Thursday, July 14, 2011

The Spirit of Edgar Dawson, M.D..................Lives On

As the INFUSE debate escalates, TSB thought it would be of interest to our bloggers to revisit a 2003 Letter to the The Spine Journal Editor by Edgar Dawson, M.D..  Dr. Dawson contributions to spine surgery was immense. An academician,  Dr. Dawson's love of medicine was something to envy.  In 2003, Dr. Dawson's letter addressed many of the concerns that have surrounded the recent INFUSE debate.

Dr. Dawson believed that the FDA approval of Bone Morphogenic Proteins was an important milestone in orthopaedic science, yet, he warned that it was time to pause and examine unresolved issues so as not to misuse a clinical treatment modality in "its infancy" despite over three decades of research.  Contrary to some peoples opinions, Zdeblick, Burkus and Haid were not the founding founders of BMP , Dr. Mashall Urist, M.D., pioneered studies on bone induction and the identification of bone morphogenic proteins.  He revolutionized the field of orthopaedic growth factors.  A little history will educate some of our younger bloggers.  But back to Dr. Dawson.

In the Letter to the Editor, Dr. Dawson warned that clinical results had not been as conclusive as pre-clinical results.  The key to his observations were that carefully designed and well controlled trials yielded much different results than an uncontrolled environment.  The preclinical and clinical studies of BMP's may not be as simple as differences in the healing potential of young healthy lab animals compared with human subjects.  The key to Dawson's then letter was that "no dosing data was available from an actual clinical study."  If ever there was a prophetic observation, Dawson warned that, "different indications will require not only different doses of proteins but potentially different carrier materials to obtain clinical efficacy." The argument can be made by those in the surgical community that it has been proven that the use of BMP-2 in posterolateral fusions has been efficacious, and rightfully so, but the question remains, how many post-op issues have never been reported or addressed?  Just eight years ago, prior to his death, Dawson warned that "the use of BMP's are not without potential significant complications."  The Marshall Urist's and Edgar Dawson's of the world were not only pioneers, they envisioned the potential side effects of a powerful therapeutic agent.  They discussed the importance of containment at the site from their experience with exuberant bone formation in the soft tissues in animal studies.

One of the unknown risks that Dawson discussed was the role of antibodies that develop to BMP's in some patients post-op.  Though the occurrence rate was higher for BMP-7, anti-body formation was reported to a lesser degree in patients that receive BMP-2.  In 1985 Urist, Hudak, Huo, and Rasmussen published a paper entitled, "Osteoporosis: A Bone Morphogenic Protein Auto-Immune Disorder," citing increased levels of antibodies to BMP's in patients with osteoporosis, speculating that osteoporosis may be a BMP auto-immune disorder.  In addition, BMP was contraindicated for pregnant women, and women were advised to use contraception for at least one year after implantation of BMP.  Finally, as Dawson writes, BMP's have been isolated and identified in osteosarcomas.

Since the time of Dawson's death, the medical community has learned much more about the effects of dosing and containment, yet the cost effectiveness, the limitations, and potential complications must continue to be explored and documented in a transparent way for the safety of the patient first, and profits second.  Sometimes people get those two things mixed up. But as Dawson points out, surgeons should never forget the basic principles of bone healing and biology, or as many of our bloggers know, it comes down to carpentry and craftsmanship and therein may lie the problem.  The use of BMP was never intended for convenience, or as another short cut to getting great results.  It all comes down to process, which includes meticulous graft site preparation and understanding how to deliver/dose this product.  Too many people fail to understand process because all they care about is results.  In closing, Dawson's prophecy is still with us whether we like it or not, the question is have we learned anything?

109 comments:

  1. TSB - outstanding post! Thx,

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    1. Dr Dawson was my surgeon in 1985 and he saved my life. His only concern was my recovery and told me he wasn't concerned if I couldn't afford to pay his bill, that he just wanted to help me. While at UCLA, his son came to see him as a student and Dr Dawson insisted his son come and help with my casting. He always had someone who had the same surgery contact you before and during your aftercare. He would then have you do the same for the next patient. He is the best surgeon or doctor that I have ever met. I was sorry to hear that he has passed away. I hope his legacy will never be forgotton for all the patients he helped. He wasn't just a great doctor, he was a great person RIP Dr Dawson Linda

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    2. As a continuous of my above post, I am searching for a docctor who was trained by Dr Dawson to help me. One of my harrington rods has broken and needs to be removed due ton stabbing pain in my back. I don't trust anyone very well, especially here in Las Vegas and would only trust someon who trained with Dr Dawson with excellent credentials. If anyone can direct me to such a doctor I would be every in your debt, knowing that if this rod isnt removed there could be some bad ramifications from it, if anyone knows of such doctor please contact me through this post

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  2. I agree. Great post!!
    This industry has lost all sight on what it was founded on.....
    "safety of the patient first, and profits second"

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  3. Every ankle-biting company seizes on any potential complication of BMP to try to get a scrap of MDT's business.

    TSB, if Robin's article is right, and you work for a small spine company, you need to disclose that you have a competitive interest in attacking MDT's product.

    Transparency, please. "Greedy companies" includes those big and small.

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  4. 11:00 dude what are smoking? TSB doesnt need to disclose JACK SHIT. He is protected by the 1st Amendment. There is no gorunds for discloser on the internet my friend. I know this firsthand. Sounds like your a little pissed off MDT sales rep trying to stir some shit up. He better yet, sounds like your blowing Robin Y. you will need to disclose that to MDT. Sounds like a conflict of interest.

