Safety Issues of Concern
as First Trials Using Embryonic Stem Cells Approach; Public
Opposes Federal Funding
Part One of Three
By Dave Andrusko
Editor's note. Be sure
to send your comments to
daveandrusko@gmail.com. Thank you!
Last
Friday I was racing to make sure every last change was properly
made to the August/September issue of National Right to Life
News before it went into the mail-stream. I mention that both
because I want you to read Part Two
which talks about that edition and because it meant I missed the
results of a Rasmussen Reports survey done on the attitude of
likely voters to using taxpayer money to fund embryonic stem
cell research (ESCR).
Almost six in ten (57%)
are opposed, saying "funding for such research should be left to
the private sector," according to Rasmussen Reports. Only 55% of
self-identified pro-choice voters supported government funding
of stem cell research, while overwhelmingly (83%) pro-lifers
opposed.
In a second I'll talk
about a very skittish Washington Post story that ran today,
headlined "First tests for [embryonic] stem cell therapy are
near." But what makes the Rasmussen Reports survey of 1,000
likely voters even more revealing is that 54% do not think ESCR
is morally wrong and "69% of voters believe it is at least
somewhat likely that embryonic stem cell research has the
potential to lead to cures to previously incurable diseases."
So even if a majority does
not find ESCR morally unacceptable and an even larger majority
has bought into the propaganda line that ESCR is a medical
elixir, they STILL don't want the research federally funded.
That voter resistance applies to ObamaCare as well. Wherever
people are on abortion, they don't want the feds using
everyone's money to undergird and expand it.
The Washington Post's
story, written by Rob Stein, is a cautionary tale, wrapped in
qualifications, inside a plea that
please-don't-let-anything-go-wrong.
In "First tests for
[embryonic] stem cell therapy are near," we learn from Rob Stein
that ESCR supporters are quietly about to reach a "portentous
landmark." Which is? "Scientists are poised to inject cells
created from embryonic stem cells into some patients with a
progressive form of blindness and others with devastating spinal
cord injuries." For good measure, Stein adds, "That's a welcome
step for researchers eager to move from the laboratory to the
clinic and for patients hoping for cures."
That's pretty much the end
of the uncritical hosannas.
The very next sentence
cuts to the chase. "But beyond being loathsome to those with
moral objections to any research using cells from human embryos,
the tests are worrying many proponents: Some argue that the
experiments are premature, others question whether they are
ethical, and many fear that the trials risk disaster for the
field if anything goes awry."
You read assurances that
"We jumped through a lot of hoops to convince a lot of
audiences," in the words of Thomas B. Okarma, president and
chief executive of Geron Corp. of Menlo Park, California.
According to Stein "after years of delay [Geron] received a
green light in July from the FDA to study patients partially
paralyzed by spinal cord injuries."
There are any number of
safety concerns surrounding the use of embryonic stem cells,
"most prominently" that "the cells could cause tumors." These
fears have been ratcheted up both by the immediate context and
the nature of the trials.
As we discussed several
times last week, Judge Royce C. Lamberth issued a temporary
injunction to prevent the Obama Administration from continuing
to fund research that requires the destruction of human embryos.
Lamberth, Chief Judge of the U.S. District Court for the
District of Columbia, wrote in his August 23 order that it
appeared that the Administration's decision to fund embryonic
stem cell research was inconsistent with a federal law known as
the Dickey-Wicker Amendment. The ruling was preliminary, but the
judge ordered the funding to cease while the case progresses.
ESCR proponents worried
that if patients in the trial do not improve--let alone if they
are injured!-- "that could be a devastating blow just as
scientists are scrambling for funding from private foundations
and benefactors."
But also it's the nature
of this first trial. It "will involve 10 [patients] partially
paralyzed by a spinal cord injury in the previous one to two
weeks." The trial is supposed to show primarily that using
embryonic stem cells is safe, "but researchers will look for
signs that the therapy restores sensation or enables patients to
regain movement."
However, spinal cord
injuries are very tricky, according to Stein. "Patients can
often improve on their own, for example, which will make it
difficult to evaluate whether the cells had any effect," he
wrote. But beyond safety issues, the most revealing part of the
story is the ethical reservations raised.
Stein quotes Stanford
University bioethicist David Magnus, who told him, "Think of it
this way: You are a healthy young person, you have had a
terrible accident, you wake up in the hospital and are told that
you will never walk again, that you will paralyzed for the rest
of your life." In an email Magnus added, "Then you are told that
there is a Phase I stem cell clinical trial that you are
eligible for, but a decision needs to be made quickly. It would
be hard to imagine that would be the optimal scenario from the
point of view of informed consent."
Meanwhile officials at
Advanced Cell Technology in California "are hoping for the FDA's
go-ahead to start possibly even sooner injecting 50,000 to
200,000 cells into the eyes of 12 patients suffering from
Stargardt's macular dystrophy." You can read more about this at
http://www.washingtonpost.com/wp-dyn/content/article/2010/08/29/AR2010082903888.html.
Stein's very useful story
ends with the people behind the two trials again issuing loads
of assurances why everything and everybody is safe. But the
final paragraph speaks volumes about the dangers.
"If human embryonic stem
cells are going to be useful in treating humans, someone has to
be the first one to try it," said Hank Greely, a Stanford lawyer
and bioethicist. "They need to have their fingers crossed and
hold their lucky rabbit's foot and be really careful in their
preparations, because before you try something in humans you
never know what's going to happen."
Part Two
Part Three |