Slashdot Log In
Draft Stem Cell Guidelines Threaten Research
Posted by
kdawson
on Fri May 15, 2009 11:24 AM
from the retroactively-applied-ethics dept.
from the retroactively-applied-ethics dept.
Death Metal suggests we peruse a piece up at Wired on how the Obama administration's draft guidelines for stem cell research could invalidate hundreds of cell lines. "Under the Obama administration's proposed rules for funding embryonic stem cell research, hundreds of existing cell lines could be ineligible, even those that qualified under President Bush. The guidelines were written by the National Institutes of Health and are currently in draft form and expected to be finalized in July. But in their current state, they restrict funding to stem cell lines produced according to new rules that are only now being established. Few existing cell lines will meet those requirements. 'The so-called Presidential lines aren't suitable for actual medical application,' said Patrick Taylor, deputy counsel at Children's Hospital Boston, who criticized the NIH guidelines in a paper published Thursday in Cell Stem Cell. 'But we're talking about many, many more lines. The new lines were created with extensive ethical oversight. They're at stake here.'"
Related Stories
[+]
Politics: US Finalizes Stem Cell Research Guidelines 249 comments
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."
This discussion has been archived.
No new comments can be posted.
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
Full
Abbreviated
Hidden
Loading... please wait.
And... (Score:5, Insightful)
And this is why I was so cynical about the election. It's the same old business as usual.
Re:And... (Score:4, Interesting)
It's the same old business as usual.
That's not true. The people in charge now are less interested in telling us who we can sleep with and more interested in telling us what kinds of foods we can eat. Yeah, the Government is still trying to micromanage our lives like an obsessed baby sitter, but hey, it's still change you can believe in ;)
Parent
Re: (Score:2)
But you'll find the average Slashdotter much more heavily invested in Doritos and Bawls than in sex (at least, the varieties that involve other persons).
Re: (Score:3, Insightful)
But you'll find the average Slashdotter much more heavily invested in Doritos and Bawls than in sex (at least, the varieties that involve other persons).
I find the opposite is true. Sex is like oxygen. When you are getting enough of it, it's not a big deal.
Re:And... (Score:5, Insightful)
I know this will hard for you US'ians to accept but it's a proper role for Government to regulate what you can eat when your obesity rates are driving up the cost of medicine.
Bzzt, no, it's not a "proper role" for Government to protect me from myself. If my insurance carrier wants to penalize me for a being a fatass then all the power to them. It's none of Washington's business.
Parent
Re:And... (Score:4, Interesting)
I think what P was suggesting is that you can have absolute freedom to harm yourself, or socialized medicine. Choose one. Me, I'd choose the second, but by failing to choose you have effectively given up your right to criticize either.
I've never wanted socialized medicine, because I fail to see how having a Government ration my health care and stick it's nose into my business is any improvement over having a private company do the same. At least the private company doesn't have well armed goons to enforce it's edicts and I can choose to do business with whichever one I'd like.
Parent
Re: (Score:3, Informative)
This will be even harder for you foreigners who don't know the proper term for American and use USian out of complete and total ignorance, but the role of the government is what the people allow it to be. Currently, the constitution and the bastardization of it is the limits for the federal government. The federal government has no power to regulate anything concerning fat nor does it have the power over the cost of medicine.
We are not subjects of the crown here in America. We are not the property of our el
Re: (Score:3, Interesting)
Actually American has become a generic term to describe USians. When speaking to my friends from Canada I'll slip in a "We're all Americans here" and wait for the indignant "I am NOT an American". Of course half the time they don't get it so I have to explain it to them.
Re:And... (Score:4, Informative)
I don't ever remember the government attempting to say who you could sleep with,
Then you must be younger than 6.
http://en.wikipedia.org/wiki/Sodomy_laws_in_the_United_States [wikipedia.org]
Parent
Re:And... (Score:5, Insightful)
Well of course no matter who you elected it was by and large going to be business as usual (yes, Ron Paulians, even if that long shot had occured).
