Tuesday, August 31, 2010

Yeah or Nay? You Be the Judge

TSB thought that this would be an interesting topic to discuss, considering that those of us that contribute to our blog site agreed that there are distinctions between the issues and observations made by the journalist that published this article. So with that said, enjoy.

On August 28th, John Fauber of the Journal Sentinel, a Milwaukee, Wisconsin based on line publication, penned an article entitled; "Bone Fusion Protein Raises Questions About Doctors Financial Stakes." For whatever reason, there seems to be no love lost between Mr. Fauber and Tom Zdeblick, M.D. of Medtronic Fame.

In retrospect, this article sheds some light on the FDA process, Dr. Zdeblick, Medtronic and Infuse. In 2002, the FDA advisory panel had raised some concerns about nine of the doctors that had lobbied their research on the efficacy of BMP-2 in spinal fusions. Ironically, not only did each physician have a vested interest in the success of the product, their clinical outcomes were twice as good as doctors that did not have financial ties to its success.

Over the last few years concerns have been raised regarding the off-label use of Infuse, and the potential adverse reactions in patients. Yet, TSB believes that this is clearly a separate issue from how Dr. Zdeblick was compensated, mainly for his IP and expertise as a spine surgeon. Industry insiders are well aware of the recent stir about off-label use of Infuse in Anterior Cervical Discectomies, whereas in 2008, Medtronic was sued by the family of a California woman claiming the company had urged off-label use of its device after the FDA had warned doctors not to do so.

The story of BMP-2 continues to raise questions about whether doctors should be allowed to do clinical trial research involving products that might enrich them, or the companies that they work for. Dr. Richard Deyo finds it alarming that so many prominent surgeons have cozy relationships with companies. For the obvious reasons, Dr. Zdeblick is the primary target of this article, having received roughly $22 million dollars in royalties and payments from Medtronic since 2002. This may surprise some of our readers, but TSB has no problem with Dr. Z being compensated for his IP, time, and expertise. Whom else is the FDA going to listen to? Historically companies have used surgeons to line their pockets. Rogazinski, Charnley, Russell-Taylor etc.... are a few surgeons that contributed to the betterment of mankind and also to the revenue and profitability of the companies that they worked with. What concerns TSB is not the compensation, but the lack of oversight by an FDA panel as to the potential side effects of this pharmaceutical.. Yes, fellow readers, regardless that this product was approved as a device, it is still a pharmaceutical. Since carpentry plays a prominent role in preparing the disc space, could it be that teaching surgeons how not to use Infuse was Medtronic's faux pas from the start. Each of you know the industry adage, give a doctor a hammer and everything becomes a nail. Well if 2cc's worked well the first time, why not administer 6cc's and see what happens? Hopefully, surgeons have learned something over the years, that its not the Infuse that makes the procedure successful. If the FDA was that concerned with off-label use, they should have addressed it at the time of the application while scrutinizing this panacea. For Medtronic to claim that it did not advocate off-label use is debatable. But, how does one legally prove a "he said, she said scenario?"

What concerns the industry and probably hurts many of the surgeons affiliated with Medtronic, is that after years of defending its reputation in various whistleblower lawsuits, Medtronic now behaves as though it has become the moral and ethical compass for the industry. As it crusades for more oversight, it continues to obfuscates its behavior and hides behind the skirt of AdvaMed. So as Amplify begins its final journey for approval, many questions are being raised by Mr. Fauber as to whether the FDA is complicit in covering up the physicians whom consulted by redacting sections of its 2001 files that listed the financial disclosure of the Infuse investigators, claiming at first that this information was no longer available, then claiming that they erred and the information is available, but, that the information would be hard to find. Old news is old news, unless we learn something from past experiences.

The North American Spine Society is just as complicit it their inability to properly police its members from becoming a commercial advocate for specific companies or products. But TSB wouldn't expect otherwise. As a minority of surgeons spend too much time worrying about how much sales reps make, rather than can they prep the disc space properly. Maybe some due diligence on their own behavior would make them ask the question, "look at whom is calling the kettle black?" Like Dr. Zdeblick, TSB would have a clear conscience being paid $22 million dollars for my expertise or intellectual property. But this raises an even greater concern, whom do you think pays for these royalties? Doctors love to cry about how they are always getting screwed, unfortunately, its difficult to side with them when you read stories like the one about Dr. Zdeblick regardless whether you believe in free-markets or not. TSB wants to know what our readers think. Is this a fair attack on Dr. Zdeblick, or, do you believe in free and unfettered markets? In closing, its there a better way to manage these scenarios, or, is the problem that this industry just can't find a better sandbox to climb into?




