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According to a recent statement (1), an invitation-only group of roughly 150 scientists, lawyers, and entrepreneurs gathered at Harvard on Tuesday May 10 to discuss making a complete synthetic human genome from scratch, and inserting it into a cell line. The event was closed to media.

Knowledge of the Harvard meeting emerged in a critical commentary co-authored by Stanford University bioengineer Drew Endy, who has been deeply involved in developing and promoting synthetic biology for many years, and Northwestern University bioethicist Laurie Zoloth, who has participated in numerous efforts to develop guidelines and public policy about emerging biotechnologies.

Endy and Zoloth report that the meeting “was originally organized to focus on 'deliverables and industry involvement,’” and that one of the topics on the agenda was “changing the human genome itself.” On Twitter, Endy posted part of an invitation to the meeting, which asked participants to refrain from talking with the media about it.

“From what we know so far, it’s hard to tell much about the actual technical purpose, business plan, or public relations agenda of the convenors. If these reports are accurate, the meeting looks like a move to privatize the current conversation about heritable genetic modification,” said Marcy Darnovsky, PhD, Executive Director of the Center for Genetics and Society, referring to the ongoing controversy about the prospect of using new gene editing techniques to alter the genes passed on to future children and generations.

Both in the US and globally, opposition to heritable genetic modification is strong. A “gene editing summit” in December 2015 convened by the national scientific academies of the United States, the United Kingdom, and China concluded with a statement by its organizing committee that “it would be irresponsible to proceed with any clinical use of germline editing unless and until...there is broad societal consensus about the appropriateness of the proposed application.”

Though the December “summit” was widely covered by news and social media, and featured speakers from a range of disciplines, it was criticized by the Center for Genetics and Society and others for being insufficiently inclusive. “A semi-secret meeting of scientists and business people to make plans about synthesizing the human genome is a new low in scientific accountability,” Darnovsky said.

“Fully synthetic humans are not close at hand,” she continued. “But genetically modified humans could be. If the next move from the convenors of the Harvard meeting is a splashy announcement about a privately financed moon-shot project, that would really make a stark contrast to the promise of broad societal consensus.”

(1) Should We Synthesize A Human Genome?, by Drew Endy and Laurie Zoloth, May 10, 2016 

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The Center for Genetics and Society is a non-profit public affairs and policy advocacy organization working to encourage responsible uses and effective societal governance of human genetic and reproductive biotechnologies.

Contact:
Marcy Darnovsky
510-625-0819, ext 305
darnovsky[AT]geneticsandsociety[DOT]org

Elliot Hosman
510-665-7760, ext 302
ehosman[AT]geneticsandsociety[DOT]org

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Center for Genetics and Society applauds expansion of funding; exclusion of cloning techniques

This statement can be attributed to Marcy Darnovsky, PhD, Associate Executive Director.

The Obama Administration and the National Institutes of Health have made the right call by expanding the funds available for responsible embryonic stem cell research, while excluding federal support for stem cell lines derived using cloning techniques.

Cloning-based stem cell research requires large numbers of women’s eggs, and extracting them poses significant risks. Now that scientists have shown they can produce disease-specific stem cell lines – the goal of cloning techniques – using cell reprogramming methods, there’s even less justification for risking women’s health to extract their eggs.

Unfortunately, New York State’s stem cell program has recently departed from the international consensus against recruiting women to provide eggs for cloning-based stem cell research by approving payments up to $10,000. Such payments pose "undue inducements" for young women to undergo a risky procedure for a failed line of research.

Furthermore, cloning-based stem cell research lays the technical groundwork for human reproductive cloning.  Dozens of other countries have already prohibited it, and the President called it `dangerous and profoundly wrong’ in his March remarks on stem cell research. It’s time for the U.S. to join the international consensus and formally prohibit reproductive cloning.

The Center for Genetics and Society has prepared a stem cell backgrounder [PDF] with brief answers to frequently asked questions about the science of stem cell research and the federal policies that apply to it.The Center is a non-profit public affairs and policy advocacy organization working to encourage responsible uses and effective societal governance of human genetic and reproductive biotechnologies.

Contact:
Marcy Darnovsky
510-625-0819 x305
510-913-7714
mdarnovsky[AT]geneticsandsociety[DOT]org

Center for Genetics and Society Calls for Moratorium on Enrolling Some Patients

The Recombinant DNA Advisory Committee (RAC), the federal body dedicated to publicly reviewing gene transfer experiments, met today to discuss a recent death in an experiment, but offered no answers to important ethical questions raised by the tragedy.

Associate Director of the Center for Genetics and Society, Marcy Darnovsky, called on the RAC to take prompt action to address these issues. "This is the only government body whose deliberations on gene transfer are in any way open to the public," she pointed out. "If the RAC doesn't take action, these problems will disappear from the public's radar and the biotech companies' agendas."

Sponsored by Targeted Genetics of Seattle, the clinical trial in question was designed to test the safety of a gene transfer product for rheumatoid arthritis. One key issue raised by the death of 36-year-old Jolee Mohr is whether patients whose conditions are not life-threatening should be enrolled in gene transfer studies. Experts at today's meeting disagreed on this point.

CGS's Darnovsky called for a moratorium on enrolling such subjects. "Gene transfer is an experimental procedure with significant risks," she said. "Until scientists have a better understanding of the deaths and the hundreds of serious adverse events that have been reported but not investigated, gene transfer studies should be limited to people with life-threatening conditions and no good alternatives."

