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Thread: Med Page Survey-Please Vote for Stem Cells

  1. #1

    Default Med Page Survey-Please Vote for Stem Cells

    We need you to go on this site and vote for your personal freedom to chose which treatments you can have without the FDA dictating to you -and taking control of medicine.

    Please vote now, and pass this around around to any of your friends and family and people you know that want a cure for disease -without FDA interference.

    The Link:

    http://www.medpagetoday.com/Surveys/

  2. #2

    Default Teriss

    I think that one of the comments on the survey is from a person that is VP for StemCells, Inc. I can't help but wonder if everything is about money, and not about the health of people needing adult stem cell treatments from their own stem cells. I know that everyone is entitled to an opinion, BUT my opinion isn't about stopping people from getting treatment nor is it about the money. Some of the other comments were very good. Maybe they don't have a financial interest.

    Here's her quote:

    "barbara araneo- Aug 21, 2010
    The FDA has the legal obligation to determine how products are classified. Cell therapies are put into 2 categories - tissue products or cell therapy drugs. Cell therapies are drugs if they alter a disease process. The clinic exceeded the definition of a tissue product and landed squarely under the drug definition. This case is unfortunate as it may set back cell therapies in general because the clinic advertised improperly and failed to regard the laws by developing a process of making the cell therapy that could endanger the lives of people getting it - even though its their own cells. There is no alternative, no confusion, the laws are very clear. If anyone wants a reference you can search the FDA website. Have a nice day.

    2003
    Barbara Araneo, Ph.D., the Company's new Vice President of Development, will be responsible for directing the effort to bring StemCells' cell-based therapeutic products from the preclinical proof of concept stage through the clinical development and regulatory approval process. Prior to joining StemCells, Dr. Araneo was a Scientific Co-Founder and Senior Vice President of Research and Development at Pharmadigm, a privately held biopharmaceutical company with a number of products in various stages of clinical development. Dr. Araneo obtained her doctorate in Cellular Immunology from the University of Rochester and completed her postdoctoral training at Washington University School of Medicine and at the Department of Microbiology at UCLA.

  3. #3
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    Default

    Kaye - You are truly amazing. Comments like this are almost always made by someone with a monetary interest in the outcome. That's why it is so very important for patients to become the driving force behind the effort to allow us to have stem cell therapy with our own stem cells made available in the U.S. It must be part of the medical practice issue between our own doctors and not a regulatory agency who lies in bed with Big Pharma. We also must be vigilant and out those that do not makes themselves transparent. Shame on Ms. Araneo.

    This comment pointed out that this boils down to discrimination of the disabled. The more I thought about that, the more I had to agree.


    A. Rahman Ford- Aug 24, 2010
    in this case, the fda has been an obstacle to healing people. i had to travel to china for my umbilical cord stem cells, and i would have loved to try my own stem cells in the u.s. first. we need president obama to take a stand on this. health care is more than health insurance. it frustrates me that i could have my own stem cells used for breast augmentation here, but not to treat my "disease." the impact of the interpretation of the regulations is to discriminate against persons with disabilities. thus, it becomes more than a medical or legal issue. this is a matter of human rights.
    First treatment in 2007. Pioneering ever since.

    Barbara

  4. #4

    Default Barbara

    I liked that comment also. It is discrimination of the disabled. I noticed that you ratted out Dr. Araneo. BRAVO! It's all about them getting to market with their product at taxpayers expense along with our health expense.

    I also noticed that Dr. Arneao's comment was "Cell therapies are drugs if they alter a disease process." Does that technically mean that only the cells that work and alter my disease are drugs? If the transplant doesn't work for me, then are the cells not drugs? Does the FDA only claim cell therapies if they alter the disease? What about injuries? This rambling around that I am doing makes about as much sense as the FDA does???

  5. #5
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    The survey is now closed for voting. 30% think the FDA should be involved, 70% do not. Here are the comments that were made. Thanks to any of you that helped out.



    daniel blue- Aug 20, 2010
    I always enjoy the surveys They are very educational

    hans huber- Aug 20, 2010
    The FDA is " Running " after it's own TAIL now, so they don't need more CONFUSION !

