Surgeries scheduled Nov., Dec. Jan.

[Lilysaidwhat]

yeesh. I know that's on the table for me. When we have the planning meeting next week, I'm hopeful that choice #1 is allograft.

[golfnut]

Dr. Lenke used a lot of BMP (I think 10 units??) He has been using it for a long time and won't do the surgery without it according to his nurse. He says the success of fusion is so much greater with it. Healthlink did not pay for it because it is still "experimental". Barnes ate the cost for it. Well, it's there now so I"m not going to read any more about it and worry about it.
Good luck with your surgery in Feb.

[Pooka1]

I found this on the downside of using BMP, which worries me since I'm about to have surgery with it...

http://www.medpagetoday.com/Surgery/Orthopedics/21908

Nice article. And interesting comment from Lenke by Golfnut that seems to dovetail with this one from the article:

Marybeth Thorsgaard, a spokeswoman for Medtronic, said the company fully disclosed the success rates of the doctors with financial ties to the company to the FDA. She noted that those doctors also had better results with the patients in the trial who did not get BMP-2.

The point here is unless they can disentangle surgeon ability with success then the results will necessarily be confounded.

It seems that if off-label use is at the root of this problem then they should disallow off label. I don't know why it is allowed.

The year 2002 is within the presidential "War on Science" years. Apparently there was a head guy at FDA acting for well over a year. This same scientific "genius" POTUS also had junior LAY cretinous "geniuses" telling climate scientists how to do climate science and were "editing" their reports. I would bet dollars to donuts none of these guys took much science in high school not to mention college.

Last, quoting from that study on why most published research results are false...(emphasis added)

Summary

There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research.

As a first cut suggestion, I think the top journals should require the data in a paper be broken out into that collected by researchers with a financial stake and that collected by others if combined in one paper. All data must be graphed and tabled separately. If all authors have a financial stake then there needs to be a statement in the abstract, introduction, methods, results, discussion, and summary/conclusions.

Just my opinion.

[Lilysaidwhat]

Your post is excellent, Sharon - and also highlights why so much of what you read out there has to be taken with a grain of salt. I skimmed the article - and honestly, a lot of what I read was typical for "ground breaking revelations about the evils of pharma and medical companies". *eyeroll*

Basically, any adverse reactions have to be reported. I am curious how many people who have actually used this product have problems. My guess is that the percentage is very low. Also, your point about the quality of the surgeon is key to interpreting results. This is different from the safety/efficacy of medicines, because placement and usage is key, and not something the patient can control. It skews the results in a (somewhat) unquantifiable manner.



ETA Karen, thanks for the well wishes. You sound like you're doing great and really progressing quickly! BTW I have a mini schnauzer myself and have already advised her that she is to cuddle with me for the days/weeks post-op when I'm feeling blue.

[SusanS]

Reassured by feedback....

I can't drive myself crazy with this. I'm stressing in a big way and I needed this reassurance, thanks. I know of two doctors who have no ties to Medtronic who seem to be very pro-BMP. I don't understand the quote above by the Medtronic spokesperson who said the results were better for those NOT receiving BMP-2.

I trust my doctor who knows a whole heck of a lot more about back surgery than I ever will. But I will be asking why they favor it, and whether or not it is true that fusion rates are basically the same as with bone graft, and if so, what are the advantages. There has to be a benefit or they wouldn't use it. I want the facts in order to make informed decisions, especially something as important as this. I get one shot at it.

[Pooka1]

I can't drive myself crazy with this. I'm stressing in a big way and I needed this reassurance, thanks. I know of two doctors who have no ties to Medtronic who seem to be very pro-BMP. I don't understand the quote above by the Medtronic spokesperson who said the results were better for those NOT receiving BMP-2.

As I understand that quote, they are saying that the Medtronic-supported surgeons who use BMP-2 have other (non-BMP-2) patients who do better than the other (non-BMP-2) patients of surgeons not supported by Medtronic.

So this is a reason to question that the reports of high success rate with BMP-2 by Medtronic-supported surgeons are due solely to their financial stake and not their higher skill level.

In other words, the higher success of the Medtronic-supported surgeons may be due to their better surgical skills PLUS BMP-2 use and evidence for that is that the non-BMP-2 patients do better than the non-BMP-2 patients of the non-supported surgeons.

This is hard to explain!

[hdugger]

I can't drive myself crazy with this.

I wouldn't stress over it. You've put thought into your decision and you've chosen a good surgeon. Beyond that, there's only so much of the universe you can control (which is probably a good thing, because, jeez, it's almost impossible to figure out the best course even in the small pieces we do control )

There's lots and lots of surgeons out there using BMP who don't benefit financially from it at all. I figure they have a good reason for using it, and that good reason outweighs any potential risk.

[SusanS]

That helps, thanks much! I just need to keep perspective. This is an article off the internet after all. My doctor is a far more reliable source of information, yet I am grateful for the article because it will cause me to get these questions answered and fears assuaged.

