There are 19 posts before this one on FaceBook. Someone named Tim doesn't believe that any of us are really ill. Nice guy. If any of you are on FaceBook and care to let him know otherwise, please join us. He says he doesn't know why he wastes time with "you people". I always love that type of statement. It sort of implies we are lesser beings than he is in my opinion. Maybe, he just sees us as foreign objects. You can find this discussion by doing a search for Support Stem Cell Research after you log into your FaceBook account. If you aren't in that group you need to join to comment, but it is really very simple. Hope to see you there.
Post #20
Jim Anderson wrote on May 4, 2009 at 8:07am
Tim, would you please be so kind as to NAME these supposedly rogue clinics (and/or doctors) and describe what you accuse each of doing? That's not a rhetorical question; I'm quite earnest. Since I'm currently seeking treatment outside of the country, I'd appreciate your steering me clear of any "non-legitimate, foreign rogue entities with no accountability" who might do me harm or just simply waste my money. I'm sure you must have access to documentation beyond your own personal opinion, and I'd be grateful for your assistance on this matter. TIA.
Post #21
May 4, 2009 at 10:17am
Tim, don?t know if you are a big pharma guy or just someone who wants to be educated on the topic. For now, I?ll assume the latter. First, to say that allogeneic fetal tissue is the same as adult, autologous stem cells is disingenuous at best. They would be in two different risk categories based even on the ISSCR guidelines.
Sec. 1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?
(a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:
(1) The HCT/P is minimally manipulated;
(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;
(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
(4) Either:
(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(a ) Is for autologous use;
Once you get bumped out of this reg (361), you end up in the drug regs. The issue above is the definition of minimally manipulated includes any type of culture expansion of the cells, however to get a relevant therapeutic effect, autologous cells usually have to be culture expanded (grown to bigger numbers). The real problem is that the FDA has left the waters very murky on minimal manipulation. See http://www.hhlaw.com/files/Publication/4c3bdd67-a5d5-44a7-9846-f2a69d44c980/Presentation/PublicationAttachment/5746894c-7da8-4de5-8c10-01a8368561dc/PharmaBioupdate_March2009.pdf .
From that hyperlink: ?Thus, how stem cells are classified will make a significant difference in how they ultimately are regulated. Regulatory criteria used to make the classification include whether the cells are more than minimally manipulated such that the characteristics of the cellular population have changed. Examples of ?more than minimal manipulation? include cell expansion, encapsulation, activation, or genetic modification, but not cell selection.?
Cells can be culture expanded without changing their relevant biologic characteristics, in fact the body does this every day. Orthopedic surgeons commonly poke holes in the bone to grow cartilage (micro fracture) to release bone marrow mesenchymal stem cells. These mesenchymal stem cells replace themselves by multiplying in the subchondral bone. So if you culture expand cells and can prove you didn?t alter them, is it a drug? Since other parts of the same reg say that all of need to do is to process them outside the body and outside of the same surgical procedure to be bumped out of 361.
Bottom line, there is no doubt bad things can be done with stem cells. Bad things can be done with a scalpel as well. Should the FDA classify a scalpel as a new device that needs new regulation? We?re talking about the use of the patient?s own autologous cells. We don?t buy that our own cells are drugs.
Post #22
Tim Peterson wroteon May 10, 2009 at 1:51am
Never once did I say they were autologous cells, just the fact that they were adult stem cells. What IS disingenuous is your propagation of ridiculous information and using it to give medical advice to those desperate enough to listen to the lunacy
"The ones that cannot travel because they are too ill or don't have the money to do so will simply die. Clinicals most often exclude the people who are the sickest and need them the most. Clinicals often will also exclude "unpopular" diseases."
Honestly, you sound more loony than the UFO conspiracy theorists.