33 comments:

  1. Yup, Medtronic sucks a big one. Next topic please!

    ReplyDelete
  2. advamed is going out of business.

    ReplyDelete
  3. Another perfect example of how crooked the industry is. I truly hope Medtronic continues to lose spine market share and the lawsuits continue to climb. Karma.

    ReplyDelete
  4. Like the Vatican, Do as we say not as we do

    ReplyDelete
  5. As a drug, this is THE most expensive on the inpatient side at roughly twice the cost of Reopro. There are no dosing instructions, and the approval was based off use in conjunction with a device that fails and is hardly used anymore. Im with TSB on this one - this shouldn't be on the shoulders of the "consultants" - the true failure here is with the FDA, disclosure or not, why on earth was this ever approved as a device!?!?

    ReplyDelete
  6. Aren't InductOS and OP-1 classified as drugs outside the USA?

    ReplyDelete
  7. i ate oscar meyer boglogna for the first time in 12 years yesterday.
    the times they are a changing.

    ReplyDelete
  8. Heard that Amedica walked away from the US Spine Deal. Too much debt, too much Paul Sendro, asking way too much. In addition, I have heard that they are looking to hire direct reps. What's this world coming to?

    ReplyDelete
  9. All these spine companies going direct to go public with their me too products is the biggest joke. The only reason they got the business is they bought it and they are all yearning for the big pay off not realizing it it will be much more difficult to imploy the same business model of buying your business.

    ReplyDelete
  10. Medtronic is a whore, but so what? She is the 700 pound gorilla in the room and we all follow her example. Who cares that Infuse is overpriced and overperscribed? well....maybe the insurance companies. Some insureres are balking at the idea of 10 grand a pop for a sponge that is of questionable advantage. i am seeing pressure from hospitals to reduce or eliminate Infuse....Did Medtronic price itself out of a market?

    ReplyDelete
  11. Much more interested in the ALIF adhesion barrier market. What is new there?

    ReplyDelete
  12. Medtronic reps don't even get paid on infuse. They have a quota on other biologics. I know cause I used to be one. Some hospitals refer to infuse as "standard of care." pretty sure its here to stay...

    ReplyDelete
  13. Strongly object to Infuse being a "standard of care." It is not. It is a bazooka where a shotgun is often much more appropriate. Read the labeling. Would you want this in your mother?

    Not getting paid on Infuse? Riiiiight. that's why it costs $10,000.

    ReplyDelete
  14. What a bunch of whining yanks get over yourselves

    ReplyDelete
  15. "Well if 2cc's worked well the first time, why not administer 6cc's and see what happens?"

    Funny, i had a customer who did just this. he would open a large kit, and only use half of the sponge and all of the solution, despite my pleadings btw.

    Remember when inFuse was first approved, they required surgeons to attend a 1 day "training" class before they would release the product to their particular facility. Good intentions (or cya) but not very realistic in the long run.

    Standard of care? Yeah, the Evil Empire started that spin before the product was even released.

    Not paying reps for selling this, but giving them a quota? Well, you Danek reps should be glad they are even letting you put this product in your bag.

    ReplyDelete
  16. I am convinced that InFuse is the single biggest cause of the pricing / product approval committees situation in spine. Hospitals have spent so many dollars on InFuse that they have finally had enough and began a few years ago trying to save money in other areas because surgeons won the InFuse battle and hospitals have to continue paying for it. Thanks for screwing the pooch for everyone Medtronic!

    ReplyDelete
  17. actually, this pricing situation was created by companies like globus or other ankle biters undercutting on price to gain market share. (Can't wait to read all the "globus is not an ankle biter" retorts.) Sure they are growing, but their aggressive business model has made Device companies margins transparent to the hospitals, which has in turn, screwed the pooch.

    ReplyDelete
  18. As a Globus rep I disagree with the 9:16 post and agree with the 9:05 post. Never have I gone to hospital and lowered my price to get in. All the hospitals in my area had pricing already in place to try and cap their spine spend. I simply met their pricing. On technology we felt was different, we along with the Synthes and Medtronic reps tried to get premium pricing for our stand alone ALIF and ACDF and Motion Preserving pedicle screw systems.

    I have actually encountered hospitals where Medtronic gets to charge a higher amount for an HA screw than I was quoted. I refused to sell at the lower price out of principal. Maybe I'm the exception. I just wanted to have the respect of my colleagues. You never know who you might end up working for one day.

    ReplyDelete
  19. 9.47 globus rep where is your territory?

    ReplyDelete
  20. As I sat down to a contract negotiation in 2008, the first thing out of the Hosptial was "We spent $4million last year on Infuse and we need to make up for it". Now I have some of the lowest capped pricing in US. Thanks Medtronic.

