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  1. cliveandrews

    REGROW Act

    Adult stem cells show enormous theraputic potential for treating a large number of degenerative conditions. That promise is already being realized in several other countries whose governments are less hostile to biotech innovation, but in the U.S., their use remains utterly encumbered by the regulatory environment here. As a result, the U.S. is underperforming third-world shitcans like Mexico and Thailand in this vital new arena. To my amazement, Senator Mark Kirk (R-Ill), with a Democrat co-sponsor, recently introduced a bill titled the REGROW Act that would drastically reduce the regulatory barriers to patient access of regenerative medicine products. It would create an altogether new regulatory pathway for cell-based products, which, among other things, would include a 5-year "conditional approval" policy that would allow these treatments to be used immediately if they show strong prima facie evidence of safety and effectiveness. This would be a game-changer for the U.S. healthcare if it passes, which is why I'm thinking it won't. It's contradictory to the spirit of ObamaCare, with its reliance on strict government-imposed treatment guidelines, and I can't see the same people who had to cram the law down our throats so we could see what's in it supporting a law like this. http://www.patientsforstemcells.org/tag/regrow-act/ http://www.celltherapynow.org/
  2. The FDA is about to strike again. Five years ago, the agency moved to begin regulating the use of adult stem cells as drugs. While it succeeded at curtailing the use of cells that have been expanded in culture (i.e. grown to greater numbers in an incubator), it did not gain control over "same-day" cell procedures in which cells are taken out of the patient's bone marrow and immediately re-injected in their original number. Lately these "same day" procedures have gained significant traction as viable treatments for orthopedic conditions, and the FDA apparently wants to put a stop to it by passing yet more regulations to classify these cell preparations as drugs. They're holding a "public meeting" later this year to solicit viewpoints on the issue: https://kg236.infusionsoft.com/app/hostedEmail/85850/79214ccd9d246826/T This issue is of great personal importance to me. However, I'm uncertain whether I should attend this event, because I surmise that their intentions are a forgone conclusion and that this is just a perfunctory formality to make it look like the FDA is open to opposing points of view. I would hate to plead for my freedom to people who have no respect for it. Maybe a politely worded, scathing denunciation of their actions would be appropriate? In that case, how harsh would be too harsh? Any thoughts on this would be appreciated.
  3. I’ve posted on this form before about the arthritis I suffer from and how government regulations are destroying the recent innovations that could potentially revolutionize the treatment of the disease. One such innovation involves adult stem cells that are extracted from a patient's body, cultured in a laboratory to multiply them to greater numbers, and re-injected into an arthritic joint. The cells have been shown to repair the damaged joint and restore the patient’s physical function. In the last 3-4 years, quite a bit of research has piled up demonstrating the safety and effectiveness of the procedure. Between about 2005 and 2010, a small number of clinics apparently used this therapy freely in the U.S., although there wasn't much research behind it and it didn't receive much attention, so I didn't become aware of it at the time. However, in 2012, shortly after the remarkable results of a study were published in a major medical journal, the FDA won a Federal lawsuit alleging that a patient’s own stem cells are actually "drugs" subject to its regulation, and this decision completely shut down the use and development of the procedure in this country. https://ari.aynrand.org/blog/2012/03/23/fda-versus-stem-cell-therapies The physician whom the FDA targeted in its lawsuit, the man most known for pioneering the use of this therapy, has taken his business overseas to a small island country whose regulators allow it, where he offers it at a far steeper price than what he used to charge for it in the U.S. I recently contacted his company to inquire about the cost of the procedure. It starts at $17,500 for one joint, and they charge an additional $2000 for every additional one thereafter. The thing is...as far as I can tell, I do not believe there are any additional inputs on his end to treating more than one joint. He simply draws bone marrow and expands the cells to the greatest number possible, which can then be used in as many sites as they are needed. Treating multiple joints is just a matter of moving the needle around from one to another. That he charges $2000 for each additional site is maddening. I would not object to his price scheme under normal cirumstances, as most people only need the treatment in a single joint, or at most a small number. However, my situation is unique since I have arthritis in several dozen joints, and at $2000 each, it is infeasible to treat enough of them to make it worthwhile to treat any. The only way I can do it at all is if he waives that extra $2000 per, or at least greatly reduced it. I am considering paying for a consultation with him to ask him to treat as many joints as possible for a flat rate. In doing so, I am essentially asking for charity care. On one hand, unless I misunderstand the effort and expense required on his part to treat multiple joints, it seems in his interest to take a flat rate as opposed to nothing. However, for reasons I’m unsure of, I still expect him to say no. And even though as an Objectivist, I have no right to resent him for charging for his service or being profit-driven, I find myself doing so anyway. That he could make my life what seems like very little sacrifice on his part, but wouldn't do so, seems awful. I would not hesitate to help someone in my position, and I thought I was as selfish as they come. I'm trying not to confuse my own despair with my evaluation of him. Am I wrong?
