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concerned dad
06-10-2009, 11:24 AM
I ran across something that may be of interest to some folks. I was reading up about the doctor Dingo interviewed and came across a chapter from an online book which mentions one of his colleagues. The book is “Money Driven Medicine” and the Chapter posted on the web is Chapter 8: Device Makers, Drug Makers and the FDA (http://www.globalpatientnetwork.com/products/moneydrivenmedicinech08.pdf). (The book received very good reviews from most Amazon reviewers)

I have not read the whole thing, but the first 15 or so pages of this chapter discuss issues related to the FDA and spinal device manufacturers, specifically a certain disc replacement device. The fellow from UC Irvine looks to me like the “good guy” in this controversy.

The chapter offers an interesting perspective, almost from the “inside” about the world of orthopedic surgery and the ethical challenges these folks face.

Searching further, I found a paper (http://www.ispub.com/journal/the_internet_journal_of_minimally_invasive_spinal_ technology/volume_1_number_2_36/article_printable/the_potential_biomechanical_etiology_for_lumbar_di sc_replacement_failures_review_of_24_patients_and_ the_rationale_for_revision.html) written by both the doctor Dingo interviewed and his colleague discussed in the Money Driven Medicine chapter. It too is very interesting but should be read second (after the first 15 pages of the Chapter). I don’t pretend to understand much of what is covered in the paper, but expect some of the folks who are more familiar with spine surgery may better comprehend it. I did understand the last part of the conclusions where they say:
The regulatory function of the FDA to provide for the safety and efficacy of devices has been breached in this case. The authors believe this may be due to the inappropriate influence of industry on both the researchers and the approval process.

Previously, I posted (http://www.scoliosis.org/forum/showpost.php?p=74865&postcount=31) an abstract to a paper in Spine Journal “Is the Spine Field a Mine Field”. This sort of relates to that.

I offer this for discussion hoping that it is not controversial.

Dingo
06-10-2009, 11:59 AM
Yep, Kiester said that he understood why today's Lumbar disc replacements didn't work properly. I guess they don't work the way the back works.


"His research on how the lumbar spine (low back) rotates helps explain why the lumbar artificial disk replacements have had such poor results"

emarismom
06-10-2009, 12:32 PM
It really is very scary. As a parent, you really can't know who to trust and who really has the "best interest" of your child and not the all mighty dollar in mind.

Pooka1
06-10-2009, 02:32 PM
I didn't read the articles yet but don't these surgeons get an annual salary that isn't tied into the exact number of procedures? The professorships come with a flat salary, yes?

Now I'm wondering.

Pooka1
06-10-2009, 03:15 PM
I ran across something that may be of interest to some folks. I was reading up about the doctor Dingo interviewed and came across a chapter from an online book which mentions one of his colleagues. The book is “Money Driven Medicine” and the Chapter posted on the web is Chapter 8: Device Makers, Drug Makers and the FDA (http://www.globalpatientnetwork.com/products/moneydrivenmedicinech08.pdf). (The book received very good reviews from most Amazon reviewers)

From that chapter...

“The speaker warned us that we had better get used to evidence-based medicine, because it’s here to stay,” Rosen remembers. “And he suggested that if physicians didn’t deal with it, other people would bring it up.”

I certainly hope so.

CD wrote...


I have not read the whole thing, but the first 15 or so pages of this chapter discuss issues related to the FDA and spinal device manufacturers, specifically a certain disc replacement device. The fellow from UC Irvine looks to me like the “good guy” in this controversy.

The chapter offers an interesting perspective, almost from the “inside” about the world of orthopedic surgery and the ethical challenges these folks face.

The FDA slipped a number of times, all related to Bush's War on Science. They were making decisions NOT based on science, they muzzled government scientists, etc.

CD wrote...


