Clinical OMICs - Issue 5 - (Page 14)

Showdown on Data Sharing Physicians who order genetic tests should only do so from labs that agree to share data publicly, in addition to satisfying test quality, turnaround time, and cost concerns, two genetic counselors and a geneticist have publicly urged. Not so, Myriad spokesman Ron Rogers told Clinical OMICs. He referred to the company's Policy Statement on Genetic Information, which states the company is not allowed to distribute its variant databases except to interpret clinical test results for patients tested in its labs, citing the Clinical Laboratory Improvement Amendments of 1988 and the FDA. The company stopped contributing to an NIH database in 2004, citing curation errors it said resulted in high rates of error and variants of uncertain significance (VUS). Writing in Evidence-Based Oncology, a news publication of the American Journal of Managed Care, Ellen T. Matloff, MS, and Rachel E. Barnett, MS, both of Yale Cancer Genetic Counseling; and Robert Nussbaum, M.D., of the University of California, San Francisco School of Medicine, cited numerous instances where physicians requested or demanded that specific labs Myriad also stated it will collaborate with laboratories perconduct genetic tests. The physicians did so without disclos- forming noncommercial, academic research projects with ing that they either were paid consultants for such laboratoInstitutional Review Board ries, or received speaking fees DNA home tests under approval, by reviewing VUS or research funding from those fire: Myriad for not sharing identified in their studies. data publicly and 23andMe entities, the co-authors wrote. The company has engaged "Our patients deserve for decisions regarding where their genetic testing is performed to be unbiased, free of conflict, and based upon considerations unrelated to the clinician's self-interest," the coauthors wrote. The co-authors also criticized Myriad Genetics-among a group that owns patents related to BRCA gene testing-for not sharing data publicly. Matloff was a co-plaintiff in last year's Supreme Court case concerning patentability of the group's BRCA patents. Dr. Nussbaum leads the nonprofit Sharing Clinical Reports Project, formed to collect data on BRCA1/2 variants and make it publicly available via the National Center for Biotechnology Information's ClinVar database. Dr. Nussbaum, Matloff, and Barnett cited a European Journal of Human Genetics article stating that unnamed "Myriad officials" told corresponding author Robert Cook-Deegan of Duke University that after 2005, the company "adopted a deliberate policy of retaining data as a trade secret." 14 Clinical OMICs June 12, 2014 was ordered by the FDA to stop dispensing medical information in hundreds of scientific collaborations with more than 50 research institutions over the last decade, Rogers said. Myriad is not the only company trying to steer doctors to its tests, Matloff told Clinical OMICs. "We have had a representative of another company show up at our office pretending to be a patient in an attempt to meet with the director of the program to sell their product. Within the BRCA market, it's not just Myriad that's aggressive. Many laboratories are being aggressive, and in some cases, inappropriate," Matloff said. She declined to identify those companies, but did say there was no difference in doctor pressure to favor certain labs in Connecticut, where genetic counselors can order tests, compared with most U.S. states, where only physicians can order such tests: "We're still getting this pressure from outside physicians who are saying, 'I am not going to send patients there anymore,' and who have even contacted administrators." www.clinicalomics.com http://www.clinicalomics.com

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Clinical OMICs - Issue 5