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The Machines

Posted by Pauline on 11/27/00 at 00:37 (033598)

Could someone please tell me if the Orbasone machine is not FDA approved
how is one allowed to use it without penalty? I personally don't see anything wrong with using it because Dr.Z seems to have good results with it. On the other hand, I have a very good friend who is diabetic and would love to use the new 'Watch' that is still not FDA approved and no
Doctor can use it, nor get his hands on it.

Does this difference indicate that the FDA puts the Orbasone in a group of quack medicine machinery and therefore doesn't care who uses it, nor who gets it used on them, while they put the Diabetic Watch into a medicine cagegory needing federal safty regulations because they believe it has some more merit.

If they were really concerned with patient care, why don't they storm the offices, remove the unregulated machines, and fine the operators. I know if a Dr. prescribed the 'Watch' in the U.S. he could get into a lot of trouble.

This leads me to believe that the Orbasone isn't too highly thought of by the FDA scientists.

Re: The Machines

alan k on 11/27/00 at 08:42 (033616)

There are many possible reasons about the FDA, as it is a complicated organization. We have to keep in mind, as Pauline seems to think, that often times the FDA saves our lives and protects us from profiteers who don't care about our well being. We are lucky to have it. When it gets corrupt or too lax people die, as in the diet pill fiasco recently.

One of obstacles to approval is the extremely high cost of the tests necessary for approval, which add huge costs to the machines or pills that get passed on to doctors and consumers. Perhaps orbasone has not come up with the money yet, or has not had enough time. I would be interested if there was an answer.

In any case, many of us have not minded being a guinea-pig in trials for orthowave, and so far I don't know of anyone who has had negative effects from that. As I said earlier, there does not seem, to me, to be any serious dangers with these shock wave devices, and that it is too early to know what is the best machine and setting, and that in terms of any specific individual's care, probably the best knowledge could only reside within the mind of the doctor performing the treatment, as there is no way to evaluate these things except with statistical averages, which may not always apply to any individual condition in any particular person. At this point, a variety of machines with a variety of results seems like it is the best thing for the future.

alan k

Re: The Machines

Kate on 11/27/00 at 08:58 (033619)

The orbasone received FDA clearance in January 2000. We have been using this FDA class 1 machine since that time.
I believe the Ossatron was FDA cleared for class III in October of this year.
This machine and treatment is most definitely not for 'quack medicine,' instead it is a remarkable treatment that gives relief within 12 weeks to patients who have been suffering for perhaps years (including myself).
If you have any questions, or would like more information on the Orbasone, or especially ESWT, please contact me, I'm always happy to help.

Kate Jurman
ESWT Coordinator

Re: The Machines/To Pauline

Beverly on 11/27/00 at 10:47 (033624)

Pauline,
I for one will be happy to try EWST by a qualified/experienced doctor as soon as I can if I am deemed a good canidate. It sounds far safer than surgery.

But Pauline, I am puzzled. After I read a brief post you made a couple of weeks ago about your dramatic relief of pain and how well you are feeling, I kept hoping you would tell us more about it. I know you suffered with much pain for a long time, and it hasn't been that long ago that you had very little hope. If I had two months of pain-free or almost pain-free living, I'd be flying my message of success on a GoodYear Blimp.
Are you still pain-free?
Beverly

Re: The Machines/To Pauline

Barbara TX on 11/27/00 at 12:01 (033635)

Nancy - I think that was PAULA and not Pauline who was now pain-free. I think that Pauline is the one who sprained both her ankles and can only walk in the water under the direction of her thug-therapists. B.

Re: The Machines/To Pauline

Barbara TX on 11/27/00 at 14:16 (033648)

Sorry, I was wrong. Its the other way 'round. B.

Re: The Machines/To Pauline

Julie F on 11/28/00 at 03:39 (033707)

Beverly, Pauline did post a message yesterday about her recovery, on the original thread which is now buried in the 'next set of messages'. It was so encouraging that I asked Scott if it could be brought forward so that people didn't miss it - of that hasn't happened or can't be done, you'll find her yesterday's message a ways back under the original thread, 'Message to Rock'.

