"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 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."
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 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 lines. Some are owned by private labs and are
unlikely to make them available to government research programs. "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. However,
according to USA Today, "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. 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 that many stem cell lines be available.
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." 5
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
The NIH has not released full information on the condition of the
60 cell lines.
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."
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."
6
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 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."
7 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 yea. 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. 9
Sponsored link:
President Bush's decision, revisited:
A year after President Bush's decision to limit studies to a small
number of stem cell lines, most of those lines had "crashed" and become
useless for research. By the end of 2002, only about a dozen of the
original 78 stem cell colonies worldwide were "...in good enough
shape to use in experiments. Even fewer — perhaps four lines — are being
routinely shared and sent to other researchers interested in breaking
into the field." 10
During 2005-MAY, when a stem cell bill was being debated in congress,
some commentators were quoting researchers as saying that none of the stem
cell lines were usable for research.
"To limit researchers to 60 cell lines, critics say, is like
telling mathematicians they can pursue their studies but they can never
use numbers bigger than 10. 'I think it's a ridiculous policy,' said
George Daley, a leading stem cell researcher at the Whitehead Institute
for Biomedical Research in Cambridge," MA. Evan Snyder, another stem
cell expert at the Harvard Medical School, called Bush's approach
'scientifically naive.' " 1
In late 2005-JUL, Bill Frist (R-TN), the
Senate Majority Leader, surprised religious and social conservatives
when he announced his support for modifying the president's policy. He
noted that only 22 lines out of the 78 originally foreseen by the
administration are still eligible for federal funding. Some of these are
deteriorating and/or contaminated. He said: "the limitation put into
place in 2001 will, over time, slow our ability to bring potential new
treatments for certain diseases.... embryonic stem cells uniquely hold
specific promise for some therapies and potential cures that adult stem
cells just cannot provide.....It's not just a matter of faith, it's a
matter of science." 11
Gradual failure of the president's plan:
The president's restrictions on stem cell research
only control the supply of cells to government-funded research programs. Most of
those cells come from WiCell Research Institute Inc. of Madison,
WI now called the National Stem Cell Bank (NSCB).
These cell lines have been steadily degrading. Some have been reproducing for
over eight years, and suffer from DNA damage. Of the over 60 lines that were
available in 2001-AUG, only 22 were still useable five years later. Eventually,
all will be useless.
However, Douglas Melton, 52,
a biologist from Harvard University, started producing stem cells independently
in 2003 using funding from the private Howard Hughes Medical Institute
in Chevy Chase, MD. He was motivated by the news that
two of his children were diagnosed with diabetes. The lines are shipped free to
non-governmental research projects.
By mid 2006, 667 stem cell batches were supplied by
Harvard; 246 came from the NSCB.
Larry Goldstein, a scientist at the University of California-San Diego noted
that Harvard cells, which he obtained at no cost, were better. They divided more
quickly than the $10,000 lot he received from the NSCB. He said: "We tend to
vote with our feet. Among the lines we've tried, the best have been from
Harvard. Those lines have been the most user-friendly.'' They are also
relatively free of the genetic abnormalities that are frequently seen in NSCB
lines.
Another problem with the NSCB stem cells is lack of ethnic diversity. They
apparently came mainly from affluent white families. Genetic diversity is
important if treatments are going to be developed that will function well for
all humans.
Bloomberg reports:
"Researchers in China, Sweden, and Colombia have recently derived new
cell lines, adding to the ethnic diversity of lines available
internationally. Because of the Bush administration's restrictions, American
scientists are unable to get government money to use any of them for
research." 12
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.
Ceci Connolly, et al., "Viability of stem cell plan doubted,"
Washington Post, 2001-AUG-20, Page A01. See:
http://www.washingtonpost.com
"Charlene Laino, Tom Curry et al., "NIH identifies 64 stem cell
colonies," MSNBC, at:
http://www.msnbc.com/
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/
Paul Elias, "Stem cell work 'a mess'," Associated Press,
2002-AUG-11.
Justin gillis & Ceci Connolly, "Stem cell research faces DNA hurdle,"
Washington Post, 2001-AUG-24, at:
http://www.washingtonpost.com
"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