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New Federal Stem Cell Rules Would Hinder Existing Research, Consumer Group Warns
Date:5/20/2009

NIH Should Fix Standards to Allow Use of Current Stem Cell Lines

SANTA MONICA, Calif., May 20 /PRNewswire-USNewswire/ -- -- Regulations governing stem cell research proposed by the Obama Administration -- unless modified before final implementation on July 1 -- prohibit federal funding of important research that had received funding under the Bush Administration, Consumer Watchdog said today. The nonpartisan, nonprofit group called on the National Institutes of Health to change the draft regulations.

On March 9, President Obama signed an executive order intended to lift restrictions on federal funding of human embryonic stem cell research. As part of the order, the National Institutes of Health (NIH) were directed to develop regulations "to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law."

"Most of us were heartened when President Obama lifted Bush Administration restrictions on funding stem cell research, but the perverse effect of these proposed NIH rules is that the limited research scientists were able to conduct under Bush will now be ineligible for federal funding," said John M. Simpson, Consumer Watchdog's Stem Cell Project Director. "Certainly this is not what President Obama intended and the regulations must be modified."

Bush allowed the NIH to fund research on embryonic stem cell lines that were derived before 9 pm, Aug. 9, 2001. In practice there were about 20 lines that were available to scientists that qualified for federal money. Embryonic stem cells, which have the potential to develop into virtually any cell in the body, are derived from embryos left over from in vitro fertilization (IVF) treatments and would otherwise be destroyed.

The Bush approved stem cell lines were derived before the proposed NIH rules and do not meet some of their specific technical standards. In addition some stem cell lines derived with state or private funding or in other countries since 2001 don't meet some of the technical specifications of the proposed NIH rules.

For instance, under the new NIH guidelines donors would have to be told that the embryos would be used for stem cell research. When some of the earlier lines were derived, donors were told more generically that the embryos would be used for research. The new regulations call for an explicit statement that the results of using the human embryonic stem cells may have commercial potential and that the donor would not receive any financial benefit from such commercial development. They also would have to be told that the stem cell lines derived from the donated embryos might be maintained for many years.

"The NIH guidelines set the highest standards and make sense going forward," said Simpson. "However the earlier lines were derived under Institutional Review Board (IRB) supervision, following ethical guidelines then in place, suggested by such organizations as the National Academies of Science, or covered by state regulations like those of the California Institute of Regenerative Medicine. It would be wrong to preclude them from federal funding going forward. You can't hold someone to standards that didn't exist when these lines were derived in good faith according to then existing standards."

Consumer Watchdog supports modifications proposed by the California Institute for Regenerative Medicine (CIRM) and suggestions raised by the Interstate Alliance on Stem Cell Research.

The draft NIH regulations are open for public comment until May 26. Comments may be made on line here: http://nihoerextra.nih.gov/stem_cells/add.htm .

Read the proposed regulations here: http://edocket.access.gpo.gov/2009/E9-9313.htm

Read CIRM's comments here: http://www.cirm.ca.gov/sites/default/files/NIH%20Comments%20NIH_guidelines%20v12_5_14.pdf

Read the Interstate Alliance on Stem Cell Research discussion of the regulations here: http://www.iascr.org/docs/May2009/IASCR_Summary_NIH_Discussion.pdf

Consumer Watchdog, formerly the Foundation for Taxpayer and Consumer Rights is a nonprofit, nonpartisan organization with offices in Washington, DC and Santa Monica, Ca. Our website is www.consumerwatchdog.org .


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SOURCE Consumer Watchdog
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