But what I'm not seeing is how this is actually the same. I RTFA (gasp) and it seems the issue is that the new rules include informed consent requirements for egg donors that the old lines, despite being collected under informed consent standards of their own, don't meet the letter of the new rules, which are applied retroactively. The new rules were drafted by the NIH, who said that they estimated the new rules would make 700 old lines available for research that weren't before. A number of researchers are saying that they don't think that's the case and many of the old lines would not meet the new standard despite being collected ethically.
So which seems more likely:
- NIH really intended to make all those old lines available, but botched the legalese, which can be fixed by loosening the retroactive requirements while keeping the new requirements for new lines or various other changes.
- NIH was lying and is trying to quash stem cell research "just like Bush, business as usual" by disqualifying these old lines, while simultaneously allowing arbitrarily many new lines to be created using standards that are qualitatively if not technically nearly identical to the old ones.
The second just doesn't make much sense to me. Why bother lying when the practical effect would be obvious and nobody can really do anything about it anyway, why even display the draft rules rather than just put them into effect, why allow new stem cell collection under standards nearly identical to the old if the goal is to quash it entirely? Why's Obama trying to quash stem cell research anyway? Pressure from the religious right? I don't get it.
Parent
Re:And... (Score:4, Insightful)
Politicians often say one thing to passify the masses and then do the opposite under some obscure justification.
You asked why? Power, support from those who have the power, and control. I don't think there has been a modern president who wasn't in support of more federal government control in the last 30 years.
I asked why does Obama want to quash stem cell research. "Power" is a non-answer; he has the power by having the guidelines researches have to follow, whether those guidelines exclude stem cell research or not. The question is, what does this accomplish, and why would he deliberately restrict the old lines from being used, yet deliberately allow new lines to be created?
So yeah. I completely get that politicians will say one thing and do another, thanks. Now please start making sense, and explain how this makes sense.
Parent
Re:And... (Score:4, Insightful)
Don't confuse the use of power with getting power. Power can be obtained by the support of powerful people. Think drug lobby and a medical system that treats symptoms instead of cures.
Okay, now explain how opening up all future stem cell lines with informed consent standards that are very similar to the old ones, but excluding those old ones, helps the drug lobby. If the motivation you ascribe was true, and stem cell research was a risk to the drug lobby, then Obama would have tried to prevent all future stem cell lines, not opened the floodgates to creating new ones. The restrictions on old lines would have been something concrete, not something they can get around by calling the former donors and getting a new form signed.
I thought it was pretty obvious as I already stated it. I guess your one of the people who are still buffaloed into thinking Obama was something special. He isn't, it's the same crap, the names have changed and who is leveraging who has changed but it's all the same BS.
You babbled some nonsense about Stalin and governments seeking more power and control even though they already had this power and more. Explain how this is the same BS, just don't declare it to be the same and act like that means anything.
See, the problem is that if I completely buy into that "Obama is the same BS" (instead of my default 50%), then this still doesn't make sense and you aren't making any either. You've posited a motivation. You have not explained how these specific actions fit those ascribed motivations, and in many ways it contradicts your posited motivation.
You sound like one of those people who was so upset on Nov. 3rd 2008 that you lost your ability to distinguish.
Parent
Re: (Score:3, Informative)
There's a third option:
- Go around NIH's new requirements by simply going back to the donating couple and asking them if they'd like to sign a new contract.
Seems nearly impossible. Most of the researchers who are actually trying to use the stem cell lines probably have no access to the identifying information. If you're working on stem cell culture, you don't know and don't care who the cells were from, you respect their privacy. Until legalese gets arbitrarily in your way that is. It's not like the cells are labeled "Embryonic stem cells harvested from Jane Smith and Joe McDonald's aborted embryo."
Plus, if you did get the identifying information, contacte
This was pretty much already the case (Score:5, Informative)
The so-called Presidential lines aren't suitable for actual medical application
They were, and still are, suitable for research. Many of these lines have been contaminated in ways which pretty much already precluded any actual medical application.
Silly question (Score:3, Insightful)
Why can't the ethical debate be side stepped, by using cord blood cells? I never hear this mentioned when the topic of federal funding for stem cells comes up. I figured someone here could explain the pros and cons of these cells from a research point of view.
