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US bone-growth studies under fire for alleged bias

MetalneckMetalneck Island of Misfit toysPosts: 1,364
edited 06/11/2012 - 8:54 AM in Back Surgery and Neck Surgery
Hmmmmmm .... I just wonder what they used for my neck surgeries??

From Yahoo News today:

A US medical journal on Tuesday published a scathing critique of industry-funded studies on spine research, alleging that they failed to report adverse events to the journals that publish them.

The review study came days after the Senate Finance Committee launched an inquiry into whether doctors being paid by device giant Medtronic failed to report serious side effects from the bone-growth agent Infuse in clinical studies.

The product was introduced in 2002 to help bones heal after spinal surgery and has been used in about 500,000 patients. Since its arrival on the market, it has also been linked to some cases of cancer, male sterility, throat swelling and leg pain.

A Loyola University spokesman told AFP that some doctors in the spinal community believe that a "small number, fewer than five" fatalities may have resulted from its use, though no published data points to any deaths.

The review article co-authored by three US-based doctors in The Spine Journal says that in 13 trials involving 780 patients, "industry-funded researchers did not report a single adverse advent involving Medtronic's Infuse Bone Graft."

Meanwhile, the authors of "nearly all the trials had financial ties with the manufacturer, with investigators earning as much as $26 million per study," the journal reported.

The product brings in about $900 million in annual revenues for Medtronic, according to US media.

In 2008, the US Food and Drug Administration issued a public health notice about "life-threatening complications" associated with the product, also known as recombinant human Bone Morphogenetic Protein (rhBMP), when used in the upper or cervical spine.

"FDA has received at least 38 reports of complications during the last four years with the use of rhBMP in cervical spine fusion," the agency said at the time.

"These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking."

Last week, Senator Max Baucus, who chairs the Senate Finance Committee, and senior member Chuck Grassley sent a letter to Medtronic asking it to "produce documents related to its controversial bone growth product Infuse."

The senators "raised concerns over recent media reports that indicate medical researchers in charge of Infuse clinical trials may have been aware of and failed to report evidence that the product may cause sterility in men and potentially harmful bone growth," the panel said on its website.

"The letter also notes many of these investigators had substantial financial ties to the device manufacturer."

Medtronic said it had received the senators' inquiry and "intend(s) to respond," but noted that the side-effects mentioned are already included in its FDA-approved product labeling.

"Patient safety is of the utmost important to Medtronic," the company statement said.

"Accordingly, we provide PMA (pre-market approval) clinical study adverse event data to the FDA irrespective of any financial relationship between the company and the clinical investigator or study author."

The doctors' editorial in The Spine Journal said that the potential dangers of the drug -- noted by the FDA years after its approval -- were never mentioned in early industry-backed studies.

"Serious potential problems, such as the association of rhBMP-2 with sterility or cancer risks, which were prominently discussed in Food and Drug Administration documents and hearings, did not receive one line of discussion in the industry-sponsored publication of those trials," they wrote.

"It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research.

"We all must do a better job going forward," the editorial concluded.

The review study was authored by Eugene Carragee of Stanford University, Eric Hurwitz of the University of Hawaii and Bradley Weiner of The Methodist Hospital in Houston, Texas.

The editorial was signed by Carragee, Weiner, Alexander Ghanayem of Loyola University, David Rothman of Columbia University and Christopher Bono of Brigham and Women's Hospital in Boston, Massachusetts.

Some of these symptoms seem to ring a bell....

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  • Dave,

    As I read this article, my head did a lot of nodding!

    "swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking."

    Rings a lot of bells! You've seen my MRI's! (G) My second one (the one that caused most of my issues to date), they used a thing called "Osteocells". From what little I could find on it though...it is more to do with stem cells vs BMP methods?

    Yankee posted the same link btw. (G) It is an interesting article for sure!!

    PCTF C4 - T2, Laminectomies C5, C6 & C7. Severe Palsy left arm/hand.
  • Dave,

    Your surgical report will show if this was used in your neck or if a cadaver bone was used. I had used on my fourth surgery, right before the warning came out. I did suffer the consequence of it being used anterior and the swelling is not like typically swelling. My neck literally looked like I had golf ball inside of it. The swelling would be at the site of use, not just a over all swelling. The reason it was used in me was due to the known case of psuedo I have had. With that said there are surgeons, my current surgeon still using the product in rare cases in the cervical spine, but it must be used posterior. He did scrape using it on this last surgery, which had a lot to do with the 360 that was done. The biggest problem on the product is some surgeons used it like if a teaspoon of sugar tasted good then why not put a tablespoon in. The other issue is the fact it can grow bone on the nerve roots, and can only be seen on direct examine. There is some great articles on the forums already discussing it, as ERNURSE, put them up.

