The first Congressional hearing on stem cells since 2001 came together suddenly. Representative Diana DeGette (Democrat, Colorado), who has already put together twice-vetoed legislation promoting embryonic stem cell research, said she was planning to put forth new legislation that could include a regulatory role for the National Institutes of Health, in Bethesda, Maryland, that might extend to research not funded by the agency.

The goal is to lift the federal funding ban on embryonic stem (ES) cells created after August 2001 and also set up the National Institutes of Health (NIH) as what DeGette called a “key player” in a new system for ethical oversight of all cell-based research.

“All this private and state development is being done without ethical oversight,” said DeGette's spokesperson, Kristofer Eisenla. “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 could be a huge expansion of the NIH'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, in Baltimore, Maryland, 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 discussions on the guidelines drafted by the National Academies of Science and research institutions' use of ES 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 that she had been trying to bring the stem cell hearing before the Committee for years, and the intention was not to bring anything before President Bush but to lay the groundwork for future legislation.

The hearing was scheduled late last week when another one was cancelled. Coincidentally, it was just two days after the NIH 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 ES cell research and Republicans stating that, so far, adult stem cells are the only type that have been used successfully in therapy. A report from BioWorld quotes George Daley of Harvard University, in Cambridge, Massachusetts, as saying that adult stem cells have been around for 40 years and ES cells for a decade, to make the point that embryonic stem cells have not been as thoroughly studied.

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 seem much more likely to be amenable to ES cell–based therapies, whereas blood-derived stem cells are more effective for treating others, particularly 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 [adult] cells won't be very helpful.”