On one hand, you've got foreign, unregulated, unproven, uncaring, money hoarding "doctors"/business men (at least the pharmaceutical companies you hate operate by rules and regulations) who promise cures by injections of who knows what, but they are claiming adult stem cells. On the other hand, you've got renowned researchers and doctors in respected institutions throughout the world and a recognized international coalition of stem cell researchers denouncing the practices of the unchecked, overhyped, unproven, costly, dangerous practices of rogue groups who find places to operate where they know the law will not touch or care about their business.
Your gross oversimplification and naivety of the science is how these rogue clinics thrive: they feed you what you want to hear, slap a price tag on it, and go after the most desperate and unknowing of folks. Expanding certain stem cells is not trivial by any means- some stem cells still cannot be cultured once isolated because it simply is not known yet how to do so or you would have to kill or severely damage the human host in order to get at some of them- and I don't know if you know or not, but not all stem cells are the same. Some clinics promise cures using adult stem cells from one lineage to fix damaged cells of another lineage which they never have the capacity of ever becoming.
In vitro expansion of human hematopoietic stem cells (the most well defined adult stem cell) are still being worked out today. What you end up with is more rapid differentiation than expansion of stem cells when you take it out of its natural niche. Test expansions in other animals require inserting genes (similar methods cannot be clinically used in humans), and while certain recombinant proteins are showing promise, this is far from something that is clear cut and ready for today. For the orthopedic surgeon story you talk about, they are not culturing anything outside of the body. That is minimal, local, internal manipulation.
For your information, scalpels are regulated such that they must be sterile at the time of use for operations. If a doctor uses a rusted scalpel he picks up out of a trashcan to use on a person's operation, his license would be revoked, he would face jail time, and end up being sued.
Post #23
Jim Anderson wrote on May 10, 2009 at 9:03pm
He demands documentation, references and sources from others, but refuses to provide any himself. He calls others vague and provides no detail himself. He ignores questions for which he has no answers. And then he lapses into juvenile ad hominems in defense of his unsubstatiated inanities.
Keep trolling, buster. Preferably somewhere else. You've been exposed here for what you are. You've been given ample opportunity to defend and substantiate your claims and statements and you've been found sadly lacking.
As for me, I've recognized that anticholinergic bronchodilators, beta-2 agonists and corticosteroids are powerless to do anything except make my day a tiny bit easier. They will not heal me, they will not make my condition better. I decided two years ago that LVRS is at best a very temporary solution, one on the short end of the cost-benefit ratio. Transplant is not an enticing option any way you cut it (that was an unintentional pun, but I'll let it stand), even if it does extend life. I will keep transplant an option for the future, but first I'll see if there's anything to this stem cell therapy. For me, I've made the decision that it's logical and it's worth a try. And it's certainly nowhere near as invasive as the other options. It would seem that you've never had to face such decisions yourself.
As for you, Mr. Troll, you've got nuthin'. Absolutely nuthin'.
Post #24
Tim Peterson wrote22 hours ago
I don't even know why I waste my time with you people. First you claim the FDA is declaring adult stem cells as drugs (a gross oversimplification at the very best, and naive misunderstanding in actuality), claim that this is somehow going to lead to the death of people because they cannot afford to go overseas for unproven, unrealistic, unjustifiably expensive treatments that these companies adamantly refuse to allow researchers to verify, and then gather a bunch of friends to bump your"sky is falling" and alien conspiracy post. Your basis is that adult stem cells are easily grown and expanded (and yet we still need blood banks?), you overhype adult stem cell treatments worse than David Prentice (Have you stopped to think about genetic disorders? What good would it be to insert a person's own HSC into himself who has sickle cell anemia? You can expand until you have millions of HSCs and insert it into the poor kid, but that is not going to magically repair a genetic defect hardwired into his cells).
Having attended research talks from San Francisco to Boston, I have seen more and more stem cell researchers open up with images of foreign websites, and American layperson who set up similar websites promoting the promise of magical cures by adult stem cells right now. The doctors and researchers in the audience of course laugh at the absurdity, but the sad part of it all is that there are people in the U.S. who actually buy into the drivel and break their friends and family's bank account because they bought into the false promises and hopes. There's a tremendous amount of inroads being made into a lot of diseases with today's technology, and hopefully cures will follow, but the cynical false hopes portrayed today is nothing more than that- lies and deceit.
