Custom Policy for “Custom Kids”? (Summer 2004 Trust Magazine article)

Jul 01, 2004

In an Atlantic Monthly article in 1971, Nobel Laureate James Watson, M.D., Ph.D., noted the "unexpectedly rapid progress" in science’s ability to routinely fertilize human eggs in test tubes. With an eye toward the cloning of humans, he asked, "Is this what we want?"

More than two decades later, his question has not only not been answered--it’s been broadened. Today, reproductive genetics--including the powerful new technologies associated with it--constitute one of the most visible parts of a dramatic biomedical revolution. This area of scientific discovery is still on a fast pace of development, and the breakthroughs get reported excitedly in the nation’s news. 

But they also leave many Americans struggling to keep up, trying to decide how they feel about advances in one of life’s most basic, yet profound, events: having a baby. Indeed, the issues raised challenge fundamental views about life, science, technology, regulation, and ethical decision-making. 

Reproductive genetic technologies have the power to shape our world for the good by offering dramatic new hope for parents struggling with a family history of genetic disease. But the very same technology that can eliminate horrific genetic diseases in children can also be used to change how they look, act, or perhaps one day, even how they think--a turn that many find profoundly disturbing. 

As this science hurtles forward, it isn’t clear who, if anyone, is guiding its uses or carefully considering the consequences for individuals and society. Even preeminent scientists--for instance Eric S. Lander, Ph.D., head of the Broad Institute of the Massachusetts Institute of Technology and Harvard University, and a leader in the Human Genome Project--have worried aloud that without broader input into the policy decision-making process, scientists, physicians and biomedical companies are alone in the driver’s seat, guiding what research will be pursued and how it will be applied. 

New reproductive genetic technologies have their history in the earlier reproduction revolution of in-vitro--literally, "in glass"--fertilization (IVF) technology in which egg and sperm are joined in a test tube, or Petri dish, and then implanted in a woman’s womb. Though the world was startled in 1978 when scientists created the first "test-tube baby," the procedure is commonplace today: Approximately one in 100 babies born in the United States is conceived through IVF, and the rate is rising rapidly. 

IVF has been used primarily as a treatment for infertility, but the process makes it possible for clinicians to conduct genetic tests on embryos while they are accessible in the Petri dish. Today’s reproductive genetic technologies include preimplantation genetic diagnosis (PGD), a process in which embryos created through IVF are tested for particular genetic diseases or characteristics. 

On the horizon are the prospects of cloning, in which the genetic content of an egg is replaced with another cell that is then stimulated to begin developing into an embryo with the same DNA as the cell; and germ-line genetic engineering, which one day may allow parents not only to screen for but also to change or correct inherited genetic characteristics before birth. 

Nationwide, fertility clinics and practitioners are already employing PGD. Until recently, it was used almost exclusively by couples who wanted to avoid passing down a few severe genetic diseases, but today some fertility clinics argue that it should become a routine part of IVF because it enables doctors to select embryos that potentially could improve the chances for a successful pregnancy. Some fertility clinics are beginning to advertise that PGD can be used to select the sex of the baby. 

And that illustrates the dilemma perfectly. While many herald PGD as an important stride in medical progress that will help people have children who are free of disabling or life-threatening genetic conditions, others are concerned that the technology will be misused. 

Especially as the number of genetic tests multiplies, those who can afford the $12,000 per round it costs to use PGD with IVF may be tempted to screen their embryos for relatively minor genetic flaws or even preferred characteristics. If PGD has already been used to select embryos based on gender, critics argue, then there is very little stopping prospective parents and practitioners from selecting embryos based on whatever identifiable genetic traits they deem desirable. 

Who is minding the store? Current oversight of genetic technologies in general in the United States is fragmented and unclear. For example, once scientists have identified the function of a particular gene, it is easy to develop a test to detect mutations in that gene; but there is no official entity that determines when a test is safe, clinically valid and ready to be offered. 

Most genetic tests do not fall within the categories of tests regulated by the Food and Drug Administration. As a result, tests of questionable validity may be introduced and marketed to providers and consumers. Similarly, the oversight of the laboratories that perform the genetic tests is patchy. The Centers for Disease Control and Prevention sets minimum standards for medical testing laboratories but has yet to adopt specific standards related to genetic tests. 

In addition, in our health care system, the federal government rarely steps in to specify the circumstances under which doctors might choose to use a particular test or procedure. These decisions are largely self-governed with guidance by medical professional societies. In some instances, an experimental technology that has been supported by federal research dollars will require review by an ethics panel, and study sponsors must inform patients of any risks. However, since 1996, there has been a ban on the use of federal funds for embryo research, and as a result, reproductive technologies may not always be subject to this higher level of oversight. 

