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Thread: Extended Wong comments

  1. #16
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    The point boils down to: why is anyone conducting a study of a specific bracing method when - they are not fully certified in the application of the method?

    From the Manufacturer:


    It has come to our attention that an article entitled “The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis” was published in the May 2008 issue of Spine Journal.[1] The SpineCorporation is the company responsible for production, supply, and training in the use of the SpineCor treatment system and we have serious concerns about the methods and validity of this study. We would like to point out two serious issues in the way in which this study was conducted and we believe these factors invalidate the data of the SpineCor treatment group and therefore the comparative results of the study.

    1) The authors in this study and the facility at which patients were treated with SpineCor are not qualified to a proficient standard in the SpineCor treatment system. They should not be providing this treatment therapeutically to patients, let alone conducting research into its efficacy. We believe this to be seriously unethical and detrimental to the patients involved.

    2) This treatment centre has not been supplied with enough initial SpineCor components to effectively brace 22 patients. They also have not received enough replacement components necessary to effectively maintain this amount of SpineCor braces. In reference to point 1, the SpineCor brace is a unique treatment system for idiopathic scoliosis that is unlike any other type of spinal orthosis ever developed[2]. It does not share the same treatment principles of 3-point pressure that rigid orthoses use and its use requires specific and extensive training. Training and an expertise in rigid bracing does not transfer to SpineCor; specific training and qualification is necessary. To attain the necessary skills to be a safe and effective SpineCor provider, candidates are required to attend an initial Phase 1 theory course. On completion of Phase 1, providers are eligible to complete a Phase 2 practical training which involves treating patients in front of a qualified SpineCor trainer. Distributors of the SpineCor brace are under a contractual obligation only to supply SpineCor braces and components to Phase 2 certified providers. To remain certified, practitioners must see a minimum number of patients using this system each year or recertification is necessary[3]. These strict systems are in place to ensure quality of treatment and consistency of results.

    None of the authors of this paper are certified in SpineCor treatment nor have they ever received significant training in the SpineCor system. Some of the technicians working with these authors at the scoliosis clinic in Hong Kong have received basic introductory training, but they are not certified SpineCor providers and are not considered to have received training to a sufficient standard to use the SpineCor system without supervision.

  2. #17
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    Quote Originally Posted by mamamax View Post
    The point boils down to: why is anyone conducting a study of a specific bracing method when - they are not fully certified in the application of the method?
    What is your evidence that this occurred?

    There is no undisputed evidence that the Wong researchers were not fully certified to fit the brace unsupervised.

    All we have are post hoc pouts from the manufacturer at this point.
    Last edited by Pooka1; 12-05-2009 at 11:11 AM.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

  3. #18
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    Sharon - the manufacturer has published a six page outline which establishes the FACTS which further outline specifically how certification is obtained - and further state such certification was NOT obtained. Even better, they outline point by point why this study could never have been successful based upon (1) lack of proper certification and (2) lack of sufficient bracing components and the method of their application.

    This statement has been out for quite awhile. If it were a false statement, you can bet it would have been in a court of law by now!

  4. #19
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    Wink

    Quote Originally Posted by mamamax View Post
    [COLOR="Navy"]I think an official word from a manufacturer is an important document (one they certainly know can be used in a court of law).
    Just about everything "can" be used in a court of law if someone was inclined to sue, etc. That doesn't mean every claim that is made by a manufacturer is true.

    I have worked in the legal field for nearly 30 years and assure you that plenty of claims are made in writing by manufacturers and others - many of which claims are either misleading or not completely true.

    I'm not necessarily saying that is the case here - just that this sort of thing happens every single day, so one should not assume, by any stretch, that a manufacturer is telling the truth just because he issues an official word or puts something in writing.

    If that were the case, there wouldn't be so many laywers out there making a very nice living.
    mariaf305@yahoo.com
    Mom to David, age 17, braced June 2000 to March 2004
    Vertebral Body Stapling 3/10/04 for 40 degree curve (currently mid 20's)

    https://www.facebook.com/groups/ScoliosisTethering/

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  5. #20
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    I think no one (in this thread, thus far) - with the exception of myself - has actually studied the six page statement from the Manufacturer who is responsible for the training required in the application of this method.

    This being the case - my time is wasted here. Should anyone actually take the time to study the referenced document and wish to discuss it further, please PM me and I'll re-join the conversation.
    Last edited by mamamax; 12-05-2009 at 11:45 AM.

  6. #21
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    In the 6 page rebuttal, they say:
    1) The authors in this study and the facility at which patients were treated with SpineCor are not qualified to a proficient standard in the SpineCor treatment system. They should not be providing this treatment therapeutically to patients, let alone conducting research into its efficacy. We believe this to be seriously unethical and detrimental to the patients involved.

    There is internet archive available to everyone. I looked to see what the Spinecor Website said about providers in China in 2005.

    Check it out. Recognize any names?
    (Third on the list)

    It was apparently “ethical” enough to list his name on the website in 2005.

  7. #22
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    Quote Originally Posted by concerned dad View Post
    In the 6 page rebuttal, they say:
    1) The authors in this study and the facility at which patients were treated with SpineCor are not qualified to a proficient standard in the SpineCor treatment system. They should not be providing this treatment therapeutically to patients, let alone conducting research into its efficacy. We believe this to be seriously unethical and detrimental to the patients involved.

    There is internet archive available to everyone. I looked to see what the Spinecor Website said about providers in China in 2005.

    Check it out. Recognize any names?
    (Third on the list)

    It was apparently “ethical” enough to list his name on the website in 2005.
    Good work.

    Dr. Wong, in his rebuttal, pointed out that some names, including his, mysteriously disappeared from the Spinecor qualified provided list.

