Wednesday, May 25, 2011

Medtronic's Endless Headache

As Medtronic prepares to head into a new fiscal calendar, the potential for additional challenges lie ahead for the once known jewel of the industry. Essentially, growth for the Goliath of the spine industry has been flat across the board.  Wild Bill reported that Medtronic had seen steady growth across most of their businesses and geographies, which was offset by challenging dynamics in the U.S. ICD and spinal markets.  As Wild Bill prepares to hand off the reign of the Evil Empire to Omar Ishrak, oh Omar if only you knew what you were really getting into, the NYT's reported this morning that a new study links spine product, INFUSE, to risk of sterility in men.

The study in question was released Wednesday suggesting that INFUSE poses a risk of male sterility.  This finding is in stark contrast to earlier research by doctors paid by Medtronic who found no connection between the product and a condition that causes sterility.  Now before everyone starts jumping down each others throats, let's get all the facts before the name calling starts.  INFUSE has been widely used and advocated by the surgeon community in spinal surgery since around 2002.  The labeling on this product does note that sterility related complications may be a side effect, but the controversy lies in that Medtronic sponsored researchers published reports attributing the complication to surgical technique and not the product itself.

A study posted Wednesday, on the web site of The Spine Journal by Dr. Eugene J. Carragee urges doctors to counsel men about INFUSE'S risks. Dr. Carragee based his study on 240 patients that he treated with INFUSE several years ago.  The spinal fusion in question is the ALIF.  The sterility complications at issue in Carragee's study affects only men and not women.

The two surgeons who were involved in the original INFUSE trial defended their findings to statements saying that not enough of men had experienced sterility-related complications in their study to statistically link the problem to INFUSE.  The two surgeons that spearheaded this study were Dr. Thomas A. Zdeblick and Dr. J. Kenneth Burkus.  In his web article, Dr. Caragee questioned why Zdeblick and Burkus had not broken out the patients in their study between those who had received INFUSE and those who had not, a method htat he said was a standard way to present a clinical trial result.

In response to Carragee, Zdeblick said the Caragee study was of limited value because it reflected the results of a retrospective look at patients rather than a clinical trial.  Such reports "are notorious for being misleading."  This new study will only add more fire as the intensity and debate surrounding INFUSE continues over having industry financed researchers present study findings in ways that favor the interests of corporate sponsors.  But the question must be asked, IS THERE A BETTER WAY?  How does one subsidize a study, if not by the company that is looking to validate its product's efficacy in the surgical arena?  Whom else does one use, if not those individuals that have the most experience with the product?  If there were "total transparency," would we look at these outcomes with a different lens?  

TSB is not going to pass judgement on Zdeblic and Burkus' findings, but one must wonder, does human nature play a role in enhancing ones outcomes?   Other surgeons have come out with opinions regarding the clinical utilization and efficacy of INFUSE, so is there a rational explanation for these differences?  So in closing fellow bloggers the INFUSE saga continues do we believe the Zdeblicks and Burkus' of the world, or, do we believe the Carragee's, somewhere in between these three parties lies the truth.  Omar welcome to the spine industry, where the show never ends.

98 comments:

  1. Burkus has been a MDT and InFuse pimp for years. I wonder if has to check-in with VendorMate before he makes his way to the Surgery department.

    Even worse is his partner Dorchak who openly brags about all the goodies Globus buys him (truck tires ... trees to surround his enormous pool). Dorchak is exhibit A as to why Globus will never go public.

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  2. Funny how now when broken out 10+ years later 5/6 of the retrograde ejaculation pts in the Berkus (FDA) trial were InFuse patients.

    Certainly they never thought to do that comparison back then, of course they just combined all patients in reviewing complications!?! Why would anyone suspect them of trying to hide something...

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  3. What's the opposite of 'Schwing'?
    I always supected Medtronic reps' verility.
    Looks like more flacid sales ahead!
    etc, etc
    Finally The Empire is falling. This took way too long.

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  4. MDT Spine just can't get their revenues up.

