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FDA Okays Embryonic Stem-Cell Trials on Humans (4377)

But Lawsuit Would Stop Expanded Funding

08/18/2010 Comments (17)
REUTERS

– REUTERS

MENLO PARK, Calif. — Even as a federal agency gave a California biotech firm the go-ahead to begin the first human trials of therapy employing human embryonic stem cells, a federal court approved a pro-life legal action that could lead to blocking President Obama’s promised expansion of federal funding for research using these cells.

Geron Corp. of Menlo Park, Calif., is seeking people paralyzed by spinal injuries to be the first human test subjects for the clinical use of human embryonic stem cells, which some scientists say is dangerous, wasteful of taxpayers’ dollars and unethical.

Stem cells are undifferentiated, primitive cells that have the ability both to multiply and to differentiate into specific blood cells and other cell/tissue types. This ability allows them replace dead or defective cells and/or tissues.

Embryonic stem-cell research, which involves the killing of a unique human being in an attempt to cure different diseases, has proven not only lethal and costly, but has not produced a single cure. On the other hand, adult stem-cell research, which utilizes cells from adult tissues or umbilical cords, does not require the taking of human life. It has proven successful in treating more than 70 kinds of cancers and autoimmune diseases such as multiple sclerosis.

Pope John Paul II said that all research using stem cells from human embryos was “morally unacceptable.”

In his 1995 encyclical Evangelium Vitae, John Paul said, “This moral condemnation also regards procedures that exploit living human embryos and fetuses — sometimes ‘produced’ for this purpose by in vitro fertilization — either to be used as ‘biological material’ or as providers or organs or tissue for transplants in the treatment of certain diseases.

“The killing of innocent human creatures, even if carried out to help others, constitutes an absolutely unacceptable act.”

At the end of July the U.S. Food and Drug Administration gave Geron permission to proceed with clinical trials for GRNOPC1, its privately-developed line of oligodendrocyte progenitor cells derived from stem cells from aborted unborn babies. A variant developed from animal embryos proved effective in regenerating damaged animal spinal cords, Geron claims in a press release, while a problem with cysts developing near the injection site in the test animals has apparently been addressed with “new markers and assays.”

Geron did not return the Register’s calls to explain just how these “markers and assays” reassured the FDA enough to get it to approve human trials. In its press release Geron stated the stem cells tested on animals had “demonstrated remyelinating and nerve growth properties.”

Remyelinating is the re-growth of the lining around nerves which is known to improve the transmission of signals to and from the brain and lead to the “restoration of function in animal models.”

However, Theresa Deisher, a Seattle adult stem-cell researcher who is seeking an injunction against any expansion of federal funding for embryonic stem-cell research, warns that embryonic stem-cell therapy has proved very problematic in animals.

“I will predict that in these early human trials we will probably see a short-term benefit, but it will be followed by devastation and disaster,” Deisher told the Register. “And I would ask why we as a society would go forward with that and put our taxpayers’ dollars in this area when we have adult stem cells that need taxpayer funding and that taxpayers could afford and that we know are successful.”

Deisher notes that “in animal models, in the short term, the functional benefits from embryonic stem-cell treatments are very dramatic and exciting. And then those animals form tumors, or they reject the cells and the benefit is lost.”

There are two potential causes: Either the embryonic cell lines are contaminated with residual tissue or DNA from the original donor embryo, which triggers an immune response in the recipient, or the tissue injected into the recipient grows too rapidly, creating tumors.

“Embryonic stem cells grow like weeds,” says Deisher. “They behave in many ways like cancer.” In fact, rapid growth is one of their most attractive properties, since the therapeutic purpose for such cells is the replacement of damaged tissue. Rapid growth also means that plenty of tissue can be quickly manufactured for experimental use.

The key attribute of embryonic stem cells, however, is that that they are pluripotent —they have potential to reproduce as any kind of human tissue.

Adult stem cells present a reverse image of the embryonic stem cells’ pros and cons. They are difficult to reproduce in the lab, while in the body, both when naturally occurring and when introduced in modified form for therapy, they perform amazing feats of regeneration.

Deisher says adult stem cells trigger none of the immune responses that embryonic stem cells do because they are grown from tissue taken from the intended recipient.

