tag:blogger.com,1999:blog-126852961571725269.post2778948876266674819..comments2024-02-24T06:25:59.743-08:00Comments on The Spine Blogger: Medtronic's Endless HeadacheMusculoskeletal Manhttp://www.blogger.com/profile/14873819014357051373noreply@blogger.comBlogger98125tag:blogger.com,1999:blog-126852961571725269.post-48622589704985068222013-04-07T16:12:25.374-07:002013-04-07T16:12:25.374-07:00Dear Drs. Or Anonymous, I’m not going to go ape sh...Dear Drs. Or Anonymous, I’m not going to go ape shit like the individual above, I’m not a doctor but I received the BMP in a ALIF on L5-S1 in 2010, my surgeon, told me about the ER, which that didn’t happen, he told me about the possible of the material growing, he told me that I might have leg pain. Which I do (A LOT). That’s the thing I’m too far out on the statute of limitations to get a lawyer involved and I wouldn’t because I trust my surgeon. He is one of the best and also I know he wouldn’t knowingly hurt me. One thing after I heard about the infuse lawsuits and all and I was telling a friend about it and he said 5 little words. What if he didn’t know? So for me if there is ever a recall on this, I’m doubting it because I have never heard of a recall, I think the medical companies hold onto money like it’s their soul. I have no point in cursing you out. One thing I wish, surgeons would do, is see if people are allergic to BMP before putting it in their bodies, to save some time. Because since I have had the surgery, I now have Crohns and surgeries from a family that both sides never had it, I have had Pneumonia twice and bronchitis 4 times. All this stuff since that fusion and seeing BMP can cause infections and cancer, I’m not happy about it, but what can I do. I have asked my surgeon to do an exploratory surgery just to see about my leg. Nope, it’s fused good. We trust you surgeons to look out for us. We don’t know crap about what’s going on. We trust you into helping us. People can rag on Carragie and the whole 9 yards. But from all this has you all have broken our trust. Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-16860875948819883572013-03-04T12:49:00.538-08:002013-03-04T12:49:00.538-08:00Really? Someone please delete 2:56. Writer, Please...Really? Someone please delete 2:56. Writer, Please seek help.<br />Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-87866197522444310312012-03-19T02:56:52.881-07:002012-03-19T02:56:52.881-07:00Dr's are bums that couldn't make it in the...Dr's are bums that couldn't make it in the real world. Anyone can be a dr, all you have to do is have absolutely no heart and lie to people all day everyday. You spine surgeons are worthless humans that do more damage then good. Really a spine surgeon is the lowest scum of the earth. You have absolutely no idea what's causing the patients pain in 99% of the cases. However most of you will cut anyone open for them $$$'s when you know the person has about a 50/50 chance of getting worse.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-23257718565197893532012-03-19T02:51:01.712-07:002012-03-19T02:51:01.712-07:00Lawsuits, lots of them. Major class action lawsuit...Lawsuits, lots of them. Major class action lawsuit is next. MDT is no longer in the spine business and will be lucky to have share holders when this is all over. You Dr's are fucking scumbag pieces of shit. Any Dr that used this without telling the patient better just watch your back. Im serious about that one. You fucking losers went to school your whole life for what? Worthless pieces of shit is what I think about every dr in the world. Bunch of pansies that take advantage of innocent people and barely help anyone. Spinal fusion itself is a total joke let alone when the idiot dr uses some synthetic protein without the patients knowledge.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-10787219259271369802011-06-03T13:31:33.104-07:002011-06-03T13:31:33.104-07:001:01 - Agreed, and it merited due schrift in the w...1:01 - Agreed, and it merited due schrift in the writeup, and the supposed omission of which justifies inquiry into the authors' motivations.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-41331402333544619472011-06-03T13:01:06.874-07:002011-06-03T13:01:06.874-07:006:13, 9:20, 9:22, the B and Z defense forces are o...6:13, 9:20, 9:22, the B and Z defense forces are out in numbers! Thank you though for pointing out the adverse event table again. The incidence of retrograde ejaculation was 5.6 x higher (!!!!) for Infuse (7.9%) than for controls (1.4%). No other adverse events had a bigger than 1.7x difference in incidence. Such a huge difference should give pause, but they managed to massage it away by assigning it to a known possible cause, i.e. surgical technique, and not even entertaining the possibility of a biological effect. Just as cervical swelling, nerve root irritation, and other complications were ignored as long as possible. All for the sake of the mighty dollar, oops, well-being of the surgeon, oops, patient! I hope the NYT continues its excellent reporting of well researched articles and will even devote more resources to these subjects.