January 8, 2013

Stem Cell Research Funding Case Rejected by Supreme Court to Hear

Stem Cell.jpgThis Monday, the U.S. Supreme Court announced that it will not review a challenge to federal funding of human embryonic stem-cell research. By rejecting the petition from a pair of scientists opposing such funding, the Court gave the green light for controversial embryo-based studies to move forward.

Scientists James L. Sherley and Theresa Deisher sued the United States Department of Health and Human Services ("HHS") and the National Institutes of Health ("NIH") in 2009, challenging NIH guidelines related to human-stem cell research promulgated pursuant to Executive Order 13,505. E.O. 13,505 was signed by President Barack Obama in March 2009 with the aim "to expand NIH support for the exploration of human stem cell research." The order loosened limitations imposed by the previous administration on the use of federal tax dollars for embryonic stem cell research and overturned an order barring NIH from conducting research on embryonic stem cells beyond the 60 cell lines then in existence. In addition, it directed NIH to review its guidelines regarding stem-cell research.

Sherley and Deisher-both adult stem-cell researchers who do not conduct research on human embryos or embryonic stem cells-challenged the Guidelines on the grounds that: (1) NIH refused to address comments submitted in response to the draft version, in violation of the Administrative Procedure Act and (2) they violate the Dickey-Wicker Amendment. The Dickey-Wicker Amendment is an appropriations rider, included in every HHS appropriations bill since 1996, prohibiting the use of federal funds for "the creation of human embryo or embryos for research purposes" and "research in which human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under [other federal regulations]." The final NIH Guidelines, published on July 7, 2009, authorized federal funding of research using live human embryos that were created "for reproductive purposes" (i.e., in vitro fertilization) but are "no longer needed for [that] purpose."

Guidelines did violate Dickey-Wicker. In April 2011, however, a D.C. Circuit panel vacated the injunction and, on remand, the district court granted summary judgment in favor of HHS and NIH. The Court of Appeals affirmed, deferring to the agencies' interpretation of the law and concluding that there was no obligation to respond to comments that directly opposed the Executive Order. The Supreme Court did not comment on its decision not to hear the appeal.

This decision is welcomed by supporters of the use of embryonic stem cells, which offer significant advantages to researchers studying diseases. Embryonic cells can be grown easily-whereas adult stem cells are difficult to isolate and to multiply-and they are undifferentiated-meaning they can become any cell in the body. According to NIH, "If scientists can reliably direct the differentiation of embryonic stem cells into specific cell types, they may be able to use the resulting, differentiated cells to treat certain diseases in the future." The list includes Parkinson's disease, diabetes, traumatic spinal cord injury, muscular dystrophy, heart disease, and vision and hearing loss. NIH has invested over $500 million in human embryonic stem cell research. If the courts had blocked further funding, many of these projects would have been put on ice. Further, while there is some private money in the field, scientists say that federal funding allows them "greater flexibility to work collaboratively within labs, across labs and around the world on the latest treatments and breakthroughs."