On again, off again, on again…Part 1

This two-part series, a response to the recent appeals court decision lifting an injunction on federal funding of human embryonic stem cell research, was co-authored by M. William Lensch, George Q. Daley, and Leonard Zon of the Stem Cell Research Program at Children’s Hospital Boston.

It came as a welcome relief when on April 29 the U.S. Court of Appeals vacated a lower court’s injunction against federal funding of human embryonic stem cell (hESC) research. For those of us working on research projects involving hESCs, whether funded through the National Institutes of Health (NIH) or other federal agencies, it meant that we are once again free to continue our work … for now.

The “for now” part relates to the fact that the recent ruling is but one chapter in the ongoing story of hESC research funding. The desultory nature of federal funding for hESC research has been a constant source of uncertainty for scientists and the general public alike, and to understand the full story, we need to look back to the mid 1990s, before the derivation of the first hESC lines.

President Clinton sought to create a supportive framework of federal funding for research on human embryos, critical for understanding infertility and birth defects. His efforts were stymied in 1996 by the Dickey-Wicker amendment, an annually reinstated federal appropriations rider prohibiting the Department of Health and Human Services (HHS), and thus the NIH, from funding research in which human embryos are created, destroyed or exposed to the risk of harm or destruction.

In 1998, hESCs were first isolated from embryos discarded from fertility clinics. At that time, the Clinton administration sought an opinion regarding the general fundability of hESC research from counsel at HHS. The so-called Rabb memorandum, released in January 1999, concluded that Dickey-Wicker applied only to research with embryos and not the cell lines generated from them. On again.

Fast-forward to 2001: President George W. Bush initially halted and then permitted narrow funding eligibility for a small number of hESC lines, using a rationale with echoes of the Rabb opinion.

On March 9, 2009, President Obama revoked Bush’s limitations via executive order, and instructed the NIH to invite public opinion prior to crafting a set of eligibility guidelines for hESC research. In these guidelines, which were implemented in July 2009, the Obama administration took the unambiguous position that the U.S. government would not fund the generation of lines of hESCs from human embryos but would fund studies involving already-established hESC lines, provided they first passed muster in an NIH review of their provenance and overall eligibility.

One month later, two researchers of adults stem cells, Drs. James Sherley and Theresa Deisher, and others sued HHS Secretary Kathleen Sebelius and NIH Director Francis Collins. Their assertion: that federal funding of hESC research put them at a competitive disadvantage in obtaining research dollars, and that the government’s efforts to fund hESC research violated Dickey-Wicker.

The Sherley-Deisher case was dismissed in federal district court in October 2009, citing the plaintiffs’ lack of standing. The case was reinstated by the federal court of appeals in mid 2010 and returned to the district court, but with the list of eligible plaintiffs pared down to Sherley and Deisher alone. And on August 23, 2010. Federal Circuit Judge Lamberth imposed an injunction against federal funding of hESC research — the injunction that was just overturned.

The reinstatement and injunction sent shock waves through academic laboratories nationwide, not only those conducting hESC research using federal funds (all of which were forced to stop immediately), but arguably every lab with NIH funding, for reasons we will discuss in our next post.