Do Presidential Bioethics Committees Shape Science Policy?

When President Barack Obama’s Commission for the Study of Bioethical Issues reconvenes tomorrow, May 18, the agenda will include the Guatemalan governments’ investigations into the intentional infection of people from 1946–48 by the U.S. Public Health Service during research on sexually transmitted diseases. It’s a far cry from the original issue for which the president formed his commission last year—the ethics of synthetic biology research.

In taking up the protection of human subjects in clinical trials, the current commission has come full circle, returning to a topic that several of its predecessor panels also grappled with. The first public national body to shape bioethics policy in the U.S. was the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created by Congress in 1974. Since then the problem of protecting people involved in life science research has been debated by several bioethics committees.

“Presidential panels have been very influential, but it’s not always obvious to people,” Jonathan Moreno, Ph.D., David and Lyn Silfen university professor of ethics and professor of medical ethics and of history and sociology of science at the University of Pennsylvania, told GEN.

“They set a professional standard, a community standard, and that’s the most important thing. And then sometimes, they stimulate a debate or they participate in a debate, like on stem cells.” Dr. Moreno, a staffer for Obama’s bioethics commission, also served as a staffer for the two Clinton-era panels.

Framing the Debate

Two separate panels formed by President Bill Clinton investigated issues related to research subjects. The latter committee, the National Bioethics Advisory Commission, became better known for offering the first federal report on the topic of stem cell research. Following the creation of Dolly the sheep, the world’s first cloned mammal, Clinton requested the panel provide advice on human cloning within 90 days.

“It’s easy to take a cynical view and say, few if any of the commission’s specific recommendations were enacted into law or policy,” Thomas H. Murray, Ph.D., a member of the National Bioethics Advisory Commission, told GEN. “On the other hand, it seems to me when presidential bioethics commissions do their work well, often the effect is to frame the debate—that is, to set out the basic terms and basic conceptual mapping around a particular subject.”

On the subject of cloning, President Clinton’s panel declared morally unacceptable any public or private sector attempts to create a human child via cloning, citing safety risks as well as ethical concerns. It recommended both a law against the practice and the continuation of a ban on using federal funds toward that end.

Yet the panel also opened the door to someday allowing precisely such research, by urging that the federal government and other parties “encourage widespread and continuing deliberation on these issues in order to further our understanding of the ethical and social implications of this technology and to enable society to produce appropriate long-term policies regarding this technology should the time come when present concerns about safety have been addressed.”

Dr. Murray said his goal for the cloning report was to respectfully present the concerns of all who weighed in on the topic, even as it took a stance some would inevitably oppose. “I think we did a pretty good job of that in cloning,” he said.

Agenda Setting

Another ethical hot potato that one of Clinton’s bioethics commissions weighed in on was whether to embrace research based on the then-new application of human embryonic stem cells (hESCs). The panel’s final report included support for research involving the derivation and use of human embryonic germ cells from cadaveric fetal tissue derived from aborted fetuses and research involving the derivation and use of hESCs from embryos remaining after infertility treatments under regulations that include public oversight and review.

The report recommended against the purchase or sale of embryos and cadaveric fetal tissue, against funding research involving hESCs from embryos made solely for research purposes using IVF or cloning, and for creation of a federal oversight board to in part establish a database of cell lines and develop protocols for their use in research.

“When it came to human embryonic stem cell research, the issue just tapped into all of the pro-life, pro-choice tensions,” Dr. Murray said. “It brought broad embryo politics to the fore. There was no way anybody could have satisfied all parties on a report on human embryonic stem cell research.”

On many issues, he recalled, the commission reached consensus only after heated discussion: “We argued about everything. We argued about justice in international research. We argued about how to think about people’s relationships to biological materials they surrendered in the course of research or medical treatment. We had lots of spirited conversations.”

Not so on issues related to abortion, where both sides proved unwilling to compromise deeply held views. Yet the panel was not supposed to act in an obviously partisan manner. While it included members with pro-life sympathies, Dr. Murray said, “it certainly had no ideological spokespersons for the right-to-life point of view.”

That’s no surprise given that Clinton was a Democrat. Also not surprising: when Republican successor George W. Bush established his own panels on bioethics, they tilted toward more conservative and pro-life positions.

A 2005 white paper from Bush’s President’s Council on Bioethics discussed four ethically uncontroversial ways to advance hESC research without destroying embryos: Extracting cells through four- to eight-cell embryos already dead; nonharmful biopsy of living embryos; artificially created nonembryonic cellular systems capable of some cell division and growth yet engineered to lack the essential elements of embryogenesis; or dedifferentiation of somatic cells back to pluripotency.

The paper highlighted the divide between the Bush administration, which opposed hESC research because they believed that embryo destruction was morally and ethically wrong, and scientists who favored the research because they believed hESCs had the potential to cure disease.