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-32592989340590900992011-06-02T21:22:08.691-07:002011-06-02T21:22:08.691-07:00The real headline on this story should be: “Faili...The real headline on this story should be: “Failing newspaper resorts to tabloid sensationalism in effort to bolster failing readership.”<br /><br />These 1-sided, poorly-researched, NYT articles are getting tiresome. Burkus et al published the findings about RE and the BMP IDE study in JSD in 2002. There was no relationship to treatment group, however there was a strong statistical relationship when comparing retro and trans-peritoneal approaches.<br /><br />Do you really think that FDA, their statisticians, and the review panel just overlooked such an obvious issue? Take a look at the following, that has been posted since MDT got their approval…free for the looking to inform us, the public:<br /><br />http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdfAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-32561734179627543802011-06-02T21:20:32.271-07:002011-06-02T21:20:32.271-07:002:
Let’s ask a few questions about the Carragee ...2:<br /><br /><br />Let’s ask a few questions about the Carragee study:<br /><br />1. Why was not a single surgery performed on-label? Were the patients informed of this? Did they consent to being treated with his experimental procedure?<br />2. How was the starting time point selected? Was it perhaps immediately after some RE complications in ALIF without BMP? Keep in mind, one or two more complications in the non-BMP group would throw the statistics back out of significance.<br />3. At one point, he claims that no 2-level cases included L5/S1, then later in the article, he says all of them were included. Which is it?<br />4. Would he be willing to subject his data and methodology to the same level of scrutiny via outside audits and governmental oversight that the BMP IDE study was subjected to?<br />5. Why did he immediately rush to a newspaper to talk about the findings? He’s an educated person, who well understands the statistical limitations of retrospective case series. The study is at best class 3 evidence. What agenda is in play for him? <br /><br />…and why doesn’t the NYT feel the need to ask questions like these? That would probably feel too much like responsible, ethical journalism.<br /><br />I wouldn’t be so hasty to pass judgment on respected surgeons like Dr. Burkus and Dr. Zdeblick.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-82471650039119893832011-06-02T21:20:09.284-07:002011-06-02T21:20:09.284-07:001:
The real headline on this story should be: “F...1:<br /><br />The real headline on this story should be: “Failing newspaper resorts to tabloid sensationalism in effort to bolster failing readership.”<br /><br />These 1-sided, poorly-researched, NYT articles are getting tiresome. Burkus et al published the findings about RE and the BMP IDE study in JSD in 2002. There was no relationship to treatment group, however there was a strong statistical relationship when comparing retro and trans-peritoneal approaches.<br /><br />Do you really think that FDA, their statisticians, and the review panel just overlooked such an obvious issue? Take a look at the following, that has been posted since MDT got their approval…free for the looking to inform us, the public:<br /><br />http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf<br /><br />Take some time out to read what the surgeons wrote in their papers as well.<br /><br />Dr. Zdeblick’s published comment on the Carragee study was exactly right, which any clinical statistician will tell you: retrospective case series are notoriously misleading. At best, they point out potential questions that we should study in randomized, controlled trials. At worst, they continually re-discover and prove the math behind self-selection bias.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-3514460072501318942011-06-02T21:18:32.581-07:002011-06-02T21:18:32.581-07:00The real headline on this story should be: “Faili...The real headline on this story should be: “Failing newspaper resorts to tabloid sensationalism in effort to bolster failing readership.”<br /><br />These 1-sided, poorly-researched, NYT articles are getting tiresome. Burkus et al published the findings about RE and the BMP IDE study in JSD in 2002. There was no relationship to treatment group, however there was a strong statistical relationship when comparing retro and trans-peritoneal approaches.<br /><br />Do you really think that FDA, their statisticians, and the review panel just overlooked such an obvious issue? Take a look at the following, that has been posted since MDT got their approval…free for the looking to inform us, the public:<br /><br />http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf<br /><br />Take some time out to read what the surgeons wrote in their papers as well.<br /><br />Dr. Zdeblick’s published comment on the Carragee study was exactly right, which any clinical statistician will tell you: retrospective case series are notoriously misleading. At best, they point out potential questions that we should study in randomized, controlled trials. At worst, they continually re-discover and prove the math behind self-selection bias.