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FDA Could Delay Adult Stem Cell Breakthroughs 261

Posted by kdawson
from the culture-club dept.
destinyland writes "A Colorado medical advocate says, 'The FDA contends that if one cultures stem cells at all...then it's a prescription drug,' in arguing that revolutionary new treatments could be delayed by 20 years — even using cells extracted from your own body. According to the FDA, even therapies that simply re-inject your body's adult stem cells could be prohibited without five years of clinical trials and millions of dollars of research. How useful are cultured stem cells? 'In animal models, they routinely cure diabetes.'"
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FDA Could Delay Adult Stem Cell Breakthroughs

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  • FTC != FDA (Score:5, Informative)

    by Anonymous Coward on Tuesday May 05, 2009 @08:33PM (#27840719)

    Heh.

  • drats (Score:2, Funny)

    by ifeelswine (1546221)
    now christopher reeve will never walk =(
  • Non-Story (Score:5, Insightful)

    by afabbro (33948) on Tuesday May 05, 2009 @08:37PM (#27840759) Homepage

    This is not the government saying this, it's a "Colorado medical advocate". It's one guy's opinion on what might happen. And, gosh, guess what industry he's in...

    • Re:Non-Story (Score:5, Interesting)

      by Kell Bengal (711123) on Tuesday May 05, 2009 @08:51PM (#27840867)
      It might be the point of view of one man, but it's not a crazy position to take. I for one would want any medical treatment fully tested and certified, irrespective of if it's made out of 'modified' bits of me. Cancers, if you recall, are actually a part of you gone wrong. If I'm dying of cancer, sure, I'll try damn near /anything/ in my last days. However, if it's something that will be offered as a routine treatment to non-critical patients then it needs to run the full gamut of testing, like every other contender.
      • Re: (Score:3, Interesting)

        by oldhack (1037484)
        Interestingly enough, some researchers see connection between tumor and stem cells.
        • Re:Non-Story (Score:4, Insightful)

          by rts008 (812749) on Tuesday May 05, 2009 @10:07PM (#27841335) Journal

          Yes, and interestingly enough, some researchers see a connection between video games and violence, running Windows and a botnet, and watching violent movies will cause you to go 'postal', and...
          Do I have to go on?

        • Re:Non-Story (Score:4, Interesting)

          by smegmatic (1145201) on Tuesday May 05, 2009 @10:37PM (#27841541) Homepage
          more specifically, the hypothesis is that cancer is caused by stem cells. http://www.economist.com/science/displayStory.cfm?story_id=12202589 [economist.com] is a decent popular science article.
          • Re:Non-Story (Score:4, Informative)

            by interkin3tic (1469267) on Wednesday May 06, 2009 @03:20AM (#27843011)

            To clarify THAT, one hypothesis is that there are stem cells in tumors. This makes it tough to treat tumors, as the cells you really need to get are the stem cells seeding the tumor, but they tend to be missed by a lot of chemotherapy drugs as they may be slower-dividing, as stem cells may be in other contexts.

            There are some cancers that may arise from normal populations of stem cells as well, but no one is saying all cancerous cells came from a population of stem cells. No one is saying all cancers have stem cells keeping them going either.

            Note that's all theory, some of it may be outdated, some or all of it may have been disproven. I'm not too up to date, and stem cell biology moves really fast compared to most other fields in bio.

      • by .orvp (208389) on Tuesday May 05, 2009 @09:11PM (#27840983)

        Definitely fully tested. I remember one episode of 7 Days involved a cure for cancer having been found, but what they didn't know was that there was a long term side effect to the cure that reared an ugly head 15 years later when it wiped out 80% of the population or something. The cure had looked so promising that they mass produced and distributed the drug to as many people as they could, even if the cancer could have been treated in other means. They did this without the full clinical trial period because it was seen as vital.

        Dealing with mutations is always a risky business. While it would be nice personally to not have to die from cancer, or have a relative die, there are safety procedures in place for a reason.

        • Maybe other people are willing to take the risk and maybe not _die_ while the clinical trials take place. Just maybe.
        • by mellon (7048) on Tuesday May 05, 2009 @10:02PM (#27841313) Homepage

          Yeah, that's almost like that episode of Sliders with the vampires. Or zombies. I forget which. Anyway, yeah, that's a really good reason why we shouldn't ever release any new medicine. It's just too dangerous to humanity as a whole! :')

        • by Celeste R (1002377) on Tuesday May 05, 2009 @10:31PM (#27841485)

          Definitely fully tested. I remember one episode...