Adult stem cells have been used for decades to treat leukemia and other blood diseases, while more recent successful treatments have seen the repair of eyes and the replacement of windpipes.


Funding Is the Goal

Why, then, is embryonic stem-cell research so appealing?

Money, says Jean Peduzzi-Nelson of the Department of Physiological Optics at the University of Alabama at Birmingham.

She told Congress that “cloned stem cells derived from embryos with genetic defects represent the possibility of millions in patentable stem-cell lines. Adult stem-cell therapies are much better for people with diseases or injuries but generate an inferior business plan.”

However, proponents of embryonic stem-cell research cite other reasons for their preference. The Coalition for the Advancement of Medical Research, for example, claims that while embryonic stem cells have the potential to re-grow any tissue, adult stem cells can only regenerate specific kinds of tissue and they have been most useful in treating blood diseases.

What’s more, the Coalition for the Advancement of Medical Research website carries an ABC News report from July on a study undermining the potential of another alternative to embryonic stem cells. The Boston study indicates that adult skin cells that are reprogrammed into behaving like stem cells — so-called induced pluripotent cells — are not “blank slates” as previously hoped, but retain some of the characteristics of the original cell.

While ABC headlined the story “Reprogrammed Adult Cells Not an Alternative to Embryonic Stem Cells,” nobody quoted in the story drew any such conclusion.

Nevertheless, Deisher insists that embryonic stem-cell research should stick to private funding and leave National Institutes of Health money for adult stem-cell research, which cannot attract private money. “We have to rely on government funding.”

That is partly why Deisher joined fellow researcher James Sherley and a group of Christian and pro-life groups in seeking an injunction to stop the NIH from funding research using new embryonic cell lines — research authorized by President Obama last year.

Deisher and Sherley contend that such funding violates the pro-life Dickey-Wicker Amendment that Congress attaches each year to NIH’s appropriations bill. It prohibits any research grants that would cause abortions.

The plaintiffs argue that any funding of new embryonic cell lines would encourage the development of new lines, which can only be generated through more abortions. (The NIH has already decreed that research using 13 additional lines of human embryonic stem cells is eligible for funding.)

The federal government — the defendant in the case — will argue that the funding comes after the abortions, which would have happened anyway.

But so far, the only argument has been over a technicality, though a crucial one: Should the case be heard by the district court of the District of Columbia? The government said it shouldn’t because none of the plaintiffs had “standing,” that is, none was materially damaged by the funding in question.

But on June 25, the U.S. Court of Appeals for the District of Columbia Circuit ruled that Deisher and Sherley had standing because funds that would otherwise go to adult stem-cell research would now go to embryonic stem-cell research.

By mid-August the case was expected to be back in district court for argument on the merits, said Sam Casey of Advocates International, a Washington D.C.-based pro-life legal organization and part of the Deisher-Sherley legal team.

Steve Weatherbe writes from Victoria, British Columbia.

 

 

 

 

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The support for embryonic stem cell research is completely irrational and, I suspect, motivated by ideological rather than humane interests. There is no other way to explain why the FDA would approve ESCR, or why the mainstream media continues to promote morally problematic research that has produced NO MEDICAL BENEFITS and virtually failed to report at all on morally-licit, uncontroversial adult stem cell therapies that are multiplying almost daily. For the poor, desperate paralytics who will submit to being guinea pigs for these potentially deadly trials, I can only pray that they will not be even worse off from the experience. I hope someone from the bioethics community will make a point of warning them of the risks they’ll be undertaking.

Those who criticize this fantastic new hopeful treatment wont be those who need it for their injuries, or their loved ones. You have no vested interest, therefore no valid opinion.
End of story.

The primary contrversy is the ethical challenge. The science is much more straightforward.  In any event, outright lies such as “At the end of July the U.S. Food and Drug Administration gave Geron permission to proceed with clinical trials for GRNOPC1, its privately-developed line of oligodendrocyte progenitor cells derived from stem cells from aborted unborn babies.” serve no one’s best interests.  Geron’s cells were derived from a petrie dish, an embyro left over from IVF.  No mother, no womb, no abortion, no babies.