Reproductive genetic testing raises additional issues beyond the general safety and efficacy concerns, and there is no clear arbiter of those concerns, either. For example, should parents and their clinicians be allowed to screen and select embryos based on any of the characteristics that can be tested for? Over the past two decades, scientists have become genetic code-crackers. Today, the genes that play a role in hundreds of diseases and characteristics have been identified, including genetic markers for perfect pitch, color blindness and baldness. Is it okay to screen for some characteristics and not others? 

This question is at the heart of the debate over whether there should be a line between the use of genetic tests for therapeutic purposes (i.e., to screen out harmful genetic conditions) and their use for "preference" purposes (i.e., screening for certain characteristics such as gender or hair or eye color). Even if there were agreement that there should be a line, who would decide what is actually therapeutic and what is not? What about parents who want to "balance" a family of all boys with a little girl? Or dwarf parents who want a child of "average" height? Or parents who want their next child to be a tissue match for a gravely ill sibling? Or deaf parents who do not view deafness as a disability and who want a child who is deaf like them? 

Some believe these are decisions for families to make in consultation with their doctors. Some believe these decisions should be left up to God. Some believe there is a role for government. Others do not want the government involved in such personal and private decisions. At their most candid, many would even say "a little bit of all of the above." 

In 2001, the Trusts decided to launch an initiative to explore the need for and interest in the creation of an oversight mechanism that can guide decisions about the use of reproductive genetic technologies, and in 2002 made a grant to the Phoebe R. Berman Bioethics Institute at The Johns Hopkins University to create the Genetics and Public Policy Center (GPPC). 

"Many nations have undertaken a detailed evaluation of the policy needs in this rapidly advancing field, conducted far-reaching public consultations and, in some cases, adopted new laws and regulations. In the U.S., there is a policy vacuum. The fact that someone didn’t come in and occupy this niche before the GPPC was created is sort of stunning," says Kathy Hudson, Ph.D., the Center’s director. 

Hudson, who earned her doctorate in molecular biology, not only understands reproduction science but also is a recognized leader in the public policy issues raised by human genetics research. She previously served for six years as assistant director of the National Human Genome Research Institute under Francis S. Collins, M.D., Ph.D., where she shaped and directed the successful public and media communications efforts of the Human Genome Project; and she was a policy analyst at the U.S. Department of Health and Human Services before becoming director of the Center. 

Hudson also appreciates how hard it is for the average person to keep up with a cutting-edge field. Fifteen years ago, as Hudson was busily sequencing DNA in the lab, she herself wondered about how policymakers in Washington were making decisions about this incredibly, and increasingly, complicated area of science. 

After finding herself looking up genetics policy in the government documents section of the library one too many times, she applied for a Congressional Science Fellowship, which funds scientists to work for a year in a congressional office and bring their expertise to relevant policy issues. She went to Washington and never left. "I caught Potomac fever," Hudson says with a shrug and a smile. 

The Center has become an important resource for the media, stakeholders and policymakers both within and outside Washington. When a team of South Korean scientists reported in February that they had successfully cloned a human embryo for the purposes of stem cell research, CNN tapped Hudson to appear on Headline News to explain the significance of this development to its audience, as did NPR on Talk of the Nation

When in June of 2003 the Center raised questions about the unknown long-term health outcomes of children conceived through assisted reproductive technologies, the two medical groups most closely connected with this technology agreed to work with the Center to find answers. And the information and discussion at a GPPC forum on problems with genetic testing for cystic fibrosis  helped prompt the U.S. Food and Drug Administration to consider requiring additional oversight of new genetic testing techniques. 

As the media and experts speculate about where advances in reproductive genetics--both real and imagined--might lead, many worry that policymakers will be tempted to react with sweeping new mandates or prohibitions that do not take account of all the interests at stake. 

The Center is creating ways in which these interests and concerns, including those of the American public, can be articulated. It is conducting a series of ambitious public-opinion research projects that are providing policymakers, the media and others with important insights into how segments of the American public view reproductive genetic technologies and what role, if any, they believe the government should play in regulating them. 

Its first survey, released in December 2002, revealed significant agreement on certain issues and distinct divisions on others. For example, 66 percent of respondents approved the use of these technologies to avoid having a child with a serious genetic disease, but 70 percent thought it wrong to use them to select socially desirable traits such as height or intelligence. 

