Friday, May 18, 2012

Medtronic's INFUSE: CASE CLOSED

The Wall Street Journal published a report today that the federal probe into Medtonic's Infuse is over.  The government led investigation began in 2008, and looked into whether the leading company in the spine industry had illegally marketed the synthetic protein for unapproved intra-operative use.  The announcement ends the civil and criminal inquiry with no further findings, nor will there be any civil penalties.  Unlike Stryker and its employees which had been raked over the coals, eventually leading to Stryker pleading guilty and agreeing to pay a $15 million dollar fine for misbranding its product, Medtronic has dodged a major bullet.  

In Medtronic's case, this had severely cut into sales over the past few years, leaving the industry leader no other recourse than to independently employ Yale University's Dr. Harlan Krumholz to investigate the research backing the products safety and efficacy without having any surgeon consultant influence.  Krumholz is looking to liberate the data and let the science speak for itself.  If all goes according to plan, the data from two independent sites, one in Oregon and the other in the United Kingdom should be finalized by this summer.   

Hopefully, this entire experience will temper Medtronic's arrogance and get them focused once again.  Who knows maybe Omar is really what the company needed?  The good old days are over, and regardless what some of our readers espouse regarding the big, bad, and evil FDA, if you never have sat in on one of these panel meetings when the consultants are spewing their company paid propaganda, maybe Medtronic would have never gotten itself into this position in the first place.  But then, when Jesus takes the wheel in the operating room, it doesn't matter how well Medtronic may have wanted to police Infuse, when its it God's hands the indications begin to get stretched.  TSB wants to know what our readers think?  Will this help or hinder Big Blues image?

Jesus take the wheel, take it from my hands
Cause I can't do this on my own, I'm letting go
So give Medtronic one more chance to save them from
the road their on, Jesus take the wheel.

38 comments:

  1. Glad none of my old coworkers have to go behind bars

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  2. If there was something to be found, the government would have found it. Sometimes the accusers simply get it wrong. This was one of those times.

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    1. Go fuck yourself faggot. Have a loved one you know have that protein put in the back and watch them suffer. Fuck you, fuck medtronic, and fuck the doctors.

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  3. When your a 12+billion dollar company there is a lot you can buy including apparently justice. However, if they don't buy some senators and congressman they will have lost their spinal division any way when PODs take over, which they are doing. PODs seem to be proliferating and not going away and this is bad news for Medtronic and all the other legit (lol) companies. When and if PODs do go away a great question would be what is the next model to induce surgeons to use your products.

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    1. Actually being a $12 billion dollar priced company makes it much harder to "buy justice" as you put it. Being a company of such size holds you to a higher level of scrutiny because the financial payoff of prosecution is so great. If Medtronic announced that it would begin forming POD's with physicians, you can bet POD's would be shut down so fast your head would spin, and Medtronic executives jailed for even speaking POD and Medtronic in the same sentence.

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  4. DePuy & Synthes will take over the #1 spot in Spine in ~5 years...

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    1. Why so long? 5 years?

      Is it because Depuy/Synthes Spinal integration will be a train wreck?

      The two companies have WAY too many reps calling on the same customers. Can not keep them all. Also, the recent decision to go direct in several Depuy Distributor areas will haunt them in the years to come. It's still a relationship business and distributor areas traditionally have long term relationships, show the most ownership of the business, and have the most tenure .

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    2. Yup! maybe that idiot Rob Sargent will be the President of J& J by that time and apply his wisdom

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  5. As a former employee, I happen to know since the launch of Infuse, Medtronic spent a great deal of money and effort towards controling how the product was marketed and advertised. The sales force was trained out the wazoo with more of an emphasis on how not to sell the product rather than how to sell it. Marketing had to put the brakes on their advertising creativity as if they had gags on their mouths and it was frustrating for them. This was long before Omar showed up. 4-5 years is a long time for an investigation and like the previous poster stated, if there was something to be found they would have found it.
    Also, all paid consultants representing the company disclose the fact that they are paid to speak for the company when at FDA panel meetings. This is with every medical device and pharmacuetical company that has ever gone to panel. The only thing they can discuss in panel meetings are the clinical trial results, analysis, saftey, and effectivness. I do not know how having an expert speak on their behalf on a specific topic has anything to do with Medtronic getting themselves "into this position in the first place" as you put it.

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    1. At the original Infuse panel meeting Hall Matthews openly declared he had no financial interest in the company or the product under discussion. Just look up the NYT disclosures of a few years later....

