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  1. ChenPengFi is offline
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    Posted On:
    12/02/2010 2:36pm

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    Hell yeah! Hell no!
    Please provide one statute, court case or regulation that supports your premise please.
  2. ChenPengFi is offline
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    Posted On:
    12/02/2010 2:43pm

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    Hell yeah! Hell no!
    Quote Originally Posted by PointyShinyBurn View Post
    What are you talking about? I am saying that is wrong for them to be now doing what they are doing without good Type 1 evidence. I never said they should have had it before they tried it in a petri dish or a lab rat. I am, and always have been, discussing their current behaviour.
    Bullshit, you are changing your position.

    I actually did. I see you blowing a lot of smoke and slinging a lot of insults
    Insults? Sure, they were well deserved. I also provided facts and documentation.

    It was you who appealed to 'market bearing economics'.
    You are thick in the head i see, that someone can pay to cover the costs of a procedure does not equate to a profit on the Dr's end.

    I am, fortunately, free of joint injuries and several thousand miles away.
    You have another option aside from slander.

    Is it your position that 'normal procedure' is to set up a private clinic and treat several hundred patients with no type 1 evidence? You would say this is how new treatments normally enter the market?
    Actually i clearly stated most day to day procedures DO NOT HAVE type 1 supporting evidence, at all.

    "This type of evidence is not completely worthless" != "This evidence is totally as good as a multi-centre RCT"
    It's called a hierarchy for a reason... Stop with the fallacies already, you are being obtuse.
    That Kaiser would consider the anecdote and you won't is lost on you?
    lamo@udumdum...
  3. PointyShinyBurn is offline
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    Posted On:
    12/02/2010 6:58pm

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    Hell yeah! Hell no!
    Quote Originally Posted by ChenPengFi View Post
    Bullshit, you are changing your position.
    My first post in this thread said it was an experimental procedure and they were fighting FDA regulation. That is still my position...
    Quote Originally Posted by ChenPengFi View Post
    Actually i clearly stated most day to day procedures DO NOT HAVE type 1 supporting evidence, at all.
    They generally have at least some cohort studies, other kinds of epidemiological evidence. Where is anything like that for this therapy? They don't even have any well collected observational data. You think it works because you met some guy. Well bully for you. I say there is no good evidence that it does work because they haven't collected any and I haven't had your anecdotal good fortune. Do you think Kaiser Permanente would accept your word on the internet that this therapy is likely effective?

    Also, novel therapies are almost always trialled. Like the two other stem cell ones I linked to earlier. Or every stem cell transplantation therapy currently in general use. Why aren't they even doing an RCT? Found that quote that totally proves they are, yet, by the way?

    Would you agree in principle that it would be unethical to offer this therapy if they didn't believe it worked?

    You don't think it's odd that FDA regs would certainly bar them from selling this interstate or to people other than their own patients (if they do not, in fact, bar from their current practices)? Why is that, exactly, if what they're doing is standard evidence-based medicine?
    Quote Originally Posted by ChenPengFi View Post
    That Kaiser would consider the anecdote and you won't is lost on you?
    lamo@udumdum...
    Considering it != considering it sufficient to prove the case. The cases you're talking about where Kaiser deemed the treatments too 'experimental' because there was solid type 1 evidence in adults but the studies hadn't been done in children. This is somewhat different from a totally novel treatment, yes?
    Quote Originally Posted by ChenPengFi View Post
    Please provide one statute, court case or regulation that supports your premise please.
    http://www.fda.gov/downloads/Drugs/G.../ucm078749.pdf
    http://edocket.access.gpo.gov/cfr_20...cfr314.126.pdf

    My position that type 1 evidence is generally sought for new therapies? I linked to two other stem cell therapy trials that are just getting started in Phase 1 above? Oh look here's Google pointing out Phase I/II trials for a whole bunch of stem cell based therapies approved by the FDA: http://www.google.com/search?q=phase+1+stem+cell+fda
  4. ChenPengFi is offline
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    Posted On:
    12/02/2010 7:34pm

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    Quote Originally Posted by PointyShinyBurn View Post
    My first post in this thread said it was an experimental procedure and they were fighting FDA regulation. That is still my position...
    I never argued this point, apparently i must go back and quote you.
    I love the edit time out function here.
    Remember this:
    There is, it pays my wages. What they are doing is not it. You start with a small randomised trial first...
    Nothing about animal studies, individual case studies etc.


