (@ChrisCoons) May 1, 2018
— Seema Verma, administrator of the Centers for Medicare and Medicaid Services, dismissed the idea of spending more money on Obamacare outreach next year to boost enrollment, telling reporters signups could have been down because of higher premiums -- and not because the administration slashed outreach and enrollment funding.
"I'm not sure that at this point where we are with Obamacare, with the high rates, with the limited networks, with the lack of choices, that we can spend a whole bunch of money on advertising and that is going to bring people into the program," Verma said in a rare sitdown with the press yesterday.
Verma didn't provide many new details about how CMS will handle a range of Medicaid revisions states have requested such as drug testing and time limits on benefits. Nor was there word on whether the agency will reject Kansas's request to impose a three-year lifetime limit on benefits (which The Hill's Peter Sullivan noted). The agency has permitted several states to add work requirements, but a number of requests for other kinds of requirements are still outstanding.
"We really want to be flexible, and we want to think of new solutions," Verma said. "We want to help people but do it in a way that tries to end poverty -- I think that's the goal here." She said work requirements -- also called "community engagement" -- are challenging to implement but effective in the long run for helping people improve their financial circumstances.
"It is actually easier, from working with a lot of Medicaid programs, it is actually easier to just say we're going to expand coverage and hand everybody a card," Verma said. "But it's much harder to say, why is this person here? They're living in poverty, they're earning 100 percent of the poverty or below. They have challenges that go beyond just needing health care coverage. So a lot of these states are saying we want to resolve this, and that's what the community engagement policy is all about, and we tried to do it in a very practical and empathetic way."
— First in The Health 202: Sen. Ron Johnson (R-Wis.) is asking Verma to look into how CMS could prevent unions from “skimming” dues from those providing home-based care to Medicaid enrollees. It's an issue conservatives have been raising, as Democratic policymakers in Illinois, Wisconsin and nine other states have allowed these workers to be classified as government employees for the purpose of collecting union dues.
Johnson asked Verma to provide information on Medicaid funds diverted for union dues and how her agency is preventing states from taking the dues from Medicaid payments. “I respectfully encourage CMS to review this practice and determine whether changes to law or regulation are necessary to ensure that Medicaid funds are provided to the program's intended beneficiaries,” Johnson wrote in a letter yesterday.
— A few more good reads from The Post and beyond:
- The 15th Annual World Health Care Congress this continues.
- The Partnership for a Healthier America summit begins.
- Politico hosts an event on the prescription drug supply chain on Thursday.
Watch Stephen Colbert on President Trump's longtime personal physician Harold Bornstein:
Trevor Noah on the 49 questions special counsel Robert S. Mueller III hopes to ask him in an interview: