Embryonic Stem Cell Advocates Protest NIH Guidelines

The Washington Post, May 25, 2009

In a strong sign of discontent, contrasting sharply with the enthusiasm that accompanied President Obama's putative reversal of embryonic stem cell federal funding restrictions earlier this year, embryonic stem cell scientists have now concluded that Obama's new policy would have the opposite effect and would instead impose new restrictions.

At the crux of the argument is the new set of guidelines proposed by the National Institutes of Health which would render ineligible for federal funding most of the current embryonic stem cell research that is already in progress and which is already receiving either federal or private funding. Contrary to popular misconception, the Bush administration did not forbid embryonic stem cell research altogether, and embryonic stem cell research has been alive and well throughout the U.S. for years, even predating the Bush administration. Now, however, under the Obama administration, the anticipated increase in the number of embryonic stem cell lines that would be eligible for federal funding is now instead jeopardized by new NIH guidelines which would actually decrease the number of eligible embryonic stem cell lines, thereby having the exact opposite effect of that which embryonic stem cell scientists had expected. In fact, under the new NIH guidelines, most of the embryonic stem cell research which is currently already in progress would suddenly be rendered ineligible and would have to be shut down.

According to Amy Comstock Rick, chief executive of the Coalition for the Advancement of Medical Research, "We're very concerned. If they don't change this, very little current research would be eligible. It's a huge issue." As Dr. Lawrence Goldstein, director of the stem cell program at the University of California at San Diego, adds, "It's not that past practices were shoddy. But they don't necessarily meet every letter of the new guidelines moving forward. We'd have to throw everything out and start all over again."

One particularly contentious point in the new NIH guidelines pertains to issues of informed consent. Couples who donate their embryos for research would now be required to sign a consent form acknowledging that they were fully informed of other options, such as the possibility of donating their embryos to other couples for the purpose of allowing the embryos to grow and be born as children. Currently, not all IVF (in vitro fertilization) clinics present such options to couples, and those clinics which do discuss such options with their clients do not always have the information specified in writing.

As Dr. George Daley of the Harvard Stem Cell Institute explains, "They take 2009 standards and attempt to apply them retroactively, which isn't really a standard that would allow most of the preexisting lines to be acceptable for NIH funding. This is essentially moving the goal post."

According to Dr. Patrick Taylor, deputy counsel of Children's Hospital in Boston, whose critique of the proposed NIH guidelines appeared last month in the journal Cell Stem Cell, "If applied retroactively, the proposed guidelines would render ineligible most stem cell lines."

Raynard Kington, acting director of the NIH, declined further comment other than to state, "We know issues like this, among many issues, have been raised, and we will take them into consideration."

NIH published their first proposed draft of the new guidelines on April 17. The final version is expected to be released by July 7.

(Please see the following related news articles on this website: "NIH Issues Guidelines Restricting Embryonic Stem Cell Research", dated April 17, 2009; "Members of The President's Council on Bioethics Object to Obama's Stem Cell Policy", dated March 26, 2009; "A High-Profile Proponent of Embryonic Stem Cell Research Sharply Criticizes Obama's Policy", dated March 13, 2009; "Obama Signs Law Restricting Federal Funding of Embryonic Stem Cell Research", dated March 11, 2009; "Obama Rescinds Bush-Era Executive Order Pushing for More Ethical Stem Cell Research", dated March 10, 2009; "Obama Decrees Changes in Embryonic Stem Cell Research, Though Not What One Might Expect", dated March 9, 2009; and "Former Director of N.I.H. Explains Why Embryonic Stem Cells are Obsolete", dated March 4, 2009).