Feature - Future of Stem Cell Research

The recent injunction against using federal dollars for research involving human embryonic stem cells (hESCs) threatens once again to disrupt progress in a promising biomedical field. This time, the ban could be much more sweeping than that imposed during the Bush Administration. The federal judge made the ruling on August 23, 2010, based on a strict interpretation of the 1996 Dickey-Wicker Amendment, which prohibits the use of federal money for the destruction of human embryos. A previous case was thrown out of court because the plaintiffs lacked legal standing, or a valid interest in the outcome. But two scientists who work on adult stem cells brought forth the new case, arguing that hESC research jeopardizes their own projects.

A few weeks after the original ruling, a temporary lifting of the ban allowed the National Institutes of Health (NIH) to administer funds that were already earmarked. Scientists though, remain apprehensive about future federal support for hESC research.

To learn about how these legal decisions may affect the future of stem cell research, Focus spoke with three BWF awardees: David Scadden, co-director of the Harvard Stem Cell Institute and director of the Massachusetts General Hospital Center for Regenerative Medicine; George Daley, director of the Stem Cell Transplantation Program at Children’s Hospital Boston; and Nicholas Gaiano, associate professor of neurology, neuroscience and oncology at Johns Hopkins University.
 
What was your reaction to the legal injunction?
 
DS: Deflation. It’s just so depressing to go through this again. There was tremendous enthusiasm and optimism when Obama took office. His comment in the inaugural address that he would restore science to its rightful place was met with rousing cheers. The latest action frankly took me and a lot of other people in the field by surprise. There is this sense that [hESC research] could very well come to a halt.
 
NG: The idea that work involving adult stem cells is harmed by the distribution of resources going to hESC is fundamentally flawed. There are limited resources and competition for money, but it doesn’t mean that when one person receives money, another person can claim they’ve been harmed. The fact is, prioritization decisions are made all the time by review panels, program officers and journal editors. The nature of the case brought to court struck me as ill-conceived.
 
How will the legal injunction impact the daily functioning of labs?
 
DS: As someone with leadership responsibility for many different laboratories working on hESCs, it was a shock to the system. People previously used to the rules of the Bush Administration raised funds to purchase equipment and pay salaries—all with money other than federal dollars. It was a tremendously time-consuming enterprise. Equipment that could not be used with federal funds was marked with a green label. We ceremoniously removed the labels when that time had passed and we could now proceed on the basis of the science alone. Now we’ll have to re-engage the dual accounting systems. I’m very concerned about what could be the consequences of this over the long term. We’ll redouble our efforts to raise funds so that science can go forward if the federal government again is out of the picture.
 
GD: We interpreted the decision very personally and immediately stopped using our federal grants to buy reagents or do any experiments with hESCs. We transferred salaries to private funds. A few scientists who were 100% supported by federal training grants stopped working on hESCs. It was very disruptive.
 
What will be the impact on future generations of stem cell researchers?
 
DS: The biggest issue is that it says to young people that this field will continue to be a political ping-pong ball. That of course is not a very pleasant way for people to consider their future. It’s just like uncertainty in the business community, which is frequently used as reason for lack of investment. Similarly, people aren’t going to invest their careers in an area where there’s so much uncertainty. It also does tremendous damage to the image of the United States as a leader in innovative science in this area.
 
GD: It’s unfortunate that some scientists have decided to go in a different direction. Uncertainty changes people’s motivation. I’m concerned that without an unambiguous new law from Congress, [hESC research] will continue to be a political football. This will drive scientists out of the field, to the detriment of stem cell research in general.
 
What role should philanthropic organizations play in supporting stem cell research?
 
DS: For laboratories to continue work in this particular area and areas of high innovation, it’s necessary to raise money from foundations or philanthropic organizations because they offer more flexible dollars and they’re more willing to tolerate risk. We estimate that we’ll have to raise millions of dollars a year to pick up where the federal government is pulling back.
 
This is the kind of thing that points to the essential nature of foundation funding. We have a national interest in moving the best science forward, and foundations can do that, independent of politics. Foundations like BWF have made it possible to really push the envelope. They play a central role in advancing a field. Moments like this are times when foundations can have the greatest impact, and I hope they’ll step into the breach.
 
GD: I’ve been incredibly fortunate to have been funded by BWF when the Bush policy was in effect. There were a lot of limitations on the kind of work we were doing. We were deriving new stem cell lines and asking very basic questions about how to make patient-specific cells. Having BWF funding gave me flexibility and a cushion so that I could do work that wouldn’t be fundable by the federal government. That kind of flexibility is enormously valuable for building a creative research endeavor. I owe an enormous debt of gratitude to BWF for investing in me regardless of the limitations we had from the federal policy. I can’t tell you how valuable that has been to have that kind of extra funding that allows me to take risks and do bold and translational work when the federal budget has been flat and the government’s policies for stem cell research have been restrictive.
 
Foundations like BWF are always central to extending and leveraging the kind of research opportunities that NIH won’t fund. They fund projects that might be more translational than typically seen under NIH. They tend to invest in people’s whole programs through career development, whereas NIH is very project-focused. They tend to fund programs, people and risky projects that are potentially high-impact, less conservative, and more essential in fields that are restricted or underappreciated, like hESC research.
 
What are your personal views on the ethics of hESC research?
 
DS: As a physician, I’m certainly very attuned to how our research is directed to relieving human misery. I view embryonic stem cells as having some potential to do that. Given that the cells are derived from the excess of in-vitro fertilization efforts, and that this material would otherwise go into the incinerator, I actually feel that I have a moral compulsion to try to use it in some productive way. Biomedical research has the potential to affect otherwise intractable conditions that steal dignity from people suffering with diseases every day. For me, it’s a clear ethical choice.
 
Will scientists adjust their research plans in light of the recent legal battle?
 
NG: I haven’t heard people talk about shifting the focus of their research. There’s a certain sense of uncertainty, but I get the sense that people would rather seek funds from other sources than drop the research. But I know several people who stared at the prospect of stopping short because a brick wall was erected in front of them.
 
GD: We’re going to continue to do the experiments, but we’re going to reapportion funding so that we’re not so vulnerable. I’m very reluctant to write hESC research into the NIH grant I’m doing right now. Where ES work is required, I’m making it very clear that the grant is not dependent on the federal policy. Clearly, once again, it’s a real problem because the amount of private philanthropic foundation dollars has dropped in the last couple of years as the economy has suffered.
 
What does the future hold for hESC research?
 
DS: It’s entirely dependent on whether the court interprets the Dickey-Wicker Amendment as something that should preclude federal funding for not just the derivation of stem cells, but also for the use of any product of any stem cell line. The alternative would be legislative action that would essentially change the language of the amendment. But given the current turmoil in the political scene, it’s unlikely there will be an appetite for people to do that.
 
NG: I personally would not count on federal funding as a source of money for hESC research. It’s not wise to anticipate continuing projects based on money from the federal government for this kind of work. The pendulum is swinging to the right, and Democrats are clearly losing ground. I’m just worried about the direction of politics in this country. There’s no reason to think that that direction is going to be any more supportive of stem cell research than it is right now, and it’s already slipping backwards.

--Interviews conducted by Janelle Weaver, a freelance science journalist.