As for immune rejection, it may crop up, but then again it may not.  The trials will tell the tale.  There is some early evidence of immune privilege for these cells, as well as a “tolerization” procedure.  Teratomas - noncancerous tumors - have shown up in animal work when undifferentiated cells were administered.  Any treatments at this point would never look at undifferentiated cells for the treatments - they are cells that have been started down their desired ultimate pathways.

There have been no hESC treatments or “cures” in the US, because hESC has not been allowed in human trials to this points.  There is anecdotal reporting, however, from around the world that says they work.

The primary challenge is the ethics, not the science.

We put our tax dollars into policing and reworking the governments in iraq. We spent money on nuclear bombs that killed thousands of people. Why not try stem cells? LOOK AT AVANDIA. The fda approved it and 43% of heart attacks are related to its usage. (TIME aug 23 2010) Why the pessimism about this topic? Its obvious that people dont approve of abortion. Why doesnt everyone who thinks like that lock arms and keep people out of cemetaries if you are so pro-life. HELP A BROTHER OUT.

Yes Lisa, embryonic stem cell research is more of less irrational. But if this is so why is it so appealing?

I think the reason is unconscious to most people. Human sacrifice was common in primitive early times because it was an ultimate sacrifice and many thought it had power and would produce great results.  And I think that is the appeal of embryonic stem cell research. It is an acceptable version of human sacrifice and because it is so dramatic to some people it may have dramatic potential. It is far more dramatic than adult stem cell efforts so therefore it must be “better” on some level.

Well, that is my take on it.

As someone with Multiple Sclerosis (and the uncertain future this disease carries), I have followed this storyline avidly.  The conclusions here are correct - follow the money!  And accept the reality that our President has no concerns for life from its earliest forms to - now apparent from the FDA decision about cancer treatments - its last moments.  It is with his permission and endorsement both decisions are being made.

Doctorate Emeritus

That’s a rather broad statement and implies so much.
It’s also false.

Sorry Mark, but Dr. Em has it exactly.  My infant son has many issues stemming from a neurological condition he suffered when his twin brother died in eurtero.  He will NEVER benefit from adult stem cells until it’s too late for his condition, if he lives that long.  My wife and I lost two other children to miscarriage and buried them, not knowing their short lives could have yielded stem cells that might have helped Noah now.  While we burried both of those children, do you know what happens to most miscarriages?  The 70,000 fetuses generated from the invetro fertilization process?  They’re thrown away as “medical waste” into the same land fills we throw our daily loads of trash.  As a Christian I know God does not smile on that act, but how much more would it be life honoring to have their short lives become the key to a healthy one for others?  And for those who cry “follow the money”...time to wake up, you live in America, it’s a capitalist country, do you think adult stem cell research is free?  It’s very easy to talk about funding for wars, or ancient practices of human sacrifice when you don’t have YOUR son, YOUR gift from God struggling to stay alive every day and a promising technology snubbed and crushed by those who believe THEY know the mind and heart of God above all others.  We’ll all be held accountable one day for our actions….if my support of fetal stem cell therapy, in the hope it may help my son winds me in judgment before God and ultimate condemnation to hell for my support of it, then may God’s will be done and may the love I have for both God and my sons be redistributed to some of the other “compassionates” I see speaking so often….

Daniel,

If I came across callous and offended someone, especially someone who has gone thru what you’ve had to endure, I am very sorry.
However, I do have a personal interest in this. I suffer from a chronic illness and I know 2 people with MS who are very close. One is a relative, the other a very good friend.
It is easy to take the high road when you don’t have a personal stake, but I really think the principal at stake is what is most important. Many people who do have an active stake in this I’m sure will opt for the morally correct path.
Good luck and God bless you, your son and family.

Daniel,

I am truly sorry for your son’s plight, however, taking the life of another is not going to save your son. 

You said “He will NEVER benefit from adult stem cells until it’s too late for his condition, if he lives that long.”

Why do you write off adult stem cells as not useful “until it’s too late for his condition,” when ADULT stem cells are the ONLY cells that we are seeing progress in, and have seen NONE in fetal stem cells?

You also said “My wife and I lost two other children to miscarriage and buried them, not knowing their short lives could have yielded stem cells that might have helped Noah now.”

Again, I am very sorry for your loss.  However, I hope it helps you to know that fetal cells can only be “harvested” from very young babies.  I believe it’s before they are 30 days past conception.  Your other children were probably too old.