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  5. I guess being 1st to market by ten years was their only true advantage. Monkeys throwing darts and poker-playing dogs could have done what they did with ZERO competitors. How's that 6% working out for you guys?
    Sincerely,
    One of the Plundering Barbarians at Medtronic's Gates

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  6. Need advice, 1099 $175k vs W2 $175k w benefits per year?

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  7. 6:44 come on," the empire is falling" not even close we still carry the big stick, and will continue to dominate this new and evolving market. 7:11 How do you like the fact that your product bag is probably half of the medtronic rep's? As hospitals continue to look to consolidate vendors Medtronic company wide product offerings will cut you out. The only thing you might be doing at the Medtronic's gates is mowing the lawn around them.

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  8. Happen to know both Zdeblic and Burkus (professionally, through CRO relationship, but not with any affiliation to MDT) . Are they in the pockets of MDT? You bet. Question is, would either sacrafic themselves, partners and affiliations with purposeful, junk reporting. Wouldn't make a lot of sense to do so, and while both pretty high on the payroll, I don't remember a time they would sacrafic results for money in the 15 or so years I have known them.

    It's important to note, yes surgeons do the studies for commercial entities, but it's not the surgeons who set the criteria or report the information to the FDA. The FDA is very involved in what and how information is reported. So, it anything, the FDA is as responsible for the results in some regards as the company. We don't hear anyone saying, "FDA, why didn't you think of that?"

    I can think we can say the same for most surgeons involved in studies related to IDE projects. Though there are known cases, it's just not the norm. And, who else is going to fund this kind of research? Don't know of any University with the power, money or ability to do the kind of FDA trial required these days. When it costs at minimum $15M to do a minimal IDE trial, and a team of specialists to manage and monitor a study, no non-commercial entity can handle the weight.

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  9. "If your erection lasts for more than six hours, please consult your physician. You may need a dose of Infuse." Can it be taken orally?

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  10. They can fix this easily....go across the street, purchase Wright Medical, do a name swap and use InBone as the new trade name for Infuse and vice versa....

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  11. Not a big Carragee fan, and Zdeblick and Burkus may be right that this is technique related not graft related, but c'mon, 6:27 is absolutely right. You can't leave out the fact that 5/6 patients were in the Infuse group in the writeup. And especially if their belief was genuine and not influenced by the finances, they would have had no trouble including that info in the data, explaining it, and letting the reader draw their own conclusion. The fact that it wasn't included sure does seem to support the contention that consciously or sub-consciously their paper was biased. Doesn't change the fact that the complications may be entirely attributable to technique, but it sure deflates their perspective in the argument.

    Now let the sophomoric jesting (of course, not actually jousting) continue...

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  12. 8:09

    Piece of advice, I wouldn't be so quick to think you're gonna benefit when Medtronic goes all Walmart up inside an account. Price concession = margin erosion. Unless they ship MFG oversees, payroll and commission plans will be given the old 'hairy eyeball'.

    I mean, really, how valuable are you when the company locks up the business on purchasing power? But good luck with that.

    Back to the news at hand, here's a question, what's the likelihood we'll see another transformative technology in bone grafting in the next 10 years?

    An no, minimally manipulated tissue that's been maximally marketed (i.e. Osteocell / Trinity) don't count. Recent panel reviews on OP-1, InFuse and Augment paint a grim picture for the new level of proof and capital one's gonna need.

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  13. Doesn't anybody appreciate the fact that Carragee's article is a single-site experience and reflects the randomization effect of a single site / single surgeon experience?

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  14. 10:42

    In a word, No.

    The continual, negative PR is destroying the brand. InFuse is quickly becoming a ruptured nuclear reactor in the MDT Spine Bag.

    Google search InFuse in a couple of days as you might a potential patient after a consult. I'd be guessing between the solicitation for class action lawsuits, cervical deaths, and shot you'll lose virility you might end up doing what most drug companies recommend, 'seek advice from your physician if you are at risk for any of these complications.'

    Yes, this is what happens when you sell a drug like a bone graft.

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  15. 8:09,
    At 35-50% I have lots of time to MOW LAWNS (hee hee) than the 6% Medtronic Schmuck who is a dead man walking when the accountants see him as redundant. Keep on fire-hosing the Kool Aid!

