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In April 2002 Kathy Hudson put in her first day of work as director of the new Genetics and Public Policy Center. With no other employees, no desks, no chairs, and no computers, the Center began work with the generous funding from the Pew Charitable Trusts -- and a vision.
“In an area where the agendas, interests, and opinions of government agencies, advocacy groups, professional organizations, and politicians come into play, I knew there was a place for a think tank that would combine independent research with rigorous policy analysis,” says Hudson. “Perhaps most importantly, I wanted to engage the many stakeholders in genetics policy – including the public – to identify common ground and catalyze change.”
A short five years later, the Center has become a significant player in human genetics policy. “Our role in this environment is to do policy-relevant research, make sure it’s understandable, disseminate it widely, and bring people together around the table to take action,” Hudson explains.
The Center’s unique approach to stakeholder involvement and policy analysis has won praise from policy makers and decision leaders in human genetics. Francis Collins, director of the National Human Genome Research Institute, commends the central role that the Center now plays. "The Genetics and Public Policy Center is filling a critical and much-needed niche in the science policy landscape,” he says. “GPPC has made major contributions to the assessment of public views on genetic testing, preimplantation diagnosis, the risk of genetic discrimination, and many other issues. The Center has developed into a muscular source of policy options and advice -- they are the ‘group to go to’ on all of these topics."
Evolving Strategies
The first initiative the Center launched focused on current and future applications of reproductive genetic technologies. It assessed the attitudes and experiences of patients, providers, and the public; held conferences and policy briefings; and published numerous reports and peer-reviewed articles on various facets of this complex issue. The approach the Center adopted for these first three years was one of explicit neutrality.
“With our reproductive genetic technology initiative, our goal was to identify what the issues actually were, who needed to understand them, and how public opinion fit into policy development,” says Susannah Baruch, the Center’s director of reproductive genetics. “We didn’t bring preferred policy approaches to the table; we did a landscape analysis of the issues and laid out all the policy options that were available.”
This approach was productive and established the Center as an objective source of information on highly controversial issues like cloning, germline modification, and “choosing” genetic traits in embryos. It helped the Center forge important partnerships with key players in human genetics policy, Baruch adds.
Indeed, participants in working groups and workshops sponsored by the Center as part of this initiative are as remarkable for their scientific depth as their political breadth. The Center’s reproductive genetics advisory committee included ethicists, theologians, consumer advocates, OB/GYNs, and IVF clinicians. One notable public conference on preimplantation genetic diagnosis brought together former House Speaker Newt Gingrich; John Podesta, who served as President Clinton’s chief of staff; and former National Institutes of Health (NIH) Director Bernadine Healy – all as part of a free-flowing panel discussion on genetic testing of human embryos.
Wrote Leon Kass, a professor at the University of Chicago, fellow at the American Enterprise Institute, and former chair of the President’s Council on Bioethics, “In your ethical and policy forums, you make honest (and successful) efforts to engage people from across the spectrum of ethical and policy opinion, and the fairness of your work to date is an achievement of which you should be especially proud, given the generally poisonous climate for open discussion of issues connected with reproductive technologies and research involving embryos.”
The Center’s products from this period include extensive reviews of the legal and regulatory framework for human reproductive cloning; policy options for preimplantation genetic diagnosis, human germline modification, and cloning; and “issue briefs” aimed at cultivating public understanding of these complex – and controversial – issues. The Center also began developing new methods of public engagement around these issues through a series of public opinion polls, focus groups, and town halls; these skills would later serve the Center well as a springboard into new activities funded by NIH.
With a new round of funding from Pew in 2005, the Center launched a new, more advocacy-oriented initiative on genetic testing quality.
“While the Center had doggedly maintained neutrality, our first project made it abundantly clear that safety and quality of genetic tests was profoundly important – in a reproductive context and across the human lifespan,” Hudson says. “Our new focus opened up a whole new avenue of policy work for us with policymakers and stakeholders.”
Gail Javitt, the Center’s law and policy director, notes that the shift from pure policy analysis to policy advocacy has been a logical extension of our previous work. “All of our current work on the quality of genetic testing flows directly out of problems we identified during the first phase of the Center’s research,” she says. “We found an oversight system that has lagged behind advances in genetic technology, with serious gaps posing a risk to public health. Now we can propose changes to those regulations that will help safeguard the public health.”
Through surveys, GPPC has assessed the quality control procedures now in place in genetic testing laboratories, as well as the public’s expectations of the government’s role in quality assurance. The Center’s reports and articles interweave the results of these surveys with analysis of relevant regulations, particularly those of the Center for Medicare and Medicaid Services and the Food and Drug Administration. This work has catalyzed renewed attention to genetic testing oversight. Sen. Barack Obama (D-Ill.) said of GPPC, “They’ve played a critical role in educating and shaping the national genetics policy agenda, and equally important, have kept the spotlight and the pressure on federal health agencies to do more to ensure the safety and effectiveness of genetic testing.”
After Hudson testified at a July 2006 hearing of the Senate Special Committee on Aging on the release of a Government Accountability Office (GAO) report on direct-to-consumer genetic testing, then-Chairman Gordon Smith (R-Ore.) wrote, “Your assistance proved essential to GAO’s report and the overall hearing. The Committee appreciates your diligent efforts on behalf of the genetics community and consumers, and we look forward to your continued insight.”
Gregory Kutz, the managing director of Forensic Audits and Special Investigations at the GAO, thanked the Center for its assistance in preparing the report released at the hearing. “Your organization was invaluable in providing the scientific, technical, legal, and other expertise we needed to appropriately analyze and report our investigative results,” he wrote.
A Vision of the Future
While much of the Center’s work has focused on the safe clinical use of genetics, there are important emerging issues in genetics research as well, particularly associated with the growing number of large-population genetic studies and the development of sizable biobanks. One area where early work is leading to new and challenging activity is in public engagement around genetic testing, notes Joan Scott, the Center’s deputy director.
Building on earlier public engagement work, GPPC won a competitive cooperative agreement award from NIH in September 2006 to develop and pilot test public engagement strategies for a long-term, large-cohort study of genes and the environment. The Center is finding ways to reach the public and understand their reactions to a proposed NHGRI project to collect genetic samples from up to 500,000 U.S. residents and track their health history, lifestyle, and environmental exposures for up to 10 years. “The expectation is that data gathered in this project would be a rich source of information about the complex interactions of genes and the environment in contributing to common diseases such as diabetes, stroke, cancer, and heart disease. But the Center is exploring whether there are public concerns about genetic privacy, consent, and recruitment that may prove barriers to citizen participation in the study, and how those concerns could be addressed through the design of the study or through policy changes,” Scott explains.
The Center’s two-year study will involve focus groups, community leader interviews, a large survey, and town halls to assess Americans' attitudes and consult with the public about the proposed NIH project. This public consultation work hints at the breadth of options for future public engagement projects at the Center.
“I feel we’re really just getting started,” says Hudson. “There are genetic policy issues we’ve barely touched – use of DNA in forensics, for example – where the opportunities for public engagement and policy analysis are ripe for the kind of work we do. The science of human genetics is growing by quantum leaps; we have to be ready to help science and policy evolve in sync. Otherwise, policy will always be playing ‘catch-up’ with science, and this benefits neither science nor the public.”
