The Business and Politics Behind How Science Gets Done 
by Andrew Kerr
July 2008

Aaron Levine is an Assistant Professor of Public Policy at Georgia Tech. He recently authored a study investigating the proportion of research being conducted in various scientific fields with an emphasis on the state of human embryonic stem cell research. Conventional wisdom would hold that in the United States, where stem cell research is a controversial subject and federal funding has thus been less generous than in some other countries, a smaller proportion of overall research would be dedicated to that field. Mr. Levine's report confirms that conventional wisdom.

You might think of scientists as people hunched over their microscopes, but the quest for funding means that researchers everywhere must also devote much time and energy to raising money to support their labs. And, in the case of stem cell research, scientists must also master the politics and rules which govern their research.

Q - What is the price we pay for not pursuing stem-cell research more aggressively?

There actually is a fair bit of embryonic stem cell research going on in the United States. We are still the single largest producer of research. But compared to other fields the U.S. is in a relatively weaker position.

We don't know for sure where some stem cell research will lead us, but it's a field that a lot of scientists and clinicians think has a lot of potential. We know it has a lot of potential as a research tool. We can learn a lot about developmental biology from studying embryonic stem cells.

There's also a lot of people who believe there really is a lot of potential for cell-based therapies or other approaches to treating disease. This may be particularly true for diseases that aren't well-treated today or for conditions that are hard to treat today. If we decide not to focus on this field, or if other countries focus more on it, then there's the chance that these sorts of advances will happen outside the United States.

Whether or not that matters is an open question. If a cure for diabetes (one thing stem-cells are often suggested as having the potential to treat) was developed in Singapore or the United Kingdom, I think that U.S. patients would have access to it quite efficiently. But from an economic point of view it might not be as advantageous for the United States. Intellectual property would probably be held by scientists in other countries, and there may be delays and insurance issues.

So it's hard to say if choosing not to invest in it is really detrimental to the healthcare enterprise. But one thing we do know from studying the history of scientific research is that the important advances that come out of basic science are really quite unpredictable. We might not get some of those serendipitous breakthroughs that come because you're exploring a new and not very well understood area. The things that may turn out to be the real breakthroughs from embryonic stem-cell-related research may be things that will not be discovered because there are fewer scientists working on them, or things that will be discovered elsewhere because there's not as much of a focus in the United States.

Q - Why do privately-financed scientists have less incentive to share their research findings than, say, your typical university-based researcher?

It depends on where you're working as a privately-financed scientist. In some private firms you are encouraged to publish. But if you're working in a company your long-term goal may be the development of a product. Your short term goal may be acquisition of a patent or intellectual property protection. If you're pursuing intellectual property protection, you might delay publication because publications can hinder your ability to patent your research. You often have to make sure you do things in the appropriate order and file your parent applications before your publications.

Another concern is sort of the opposite of patenting. When you file a patent, the inventor is disclosing their invention in exchange for a time-limited monopoly. So, if you had an invention and you patented it you would be telling the world how to make your invention, but you would have a monopoly over that for a period of time.

The other option is to keep your invention a secret. That's what is known as a "trade secret." Coca-Cola doesn't patent their formula for Coca-Cola because then they would have to disclose what they put into Coca-Cola to make it taste the way that it does.

It's not clear that in science you'd see people moving towards trade secrets. But what you have is less incentive to push your newest and most exciting information out into the public domain. If your ultimate goal was to make a profit, it may be better to hold onto your research for a little while and pursue it while you see if you could get a patent, whereas if you're in an academic setting you're evaluated primarily based on your publications, your contributions to the literature, and so your incentive is to publish as important an article as you can, and also to publish frequently. So the incentives are quite different.

Q - Can we go over some of the sources of funding for science? For example, I hear about "private companies." Is that the same as "corporate" research?

[Private companies] are corporate—typically pharmaceutical firms or biotech companies. There are a number of small biotechnology firms that are pursuing research in this area. And there's a lot of research and development money that comes from pharmaceutical firms from the United States and around the world. So far pharmaceutical firms have not moved too aggressively into embryonic stem cells, in part because embryonic stem cells are a long ways from the clinic. Pharmaceutical companies prefer to see at least early stage clinical trial data so they know where they're likely to get return on that investment. Biotech tends to be funded by venture capital and is more speculative.