          I know of lots of "end of the earth stories". Science doesn't back it up completely, unless you're talking about real threats (like grey goo or a mutant airborne and massively contagious e-bola virus).

          Just because there's media hype about "what if" doesn't make it true. Yes, "fully tested" has to involve human trials at some point; but with the success we've had in curing rat diabetes and growing spare organs, I believe it has proved itself (definitely at least as an experimental therapy).

          Dealing with mutations is always a risky business. --- there are safety procedures in place for a reason.

          There are already therapies available that are much more dangerous. Mutations are a problem though? Wow, there's been too many horror movies on that subject; and that's all they continue being. Mutations mean cancer at worst, not the next fictional zombie threat.

          Take for example: bone marrow cancer. Treatment is difficult, and even -if- it is successful, it can still rear problems that will kill. This is a treatment, because people choose to try an experimental (albeit common) treatment rather than none at all.

          What I see in this is the drug companies saying "no" to alternative treatment. They like the profits they make! (after all, who wouldn't?). They are also effective lobbyists (because they have moolah to throw around) and have the most to lose from independence of various drugs.

          Is it so surprising that we're simply dealing with an antiquated business model that is stifling innovation?

          ...Oh wait, this is /. That should go without saying.

          • Re: (Score:3, Interesting)

            by rts008 (812749)

            Yes, "fully tested" has to involve human trials at some point;

            While I singled this quote to respond to, I do agree with the 'nature' and content of your post. But, I felt the need to address this statement, if even as a pedant.

            The 'scientific/research' community may consider "x" to be 'fully tested' in 'human trials', but currently does not address the misconceptions between 'populace's perceptions' and these trials.
            *disclaimer-I am currently dismayed by the divide between science and 'public perception', and see a 'hard road ahead' for any new advances in science.*

            I

          • Re: (Score:3, Insightful)

            by interkin3tic (1469267)

            Mutations mean cancer at worst, not the next fictional zombie threat.

            Er... I think zombies actually are worse than cancer. Less likely yes, but still worse.

        • Re: (Score:3, Insightful)

          by Thaelon (250687)

          But when you're dying of cancer, what are you going to do if it doesn't work, die?

        • by johannesg (664142)

          So will you take uncertain chances of success with conventional therapy, knowing that those often include a reduced life expectancy as well, or would you go with another (pretty much guaranteed) 15 years in good health? And take your chances with the possibility that someone might figure out how to fix the new problem as well before your time is up?

          Besides, cancer is a disease that for many people strikes in their later years anyway. 15 years is not really that bad. It would even allow some proper planning:

      • Re:Non-Story (Score:5, Insightful)

        by Smallpond (221300) on Tuesday May 05, 2009 @09:20PM (#27841027) Homepage Journal

        After all, we don't want to have doctors developing new treatments. That's what government bureaucrats are best at.

        • Re:Non-Story (Score:5, Informative)

          by fuzzyfuzzyfungus (1223518) on Tuesday May 05, 2009 @09:45PM (#27841167) Journal
          But we just might want them telling drug companies that, yes, they do actually have to test for safety and efficacy before they start selling the stuff...

          The private sector has the virtue of (mostly) being extremely responsive to competitive incentives. This is good when those incentives drive development. This is bad when those incentives drive obfuscation, misdirection, and the burial of inconvenient data. Consider the twisted tale of the "Australasian Journal of Bone and Joint Medicine" [ft.com] an entire sham scientific journal printed to order by Elsevier, for Merck.
        • Re: (Score:3, Interesting)

          by QuantumG (50515) *

          Meh, if you sign a waiver you can pay a doctor to do anything to you.. short of deliberately killing you.. the legality of that varies from state to state.

        • Re: (Score:3, Insightful)

          by darkmeridian (119044)

          And I guess doctors should be allowed to sell whatever treatments they want without any government interference. The Dalkon Shield, thalidomide, etc. should have all been allowed without any government regulation. Yay! Doctor knows best. Government is ineffective and useless, etc.

        • After all, we don't want to have doctors developing new treatments. That's what goveernment bureaucrats are best at.

          [my emphasis]

          Mod's: Give +1 for 'tongue-in-cheek-funny' responses...and hope the 'parent' was trying for +1'funny', if not, then 'Epic Fail!'

          Get off of the fence, and say what you mean to say. Why be obtuse?

      • by iluvcapra (782887)

        If I'm dying of cancer, sure, I'll try damn near /anything/ in my last days.

        Yes, and you'll agree to damn near any price, even if the treatment in question only works in one in a thousand cases. Even if you're dying, it's still not permissible for an unscrupulous doctor or medical service company to defraud you (or your insurance, as the case may be), and divert gobs of money from desperate people. Money that should be going to the genius that can cure cancer, and not to some dude that's selling Persian wheat infused with "medicinal silver ions" in an alcohol suspension.

        I'm parti

        • Re: (Score:3, Insightful)

          by mal3 (59208)

          I'm particularly not crazy about stem cells being cultivated, and possibly embryos destroyed, for frivolous treatments.

          I'm not particularly crazy about you not realizing that this has nothing to do with embryos even though the article summary(not even the article itself), mentions twice that the stem cells don't come from embryos.

          • Re: (Score:3, Interesting)

            by iluvcapra (782887)

            I wasn't replying to the article, I was replying to Kell Bengal. The article excludes embryonic stem cells artificially, probably because the author didn't want to start a fight, even though everything he says applies to embryonic cells too. He's a coward.

            You can chill, I'm not a pro-lifer or anything, I'd just like to know that embryos are destroyed to saving life and curing disease, not make some guy rich peddling a fraud. Even if they ain't people, and even if we're talking about adult stem cells, the

      • by DJRumpy (1345787)
        They could always expedite the approval if it can be proven to be life saving. Didn't they do the same for HIV medications when early clinical trials showed very promising results with some of the drugs?
    • by Brickwall (985910)
      He's the executive producer of the new Food Network show "What Would Brian Boitano Make"?
    • by mellon (7048)

      Yup, this is basically an infomercial for the next laetrile. Oh noes! We have to test the treatment to see if it works before we try it on live subjects! Regulation is bad! Don't you *want* three arms?

  • Delayed (Score:4, Interesting)

    by dmomo (256005) on Tuesday May 05, 2009 @08:38PM (#27840767) Homepage

    My stem cells couldn't be any more delayed than they already are. Ohh. Pickles.

  • by NotSoHeavyD3 (1400425) on Tuesday May 05, 2009 @08:38PM (#27840769)
    Considering it took over a decade to go from the hypothesis of "bacteria cause peptic ulcers so lets use antibiotics" to it being standard practice why would anybody expect stem cells to appear with any speed at all. (I mean that example we're talking about giving people an already existing drug with already known properties in humans and it still took years. Stem cells will be MUCH slower to go from any discovery to actual treatment.)
  • by spinkham (56603) on Tuesday May 05, 2009 @08:40PM (#27840791)

    When a drug is found to cause significant problems after it's release, we're outraged, and when the FDA says we actually need to test radical new treatments before giving them to people, we're outraged.

    Either we're stupid, or we just enjoy being outraged by stupid stuff, I can't tell which...

    • by Anonymous Coward on Tuesday May 05, 2009 @08:46PM (#27840843)

      Don't underestimate the ability of average citizens to be both stupid and angry.

    • Re: (Score:3, Interesting)

      by jmorris42 (1458) *

      > Either we're stupid, or we just enjoy being outraged by stupid stuff, I can't tell which...

      Oh it gets worse. Ok, you are a drug company and you have a promising drug. After jumping through hoops for as long as a decade you finally get FDA approval. You have tested your new drug in various animals, several stages of human trials and the whole bit. The government has finally certified your drug to be safe and effective. So you go on the market. We will ignore the untold human misery that could have

      • by AlexMax2742 (602517) on Wednesday May 06, 2009 @12:10AM (#27842083)

        The FDA, being the State, is of course blameless.

        I know you love shoe-horning in "capitalism good government bad" bullshit in every single one of your posts, but I'm curious as to what exactly the FDA did in your hypothetical situation that you imply was worthy of blame?

        • due diligence (Score:4, Interesting)

          by nten (709128) on Wednesday May 06, 2009 @06:07AM (#27843571)

          I think the notion was that at some point there is a level of effort in testing that should count as due diligence. That any side effects found in the future after that amount of testing should be treated as unfortunate accidents and not cause for litigation. If the FDA isn't implying that this sufficient level of testing has been done by signing off, what is it implying? If it is implying that, it should be solely culpable for the subsequent side effects as the company believed in good faith it had done due diligence. Unless of course it bribed the FDA directly or indirectly, which wouldn't surprise me either. Or falsified test results, which wouldn't raise my eyebrows even a little.

          That said, if I want to do something stupid to myself, I should be able to buy "dietary supplements" made from my own stem cells and inject them wherever I please.

    • by Brett Buck (811747) on Tuesday May 05, 2009 @09:27PM (#27841071)

      Either we're stupid, or we just enjoy being outraged by stupid stuff, I can't tell which...

            Can't it be both?

            It's just another example of not wanting to accept EITHER the risk, or the delay, because no one can make a fucking decision and stick with it anymore.

              Brett

      • by rts008 (812749)

        Kudos for the most '+n insightful' comment I have read this month on /.
        Personal responsibility is so last century/era. IP has 'enabled/entitled' us to pass the buck. It is no longer our/my fault.[apply sarcasm filter]
        Entitlement and bailout is the answer!!!!Please don't make us think or actually take responsibility for our actions/choices...it's the 'American way' now.

        Learning and understanding stuff is 'just too hard' now days! Can't some corporation or government think of us that are 'too stupid/can't be

    • I read it as meaning that each culture of a different DNA is a different drug, which I can imagine some trying to push if they're trying to curtail stem sell research. The process does need to be tested. But is 20 years of testing necessary to properly test a treatment like this? Maybe that's all hyperbolic.

      • by xouumalperxe (815707) on Wednesday May 06, 2009 @05:35AM (#27843469)

        TFA, in all its incredibly biased glory (Dr Centeno this, Dr Centeno that, FDA is in Big Pharma's pocket, stem cells are a panacea, end of article) only implied that the protocol itself would be treated like a drug (requiring their standard for clinical trials), and disingenuously compares stem cell treatments to fertility treatments. 'cause implanting an embryo in an uterus, essentially mimicking a natural process and with a "safe" mechanism for rejection, is exactly the same as using stem cells to produce stuff that has no clear parallel -- or maybe not.

        Besides, we're talking about implanting engineered tissues based on highly plastic and division-propensic cells. Really, it barely requires long-term testing. I mean, what could possibly go wrong?

    • by mcrbids (148650)

      Why would you think it's the same people complaining in bost cases?

  • by meehawl (73285) <meehawl@spam.gmail@com> on Tuesday May 05, 2009 @08:40PM (#27840793) Homepage Journal

    Take one of your own well-behaved, tightly regulated stem cell out of its milieu, subject it to various biochemical stresses, and then re-introduce it to your body. You may just have transformed it into an unregulated, tumour-producing cell. Or accelerated it along a transformational path that could take a long time to become apparent.

    I'd say that precaution is warranted dealing with something like this. Especially when you have a very long-lived animal like a human, with decades of time during which manipulated stem cells could transform malignantly, versus the limited lifespan of most animal models.

    • Re: (Score:3, Interesting)

      by nilbog (732352)

      Okay but if you know X will kill you in a month, and Y *might* kill you some unknown amount of time down the road, which would you choose?

      • Diabetes (Score:3, Insightful)

        by meehawl (73285)

        It's going to take longer than a month for *any* putative stem cell treatment to show results. Human cells simply cannot divide that quickly. So the "ticking time bomb" argument is a little fanciful. Further, the cardinal example given here, diabetes, will not kill you quickly as long as you manage it with meds. Properly controlled, diabetes (either Type 1, Type 2, or gestational/MODY) is a serious disease, but an eminently treatable disease.

  • Urm? (Score:5, Insightful)

    by fuzzyfuzzyfungus (1223518) on Tuesday May 05, 2009 @08:42PM (#27840811) Journal
    The risks, while no doubt ultimately manageable, of playing with pluripotent cells are neither trivial nor theoretical. They have this nasty habit of turning into good old tumors [scientificamerican.com].

    Now, if you don't like the FDA, or think that the FDA approval process needs to be modified, great. That is a perfectly legitimate position, and might even be true(the situation is complex enough that it probably varies a bit from case to case). However, if that is so, just say so. A strategy of attempting piecemeal exemptions for various powerful biological interventions is just bullshit.

