Stem Cell Decision Could Have Broader Reach

Some biomedical research watchers are feeling blindsided by a federal appeals court decision last week that reversed a lower court’s rejection of a lawsuit challenging the Obama Administration’s stem cell policy.

by Jocelyn Kaiser on June 29, 2010

The decision could have implications far beyond stem cell research. It seems to invite disgruntled scientists whose proposals to the National Institutes of Health aren’t funded to argue in court that NIH is at fault for funding a new research area.

The suit was filed last August by Christian groups that argued that NIH’s stem cell guidelines violate a federal ban on using federal funds to create or destroy human embryos. A U.S. District Court rejected the suit for several reasons, including that none of the plaintiffs had legal standing to sue. But on Friday, the U.S. Court of Appeals in Washington, D.C., found (pdf) that two doctors on the suit do have standing.

The doctors, who include James Sherley, an adult stem cell researcher at the Boston Biomedical Research Institute, had argued that by opening up federal funding for research on human embryonic stem cells (ESCs), the NIH guidelines made them less likely to win funding to study adult stem cells (ACSs). The court agreed:

Because the Guidelines have intensified the competition for a share in a fixed amount of money, the plaintiffs will have to invest more time and resources to craft a successful grant application. That is an actual, here-and-now injury.

The Doctors will suffer an additional injury whenever a project involving ESCs receives funding that, but for the broadened eligibility in the Guidelines, would have gone to fund a project of theirs. They are more likely to lose funding to projects involving ESCs than are researchers who do not work with stem cells because ASCs and ESCs are substitutes in some uses. The Doctors illustrated this point in a post-argument letter in which they report Dr. Sherley recently submitted a grant for a project in which ASCs will be used to create a surrogate for a human liver and suggest his “chief competitor” will be a company that “engages in similar research using [ESCs].” Although no one can say exactly how likely the Doctors are to lose funding to projects involving ESCs, having been put into competition with those projects, the Doctors face a substantial enough probability to deem the injury to them imminent.

The decision “seems to challenge core principles of priority setting, funds allocation, and competition” at NIH, says Anthony Mazzaschi of the Association of American Medical Colleges in Washington, D.C. That is, if NIH expands funding for any new research area, or creates a new type of grant program, a researcher could claim the agency is taking money away from his or her related area, Mazzaschi suggests. But he’s not sure if the court’s reasoning would have weight in cases involving projects other than stem cells.

The suit now goes back to the lower court, which must reconsider its rejection of the plaintiffs’ request for a motion to block federal funding of ESC research. The federal government seems ready to counter the appeals court’s reasoning. In a response to Friday’s decision, NIH spokesperson John Burklow said NIH doesn’t set aside fixed amounts of money for studying adult or embryonic stem cells, but instead makes award decisions based on scientific merit and relevance to NIH’s priorities. “As a result, adult and [ESCs] projects are not in direct competition for funding,” Burklow said in a statement.

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