I appreciate your taking the time to clarify, Sharon. I knew I must be missing something!

I just got the news rather suddenly that my surgery date got moved up and it has thrown me into a bit of an emotional tailspin. They moved it up to help me out, but I just panicked. I'm kind of laughing at myself, I recently read a post by someone who was in a heap on the floor sobbing because she thought she was out of yogurt. I laughed so hard at that because I could so relate. I want to thank everyone on this discussion board. I can't imagine going through this without the wisdom, advice insight and humor everyone has so graciously shared.

[Pooka1]

SusanS,

Here's something else you may or may not want to consider...

Before my first kid was fused, I was talking to a friend who was fused many years ago who had bone harvested from the iliac crest. All these years later, she still has bad pain at the harvest site but no pain in her back.

On the basis of what she said, I was prepared to refuse permission for bone harvesting from the hip for my kid. That's how much it wigged me out. If my kid had a lifetime of hip pain because of that, that would be a hard thing for her or me to live with.

If the BMP-2 saves you from having bone harvested at the hip, that might be a VERY GOOD THING, all else equal.

[Doodles]

Wow--this is all really interesting. Made me get out my surgery notes. I knew I had BMP. Had 12 units of Infuse BMP-2. And like Karen, they said in STL if insurance didn't pay--the hospital eats the cost because they (Lenke at least) feel so strongly about it. Well, for sure I don't have an aching hip from harvested bone. Be interesting if Ed or Linda could shed a little light here. Thanks. Janet

[SusanS]

Sharon, thanks for helping keep my eyes on the prize. I regret very much posting the link. I didn't think it through and I sincerely apologize to everyone. I just have to believe that if the top surgeons in the world for this procedure are solidly behind it we are not only safe, but better off for having the benefit of it.

[Pooka1]

I think the link is fine. If it was of interest to you then it is probably of interest to others.

The main problem is we are bunnies and not surgeons and may never have the entire picture. But knowing and acknowledging that is half the battle.

Are you allowed to barrel race after your recovery?

[hdugger]

I think posting links and discussing this kind of thing is really valuable. The only caution is to rely heavily on your surgeon to interpret any of these things, because noone here is really qualified to interpret research. The fact that surgeons are using BMP indicates to me that they've sorted through the risks and benefits, but any good surgeon will talk through their assessment of the issue.

Having said that, of course, I started googling

In general, I'm reassured enough that I probably wouldn't pursue discussing this with our doctor (although my son hasn't yet had spinal surgery, I'm pretty sure they used BMP in his recent jaw surgery). There was a clear caution against using BMP in cervical fusions - that's considered off-label and risky (although sometimes done through necessity). I didn't see anything to set off alarms about cancer risk. There have been something like 500,000 surgeries using BMP, and no increased cancer risk has been noted so far.

The only thing I saw of any concern (and not in relation to this particular discussion) is that BMP is considered off-label for skeletally immature patients. That may be an old caution, but it's probably worth finding out a little more for parents who have children and teenagers going into surgery. Off-label doesn't necessarily mean there's a problem - it often means that they don't have enough information to evaluate the issue - but it does seem like a little bit of a red flag. Again, just one of many things worth discussing with your surgeon if you have a child going in for spinal fusion.

[SusanS]

Thank you so much... I'm bawling again, this time at the thought of spreading fear especially to those who already have had their surgery and need to have nothing but positive thoughts for restoration and healing.

I will be glad when I'm through this, I'm just falling apart! I'm stressed about the surgery and my job and wah wah wah...

I just need to buck up and focus on how fortunate I am, because I truly am blessed.

In answer to your question about barrel racing, Sharon, I hope so! I talked with a good friend today who has had four spinal fusion surgeries now and she is barrel racing again wearing a clamshell brace. One of my best friends has also had two spinal fusion surgeries and a hip replacement and she is riding again and hopes to get back to barrel racing (those two aren't yet 50!) Wednesday I'm having dinner with them and another friend who recently had her hip broken when her horse spooked and smacked into her-- she plans to get back to it as well. We'll all be chock full of hardware. We should form a drill team since we'll be so full of screws.

[Pooka1]

In answer to your question about barrel racing, Sharon, I hope so! I talked with a good friend today who has had four spinal fusion surgeries now and she is barrel racing again wearing a clamshell brace. One of my best friends has also had two spinal fusion surgeries and a hip replacement and she is riding again and hopes to get back to barrel racing (those two aren't yet 50!) Wednesday I'm having dinner with them and another friend who recently had her hip broken when her horse spooked and smacked into her-- she plans to get back to it as well. We'll all be chock full of hardware. We should form a drill team since we'll be so full of screws.

That's good news. My kids were released to ride if they wanted but they had given it up several years ago.

Bonnie Bonnello, former and perhaps future Olympian for Canada, had hip replacement recently. She is in her fifties I believe or possibly early sixties. She has a kick-ass horse again and was at he World Equestrian Games representing Canada. I read her only regret was not doing the surgery sooner.

Never lose hope.