    I try to caution anyone whom is letting a surgeon put this in them and we have had several post the warning in July of 08, that have had it done with success. If your concerned it was used on you, read your surgical reports. The product is kept frozen and facilities keep track of it's use, as it is very expensive to use. It is not like one of those hundred dollar items it runs about $10,000 if I remember the price I seen correctly. So it will be definitely be itemized even on the billing. NO surgeon should use this on anyone without them knowing it. If they do, I would run and run fast. You should always know on any surgical procedure what they are doing and any thing they are using that could be recalled. Also I did leave with a brochure on it that it had been used in my spine and the things to look for. I did also know up front it was being used, but that was before the warning. Did I mention I fused completely inside 2 months with it.
  • MetalneckMetalneck Island of Misfit toysPosts: 1,364
    scary surgical stuff .... It would appear that at my last surgery both autograph (my own hippie bone) and BMP-2 Infuse was used for my procedure.

    Not that I'm complaining as I was declared fully fused at 6 weeks post 3 level Anterior - Posterior revision.

    This was after my 2 level ACDF was non-union at over 1.5 years using allograft (cadaver) implant.

    As I said - HHMMMMMMmmm!?


    Spine-health Moderator
    Welcome to Spine-Health  Please read the linked guidelines!!

  • jlrfryejjlrfrye ohioPosts: 1,110
    All I can say is it worked for me after 4 previous failed fusions
  • Well Dave,

    Apparently (as we found out) "Osteocel Plus" that they used on my last fusion *is* in the BMP classification for boosting bone growth. Grrrr...Different company, but same results are desired. I even found some trials that paralleled Osteocel with BMP - interesting.

    Oh, fusion...failed. I did fine on the first one with the good ole cadaver graph! Sigh...

    PCTF C4 - T2, Laminectomies C5, C6 & C7. Severe Palsy left arm/hand.
  • From: CindeeSunnyFL
    To: CindeeSunnyFL
    Subject: 10/31/07-3-level acdf -c4/5,5/6,6/7; did not operate on t1/2:major Curious, heard re medtronic, but I had biomet EBI spinalpakII, pads on neck, electrical or magnetic stuff put between disks; just April after prev 11-1 '07, I already developed herniated c3/4, no cord compression. another MRI 13 mos ago, between then and now, voice started changing last august, now i sound like long term smoker. I told all docs-No more ever surgery, took me years just to accept my major changed life with pain. I spent yrs on meds, Pain like crazy, still have but came to terms as I was improving mentally, off so many meds.

    New spine brd told me to bring husband back with me: NEW osteophyte complex bone growth, serious 360 degrees developed in only 13 months at post complication NY acdf surgery and so serious that I have only five weeks b Research before I could lose breathing, being super careful.
    Post surgery, doc sent man to show me how to wear it, though on brochure it showed LUMBAR. I Was in so much pain for two of those first years, I know I did not notice.
    these pads I wore for a year-24/7, right at a year, i am concerned as docs are investors. I should have noticed all brochures just had lumbar/not C-spine. Has anyone had it taken out. They say I have cord compression fr c3/4-t1/2, no way.

    I have tried all to get rid of pain-acupuncture, epidural, rhizotomy, plus...
    Any info on Ga or Fl neurosurgeons, no investments. I just keep thinking my doc was best in our big town. Good schools, I check them. H e l p! X(
    Geez, more painful surgery. Do they take fusion stuff out? Both spinevsurgeons wantbto fuscc3/4. Take metal 3-level fusion. I want them to only do what it takes to breath, geez. I am in fl, good health, 52. Hardest srurgery ever vvdepressed stay ing homevall day with son, just need break.
    Any help is appreciated. I love my career. Kids in college. Really upset, do not want to upset good surgeon who used this off label. Do they chip it out? Leave it? What to do. Thx...breathing is not an option
  • So glad to see more attention to BMP complications. Now, if I was a failed fusion patient, diabetic, others complications, and desparate, I MIGHT agree to it. As a healthy person who had it in lumbar fusion, darn. I have arachnoiditis. It is directly from BMP. Also, studies are showing BMP can cause some types of cancers. I am being treated for breast cancer(hence my absence from the boards.)

    Now, I'm NOT a spine professional but I can share my experiences and have posted lots of links to research. Please discuss it with your doctor. Print off the articles. It's a great way to open a dialog with your surgeon, pain management guy, lawyer, whatever your reasons are.

    But, cancer sure does change your perspective. I'm not happy about BMP. I still would have changed that decision. However, I've moved from anger to advocacy.
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