    John Driessen RN- Aug 21, 2010
    It is the obligation of the FDA tp review current data as it relates to safety & efficacy of any new procedure, medication or device. Once this is accomplished they need to take a watchful approach. If problems develop then review data. Otherwise back off!

    peter anyakora, MD., Sc.M- Aug 21, 2010
    This procedure is beyond FDA's statutory mandate. Autologous transplants should be exanimed by experts in hematology.

    bruce nilson- Aug 21, 2010
    Next on the FDA's menu: Classifying fat cells as drugs if they are moved from your butt to your lips.

    barbara araneo- Aug 21, 2010
    The FDA has the legal obligation to determine how products are classified. Cell therapies are put into 2 categories - tissue products or cell therapy drugs. Cell therapies are drugs if they alter a disease process. The clinic exceeded the definition of a tissue product and landed squarely under the drug definition. This case is unfortunate as it may set back cell therapies in general because the clinic advertised improperly and failed to regard the laws by developing a process of making the cell therapy that could endanger the lives of people getting it - even though its their own cells. There is no alternative, no confusion, the laws are very clear. If anyone wants a reference you can search the FDA website. Have a nice day.

    varian keller- Aug 22, 2010
    Placing ever more "therapies" under FDA control is in line with what one would expect from a society where every part of government is motivated to become relentlessly larger and controlling of its citizens. This could be a disconcerting trend unless one makes a living from government money. I would expect these folks to answer "yes" to this question and justify this profit biased answer in very logical, altruistic and emotionally convincing ways.

    marcus edwards- Aug 23, 2010
    Unless some one tries these ideas we will never know if they work. People are aware and are explained of the risk in any procecure. The FDA should stick to what they do and not venture in to areas they do not belong. To much control by the FDA stops many promising project to never be completed.

    Jose Navarro, MD- Aug 23, 2010
    All time blood and hemocomponents including stem cells (even from other sources) have been regulated by FDA, this is no news.

    jade- Aug 23, 2010
    unless this is a food, drug, or cosmetic, i don't see how the FDA has any role? i don't think i see how a surgical tool falls into either of those categories...

    Ronald Hanson, MD- Aug 23, 2010
    I think there is some confusion I'd like to clear up: 1. FDA has no authority over any medical procedure or any part of medical practice. The courts and congress (as well as the agency) have always restricted FDA intervention in medical practice. 2. Cell therapy if it alters a disease or process is not the definition of a drug. If it were, then any surgical procedure would be a drug. 3. The clinic in discussion here was not performing a dangerous procedure, see their safety publication at http://www.ncbi.nlm.nih.gov/pubmed/19951252. Based on this peer reviewed study, the procedure was dramatically safer than the surgeries it helped many patients prevent. The FDA's language on safety seems to be included because the clinic refused to follow drug factory guidelines. 4. The big question here is are these cells drugs in the first place? As a physician that makes no sense...

    nancy j. anderson, MAHH,RMT- Aug 23, 2010
    Shouldn't the patient have a say in how their DNA is to be used or treated before the government gets involved in any of this? The arrogance of research, medicine, and government is their deciding what they want and how to use the information, sometimes without informing the patient or requesting permission for its use.

    henry young- Aug 23, 2010
    I agree with the post of Ronald Hanson, MD.

    Barbara Hanson- Aug 23, 2010
    As a patient, I want my own doctor to be the one in charge of any medical treatment I need. I should have this choice. These are my own stem cells the FDA is calling drugs. I have had treatment offshore that has saved my life. I should have been able to have that same treatment in the U.S. The FDA must step aside and leave the practice of medicine to doctors. While they pursue this case, millions are in critical need of stem cell therapy. It's horrible what they are putting sick people through.

    jack parker- Aug 23, 2010
    the FDA has no business regulating a person's own stem cells

    A. Rahman Ford- Aug 24, 2010
    in this case, the fda has been an obstacle to healing people. i had to travel to china for my umbilical cord stem cells, and i would have loved to try my own stem cells in the u.s. first. we need president obama to take a stand on this. health care is more than health insurance. it frustrates me that i could have my own stem cells used for breast augmentation here, but not to treat my "disease." the impact of the interpretation of the regulations is to discriminate against persons with disabilities. thus, it becomes more than a medical or legal issue. this is a matter of human rights.