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  5. and another thing about BMP (Infuse) to you dumb ass MDT reps. Lets call it like it is...while MDT make manufacture BMP, the carrier spong/pad that is used is produced by Integra.

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  6. Great post. It reminds us once again to do the right thing. The ends do not justify the means.

    And don't worry about those "greedy companies". Eventually, life is fair. We are witnessing that. But the only problem is, others will unfortunately get effected during this "fairness" process.

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  7. Great posting. Thanks for getting back to issues of substance.

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  8. This is a great post and TSB doesn't have to disclose anything. This is a blog, not a senate investigative committee.

    I think the whole Infuse debacle, as it is becoming or has already become, is just a indicator of what has gone wrong at MDT over the last decade. There has been a consistent and diligent effort to bypass the FDA marketing restrictions for Infuse and many other products. All for the sake of "differentiation" or for a product that has no competition. Every company is looking for a unique and differentiated product, but how far will they go to promote a new product without data that proves it holds any benefit to the patient or surgeon. We all know that MDT had Yolanda Cillo and Hal Matthews on board to provide off label data to surgeons. We all know that MDT structured the comp plan to reward reps for selling PEEK rods, Agile and Prestige when the former 2 had zero clinical data and the latter showed no better outcomes than and acdf with a plate, only the hope for lower adjacent level degeneration (but no actual claim for that benefit).

    What they lost in innovation in the R and D department, they tried to make up for in the marketing department. Now they find themselves in the unenviable position of being on par with all of the "me too" and "ankle biters" when it comes to innovation, but they are still trying to hold on to "integrity pricing". When you add to that the fact that they pay the lowest commissions in the industry, it doesn't add up to a bright future. No longer can they say that they should be able to charge more because they drive the innovation in the industry and others just copy.

    Infuse offered them the monopoly in that segment for a long while, but instead of advancing the product and solidifying it's dominance across all applications, they chose to let a few cleared indications suffice and then let the docs figure out where it works and what carriers work, at the expense of the patients who were experimented on. While the FDA clearances are ridiculously expensive, I think the current and potential revenues justified some more study in different applications with different carriers. Now sales are flat or shrinking, they have a big black eye, and surgeons see Infuse as a liability because of the bad press.

    Old Spine Doc, I think you are right that life is fair, except for the patients who were harmed and the fact that MDT has already banked billions in sales. It's a shame really, because BMP has the potential to knock ALL other bone graft options to the curb. If using it causes ann immune response that results in osteoporosis as suggested by the study TSB referenced, they will be paying it all back.

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  9. Here's what I've learned:

    1. This blog is begining to sound like a broken record.

    2. This industry has gone to hell.

    3. When you're as large as Medtronic, you can continue to do as you wish w/ little to no repercussions.

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  10. wow! that was very educational. normally I despise you and most of your fellow sycophants. this was actually a good piece.

    Thank you

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  11. I concur with the comments before 1:22. Great post TSB and kudos. And no, you don't need to disclose anything. As you're as anonymous as everyone else here I take everything you say with an appropriately measured grain of salt.

    (Disclosure is needed when someone is placing their reputation behind their statement, not when you don't even know who the someone is that's doing the talking.)

    What Dr. Dawson elegantly pointed out is that there are significant unknowns and unanticipated effects from new advancements of this ilk.

    It doesn't mean they shouldn't be used, or that they can't be great advancements. It just means that early use should be judicious, with these possible unknowns in mind, and that we shouldn't be surprised, but rather embrace them, accept them, and move forward when the unknowns actually do surface.

    Some folks are crying because as the unknowns come to light it's affecting them commercially (MDT), professionally (docs) or personally (patients), and they realize they weren't as judicious as they perhaps should have been.

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  12. Often, I'm in the room with a surgeon(s) who refuses to acknowledge the Danek rep in the hallway...they badmouth danek non-stop etc.

    Yet, still continue to use BMP in their lateral cage/alif cage or on a multi level revision etc.

    While BMP's best days may be behind them because of educated patients/negative outcomes/bad press etc. I still think the biologic won't be going away anytime soon. Can anyone else name another device/biologic where if the rep/mgt/company are "dead to" the surgeon, that he/she still continues to use the product.

    What other implant company can say this about one of their products?

    If I've had 2-3 failed fusions and this was my last chance...by all means, use BMP please

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  13. Here's what I've learned

    1. This blog has been free, stop whining 1:22, you sound selfish

    2. This industry needed a forum, it is a blog and that's what separates it from OTW or Orthoworld. None of those people ever work in the industry, they are outsiders that invited themselves to our party.

    3. If you think this industry hasn't gone to hell then you must be living on another planet.

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  14. Uh...me too! Here's what *I've* learned:

    1. This blog is populated by bitter, disenfranchised sales reps that work for small companies.
    2. Said companies all hate Medtronic because they can't seem to sell to the MDT accounts.
    3. Nobody knows when Globus is going public.
    4. 7/11 was born on 7/11 and gives away free slurpies that day each year.

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  15. WAAAAAHHH! Is this Burger King and can I have it my way?

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  16. I want what I want and I want it.

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  17. Can we get back to the post and have an intelligent discussion on the pros and cons of infuse or is that asking too much

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  18. Safety of the patient's first, profit's second...

    I had a family member visit a surgeon that is part of a POD/Surgeon owned company. I asked to see his pt educational packet...last page of the packet had the industry relationship disclosure.

    Dr (Blank) uses products/services from companies and others in the care of his patients. Dr (Blank) can assure you that the selection of a product or service to use in your care, and in the care of all of his patients, is based only on what is best for the patient, not which company offers the product/service.

