AUG 28, 2001 List of Stem Cell Researchers Shows Hands Had Been Tied By NICHOLAS WADE
An unexpected new order of world powers has emerged, at least in the field of human embryonic stem cell research. The roster, say scientists who back the research, is evidence of the inventiveness of the newcomers but also shows how much the usual powerhouses of biomedical research in the United States and Europe have been held back by political and ethical debate.
The National Institutes of Health yesterday announced the organizations that had developed colonies of human embryonic stem cells before Aug. 9, the cutoff date set by President Bush in allowing federal money to be used for research. Sweden led the pack with colonies derived from 24 different embryos, followed by the United States with 20, India with 10, Australia with 6 and Israel with 4.
"With any other biotech material you'd find a dramatically different list," a senior American biologist said on condition of anonymity. "That's a telling comment on how much we have been held back."
Dr. James D. Watson, president of the Cold Spring Harbor Laboratory, said, "We've been held back, there is no doubt."
But Dr. Watson noted that even if research had begun earlier, several critical tools for analyzing human embryonic stem cells, like the human genome sequence and DNA chips, had only just become available.
In an interview from London, the secretary of health and human services, Tommy G. Thompson, said that the president had set "a definable policy" that would allow research to go forward and that "now is not the time to be looking for excuses but to be moving full speed ahead."
The human genome, for instance, was decoded by an international coalition whose leading members were the United States and Britain, with contributions from Germany, France, Japan and China. None of the last five countries are yet known to have derived human embryonic stem cells.
The absence of Britain from the list is notable because British biologists developed the technique for growing embryonic stem cells from mouse embryos, the underpinning of the methods that others have used with human cells. The British agency that regulates research with embryos only allowed them to be used for exploring tissue regeneration a few months ago, too late for British researchers to translate their lead with mouse embryonic cells to humans.
Unlike the costlier forms of biological research, like the DNA sequencing machines required in genomics, cell culture has fewer barriers to entry. This, and the absence of political dissent, may be why two organizations in India, Reliance Life Sciences of Bombay and the National Center for Biological Sciences in Bangalore, have been able to develop N.I.H.-approved human embryonic stem cells.
Reliance Life Sciences is part of Reliance, a large oil and textile conglomerate. Dr. Firuza Parikh, the founder and director of the company, said in an interview that its goal was to make the cells mature into tissues and organs like the heart, pancreas and central nervous system.
"There are no religious, cultural, political or social barriers to this research in India," she said.
Dr. Parikh, who is a fertility expert and visiting professor at Yale University Medical School, said that with a group of 60 researchers, Reliance's goal was "to put India in the forefront of global biotech work."
The cells owned by Reliance and the other nine organizations on the National Institutes of Health list are probably enough for government- supported biologists in the United States to get started, many scientists believe, even though questions about the availability, quality and terms of use of the cells remain open.
"Give me the cells, and I'll give you the answer," said Dr. Ronald D. McKay of the health institutes.
At least two of the cell owners on the N.I.H. list, CyThera of San Diego and Reliance Life Sciences, have made clear that they intend to do more work on characterizing their cells before making them generally available.
Scientists are also waiting for the outcome of negotiations between the health institutes and the Wisconsin Alumni Research Foundation as to the terms under which N.I.H. researchers may use the cells derived at the University of Wisconsin.
But even if research now starts in earnest and its promise is fulfilled, many scientists believe it will be necessary to derive cells from new embryos before clinical applications can begin.
"With time, people will want more than those 60 cells," Dr. Watson said.
Tony Mazzaschi, associate vice president of the Association of American Medical Colleges, said that limiting the number of embryonic stem cell lines - colonies of self-perpetuating cells - available to federally financed scientists was unwise public policy.
"This may allow some limited basic research to get started," Mr. Mazzaschi said, "but I don't think anybody thinks this list will be sufficient when we start going into clinical research."
Mr. Thompson, the secretary of health and human services, said that he was not open to the idea of deriving new cells for government researchers to work on, but that there were no restrictions on the private sector.
"The administration has set a policy," he said, "but this does not impede anything the private sector wants to do.
"It's normal for basic research to get to a certain point, then therapy and human trials are usually done by the private sector."
But Dr. Irving Weissman, a leading stem cell researcher at Stanford University, said that because of the fundamental nature of embryonic stem cells and their ability to construct the entire human body, "most of the important research is going to go on at academic centers for some time."
Dr. Weissman said that lack of new cell lines would probably have a restraining effect on research, and he suggested that the president's new council on bioethics might provide a mechanism for reviewing the policy.
"All of us are sensitive to how far Bush came to make these decisions, and the real issue would be whether his bioethics panel will consider reasonable arguments for new cell lines to be created," Dr. Weissman said.