Searching further, I found a paper (http://www.ispub.com/journal/the_internet_journal_of_minimally_invasive_spinal_ technology/volume_1_number_2_36/article_printable/the_potential_biomechanical_etiology_for_lumbar_di sc_replacement_failures_review_of_24_patients_and_ the_rationale_for_revision.html) written by both the doctor Dingo interviewed and his colleague discussed in the Money Driven Medicine chapter. It too is very interesting but should be read second (after the first 15 pages of the Chapter). I don’t pretend to understand much of what is covered in the paper, but expect some of the folks who are more familiar with spine surgery may better comprehend it. I did understand the last part of the conclusions where they say:
The regulatory function of the FDA to provide for the safety and efficacy of devices has been breached in this case. The authors believe this may be due to the inappropriate influence of industry on both the researchers and the approval process.

Again, Bush's War on Science. President Obama has vowed to put science back front and center where it belongs.

CD wrote...


Previously, I posted (http://www.scoliosis.org/forum/showpost.php?p=74865&postcount=31) an abstract to a paper in Spine Journal “Is the Spine Field a Mine Field”. This sort of relates to that.

From that citation...


A recent commentary in JAMA labeled the current system of industry-sponsored clinical research as “broken” and suggested that clinicians can no longer rely on the medical literature for valid and reliable information.47

(That last paragraph is especially for Sharon)

That is one very important though by no means the only reason the literature is a mess. I'm just saying I know zip about orthopedics and medicine and can spot elementary problems with most papers I have read. That is shocking to me if nobody else.

If there is a runaway train here, I wish the journal editors would do more to put the brakes on this stuff. Or start retracting papers after the fact. Something. Publishing uncontrolled studies has got to stop yesterday. It seems like this is the last outpost of science that hasn't gotten the news about the necessity of controlled studies. I need to reorient myself after reading these scoli papers when I pick up a journal article in my field.

LindaRacine
06-10-2009, 04:06 PM
From that chapter...

“The speaker warned us that we had better get used to evidence-based medicine, because it’s here to stay,” Rosen remembers. “And he suggested that if physicians didn’t deal with it, other people would bring it up.”


I was at a spine symposium at UCSF at the end of last week. Dr. Daniel Resnick spoke on just this subject. It's interesting to me that the things that are getting looked at are from mainstream medicine. As far as I can tell, alternative procedures are flying under the radar.

If you're really interested in this topic, I read a VERY long article this morning by Atul Gawande (author of one of my favorite books, "Complications: A Surgeon's Notes on an Imperfect Science.") You can read the article here:

http://www.newyorker.com/reporting/2009/06/01/090601fa_fact_gawande?currentPage=all

Regards,
Linda

mmm2001
06-10-2009, 07:31 PM
In any profession there are corrupt individuals. I would say, in my experience, most money driven people would not become pediatric subspecialists. In any medical specialty, the adult version inevitably makes more money. Also, I could argue that most people with the ability to make it through 4 yrs of med school and 5-8 years of fellowship/residency, probably has the ability to make a lot more money with a lot less work/call/responsibility in another field.

Evidence based medicine and rcts sound great and are ideal. But I know personally that if I only used FDA approved drugs for approved purposes and with ebm behind them, I would not be able to treat 90 percent of kids with epilepsy... Parents do not like to place their kids in studies, understandably so.

You have to have a good relationship with your doctor- find one that you can trust. I don't think it's naive to believe that the majority are still trying to do what's right for their pts.

Just my opinion...d

concerned dad
06-11-2009, 09:26 AM
mmm2001
I agree. I saw an interesting program on TV the other night and they compared the salaries of top surgeons (I think they said they were neurosurgeons) and they made a fraction of what the top people in the financial world make (still, not chump change).

I suppose the point of my post was that the Spine field, in particular, seems to be more susceptible to allegations of corruption. As the author of the paper in Spine noted, this is not where they “want to be”. Poor decisions by a few can cast a shadow over many.

