blog.bioethics.net

Do iPS cells mean an end to stem cell federalism? It might just mean the opposite

By James Fossett

There’s been enormous speculation about the scientific and political consequences of the development of “induced pluripotent stem cells” (iPSC) by labs in Wisconsin and Japan for the entire stem cell research enterprise. One line of speculation, as described in an article by Rick Weiss in the Washington Post, centers around the state funded stem cell research programs that we’ve been so vocal about. If the Bush Administration embraces iPSC and induces NIH to support this method of making stem cells in a serious way, some claim, then the feds could become major players again in the stem cell research arena and all the problems of the “patchwork” of state regulation would disappear.

Not surprisingly, we’re dubious.

First, as most of the scientific types who’ve been willing to be quoted have argued, not much is going to happen right away. It’s still not clear yet whether iPSC are perfect substitutes for stem cells derived from human embryos and it’s likely to take some time to find that out. Potentially more consequential in the long run is the question of how the FDA is likely to react to a proposed treatment that is genetically engineered for each patient. Consistency of treatment has become a sizeable issue in the approval process for biologic drugs, and the FDA may be reluctant to approve individualized therapies using modified cells until the risks are better understood. As a result, the approval process could actually be longer and more expensive than that for therapies derived from embryonic stem cells. As the AP reported reported, at least some commercial observers are betting that therapeutic results may come sooner with embryonic stem cells than with iPSC.

Second is the question of how much money the feds can afford to spend on iPSC. While it seems very likely that NIH management could find some money to spend, particularly if the White House decided it wanted money spent, there may not be that much extra to spend. NIH’s stem cell spending and the entire NIH budget have been flat-lined for the last couple of years. Absent new money, which may be hard to come by, this means that any new spending for iPSC will have to come out of someone else’s pocket. This is by no means politically impossible, but there is also a practical limit on how much NIH can afford to transfer from other research programs. States could be spending as much as $450 million annually on stem cell research over the next 8-10 years and private donors have given as much as $2 billion, as against less than $40 million annually for human embryonic stem cell research and about $640 million annually on all types of stem cell research for NIH. Several tens of millions of dollars, which may be all NIH management can squeeze out of a base that size, would result in more spending on iPSC than before, but it still would only make the feds one stem cell funder among many, and not the most influential one at that.

Finally, the state stem cell programs aren’t going away, regardless of what the feds do or don’t do. As we’ve noted earlier, many of the state programs, particularly California, have invested heavily in embryonic stem cell research to date, but this could easily change. The possibility of a cheap, technologically straightforward process that can readily produce large numbers of stem cells without attracting political controversy is something any funder would be crazy not to pursue, so states may begin to diversify their research portfolios to pursue reprogramming without abandoning on-going embryonic research. The potential elimination of the controversy around the source of stem cells may, in fact, get more states into the stem cell funding process. More conservative states such as Texas and Florida with major medical research institutions may find stem cells more attractive if the controversy over cell origins were diffused. Stem cell research is still a hot topic, and the threat of losing major researchers to other states is still a politically credible one -- CIRM’s most recent annual report (pdf) lists over a dozen researchers who have relocated to California to pursue state-supported research, and the smaller Connecticut program has apparently attracted senior researchers from elsewhere -- North Carolina and Wisconsin -- to run expanded stem cell programs at UConn and Yale. If institutions in California and other states which support stem cell research continue to hire, look for stem cell researchers and medical school deans to be sure to call such hiring to the attention of the political process.

James W. Fossett co-directs the Rockefeller Institute of Government/AMBI states and bioethics program. He is also responsible for the Rockefeller Institute's health and Medicaid studies and is Associate Professor of Public Administration and Public Health at the Rockefeller College of Public Affairs and Policy, University at Albany.

Earlier coverage of induced pluripotent stem cells on blog.bioethics.net