Here are a couple of links for those who seriously want to read more about these charlatans:
http://www.nature.com/stemcells/2008/0806/080605/full/stemcells.2008.89.html
http://www.newscientist.com/article/dn14137-new-task-force-to-tackle-stemcell-tourism.html
Post #25
Bea Luis wrote about an hour ago
Well, well, well. Look what the FDA wants to claim is a drug now!
"Today the FDA announced that Cheerios are officially a drug. Just when you thought it was safe to go back in the water after hearing that the stem cell in your own body are drugs, now your breakfast cereal. What next? Will we wake up to find our socks are drugs? Please share this on social media, my space, digg, etc? Spread the word that we don?t believe that our stem cells and breakfast cereal are drugs. The FDA needs to focus on actually producing real drugs that are safe and stop worrying about the tissue in our body and the health claims of breakfast cereals."
Post #26
Tim - I have no clue what your real agenda is because you refuse to be honest and open here. I do know, for a fact, that people are dying that might otherwise not do so if they were able to get A-ASC treatment near where they live. I resent your insinuations that this isn't true. It is true. I deal with it daily on my Pioneer forum and it takes an emotional toll I can assure you. I also have a terminal disease that I have to think about every waking moment. I do not need your pious determination to play God put on me or anyone else. I am not asking you to have treatment. I doubt that anyone treats paper cuts anyway, but you need to put yourself in a person's position who has been told by his or her doctor that there is nothing else that can be done for them. Stem cells offer us that hope and if we want to have treatment, it should be available for us by our local doctors. You are an unfeeling, cold fish if you cannot understand that. Either that or you are spending too much time in the lecture hall and not enough time in real life. We are real people and deserve to be treated as such. Obviously, you enjoy posting here. You remind me of someone who enjoys stepping on ants or leaving your dog out all night in the cold and then saying it wasn't really that cold. Maybe, you just haven't been eating enough Cheerios. I really don't know, but some of your comments are way off base. Maybe, you are a wannabe researcher. Please let us know who you really are. I doubt the caring doctors and researchers that I know would appreciate the title charlatan.
Post #24
Tim Peterson wroteon May 11, 2009 at 11:28pm
I don't even know why I waste my time with you people. First you claim the FDA is declaring adult stem cells as drugs (a gross oversimplification at the very best, and naive misunderstanding in actuality), claim that this is somehow going to lead to the death of people because they cannot afford to go overseas for unproven, unrealistic, unjustifiably expensive treatments that these companies adamantly refuse to allow researchers to verify, and then gather a bunch of friends to bump your"sky is falling" and alien conspiracy post. Your basis is that adult stem cells are easily grown and expanded (and yet we still need blood banks?), you overhype adult stem cell treatments worse than David Prentice (Have you stopped to think about genetic disorders? What good would it be to insert a person's own HSC into himself who has sickle cell anemia? You can expand until you have millions of HSCs and insert it into the poor kid, but that is not going to magically repair a genetic defect hardwired into his cells).
Having attended research talks from San Francisco to Boston, I have seen more and more stem cell researchers open up with images of foreign websites, and American layperson who set up similar websites promoting the promise of magical cures by adult stem cells right now. The doctors and researchers in the audience of course laugh at the absurdity, but the sad part of it all is that there are people in the U.S. who actually buy into the drivel and break their friends and family's bank account because they bought into the false promises and hopes. There's a tremendous amount of inroads being made into a lot of diseases with today's technology, and hopefully cures will follow, but the cynical false hopes portrayed today is nothing more than that- lies and deceit.
