ACLU to Myriad Genetics: Patients, not companies, own personal genetic data

| July 12, 2016
Screen Shot at AM
This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

Ken Deutsch was diagnosed with metastatic bladder cancer two years ago. As part of his treatment plan, he was genetically tested for genetic mutations by Myriad Genetics, a company that specializes in identifying cancer genes.

But when Deutsch wanted to share the full results of that testing with researchers at the National Institutes of Health, Myriad refused to release it. While the company gave him his results for cancer, Myriad also looks at other mutations in these cancer genes. These are benign mutations that are not known to increase cancer risk and, as a result, aren’t usually reported back to patients. But Deutsch wanted these data included in the information he submitted to the ClinVar network, a database of patients’ genetic information run by the NIH. Myriad said no.

Deutsch was not alone. He and three other Myriad customers are named as complainants in a formal action filed by the ACLU on May 17, 2016 with the U.S. Department of Health and Human Services. The complainants want Myriad to release this information to anyone who wants it saying they as patients and customers have the right to their own medical information under the Health Insurance Portability and Accountability Act (HIPAA). From STAT:

The Health Insurance Portability and Accountability Act (HIPAA), mostly known for its protections on patients’ privacy, also includes provisions guaranteeing patients access to their health information. A complaint filed on Thursday by the American Civil Liberties Union claims that Myriad has violated HIPAA by refusing to provide the full gene data that they generated from patients.

The day after the complaint was filed Myriad provided the information to the four patients. A spokesman for Myriad told Bloomberg that the patients should withdraw the complaint, accordingly. But the ACLU declined. From Bloomberg:

A patient’s right to their entire genetic record set is a focus of the ACLU, Sandra Park, a senior attorney with the ACLU, told Bloomberg BNA May 20. Park said the complaint is the ACLU’s first foray into ensuring patients’ full access to their medical records. She said the ACLU is looking for Myriad to willingly acknowledge a patient’s right to full access, either through a voluntary posting on its website or through a resolution agreement.

In 2013, Myriad lost a high profile Supreme Court case over the patent rights to the BRCA1 & 2 genes, which are linked to higher incidences of breast, ovarian and prostate cancer. The case set the precedence that naturally occurring DNA cannot be patented.

Related article:  Can a simple breath test detect cancer?

ACLUgene
Beyond patient access, there is a second issue with the fact that Myriad is collecting and keeping results on benign mutations. Sometimes these mutations do turn out to be disease-linked. When they are, there is not standardized notification to patients. Last year a two-year-old boy died because a mutation that his genetic testing lab classified as benign turned out not to be. That case spotlighted the lack of follow up communication between testing companies and patients about mutations. It also highlighted the need for non-profit databases like ClinVar to speed up the process of implicating or exonerating unknown mutations in causing disease.

Patients who are willing to accept the potential risks of sharing their genetic information for research purposes should not be kept from that because of the wishes of the company that did their testing. Nor should these companies sequester a patient’s data while they wait to discover its significance for themselves.

Meredith Knight is a contributor to the human genetics section for Genetic Literacy Project and a freelance science and health writer in Austin, Texas. Follow her @meremereknight.

The GLP featured this article to reflect the diversity of news, opinion and analysis. The viewpoint is the author’s own. The GLP’s goal is to stimulate constructive discourse on challenging science issues.

Outbreak
Outbreak Daily Digest
Biotech Facts & Fallacies
Talking Biotech
Genetics Unzipped
a a b b a f ac a

Video: Death by COVID: The projected grim toll in historical context

The latest statistics, as of July 10, show COVID-19-related deaths in U.S. are just under 1,000 per day nationally, which is ...
mag insects image superjumbo v

Disaster interrupted: Which farming system better preserves insect populations: Organic or conventional?

A three-year run of fragmentary Armageddon-like studies had primed the journalism pumps and settled the media framing about the future ...
dead bee desolate city

Are we facing an ‘Insect Apocalypse’ caused by ‘intensive, industrial’ farming and agricultural chemicals? The media say yes; Science says ‘no’

The media call it the “Insect Apocalypse”. In the past three years, the phrase has become an accepted truth of ...
types of oak trees

Infographic: Power of evolution? How oak trees came to dominate North American forests

Over the course of some 56 million years, oaks, which all belong to the genus Quercus, evolved from a single undifferentiated ...
biotechnology worker x

Can GMOs rescue threatened plants and crops?

Some scientists and ecologists argue that humans are in the midst of an "extinction crisis" — the sixth wave of ...
food globe x

Are GMOs necessary to feed the world?

Experts estimate that agricultural production needs to roughly double in the coming decades. How can that be achieved? ...
eating gmo corn on the cob x

Are GMOs safe?

In 2015, 15 scientists and activists issued a statement, "No Scientific consensus on GMO safety," in the journal Environmental Sciences ...
Screen Shot at PM

Charles Benbrook: Agricultural economist and consultant for the organic industry and anti-biotechnology advocacy groups

Independent scientists rip Benbrook's co-authored commentary in New England Journal calling for reassessment of dangers of all GMO crops and herbicides ...
Screen Shot at PM

ETC Group: ‘Extreme’ biotechnology critic campaigns against synthetic biology and other forms of ‘extreme genetic engineering’

The ETC Group is an international environmental non-governmental organization (NGO) based in Canada whose stated purpose is to monitor "the impact of emerging technologies and ...
Share via
News on human & agricultural genetics and biotechnology delivered to your inbox.
Optional. Mail on special occasions.
Send this to a friend