    My advice to you: Start drinking heavily.

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  16. 8:08
    1099 is the way to go if you want to truly be a consultant to your docs. W2 is 'safer' if you want bennies, but you will always be limited in your bag and beholden to The Man. Are you a company man or an entrepeneur is what it comes down to, and in my experience loyalty to The Man is a one-way street. If you want safety you're in the wrong business.

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  17. 8:09 - Consolidating vendors? HCA is letting anybody in who meets their Nazi pricing! You need a reality check Big Stick!

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  18. That 8:09 Medtronic tool is a glittering jewel of ignorance. A decent distributor can have a better/fuller bag than a Medtronic rep if he knows what he's doing. Good example of why they've got negative growth. The good old days are over for you Mr. 6%

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  19. 11:30, 1099 for distributor? it's same as W2, just without benefits

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  20. i thought all mdt reps were already cut out of INFUSE deals (it's a direct purchase). it's not "in the bag" any more.

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  21. 11:59 aka Forest for the Trees

    Earnestly, do you really think anyone but you (and your fellow hardware reps) care that you don't get commissions on sales?

    Is it a Medtronic Spinal and Biologics product?

    Ooops, it just jumped back in the 'bag'.

    I'll give you that in some cases, you can make that separation between products to a doc or an administrator. But to Joe Q, NY Times reader, Medtronic is the company that sponsors my NPR and has a product that could sterilize me.

    I guess the real, bummer for you, is you have to act like BMP is some inlaw with a drinking problem. "Yeah, he's my sister's husband, so we're not really related or anything."

    InFuse was a huge asset to hardware sales in the early / middle 2000's. Now it's, 'not your problem'. That can't possibly feel good?

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  22. ...And all this time I thought infuse could grow a bone anywhere! So much for that marketing effort.

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  23. Do you mean I dont have to worry about kids ever again and get my back surgery? Count me in. This should be marketed in the Urologist office.

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  24. This NYT article is a joke. Anyone who has been in spine for any length of time knows that the ALIF procedure has a 1-2% complication rate with Retrograde Ejaculation (RE). Surgeons already warn patients about RE risk in ALIF and will usually use a posterior approach for young men. RE has nothing to do with Infuse other than that MDT is an easy target and is completely incompetent when it comes to Public Relations. The new MDT CEO should save the shareholders some money and fire the entire PR department.

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  25. Ken Burkus, MD and Tom Zdeblick, MD are two very talented and honorable leaders in the spine surgeon community. I have the utmost respect for them and the research they've done to advance the field of spine surgery over the last 15 years. I would trust either to operate on myself or a family member.

    Just my opinion and since it's a blog I'm entitled to it.

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  26. Just another attack on our industry by the NYT. Not good for anyone involved in spine surgery, surgeons or companies. Fun to see MDT and a successful product like Infuse get cut down isn't it?

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  27. absolutly LOVE hearing and reading all you dumb asses post comments and cut each other up on this blog and dont have the balls to post your fucking names rather you post Anonymous!I was told by my rep about this site and it absolutly facinates me and really makes me laugh. Bunch of wet the bed crying fucking babies is what you are. Have the balls and step up to plate if you want some!!

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  28. What is your address you freakin NIT WIT...?

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  29. Dr. Hansen(I assume)....Can't wait for ur patients to google YOUR name and see what a class act u really are!......Putz.

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  30. Did globus go public yet?

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  31. guess you guys didnt read his post. Your doing exactly what he said you would do. You all should be proud of yourself's, you are all true professionals.

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  32. Hey 2:10 Plz Plz Plz post your name so we in the office can google your name and see what a Putz you really are that you have to hide behind the anonymous name. Now who is the PUTZ??

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  33. Thanks Ted. You're a real man for posting a name.

    Too bad no one knows who you are!

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  34. Firstly, Dr. Hansen, welcome to the internet!

    Secondly, '...want some' what? What does that mean, seriously?

    This blog has been chronically filled by 'anonymous' postings, no mystery. And for the most part, the administrator has been diligent in redacting person-specific vitriole. What I don't get, is, if it's so entertaining, why are you are so angered?

