By Robert Klitzman, M.D. & Ross Frommer, J.D.
The U.S. District Court's injunction on August 23, 2010 against President Obama's Executive Order expanding the use of federal funds for stem cell research sets back research that can potentially help millions of Americans and sets dangerous precedents that -- despite recent discussion about this ruling -- have still received little attention.
In brief, this decision turns the clock back to the time before President Bush's 2001 partial moratorium on this research. Specifically, the decision argues that the intent of Congress in the Dickey-Wicker Amendment of 1996 was to ban federal funds for any research that involved the creation or destruction of human embryos -- even if these funds were used not for the creation of such stem cells, but to study them afterwards.
But President Bush interpreted this amendment to mean that federal funds could be used for research on such lines that were developed prior to 2001. Congress has had nine years, during four of which Republicans controlled both Houses of Congress, to clarify if its intent was otherwise -- to ban funding of research on lines that were created using non-federal funds. But Congress allowed Bush to permit funding for these 21 lines, and has not reversed its decision.
President Obama interpreted the Dickey-Wicker Amendment the same way as did President Bush, and as had President Clinton. The President now simply permits federal funding for research on more cell lines that have been created in the interim using non-federal funds.
But the Court placed an injunction on such funding, arguing that that was not Congress' intent -- even though the fact that Congress has allowed Bush's funding to go forward all these years suggests otherwise.
The court argues that the public interest is only served by obeying what the court interprets to be the will of the Congress. We would argue that the public interest is also served by allowing research to proceed that can potentially benefit millions of people.
The main plaintiffs, two Adult Stem Cell (ASC) researchers, argue that they are harmed because they must compete for funds against HESC researchers. The existence of such harm is necessary for the court to mandate an injunction against funding. But the court's argument is also flawed and misleading, since the NIH awards grants based on the individual merit of each application -- each independently evaluated. There is no evidence that these plaintiffs in fact receive less funding as a result of the NIH also funding HESC. Additional monies that NIH may devote to ESCs would not necessarily go instead to ASCs. Adult stem cell research still gets funded, and in fact, the bulk of the funds still go to ASC. Under the Court's ruling, the plaintiffs' are not guaranteed funding. Their odds might increase slightly, but that is highly speculative.
Moreover, the court's reasoning is wrong, since there is no right to federal grant money. Following the court's argument, any time a scientist feels that a federal agency policy lowers her chances of getting a grant, she can sue. If the NIH decides to focus on one strain of a virus instead of another -- because the agency thinks the first strain is more virulent -- can every researcher studying the second strain sue? This could lead to widespread confusion and inefficient expenditures of money.
The court's decision states, too, that "Other scientists... believe that research should be conducted only on ASCs and IPSCs [Induced pluripotent stem cells] because ESC research has not produced positive results." That statement is also misleading since ASCs are limited because they are multipotent but not totipotent - they can form some, but by no means all of the different kinds of cells in the body. ESCs can potentially form all types of cells in the body. IPSCs can produce more types of cells than ASCs, but to date have not produced any effective treatments. The fact is that IPSC and ESC research are both in their infancy -- neither has yet led to effective treatments, in part because of limitations in government support.
The court believes that the benefit of ESC research is speculative, whereas the harm to the ASC researchers is real -- also a wholly unsupported, and unsupportable notion.
The Justice Department has decided to appeal this decision, which will hopefully then be reversed. Dr. Francis Collins, the Director of the NIH, has told scientists who now receive funds that they can continue their research. But the decision nonetheless causes widespread confusion. Will there be new grants? Should researchers think of switching to other projects instead that may not yield as beneficial results? This decision could create chaos in the research community, delaying progress, and ultimately hurting patients.
The court has unfortunately entered into scientific areas in which it has no expertise; and appears to reflect ideological bias over scientific facts, favoring the Christian Medical Association which initiated this legal blockage. As midterm elections approach, this decision reminds us of the Religious Right's continuing strength and growth. Yet this decision, and its supporters, have utterly ignored the harms they may now causes millions of Americans who might otherwise benefit from stem cell treatments.
Robert Klitzman, M.D., directs the Masters of Bioethics Program at Columbia University
Ross Frommer, J.D., is the Deputy Vice President and Associate Dean for Government & Community Affairs at Columbia University Medical Center
Follow Robert Klitzman, M.D. on Twitter: www.twitter.com/cubioethics