5 ms·

To bring a new fight to the attention of more of the public: big pharma is attempting to have the FDA prevent people from using their own stem cells for healing

by loceng 7y ago

To bring a new fight to the attention of more of the public: big pharma is attempting to have the FDA prevent people from using their own stem cells for healing via regenerative medicine - either fat or bone marrow derived. They want to force centralization and also for consumers to buy the stem cell products they're developing. Their arguments are fear mongering and non-sense, however they've so far been doing a good job manipulating the FDA.

costcopizza 7y ago
Any links or ways to push back on this?
- loceng 7y ago
  The source is from doctors I've had stem cell treatments from. The state of California also has had a lot of difficulty - spending $4 billion on stem cell research, only to run into problems with FDA who greatly limit treatments that the science of regenerative medicine shows to be greatly effective. There aren't many regenerative medicine doctors at the moment and the public isn't educated enough to push back against the regulatory capture that's currently developing. The doctors themselves are adapting to provide certain treatments outside the jurisdiction of the US, otherwise they will continue to provide treatment - knowing that the centralization efforts of big pharma will increase costs to consumers by 2x; people who are in pain of course are arguably the most desperate and whether a treatment that works costs $5,000 or $10,000 - they will pay it. https://news.ycombinator.com/item?id=21694620 https://news.ycombinator.com/item?id=21694620
  - sfkdjf9j3j 7y ago
    I think people mean citations of the medical research behind these procedures, not that there exist doctors willing to perform them.
    - loceng 7y ago
      Fair enough. Here's research from one clinic: https://regenexx.com/results/research/ https://regenexx.com/results/research/
      - gamblor956 7y ago
        People mean citations to researchers that don't stand to directly profit from their spurious (i.e., fake) research, like the idiot/murderer that spawned the anti-vaxx movement. So far you've only cited doctors and clinics that directly benefit from promoting stem-cell research, and no unbiased (i.e., academic) studies showing any sort of statistical benefit.
        lightedman 7y ago
        https://www.sciencedirect.com/science/article/pii/S0735109706003500 https://www.sciencedirect.com/science/article/pii/S073510970... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2095130/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2095130/ https://www.researchgate.net/profile/Daisuke_Sakai/publication/272843641_Stem_cell_therapy_for_intervertebral_disc_regeneration_Obstacles_and_solutions/links/54fe328f0cf2eaf210b22ed2.pdf https://www.researchgate.net/profile/Daisuke_Sakai/publicati... https://www.liebertpub.com/doi/abs/10.1089/ten.tea.2010.0248 https://www.liebertpub.com/doi/abs/10.1089/ten.tea.2010.0248 https://www.sciencedirect.com/science/article/abs/pii/S0300908413001570 https://www.sciencedirect.com/science/article/abs/pii/S03009... https://link.springer.com/article/10.1007/s00395-005-0553-4 https://link.springer.com/article/10.1007/s00395-005-0553-4 https://onlinelibrary.wiley.com/doi/full/10.1111/j.1582-4934.2011.01265.x https://onlinelibrary.wiley.com/doi/full/10.1111/j.1582-4934... https://scholar.google.com/scholar?q=stem+cell+regenerative+therapy+study&hl=en&as_sdt=0&as_vis=1&oi=scholart https://scholar.google.com/scholar?q=stem+cell+regenerative+...