    The precedent you set is actually a bit more concerning, as I could easily write the name of any surgeon, rep, corporate officer in my posting....who would know...?!

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  35. Hi Ted,

    I am SOOO glad I told you about this site. See what I have to put up with? This is exactly what sets me apart from the other dildos in the field and why I deserve to be your only rep and get 100% of your business. Thanks for defending me and I will see you tonight when I get home.

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  36. The Docs I've met have had little trouble spelling big words like "absolutely" and "fascinate." 1:35 is no doc, he's no Hansen, and he probably doesn't have a "rep." Just a punk looking to stir the pot!

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  37. now your getting it...

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  38. I haven't seen it yet, so I just have to ask:

    Anyone think Globus will go public?

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  39. Could be asswipe Dr. hansen up in washington. 2 dollar haircut and the accumen to match

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  40. I know Dr. Hansen and you sir are are not him.....

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  41. Wow, Ted Hansen's a badass!
    Sincerly,
    Anonymous

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  42. What's Ted Dansen got to do with anything? Is he still dating Whoopee?

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  43. The Real Ted HansenMay 25, 2011 at 6:28 PM

    Please stop using my name. You make me sound like a clueless idiot. I'd sue if TSB would tell me who you are...

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  44. Hey 6%'ers:
    Glory days
    Oh they'll pass you by
    Glory days
    In the blink of a young girl's eyes
    Glory days, glory days

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  45. Tampa 3 Bruins 2

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  46. I heard Olympus is cutting deals with PODs for OP1; and Nuvasive was buying Globus.
    I'll take puns over lyrics any day.
    Forget Dr Zdeblick, I'd want Ted to do my ALIF. He seems like an honest guy.
    Go Bruins!!!

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  47. Let's cut to the chase and get to know MM...
    Do you wear the mask to bed?
    What number wife are you on?
    What is the highest position you have held with a spine company?
    Does Robin Young swallow? (Opinion or fact?)
    Why do you always ask if Globus is going public as anonymous?
    Do you track IP addresses?
    Have you ever banned someone from your blog?
    If so, will I be one of them?
    Are your initials (first and last) contained within the first 3 letters of the alphabet?
    Is Oprah really gone?

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  48. Back to topic, MM. Did Caragee have all his male patients produce their sperm to count it pre op? Then did he have them come in post op and make another donation? Who was his exposure surgeon, same or multiple people and did that correlate to the RE?

    What type of implant was Dr. Caragee using with these infuse patients? Was it on label with LT Cage? Or did he use some other device, I wonder if he told his patients that it was an off label use of infuse?

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  49. Call him and ask, sure he would be willing to discuss it with you, 888.LOC-OUNT

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  50. Would the real Ted Hansen please stand up....

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  51. If Danek asked Burkus to piss on Mastergraft and place it in the gutters ... he would. Then he'd write a paper, have it published, and present it at NASS. Then browbeat anyone who questioned his magical pee/mastergraft combination.

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  52. 5:18 make sure before you slander a well respected surgeon. your comments are completely without merit, are inaccurate and mean spirited. if i remember, my colleague ken burkus was not even a consultant at the time of the bmp studies

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  53. Dr 5:34 (If a physician)

    Did 5:18 make any specific reference to the NYT study? This comment is an opinion. As for the difference between libel and slander, as spine blogger implores readers, please learn to distinguish. As a surgeon you must be an intelligent individual. A word of advice, if you would like to practice law, please go to law school. If I wanted to practice medicine, I wouldn't make diagnoses without the training. This is a highly charged and testosterone driven industry. Interesting

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  54. interesting... http://www.medpagetoday.com/special-reports/SpecialReports/26685

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  55. Steve Hochschuler says PODS are legit and industry is illegit. I totally believe him. He is such a stand-up guy.

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  56. "Ken Burkus, MD and Tom Zdeblick, MD are two very talented and honorable leaders in the spine surgeon community. I have the utmost respect for them and the research they've done to advance the field of spine surgery over the last 15 years. I would trust either to operate on myself or a family member."

