Monday, July 26, 2010

Will the FDA Execute or Issue a Stay?

On Tuesday, July 27th, the FDA will convene an Advisory Panel meeting that will evaluate and question the clinical efficacy of Medtronic's Amplify rhBMP-2 Matrix. The FDA has some major concerns regarding the high number of cancer related incidents in patients that have been treated with the Amplify rhBMP-2 as compared to patients treated without it. For those of you that read our blog, many of you are aware of the cynical comments that have already been posted regarding the name Amplify. For those of you not familiar with our lexicon, the word Amplify means to make larger, greater, or stronger, to enlarge, to extend. And that my fellow readers is what the FDA is concerned with.

The FDA's concerns center on the IDE (Investigational Device Exemption) along with Medtronic's, Wyeth's and Medicare's data. In all likelihood the significance of this data and the reviewers evaluation will determine whether additional evaluations and analyses will be needed. The panel will have to take a position on whether they believe that there is a statistical significant rate of incidence of overall cancer and pancreatic events in patients treated with Amplify (the test group) as compared to the control group.

In addition, the panel is being asked to consider the difference between Medtronic's and Wyeth's clinical studies, the methodology, the location or placement of Amplify in the body, when the patient was treated, the dosing and concentration, length of follow-up and potential patient co-morbidity. What it comes down to fellow bloggers is that the Federalis are concerned about the number of reported pancreatic cancer events in patients treated with the magic dust. An interpretation of this data will focus on patient demographics, limitations, follow-up and validation of the study.

At this juncture we know that any rhBMP-2 is not recommended for use in women of child-bearing age, yet, the panel will also review secondary procedures due to failure where rhBMP-2 had been used. It will be interesting to see who steps up to the plate on behalf of the evil empire. Will it be the usual suspects? The panel members for the FDA will include three cancer experts and an expert in reproductive biology. Hopefully, the FDA will perform a much better and more thorough proctological examination on Amplify and for that matter Medtronic than they did on Infuse. TSB would like to think that surgeons would take pancreatic cancer a little more seriously, than they did having boney ingrowth into the spinal canal, but what do I know, considering that TSB has no financial interest in these products. TSB wants to know what our readers think?


  1. All tumors aside, which are serious enough, FDA also asked for new analyses. One should list all repeat surgeries, especially those for further decompressions, and indicate whether it was for incomplete and inadequate work at the original surgery or new compression due to ectopic bone, soft tissue swelling and whatever else may have happened. It is mind boggling that they were not part of the original filing, if that is the case. In addition, MDT has to come up with a better definition of success than "the score is lower than at baseline". Duh! So the pain went from 10 to 9.5, that's a success??? It will be an interesting day tomorrow, and I for one would not be surprised if after the new analyses very few realistic claims survive. Lastly, getting back to the tumors, didn't the original approval in 2002 require MDT to do long term post-market studies with an emphasis on keeping a look-out for cancer rates? Whatever happened there?

  2. Of course the analysts do not give a rats ass whether this can potentially be a stimulus for pancreatic cancer, all that they care about is that they protect their interest in MDT. Maybe we need to have them undergo some back surgery so they could have first hand experience at what this can do. Oh, I forgot, it was supposed to work so well in cervical fusions that it is no longer advocated for ACDF's. What would anyone expect from people that provide no social utility except for making money.

  3. Where's Mr. BMP, Scott Boden, in all this? Back to selling Grafton?

  4. I find it interesting how all of you denegrate the product. I wonder if any of you have had any clinical experience.
    As for the comment on investors, ever think there is just as many who are shorting the stock and put bad news out there?
    Lastly, it was never advocated for ACDF's. It was the surgeons choice, and like many other products, its success is dose related..go figure.

  5. Now the Evil Empire can blame surgeons for using Infuse off label, I suspect the company never pushed the envelop on off-label use. Of course we would be adversarial considering how little was reported initially about Infuse. I haven"t read one analyst predicting gloom and doom.

  6. Look, I compete directly with Medtronic, so don't take me as a "homer." I think a lot of these posts are waaay out of line. I challenge anyone to consider what you would want in your back if you were a patient. You would be an IDIOT not to pick INFUSE. Also, as for that last post about off-label promotion, if you have worked in spine, you have promoted something off-label. You say differently, you are lying. Why is it so bad if Medtronic does the same thing, because they have been kicking everyone's butt for years? Why don't you people grow a pair and go out and try to beat them instead of whining on the internet all day?

