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  • BIOETHICS FORUM ESSAY

It’s Still Gonna Be the States

Sam Berger from the Center for American Progress thinks we’ve got it all wrong. In a recent post on Bioethics Forum and in a recent report co-authored with Jonathan Moreno and Alix Rogers, he claims our emphasis on states as the driving force in national stem cell policy is wrong on the facts and wrong on the values. The federal government is still spending the bulk of public money supporting stem cell research, Berger alleges, and advocates should “keep the focus on the feds” to avoid conflicting state laws and research guidelines, the need to segregate federally funded activities from others, and realize all the advantages of centralized research administration.

We don’t agree. Berger’s misleading on the money, and way too optimistic about the politics. The federal government doesn’t spend much money at all on human stem cell research, and the odds for big changes in Washington’s stem cell policy in the foreseeable future, even after the election of 2008, are slim. Advocates may be able to undo some of the adverse effects of current federal stem cell policies, but the odds that they can get the feds back into the game as major players are very long.

First, the numbers. Berger claims that the feds are still spending the bulk of public support for stem cell research, but his numbers don’t separate human from nonhuman stem cell research. He quotes an estimate of $639 million for all federal stem cell research spending in fiscal year 2008, which is true enough, but he doesn’t bother to note that less than 40 percent of that – some $242 million – is for human stem cell research of any sort, and that only about 6 percent – some $37 million – is spent on human embryonic stem cell research, which is what all the stink has been about. While not much state money’s been spent yet, the early returns suggest that states will likely be spending significantly more than that. California’s first round of comprehensive research grants, awarded earlier this year, allocated $74.6 million to human embryonic stem cell projects, or more than twice what the National Institutes of Health is expected to spend. An earlier round of $45 million in seed grants to develop research capacity on human embryonic stem cells was approved last year, bringing California’s total annual investment in the research to some $120 million, or more than three times what the feds are expected to spend. While California officials have indicated they also intend to invest in other forms of stem cell research, California is already a significantly bigger funder of human embryonic stem cell research than the feds.

In the longer report, Berger et al further minimize state support for stem cell research by trying to separate what they label state “research” spending from “general” spending, which they say includes building labs, buying equipment, training researchers, and other “non-research” expenses. This distinction is misleading and arbitrary. Scientific research grants, whether they come from NIH or the California Institute for Regenerative Medicine, include the direct or indirect financing of lab space, the purchase of specialized equipment, support for training researchers (in the form of pre-docs and post-docs), and the like. What Berger’s labeling “general” in state budgets is included as “research” at NIH, making the comparison one of apples and kumqwats. While it’s certainly true that states have had to spend more money on new labs and equipment than they would had federal rules prohibiting the use of federal money to support ineligible stem cell lines not been so onerous, the notion that these expenditures have nothing to do with the research enterprise or are not supported in “research” grants is wrong.

Berger and colleagues are also wildly optimistic about the ability of the feds to change things very much. It’s apparent that little is likely to change in the balance of the Bush Administration. Stem cell advocates lack the votes to override a presidential veto of bills expanding the number of stem cell lines eligible for federal support, and policies requiring the construction of “NIH-free” zones will almost certainly remain in place. What’s becoming increasingly apparent is that not much more will happen after 2008, regardless of who wins either the White House or Congress. Whoever gets elected President in 2008 will have to deal with an ongoing war in Iraq, a $400 billion on-budget deficit, large expiring tax cuts, and a serious health care coverage problem.

Under these conditions, the odds of a major expansion of the federal role in stem cell research are pretty slim. A Democratic president, and at least a couple of the potential Republican ones, will very likely sign a version of the bill Bush has vetoed, and may well eliminate the regulations on avoiding federal support of ineligible stem cell lines. These are not small things, but they’re a long way from putting the feds back in the driver’s seat on stem cell policy. Restrictions on the stem cell lines that federal funds can be used to support would still remain, and these actions would not increase the amount of federal support for human embryonic stem cell research.

The odds of a major bump in stem cell funding – and it would take a major one to establish the feds as the dominant actors in stem cell policy – have to be rated as slim. The overall budget picture is lousy, and there are a lot of popular programs in the funding queue. Every one of the Democratic contenders already has a major proposal to improve health care coverage, which should provide a pretty good clue about what their major domestic priority is likely to be. Any proposal to expand health care is likely to be expensive, which means less for other purposes. In a further development unlikely to have been noticed by anyone besides budget geeks, both Houses of Congress have adopted “pay-as-you-go” budget rules under which tax cuts or changes in popular entitlement programs have to be offset by spending cuts or tax increases somewhere else. These rules mean, for example, that Democratic proposals to expand coverage under the popular Children’s Health Insurance Program will have to be paid for by cutting something else or raising taxes in some form. This requirement lessens the amount of money available in the rest of the budget. Finding the resources to finance an expansion of human embryonic stem cell research under these conditions is likely to be difficult.

Proposals to dump a lot of additional money into human embryonic stem cell research are likely to be controversial, even if both Congress and the administration are favorably disposed. Opposition will come from the same groups that have opposed this research all along, and will likely even come from elsewhere in the scientific community. After doubling between 1999 and 2003, NIH’s overall budget has remained flat and even declined in real terms in recent years. Scientists who are having trouble supporting their own research are likely to protest vehemently if their stem cell colleagues, who are already getting money from states and private foundations, now get additional support from NIH as well. Stranger things have happened, but the odds of a lot of additional federal money going to stem cell research seem slim. Even if the NIH is able to expand support for stem cell research, it will only be one payer among many, and not even the largest one.

