NIH Committee Recommends Withholding Federal Support For 47 Stem Cell Lines

[barbara]

By all means, let's spend a lot of time and money on this!



The NIH Advisory Committee to Director Francis Collins recommended that the agency reject federal research funding for 47 embryonic stem cell lines because of a sentence of legal language in a contract signed by embryo donors, USA Today reports. RGI, "one of the world's leading performers of pre-implantation genetic diagnosis," received the stem cells from clients who donated unwanted embryos for research, USA Today reports. According to USA Today, NIH has not yet issued Collins' decision on the panel's recommendations.
Shortly after his inauguration, President Obama lifted many of President George W. Bush's restrictions on federal funding of embryonic stem cell research that had limited federal funding for research to 21 existing lines. Under Obama's policy, the number of embryonic stem cell lines eligible for federal research funds has more than tripled to 67 lines, according to the NIH Human Embryonic Stem Cell Registry.

Members of the advisory committee objected to a sentence in RGI's donation contracts that they said creates "exculpatory" language barring patients from subsequently filing lawsuits for negligence or harm -- language forbidden under federal research rules. The panel recommended approval of six lines from other institutions.

Jeffrey Botkin, who leads the committee's stem cell group, said RGI could track down donors from six or seven years ago and ask them to sign a new consent form with approved language. RGI's Oleg Verlinsky said federal patient privacy laws forbid that option because the embryos were carefully stripped of identifying information about the donors. He said that "[w]ithout federal support, no one will use [the lines] for research," adding, "They will remain frozen, or discarded, forever" (Vergano, USA Today, 6/11).



? 2010 National Partnership for Women & Families. All rights reserved.

 

[barbara]

NIH rejects use of dozens of stem cell colonies by federally funded researchers

The NIH's strict new ethical guidelines seem like they belong in the Bush administration. I am surprised to see this happening and think in this instance that what has happened is a set back, not only monetarily, but research wise as well. I would like to know who the group of experts were.


By Rob Stein
Washington Post Staff Writer
Tuesday, June 22, 2010
The National Institutes of Health rejected Monday a request to approve dozens of colonies of human embryonic stem cells for use by federally funded researchers. Scientists had been hoping the lines would become available for their research under a new policy from the Obama administration.

But NIH Director Francis Collins agreed with a group of experts gathered by NIH that use of the stem cell lines violated strict new ethical guidelines.

The availability of the lines, which were created by the private infertility clinic Reproductive Genetics Institute in Chicago, had been eagerly awaited because they carry mutations for a wide variety of diseases, including cystic fibrosis, Huntington's disease and muscular dystrophy. Scientists hope studying them will yield a wealth of information about those and other diseases, leading to new treatments.

The lines had been obtained from embryos donated by couples who were undergoing treatment for infertility and had decided not to use them because tests showed the embryos carried genetic defects.

But the advisory panel found that consent forms permitting use of the embryos contained unusually broad language and those who signed the forms gave up all rights to sue the clinic for any reason.

"The NIH guidelines for reviewing stem cell lines for federal funding were set up to adhere rigorously to the well-established norms for informed consent," Collins said in a statement. "It was frankly rather painful for my expert advisory committee to recommend against approval of 47 additional lines from RGI because of a consent problem, but rigorous guidelines are only meaningful if they are rigorously applied."

The decision means that only researchers with private funding will be able to continue working on the lines.

"We are the only institution that has established this unique resource for the world," said Anver Kuliev, the institute's director of research. "Much more progress might occur . . . if they were approved by the NIH."

Collins did approve eight other new lines, bringing to 75 the total number of lines now eligible for federal funding.



As president, George W. Bush had restricted federal funding to 21 lines of cells that were already in existence in 2001 to prevent taxpayer dollars from encouraging the destruction of more embryos to create additional lines.

Critics of human embryonic stem cell research praised Bush's move, saying that destroying embryos to advance academic study is immoral. But many scientists condemned the restrictions, saying they were hindering research that could lead to cures for Alzheimer's disease, diabetes, paralysis and other ailments.

Soon after taking office, President Obama announced that he was lifting his predecessor's restrictions. But some scientists have complained that the new policy remained too restrictive because of the NIH's strict new ethical guidelines, which among other things were designed to make sure couples were advised of other options.