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Thread: Jeff Hayes and “The Healing Miracle: The Truth About Stem Cells”

  1. #1
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    Default Jeff Hayes and “The Healing Miracle: The Truth About Stem Cells”

    Regenexx Blog
    Dr. Chris Centeno
    1-7-18

    Click on the link for embedded links and videos:

    https://www.regenexx.com/jeff-hayes-...th-stem-cells/

    Also, please read the reply below this post written by one of the patient adovates in the video.

    You might have wondered why in yesterday’s blog (https://www.regenexx.com/serious-pub...-switch-fraud/) I would be so concerned about chiropractors, naturopaths, and acupuncturists entering into the field of stem cell therapy. After all, if you read this blog, you know that I’m a huge fan of chiropractors, naturopaths, acupuncturists, and other alternative-health practitioners. I’ve even called out my own profession as ignorant because of new research showing that certain alternative therapies have a real basis for working and new research showing efficacy. So what evidence do I have that alternative-health practitioners in orthopedic stem cell therapy will damage the field? Look no further than the ad for an upcoming documentary by Jeff Hayes entitled, “The Healing Miracle: The Truth About Stem Cells.” Let me explain.

    I Love Alternative-Health Practitioners
    There are days when I see how my own medical profession can be the worst type of proverbial bull in the china shop of the body. It’s on these days that I can’t stand my colleagues. When I see how a long spinal fusion has permanently ruined a life. When I observe botched joint replacements or patients on their 10th knee surgery, I’m incensed. On the other hand, living in Boulder, Colorado, the alternative-health capital of the earth, I get to see some crazy stuff, but I also see patients who aren’t maimed and who are generally happy with their results.

    Having said that, I also realize that some alternative practitioners live in an alternate universe of hyperbole. As an example, I will never forget spending time with a chiropractor in a mini-externship when I was a resident physician. This was an unusual request that freaked out Baylor College of Medicine, so I did it over a couple vacation days. While I learned much about chiropractic, one thing disturbed me. While we had been taught to never bias a patient result by suggesting anything about whether our therapy was effective, the chiropractor said to every single patient as they got off the adjusting table, “Now tell me how good you feel.” That was when I learned that some alternative-health practitioners viewed patient outcome in a more hyperbolic and subjective fashion. I’ve also since come to understand that this is much less common among younger chiros and more common with older chiros. In fact, chiro colleges have been trying to adopt more and more medical approaches for the last one to two decades.

    The Jeff Hayes Film “The Healing Miracle: The Truth About Stem Cells”
    So why is it that I’m so concerned about alternative-health practitioners entering into orthopedic stem cell therapy? One only need look as far as the new ad for the film “The Healing Miracle: The Truth About Stem Cells.” We’ve known about this Stem Cell Institute of America (SCIA) sponsored film series since earlier this year when the company took out full-page ads in chiropractic magazines to announce that the film would be “distributed to millions of consumers.” They also claimed that chiropractors needed to join the SCIA network now because the films would generate massive patient interest in SCIA stem cell treatments. To see the ad I’m talking about, see about 1:28 in the video below (this is the investigative video I posted yesterday and not the Jeff Hayes film):

    Is this Stem Cell Fraud?
    At that time, the Jeff Hayes film looks like it had a different title (“Stem Cells Revealed”) and it was to be released in October of 2017, which came and went.

    The Ad for the New Film Is a Prime Example of Why I’m VERY Concerned
    As I said yesterday, the single thing keeping stem cells out of everyday clinical use is credibility. That extends from the idea of “street cred” to the more stringent “academic cred.” That credibility increases when physicians publish more data, find out who is and isn’t a candidate for this therapy, and underpromise and overdeliver. In fact, it’s this last part that the ad and film really violates.

    One need go no further than the name of the film. The word “miracle,” while likely fine in how patients describe some therapies, is a huge problem in medicine. All therapies have a success and failure rate, and stem cells are no different. Referring to stem cell treatment as a miracle is irresponsible. Why? Because it’s not a miracle for those patients that don’t respond or who partially respond. It’s also not a miracle for those who have complications. More importantly, suggesting that stem cells are a miracle cure reduces the credibility of the field.

    Next up we have this ridiculous image:

    the healing miracle review

    On the left, we see a patient with moderate to several lateral compartment arthritis with severe valgus deformity. The X-ray film on the right purports to show that cartilage has been restored. Even the deformity (the angle of the knees) has resolved. What’s interesting here is that I have asked every orthopedic stem cell expert I know whether they have ever seen a patient with moderate to severe knee arthritis get complete cartilage restoration or any significant restoration for that matter. Despite my expert panel (which includes myself) never having seen this happen using any number of different technologies (including those used by SCIA), we have the hyperbole above.

    So how did this happen in the images above? First, what’s not shown is interesting. We don’t ever see an MRI image, despite there being about 12,000 MRI scanners in the U.S. Why? Second, the image seems to show an increase in joint-space width, but anyone can create or delete joint space width simply by changing the angle of the X-ray beam relative to the joint. Finally, the dead-giveaway clue about what happened with these knees is found in the dramatic change in angle of joint. If the knee has loose ligaments, the patient could literally create both images without any change in cartilage simply by standing a different way. Finally, despite the fact that you can’t see cartilage on an X-ray and no MRI is shown (that can see cartilage), the caption of the image states that the cartilage has been restored.

    More Irresponsible Statements
    How about these humdingers?

    “…the cure for what will someday surely kill you is already available, already in…you.

    …the “fountain of youth” was REAL? (ok, not the fountain of youth, but at least a few drops from it….)”

    We have no evidence that using your body’s own stem cells or dead amniotic tissue will cure fatal diseases and allow you to live a longer life. This statement is so badly worded that it includes all diseases that could kill us, which is quite a wide list. I’m not even going to comment on the fountain of youth gaffe.

    Getting into the Trailer
    The lalapalooza of crazy statements not supported by any clinical research or even responsible observation continues. I know a few people in the film and was very concerned to see Neil Riordon say that in tens of thousands of stem cell procedures, there have been no serious adverse events (SAE). While Neil is one of the only “experts” featured in this trailer who has any clinical publications, I can find no safety paper published by Neil that supports that statement. Neil may not understand that the NIH/HHS definition of SAE is any complication that requires significant medical care to remediate it. We’ve actually published the world’s largest safety paper in stem cell therapy with 2,372 patients, and while there were no serious complications related to the therapies we use, there were SAEs.

    Regrettably, the vast majority of those quoted in the trailer and claimed to be experts, aren’t experts. Most are chiropractors who have no publications in this area. Given that the definition of “expert” in medicine is someone who has published in the peer-reviewed medical literature or who would be invited to speak on the podium of a medical conference because of his or her experience and expertise, these are what I call “faux insta-experts.” For example, due to lack of actual expertise, none of these “experts” would be invited to speak at an academic orthopedic stem cell conference.

    In this “stem cell” documentary, we also continue to see amniotic-tissue patients, which you’ve now learned doesn’t have any live and viable stem cells (see the video above). So the bait and switch exposed in the investigative film above continues to happen in the film.

    We also see a blind injection without guidance, a “no-no” if you read this blog (at 1:08), using improper sterile technique (no drapes). In addition, that blind injection is medial patellofemoral, which has a much higher blind miss rate for being in the joint (due to the large medial PF fat pad). Meaning there was a significant chance that this knee injection never made it into the joint. It’s 2017 folks—there is no rationale for not using ultrasound or fluoroscopic guidance in a knee injection.

    We also see Kristin Comella, who is with US Stem Cell, where three patients were blinded by stem cell injections into their eyes. She and the company also just received a warning letter from the FDA and were called out by the new FDA commissioner, Scott Gottlieb, as “bad actors” (not in the film sense). Mark Berman is also there, also called out by Gottlieb as a bad actor after his Rancho Mirage office was raided by the FBI for the possession of a smallpox vaccine being used to transfect stem cells used to treat cancer. He also recently received a 483 inspection report from FDA stating that his office was producing a cell drug without FDA approval. Both US Stem Cell and Berman were called out for not meeting drug manufacturing standards.

    I also know others in the documentary who are well-meaning patient activists, and my guess is that they had no idea that they were being asked to participate in a sales piece for SCIA. How do I know this is an SCIA-sponsored piece? One bit of evidence is that that’s what it says in the SCIA advertisement. The second is found in an e-mail sent by a colleague who turned down being involved in this film.

