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Draft Stem Cell Guidelines Threaten Research

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.'"

26 of 206 comments (clear)

  1. And... by Spazztastic · · Score: 4, Insightful

    And this is why I was so cynical about the election. It's the same old business as usual.

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    1. Re:And... by Shakrai · · 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 ;)

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    2. Re:And... by Chris+Burke · · 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.

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    3. Re:And... by Shakrai · · 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.

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    4. Re:And... by Chris+Burke · · Score: 3, 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.

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      The enemies of Democracy are
    5. Re:And... by mazarin5 · · Score: 3, 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

      --
      Fnord.
    6. Re:And... by Shakrai · · Score: 3, 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.

      --
      I want peace on earth and goodwill toward man.
      We are the United States Government! We don't do that sort of thing.
    7. Re:And... by Chris+Burke · · Score: 3, 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.

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      The enemies of Democracy are
  2. This was pretty much already the case by Gat0r30y · · Score: 4, 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.

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  3. Silly question by Anonymous Coward · · 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.

    1. Re:Silly question by Anonymous Coward · · 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.

    2. Re:Silly question by brkello · · Score: 3, Insightful

      How in the hell did this get modded +5? Seriously, what is wrong with you people? People are going to have abortions (even if it were illegal). Why don't we actually use those stem cells to do something good? That's fine that there are other methods, use them too. But stem cells is not something that I have ever heard anyone use as a justification for abortion.

      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.

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  4. its called by nimbius · · Score: 4, Insightful

    a draft...meaning its up for review and revision...

    there can also be, get this, several of them created until they get it right.

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    1. Re:its called by flitty · · Score: 5, Insightful
      The base of the problem:

      The NIH requires consent forms that clearly mention human embryonic stem cell research, forbid donating eggs for the benefit of a specific person, and contain various other stipulations that were generally mentioned during older consent processes, but not rigorously codified. These rules could have a massive impact on existing and proposed research.

      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.

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  5. so much for getting government "out of" science... by Shakrai · · Score: 3, 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.

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    I want peace on earth and goodwill toward man.
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  6. at least ... by jsnipy · · Score: 3, Funny

    At least the "I support stem cell research" sound byte sounded good!

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  7. At Least These Concerns Were Based On Ethics by darkmeridian · · Score: 4, 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.

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    1. Re:At Least These Concerns Were Based On Ethics by Chris+Burke · · Score: 4, 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.

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      The enemies of Democracy are
  8. Re:Why does federal funding equate to research? by Anonymous Coward · · 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 US.

  9. Re:How hard can it be? by ColdWetDog · · Score: 3, Funny

    Just write it in plain, understandable English and move on to the next issue please.

    We're from the Government. We don't do that sort of thing.

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  10. They needn't be abandoned by necro81 · · Score: 3, Insightful

    Keep in mind that these rules for stem cell lines only concern what the US Government (mainly the NIH) will be permitted to fund with research dollars. The other stem cell lines needn't be abandoned or thrown away, they just can't be publicly funded.

    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.

  11. Re:so much for getting government "out of" science by Shakrai · · Score: 3, 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.

    --
    I want peace on earth and goodwill toward man.
    We are the United States Government! We don't do that sort of thing.
  12. Re:so much for getting government "out of" science by Shakrai · · Score: 3, 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.

    --
    I want peace on earth and goodwill toward man.
    We are the United States Government! We don't do that sort of thing.
  13. The Obama Ban by SnarfQuest · · Score: 3, 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?

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  14. Re:so much for getting government "out of" science by Reality+Master+201 · · Score: 3, Insightful

    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.

    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.

  15. Re:so much for getting government "out of" science by Reality+Master+201 · · Score: 3, Insightful

    I don't believe that the government should be using my money for those purposes. When you buy an electrical appliance are you content with the UL listing or do you limit your purchases to those appliances that have been tested by some Federal agency?

    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?

    The difference is that the military is actually envisioned by the Constitution. Federal funding for scientific research and slaughterhouse inspection is not.

    Article 1, Section 8, which grants congress the power to:

    provide for the common Defence and general Welfare of the United States

    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:

    When the Government takes my money and uses it to fund things that I have moral objections to I have no recourse.

    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.