    Dr (Blank) is a member of AAOS which holds its members to extremely high ethical standards to ensure that even the appearance of a conflict of interest does not jeopardize the trust that patients place on doctors.

    It is important to Dr (Blank) that you are aware of these relationships with other healtcare professionals, that he puts your interest first, and he is available to answer any questions you may have.

    I have a couple questions?

    Why do you use the same company for 100% of all your fusions?

    Why did you stop operating at a certain hospital when they told you that you could use 3 vendors and not the company that you are involved with? Didn't you tell me "you could make anything work?"

    Why did you leave your wife and start dating the distributor for this company?

    Is that why you use this company that nobody has ever heard of for ALL of your cases?

    Privately, kudos to you for double dipping (on more than one level)...I've seen the distributor, she's easy on the eye's. Still comical that you hide behind the Academy and their standards of professionalism. How grey can this area get

    Let's face it, the industry will never be the same. Money can ruin ANYTHING.

    I'm sure just about everyone can relate to a story like this...

    Sad that this info is left out of the patient educational packet.

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  19. 1. Infuse is not sold by Reps, it sells itself
    2. MDT Reps do not get paid for sales of Infuse
    3. It works!!!!!
    4. All drugs have warnings and side effects and complications, Infuse is a Drug, not a Device
    5. The People who have influence in this country are paid by the by people who have none!!

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  20. When the clinical trial data came out, everyone seemed to overlook the fact that the BMP did not exhibit any reliable dose dependency. It was shown to be efficacious at that particular dose in that particular environment, but at 2x the dosage or 1/2 the dosage there was no corresponding effect.
    Something tells me that Wyeth didn't neglect to notice this; as a pharma company, they were well aware that a drug that doesn't show a dose response curve can't be prescribed predictably. Something tells me the MDT insiders weren't ignorant on this fact either. So in the end, we reap what we sow...

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  21. 2:36 you are asking way too much

    That being said, when will Globus go public???

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  22. 3:19...
    Are you saying a controlled dose-dependency study was performed? If so, where and when? The pilot & pivotal trials were all single dose studies (or as close as one can get given it's not exactly 100% adsorbed in the collagen sponge and then placed with the exact same amount into the patient everytime...)

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  23. TSB great post and remember what kristofferson sang

    we have seen the ones that have killed the ones with vision
    cold blooded murder right before your eyes
    today they hold the power and the money and the guns
    its getting hard to listen to their lies
    try to tell the truth and don't let the bastards get you down
    fight the fight keep on blogging

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  24. Very informative post. Keep the information and education coming.
    And as you state in the last paragragh, carpentry and craftsmanship are what counts. How many surgeons use Infuse to overcome their poor technique.
    You have first assistants doing surgery while the surgeon is out of the room. But pack in some InFuse and call it a day, but not until you dictate for coding and billing.

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  25. Bottom line. FDA approved this product 10 years ago. It was proven to be safe and efficant. All of the complications were reported. I don't work for Medtronic, but there is no way anyone can possibly believe this product has caused impotency in thousands of patients. If so why doesn't the FDA step in and recall the product. There are recalls everyday.

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  26. 11:17

    give me a break. What an idiot. Collagen carriers are a dime a dozen. Almost every small and large company has a collagen/ceramic type product. The science is in the BMP. Collagen, the breakthrough of the decade in spine. lol.. Nice try rookie.

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  27. Dear Fellow AME, NASS and AAOS Members,
     
    In the media recently, there has been a lot of coverage concerning the corruption of medical research by Medtronics’ medical minions, which has led to thousands of men being rendered sterile from retrograde ejaculation, a complication of using Bone Morphogenetic Protein (BMP) in spine surgery. This all started with the paper by Dr. Eugene Carragee, editor in chief of The Spine Journal, that was recently released and reviewed all the data and literature on BMP over the last nine years. As a spinal surgeon and clinical professor of orthopaedic surgery, I have examined the data in detail as presented in the paper. It is accurate, unbiased and statistically ironclad. I come to the inescapable conclusion that the authors of the BMP research, as well as Medtronics employees, in my opinion knew from the beginning that this complication occurred in 7% of patients. Since BMP has been used in hundreds of thousands of patients over the last nine years, this equates to tens of thousands of young men made sterile, and for reasons they – and their surgeons- may never have known. I believe this high incidence of sterility was knowingly covered up in the publication by the authors for fear that the millions of dollars being paid to them would be stopped, and that the company paying them would lose hundreds of millions in profit if this was revealed. As a consequence, and as Dr. Carragee demonstrates, repeated denials by the authors occurred for years despite overwhelming evidence that patient injuries were unnecessarily being incurred by use of this product instead of the less profitable alternative of using the patients’ own bone graft. As the co-founder of the Association for Medical Ethics for the past five years, I’ve been fighting this despicable behavior which inspired Congress to pass the Physician Payments Sunshine Act, calling for disclosure of all monies paid to medical researchers by manufacturers. Unfortunately, this is not just a case of financial corruption but a criminal cover-up that has led to thousands of men being robbed of fatherhood in my opinion.
     
    As President of the Association for Medical Ethics, I believe it is time for Washington to wake up to this kind of assault on the integrity of medicine by a minority of doctors ruining all our reputations, and begin criminal prosecution of those involved at both the medical and corporate level. If we as a society will send someone to jail for willfully causing bodily harm to another person in the street, why should punishment be any different for these acts? Failure do so would be putting those culpable as being above the law under the guise of the vagaries of research and their prominent status as physicians. As an academic and having performed spinal surgery and research for 22 years, in my opinion the evidence is as clear as day that intentional harm to people was not only allowed to occur, but encouraged and promulgated by lying about data to increase usage of this product.
     
