-Caveat Lector-
Oh, drat! But it was going to be sooooo EASY to CURE everything if
ONLY Bush would approve this! Note NO cures promised, only more
treatments which means big bucks for pharmaceutical companies, IF
(big if) anything should ever be developed. Remember the U of
Wisconsin holds the patent on this, at stem cell research,
already. Always follow the money. Beginning to look as though
maybe not quite as much is known about this as was implied. Well,
looks like we will just have to whip up a new batch of human life
to tinker around with conducting bogus experiments to see what
happens. Either that or we can develop cures with tales.
Told you so. Told you so. Told you so.
~Amelia~
Stem cell research faces FDA hurdle
With mouse cells used as a base, tough rules apply
By Justin Gillis and Ceci Connolly
THE WASHINGTON POST
Aug. 24 - Most or all of the human embryonic stem cell colonies
approved for research funding under a new Bush administration
policy have been mixed in the laboratory with mouse cells, which
may create substantial hurdles for scientists trying to turn the
colonies into treatments for Parkinson's disease, spinal-cord
injuries and other ailments.
The human embryonic stem cell lines reported in scientific
literature were all grown in direct contact with mouse cells and
might have picked up mouse viruses.
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. But that is the
status President Bush conferred on them in his first prime-time
address to the nation on Aug. 9.
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 that, under guidelines the Food and Drug
Administration has been developing for several years, it would be
difficult, though not impossible, to use the cells in human
clinical tests.
XENOTRANSPLANTS
Under the FDA rules, which are designed to prevent the
accidental creation of a new plague, transplants of these embryonic
cells into people would be treated as though they were
"xenotransplants," or transplants of animal tissue. The guidelines
impose stringent requirements on researchers and patients alike.
They would likely rule out some groups of patients who might
otherwise be eligible to participate in human stem cell tests -
notably, for instance, young diabetes patients whose disease can be
treated in other ways.
The human embryonic stem cell lines reported in scientific
literature were all grown in direct contact with mouse cells and
might have picked up mouse viruses, which government officials
acknowledged would bring them under the FDA policy.
Scientists are working on ways to grow human embryonic cell
lines without using mouse cells, but any created after Bush's
speech Aug. 9 would be ineligible for federal research money.
Patient groups and people who work with them expressed
concern when told about the xenotransplant restrictions.
'THE EXCLAMATION POINT'
"This would be the exclamation point" on an already lengthy
list of questions about the quantity and quality of the cell lines
eligible for research funding under the Bush policy, said Kevin
Ryder, a consultant to the American Cell Therapy Research
Foundation, a New York foundation that supports research into many
types of treatments using cells. "We would have a very difficult
time getting those advanced into the clinical setting unless we get
the FDA to make some exceptions down the road."
Most people on Capitol Hill are unaware of the issue, but as
word of it began spreading late yesterday, some legislators
expressed concern. "The president's going to have to make available
lines of stem cells that will be available for the full measure of
research anticipated," said Sen. John F. Kerry (D-Mass.) "If he
doesn't, Congress will need to act to make that happen."
Jay Lefkowitz, a White House adviser who helped craft the
Bush policy, said the administration was aware that the stem cell
lines Bush approved for funding had been mixed with mouse cells and
would come under the FDA's xenotransplant rules.
The White House concluded that the issue would not be a
serious barrier at this stage, when scientists still need to do
several years of fundamental laboratory work before human tests can
begin, he said. By the time researchers are ready to begin those
tests, he said, officials are confident that scientists will have
found a way to grow stem cells without mouse cells, or will be able
to work within the FDA's guidelines.
Advertisement
"President Bush has unlocked the door so that critical,
basic research can be conducted in an area that is currently
uncharted," Lefkowitz said. "To fulfill that mission, we believe
the existing stem cell lines are more than adequate."
HOW BIG A PROBLEM IS IT?
Opinion among scientists is mixed about how much of a
problem the xenotransplant issue will be, but at the least, they
say, it presents yet more practical difficulties in the execution
of a policy already rife with them.
In the 15 days since Bush announced his policy, other
lingering questions - about how many cell lines exist, who owns
them and how accessible they will be to academic scientists - have
gone largely unanswered by the National Institutes of Health and
the Department of Health and Human Services. NIH administrators are
negotiating with companies and labs to try to work out many of the
details. Congressional hearings are scheduled in two weeks.
In an interview, a senior NIH administrator and an FDA
regulator acknowledged that the xenotransplant issue could pose
hurdles but said it was premature to speculate about how serious
those might be.
"There is so little experience with these cells," said Lana
Skirboll, director of science policy at the NIH. "There's a lot
that needs to be done. I just think the scientific community is in
a position that we have a lot more to learn."