What seems likely to happen instead is more of what we’ve got now – more states weighing in with funding programs of widely varying sizes, so that human embryonic stem cell research is heavily supported in some states even while it is illegal in others. In addition to the states already supporting the research, Wisconsin is making a concerted effort to attract stem cell researchers to that state, and Florida and Massachusetts are reported to be considering stem cell initiatives. The inter-state competition that Berger and colleagues decry is actually a good thing for human embryonic stem cell research – more governors and gubernatorial candidates may find it in their political interest to support state financing for this research if they can claim that state support will keep their state from “falling behind.” There will be increasingly vocal debates over royalties and product pricing that will be resolved in a wide range of ways, and conflicts between the rules that apply to collaborating researchers located in different states. This system is less efficient and more administratively difficult than a single funding source and set of rules would be, but it’s an accurate reflection of conflicting and diverse national public and political views about human embryonic stem cell research that show no sign of going away any time soon.

 

Readers respond

I argued last month that federal support for stem cell research is crucial to advancing the field. Jim Fossett, co-director of the State and Bioethics program at the Alden March Bioethics Institute, responded by claiming that states were, and to a certain extent should be, the primary supporters of stem cell research. While Fossett is correct that states have done tremendous work in funding this science, the importance of strong federal support to both stem cell research and future biomedical research cannot be ignored.

It may seem strange to argue that federal support is critical in the wake of Massachusetts Governor Deval Patrick’s proposal to spend a billion dollars of state money on stem cell research over the next 10 years. But this development just underscores the funding disparities between the states and the federal government. Even with this huge investment, states will still spend only about 50 percent of what the federal government will spend on stem cell research through 2018. And these numbers are unlikely to change much, as there are few states left with the resources to significantly support the research and funding efforts have stalled in Texas and Florida.

But is this money from the state and federal governments going to the same research? Fossett contends that not distinguishing human from nonhuman stem cell research funding obscures the fact that states spend more on human embryonic stem cell research than the federal government does. Yet with such a nascent science, this distinction is largely artificial. The purpose of nonhuman embryonic stem cell research is to better understand the basic science for future use in humans; after all, Dr. Douglas Kerr is seeking to help humans, not just rats, walk again.

The allocation of resources for human and nonhuman stem cell research does provide some clues to institutional priorities. The National Institutes of Health has always concerned itself with basic science, including extensive research on animal models – not the quick-return projects often funded by other sources. Over the last four years, NIH spent $320 million more on nonhuman than human adult stem cell research, and this science is 30 years older than embryonic stem cell research.

States, on the other hand, are under pressure to deliver quick returns, and may therefore find it difficult to focus as much on long-term basic research that is currently needed to advance the field. California is already having a debate over whether funding for research infrastructure should be given to universities or biotech firms, spurred by skepticism among advocates that universities “will press ahead quickly to develop the new cures and medical treatments expected by the state’s voters.”

The California debate involves a good deal of money, because states are spending a lot on infrastructure rather than research. As Fossett rightly points out, portions of NIH grants are used to finance lab space, purchase specialized equipment, and train researchers. These expenditures, however, are dwarfed by the massive amount states spend in building infrastructure from the ground up. California, Wisconsin, and New Jersey are each spending close to $300 million on new buildings so they can conduct research on federally ineligible lines, and similar facilities are being considered in New York and Massachusetts. The added expense to states due to our federal policy is significant.

Meanwhile, the national political prospects for stem cell research are by no means dire. Fossett may be correct that the prospects are unlikely for a major revamping of federal policy under President Bush, but his prediction that “not much more will happen after 2008, regardless of who wins either the White House or Congress” seems extremely unlikely to come true.

While the next president will certainly have a number of issues to deal with, this will not preclude action on stem cell research. Since the current policy is the result of an executive order, altering it would not even require the time-consuming process of passing a new law; the president could change our national stem cell policy with the stroke of a pen. In fact, loosening federal restrictions on stem cell research could be the easiest and most popular move a new president could make.

Even without allocating more money to stem cell research, removing federal restrictions on embryonic stem cell research would be a tremendous boon. The immediate result would likely be a flood of grant requests for research using newer lines, similar to what California experienced when it first allocated funding. And because NIH provides so much money to stem cell research – close to 70 percent of the total public funding for stem cell research through 2018, according to conservative estimates – even a small shift of NIH stem cell funding toward embryonic stem cell research would be hugely important.

Looking beyond this particular debate, allowing states to replace the federal government as the primary funder of embryonic stem cell research would also set a terrible precedent. Federal funding is necessary to advance basic research; as Dr. James Thomson has commented, “the federal government, the [NIH], is the funding that drives basic research and research into new therapies in this country.” Even if states could replace government funding for stem cell research, would they be able to do so for the next controversial field of biomedical research, or the next one after that?

Fossett contends that an inefficient and wasteful state stem cell funding system is necessary because it is a “reflection of conflicting and diverse national public and political views about human embryonic stem cell research.” But this sets the bar awfully high for federally funded research. Support for embryonic stem cell research is not particularly controversial; it enjoys broad, bipartisan support from the American people and from Congress. Progress has been slowed only by a vocal and politically influential minority, aided in large part by the support of the president.

If this standard were to be applied to future biomedical research, it is difficult to think what would pass. Should we only provide robust federal funding for research that is supported by 70 to 80 percent of the populace and supermajorities in each house of Congress? Such a standard seems particularly difficult to meet in the current scientific climate, in which biomedical research will continue to challenge our preconceptions about human life.

This is not to say we should ignore public concerns with biomedical research; science must be responsive to our shared human values. But to abandon efforts to expand federal funding for research with such widespread support would preclude doing so for future research as well, and states can only pick up so much slack. If the future of biomedical research is “still gonna be the states,” then it’s gonna be a bleak future indeed.

– Sam Berger

Published on: May 5, 2007
Published in: Emerging Biotechnology, Health Care Reform & Policy, Science and Society

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