    You must not really get along with your family. I distinctly remember how The Honorable Tom Zdeblick changed the fusion rates he reported for cylindrical cages overnight from 90% plus to the low 60% as soon as his LT cage came out. The LT cage of course showed fusion in over 90% of patients within 9 months...even without Infuse. It's always been about the mullah, not the science or the patient.

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  57. To 5:34

    Right. Just as Hall Mathews stood in front of the FDA panel presenting the original Infuse PMA data, and declared without even blushing that he had no financial relationships with either the company or the product...... His employee contract had not been signed yet.

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  58. @7:11 am, OP-1 was actually first to market, then floundered when the better product came out.

    On another note regarding Dr. Burkus (who is a very good guy), he was NOT a consultant to Medtronic at the time of the bmp-2 studies.

    Check your facts, people!!!

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  59. 2:12 pm. Check your facts. This is still on the web today:

    "SpineUniverse: Now that you are using BMP, how is the surgical procedure different?

    Dr. Burkus: I am using rhBMP-2 in anterior and posterior lumbar spinal fusion surgeries. These surgical procedures have been significantly changed. The use of rhBMP-2 enables me as a surgeon to complete the surgery in a shorter amount of time and with less blood loss. Patients postoperatively have an easier time getting out of bed, ambulating and returning to activities of daily living including returning to work.
    SpineUniverse: What have the results been with your BMP patients?

    Dr. Burkus: Patients treated with rhBMP-2 have experienced less blood loss, shorter hospital stays and shorter operating room times. No patients receiving rhBMP-2 have required a postoperative transfusion. They, of course, have no complaints of bone graft site pain. They are able to return to work earlier.

    SpineUniverse: Are there any complications or side-effects patients should be aware of?

    Dr. Burkus: No adverse events have been linked to the use of rhBMP-2."

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  60. NYT 2007

    "Other doctors receiving generous consulting payments through the first 10 months of 2006 include Dr. David Polly Jr., a spine surgeon at the University of Minnesota, who received consulting fees of nearly $262,000, and Dr. J. Kenneth Burkus, a surgeon in Columbus, Ga., who received fees of more than $250,000"

    Royalties in 2010: $782,000

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  61. jsonline.com december 2010

    "Approval process

    The clinical trial that ultimately led to FDA approval of BMP-2 focused on another type of spinal fusion surgery.

    The four co-authors of a 2002 paper about that trial received a total of $2.8 million this year from Medtronic in royalties for products not including BMP-2.

    The paper made no mention of any financial relationship between the authors and Medtronic.

    Burkus, who also was involved in the 2004 study, again declined to say if he was receiving royalties from Medtronic or if had some other financial connection with the company at the time the 2002 paper was published. He got $573,000 through September.

    Curtis Dickman, a Phoenix surgeon, did not respond to phone calls and e-mails. He and Vantage Investments LLC received $306,000 in royalties.

    Matthew Gornet, a St. Louis surgeon, and Gornet Enterprises got $591,000 in royalty payments.

    Gornet said he did not have a financial connection with the company at the time of the study, though he developed a relationship as a consultant right after the trial, an arrangement that ended after about a year.

    He said his patent rights with Medtronic did not begin until 2003 and none of his royalties involves BMP-2.

    The last author listed was Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health. Through September, he and Taz Consulting received $1.4 million in royalties for a variety of products.

    Other records show Zdeblick has received more than $23 million in royalties from Medtronic since 2002.

    In an e-mail, Zdeblick said he had no financial interest in BMP-2. He does receive royalties for the invention of the LT-Cage, which was used in the BMP-2 clinical trial, but the two products are sold separately.

    Another surgeon, Thomas Kleeman of New Hampshire, was not an author the 2002 paper, but co-authored a 2009 paper on the BMP-2 clinical trial and also is listed as an author on an abstract on the clinical at the 2007 North American Spine Society meeting.

    Kleeman, who did not return phone calls, received $56,000 in royalties this year.

    This article is part of an ongoing series about how money and conflicts of interest affect medicine and patient care." To read more stories in the series, go to jsonline.com/sideeffects.

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  62. December 2010

    "Approval process

    The clinical trial that ultimately led to FDA approval of BMP-2 focused on another type of spinal fusion surgery.

