-Caveat Lector-
." Cell lines can "crash" - or die - at any moment, or they can
spontaneously turn into specialized cells, rendering them useless
for later work. In addition, there are subtle genetic differences
between each cell line, differences that can affect their behavior
and utility in research." Or they can turn into hair/teeth instead
of the desired organ as has already happened in one experiment.
Could the difference in the count of existing lines come from the
fact that 3 are required for any growth of consequence so maybe 60
should read 20. And note some are already creating new embryos
exclusively to be destroyed and used for similar research in
private companies. Note, too, cures are not being claimed, only
'treatments' which sounds like products for enriching the
pharmaceutical companies to me. So before the ink is dry, more
lines are needed and the slope just became more slippery.
The wealthy and celebs already have their DNA safely stored
awaiting cloning. Do you? Do you mind paying for theirs? Would
you mind being a clone whose organs are for harvesting? The number
of people, even in this country, without access to even basic
healthcare is alarming and those who think the 'benefits' of this
research are ever going to reach the masses are deluding
themselves, IMHO. Oh, sure, a procedure or two may eventually be
incorporated into standard practices but like all truly advanced
technology, most will never see any benefit at all. And as the
demand grows for more material as it already has done, the
contributions may become more than financial. So the 'limited'
plan just will not do at all and another must be devised quickly so
let's see what they come up with next. Should be very telling.
~Amelia~
Viability of stem cell plan doubted
Bush policy could limit research, scientists say
August 9 - President Bush announces his policy on embryonic stem
cell research.
By Ceci Connolly, Justin Gillis and Rick Weiss
THE WASHINGTON POST
WASHINGTON, Aug. 20 - Mounting uncertainties about the quantity
and quality of embryonic stem cells available for research under a
new Bush administration policy have persuaded many biologists that
the president's approach poses serious constraints for the
development of new medical treatments for diseases such as
Parkinson's, diabetes and stroke.
Requests from lawmakers and news organizations that the White
House document its claim of 60 cell lines have gone unanswered.
SKEPTICISM AMONG those scientists focuses on the existing
stocks of stem cells available for research. Under Bush's
guidelines, federal dollars may be used to study the versatile and
medically promising cells only if they came from donated fertility
clinic embryos that were already destroyed by Aug. 9.
Bush said at least 60 self-replenishing colonies, or
"lines," of such cells existed by that date, a number four times
greater than many scientists were aware of. But 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.
NIH officials have asked scientists to be patient,
reassuring them that plenty of cells are available and promising
that details will soon be forthcoming. But contrary to predictions
made by top government officials, only a few companies or
laboratories have emerged after Bush's announcement to say publicly
that they, too, have eligible cell lines.
And new questions have begun to arise about the adequacy of
the consent processes used to obtain the cells and the racial
diversity of the available cells - a factor that could ultimately
affect the availability of stem cell-based therapies for some
minorities.
The number and variety of cell lines available is important
because stem cells are highly finicky and quite volatile. Cell
lines can "crash" - or die - at any moment, or they can
spontaneously turn into specialized cells, rendering them useless
for later work. In addition, there are subtle genetic differences
between each cell line, differences that can affect their behavior
and utility in 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, Mass. Evan Snyder, another stem
cell expert at the Harvard Medical School, called Bush's approach
"scientifically naive."
NIH SEEKS COOPERATION
The NIH has not yet produced any information on the
condition of the 60 cell lines, a critical issue for scientists
aiming to work with them. And the agency appears to have only
sketchy information on whether the cell lines were created after
receiving proper consent from the embryos' donors, a fundamental
criterion laid down by the president.
NIH administrators say the Bush policy is workable, and they
are scrambling to answer growing doubts. They have summoned top
executives and scientists from about nine stem cell laboratories
around the world to attend meetings at the NIH's Bethesda campus
this week to gather information and seek pledges of cooperation.
Bush administration lawyers are negotiating an initial
agreement to give government scientists access to some of the most
important cell lines. They hope that agreement will become a model
for universities around the world.
Lana Skirboll, director of science policy at the agency,
said NIH aims to release more detailed information on the cell
lines in coming weeks. "Our goal, our single goal, is to get these
cells to the investigator community," she said.
Still, it is clear the Bush administration will have to work
hard to reassure the scientific community of its approach. On
Friday, the world's largest scientific body, the American
Association for the Advancement of Science, called on the White
House to give immediate access to the list of 60 cell lines as well
as details of how the White House policy will work.
Research on human embryonic stem cells is one of the most
promising, but controversial, fields of modern biology. The cells
are usually derived from microscopic, days-old embryos that are due
to be discarded at fertility clinics. The value of the cells is
their flexibility - they have the ability to become any of the more
than 200 specialized cell types in the human body, offering a
potentially unlimited source of new tissues for ailing patients.
But because an embryo is destroyed to extract the cells,
many people oppose the research for moral reasons, arguing that the
embryo is a form of human life.
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.
'Our goal, our single goal, is to get these cells to the
investigator community.'
- LANA SKIRBOLL
NIH director of science policy The government was on the
verge of issuing its first stem cell grants when Bill Clinton left
office. Bush's new policy seemed to be an artful compromise between
the Clinton plan and conservatives' calls to ban the research
altogether. Bush's plan will permit federal funding on stem cell
lines created before his speech Aug. 9, but prohibit funding for
any that might be created later.
SEARCH FOR CELL LINES
The policy was predicated on the existence of 60 genetically
distinct lines of stem cells, which the administration said would
supply enough diversity to allow scientists to undertake serious
work on new treatments.