Regarding the example you posted about going off label to assist your patients, that’s fine. Your decision is based on your knowledge and experience. However, I’m sure you would agree that if the off label product happens to be something you are financially tied to, well, that should at least be disclosed.

mmm2001
06-11-2009, 02:44 PM
I agree with that 100%. I personally am not tied to any pharma co- won't speak for them, won't take their money. But if I were, I would certainly disclose, and anyone should.

Neurosurgeons don't do too badly- but let's face it, their job is insane. Imagine the risk/requirements of being able to do surgery in such a delicate area. One of the peds neurosurg's at our hospital is at work about 20 hrs a day- on call 1 of every 3 weeks. Hourly, I bet his salary is none too impressive considering the training (15 years if you count college) and risk.

I'm not whining- we all have the ability to chose what we want to do. I love my job. But docs get bashed a lot now-a-days, and I would like people to know there is another side to it.

Still, we must weed out unscrupulous physicians, because it makes everyone look bad. Full disclosure is very important. I personally never really appreciated surgeons until my daughter decided to grow crooked- now I'm very thankful for them. (Well, at least one of them...)

: )

PNUTTRO
06-12-2009, 10:20 AM
It really is very scary. As a parent, you really can't know who to trust and who really has the "best interest" of your child and not the all mighty dollar in mind.

The ONLY person with your child's best interest in mind is you--the parent. Others think they know what is right or good, but the only person who really has a vested interest in the outcome for YOUR child is you.

That is why I like our health care system in the US. If I don't like a specific treatment, I can spend my money somewhere else. I get to decide what is good or right for me in my situation--not what the general consensus of doctors think or what is the current trend or, heaven forbid, what the government thinks is right for me.

Ballet Mom
06-12-2009, 10:52 AM
PNUTTRO,

Great post! Totally agree with your thoughts.

aterry
06-12-2009, 11:32 AM
PNUTTRO I agree with the jist of your comment but lots of people don't have money for choosing which doctor or treatment to use. In NY (and maybe everywhere) the most highly thought of spine doctors don't take insurance (or only a couple of fancy plans)--you have to pay out of pocket. This has lead to a disagreement between my husband and me. I want to go to the highly recommended Boacie, at least for a consult, but my husband says why get started with someone we can't afford, even if he is the best?

concerned dad
06-12-2009, 03:06 PM
I ran across the newspaper article (http://www.nytimes.com/2007/09/27/business/27letter.html?pagewanted=1&_r=1&ei=5088&en=d1bf8faf58bac33b&ex=1349150400&partner=rssnyt&emc=rss)that is referenced in the Spine paper "Is the Spine Field a Mine Field" . Pretty disturbing.


From another news article (http://query.nytimes.com/gst/fullpage.html?res=9C02EFDD1630F933A05751C1A9609C8B 63&sec=&spon=&pagewanted=print)by the same author:
Spinal-fusion surgery is one of the most lucrative areas of medicine. An estimated half-million Americans had the operation this year, generating billions of dollars for hospitals and doctors.

But there have been serious questions about how much the surgery actually helps patients with back pain and whether surgeons' generous fees might motivate them to overuse the procedure. Those concerns are now heightened by a growing trend among some surgeons to profit in yet another way -- by investing in companies that make screws and other hardware they install.

The parts can be highly profitable. A single screw that goes into the spine, for example, sells for about $1,000 -- at least 10 times the cost of making it.

These are pretty old. I sure hope they have their act together now. I think the recent "Is the Spine field a mine field" paper in Spine al least shows that they are aware of it and hopefully working on cleaning things up.

further in the article they say
Some spine surgeons are also concerned about whether they and their colleagues should enter into such arrangements. ''These are, I believe, unethical and bias the doctors' choice for what is best for the patient,'' said Dr. Charles D. Rosen, a spine surgeon at the University of California at Irvine, who is the president of the newly formed Association of Ethical Spine Surgeons. The group has about 75 members so far, who have agreed not to invest in companies whose devices they use.

For anyone not following along closely, Rosen is a colleague of the doctor Dingo interviewed. Maybe membership in the "Association of Ethical Spine Surgeons" should be viewed in the same way we often look at SRS membership.

