Bush policy impedes stem cell research

In a brief but defining moment in August 2001, President Bush conveyed the mental anguish he experienced while crafting a national policy on stem cell research. “At its core,” Bush said in a prime-time speech broadcast from his Texas ranch, “this issue forces us to confront fundamental questions about the beginnings of life and the ends of science.”

The president went on to impose what he regarded as a tough compromise: Research on stem cell lines created before the speech could receive government funding. But, in the hopes that embryos would not be created expressly for research, he prohibited federal support for research on stem cell lines developed after that date.

Now, nearly four years later, a consensus is emerging – even among those who have long embraced Bush’s policy – that science has moved beyond the boundaries he imposed. Adding urgency to this shift in sentiment is a growing concern that other nations are taking advantage of Bush’s qualms to race ahead of American scientists.

“I supported President Bush at the time of his stem cell announcement. I thought it was a fair compromise,” said Carl Gulbrandsen, the managing director of the Wisconsin Alumni Research Foundation, which oversees patent protection for the University of Wisconsin, including key patents on stem cell lines. “But I believe things have changed, the science especially. It’s no longer justifiable.”

Gulbrandsen made his comments this month at a Washington conference sponsored by the American Enterprise Institute, a conservative think tank that emphasizes free-market ideas and serves as the home base for Leon Kass, a bioethicist and Bush’s main guru on stem cell policy. Jon Entine, an adjunct fellow at the institute and the organizer of the conference, was among those who said it is time for Bush to reassess federal policy.

One problem, Entine and others point out, is that the number of stem cell lines that qualify for federal funding has turned out to be lower than expected. At the time of Bush’s announcement, the White House projected that about 60 to 70 lines would qualify; the number is now estimated at between eight and 23.

Another problem is that scientific discovery is pushing the field away from the types of lines that Bush’s policy focused on – cells produced through therapeutic cloning.

Instead, the private sector has developed new lines using cells taken from frozen embryos, stored at in-vitro fertilization clinics, that would have been discarded. And scientists everywhere are working on creating cloned stem cells using a variety of techniques that may not involve eggs taken from embryos.

At the same time, an alarm is sounding among American intellectuals – some of them new voices in this debate – that federal restrictions are allowing other nations to take the lead in a field that was discovered and fostered in America.

Lori Knowles, a bioethics policy consultant at the University of Alberta who has served as a consultant to Bush’s Council on Bioethics, said stem cell research is now being conducted throughout the world. She likes to show conference audiences a “world stem cell map,” with its checkerboard pattern of activity, to illustrate how widespread the technology has become.

Few countries have policies as limiting as the United States, she said. Scientists in Britain, Korea, China, Singapore, Japan and Israel, especially, are conducting leading-edge research, unfettered by restrictions on cell lines.

“Singapore is spending more money than the U.S. government on stem cell research,” said Wise Young, a spinal cord researcher and stem cell expert who heads the Keck Center for Collaborative Research at Rutgers University. “Can you imagine?”

It’s not merely limited access to good cell lines that hampers American scientists. James Battey, director of the task force on stem cell research run by the National Institutes of Health, complained that insufficient numbers of young scientists are applying for grants to use the federally sanctioned lines.

That could have something to do with the fact that, according to a study published recently in the journal Nature Medicine, all the approved lines are contaminated with the genetic material of mice because of the way the cells were grown. This means that the cells could never be used in humans, for fear of trans-species transmission of disease.

State laws can also get in the way. Charles Jennings of the Harvard Stem Cell Institute in Cambridge, Mass., said that any scientist in his state proposing research with an unfertilized egg must seek the permission of the district attorney because of a long-standing law that prohibits experiments on human fetuses.

In addition to limiting scientists’ options, government regulations sometimes lead to waste. Gulbrandsen said the University of Wisconsin spends millions of dollars – money that could be better spent, he suggested – on duplicate research facilities so as not to combine investigations using approved federal stem cell lines with those using other lines.

And private investors, it appears, are leery of pouring money into such tightly regulated areas of research. Such reticence – understandable as it may be, due to present restrictions – doesn’t bode well for a science that could be the undergirding of an entire new industry: regenerative medicine.

Starving a science in its early research years, scientists fear, will either retard its advancement or allow the breakthroughs to occur overseas.

Robert Lanza, a former Fulbright Scholar and vice president of Advanced Cell Technology in Massachusetts, said his firm – one of the leading centers for stem cell research in the world – was saved from insolvency a few weeks ago by some last-minute venture capital. The firm’s phone had been turned off, and it was having trouble meeting payroll expenses.

“We are doing excellent work,” Lanza said. “And we are trying to stay alive.”

The progenitors of this new science, which could have the makings of a new economic engine, are sending up the first smoke signals of distress. Whether the Bush administration will read those signals, and choose to act on them, is anyone’s guess.