PDA

View Full Version : BMP and cancer risk



Lorz
04-07-2011, 09:04 AM
A while back, someone posted an article about a possible connection between BMP use and cancer. I just asked Dr. Boachie about this. His answer was "There is no clinical evidence of this in humans(the study was done on rats), and the benefits clearly outweigh the risks" Just wanted to share this info. with everyone.

jesscv
04-07-2011, 12:21 PM
this still kind of concerns me. I am loaded up with BMP and wish I was aware of the cancer correlation (or other complications) two years ago when I had my surgery.

Lorz
04-07-2011, 04:40 PM
I read the same info about BMP-2 , and found it somewhat reassuring, but, I, too still worry about it.

LisaB
04-09-2011, 11:56 AM
Thanks for posting Lori. I'm loaded up with BMP but Dr Bridwell said that it was safe and I've read more good than bad. (also read the tumor suppressant info) it seems that everything carries some sort of cancer risk anymore. I'm not worried. Can't imagine that all of these top surgeons would use BMP (primarily on older adults who may be at higher risk of non fusion) if it wasn't safe!

golfnut
04-09-2011, 01:40 PM
Lisa,
I'm not going to worry about the BMP either. I am glad I have it because my main goal is to fuse! If I end up having cancer sometime in my life, I'll blame the plastic on
the Healthy Choice meals.

jeneemohler
04-09-2011, 02:10 PM
I love it! Good one, Karen. I really wish I were funny instead of analytical....

I'm with you guys. I'm not going to worry about the BMP. It seems like EVERYTHING causes cancer. I don't use salt, but do use lots of pepper. I read once that peppper may cause cancer. I have been using tanning lotion instead of tanning booths, and now there is info out there that says the active ingredient in the self tanners may cause cancer. I may as well just enjoy the warm sunshine!!!
You just can't do anything anymore without someone saying it is bad for you. I believe all things in moderation is the key. Just eat healthy, exercise, cut out all the stress you can, and enjoy a quality (not necessarily quantity) life!! It will be over before you know it...

Doodles
04-10-2011, 08:26 PM
Self tanners too! Darn. Janet

Confusedmom
04-11-2011, 10:07 AM
Hi all,

I asked Dr. Lenke about this, too. He said that the original study used a much higher concentration in rats than is used in humans. Also that of course some scoli patients will get cancer (as it is so prevalent in the entire population), and that it would probably take decades to determine whether there is a link between BMP and cancer in humans. He said it might not be determined "in our lifetimes." Also he said that if he were having the operation himself he would definitely opt for BMP. It cuts the risk of non-fusion dramatically. I'm going for it!

:),
Evelyn

JenniferG
04-11-2011, 04:02 PM
Yes, I would definitely want it if I was having this surgery. Fusion is what it's all about. Risks are everywhere.

patty22
10-26-2011, 02:22 PM
My brother just sent me this article and I was wondering what you all think? Do all surgeons use BMP?

http://www.jsonline.com/watchdog/watchdogreports/doctors-didnt-disclose-spine-product-cancer-risk-in-journal-132391068.html

Doctors didn't disclose spine product cancer risk in journal
Spine-product paper omitted key data
By John Fauber of the Journal Sentinel

Doctors paid millions of dollars by Medtronic failed to identify a significant cancer risk with the company's spine surgery product in a 2009 paper about results of a large clinical trial.

The surgeons left out important data and claimed there was no significant link between the product and cancer.

The company and doctors had become aware of information on an additional cancer case, which pushed the concern to a critical level, at least two months before the paper was published, a Journal Sentinel/MedPage Today investigation found. Independent researchers say they had an ethical duty to report the cancer risk.

The breach is the latest conflict-of-interest controversy facing Medtronic, which is under investigation by a U.S. Senate committee and the U.S. Justice Department for its marketing of the spine surgery product known as bone morphogenetic protein-2, or BMP-2.

The product is the bone growth stimulating biological agent used in the company's Infuse, which has been approved by the U.S. Food and Drug Administration, and Amplify, the unapproved product that was the subject of the 2009 paper.

................

First, the paper said there were eight patients who were diagnosed with cancer 24 months after being treated with Amplify, compared with two patients who got the standard treatment - a graft of their own hip bone. That resulted in the probability of a real cancer risk that fell a little short of what is considered statistically significant.

However, the actual cancer numbers were nine for those receiving Amplify and two for those who received bone grafts, according to the FDA records. At nine patients the cancer risk becomes significant, based on the way it is measured.

The ninth case involved a woman in the trial who underwent surgery with Amplify in 2003 and was diagnosed with stomach cancer in 2005. The patient did not report the cancer to researchers until her five-year follow-up in 2009.