Darnovsky also commented on one longstanding problem of the informed consent process that accompanies clinical trials. "Many patients would be astonished to learn that their own doctors are being paid to sign them up," she said. "Some might well see this as a betrayal of trust. This sort of payment should not be allowed. Yet in this case, it was not even disclosed."

Other departures from accepted "best practices" were raised at today's meeting but not fully addressed. Some language in the Targeted Genetics consent form suggested that prospective subjects could expect medical benefits from their participation, although the goal of this stage of trials was to merely determine safety. In addition, Mohr was asked to sign the consent form immediately rather than taking it home for further consideration.

According to experts who testified at today's meeting, attribution of Mohr's death to the gene transfer procedure cannot be ruled out based on current information. The RAC, which advises the National Institutes of Health, adopted several recommendations about its role in the ongoing investigation of the direct cause of death. However, no plans for additional consideration about enrolling subjects not suffering from life-threatening conditions, or other ethical issues, were discussed.

The Center for Genetics and Society is a nonprofit information and public affairs organization working to encourage responsible uses and effective societal governance of the new human genetic and reproductive technologies. It supports women's health and reproductive rights, including the right to terminate an unwanted pregnancy.

Contact:
Marcy Darnovsky
510-625-0819 x305

Dear Dr. Cicerone, Dr. Fineberg, Dr. Pope, Dr. Sharples, and Dr. Fagen:

We are writing to express concern about the composition of the National Academies Human Embryonic Stem Cell Research Advisory Committee. While we applaud the National Academies for taking leadership in the critical area of human embryonic stem cell research (hESCR) oversight, we feel that the composition of the new committee lacks needed balance, both in terms of areas of expertise and in terms of viewpoint.

The Center for Genetics and Society (CGS) is a nonprofit information and public affairs organization working to encourage responsible uses and effective societal governance of the new human genetic and reproductive technologies. The Integrity in Science Project at the Center for Science in the Public Interest (CSPI) is a consumer advocacy organization that encourages policy-makers at all levels of government to seek balance on expert advisory committees.

The emerging technologies of hESCR and, particularly, somatic cell nuclear transfer (SCNT) raise a number of challenges for society and for potential regulators. Of course, these techniques hold potential to improve human well being. But they also hold potential for harm. For example, SCNT requires human eggs, and women could be harmed or exploited in the egg collection process. Furthermore, the current need for women's eggs indicates that any stem cell or SCNT therapies are likely to be extremely expensive, and likely out of reach of many Americans. In addition, these techniques lay the technological groundwork for applications such as human reproductive cloning and inheritable genetic modification that are widely seen as unacceptable.

The proposed members of the committee bring a wealth of experience in the biological sciences and health law. However, given the nature of hESCR and SCNT, we believe that a number of critical perspectives and backgrounds are inadequately represented.

The predecessor to this committee expressed qualified support for hESCR and SCNT, yet eschewed any federal regulatory role for these emerging technologies. The UK, Canada, and many European countries have taken a very different approach. Though their approaches are dissimilar in some respects, they have all established comprehensive oversight and regulation of hESCR and related technologies. Since the proposed panel contains a number of members who served on the previous panel, it would serve the interests of a full debate on oversight issues if lawyers, bioethicists, public health experts, or policy experts who have expressed caution and a need for effective public oversight, including formal structures of federal regulation, were added to the committee.

We also suggest that the committee include experts with a professional background in the provision of women's health. The women who provide eggs for SCNT will, in a sense, be the first research subjects of stem cell investigations. Their well-being must be protected. And while lawyers and bioethicists bring one needed perspective to these issues, someone whose primary focus is the well-being of women who may provide eggs for research is currently absent from this committee.

Finally, the committee should include experts who will bring a demonstrated research experience and concern for access to health care for ethnic minorities and the economically vulnerable. If treatments based on stem cells, and even more so any that rely on SCNT, turn out to be as expensive as some experts predict, then stem cell-related scientific and technological developments may exacerbate existing health care inequities. Legal and policy questions governing intellectual property or the relationship between government funding and pricing may come before this committee and could significantly shape the extent to which equitable public access to these technologies can be ensured.

Will such discussions be balanced? The current committee is co-chaired by Richard O. Hynes, who sits on Genentech's Scientific Resource Board, and includes Harold Shapiro, a director of Dow Chemical who also sits on the Merck Vaccine Advisory Board, and John Wagner, whose research has been funded by Viacell and Athersys. Their presence ensures that industry's concerns will be adequately represented when such deliberations occur. While there are at least two bioethicists on this panel, we recommend you add at least one person whose research and writing suggest a concern for ensuring public access to leading-edge medical technologies like those that may result from stem cell research.

In the current politically polarized climate, the controversies over hESCR and SCNT are too often portrayed as full support versus complete opposition. But an increasing number of scientists, health law experts, and public-interest advocates have taken a more nuanced approach, and opinion surveys that probe public attitudes reveal a mix of support and legitimate concerns. In particular, we feel that technologies with such potential for both good and harm, such as SCNT, call for moving forward with an attitude of cautious optimism and under a well-regulated system of responsible oversight.

Including this perspective on the committee would give it a balance that it currently lacks. We believe that the committee would be stronger, and the recommendations it issues more credible, if its composition reflected this perspective as well as the one that currently dominates the membership.

Sincerely,

Marcy Darnovsky, Ph.D.
Associate Executive Director
Center for Genetics and Society

Merrill Goozner
Director
Integrity in Science Project
Center for Science in the Public Interest