    ReplyDelete
  21. OMG....look what made the list!

    28 september 2010 : International Prix Galien candidates
    Adalimumab (HUMIRA, Abbot), Eculizumab (SOLIRIS, Alexion), Romiplostim (Nplate, Amgen), Rivaroxaban (XARELTO, Bayer Schering Pharma), Abatacept (ORENCIA, B.M.S.), Natalizumab (TISABRI, Biogen Idec), Lenalidomide (REVLIMID, Celgene), Human Papillomavirus Bivalent (CERVARIX, G.S.K.), Eltrombopag (PROMACTA, G.S.K.), Sitagliptine (JANUVIA, Merck), Radegravir (ISENTRESS, Merck), Deferasirox (EXJADE, Novartis), Ranibizumab (LUCENTIS, Novartis), Maravirox (SELZENTRY, Pfizer), Varenicline (CHANTIX, Pfizer), Ivabradine (PROCORALAN, Servier), RhBMP-2 (INFUSE BMP-2, Wyeth), Nitisinon (ORFADIN, Swedish Orphan)

    ReplyDelete
  22. my guess....Medtronic will buy Nuvasive in 2011

    ReplyDelete
  23. That's weird...I heard that NuVasive is planning to buy Medtronic in 2011.

    ReplyDelete
  24. 11:04 I was in SOCal

    ReplyDelete
  25. I imagine that Medtronic will be too gun-shy after the Kyphon deal to shell out the kind of money it will take to get NuVasive

    ReplyDelete
  26. 11.04 I remember you

    ReplyDelete
  27. It's interesting to read comments from highly intellectual sales reps on this blog.
    Think about the cost of performing a FDA approved study. Studies are strictly controlled by the FDA. Do you thing the follow up MRI/CT and x-ray studies are free? How about the administrative costs of filing the proper documents. Doctors will not incur those costs. Companies pay doctors for their time and expenses. News papers sell their product on sensationalism thus creating somewhat false information.
    Dr. Zdeblick designed the Z-Plate and the LT cage for Danek, among others. He was smart enough to help create a FDA study to approve BMP utilizing the LT cage. Since BMP is only cleared for use with the LT cage he is profiting handsomely.
    It's interesting Mr. Farber of the Journal Sentinal didn't discuss the $1.3 billion Dr. Michelson received from Danek for ALL of his IP. Nothing has been said about Dr. Pimenta's royality stream for designing the XLIF.
    When Alan Olsen and doctors presented their results from a prospective study to the FDA for the clearance of "Pedicle Screws" there was a cost to the doctors that was reimbursed. That clearance also created an environment that has allowed other companies, without the funds to conduct that study, a pathway to market and sell their pedicle screw system. That creates the pricing platform via supply and demand. There are far too many systems on the market.

    ReplyDelete
  28. It's funny reading the above comments. There is a reason infuse is so succesful. Its not because the reps are selling the hell out it, its because the stuff actually works. Surgeons demand it because of results. You cant argue with that.

    Most the negative reports on infuse are spread, not by the surgeon, but by competitive reps.

    Yes its an easy target, but lets move on already. Lets talk about how big the ALIF adhesion barrier market is. Right.

    ReplyDelete
  29. Lets get back to the dude from Alphatec. whats up with him. The stock is on the rise. maybe hes onto something

    ReplyDelete
  30. Zdeblick designed the LT? Than he probably also designed the wheel and the pyramids. Most of these patent/royalty deals came into being when pure pay for play became too blatant. And Michelson's practices have been described in detail before, despicable. Just for perspective, how much did John Charnley gain from his invention, beyond recognition and honor?

    ReplyDelete
  31. Zdeblick should have received royalty payments on BMP for on-label sales only. That said, off label BMP use took up the remaining profitability of the DRG payment and clearly started the capitated cost containment initiative. While capitation may have been inevitable at some point given the over-supply of vendors, off label BMP was a major driver for capitation.

    ReplyDelete
  32. You all are lost in your own myths and dream world. I think they call that delusional. It's over. Remember "One Flew over the Cuckoo's Nest"? Many of you resemble the zombies that walked waywardly and drooled throughout. Too few of you seem to still maintain the sanity of Jack Nicholson. Those of you sane enough to get out the door....start running! The end is near and euthanasia for the remainder might be the only remedy. Your good ole days are just that. Stories that you re-run in your mind and tell anyone who listens, as if they care how you 'built the INTERNET...so to speak'. Time to get out of the way and let the professionals takeover.

    ReplyDelete