But the number 60, based on a relatively hasty NIH telephone
survey, came as a shock to virtually every scientist working in the
field. Fewer than a dozen cell lines have been identified in
scientific literature.
Andy Cohn, spokesman for a University of Wisconsin
foundation, watched the Bush speech with James Thomson, the
scientist who in 1998 first isolated human embryonic stem cells.
When Bush made the claim about 60 cell lines, "we both almost fell
off our chairs," Cohn said.
Since then, counting by news organizations, including The
Washington Post, has turned up new cell lines, mostly in
laboratories already known to be working in the field. But none of
those counts has produced more than 23 lines.
Requests from lawmakers and news organizations that the
White House document its claim of 60 cell lines have gone
unanswered. "The burden of proof is on anyone who doubts" the
claim, White House spokesman Ari Fleischer said.
'I think it's a ridiculous policy.'
- GEORGE DALEY
Whitehead Institute for Biomedical Research The debate
over the number is more central than it might seem at first, for
several reasons. For one, a larger number of cell lines would be
insurance against the risk that some of the existing cell lines
prove unusable.
Secondly, there is the issue of genetic diversity.
Scientists envision using stem cells to create more specialized
cells, such as those of the heart, liver or brain. Those would be
implanted into ailing patients to restore organ function. Much as
with a liver or heart transplant, it may prove critical to find a
good immunological match between the implanted cells and the
recipient to try to stave off rejection.
Such matching is easier within racial and ethnic groups that
are more closely related. The NIH has not obtained information
about the ethnic origin of the 60 cell lines. Many of the ones that
have come to light in recent days were created in Asia, which might
limit their usefulness in treating people of European or African
ancestry. "Ours would come from people of Chinese-Asian
background," said Robert Klupacs, chief executive of a Singapore
company, ES Cell International Pte Ltd., that controls six stem
cell lines - 10 percent of the total cited by Bush.
STANDARDS OF CONSENT
Researchers have also grown worried about whether the stem
cell laboratories obtained adequate consent from the embryos'
donors. In their phone survey, NIH officials were assured some type
of informed consent had been secured on each of the existing lines.
They asked for copies of the forms, but did not study their
adequacy.
"We didn't analyze the informed-consent forms," Skirboll
said. "We received them to make sure there was informed consent.
These people who provided us informed consent, they were held to
whatever standard was in place for the country, the hospital or the
facility they were working in."
NIH officials have asked scientists to be patient, reassuring them
that plenty of cells are available and promising that details will
soon be forthcoming.
That could leave scientists running afoul of the ethics
committees at their universities or research institutions, which in
this country typically demand strict standards of consent before
approving research proposals.
"Too often we have learned that procedures used in other
parts of the world in research with human subjects do not measure
up to the ethical standards we embrace in this country," according
to AAAS, the scientists' federation.
If some of the consent forms are inadequate, American
researchers would be left with an even smaller pool of cell lines.
Another unresolved issue is the degree to which American
academic researchers will have access to the 60 cell lines covered
by the Bush policy. They are controlled by a few companies and
laboratories around the world. Those labs have been filing patent
applications on aspects of stem cell technology, and the pending
applications are believed to number in the dozens.
Researchers may get ready access to the cells, but on the
terms of the labs that created them - namely, that those labs
retain potentially lucrative commercial rights to future
discoveries. This is likely to be unacceptable to many
universities, which hope to profit from fresh discoveries their
scientists make.
NIH lawyers are negotiating a master agreement with the
Wisconsin Alumni Research Foundation to give government scientists
access to five cell lines it controls. The agency hopes that
agreement will serve as a "gold standard," a model that
universities could use to cut deals of their own with the cells'
owners.
'Too often we have learned that procedures used in other parts of
the world in research with human subjects do not measure up to the
ethical standards we embrace in this country.'
- AMERICAN ASSOCIATION FOR THE ADVANCEMENT OF SCIENCE
But each university will be responsible for making its own
deals with the labs and companies that control cell lines, and the
Bush policy could make that more complicated. Because no new cell
lines will be eligible for federal funds, the owners of old lines
are likely to have more leverage in their dealings with scientists
who want to undertake such work. Most people in the field express
optimism that the patent difficulties can be worked out, but they
acknowledge it will be tricky.
"These are not our cells," Skirboll said, so the NIH can
only do so much to make them available. Nonetheless, she said, the
owners "have told us they have an interest in making these cells
available to scientists."
Antiabortion groups are divided over the Bush compromise,
and although many have accepted his policy as the best they can
get, others have said they will urge Congress to pass a complete
ban on federal funding.
Advocates of the research regard the new policy as
imperfect, but they also see it as a foot in the door, a chance to
expand the work using millions of federal dollars. They have
therefore made a tactical decision not to fight the administration.
Many hope to increase the number of cell lines scientists can use,
but incrementally, rather than by going to war again with
antiabortion groups, one of Bush's most important constituencies.
"Does anybody believe that if the University of Edinburgh
came up with a 61st cell line that can cure Parkinson's or
Alzheimer's, that number of 60 would not expand?" asked a top
biotechnology strategist who spoke on condition of anonymity. "In
the long run, this number of 60 will be a forgotten relic of the
political debate. The important thing is not so much the number 60.
It's really that the green light went on for federal funding of
this research."
This strategist said the groups with which he is allied have
made a conscious decision to back off, give Bush some breathing
room and let the controversy die down.
"He had a particularly difficult political situation and he
came out the right way," the strategist said. "I don't think there'
s any instinct to punish him for that. This took a bit of political
courage."
© 2001 The Washington Post Company
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