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The Importance of Stem Cell Policy
The Importance of Stem Cell Policy
On Oct. 10, 2004, we lost the world's most effective voice on behalf of stem cell research - Christopher Reeve. His death, which occurred at the height of the presidential election season, brought into focus once again the serious implications of current U.S. policy on this issue - both for the future of our health care system, and for the health of each of us as individuals.
How can we best honor the life of Christopher Reeve and what he stood for? As with President Kennedy and the civil rights legislation that was passed following his death, perhaps the best way to honor Christopher Reeve is with legislative action.
We'll come back to that in just a moment. But first, let's review what's happening with stem cell research here in the United States.
The field of embryonic stem cell research is only two decades old but it is moving at the speed of light.1 Mouse embryonic stem cells were first isolated in 1981. Over the following 15 years, scientific questions and ethical concerns advanced side by side.
On Aug. 9, 2001, the federal government announced that research on human embryonic stem cells created before this date would be supported by federal dollars; research on lines created later would not.3 Now, three years later, there are 21 lines of federally approved stem cells and 128 new embryonic stem cell lines around the world that do not qualify for support from the National Institutes of Health.1
During this period, there has been significant progress in the field of stem cell research worldwide. The 128 new lines are the result of new, less cumbersome production techniques and the need to create pure lines suitable for investigating genetic diseases and treatments.1,2
The 21 federally approved stem cell lines are fundamentally flawed and have limited potential for use in clinical therapy. As Dr. George Daley of Harvard Medical School notes, "All were cultured in contact with mouse cells and bovine serum, which renders them inferior to newer lines, derived under pristine conditions, for potential therapeutic applications. Moreover, given the limited genetic diversity of the lines, transplantation of their products would face the same immune barrier as organ transplantation."1
Experts now agree that the most important clinical questions cannot be addressed by the federally approved stem cell lines. Using these lines, one can only explore generic questions about human embryonic stem cells, like what are the optimal culturing conditions; what factors promote growth and differentiation; and how do genes modify and express themselves? The more important questions can only be addressed by means of lines that model specific diseases. Pursuing therapies requires uncontaminated stem cells with lines genetically matched to the specific therapy needs of patients. Such lines already exist, having been created after August 9, 2001, for diseases like neurofibromatosis, Marfan's syndrome, fragile X syndrome, myotonic dystrophy, and Fanconi's anemia.1
Who has inherited the platform leadership for stem cell research? First and foremost, other nations - as I noted in a previous Health Politics segment on stem cell policy.5 On February 12, 2004, South Korea announced their successful process for somatic cell nuclear transfer - taking the nucleus out of a human egg cell and replacing it with genetic material from an adult cell. With this transfer successfully completed, they were able to stimulate the new cell to divide into pluripotent stem cells capable of becoming a nerve cell line that may in the future prove useful in the treatment of diseases like Parkinson's.6
During this same year, Canada's parliament legalized the use of excess embryos for stem cell research, and Sweden announced support for therapeutic use of stem cells. The U.K. authorized development of embryonic stem cells, and Singapore struck a deal with the Juvenile Diabetes Research Foundation, which found that a "more favorable research climate" exists overseas.6,7 Singapore committed $300 million to a new Biopolis stem cell project. And Spain, Japan, and the U.K are all developing their own stem cell banks. Back in the United States, the NIH awarded $10.6 million in grants in 2002 and $17 million in 2003.8
Just as other nations have recognized the opportunity of stem cell research, so have U.S. states. Thirty states have generated 78 bills relating to stem cells. Nine states have legislation to approve state funding of this research, and California, Missouri, New Jersey, and Rhode Island are moving forward with concrete plans.9,10
Universities have been active as well. Harvard has committed $100 million in funds; Stanford, $12 million; University of California, $11 million; and the University of Minnesota, $8 million.10
These universities and states do so with considerable support from major U.S. medical and scientific organizations, including the American Medical Association,11 the Association of American Medical Colleges,12 the Institute of Medicine,13 the National Academy of Science,14 and 125 other U.S. medical, science, and patient advocacy organizations who first publicly voiced their support for federal funding of research using human pluripotent stem cells on July 29, 1999.15
In May 2004, Nancy Reagan, in the final days of President Reagan's life, publicly encouraged broadening U.S. involvement in stem cell research. One month later, on June 4, 2004, 58 senators came out in support of relaxing federal restrictions.16
Dr. George Daley captured what many medical and scientific leaders believe to be our current reality:
First, that the current approach "has severely curtailed opportunities for U.S. scientists to study the cell lines that have since been established, many of which have unique attributes or represent invaluable models of human disease." Second, that "as research struggles forward in the absence of federal funding, the number of embryonic stem cell lines will continue to grow, creating ever more valuable tools that are out of the reach for U.S. scientists."1
Christopher Reeve never walked after his horseback riding accident in 1995, but that is not to say that his vision for stem cell research and discovery should not fly.
For Health Politics, I'm Mike Magee.
References
1.Daley GQ. Missed opportunities in embryonic stem-cell research. NEJM. 2004;351:627-628.
4.Cook G. 94 new cell lines created abroad since Bush decision. Boston Globe. May 23, 2004:A14.
5.Spar D. The business of stem cells. NEJM. 2004;351:211-213.
8.Rosenthal E. Britain embraces embryonic stem cell research. New York Times. Aug. 24, 2004:F6.
9.Murphy K. Embryonic stem cell debate bursts onto state level. Available at: http://www.stateline.org/stateline/?pa=story&sa=showStoryInfo&id=391906&columns=false. Accessed Sept. 15, 2004.
10.Vastag B. Private efforts to pick up stem cell slack. JAMA. 2004;291:2059-2060.
12.AAMC Applauds Congressional Support for Expanded Stem Cell Funding [news release on AAMC Web site]. April 28, 2004. Available at: http://www.aamc.org/newsroom/pressrel/2004/040428.htm. Accessed on Sept. 15, 2004.
13.Stem Cells and the Future of Regenerative Medicine. Washington, D.C.: National Academy Press; 2004.
14.Public Funding of Stem Cell Research Enhances Likelihood of Attaining Medical Breakthroughs [news release on The National Academies Web site]. Sept. 11, 2001. Available at: http://www4.nationalacademies.org/news.nsf/isbn/0309076307?opendocument.
15.Letter from the research community to Representative John Porter [March Of Dimes Update on Life Issues Institute, Inc. Web site]. July 29, 1999. Available at: http://www.lifeissues.org/cloningstemcell/escrletter.html. Accessed on Sept. 15, 2004.
16.Associated Press. Senators ask Bush to relax stem cell restrictions. June 8, 2004. Available at: http://msnbc.msn.com/id/5165300. Accessed Sept. 15, 2004.
October 27, 2004
