Special report: Regenerative medicine looks East

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专题报告: 再生医学看起来东部

Brendon Nafziger, DOTmed News Associate Editor | July 08, 2011
From the April 2011 issue of HealthCare Business News magazine

Here, the struggle moved from the White House to the court house, as a lawsuit was filed against the Obama Administration, claiming the policy violated the Dickey-Wicker Amendment, a rider to a budget bill first passed in 1996 and renewed every year since then, which forbids federal funds to be used on research which destroys human embryos.

It was this lawsuit, filed actually by two adult stem cell researchers, that would make scientists sweat. That’s because on August 23, 2010, U.S. District Court Judge Royce Lamberth granted the request of the plaintiffs for an injunction stopping Obama’s new policy. As a result, the National Institutes of Health temporarily suspended funding and reviews of new human embryonic stem cell research proposals and cell lines.

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True, a little over two weeks later, the U.S. Court of Appeals for the District of Columbia overturned the injunction, letting the NIH funding continue. But the final outcome – expected any day now – is anything but certain, “placing some scientists in the situation of checking the news each day to determine the legal status of their research,” according to Aaron D. Levine, a public policy researcher with the Georgia Institute of Technology in Atlanta, who has investigated the issue (and whose research into its history helped inform the previous summary).

Levine’s research also suggests this uncertainty seems to have had a fairly substantial impact on the U.S. industry, contrary to the opinion of Judge Lamberth. When granting the injunction, he argued that the adult stem cells researchers would be hurt by the added competition for federal funding, but that embryonic cell researchers wouldn’t be harmed by returning to the “status quo.”

But in a study published earlier this year in the journal Cell: Stem Cell, Levine found the judge was probably wrong. “Rather than simply preserving the status quo, this injunction substantively changed the playing field,” Levine wrote.

In his study, Levine relied on a survey of 370 stem cell scientists. He found those working with human embryonic cells were hit hardest: 75 percent said the temporary ban affected their research, with one-quarter deeming the impact substantial. Nearly half said policy uncertainty also affected their work.

Interestingly, 41 percent of stem cell scientists who didn’t work with human embryonic stem cells also said the temporary ban affected their research, with one out of 10 of these saying the effects were moderate or substantial.

“No one said, ‘Here was a project I was working on that was exciting that I stopped,’” Levine told DOTmed News. “But some people said if next round of lawsuits stopped federal funding, they wouldn’t be able to do [the research].”

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