Legislator proposes NIH provide "ethical oversight" for all US stem-cell research
The first Congressional hearing on stem cells in years came together suddenly. Once called, Representative Diana DeGette (a Democrat from Colorado), who’d previously put together twice-vetoed legislation promoting stem cells said she was planning to put forward another version, one that could include a regulatory role for the NIH, even over research it did not fund.
The goal is to lift the federal funding ban on embryonic stem cells created after August 2001 and also set up the National Institutes of Health as a “key player” in a new system for ethical oversight over all cell-based research.
“All this private and state development is being done without ethical oversight,” DeGette’s spokesperson Kristofer Eisenla told me. “A lot of the substance of the bill is still in development, but the overall goal is that all cell-based research would be done under strict ethical guidelines that would be overseen by the NIH.”
How that would play out is still unclear, but it ould be a huge expansion of the Institute’s role. “Historically, the NIH does not have a regulatory role in research, that’s the FDA’s jurisdiction. It could create a very different dynamic [between scientists and the NIH],” said Michael Werner, head of a consultancy specializing in legislative issues affecting biotech. “All stakeholders want to make sure that research is done ethically and appropriately. We need more details of what the Congresswoman is proposing.”
The title of the hearing was “Stem Cell Science: The Foundation for Future Cures.” John Gearhart, a professor of medicine at John Hopkins University, said that he and others testifying before the committee had submitted testimony on that topic and had not known that DeGette would be proposing an oversight role. Otherwise, he said, there could have been discussion on the guidelines drafted by the National Academies of Science and research institutions' use of embryonic stem cell research oversight (ESCRO) committees. "We did not have the opportunity to respond to her, that all institutions are complying with ESCRO guidelines. We’re not just doing what we want."
DeGette’s spokesperson said that the Representative had been trying to bring the stem-cell hearing before the Committee for years, and that the intention was not to bring anything before President Bush but to lay groundwork for future legislation.
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The hearing was scheduled late last week when another one was cancelled. Coincidentally, it was just two days after the National Institutes of Health had held a long-scheduled meeting on the challenges and promises of cell-based therapies.
Reports from the hearing said that conversation broke down mainly along party lines, with Democrats interested in scientific advances from embryonic stem cell research and Republicans stating that only adult stem cells were so far the only type that had been used in therapy. A report from BioWorld quotes Harvard’s George Daley that adult stem cells have been around for 40 years and embryonic stem cells around for a decade.
Story Landis, head of the NIH Stem Cell Task Force said that if there was any take-home lesson from the symposium, it was that the best source of cells for cell therapies would depend on the disease. For example, neurodegenerative diseases seemed much more likely to be amenable to work from embryonic stem cells, while blood-derived stem cells were effective with some blood disorders.
“It’s clear that adult stem cells are being used in approved trials or early stage clinical trials and other cases where it’s clear that those cells won’t be very helpful.”