Published online 23 September 2010 | Nature | doi:10.1038/news.2010.485

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Our expert panel examines the recent stem cell injunction from all angles.

The funding fates of hundreds of US scientists were thrown into question last month when a federal district court judge issued an injunction stopping the National Institutes of Health (NIH) from funding human embryonic stem cell research (see Case History). The injunction, temporarily lifted on 9 September after an appeal from the Department of Justice, has raised questions and confusion about what research may or may not be funded while the case is before the Court and what may happen afterwards.

To help shed light on these matters, Nature asked three legal experts to weigh in on the case.

OUR PANEL:

Alta Charo is the Warren P. Knowles Professor of Law & Bioethics at the University of Wisconsin Law School at Madison. She was a member of the NIH Human Embryo Research Panel and the National Bioethics Advisory Commission during the Clinton administration and co-chaired the National Academies' Human Embryonic Stem Cell Research Advisory Committee. She is on leave to serve as a senior adviser at the Food and Drug Administration, but does not work on stem cell-related topics and is not speaking on behalf of the Food and Drug Administration but solely in her academic capacity.

Robert George is the McCormick Professor of Jurisprudence and the Director of the James Madison Program in American Ideals and Institutions at Princeton University in New Jersey. He was a member of the President's Council on Bioethics during the George W. Bush administration and has served on UNESCO's World Commission on the Ethics of Scientific Knowledge and Technology (COMEST).

Patrick Taylor is an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School in Cambridge, Massachusetts. He is also an assistant clinical professor at Harvard Medical School and until recently was Deputy General Counsel and Chief Counsel for Research Affairs at Children's Hospital Boston.

DISCUSSION:

If the district court injunction is upheld as written, and a permanent injunction in the same terms is issued and upheld, will it be the end of all federally funded embryonic stem research in the United States, or will the NIH still be empowered to fund research using the so-called 'Bush lines' approved in 2001?

Charo: Read literally and in the absence of any clarification, the prohibition on funding effectively bars funding for any human embryonic stem cell research, including research using lines approved by President Bush's administration, as those lines are included in the new NIH guidelines and are being reviewed and approved (or not) under these new guidelines. Therefore, the Obama administration's guidelines encompass both the pre-2001 lines (approved by President Bush) and the more recently derived lines.

George: It will end federally funded human embryonic stem cell research authorized under the existing NIH guidelines that have been enjoined by the Court. Should the NIH wish to fund research using the so-called 'Bush lines' (derived from human embryos killed before August 9, 2001), I believe it would be necessary for the NIH to engage in new rule-making activity to authorize funding that has now, in effect, been rescinded by the Obama administration. The question would then be whether the agency action adopting the new (or resurrected) guidelines would be in compliance with the Dickey-Wicker Amendment. That would likely be the subject of new litigation, and I cannot predict the outcome.

Taylor: No, although unless Congress acts it would mean the end of NIH funding for embryonic stem cell research, and arguably some other research, for the duration of this year's budget. The Dickey-Wicker Amendment is not what we might think of as a typical law, permanent or enduring until repealed. It is 'budget language', annually enacted and re-enacted. For this to end all, Dickey-Wicker would have to be re-enacted, and appropriations for stem cell research would have to be limited to an agency to which it applied. For all of its apparent power, this language is not some sort of self-perpetuating stem cell; it is a differentiated and fragile creation, kept alive through regular re-infusions from the peculiar life blood of politics.

As to the Bush lines or others, the Court does not explicitly differentiate them, such as by grandfathering them. That might have protected such research, but the Court did not. Hopefully this will be raised on appeal, together with question about whom the order applies to.

The Bush-line research might still be indirectly protected. The court barred the NIH from "funding" research, a special term applicable to when an agency sends the investigator and institution a notice of award: thereafter, the institution and investigator may spend their own funds, and the government promises to reimburse them. Perhaps ongoing awards may continue, even through renewals that do not require reapplication. At least, as Justice implied, there would be problems with the Court ordering the NIH to take "affirmative steps" to go over such recipients. That is particularly true for awards preceding the guidelines and Executive Order.

Under the circumstances described above, what about research using stem cell lines that were approved after Obama's 2009 executive order?

Charo: The new NIH Guidelines address all lines, regardless of when they were derived.

George: I do not see how these lines could lawfully be used without reauthorization under new NIH guidelines. As these have not yet been proposed, once again I am not in a position to hazard a prediction as to whether they would be held by a court to be in compliance with the Dickey-Wicker Amendment.