<br /><br />Let’s ask a few questions about the Carragee study:<br /><br />1. Why was not a single surgery performed on-label? Were the patients informed of this? Did they consent to being treated with his experimental procedure?<br />2. How was the starting time point selected? Was it perhaps immediately after some RE complications in ALIF without BMP? Keep in mind, one or two more complications in the non-BMP group would throw the statistics back out of significance.<br />3. At one point, he claims that no 2-level cases included L5/S1, then later in the article, he says all of them were included. Which is it?<br />4. Would he be willing to subject his data and methodology to the same level of scrutiny via outside audits and governmental oversight that the BMP IDE study was subjected to?<br />5. Why did he immediately rush to a newspaper to talk about the findings? He’s an educated person, who well understands the statistical limitations of retrospective case series. The study is at best class 3 evidence. What agenda is in play for him? <br /><br />…and why doesn’t the NYT feel the need to ask questions like these? That would probably feel too much like responsible, ethical journalism.<br /><br />I wouldn’t be so hasty to pass judgment on respected surgeons like Dr. Burkus and Dr. Zdeblick. <br /><br />Take a close look at the accusers.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-15549667013098140872011-06-02T21:16:16.664-07:002011-06-02T21:16:16.664-07:00http://www.accessdata.fda.gov/cdrh_docs/pdf/P00005...http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf<br /><br />it's the table on page 8Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-9182296167087108782011-06-02T21:15:17.537-07:002011-06-02T21:15:17.537-07:00The real headline on this story should be: “Faili...The real headline on this story should be: “Failing newspaper resorts to tabloid sensationalism in effort to bolster failing readership.”<br /><br />These 1-sided, poorly-researched, NYT articles are getting tiresome. Burkus et al published the findings about RE and the BMP IDE study in JSD in 2002. There was no relationship to treatment group, however there was a strong statistical relationship when comparing retro and trans-peritoneal approaches.<br /><br />Do you really think that FDA, their statisticians, and the review panel just overlooked such an obvious issue? Take a look at the following, that has been posted since MDT got their approval…free for the looking to inform us, the public:<br /><br />http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf<br /><br />Take some time out to read what the surgeons wrote in their papers as well.<br /><br />Dr. Zdeblick’s published comment on the Carragee study was exactly right, which any clinical statistician will tell you: retrospective case series are notoriously misleading. At best, they point out potential questions that we should study in randomized, controlled trials. At worst, they continually re-discover and prove the math behind self-selection bias.<br /><br />Let’s ask a few questions about the Carragee study:<br /><br />1. Why was not a single surgery performed on-label? Were the patients informed of this? Did they consent to being treated with his experimental procedure?<br />2. How was the starting time point selected? Was it perhaps immediately after some RE complications in ALIF without BMP? Keep in mind, one or two more complications in the non-BMP group would throw the statistics back out of significance. What was the methodology whereby some patients received BMP but others did not? Did the investigator have a financial incentive in one group vs. the other?<br />3. At one point, he claims that no 2-level cases included L5/S1, then later in the article, he says all of them were included. Which is it?<br />4. Would he be willing to subject his data and methodology to the same level of scrutiny via outside audits and governmental oversight that the BMP IDE study was subjected to?<br />5. Why did he immediately rush to a newspaper to talk about the findings? He’s an educated person, who well understands the statistical limitations of retrospective case series. The study is at best class 3 evidence. What agenda is in play for him? <br /><br />…and why doesn’t the NYT feel the need to ask questions like these? That would probably feel too much like responsible, ethical journalism.<br /><br />I wouldn’t be so hasty to pass judgment on respected surgeons like Dr. Burkus and Dr. Zdeblick. <br /><br />Take a close look at the accusers.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-14780865502031308482011-06-02T19:50:22.285-07:002011-06-02T19:50:22.285-07:008:07,