Dingo
06-12-2009, 03:28 PM
PNUTTRO


The ONLY person with your child's best interest in mind is you--the parent.


That is why I like our health care system in the US.

100% correct.

Pooka1
06-12-2009, 03:48 PM
From another news article (http://query.nytimes.com/gst/fullpage.html?res=9C02EFDD1630F933A05751C1A9609C8B 63&sec=&spon=&pagewanted=print)by the same author:
Spinal-fusion surgery is one of the most lucrative areas of medicine. An estimated half-million Americans had the operation this year, generating billions of dollars for hospitals and doctors.

But there have been serious questions about how much the surgery actually helps patients with back pain and whether surgeons' generous fees might motivate them to overuse the procedure. Those concerns are now heightened by a growing trend among some surgeons to profit in yet another way -- by investing in companies that make screws and other hardware they install.

The parts can be highly profitable. A single screw that goes into the spine, for example, sells for about $1,000 -- at least 10 times the cost of making it.

CD, way back before my kids developed scoliosis, I had heard that surgery, presumably including fusion, is NOT the answer for back pain. The figure I recall is that ~60% of people operated on for back pain have MORE pain afterward long-term. In other words, the state of the art of surgery to address back pain is not there apparently. This is a legitimate area for alternative treatment in my opinion if only because we have evidence surgery fails to relieve pain often.

I think many accept that too mush surgery for back pain is going on and too much of that is not helping.

All of that given, it is IRRELEVANT to surgery (fusion) for scoliosis and by extension back pain associated with conditions associated with scoliosis where pain is only one indicator.

LindaRacine
06-12-2009, 08:18 PM
CD, way back before my kids developed scoliosis, I had heard that surgery, presumably including fusion, is NOT the answer for back pain. The figure I recall is that ~60% of people operated on for back pain have MORE pain afterward long-term. In other words, the state of the art of surgery to address back pain is not there apparently. This is a legitimate area for alternative treatment in my opinion if only because we have evidence surgery fails to relieve pain often.

I think many accept that too mush surgery for back pain is going on and too much of that is not helping.

All of that given, it is IRRELEVANT to surgery (fusion) for scoliosis and by extension back pain associated with conditions associated with scoliosis where pain is only one indicator.
At an SRS meeting quite awhile ago, there was a paper on who was doing scoliosis surgeries. The vast majority of scoliosis surgeries, at that time, were being done by non-SRS doctors. (Hopefully the internet has changed that at least a little!) I suspect the same thing is true for all spine surgeries. That is, general orthopaedists are doing most of the spine surgeries. If that's the case, it explains why 1) too many spine surgeries are being done and 2) why so many people who have back surgery end up with residual pain.

--Linda

Pooka1
06-12-2009, 08:30 PM
At an SRS meeting quite awhile ago, there was a paper on who was doing scoliosis surgeries. The vast majority of scoliosis surgeries, at that time, were being done by non-SRS doctors. (Hopefully the internet has changed that at least a little!) I suspect the same thing is true for all spine surgeries. That is, general orthopaedists are doing most of the spine surgeries. If that's the case, it explains why 1) too many spine surgeries are being done and 2) why so many people who have back surgery end up with residual pain.

--Linda

That might explain it.

But I question the general question about non-SRS folks doing scoli fusions.

Our SRS surgeon referred us to a non-SRS surgeon for my daughter's surgery. So at least some SRS guys seem to think some non-SRS guys are up to the task.

LindaRacine
06-12-2009, 08:40 PM
That might explain it.

But I question the general question about non-SRS folks doing scoli fusions.

Our SRS surgeon referred us to a non-SRS surgeon for my daughter's surgery. So at least some SRS guys seem to think some non-SRS guys are up to the task.

Maybe, but I think non-SRS surgeons with adequate training in scoliosis surgeries are exception rather than the rule.

--Linda

Pooka1
06-12-2009, 08:48 PM
Maybe, but I think non-SRS surgeons with adequate training in scoliosis surgeries are exception rather than the rule.

