Kevin Casey, Associate Vice President for the Office of Government, Community, and Public Affairs at Harvard, takes a moment to reflect on the last seven years of restrictive federal policy in stem cell research, and considers what we might expect as we head into what may be a more favorable political climate.
We are clearly in for a change of political climate. What kind of scenarios do you think could play out at the federal level, say in the first few months after a new administration is sworn in?
It will depend on which of the presidential nominees is elected. Both have supported embryonic stem cell research in terms of their backing favorable legislation in the House and Senate. I am very watchful of where Senator McCain might evolve during the rest of this election cycle. His interests in solidifying his conservative base can create twists and turns that might not be foreseeable. I’m not fully optimistic that a McCain administration would immediately repeal the Bush restrictions. There is also the possibility that IPS [induced pluripotent stem cell] technology could offer a fig leaf for some folks who are inclined to retreat from their earlier positions supporting embryonic stem cell research. They might draw false conclusions that the science makes it no longer necessary to use embryos. I think that an Obama administration might be more inclined to reverse the Bush policies very early on.
There are good indications that the NIH and others are prepared to accept modifications in the Bush restrictions, so the machinations of government appear to be ready to deploy resources, but I’m cautious about forecasting a quick change in this area.
Are there any potential repercussions to watch out for if the current restrictions on stem cell funding are lifted?
Even if both candidates plan to move forward to repeal the Bush administration restrictions, it is possible that they would envelope the research in certain regulations and oversight that inadvertently constrain the progress of the research. That’s what happened recently with the prostem cell legislation in Massachusetts. It didn’t provide direct funding for stem cell research and actually imposed some new regulations on the conduct of the research. For example, there are now restrictions on how you can reimburse women for ova donations, making it difficult to get volunteers, and there’s a prohibition against doing in vitro fertilization for research purposes. The added constraints can be a consequence of the tension that comes into play during the legislative process. We will have to be concerned about what kind of regulations will be put in place if they lift the Bush restrictions.
One of the things that we have learned through this is that micromanagement of research is not done well by legislative bodies. We are much better off in the hands of the National Institutes of Health (NIH) or the National Academy of Sciences (NAS), where there’s a high level of scientific sophistication in managing the conduct of science and recommending oversight and guidelines.
What do you think will happen to the state initiatives when the federal government returns to the role of supporting stem cell research?
That depends on how broadly the federal government lifts the ban. A lot of states have staked some of their economic development in this area. When the federal government relinquished the field, it created a competitive environment for attracting stem cell research and business, with many states hoping to replicate the life science clusters of Massachusetts and California. If the federal government takes away that particular competitive advantage, because it more generally funds all the players, I would not be surprised if some of these states begin to broaden how they apply their funding to the life sciences.
We can assume that changes at the federal level will take a while to play out. In the meantime, it would be productive to establish greater uniformity between the states in how they regulate the research. There is a lot of interest in the Interstate Alliance on Stem Cell Research, which seeks to find a common framework for collaborations, the approval of grant applications and so on. That would all be to the betterment of the science.
How would you assess the damage that may have been caused over the last seven years in terms of brain drain, education and training?
It would be hard for me to cite data, but there's no doubt in my mind that young people have left or avoided the field. The past seven or eight years have made it very difficult to build a career. Your success as an academic researcher in the US is built upon gaining independence through NIH support, but NIH funding has been flat for going on six years now, and overall grant success rates at NIH are at an all-time low. Only about 20% of grants are ultimately funded after several resubmissions, and the average age for a first-time R01 grant recipient is 43. In a field where you're barred from getting federal money, the disincentive for a young investigator to choose that field is even greater. Have we diverted smart people from stem cell research? The anecdotal evidence is yes. A report I released in March 2008, called “A Broken Pipeline?” (see www.brokenpipeline. org) confirms the negative impact that flat NIH funding has had on all areas of the life sciences.
Many who are involved with CIRM [California Institute for Regenerative Medicine] have observed that the training of new researchers had been stunted because of a lack of federal money in the field, and that led to a bidding war for the few remaining scientists when the money started to flow. We can't make a decision to turn the spigot back on without building up the infrastructure – which means training new scientists.
Some areas of science have become greatly politicized over the past 7 years.What can be done to minimize this tendency in the future?
In stem cell research, political constituencies have mischaracterized or obfuscated scientific evidence and questioned the motivation of researchers and institutions. The most recent ballot initiative fight in Missouri is an extreme example where huge amounts of money were spent on advertising which was just as confusing and nasty as you can get, putting into doubt the integrity of the science. At the end of the day it served to only to confuse both supporters and opponents, and nobody can win in that kind of a situation.
Polls have always shown that researchers in academic institutions have very high public standing for independence and credibility. If you start confusing that by suggesting industry and profit motivations are at play, that can be really damaging over time.
So is the best protection against that more information and public education?
I think that it’s really hard to do in the current context. Information sources are much more distributed, and we can’t answer every charge in the blogs. Our experience is that when you bring respected scientists like Kevin Eggan, Doug Melton and David Scadden, or their counterparts from other institutions to the state legislatures and Congress, they have a very positive impact. When the political players have the opportunity to sit down with the human beings who are devoted to this research and convey how important it is, it’s very hard to demonize them. This is true for patients as well. Economic development may be a rationale for legislative action, but the bottom line is that most people support stem cell research because they want to help the patients.