Here are a couple of links for those who seriously want to read more about these charlatans:
http://www.nature.com/stemcells/2008/0806/080605/full/stemcells.2008.89.html
http://www.newscientist.com/article/dn14137-new-task-force-to-tackle-stemcell-tourism.html
Post #25
Bea Luis wrote17 hours ago
Well, well, well. Look what the FDA wants to claim is a drug now! After learning this, ASCTA (American Stem Cell Therapy Association) says:
"Today the FDA announced that Cheerios are officially a drug. Just when you thought it was safe to go back in the water after hearing that the stem cell in your own body are drugs, now your breakfast cereal. What next? Will we wake up to find our socks are drugs? Please share this on social media, my space, digg, etc? Spread the word that we don?t believe that our stem cells and breakfast cereal are drugs. The FDA needs to focus on actually producing real drugs that are safe and stop worrying about the tissue in our body and the health claims of breakfast cereals."
Post #26
You wrote16 hours ago
Tim - I have no clue what your real agenda is because you refuse to be honest and open here. I do know, for a fact, that people are dying that might otherwise not do so if they were able to get A-ASC treatment near where they live. I resent your insinuations that this isn't true. It is true. I deal with it daily on my Pioneer forum and it takes an emotional toll I can assure you. I also have a terminal disease that I have to think about every waking moment. I do not need your pious determination to play God put on me or anyone else. I am not asking you to have treatment. I doubt that anyone treats paper cuts anyway, but you need to put yourself in a person's position who has been told by his or her doctor that there is nothing else that can be done for them. Stem cells offer us that hope and if we want to have treatment, it should be available for us by our local doctors. You are an unfeeling, cold fish if you cannot understand that. Either that or you are spending too much time in the lecture hall and not enough time in real life. We are real people and deserve to be treated as such. Obviously, you enjoy posting here. You remind me of someone who enjoys stepping on ants or leaving your dog out all night in the cold and then saying it wasn't really that cold. Maybe, you just haven't been eating enough Cheerios. I really don't know, but some of your comments are way off base. Maybe, you are a wannabe researcher. Please let us know who you really are. I doubt the caring doctors and researchers that I know would appreciate the title charlatan.
Post #27
Jane Lind wrote5 hours ago
Tim - When my Cardiologist, well respected for his knowledge and treatment of heart disease, told me that the only think that would heal my heart would be stem cells and that I would have to leave the country for that treatment. He keeps up on research as does a cousin at U of NC doing research on stem cell treatment on liver.
You need to either be upfront as to your motives or go away.
Post #28
Jane Lind
My understanding of the FDA/Cheerios is that the FDA took exception to the company claiming on labels and advertising that the product "will" lower cholerstrol and treat heart disease. I have no problem with that exception.
Post #29
Jane - My only problem with it is why wait years to come to this conclusion? This is the same thing that can happen with dangerous approved drugs. I believe that the FDA needs to be revamped in its entirety.
As for Tim -
Tim, if you actually knew the issues/science you?d be dangerous. The issues: we?re talking about putting into place clinical and lab guidelines as well as a national treatment registry so that American doctors can do this work safely. You?re focused on what?s going on in clinics overseas, we?re focused on allowing safe clinical translation to happen here. The science: we?re talking about autologous cells, it you?re talking about something else, end of conversation. Let me quote you, ?In vitro expansion of human hematopoietic stem cells (the most well defined adult stem cell) are still being worked out today. What you end up with is more rapid differentiation than expansion of stem cells when you take it out of its natural niche. Test expansions in other animals require inserting genes (similar methods cannot be clinically used in humans), and while certain recombinant proteins are showing promise, this is far from something that is clear cut and ready for today. For the orthopedic surgeon story you talk about, they are not culturing anything outside of the body. That is minimal, local, internal manipulation? Huh??? Let?s look at MSC?s. As of this morning there are over 8,000 articles listed here in pubmed: http://xrl.us/besh83 . Hundreds of these describe various techniques for culture expansion of MSC?s. Thousands more describe healing of various tissues with these culture expanded cells. Inserting genes is absolutely not needed and frankly dangerous. So what you?re proposing is that we insert genes into autologous adult stem cells so that we take what is a safe, natural repair tissue and turn into a dangerous science experiment? The orthopedic clinic we?ve referenced is using culture expanded MSC?s (see www.regenexx.com). Learn some of the science by reviewing these 8,000 plus articles and then get back to me.