    It can be a lifetime of anguish and regret for a young couple to be deprived of giving birth to children of their own. To intentionally allow - no less promulgate - such mental and physical harm is a crime and those responsible should be brought to justice.
     

    http://www.ethicaldoctor.org/video-msnbc.html
     
    Sincerely,
    Charles Rosen, M.D.
    President, Association for Medical Ethics
    Clinical Professor of Orthopaedic Surgery
    University of California, Irvine, School of Medicine

     

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  28. The American Journal of Roentgenology July 2011 reports on The X-Ray & CT Evaluation of RhBMP-2 assisted fusion in 95 patients:

    "Endplate resorption was observed in 100% of patients who underwent cervical fusion and in 82% of the lumbar levels. Subsidence of the cage resulting in narrowing of the disk space was seen in more than 50% of cases. Cage migration and heterotopic bone formation in the spinal canal and neural foramen occurred maximally in the lumbar spine of patients in whom a polyetheretherketone cage was placed using a transforaminal approach."
    The evidence against InFuse keeps on mounting.....

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  29. BMP or cigarettes,,, What's the difference?

    Everyone knows what they can cause, the data is readily available & known, but yet nothing is done to stop the use of either.

    WHY? Because they both generate hundreds of millions of dollars in revenue each year for the companies that produce them. Said companies in turn, pay fines, etc. but also continue to support political agendas which allow noted products to continue to be used and harm society.

    At the end of the day, it's all about the $$$$$.

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  30. Dear Dr. Rosen:

    Thank you for restoring my faith in decency within our industry. Having worked in the spine for 22 years I have seen a rapid degeneration of ethics and morality by both physicians and industry folks alike. What is most frightening is the amount of corrupted science that is permitted to be spewn from the podiums of NASS, CSRS, SAS, and IMAST. Those in positions of influence and power should be held culpable for their greed. They should be vilified for the criminals that they have become.

    Your plea for decency and culpability is admirable and greatly needed. Thank you once again.

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  31. 12:02 you are on the $$$$ !

    Very factual and to the point. It's time to get it out there.

    All started with the MSD Dougy Doodie initiatives regarding commissioned dollars. Paid us highly on nich implants with no clinical benefit. Some that broke in Parients and were recalled. Others that never saw the light of the OR.

    And why such a loss of focus in a game we so skillfully spearheaded?

    Arrogance and Greed of MSD.

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  32. Since BMP has been used in hundreds of thousands of patients over the last nine years, this equates to tens of thousands of young men made sterile, and for reasons they – and their surgeons- may never have known. -Dr Rosen

    Rosen needs to check his own facts, tens of thousands of young men, would only be true if Infuse had a 100% on label usage with Laproscopic ALIF like in the study__doubt many Infuse cases are done that way

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  33. Sounds like another "Ford Pinto Case"', the $ benefits outweigh the risk.

    http://cset.sp.utoledo.edu/engt2000/Lesson11.pdf

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  34. I struggle to see how RCT's reviewed and audited by FDA - that reported RE complications - were a cover-up. Carraggee just got different results in his class IV trial that weren't seen in the FDA-reviewed class I trials. It happens all the time in research. That's not proof of corruption, but rather an incentive to research why there is a different outcome in a different setting.

    The journals not reporting all the data that were reported to FDA...now that's a different story. There's something the editorial boards of those journals and the submitting authors (and corporate researchers helping them with the data presentations) need to sort out.

    Comparing the FDA labeling against the journal publications suggests perhaps there is something there (almost a decade old now...wonder why it never came up before?) to investigate. I haven't seen a credible class I RCT refute the complication rates of the original trials though.

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  35. Rosen: "this equates to tens of thousands of YOUNG men made sterile."

    I fully respect Carragee's research and believe we all will benefit from removing industry from research (good luck).

    I do take issue with Rosen throwing in the adjective "young." Define "young," Dr. Rosen. Using this adjective makes me feel like he is a member of the media, and not the medical community.

    One is absolutely too many, but I have not seen too many "young" men (who still want to procreate) on the OR table for elective surgery.

    Leave the "young" out of there, and I'll have a lot more respect for your pen, Dr. Rosen.

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  36. Agree with most of 11:00's points, with the exception that a higher rate of RE *was* observed in the original RCT (appropriately, no significance tests were performed on individual complications). The RCT met its clinical endpoint of non-inferiority of 'safety and effectiveness' but wasn't designed to evaluate all the individual complications. This is how research is supposed to work. Further research is always needed to confirm secondary endpoints or observations in the primary study. No study is going to tell us everything we would possibly want to know about a product.

    If a single RCT for FDA approval was to be powered to give us all the information we could ever want, we would simply *never* have any new products. Then we would be stuck with fusion using autograft and the associated 40% success rates (based on a combined safety and efficacy endpoint), forever. That's not so good either.

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  37. 12:16 again. Dr. Rosen's post got me thinking about the impact of the sterility issue on the population. I knew that RE after ALIF may not always be permanent. I just looked at the Carragee study abstract again and note that three of the six RE events with BMP resolved within one year (doesn't say when in the abstract). Presumably that makes the 'permanent' RE incident rate to something like 3.5% (not 7%) and there are only half the number of 'sterile young men' out there as might be predicted when taking the numbers at first glance.

    Both sides may be slanting the data.

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  38. Along the lines of 12:32's comments, RE does not equate to sterility. Sperm can be "harvested" from the bladder after an RE event and used for procreation.