        gamblor956 7y ago
        I don't think you bothered to read the citations you provided. Half of them merely describe what stem cell therapy is, several of them describe what they hope stem cell research will accomplish, and only a handful of them actually consist of research on stem cell therapy itself, almost all of which involve animal trials or laboratory trials on human cells outside of the human body. One of these articles even noted that stem cell treatment appeared to be more dangerous than chemotherapy with respect to cancer treatment... So yes, thanks for the cites but you still haven't provided any cites that support the notion that stem cell treatment is either safe or effective in humans.
ceejayoz 7y ago
Without citations, this is pegging my woo-meter. A stem cell treatment provider recently lost a court case where they argued they're not subject to FDA approval, claiming it's not a medication, drug, or treatment. That seems like an untenable position to me.
- loceng 7y ago
  Citations would require the doctors that I have had multiple of both fat and bone marrow derived stem cell treatments from over the last 3 years including last month. The FDA has considered your own stem cells as a medication to bring it under their control - honestly that claim alone is pretty disingenuous, stem cells and properties of your blood are your body's natural healing mechanisms; with these treatments they're not changing or manipulating the stem cells, which you could more reasonably argue should be classified as a medication. Another claim big pharma is trying to use is that injecting bone marrow into joints shouldn't be allowed because it's non-homologous - meaning that bone marrow isn't naturally in the joints, so it shouldn't be allowed to be injected - the reason they want to prevent it is because injecting stem cells into joints will clear up the pain caused by osteoarthritis.
  - ceejayoz 7y ago
    So, no citations then? Just the say-so from the people selling you expensive treatments insurance won't cover? https://www.nytimes.com/2019/05/13/health/stem-cells-fda.html https://www.nytimes.com/2019/05/13/health/stem-cells-fda.htm... > There is almost no regulatory oversight of orthopedic procedures using bone-marrow extracts or platelets, which are regarded as low risk. While the Food and Drug Administration insists that it does have the authority to regulate stem cell treatments, it adopted an industry-friendly approach in 2017 by giving companies a three-year grace period in which to describe their products or treatments so the agency can determine whether they meet the criteria of drugs that would require agency approval. So far, few companies have submitted any information. > In the meantime, rogue clinics offering other kinds of procedures have flourished, accused of blinding people by injecting cells into their eyes, mixing stem cells with smallpox vaccine to treat cancer or causing severe infections by administering contaminated blood from umbilical cords into patients’ joints or spines. In some of the worst cases, patients had already been harmed before the agency took any action, and the patients took legal steps themselves, suing the clinics that injured them.
refurb 7y ago
No, what they want to do is stop stem cell centers from make unsupported claims.
SolaceQuantum 7y ago
Isn't there a podcast series by Wondery about this? I think it's called Bad Batch, regarding the non-scientifically backed woo that is stem cell treatments?