If you are pushing universal standards, it will never happen. As far as hitting the lecture circuit, I could do the same thing with a band. I could attend every concert and still never be able to sing.
Post #20
Jim Anderson wrote on May 4, 2009 at 8:07am
Tim, would you please be so kind as to NAME these supposedly rogue clinics (and/or doctors) and describe what you accuse each of doing? That's not a rhetorical question; I'm quite earnest. Since I'm currently seeking treatment outside of the country, I'd appreciate your steering me clear of any "non-legitimate, foreign rogue entities with no accountability" who might do me harm or just simply waste my money. I'm sure you must have access to documentation beyond your own personal opinion, and I'd be grateful for your assistance on this matter. TIA.
Post #21
May 4, 2009 at 10:17am
Tim, don?t know if you are a big pharma guy or just someone who wants to be educated on the topic. For now, I?ll assume the latter. First, to say that allogeneic fetal tissue is the same as adult, autologous stem cells is disingenuous at best. They would be in two different risk categories based even on the ISSCR guidelines.
Sec. 1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?
(a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:
(1) The HCT/P is minimally manipulated;
(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;
(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
(4) Either:
(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(a ) Is for autologous use;
Once you get bumped out of this reg (361), you end up in the drug regs. The issue above is the definition of minimally manipulated includes any type of culture expansion of the cells, however to get a relevant therapeutic effect, autologous cells usually have to be culture expanded (grown to bigger numbers). The real problem is that the FDA has left the waters very murky on minimal manipulation. See http://www.hhlaw.com/files/Publication/4c3bdd67-a5d5-44a7-9846-f2a69d44c980/Presentation/PublicationAttachment/5746894c-7da8-4de5-8c10-01a8368561dc/PharmaBioupdate_March2009.pdf .
From that hyperlink: ?Thus, how stem cells are classified will make a significant difference in how they ultimately are regulated. Regulatory criteria used to make the classification include whether the cells are more than minimally manipulated such that the characteristics of the cellular population have changed. Examples of ?more than minimal manipulation? include cell expansion, encapsulation, activation, or genetic modification, but not cell selection.?
Cells can be culture expanded without changing their relevant biologic characteristics, in fact the body does this every day. Orthopedic surgeons commonly poke holes in the bone to grow cartilage (micro fracture) to release bone marrow mesenchymal stem cells. These mesenchymal stem cells replace themselves by multiplying in the subchondral bone. So if you culture expand cells and can prove you didn?t alter them, is it a drug? Since other parts of the same reg say that all of need to do is to process them outside the body and outside of the same surgical procedure to be bumped out of 361.
Bottom line, there is no doubt bad things can be done with stem cells. Bad things can be done with a scalpel as well. Should the FDA classify a scalpel as a new device that needs new regulation? We?re talking about the use of the patient?s own autologous cells. We don?t buy that our own cells are drugs.
Post #22
Tim Peterson wroteon May 10, 2009 at 1:51am
Never once did I say they were autologous cells, just the fact that they were adult stem cells. What IS disingenuous is your propagation of ridiculous information and using it to give medical advice to those desperate enough to listen to the lunacy
"The ones that cannot travel because they are too ill or don't have the money to do so will simply die. Clinicals most often exclude the people who are the sickest and need them the most. Clinicals often will also exclude "unpopular" diseases."
Honestly, you sound more loony than the UFO conspiracy theorists.
On one hand, you've got foreign, unregulated, unproven, uncaring, money hoarding "doctors"/business men (at least the pharmaceutical companies you hate operate by rules and regulations) who promise cures by injections of who knows what, but they are claiming adult stem cells. On the other hand, you've got renowned researchers and doctors in respected institutions throughout the world and a recognized international coalition of stem cell researchers denouncing the practices of the unchecked, overhyped, unproven, costly, dangerous practices of rogue groups who find places to operate where they know the law will not touch or care about their business.
