A Stem Cell Ethics Rule Is Eased Bush Decision May Add Colonies for Research
By Rick Weiss Washington Post Staff Writer Saturday, August 11, 2001; Page A01
For all the restrictions President Bush imposed on federal funding of human embryonic stem cell research, he also made a little-noticed policy change that in one area makes his rules more permissive than those of President Bill Clinton.
That policy change -- the removal of strict ethics guidelines governing the procurement of stem cell-laden embryos from fertility clinics -- means that colonies of cells that had flunked the Clinton administration's ethics guidelines will now be eligible for use in federally funded studies.
The subtle but potentially significant difference between the Bush and Clinton rules was one of several areas that federal officials tried to clarify yesterday in the aftermath of the stem cell announcement, highlighting some of the perils that Bush faced as he navigated through the sensitive, high-profile issue.
Bush announced Thursday night that he would permit federal funding only for research on existing lines, or colonies, of stem cells, barring taxpayer money for research involving the creation or destruction of new embryos as sources of cells.
The long-awaited announcement drew a range of reactions, but seemed, at least for the moment, to quell a drive in Congress to demand more funding for stem cell research, which scientists hope will lead to new treatments for a wide range of diseases.
Much of the reaction focused on Bush's decision to limit federal subsidies to existing cell lines, with some scientists challenging the administration's estimate of how many lines actually exist and questioning how useful those lines will be.
On the whole, Bush's new stem cell rules are far more restrictive than the ones Clinton had put in place because they limit research to cells derived from embryos that were destroyed before Bush made his announcement.
But on the question of embryo procurement, the Bush plan demands only that donors at fertility clinics give "proper informed consent," without defining what that means. By contrast, the Clinton rules specified in great detail how the informed consent process should proceed. It demanded that consent documents use specific wording to ensure that women did not feel coerced to donate their embryos.
In addition, the Clinton rules also required that only frozen embryos be used for research so that embryos would not be taken just as a woman was undergoing in vitro fertilization -- an emotionally vulnerable time that ethicists have said should be off-limits to researchers seeking embryos. Bush has made no mention of such a restriction.
Among the cells that now will be eligible for federal funding are colonies created at the University of Wisconsin, the leading academic research institution located in the home state of Health and Human Services Secretary Tommy G. Thompson, a National Institutes of Health official confirmed.
The cells were cultured by James Thomson and were the first human embryonic stem cells to be isolated in the United States. Thomson used fresh embryos and also used consent wording that differed slightly from the language specified under the Clinton rules.
Under Bush's new rules, however, a University of Wisconsin foundation that holds two key patents on Thomson's stem cells will be able to distribute those cells to researchers who want to study them -- and, if the research proves useful, perhaps collect substantial royalties.
HHS spokesman Bill Hall said the Wisconsin connection had nothing to do with Bush's decision to change the rules the way he did. "It played no role whatsoever in the deliberations" leading up to the new rules, Hall said. "It had nothing to do with who owned which [cell] lines."
Others said that in any case, Bush's dilution of the ethics rules was disturbing.
"It's very troubling to find that this policy may actually grandfather in cell lines that were ineligible on ethical grounds even under the Clinton guidelines," said Richard Doerflinger of the U.S. Conference of Catholic Bishops, which opposes federal funding of human embryo stem cell research.
"To be sure, our moral objection has not centered on how informed the parents' consent is," Doerflinger said, noting that it focuses instead on the well-being of the embryos. "But at least the Clinton guidelines spelled all this out. This is distressing."
Bush's statement Thursday that there are 60 human embryonic stem cell lines already in existence eligible for study with federal funds under the new plan caught many researchers by surprise. Even specialists in the field had been unaware there were more than 10 or 15 lines.
Lana Skirbol, NIH director of science policy, said the number Bush referred to was derived from a recent intensive round of inquiries to laboratories around the world by the agency. Many more lines are in existence than previously believed, she said, with several being kept behind closed doors to protect commercial and proprietary interests.
Some scientists said they suspect that many of those cells are not truly stem cells. The criteria for stem cells are quite strict; the cells must be able to reproduce without limit, and all progeny cells must be able to reproduce indefinitely and develop into every cell type in the body.
Many cells that at first appear to be stem cells have proven not to be, but Skirbol said the agency used strict definitional rules in its survey. Moreover, she said, all appear to be eligible for federally funded studies.
"The NIH believes that all 60 cell lines meet the president's criteria" for federal funding, she said. To meet the criteria, cells must be from embryos left over from fertility treatments (as opposed to having been created for research); parents must not have been compensated for donating the embryos; proper informed consent must have been obtained; and the embryos must have been destroyed before 9 p.m. Aug. 9 -- the day of the president's announcement.
In an interview, Skirbol acknowledged that a few of the existing cell lines may be found to be of little or no use, perhaps because they don't grow well or cannot be easily manipulated. But new lines are also expected to become available she said, as researchers reveal lines created in recent months.
The NIH will require documentation that the cells are from embryos destroyed before Thursday, she said. The agency is creating a registry of all eligible stem cell lines -- and, in a difficult task, devising material transfer agreements that specify the legal conditions under which cells can be shared -- so that researchers will soon be able to choose from a menu of embryo cells.
New grants will not be available until next year, Skirbol said. But scientists who already have NIH grants can file for supplemental money for stem cell work -- a system that works faster than the normal grant approval process. And many researchers already working with conventional cells are expected to apply to NIH for permission to add stem cells to their experiments. That process does not require grant approval and can take just a few weeks.
Depending on how long it takes to work out legal arrangements, some stem cells could be available on this basis within a few weeks.
The Bush system will work much more efficiently than the Clinton system would have, Skirbol said, in part because it eliminates a layer of scientific and ethical oversight from a special committee called for under the Clinton plan. That committee was formed earlier this year but never met.
One of the more complicated aspects of getting the system in place will be coordinating patent and royalty arrangements that may be demanded by laboratories that have stem cells to share. The arrangement at Wisconsin in particular makes it difficult to predict how much profit, if any, the university may make from its stem cells.
Thomson and the university's alumni research foundation share two key patents on stem cell processes and products, with commercial rights licensed to Geron Corp., a Menlo Park, Calif., biotechnology company. A nonprofit corporation, WiCell Inc., distributes the Wisconsin cells to scientists for $5,000 per batch. That amount barely covers costs, said spokesman Andrew Cohn.
But scientists who find lucrative uses for those cells, such as a treatment for diabetes, may have to pay a portion of their revenue or profits to the university foundation, depending on what kind of arrangement they have made and how much of the work is covered by the university's patents. Cohn said he had no profit projections for the stem cell business, and said any suggestion that Thompson considered the university's finances during the stem cell decision-making process was "ludicrous."
Last year, the foundation made $35 million for the university.
© 2001 The Washington Post Company