    It's like the difference between being a libertarian and having an accountant in the cayman islands.
    • I just think that maybe people who stand to die while the FDA employs useless parasites to carry cars full of files around should have the right to take the risk. You know? You own your own body? Sounds crazy doesn't it? Sorry... :-)

      And no, I don't have an account in the Caymans.

      • Re: (Score:3, Insightful)

        Then you would fall under: "if you don't like the FDA, or think that the FDA approval process needs to be modified, great. That is a perfectly legitimate position, and might even be true".(which is the "libertarian" half of the analogy)

        My objection is not to that position; but to the special pleading with which TFS and TFA are laced. "I think that the FDA is wrong/illegal/unethical" is a perfectly coherent and respectable position. "I think that my area of interest should be excluded from FDA oversight b
  • by Austerity Empowers (669817) on Tuesday May 05, 2009 @08:46PM (#27840841)

    'In animal models, they routinely cure diabetes.'

    That's great for models, but what about ugly people? Don't we get a cure?

  • Doctors can write prescriptions for experimental drugs.
    • Re:So? (Score:4, Insightful)

      by ColdWetDog (752185) on Tuesday May 05, 2009 @09:56PM (#27841265) Homepage

      Doctors can write prescriptions for experimental drugs.

      But if they aren't available, then you don't get them.
      If they aren't well tested, and you have problems with the drug, the doctor is much more open to malpractice suits or investigations by the friendly Board of Medical Examiners.
      Insurance companies routinely won't pay for 'experimental' therapies.

      Besides, this whole article is a bunch of whining from the people invested in the new tech. The writer waxes breathlessly enthusiastic about something that has barely been attempted. It is really unclear that dumping pluripotent cells back into the body is either safe or effective or even particularly sane given the fact that MOST of a multicellular organism's time and energy is spent controlling cell division and PREVENTING things from growing.

      Whatcouldpossiblygowrong?

  • I might actually live long enough to see, and maybe even benefit from this!
  • When one realizes (Score:3, Insightful)

    by WillRobinson (159226) on Tuesday May 05, 2009 @09:26PM (#27841065) Journal

    Some doctors and all pharmaceutical companies and hospitals do not want to cure you with a blue pill. Their whole existence in life is to maximize their profits, to do otherwise is not in the interest of their share holders.

    • Well, if the government doesn't have the power to regulate drug "safety", then when somebody else comes up with a blue pill to sell they don't have much else to do except put up or shut up.
    • by tftp (111690)

      Their whole existence in life is to maximize their profits, to do otherwise is not in the interest of their share holders.

      Then it is in their interest to cure you from many maladies, not to let you die from the first one. Dead people don't need doctors.

      • Re: (Score:2, Insightful)

        by Burdell (228580)
        They don't want to cure you, they want to treat you. A cure is a treatment that ends (because duh, you're cured). If you aren't cured, you have to keep going back to the doctor, getting nice expensive prescriptions, month after month, year after year.
    • by rts008 (812749) on Wednesday May 06, 2009 @03:32AM (#27843047) Journal

      Okay, I've seen this 'mindlessness' echoed down this thread, so I 'went for the head of the serpent', so to speak.
      Speaking as someone that has worked in the medical profession, and has close ties to those that still do, I will categorically deny the delusional accusations of your post.

      What you accuse all of us for may be true on the 'C*O', PHB level, but I can assure you from the 'Doctor' level and down, that the prevailing attitude is 'take care of the patient to the best of our abilities'. Period.
      Yes, there will be exceptions/outliers, but that is true with any profession.

      Your blanket assertions and overly broad generalizations do an insulting disservice to the medical community.

      I await your apology.

    • Re:When one realizes (Score:4, Informative)

      by the_humeister (922869) on Wednesday May 06, 2009 @10:02AM (#27845925)

      Some doctors and all pharmaceutical companies and hospitals do not want to cure you with a blue pill. Their whole existence in life is to maximize their profits, to do otherwise is not in the interest of their share holders.

      As a physician, let me ask: What are you talking about? What are these diseases that you speak of that can be easily cured with a pill that the pharmaceutical companies don't want to make?