You also stated “The 70,000 fetuses generated from the invetro fertilization process?  They’re thrown away as “medical waste” into the same land fills we throw our daily loads of trash.”

And you are OK with that?  These are babies, who SHOULD have the right to life.  They are entitled to human dignity!  The answer isn’t to suck their cells out (thus killing them,) before they are thrown into the trash!  They SHOULDN’T be thrown into the trash!  So many people have questioned the church’s stance on Invitro fertilization.  Can you clearly see the problems now?  And, in response to the problems created, there are much better answers! For example, Frozen Embroyo Transfers.  This is taken from an IVF site:

“If you have recently gone through infertility treatments or if you are considering undertaking IVF, you may be wondering what will happen to any extra embryos that are created during the procedure. If you and your partner have extra embryos that are not used during initial IVF procedures, these embryos can be frozen and then transferred to your uterus at a later date. Known as frozen embryo transfer (FET), this procedure is now widely available throughout the United States, and has helped many couples facing infertility achieve pregnancy.”

Cells taken from the umbilical cords after the birth of these LIVE healthy babies could provide the live saving cells that will help your son.

Sincerely wishing your family, and especially your son all the best.  I will pray for his healing.

Mark, thank you for your words, and don’t think anything is directed at you.  I’ve been attacked by fellow Christians for even giving thought to allowing fetal stem cell therapy to benefit Noah, all from people who put more value in their pius appearance than they do using their intelligence, reason or compassion.  Please know I see you have all this in the words you share.  We all often forget we’re in the same boat…as a former soldier, I love my country, I loathe the current presidency yet my duty to God demands that I pray for Obama and his cabinet for the greater good of America.  Once we see each other for the miracles we all are, I think it become much easier to look at a situation through love, through God’s eyes if you will to make decisions that yeild the best fruit.  I’m thankful for the fact you and I can make exchanges like this, and I pray God blesses us all in each of the struggles we all face.  Take care brother….

-Daniel-

As a paralyzed US army veteran I applaud the president for not letting mindless religion win out over solid science.

Say yes to stem cell research of all kinds. All paralyzed veterans are looking forward to walking again, stroke victims are ready to think, diabetics are ready to stop using insulin, heart attack victims are ready for strong hearts.

Yes, all paralyzed veterans are looking forward to walking again.  And, with their glorified bodies in heaven, indeed they will.

However, while still on earth, most veterans I know and love still hold true to their vow to defend and protect.  My father, for example would never say “kill the baby, in HOPES that I may someday walk again.”

No, he would defend and protect the baby!

@Kathy

The truth is that Christian theology, like every other theology, is
not only opposed to the scientific spirit; it is also opposed to all
other attempts at rational thinking. Not by accident does Genesis 3
make the father of knowledge a serpent—slimy, sneaking and
abominable. Since the earliest days the church, as an organization,
has thrown itself violently against every effort to liberate the body
and mind of man. It has been, at all times and everywhere, the
habitual and incorrigible defender of bad governments, bad laws, bad
social theories, bad institutions. It was, for centuries, an apologist
for slavery, as it was the apologist for the divine right of kings.
—H.L.Mencken

@rich,

There are many people who hate the Catholic church, and are totally ignorant of what the Church teaches.  Menchken is just one such individual.

There are also many people who know that science and faith are neccessary for full understanding.  They are not rivals, but 2 edges on the same sword.  Completely compatible.

Here’s a quote from a famous scientist I’ll share with you:

“A priori one should expect a chaotic world which cannot be grasped by the mind in any way…  [T]he kind of order created by Newton’s theory of gravitation…is wholly different.  Even if the axioms of the theory are proposed by man, the success of such a project presupposes a high degree of ordering of the objective world….  That is the “miracle” which is being constantly reinforced as our knowledge expands.”  Albert Einstein

Embryonic stem cells do not come from fetuses. They are cells grown in a petri dish and no fetus is involved in the process in any way, nor is an abortion. Not only that, but these cells are not able to grow beyond the blastocyst phase, so they could never grow into a fetus. Also, thousands of these cells are thrown away in fertility clinics all the time. I don’t understand the mindset that allows their destruction, but not their use.

It’s insane how much ridiculous disinformation there is regarding this subject.

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