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FDA Approves Trials
Using Embryonic Stem Cells
Part Three of Three
Three days after pro-abortion
Barack Obama becomes President, the federal
government (as the New York Times describes
it this morning) “will allow the world’s
first test in people of a therapy derived
from human embryonic stem cells,” a
“research milestone.”
Geron, the biotech firm
that received permission from the Food and
Drug Administration (FDA), first applied to
conduct the trials last March, according to
the Times. The FDA asked for more data.
However, there is less and
less here than meets the eye.
First, the trial is not a
treatment. Geron will begin a Phase I trial
in humans with recent spinal cord injuries
to test for safety. “We don’t expect to take
someone who is completely paralyzed from the
waist down and have them dance six months
later,” said Dr. Tom Okarma, Geron’s chief
executive. Added Times reporter Andrew
Pollack, “There would still be years of
testing and many hurdles to overcome before
the treatment would become routinely
available to patients.”
Second, studies using adult
stem cells have “already shown safety and
improvement of patient function for spinal
cord injuries,” according to Dr. David
Prentice. However, there has been virtually
no popular press coverage of improvements
which do not immerse the research in
controversy over harvesting stem cells from
human embryos. Read
carefully and it’s easy to see that there
are caveats galore in the Times story.
“Geron’s trial will involve 8
to 10 people with severe spinal cord
injuries,” according to Pollack. “The cells
will be injected into the spinal cord at the
injury site 7 to 14 days after the injury
occurs, because there is evidence the
therapy will not work for much older
injuries.” More
importantly, “the main safety concern is
that if raw embryonic cells are put into the
body, they can form tumors.” Unmentioned in
the story is, of course, that patients would
have to be monitored for the rest of their
lives. And unlike other ethically acceptable
alternatives, because the stem cells are not
genetically matched to the patients, they
will require immunosuppressive drugs.
Returning to the
safety/efficacy question, it is not just
those who are opposed to the use of
embryonic stem cells in principal who are
skeptical. Pollack
writes, “Even as some researchers hailed the
onset of clinical trials, others expressed
trepidation that if the therapy proves
unsafe — or even if it is safe but does not
work — it could cause a backlash that would
set the field back for years." He then
quotes Dr. John A. Kessler, the chairman of
neurology and director of the stem cell
institute at Northwestern University, who
says, “It would be a disaster, a nightmare,
if we ran into these kinds of problems in
this very first trial.”
Adds Pollack, "Dr.
Kessler, whose own daughter was paralyzed
from the waist down in a skiing accident,
said he thought Geron’s therapy was not the
ideal candidate for the first trial. He said
results showing the therapy worked in
moderately injured animals might not apply
to more seriously injured people,” according
to the Times.
Kessler warns, “We really
want the best trial to be done for this
first trial, and this might not be it.”
Please send your thoughts
and comments to
daveandrusko@gmail.com.
Part One
Part Two |
