California Technology Assessment Forum recommendation on ADR

[mmglobal]

Yesterday, I went up to San Francisco to attend a meeting of the California Technology Assessment Forum. What I write here are my impressions as a patient attending this meeting. I give you my impressions, and will relay the information as I perceive it. I can not vouch for the veracity of the information I received. It was a tough decision to go. Airfare at the last minute is not cheap and I wasn't even sure I'd get in, no less speak. Fortunately, I was able to put myself on the agenda to testify before the panel.

The CTAF forum is supposed to be an independent review board that reviews new technologies to determine if a medical technology improves health outcomes and is safe and effective. I'm not 100% certain of the relationship between the insurer and the 'independent panel', but everything I could discover seemed to indicate that CTAF is funded by BC/BS California. I will update this thread if I discover otherwise.

This meeting was not only for Artificial Disc Replacement. Other topics were; Laparoscipic Adjustable Gastric Banding, Low Dose Spiral CT Screening for Lung Cancer, and Drug-Eluting Stents: an Update with a Focus on Safety.

The ADR session started with a comprehensive review of the status of Charite' and ProDisc data by Jeffrey A. Tice, M.D. from UCSF. Dr. Rick Delamarter then presented ProDisc data. I'd say that the major theme of his presentation was, ProDisc is not Charite'.

(This is Mark's assessment, not Delamarter's presentation: After all of the problems with the roll-out of the Charite', who can blame Synthes for such an approach. They have learned from the mistakes of DePuy Spine and are doing a much better job of packaging that data. Where the Charite' study was designed to demonstrate non-inferiority to fusion, the ProDisc data is said to demonstrate superiority. ProDisc numbers are somewhat better than Charite' data. I believe that there are 2 major reasons for this. First, the lessons learned from the early months of the Charite' study were shared with the ProDisc investigators. The state of the collective knowledge in the US surgeon community at the start of the Charite' study was almost zero. Lessons learned regarding implant sizing, positioning, patient selection, access related complications, etc... were all carried into the ProDisc study. Second, with the roll-out of Charite' after the study population was filled and after FDA approval we saw a lot of surgeons with little experience, only recently trained, experiencing their 'learning curve' with little oversight. Synthes did a much better job of making sure that quality surgeons were properly trained and would not release the device for extreme. Only the most experienced ProDisc surgeons have been allowed to do multi-level cases. There are much tighter controls, self-imposed by Synthes.)

After Dr. Delamarter, Dr. Tim Peppers of Core Orthopaedics in San Diego spoke. He's got a couple of hundred ADR's of several different varieties under his belt and provided his positive data. After Dr. Peppers spoke (10, 2, 4), I took my turn. I'd prepared some notes that I'll include below. However, speaker guidelines (that I'd only received 1/2 hour before) and time constraints got in the way. I got most of it in and I believe provided a unique perspective, not only from my personal experience as a Blue Shield customer with multi-level ADR, but also from my perspective as a professional spine patient advocate with hundreds of clients with all different types of spine surgery.

Having lived in the spine patient community for almost a decade now, I could tell that we were in trouble as soon as my presentation was over and the discussion began. An MD came up to the audience mike and began talking about a new training regimen called 'pilandes, or something like that.' He'd tried it, strengthened his abdominal muscles and it improved his back pain. Maybe we should try that? From that point on, I felt like I was on another planet and that these critical decisions would be make by people who have little or no understanding of what we face as spine patients. I understand that they see negative outcomes. I understand that it would be nice if there was a sure fix for our problem, but there isn't. Denying us access to the best technology available because it is less than perfect does so much more harm than good.

Edit to add: There were some comments by some, stating that they don't believe that fusion results meet the approval criterion either. IMHO, back in the day when fusion was even worse than it is now, many came to believe that fusion is a bad idea and don't believe that they are warranted. The draft recommendations mentions the studies that have demonstrated that long term results for conservative treatment demonstrated numbers similar to fusion results.
End of edit.

Dr. Charles Wilson made a motion that they agree to bifurcate the discussion of ADR and vote on two separate recommendations; Charite' and ProDisc. It was agreed and they then voted separately on motions (also made by Dr. Wilson) to continue to recommend that the use of Charite' and ProDisc doesn't not meet Technology Assessment Criterion 4 and 5 for safety, effectiveness and improvement in health outcomes when used to treat pain and disability from degenerative disc disease of the lumbar spine.

