Earlier this month, a federal judge blocked the federal government from funding human embryonic stem cell research, saying to do so would conflict with existing law. As a result, the National Institutes of Health (NIH) and stem cell researchers have had to drastically alter their research plans. For stem cell research, “it’s going to be enormously disruptive to anyone holding NIH money,” believes stem cell researcher George Daley of Harvard University. This is also true for research in Texas and in the Texas Medical Center in Houston.
Judge Royce C. Lamberth’s ruling was the result of a lawsuit challenging the NIH guidelines for human embryonic stem cell research. The new guidelines, released in July 2009, require human embryonic stem cell lines to go through a review process to make sure they followed established ethical and informed consent policies to become eligible for federal funding. Unlike during the George W. Bush administration, the new policy did not set a date deadline for the lines to be created.
The plaintiffs believed the new guidelines were in direct conflict with existing legislation, the Dickey-Wicker Amendment. Described in the October 2009 blog post “Why are we afraid to regulate embryonic research,” the Dickey-Wicker Amendment is an amendment attached to the appropriation bill for the Department of Health and Human Services (which includes NIH). The amendment prohibits the use of federal funds for research in which embryos are “destroyed, discarded or knowingly subjected to risk of injury or death.” This was interpreted by Presidents Clinton, G.W. Bush and Obama to mean that no federal funds could be used to create human embryonic stem cells because to do so would result in the destruction of a 5- to 6-day-old embryo. But federal funding could be allowed to support research using existing lines that were created using private, state or local funding.
The judge issued his ruling based on his determination that the Dickey-Wicker Amendment applied to both the creation and use of human embryonic stem cells. In his ruling, Lamberth stated, “It is not limited to prohibit federal funding of only the ‘piece of research’ in which an embryo is destroyed. Thus, if ESC research is research in which an embryo is destroyed, the Guidelines, by funding ESC research, violate the Dickey-Wicker Amendment.”
The day after Lamberth’s ruling, Francis Collins, the director of NIH, announced that NIH was halting the review of all human embryonic stem cell grants, lines and the renewal of existing grants. Furthermore, any grant that was approved but not yet funded will be halted. Existing grants can continue with this year’s funds, but will not receive annual renewals. In addition, all human embryonic stem cell research conducted within the NIH campus in Bethesda, Md., had to be discontinued, which includes eight projects as well as a unit that characterizes lines for the NIH registry. According to their website, NIH gave out $143 million in 2009 for human embryonic stem cell research out of a $31 billion total budget. It is estimated that $15-20 million of research that was already approved will not be distributed to scientists. Additionally $54 million in grants up for renewal in September are also on hold.
Texas risks losing millions of federal funds per year as well. In 2009, the state received approximately $6.6 million in funding for human embryonic stem cell research from NIH. In addition, there are two cell lines waiting for approval from NIH to become eligible for federal funding.
Government officials plan to appeal the ruling. Hopefully Congress will use this as a reason to update the Dickey-Wicker Amendment and pass legislation formalizing in law the policies President Obama and NIH put into place this past year.
Kirstin Matthews is a fellow in science and technology policy at the Baker Institute. Her research focuses on the intersection between traditional biomedical research and public policy. Matthews’ current projects include the Baker Institute International Stem Cell Policy Program, the Civic Scientist Lecture Series and policy studies in research and development funding, genomics and climate change.