This Again?

Just when you thought the question of federal funding for embryonic-stem-cell (ESC) research had been settled, along comes a shocking decision by Royce Lamberth, chief judge of the Federal District Court for the District of Columbia, to remind you it's not. In August, Judge Lamberth made a decision that halted all federally funded ESC research. The decision was made in favor of the plaintiffs, Drs. James Sherley and Theresa Deisher, in their second attempt to sue the US Department of Health and Human Services (HHS), HHS Secretary Kathleen Sebelius, and the National Institutes of Health. The plaintiffs, who work exclusively with adult stem cells, allege that "obtaining NIH funding is necessary for their continued research," wrote Judge Lamberth in his decision. The judge goes on to say that, "allowing federal funding of ESC research ... increases competition for NIH's limited resources," and that such increased competition "is an actual, imminent injury." Later in the decision, Judge Lamberth writes, "the Guidelines [allowing federal funding for ESC research] threaten the very livelihood of plaintiffs, Drs. Sherley and Deisher."

Michelle Hoffman

The plaintiffs filed a similar suit last year along with a list of other plaintiffs that included "embryos," and were denied standing. Acting as the only plaintiffs, Drs. Sherley and Deisher appealed that decision and were granted standing earlier this year. Writing the opinion for that appeal, Circuit Judge Ginsburg of the United States District Court for the District of Columbia said that permitting federal funding for ESC research so intensified competition for grants that the plaintiffs "will have to invest more time and resources to craft a successful grant application. That is an actual, here-and-now injury." Judge Ginsburg continues with, "The Doctors will suffer an additional injury whenever a project involving ESCs receives funding that, but for the broadened eligibility in the [federal funding] Guidelines, would have gone to fund a project of theirs."

In all likelihood, the plaintiffs are using the "competition" argument to put an end to a technology they oppose on moral and/or religious grounds. A flyer promoting an April presentation at the Massachusetts Institute of Technology by Dr. Sherley identifies him as an "outspoken critic of human embryonic stem cell research" because it promotes "the destruction of innocent human beings." And the website for AVM Biotechnology, for which Dr. Deisher is listed as "Managing Member and Research and Development Director," advertises its work on "adult and other morally acceptable stem cell therapies" as part of its program to deliver "effective and affordable prolife therapeutics."

At the moment, the injunction has been temporally lifted pending further legal action. Nevertheless, the opinion itself, not to mention the on-again, off-again support for ESC research, will undoubtedly have a chilling effect on the future of ESC research in particular, but may also have implications for grant funding in general.

By virtue of this decision, the courts seem to be setting a precedent for any researcher in any field to quash competition and improve their own chances of being funded.

It is discouraging to think we will be perpetually stuck in an argument over ESC research, and it would behoove us to have a national discussion to decide once and for all whether we'll fund the research. It is disgraceful that a specious argument intended to stifle one field of scientific inquiry could potentially stymie any legitimate scientific pursuit, and it defies reason that our legal system could defend such an argument and fail to recognize the broader consequences.

Science is a competition of ideas, with newer ones supplanting the old. Public funds to support research are limited, and our system—although not perfect—is meant to reward the best ideas with the most funding. Hopefully, the courts will permanently reverse this decision. Hopefully, too, we'll find a better way to negotiate the difficult moral issues inevitably raised by our scientific advancements without threatening the entire system that generates them.

Michelle Hoffman is editor-in-chief of Pharmaceutical Technology.

Comment from Reader

Dear Ms. Hoffman,

After reading your "From the Editor" article in the October 2010 issuetitled "This Again?" it's clear that the editor-in-chief of a majorpharmaceutical publication such as this has ventured off of science andinto the political world without knowing the facts. To make thestatement that "in all likelihood" the plaintiffs are using thecompetition argument when they really have moral and/or religiousobjections to embryonic stem cell research is speculative at best andexposes your position. It is very possible and likely that they dohave moral objections, but to say that their competition argument isunfounded shows that you don't understand how competitive it is forfunding. Funding dollars are not unlimited and to blindly head down apath that has shown absolutely no success in any area of treatment isirresponsible and foolish. Stem cell therapy has been tremendous fromsources that make sense, those that are not a risk of rejection andtumor growth. To starve this area of funding and put it toward ESCslows down the rate at which we can legitimately help people who arehurting and dying while we play politics with an unfounded field. Don't you get it that ESC is being pushed not for real science but forpolitics and to devalue human life at all stages. You cannot use ESC'swithout cloning someone and quite frankly, President Bush's originalfunding limit forced our scientists to find an ethical way to generateESC's which has been done by inducing skin cells into pluripotentcells. These cells have not shown rejection issues like ESC's and haveshown promise in therapies. Finally, your statements put women at riskin search of eggs that scientists will need for research. Collegestudents, poor women, lured by dollars, will be put through anextremely dangerous procedure in the name of science when it isabsolutely unnecessary. Please look into this topic closer and I thinkyou will recognize that we are fortunate so many people are objectingto this research for legitimate reasons.

Sincerely,Doug LuggeMillstadt, IL

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