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  6. Two wins in row! Maybe big blue is back. I would not, however, expect them to go about their daily business with any less arrogance than they always have. If anything, there will be more of the same from top to bottom.

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  7. Is Globus STILL going public?

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  8. InFuse still needs to be thoughly studied. It is a drug..period. It received FDA approval as a device. This leaves many clinical and biological questions unanswered. The problem becomes how this drug reacts in a pateint is uncovered via it's use in the maketplace. That's not good, because the pateints become the ginny pigs. Medtronic knew exactly what they were doing when they reqested approval on the device pathway.

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    1. reminds me of Razzles! is it candy? is it gum?

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  9. Heard Pioneer is being purchased. Anyone with details?

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  10. Pioneer sure has re-organized their leadership team.
    good question?

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    1. Heard Zimmer is buying them.

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    2. Zimmer should buy whatever they can..their bag sucks!

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    3. SUCKERS!!!!!!!!!!!!!!!!!!!!!!!

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    4. So I heard that Zimmer and Lanx are working out a deal

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  11. FDA made Medtronic go the Device route because that’s how it fits in FDA’s categorization scheme. Regardless of what anyone’s personal views of what Infuse is, in the USA, it is FDA who decides. FDA’s definitions of what a drug is and what a device is posted on their website and Infuse is clearly a device.

    “The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; …”

    “The term “device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”

    Since Infuse is not metabolized, it is not a drug in the USA. It is however a Drug in Europe (but it has a different trade name there).

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    1. 2:19..InFuse is clearly not a device. It looks as those it falls into a gray area of the FDA's description of a drug, but c'mon..90% drug - 10% device? Also, FDA granted InFuse approval based on the condition that Medtronic provide answers to follow up questions regarding how rh-BmP-2 reacts with a number of different cancer cell lines. Medtronic never aswered those questions and/or suppiled the FDA with the follow up information.

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    2. Under the FDA definition of 'drug".."(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;"..isn't InFuse used, in part, as a treatment of DDD?

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    3. Well I guess you didn't read the definition of device then.

      The definition of "Device" also says the exact same thing...

      "...2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,..."

      The difference is whether it is metabolized or not.


      "...and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”

      I do belive Medtronic complied with the follow-up study but I don't know if the data is publicly available information. I've been gone for a while now. I wonder if someone else knows the answer to that and can let us know. It would be time consuming to try and find it.

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    4. They did not supply the follow up questions and studies to the FDA.

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    5. In the AMPLIFY PMA and panel meeting July 27 2010, lots more information re the followup studies (cancer, reproductive concerns) was disclosed. Not statistically different, but cancer rate ~2X in the Amplify (high dose InFuse) group vs. control. FDA in their remarks noted ~2X cancer rate in InFuse group in all 16/16 IDE studies to date, with none individually statistically significant. Also disclosed, BMP-2 antibodies cross the placental barrier in breeding rabbits.

      You may all follow the below link and become better informed before you continue sharing your "knowlege."

      http://www.fda.gov/downloads/AdvisoryCommittees/Committees
      MeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/
      OrthopaedicandRehabilitationDevicesPanel/UCM220079.pdf

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    6. Was referring to original study with LT cages.

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    7. Having spent 11 years working with a BMP, I have no doubt they must be classed as a drug. Both OP-1 and InFuse have a "bioactive" effect in recruiting and differentiating stem cells. The future is bright for both products in other applications. However they should not be used in applications without an indication. This is all about outcomes for patients and not financial gain. Maybe one day we all may need one of these products in a therapeutic application. I for one would like to be absolutely sure I'm not a lab rat

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  12. Medtronic (or soon to be Danek again) simply has better lawyers than the hapless Stryker.

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    1. Medtronic actually used the exact same Boston law firm as Stryker, and these attorneys already had experience defending similar bullshit allegations by the same incompetent and ignorant prosecutors. Bottom line: surgeons should and do know the FDA indications for BMP's, and choose to use it anyway they wish.

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  13. Did Stryker buy Pioneer Surgical?

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    1. Why the fuck would Stryker buy Pioneer? 8:04 you are an idiot.

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    2. You must have a boil on your ass 11:47 that just won't go away. So young. So angry.
      Smile. You'll live longer.

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  14. Word is Colson is going to acquire Pioneer's spine portfolio to flesh out OsteoMed's spine unit.

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  15. Heard Zimmer was buying Pioneer. Just rumors so far.

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  16. why the fuck would Zimmer need to buy Pioneer? Damn stupid rumor.

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  17. If this were China the Medronic thugs would be executed.

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    1. If it were china we would have a billion guinea pigs and no one would care about safety and efficacy.

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