  4. Just to further illustrate how much havoc the the FDA is wreaking on the cause, here's the second of the three questions I sent him: 2. I understand that your work focuses on in-vitro tissue engineering approaches to treating cartilage ailments, however, I’ve also read about several potential in-vivo, regenerative approaches to treating OA that apparently show promise. One such approach, direct injections of mesenchymal stem cells, has apparently been shown to have the potential to regenerate osteoarthritic cartilage (here's one study documenting this). Although the FDA shut this down in 2012 when they declared that stem cells now qualify as "drugs," this therapy is still available in places beyond the reach of U.S. regulators. Do you have an opinion on whether the intra-articular injection of MSCs holds promise and may be worth pursuing? Too difficult of a subject to respond to. All I will say is that one needs to proceed w extreme caution w anything that has not been verified and confirmed in appropriately controlled studies.
  5. I got a reply today. It makes me so happy that the FDA protects the public...from the cure for the nation's leading cause of disability!! __________________ Dear Clive, Below in your original email you will find very brief responses. I am sorry in advance that I cannot provide fuller responses to such inquiries. The best of health. Kyriacos (Kerry) Kyriacos A. Athanasiou, Ph.D., P.E. Distinguished Professor of Biomedical Engineering and Orthopaedic Surgery Child Family Professor of Engineering University of California Davis Editor-in-Chief, Annals of Biomedical Engineering [email protected] http://bme.ucdavis.edu/people/departmental-faculty/athanasiou/ (BME) http://www.bme.ucdavis.edu/athanasioulab/ (lab) http://www.ucdmc.ucdavis.edu/orthopaedics/ourteam/biodetail.asp?bioid=1481 (Orthopaedic Surgery) My questions: What is the status of tissue engineering and regenerative medicine with respect to the goal of resurfacing entire joints afflicted with OA? In a 2012 speech at the UC Davis Stem Cell Dialogues, you announced that your lab has succeeded in creating the entire articular surface of a human distal femur; however, your book “Articular Cartilage” published the following year states that there is still no successful tissue engineering approach to treating OA. Can you explain the apparent contradiction? Will your “HyCart” product include constructs capable of resurfacing whole joints as opposed to ones intended to repair focal defects only? And if biological whole-joint repair it isn’t already on the horizon, can you comment on whether you see it as a future likelihood and how distant the prospect is? Is it a goal of yours? I am not pursuing commercialization of any products currently. In the lab we have been able to resurface entire joints of animals, but we have not done so beyond the lab. It is a goal of ours but with the way the FDA requirements are it will take a long time to achieve. The reason is that engineered biological tissue is one of the most complicated pursuits in terms of regulatory processes. I am glad that the FDA has rules and regulations; it is just this particular objective is one of the most difficult ones to pursue. Because of the regulatory complications, there is no funding by investors toward this goal (they prefer snapchat and facebook). I cannot provide any timelines for commercialization. I am deeply concerned that that regulatory burdens will delay patient access to tissue engineering and regenerative therapies for long after they become technologically feasible. My understanding is that the FDA considers every diseased joint a discrete “indication,” implying that biological joint resurfacing products may have to go through separate approval processes for all of the different joints in which they are to be used. If this is the case, it seems that there is likely to be a very long wait before a tissue engineering therapy for OA can be used anywhere in the body it is needed. Is this inference correct, or do you see a way around this? I guess I anticipated this question in my answer 1 above. I share your opinion fully
  6. I've decided to write a letter to the researcher in question. Here's what I have so far; it includes everything I want to ask. However, it seems as though I'm bombarding him with too many questions, and it also seems too long. Is a letter like this appropriate, and can anyone suggest appropriate edits? Would it be better to first ask him if he would be willing to answer questions, then send him the questions in a separate document? Any advice would be appreciated. Dear Dr. Athanasiou, I hope this letter doesn't come as a nuisance. I'm writing because your work with articular cartilage is of enormous interest to me. At 32, I am afflicted with whole-body osteoarthritis, i.e. degenerative joint disease affecting almost every synovial joint in my body individually, the only apparent exceptions being the facet joints of my spine. I acquired this condition nine years ago as a result of a specific cause that I'm certain of. While thankfully still in