Stem cell lines may not meet guidelines

By STEVE MITCHELL  |  May 3, 2005 at 2:10 PM
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WASHINGTON, May 3 (UPI) -- Some of the human embryonic stem-cell lines approved for federally funded research may not meet newly recommended ethical criteria for conducting that research -- a conflict that could further limit access to the cell lines and impede progress in the field, experts told United Press International.

The scientific consensus is embryonic stem cells may yield insights and treatments for various diseases, but the research is controversial because it requires the destruction of human embryos.

Last week, the National Academy of Sciences issued voluntary guidelines aimed at ensuring the research is conducted in an ethical manner. This includes obtaining explicit and detailed consent from women who donate their eggs and men who donate sperm to create lines of embryonic stem cells.

James Battey, former chair of the task force at the National Institutes of Health in Bethesda, Md., that oversees federal funding of embryonic stem-cell research, told UPI some of the cell lines approved under President George W. Bush's 2001 policy may not meet the informed-consent criteria established by the national academies.

The president's policy, issued Aug. 9, 2001, stipulated informed consent must have been obtained from couples who donated embryos used to generate the government's approved stem-cell lines. In some cases, however, couples with fertility problems obtained sperm from donors who may not have given their consent for the resulting embryo to be used in research, said Battey, who also serves as director of the National Institute on Deafness and Other Communication Disorders.

"That would not conform to the National Academies' guidelines," he said, but added he did not know for certain if any such cell lines existed in the registry. Verification would require checking with the cell-line suppliers, which has not yet been done, he noted.

Asked whether this was an issue the NIH would reconsider in light of the NAS guidelines, Battey said such action would have to be initiated by the president, in the form of an executive order, because he has "the last word on policy in the executive branch."

The White House did not return a phone call from UPI seeking comment.

Bush's policy approved 78 human cell lines -- all of which were in existence prior to his decision -- for use in federally funded research. However, only 22 of the lines currently are listed as available on the NIH Web site, and even some of those are not considered viable. In addition, some researchers worry the lines are contaminated with animal molecules because they were grown initially on mouse and fetal calf cells.

The limited availability of the cell lines has inhibited progress in this field and has long been an area of concern among scientists. The NAS guidelines are not binding, but if they become widely adopted by the scientific community, they could further reduce the number of available federal lines due to the ethical conflicts.

Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics in Philadelphia, said he does not think the federally controlled cell lines carry "explicit consent."

"Under these rules, I don't think you could use them," Caplan told UPI.

"It could put (scientists) in a bind," said Ronald Green, director of Dartmouth University's Ethics Institute in Hanover, N.H. "These are the only lines approved for federal research and there's no indication the president wants to change that."

This may not rule out use of those embryos entirely, however, Green told UPI. "People will have to go back to the donors, if we can find them, to get consent," if the initial consent was not up to the standards dictated by the academies.

Dr. George Daley, associate director of the Stem Cell/Developmental Biology research program at Children's Hospital Boston and associate professor at Harvard Medical School, told UPI if the NAS guidelines made some of the federal lines unavailable, "that would be of real concern," and added "there will have to be reassurances that all of the lines have gone through" an appropriate informed-consent process.

Opponents to the research agreed the federal stem-cell lines should meet the informed-consent criteria.

"If these lines were not acquired through what we now consider an informed-consent process, we'd have to do it again," said Kevin Fitzgerald, a molecular scientist and a Jesuit Priest at Georgetown University and co-founder of Do No Harm: The Coalition of Americans for Research Ethics, a group in Washington that opposes embryonic stem cell research.

Dr. Robert Lanza, vice president of medical and scientific development at Advanced Cell Technology in Worcester, Mass., a company focused on turning embryonic stem cells into therapies for disease, said he would "be very surprised" if some of the federally approved cell lines from India and other foreign nations met all of the requirements stipulated in the NAS guidelines.

The potential ethical conflict is all the more reason for loosening the restrictions on federally funded stem-cell research, Lanza said, so lines such as those generated by Douglas Melton of Harvard University could qualify. Melton used private funds to produce 17 new stem-cell lines, but they are not eligible for federal funding because they were created after Bush's policy took effect.


Steve Mitchell is UPI's Medical Correspondent. E-mail:

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