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SACGHS To Draft Report on Genetics Education By Next Summer; Leavitt Calls DTC Testing Debate a 'Good Struggle'

This article has been updated from a previous version, which reported incorrectly that the SACGHS Priority Setting Task Force plans to publish a report next summer on direct-to-consumer testing. As reported previously, that task force plans to vote in December on the recommendations it plans to submit to the Secretary of the Department of Health and Human Services. The SACGHS committee instead plans to publish a report next summer from the Genetics Education and Training Task Force.
WASHINGTON, DC (GenomeWeb News) – The HHS Secretary’s Advisory Committee on Genetics, Health and Society plans to release a draft report covering its recommendations on genetics education by next summer, a SACGHS official said this week.
During a session on personalized genomics during a SACGHS meeting here, SACGHS member Barbara Burns-McGrath said that the committee expects to prepare a draft report that will cover its priorities and recommendations concerning genetics education by the summer of 2009, and a final report by 2010.
Department of Health and Human Services Secretary Michael Leavitt, who unexpectedly dropped in on the meeting on Tuesday, told attendees that consumer genomics “is an area of particular interest to me.”
Leavitt offered encouragement to meeting attendees who had gathered to hash out a range of complex issues, such as the scientific validity of these tests and the regulatory status of the field.
“We’re struggling with so many different issues and trying to find a balance, and [trying to find] that place between fostering innovation and at the same time giving people that sense of confidence” that products and services are safe, Leavitt told the group.
He added that this debate is a “good struggle” and a necessary one.
“It’s evident to me that at some point [direct-to-consumer genetic testing] is going to be very common, and if we don’t have the ability to manage this information in a standardized way, and we don’t have the capacity to protect the privacy of those [who take these tests], then there will be a great opportunity cost,” Leavitt explained.
“I believe that if people are given information that is high quality and that is consistent then they will use it in a way that will drive their own interests and in doing so will drive the quality up and the costs, ultimately, down,” he said.
Leavitt also made it clear that he does not view consumers as being unable to comprehend the subtleties involved in interpreting genetic information, particularly in terms of utilizing knowledge about disease risk.
“I think that it’s often the case that consumers are underestimated in terms of their capacity to sort through this, and there’s often a sense of well-intended protection that we want to provide that sometimes can strain the process,” he said.
Leavitt added that he tries to look at the issue through a broad scope. “It’s the tension of those on both sides of the debate that ultimately will bring improvement,” he said.
Muin Khoury, director of the Center for Human Genomics at the US Centers for Disease Control and Prevention, told the committee that the discussions this week “should not go unnoticed,” and urged SACGHS to act quickly.
Raising the question of whether the group was just “buying time between now and December,” when another administration will run HHS, he warned that this would amount to “missed opportunities for coordinated action.”
Khoury advocated drafting a letter for Secretary Leavitt that would offer advice on some of the issues the committee views as most important or pressing.
SACGHS is not the only group planning to issue a set of recommendations regarding consumer genomics. The Personalized Medicine Coalition, an industry advocacy group, spoke on Monday with several DTC genomics companies, including Navigenics, DeCode, and 23andMe, about strategies they could take to show both compliance and to begin to assuage concerns about their business.
Amy Miller, public policy director at PMC, said the group may continue to work with the companies to develop “basic guidelines for how these companies should act.”
Miller said PMC is considering several sets of guidelines, including a set for companies, one for consumers who are considering DTC genetic services, and another for physicians educating them about what the services do.
Miller described the meetings between the committee and industry as “the beginning of a conversation” about how consumer genomics can work in all the US without running afoul of regulatory bodies.

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