by loceng 7y ago

costcopizza 7y ago

Any links or ways to push back on this?

loceng 7y ago
The source is from doctors I've had stem cell treatments from. The state of California also has had a lot of difficulty - spending $4 billion on stem cell research, only to run into problems with FDA who greatly limit treatments that the science of regenerative medicine shows to be greatly effective. There aren't many regenerative medicine doctors at the moment and the public isn't educated enough to push back against the regulatory capture that's currently developing. The doctors themselves are adapting to provide certain treatments outside the jurisdiction of the US, otherwise they will continue to provide treatment - knowing that the centralization efforts of big pharma will increase costs to consumers by 2x; people who are in pain of course are arguably the most desperate and whether a treatment that works costs $5,000 or $10,000 - they will pay it. https://news.ycombinator.com/item?id=21694620 https://news.ycombinator.com/item?id=21694620
- sfkdjf9j3j 7y ago
  I think people mean citations of the medical research behind these procedures, not that there exist doctors willing to perform them.
  - loceng 7y ago
    Fair enough. Here's research from one clinic: https://regenexx.com/results/research/ https://regenexx.com/results/research/
    - gamblor956 7y ago
      People mean citations to researchers that don't stand to directly profit from their spurious (i.e., fake) research, like the idiot/murderer that spawned the anti-vaxx movement. So far you've only cited doctors and clinics that directly benefit from promoting stem-cell research, and no unbiased (i.e., academic) studies showing any sort of statistical benefit.
      - lightedman 7y ago
        https://www.sciencedirect.com/science/article/pii/S0735109706003500 https://www.sciencedirect.com/science/article/pii/S073510970... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2095130/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2095130/ https://www.researchgate.net/profile/Daisuke_Sakai/publication/272843641_Stem_cell_therapy_for_intervertebral_disc_regeneration_Obstacles_and_solutions/links/54fe328f0cf2eaf210b22ed2.pdf https://www.researchgate.net/profile/Daisuke_Sakai/publicati... https://www.liebertpub.com/doi/abs/10.1089/ten.tea.2010.0248 https://www.liebertpub.com/doi/abs/10.1089/ten.tea.2010.0248 https://www.sciencedirect.com/science/article/abs/pii/S0300908413001570 https://www.sciencedirect.com/science/article/abs/pii/S03009... https://link.springer.com/article/10.1007/s00395-005-0553-4 https://link.springer.com/article/10.1007/s00395-005-0553-4 https://onlinelibrary.wiley.com/doi/full/10.1111/j.1582-4934.2011.01265.x https://onlinelibrary.wiley.com/doi/full/10.1111/j.1582-4934... https://scholar.google.com/scholar?q=stem+cell+regenerative+therapy+study&hl=en&as_sdt=0&as_vis=1&oi=scholart https://scholar.google.com/scholar?q=stem+cell+regenerative+...
        gamblor956 7y ago
        I don't think you bothered to read the citations you provided. Half of them merely describe what stem cell therapy is, several of them describe what they hope stem cell research will accomplish, and only a handful of them actually consist of research on stem cell therapy itself, almost all of which involve animal trials or laboratory trials on human cells outside of the human body. One of these articles even noted that stem cell treatment appeared to be more dangerous than chemotherapy with respect to cancer treatment... So yes, thanks for the cites but you still haven't provided any cites that support the notion that stem cell treatment is either safe or effective in humans.

ceejayoz 7y ago

Without citations, this is pegging my woo-meter. A stem cell treatment provider recently lost a court case where they argued they're not subject to FDA approval, claiming it's not a medication, drug, or treatment. That seems like an untenable position to me.

loceng 7y ago
Citations would require the doctors that I have had multiple of both fat and bone marrow derived stem cell treatments from over the last 3 years including last month. The FDA has considered your own stem cells as a medication to bring it under their control - honestly that claim alone is pretty disingenuous, stem cells and properties of your blood are your body's natural healing mechanisms; with these treatments they're not changing or manipulating the stem cells, which you could more reasonably argue should be classified as a medication. Another claim big pharma is trying to use is that injecting bone marrow into joints shouldn't be allowed because it's non-homologous - meaning that bone marrow isn't naturally in the joints, so it shouldn't be allowed to be injected - the reason they want to prevent it is because injecting stem cells into joints will clear up the pain caused by osteoarthritis.
- ceejayoz 7y ago
  So, no citations then? Just the say-so from the people selling you expensive treatments insurance won't cover? https://www.nytimes.com/2019/05/13/health/stem-cells-fda.html https://www.nytimes.com/2019/05/13/health/stem-cells-fda.htm... > There is almost no regulatory oversight of orthopedic procedures using bone-marrow extracts or platelets, which are regarded as low risk. While the Food and Drug Administration insists that it does have the authority to regulate stem cell treatments, it adopted an industry-friendly approach in 2017 by giving companies a three-year grace period in which to describe their products or treatments so the agency can determine whether they meet the criteria of drugs that would require agency approval. So far, few companies have submitted any information. > In the meantime, rogue clinics offering other kinds of procedures have flourished, accused of blinding people by injecting cells into their eyes, mixing stem cells with smallpox vaccine to treat cancer or causing severe infections by administering contaminated blood from umbilical cords into patients’ joints or spines. In some of the worst cases, patients had already been harmed before the agency took any action, and the patients took legal steps themselves, suing the clinics that injured them.

refurb 7y ago

No, what they want to do is stop stem cell centers from make unsupported claims.

SolaceQuantum 7y ago

Isn't there a podcast series by Wondery about this? I think it's called Bad Batch, regarding the non-scientifically backed woo that is stem cell treatments?