Re: To Beverly

Pauline on 11/28/00 at 18:16 (033749)

Beverly, Beverly, would you like to see me walk and put your hands on the bottom of my feet?

Yes it is true that I am pain free and back to doing everything before PF. I am standing guard that it may return and still continue to do all the things everyone else is doing on this board. The only reason I didn't fly my message from the Good Year Blimp is because I prefer to spend my money on travel. Posting here is a lot cheaper.

There is no magic to curing PF. We all get it the same and yet differently. Symptoms similar, but recovery is certainly different. I can't begin to explain why I am better and your case may still be lingering. The last time I had it it lasted 2 1/2 years and then finally went away.

Knowing what I do now and doing all the things that most everyone has writen about, besides thinking up my own things---if it comes back I would try ESWT. I have no fear of it, nor feel that it will make matters worse. I'd rather try that then to have surgery. They can always cut you so my feeling is save that for last. This time I was not a good candidate for ESWT because my inflammation and pain never localized. It was spread throughout my entire arch on both feet. If things didn't take a turn I might have attempted to try it anyway, if I could get a doctor to agree
to give me the treatment. Who knows it might have speeded things up for me.

I don't believe that I will be truely free of PF only pain free from time to time. I plan to continue to do the same treatment, stretches etc. as though I had it. I have however, put my night splints back up on the shelf for the time being.

I'll continue to pray for you and everyone else afflicted with PF and all the other health problems they may be dealing with. My belief is we should never leave anyone behind, so I will continue to post to encourage and share my limited experiences and pray for all because I know my limitations.

Wishing you a speedy recovery, the patience to wait and the faith to believe you will recover.

Re: The Machines

To Kate in Dr.Z's office on 12/04/00 at 09:15 (034129)

Kate,
Can you explain to me the difference between receiving FDA clearance and FDA approval. What exactly did the FDA mean when it gave clearance to the Orsabase Machine? What did it give clearance too and what was it cleared for? Do you know if there any trials, blind, double blind or otherwise done?

Have any major medical centers purchased this machine? One would assume if it is less costly, given FDA clearance for treating Plantar Fasciitis and has documentation (sudies) to back it up, many of the large teaching facilities with Sports Medicine areas would be lining up to purchase one. Are Pods the only Dr's currently using this machine?

Re: The Machines

alan k on 11/27/00 at 08:42 (033616)

There are many possible reasons about the FDA, as it is a complicated organization. We have to keep in mind, as Pauline seems to think, that often times the FDA saves our lives and protects us from profiteers who don't care about our well being. We are lucky to have it. When it gets corrupt or too lax people die, as in the diet pill fiasco recently.

One of obstacles to approval is the extremely high cost of the tests necessary for approval, which add huge costs to the machines or pills that get passed on to doctors and consumers. Perhaps orbasone has not come up with the money yet, or has not had enough time. I would be interested if there was an answer.

In any case, many of us have not minded being a guinea-pig in trials for orthowave, and so far I don't know of anyone who has had negative effects from that. As I said earlier, there does not seem, to me, to be any serious dangers with these shock wave devices, and that it is too early to know what is the best machine and setting, and that in terms of any specific individual's care, probably the best knowledge could only reside within the mind of the doctor performing the treatment, as there is no way to evaluate these things except with statistical averages, which may not always apply to any individual condition in any particular person. At this point, a variety of machines with a variety of results seems like it is the best thing for the future.

alan k

Re: The Machines

Kate on 11/27/00 at 08:58 (033619)

The orbasone received FDA clearance in January 2000. We have been using this FDA class 1 machine since that time.
I believe the Ossatron was FDA cleared for class III in October of this year.
This machine and treatment is most definitely not for 'quack medicine,' instead it is a remarkable treatment that gives relief within 12 weeks to patients who have been suffering for perhaps years (including myself).
If you have any questions, or would like more information on the Orbasone, or especially ESWT, please contact me, I'm always happy to help.

