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LIFE SCIENCES

If You Can’t Win on the Science, Take ‘Em to Court

Embryonic Stem Cell Ruling Threatens Key Federal Research

Bush at NIH President Bush looks through a microscope during a tour of the National Institutes of Health campus in Bethesda Maryland in 2003. On Monday, August 23, 2010, a federal judge placed an injunction on use of NIH grant money for research into potentially life saving therapies using existing lines of embryonic stem cells, a practice that has been sanctioned without issue by the Clinton, Bush, and Obama administrations.

Imagine a bizzaro universe in which Bush administration officials have to explain why they were so intent on paying for human embryonic stem cell research that they violated federal law to do it. In that same alternate reality, a court rules that none of the embryonic cell lines used by medical scientists for 10 years could continue to be applied to important research.

If your credulity hasn’t already been strained to the breaking point, now imagine that you’re a scientist who went to his or her lab this morning not knowing if you could continue your work on, say, Alzheimer’s disease, Parkinson’s or diabetes, work that was funded by the National Institutes of Health months ago that you were doing just yesterday. These are all plausible inferences that could be drawn from a United States District Court judge’s August 23 decision.

Welcome to the real world.

Judge Royce Lamberth issued a preliminary injunction that stops funding for human embryonic stem cell research because, he said, the plaintiffs are likely to succeed when their complaint has a full hearing and they would be irreparably harmed if the funding were to continue in the meantime. Why did the judge reason that this attempt to stop the research would likely succeed?  Mainly because he agrees that the federal funding violates the 1995 Dickey-Wicker amendment to the National Institutes of Health budget, which prohibits the federal government from paying for research that destroys human embryos.

Yet the Clinton, Bush, and Obama administrations all agreed that federal funds can be used to support research on cells that are laboratory-grown descendents of human embryo cells since that research is on cultured cells, not on embryos, and because the federal funds were not used to conduct research on, much less harm, any embryos themselves. No one during the Bush administration, which was not terribly friendly to embryonic stem cell research, objected to this interpretation of the law.

The Department of Justice has yet to interpret fully the judge’s decision, but one reading of the injunction is that the clock on federal stem cell policy is turned back to 2000. Even research on stem cell lines still in use that were approved for research by the Bush administration would have to stop.

Moreover, Judge Lamberth’s decision reveals a stunning disregard for the precedents he is compelled to follow. Under the Supreme Court’s landmark decision in Chevron v. NRDC, a judge must apply a high degree of deference to an agency’s reading of a statute unless the statute’s words are completely unambiguous. So, in refusing to defer to three administrations’ interpretation of the law, Judge Lamberth effectively concluded that all three of them don’t know how to read.

Simply put, it’s far more likely that a single trial judge misread the law than it is that three ideologically diverse administrations all made the same blatant mistake.

Even the application of the Dickey-Wicker amendment to embryonic stem cell research that the court relies on is forced. When Congress passed Dickey-Wicker in 1995 it could not have been thinking about human embryonic stem cell research, which didn’t start until a breakthrough at the University of Wisconsin in 1998. Rather, the amendment was created out of concern for using whole embryos in research, perhaps even creating them for that purpose. Congress wasn’t thinking one way or another about work on cell lines descended from embryos long ago. But now the judge is telling us that the law applies to a condition that could not have been part of congressional intent and is logically distinct from its object.

And the very legal standing that allowed the complainants to get into the court in the first place makes little sense. The plaintiffs include scientists who do research on adult stem cells. They claim they are harmed by the current funding policy because of unfair competition with embryonic stem cell research. But there is no cap on stem cell funding. The NIH will give grants based on the quality of the proposed work, not on the materials to be used.

In fact, adult stem cell research has received three times as much funding as embryonic. Over the past decade funding for adult stem cells has increased, not declined, and it has done so partly because of the greater understanding of stem cell biology gained from work with embryonic stem cells. Where’s the harm to the scientists who work on the adult cells? If their argument prevails they will have used to the courts to elbow out their scientific competition!

The scientists who in good faith have been working on NIH funding for the embryonic stem cell work are the ones who could suffer irreparable harm. More important, so could the rest of us. What the opposition to this legitimate and globalized field has been unable to do through science and the ballot box they are trying to do through the courts.  Let us hope they have only been able to delude a single poorly informed judge.

Update 8-25-10: NIH director Francis Collins has announced that, in light of the court’s preliminary injunction, 50 new grant applications will be withdrawn from scheduled peer review and 12 grants worth an estimated $15 million to $20 million that have already gone through initial review will be stopped.  Another 22 grants totaling $54 million that already are under way and scheduled for annual review in September will be stopped.

As Dr. Collins told reporters: “This will mean very promising research will not get done, screening for new drugs will stop, and researchers who have been energized will likely grow discouraged and move to other countries or on to other research.”

So much for the plaintiffs’ contribution to American science.

Jonathan D. Moreno, Ph.D., is the David and Lyn Silfen University Professor of Ethics and Professor of Medical Ethics and of the History and Sociology of Science at the University of Pennsylvania, and the Editor-in-Chief of Science Progress.

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