Scientific progress sometimes requires a leap of faith. And patients who volunteer their records to a national genomic database under President Obamas new initiative for precision medicine will be taking a big one.
In the young field of genomics, scientists are still drawing the ethical road map for open-ended exploration and realizing the privacy implications for what they might uncover. In the meantime, those who sign up for genomic studies are essentially along for the ride.
President Obama is asking Congress to embark down a new path in medicine to create treatments for diseases that have long stumped the scientific community. Obamas 2016 budget proposal grants $215 million to advance the field of precision medicine, an approach in which experts toss out their one-size-fits-all strategy to develop drugs or therapies that target the genetic makeup and lifestyle choices of each patient.
As part of the proposal, the Obama administration intends to give $130 million to the National Institutes of Health (NIH) to build a database of records that will include biological samples, test results, medical histories and genomic profiles of a million or more Americans. Theproject should present unprecedented opportunities for researchers but also a host of new challenges for an administration with a dicey record of data protection at HealthCare.gov and a history ofelectronic surveillance in the name of national security.
I think this is a bold initiative, says Michael Zimmer, an expert in Internet privacy issues at University of Wisconsin-Madison. What I'm hoping here is that, given the sensitivity of this data, they will engage with the right communities and do it in a transparent way.
Francis Collins, director of the NIH, has confirmed to International Business Times that many of the genomes included in the database will be gleaned from a network of 200 groups of scientists around the country who have enrolled, or are enrolling, at least 10,000 participants each for the studies. It should be possible to build the precision medicine initiative largely from existing studies, saving a great deal of time and money, he says.
Of course, amassing the data will only be half of the challenge; the federal government must also keep it safe. Holding a persons genomic and medical records is like having a window into their lifestyle, family history and possible future, and the risk is that such intimate information could be abused or misused if found in the wrong hands.
Some patient protections are already in place. The Common Rule, by which most federal agencies abide, prohibits research on human subjects without their consent except in special situations. The Privacy Rule of the Health Insurance Portability and Accountability Act also generally prohibits research on or the disclosure of information related to a patient's health without their consent among many universities and hospitals that may contribute to the nationwide study. And should this information ever leak out, Congress also passed the Genetic Information Nondiscrimination Act in 2008 to prevent insurers or employers from holding genetic findings against a person. Regardless, concerns still loom large in the minds of privacy advocates.
Pam Dixon, founder of a nonprofit concerned with privacy issues called the World Privacy Forum, argues that genomic data can be mishandled in ways that might impact an individuals family or children as well as themselves -- for instance, detecting an inheritable disease or predisposition for a late-onset illness. She thinks these concerns merit extra layers of protection. We cannot miss the mark on this one, she says.
The administration plans to grant $5 million to the Office of the National Coordinator for Health Information Technology for the sole purpose of ensuring data security. Zimmer takes this investment as a sign that the administration is making privacy a priority from the start.
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Obamas 'Precision Medicine' Database: How Safe And Private Is The Patient Data?