Jamie's Policy

Policy Proposal for Funding of Stem Cell Research

Human stem cells are unspecialized cells that have the ability to differentiate into almost any of the specialized tissue types in the human body. There are two primary types of human stem cells: adult stem cells (ASC) and embryonic stem cells (ESC). ASC are found in most tissue types, including nerve, skeletal muscle, bone marrow, placenta, and umbilical cord blood (de Wert & Mummery, 2003). On the other hand, ESC exist only in embryos. In order to obtain ESC, the embryo must be destroyed, raising ethical questions about the value of human life at this stage of human development. There has been much debate in the United States about research involving stem cells, especially in regards to government spending on this research. As more is being discovered about the properties of ASC, the current United States policy and funding distribution in regards to stem cell research needs to be altered in such a way as to promote the increased study for therapeutic uses of ASC.
August 9, 2001, President Bush established new parameters for the distribution of government funds for stem cell research. Under this policy, government funds for ESC research could only go to stem cell lines that were: established before 9:00 pm Eastern Daylight Time August 9, 2001; derived from embryos originally created for reproductive purposes and were no longer needed; and donated deliberately, without monetary incentives (Stem Cell Information, 2006). In response to this policy, the National Institutes of Health (NIH) created a Human Embryonic Stem Cell Registry. This registry lists seventy-two cell lines that meet the president’s requirements. Researchers seeking government funding for ESC research must use one of these cell lines as their source for ESC (McLellan, 2001). Some of these lines, however, are not actually independent lines, but are instead duplicates of one another, which reduces their variability. This limited flexibility even further diminishes the potential of ESC.
In the year 2007, the NIH allocated 657 million dollars to stem cell research. Of that $657 million, $42 million went to human ESC research, $203 million for human ASC research, $106 million to non-human ESC research, and $306 million to non-human ASC research (National Institutes of Health, 2008). The NIH releases information about available funds for grant programs in the form of funding opportunity announcements (FOA). The FOAs contain the necessary information about the proper application process for that particular grant program (Office of Extramural Research, 2007).
Since President George W. Bush established the current policy pertaining to stem cell funding, many new advancements in the field have been made. At the time it was believed that ASC did not have the pluripotent ability of ESC and were unable to be grown indefinitely in vitro without losing differentiation potential. Discoveries since this time have found both of these to be false, ASC could have same differentiating flexibility as ESC (Prentice, 2005) and can be grown outside of the body without losing this potential. ASC also tend to be easier to control than ESC, which, due to their nature, often differentiate spontaneously whereas ASC do not (Ruiz-Canela, 2002).
The usable results of ASC far exceed ESC. To date, no human patient has benefitted from ESC. In contrast, ASC have effectively treated over sixty-five diseases in humans (Prentice, 2005). One of the key hopes for ESC was for use in the repair and regeneration of human tissues for transplants. Transplants, however, are difficult because of the body’s immune response to reject foreign tissue, and this problem is not significantly diminished by the use of ASC (Outka, 2002), even those transformed by the genes of the recipient. Those that make use of the subjects own ASC have a greatly reduced chance of rejection (Prentice, 2005).
James Kelly, a paraplegic with a lot to be gained from stem cell research, described the issue very accurately before Senate saying: “Huge obstacles stand in the way of cloned embryonic stem cells leading to cures for any condition. To overcome these obstacles, crucial funds, resources, and research careers will need to be diverted for many years to come. These obstacles include tumor formation, short and long-term genetic mutations, tissue rejection, prohibitive costs, and the need for eggs from literally tens of millions of women to treat a single major condition, such as stroke, heart disease, or diabetes. Every condition that cloned embryos someday may address is already being addressed more safely, effectively and cheaply by adult stem cells” (Tada, 2003). One thing that ASC cannot take the place of ESC is in the study of embryo development. Therefore, a change in the current policy and spending allowances is proposed.
The NIH grant funds allocated to stem cell research will be shifted to encourage more research of human ASC. Specifically, a pool of $655 million for overall stem cell research will be divided as such: $25 million for human ESC, $250 million for human ASC, $100 million for non-human ESC, and $280 million for non-human ASC. ESC grants will be awarded strictly for the study of embryonic development while ASC grant money will concentrate on research for the development of new drugs, cell therapy, transplant possibilities, and other therapeutic prospects (Ruiz-Canela, 2002). The procedure to apply for these grants will not be altered. Additionally, researchers seeking government grant money will be able to utilize new embryonic stem cell lines originating from unused embryos from in vitro fertilization clinics, but only if they follow strict conditions. These conditions are as follows: (1) the embryos are no longer needed by the clinic for reproductive purposes, (2) the donors (the couples whose gametes created the embryos) specifically decide to donate the embryos to research, (3) the donation is completely voluntary and does not involve incentives, monetary or otherwise, (4) the physician(s) carrying out the fertility treatments should not perform research using the embryos they helped engineer nor should they receive monetary benefits for donated embryos, (5) embryos used in research will not have the personal identifiers to relate them to their donors, (6) the research may, but does not have to directly aid the donors, (7) and the research does not include reproductive cloning or the transference of a changed embryo to a woman’s uterus (Human embryo research, 2001).
To ensure that these conditions are followed, as well as the proper allocation of grant funds, an external review board (ERB) will be formed by the NIH. The funds for the ERB will come from the excess $2 million dollars previously delegated by the NIH to serve as grant money for stem cell research. Members of this ERB will be selected based on their credibility and knowledge of the field. This shall be determined by their published reports in the area and peer recommendation. In addition, they must have no personal motivation to support specific types of research, such as their own monetary advancement.
With constant advancements in ASC research, the United States policy and funding allotment for stem cell research needs to be altered to encourage optimal study of the therapeutic uses of ASC. The current agenda is outdated and provides little flexibility in usable ESC lines. ESC, while maintaining their significance in the study of embryo development, are becoming increasingly obsolete in the areas of transplantation and disease treatment. ASC have produced applicable results in these categories, with fewer scientific and ethical obstacles. By increasing funding of ASC research, more usable human treatments will be developed than that same amount of money would have produced from ESC research.

References
de Wert, G., & Mummery, C. (2003). Human embryonic stem cells: research, ethics and policy. Human Reproduction 18(4): 672-682.

Human embryo research. (2001). Pediatrics, 108(3), 813. Retrieved February 10, 2008, from Academic Search Premier database.

McLellan, F. (2001). NIH creates registry of stem cells. Lancet, 358(9294), 1706. Retrieved February 10, 2008, from Academic Search Premier database.

National Institutes of Health. (2008). Estimates of funding for various diseases, conditions, and research areas [Brochure]. Bethesda, MD: U.S. Department of Health and Human Services.

Office of Extramural Research. (2007). Grant application basics. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services.

Outka, G. (2002). The ethics of human stem cell research. Kennedy Institute of Ethics Journal 12(2): 175-213.

Prentice, D. A. (2005). Live patients & dead mice, the little-known story of the stem cells that actually work. Christianity Today 49(10).

Ruiz-Canela, M. (2002). Embryonic stem cell research: the relevance of ethics in the progress of science. Med Sci Monit, 8(5): SR21-26.

Stem Cell Information. (2006). Federal policy. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services.

Tada, J. (2003). The threat of biotech. Christianity Today, 47(3), 60. Retrieved February 10, 2008, from Academic Search Premier database.

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