When President Obama vowed in his inaugural address to return science to its “rightful place,” there was little doubt that a reversal of his predecessor’s moratorium on stem cell research would be part of that agenda. That policy, enacted by President Bush on August 9, 2001, prohibited federal funding for deriving new stem cell lines from human embryos—and led to the creation of several state-based funding initiatives that aimed to pick up the slack. California led the charge with a $3 billion program, but other states with large research communities, including New York, Massachusetts, and Connecticut, have followed suit with pledges of hundreds of millions of dollars.
After Obama axed the Bush moratorium in May, many US stem cell policies were updated, most notably with the NIH’s new guidelines for stem cell research that were announced earlier this month. The new guidelines allow federal funding for new cell lines derived from embryos left over from in vitro fertilization attempts, but not for ones created expressly for research. And while stem cell scientists were generally happy to see one barrier to new stem cell lines fall away, there are questions as to whether the quality of surplus IVF embryos are sufficient to push research in this field forward.
The remaining prohibition against creating new embryos leaves researchers once again looking to state-based stem cell initiatives to fill the gaps. Now all eyes are on New York, where a recent policy shift could open new possibilities for the state’s researchers. In June the Empire State Stem Cell Board (ESSCB)—New York’s funding and ethical oversight body—voted to allow compensation for women who donate their eggs toward research. As the first state to officially allow the practice, New York’s science community is uniquely positioned to create new stem cell lines and develop treatments based on them.
The ESSCB’s statement on the decision chiefly expressed the value in having a standard position on donation practices whether the eggs are intended for reproductive or research purposes. But according to Robert Klitzman, a member of the ESSCB’s ethics committee and director of Columbia University’s forthcoming Masters of Bioethics program, there is no denying the practical dimensions that prompted the shift.
“Across the country, there’s been virtually no donation by women of eggs for research. The national guidelines recommend against compensating donors, and that has become the norm,” Klitzman says. “We know that women would be happy to contribute eggs toward research, but if they’re not getting paid, it just doesn’t happen.”
Some opponents of compensation feel that a monetary reward might cause women to underestimate the medical risks involved in egg donation; others feel that eggs simply should not be fertilized except with the intention of reproducing.
But the primary alternative—using excess embryos from IVF treatments—may not be sufficient for advancing research, says Klitzman. “The eggs that were rejected at IVF clinics were done so for a reason—there were problems with them or they don’t look as healthy,” he says. “Additionally, they’ve been sitting in a freezer, sometimes for years. They’re not as good eggs.”
Klitzman said that the issue of donor compensation had been on the table since the ESSCB’s inception in 2007, and that this decision has been long-awaited by New York’s research community. He believes that other states, particularly California, will reconsider their own stem cell initiatives based on the changing political winds both in New York and the nation at large, but whether these states’ widely varying legal frameworks for stem cell research will allow similar decisions remains to be seen.
California’s stem cell initiative—and its ethical oversight body, the California Institute of Regenerative Medicine (CIRM)—were established by a 2004 referendum known as Proposition 71. While the proposition did allocate $3 billion to research, it did so with the proviso that such money could not go to the compensation of egg donors beyond “direct expenses” incurred in the donation process.
Geoff Lomax, the coordinator of CIRM’s Standards Working Group, feels that this concession was included in Proposition 71 as a compromise at a time when opposition to stem cell research was higher than it is today. And while public opinion may have shifted, it would take another legislative effort to allow CIRM to compensate donors. CIRM is even prohibited from funding research that uses stem cell lines derived out-of-state from compensated donors, due to a second piece of state legislation passed in 2006.
Lomax says he was very excited to see New York open this path to new stem cell lines, but he feels CIRM will wait for results before making any attempt at revising California’s policy on compensation. “Certainly, if a line were to emerge that ends up having a tremendous therapeutic benefit, I would imagine there would be a willingness to rethink this decision,” he says. “We want to revisit any and every decision in light of new science.”
With similar compensation-prohibitive legal frameworks in Connecticut and Massachusetts, it looks as if New York’s ability to derive new stem cell lines will be in a class by itself for the immediate future. New techniques, such as induced pluripotency (where a developed adult cell is turned back into a stem cell) may obviate this debate entirely, but, as with the true potential of stem-cell-based medical treatments, only time and further research will tell.
“We do not know if induced pluripotency will work, but we don’t know whether stem cells derived from donated eggs will work either,” says Klitzman. “There’s just no evidence yet. You need to do both to see which will lead to the best treatment.”
Originally published July 22, 2009