Your gross oversimplification and naivety of the science is how these rogue clinics thrive: they feed you what you want to hear, slap a price tag on it, and go after the most desperate and unknowing of folks. Expanding certain stem cells is not trivial by any means- some stem cells still cannot be cultured once isolated because it simply is not known yet how to do so or you would have to kill or severely damage the human host in order to get at some of them- and I don't know if you know or not, but not all stem cells are the same. Some clinics promise cures using adult stem cells from one lineage to fix damaged cells of another lineage which they never have the capacity of ever becoming.
In vitro expansion of human hematopoietic stem cells (the most well defined adult stem cell) are still being worked out today. What you end up with is more rapid differentiation than expansion of stem cells when you take it out of its natural niche. Test expansions in other animals require inserting genes (similar methods cannot be clinically used in humans), and while certain recombinant proteins are showing promise, this is far from something that is clear cut and ready for today. For the orthopedic surgeon story you talk about, they are not culturing anything outside of the body. That is minimal, local, internal manipulation.
For your information, scalpels are regulated such that they must be sterile at the time of use for operations. If a doctor uses a rusted scalpel he picks up out of a trashcan to use on a person's operation, his license would be revoked, he would face jail time, and end up being sued.
Post #23
Jim Anderson wrote on May 10, 2009 at 9:03pm
He demands documentation, references and sources from others, but refuses to provide any himself. He calls others vague and provides no detail himself. He ignores questions for which he has no answers. And then he lapses into juvenile ad hominems in defense of his unsubstatiated inanities.
Keep trolling, buster. Preferably somewhere else. You've been exposed here for what you are. You've been given ample opportunity to defend and substantiate your claims and statements and you've been found sadly lacking.
As for me, I've recognized that anticholinergic bronchodilators, beta-2 agonists and corticosteroids are powerless to do anything except make my day a tiny bit easier. They will not heal me, they will not make my condition better. I decided two years ago that LVRS is at best a very temporary solution, one on the short end of the cost-benefit ratio. Transplant is not an enticing option any way you cut it (that was an unintentional pun, but I'll let it stand), even if it does extend life. I will keep transplant an option for the future, but first I'll see if there's anything to this stem cell therapy. For me, I've made the decision that it's logical and it's worth a try. And it's certainly nowhere near as invasive as the other options. It would seem that you've never had to face such decisions yourself.
As for you, Mr. Troll, you've got nuthin'. Absolutely nuthin'.
Post #24
Tim Peterson wrote22 hours ago
I don't even know why I waste my time with you people. First you claim the FDA is declaring adult stem cells as drugs (a gross oversimplification at the very best, and naive misunderstanding in actuality), claim that this is somehow going to lead to the death of people because they cannot afford to go overseas for unproven, unrealistic, unjustifiably expensive treatments that these companies adamantly refuse to allow researchers to verify, and then gather a bunch of friends to bump your"sky is falling" and alien conspiracy post. Your basis is that adult stem cells are easily grown and expanded (and yet we still need blood banks?), you overhype adult stem cell treatments worse than David Prentice (Have you stopped to think about genetic disorders? What good would it be to insert a person's own HSC into himself who has sickle cell anemia? You can expand until you have millions of HSCs and insert it into the poor kid, but that is not going to magically repair a genetic defect hardwired into his cells).
Having attended research talks from San Francisco to Boston, I have seen more and more stem cell researchers open up with images of foreign websites, and American layperson who set up similar websites promoting the promise of magical cures by adult stem cells right now. The doctors and researchers in the audience of course laugh at the absurdity, but the sad part of it all is that there are people in the U.S. who actually buy into the drivel and break their friends and family's bank account because they bought into the false promises and hopes. There's a tremendous amount of inroads being made into a lot of diseases with today's technology, and hopefully cures will follow, but the cynical false hopes portrayed today is nothing more than that- lies and deceit.
