The American Civil Liberties Union (ACLU) said Thursday it will proceed with a complaint against Myriad Genetics Inc. for the company's reluctance to fully disclose all genomic data to patients, a predicament that would seem to put the company in violation of a federal guideline on disclosure.
Sandra Park, of the ACLU, said during a conference call that "this is the first complaint we are aware of seeking to enforce patient rights" regarding genomic data under the Health Insurance Portability and Accountability Act (HIPAA) of 1996, adding that the complaint will be filed with the Office of Civil Rights at the Department of Health and Human Services (HHS). Park said Myriad had previously taken the position that HIPAA "does not extend to all the patients' genetic information."
The four patients involved in the ACLU action had requested the data from Myriad in February, and the company declined to disclose the entirety of the requested data the following month. Park said Myriad's earlier position was "akin to a hospital saying that a patient can have only a portion of their MRI. This position in our view . . . clearly violates the law," she stated.
Park pointed to a guidance released by HHS in January, which she said had mandated that patients have access to not only test reports, but to all related genomic data, "including the full gene information provided by the test."
Myriad told BioWorld Today it had received a total of seven letters of request for test results and personal gene data following the January HHS guidance, and that it had provided "all seven patients with their designated record set, including their test results."
The company argued that this has been the industry standard up to now, and noted that it and the American Clinical Laboratory Association had met with the Office of Civil Rights at HHS earlier this year for clarification on the January subguidance. According to Myriad, it "voluntarily began the process of collecting" the requested data for the seven patients earlier this month, and had "voluntarily provided" those data to the requesters.
The company added that "until now, it is very unusual for patient[s] to ask for their polymorphism data."
Regarding the company's disclosure to the four patients taking part in the complaint, Park said, "we were so pleased that Myriad took that forward-looking step," and said the company "acknowledged that patients should have access" to those data. Nonetheless, the ACLU will press forward with the complaint as a policy matter, and on the question of whether such disclosures are voluntary, Park said, "we fully expect that Myriad will ultimately adopt the right position."
Rachel Liao, of the BRCA Challenge, a program at the Global Alliance for Genomics and Health, said her organization has offered a letter of support for the action. She said the organization's work toward development of genetic variant data has run into a stop at Myriad, which lost the well-known Supreme Court case over whether genetic material can be patented in a case that eliminated the company's patents for the BRCA 1 and 2 genes.
"Myriad Genetics stands alone in its unwillingness to improve clinical decision-making around the globe through data sharing" for the BRCA genes, Liao said, making the case that data pooling is the only effective means by which patients can make "informed decisions about their own health management."
Park acknowledged that Myriad had initially provided the patients with data on variants of known significance, but said "they did not provide other variants that had been identified" in the company's tests, including those of no known correlation with breast cancer.
She said Myriad is not necessarily alone in its reluctance to disclose full genomic data, stating that "other labs are looking at their policies, and trying to design policies such that patients will be able to receive this information once they request it" as well.
Myriad told BioWorld Today that disclosure of genomic data is governed by both federal and state law, and that "we cannot share patients' personal data with public databases." The company said the elimination of typical identifiers, such as Social Security numbers and birth dates, does not always ensure anonymity.
"Scientific studies have shown that it is possible to determine the identity of patients using genetic sequence data and publicly searchable online databases of genealogy and address information," Myriad argued, adding that the Presidential Commission for the Study of Bioethical Issues has raised concerns about such matters.
The company added that it had been working on a patient data portal system "for weeks" prior to the ACLU announcement, noting that the company's subsidiary, Crescendo Bioscience, of South San Francisco, had announced the launch of the Myvectra portal May 11. Myriad said the May 18 announcement of a similar effort for other tests it provides "underscores the company's ongoing commitment to providing patients with their test results and additional information to help them manage their health."