its early stages and only mildly symptomatic, it has already caused significant hardship by cutting me off from my preferred work options and the lifestyle I love. Obviously, the eventual implications of having osteoarthritis in so many joints are devastating. I became aware of your work in 2006, the same day I learned of my condition, when I read of your success fabricating the articular surfaces of specific rabbit femurs via self-assembly. More recently, I've read that you are able to create large pieces of cartilage that can potentially be used to repair damaged joints, and that you actually have products based on this technology in development through your company Ariston Medical. It's truly heroic that you're actually creating biological solutions to the plague of cartilage ailments; it seems that your work has the potential to revolutionize the field of musculoskeletal medicine and quality of life for untold numbers of people. I would like to ask some questions about about your work. My reasons are to indulge my fascination and assess the likelihood that I will eventually be able to benefit from your technology. I understand that a letter like this doesn't warrant exhaustive explanations, and also if you don't want to answer at all. However, as these issues are of great importance to me, any response would mean a great deal. To let you know your audience, you can assume I know the basic facts about the function and physiology of articular cartilage and joints in general. My questions: What is the status of tissue engineering technology with respect to the goal of resurfacing entire joints afflicted with OA? In a 2012 speech at the UC Davis Stem Cell Dialogues, you announced that your lab has succeeded in creating the entire articular surface of a human distal femur; however, your book Articular Cartilage published the following year states that there is still no successful tissue engineering approach to treating OA. Can you explain the apparent contradiction? If you can now resurface a large focal defect in the knee, what stops you from being able to replace the entire surfaces of smaller joint? Will your "HyCart" product include constructs capable of resurfacing whole joints as opposed to ones intended to repair focal defects only? If you aren't already, is it your goal to eventually create biological whole-joint replacements? Is one of the challenges of resurfacing whole joints to create opposing surfaces with compatible geometries, e.g. a patellar surface that perfectly fits the opposing trochlear groove? Are you as of yet able to control things with this degree of precision? Once you can create a cartilage construct suitable for resurfacing an entire joint, how will you integrate it with the patient's native bone tissue? I've read that HyCart will be "functionally interdigitated with nano-hydroxyapatite," which at risk of betraying my amateurism I infer to mean that the engineered cartilage will interface with a material ("nHa") intended to serve as a bone substitute. Subsequent to this: Once installed in the patient's joint, does this nHa implant mature into true bone tissue, or remain as is? Will you be able accommodate the steep contours of many joint surfaces without resecting too much of the original bone tissue? What about vital support structures such as the meniscus of the knee and ligamentum teres of the hip that would inevitably be compromised by the removal of the original joint surfaces? Will you be able to preserve or restore them? How will you fixate a construct in the patient's joint? Will the emergence of biological joint resurfacing be complicated by the need to develop new surgical equipment such as jigs, saws, and screws particular to the different joints in which they are to be used? When your cartilage resurfacing technology is ready, will it be for use in specific joints only, or do you plan to make it available for use anywhere in the body? Do you have time frames in mind as to when you will start resurfacing whole joints in humans pre-commercially and when you hope to be able to make it commercially available? I am greatly concerned that that regulatory barriers will make it impossible to benefit from cartilage resurfacing technology for long after it otherwise becomes feasible. I understand the average time to market from discovery is approximately 15 years for a novel product. I also understand that the FDA considers every diseased joint a discrete "indication," implying that tissue-engineered joint replacement products will have to go through separate approval processes for all of the joints in which they are to be used. If so, it seems that the wait until this technology can be used anywhere in the body it is needed is likely to be a very long time. Is this inference correct, or do you see a way around this? How would one partake in an experiment or clinical trial when the technology is ready to be used in human patients? Are there currently any opportunities to do so? My final question relates to the complications of my particular predicament of having OA in almost all of my joints. Obviously, I would like to have all of my arthritic joints "fixed" with biological joint replacements one day. In theory, if it's possible to resurface one joint, it should be possible to resurface any number; however, realistically, I assume that the combination of technological, surgical, regulatory, and financial barriers to resurfacing so many joints will probably be too great to overcome anytime in the foreseeable future, so ultimately, the prospect seems utterly remote. Do you agree with this assessment, or do you think any optimism is justified? Regardless of the answers to my questions, thank you for your heroic work and taking the time to read this letter. Sincerely, cliveandrews