  7. Is that all there is? Quite the contrary, I would never let anyone put BMP"s in my body, it's my body, and I'll decide what someone should use. Who's whining? How many cases that initially had bad results were ever reported? Dosing is a big issue. Besides, we are attempting to have an intelligent conversation unless you"re willing to take a trip with Dr. Leary down try memory lane. By the way I am in the spine Industry and have never promoted anything off label, touché!

  8. Ok, you are either bad at what you do or misinformed. If you've ever sold a lateral mass screw, interbody device (other than 3 exceptions prior to about a year ago), pedicle screw for AIS, etc, etc, etc, then you have sold something off label. By the way, I agree with many here that this is a great blog and I come here often, but I stongly stand by my assertion that you are an idiot.

  9. Hey Einstein, before you use big words like assertion, you should learn how to use it in the appropriate context. The word means a declaration often without support or reason. But then I wouldn't expect you to be a lexicographer considering you sell spinal implants for a living. As usual, thanks for your opinion, like any other reader you are entitled to be heard.

  10. Boys, boys, there's enough infuse, cancerous ingrowth, and impinged airways for everyone and their debilitated parents, parents in laws, veterans, etc. etc! Let's face it, InFuse, Amplify, OP1, Emdogain are all technologies with promise that aren't refined yet. Debating clinical efficacy is a moot point. And for all your daredevils promoting it off label, good luck! BMPs are about as risky as you get as it is. What goes around comes around. Would you be so insensitive if it was your own mother who falls victim to some jackass MDT InFuse salesman trying to make an extra buck?

  11. Last poster here

    PS I know Emdogain isn't used in Spine so the peanut gallery can relax. Just trying to make a point.

  12. Hey 'homer'.... I've been in this industry, including the direct clinical side, for over 25 years.....

    First of all, having read and studied everything that is published, but also what is unpublished but spoken about in the back alleys, I will not have any Infuse put in my body until I have reached the ripe old age of 75+, and my stem cells are few and tired, and the time it takes to induce cancer exceeds my life expectancy. Until then, no thank you! (Rest assured, 75 is not that far away anymore.....)

    Second, I was born with a pair, and in spite of my age they are still functioning quite well, thank you. Having been associated with this industry in one capacity or another for so long I can say one thing with certainty: No other company than Danek has perpetually walked so close to the edge of the ethical and legal boundaries of health care, and regularly crossed them. And Medtronic management has failed to change this culture. For example, their latest disclosure on their web page as to which surgeons they pay to use their products is surprisingly short, and appears, to those of us in the know, to be less than complete (sic!).

    'Homer', use your brain and get a little education on bone biology and healing. Unless you as a competitor work for either Nuvasive (Danek West) or Globus (Ali Baba East), in which case there is not much hope.

    All jokes aside, and most importantly, I hope that the panel tomorrow will be strong enough to ask fair, scientific and tough questions and force MDT to (finally) disclose all they have learned about Infuse, both the positive AND the negative.

  13. most selling in med device spine havent a clue what a scientific journal or referred article is. Sorry to those that pay the fee to receive the yearly subscription-what do you know? Nothing! Bottom line is that this is about company, doc, rep making lots of money with very little clinical efficacy. Deformity different story-however adding hooks to a standard degen set does not make you a deformity company. This to will end...

  14. Hey jackO
    no one uses hooks anymore. Duh.

  15. True science would be:
    *Easy fast effective hip harvesting insts
    *Fast effective jigs for capentry
    *Pain pump etc long term.
    *Remodeling agent for deformity correction of the harvest site.

    The body is a self-contained agent for healing.
    I would never use synthetic BMP or allograph.
    The only stuff that REALLY works is the iliac treasure.

    Industry is too greedy and docs too lazy and too impatient (to hear patients complain) to use it.

    Truth hurts bitches.

  16. 8:03am
    You really lose some credibility when you use big words like "allograph"

  17. Advisers on Tuesday narrowly backed an experimental Medtronic Inc spine implant that uses a protein to stimulate bone growth and help relieve low-back pain.

    Just reporting what reuters is reporting. So.... how does this make everybody feel?

  18. Seriously people, everything in this industry has risk or issues.......including autograft, allografts, BMP's, DBM's and ceramics. You could question effectiveness, cost, morbidities etc of every one of those. However, there has not been any other product that has impacted the Spine Industry the way Infuse has, like it or not; whether selling it or against it. Revision surgeries have gone down across the board, infections as well. Spine innovation has exploded because there is less risk in the biological race to fusion. Every company has benfited from this. Everything has changed because of it.....size and shape of implants, materials, procedures, etc. Is it over used? Yes! Too expensive? Yes! In small amounts, in the right procedure, for the right one in their right mind can question it's effectiveness. Again, everyone in this industry has benefitted from it, and everyone is entitled to their opinion