Stem cell research restrictions, & their reversal

President Bush's 2001 restrictions

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Restrictions on stem cell research:

According to the Washington Post:

"Since 1996, federal law has prohibited the use of tax dollars to destroy human embryos. The Clinton administration, however, adopted rules saying federally funded scientists could conduct experiments on stem cell lines as long as they did not themselves participate in embryo destruction. Cells were to be derived from embryos destroyed with private money in private labs, then shipped to federally funded scientists for study. The government was on the verge of issuing its first stem cell grants when Bill Clinton left office." ₁

President George W. Bush initially banned stem cell research funding while his administration's policy was being developed. On 2001-AUG-9, President Bush decided to allow limited future stem cell funding. He said the issue was "one of the most profound of our time." He decided to approve funding because stem cell research offered immense promise for the cure of diseases and disorders. But he said it was "important that we pay attention to the moral concerns of the new frontier." However, research would be limited to what he said were 60 existing lines of stem cells that are already being cultured in labs. Government labs could not use stem cells that were obtained from embryos after 2001-AUG-9. President Bush said:

"As I thought through this issue I kept returning to two fundamental questions. First, are these frozen embryos human life and therefore something precious to be protected? And second, if they're going to be destroyed anyway, shouldn't they be used for a greater good, for research that has the potential to save and improve other lives?" ₂

A number of scientists who were interviewed expressed confusion over Bush's statement that there are 60 existing stem cell lines. They believed that there are perhaps only about a dozen. Some are owned by private labs and are unlikely to make them available to government research programs. According to the Washington Post:

"Even specialists in the field had been unaware there were more than 10 or 15 lines." ₃ "The National Institutes of Health has yet to produce information about the lines or their producers, feeding speculation that many of those 60 do not exist, are of poor quality or are under such tight commercial control as to make them unattractive to researchers hoping to study and perhaps profit from them." ₁

The Washington Post and other news organizations have compiled their own lists of stem cell lines. None have come up with more than 23. However, on 2001-AUG-27, the National Institutes of Health stated that they had found 64 cell lines from "genetically diverse" embryos. USA Today notes that "As many as 30 cell lines don't show all of the chemical and biological characteristics needed for the widest possible use." ₄ They are located in laboratories around the world: 24 lines in two Swedish labs, 20 lines in four U.S. labs, 10 lines in two Indian labs, 6 lines in one Australian lab, and 4 lines in  one Israeli lab. ₆ All lines were derived from embryos that meet President Bush's criteria.

Researchers have many other concerns:

	The available cells may not contain sufficient genetic diversity to allow meaningful research and treatment. In order to avoid organ rejection, doctors try to match the DNA of the donor and recipient. This requires the availability of many more stem cell lines.
	The limited racial diversity of the available cells could affect the availability of future therapies for certain racial minorities. Many of the existing stem cell lines come from Oriental people. "Kevin Wilson, director of public policy at the American Society for Cell Biology, said many researchers believe 'there is a question about the quality of the [64] cell lines and if they are of sufficient genetic diversity for scientists to do the work that needs to be done.' "
	Cell lines are "highly finicky...Cell lines can 'crash' -- or die -- at any moment." 1 "NBC's Robert Bazell has reported that existing stem-cell colonies were believed to have a 'shelf life' of only about two years. But Leon Kass, a University of Chicago bioethicist heading a Bush-appointed panel monitoring stem-cell research, said the existing lines should last at least a decade." 6
	Some stem cells that successfully grow in one laboratory, cannot be grown in another.
	Stem cells are "quite volatile...They can spontaneously turn into specialized cells, thus rendering them useless for later work." 1

According to the Washington Post, most, perhaps all, of the existing embryonic stem cell lines have been mixed with mouse cells: "The cell colonies, or 'lines,' were created for early-stage research with no thought that they would become the only embryonic cells eligible for federal money. The standard technique for creating human embryonic stem cell lines has been to extract cells from inside a microscopic embryo, then grow them atop embryonic mouse cells, known as "feeder" cells. The latter excrete some unknown nutritional or growth factor that helps the human cells stay healthy. Because they have been in close contact with mouse cells, the human cells pose a small but real risk of transferring potentially deadly animal viruses to people." 7 Because of Food and Drug Administration guidelines, it would be difficult or impossible to use the cells in human clinical tests. The total number of stem cell lines usable in human clinical trials may well be note 60 as the president indicated, but zero!