  7. I am afflicted with a rare and potentially devastating muscuoloskeltal disorder—osteoarthritis, a.k.a. degenerative joint disease, in virtually all of my joints. While many millions of people have osteoarthritis in at least one joint (it is the nation's leading cause of diability), I have it everywhere, which cumulatively is the mother of all orthopedic problems. Although the disease has progressed much slower than I originally expected, and is still in its early stages of progression after eight years, it's slowly getting worse. Osteoarthritis, if you don't know, is degenation of the cartilage that lines the surface of joints. Cartilage is an amazing tissue capable of withstanding an enormous amount of stress when healthy, but lacks the ability to heal once damaged, so any injury sustained is permanent. The existing treatment options for osteoarthritis and other cartilage problems are generally ineffective and dangerous and have not advanced significantly in my lifetime. Fortunately for mankind, a genius by the name of Dr. Kyriacos Athansiou, Chair of the Department of Bioengineering at the University of California, Davis, has astoundingly developed the "holy grail" of therapies for cartilage problems: a process that can fabricate tissue-engineered cartilage that is identical to the real thing, custom-shaped to fit an individual bone surface, that can be used to biologically resurface an arthritic joint. I have been following his work for years, but never thought I would see the day when this would become possible: This technology, if made commercially availible, would revolutionize the field of orthopedic medicine and effectively "cure" the nation's leading cause of disability. Of course, thanks to our political system and the kind of world we live in, the dream of clinicians being able to provide this therapy to the people who despeately need it is probably decades away from becoming a reality, and may well never become a reality in our lifetimes for use in most joints. The process of getting FDA approval is so torturous and expensive that I expect it to be infeasible for anyone to bring this technology to market anytime soon for anything other than the most common "indications," i.e. the joints most commonly afflicted with osteoarthritis. Because the FDA classifies arthritis of each joint as a discrete "indication," a new therapy would have to get separate approval for use in each one. With an average time of 15 years to complete clinical trials for any new medical product, and ~170 joints in the body, it will take 2,550 years of clinical trials before it becomes legal to use this technology anywhere in the body it is needed under the current system.
  8. There were no damages and I don't intent to sue. A doctor serious misjudged a serious situation and provided some bizarrely erroneous medical information that even a lay person should know is wrong.
  9. If a doctor gives you grossly negligent medical advice, is there anything wrong with filing a complaint with the state agency that regulates physician licensure?
  10. When I started the thread, I was seriously considering doing what I said; I have since vetoed the idea.
  11. I'm not going to do anything more than leave him a damning review online. It makes me irate that I have no real recourse, which I why I fantasize about doing stuff like messing up his office.
  12. You're wrong. It's wrong to dismiss the role that the podiatrist's terrible judgment played in precipitating my injury. By first pathetically misdiagnosing my running injury, and then prescribing a course of treatment that was both worthless and harmful, he needlessly created an abnormal danger that I had no way to be aware of. He is culpable.
  13. The running injury (shin splints) for which I originally sought treatment, and the arthritis that resulted from that treatment, are two different issues. The podiatrist in question misdiagnosed the cause of my shin splints and prescribed a course of treatment that was preposterously inappropriate. Most doctors would not have done that. However, I would not reasonably expect most doctors to understand how that treatment would lead to the injuries I sustained.
  14. So that doctors and therapists will stop questioning my mental health when I complain of serious problems that haven't been diagnosed and that they can't see.
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