The vote was unanimous against Charite'. (I believe that there were about a dozen or so voting members. I'll correct the count when I get the minutes.)

There were three votes for ProDisc. I guess that's progress.

---------------


The materials handed out before the meeting included a draft recommendation. Here are the five criteria and the assessment of the forum:

Technology Assessment (TA) Criterion 1: The technology must have the appropriate regulatory approval. Met

TA Criterion 2: The scientific evidence must permit conclusions concerning the effectiveness of the technology regarding health outcomes: Met

TA Criterion 3: The technology must improve the net health outcomes. Met.

TA Criterion 4: The technology must be as beneficial as any established alternatives. Not met.

TA Criterion 5: The improvement must be attainable outside the investigational setting. Not met.

From the conclusion of the draft recommendation, "... despite the promising results of the two randomized trials, it is not clear that the possible benefits fo the artificial discs outweigh the attendant surgical risks and the possibility of log-term device failure."

I guess they've never experienced years of unrelenting, severe, chronic pain.

I'll post my presentation later. Gotta go now... tickets to see Bob Seger tonight. Going to a concert is something I could not have conceived of doing in the years before my ADR surgery. "Thank you Dr. Zeegers, I love my artificial discs!"

Mark

[Poncho]

Mark,

I'm trying to wrap my mind around criterion 4 & 5... The numbers in the studies I have read proved to be as beneficial as the "golden standard" of fusion.

I'm not sure what they mean that improvement must be obtainable outside the clinical study. My impression is that there must be some sort of measurable improvement of the patient population after the 2 year study is completed???

I'll think it through a bit more...

Have fun at the concert.

Poncho

[mmglobal]

I forgot an important point. Before Dr. Wilson made his motion, he and others made some comments stating that they don't believe that fusion results meet the approval criterion either. IMHO, back in the day when fusion was even worse than it is now, many came to believe that fusion is a bad idea and don't believe that they are warranted. The draft recommendations mentions the studies that have demonstrated that long term results for conservative treatment demonstrated numbers similar to fusion results.

More later,

Mark

[letteski]

Dr. Wilson should be ashamed of himself for not looking at what technology can do and how it can change people’s lives. I can’t wait for the day my fellow ADR study patents and I grow up and prove him wrong. I will do every thing I can as a ProDisc study patent to make this happen. He will be down right embarrassed that he made statements like this that robed people of a change to get their lives back.

Mark can’t wait to here more about this forum meeting.

See you soon.

[dshobbies]

For once, I have no comment. I am astounded and disappointed. I was one of the fortunate ones who could afford to go to Germany, the U.S. cost being double or more.

So if fusion doesn't meet the criteria either, what are we supposed to do for relief? Maybe we can enter the Twilight Zone where they put our head on someone else's otherwise healthy body... a body transplant!

I actually do have a comment but it's not printable.

Dale

[mmglobal]

There is another CTAF meeting today in Los Angeles. ADR is not on the agenda, but PLLD is. (Percutaneous Laser Disc Decompression)

I was not planning on going, but I can't resist. I'm interested to see if the anti-spine surgery bent I witnessed when ADR was the topic applies to MISS procedures as well.

I'll report back tonight.

In case anyone is interested and hasn't already seen it, here is the assessment from the ProDisc session last year. (From the ctaf.org website)

[mmglobal]

Looks pretty grim for PLLD

http://www.ctaf.org/UserFiles/File/J...al%20draft.pdf

[nopain]

The answer of course is Prolotherapy (Okay don't kick me off the boards I'm just teasing to make a point).

Caring Medical in Chicago:

Pain that comes and goes is not originating from a herniated disc. Herniated discs pressing on nerves are severely painful. The person is hunched over, has difficulty moving, and is in obvious distress.

Let's say, for argument's sake, that a person does have a herniated disc pressing on a nerve. The best treatment for this case is Prolotherapy, along with nerve blocks given using plant extracts. In this scenario, the Prolotherapy treatment is given once per month and the nerve blocks are given every week to two weeks, until the nerve pain is resolved. Typically, after three to four nerve blocks, the acute pain is resolved. The more low level chronic pain is helped by the Prolotherapy. This regime has been successful in over 90% (actually closer to 95%) of herniated disc cases at Caring Medical. In the over 45 years the clinic (with Dr. Hemwall) has been treating herniated disc cases, only a handful have needed a surgical procedure.