In addition, cancer cases occurring three years after Amplify was implanted showed a clear statistical significance, said Brook Martin, a researcher with Dartmouth Medical School who analyzed the data for the Journal Sentinel. That data indicates that 12 patients had been diagnosed with cancer in the Amplify group, compared with three who got their own hip bone.

Martin said the authors had an ethical obligation to report all the cancer information.

"It absolutely should be presented, in my view," he said.

A three-year analysis was not done because that time point was not pre-specified, Marybeth Thorsgaard, a Medtronic spokeswoman, said in an email.

Thorsgaard and the paper's lead author said the ninth cancer patient wasn't discovered until after the paper had been accepted for publication in the journal, but they refused to provide the date. Thorsgaard said that when the company became aware of the case, it reported to the FDA in an April 2009 update.

That was at least two months before the paper actually was published. Neither Medtronic nor the authors could point to any evidence they moved to update the paper to reflect the accurate and more alarming cancer report.

Lorz
10-26-2011, 04:18 PM
I have done a lot of research on this subject, as it was also a big concern of mine prior to my surgery. The article is talking about BMP-2, or Amplify, not BMP-1, Infuse, which is what the surgeons use. BMP-2 has not gotten FDA approval yet. I have read all the reports of the researchers under reporting the side effects associated with Infuse, which is under investigation by the FDA. I spoke to Dr. Boachie about my concerns, and he feels it is safe, and has never seen any ill effects from it with his pts. I elected to have it, even with my history of thyroid cancer, because the thought of more surgery because of non-fusion scares me more.

Doreen1
10-26-2011, 04:45 PM
Dr. Lenke will not do surgery with out using BMP. He said BMP provides a 23% faster/stronger fusion which means less issues for his patients in the future.

Warmly,
Doreen

LindaRacine
10-26-2011, 05:04 PM
Hi Lori...

I think BMP-2 is INFUSE. No?

I'm in clinic today and we have been talking about INFUSE all day today. A patient (in Florida) who had a bad outcome, has now sued Medtronic because the problem is believed to have been caused by INFUSE. However, the surgeon used INFUSE in a TLIF, which is an off-label use. While I absolutely know it's wrong for a manufacturer to pay consultants to do favorable research, at the moment, there's quite a bit of controversy over whether or not complications were under-reported, which is supposedly the issue (reported recently by Carragee, et. al.) If this patient wins her suit, the flood gates will open, and thousands of lawsuits, or more probably, a class action suit, will probably be filed. This all ends up costing you and me a huge amount of our healthcare $. It could also mean that INFUSE is taken off the market, which could result in a lot more bad outcomes, and certainly a longer recovery time for people needing long fusions to the sacrum.

--Linda

Mojo's Mom
10-27-2011, 07:23 AM
My surgeon also will not do a fusion without BMP, at least not the kind of fusion I need.

One thing we all have to accept is that we have a potentially life-threatening progressive condition that requires fairly drastic action to combat. We have to make some tough choices. BMP will greatly increase the chances of successful fusion, and speed recovery. Our surgeons will likely insist on it, but should that make you feel confident it's safe in the long term? Not really...because you have to remember these are highly specialized spine surgeons. Their focus is on creating a successful fusion on a corrected spine. That is what they do and all they do, and they will choose the best tools for their job. I wouldn't really expect my surgeon to be that concerned with my overall health down the road. Neither do I expect that he would choose to use something that had a significant chance of causing cancer...but again, I understand what his priority is and where his focus is in treating me.

I will accept the risk because very little scares me more than a failure to fuse.

mabeckoff
10-27-2011, 08:49 AM
As you all are aware using BMP does NOT guarantee fusion .My first surgeon in NC used it and I still did not fuse.

Lorz
10-27-2011, 09:24 AM
Yes, Linda, you are right. Infuse and Amplify are both BMP-2, the Amplify is just a higher concentration. Sorry for the wrong info, it was a while since I did my research, and I should have refreshed my memory first!

titaniumed
10-27-2011, 09:34 AM
If your parents warn you not to play with fire, and you do and get burned, does that give you the right to sue?

Ed

Mojo's Mom
10-27-2011, 12:07 PM
As you all are aware using BMP does NOT guarantee fusion .My first surgeon in NC used it and I still did not fuse.

Gosh, I would hope we all know that NOTHING is guaranteed out of these surgeries, other than a long, hard recovery.

That said, the top surgeons seem to all use BMP at this point.

Mojo's Mom
10-27-2011, 12:08 PM
If your parents warn you not to play with fire, and you do and get burned, does that give you the right to sue?

Ed

In today's litigious society, Ed, apparently so. It plays out in courtrooms every day.