By Rick Weiss Washington Post Staff Writer Wednesday, December 2, 1998;
Page A02
In the beginning, a single embryo cell becomes two, then four, then eight,
and each cell is identical to every other. There is no muscle, no brain, no
bone.
That peculiar unconditioned state of biological genesis, in which nothing
is fixed and everything is possible, has long been veiled in mystery. But a
quick succession of scientific advances has raised that veil, reigniting a
long-simmering debate over the appropriateness of conducting research on
human embryos.
In the past month, three teams of researchers have reported dramatic
advances in their work with human "stem cells," the most primordial of
embryonic cells, each of which has the potential to grow into any kind of
tissue in the body. They have watched with wonder as these cells, sitting
in laboratory dishes, made their respective decisions and became nerve
cells, blood cells or heart cells beating in unison.
They have even combined genetic material from people and cows in an effort
to make more of these valuable cells. And they have begun to learn how to
force the cells to grow into one kind of tissue or another.
The goal is to grow replacement parts for people with life-threatening
diseases. But the research also has shaken up such disparate fields as
patent law, medical ethics and theology.
At a Senate hearing today, Congress will make its first foray into this
quickly changing landscape. The hearing, called by Sen. Arlen Specter
(R-Pa.), marks the beginning of what will be a difficult journey for
Congress as it contemplates whether federal dollars should support research
on stem cells -- which are ethically controversial because of their
embryo-like qualities -- and whether there is a need to regulate the
emerging field, which in some cases uses contentious human cloning techniques.
Congress is not alone as it sifts through the scientific and social
implications of stem cell research. Ethicists and theologians also are
asking whether it is justifiable for researchers to mix human genes with
those of cows or other animals to create tissues for transplantation into
needy patients.
Some intellectual property attorneys are questioning whether the government
should allow patents on human stem cells, saying they are not "inventions"
but products of nature.
And scientists are having to reconsider some long-standing axioms of
biology, including the basic notion that embryo cells deserve special
protections because they are uniquely able to create a new person. In the
new biology, the distinction between embryo cells and other cells has blurred.
"Every cell we shed every day is potentially a new human being," said
Michael West, president of Advanced Cell Technology (ACT) in Worcester,
Mass., the company that combined a human skin cell with a cow cell to grow
human stem cells.
Similarly, he and others said, it is not clear whether stem cells are
technically embryo cells or not, especially after they have been growing
and multiplying in a lab dish for months.
That fuzzy reality is problematic for Congress, which for the past four
years has banned the use of federal funds for human embryo research. Now,
with definitions in flux and the medical potential of stem cells more
certain than a few years ago, Congress is under pressure from patient
groups such as the Juvenile Diabetes Foundation and the Alliance for Aging
Research to consider whether it would be medically appropriate -- and
politically palatable -- to loosen the ban.
"The basic question is: What issues are raised by the breakthroughs in this
research and should Congress look at the issue of making federal funds
available for that?" said Jonathan Ullyot, a spokesman for Specter.
For many people, the stem cell revolution seemed to come out of nowhere.
But it was built during years of quiet research in privately funded
laboratories where scientists, working with human and animal embryos,
gradually improved their cell-growing techniques.
Researchers years ago had identified what looked like stem cells in human
embryos and fetuses. But not until this year did they perfect the art of
getting them to grow in glass dishes, where they could prove that the cells
were stem cells by watching them grow into all kinds of tissues.
The secret was to mimic the precise conditions found within a developing
embryo, but it took years for scientists to come up with a hormone and
nutrient recipe that worked. Even today, the only way to keep stem cells
alive in the lab is with the help of "feeder cells" -- living cells taken
from mouse embryos that secrete unknown but necessary chemicals to support
stem cell growth.
Last month, two teams finally reported that they had grown stable,
self-replenishing cultures of human stem cells from starter cells taken
from embryos and fetuses. ACT followed with its report that researchers had
fused a human skin cell and a cow's egg to make a new and expanding mass of
cells resembling an embryo, from which stem-like cells had been retrieved.
Scientists at the National Institutes of Health and other federally funded
labs say they are eager to study the cells, which may be teased to grow
into neurons for people with Alzheimer's disease or cardiac tissues for
heart attack victims. But after weeks of looking into the matter, NIH
lawyers remain uncertain whether these researchers are allowed to work with
stem cells.
The current congressional ban clearly precludes them from isolating stem
cells from human embryos, since embryos are destroyed in that process. By
contrast, the ban's wording seems to allow federally funded experiments on
laboratory-grown stem cells, which are many cell generations removed from
the embryos that first produced them. Yet NIH officials have said they
would rather not force the issue, especially given Congress's recent
generosity in research funding.
Conservative and antiabortion forces have opposed any loosening of the ban.
But with stem cells now in hand and their therapeutic potential making
news, lawmakers may find it hard to justify denying federal dollars for at
least some kinds of embryo cell research.
"It's very difficult to be a such an absolutist that you would withhold a
promising treatment from people with cancer or Alzheimer's or spinal cord
injuries," said John Fletcher, a bioethicist at the University of Virginia.
The ACT experiment raises even tougher questions. The company envisions
making personalized stem cells for anyone who needs them by fusing a skin
cell from that person with a cow's egg. (An egg of some kind is needed to
make stem cells, and cow eggs are easier to get than human eggs.) The
product of that fusion is a mass of cells resembling an embryo, from which
stem cells could be plucked and grown into tissues.
The National Bioethics Advisory Commission has started to study the
implications of that research, which the company has voluntarily suspended.
But in a letter to President Clinton last week, the commission's chairman,
Harold Shapiro, hinted that there may be no simple answer.
Whether ACT's work crosses the ethical line, Shapiro wrote, depends largely
on whether the newly created mass of cow-human cells is actually an embryo.
In other words, if it were placed in a woman's womb, could it develop into
a living being? Since the only way to find out is to perform that
experiment, and since to do so would be unethical given the uncertainties
of what might be born, the answer may never be known.
As a compromise, some experts are proposing to preclude the creation of new
human embryos just for research purposes but allow federally funded
experiments to be conducted on leftover embryos that are about to be
discarded by couples who underwent fertility treatments.
That approach is being considered in France, a country that does not allow
human embryo research but is due to redraft its ban in 1999. It also would
be more in line with recommendations made in 1994 by an NIH panel on human
embryo research.
Even if Congress resolves the issue of research funding, stem cells may
remain on its agenda because of a brewing dispute over patents.
The U.S. Patent and Trademark Office allows patents on living inventions
but not on human beings. It has not stated whether it intends to grant
patents on human stem cells.
Two universities already have applied for such patents, galling patent
experts who see stem cells as inventions of nature and whose applications
for patents on chemical elements have been rejected on the grounds that
they are naturally occurring. ACT has asked for a patent on its cow-human
cells, angering activists opposed to human-animal hybrids.
Some see in stem cells a chance to reopen the larger debate over patenting
living things -- a practice less common in Europe and Canada that has
evolved in the United States with very little public review.
"We're working in an area where there is no legislation or regulatory
guidance and there is nothing in the manual of patent-examining procedure,"
said Patrick Coyne, a Washington patent attorney. "We'd prefer to settle
this debate at a legislative level."
¨ Copyright 1998 The Washington Post Company
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mail to: imax(AT)odyssee.net
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