Taylor: It is the same analysis as above concerning the ambiguity in "funding" prohibited by the court. However it cannot be argued that the lines are independent of the Court's focus on the Obama Executive Order.

Under the circumstances described above, if the NIH were to approve new stem cell lines between now and when an injunction became permanent, would research on those lines be eligible for federal funding?

Charo: It would depend upon the wording of the permanent injunction. If written to cover "all research" using human embryonic stem cell lines, then — again — the timing of derivation would be irrelevant.

George: No. The problem is that they would have been authorized and funded under NIH guidelines that had been held to be unlawful.

Taylor: Yes, at least until a permanent injunction became and remained in effect, or until the Circuit Court of Appeals for the District of Columbia Circuit dissolved its stay of the preliminary injunction. This depends on specifics of the final order, and this question will surely be addressed. It is possible that, if the Circuit Court were to affirm the District Court, it might do so from the date of the preliminary injunction, and apply it to all lines, if it thought recipients should have understood funds were "at risk", that there is "no harm" and that Dickey-Wicker permits no other option. A court might distinguish previous research from new research, as your question does.

Under the circumstances described above, would the government be able to continue funding human embryonic stem cell work on the NIH campus, since outside researchers, such at the plaintiffs, cannot compete for intramural funding?

Charo: The logic of the plaintiffs' complaint (that they are disadvantaged in competing for extramural grants) would suggest that intramural research could continue. But the District Court's interpretation of the Dickey-Wicker Amendment is not premised on intra- or extramural research settings, but rather on the use of federal funds — which would be the case for both sorts of research.

George: No. This approach could not withstand a legal challenge. The research would be in violation of the plain meaning of the principle and the specific prohibitions in the Dickey-Wicker Amendment.

Taylor: Article III of the US Constitution is explicit on this: the job of the courts is to decide the case or controversy before them, and that's it. A decision limited to extramural research would have shown appropriate respect for the Executive, in the form of Francis Collins, the NIH director, and his various legal advisers. So we must wait and see what the appellate courts do with this.

What if the NIH shovels scads of human embryonic stem cell grant money out the door — far more than it previously planned — while the injunction is lifted and then the injunction is reinstated sometime later? What happens to the money?

Charo: This depends on the wording of the injunction, and whether it applies prospectively only.

George: The NIH needs to be very careful not to engage in dubious conduct of this sort. If the funds granted have not been expended, the NIH will no doubt be ordered to notify grantees that the money must be returned to the NIH for lawful reallocation. If they have already been expended, the grantees themselves would be at risk of incurring liability for expending federal dollars in violation of law.

Taylor: The Circuit Court's stay of the District Court's preliminary injunction means that the District Court's order is of no present effect. If the NIH were to take action perceived by the Circuit Court as abusing the stay (which I think is unlikely), then the Circuit Court might well reconsider its stay. The 'status quo' does not mean the NIH is frozen; ideally, it can adhere to the course it previously charted, independent of the lawsuit. I think it would also be defensible to increase spending, if the purpose and effect were to rectify a harm caused by the district court order, by restoring the previous status quo. A purely hypothetical example might be recreating a frozen stem cell biobank that was destroyed or dispersed due to the inability to fund it before the Circuit Court stay.

The NIH read the district court's preliminary injunction as permitting continued funding of some research that was already under way, such as research for which grantees had already received NIH money. But in seeking a stay of that order, the Justice Department read it as affecting that research as well. Which is correct?

Charo: It is not entirely clear from the wording — which is one of many reasons why clarification is needed.

George: The Department of Justice is correct that the Dickey-Wicker Amendment prohibits the use of federal funds in any research in which embryonic humans are destroyed, discarded, or exposed to risk of injury or harm. All unexpended money involved in such research will have to be returned to the NIH for lawful reallocation, even in cases in which research is currently underway. I am quite confident that the Court will so rule in the event that the NIH attempts to stand by its interpretation of the preliminary injunction (which I predict in the end it will not do).