For all other disc conditions, it is not the disc that is causing the pain. For the person desiring a in-depth explanation as to why this is the case, please read Chapter 17 in the book Prolo Your Sports Injuries Away! entitled, "Prolo Your Back Pain Away!" by Jean-Paul Ouellette, M.D (available by calling Beulah Land Press at 1-800-RX-PROLO or www.beulahlandpress.com.) Dr. Ouellette explains that vertebral instability caused by ligament laxity is the cause of degenerated discs. If a person does not correct the vertebral instability by repairing the ligament laxity, the low back will continue. Epidural cortisone shots, intradiscal electrothermal therapy (IDET), and other anesthesia techniques under fluoroscopy do not repair the ligaments that support the vertebrae. Top

Techniques such as epidural cortisone shots, IDET, and anesthesia-directed nerve blocks are done under fluoroscopy. The cost is enormous, often being in the several thousands of dollars range. We recently saw a patient who stated his IDET procedure cost $6000.00. Prolotherapy to the discs under fluoroscopy (a technique that we do not use) also costs several thousand dollars. All of these procedures do nothing to correct the ligament laxity that is causing the disc degeneration. Prolotherapy is the treatment of choice in this situation.

Epidural cortisone shots do nothing but mask the pain for a week, possibly a month. IDET involves frying or heating up the disc, so, at best, it represents destroying the nerves to the disc. Prolotherapy to the disc sounds great, but in reality, why go through all of the expense of this when all that is needed is Prolotherapy to the lower lumbar vertebrae to repair the ligaments that are causing the degenerated discs?

Hackett-Hemwall Prolotherapy for low back conditions, including degenerative disc disease, spondylolisthesis, spondylosis, and herniated discs, done at Caring Medical has an over 90% success level. There is no need for someone with low back pain to do these other "high-tech" procedures. Hackett-Hemwall Prolotherapy costs $300-400 per session for a complete lower back treatment. The typical patient requires three to six sessions. It is much more cost effective than these other low back procedures that do not stimulate the repair of the painful areas that are causing the degenerative discs.

One should also realize that many people with low back pain have normal MRI's and those with no back pain have terrible discs on MRI's.

only a handful have needed a surgical procedure.

What it didn't work for everyone?

It's the people that these therapies don't work for that Doctors seem to care less about.

One should also realize that many people with low back pain have normal MRI's and those with no back pain have terrible discs on MRI's.

I might just have to punch the next Doctor that throws this bullshit line in my face. While this may be true, the opposite is also true so it's a bullshit statement. To generalize a patients suffering with a statement like this is poor medicine. I've never heard this out of the mouth of a Doctor who understands the suffering of pain patients, only those who think they have all the answers and are quick to dismiss my suffering. I'm not stupid. I get it. MRI's don't diagnose pain, they just provide an image. Why am I venting today?

If I try a therapy and my back pain goes away does that mean that the therapy "works" and that's what everyone should do? That is exactly what the MD that hit the microphone is implying. Maybe a career in Chiropractic would have been more suited to his methods, as they seem to believe they can cure everything too. - ought oh, my ornery side is coming out.

The point being there are many treatments and many advocates of a treatment. To date there is no "cure" that fits all people. So it's extremely frustrating when supposedly educated people are so close minded. The products on the market today may not be the "fix", but if you shut them down and don't investigate further you won't make any progress.

The first airplane didn't fly!!! Neither did the second or third.

Mark you must be incredibly patient to attend these kind of meetings and get shut down in that manner. My personal frustration levels with those kind of Doctors just make me not want to see any Doctors.

People who have not experienced the disability themselves just "Don't get it". Not treating a problem, is not a solution.

What's the cliche'? "You can't keep doing the same thing and expect a different result".

Fortunately this is one group of Physicians and who knows if there is a backdoor agenda.

How does muscle strengthening repair a herniated disc that has collapsed? If the foundation of a building is rotted away, you can patch the walls all you want, the building is still going to fall. When doctors can pinpoint 100% the cause of pain in every case then they can find the magic cure. Until then I have to believe there is a reason people look outside the US for Medical Care.