Re: (Score:3, Interesting)
Pushing embryonic stem cells is more about justifying abortion than actual stem cell treatments. Adult stem cells have shown the best treatment options while embryonic stem cells would have the same issues as organ transplants. Cord blood would likely be as effective as embryonic but does not help the abortion stance. Pharmaceuticals benefits as well in making drugs to prevent rejection from treatments made with embryonic sources.
It is more about politics and money at the cost of ethics and good science.
Re:Silly question (Score:4, Insightful)
Justification for abortion go along these lines: people do not believe it is a human life yet, they can not afford to have the child so having abortion makes it less of a burden on the state, if you make abortions illegal, people will still get them but not in the safety of a doctor's office causing deaths and injury.
It's fine if you believe abortion is taking away a life and that it should be illegal. That is a completely rational stance and there are good options like adoption. But no one ever gets pregnant so that they can have an abortion to give stem cells. No one is arguing that we should have abortions to get stem cells. But since it is legal, why would you not utilize something that could help other people? I haven't heard even the most left pro-choice person ever give that argument as a reason to conduct abortions.
Parent
its called (Score:5, Insightful)
there can also be, get this, several of them created until they get it right.
Re:its called (Score:5, Insightful)
So, the previous consent forms conflict with the new consent forms, rendering most cell lines unusable. Sounds like the DRAFT needs to add a grandfather clause. This isn't that big of a deal other than it's sloppy standards writing. Good on Wired for bringing it up so that it can be fixed.
Parent
Re: (Score:3, Interesting)
Man, the best way to get around things is to call something a "draft". That way, no one's head it ever on the chopping block about it, since it's "only" a draft. You can easily change it, because it's "just" a draft. Yet you can still hold people to it because it's "the latest draft of what will be the policy". I see & hear about it a _lot_ at work. Some "policies" that are being enforced have been in "draft" form for a decade... Granted, it's IT, but these things cross-contaminate.
so much for getting government "out of" science... (Score:4, Insightful)
Wouldn't it be better to really get the government out of science altogether and let the actual scientists decide what to research instead of having some politically and/or religiously motivated bureaucrat making those decisions for them? Federal funding has always come with politically motivated restrictions. When Obama said he was getting the government "out of" science by increasing governmental funding I couldn't help but roll my eyes.
Re: (Score:2)
Seems like they'd find some other way to pay for it, doesn't it?
Actually (Score:2)
What Obama talked about was taking the politics out of science, not the government. Those aren't the same thing.
Re: (Score:3, Insightful)
How do you take the politics out of the science when you hold the science hostage to political considerations to get the required funds?
Re: (Score:3, Interesting)
No. The scientists have to get their funding from somewhere; and the government throws a lot of money around. The other options for funding are worse: You can get it from corporations, who will only fund research if they see a way to make a profit from it in the next three to five years; or you can get from universities, but I understand that the political games in academia are far more vicious than they are in government.
Re: (Score:3, Insightful)
My brother works for the BFRL [nist.gov] at NIST [nist.gov]. Now, a lot of what they work on does not affect you.
Re:so much for getting government "out of" science (Score:4, Insightful)
The taxpayers absolutely have the right (under a Democratic system) to ensure expenditures of those funds are in line with their needs, values, etc. The elected officials properly make political decisions regarding spending taxpayer money--as it should be.
For better or worse a large number of those tax payers are going to object that the expenditures of these funds don't match their values regardless of what you do. Hence why it would make more sense to get the Government out of it altogether and let private capital fund this research.
Parent
Re:so much for getting government "out of" science (Score:4, Insightful)
They might object but they will have been represented. That is the key difference. If the political leaders truly, routinely make decisions against the majority then they will no longer be the political leaders.
The tyranny of the majority is just as insidious as other kinds of tyranny. When the Government takes my money and uses it to fund things that I have moral objections to I have no recourse. When private capital does it I can choose to invest my funds with a different firm.