Taylor: The NIH and the Department of Justice are engaged in two very different tasks. Justice is trying to demonstrate the order's horrible effect, and also to fend off a contempt hearing if the order is misinterpreted. They should be testing the order's outer bounds. The NIH, on the other hand, has the constitutionally grounded job of applying its discretion within areas of ambiguity. It is natural and professionally ethical to take those factors into account. The order is imprecise in many respects, partly because the Court gave unique interpretations to terms of art shaped by practice and regulations, like "research" and "funding". It also mixes a specific focus on the guidelines and Executive Order, with broad language barring any actions related to them which would be unconstitutional if taken literally (for example, the idea that the NIH cannot spend funds to communicate or appeal the decision). If there is a fault, it is the Court's, which has an obligation to be crystal clear.

Judge Royce Lamberth wrote that the Dickey-Wicker Amendment was "unambiguous" in making illegal federal funding for human embryonic stem cell research. By saying so, he implied that the Clinton, Bush and Obama administrations have been wrong to read the law as permitting federal funding for the research. How important will it be in court that successive administrations have in fact funded human embryonic stem cell research for nearly a decade and have not disputed the 1999 interpretation by a Clinton administration lawyer saying that the funding is legally permissible under Dickey-Wicker?

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Charo: Ordinarily agencies are given great deference by the courts with respect to interpretations of the key statutory provisions governing their operation. This would suggest a very high burden on the plaintiffs to show the interpretation is wrong. Not only did multiple administrations — of two different parties and two different general ideologies on reproductive medicine — agree to this interpretation, but Congress itself twice passed human embryonic stem cell funding bills. And there was language in the bills and in the committee reports that indicated the Dickey-Wicker Amendment could continue in force — without any effect on the legality of funding the work on the cell lines.

George: The actual legislative history of Dickey-Wicker strongly favours the plaintiffs, as Judge Lamberth rightly saw. This makes the 'post-enactment' history of interpretation even less important than it usually is — and it usually isn't very important. If someone's 'post-enactment' interpretation is to count at all, it would ordinarily be the interpretation of supporters of the law and the principle it contains at the time of its enactment. In this case, that means it would be the interpretation of those who supported Dickey-Wicker's principle of preventing taxpayer funding of research involving the killing or harming of members of the human species — including those in the embryonic stage of development.

Taylor: I can't predict with certainty how important these facts will be as this moves through the courts, but they ought to be important. The Court had actual knowledge that others had interpreted the language differently, including the agency charged with implementing it; three presidents, who acted transparently in explaining what they were doing and why; and numerous Congresses that not only ratified that interpretation through continuing to fund the NIH without altering Dickey-Wicker, but who oversaw the actual expenditures for that purpose.

And then there is the most recent Congress, whose intent the court was tasked to discover. It provided more data for the purpose than any previous Congress, because it passed bills to direct the NIH to fund Obama-style stem cell research. Passing them without changing the Dickey-Wicker Amendment to the budget bill suggests Congress thought the provisions were harmonious.

The Court's counterfactual decision rests on a technical rule that allows it to ignore any evidence affecting interpretation if it finds the language of the law to be unambiguous. This case shows that there needs to be an exception to that rule.

What would Congress have to do to craft a bill that would fend off future legal challenges like this? Is the Castle-DeGette bill, as written, adequate to do this? If not, what would be needed to unambiguously address this issue?

Charo: No bill can fend off a future change in the statutes by legislative action. But for the moment, a bill that specifically notes that the Dickey-Wicker Amendment does not apply to cell lines derived from embryos would clarify the situation. That said, it is worth noting that the situation actually isn't unclear, given the consistent view across parties and administrations that Dickey-Wicker does not apply to cell lines derived from embryos.

George: My understanding of the DeGette bill is that it does not eliminate the Dickey-Wicker Amendment. I suspect that those who want to authorize the funding of human embryo–destructive research will ultimately need to do away with Dickey-Wicker in order to get what they want. As I myself strongly favour the Dickey-Wicker principle, I am not eager to advise them as to how to achieve this goal. In any event, the political climate is not favourable right now for the elimination of Dickey-Wicker, and by most accounts the climate is likely to get even less favourable going forward.

Taylor: The safest course at this point, now that the Court has written what it says Dickey Wicker means — unless an appellate court disagrees — is for Congress to unambiguously change the language of Dickey-Wicker, or explicitly supersede it by attaching language to the budget bill along the lines of "notwithstanding Dickey-Wicker, funds made available under this budget shall be available to fund research, approved by the NIH pursuant to such-and-such a process, on stem cell lines derived, in the determination of the Director, consistent with the provisions of this Act."

See our Stem Cell Injunction special section for full coverage of this developing story.