So what? You are a rep that pretends to be...8:07,<br /><br />So what? You are a rep that pretends to be a surgeon on TSB. Pathetic. <br /><br />Your friend,<br /><br />11:56Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-14934261703577225802011-06-02T17:17:32.686-07:002011-06-02T17:17:32.686-07:006:13...agree. The study has inherent biases, the ...6:13...agree. The study has inherent biases, the largest being that it's a retrospective case series involving a self-selected timeframe. How do we know that there aren't 2 or 3 RE's in his non-BMP group just weeks prior to the selected "start" of the study? <br /><br />How did he confirm the diagnosis of RE? Was there a lab test comparing pre- and post- measurements? It's quite an oversight, considering that it is the main point of his paper.<br /><br />A retrospective case series is nothing more than a starting point from which we should be drawing ideas for future randomized, controlled studies.<br /><br />It's sad, though sadly expected of the lowered-journalistic-standards NYT, that they would trumpet the value of letters to the editor and a retrospective case series over a class 1 randomized, controlled trial regulated by FDA and reviewed by numerous outside experts prior to approval. They are quickly falling to the journalistic standards of the Enquirer. Gleefully shouting any Schadenfreude they can to bolster their dwindling readership and avoid bankruptcy. It's sad. There was a time when it was a respectable publication.<br /><br />If you read the 2002 JSD article, the RE cases were noted. They were divided between trans and retro peritoneal approaches, with quite a large difference between the groups. It would be interesting to see a 4-way analysis that includes the randomization group as well as the surgical approach. I suspect that FDA and MDT had to do that in the submission and found no link. That's not the sort of complication that FDA lets slide in the review process. btw - the numbers of RE in each group are clearly listed in the PMA. <br /><br />http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf<br /><br />See page 8...they are even broken out by time point for your reading pleasure.<br /><br />I wouldn't be so quick to pass judgement on Drs. Burkus and Zdeblick.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-42687528218193109142011-05-31T18:13:56.034-07:002011-05-31T18:13:56.034-07:00Carragee's study is worthless. Level 3 retrosp...Carragee's study is worthless. Level 3 retrospective noncontrolled single site- shouldn't even make it into print except he is editor. So he gets lots of press for crappy study. Let's get realAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-28386141431079182032011-05-31T18:00:37.422-07:002011-05-31T18:00:37.422-07:00Hey 11:56
Your narcism reeks. Since you are so sma...Hey 11:56<br />Your narcism reeks. Since you are so smart you won't have to look up the big words. Sincerely 8:07Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-63600900114028003482011-05-31T10:26:39.848-07:002011-05-31T10:26:39.848-07:00Okay 8:39, but the commentary was about contributi...Okay 8:39, but the commentary was about contribution, i.e. impact on the specialty. There are many brilliant, resourceful, patient centered, noble, ethical, creative, etc. docs who never actually make great contributions that advance the specialty. Foley has made them in spades. Heinig, while definitely a contributor, and a good doctor and person, I don't think was quite in the same league. I'm afraid nothing in your post suggests otherwise either. <br /><br />As to money, why do you bring it up? The amount paid has nothing to do with the contribution, which was exactly your original point. Foley has profited tremendously from his contributions, in contrast to others. But that doesn't take anything away from the contributions themselves. He who profited the most, Michelson, arguably actually contributed relatively little to advancing the field. I may be wrong, but it seems few of his "inventions" were actually true advancements, but rather just very commercially appealing innovations, alternatives or workarounds.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-77352015260274764372011-05-30T23:56:15.203-07:002011-05-30T23:56:15.203-07:00No way 8:07 is a surgeon! Stop pretending to be o...No way 8:07 is a surgeon! Stop pretending to be one, you wannabe. I can't believe that I compete against someone of your IQ. Total fugazi.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-12456348633199217802011-05-30T20:39:49.497-07:002011-05-30T20:39:49.497-07:0012:55, Ok, so Foley has made contributions to IGS....12:55, Ok, so Foley has made contributions to IGS. Are the totality of his contributions to the spine world worth 17,660,000 dollar a year (2010)?<br /><br />I already said that there are a few more than those names I listed. My bias is towards surgeons who tried to solve patient problems that nobody else dared to touch. Cloward was definitely one of those, as was Heinig. <br /><br />He started for a number of years as a country doctor doing literally everything, then focused on surgery. As a surgeon, he was continuously looking for better options, especially for spine. He translated his ideas in models which he created in his own workshop behind his house. At the same time he had the maturity to warn the younger generation that the solution to a problem is not necessarily found in more heroic procedures and more metal. He was a wonderful clinician worthy to be mentioned. Such clinicians still exits today, only in spine they seem to have become quite rare.