ACLU Complaint Against Myriad Genetics Suggests Broader Campaign to Compel Data Sharing

A regulatory change that went unnoticed in January has triggered a complaint against Myriad Genetics, a leading molecular diagnostics company at odds with some scientists because it declines to share years’ worth of results with public databases.

Four patients represented by the American Civil Liberties Union (ACLU) on Thursday filed a complaint with the Office of Civil Rights based on the Health Insurance Portability and Accountability Act. They say Myriad violated a new interpretation of an HHS rule by withholding genomic data they say belongs to them. ACLU’s action, announced in a press conference, follows weeks of behind-the-scenes efforts by Myriad and other laboratory companies to understand the regulatory change.

Myriad released a statement that said the company “has complied with these requests and provided these 4 patients with their designated record set and all requested personal health information.”

Company officials said the complaint should be dropped, but the ACLU is moving ahead. This suggests the complaint is part of a broader effort to force Myriad to make public its genetic warehouse, which includes results from more than 2 million patients. In a blog post today, ACLU Senior Staff Attorney Sandra Park accuses Myriad of creating a business model based on “monopolizing” patient information; she writes that the Obama Administration’s “moonshot” effort against cancer calls for “responsible, patient-centered data sharing” as key to understanding “relationships between all genetic variants and more effective ways of diagnosing cancer risk and making treatment decisions.”

Nearly 3 years ago, the US Supreme Court ruled against Myriad in a landmark case, in which the Association for Molecular Pathology won a decision that human genes could not be patented. Competitors entered the arena immediately to test for the presence of BRCA1 and BRCA2, which have been linked to higher rates of breast and ovarian cancer.

With that battle over, the fight today is over sharing of information. Scientists opposed to Myriad’s position believe that company should join many academic institutions in making genetic data available, which they say would speed work into cures for cancer and other diseases. But Myriad, which is publicly traded, has said its position is rooted in concerns for patient privacy and protection of intellectual property.

Myriad “takes patient privacy seriously,” the company’s statement said. “The company only provides personal information that correlates to the person who requested it.” Patients who want to share their data should seek legal counsel and understand the risks first, the statement warned.

In an interview last year with The American Journal of Managed Care, Myriad CEO Mark Capone discussed “the erosion of intellectual property rights,” which he said stands apart from the position taken in other developed countries.

For Myriad, the “moonshot” is at once a boon and a threat. Capone said in last year’s interview that he was “delighted” to hear president say the words “precision medicine” in the State of the Union, which might mean answers to reimbursement issues with Medicare, which have plagued the entire industry. But Vice President Joe Biden’s increased call to “tear down silos” in research challenges the company’s long-held position.

The process that led to Thursday’s complaint strongly suggests a coordinated effort. Company spokesman Ron Rogers explained that Myriad had no idea that HHS had quietly put up a blog post reinterpreting existing regulations on genetic data until it received 7 identical letters from patients asking for results that included benign variants–something the company doesn’t typically include with the data set sent back to patients. The letters all cited the guidance in the blog post. Initially, the company responded by sending patients a repeat of data previously sent.

In the meantime, Myriad, along with LabCorp and the American Clinical Laboratory Association, set up a meeting with the Office of Civil Rights (OCR) to better understand the January guidance from HHS. Rogers said OCR officials at the meeting not only told the group to provide benign variants, but also that the guidance would not be rescinded to allow for input, which is part of the normal rulemaking process.

After the meeting, Rogers said, Myriad collected the benign variant information and forwarded it to the 7 patients. He said Myriad has no issue giving individual patients their data. “For 20 years we’ve provided patients access for their test results,” he said.

ACLU declined to tell Science whether the group was connected to the 7 letters sent to Myriad in January. One of the 4 patients quoted in the story, breast cancer survivor AnneMarie Ciccarella, said “It’s my body, my blood, my data, my choice how I wish to share the information,” and that she wanted her results with the database ClinVar.

Myriad sees its position as protecting a 25-year, multimillion dollar investment, while some researchers see this position as “hoarding” material that should be shared in the interest of saving lives. Genetic counselor Ellen T. Matloff, MS, CGC, has long criticized Myriad’s position; in a 2014 commentary for Evidence-Based Oncology, she and co-authors argued that patients should have the right to demand their data be sent to laboratories willing to participate in public databases, especially if tests were funded by Medicare or Medicaid.

AJMC asked Rogers if it would even be possible to retroactively share data, since tests are given with the assumption that material is not included on public databases. Rogers said that patients are informed their information is not shared publicly, and that it would be “impractical” to gain consent from millions of them to change course.

Privacy issues of databases are often “glossed over” by those who promoting sharing genetic material, Rogers said. He also said the January guidance, which calls for releasing “not only the laboratory test reports but also the underlying information generated as part of the test,” and “full gene variant information,” could be interpreted so broadly that labs would need to submit reams of material about how results are calculated.