Students from the law and medical schools at Stanford University brought together an impressive group of world-class experts last week to discuss stem cell policy. I’ll describe some (very select) highlights over the next few blogs. Check the site for the Stanford Journal of Law Science & Policy over the next few weeks for powerpoints presentations and audiorecordings.
The people who will assess which human embryonic stem cell lines should be eligible for U.S. federal funding will meet next week, said Story Landis, head of the Stem Cell Task Force at the U.S. National Institutes of Health. In March this year, President Barack Obama charged the NIH with crafting policy to allow the funding of responsible embryonic stem cell research. In July, the NIH declared that this would include cell lines created from embryos made for reproductive purposes and donated without financial inducements and with proper informed consent. Determining proper informed consent is a bit of a minefield, particularly for embryos donated in the 1990s, before much of the debate and consensus-building around the issue occurred. See Stem cell vetting raises concerns, confusion
In July, the NIH announced that it would assemble a working group to decide which cell lines closely conform with current thinking on informed consent criteria and to establish a central registry of cell lines deemed eligible for federal funding. “This is incredibly fast work for the federal government,” Landis said.
The NIH also established a registry under President George W. Bush, but that was restricted to cell lines created before 9 August 2001, the date of Bush’s speech describing the policy. For the updated NIH registry, new cell lines can be added as long as they meet the NIH’s criteria. Moreover, Landis said, the guidelines will be reviewed periodically. That would potentially allow future inclusion of embryos created by nuclear transfer (cloning) or from unfertilized eggs, assuming adequate public support and a clear scientific case for the use of these cells. (A cell line’s inclusion in the registry, Landis said, is expected to be permanent.) Stanford’s Irving Weissman, who believes that lines from unfertilized eggs and cloned early embryos should be considered now, asked about the role of politics and ideology in decisions of setting scientific policy. Landis replied that “no one was happy with the guidelines”, referring to the tension between those who would restrict which lines could be funded and those who would expand eligibility. She said that the guidelines had not been drafted “in a vacuum”.
Landis also discussed Congressional legislation governing research on embryos. The Dickey-Wicker Amendment, which prohibits the use of appropriated funds for the creation of human embryos intended for research purposes, became law in 1996 and must be renewed regularly. Landis said that the scope of the legislation has expanded since its first implementation; she seemed to think such expansion would continue and that this situation should be more closely monitored by researchers.
Don Reed, a long opponent of the legislation, suggested reinterpreting it so that the word ‘embryo’ refers only to implanted embryos rather than to fertilized eggs in laboratories, and Landis indicated that she favoured a more direct discussion of what research could (and should) be funded.
Research by Stanford’s Renee Reijo Pera gave a clear example of the kind of work that the federal government cannot support. Using a very high-tech system, she and her colleagues tracked the development of human fertilized eggs. This led to a better understanding of what goes wrong when a zygote fails to develop into a ball-shaped embryo and what markers indicate which very early-stage embryos will form blastocysts. The application of this work, she said, is not only that couples receiving fertility treatment would need to make and implant fewer embryos, but also that embryos could be transplanted at an earlier stage. (I’m being a little vague here because the results are not yet published.) This, in turn, could mean that fewer in vitro fertilization procedures would result in multiple pregnancies (carrying twins, triplets, quadruplets and so on), a situation that increases risks for both mother and offspring and that requires painful decisions of whether to selectively terminate one or more foetuses to increase the chances of delivering a healthy baby. “All you have to see is one couple who has to do a foetal reduction, and you think you’ve entered hell,” Pera said.