ProDisc Fraud

[dogmattic]

I am conducting research on the fraud of the general public, as perpetrated by the fixing of the Prodisc trials. By 'fixing' I refer to the fact that most of the surgeons involved, were financially invested in the success of the Prodisc. From a scientific point of view, I have not found any (untarnished, unbiased) evidence to support the various claims of Prodisc success and superiority over alternative devices or methods. That is, if you discount all the trial data which is championed by financially interested parties, as well as journal papers, then you tend to end up with quite a lot of negative reports. Of course, you have to cancel out the negative reports which are generated by parties literally 'short selling' the Prodisc, due to their investments in competitors such as the Charite, Maverick or M5.

[Hooch]

Gday,

Can you link to some studies you consider unbiased.

Cheers.

[dogmattic]

Well, that's actually what I'm looking for. But here, for example, is a study which kinda puts things into perspective. Note, this is not a clinical trial, but a review of such papers. In statistical terms, the variance in results is so great that it can not be attributed to surgeon experience or random variation. Therefore, someone is fabricating data ..

Total disc replacement for chronic low back pain: background and a systematic review of the literature

SpringerLink - European Spine Journal, Volume 12, Number 2

In this paper the rationale for total disc replacement is discussed, and the authors suggest seven requirements that should be met before the implantation of these devices can be accepted as regular procedures. In an attempt to answer the questions raised, a systematic literature search was performed. The search yielded no controlled trials and nine case series with a total of 564 arthroplasties in 411 patients. The devices used were SB Charité in eight and Acroflex in one study. The percentage results classified as "good" or "excellent" in the studies varied from 50 to 81%. Complications were observed in 3-50% of the patients. Twenty-two of the operated levels were fused either spontaneously or after additional surgery. A meta-analysis to compare the results with other treatments could not be performed due to the lack of comparative studies. Despite the fact that these devices have been implanted for almost 15 years, on the basis of this literature survey there are currently insufficient data to assess the performance of total disc replacement adequately. There is no evidence that disc replacement reliably, reproducibly, and over longer periods of time fulfils the three primary aims of clinical efficacy, continued motion, and few adjacent segment degenerative problems. Total disc replacement seems to be associated with a high rate of re-operations, and the potential problems that may occur with longer follow-up have not been addressed. Therefore, total disc replacements should be considered experimental procedures and should only be used in strict clinical trials.

[Metalneck07]

Dog- The information you have found was written on the Charite not the Prodisc.And it was written in 2002 who knows when the actual trail was done.But again if your doing research to notify the Public of the potential of false information that was given by Prodisc trials I'm not seeing any such claims. I'm not sure if you noticed but this site was founded to support Spine patient in there journey to overcome there issues.As well as provide Educational information to help them.Throwing around false unfounded information is not one of the purposes of this site.
Metalneck07

[runagain]

Dog,

The FDA approved the ProDisc in 2006 and this article, that you posted, was written or published in 2003.
So this article does not even pertain to the ProDisc artificial disc.
I don't know if there is any 'fraud of the general public" as you say and the same thing about financial investment in the companies has also happened with fusion products or devices.
It does sound like the FDA has been tightening ship as they have increased their scrutiny on products--at least that is what I see after reading medical publications and the like.
There are several of us who are very happy with their ADRs and like fusion surgery there have been revisions. But as several of us have said on here, the most important factor is that a person has a very good surgeon before they have any spinal surgery.
There is some discrepancy between what Dr. B reports or reported as his initial success rate for the ProDisc and the American trials but that is well documented.
There is a learning curve for any device with any surgery for a surgeon and that number is targeted to be around 100 cases. I have seen the articles in the New York Times before and I will have to say this for anything that is printed in the news--you have to take anything you read with a grain of salt.
Are you trying to prove that ADRs are experimental??
If so, well than maybe you should speak to all the people that are happy with their surgeries. There are five ADRs that are FDA-approved, well past the experimental stage, I would say.
What is your background, are you a spinal patient?

[trkdoc714]

Maybe this thread should stop here. dogmattic, please refer to the user agreement as to promoting or criticizing surgeons, hospitals, devices or procedures.

If your investigation leads to anything substantial, perhaps you should contact the proper authorities and let them handle it.

[dogmattic]

My apologies. As an engineer, with about 25 years experience in experiments, I felt compelled to present a truthful, unbiased account as to my interest here: To gather data pro/con regarding the integrity of FDA experiment data. I have no financial interest in ADR, fusion or any medical field at all. I had not planned to post - just lurk. I guess I should have not said anything, as people obviously have strong allegiances.