    The four co-authors of a 2002 paper about that trial received a total of $2.8 million this year from Medtronic in royalties for products not including BMP-2.

    The paper made no mention of any financial relationship between the authors and Medtronic.

    Burkus, who also was involved in the 2004 study, again declined to say if he was receiving royalties from Medtronic or if had some other financial connection with the company at the time the 2002 paper was published. He got $573,000 through September.

    Curtis Dickman, a Phoenix surgeon, did not respond to phone calls and e-mails. He and Vantage Investments LLC received $306,000 in royalties.

    Matthew Gornet, a St. Louis surgeon, and Gornet Enterprises got $591,000 in royalty payments.

    Gornet said he did not have a financial connection with the company at the time of the study, though he developed a relationship as a consultant right after the trial, an arrangement that ended after about a year.

    He said his patent rights with Medtronic did not begin until 2003 and none of his royalties involves BMP-2.

    The last author listed was Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health. Through September, he and Taz Consulting received $1.4 million in royalties for a variety of products.

    Other records show Zdeblick has received more than $23 million in royalties from Medtronic since 2002.

    In an e-mail, Zdeblick said he had no financial interest in BMP-2. He does receive royalties for the invention of the LT-Cage, which was used in the BMP-2 clinical trial, but the two products are sold separately.

    Another surgeon, Thomas Kleeman of New Hampshire, was not an author the 2002 paper, but co-authored a 2009 paper on the BMP-2 clinical trial and also is listed as an author on an abstract on the clinical at the 2007 North American Spine Society meeting.

    Kleeman, who did not return phone calls, received $56,000 in royalties this year.

    This article is part of an ongoing series about how money and conflicts of interest affect medicine and patient care."

    To read more stories in the series, go to jsonline.com/sideeffects.

    ReplyDelete
  63. December 2010:

    "Approval process

    The clinical trial that ultimately led to FDA approval of BMP-2 focused on another type of spinal fusion surgery.

    The four co-authors of a 2002 paper about that trial received a total of $2.8 million this year from Medtronic in royalties for products not including BMP-2.

    The paper made no mention of any financial relationship between the authors and Medtronic.

    Burkus, who also was involved in the 2004 study, again declined to say if he was receiving royalties from Medtronic or if had some other financial connection with the company at the time the 2002 paper was published. He got $573,000 through September.

    Curtis Dickman, a Phoenix surgeon, did not respond to phone calls and e-mails. He and Vantage Investments LLC received $306,000 in royalties.

    Matthew Gornet, a St. Louis surgeon, and Gornet Enterprises got $591,000 in royalty payments.

    Gornet said he did not have a financial connection with the company at the time of the study, though he developed a relationship as a consultant right after the trial, an arrangement that ended after about a year.

    He said his patent rights with Medtronic did not begin until 2003 and none of his royalties involves BMP-2.

    The last author listed was Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health. Through September, he and Taz Consulting received $1.4 million in royalties for a variety of products.

    Other records show Zdeblick has received more than $23 million in royalties from Medtronic since 2002.

    In an e-mail, Zdeblick said he had no financial interest in BMP-2. He does receive royalties for the invention of the LT-Cage, which was used in the BMP-2 clinical trial, but the two products are sold separately.

    Another surgeon, Thomas Kleeman of New Hampshire, was not an author the 2002 paper, but co-authored a 2009 paper on the BMP-2 clinical trial and also is listed as an author on an abstract on the clinical at the 2007 North American Spine Society meeting.

    Kleeman, who did not return phone calls, received $56,000 in royalties this year.

    This article is part of an ongoing series about how money and conflicts of interest affect medicine and patient care."

    To read more stories in the series, go to jsonline.com/sideeffects.

    ReplyDelete
  64. There are so many questions to ask...what were the treated levels? what other comorbidities did these patients have? ie diabetes, what was the approach? the percentage of retrograde can be any where from .5% to 8% depending on what study you read. Are patients experiencing retrograde when BMP is used in other parts of the body? Tibial Fractures, OMF?

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  65. were there any West Coast surgeons involved in that study? All I am seeing are the blood suckers from the South/East Coast.

