US Finalizes Stem Cell Research Guidelines

An anonymous reader writes with an excerpt from Cosmos Magazine, to wit: "The US government unveiled final rules for embryonic stem cell research, laying out ground rules for 'ethically responsible, scientifically worthy' studies eligible for federal funds. The new rules, which go into effect today, follow President Barack Obama's March 9 executive order lifting a ban on embryonic stem cell research, an order that went into effect under his predecessor, George W. Bush. ... The US National Institutes of Health's (NIH) guidelines are slightly less restrictive than those outlined in a draft document released in April in that they allow the use of existing stem cell lines, in addition to new ones derived from IVF procedures. ... The NIH received some 49,000 comments from patient advocacy groups, scientists, medical groups, and other interested parties before issuing the guidelines."

Comments

Existing lines

[JobyOne]

I've never understood the opposition to using existing stem cell lines for research.

Assuming there is a moral problem with destroying embryos, the damage is done. At this point you're pretty much saying "don't eat that cow" when the cow is already dead. Once it's dead you can either eat the cow and have a delicious steak or waste the cow and let it rot.

Same thing with a stem cell. Once the embryo is destroyed you can either waste it...or maybe find ways to cure a zillion diseases. Either way the embryo is still dead.

Re:Existing lines

[NecroPuppy]

The point is that if the bans were there, then the embryos wouldn't be destroyed in the first place.

This, of course, ignores comepletely that most embryos held by fertility clinics (and other sources) are ultimately destroyed anyway.

My view is simple: Why not recycle? If another use can be found for them, great. If not, that's fine too.

Re:Existing lines

[NecroPuppy]

Actually, with IVF, many embryos are normally grown simultaniously, with only the best two or three candidates considered for implantation.

Given the inherant dangers of the egg harvesting procedures, it is unlikely that any ethical doctor would purposefully subject a woman to that, just for the purpose of additional stem cell lines.

Re:Existing lines

[ArcherB]

The anti-stem cell research, anti-abortion, and anti-sex education positions of conservatives is primarily motivated by sin.

Is there a fallacy of stereotyping? Doesn't matter. Let me give you some advice: If you don't know what you are talking about, shut up. As a conservative, allow me to correct you and alleviate your ignorance.

Some of us conservatives are against embryonic stem cell research because it is killing human life for research purposes. I know, it's only a few cells, so it doesn't count right? So, tell me then, when do human beings earn the right to not be destroyed and experimented on? Is it at birth? Is it after the first trimester? How about voting age? Don't have an answer? Me neither. That's why I'm "conservative" in my answer and simply say, "NO RESEARCH ON HUMANS WITHOUT THEIR CONSENT, PERIOD!"

Is the right to not be experimented on so unimportant that you guess when people get this right?

Re:Existing lines

[ppanon]

So, tell me then, when do human beings earn the right to not be destroyed and experimented on?

There's a few possible candidate thresholds but, when it comes to destruction, the ones that make the most sense are:

1. "self-sustaining" viability outside the womb (currently around 22 weeks gestation) or
2. significant nervous system complexity (somewhere between 9 to 20 weeks).

Experimentation is a much broader issue with many more possible scenarios and lots of grey areas. That said, I can't see a significant ethical problem with experimentation if you're dealing with individual cells for therapeutic purposes.

As someone else pointed out, there may be significant ethical issues in how you obtained the embryos or eggs due to the risk it poses to the donor. I think some totalitarian state having "farms" with captive unwilling donor women to produce embryos for export to Western hospitals is definitely a scenario we would want to prevent through legislation, and the source tracking as with the current legislation should address that.

To use your example, experimenting with cells from low-division embryos is not significantly different from experimenting with skin or bone marrow cells. You don't have a problem with donating a few skin cells because, with a local anaesthetic, you wouldn't even feel it. On the other hand, if someone endangered your life by ripping 50% or more of your skin off for stem cell material, I expect you would be pretty upset. Conversely, an undifferentiated embryo has no nerve cells to feel, know, or want anything.

Certainly, if successful embryonic stem cell therapies actually get developed, then there will be an issue with supply vs. demand and access criteria. That said even if we don't find an ethically satisfactory technical solution for solving the supply scarcity problem, we've already got a similar issue with a limited supply in the case of organ transplants. Yet there doesn't seem to be a credible broad movement arguing for the cessation of organ transplants.