But you have a lot of private foundations (the Juvenile Diabetes Research Foundation, the Starr Foundation, the Dolby Foundation, probably several more) that are out there that have contributed sizable chunks of money—in at least the tens of millions in certain cases.

Q - Where do foundations get their money from?

I'm not an expert in non-profits. I think a lot of foundations have large endowments and they're giving out the interest on their endowment funds. Some foundations I believe raise money. Some of the disease advocacy groups may be actively recruiting donors, using money that people actually donate and then distributing it to individual scientists in the form of research grants. The foundations tend to distribute their money around to scientists at academic centers.

Some private companies will fund research that is going on at universities as well. But typically private companies will fund in-house research, which makes it easier to hold on to or keep your knowledge private if you'd like.

Foundations are sort of filling in as a substitute for federal funding—areas where the federal funding is insufficient, or where they think there's really a need for additional funding. You often see foundations having a specific disease advocacy role. For instance, "We think there really should be more effort on juvenile diabetes or more effort on disease X or disease Y," and spending their money in that direction.

There's one case up at Harvard, the Harvard Stem Cell Institute, where they've been getting private donations. People just say, "I'd like to donate money to stem-cell research at Harvard." They've been pretty successful in that regard. It's sort of like a foundation, but it's specifically for stem-cell research at Harvard. They probably have had some pretty big donors, but they claim to have had some success with small donors as well.

Q - The idea of appealing to the public for small donations, perhaps over the internet, reminds me of the success of the web-based campaign fundraising we've seen in this year's presidential race. I suspect we'll see more of that sort of thing in the future.

If you can do it well it can be remarkably powerful.

Q - Massachusetts recently signed into law a bill that will devote a billion dollars to embryonic stem cell research. Articles about that pointedly state that this money is to fill the federal funding shortfall. What are the disadvantages of state funding vs. federal funding?

States have really come through and provided quite a bit of money for this field, led by California (which pledged $3 billion several years ago), Connecticut, and New York now has a program, I believe. Illinois, Maryland, and New Jersey do as well. Scientists are quite happy to have these funding sources.

There are potential downsides, though. There's been some concern that you have different rules in different states. So if you're working in California and you want to collaborate with somebody in New Jersey, is that acceptable, or do you have to have your research approved by regulators in both states and potentially meet different sets of conditions and different sets of rules? So there have been some concerns that a patchwork of policies may make it actually harder to get work done.

Q - Different states playing by different rules hinders the circulation of knowledge.

More the generation of knowledge. If it's important to work on a team or to transfer material from one lab to another, there's some concern that the differences in rules could slow things down. And there are concerns amongst scientists now that they're being overburdened, because one of the key elements of the scientific enterprise in the United States and a lot of other countries is peer evaluation, the idea that grants should be funded based on expert evaluations of which grants really represent the best science. Now, instead of just having the National Institutes of Health [NIH] running a big funding program, we have the California Institute for Regenerative Medicine, the Connecticut Department of Public Health, so on and so forth, for all the other states—not to mention the Juvenile Diabetes Foundation and four or five other foundations. These scientists are starting to feel like they're getting overwhelmed by the number of times they need to review grant applications. Whether that's a serious concern or not is debatable, but the extent that scientists are spending their time reviewing other people's grants instead of doing research can only slow down the actual development and the production of the knowledge.

There's another concern that deals with the duplication of facilities for this research. Funding from the federal government is available for research on human embryonic stem cells, but only for research on embryonic stem cell lines that were derived before August 9, 2001, which was when the president announced his policy. It turns out that it becomes a bit difficult for scientists, particularly at academic centers, if they want to work on newer lines as well. So let's say you're a scientist with access to the approved lines, and you've been doing research on them, perhaps even with federal money, but then you also want to study some newer lines that aren't eligible for federal money. There's been a lot of debate about how you can do that, because you have to be very careful to ensure that none of your federal money goes to that research on new stem cell lines that aren't approved. There's potentially a really big downside for universities for violating these rules. Their NIH grants could be at risk not just for stem cells, but for the much broader research enterprise.

Q - Seems that such a violation of the fed's rules in today's climate, if discovered and made public, could be an utter disaster for a research institution.

Yes. So what people have done has been very conservative for the most part, by creating "clean facilities"—separate labs or often entire buildings that have no federal funding used to support them. But the offshoot is you're spending a lot of money that might support this field on new construction for buildings, new microscopes, and all these things you might not have really needed except that you're trying to draw a clear and bright line between the research you are doing with federal funds and without federal funds. So there's a real risk that having these different rules has added another layer of inefficiency to the system.