Most respondents--including majorities of Republicans, Democrats and Independents--said that the government should regulate the quality and safety of reproductive genetic technologies. Just over half of Americans view these technologies primarily in terms of health and safety, while another third view them primarily in moral or religious terms. Those who view them in terms of religion and morality are more likely to disapprove of them. Men are twice as likely as women to be in favor of cloning and more "extreme," if currently impossible, applications of reproductive genetic technologies, such as engineering a person’s athletic ability. 

The Center also conducted a series of focus groups and one-on-one interviews with specific subsets of the American public, including religious Americans and people who have special experience with reproductive genetics, such as medical professionals and patients who have decided for and against using the technologies in question. 

This research revealed that those with reservations about where reproductive genetics might lead have many different reasons for their hesitation--among them, parents’ unrealistic expectations of a "perfect child"; potential inequities in access to the technology, leading to deeper divides between classes and races; the difficulty of enforcing regulations that might just drive technology underground; and decreased motivation to cure or treat diseases that can be screened out in vitro. 

Currently the Center is conducting a series of small-group and online discussions with a representative sample of Americans to learn whether and how people’s thoughts about reproductive genetic technologies and possible oversight mechanisms change after they have been given the opportunity to learn and think more deeply about the science and hear the issues debated. 

In addition to its public opinion research, the Center is working with many groups that have a significant interest in the development and use of reproductive technologies. These groups include disease-specific organizations for which these new technologies may promise cures, the disability community for whom these technologies pose the specter of eugenics, women’s organizations, those concerned about race and genetics issues, those with strong pro-life and pro-choice positions, health-care providers and others. 

One of the Center’s primary objectives is to develop a series of policy options that decision-makers in both the public and private sectors might turn to as they consider various ways to guide the development and use of reproductive genetic technologies. To inform its work on these options, the Center has assembled a Reproductive Genetics Advisory Committee, which is made up of leaders from science, law, bioethics, theology, industry, sociology, public policy and medicine. 

So far, this committee has been asked to react and respond to the Center’s first set of draft policy options which focused on the use of PGD. "Ordinarily, you would think the members of this committee would sit on opposite sides of the table and stake out their positions," Hudson says, "but the fact is that each contributes his or her sincere perspective in non-posturing conversation. They enrich our work enormously." 

"The Center’s goal is to lay out the options free from bias. That helps us to hear each other’s voices in good faith," says committee member C. Ben Mitchell, Ph.D., senior fellow at the Center for Bioethics and Human Dignity. "The disagreements we experience are a microcosm of the disagreements in the larger culture--and the unity there as well. I’m convinced that by asking the right questions, consensus can develop." 

Joe Leigh Simpson, M.D., chair of obstetrics and gynecology at Baylor Medical School and co-director of Baylor’s PGD program, agrees: "We need a neutral broker, and the Center seems to be doing a good job, bringing in the players over a diverse breadth of expertise and listening without an agenda." 

In January, the Center unveiled its preliminary report on PGD policy options in an event called "Custom Kids: Genetic Testing of Embryos." The event included a panel discussion with public figures and experts, including former House Speaker Newt Gingrich and Bernadine Healy, M.D., former director of the National Institutes of Health. 

Following the forum, GPPC posted its draft policy options to its Web site for additional comment and feedback and also plans to vet them with a cross section of the American public as part of its public opinion work before finalizing them for release this fall. Over the coming months, the Center plans to release a series of policy options for other reproductive genetic technologies. 

Leon R. Kass, M.D., Ph.D., chair of the President’s Council on Bioethics, has praise for the Center’s unconventional approach. "By gathering information on public opinion, the Center is helping to make visible the important new ethical challenges society will increasingly face from the fusing of reproductive technologies and genetic knowledge," he says. 

Opinion data "don’t substitute for ethical reflection and political debate," Kass cautions, but he expresses optimism that by clarifying the fault lines in public opinion and then laying out policy alternatives, the Center’s work will help focus public deliberation and move the policy process beyond "business as usual." 

Though only two years old, the Center has "more influence than you might think," according to PGD practitioner Joe Leigh Simpson. "Most foundations have less influence than they hope for because they find their own initiatives in competition with the NIH for public attention," he explains. "By contrast, the Center seems to have the field to itself." 

The Genetics and Public Policy Center is located at 1717 Massachusetts Avenue, NW, Suite 530 Washington, DC 20036. Its phone number is 202.663.5971. Its Web site, www.DNApolicy.org, contains genetics issues, policy concerns, polls and research, and offers the run of its quarterly newsletter.

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