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Posted Friday, June 05, 2009 12:17 PM

Breaking: Almost 50,000 Individuals Weigh In On Proposed Stem Cell Guidelines

Newsweek
by Claudia Kalb

This just in: NEWSWEEK has learned that in the one-month period allotted by the National Institute of Health, the NIH received 49,015 comments in response to its draft guidelines for human stem cell research. Between April and May, remarks poured in from all over the country and from a wide variety of interested parties: stem cell scientists, religious organizations and the general public.

There has been something of a collective mood swing among stem cell scientists this year. Researchers were ebullient when President Obama lifted Bush-era restrictions on federal funding for embryonic stem cell research in March. But many were hugely disappointed when the NIH’s draft guidelines came out a month later. Two major concerns: first, the government has proposed very specific standards for the informed consent process—i.e. what couples need to know before they agree to donate their frozen embryos to research. Many of the lines developed from human embryos over the last decade would not meet these stringent new standards, and research using those cells would therefore be ineligible for government money. The International Society for Stem Cell Research (ISSCR) submitted a letter saying that researchers shouldn’t have to start from scratch. “It is critical that a mechanism be developed to ensure that the past ten years of scientific progress with these lines not be lost to federally-funded research,” the ISSCR wrote. The guidelines also rule out somatic cell nuclear transfer (SCNT) or so-called therapeutic cloning. Scientists want to use SCNT to create cell lines that have genetic conditions built in, which they say would allow them to study diseases as they develop and ideally create more targeted ways to treat them.

Religious groups had their own take. The United States Conference of Catholic Bishops argued in their letter that other stem cell research, including adult stem cells and newer induced pluripotent stem cells (iPS cells), show great promise, and that destroying human embryos is morally flawed

The NIH will be reviewing the comments over the next few weeks and expects to release its final guidelines no later than July 7. Fireworks expected one way or the other. Stay tuned.

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Member Comments

Posted By: bird5 (June 5, 2009 at 3:06 PM)

There is a group of physicians, patients and other interested people working together to get treatment with adult stem cells legalized in the U.S. as it should be. The organization was formed in response to the Food and Drug Administration's (FDA) recent position that the adult stem cells found in everyone’s body are drugs. A person's cells (autologous) should be their own and NOT regulated by the FDA. That is one of the major reasons why most stem cell clinics are overseas. This stance is ridiculous and is costing millions of lives while sick Americans wait for the use of their own stem cells which would improve their quality of life. The FDA is not protecting us, but hurting us. Please ask your family and friends to sign up ("JOIN"), and get as many doctors to sign up as well. Please see The American Stem Cell Therapy Association (ASCTA) site and the associated Safe Stem Cells Now patient site. If enough people sign up and show a protest to this thing, the FDA will have to back down. They have no right to claim your own tissue is a "drug" to be regulated by them in the first place.

Patient Site: http://www.safestemcells.org

Physician Site: http://www.stemcelldocs.org