The US regulator, the Food and Drug Administration (FDA), has approved the first trials in humans of embryonic stem cell research.
The approval came just 2 days after the inauguration of President Barack Obama, causing some to speculate that the new administration is set to remove some of the financial obstacles faced by research in this area. Soon after taking office for his second term in 2001, President George W Bush announced, 9th August, a restriction on federal funding for embryonic stem-cell research. Although not a ban of the research per se, the lack of federal funding was variously described as leading to more or less the same result. In 2oo6, President Bush vetoed H.R 810 / S 471 to amend the Public Health Service Act to provide for human embryonic stem cell research. President Barack Obama had been expected to reverse the ban soon after taking office this year.
The approval authorises the US biotech company, Geron, to commence clinical trials of GRNOPC1 in patients with severe spinal cord injuries. Upon the completion of these trials, the company will be required to demonstrate efficacy before marketing authorisation can be granted. The Financial Times reports that such commercial availability could be achieved within 3 years. In a news release, Geron describes the approval as "A new chapter in medical therapeutics — one that reaches beyond pills to a new level of healing."
The Christopher and Dana Reeve Foundation responded to the announcement in a news release welcoming the decision. The actor Christopher Reeve sustained serious spinal cord injuries in a horse-riding accident, 27th May 1995. Shortly before his death, 10 October 2004, Reeve spoke on the US stem cell debate saying, "No obstacle should stand in the way of responsible investigation."
1 comment:
Common sense and rational thinking appear to be overshadowed by a relatively small percentage of Americans, a group that prefers to adhere to dogma, whether logical or not.
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