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  66. 3:18, those are valid questions to ask. Point is, the paid authors of the Infuse papers never gave the information that would cause the general public, including their colleagues, to ask the question. And when the courageous Croatian did, he was not exactly welcomed. Interestingly, the 5 Infuse and 1 control patients with retrograde ejaculation can be found in the transcript of the FDA Orthopedic Panel Meeting of January 2002.... To answer your question, the placement of BMP in an ALIF is a heck of a lot closer to the nerves regulating your urogenital sphincters than when placed in the tibia or the skull. Although it raises the interesting question which cranial nerve might be affected.....

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  67. Most of you clearly do not know what Retrograde Ejaculation (RE) is. If you did, you might be cringing more and joking less about its convenient birth control measures.

    Imagine a really hot night of wanton sex....
    Oh this is gonna be GOOOD!

    However,... ummm, ... uh oh.
    Whenever you climax, no bodily fluid is ever excreted. Oops! Your semen backtracked. Try handling that psychological thriller! Sterility is a rather polite way of describing the obvious ramificiations to that little snaffoo.

    Feel like some Infuse??

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  68. Well, at least they can still grab the swimmers out of your bladder and inseminate your girlfriend/fiancee/wife/concubine.

    There was a young man of Ghent
    Who had a tool so long that it bent
    To save himself trouble
    He put it in double
    Instead of coming he went....

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  69. Burkus and Z were very selective in the data they presented. It doesn't hurt that Z has been the editor-in-chief of JDST for almost 10 years. Geezz no conflict hug Dr. Z? Not sure i've ever seen you disclose the $15M+ in royalties you've received.

    As for Burkus ... he's famous for trashing everyone's technology and bashing InFuse opponents. Only to "embrace" every Medtronic new technology that comes that line that was ripped off from competitors.

    It's no f'n secret these docs, and many others, had big $$ in the game with the InFuse approval. Look at all the sham studies this group has authored ... "gee if you put 3 large boxes in each gutter, you'll have a 90% fusion rate in smokers that undergo a single level instrumented PLF"
    ----- and you're telling these guys are in it for the "science"? Advocating $25K in biologics?

    hopefully the truth will come out but it's highly unlikely considering Medtronic docs dominate the editorial boards and education committees of all the meaningful spine societies.

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  70. Gents I will tell you from my experience being a rep for over 12 years and finally have a L5-S1 360 with cages and Infuse back 7 years the last thing I was concerned about or even wanted was sex. This f*ing procedure is a bitch and hurts like hell. It took me a full month to even start shitting right. I am a very active, ex professional baseball player so I was very impressed with my fusion rate only 6 months out. And I am NOT a MSD Rep. I chose to have the 360 at the age of 32 and I will tell you I have 6 and 4 year sons so no problem with that. Please note, this was just my experience.

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  71. Ive sat next to Burkus at many MSD dinners and can tell you that he is a charming fella who without a doubt is in it for the dollar bill.
    He has advised some of my past surgeons on how to set up 'research' foundations to legally accept money from MSD in the name of science.
    Where do you think the money goes after it is received by the foundation?


    Liars ??
    How about a few more docs on the Wall O Shame

    Polly -lied before congress RE infuse/consultancy $ and MSD
    Kucklo - Lied/forged signatures in a published Study RE infuse
    Zedlic - lied as stated in previous post -2:55
    Mathews - lied as stated in previous post - 2:55

    All MSD lackeys.
    They hide behind their own walls of hardened BS.


    MSD is Dying...

    I had the good fortune to watch the blood slowly drain from it's fat greedy arrogant body for some time.
    Thankfully I left at the top of my game to a much better company with much better products.
    I am kicking the Tar out of MSD now and love every second of it.

    RIP 6 percenters !!

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  72. 3:28pm A little bitter for someone so successfully kicking their former company's ass aren't you? The spine industry is littered with former MSD reps. Most move on to their 3rd spine company within 24 months of leaving. Medtronic has a lot of work to do but we won't miss your whiney ungrateful ass as much as you'll miss us. Good luck and hope you're up to date on LinkedIn sucka,

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  73. 8:10am You are completely off base. Both Dr. Zdeblick and Dr. Burkus have fully reported their data and unlike every other non-Medtronic consulting spine surgeon in our industry have had all of their consulting and royalty payments transparently available on the Medtronic website for the last two years. Infuse is the one of the most studied and successful technology used in spine surgery. How else would it reach $700m/yr in sales? Like any technology if it is overused or improperly used problems can potentially occur.

