It's disappointing that the new NIH Draft Guidelines seem more restrictive than the earlier ones, by limiting NIH funded research to research using only excess embryos from fertility clinics and  prohibiting federal funding of SCNT to create new stem cells. 
The earlier guidelines , issued in 2000 , through legal interpretation and support by then NIH director Harold Varmus allowed for NIH funding for  research  on newly derived human  embryonic stem cells (not from fertillity clinics, but the NIH still  could not fund  research to  produce the  cells.  The Clinton  administration backed  the  policy  that federal  funds  could be  used for  research on  human embryonic  stem cells  obtained from the  private sector. These guidelines were abandoned before any funding could take place when Bush took office in 2001.
These new draft Guidelines are more restrictive. They would allow funding for research using only those human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose." 
They also cite the Dickey-Wicker amendment, which complicates the issue - it prohibits NIH funding of the derivation of stem cells from human embryos  by the annual appropriations ban on funding of human embryo research .
Another issue is that the bills passed by two Congresses during the Bush years (and vetoed by Bush) to lift his restrictiions on funding ESCR, also only addressed excess IVF   embryos. This is what we asked for. Funding for therapeutic cloning research (SCNT) has not really been strongly advocated for in the last few years. Could this be a factor?
The draft guidelines are online at:
http://stemcells.nih.gov/policy/2009draft
There is a 30 day public response period. By April 24th, the guidelines should be published in the Federal Register and a URL will be availaable to send comments to. More information should be coming from PAN and CAMR in the next few days, with a request to send your comments to the NIH. It will be important that all of our voices are heard. 
-- Original Message ----------
From: rayilynlee <[log in to unmask]>
To: [log in to unmask]
Subject: New NIH Guidelines thwart  SCNT
Date: Sat, 18 Apr 2009 12:14:35 -0700

Proposed NIH Stem Cell Guidelines Dismay Leading Stanford Researcher
 a.. Friday April 17, 2009, 6:39 pm EDT 
STANFORD, Calif.--(BUSINESS WIRE)--The director of stem cell research at the Stanford University School of Medicine says he is troubled by draft guidelines issued today by the National Institutes of Health that would prohibit federal funding for research on stem cell lines created through a technique sometimes referred to as "therapeutic cloning" or somatic cell nuclear transfer.

Irving Weissman, MD, director of Stanford's Institute for Stem Cell Biology and Regenerative Medicine, said the SCNT technique is one way to create disease-specific human embryonic stem cell lines on which to conduct research and test therapies. He also took issue with the assertion that the NIH consulted existing guidelines from the National Academy of Sciences and the International Society for Stem Cell Research-both of which sanction the use of SCNT-derived cell lines-in coming up with its draft recommendations.

"Instead of facts, the NIH placed its own version of ethics in place of the president's clear proclamation," said Weissman, the Virginia & D.K. Ludwig Professor for Clinical Investigation in Cancer Research. "As head of the National Academy of Sciences' panel that unanimously endorsed research using SCNT, and as a drafter of the guidelines for the International Society for Stem Cell Research, I know that this suggested ban on federal funding of SCNT-derived human embryonic stem cell lines is against our policies and against President Obama's March 9 comments. The NIH has not served its president well."

On March 9, President Barack Obama signed an executive order removing previous restrictions on the use of federal funds for research on any human embryonic stem cell line derived after Aug. 9, 2001. He used the ceremony to remark that it is important to ensure "that scientific data is never distorted or concealed to serve a political agenda-and that we make scientific decisions based on facts, not ideology."

In announcing the draft guidelines, acting NIH director Raynard Kington, MD, PhD, justified the restriction in part by saying that there is a lack of scientific consensus as to the necessity of funding lines derived by SCNT and that, although the technique has been used to create many embryonic stem cell lines in animals, such human embryonic stem cell lines have not yet been documented.

"We believe there is strong, broad public and scientific support for the use of federal funds for research on cell lines from embryos derived through in vitro fertilization for reproductive purposes that would not otherwise be used," said Kington, noting that similar legislation had twice passed both the House and Senate only to be vetoed by former President George W. Bush. "We do not see similar broad support for using federal funding for research on cell lines from other sources."

The somatic cell nuclear transfer technique involves removing the nucleus from an egg cell and replacing it with a nucleus from a different cell in order to create an embryonic stem cell line genetically identical to the donor nucleus. In the case of a donor who suffers from a condition like Parkinson's disease, the SCNT process would yield an embryonic stem cell line that could be used to test specific therapies for that patient.

If the draft guidelines are adopted, they would underscore the continued need for the California Institute for Regenerative Medicine, which has funded grants to several scientists working to create specific human embryonic stem cell lines for research purposes. The institute was established in 2005 by Proposition 71 to counteract the effect of President Bush's limits on federal funding of such research.

"Methods like SCNT were specifically sanctioned by Prop. 71," said Geoff Lomax, PhD, the senior officer to the state institute's Standards Working Group, which was instituted to develop ethical guidelines for the use of embryos in CIRM-funded research. "These potential restrictions on the range of research materials available for federal funding ensure that CIRM will continue to play a unique role in the world of stem cell research."

"For certain types of research, CIRM could remain very important," concurred Renee Reijo Pera, PhD, director of Stanford's Center for Human Embryonic Stem Cell Research and Education. Reijo Pera said she had expected the NIH guidelines to be somewhat conservative, particularly where SCNT is concerned.

"I am happy that these are draft guidelines," said Weissman, who noted that the NIH did not solicit input from either the National Academy of Sciences or the International Society for Stem Cell Research during the consensus process. "I'd like to remind the NIH of the principles enunciated by the president on March 9. Research in this area is moving very fast, and it's not possible to say whether advances will come from work on adult-derived iPS cells or from embryonic stem cells created by nuclear transfer. Policy needs to be developed as the field develops, rather than precluding something based on ideology."

The proposed NIH guidelines will be available for public comment for 30 days, and the final guidelines will be released by the agency on or before July 7. They can be viewed at http://stemcells.nih.gov/policy/2009draft. Comments can be mailed, or submitted electronically after the guidelines are published in the Federal Register by April 24.

The Stanford University School of Medicine consistently ranks among the nation's top 10 medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children's Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.


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