“With the stem cell debate, cloning, and so forth, the Bush council was very much part of the culture wars. It was not entirely their fault. You have to say they were really at the cutting edge of that cultural political debate,” said Dr. Moreno. “All presidents are entitled to choose their own advisors. I didn’t agree with much of what the Bush council did. But that was President Bush’s advisors, and he had the right to appoint who he wanted.”

Over the past nearly four decades of presidential science and bioethics commissions, Dr. Moreno said, the panels have largely been able to function with some degree of removal from politics. The chairs and members of those panels usually serve without pay and are usually people with backgrounds in science, ethics, or academia rather than in politics.

“I can’t deny that presidents get to choose who they want to be on these commissions,” Dr. Moreno acknowledged. “But after that, the commissions have pretty much worked independently. Frankly, [members] could quit if they didn’t like what was going on, if they felt pressured by the White House.”

Trying to Be Bi-Partisan

While President Clinton’s bioethics committee set out its own guidelines for cloning, in 2002 President Bush’s bioethics council also produced a report. The referral of the cloning issue to presidential bioethics committees reflects the most obvious source of influence over such panels—agenda-setting by the White House.

“When cloning happened, the president said, ‘I want a report on cloning,’ so we had to be responsive to those kinds of concerns. Now the president didn’t tell us what the report should say and as far as I know had no hand in preparation of the document at all,” according to Dr. Murray.

Bush’s bioethics council’s 2002 report, “Human Cloning and Human Dignity: An Ethical Inquiry,” recommended a ban on cloning to produce children as well as a four-year moratorium on cloning for biomedical research. But that advice was endorsed by only a 10-member majority; a seven-member minority of the panel issued its own recommendation supporting the ban on cloning for children but calling instead for regulation of the use of cloned embryos for biomedical research.

Yet that’s not the deepest rift to befall a presidential commission. That dubious distinction falls to the Biomedical Ethical Advisory Committee (1988–90), which consisted of six U.S. Senators and six U.S. Representatives, divided among the two political parties. That arrangement, intended to reduce political pressure, ended up deadlocking the panel since each faction proved unable to compromise with the other, especially on issues related to abortion.

It is a mistake not repeated by later panels including President Obama’s bioethical commission. That panel met its 180-day deadline for completing a report on ethical issues surrounding synthetic biology research, which was sparked by J. Craig Venter’s May 2010 announcement that his team completed a key step toward creating a fully synthetic organism. Obama’s commission is now taking up the decades-old issue of sexually transmitted disease research in Guatemala, with briefings from executive director Valerie Bonham and Guatemala’s vp Rafael Espada, M.D.

“That’s the fate of such commissions,” Dr. Murray said. “You set out a plan of work in issues you think are really important but not necessarily politically visible and then you get ambushed by some hot issue that pops up. Then the White House says, ‘Put aside what you want to do and take this on.’ When you’re on such a commission, you regret that sometimes.”

Getting Back to Subject Protection

Protection of human subjects involved in research came to the forefront almost three decades ago when the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was set up. It explored the treatment of several vulnerable populations during research, including fetuses, children, and prisoners.

Members followed press reports that from the 1930s to the early 1970s, the U.S. Public Health Service lied to hundreds of African-American men by telling them they were being treated for syphilis when they weren’t. Based on their investigations, in 1979, they issued “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.”

Almost a decade later the president’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research developed guidelines aimed at protecting human subjects by securing their informed consent on research.

Presidential panels once again returned to the issue in the 1990s. President Clinton’s Advisory Committee on Human Radiation Experiments (1994–95) concluded that the federal government funded or provided equipment for or even isotopes toward about 4,000 human radiation experiments between 1944 and 1974. Among its recommendations were a personalized apology and compensation to each subject or their next of kin as well as efforts “to ensure the centrality of ethics in the conduct of scientists whose research involves human subjects.”

A later panel formed by Clinton’s administration, the National Bioethics Advisory Commission (1996–2001), explored the treatment of research subjects unable to give consent due to mental disorders. Some 30 years after human protection was made a focus for the bioethics committee of that time, President Obama’s bioethics panel will take up the matter once again.

The opportunity to shape science policy, limited as it is by White House agenda-setting and the need to address hot issues, will likely continue to draw scientists and others to future presidential commissions. Given the contentious times, presidents will likely continue to seek input largely from those they would agree with, so their panels can move past ideological paralysis and toward action.

“Your job is to help frame a public debate, ground it in good science, in the right facts, gather thoughtfully a wide range of views, and then provide a report where people can find their ideas echoed respectfully, and then make whatever recommendations you can,” Dr. Murray said. “I do not begrudge the politicians the right to ask these commissions to take on particular issues.”