Wanted: A million people willing to share their DNA and 10 years of health habits, big and small, for science.
On Sunday, the U.S. government will open nationwide enrollment for an ambitious experiment: If they can build a large enough database comparing the genetics, lifestyles and environments of people from all walks of life, researchers hope to learn why some escape illness and others don’t, and better customize ways to prevent and treat disease.
‘A national adventure that is going to transform medical care,’ is how Dr. Francis Collins, director of the National Institutes of Health, describes his agency’s All of Us Research Program.
On Sunday, the U.S. government will open enrollment to try and build a large enough database to learn why some escape illness and others don’t, and better customize treatments.
Congress has authorized $1.45 billion over 10 years for the project.
It all hinges on whether enough people around the country will sign up, either online or through participating health centers.
There’s already interest: More than 25,000 people got early entry to the project over the past year through an invitation-only pilot test run by participating universities and health providers.
Most of today’s medical care is one-size-fits-all, based on what happened to the average person in short studies of a few hundred or thousand patients with a specific health condition.
And most people who volunteer for those studies are white, leaving questions about the best care for people of different races.
All of Us is part of a move toward ‘precision medicine,’ using traits that make us unique to forecast and treat disease. Learning enough to individualize care requires studying a massive number of participants: The healthy and not-so-healthy, young and old, rural and urban, blue-collar and white-collar – and people of all races and ethnicities.
WHAT ARE THE PRIVACY IMPLICATIONS OF DNA DATABASES?
The privacy of DNA databases made headlines last week when investigators used a free genealogy website to track down a suspected California serial killer.
That’s pretty different than the security under which medical DNA must be handled.
NIH said it has taken as many steps as possible to safeguard against would-be hackers.
Joseph DeAngelo (left), the man suspected of being the Golden State Killer (sketch, right), was arrested on Tuesday, after investigators used a DNA ancestry website to identify him
Volunteers’ medical data is stripped of identifying information and replaced with a code.
Only scientists meeting specific security requirements will be cleared to study the data. NIH also said federal ‘certificates of confidentiality’ prohibit disclosure to law enforcement.
Privacy wasn’t a worry for Michelle McNeely, 41, an early participant at Dallas’ Baylor Scot & White Health System. She underwent breast cancer treatment in 2016 and considers taking part in All of Us a way to give back.
‘If they can use my genes and someone’s genes in California and someone’s genes in New York to find some common ground, to help discover some cure – they can use my genes all day long,’ McNeely said.
For now, participants must be at least 18. Later, the study will open to children, too.
While there are other big ‘biobanks’ of genetic data from at least 100,000 people, the NIH project aims to be the largest and most diverse of its kind. At least half of the participants must be from groups traditionally under-represented in medical research, Collins stressed.
Sure, what genes you harbor can raise your risk for various diseases.
But other factors can increase or reduce some genetic risks.
So first volunteers will share their electronic health records, and answer periodic questionnaires about their diet, sleep, environmental exposures and other lifestyle factors.
Congress has authorized $1.45 billion over 10 years for the project. It all hinges on whether enough people around the country will sign up, either online or through participating health centers.
They might wear fitness trackers and other sensors.
And they’ll give a blood sample that later this year will undergo genetic testing, to look for so-called ‘variants’ in DNA that affect disease risk, similar to what some private companies now sell, Collins said.
Fully mapping the genetic code remains too pricey for a million people, but that more comprehensive approach will be pilot-tested with some volunteers, he said.
Among the first lessons Collins hopes to learn is about resilience: Why do some people stay healthy despite smoking or pollution or poor nutrition?
‘We have no idea how those people escape those odds,’ he said.
Unlike with most medical studies, participants can choose to see their own test results and share them with their physician long before the study reaches any big-picture conclusions.
A caution: There are still many questions about how best to use the results of genetic tests. Still, ‘we will try to help their doctors sort through what it means,’ Collins said.
One result that might bring a quick benefit: Genetic variants can signal who is prone to side effects from more than 100 drugs, information that could be used to prescribe a safer drug if only their doctors knew, Collins added.
WHAT DNA TESTING KIT COMPANIES HAVE TO SAY ABOUT GOLDEN STATE KILLER’S ARREST
23andMe
’23andMe chooses to use all practical legal and administrative resources to resist requests from law enforcement, and we do not share customer data with any public databases, or with entities that may increase the risk of law enforcement access.
‘In certain circumstances, however, 23andMe may be required by law to comply with a valid court order, subpoena, or search warrant for genetic or personal information.’
Ancestry.com
‘Ancestry advocates for its members’ privacy and will not share any information with law enforcement unless compelled to by valid legal process, such as a court order or search warrant.
‘Additionally, we publish law enforcement requests in our transparency report annually. It’s important to note that in all of 2015, 2016, and 2017 we received no valid legal requests for genetic information.’
Helix
‘Helix has not been contacted by law enforcement and has not received requests for information relating to the suspected ‘Golden State Killer’ or any other investigation.
‘In the event that we do receive a request, Helix limits what information and under what conditions its customers’ personal information is provided to law enforcement. Specifically, Helix operates consistently with its Privacy Policy which provides that Helix may disclose customer’s personal information, including Genetic Information: ‘to comply with law, a valid court order, a judicial proceeding, subpoenas, warrants, bankruptcy proceedings, or in connection with any legal process, provided that we will not disclose your Genetic Information without a valid subpoena or search warrant specific to your Genetic Information. If we are required to disclose your information, we will do our best to provide you with notice in advance, unless we are prohibited by law from doing so.”
FamilyTreeDNA
FamilyTreeDNA, the pioneer company in the field of genetic genealogy, was not contacted formally, by any law enforcement agency, regarding the Golden State Killer case.
While we take our customers’ privacy and confidentiality extremely seriously, we support ethically and legally justified uses of groundbreaking advancements of scientific research in genetics and genealogy.
The irony is the fact that this arrest was made on National DNA day, which should not be lost on any of us.
Living DNA
‘Living DNA is under strict English and EU laws when it comes to data security. We would resist any request to access customer data without the consent of the customer, and would only release data where legally compelled to do so, e.g by where ordered by a court having jurisdiction over us.
We have not been asked to provide, nor have we provided any customer details/data to any authority worldwide including the US authorities.’
MyHeritage
According to Motherboard reporter Sarah Emerson: ‘MyHeritage, a similar genealogy site that lets you upload raw DNA data, just confirmed that it was not involved with the case, and says it was not used by [law enforcement] as a tool to compare genetic profiles.’
