The Axial Biotech Test is Here

[flerc]

Flerc,

I don't believe the government validates the efficacy of medical tests (or devices, btw). The only arm of the government involved in this kind of oversight, the FDA, only approves drugs. Again, to the best of my knowledge.

There's whatever efficacy is reported by the test maker would only be coming from the test maker.

FDA might not be the governmental organism for this, but should to be another available to test this product. I suppose they could not have any problem in collecting hundreds or thousands of samples of adults with small or big curves not belonging to the AB data base. It would be something extremely simple to do that test. How much could be the cost? Surely insignificant for something so important.

[Pooka1]

FDA might not be the governmental organism for this, but should to be another available to test this product. I suppose they could not have any problem in collecting hundreds or thousands of samples of adults with small or big curves not belonging to the AB data base. It would be something extremely simple to do that test. How much could be the cost? Surely insignificant for something so important.

Here is the paper. Any scientist is invited to replicate the study.

http://www.ncbi.nlm.nih.gov/pubmed/21102273.1

This stuff (molecular biology) is extremely expensive to do. Scoliosis, while not an orphan disease, is close to that. It is important to you and us but in the grand scheme of medical research, IS etiology is barely on the radar as far as I can tell. There are no more than two or three major groups studying it IN THE ENTIRE WORLD. Now compare and contrast that with cancer research where the number of major groups studying that is probably in the hundreds if not thousands.

Perspective always.

[flerc]

Here is the paper. Any scientist is invited to replicate the study.

http://www.ncbi.nlm.nih.gov/pubmed/21102273.1

This stuff (molecular biology) is extremely expensive to do. Scoliosis, while not an orphan disease, is close to that. It is important to you and us but in the grand scheme of medical research, IS etiology is barely on the radar as far as I can tell. There are no more than two or three major groups studying it IN THE ENTIRE WORLD. Now compare and contrast that with cancer research where the number of major groups studying that is probably in the hundreds if not thousands.

Perspective always.

I'm not saying to do any kind of study but to test the scolioscore. I understand it could not be any complication in doing that test.
How much expensive is to test a sample with that model? How much could be the cost for the Goverment to test some hundreds of samples? Certainly AB should to take charge of a considerable part of the cost, I believe.

[rohrer01]

I think the ultimate "test" of the Scoliscore will come with time and the collection of data from those who are being tested as a part of their workup by their physicians. This information will almost certainly be passed along to Axial Biotech through physician reporting.

[flerc]

I think the ultimate "test" of the Scoliscore will come with time and the collection of data from those who are being tested as a part of their workup by their physicians. This information will almost certainly be passed along to Axial Biotech through physician reporting.

Why to wait so many years if it may be done now? What if then is discovered that the reliability of that model was so lesser that the declared by the Company? And people taking fusion early? There would not way to know if the test was right or not.

[Pooka1]

And people taking fusion early?

How do you know this? It sounds wrong.

[flerc]

How do you know this? It sounds wrong.

Ok, I believe I have read something like this but surely I'm wrong.

[LindaRacine]

This thread gets more bizarre by the moment. What, exactly, would the government test? A bunch of people's spit?

Axial Biotech has tens of millions of dollars invested in ScoliScore. They expect to never make a profit. Individual families rarely, if ever, have to pay anything for this test. First, most insurance companies are picking up the cost. American insurance companies apparently believe the research, or they wouldn't reimburse for it. If for some reason, the insurance company doesn't pay, the amount a patient's family has to pay is based on the family income. The family has to earn something like $450,000 per year to have to pay outright for the test.

If you want to find a company that is far more likely to be bilking the public, Fierc, you need only look at the companies and products of the dozens of threads you've started.

[flerc]

My god!!

If you want to find a company that is far more likely to be bilking the public, Fierc, you need only look at the companies and products of the dozens of threads you've started.

I have not any interest in that kind of discussions.

Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Dilber

Thanks for the advice!

[flerc]

I should know this, because I used to be in Public Health, but I don't think the government actually tests any of these things - not even drugs. They ask drug manufacturers to run tests, but the federal government does not validate these things themselves (and, again, I don't think they even require that medical test manufacturers validate them, but I'm not sure).

And drugs are the bright spot in federal government oversight. If you get a medical device put in your body, like the pedicle screws used in scoliosis surgery, *no one* is responsible for vetting those. If there's a problem, the government can step in afterwards and ban them, but no one is ensuring that these things are safe/effective/etc before they go into you.

I think people believe that these things are under greater oversight then they actually are. But, it's really pretty wild west-y in the medical field.

I believe that if in fact, this is also the case with the scolioscore, surgeons should to remarks this fact when they recommends (they does?) the scolioscore to parents. Much people may trust so much in Goverment Organism and not so much in private companies and they are in their all right to think in that way.

[flerc]

I'm not so sure they trust that much in government organisms either

What Rohrer and Maria are saying is right. No doctor is going to rely solely on the results of this test to recommend a treatment. Doctors tend to be very conservative - they do things the way they've always done them. If a doctor has a hunch or an intuition, based on experience, that a curve is going to progress, they're likely to go with their hunch rather then with the results of the test. If, over time, they feel that the test is more reliable then their hunches, then they'll start to depend on the test. But no doctor worth their salt is going to instantly start relying on a test which they have no experience with. That's just not how medicine works.

But they not give the score to parents?

[flerc]

I believe that if in fact, this is also the case with the scolioscore, surgeons should to remarks this fact when they recommends (they does?) the scolioscore to parents. Much people may trust so much in Goverment Organism and not so much in private companies and they are in their all right to think in that way.

Hudger, in ultimate instance who decide are parents, or not? Then surgeons should to give all the information leading they to recommend what they recommend. So I not see what is wrong in what I said.