Here are a couple of links for those who seriously want to read more about these charlatans:
http://www.nature.com/stemcells/2008/0806/080605/full/stemcells.2008.89.html
http://www.newscientist.com/article/dn14137-new-task-force-to-tackle-stemcell-tourism.html
Post #25
Bea Luis wrote about an hour ago
Well, well, well. Look what the FDA wants to claim is a drug now!
"Today the FDA announced that Cheerios are officially a drug. Just when you thought it was safe to go back in the water after hearing that the stem cell in your own body are drugs, now your breakfast cereal. What next? Will we wake up to find our socks are drugs? Please share this on social media, my space, digg, etc? Spread the word that we don?t believe that our stem cells and breakfast cereal are drugs. The FDA needs to focus on actually producing real drugs that are safe and stop worrying about the tissue in our body and the health claims of breakfast cereals."
Post #26
Tim - I have no clue what your real agenda is because you refuse to be honest and open here. I do know, for a fact, that people are dying that might otherwise not do so if they were able to get A-ASC treatment near where they live. I resent your insinuations that this isn't true. It is true. I deal with it daily on my Pioneer forum and it takes an emotional toll I can assure you. I also have a terminal disease that I have to think about every waking moment. I do not need your pious determination to play God put on me or anyone else. I am not asking you to have treatment. I doubt that anyone treats paper cuts anyway, but you need to put yourself in a person's position who has been told by his or her doctor that there is nothing else that can be done for them. Stem cells offer us that hope and if we want to have treatment, it should be available for us by our local doctors. You are an unfeeling, cold fish if you cannot understand that. Either that or you are spending too much time in the lecture hall and not enough time in real life. We are real people and deserve to be treated as such. Obviously, you enjoy posting here. You remind me of someone who enjoys stepping on ants or leaving your dog out all night in the cold and then saying it wasn't really that cold. Maybe, you just haven't been eating enough Cheerios. I really don't know, but some of your comments are way off base. Maybe, you are a wannabe researcher. Please let us know who you really are. I doubt the caring doctors and researchers that I know would appreciate the title charlatan.
Post #24
Tim Peterson wroteon May 11, 2009 at 11:28pm
I don't even know why I waste my time with you people. First you claim the FDA is declaring adult stem cells as drugs (a gross oversimplification at the very best, and naive misunderstanding in actuality), claim that this is somehow going to lead to the death of people because they cannot afford to go overseas for unproven, unrealistic, unjustifiably expensive treatments that these companies adamantly refuse to allow researchers to verify, and then gather a bunch of friends to bump your"sky is falling" and alien conspiracy post. Your basis is that adult stem cells are easily grown and expanded (and yet we still need blood banks?), you overhype adult stem cell treatments worse than David Prentice (Have you stopped to think about genetic disorders? What good would it be to insert a person's own HSC into himself who has sickle cell anemia? You can expand until you have millions of HSCs and insert it into the poor kid, but that is not going to magically repair a genetic defect hardwired into his cells).
Having attended research talks from San Francisco to Boston, I have seen more and more stem cell researchers open up with images of foreign websites, and American layperson who set up similar websites promoting the promise of magical cures by adult stem cells right now. The doctors and researchers in the audience of course laugh at the absurdity, but the sad part of it all is that there are people in the U.S. who actually buy into the drivel and break their friends and family's bank account because they bought into the false promises and hopes. There's a tremendous amount of inroads being made into a lot of diseases with today's technology, and hopefully cures will follow, but the cynical false hopes portrayed today is nothing more than that- lies and deceit.
Here are a couple of links for those who seriously want to read more about these charlatans:
http://www.nature.com/stemcells/2008/0806/080605/full/stemcells.2008.89.html
http://www.newscientist.com/article/dn14137-new-task-force-to-tackle-stemcell-tourism.html
Post #25
Bea Luis wrote17 hours ago
Well, well, well. Look what the FDA wants to claim is a drug now! After learning this, ASCTA (American Stem Cell Therapy Association) says:
"Today the FDA announced that Cheerios are officially a drug. Just when you thought it was safe to go back in the water after hearing that the stem cell in your own body are drugs, now your breakfast cereal. What next? Will we wake up to find our socks are drugs? Please share this on social media, my space, digg, etc? Spread the word that we don?t believe that our stem cells and breakfast cereal are drugs. The FDA needs to focus on actually producing real drugs that are safe and stop worrying about the tissue in our body and the health claims of breakfast cereals."