Q - Is that a fairly common thing? Are people really building whole duplicate research facilities in order to avoid those issues?

California just awarded a whole bunch of money from their $3 billion initiative to build new facilities; part of the reason was to create this division. I believe Wisconsin has private facilities. I'm pretty sure there are private facilities up in Massachusetts, near Harvard. There are private facilities in New York that are shared by several universities there. It's not happening everywhere, but it's definitely been occurring. No one really knows how the rules are being interpreted, but universities tend to be fairly risk-averse and would rather be cautious than put their federal funding at risk.

Q - Is Georgia Tech doing any stem cell research?

Georgia Tech is doing some research on human embryonic stem cells. I believe all of the research is with the approved lines derived before August 9, 2001, and, thus, eligible for federal funding.

Q - Obviously this is a controversial field, and there are undoubtedly some who would read about these difficulties researchers face and cheer. Libertarians and states-rights proponents might also opine that the funding of such controversial programs would best be left at the local or individual level. What are we losing by seeing a reduced role of the federal government in supporting stem cell research?

It's very important to consider, as you point out, that science does raise a whole range of ethical and social issues. It's very important for society to debate and consider those issues and take those into mind when developing policy. If you pursue that, yes, there's sort of an appealing model where you have different funders, states, foundations, whoever's supportive of the research...there is some appeal to that model.

But when you look back at the history of scientific research in the United States, particularly in the post-World War II era, science has been primarily a federal responsibility. I think there are a lot of benefits to centralizing support for science at the federal level. And the policy that we've adopted in the United States limits the role the federal government can play in this field—and actually has really restricted the ability of the federal government to oversee this field and ensure it advances in an ethical manner—I think that's had some potentially negative repercussions for the development of this field. So while there may be some appeal to getting other people involved, there may also be some reason to stick with or at least stay close to the model that has helped the U.S. scientific enterprise be so strong for the last half of the 20th century and into the 21st.

Q - Is a strong central government role in science typical for those countries that are most successful at pursuing it, be it the U.S., U.K., or China?

There are a number of different models for science out there. The UK has a number of similarities to the U.S. system. They have a centralized agency similar to the National Institutes of Health called the Medical Research Council. There are differences, though, and each country has its own quirks and different approaches. The U.K. has a separate regulatory system for embryo research that came out of in-vitro fertilization. It is now viewed as one of the countries with the clearest regulatory system for this kind of research. But from country to country things do vary quite a bit. I don't think it's fair to say that centralized support is necessarily the norm, it's just the norm in the United States, and it helped the United States grow into a real power in not just biomedical research but scientific research. Whether that's the right model going forward is a question that could be open for debate, but there have been a lot of benefits from that model and I don't think anything should just be discarded out-of-hand.

Q - Do you think it would be fair to characterize China's relatively bigger investment in embryonic research as a sort of power-grab?

I wouldn't characterize it as a power-grab so much as an economic development strategy. I think the motivation in both China and Singapore—two countries which shouldn't necessarily be grouped together, but share some similarities here—is economic development. Both countries see economic development as a very important priority, and science is seen as an engine for economic development. And so I think there was sort of a sense that here's an opportunity to really move out to the research frontier, to be at the most cutting-edge, and because the United States is a little tentative and a number of other countries are tentative in this area, it may be easier to approach the research frontier here in short order. I think both China and Singapore are really rapidly building world-class scientific communities, but you can approach the research front a little more quickly if you target an area where there is a little controversy and where other countries are not pursuing it as aggressively.

Q - Would it be fair to sum up your report as follows: "The United States conducts more embryonic stem cell research than any other country, but if we invested as much into that field as some other countries are doing we would be utterly and decisively dominating that area"?

I don't know if I'd quite say we'd be "dominating." We lead the world, but compared to other fields we don't produce quite as much, and it's hard to know how much of that is because we have less investment or more restrictions versus other countries. I'm working with share-data, so when someone goes up someone goes down, and so it's hard to identify the cause of differences. Is it the aggressive countries that are really pursuing this field that are shifting the distribution, or is it restrictive countries that are not as willing to get into it that are shifting it? But I think if we pursued this field without restriction our share of human embryonic stem cell related research would probably look a lot closer to what it does in the control sets.