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-53861464864996821422011-05-30T12:55:10.173-07:002011-05-30T12:55:10.173-07:002:22 can't fault most of your "contributo...2:22 can't fault most of your "contributors" but you're showing ignorance in not including Foley in the club. His contributions in image guided surgery (along with those of Iain Kalfas) and exposure (MED) merit inclusion. And I'm not sure if I'd have Jake Heinig quite so well honored. Showing a little AcroMed bias are we? But perhaps that's my ignorance. And leaving off Fritz Magerl is a crime. The C1-C2 transarticular screw was sheer genius, but only one of his many contributions.<br /><br />Hey TSB, might be fun to occasionally bat around which surgeons made the greatest contributions in a particular aspect of spine surgery. Be kind of like debating who the greatest base stealer, home run hitter, etc. was. Closer to home though. <br /><br />While some might say it's a waste of keystrokes, one of the really cool aspects of medicine is that the greats of the past are honored by those that follow. Given those that follow are our customers, it's very worthwhile for any rep to have that knowledge in their repertoire.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-88485211497933487972011-05-29T16:17:17.989-07:002011-05-29T16:17:17.989-07:00That's not Rudy White Shoes BertagnoliThat's not Rudy White Shoes BertagnoliAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-60548331971537870212011-05-29T16:11:46.165-07:002011-05-29T16:11:46.165-07:00All changes are small and incremental like the pol...All changes are small and incremental like the polyhedral shape og the LT compared to cylinders(BAK etc). BMP is the largest new biological in our generation. Yes Boden was instrumental in the basic science but Z andB were instumental in getting the clinical study finished and published. <br /><br />foley has a bucket of patents that have added incrementally to spine. The others I agree with you. <br /><br />There are few giants in each generation but many are doing what they can to improve patients lives. Let's give some reasonable credit.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-43358200053824596382011-05-29T14:22:14.581-07:002011-05-29T14:22:14.581-07:00The biggest beneficiary of Infuse has been silent ...The biggest beneficiary of Infuse has been silent and off the radar right from the moment more openness was forced upon the system. I'm talking of course of the illustrous Scott D. Boden. B and Z not getting royalties on Infuse is part of the genius of the Danek system; place a thousand mirrors, light up some cigars and nobody knows who gets paid how much for what. B and Z advanced the science of spine? Now you really make me laugh. At least Boden can lay some claim to that, B and Z certainly cannot. When Z introduced his (really?) LT cage, he publicly changed the fusion rates for the previous generation cages he worked with from in the 90's to the low 60. He's the only surgeon I know whose results with the same implant got worse over time, but it sure was convenient to promote the LT cage. FYI, some names that advanced the science in spine are Harrington, Cloward, Roy-Camille, Dubousset, Wiltse, White, Asher, Heinig, Shufflebarger, Harms, Steffee, and a few more. Not names like Foley, Mathews, Burkus, Zdeblick, Hochschuler, Anand, Lieberman, Puno, Kuklo, Heller, Bertagnoli and many many others.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-66764552721959558472011-05-29T08:07:30.682-07:002011-05-29T08:07:30.682-07:00Drs Z andB are both good guys and don't deserv...Drs Z andB are both good guys and don't deserve this ridicule. They analyzed data supplied by many other docs and put it in publishable format. They can't b accused of making up the data, each site was monitored and was under the eye of the FDA. They're royalties are based on real patents and work on implants that each added to the advancement of our surgeries. These guys actually gave you guys something to sell and other companies something to copy<br /><br />I've used BMP for years without RE. And yes I ask all my patients. I even put BMP out front of the cages. RE is all about moving tha parasympathetics out of the way properly. It has nothing to do with the BMP<br /><br />Carriage needs a new access surgeon. <br /><br />Let's not besmirch good surgeons just because they have help move our specialty foreword! Who else is going to do the studies and write them up? Not the reps! Writing these studies in the way that they can get published is not something that all surgeons can do and these two guys have the knowledge to do it. You may not like Mrdtronics put let's give good surgeons and investigative some credit. I don't think either f them have royalties on BMP!Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-126852961571725269.post-82664272754872238682011-05-28T18:13:20.561-07:002011-05-28T18:13:20.561-07:00......and Medtronic tacitly endorsed if not outrig.........and Medtronic tacitly endorsed if not outright promoted this improper off-label overuse. And they were aware of the potential issues years before they acknowledged (some of) them. Drs B and Z are completely embedded in Medtronic's, or, more specifically Danek's, ethically challenged system, as are many others who receive substantial amounts of money from them. How many people can hold a patent on a cervical plate? <br /><br />7.49, you're the one who is completely off-base.Anonymousnoreply@blogger.com