    Judith Levine RN BSN- Aug 24, 2010
    It seems so easy to say no and I almost did. Then I thought about thalidomide. As soon as something goes wrong, everyone is going to start screaming, "Why didn't they take action before this happened?" Sorry Varian but we no longer live in a small agrarian society where we can do whatever we want as long as we don't openly kill someone.

    Stephen Bachhuber- Aug 24, 2010
    As long as the transfer is autologous and does not involve any non-FDA approved substances, I believe that would make this a medical procedure and outside the congressional mandate for the FDA. Furthermore, I believe that the FDA's pressure may be an enormous setback for medicine as a whole. Medical procedures are outside of the FDA's jurisdiction for a reason. It limits progress.

    Barbara Hanson- Aug 24, 2010
    I wish that Barbara Araneo who posted on 8/21 would have let us know her background. It helps to assess why some one would take such a hard line against people who need therapy now. 2003 Barbara Araneo, Ph.D., the Company's new Vice President of Development, will be responsible for directing the effort to bring StemCells' cell-based therapeutic products from the preclinical proof of concept stage through the clinical development and regulatory approval process. Prior to joining StemCells, Dr. Araneo was a Scientific Co-Founder and Senior Vice President of Research and Development at Pharmadigm, a privately held biopharmaceutical company with a number of products in various stages of clinical development. Dr. Araneo obtained her doctorate in Cellular Immunology from the University of Rochester and completed her postdoctoral training at Washington University School of Medicine and at the Department of Microbiology at UCLA.

    sam smithers- Aug 24, 2010
    We don't need a clinical trial to prove the body has an immune system that can heal itself using your own stem cells. Using your own cells is not harmful and thalidomide babies were caused by an experimental drug so that argument does not hold water. In fact it is very suspicious that the drug companies have a financial interest here if our own cells can heal us they lost billions. Outside interests or lobbyists must be kept out of medicine, this is about saving lives not profits or politics. If the FDA doesn't acknowledge the body's ability to heal - they need to go back to health classes in Grade 3.

    johnnyz, md- Aug 25, 2010
    I support Dr. Hanson. I've been doing clinical research requiring FDA involvement for 35 years so I am not surprised what they might try next. Barbara Araneo is a PhD., and I don't care where she trained for this, her understanding of the FDA and medicine is woeful. Indeed, we have too many non-physicians trying to tell physicians how to practice medicine.

    Patrina McCauley, BS, PharmD, BCPS- Aug 25, 2010
    It is important that there is oversight for procedures, medications, and interventions. For the FDA to have the power it has now a lot of people were harmed along the way. It is also important there is oversight for physician action. In every profession there are those who are able, those who are outstanding and those who are sub-par. I do not exclude my profession in that. Anyone who went through a professional curriculum knows another person they would not send their mother to, for care. The statements on the site about physician independence... that thinking led to the creation of the FDA. Every medical professional should know ?Natural? is not synonyms with innocuous. I question the use of "Natural" to describe the procedure. A better word for this treatment is hopeful.

    Tamara JJ- Aug 25, 2010
    The FDA CAN NOT regulate procedures, as some say in their comments. Only drugs and medical devices. Cell therapies are NOT drugs if they alter a disease process. Would you say walnuts are drugs? Apparently the FDA does think so, exactly by defining a drug when a product alters a disease process(even if it is nature's product like walnuts which decrease cholesterol and prevent cardiovascular disease). Not all stem cells used for therapy are under the DRUG name: for example if they use cells, which have minimal manipulation (no cultivation, differentiation or genetic manipulation). one or two hours after the extraction, they are implanted intra arterially, near the damaged area. The FDA does not require clinical studies for this. They regulate, drugs, devices and HCTPs(human cells, tissues and their products) they need to asses their safety (to secure no infections will be transmitted and that the product is safe), then efficacy, and all the rest is for the commercialization of these products. FDA itself has established some exceptions to HCTPs: As can be seen on the Code of Federal Regulations, Title 21 Sec. 1271.10. Are my HCT/P's regulated solely under section 361 (which guards contamination and infections) of the PHS Act and the regulations in this part... SEE for Yourself!

