Stem Cells: A Promise Deferred? - Pharmaceutical Executive


Stem Cells: A Promise Deferred?

Pharmaceutical Executive

Politics and perceptions

Even if stem cell therapies turn out to be as successful as, for example, the monoclonal antibodies have been, there will continue to be societal and political headwinds. It's notable that every stem cell executive interviewed for this article sought to distance his company from the traditional means of stem cell derivation, which by necessity destroys a human embryo. Questions of when precisely life begins, and the implications of that largely subjective determination, are far beyond the scope of this article. It is important, however, to understand the complexities of the current political landscape with respect to funding stem cell research, and how companies working in the space have managed to innovate around the most controversial practices.

Roughly 64 percent of Americans support federal funding of stem cell research, according to data presented at the aforementioned BIO panel. Sensing this majority sentiment, President Obama, during his first 100 days in office, repealed former President Bush's executive order which limited NIH funding of hESC research to cell lines already in existence, of which there were approximately 60. As a result, "the federal government removed itself from the marketplace for innovation on hESC because its money couldn't be used," according to Jennifer Geetter, partner at the law firm McDermott Will & Emery. "The second impact was that if the existing stem cell lines weren't adequate from a quantity or quality perspective, [researchers] were frozen in what they could do, if they rely on federal funds to do it."

With Obama's repeal of the Bush order, NIH was allowed to develop its own guidelines on funding hESC research, which involved an interpretation of the Dickey-Wicker amendment, the latter of which was signed into law in 1995 by Bill Clinton, three years before James Thomson, of the University of Wisconsin, successfully derived the first hESC. The Dickey-Wicker amendment states that no federal funds be made available for "the creation of a human embryo or embryos for research purposes," or "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero" under the Public Health Service Act.

NIH produced guidelines, which allowed for funding of research on hESC, so long as the scope of the specific research program didn't involve creating an embryo or destroying an embryo, even if researchers did indeed use cell lines derived from newly created embryos, or destroyed them as part of the derivation process. This reading of the Dickey-Wicker amendment was challenged in court, and even after two appellate courts considered the matter, first in 2011 and most recently in August of this year, the NIH guidelines continue to stand, for now.

How important is government's preclinical research funding on hESC? "Since there isn't a whole hell of a lot of private activity in the stem cell area, it's crucial," says Hank Greely, a professor of law and genetics and director of Stanford University's Center for Law and the Biosciences. "If stem cells are ever going to make a significant medical contribution through the biotech or associated industries, there has to be some sustainable source of funding for the kinds of basic research that is going on now."


blog comments powered by Disqus

Source: Pharmaceutical Executive,
Click here