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THE STEM CELL DECISION
Bush's Decision Greeted Cautiously by Research Community; Many Express
Doubt Over Number of Available Cell Lines
President Bush's decision last night to allow federal funding for
research on stem cells already extracted from embryos was greeted as a
step forward for the research, but as a "baby step, rather than a giant
leap, for medical research," the
New York Times reports (Stolberg, New York Times, 8/10). Cell lines are
"genetically identical colon[ies] of cells that can replicate
indefinitely." In stem cell research practices, a parent cell is derived
from a human embryo and then replicates itself in a petri dish to create
the colony. Bush declared that he will allow federal funding for
research on embryonic stem cells derived from 60 existing cell lines, a
figure that surprised many in the research community.
"The president seems to have information far different from that of the
bulk of the medical community," Dr. Michael Soules, president of the
American Society of Reproductive Medicine, said, adding that the society
was "only aware of a very small number of stem cell-derived tissue lines
and cannot confirm the existence of the large number the president
mentioned in his speech" (Hall, San Francisco Chronicle, 8/10). Fewer
than 10 lines have been reported in scientific journals and another 10
may have been "described" at scientific forums; an NIH report earlier
this summer estimated that perhaps 30 lines existed (Weiss, Washington
Post, 8/10). According to a senior Bush adviser, the president had
"grown frustrated with vague estimates on how many stem cell lines exist"
and asked policy adviser Jay Lefkowitz to request that the NIH determine
the actual number (Friend, USA Today, 8/10). The determination that
there are 60 lines resulted from NIH officials "calling around the world
to talk to researchers." Various lines have been derived in the United
States, Austria, India, Israel, Singapore and Sweden, according to
another senior administration official, and represent a "diverse genetic
and ethnic pool."
Quality Control
Many researchers also questioned whether all of the lines reportedly
available would prove useful for research. Cell lines have a "precarious
existence" and are liable to "'crash' at any time, disappearing into a
shriveled gelatinous mess beyond hope of resuscitation," the Washington
Post reports. Of the six cell lines created by Geron Inc., the biotech
firm that has funded most American research on embryonic stem cells, only
two have been "deemed sufficiently stable and useful to be distributed to
stem cell scientists." Furthermore, even 60 cell lines would be
"woefully short of representing the genetic diversity of a nation of 200
million Americans, not to mention the rest of the world," Dan Perry,
president of the Alliance for Aging Research, noted. Cell lines also
have "subtle genetic differences" and those differences "can affect how
they behave and what they can teach," the Post reports (Washington Post,
8/10).
Dr. Harold Varmus, head of the New York-based Memorial Sloan-Kettering
Cancer Center and former director of the NIH, said that the limited
number of lines "would be a very poor investment federally, and a very
cruel investment if we ended up with knowledge of how to make
differentiated cells to treat people and then we were stuck" because of a
lack of cell lines (New York Times, 8/10).
Gail Martin, the University of California-San Francisco researcher who
"laid the groundwork" for human embryonic stem cell research by first
isolating stem cells in mice, said that limiting the number of cell lines
"puts restrictions on what's going to be possible," and added that
"[h]aving a big pot" of cells available was a "very big plus" to her
early research (Torassa, San Francisco Chronicle, 8/10).
Timothy McCaffrey, an associate professor of biochemistry and molecular
biology at George Washington University Medical Center, called Bush's
decision to limit the number of cell lines made available "quite ...
fair," adding, "Obviously, as a scientist, you want as few restrictions
on your work as possible. But this doesn't disable the field at all.
Compared with being unable to use federal funds, period, for stem cell
research, this is a big step forward" (San Francisco Chronicle, 8/10).
It is unclear whether the cell lines Bush mentioned will have to meet
ethical guidelines established by the National Bioethics Advisory
Commission and the NIH. Those guidelines "explicit[ly]" require that
"informed consent" must be obtained from the couples that created the
embryos for in vitro fertilization treatments before they can be used for
research (Friend, USA Today, 8/10). James Thomson, the University of
Wisconsin researcher who first isolated human embryonic stem cells, said
the lines derived from his work do not meet those standards, but added
that he was "prepared to produce additional lines ... that did"
(Lane,Newsday, 8/10).
The Effect on Biotech
Bush's decision "will do little to help or harm most biotech firms in
the short run," the San Francisco Chronicle reports. However, "over
time, his tepid support could drive research abroad and slow the pace of
new discoveries." There are only a "handful" of companies are currently
conducting stem cell research in the United States and it will be years
before research will "yield discoveries with commercial importance." But
many researchers were "concerned" that limiting the number of cell lines
available in the United States will "let other nations tale the lead" on
the research. "We saw this in the late 1970s when the United States
didn't allow cloning to be done on pathogens," allowing researchers in
Europe to "t[ake] the lead" on research of diseases such as hepatitis B,
Ed Penhoet, co-founder of Chiron Corp. and dean of public health at the
University of
California-Berkeley, said. Stem cell research is already permissible in
Great Britain, Japan, Israel and parts of Australia (Abate, San Francisco
Chronicle, 8/10).
The fact that the majority of cell lines in the United States are
controlled by a few companies is also troublesome to some researchers.
Geron, which funded Thomson's work, controls many of the lines and "can
effectively lay claim to anything commercial that arises from those
cells," the Boston Globe reports. "You have to agree to their
conditions, which most researchers find unacceptable. We would be de
facto reporting to a company on the research we want to do," Melton
explained. But Geron CEO Thomas Okrama said his company has "no desire
to constrain research." However, Geron "will defend its intellectual
property rights," he said, adding "Patents are what patents are. We
funded the work, we have the rights" (Shadid, Boston Globe, 8/10).
Michael West, CEO of Massachusetts-based Advanced Cell Technology,
Geron's chief competitor, said the stem cell debate is already giving way
to the next issue: cloning. "Stem cells will be history. This will
shift the fight to nuclear transfer," he said (San Francisco Chronicle,
8/10). Advanced Cell is attempting to derive stem cells by taking human
eggs, removing their DNA and replacing it with genetic material from a
mature adult skin cell to create what West calls an "ovumsum." This
process has yet to create a viable stem cell (Elias, AP/Baltimore Sun,
7/16).
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