What ESC advocates are telling the NIH

Yesterday was the last day to give the NIH your opinion on the 2009 draft guidelines for the federal funding of embryonic stem cell research.  I was sure that ESC advocates would be screaming about the fact that the NIH guidelines restricted the federal funding of ESC research to lines created by embryos "leftover" from infertility treatments.  The NIH guidelines did not allow for funding ESC lines extracted from embryos created especially for research including cloned embryos, and I was positive that restriction would get the most criticism.

I was wrong, and I am glad.  It turns out that the 2009 guidelines, which are very strict on the donation by parents of their surplus embryonic children to research, are also retroactive.   This means that some of the ESC lines that researchers had been working with under the Bush administration, would no longer be eligible for federal funding.  This is where the criticism of the NIH guidelines has focused, on the retroactive nature of the restrictions.  From Nature.com:

During the 30-day period of public comment on the guidelines that ends today (26 May), the NIH received tens of thousands of comments. Although a large number came from religious conservatives opposed to any expansion of federal funding for the research, scientists' concerns centred on the fate of existing research....

In August 2001, former President George W. Bush said that the government would fund research on only a score of lines available at the time. "Even an initial analysis of the 21 NIH-approved cell lines shows that the vast majority would not be available for NIH funding under a strict interpretation of the draft NIH guidelines," says George Daley, a stem-cell researcher at Children's Hospital Boston. "Hopefully the NIH will revise their draft to grandfather in the hundreds of existing lines that have been derived under the highest standards of their time."

Patrick Taylor comments in Cell Stem Cell:

Prospectively applied, the proposed NIH rules as they stand would present a challenge to the field. But retroactively applied, the draft regulations would create a tectonic shift: previously, only certain old lines were fundable, and now conceivably only certain new lines will be, and there will continue to be no federal funding available for research using cells created ethically since 2001. Important research will need to be repeated, and assays and data rebuilt. As currently outlined, it's as if the last 8 years of cell line creation and ethical self-regulation have just vanished, to be replaced by a new funding structure that does not give weight to the existing science, ethics, self-regulation, donor intentions, or diverse cell lines. Resolving this situation is critically important for stem cell research. But the broader principle should government guidance be retroactive is vital for all areas of scientific research.

The International Society for Stem Cell Research drafted this suggested response to the NIH guidelines.  It begins:

Dear NIH:

President Obama’s Executive Order 13505 represents a tremendous opportunity for the NIH to support ethically responsible and scientifically worthy stem cell research. The NIH deserves credit for producing draft Guidelines quickly to provide time for public comment.  However, I am worried that that the NIH proposal will exclude funding for many existing stem cell lines ethically created over the last eight years.

The California Institute for Regenerative Medicine wrote this in response to the NIH:

A fundamental concern is that established research materials that have already been deemed ethically derived and that are currently being used in NIH funded research could be disqualified by the retroactive application of technical requirements for procurement and consent. For instance new requirements not found in 46 CFR 116 informed consent requirements include: explicit discussion regarding the commercial potential of research results. Potential research materials at risk include the Pre-2001 hESC lines, post-2001 hESC lines, and blastocysts stored in research tissue banks. Table 2 summarizes the scientific importance of some of these lines for research into chronic disease.

The Bedford Stem Cell Research Foundation urged anyone who supports ESC research to write to the NIH with the following:

I urge the NIH to adopt alternative criteria that will allow federal money to be used with stem cell lines currently approved for NIH-funding. Eliminating federal support for use of these lines would seriously undermine current research programs. I recommend that the criterion for acceptable derivation be oversight of embryo and oocyte donation by an Institutional Review Board (IRB) or its equivalent. The IRB should ensure that the informed consent process conformed to accepted regulations and guidelines at the time and place of donation. This alternative IRB criterion for informed consent continues support for current research programs and supports use of an expanded set of valuable stem cell lines.

There were mentions of expanding the funding to including embryos created for research including cloned embryos, but overwhelmingly the response focused on making sure that existing lines that are eligible for funding stay eligible.

What is the upshot?  ESC advocates have bigger fish to fry than the funding of research using cells from cloned embryos or embryos created just for research.  Their problem is not so much with the restriction of funding to ESC lines created from "leftover" embryos as I thought it would be.  Their focus is on the retroactive nature of the new guidelines.  For now.