    Not trying to take a side in the BMP wars...just pointing out Rosen's slanting statement: "tens of thousands of young men made sterile".

    It kind of reduces the punch of his conclusion: "It can be a lifetime of anguish and regret for a young couple to be deprived of giving birth to children of their own. To intentionally allow - no less promulgate - such mental and physical harm is a crime and those responsible should be brought to justice."

    ...so maybe they shouldn't be brought to justice? Or maybe the justice should be in helping fund fertility treatments?

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  39. 1:16

    Yes, thank god I can still take a leak in my wife after I toss a load in my bladder and hope for the best. STFU.

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  40. A well written piece and as an added bonus - NO QUOTED SONG LYRICS AGAIN! ; )

    TY TSB

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  41. who is the new acting President for Zimmer Spine now and what role will Chris Ryan take on with ZS??

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  42. The immune response which was much lower in Infuse used a different assay than Op1. The FDA requested Medtronic use/develop a more comprehensive assay test (public record) as some of the terms for approval, which of course Medtronic didn't. Nobody can know what the long-term implications of your body developing antibodies to a protein that is used in almost every bodily function but if I was the patient I wouldn't want to take that risk. Only time will tell but with all the other known complications/adverse events associated with this product I believe the product has a short life and the corporate folks and physicians associated with this product ought to be looking for cover. This is clearly criminal negligence by MSD and the physicians associated and I would be surprised to see some folks spending some time at the crossbar Hotel. You can pick any argument, RE, ectopic bone, immune response, inflammation, death, re-operation, etc. (long list) but when you group all of the issues together including the promotion of off label use it looks to me like an indefensible position for MSD and the physicians. Of course we live in America where they rarely put money in jail. Thank you Dr. Rosen for your eloquent response, like many others you and others including some of the physicians I work with provide hope we haven't forgotten about the patient and results in this hyper capitalized industry. Can I set up a meeting with you to show you my new cervical plate and pedicle screws... Kidding.

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  43. 8:12 here... Wouldn't be surprised sorry typing on an iPad

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  44. I am done with this Blog...

    Can someone else please creat a blog that is not as anti-medtronic, Nuvasive, etc.?

    We all know you are a bitter Synthes check collector

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  45. Dawson's letter to TSJ is an anti-Medtronic letter, 8:20 are you reading the same thing that I read lol, the intelligence exhibited by my mates in the industry is frightening. Your assignment go back read it and tell us what Dawson said

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  46. TSB can you write about something that's not news, you may be able to win over 8:20

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  47. Actually I don't work for Synthes. I have worked for Zimmer Spine and Stryker Spine as a Rep and then I started my owns distributorship. No pods or consultant surgeons but apparently with MSD, Synthes, Stryker, and Zimmer's declining sales and my sales that are increasing I am cashing all of your checks. I guess a little knowledge, service and being able to speak inteligently with your surgeons brings more value to the proposition than arrogance, greed and products that harm the very patients the surgeons are trying to heal. Go figure? The 800 lb gorilla is looking more and more like the titanic. See if MSD gets through this how many more surgeons will you have ostracized? I know a ton of surgeons before all of this that would not use MSD because of their past shenanigans. What will the Spine landscape look like in ten years? I am very excited about the potential are you? Thanks for the hook up! Besides if it all goes down hill, I can sell (means I will have a job) and I won't be in jail. Finally a MSD rep calling another a check collector is rich. You mean because you converted those doctors? It had nothing to do with the consultant agreements, hospital compliance contracts, bundling, surgeons being trained on the products or the many other advantages you have over the competition? and yet your still hemorrhaging business. They ought to teach this in business school about what not to do. I am afraid of you as the professional golfers are of Tiger Woods!

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  48. Hey D Bags...Ed Dawson was a gentleman. Please move your immature, frat boy, my dick is bigger than yours comments to another post. Sweet Jesus...have a little respect.

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  49. Burkus ... what a joke ... whatever Medtronic wanted him to say he said it and is paid handsomely to do so. Whatever Burkus was told to implant, he put it in with almost zero questions asked. Satelite implant? sure let's do it. Truckloads of InFuse? why not?

    His partner Dorchak has learned from the best! New truck tires and a swimming pool? Globus happily obliged! But don't forget to go to Dorchak's wife's store and drop a few thousand (I bet the Stryker distributor regrets those purchases after he lost his biz)

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  50. MDT is and will continue to be a force to be reckoned with in this industry. Danek, Sofamor Danek and now MDT started by manufacturing and selling products that spine surgeons wanted, yet no one provided. Were some of those product controversial? Of course - remember when pedicle screws were the news of the day? Someone has to run the risk of pushing the envelope.

    The company has many benefits and has offered many of those benefits to surgeons who of their own free will have indulged themselves - a lot have overindulged - that is human nature - greed - capitalism, whatever name you want to put on it.

    I was not in spine implants at the time Infuse was released but I read and heard about the concerns and complications from Infuse - so the surgeons must have known and chose to use it anyway or chose to be paid to use it.

    Infuse is a great product in the right hands, on the right patient( as an earlier post said 2-3 failed fusions, non smoker, etc) and this will sort itself out. The question that all should focus on, IMO, is what do we do now? How do we insure that surgeons and patients are aware of the possible complications? How do we as an industry cope with this and learn from it? If there are 'guilty' at MDT remember what goes around comes around.

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  51. Unbelievable! While Carragee and others are clearly on the right track calling out the surgeon authors for apparent bias in their journal reporting, the self-righteous critics are now risking their credibility as they are certain to shortly accuse MDT of producing exploding breast implants.