FDA ADMINISTRATORS DECLINE COMMENT
FDA administrators who developed the xenotransplant policy
declined comment. But they pointed to written reports and meeting
transcripts going back five years that make their position clear.
The documents, posted on the Internet, leave little doubt that stem
cells grown by current techniques would be covered. Although the
guidelines are not final, officials said the agency has been
following them.
Some laboratories that work with stem cells appear to be
unaware of the policy; others are operating under the assumption
that it will be a large hurdle in creating treatments from any of
the existing cell lines. "It could be a real killer," said George
Daley, a stem cell researcher at the Whitehead Institute for
Biomedical Research in Cambridge, Mass.
Executives of BresaGen Inc., the U.S. unit of an Australian
stem cell company, met with the FDA last spring and learned then
that their four lines of human embryonic stem cells, all grown atop
a layer of mouse cells, would be treated as xenotransplant
products. "We were a little bit shell-shocked," said Allan Robins,
senior vice president and chief scientific officer. "I think a lot
of companies will see it as a large burden."
NOT AN ABSOLUTE BAR TO RESEARCH
This view is not universal, however, even among scientists
who oppose the Bush plan.
Hugh Auchincloss Jr., a surgeon at Harvard Medical School
and chairman of an FDA committee that reviewed the xenotransplant
issue, noted that the FDA policy, while stringent, is not an
absolute bar to research. Indeed, several hundred patients have
already participated in various types of xenotransplant tests,
including the transfer of fetal pig cells into patients' brains in
an attempt to treat Parkinson's disease.
Moreover, Auchincloss said, with enough time and lab work,
scientists might be able to alleviate FDA concerns. He noted that
human tests of stem cell therapies are probably years away, largely
because scientists know so little about the cells.
In his speech Aug. 9, Bush said 60 genetically distinct
embryonic stem cell lines had been derived by laboratories around
the world and approved federal funding only for work on those cell
lines. To reduce incentives for further destruction of embryos, he
ruled out funding for any cell lines created after his speech.
Because they can be used to grow almost any kind of human
tissue, which could then be used to repair ailing body parts, the
cells offer considerable, but unproven, hope for cures. The cell
lines were created from early-stage human embryos slated for
destruction at fertility clinics. Many anti-abortion activists, one
of Bush's most important constituencies, oppose the research.
MOUSE CELLS LIKELY USED IN ALL LINES
Several scientists have said publicly that they are working
on ways to grow embryonic stem cells without mixing them with mouse
cells. But no scientist has publicly claimed to have created an
entirely new cell line by such a method before Aug. 9.
That has led most scientists familiar with the issue to
conclude that all 60 lines were probably created using mouse feeder
cells and will have to be treated as xenotransplant products.
"I don't think there's any one of the 60 lines that has not
been derived using mouse embryonic feeders," said Daley, of the
Whitehead Institute.
However, the possibility cannot be entirely ruled out until
the location and details of all 60 cell lines have been disclosed.
The implications of treating most or all of the lines as
xenotransplant products would be substantial.
The draft FDA guidelines make clear that labs researching
stem cells will have to meet special burdens to win approval for
any human test involving xenotransplantation. They will have to
perform extensive research and documentation on their cells that go
beyond normal FDA requirements, including elaborate study of
potential animal viruses. At a minimum, this will introduce delay
and extra expense.
A BEHIND-THE-SCENES RACE
Given the complexity of the FDA restrictions, Robins, the
BresaGen scientist, predicted that few companies would plunge into
human tests of stem cells grown together with mouse cells. He said
those will be used for research for the next few years, but
eventually companies will create new cell lines grown only on human
feeder cells. They will do so either with private money or by
overturning the Bush limitations on federal funding, Robins and
other researchers predicted.
In fact, it appears the FDA restrictions have already set
off a behind-the-scenes race among labs to create - and patent -
alternative means of growing stem cells that don't depend on mouse
feeders.
The only company that has publicly claimed success with a
mouse-free technique is Geron Corp. of Menlo Park, Calif. "We have
accomplished it," said David Greenwood, the company's chief
financial officer. But he declined to say whether Geron had managed
to create any new stem cell lines using the technique before Aug.
9.
Several researchers predicted that if stem cells began to
show promise, the politics would change, and they would win
permission to work on new cell lines with federal money.
"If the research looks great and we're ready to go to human
trials, we will need more stem cells," said Jeffrey Rothstein, a
neurologist at Johns Hopkins University in Baltimore who works in
the field. "We'll turn to the president or Congress and get them to
do the right thing."
Staff writer Rick Weiss contributed to this report.
� 2001 The Washington Post Company| Living
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