    They generally have at least some cohort studies, other kinds of epidemiological evidence. Where is anything like that for this therapy? They don't even have any well collected observational data.
    Now you are lying, i provided the links.

    You think it works because you met some guy.
    Quote where i said that, i contend just the opposite if you'd just read.

    I say there is no good evidence that it does work because they haven't collected any and I haven't had your anecdotal good fortune.
    Did you not read the links i posted?




    Do you think Kaiser Permanente would accept your word on the internet that this therapy is likely effective?
    That was never my contention.

    Also, novel therapies are almost always trialled.
    HAHAHAHAHAAAA!
    Moving the goalposts! Almost? **** you, you said always.



    Like the two other stem cell ones I linked to earlier. Or every stem cell transplantation therapy currently in general use.
    Prove that was the first step like you claimed dipshit.
    hint. it wasn't.


    Found that quote that totally proves they are, yet, by the way?
    I have it, just haven't vetted the author.
    When you go back and address all of the points i made without resorting to lies or fallacy you can bitch about a timeline.

    Would you agree in principle that it would be unethical to offer this therapy if they didn't believe it worked?
    Ummm, yes. Risk vs benefit analysis and tranparency are all that's required.

    You don't think it's odd that FDA regs would certainly bar them from selling this interstate or to people other than their own patients (if they do not, in fact, bar from their current practices)? Why is that, exactly, if what they're doing is standard evidence-based medicine?
    Many things change once you cross state lines, you are ignorant about this clearly.

    Considering it != considering it sufficient to prove the case.
    Nice strawman again...

    The cases you're talking about where Kaiser deemed the treatments too 'experimental' because there was solid type 1 evidence in adults but the studies hadn't been done in children.
    You have proof of this?
    I took "widely considered experimental" to mean they did not.
    The PROCEDURE had never been done on children, the procedure would not be the same for children either.
    Show proof of these studies and their typ1 evidence.


    Again, not a drug in that sense and out of the scope of the FDA as per the courts of law.

    My position that type 1 evidence is generally sought for new therapies? I linked to two other stem cell therapy trials that are just getting started in Phase 1 above? Oh look here's Google pointing out Phase I/II trials for a whole bunch of stem cell based therapies approved by the FDA: http://www.google.com/search?q=phase+1+stem+cell+fda
    First AA stem cells are a whole different animal than the embryonic or donor cells mentioned in most of those articles, refine query plz.
    You claimed it was a starting point.
    It simply cannot be.
    Conversely i never claimed they were never done or should not be, merely that they are the end point of a long and expensive process.

    Your reading comprehension sucks bigtime.
  5. ChenPengFi is offline
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    Posted On:
    12/03/2010 1:48am

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    Hell yeah! Hell no!
    The Patients Bill of Rights as per the Association of American Surgeons and Physicians:

    All patients should be guaranteed the following freedoms:

    * To seek consultation with the physician(s) of their choice;
    * To contract with their physician(s) on mutually agreeable terms;
    * To be treated confidentially, with access to their records limited to those involved in their care or designated by the patient;
    * To use their own resources to purchase the care of their choice;
    * To refuse medical treatment even if it is recommended by their physician(s);
    * To be informed about their medical condition, the risks and benefits of treatment and appropriate alternatives;
    * To refuse third-party interference in their medical care, and to be confident that their actions in seeking or declining medical care will not result in third-party-imposed penalties for patients or physicians;
    * To receive full disclosure of their insurance plan in plain language
    (My bold)

