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Thread: court blocks fedearl funding of stem cells resaerch

  1. #1
    Senior Member giambjj's Avatar
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    Thumbs down court blocks fedearl funding of stem cells resaerch

    A federal district judge has put a temporary block on federal funding for human embryonic stem cell (ESC) research, which was okayed by the Obama administration last year. The judge agreed with plaintiffs in a lawsuit contending that such research is illegal because it destroys embryos.

    In August 2009, a number of Christian groups filed a lawsuit against the HHS and the NIH, charging that the Obama administration's ESC policy violated the Dickey-Wicker Amendment. The law, passed annually by Congress, bans federal financing for any “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death.” The suit was dismissed because the court felt that the plaintiffs had no real chance of winning.

    The case was appealed by James Sherley, M.D., Ph.D., an adult stem cell researcher at Boston Biomedical Research Institute, and Theresa Deisher, Ph.D., managing member and R&D director of AVM Biotechnology. To justify their standing as plaintiffs, they argued that Congress’ policy to support ESC research caused increased competition for adult stem cell researchers.

    In June the Court of Appeals reversed the previous decision, holding that plaintiffs Drs. Sherley and Deisher have standing under the competitor standing doctrine. The matter was remanded to the Federal District Court for the District of Columbia for consideration of the plaintiffs’ motion for a preliminary injunction. Yesterday chief judge Royce C. Lamberth went on to issue a temporary halt on federal funding of ESC research.

    Since 1999, defendants determined that the Dickey-Wicker Amendment was not applicable to ESC research because ESCs are not embryos. They also made the distinction that derivation of ESCs from embryos results in destruction of embryos but research on ESCs did not. This argument was once again leveraged by the NIH and HHS. They also argued that the term “research” in the Dickey-Wicker Amendment is ambiguous.

    Judge Lamberth, however, found that the distinction between ESC research and embryo destruction could not be made. “ESC research is clearly research in which an embryo is destroyed. To conduct ESC research, ESCs must be derived from an embryo. The process of deriving ESCs from an embryo results in the destruction of the embryo. Thus, ESC research necessarily depends upon the destruction of a human embryo,” judge Lamberth noted.

    He also ruled that there was nothing ambiguous about the word “research” in the Dickey-Wicker Amendment. “Contrary to defendants’ argument, the term ‘research’ as used in the Dickey-Wicker Amendment has only one meaning, i.e., a systematic investigation including research, development, testing, and evaluation designed to develop or contribute to generalizable knowledge.”

    After an initial review of judge Lamberth's decision, Lisa A. Haile, co-chair of the global life sciences practice at international law firm DLA Piper, wonders whether the Dickey-Wicker Amendment should be overturned or clarified given that much ESC research uses excess embryos from in vitro fertilization clinics that would likely get destroyed anyway.
    Jake's Pop

  2. #2
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    things can be killed by delay

  3. #3
    Giambjj,

    It is so sad that this fiasco continues. A little history is useful. A decade ago, in January 2001, when he came into office, George W. Bush stopped the Clinton plan for NIH to fund some embryonic stem cell research. The Clinton plan had taken four year to rationalize and implement, after many meetings with churches leaders, ethicists, and scientists to figure out a way to allow scientists to study the most fundamental of stem cells. That policy was derived to ensure that the NIH policy would meet with everybody's objections. For example, only embryonic stem cells derived from fertilized eggs that are created for the purposes of procreation, would be destroyed anyway, and donated by the parents under strict informed consent conditions could be studied with NIH money. NIH itself would not fund such derivations. The cells themselves would not be used for therapy but only for scientific studies.

    Bush determined that only cells that had been derived before August 2001 could be studied by NIH and essentially stopped all NIH funding of new embryonic stem cell lines or methods to derive stem cells. At the time, NIH estimated that there were perhaps 60-something lines around the world. However, it turned out that only about 21 lines were verified and available for study. In practice, really only two of these cells lines were studied by scientists, the original H1 and H9 lines, the derivation of which were funded by Geron and the patents held by Wicell (the University of Wisconsin Alumni Association group that was formed to license these cells and stem cell products derived from the research).

    The study of embryonic stem cells is important for several reasons. First and foremost, embryonic stem cells are responsible for the development of embryos. They are pluripotent and need only each other to create the embryo. Therefore, understanding how they do so will provide important insights into why these cells are pluripotent and what signals tells these cells to create the over 400 different cells that populate our bodies. Restriction of NIH funding of embryonic stem cells is tantamount to saying that we should stop studying embryonic development and leave such studies to scientists in other countries. Second, embryonic stem cell lines will give us populations of stem cells and other human cells to study in the laboratory without having to kill animals or harvest fetuses to do so. At the present, in order to study fetal stem cells, one has to kill animals or use aborted fetuses. Contrary to what is being claimed by opponents of embryonic stem cell research, availability of embryonic stem cells would reduce the use of fetal cells. Third, of course, embryonic stem cells may provide a source of transplantable cells for the treatment of many diseases, particularly of injuries of the central nervous system and many other conditions.

