Illustration of a man and a woman standing in front of a DNA helix

A Proposal for Localized Review to Safeguard Genetic Database Privacy

By Robert I. Field, Anthony W. Orlando, and Arnold J. Rosoff

Large genetic databases pose well-known privacy risks. Unauthorized disclosure of an individual’s data can lead to discrimination, public embarrassment, and unwanted revelation of family secrets. Data leaks are of increasing concern as technology for reidentifying anonymous genomes continues to advance.

Yet, with the exception of California and Virginia, state legislative attempts to protect data privacy, most recently in Florida, Oklahoma, and Wisconsin, have failed to garner widespread support. Political resistance is particularly stiff with respect to a private right of action. Therefore, we propose a federal regulatory approach, which we describe below.

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a pill in place of a model globe

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Beatrice Brown, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

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Illustration of a man and a woman standing in front of a DNA helix

Research Reveals Potential Concerns About Genetic Testing for Suicide Risk

By Brent Kious, Anna Docherty, Leslie Francis, Teneille Brown, Jeffrey Botkin, Douglas Gray, Brooks Keeshin, Louisa Stark, Brieanne Witte, and Hilary Coon

Companies that offer direct-to-consumer genetic testing (DTC-GT) will soon be able to provide scores that estimate suicide risk.

Our recent study, appearing in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG) raises ethical questions about how these risk scores will be understood.

The causes of suicide are complex. Many risk factors intersect: psychiatric symptoms like depression, different life stressors, family history, access to lethal firearms, and substance abuse, among many others.

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ancestry dna kit box

Gamete Donor Anonymity is a Myth: Q&A With Seema Mohapatra

By some accounts, 26 million people have undergone direct-to-consumer (DTC) genetic or ancestry tests. While some of the results of these tests seem might seem obvious (I turned out to be half-Hungarian and half-Ashkenazi, to no one’s surprise), there have been a number of accounts in the media of test results that have been considerably more dramatic.

Some of the more shocking — and now shockingly common — scenarios are the ones in which a consumer finds out through a DTC test that they were donor-conceived, and that one or both of the parents who raised them are not their genetic relatives. Gamete donors, who often provide genetic material (eggs or sperm) with the promise of anonymity, are finding themselves the recipients of messages from genetic children they never intended to meet.

Gamete donors could argue that they have a right to privacy. But Prof. Seema Mohapatra suggests the idea of gamete donor privacy is no longer realistic, due to the state of genetic technology.

I sat down with Prof. Mohapatra to learn more about the many ethical and legal questions DTC genetic testing raises for donors, recipients, and clinics.

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