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Table ii-bills from 109th congress

With or without the expansion of federal funding, some states (such as California, Massachusetts, and New Jersey) are beginning to pick up the reins by passing their own laws related to embryonic stem cell research (see page 15 “State Cloning Legislation”). In November 2004, Californians (with 59% of the vote) approved Proposition 71, or the California Stem Cell Research and Cures Initiative , which called for the creation of a California Institute for Regenerative Medicine (CIRM) and authorized $3 billion of state funds to support the effort over the next five years. The proposal also established the right to conduct embryonic stem cell research in California, but prohibits reproductive cloning. President Bush’s policy only limits federal funding, but does not make the research itself illegal therefore the states are able to determine how they wish to regulate and fund research using state funds. CIRM supports embryonic stem cell (and adult stem cell) research regardless of the date the cells were generated, to create new cell lines, and to use SCNT to create cell lines with specific genes. This new institute is expected to attract stem cell researchers and investors to California allowing it to corner the market on any promising findings.

Despite the passage of Proposition 71, several obstacles have delayed its implementation in California. A lawsuit by taxpayer groups contended that CIRM could not sell bonds backed by taxpayer money to fund research, because it is not under direct state control. Bond sales that would be used to fund the institute are on hold until the lawsuit is settled. In April 2006, the court ruled in favor of CIRM, but the case is still in appeals. Furthermore, CIRM needed time to determine the rules for awarding grants, conducting research, and handling patent rights before it started funding grants. However, in April 2006 CIRM was still able to award their first round of grants, which totaled $12.1 million, and in July 2006 California Governor Arnold Schwarzenegger agreed to give the institute a $150 million loan to help while litigation was pending.

Summary

The debates on stem cell research essentially started in 1997, after the first mammal, “Dolly,” was cloned. Through the past decade, the United States government has not been able to agree on the best policy. The Bush Administration put into place a policy that allows some research to proceed, but at the same time it fails to address the research that is taking place with private and other non-federal funds. Recently, Congress finally settled their stalemate and passed legislation to increase the number of cell lines derived from leftover IVF eggs. Unfortunately, this was vetoed, leaving the question of regulation of this research unresolved. Whether we should fund embryonic stem cell research and therapeutic cloning and how to regulate the current research done with private funds are questions U.S. lawmakers still need to address.

Effects of president bush's stem cell policy

In an effort to appease the advocates for embryonic stem cell research, but still stay true to his conservative base, President Bush allowed federal funding of research on human embryonic stem cells derived on or before August 9, 2001. At the time of the announcement, the NIH believed that there were 60-75 lines which met the qualification for federal funding. Since the announcement, scientists have found several problems with the cell lines which were approved:

  • Currently there are only 22 lines available for distribution by the NIH (the other lines were unavailable for distribution). Many of the other cell lines were either unavailable to researchers or had contamination problems, chromosomal abnormalities, or were unstable.
  • All the cells had been created using mouse cells; therefore, they cannot be used in humans for fear of spreading mouse viruses in humans. It also has been shown recently that all the lines tested contained mouse proteins on their surface which causes them to be rejected by the immune system in a human. This means the cells are unlikely to ever be used for medical purposes.
  • Older cell lines are more susceptible to chromosomal abnormalities than newer lines. So over time, the current stem cell lines will degrade and are not medically viable.
  • Several of the lines have been difficult to grow, giving them very limited uses.
  • Each approved cell line has the propensity to grow into only one specific cell-type. This decreases the breadth of research opportunities for scientists.
  • The cell lines lack genetic diversity necessary to create therapeutic treatment for a broad number of patients
  • There is an absence of disease-specific cell lines, thereby limiting stem cell research on genetic diseases.

Improvements in how scientists can grow the cells in vitro have made new cell lines created in other countries and from private funding (now numbering over 150 lines) more appealing than the lines approved for federal funding. This discourages scientists from using the cell lines, applying for the federal funds, or even entering the field. Most scientists, especially new faculty and graduate students, rely heavily on public funding during their careers.

This policy also limits the availability of subsequent discoveries to the general public. Since private firms will own any therapies derived from such research and may charge heavily to recoup their investments, they have no incentives to publicly release their data.

Reference and further suggested readings

  • Thomas, Legislative Information on the Internet: (External Link)
  • American Association for the Advancement of Science. (2003) Regulating Human Cloning. Washington D.C.: AAAS: (External Link)
  • California Institute for Regenerative Medicine: (External Link) .
  • National Research Council and Institute of Medicine. (2002) Stem Cells and the Future of Regenerative Medicine. Washington D.C.: National Academy Press: (External Link) .
  • National Research Council and Institute of Medicine. (2002) Scientific and Medical Aspects of Human Reproductive Cloning. Washington D.C.: National Academy Press: (External Link) .
  • National Research Council and Institute of Medicine. (2005) Guidelines for Human Embryonic Stem Cell Research. Washington D.C.: National Academy Press: (External Link) .
  • President’s Council on Bioethics. (2004), Monitoring Stem Cell Research: (External Link)
  • Bonnicksen, A.L. (2002) Crafting a Cloning Policy, From Dolly to Stem Cells. Washington D.C.: Georgetown University Press.
  • Thomson, J.A. et. al. (1998) Embryonic Stem Cell Lines Derived from Human Blastocysts. Science 282:1145-7.Wilmut, I., et. al. (1997) Viable Offspring Derived from Fetal and Adult Mammalian Cells. Nature 385:810-13.

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Source:  OpenStax, Stem cell research: a science and policy overview. OpenStax CNX. Aug 03, 2007 Download for free at http://cnx.org/content/col10445/1.1
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