    By studying the limited cells that Bush allowed, U.S. scientists identified several pluripotency genes that were expressed by embryonic stem cells, i.e. the Ox and Sox family of genes. By 2007, Yamanaka in Japan identified four genes that could be used to make adult skin cells (fibroblasts) form embryonic stem cells in mice and then in human. These so-called induced pluripotent stem (IPS) cells soon became the rage and, because NIH funding of embryonic stem cells was not available, this pushed the rapid development of IPS cells. By 2008, it was clear that we can reprogram cells to become many different kinds of cells, including neurons and even insulin-producing cells. Because of the self-imposed limitations on embryonic stem cells in the United States, the lead in stem cell research went overseas.

    Obama campaigned on the promise to reverse Bush's embryonic stem cell policy and to provide an enlightened stem cell policy in this country. Unfortunately, he failed to provide leadership on this issue. In April 2009, he rescinded Bush's executive order limiting NIH funding of embryonic stem cells to lines derived before August 2001 and ordered NIH to come up with a better policy that followed the law. NIH took over 6 months to come up with a policy that was implemented by the beginning of 2010. This policy developed strict informed consent criteria for embryonic stem cells, explicitly and unnecessarily denied alternative routes to creating human embryonic stem cells that were available (such as parthenogenesis, somatic cell nuclear cloning), put into a place procedures for a stem cell bank that would contain the cells that NIH could fund studies of. Many stem cells lines, including the ones approved by Bush, were excluded.

    During the first two years of its administration, when both houses of Congress and the White House were controlled by democrats, the Obama administration did not make any moves to rescind the Wicker-Dickey amendment that forbade NIH to fund any research that would harm human embryos. This amendment which was first appended to NIH appropriations in the 1990's could and should have been repealed. But, nothing was done about it. Three years into Obama's administration, the NIH is just beginning to fund embryonic stem cell research. The number of cells that are available for study are still limited. In the meantime, science has moved away from embryonic stem cell research into reprogramming of cells. Induced pluripotent stem cells and neuronal progenitor cells have become all the rage. Now, Judge Lamberth rules that embryonic stem cell research is illegal. While the Obama administration is appealing that decision, NIH funding of embryonic stem cell research is essentially dead.

    Wise.



    Quote Originally Posted by giambjj View Post
    A federal district judge has put a temporary block on federal funding for human embryonic stem cell (ESC) research, which was okayed by the Obama administration last year. The judge agreed with plaintiffs in a lawsuit contending that such research is illegal because it destroys embryos.

    In August 2009, a number of Christian groups filed a lawsuit against the HHS and the NIH, charging that the Obama administration's ESC policy violated the Dickey-Wicker Amendment. The law, passed annually by Congress, bans federal financing for any “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death.” The suit was dismissed because the court felt that the plaintiffs had no real chance of winning.

    The case was appealed by James Sherley, M.D., Ph.D., an adult stem cell researcher at Boston Biomedical Research Institute, and Theresa Deisher, Ph.D., managing member and R&D director of AVM Biotechnology. To justify their standing as plaintiffs, they argued that Congress’ policy to support ESC research caused increased competition for adult stem cell researchers.

    In June the Court of Appeals reversed the previous decision, holding that plaintiffs Drs. Sherley and Deisher have standing under the competitor standing doctrine. The matter was remanded to the Federal District Court for the District of Columbia for consideration of the plaintiffs’ motion for a preliminary injunction. Yesterday chief judge Royce C. Lamberth went on to issue a temporary halt on federal funding of ESC research.

    Since 1999, defendants determined that the Dickey-Wicker Amendment was not applicable to ESC research because ESCs are not embryos. They also made the distinction that derivation of ESCs from embryos results in destruction of embryos but research on ESCs did not. This argument was once again leveraged by the NIH and HHS. They also argued that the term “research” in the Dickey-Wicker Amendment is ambiguous.

    Judge Lamberth, however, found that the distinction between ESC research and embryo destruction could not be made. “ESC research is clearly research in which an embryo is destroyed. To conduct ESC research, ESCs must be derived from an embryo. The process of deriving ESCs from an embryo results in the destruction of the embryo. Thus, ESC research necessarily depends upon the destruction of a human embryo,” judge Lamberth noted.

    He also ruled that there was nothing ambiguous about the word “research” in the Dickey-Wicker Amendment. “Contrary to defendants’ argument, the term ‘research’ as used in the Dickey-Wicker Amendment has only one meaning, i.e., a systematic investigation including research, development, testing, and evaluation designed to develop or contribute to generalizable knowledge.”

    After an initial review of judge Lamberth's decision, Lisa A. Haile, co-chair of the global life sciences practice at international law firm DLA Piper, wonders whether the Dickey-Wicker Amendment should be overturned or clarified given that much ESC research uses excess embryos from in vitro fertilization clinics that would likely get destroyed anyway.

  4. #4
    Wise, the current political climate and the ineptitude of many Reublicans would not doubt lead this conversation nowhere. their voices would imminate loudly and nothing would get done. i agree that Obama missed the opportunity to move ahead on this matter. the lame duck session foretold the future by not even bringing the subject up. Sen Harkin, though powerful and influentil, is not enought to break the inpasse. the private fundign that you've spoken to in the past seems to be the avenue of progress at this time. It would seem logical that sucess of some of the trials would gain momentum for funding and investing by the private sector.

    keeping on

  5. #5
    I just noticed a thumbs down on this thread. Is this referring to my entry or to he thread in general? Also, who puts the thumbs down on the thread; in other words , who makes that judgement.


    keeping on

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