    Obviously Spinecor doesn't realize wayback or other web archive machines are out there.

    They have now been caught in a blatant lie, sending their credibility to even lower levels (if that is possible).
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

  8. #23
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    As the world turns ...

    In 2006, Spinecor discontinued distribution to China because those who had enrolled for full certification did not follow up despite repeated requests for them to do so. Naturally their names were removed as certified providers. That information is found on page two of the Spinecor rebuttal.

    Without full certification - what were their names doing on a fully certified provider list in the first place? That is my question. Was it once corporate policy to place a provider on the list when full payment for full certification was made (before full certification was obtained)? And has corporate policy now changed to reflect only fully certified providers (regardless of any advance payment made for training) on their web site?

    Regarding the disappearance of Rivard and a few others - Searching WaybackMachine for Canada, there is no absence of Rivard and Colliard. When the web pages were updated (2006) there may have been a temporary oversight that was corrected - human error always a factor.

    What drama - more fun than the Cardashians. Reminds me of the class action law suit involving pedicale screws and spinal surgery awhile back.

    When such controversy arises, and both parties appear to have a valid legal stand that they should be using - but don't ... I wonder - why? Maybe both parties would stand to lose more than they would gain by airing dirty laundry. I don't know - and probably never will.

    Fortunately, this controversy does not effect the efficiency of the brace in the hands of fully certified providers. And that is what I must remember as a patient currently in treatment ;-)

  9. #24
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    Quote Originally Posted by mamamax View Post
    Fortunately, this controversy does not effect the efficiency of the brace in the hands of fully certified providers. And that is what I must remember as a patient currently in treatment ;-)
    The Wong article is about AIS.

    None of that per se is relevant to your situation other than the general issue of disingenuous Spinecor claims.

    I think Spinecor will eventually be used just by JIS patients if it pans out (and it might) and adult patients for pain. You won't be seeing it used for AIS at all eventually except by the hard core alternative therapy aficionados.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

  10. #25
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    ok then ...

    Fortunately, this controversy does not effect the efficiency of the brace in the hands of fully certified providers. A fact patients currently in treatment, may take comfort in.

    I keep forgetting I'm part of a grand experiment - thank you for reminding me Sharon

    An experiment that is going rather well bty (and has been for other adults since 2005).

    And what I said upthread Found Here is totally relevant to all
    Last edited by mamamax; 12-06-2009 at 11:16 AM.

  11. #26
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    This DIRECTLY affects AIS patients as the Wong study was done by certified brace fitters and Spinecor is lying about it after the fact.

    You are getting pain relief which is very good. I suspect the adult back pain crowd is a far larger market than AIS. I can't understand why Spinecor isn't going all out on that rather than pushing against a wall on AIS. It's inexplicable.

    The JIS crowd is relatively small (luckily!) but I hope they start doing studies on that and quit screwing around with AIS where nobody seems to believe their numbers and where we have seen a real life example of incorrect numbers from right on this group. Just like in this case, I suspect enough surgeons remeasured the Cobb angles from Montreal and formed an opinion about the quality of the data coming out of that group.
    Last edited by Pooka1; 12-06-2009 at 11:19 AM.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

  12. #27
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    Who can prove that any one party is lying? Can you prove something Sharon? I don't think so. What is your proof - outside your spirited opinion?

  13. #28
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    Quote Originally Posted by mamamax View Post
    Who can prove that any one party is lying? Can you prove something Sharon? I don't think so. What is your proof - outside your spirited opinion?
    wayback is my proof.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

  14. #29
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    You call that proof? I call that very limited evidence that has been explained with an official response. My thoughts on that Found Here

    Spinecor on page two of the rebuttal explains the removal of those in China from the list of certified providers - because they did not follow up on the full certification they signed up for.

    So the question becomes - why were they on the list in the first place. If they were fully certified and Spinecor is telling the world that they were not - well, we certainly have a controversy. And not one that will be solved by looking at an archived web page.

    Like I said - more fun than the Cardashians and reminiscent of the class action law suit involving pedicle screws and spinal surgery.

  15. #30
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    Irrelevant to the pedicle crew class action suit

    The appellate court upheld the dismissal of plaintiffs' law suit against several medical/professional associations. So the plaintiff's claims did not carry the day but nor did the defendants' defense as far as I can tell (they didn't get costs).

    http://biotech.law.lsu.edu/cases/dev...93_F3d_781.htm

    [11] OPINION OF THE COURT

    [12] This is an appeal of the District Court's dismissal under Fed. R. Civ. P. 12(b)(6) of conspiracy and concert of action claims alleged by thousands of plaintiffs in multidistrict litigation involving allegedly defective bone screw implantation devices. The District Court held the claims, insofar as they alleged a conspiracy to violate the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C.A. § 301- 397 (West Supp. 1999), did not state a cause of action upon which relief can be granted. Accordingly, the court granted defendants' motions to dismiss those claims.

    [13] The District Court also made several rulings unfavorable to the defendants. The court denied with prejudice their motions to dismiss based on improper pleading and First Amendment protection. Additionally, the District Court denied the motions of several defendants for attorney's fees, costs, and sanctions. These rulings are now challenged on cross-appeal.

    [14] We will affirm the judgment of the District Court on all issues.
    So the bottom line here is the medical/professional societies were not liable as claimed by plaintiffs whereas in the Spinecor case, there is evidence they certified Wong et al. and then later claimed they didn't when the results were bad for the brace.

    The two situations are completely distinguishable, mutually irrelevant, and go counter to what you appear to be alluding to... the case in Spinecor (i.e., the medical societies' position was upheld). If the Spinecor case puts you in mind of the this pedicle screw case then I suggest you haven't read the case. I've posted it if you do want to read the decision.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

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