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Published online 8 April 2008 | Nature 452, 670- (2008) | doi:10.1038/452670a

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FDA to vet embryonic stem cells’ safety

US agency holds first public hearings to assess therapies.

Investors, biotech companies and other stem-cell stakeholders are meeting in Gaithersburg, Maryland, this week for the US Food and Drug Administration’s (FDA’s) first public hearing on the safety of therapies that use human embryonic stem cells.

The meeting is “a big deal”, says Michael Werner, former chief of policy at the Biotechnology Industry Organization in Washington DC.

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  • So many opponents of stem cell research have argued, "If embryonic stem cells are so great, then how come we have so many more therapies from adult stem cells?" They don't realize that while adult stem cells have been available for research since the 1960's, embryonics weren't isolated until 1998. They also don't realize that a timeline of fifteen or even twenty years from petri dish to patient isn't remotely unusual. And here we are only ten years later. I don't think the technology's ready, but we're well on our way.

    • 09 Apr, 2008
    • Posted by: Diana Flynn
  • Has medical science fallen into the politically correct abyss of requiring near zero risk of a procedure with so much promise? If one were to collect all previous medical scientific findings together, this sum of previous knowledge would pale in comparison with the potential of recent hESC discoveries that suggest the science could change all the previous paradigms of medical practice and possibly the definitions of life. Even though the anathema of design by committee is well understood, there remains great risk that this remarkable science will be dogmatically chewed to death by government tinkering in the name of safety and social mores.

    • 09 Apr, 2008
    • Posted by: Don Carpenter