Re:Existing lines

[ArcherB]

Thank you for a well thought out, fair minded response. However, there are some points I have issue with:

"self-sustaining" viability outside the womb (currently around 22 weeks gestation) or

A newborn is not "self-sustaining". Hell, I know a few 30-year olds that are not "self-sustaining". What about premature babies that require incubation? They are not "self-sustaining". Are they available for experimentation?

Also, embryos in a petri dish can survive outside the womb about as long as newborn.

significant nervous system complexity (somewhere between 9 to 20 weeks).

9 to 20 weeks is a big range. I'm guessing you are setting it so broad because you don't know. I don't either. Let's just say it's 14 weeks, 3.5 days. What about the baby that is 14 weeks, 2 days? Some babies mature at different rates than others. How do you know which babies have a nervous system? What happens in 20 years if we find out that embryos can feel pain without a nervous system? My point is that too many times, we've thought "things" couldn't feel pain or were labeled as not or less-than human with horrific results. We should have learned by now that man is not perfect enough to decide who deserves basic rights or what is human.

To use your example, experimenting with cells from low-division embryos is not significantly different from experimenting with skin or bone marrow cells.

Right. Under a microscope, they are pretty much the same thing. The difference is the donor and what damage it does to the donor. You mentioned skin and bone marrow. I have both. If I want to donate tissue or take part in a scientific experiment, I am free to do so (and I have). If you can find an embryo that will consent to experimentation, then I guess that's OK too. But even with parental consent, I don't feel that parents have the right to give permission to anyone to kill a child for the purpose of experimentation. And would it even be legal for me to volunteer for an experiment when the end result is certain death? It certainly wouldn't be legal to hold such an experiment.

The other point is that donating a few cells won't kill me. Embryos are destroyed in the process of harvesting cells. If you could harvest stem cells while not killing the embryo, then I wouldn't really have a problem with it, provided you have the parent's permission.

Certainly, if successful embryonic stem cell therapies actually get developed, then there will be an issue with supply vs. demand and access criteria.

So far, all the therapies that have been developed have come from adult derived stem cells. There will be no shortage of those as they can be taken directly from the patient.

And, it's nothing like an organ donor. Even as you mentioned before, it's no big deal giving a cheek swab or skin sample. Giving up a liver is nothing like giving a blood, marrow, or skin sample. Something about organs make them a requirement to life. Skin samples? Not so much.

Re:Existing lines

[Omestes]

Jumping in here...

A bit of background, I am an atheist, and I am against abortion (except in the cases where the mother could die). I am not against stem-cell research though, because the cells were already extracted, and would be destroyed if otherwise not used. If every cluster was brought to term (an absurdity), then I would be against stem-cell research as well.

The reason I stated I am an atheist is to make it perfectly clear that I don't have an idea of sin, or "ensoulment" involved here, basically this is ethical and not a moral judgment. I bring up my opposition to abortion, because these are related issues, and I am for stem-cell research for the same reasons I am against abortion, and have the same caveats to my support as I do my opposition.

I also agree with the person above you; the "humanity" of an embryo is determined by its neurological properties. Without a brain, or a nervous system above a certain threshold of complexity, you cannot be considered to be human, much less sencient. The caveat here is potential, an embryo may be a person someday, and this must be weighed as well. In the case of abortion, the odds of fulfilling this potential is rather high left to its own devices, wherein the case of stem-cells the odds of reaching the point of being human is completely nill. The cells that we use for research will NEVER turn into people left to their own devices, and thus their potential is much much lower than an organic (in utero) cell mass.

We must weigh the potential here. Being a human is obviously the most important, but we must also balance this with the utility to science, and the well-being of humanity as a whole.

The caveat here is that I will not inflict these opinions on anyone, this should be the choice of the parent or donor. I say this because I am pretty sure I don't know any better than any other person, much less the people effected by these decisions. While being against abortion, I still am pro-choice, as I am towards stem-cells.