    sam and mary smithers- Aug 25, 2010
    "To Tamara JJ-You're correct in saying FDA has no authority over procedure and no authority over things that are advertised to alter a disease process-as that's medical practice. The PHS act was adopted by congress is to reduce the transmission of communicable disease in transplants, but that's all congress ever authorized FDA to do. As you know, a transplant is from person A to person B. Where FDA has exceeded their authority here is that congress never authorized or intended FDA to have any control over autologous processing, as there is no communicable disease transmission risk there (person's A's diseases get transmitted back to person A). In fact 1271.7, .75, .8., and.9 explicitly state that the earlier adopted parts (1271.1) don't apply for autologous processing. The issue here is that FDA has created out of thin air its ability to regulate autologous cell processing or to declare certain autologous cells a drug using arbitrary guidelines. As an example, when doctors activate PRP with thrombin to promote healing, that alters the biologic characteristics of the cells and consequently exceeds FDA's definition of "more than minimal manipulation" under 1271.1. Does a doctor using this common technique of activation of the platelet rich plasma (PRP) make it a mass produced drug worthy of federal regulation? A second example of how crazy these regulations are-recent research has shown that taking an MRI of adult stem cells alters their biologic characteristics. Does taking the MRI of the cells make them drugs under 1271.1? Bottom line, a drug is something that is mass produced and sold interstate, medical practice is one on one care-period. If you start drawing arbitrary lines through autologous use of anything you end up with a regulatory mess!"

    Ron Hanson, MD- Aug 26, 2010
    A few more things to clear up: An excellent and well informed post by the Smithers'!!! 1) Minimal manipulation is a grey area in section 1271.10 that has yet to be made clear by the agency. If you culture a person's stem cells and they have the same relevant biologic characteristics after the culture, by definition these cells are not more than minimally manipulated. If you look at their data, this is what the Centeno-Schultz clinic was doing. 2) 1271.10 and 1271.15 in and of themselves reach beyond the mandates afforded the FDA by Congress in that the FDA has no regulatory authority over the practice of medicine, as Patrina incorrectly points out. Physicians are exclusively regulated by state medical boards and their respective professional societies. In addition, 1271.1, .15, .2, and .3 are contradicted by the later adopted section, namely .7, .75, .8, and .9-which state that autologous tissue processing do not apply to these regulations 3) The vast majority of surgical procedures in the United States are not FDA approved (look it up). The surgical procedures avoided by the stem cell therapies of this clinic are far more invasive with greater recovery periods, morbidity and mortality. Where is the outcry to regulate these now seemingly needless surgical procedures in light of a better solution? 4) You avoid and fail to answer the fundamental question: can a person's body parts, for which they have given consent under the education and full disclosure of a physician in good standing be lawfully regulated by a bureaucrat? I don't think so. But more important....why would you?.....

    Stephen Bachhuber- Aug 26, 2010
    To Sam and Mary Smithers, you nailed it exactly. Things that are mass-produced such as drugs and food sold on an interstate basis are the domain of the FDA. Single-shot procedures are the domain of medical doctors and standards are set within the profession through professional organizations.

    Linda Miller, RN- Aug 27, 2010
    Every industry -- including the medical industry -- needs some oversight. Otherwise we get bankers providing their own oversight, or medical companies providing their own oversight. Once a body tissue is out of the body and is changed/processed, there is the possibility of something going wrong. If we have issues with the FDA, let's change it -- but meantime we still need some oversight and the FDA, even with all it's faults, is probably the best thing we have for now.
    First treatment in 2007. Pioneering ever since.

    Barbara

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