Parent
Re:so much for getting government "out of" science (Score:4, Insightful)
Taken to it's logical conclusion, this is merely an argument for anarchy. Say I'm a vegetarian for ethical reasons, and I don't want my tax dollars spent encouraging or enabling people to eat meat. Consequently, I don't think the government should take my money and use it to fund stuff like health inspections at slaughterhouses or meat packing plants, etc. because that encourages people to eat meat. Also, I'm a religious fundamentalist and believe that I must literally cleave to the proscriptions in Leviticus, meaning I also don't want the government doing anything that involves shellfish, pork, or garments with more than one kind of material in them. And finally, I'm a pacifist and believe that all violence is wrong. Therefore, none of my money should be spent on the military; for that matter, I don't want that money going to my local police force because they carry guns and nightsticks.
Eventually, you'll find someone who has an objection to everything. So then, anarchy, because there's nothing at all you'll be able to find the government can fund and not run afoul of someone's ethical concerns.
Parent
Re:so much for getting government "out of" science (Score:4, Insightful)
Depends on the appliance; I do pay attention to the Energy star ratings and consumption figures that are on major appliances. If you're buying medicines, do you buy the ones that are tested by an independent agency that at least ought to provide a reasonable expectation of independence from manufacturers, or do you just trust that whatever Dr. Watson has bottled up for his patent medicine show is perfectly safe and does what it's marketed to do?
Article 1, Section 8, which grants congress the power to:
The authority to write laws providing for health inspections of slaughterhouses, among other things, rather obviously fall under such a power.
But, to return to something you said initially:
In what way do you not have recourse? We have elections in the US, as well as a free press. Vote for that person who will best represent you, and make use of your freedom of speech to convince others to see things your way.
Parent
at least ... (Score:3, Funny)
Why does federal funding equate to research? (Score:3, Interesting)
Or more to the point, does it, really work that way?
Taylor noted that removing federal support for ESC lines supported by Bush wouldnâ(TM)t only affect use of the cells, but all the work done to characterize line-specific behaviors and tendencies. âoeWhen you take a cell line and say weâ(TM)re not going to use it any more, youâ(TM)re talking about a tremendous body of information,â he said.
So if Uncle Sam isn't willing to pay the bills any more, the whole lot goes into the trash?
Why, then, are there more than 21 lines in existence now? And how is it possible that there are as many as 700 lines that are over 10 years old?
No, it seems to me that they will just have to get their money from somewhere else. And if their research is as appealing as they claim it should be, there should be other sources of funding.
This is more about Chicken Little than anything actually important to humanity...
Re: (Score:3, Interesting)
Allow me to explain.
The world is pretty big, so pharmaceutical and other research companies like to shop around before doing anything.
So outside of the fact that some areas have more local expertise than others, public money is key to attracting research. (The US also has a natural advantage with its market size and anything goes marketing regulations)
Let's just say that Bush's finance strategy didn't really hurt the global stem cell research effort, it just hurt the stem cell research community inside the
Re: (Score:3, Informative)
Yes. I will definitely tell you that stem cell research would be better off without Bush. In fact, I would bet that if we had a time machine, ALL research would probably do better without Bush, with the exception of "research" done to support abstinence only programs and homosexual conversion therapy.
Although it is true that it was during Bush's term that the first funding actually got passed out, Clinton and Congress actually allowed the NIH to fund stem cell research.
Bush ended the legal arguments that
At Least These Concerns Were Based On Ethics (Score:5, Informative)
At issue here are the NIH's proposed guidelines regarding a woman's consent to stem cell research when her donated eggs and embryos are used to create a cell line. The NIH wants to stiffen them to make sure that a woman has to specifically agree to let her eggs be used for stem cell research. I can understand that because I sure as hell wouldn't want cell lines made from my genetic material without my consent.
The problem is that these standards, if applied retroactively, would invalidate many of the currently-available stem cell lines. Scientists are more than happy to apply these new standards going forward, but obviously want current stem cell lines to be grandfathered in. I hope that the NIH clarifies the guidelines to allow already-existing stem cell lines to be used. After all, these are the draft standards, not the final ones.
I am happy that the NIH concerns do not seem to be motivated by a political agenda. Informed consent is the keystone of all medical treatment and medical research. This is a welcome change compared to the Bush Administration, which made scientific decisions based on religious and political grounds. Snow flake babies? Really? Come on.
Re: (Score:2)
"I can understand that because I sure as hell wouldn't want cell lines made from my genetic material without my consent."
