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Thread: Stem Cell Research Perseveres in the Midst of Funding Crisis

  1. #1
    Senior Member giambjj's Avatar
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    Thumbs up Stem Cell Research Perseveres in the Midst of Funding Crisis

    Chris Parker

    The recent legal wrangling regarding the use or prohibition of the use of federal funds in scientific research utilizing human embryonic stem cells (hESCs) has generated significant uncertainty in the stem cell research community and is very unfortunate. The ruling places current hESC research in jeopardy and casts a cloud over future projects.

    Congress should pass legislation to reverse this ruling and permit funding for hESC science. Even though the research community is moving toward the human induced pluripotent stem cell (iPSC) model introduced in 2007 by James Thomson, V.M.D., Ph.D., and Shinya Yamanaka, M.D., Ph.D., hESCs still retain utility as a benchmark for pluripotency and for differentiation protocols.

    Under the hESC ban instituted by the Bush administration, federally funded research could continue on hESC lines that had been developed before August 2001, but federal funding of research on new hESC lines was prohibited.

    The recent U.S. District Court decision, based on the Dickey-Wicker Amendment that Congress adds to budget legislation each year, is much more expansive. It prohibits federal funding of research on any hESC line regardless of when it was developed.

    Ultimately, if the ban is not overturned by Congress or upon appeal to the U.S. Court of Appeals or the U.S. Supreme Court, then federally funded hESC research is in danger of grinding to a halt.

    Numerous research projects will have to be redesigned or shut down. hESCs are the current stem cell benchmark for pluripotency to which all stem cell models are currently compared. At this time, hESCs are the stem cell benchmark for pluripotency to which all stem cell models are compared, and thus the lack of new hESC lines will ultimately inhibit progress of our understanding of pluripotency.

    In addition, the ban could have a negative impact on the development of stem cell therapeutics since virtually all in development today are hESC-based. Thus the ban could potentially slow the development of important new therapeutic breakthroughs.

    How does the ruling, if affirmed by a higher court, impact companies developing hESC-based products? hESC research will be able to proceed for now in instances where it is not directly federally funded. However, much hESC-based therapeutic R&D is based on the accumulated knowledge from federally funded basic research. Eventually, if the funding ban continues, then the decline on the rate of accumulation of new information on stem cell biology will begin to be a drag on therapeutic stem cell development as well.
    Jake's Pop

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    There has been an ongoing argument over adult v. embryonic stem cells. We are right to be concerned with the ethics.

    However, some opinion is that ASCs have proved more successful than EBCs, while admitting that there is greater potential in EBCs. Another argument against EBCs is that their primary function is to produce more and more sibling cells, and this code of instruction could lead to tumor production.

    The really confusing thing about this for the layman, is that there appear to be many research groups that use different hymn sheets.

  3. #3
    Quote Originally Posted by chris arnold View Post
    There has been an ongoing argument over adult v. embryonic stem cells. We are right to be concerned with the ethics.

    However, some opinion is that ASCs have proved more successful than EBCs, while admitting that there is greater potential in EBCs. Another argument against EBCs is that their primary function is to produce more and more sibling cells, and this code of instruction could lead to tumor production.

    The really confusing thing about this for the layman, is that there appear to be many research groups that use different hymn sheets.
    The public is unfortunately being confused by those who oppose embryonic stem cell research. It is not true that this research has been, is, or will be killing embryos. NIH will not be funding the actual derivation of the embryonic stem cells. NIH will be funding research on embryonic stem cells that have already been derived from blastocyts.

    The only cells that would be eligible for NIH funding must have been derived from excess blastocysts donated by parents who would be discarding them anyway, if they were not used for research. Hundreds of thousands of these blastocysts are being discarded each year during in vitro fertilization. The process of derivation is not being funded by NIH.

    Hundreds of embryonic stem cell lines have been derived, including 22 lines that were derived before 2001 that George W. Bush approved for NIH funding, the so-called Presidential lines. Since that time, several hundreds of additional lines have been derived. The NIH is considering which of these already derived cell lines would be eligible for study.

    The consent procedure (e.g. the parents must have given permission twice to donate the cells for research, once at the beginning of the IVF procedure and once just before the actual donation) required for NIH eligibility is so stringent right now that many of the cell lines that were funded by the NIH under George W. Bush are no longer eligible.

    The judge's decision is based on interpretation of an amendment called the Dickey-Wicker's amendment that has been appended to NIH appropriation bills since 1997. The language of the amendment has change somewhat over the years but it basically forbids the use of NIH funds to support any research that harms human embryos.

    Congress has passed other laws that explicitly and in fact encourages NIH funding of research on embryonic stem cell research. The judge apparently did not consider this law, called the Stem Cell Research Enhancement Act (SCREA) that was passed three times by Congress and vetoed twice by President George W. Bush and finally passed during the Obama administration.