    The bolded are relevant here.
  6. PointyShinyBurn is offline
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    Posted On:
    12/03/2010 8:04am

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    Quote Originally Posted by ChenPengFi View Post
    Remember this:

    Nothing about animal studies, individual case studies etc.
    I was saying that they usually come before the stage of the process they are currently at, which appears to be marketing and large scale use.
    Quote Originally Posted by ChenPengFi View Post
    Now you are lying, i provided the links.
    They have a few case studies. There are no large datasets about their patients, at all, other than the safety follow-up.
    Quote Originally Posted by ChenPengFi View Post
    Quote where i said that, i contend just the opposite if you'd just read.
    What's the opposite? You're saying it doesn't work because you met some guy? Or it does work because you didn't?
    Quote Originally Posted by ChenPengFi View Post
    Did you not read the links i posted?
    Which of the links, in your opinion, is good evidence of efficacy?
    Quote Originally Posted by ChenPengFi View Post
    Prove that was the first step like you claimed dipshit.
    Still this ****? I said that it came before SALE, not before EVERYTHING.
    Quote Originally Posted by ChenPengFi View Post
    Ummm, yes. Risk vs benefit analysis and tranparency are all that's required.
    And if that analysis shows that the treatment is a bad idea then an ethical doctor can offer it, for money, anyway as long as they feel the patient understands that?

    "First, do no harm"?
    Quote Originally Posted by ChenPengFi View Post
    Many things change once you cross state lines, you are ignorant about this clearly.
    Does what counts as good evidence change? Not what legally might count, but what actually counts in terms of science?
    Quote Originally Posted by ChenPengFi View Post
    I took "widely considered experimental" to mean they did not.
    The PROCEDURE had never been done on children, the procedure would not be the same for children either.
    Show proof of these studies and their typ1 evidence.
    If you can find information about exactly when it was that this refusal was (I am having trouble digging it up) I can do that.

    Somewhat tangential to the main point, however? That one 'experimental' therapy was successfully sued over does not make all 'experimental' therapies equally valid, does it? Especially since both of those patients, as pointed out above, died.
    Quote Originally Posted by ChenPengFi View Post
    Again, not a drug in that sense and out of the scope of the FDA as per the courts of law.
    That appears to be a moot point. Whether or not they ultimately fall under FDA regs (whether drug or 'bologics' production) seems to be somewhat sub-judice at the mo?
    Quote Originally Posted by ChenPengFi View Post
    First AA stem cells are a whole different animal than the embryonic or donor cells mentioned in most of those articles, refine query plz.
    Really? Totally different in terms of what evidence your would require to believe it effective?
    Quote Originally Posted by ChenPengFi View Post
    Conversely i never claimed they were never done or should not be, merely that they are the end point of a long and expensive process.
    Do they come, normally, before or after rolling out to 1,000 paying patients?
    Last edited by PointyShinyBurn; 12/03/2010 8:07am at .
  7. ChenPengFi is offline
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    Posted On:
    12/03/2010 12:08pm

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    Quote Originally Posted by PointyShinyBurn View Post
    I was saying that they usually come before the stage of the process they are currently at, which appears to be marketing and large scale use.
    Liar.
    I even gave you the benefit of the doubt and posted the NIH definitions.
    The IRB rules and Patient Bill of Rights together clearly refute your position, even with the moved goalposts.

    They have a few case studies. There are no large datasets about their patients, at all, other than the safety follow-up.
    Again, your measures are not the accepted legal ones.

    What's the opposite?
    I said, "Nope" meaning i do not know if it works at all.

    Which of the links, in your opinion, is good evidence of efficacy?
    I never made that claim, only that the doctor and patient have the right to determine that, not us.

    Still this ****? I said that it came before SALE, not before EVERYTHING.
    No, liar, you did not. That is why i reiterated so many times.
    You are still wrong with your moved goalposts.