Kate Jurman
ESWT Coordinator

Re: The Machines/To Pauline

Beverly on 11/27/00 at 10:47 (033624)

Pauline,
I for one will be happy to try EWST by a qualified/experienced doctor as soon as I can if I am deemed a good canidate. It sounds far safer than surgery.

But Pauline, I am puzzled. After I read a brief post you made a couple of weeks ago about your dramatic relief of pain and how well you are feeling, I kept hoping you would tell us more about it. I know you suffered with much pain for a long time, and it hasn't been that long ago that you had very little hope. If I had two months of pain-free or almost pain-free living, I'd be flying my message of success on a GoodYear Blimp.
Are you still pain-free?
Beverly

Re: The Machines/To Pauline

Barbara TX on 11/27/00 at 12:01 (033635)

Nancy - I think that was PAULA and not Pauline who was now pain-free. I think that Pauline is the one who sprained both her ankles and can only walk in the water under the direction of her thug-therapists. B.

Re: The Machines/To Pauline

Barbara TX on 11/27/00 at 14:16 (033648)

Sorry, I was wrong. Its the other way 'round. B.

Re: The Machines/To Pauline

Julie F on 11/28/00 at 03:39 (033707)

Beverly, Pauline did post a message yesterday about her recovery, on the original thread which is now buried in the 'next set of messages'. It was so encouraging that I asked Scott if it could be brought forward so that people didn't miss it - of that hasn't happened or can't be done, you'll find her yesterday's message a ways back under the original thread, 'Message to Rock'.

Re: To Beverly

Pauline on 11/28/00 at 18:16 (033749)

Beverly, Beverly, would you like to see me walk and put your hands on the bottom of my feet?

Yes it is true that I am pain free and back to doing everything before PF. I am standing guard that it may return and still continue to do all the things everyone else is doing on this board. The only reason I didn't fly my message from the Good Year Blimp is because I prefer to spend my money on travel. Posting here is a lot cheaper.

There is no magic to curing PF. We all get it the same and yet differently. Symptoms similar, but recovery is certainly different. I can't begin to explain why I am better and your case may still be lingering. The last time I had it it lasted 2 1/2 years and then finally went away.

Knowing what I do now and doing all the things that most everyone has writen about, besides thinking up my own things---if it comes back I would try ESWT. I have no fear of it, nor feel that it will make matters worse. I'd rather try that then to have surgery. They can always cut you so my feeling is save that for last. This time I was not a good candidate for ESWT because my inflammation and pain never localized. It was spread throughout my entire arch on both feet. If things didn't take a turn I might have attempted to try it anyway, if I could get a doctor to agree
to give me the treatment. Who knows it might have speeded things up for me.

I don't believe that I will be truely free of PF only pain free from time to time. I plan to continue to do the same treatment, stretches etc. as though I had it. I have however, put my night splints back up on the shelf for the time being.

I'll continue to pray for you and everyone else afflicted with PF and all the other health problems they may be dealing with. My belief is we should never leave anyone behind, so I will continue to post to encourage and share my limited experiences and pray for all because I know my limitations.

Wishing you a speedy recovery, the patience to wait and the faith to believe you will recover.

Re: The Machines

To Kate in Dr.Z's office on 12/04/00 at 09:15 (034129)

Kate,
Can you explain to me the difference between receiving FDA clearance and FDA approval. What exactly did the FDA mean when it gave clearance to the Orsabase Machine? What did it give clearance too and what was it cleared for? Do you know if there any trials, blind, double blind or otherwise done?

Have any major medical centers purchased this machine? One would assume if it is less costly, given FDA clearance for treating Plantar Fasciitis and has documentation (sudies) to back it up, many of the large teaching facilities with Sports Medicine areas would be lining up to purchase one. Are Pods the only Dr's currently using this machine?