      Heart disease is the most common cause of death in this country. Why? Usually, it's because of lifestyle issues: no exercise, eating poorly, smoking, etc.

      The most common cancer that kills people? Lung cancer. Want to decrease the risk of lung cancer? Stop smoking.

  • by topham (32406) on Tuesday May 05, 2009 @09:41PM (#27841147) Homepage

    Stem cell results are dangerous. Should we just ignore the risks?

    Until we get a good handle on it it certainly should be treated like it is potentially hazardous, because it is.

    • by rts008 (812749)

      Stem cell results are dangerous.

      As is too much sunlight(UV causing melanomas), and too much water(see:water intoxication.

      So, what is your agenda here?

    • by khallow (566160)
      Stem cells may be dangerous, but people die when medical research is delayed. Possible small harm versus big sure harm. There isn't a contest here especially since medical research can be moved to China where it won't be obstructed by US bureaucracy.
  • Larry King (CNN) got a stem cell treatment years ago. Dr Chris barnard (first heart transplanter), got it decades ago and died in his late eighties.
  • by Jane Q. Public (1010737) on Tuesday May 05, 2009 @09:45PM (#27841171)
    This is even worse -- much worse -- than the time the FDA tried to regulate the newly-invented pepper spray for defense against bears as a "pesticide".

    They want their own fingers in the pie. It is as simple as that. And we should not let them do it.
    • by jcr (53032)

      the FDA tried to regulate the newly-invented pepper spray for defense against bears as a "pesticide".

      Are you sure that was FDA? I know they try to extend their jurisdiction over anything they can, but I thought pesticides were the USDA's bailiwick.

      -jcr

      • My bad. Yes, it was USDA. But they are both typical of bureaucratic "me me me" behavior. Wanting to get their fingers into everything.
    • "Off-Topic"? How was that off-topic? Yes I meant USDA rather than FDA on the pepper-spray thing, but they are both classic examples of government bureaucratic behavior.
  • According to the FDA, even therapies that simply re-inject your body's adult stem cells could be prohibited without five years of clinical trials and millions of dollars of research.

    If I piss into a bottle, it comes out of my body sterile and is safe to drink, but left to sit for a few days, it is full of bacteria and not safe. Just because it came from my body doesn't mean it's safe to put back in later or after things have been done to it.

  • by jcr (53032) <jcr.mac@com> on Tuesday May 05, 2009 @09:57PM (#27841271) Journal

    Anyone who needs treatments that the FDA doesn't want to allow will have to incur the added expense of going somewhere with a free market for medicine. Sucks for the people who can't afford it.

    -jcr

    • Re: (Score:3, Insightful)

      by ultramk (470198)

      So, I don't quite get it: Are you not old enough to remember thalidomide, or are you so old that you've forgotten it? Thalidomide was the logical result of the kind of free market you're promoting.

      If you think that we as a society are now, or will ever be inclined to accept a certain percentage of flipper-babies as the natural result of the implementation of your anarcho-capitalist ideals, well, you're even more naive than you seem.

      • by Wilson_6500 (896824) on Wednesday May 06, 2009 @12:41AM (#27842233)
        I'd suggest that a more appropriate example would be laetrile, if we're talking about people exporting their health care. People went to Mexico for that one, despite that it is apparently ineffective for treating cancer. Those people paid plenty of money and put their health at (further) risk for something unlikely to provide any benefit. Even undergoing currently accepted chemotherapy regimens is placing one's health at risk--but there is generally expected to be a benefit that outweighs that risk, since we have confidence that our chemotherapy regimens can actually provide that benefit.

        Laypeople are not and really can't be expected to be health care experts, in general, and so it's somewhat unreasonable to expect that the average person is sufficiently knowledgeable to solely determine what kind of treatment will be effective for his major illnesses. That is one of the reasons we have medical doctors and researchers, after all. Health and health care have a connection that is so nebulous that it's very difficult to make informed choices without well-organized bodies, ones which do, compile, and disseminate the kind of intensive research necessary to provide the information that enables people to make sound medical choices.

        Simply because there is a market for fake cancer cures, for instance, does it then become ethical to let people exploit that market and make money off of the completely natural ignorance of the lay public? However, it'd be hard to stop people from going to Mexico to get these "cures," so I guess perhaps we have to ask ourselves--assuming that we can't dissuade people from wanting these fake cures--if we would rather have them getting them in the States or in Mexico. Honestly, that's a dimension of the problem I hadn't really thought of until I was writing this comment today.
  • Government stands in the way of growth! Interview at 8.