--Linda

Well if that were true, you are in the best position to know it. I certainly have no idea how true the comment is in general.

If you look at the requirements for SRS membership, I think you have to devote at least 20% of your practice to scoliosis cases. Apparently that might be easy enough to do while maintaining a specialty elsewhere. I asked the nurses how many scoli fusions our non-SRS surgeon does a year and it is comparable to some SRS surgeons based on what I have read.

LindaRacine
06-12-2009, 09:10 PM
Well if that were true, you are in the best position to know it. I certainly have no idea how true the comment is in general.

If you look at the requirements for SRS membership, I think you have to devote at least 20% of your practice to scoliosis cases. Apparently that might be easy enough to do while maintaining a specialty elsewhere. I asked the nurses how many scoli fusions our non-SRS surgeon does a year and it is comparable to some SRS surgeons based on what I have read.

Actually, they have to devote 20% of their practice to spinal deformity (which includes scoliosis, kyphosis, and spondylolisthesis).

--Linda

Pooka1
06-12-2009, 09:25 PM
Actually, they have to devote 20% of their practice to spinal deformity (which includes scoliosis, kyphosis, and spondylolisthesis).

--Linda

Yikes. Okay that even makes my point further!

That would definitely explain how a non-SRS guy can be doing similar numbers of scoli fusions as the SRS.

When I realized he was doing so many, I asked someone who would know why he didn't get the SRS certification and the answer was he had no reason to do so. There is no advantage to him I guess. He certainly seems to get enough scoli cases from SRS surgeons without it through word of mouth seemingly.

I guess this is similar to whether I join a particular scientific research society or not. Now that I can get any journal article I want free through work, there is no need to join. I may rejoin a few when I think I'm close to a promotion though, which may or may not be in this lifetime while I'm part time. :D

LindaRacine
06-12-2009, 09:38 PM
There are plenty of reasons to join the SRS, including supporting the organization that funds a lot of scoliosis research, and participating in multi-center studies on the discipline that pays one's bills.

With that said, I don't think being an SRS member is an absolutely necessity when one is trying to find a specialist, but I personally think it counts for a lot. The most important factor, in my mind, is whether the doctor has done a fellowship at one of the better spine centers.

--Linda


Yikes. Okay that even makes my point further!

When I realized he was doing so many, I asked someone who would know why he didn't get the SRS certification and the answer was he had no reason to do so. There is no advantage to him I guess. He certainly seems to get enough scoli cases from SRS surgeons without it through word of mouth seemingly.

I guess this is similar to whether I join a particular scientific research society or not. Now that I can get any journal article I want free through work, there is no need to join. I may rejoin a few when I think I'm close to a promotion though, which may or may not be in this lifetime while I'm part time. :D

leahdragonfly
06-13-2009, 11:32 AM
Hi Linda,

I agree with your comments above. I'm wondering though, in evaluating a doc's credentials, how is one to know if a fellowship site is one of the "better spine centers?" I am sure others have wondered this also.

Thanks,

Pooka1
06-13-2009, 11:43 AM
Hi Linda,

I agree with your comments above. I'm wondering though, in evaluating a doc's credentials, how is one to know if a fellowship site is one of the "better spine centers?" I am sure others have wondered this also.

Thanks,

Scottish Rite I think is one of the "better" spine centers AFAIK.

That's where the SRS guy went who handed us off to the non-SRS guy for the surgery.

At 20% of ALL spinal deformities not just scoliosis to be in SRS, I am thinking many, if not most non-SRS guys might be doing as many scoli fusions as many SRS guys. At least I wouldn't be surprised at this point if it were true.

LindaRacine
06-13-2009, 01:05 PM
Hi Linda,

I agree with your comments above. I'm wondering though, in evaluating a doc's credentials, how is one to know if a fellowship site is one of the "better spine centers?" I am sure others have wondered this also.

Thanks,

Hi Leah...

