Cloning-based stem cell research puts women's health on the line. It requires large numbers of fresh human eggs, whose extraction poses significant risks. The politicized and well-funded drive for research cloning has been balanced by a policy consensus that women should not be paid to provide eggs for research. But now, advocates and (hopeful) practitioners of cloning-based work are pushing to undo the rules (1, 2, 3, 4) that protect women’s health in this speculative line of work.
This is most evident in California, where biotech startup Stemagen recently created the first human clonal embryos [PDF] while skirting California law and national guidelines:
- Its fertility arm paid women for eggs for reproduction, got them to agree to let some of the same batch be used for research, and claimed it didn’t pay for the eggs sent to the cloning work.
- The medical staff treating the egg providers share the same address, supervisor, and authorship credits as the Stemagen researchers, in violation of requirements that medical personnel not have conflicts of interest with researchers, so that doctors’ duty of care toward women providing egg isn’t compromised.
- It didn't consult an Embryonic Stem Cell Research Oversight Committee, a review body that is a critical part of the National Academies Guidelines for Embryonic Stem Cell Research.
Stemagen's executives, it turns out, are friends and colleagues of Alan Trounson, the new president of the $3 billion California stem cell research institute. He helped recruit his old friend Andrew French from their common homeland of Australia to serve as Stemagen's Chief Scientific Officer. And Trounson, French, and Stemagen CEO Samuel Wood authored a 2006 paper advocating cloning-based stem cell research. So it wasn't surprising when Trounson took his first opportunity at last month’s CIRM Standards Working Group to call for undermining California's prohibition on paying women (beyond their expenses) to provide eggs for research, even though this policy is enshrined in Proposition 71, the statewide initiative that created CIRM, the California Institute for Regenerative Medicine.
At last night’s meeting of the CIRM governing board, as reported by Susan Berke Fogel of Pro-Choice Alliance for Responsible Research, Trounson and Robert Klein, board chair, tag-teamed a renewed effort to find a tortured interpretation of Proposition 71 that would allow paying women for eggs. Klein set it up with a softball question to which he knew the answer: Is CIRM funding cloning-based work? Trounson obliged with laments about how access to eggs is “a terrible problem," and how the science is “floundering.” Klein tried to force a discussion which would have changed the policy by circumventing the role of CIRM's Standards Working Group.
But some members of the CIRM board made it clear they were uncomfortable with this Trounson-Klein proposal. Jeff Sheehy, who serves on both the governing board and the Standards Working Group, articulated the concerns about research cloning and the risks associated with collecting women’s eggs. Sheehy ended with, “Just because some scientists want to do something, doesn’t mean they should.” Sheehy and Sherry Lansing, who is on the board and co-chairs the Standards Working Group, stressed that this is an issue for the Working Group, and that there is a process already in place for examining these issues.
Concerns about risks to women’s health are bolstered by other doubts about cloning-based stem cell research. During the current round of funding, the institute's Research Grants Working Group recommended against funding all four applications (1, 2, 3, 4) that would use human eggs, citing - among other concerns - the uncertain supply of eggs in each case. Notably, the grant application from Stemagen was raked over the coals by the Grants Working Group:
Reviewers were not supportive of this application due to significant weaknesses in the project and the lack of experience of the principal investigator on the project….
Overall, the preliminary data presented was weak and the project was poorly described. Aim 1 is an assembly of different protocols for oocyte activation and delivery of the nucleus into the oocyte, with no sound rationale other than a handful of manuscripts gathered from experience in farm animals. The applicant describes the use of chromatin transfer but there is no explanation of how this is done or reference of work done by the applicant or some of the collaborators. … The applicant proposes to use factors that favor the development of fertilized embryos, but does not take into account the work done by others that demonstrated that SCNT embryos need culture systems that resemble more those from somatic cells rather than embryo culture.
The availability and source of oocytes was also of concern. Reviewers were unclear about how many oocytes were needed, how many oocytes would be used in each aim, and how many of these oocytes would be used fresh or be supplied frozen. This information impacts the overall budget of the proposal and the statistical power of the results....
Reviewers were also concerned about whether the project was feasible as described…. In addition, the applicant appears to have no experience managing a major project. The applicant also failed to cite key publications on motor-neuron disease, perhaps reflecting lack of understanding/knowledge of the field.
Meanwhile, despite Trounson's claim that the work is "floundering," alternatives are developing - and even surpassing cloning-based stem cell research. The most promising is cell reprogramming through induced pluripotency (iPS). Given these, calls to toss aside a critical rule to protect women's health - one that Klein himself wrote into law - simply because it is interfering with the aims of a handful of researchers and biotech companies is far from warranted.
Update (August 22): It appears that the application described above may not have been from Stemagen itself, but instead from some of its scientists. My original thinking was based on the fact that the public summary of the application said that, "Members of our team have recently reported the first successful
derivation of SCNT-embryos from cultured adult cells (skin) in the
human." The only such report so far is the paper from Stemagen. After publishing this post, I head through the grapevine that the application was from some Stemagen researchers acting in another capacity. And today the Consumer Watchdog group released a list of all the private companies that had applied for funding, and Stemagen was not among them.
Previously on Biopolitical Times: