If you did not have an opportunity to watch The Sunday CBS Morning Show, an expose highlighted the ongoing work at the Texas Spine and Joint Hospital located in Tyler, Texas featuring Dr. Kevin Pauza. For those not familiar with Dr. Pauza, he is working with fibrin a combination of thrombin and fibrinogen found in our own body as an alternative modality of treatment for certain back ailments? What jumps out is the staggering differences in the number of surgical procedures that are performed in spine compared to coronary heart disease and hip replacements.
Regardless whether 90% of disc injuries heal themselves, the numbers speak volumes about the politics of spine surgery and healthcare in the United States. It was reported that 1.2 million spine procedures are performed annually, three times the number of coronary procedures and four times the number of hip replacements. A third of those spine procedures were fusions. In the opinion of Dr. Pauza fusion in many instances is the wrong answer. But the question must be asked, what if Dr. Pauza's work substantiates his hypothesis regarding a cocktail of thrombin and fibrinogen? What happens if one can regenerate the disc without surgical intervention? Surely, the usual suspects or skeptics will say other wise, especially, if they have done a tremendous job lining their coffers on the back of pedicle screws and inter-body devices.
What is encouraging is that Dr. Michael DePalma of Richmond, Virginia believes that the ongoing efforts of those surgeons working with stem cells or those that are involved with the fibrin study could alter the way patients with back pain are treated. What we did learn is that there are 20 facilities across the United States that are currently involved with the study with a success rate of 86%. Dr. DePalma's observations were that even if the fibrin works on 50% of the patient that this will be a major breakthrough. TSB is sure that the naysayers that are sitting around selling pedicle screws will attempt to throw some cold water on this post, or on the work that surgeons like Dr. Pauza are doing, but you know one way or another you can't make everyone happy.
So the question that TSB must ask our readers, are we looking into the crystal ball of spine? Who needs a vending machine or POD, all you have to do is identify a material that will regenerate the spine and all our troubles are over. Is the future now? TSB wants to know what our readers think, could this Delorean be taking us to the future?
Regardless whether 90% of disc injuries heal themselves, the numbers speak volumes about the politics of spine surgery and healthcare in the United States. It was reported that 1.2 million spine procedures are performed annually, three times the number of coronary procedures and four times the number of hip replacements. A third of those spine procedures were fusions. In the opinion of Dr. Pauza fusion in many instances is the wrong answer. But the question must be asked, what if Dr. Pauza's work substantiates his hypothesis regarding a cocktail of thrombin and fibrinogen? What happens if one can regenerate the disc without surgical intervention? Surely, the usual suspects or skeptics will say other wise, especially, if they have done a tremendous job lining their coffers on the back of pedicle screws and inter-body devices.
What is encouraging is that Dr. Michael DePalma of Richmond, Virginia believes that the ongoing efforts of those surgeons working with stem cells or those that are involved with the fibrin study could alter the way patients with back pain are treated. What we did learn is that there are 20 facilities across the United States that are currently involved with the study with a success rate of 86%. Dr. DePalma's observations were that even if the fibrin works on 50% of the patient that this will be a major breakthrough. TSB is sure that the naysayers that are sitting around selling pedicle screws will attempt to throw some cold water on this post, or on the work that surgeons like Dr. Pauza are doing, but you know one way or another you can't make everyone happy.
So the question that TSB must ask our readers, are we looking into the crystal ball of spine? Who needs a vending machine or POD, all you have to do is identify a material that will regenerate the spine and all our troubles are over. Is the future now? TSB wants to know what our readers think, could this Delorean be taking us to the future?
This is just another PRP venture, made popular by people like Tiger Woods, etc etc. There is no science nor data to support this, not in the elbow, knee, nor shoulder. It is a shame that the press is jumping on this and selling the snake oil for these hucksters. Keep in mind, the placebo effect can be strong and there are many NONspine reasons for axial pain. The placebo effect may be even stronger for nonoperative interventions for axial pain.
ReplyDeleteWho are you and what have you done with tsb
ReplyDeleteActually, it is an FDA, randomized, double blind, placebo controlled Phase three study. This is more than any spine survey can claim.
ReplyDeleteThe Kevin Pauza Spine Disc Biological Fibrin study is for real. Pauza has a method to reverse degenerative disc disease, according to the FDA results. I read the FDA Website. Pauza is doing spine research that deserves the Nobel Prize in Medicine. Shame on those naysayers who can't substantiate their facts, like Pauza has substantiated his finding.ga in the most scientific manner.
ReplyDeletePauza should teach the spine hardware companies how to do research. Pauza research has nothing to do with PRBC.
According to the FDA, Kevin Pauza has headed a multicenter, randomized, double blind, placebo controlled study. Pauza should replace Dr. Oz, then people will know the difference between good medicine and the converse.
PRBC and PRP are totally different, that you have correct. The XStop study was "for real" too. PRP/Fibrin injections are nothing new, this guy was first to get his name out there for spine. Do some reading on lateral epicondylitis etc etc and read what nonconflicted experts have to say about the stuff. This is good for Pauza et al though. You need to have a worthless, damaging discogram first (that they will get paid for) then get paid to squirt a clot in your disc.
ReplyDeleteEven if the treatment has a 40% success rate that will be better than a bunch of POD sponsored me to implants.
ReplyDeleteI wonder if there is a parallel method for arthritic knee joints
ReplyDeleteI also read that Dr Kevin Pauza has Patented a Similiarly method to regenerate knee and hip cartilage utilizing a Similiarly biological.
ReplyDeleteThe best inventions, like the light bulb, and like the Pauza Invention are simple. Kudos to Dr Pauza for stepping beyond surgery and the PRBC to something validated scientifically in a rigorous manner. Pauza also has no financial incentive for his work.
Pauza, IDET study! Enough said, hope it works.
ReplyDeleteKevin Pauza would win the Nobel prize in Medicine, but Pauza is not supported by the financial goons of wall street, so his work is best, but he will not get the recognition he deserves.
ReplyDeletePauza is an investor in the company that has "designed" the delivery device. He has everything to gain from this. I doubt this is disclosed anywhere in the media promotion. Wall Street will support anything that will give them a buck. Time will tell, but you guys need to do some more homework. And surgery is not the answer for "annular tears" either, so please don't think I am advocating that. If it works better than nonoperative care, I will be happy to add it to my aresenal. Until then, this is bunk just like PRP injections for any other joint or -itis.
ReplyDeleteTo the guy impressed with the "FDA, double blind" study - all randomized trials MUST be registered with the FDA to be published in any journal worth it's salt. In the methods, one must include the registration number. Without this registration, you have an unpublishable work. I would LOVE to hear how you'd propose a "double blind" study for surgery and get it past an IRB. "The surgeons will be blinded as to whether or not they are actually performing surgery."
ReplyDelete23 years of severn cronic back pain and not enough nerve to go under the knife one more time...I WANT TO KNOW...where do I sign up for this study?!?!!
ReplyDeleteSo is Yuan in Pioneer, MacClellan in Custom Spine, Asdourian in VTI. and the list goes on, so does that mean that Pauza shouldn't be able to invest in something that he is working on and believes in. Ar least he's not calling up investors begging for them to pump money into another me too company.
ReplyDeleteSorry, PRP is just another me too. He is free to invest in it, but it should be disclosed, so that people like 11:07 don't think that there is not considerable financial gain for promoting this. Look at the comments on the websites with this write up, people clamoring to get in to the trial now. McClellan's comments on why he supports that crazy articulated thing make no sense, from the OTW website. Larger footprint = POSSIBLY higher fusion rates - improved HRQOL scores? Not sure, maybe. Make no mistake, Yuan is one of the guys who will sign up for whatever crosses his desk.
ReplyDeleteTSBs commission from this article is going to make the rest of us look like amateurs.
ReplyDeleteThere, I said it!
When you work at Nuvasive..you become angry;
ReplyDeletewhen you become angry..you go to the gyn for some racketball;
when you play racketball..you get injured;
when you get injured..you get a patch on your eye;
when you get a patch on your eye..thugs think you're tough;
when thugs think you're tough..they want to find out how tough,
and you end up in a roadside ditch.
Don't end up in a roadside ditch..don't work at Nuvasive!
You couldn't get a job with NuVasive if your life depended on it. Alphatec on the other hand...
DeleteWhen you work at Nuvasive, you probably have a consultant surgeon using your product.
DeleteWhen consultant surgeon gets offered more by Lanx, you again end up in roadside Ditch...
And prey that you can go back to pharma!
Nuvasive is a house of cards..smoke and mirrors..you pick. The Nuvasive reps in my area can't find their a** with both hands. Never wanted to work at Nuvasive..wouldn't want the cut in pay..can't drink that koolaid.
DeleteWhen you work at Depuy you get your doc a nice deal
DeleteWhen your doc gets a nice deal you begin to make over 400K a year
when you make over 400K a year you get cocky and start buying expensive cars and fancy homes
when you buy fancy, expensive things you need more income
when you need more income you start pressing docs too hard
when you press docs too hard they get sick and tired of you
when docs get sick and tired of you they start avoiding you
don't have docs avoid you, don't be a consultant based rep
MSK Man - sometimes you sound insightful, while at other times, like in this posting, you come across as just plain silly. Is this intentional? If so, you missed April Fools Day by over a month.
ReplyDeleteLiterally 90% of people who experience severe acute back pain problems at any given time feel better (not necessarily pain free) in a few months. 86% "success rate" means squat. 50% "success rate" means that you're hurting people. Do you really think anyone, let along a self-serving evangelical disc poking "healer", can turn a ruptured disc into one that looks "as if it were new" and "restore full disc height" with a blood clot? If their studies are performed with anything akin to Carragee quality, (extremely unlikely), then the data won't support the claims. He's a huckster. FDA should (and hopefully will) slam him for making clearly unproven claims on national television.
couldnt agree with you more! TSB says that they stated there are 3x as many back surg than there are hips? My ass. There are over 1.25 million hips done each and every year. And lets not forget the #1 leading reason a person misses work? It sure in the hell is'nt from their hip hurting them. Lets not forget, there is but only one way (well 2 now) to put in a hip or knee, yet there are now over 10 ways to fuse the spine.
DeleteIt's from being hung over, your ass.
DeleteTrader, you are confused. Please Read the Pauza FDA Protocol. His study is excellent, because no one is allowed to enroll in the Pauza Disc biological study unless they have experienced severe, chronic low back pain lasting longer than one year, and have first tried, and failed other spine treatments. His petients have all suffered with pain for an average duration of 20 months.
DeletePauza is doing good spine science. That is why he also uncovered the facts regarding IDET outcomes, in his study which was the NASS Outstanding Study.And Pauza had zero financial involvement. Naysayers abound. You do what Pauza did.
Hey 7:41pm whats up with you lame comment?
DeleteOK, so Pauza and Co. are using a commercially available biologic--aka fibrin--that's been out there for years. So why hasn't that company--either JNJ or BAX--invested in this technology since they would have seen it in the first place? Presumably they evaluated this theory / approach when it first came across their desks...
ReplyDeleteThey did, but could not find a carrier that could 1, be inserted with out too much disruption and 2. Stay in the disc space for an extended period of time to work. The fibrin shot blindly into the disc would be gone in 24 hours. There needs to be a carrier. University of Michigan is also working on a "disc healer" and realize the need for a carrier. Promising stuff, but we have a ways to go.
DeleteSorry for any typos. IPhone typing
So again, same question: if Pauza and company are on to something that can actually "regenerate" the disc, why didn't either JNJ or BAX invest in this venture or acquire the sponsor company? With or without carrier, Fibrin alone probably doesn't "heal" the disc...
ReplyDeleteYou didn't have to repeat your dumb question twice. To think JNJ or BAX are able to have the ability or are all knowing to determine blockbuster products you are quite ignorant.
DeleteWe all know that whether a product is ablockbuster or not has littl to do with the science, much more to do with the how a company / reps presents and sells it. But I'd like to understand how the science is different for the various therapies (fibrin, stem cell, etc.)--not clear from the CBS piece...
DeleteActually it's just Tisseel or fibrin glue injected into the disc space. Surgeons already do this when we try to seal in BMP to prevent radiculitis. Fibrin glue placed on the dura for dural tears causes an awful scar that is hard to dissect through when you come back in. Basically it's just making scar form inside the disc. Nothing special. Pauza misrepresents his procedure in the CBS clip (seen on Youtube). He tells the patient that he is restoring the height back to normal. He also says his procedure causes the disc to heal. Problem is 1. what happens when you inject saline into a problem disc during a discogram? Patients scream with the worse pain ever. So now you've pressurized the diseased disc trying to restore height "back to when you were a teenager" and turn it into "young healthy normal disc." So can you inject it into vertebrate fractures to restore vertebrate height and heal fractures? Not!
ReplyDelete2. If it's injected into diseased discs with leakage of dye, won't the fibrin glue leak out through the cracks into the epidural space? Also Why does he not use radioopaque fibrin glue in his demonstration? because you'll see the stuff leak out everywhere just like in a discogram.
3. Fibrin glue is pretty fragile stuff, as you see when the reporter plays with it. In the OR, it's just alittle more firm than rubber cement. What happens when you stand up? the 100-200lbs of weight that then sits on the stuff will just squish it out if there are any weaknesses in the annulus.
He presents it as some new novel idea. It's just Fibrin glue with a longer applicator gun. Why charge 5% of $100,000 or $5,000 for this device. We get it in the OR for $50. Also why do you need a trial or FDA approval for a product that is already FDA approved and that he is using off label. Where is there any real novelty or IP in this idea?
I do have to say that in some patients with chemical radiculitis possibly with annular tears, if you can seal things up just a little to prevent leakage of disc fluid, it could help. But to present it on national TV as the next cure for 86% of all patients with disc disease is ridiculous. Just wait until lots of pain specialists start to inject fibrin glue into thousands of discs including patients with post discectomy syndrome with a large annular hole, and a large glob comes out causing cauda equina syndrome. Then it'll be the end of that idea.
Great Post. Good Stuff.
DeleteIt is my understanding that an FDA approval must occur in order for any procedure or medication to become insurable. I need something insurable. Maybe Dr. Pauza's study will enable millions of people worldwide, like myself, to have affordable access to f.s. for degenerated discs, or leaky discs. Does anyone know, am I correct in my understanding that according to W.H.O. ~23% of of back pain is chronic.
DeleteDoes anyone know what percentage of chronic low backpain is attributed to DDD?
In your Thursday 10 May post you ask the question whether Science is of importance in relation to Biologics and Bone formation. While good product development, quality marketing and a suitable reimbursement environment are important for commercial success, the fundamental basis of an excellent science is the only thing that will stand the test of time and make any product a classic. Needless to say rhBMP-2 made by Wyeth and marketed by Medtronics is the clear winner not by a head or a horse length but yards, and will stay so. This molecule remains the most potent bone maker of all bone makers and of all times.
ReplyDeleteSo which molecule will make disc or be responsible for disc regeneration. As BMP was bone dervived, this putative molecule has to be a Cartilage Derived Morphogeneic Protein or a CDMP. For poetic reasons let us call it rhCDMP-2. Logically, an absence of CDMP-2 should lead to an absent disc and if this happens via a mutation then a birth defect should be seen; Like Klippel-Feil Syndrome (where kids lack segmentation of cervical vertebra or have absent discs) [Wow in fact it does PMID: 18425797]. Further logic states that in an injured disc, injecting rhCDMP-2 intradiscally should lead to healthy or new disc formation [interestingly it does PMID: 20069037]
So, now what is required is a smart bunch of product development guys, backed by a visionary management(ie who will support a 5-6 year development plan), followed by a dynamic marketing team to bring this to market. Our politics and national debt burden (oh yes by the way, patients too) are demanding something like this. If we keep on biting at the edges in our efforts to develop biologic solution for disc degeneration, our generation will miss out on creating a classic. Someone needs to go big in this area.
By chance do any of you responders have degenerative disk disease. I do, my lady does as well as many of our friends. We all know we did not treat our bodies as we should have or had auto accidents, played sports giving us DDD in our middle years. Problem is we all learned way to late for our spine health. Fortunately not to late to guide our own children to a healthier life spine life.
ReplyDeleteWith that said those of you who may have DDD what do you think if this procedure was approved today. Would you opt for a chance to a better life? Would you do another procedure/treatment?
Those of you who do not have DDD what are our best options 1, 2, 3 for us to discuss with her surgeon next week?. The Surgeon is talking fusion as he does not believe injections are an option. However, I will mention this procedure for his opinion.
Until you suffer from DDD in your everyday life you will never know our urgency for a solution. So here we are waiting for FDA approval. Never thought I would say help but at a 40, 50, 86% possibility do you have a better idea and percentage of possible relief?
If this is in a phase 3 study how much longer could it possibly be? Plus the head of the American Spine Assoc or something like that said after the segment aired he thought Dr Pauza was on the right track and felt he is diffinately on to something big with the possibility of a breakthough.
This comment has been removed by the author.
ReplyDeleteGlad to come across this post. For more information and suggestions check back pain specialist in nj. Good post.
ReplyDeleteThat's the post i was looking for. This is a great explanation and a valuable information in such a perfect approach of writing?
ReplyDeleteThank you, 'anonymous' of May 9 (11:17PM), re: Pauza's sealant basically being Tisseel.
ReplyDeleteI was about to have Dr KP do the biostat on me, and I'd been paying out of pocket since the study is closed. But he literally REFUSED to tell me, on average, how long does his Biostat FS seem to work. I know he can't guarantee anything; I wasn't asking for that. I'm an M.D. too, and I understand trials, and what you can/can't say/promise, etc. But he seemed to cop an attitude simply because I asked 1) what complications have you noted so far? and, 2) How long does the Biostat seeme to last? Those are basic questions for which he should not have been put off.
Either it's not lasting very long at all, or he's got some God-complex and no on can ask him anything. Without that basic info, I refused to go to TX for Rx. I'll look elsewhere. May see if anyone is using the Tisseel for intradiscal Rx. If anyone knows someone doing Tisseel for intradisc repair (or attempt to ease pain), post info, please. Thank you. Happy new year.
Spine Surgery India offers info on Spine Surgery India,Spine Surgeon,Spinal Surgery India,Back Pain,Spine Implant,Cost Spine Surgery Hospital India.If you are thinking to go INDIA for surgery, then you must search for Spine surgery India, Laser spine surgery India, Best spine surgeon India, Spine surgery best hospital India & spine surgery cost india
ReplyDelete