    And if that analysis shows that the treatment is a bad idea then an ethical doctor can offer it, for money, anyway as long as they feel the patient understands that?
    Go read that bill of rights again.
    No, he MUST do so to be ethical.
    The patient can also refuse sound treatment.
    It's called autonomy.
    You have never taken a medical ethics class.

    "First, do no harm"?
    Are you implying harm? I'd like some proof.
    Conversely, go read the warnings on your average FDA approved drug.



    Does what counts as good evidence change? Not what legally might count, but what actually counts in terms of science?
    Nice red herring. The laws are what matter here, and you are ignorant of same.
    Just transporting goods across state lines changes everything...
    Certain agencies are only interested once state lines are crossed.

    If you can find information about exactly when it was that this refusal was (I am having trouble digging it up) I can do that.
    FUCKING LIAR.
    You made the claim without the evidence? **** you.
    I really need to quote all of your lies, don't i?


    Somewhat tangential to the main point, however? That one 'experimental' therapy was successfully sued over does not make all 'experimental' therapies equally valid, does it? Especially since both of those patients, as pointed out above, died.
    No it does not you morAn.
    It does strengthen my argument that there need not be type 1 evidence nor even adequate research fror a procedure to be performed, or in this case INSURANCE PAID FOR IT!
    Remember this is not a given in the US, that a PRIVATE company was found at fault destroys your position, period.



    That appears to be a moot point. Whether or not they ultimately fall under FDA regs (whether drug or 'bologics' production) seems to be somewhat sub-judice at the mo?
    No, you are confusing the relationship between two individuals, doctor and patient with that between a drug manufacturer and the general public.
    Simply put so long as there is transparency and no outright fraud, the gov't cannot interfere.



    Really? Totally different in terms of what evidence your would require to believe it effective?
    Yes, because there is a much lower risk associated with using YOUR OWN TISSUE as opposed to someone else's[/quote]

    Do they come, normally, before or after rolling out to 1,000 paying patients?
    You need to do more research on how much evidence is gathered for procedures as opposed to drugs before they are implemented.
    Go read that dissertation i posted earlier for a starter.
    It refutes RCTs outright.
    Then you should go read a little about medical bio-ethics.
    You are woefully ignorant on this topic.

    Stop lying and provide some evidence to support your position.
  8. ChenPengFi is offline
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    Posted On:
    12/03/2010 1:25pm

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    Hell yeah! Hell no!
    Article on the procedure and all of the mess described in this thread...
    http://singularityhub.com/2010/03/09...erapies-video/
    Here's a few quotes re: the practice of new techniques, dosages etc.
    ...doctors and surgeons are developing new procedures all the time. Surgeons will often create new devices for their own use in surgery, doctors routinely try out new dosing regimes, or therapies on their patients. This is part of the medical profession.
    ....RSI is doing what many other doctors routinely do (develop a new therapy for use in their own practice)...
    Overall, RSI is claiming around 80% patient satisfaction according to its own surveys. That’s incredible, especially when you see some of their patients walking and running again on joints that have experienced years of chronic damage. It also seems Centeno and Schultz have the documented evidence to back up the claims for Regenexx’s success. RSI provides case studies for each of its treatments as well as published scientific research.
    According to my conversation with Centeno, RSI is currently working on a comprehensive statistical analysis of their more popular treatments so they can publish quantitative results in a peer review journal. In other words, they’ll soon publish the hard numbers – X% of patients feel Y% better Z months after the procedure.

    Importantly, RSI seems to be upfront with patients about the limits of their own technique. The website FAQ clearly states that not all results will be like the testimonials, and they even have a dedicated page explaining that stem cell therapies won’t work for everyone.
    Furthermore, RSI has published the largest study of risks and complications associated with stem cell treatments yet produced in the US (N=227). That paper demonstrates the very low harm associated with stem cell therapies – much lower than the alternative surgery(published in Current Stem Cell Research & Therapy).
    (All bolds mine)
    Last edited by ChenPengFi; 12/03/2010 1:40pm at .
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