Industry pioneers discuss the pros and cons.
By Kevin Davies
June 10, 2008 | BOSTON—Avey’s keynote was followed by a formidable group of personal genomics experts in a plenary panel, including Dietrich Stephan (co-founder, Navigenics); George Church (Harvard Medical School); Jeff Drazen (editor-in-chief, New England Journal Medicine); Fred Ledley (Bentley College); John Halamka (CIO, Harvard Medical School); and Linda Avey (23andMe).
Stephan spoke of the looming health care crisis, and the need to maximize individual wellness and focus on prevention. “We refuse to test for quantitative traits, minors who can’t give informed consent, family units because of high non-paternity rate, ancestry testing because of blowback.” To wait a generation before offering personalized information “would be unconscionable.”
Church is both an advisor to 23andMe and co-founder of Knome, which is offering full-genome sequencing to a few well-heeled customers. He’s also expanding the Personal Genome Project, looking for 100,000 volunteers. “We’re definitely keeping an eye on all of these companies,” added Avey. “We’re all about the consumer, what they’re willing to spend for this information.”
Will consumers use this information to change their lifestyle? Drazen recalled an asthma patient with serious cat allergies whose wife noted that she’d been married for 6 months, but she’d had the cats for 10 years. “What they did based on that information is very difficult to know,” said Drazen. “There’s potential promise but we’re a long way from utility... We don’t want to come across like we don’t care about this… we have to show that it works. I’m from Missouri, show me!”
Halamka is a volunteer in Church’s Personal Genome Project, and one of his challenges is to turn medical data into a semantically operable format and make them readable and computable.
Avey struck a conciliatory note on the question of regulation. “We all want to protect consumers,” she said, and is talking to FDA, the CDC, and state legislators. 23andMe did not initially seek CLIA certification because, “We don’t claim this to be a clinically relevant test yet, it’s genetic information, it’s not a test… Coming out and saying we were CLIA-certified was going to be disingenuous to our customers.” That policy recently changed.
Drazen picked up the theme of a recent commentary in the New England Journal, raising concerns about consumer privacy, data security, and the “commercial personal interface.” Fifteen years ago, big pharma was considered ethical. “The stakes getting big… I’m basically a futurist, but I want it to help everybody, not just help somebody get rich.”
Church, playing devil’s advocate, envisioned a ruse in which a synthetic saliva could be combined with whole-genome amplification, and Drazen raised the possibility that insurance companies could collect patient saliva samples and submit them for analysis without consent.
“Having crisp, well-understood privacy policies is really a prerequisite to having bigger and better technology to share data,” said Halamka.
View the webcast of this event.
This article appeared in Bio-IT World Magazine.
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