I am not 'sophia' or callmegee, as accused. This is my 3rd post ever - after the 2 above. I think the sophia account was created long ago, and never used by my wife. Please delete. Since i have not been on this forum , I do not know anyone, including callmeggee. If the IP address is the same, it might be because there are over 87,000 people in this company. By the looks of it, many of them spend more time sitting on their degenerating sacrums than I do - which is scary.

My intro points out that there are biased data on both sides of the ADR/Fusion debate, therefore I am not promoting either: "of course, you have to cancel out the negative reports which are generated by parties literally 'short selling' the Prodisc, due to their investments in competitors such as the Charite, Maverick or M[6]"

The 2003 article regarding Charite data, obviously does not weigh against the Prodisc. What it presents, to me, is an early trend in irregularity in trial data - which is published to the public. It is just an example.

Personally, I find it disturbing that there are people who do not care if investigators of drugs, medical devices and foods, invest massively (ie over $500K) in the product they have a fiduciary responsibility to be disinterested in. However, when I read that the Prodisc trials were overwhelmed with such bias, and that there was $175 million to be gained by a positive regulatory outcome, I could not help but wonder if the data were tarnished. As far as I can tell, there is a high correlation between investment and positive outcome in various trial data.

I am simply looking for data and articles to refute the de facto evidence. I needed an account to read the information here. I plan to report to the investigating board of the US Senate Finance Committee, whom have interviewed me and others.

Therefore, I have not "promoted or criticized any surgeon, hospital, or device or procedure" as accused. My critique is of the ethics behind referrees massively betting on the games they are officiating ... and moreover, the US agencies which turn a blind eye to it. I can see this site is replete with people providing opinions on devices and procedures. I say hooray for them. Welcome to America, land of the free, home of the opinionated.

If you are against ethical trials, research, or scientific process ... feel free to ban me - as stated.

[Justin]

If you are against ethical trials, research, or scientific process ... feel free to ban me - as stated.

Hi Matt,

I wanted to address your quoted text above. The Spine Patient Society does not take banning Members lightly. We only ban Members that break the SPS Terms of Service for severe infractions (solicitation of services from Spine Brokers, using the Forum to engage in illegal activity as defined by State and Federal Law in the United States, etc.). We don't ban Members because of difference of opinion; actually, we encourage freedom of speech as we do not censor what our Members have to say.

I hope you are well.

[Hooch]

This is the game they play. Good luck (sincerely).

Who are you man? Are you a patient, relative of a patient, interested observer? Do you know someone who has been badly damaged by this surgery? It's not exactly unknown for people to be damn near destroyed by the helping professions.

Charles Rosen has a website, association for medical ethics. I can't understand his interpretation of the studies in rating different surgical interventions, but if you want to see a voice in opposition, his is one. And he is a Professor. A number of surgeons flat out won't install artificial discs.

If you reckon you're going to roll the FDA studies tho, well, you'd have to be in the inner sanctum for starters. The charite one was performed against an anterior fusion without (correct me if I'm wrong), stabilisation. This method is no longer favoured. Cochrane collaboration reckons fusion flat out doesn't work for ddd. No difference in long term results to non-surgical management. Most surgical trials aren't conducted with a placebo control.

If you want to oppose the whole process there is strong grounds for criticism.

[trkdoc714]

Dog,

Perhaps I was in a hurry when I responded earlier. These comments come as a member of SPS, not as moderator.

1) I think your thread should have been posted in the Lounge as an unmoderated sociopolitical thread if the post was
appropriate in the first place.

2) This forum was created to help patients searching for the treatments that can help their conditions, not investigate
corporations or their methods of obtaining an FDA approval.

3) I found it insensitive in regard to your criticism of a disc that a large number of our membership have implanted in
their spines and that has enriched the quality of their lives.

4) I think it would be appropriate (given the gravity of your accusations) that you qualify your remarks with your
specific professional background and affiliations.

5) I spent about an hour tonight giving my 4 year old piggy back rides and wrestling with him on the floor. I could
care less that the Maverick wasn't approved by the FDA or, if I had gotten ProDiscs, the method how they were
approved. I am now pain free thanks to this technology that has gotten onto the market. I'm just glad they're here.
I'm not going to ask how they got here.

Now, as a moderator, I can't and won't add anything that hasn't been stated previously by Justin or myself.

Good luck with your investigation.

Bob