  • Totally offtopic (Score:3, Insightful)

    by rantingkitten (938138) <(kitten) (at) (mirrorshades.org)> on Tuesday May 05, 2009 @10:03PM (#27841319) Homepage
    I realise this is totally offtopic, but it did catch my eye that the vogue phrase is "animal models" instead of "animal experiments". I don't want to even start a battle about the ethics of animal experimentation, but I just found it interesting that they seem to try to sidestep the issue altogether by cushioning their words. Sounds like politics as usual.. so hey, maybe it's not all that off-topic after all.

    Now, back to your regularly scheduled Slashdot mayhem.
    • Re:Totally offtopic (Score:4, Informative)

      by Anonymous Coward on Tuesday May 05, 2009 @10:22PM (#27841433)

      Those are trade terms...

      An animal model is a well characterized and well understood animal, often a very specific line of a given species, used as a model for a disease. You can't know that the results you're seeing are mappable to what would happen in a human if you haven't characterized your model yet. For example, to model a respiratory virus you need an animal that can be infected by it and exhibits similar pathology to humans. Chimps are not a good model for HIV as they don't develop AIDS, as another example.

      Animal experimentation would apply to all sorts of things that might not be considered animal models.

      • Perhaps scientists are also trying to avoid the negative connotations of the words "animal experimentation" out of fear for having their labs destroyed, houses firebombed, or so on. I don't know if that alone would stop the sort of people who commit those kinds of crimes, but it might just garner public sympathy (or at least stop propagating the negative images of researchers who use animals).
    • by zrobotics (760688)

      Oh that?

      That's just the good old All-American tradition of coming up with euphemisms for everything. What we now know as Post Traumatic Stress Disorder was once known as shell shock. Being a fatass is now obesity. Old people are senior citizens. Now lab-rats are called 'animal models'. It's a vicious cycle designed to protect middle-class Americans from anything they might think is even remotely scary.

      • Re: (Score:3, Informative)

        by jcr (53032)

        That's just the good old All-American tradition of coming up with euphemisms for everything.

        Animal model [wikipedia.org] isn't a euphemism, it's a jargon. [wikipedia.org] It's a more specific term than "animal experimentation".

        -jcr

    • by Trepidity (597)

      I believe it's intended in the sense of modeling a particular feature of human biology by using an animal whose biology supposedly functions similarly in the relevant respect.

      I agree it's often over-used as a euphemism, though. It makes the most sense when used in a comparative context, for example explaining the pros and cons of "computational models" vs "animal models" (or even occasionally "physical models") for modeling particular elements of human biology.

  • by gordguide (307383) on Tuesday May 05, 2009 @10:17PM (#27841409)

    "FTC could delay Adult Stem Cell Breakthroughs"

    In related news, the FDA has decided to intervene in the Janet Jackson Superbowl "Wardrobe Malfunction" litigation.

  • by esinclair (1532509) on Tuesday May 05, 2009 @10:34PM (#27841509)
    I understand the FDA's desire for caution if caution truly represents its motives but there are also other considerations. Encouraging widespread use of a substance with possible long term effects is not a good idea. However, for many of the people adult stem-cell therapy could help, getting cancer twenty years down the road, or even five, isn't an issue if they die waiting for approval of the treatment. Unfortunately, many people including my Mom, are inflicted with diseases stem-cell therapy has been proven to cure, or effectively treat. Many of these ailments such as ALS or Multiple Sclerosis progress quickly and kill or deteriorate people's quality of life at an aggressive rate. Within a period of six months a twenty-two year old male can go from perfect health to a hospital bed in which he cannot move, talk, breathe or eat on his own. Within six months his only form of communication becomes blinking. Many of the people with these illnesses cannot work or live their life and as their conditions endure they suffer waiting for the final blow. Would it not be more in people's interest to give them the choice. If they don't want to risk getting cancer from a treatment they do not have to get it and can use alternative methods until more research is available. But for those who could benefit and cancer is a less dangerous risk than their original illness or for people who are willing to take the risk for reasons of their own shouldn't they be able to? I just wonder what happened to the allowance for personal responsibility.

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