The available sources of stem cells are not of proven usefulness. Referring to the stem cells at Goteborg University in Sweden, a Washington Post writer said: "At least one-third of the 64 embryonic stem cell colonies approved for funding under a new Bush administration policy are so young and fragile it remains unclear whether they will ever prove useful to scientists." Goteborg neurobiologist Peter ErikssonI said: "I was a little surprised to see the NIH calling them 19 lines. Maybe they misinterpreted a little bit." Firuza Parikh, founder and director of Reliance Life Sciences in India, said that four of the seven cell lines included in the NIH list have barely cleared the first hurdles in the long process of proving their identity and usefulness as stem cells. The three remaining lines are even younger and could easily "peter out." 8

It seemed obvious that the President's policy was only a stop-gap measure. Sooner or later, the existing stem cell lines will be exhausted, and government research will have to grind to a stop, unless President Bush's restrictions are cancelled and the extraction of new stem cells are allowed. Paul Elias of the Associated Press interviewed stem cell researchers one year after the President's decision. He reported that researchers complained: "An overwhelming majority of the stem cells the Bush administrated approved are in poor condition and useless for research." ₉ In the meantime, some restricted research can proceed. But if new cures or treatments are developed, they may not be useable by some racial minorities.

Germany follows suit:

After several years of debate, the German government passed a law which is similar to President Bush's regulation. The law permits imports of stem cells produced before 2002-JAN-1 for projects of "overwhelming significance" where no other research method can be used. The first permit was issued to the University of Bonn on 2002-DEC-20. Cells will will be used for research into Parkinson's and other currently incurable diseases. Oliver Bruestle, a neurobiologist at the University, said: "I am very happy and relieved that everything came together this year. I have waited more than two years." He plans to start research in 2003-JAN. There is a narrow window of opportunity during which such stem cells will be useable. Probably by the end of 2004, all stem cells that can be imported under this law will be useless for research. ₁₀

References used in the above essay:

The following information sources were used to prepare and update the above essay. The hyperlinks are not necessarily still active today.

1. Ceci Connolly, et al., "Viability of stem cell plan doubted," Washington Post, 2001-AUG-20, Page A01. See: http://www.washingtonpost.com
2. Scott Lindlaw, "Bush allows some stem cell funding," Associated Press, 2001-AUG-9, at: http://www.washingtonpost.com/
3. Rick Weiss, "Stem cell policy eased by Bush decision," Washington Post, at: http://www.washingtonpost.com/
4. "Green light on stem cells," USAToday, at: http://www.usatoday.com/
5. "Labs Say They Can Supply Enough Stem Cells," Associated Press, 2001-AUG-28, at: http://www.foxnews.com/
6. "Charlene Laino, Tom Curry et al., "NIH identifies 64 stem cell colonies," MSNBC, at: http://www.msnbc.com/
7. Justin Gillis & Ceci Connolly, "Stem Cell Research Faces FDA Hurdle; With Mouse Cell Base, Tough Rules Apply," Washington Post, 2001-AUG-24, at:
    https://listserv.utoronto.ca/
8. Ceci Connolly & rick Weiss, "Stem cell colonies' viability unproven: Some in NIH list of 64 [lines] termed young, fragile," Washington Post, at: http://www.washingtonpost.com/
9. Paul Elias, "Stem cell work 'a mess'," Associated Press, 2002-AUG-11.
10. "Germany Clears Embryonic Stem Cell Import. Germany Issues First Permit to Import Human Embryo Cells for Research Under New Law," Associated Press, 2002-DEC-13. Online at: http://abcnews.go.com/wire

Copyright © 1998 to 2009 by Ontario Consultants on Religious Tolerance
Latest update: 2009-MAR-08
Author: B.A. Robinson

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