    The E-mail That Shows This Is an SCIA Ad
    A while back I was told by a colleague who is a stem cell expert that he was asked to participate in this film. He turned them down as he had concerns about the e-mail and the film itself. Who sent the e-mail? No other than the president of Stem Cell Institute of America, Brent Detelich (a convicted felon—see video above). Brent was recruiting for people to be in the documentary. Note that while the e-mail was cc’d to Jeff Hayes and a production assistant, it was from Detelich.

    The upshot? Now you see why I’m concerned about chiropractors entering this space. Orthopedic stem cell therapy has serious work to do to hit the mainstream, and documentaries like this and advertising like that used by this film and SCIA move that credibility matrix backward and not forward. In addition, this film looks to me to squarely fit into the category of “bad actors” described by the new FDA commissioner. Hence, my concern is that rather than the FDA allowing orthopedic stem cell therapy to find its own way and gain needed street cred with the medical community at large, my opinion is that this film will force the FDA’s hand to get rid of all physician-centered therapies in orthopedics. Basically, the approach will change from allowing orthopedic therapies to continue while targeting the out-of-control miracle-cure clinics offering therapy for every known incurable disease to “throw the baby out with the bathwater.”
    First treatment in 2007. Pioneering ever since.

    Barbara

  2. #2
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    Default Reply from a patient advocate

    One of the patient advocates who participated in Jeff Hayes' docu series project sent me an e-mail. I think it's important to hear from all sides and I think that it is entirely possible that SCIA has taken advantage of the project to tag onto it using it for their own advertising gain. I may or may not be right about that, but again, it is entirely possible and it would not be the first time a company did something like that. I hope that Dr. Centeno will delve into the matter deeper and not hold patients responsible for participating in a project that they felt was worthy of their time, but may have been hijacked by SCIA to appear to be its project instead of an independent piece about the miracle of stem cell therapy. Just my two cents......

    First let me begin by saying if any of you are not familiar with Jeff Hayes please look him up. He is a long time advocate for empowering people with facts to make informed choices regarding their health, food and medicine. He is best known as Michael Moore's nemisis. He is a major producer who does not rely on so called "sponsors" for his movies. He does not believe in government overreach. The film was originally due to be released in October. However, we were contacted when they heard about what happened in Texas. They delayed production intentionally to add our Texas victory to the film. We were aware of all participants and felt we needed to provide a credible voice. We agree and knew that some of the participants had recently had negative events aka Kristen Comella. That did not distract us from taking advantage of a visible platform provided for us to tell our story. Sadly, it appears that a misinformation campaign has already been launched.
    It is disheartening that we were not directly contacted to give our side of the story prior to a blog post rather it was assumed we were just ignorant and in some way have caused damage to our plight. It would have been so much better to be directly contacted and help direct the intentions behind the film. Instead we find ourselves victims of a misinformation campaign. It has always been our mission to provide hope and provide a voice. This aligned with the vision of the producer and what he stands for. The link in which the series will be released does not belong to a SCIA nor do they sponsor this. Any claims stating so are false. It is a compilation of over 40 participants and does not endorse any specific clinic. Here is a link to the website for your review www.thehealingmiracle.com. The film will be released in its entirety on Jan 16th. This is an online only production. We all need to remember each persons personal agenda here. We ARE patients. We ARE not paid. We have no monetary incentive. It took everything in our body to show up that day. One patient drove a considerable distance. I think it's easily forgotten what a patient goes through and the physical challenges posed. We press on and continue despite the accusations and attacks. At the end of the day this is about spreading hope and we will never allow anyone to stop us or dampen our spirit. Thank you to each and every one of you for your support. Unless you walk in our shoes I think it's so easy to disregard and pass judgement.
    First treatment in 2007. Pioneering ever since.

    Barbara

  3. #3
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    Default Patients for Stem Cells Responds

    A Message of Hope
    Happy New Year! Our first post of 2018. Patients for Stem Cells was asked to participate in a docu series on adult stem cells. Follow the link below to view the series. The series was due to release in October. When the producer found out about the passage of the historical medical liberty legislation “Charlie’s Law” in Texas we were contacted and asked to participate. They were gracious enough to delay the release date so we could tell the story of our Texas victory. It was a great honor and we are very grateful to have been given an opportunity to share our personal stories and how Texas led the nation in passing legislation allowing chronic patients to receive adult stem cell therapy in Texas.

    There is already a misinformation campaign underway to discredit the series. We stand by the fact that the overall message is a message of HOPE. Countless patients with an array of afflictions have reaped the benefits of adult stem cell therapy. There will always be debate over running it through clinical trials even though we have numerous patients who have received elevation in quality of health. There never seems to be a place at the table for those patients. We at PFSC do not believe our cells are a drug. Therefore, the ongoing debate over running it through clinical trials are irrelevant. We believe this is a decision that should be made between a doctor and a patient and falls solely under the practice of medicine.

    It can be exhausting to just make it through the day when you battle a chronic disease. Add to that the need to constantly defend your choice as a patient to seek a non FDA approved effective safe treatment and it can be completely overwhelming. We see this happening within our own families. Some well intended family members express grave concerns because they hear all the rhetoric about adult stem cell therapy and how it is not a proven therapy. We are here to dispel that. The voices of the countless patients who have been successfully treated are strong! We may not be scientists, but we are experts in our health and managing life with a chronic disease. It’s fair to say we all have our PHD’s in what’s good for our own chronic condition! So what is PFSC’s job? It’s simple, we are a safe zone. The voice of reason. We understand without judgment. We are here in the trenches living this chronic life with you. We are proud of the project and hope it touches the lives of those who are struggling or simply lost hope. Patients For Stem Cells is a patient based group and we stand united with a clear message of HOPE and HEALING.

    Here is a 3 min clip of the upcoming docu series on adult stem cell therapy. The series can be viewed at thehealingmiracle.com. The full release will be January 16th. Please forward and share. It’s important that we get the word out.


    https://www.thehealingmiracle.com/
    First treatment in 2007. Pioneering ever since.

    Barbara

  4. #4

    Default

    I checked out Jeff Hayes, and he isn’t doing patients any favors by representing our cause. Him just being against government overreach doesn't make him an ally. The guy has every appearance of being the kind of charlatan whose activities fuel negative press and calls for more regulation. I realize some member of this community agree with him on issues like GMOs, vaccines, and alternative medicine, and I truly don’t mean any disrespect to anyone by saying this, but publicly packaging adult stem cell therapy with these notions only makes it easier for the other side to characterize us patient advocates as easily misled. I share Dr. Centeno's objection to hyping stem cell therapy by calling it a “miracle” for the same reason. I had the best stem cell procedure in the world at the Regenexx Cayman facility, and while I got undeniable positive results, they were far from miraculous. We don't need hope, we need good science and the freedom to act on the best information available. With all due respect to PFSC, to whom I am grateful for what they accomplished in Texas, I wish they would be more discerning about whom they associate with. We need to be careful to present ourselves as realists who can distinguish fact from fiction.
    Last edited by gh253; 02-06-2018 at 04:57 PM.

  5. #5
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    Default

    If you listened to the full 10 sessions, it didn't come across as any type of sales gimmick in my opinion. The 2 PFCS members who participated did an excellent job. It was an opportunity for them to talk about the Texas legislation and their own personal stories. Several legislators also participated. I don't think there were any ulterior motives for any of them to do the interviews. I don't know Jeff Hayes personally, but no one who participated in the interviews was paid is what I was told. It was strictly on a volunteer basis.

    I understand Dr. Centeno's concerns as well. He has worked very hard and doesn't want anything to interfere with the progress he has brought to the field, however, I don't think those like Paul Knoepfler or Leigh Turner care how much is published, how few adverse effects are reported or how many patients testify to an improved quality of life. They are DEAD set against anyone interfering in their sphere of endless research and the grant guzzling that goes with it as well as the power they are enjoying being the darlings of a complicit media. They have NO alternatives for suffering patients and that is the sad part. Their goal is to shut down every clinic, including Dr. Centeno's in my opinion. Many share that same opinion, so I'm not just standing in the forest alone.

    The use of the word miracle may be a bit overboard, although for some, their treatments may be their own personal miracles. I do have to tell you that I am one that believes in complementary treatments that enhance stem cell therapies. Whether it is supplements (even Dr. Centeno sells supplements), PEMF, inhalation therapy for home use, rehab, etc., I think they have a place in medicine even if some consider them to be alternative type treatments. The FDA is not concerned, to my knowledge, with doctors who offer these in addition to stem cell treatments.

    I do appreciate you taking the time to voice your opinion. Perhaps others who watched the docuseries would like to comment as well.
    First treatment in 2007. Pioneering ever since.

    Barbara

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