Stanford University researcher Irving L. Weissman, MD, said draft rules denying federal funds for some stem cell techniques imply "that it's OK to regulate science policy by the politics of the moment."

NIH policy loosening stem cell research restrictions disappoints both sides in debate

Some research advocates and scientists are upset that techniques they support would get no federal money.

By Kevin B. O’Reilly — Posted May 4, 2009

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Many scientists hoped President Obama would end what they saw as the politicization of embryonic stem cell research. They thought all Bush administration funding bans would vanish, easing the way for unimpeded research that could yield interventions for physicians to use in treating everything from Parkinson's disease to diabetes. But those hopes may be running into political reality.

The National Institutes of Health in April proposed overturning some Bush-era restrictions on federal funding for stem cell research while leaving others in place. The rules would allow federal funds to go to research using stem cell lines derived from human embryos that are left over from fertility treatments and otherwise would be discarded. But techniques that scientists say hold promise and should be funded would be ineligible for NIH money.

At the same time, opponents of human embryonic stem cell research are disappointed that more federal money would go to fund research they consider immoral.

Researcher Irving L. Weissman, MD, said he was shocked by the NIH's proposal, given Obama's support for putting science before ideology. In March, Obama ordered the NIH to devise rules to govern stem cell funding.

"The primary mission of the NIH is to advance biomedical research and clinical trials to better the health of the American people. Anything else is secondary to that," said Dr. Weissman, director of the Institute for Stem Cell Biology and Regenerative Medicine at the Stanford University School of Medicine in California.

The NIH rules would ban federal funding for stem cell lines derived from somatic cell nuclear transfer, also called therapeutic or research cloning. It's "a revolutionary way to look at human disease," said Dr. Weissman, president-elect of the International Society for Stem Cell Research, a nonprofit standards-setting group. He said there is no scientific reason to hold back federal funds for SCNT.

"What kind of principle would you have that you wouldn't do research using [SCNT-derived] cell lines?" said Dr. Weissman, who chaired a 2002 National Academy of Sciences panel that supported SCNT. "It would have to be a political or a personal reason."

In SCNT, the donor egg is typically fused with the nucleus of a diseased cell to create a genetically identical blastocyst. Scientists say stem cell lines could be derived from the embryo and studied to see how diseases develop and how to treat them. But the nuclear transfer process is also the first step in cloning a human embryo for reproduction, widely opposed for moral or safety reasons.

Some experts speculated that the Obama administration opted to bar funding for research cloning to skirt controversy. "It's a lot easier to frighten people with science-fiction stories about cloning than anything else," said Sean J. Morrison, PhD, director of the University of Michigan Center for Stem Cell Biology.

NIH Acting Director Raynard Kington, MD, PhD, cited the level of public backing for different research techniques as a factor in formulating the agency's guidelines. Comments on the proposed rules are due May 26 (link). The NIH will issue its final rule July 7.

"There is strong, broad support for the use of federal funds to conduct human embryonic stem cell research on cell lines derived from embryos created for reproductive purposes and no longer needed for that purpose," Dr. Kington said at a news briefing. "There is not similar broad support for using the other sources."

Several prominent research labs are doing SCNT work using private or state money, but none has yet derived a stem cell line using the technique. Dr. Kington estimated that scientists are working with 700 stem cell lines, and he predicted that many of those lines would be eligible for federal funds under the new guidelines.

The NIH spent $88 million on embryonic stem cell research in fiscal 2008. That likely would rise dramatically under the new rules, with the most recent stimulus package giving the NIH $10 billion more for biomedical research. A White House spokesman said that, consistent with Obama's commitment to putting science before politics, the NIH independently wrote guidelines according to the best available evidence.

Rules rile both sides

While some stem cell scientists and advocates were disappointed, others said the NIH made the right call.

"What they did is issue guidelines for the kinds of cell lines that are available for research," said R. Alta Charo, a professor of law and bioethics at the University of Wisconsin-Madison. "Since [SCNT-derived lines] don't exist, it doesn't make sense that they write guidelines for research it's physically incapable of funding. It's not a political issue. It's not an ethical issue. It's a logistical issue."

Opponents of human embryonic stem cell research also were upset by the NIH's proposal, though they took some comfort from the decision to bar funding for research cloning.

"It could have been worse," said David Stevens, MD, CEO of the Christian Medical & Dental Assns. "I still think that what's being done is not right, and the reason for it is there's a huge ethical difference between someone dying a natural death and taking their life. And if you consider the embryo to be a person, that's a huge issue."

The AMA supports funding human embryonic stem cell research and cheered Obama's executive order. The AMA did not comment on the NIH's draft guidelines.

Scientists also voiced concern about how the proposed rules could affect existing stem cell lines. A central element of the rules is a set of detailed informed-consent procedures for researchers to follow when obtaining embryos from potential donors. The University of Michigan's Morrison and other experts said the NIH rules, which are more stringent than guidelines promulgated by the ISSCR and other national governments, could disqualify existing stem cell lines from federal funding.

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Proposed stem cell rules

NIH funding is allowed for research on stem cell lines derived from human embryos that:

  • Were created for reproductive purposes.
  • Are no longer needed for fertility treatments.
  • Were subsequently donated for research purposes.
  • Were obtained in accordance with stringent informed-consent protocols.

NIH funding is not allowed for research:

  • On human embryos themselves. That is prohibited by the annual appropriations ban on funding such science, known as the Dickey-Wicker Amendment.
  • In which human embryonic stem cells or induced pluripotent cells are introduced into nonhuman primate blastocysts.
  • Involving the breeding of animals where the introduction of human embryonic stem cells or human-induced pluripotent stem cells may have contributed to the germ line -- genetic material that could be passed onto the next generation.
  • That uses stem cell lines derived from: IVF embryos created for research purposes; somatic cell nuclear transfer; or parthenogenesis, a method of artificially developing an unfertilized egg as if it were an embryo.

Source: "Draft National Institutes of Health Guidelines for Stem Cell Research," Federal Register, Vol. 74, No. 77, April 23

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External links

National Institutes of Health's draft guidelines for human stem cell research (link)

Draft NIH Stem Cell Guidelines Comments Form, May 26 deadline (link)

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