Why?
If they are going to be thrown away anyways, why do you think there still yours?
Re:At Least These Concerns Were Based On Ethics (Score:5, Insightful)
For the same reason I think the genetic material in the condom I threw away is "mine", and would be upset if someone used it to procreate without my consent!
Go ahead and make a property rights argument about how I don't legally get to say what is done with my stuff that lands in the landfill. Who cares. This is about ethics, and I for one am glad that the medical research profession takes ethics into consideration.
Parent
Re: (Score:3, Interesting)
Now, I don't disagree that that would be an upsetting situation, but I have a question.
Would it be upsetting because it was your DNA and you wanted it to get thrown away, or because it was used to create this offspring with needs and attached responsibilities and long lasting and expensive legal obligations that you didn't have a say in? Because really, would you be so upset if they used it to condition their hair instead?
You can discard something that you don't need in a lot of different ways. And some o
Re: (Score:3, Interesting)
I don't think we HAVE to answer the question of whether an embryo is a person or not. At the end of the day, there are some regulations that dictate what can and can't be done with that embryo, be it a person or not. You can implant it in a uterus and make a baby, or throw it on the sidewalk, or donate it to science.
You can argue that Bush felt it was morally wrong to use embryos to develop cell lines. I personally think that Bush doesn't really care what you do with embryos, so long as you vote for him,
Re: (Score:3, Informative)
It's my genetic material inside of those cells and I may not have a problem with them being used, but I deserve to be asked first. I agree that a grandfather clause is in order to enable the use of previously established
Re: (Score:3, Informative)
And if they were making stem cell lines out of embryos without consent, you'd have a point. As it is, they are making them WITH consent, and they are now making the consent form more specific. It isn't the same at all, really.
A right to privacy based on information in your genetic code is already a BIG DEAL in bioethics. While it really has nothing to do with stem cell lines, it is scary to think that your health insurance company could refuse to cover you because you carry genes that make you susceptibl
Re: (Score:2)
"I can understand that because I sure as hell wouldn't want cell lines made from my genetic material without my consent."
You are Jango Fett and I claim my five pounds.
If you don't like the requirements . . . (Score:2, Insightful)
. . . come up with your own funding. It's not as though embryonic stem cell research is illegal.
Screw Obama (Score:2)
All hail capitalism!!!
How hard can it be? (Score:3)
"Only stem cells created from sources which have little chance of ever being implanted for pregnancy may be used, and only with the consent of the genetic donors"
Ta-Da!!
One sentence that captures what they're actually trying to say, without invalidating the work that has already been done. Just write it in plain, understandable English and move on to the next issue please.
Re:How hard can it be? (Score:4, Funny)
We're from the Government. We don't do that sort of thing.
Parent
They needn't be abandoned (Score:4, Insightful)
Private and public companies can still conduct research on them, and several states (notably California) have alternate stem cell research funding programs available, with less stringent guidelines.
The government (not merely the Obama administration) is in a tight spot between those that want absolutely no research conducted on embryonic stem cells, and those that want to follow where the science leads them regardless of tricky ethical considerations.
I think the administration's position is a decent compromise. Plus, it is a foot in the door to loosening restrictions further. In this particular area of research, I feel a conservative (in the literal sense: resistant to change, hesitant, deliberate; NOT the political, neocon meaning), incremental approach is best until we have a good sense of what we are dealing with - the incredible benefits and the awesome risks. This grasp and understanding must be pervasive, too, not just within the small cadre of cutting-edge researchers, but also in the minds of policy-makers and the general public who would be funding this research.
WHile this story should be here (Score:2)
it is also painful to read these ignorant posts.
Read the damn guidelines and at least understand which one aren't allowed, why, and which ones are allowed.
In the long run, this opens up a lot or new lines then where allowed in the previous administration.
RAINBOWS (Score:2, Funny)
Rainbows and ponies, glued together with hope! Vote Obama '08!
Sigh...
The Obama Ban (Score:4, Informative)
Are the media going to do reports on the "Obama ban", like they've been doing on the "Bush ban"? Is it only a "ban" when you take funding from 0 to something non-0?