    Surgeons are responsible for knowing and understanding the risks associated with any product they choose to use, based on what's on the product label. As of this point, nothing suggests the actual risks are different than those that have been on the label from the outset. Yes, if Tommy Z, Burkus and co fudged the data, they need to be held accountable. And if MDT personnel encouraged or facilitated that, they need to face prosecution.

    But I love how Bazell and the NBC Co neglected to mention that the Infuse was used in a COMPLETELY off-label application in their patient example. And that it was OFF-LABEL use that the FDA was cracking down on in their warnings. And that the actual incidence of complications appears to be no different than those that the FDA approved the product on the basis of.

    Bottom line is, surgeons that applied an appropriately cautious and judicious approach to using Infuse, including sticking to on-label use or only carefully deviating from it, are happy they did. Those that were more aggressive are suffering the consequences. Now everyone is learning a lesson. (Sounds like the mortgage crisis.)

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  52. 12:54 Well written.... However if surgeons stuck to an on label usage of Infuse there would be little to no usage of Infuse. You see many LT or even titanium threaded cages being used? I don't.

    11:34 yes the surgeons you should be educated on the product. However, if their peers, company and sales reps are intentionally misinforming the surgeons about the advantages and disadvantages who bears the responsibility? I guess that is where you start blaming the patients again?

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  53. Sorry guys that you don't work for MDT. Don't know what to tell you. Maybe see what you can do to join. They'll continue to lose market share, but the landscape will also continue to change in their favor - consolidation, r&d, acquisitions. I wouldn't want to be anywhere else. But listen, I can't stand the Yankees either. So I get where you and TSB are coming from.

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  54. Happy Friday All.

    Thanks TSB for doing what you do. Rejoice you are employed and have the privilege to work in a dynamic industry with lots of excitement and opportunity. Times they are a changin' but then again the always do.

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  55. Hey 11:34, what a joke. You make refference that you were not around the spine implant field when Infuse was released, so I am assuming you have only been in this market for...lets say 5 or less years? But you also make yourself sound like quit the expert. "Of course - remember when pedicle screws were the news of the day? Someone has to run the risk of pushing the envelope". Where you in the business back in the 70's, only to get out and reservice again in 2004??

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  56. 3:47
    Excellent point, but holy crap you have HORRIBLE grammar skills!

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  57. This was one of your better pieces, Mr. Nieradka.

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  58. 2:58 you speak volumes in your brief post.
    You can't stand the successful dynasty of the Yankees and yet *proudly* love your job at MDT, while no less admitting "they'll continue to lose market share." However, (my favorite part) you will compansate for that in the future by making acquisitions and consolidations.

    Some people really should learn to refrain more often.

    and to July 14, 2011 1:38 PM:
    "wow! that was very educational. normally I despise you and most of your fellow sycophants. this was actually a good piece."

    Nice try at a left-handed compliment! Keep working on it. Additionally, I think using the term "sycophants" is a bit extreme and loathsome. If we are such awful, submissive, parasites, why do you continue to willfully subject yourself to reading this Blog?? You slay me.


    4:43 Good call! I think 80% of the bloggers here have atrocious grammar skills. It is embarrassing to be a peer at times. But some excellent points are raised. I will chalk it up to poor typing.

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  59. hey 5:47 hear is zome good gramer for you...b-low me!

    Let me ask you, how many times did you have to spell check and look up every word while typing that? This is a fucking Blog buddy. Don't like how or what your "peers" say? Then I suggest you find something else to do instead of critizing!!! Did that really make you feel good and important to write that? What another bad day at getting your ass kicked out on the streets man???

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  60. I heard in NJ there's a law firm going after surgeons using Infuse off label and advertising for patients who may have been harmed.

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  61. 4:43 give the writter a break! I saw one misspelled word. The writter spelled "where" instead of Were. Was there something else we missed?

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  62. This thread has grown tiresome.
    http://www.youtube.com/watch?v=QHZR9SA5pOg

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  63. You mean the "writer?" Good grief!

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  64. Anybody work in Florida or any of the other markets where fusions continue to get denied by insurance carriers?

    TSB,, Perhaps you should start a blog on healthcare policies as they continue to get more & more strict when it comes to approving/ authorizing fusions. What will be the wave of the future? Will companies need to look more closely at alternatives to fusion as insurers continue to drive costs down or simpyl refuse the procedures all together?

    Enough about PODs, Infuse, etc. Let's talk about where spine is heading & what the future holds as it appears that things are changing pretty quickly,,

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  65. I think Dr Rosen is a giant fraud. I is on a self described mission to end the corruption between industry and clinicians.
    Great, then whom is going fund the next new discovery?
    How will the next great advancement be led into clinical use if there is no collaboration.
    This holier than though mentality is not what we need! Why doesn't here present his own prospective RCT if he can do it so easily? I don't see his great list of publications, where has he done anything to give him the right to besmirch other well known surgeons who have actually contributed to our speciality.
    He is all about criticizing from a position of jealousy.
    He loses all credibility by making such self aggrandizing statements when he has done nothing himself.
    Has he produced one prospective study? Has developed a single usable novel idea? His own bio on the Internet says that he specializes in revision of TDR. Where has he published his sees? Has he patented any better designs than the ones he says are flaws? No! He just holds himself out as the leader in ethics and criticism of other really successful surgeons and clinicians. His hands may be " clean" but it is because he has done nothing, no work!

    Get off you high horse Dr Rosen

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  66. Yeah, no contributions, unless you count that

    "National Gold Medal in Figure Skating (Ice Dancing)

    WTF?

