NYT Article on Infuse product used in some spinal fusion surgeries

[djkinkead]

Saw an article on some questions regarding the use of this product in the NYT.

Here is the link if you are interested:

http://www.nytimes.com/2011/06/29/bu...ines&emc=tha25

The big controversy with the product is that currently it is stated there are no side-effects, but apparently there might be.

Also, as with any medical product, there are some doctors who might be using it when it may not really be needed--but receive money for using it.

Anyway, it is an interesting article, well worth reading for those of us planning for the surgery.

[SEThatcher]

Thanks!

djkinkead,

Thanks for posting a link to this article. I saw something about this on "The Today Show" this morning, but wanted to know more. Scary stuff for those of us considering surgery.

[LindaRacine]

This is the topic of much discussion this morning at UCSF. We have patients calling, wanting to know if BMP was used on them. Thankfully, none of the UCSF physicians or researchers were paid by Medtronic for any Infuse studies.

I haven't read the full journal articles yet, but the issue, as djkinkead stated, is that the complication rates may have been understated. The research in question apparently does make mention of the complications, but stated that the complications were not statistically significant. Gene Carragee at Stanford claims that the complication rates were actually 10-50% higher than what has been reported. Carragee is sort of known for being an alarmist, so I'm withholding judgement until I hear more. I knew about this research, and still chose to allow BMP to be used on me in my January surgery.

This, however, is just another example of why we should not rush into scoliosis surgery, especially with borderline curves.

--Linda

[judyat60]

Linda,
what is UCSF ?

[LindaRacine]

Linda,
what is UCSF ?

University of California San Francisco. We are one of the top 5ish spinal deformity centers in the US.

[titaniumed]

Dj
Its wise to be aware of potential complications. There is no way that you could walk down the street without a list of things that could go wrong. One could trip off a curb and end up with a permanent problem.

Even though many of us including myself came through ok, there is always that very remote possibility that something is going to happen. Many of us have to take that chance. We have to be very brave.

BMP is usually used in older patients. If there is a reason other than financial, I hope I don’t find out too soon. (small smile)

Tomorrow, I’m off to go skiing at Mammoth for the 4th of July for a much needed break. I will post some pics on the forum.
I have not been reading here everyday, life is back to normal. If you or anyone needs to chat, pm me and I will give out my phone #. There are also many members here that might be quiet online that would love to talk.

Good thread, and good that you are reading.....
Ed

[jrnyc]

brrrr...
have a GREAT time, Ed...i kinda know you will!

as for me...i'll be at the warmest place i can get to in New England...until i visit southern CA mid August...(smiley face)

wishing everyone a Happy Fourth...

jess

[Confusedmom]

I asked Dr. Lenke about possible side effects of BMP, and he basically said that taking all the pros and cons into consideration, he would use in on himself if he had to have the surgery.

Evelyn

[backissues]

I had forgotten about this discussion. I met someone at Dr. Rand's office who brought the issue about Infuse by Medtronic. After looking it up on the net, here is the latest info I got from
http://www.lawyersandsettlements.com...one-graft.html

I don't know how reliable this source is but here is some of the latest information:

"In June 2011, the US Senate Finance Committee announced it is investigating surgeons who were paid consultants for Medtronic. Committee members Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) sent Medtronic a letter to demand that key financial records, communications and documents be turned over to the Committee. The inquiry, which will look into whether those surgeons failed to report complications associated with the Medtronic Infuse Bone Graft, was announced because a soon-to-be-published study suggests that the bone graft product was linked to complications during clinical trials but those complications were not properly reported. Some of those complications reportedly include swelling in the neck and throat, abnormal bone growth and sterility.

In August 2011, Medtronic announced that it had agreed to have researchers from Yale University conduct an independent review of the Medtronic Infuse spinal bone graft. The review team, headed by Harlan Krumholz, MD, will look at patient data from Medtronic Infuse clinical trials and also all Infuse FDA adverse event reports since it came on the market in 2002. The Yale independent review will reportedly cost Medtronic $2.5 million and is anticipated to take six months to complete."

Does anyone have any further information?

[leahdragonfly]

This article is about problems that happened when Infuse (rBMP) was used OFF-LABEL during surgeries in the neck (cervical spine). It is not related to scoliosis fusions (which almost never include the cervical spine). The untoward side effects also happened between 2-14 days after surgery. I think that should be pointed out before people get worried about BMP. These concerns do not pertain to surgeries where it was used in the thoracic or lumbar spine.

[backissues]

Thank you very much for the clarification.

[LindaRacine]

More on the subject of rhBMP2 (Infuse). I had hoped to upload the article, but it's too big.

You can read the entire message here:

http://ryortho.com/spine.php?article...es-Dangerously

Unfortunately, you'll have to register to get it.

If you want the short story:

Intellectual Dishonesty
In the two studies we reviewed, we found material information that had been omitted from the Carragee study and gives the strong appearance of intellectual dishonesty. Accusing the authors of, in effect, spinning the results of their studies for pay from Medtronic, which Carragee and his co-authors are clearly doing, is a serious charge.
That charge impugns the integrity of each and every individual researcher whose name is associated with those studies.
But, when individual authors are examined at the time these studies were conducted, a very different picture emerges, as we saw with Boden.
TSJ and the authors of the June 2011 issue engaged, we believe, in advocacy journalism which created the appearance if not the fact of intellectual dishonesty. The expanding body of evidence includes, but is not limited to, omitting material information which would have changed the study’s conclusions as well as failing to apply standard and appropriate standards of research to the question of financial ties to the supplier of rhBMP-2 and the real issue of bias.
Bottom line, we think that Carragee et al are guilty of pulling The Spine Journal into a morass of methodological errors and unapologetic bias. In short, living dangerously.