Post #26
You wrote16 hours ago
Tim - I have no clue what your real agenda is because you refuse to be honest and open here. I do know, for a fact, that people are dying that might otherwise not do so if they were able to get A-ASC treatment near where they live. I resent your insinuations that this isn't true. It is true. I deal with it daily on my Pioneer forum and it takes an emotional toll I can assure you. I also have a terminal disease that I have to think about every waking moment. I do not need your pious determination to play God put on me or anyone else. I am not asking you to have treatment. I doubt that anyone treats paper cuts anyway, but you need to put yourself in a person's position who has been told by his or her doctor that there is nothing else that can be done for them. Stem cells offer us that hope and if we want to have treatment, it should be available for us by our local doctors. You are an unfeeling, cold fish if you cannot understand that. Either that or you are spending too much time in the lecture hall and not enough time in real life. We are real people and deserve to be treated as such. Obviously, you enjoy posting here. You remind me of someone who enjoys stepping on ants or leaving your dog out all night in the cold and then saying it wasn't really that cold. Maybe, you just haven't been eating enough Cheerios. I really don't know, but some of your comments are way off base. Maybe, you are a wannabe researcher. Please let us know who you really are. I doubt the caring doctors and researchers that I know would appreciate the title charlatan.
Post #27
Jane Lind wrote5 hours ago
Tim - When my Cardiologist, well respected for his knowledge and treatment of heart disease, told me that the only think that would heal my heart would be stem cells and that I would have to leave the country for that treatment. He keeps up on research as does a cousin at U of NC doing research on stem cell treatment on liver.
You need to either be upfront as to your motives or go away.
Post #28
Jane Lind
My understanding of the FDA/Cheerios is that the FDA took exception to the company claiming on labels and advertising that the product "will" lower cholerstrol and treat heart disease. I have no problem with that exception.
Post #29
Jane - My only problem with it is why wait years to come to this conclusion? This is the same thing that can happen with dangerous approved drugs. I believe that the FDA needs to be revamped in its entirety.
As for Tim -
Tim, if you actually knew the issues/science you?d be dangerous. The issues: we?re talking about putting into place clinical and lab guidelines as well as a national treatment registry so that American doctors can do this work safely. You?re focused on what?s going on in clinics overseas, we?re focused on allowing safe clinical translation to happen here. The science: we?re talking about autologous cells, it you?re talking about something else, end of conversation. Let me quote you, ?In vitro expansion of human hematopoietic stem cells (the most well defined adult stem cell) are still being worked out today. What you end up with is more rapid differentiation than expansion of stem cells when you take it out of its natural niche. Test expansions in other animals require inserting genes (similar methods cannot be clinically used in humans), and while certain recombinant proteins are showing promise, this is far from something that is clear cut and ready for today. For the orthopedic surgeon story you talk about, they are not culturing anything outside of the body. That is minimal, local, internal manipulation? Huh??? Let?s look at MSC?s. As of this morning there are over 8,000 articles listed here in pubmed: http://xrl.us/besh83 . Hundreds of these describe various techniques for culture expansion of MSC?s. Thousands more describe healing of various tissues with these culture expanded cells. Inserting genes is absolutely not needed and frankly dangerous. So what you?re proposing is that we insert genes into autologous adult stem cells so that we take what is a safe, natural repair tissue and turn into a dangerous science experiment? The orthopedic clinic we?ve referenced is using culture expanded MSC?s (see www.regenexx.com). Learn some of the science by reviewing these 8,000 plus articles and then get back to me.
If you are pushing universal standards, it will never happen. As far as hitting the lecture circuit, I could do the same thing with a band. I could attend every concert and still never be able to sing.
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