That's a good question. I don't think there's any easy way to know this, with the exception of checking out the amount of research done by at the center. I think it's best to at least check to see if the surgeon has done a spine fellowship.

My top picks would be UCSF, Washington University (St. Louis), Hospital for Special Surgery (New York), and Leatherman (Kentucky). With that said, there are a handful of surgeons that I've heard really great things about, who did not perform a fellowship in one of those places.

Although this list is dated, I try to track scoliosis specialists and list where they did their fellowship (if at all). You can find the list here:

http://www.scoliosislinks.com/ScoliosisSpecialists.htm

I'm sure that my short list will piss a few people off. So, I suspect we'll hear about other quality centers as well.

Regards,
Linda

dianew
06-14-2009, 03:02 PM
PNUTTRO I agree with the jist of your comment but lots of people don't have money for choosing which doctor or treatment to use. In NY (and maybe everywhere) the most highly thought of spine doctors don't take insurance (or only a couple of fancy plans)--you have to pay out of pocket. This has lead to a disagreement between my husband and me. I want to go to the highly recommended Boacie, at least for a consult, but my husband says why get started with someone we can't afford, even if he is the best?
Why go to this doc? If he has alot of valuable info to offer that others dont, its worth it. On the other hand if he has alot of valuable info. but doesn't want to share it unless you are financially commited to continuing with him, than it's a bust. How do find out the answer to that before your first visit???

dianew
06-14-2009, 03:28 PM
There are plenty of reasons to join the SRS, including supporting the organization that funds a lot of scoliosis research, and participating in multi-center studies on the discipline that pays one's bills.

With that said, I don't think being an SRS member is an absolutely necessity when one is trying to find a specialist, but I personally think it counts for a lot. The most important factor, in my mind, is whether the doctor has done a fellowship at one of the better spine centers.

--LindaThe most important factor, in my mind, is whether the doctor has done a fellowship at one of the better spine centers.

--Linda
with all due respect. coming from the perspective of a chronic sufferer and patient the most important factor, is if the highly experienced and educated physician actually cares about his patients. I've had much better patient care from my regular MD, (no specialty) than from somone on that referral list. I actually left a certain specialist office completely distraught from being told within 2 minutes of the doctor entering the treatment room there was nothing that could be done for me.period. It was both the"lack" of attention given my condition and the way it was verbalized to me. Unbelievably bad.

Pooka1
06-14-2009, 03:42 PM
The most important factor, in my mind, is whether the doctor has done a fellowship at one of the better spine centers.

--Linda
with all due respect. coming from the perspective of a chronic sufferer and patient the most important factor, is if the highly experienced and educated physician actually cares about his patients. I've had much better patient care from my regular MD, (no specialty) than from somone on that referral list. I actually left a certain specialist office completely distraught from being told within 2 minutes of the doctor entering the treatment room there was nothing that could be done for me.period. It was both the"lack" of attention given my condition and the way it was verbalized to me. Unbelievably bad.

Bedside manner matters for sure.

Other important considerations for me include the number of relevant procedures they do and their outcome. I take it as a given that someone doing a bunch of procedures is up on the relevant literature even if they aren't a member of a specialty society. I have yet to stump our non-SRS guy with any scoliosis question. I expect if he is doing scoliosis fusions that he knows the literature up and down, front and back, sideways, etc.

Dingo
06-18-2009, 12:36 PM
$788,000 Paid to Doctor Accused of Faking Study (http://www.nytimes.com/2009/06/18/business/18surgeon.html)


Medtronic said on Wednesday that it had paid nearly $800,000 over an eight-year period to a former military surgeon who has been accused by the Army of falsifying a medical journal study involving one of the company’s products.

Bio with photo of Dr. Timothy Kuklo (http://www.ortho.wustl.edu/FindaPhysician/Spine/kuklot/print.aspx)

Clinical Specialties
Cervical Spine (all pathologies); Spinal Deformity (both pediatric and adult); Spinal Tumors; Spine Trauma