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  67. For the record his CV states he did publish a RS study on lumbar disc revisions.

    His co-author was Kiester.

    I'm not making this up.

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  69. Dr Rosen is a very accomplished figure skater. This is what qualifies him to ridicule some of the most well know and respected surgeons in spine. He has really advanced the latest techniques in the compulsories and the figure eight!
    I hope he and his ilk stay engaged in their hobbies because they don't add much to our profession!

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  70. Hey Rosen, since you live close to Wang, maybe you two could hook up for a cozy conversation about our industry.

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  71. There's that old saying:
    "If you strip off the covering of a Crusader....

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  72. 9:33
    Let's see....'where', 'quite','resurface'....HORRIBLE.

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  73. Im a former danek rep who has since launched a distributorship selling the same parts for 30 points instead of 6...I'm certainly incentivized to sell competitive biologics to generate revenues and in today's climate it is definitely low hanging fruit.

    But if i was the patient on the table I would hope the surgeon and team could tell me the science behind their decision making. The science behind infuse INCLUDING the adverse event profile is far more convincing than MY BULLSHIT DBM FROM SOME DONOR WE KNOW NOTHING ABOUT. Osteoinductive? Sure it is. I think. Osteoconductive? STFU. You and everybody else is trying to sell shit. Infuse is the only novel improvement made in spine in 25 years. Not your POD. Not your dual thread pitch stupid fucking screw. Not your trans anal approach. Dr Rosen I'm a disgruntled former danek rep who thinks your post was reckless and wrong. You should thank Marshall for the opportunity to help your patients.

    Kind regards
    tB

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  74. According to published data, Dr Charles D. Rosen was in 2004 paid by UCI a base pay of $31, 254.96, but was in addition given something called "Extra Pay" of SIX times that, $193,745.04! Does that sound to anyone like a way to avoid some sort of scrutiny maybe? I know govt administrators sometimes slyly use this tactic to avoid various ceilings, but has this been scrutinized? Is it all above board? Should anyone do a retrospective, after the fact investigation to ensure taxpayers money was being spent according to law? Have standards changed, would anyone avoiding pay limits then, be called up for it now by crusaders ? Aren't there people out there who are investigating conflicts between physicians and their comfy civil servant bully pulpit civil servant positions?

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  75. 5:33 - for someone who's comfortable with their skills/relationships what are potential decent spine lines to look into, if I'd like to be my own distributor?

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  76. Well, the word is Blo-us hires anyone now. Heard they recently set new low standards in this regard.

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  77. 7:36- are you serious? Would they take me if I can bring some business?
    I don't like doing paperwork or reports really, and I think Advamed is a joke so I pretty much ignore it.

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  78. Sounds like a match made in heaven. Go for it kid.

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  79. Come on guys. Dr Rosen is president of a very important society.....membership of one.

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  80. This comment has been removed by a blog administrator.

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  81. This comment has been removed by a blog administrator.

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  82. Again, I can't believe the responses. The outrage from the reps about a physician that openly calls for the return of transparency, ethics and accountability in medical reasearch. Oh the horror! He and all the rest of the "Democrats" are ruining this country. I forgot the Trial Attornies and District Attornies, they don't help either. I wish they would all just leave us all to our own DEVICES. But there is a little problem with that. They did and MSD and others glutted the system and now Medicare/Medicaid and private insurers are declinining fusions. You mean they are declining those lumbar operations that have driven up healthcare costs, require re-operations, and don't have great success rates? Why? Duh. Maybe it is all related. Ahh.... You see Medtronic we didn't ruin it for you, you ruined it for all of us. I think an appropriate penalty for all Danek employees of the last ten years to be subjected to a lumbar fusion with a large Infuse kit.

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  83. Nice post TSB, amazing that some of the miscreants that read this blog taint it with their saturday night non-sense. If we're going to have a debate let's debate, the machismo that is exhibited by some on this site is a poor reflection on our industry, but what can one expect? At least Rosen signed his name to his post.

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  84. 5:33 - Do what I did and google ortho streams spine startups and have a look at the 140 or so who have launched in past five years. 15 % have failed and probably only another 30% will fail due to the utter absurdity of our biz margins.

    So out of those companies, I looked for financial foundation, "cleanliness" of internal operations, quality of the parts, credibility of KOLs, and finally compensation model.

    Obviously Globus is a NO given it fails most of the above parameters. I did interview LANX and they were a no. K2M became my home and I'm proud to be working with them.

    kind regards,
    tB

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  85. I love it when they say "triple Sow Cow" in figure skating! don't really know what that move is though?

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  86. tB - thanks for the input, I'll check in to it.

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  87. One needs to read no further than this blog roll to understand the demise of our industry. We have always had a certain amount of greed and stupidity, but it has become the norm rather than the exception. My hope is that the difficult years ahead will flush some of the junk out of our field; the stupid, the lazy, and the dishonest will struggle and the intelligent, the hard working, and the committed will flourish.
    Try explaining to a stranger why it's reasonable for a 26 y.o. with a history degree to make $200k a year to basically be a glorified courier. Change seems pretty inevitable to me.

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  88. tB,
    Would love to talk to you more about K2M. I am a rep in the business of over 10 years looking to make a move and have been interested in K2M. Please email if you can and lets talk.

    onespineguy@hotmail.com

    thanks and have a great day. GO USA Womens Soccer.