If you have a brain-dead dependent, you, granted power of eternity, can pull the plug. This should be no different for undeveloped cell masses in deep freeze. The donor should choose the fate. Not a bunch of self-righteous asses such as me and you (or really anyone else).

Re:Existing lines

[interactive_civilian]

A few things:

A newborn is not "self-sustaining". Hell, I know a few 30-year olds that are not "self-sustaining". What about premature babies that require incubation? They are not "self-sustaining". Are they available for experimentation?

Also, embryos in a petri dish can survive outside the womb about as long as newborn.

I suspect that the GPP was saying "self-sustaining" as in "able to survive without being directly attached to the mother's life support". A newborn can obtain oxygen and get rid of carbon dioxide and other metabolic waste without having to be connected via an umbilical to the mother. One's take on that kind of alters the scape of your other questions. A premature birth can survive, grow, and develop without being directly attached to the mother's life-support. An embryo in a petri dish cannot, as we do not have the technology or knowledge to artificially replicate a womb.

significant nervous system complexity (somewhere between 9 to 20 weeks).

9 to 20 weeks is a big range. I'm guessing you are setting it so broad because you don't know.

Again I am assuming the GPP used such a big range for a number of reasons: different individuals will develop at different rates, different people will disagree what constitutes "significant nervous system complexity", etc. Therefore your example using an exact time measurement is inapplicable.

What happens in 20 years if we find out that embryos can feel pain without a nervous system? My point is that too many times, we've thought "things" couldn't feel pain or were labeled as not or less-than human with horrific results. We should have learned by now that man is not perfect enough to decide who deserves basic rights or what is human.

This is a nonsense question. To "feel pain" you need three things: 1.) a sensor to detect damage, 2.) a transmission system to send that information to 3.) a processor to interpret that data. In mammals, this requires a nervous system. It is part of our biology. No nervous system, no pain.

May I ask a question: are you against In Vitro Fertilization? In such situations, as has been mentioned numerous times, several eggs are fertilized, a select few most viable embryos are selected for implantation, while all others which may or may not be viable are destroyed. Is this murder in your eyes? I'm not trying to jump on your case, I'm just trying to gauge your consistency.

How many lives have been lost?

[QuantumG]

During the 6 years that this has been banned how much research into life saving treatments has been delayed? How many living, breathing, people have been denied these treatments? How many more will die over the next 10 years that could have been saved?

And all to placate the extreme pro-life fringe, who count fertilized embryos (that would be destroyed anyway) as sacred, and the ignorant who continually refer to "aborted fetuses" whenever the subject comes up.

For shame.

Re:How many lives have been lost?

[CrimsonAvenger]

During the 6 years that this has been banned how much research into life saving treatments has been delayed?

Probably none at all. It's not like the "ban" prevented research, it just prevented Federal funding for research. And it didn't even really prevent that, as long as you were willing to abide by Federal rules.

BLOCKQUOTE>How many living, breathing, people have been denied these treatments?

Zero. Latest guesstimates I've seen say it'll be 20 years minimum before any of these treatments get all the way through clinical trials to general use. So none of them would be ready for use today, even if we'd started six years back.

How many more will die over the next 10 years that could have been saved?

Zero. See above. If we'd started six years ago, best guess says we'd have no usable treatments for another 14 years.

Again, note that President Bush's "ban" wasn't actually a ban. It wasn't even a ban on Federal funding (for that, we have to drop back to Clinton's Presidency, when no Federal funding for stem cell research was available at all).

Was Bush's "ban" a good thing? I doubt it, myself, but it's arguable.

Would we be better off if it had not been done? No, since absent his "ban", we'd have been operating under the old rules (which WAS a ban).

Would we have these miracle cures available now? No. Clinical trials take much longer, especially when we're dealing with "treatments" that might give us novel new cancers.

Would they be available soon? It'll be a bloody miracle if I live that long, but then I'm an old guy with cancer.

Would they be available SOONER? Probably. Probably not soon enough to do anything for me, even assuming they'd fix what I have.

Bad Summary

[CorporateSuit]

There was no ban on embryonic stem cell research. There was a ban on the federal government using tax dollars to fund embryonic stem cell research.

Re:Bad Summary

[NecroPuppy]

Which, for more than a few labs or research centers, was effectively a ban.