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  74. ......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?

    7.49, you're the one who is completely off-base.

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  75. 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

    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

    Carriage needs a new access surgeon.

    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!

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  76. 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.

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  77. 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.

    foley has a bucket of patents that have added incrementally to spine. The others I agree with you.

    There are few giants in each generation but many are doing what they can to improve patients lives. Let's give some reasonable credit.

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  78. That's not Rudy White Shoes Bertagnoli

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  79. 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.

    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.

    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.

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  80. 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)?

    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.

    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.

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  81. 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.

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  82. 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.

    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.

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  83. Hey 11:56
    Your narcism reeks. Since you are so smart you won't have to look up the big words. Sincerely 8:07

    ReplyDelete
  84. 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 real

    ReplyDelete
  85. 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?

    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.

    A retrospective case series is nothing more than a starting point from which we should be drawing ideas for future randomized, controlled studies.

    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.

    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.

    http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf

    See page 8...they are even broken out by time point for your reading pleasure.

    I wouldn't be so quick to pass judgement on Drs. Burkus and Zdeblick.

    ReplyDelete
  86. 8:07,

    So what? You are a rep that pretends to be a surgeon on TSB. Pathetic.

    Your friend,

    11:56

    ReplyDelete
  87. The real headline on this story should be: “Failing newspaper resorts to tabloid sensationalism in effort to bolster failing readership.”

    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.

    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:

    http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf

    Take some time out to read what the surgeons wrote in their papers as well.

    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.

    Let’s ask a few questions about the Carragee study:

    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?
    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?
    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?
    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?
    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?

    …and why doesn’t the NYT feel the need to ask questions like these? That would probably feel too much like responsible, ethical journalism.

    I wouldn’t be so hasty to pass judgment on respected surgeons like Dr. Burkus and Dr. Zdeblick.

    Take a close look at the accusers.

    ReplyDelete
  88. http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf

    it's the table on page 8

    ReplyDelete
  89. The real headline on this story should be: “Failing newspaper resorts to tabloid sensationalism in effort to bolster failing readership.”

    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.

    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:

    http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf

    Take some time out to read what the surgeons wrote in their papers as well.

    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.

    Let’s ask a few questions about the Carragee study:

    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?
    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.
    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?
    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?
    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?

    …and why doesn’t the NYT feel the need to ask questions like these? That would probably feel too much like responsible, ethical journalism.

    I wouldn’t be so hasty to pass judgment on respected surgeons like Dr. Burkus and Dr. Zdeblick.

    Take a close look at the accusers.

    ReplyDelete
  90. 1:

    The real headline on this story should be: “Failing newspaper resorts to tabloid sensationalism in effort to bolster failing readership.”

    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.

    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:

    http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf

    Take some time out to read what the surgeons wrote in their papers as well.

    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.

    ReplyDelete
  91. 2:


    Let’s ask a few questions about the Carragee study:

    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?
    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.
    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?
    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?
    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?

    …and why doesn’t the NYT feel the need to ask questions like these? That would probably feel too much like responsible, ethical journalism.

    I wouldn’t be so hasty to pass judgment on respected surgeons like Dr. Burkus and Dr. Zdeblick.

    ReplyDelete
  92. The real headline on this story should be: “Failing newspaper resorts to tabloid sensationalism in effort to bolster failing readership.”

    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.

    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:

    http://www.accessdata.fda.gov/cdrh_docs/pdf/P000058b.pdf

    ReplyDelete
  93. 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.

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  94. 1:01 - Agreed, and it merited due schrift in the writeup, and the supposed omission of which justifies inquiry into the authors' motivations.

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  95. 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.

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  96. 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.

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  97. Really? Someone please delete 2:56. Writer, Please seek help.

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  98. 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.

    ReplyDelete