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  89. 7:07- here is the answer to your question.
    The move you described was a reaction of joy involving a complex leap and spin, at the prospect of not having to deal with the following. Instead, male skaters stuck to " their own team".

    http://1.bp.blogspot.com/-aefbZyMKcuo/Tg1k-J3wngI/AAAAAAAAAGc/u0PmYRzB1Ro/s1600/Fat_chicks_1.jpg

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  90. 8:54 you sound like you speak from experience?? I think the average Joe out on the street, if I told him what I do for a living (oh, and I make more than $200K a year), would LOVE to be in my position and hell, I don’t even have a History major...does Chemistry count?

    We chose this business just like a teacher chooses their business, knowing that it’s not a glamour’s job and the pay sucks. While I do agree with you that this business has very much changed over the last 3 years, there are still some very good, honest and hard working guys and gals out there that consider themselves more than just a “glamorous courier”. But heck, I do pay a lot in courier fees too.

    If you are looking to make changes, maybe start with your attitude and attacks on those out there, such as myself, trying to do a job and possibly a family has well. I take it personally when guys/gals like you insult and through out these little jabs about how much we make for what we do. Again, its our choice just like its yours to find something else to do making $200K a year. I have a question? On your resume do you put Glamorous Courier as the job title you have? Think not! You probably like to over state your qualifications and are a Territory/Area Manager, right?

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  91. Hey TSB, how about a new topic. Let's address laser spine surgery on the next blog. How about mass advertising of procedures with little or no clinical benefit and the lack of any patient/consumer protection regarding similar procedures...

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  93. One of the things Dr Rosen accuses the researchers of wrongdoing, is not listing all the adverse events in their papers (events that were deemed not-significant and which did not have a causal relationship to Infuse). I do not think that listing of every single adverse event is routine practice for clinical papers. The clinical paper is supposed to be a summary of the clinical trial methods, limitations, results and conclusions, etc. If the papers were so detailed to list out the dozens and dozens of different adverse events including ones that did not have a causal relationship and were not significant, then the paper would be huge and never read, and probably not approved for publication.

    I think it unfair that he jumps on his fellow spine surgeons for this when he himself may be considered of doing something similar by using Infuse off-label, in new and unique procedures and promoting this use to other surgeons and yet not disclosing any risks of the Infuse at all.

    Here it is in his Department’s Newsletter. http://www.ethicalspinesurgeon.com/articles/Jan06.pdf

    The article touts the wonderfulness of the Infuse and how it speeds healing and higher fusion rates, less pain, quicker return to work etc. (nothing in the PMA or the IFU say that Infuse will do those things, BTW) and nowhere in the article does it explain any of the risks of the Infuse, implants ,or the new TranS1 procedure. I realize a newsletter is not the same as a peer reviewed clinical paper but is it not the same principle? Isn’t this non-disclosure of risks similar to non-disclosure of adverse events that he is accusing the Infuse researchers of doing?

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  94. hey Spine blogger. Let's talk about Kyphon and what's going to happen with the business unit. Rumors of selloff/widespread downsize are increasing.

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  95. In everyone's opinion what smaller companies make solid pedicle screw systems, have nice instrumentation and have a good cervical plate/interbod spacers that pays good points and is priced lower?

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  96. 1:54

    Talk to someone in the industry you respect and get some recommendations. Call the companies yourself and check pricing/commission. Have your surgeon relationships review and give feedback on the product.

    You will never get a straight answer (positive or negative) from the psychopaths populating this blog.

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  97. Great points 1:36. Dr Rosen sure seems to be hypercritical of others surgeons, while clearly crossing some of the same boundaries. You can't have it both ways. And remember, when someone points their finger at others, four of their own fingers are pointing back at them. And the most adamant zealots usually are guilty of the same offense they rail against, it's a personality overcompensation. Too many examples to list, from priests, congressman, Eliot Spitzer, etc etc etc.

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  98. 2:50 Does that mean that you also are a psychopath? Just keeping things honest

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  99. Oh and by the way 1:36 when did you receive your PhD in psychotherapy considering that you are on this blog and pontificating about pointing fingers.

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  100. Ok, fine then, so now it's priests, congressmen, Eliot spritzer, and now 7:10.....

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  101. I work for a competitive company, but as many years experience in the OR, what I have found through many situations is that the techs truly do not understand that the rhBMP is not the sponge they are given but the actual liquid that is placed on the CARRIER collegan sponge. I do not promote the use of BMP on every case but it does have a valuable use in spine surgery if used properly.

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  102. My gosh. You guys are just horrible. This site has reached an all time low. What a sad bunch you are!

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  103. Medtronic layoff's on the way...again. Can you imagine all of the Synthes and MDT reps looking for jobs at the same time?

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  104. Foraminotomy Spine Surgery in India info on cost Foraminotomy Surgery India, Foraminotomy surgery hospitals India, Foraminotomy surgeons India. Here i suggest peoples 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

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  105. How about this one.......ASK ME IF I WANT IT IN ME FIRST!!!!! I was NOT asked and I now have two BMP's implanted in me, that I did not want!!!!!!

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  106. It was August 1970 and I was brought to UCLA hospital with a badly broken leg and head lacerations from a car wreck. Dr. Dawson was on duty as I was wheeled in. While under that influence of morphine I'd gain conscienceness, then pass out again. I overheard a group of doctors discussing amputating my left leg below the knee. I raised myself up on one elbow and shook my fist and said "you bastards ain't cutting my leg off". Well, Dr. Dawson heard me and said "We WILL save this man's leg".....and DID.
    Dr. Dawson didn't turn me over to any other of his staff there as he easily could have. He kept himself as my doctor. I was impressed with his genuine concern for me and other patients.....he really did give a damn.....and was THE BEST DOCTOR TO THIS DAY I'VE EVER SEEN.....

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