While some locations were able to get private funding (and thus get around the relatively useless lines approved by the Bush govt), this sort of blue sky health research has generally seen a lot more money from the government.

Because of that ban, for example, DARPA couldn't effectively spend money on research into experimental treatments for spinal cord injuries involving stem cells. Now they can. And, quite likely, will.

Re:Bad Summary

[jo_ham]

It was effectively a ban, since if you ran any privately funded stem cell research in the same labs as any work (even with nothing to do with stem cells), the federal funding would be withdrawn for that research.

Let's be accurate here.

[caladine]

The new rules, which go into effect today, follow President Barack Obama's March 9 executive order lifting a ban on embryonic stem cell research, an order that went into effect under his predecessor, George W. Bush. ...

In the interest of accuracy, I wish people would stop calling it a "ban on embryonic stem cell research".

While calling it a all out "ban on embryonic stem cell research" makes a great sound bite, it's horribly inaccurate. It was only a ban on federal funding for embryonic stem cell research for stem cell lines created after August 9, 2001. If you were willing to fund it yourself, you were free to do so. Bush's executive order didn't change that part at all which the misleading sound bite alludes to.

Now, with that interjected, back our regularly scheduled flame wars on this topic.

Re:Let's be accurate here.

[QuantumG]

Understand this, any institution that took federal funding for any research was banned from doing stem cell research.. so basically what you're saying is that they should have started a completely new lab, separated themselves from the rest of their scientific community, to do underfunded research. Well obviously they're just whiners.

Re:Let's be accurate here.

[interkin3tic]

Corporations set up separate legal entities all the time to mitigate liability.

If we were talking about a paper issue that would be great, assuming researchers could afford the cadre of lawyers that corporations use (which they can't). But we're actually talking about physical labs, not imaginary companies.

What exactly was stopping them from using the existing stem cell lines? I don't believe I've ever received a satisfactory answer for this other then "They just couldn't!"

Some labs may have been heavily invested in a line of stem cells created after that date. For example, switching to another cell line is incredibly wastefull if you've already spent millions on microarray analysis of a new stem cell line that happened to have been made after the magic date.

Some necessary stem cell lines have not yet been created. If you want to study an inherited disease, say one that causes brains to be malformed, you might want to study how neurons differentiate. Generating a stem cell line from an embryo that would have that disorder would be more convinient, not to mention more humane, than having carriers of the disease continually reproduce and harvesting the fetuses after they've started growing brains.

There's no guarantee that the existing stem cell lines are good for all things that ESC could be used for.

And it's an artificial distinction that pointlessly limits research in a developing field. If you have an ethical problem with ESC, using existing lines is still problematic. If not, there's no reason for the ban.

Not an exhaustive list, and I think if you searched there are plenty of people who have better answered questions like yours.

Re:Let's be accurate here.

[ring-eldest]

A "ban on federal funding for X, Y, and Z" is effectively a ban on X, Y, and Z.

Take abstinence only sex-education for example. I'm not sure what the current situation is, but for a long time schools either taught abstinence only sex ed (no instruction about condom use. No mention of birth control at all, unless it paints the users as morally bankrupt) or they had to stop taking certain funds from the state and federal government. There aren't too many school boards that will vote to turn down money... Even if it hurts the kids.

If you control the purse strings, you control the outcome. Are you surprised people see this as a ban?

Re:NEVER WAS BANNED!

[darkmeridian]

Your entire post is misleading. President Bush was the first President who had to make a decision regarding stem cells. He limited federal funds to existing adult stem cells because of misplaced moral considerations. The embryos would have been destroyed by the fertility labs anyway, but when signing the bill, Bush was flanked by children conceived from embryos. There was no scientific reason to limit the federal funding. It's not even clear the moral justification was that great, either.

After Bush crippled competing research, it's no wonder that adult stem cells are ahead in the race. Imagine what would have happened if stem cell research was not limited out of political considerations.

Discrimination against human-animal hybrids

[greenreaper]

Speaking as a furry, I'm disappointed in section IV of the guidelines. Who will give us our fluffy tails, or make Piccinini's disturbing sculptures a reality now? At this rate I might as well just buy my own island and experiment there . . .