    There is a general consensus amongst stem cell research advocates now that, given this judge's ruling, Congress must modify the Dickey-Wicker's amendment so that it gives explicit permission for embryonic stem cell research as defined by SCREA. Some people feel that this must be done within 2010 because the election may given the Republicans a majority in the House of Representatives.

    Wise.
    Last edited by Wise Young; 11-02-2010 at 07:40 PM.

  4. #4
    Wise, thank you for your comprehensive ansewer and explantion of the embryonic stem cell research. I've thought about the reamining 2 months of time to ammend the dickey Bill and wonder if Harkin can get it done. Your efforts and other ongoing efforts will dirve this program forward and the action of congress could put this argument to rest.

    keeping on

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    Thank You

    Many thanks Dr Young! This is a comprehensive and informative post

  6. #6
    The saddest part of the situation is that people who oppose embryonic stem cell research are giving the impression that they don't care about the people who would benefit from the stem cell research. They are not lobbying Congress to increase adult stem cell research. Instead, they are lobbying Congress and trying to convince judges to stop embryonic stem cell research.

    As I have pointed out many times, NIH is spending about $300 million per year on all human stem cell research, less than 1% of the total $30 billion of NIH funds. Only $30 million was being spent on embryonic stem cell research. The NIH is probably spending less than $100 million per year on all of spinal cord injury research.

    When you go and lobby Congress for more funding, you are told by Senators and Representatives, and their aides, that they should not and cannot advocate for specific areas of research and that we should push for an overall increase in funding of NIH. But, of course, they have have allocated targeted for many other diseases.

    Congress has long allocated many billions of dollars each year specifically for AIDS, Alzheimer's disease, cancer, anti-terrorism biomedical research, etc. Congress directly allocated billions of dollars for the Human Genome Project. Over the decades, they have created many institutes that target certain diseases.

    It is just a matter of priority. It is clear that spinal cord injury research has had a low priority with Congress. The Christopher Reeve Paralysis Act languished in Congress for nearly a decade before several hundred families with spinal cord injury pulled that legislation off the shelves and convinced Congress to pass it.

    Republicans blocked the Christopher Reeve Paralysis Act over and over again during the Bush administration. Although it was passed several times by the House of Representatives and enough votes were available in the Senate to pass it, a Republican senator put a hold on the legislation. The bill passed in the first year of the Obama administration but no funds were allocated.

    It was not clear which was worse for stem cell research, politics or economics. Politics held back the research forever 10 years. But, for the past two years, the reasons are a combination of politics and For the first 6 years of the Bush Administration, funding for stem cell research was blocked by Republicans, even though many individual Republicans supported embryonic stem cells.

    Wise.

  7. #7
    Wise, we're ---ed. To fight for funding , let alone trials, is just too massive. We're the polio victimes before the vaciine was discovered. I can't see the treatments for us to be successful in time for most of us. I feel strongly that the treatment sfor acutes will be available and will bring treatments that are not immaginable at his time.

    keeping on

  8. #8
    Quote Originally Posted by keeping on View Post
    Wise, we're ---ed. To fight for funding , let alone trials, is just too massive. We're the polio victimes before the vaciine was discovered. I can't see the treatments for us to be successful in time for most of us. I feel strongly that the treatment sfor acutes will be available and will bring treatments that are not immaginable at his time.

    keeping on
    keeping on,

    I think that people just have to continue to make noise about it. We should not sit and wait for manna from heaven, however. We need to make the manna ourselves. I don't really see many clinical trials for acutes coming up. Most of the therapies are phase 1 subacutes, in part because it is easier and cheaper in the United States to provide the therapy for patients who are in the hospital for their acute injury anyway. It is more expensive to bring chronic patients to the hospital for an elective procedure. But, we are doing it and will continue to do so. More groups will follow suit when they see that it is doable.

    Wise.

  9. #9
    I agree, the squeaky wheel definitely applies here. I recently contacted Secretary Sebeillus (sp?), appealed to her as a mother, told her the story of my 15 year old son, she also has boys. That is the only way we will get attention, pull on the heart strings of decision makers and funders. We will see if I get a reply or where it takes us.

    In the meantime, I cant wait to get to Phoenix to share ideas and learn more about advocacy. I have a BIG MOUTH just need some knowledge and direction.

  10. #10
    Wise, I respect your views and intrepretation of current events. Geron trials are for acutes; yours are for chronics. I want to believe that chronics will benefit, but really think that acutes will benefit first. Chronics can look forward to some improvements though; the question is when. It's nice to know that China and INdia will be the firsto of your trials and maybe embarass the USA in it's temppry stoppage of progress.
    good luck and I hope that chronics will get posotve news of your trials and will able to benefit from your therapies.

    keeping on

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