[rohrer01]

Flerc,
Science and research are NOT usually overseen by a government agency in this country. I don't know what you keep asking about that for. Maybe in your country it is different, but here in the U.S. that is the way things are done. The federal government will give grants (money) for research, but that's as far as it usually goes, execpt for the FDA overseeing drugs. I would guess that this is because the development of new drugs has much more potential for dishonesty for monetary gain and could kill people. Medical tests harm no one, so why should there be governmental oversight? Do doctors need governmental oversight to test someone's blood for disease? No, they don't. There are agencies in place like the American Medical Association and the different medical licensing agencies that take care of quack doctors and can pull their license to practice medicine if they are hurting people. There is absolutely no harm that could come from getting a Scoliscore test. It is simply a tool to help give a doctor more information about the patient. If he bases his decisions strictly on that test, then he is inept and shouldn't be allowed to practice medicine. There is, in fact, a large pool of adults with known outcomes in the Axial Biotech database. Any other research organization, or individual, would be welcome to repeat AB's study. It is encouraged in science. But because there is medical reporting, why do they need to? That is what peer review is for. Scientists oversee other scientists. If the test proves inaccurate over time, people will quit using it. It's that simple. I gave you the web address to Axial Biotech. You can ask them these questions and I'll bet you'll get the same answers. I think you are beating a dead horse here. We've given you as much information as we can. I'm sorry that you don't find the answers satisfactory, but it is what it is. Sorry we can't come up with what you are looking for. It just doesn't exist, unless we are still misunderstanding you.

[flerc]

The federal government will give grants (money) for research, but that's as far as it usually goes, execpt for the FDA overseeing drugs. I would guess that this is because the development of new drugs has much more potential for dishonesty for monetary gain and could kill people. Medical tests harm no one, so why should there be governmental oversight?

I don’t agree. A bad decision leading to something harmful may be taken believing in the test. The test is done to takes decisions although sometimes (as may occurs with the scolioscore) it may not the only the only source of information for that.
Do you really believe that a bad testing product saying about the existence or not of cancer may not be harmful????

Do doctors need governmental oversight to test someone's blood for disease? No, they don't. There are agencies in place like the American Medical Association and the different medical licensing agencies that take care of quack doctors and can pull their license to practice medicine if they are hurting people.

This is something absolutely different. I never suggested to oversight the doctor’s work, but the product they use.

There is absolutely no harm that could come from getting a Scoliscore test. It is simply a tool to help give a doctor more information about the patient.

Again I absolutely disagree because the same reason.

If he bases his decisions strictly on that test, then he is inept and shouldn't be allowed to practice medicine.

His decision may be different trusting in the test than don’t doing it. Otherwise which could be sense in doing that test???

There is, in fact, a large pool of adults with known outcomes in the Axial Biotech database. Any other research organization, or individual, would be welcome to repeat AB's study. It is encouraged in science. But because there is medical reporting, why do they need to?

What do you means about AB’s study? The construction of the scolioscore or the test of the scolioscore? If you means the first, I have never suggested that. If you suggest the last, I believe is a way to control this product, as FDA control drugs, that is, another kind of product. What is so bad in thinking that would be good to have a similar kind of control also in this case? Really I don’t understand. If it is impossible, ok is impossible, but nobody may say that would not have sense.

If the test proves inaccurate over time, people will quit using it. It's that simple.

I not see it so simple. I don’ t believe that any parent may see it so simple. I believe they prefer to know now if it’s inaccurate or not. So I believe they'd prefer to have the best guarantee that is a good product, so I believe that if the goverment gives such kind of guarantee (for example doing the simple test I said) they would see it as a more reliable product. But ok, I may be wrong and for all parents, the guarantee of the Company would be absolutely enough and they not need any more.

I think you are beating a dead horse here. We've given you as much information as we can. I'm sorry that you don't find the answers satisfactory, but it is what it is. Sorry we can't come up with what you are looking for.

No, I don’t believe that

It just doesn't exist, unless we are still misunderstanding you.

I believe Hdugger understand me what I was asking and saying and I perfectly understood her response. Then I was commenting what I believe about that.. and then we may agree or not with our comments .. nothing else. And of course nothing bad is in thinking different.. I try to believe..

Thanks for your interest in clarifying my doubts

[flerc]

I'm not sure if they should or not (or if they could or not), but they don't. Parents will likely get a few numbers (a Cobb angle, maybe a Riser score, and a scoliscore test, if it's given), but they aren't expected to make a decision based on that information. They couldn't, I don't think. They're supposed to trust the doctor to make a recommendation based on those few numbers and lots more information that the doctor likely couldn't put into words.

I've been on the forum, pretty actively reading about scoliosis for several years now. I couldn't tell you if my son should have surgery or not if you held a gun to my head. I doubt I'd ever have enough information to make that decision. All I can do is get enough information from a site like this to figure out who a good doctor is, and trust them to parse the information enough to allow me to reach a decision. The last time I saw my son's surgeon, he did not recommend surgery. So, we didn't get surgery. If he does recommend it when we go again in December, and if someone else I respect concurs, my son would likely get surgery. It's really that simple.

So, a number on a scoliscore test one way or another isn't really going to matter to me. If my surgeon feels like it's a good predictor or feels like it's a poor predictor, then I have to trust his judgement. There's just no good way I could reach a sound decision on the topic.

Certainly is not the point if only Dr. may decide or not. As I said to Rorhrer, Dr's decision may be different trusting in the outcome of the test than don’t doing it. Otherwise which could be sense in doing that test??? So it would be good to count with a good predictive model. So it would be good to have the best guarantees.. so..