[Maria]

This sounds akin to those that make Social Security/Medicare policy/decisions/legislation. They just don't *get it*.. and those of us that do, or have to live by it suffer the consequences of the decisions made by those that don't have to really live it.

[wilsonrob]

I have had many surgeries that were successful in which the MRI showed nothing. In addition I have had insurance companies state that their board certified neurosurgeon believed that there was no spine surgery indicated. However, I had the surgery (out of my own pocket) and it got rid of my pain. When I called the insurance company to ask them if they cared about my outcome they did not respond. So obviously this situation is not about the patient.

[dshobbies]

I heard about prolotherapy for my knee. I had a consultation and threw out $75 on that quack. I only had pain for about 1 month, not chronic enough to be treated????? No wonder insurance doesn't cover it!

However, before I condemn this alternative treatment, I will also tell you that I had accupuncture for my nerve damage and it has helped immensely. Not that I'm trying to compare one to the other. Maybe in 500 years we'll give prolotherapy its due.

[nopain]

Who knows if Prolotherapy works. That wasn't really my point. Prolotherapy advocates like to point out C. Everett Koop as a patient/believer. I'd imagine it's like any other treatment - proper patient selection + and experienced Physician.

More interesting to me as a Cervical Spine patient, I don't read a lot of back related ADR literature. So this interested me a bit when I read what Mark wrote...

An MD came up to the audience mike and began talking about a new training regimen called 'pilandes, or something like that.

I don't know what Pilandes is or if it's the same as Pilates? http://en.wikipedia.org/wiki/Pilates (Yeah I know Wikipedia - accept my apology).

Seems like a Yoga type modality to me. Again I don't see how exercise will restore a disc that has completely collapsed. Anyone that watched this past Weeks US Open at Torrey Pines probably knows Tiger Woods has torn cartlidge in his knee. He played through the pain. He "Pilates" right through it! Mind over matter! And now he is off to have surgery, because exercising his bad knee joint caused more pain and damage.

So it's hard for me to fathom that a modality that exercises a severely damaged joint in the back would be any more effective than exercising a severely damaged joint in the knee. And believe me I understand the benefits of exercise to ones body. But mechanical failure is physics and gravity.

I'm sure Mark has knowledge of this interview with Dr. Rosen on the Charite http://www.ethicalspinesurgeon.com/a...ealthpoint.htm.

What I find troublesome is the exclusion of data, but more so the implication that the company behind the device was so eager to push it forward that they were willing to push aside science in the name of profit.

That sets a really bad precedent for other companies who "play by the rules".

It puts the new trials of other disc replacements at an immediate disadvantage in the eyes of the medical community. It's like having a trial by jury except there is no exclusionary process to weed out the juror bias.

I get very frustrated when I read these things.

[Poncho]

I'm impressed with the interesting and well researched responses on this forum.

Unfortunately, many of those that make these so called "informed decisions" based on so many "evidence based" documents may or may not truly understand what living in chronic pain (especially neurogenic) is all about. There are just too many companies out there trying to gain market share for their company - if they can just slide through the approval process to push through their device for a patent......I think most of you can finish out what I am thinking here.

I'm glad that Mark went to represent us as a spine community to shed some light on what living as a spiney with minimal options is all about. Even spine surgeons truly don't understand what living this kind of life is about - unless they suffer a similar injury.

We all need to keep fighting and researching (we - meaning myself included)

Soon, I will try to put up more articles available in the medical community where I work. Hopefully, discussing them will allow for a constructive critical analysis of the data. If such a discussion can help just one person - then I/we are fulfilling our mission on iSpine (in my eyes).

Wishing all less pain / no pain today.

Sincerely,
Poncho (Ponchita)

[nomorepain]

Maybe all of us ADR recipients in the Los Angeles area should go and crash the CTAF meeting and make ADR a part of the local meeting & show how
ADR has changed our lives for the better!!
I'm game, who else?

[ans]

You would think that cost-wise an ADR under the best circumstances is a better option than fusion - especially if there's DDD. Although there may be no incredible evidence (imo) that supports diminished adjacent segment deterioration, is this worth the cost of them paying for another fusion, then another?