Upsetting the stem cell applecart

Michael Cook
26 August 2010
Reproduced with Permission

The most positive development in American stem cell research in recent months may have occurred in a courtroom rather than in a laboratory. Earlier this week, US District Judge Royce Lamberth granted an injunction banning Federal funding for the research. He found that a lawsuit brought by two researchers would probably succeed in the courts. This overturns not only President Barack Obama's guidelines for research on embryonic stem cells, but also President George W. Bush's more restrictive ones.

The Department of Justice has announced that it will appeal the decision.

The news has appalled supporters. A New York Times editorial described the injunction as "a huge overreach" of judicial power which would be "a serious blow to medical research" if it succeeds.

The head of the National Institutes of Health, Francis S. Collins, said that it pours sand in the engine of medical progress: "This decision has the potential to do serious harm to one of the most promising areas of biomedical research".

The NIH has already declared that 50 pending requests for new funding will not be considered. About a dozen other requests for US$15 million to $20 million which were likely to be approved have been frozen, Collins said. Another 22 grants of about $54 million which are due for renewal in September will be cut off.

The decision was politically inspired, critics said. Jonathan Moreno, a University of Pennsylvania bioethicist with close ties to the Obama Adminstration commented disgustedly that "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." And a founding member of the International Society for Stem Cell Research, David J. Anderson, of Cal Tech, said that "The cynicism of the religious right's latest attack on science is absolutely breathtaking."

Slate columnist William Saletan was so disconsolate that he moaned: "I never thought I'd say this, but I'm starting to miss George W. Bush."

In fact, the the lawsuit was not the handiwork of a well-funded organisation but basically of two researchers who work exclusively on adult stem cells, which do not involve the destruction of embryos. James L. Sherley, a biological engineer at Boston Biomedical Research Institute, and Theresa Deisher, of Ave Maria Biotechnology Company contend that the Dickey-Wicker Amendment, which was first passed in 1996 and has been renewed every year since as a rider to appropriations bills for the Department of Health and Human Services, explicitly forbids funding for hESC research.

President Bush and President Obama differed on their views on the destruction of human embryos for research. But they did agree that destroying them and using the by-products were two entirely different issues. All subsequent regulation has rested upon that assumption. No Federal funding has ever been made available for the destruction of embryos, but work on embryonic stem cells was supported by both presidents, albeit to different extents.

But Judge Lamberth firmly declared that this assumption is wrong.

Despite defendants' attempt to separate the derivation of ESCs from research on the ESCs, the two cannot be separated. Derivation of ESCs from an embryo is an integral step in conducting ESC research... If one step or "piece of research" of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment.

True, Federal agencies and two Presidents have been interpreting the Amendment differently for at least a decade, but Judge Lamberth says that this is clearly mistaken: "as demonstrated by the plain language of the statute, the unambiguous intent of Congress is to prohibit the expenditure of federal funds on 'research in which a human embryo or embryos are destroyed'".

Americans are more accustomed to complaining about judicial creativity than about black letter conservativism. The outcome of the last intervention of a judge in American social policy was the legalisation of same-sex marriage in California. Judge Vaughn Walker rewrote the state's constitution to accommodate evolving social mores. But Judge Lamberth is simply saying that Federal law should be applied as Congress wrote it.

This view also makes excellent moral sense. A No to funding for dicing embryos into parts and a Yes to funding research on the constituent parts is ethically schizophrenic. It's like banning hunting for whales and setting up agencies to regulate the sale of whale meat.

As the Vatican pointed out in 2008 in a discerning document on reproductive technology, Dignitas Personae, scientists cannot build an ethical firewall between how material is obtained and what they do with it. A "person who says that he does not approve of the injustice perpetrated by others, but at the same time accepts for his own work the 'biological material' which the others have obtained by means of that injustice" contradicts himself.

What happens now?

If an appeal fails in the courts, the whole embryonic stem cell debate will go back to Congress. Whether the Obama Administration will have the stomach for leading the charge in a new battle is anyone's guess. With the Democrats facing stiff headwinds as mid-term elections approach, they may want to defer a highly polarizing stem cell debate.

Embryonic stem cell research will not grind to a halt -- it is still being funded by private investors, state governments, and universities -- but it could slow to a very slow walk.

There is a potential winner in this: California, which has hundred of millions of dollars of funding to splurge on researchers based in the state. The president of the California Institute of Regenerative Medicine (CIRM), Alan Trounson, declared somewhat smugly, amidst expostulations of revulsion at the "deplorable" injunction, "This decision leaves CIRM as the most significant source of funding for human embryonic stem cells in the US."

However, a slow-down in hESC research is unlikely to affect the pace of cures.

One reason why the CIRM has so much money and so few research projects is that there have been almost no significant practical advances using hESCs. Geron Corporation has announced that it is on the brink of conducting human trials on patients with spinal cord injury -- but it has been poised to plunge for several years. Maintaining this posture for so long without exciting the scepticism of the New York Times and Slate is one of the few unambiguous miracles that embryonic stem cell research has delivered.

In fact, Slate inopportunely published a lengthy survey of "The Medical Revolution" the day after Judge Lambert published his injunction. "Where are the cures promised by stem cells, gene therapy, and the human genome?" asked Emily Yoffe. She pointed out that embryonic stem cells can be very dangerous and cites the NIH's Francis S. Collins: "I'm very excited for the potential of stem cells" but "We have to be very careful."