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My Pod just recommended ESWT!

Posted by Valerie S on 4/16/01 at hrmin (044724)

Hi.

I saw my pod today, and he has recently been told about ESWT from a colleague of his. He is looking into it, and is hoping that I will be able to go for it. He is still researching the treatment for himself, but I have new hope in this doc, now that he is finally getting with the program. I live in Grand Rapids, Michigan, and have found not a single doctor here that currently uses ESWT.

Dr. Z, I don't want to step on his toes, but wonder if there is any way that you can help him along in his search for information?

Thanks for all your help!!

Val.

Re: Valerie be sure you let your Pod know there are differences!

Kim B. on 4/16/01 at hrmin (044748)

Hi Valerie,

I would recommend that you help your Pod understand that there are huge differnces between ESWT machines. The Orbasone is carrying a cloud of doubt over it's head at this time. Where as the OssaTron is not. The last thing you want is for him to hear the bad information first and then throw the baby out with the bathwater.

It is my understanding that The Orbasone is basically a 'Theraputic Vibrator' and is NOT currently approved by the FDA as a machine that is to be marketed for Heel Pain. The OssaTron on the other hand is.

Be sure he understands they are very different machines that come with different capabilities. If your pod was to just read about the things going on with the Orbasone, he may conclude that all ESWT is currently under dention by the department of Health and human services.

If you want him to pursue the more successful EWST route, You'll want to be sure that he hears the Good News about the OssaTron and/or other FDA APPROVED devices that will be entering the market soon.

Good luck! Like you, I want every Podiatrist, surgeon and Orthopedic Specialist in the U.S. to become educated about ESWT. The good machines that are FDA APPROVED for heel pain. NOT the machine that is currently under detention, due to it's manufacture failing to prove it safe and effective.

Regards, Kim B.

Re: My Pod just recommended ESWT!

Steve P on 4/16/01 at 18:44 (044766)

Hi Val -- Good for you!

The ESWT Locations database shows a treatment center in Birmingham, Mich. I don't know how far that is from Grand Rapids. ????? There are also several in the Chicago area, including Dr. Marlene Reid's practice. (She is a frequent poster on this board.)

Also, there is Heidi Brunner in the Toronto area (whom Rose from our board recently visited & posted about). So there are a lot of choices.

You might want to make your first phone call to Dr. Z, just to get his feeling on whether you are a candidate for ESWT & any recommendations he may have.

I don't share the view that one machine is clearly better than the others. Scott's database shows remarkably similar results for all 3 machines based on data gathered to date.

Good luck............Steve

Re: Valerie be sure you let your Pod know there are differences!

JudyS on 4/16/01 at 20:46 (044776)

Is it not true that the Orbasone has indeed been approved, generally, for the 'treatment of pain.....'? Does not having 2 certain forms on file with the FDA mean, specifically, that Norland has 'failed to prove it's safe and effective...' Is that the specific language of the FDA?
I happily applaud any member of this board wanting to provide as much information as possible about ANY tool used for PF. And I especially appreciate the research that some have done for the benefit of all. What I'm confused about is the seemingly secretive nature of FDA information and what seems to be a determination to discredit Dr. Z's use of the Orbasone.
Scott, is it possible for this documentation to be posted here so we can all evaluate it and, as with all else here, make our own conclusions?

Re: Valerie be sure you let your Pod know there are differences!

Dr. Zuckerman on 4/17/01 at 09:07 (044803)

Kim,

There is over four hundred pages of proof for the safey and effectiveness for the orbasone machine. Much of this in on file with the FDA.

The safety of the orbasone was determined and proven in the orginal application to the FDA.

The orbasone has a long and proven track record in the treatment of pain in the USA and European. In fact the orbasone has been used in more patients then any other ESWT machine in the USA.

There has never been an indication by the FDA that the machine itself is a problem . The problem has been with the way Norland Medical has been marketing the orbasone to doctors.

Now go take a look at the FDA studies for the ossatron and you tell me it they proved that the machine is effective. Scott has pointed out the the control was 48% and the treating patients was 62%

Re: Valerie be sure you let your Pod know there are differences!

Pauline on 4/17/01 at 10:47 (044817)

DR, Z,
Dr Z, You are correct in everything you said. Indeed the Orbasone machine has proof for the safety and effectiveness in the device classification,
Class I, in accordance with it's original application.

The FDA never indicated it had a problem with the machine itself, it simply said that the machine in order to be used to treat soft tissue diseases (ie PF) it needs to provide much more documentation and be reclassified with similar machines and cannot be marketed as it is currently classified. Norland Medical, cannot apply for one type of clearance then label and market it machine for a different purpose.

Its been used the longest in the U.S. simply because it was labeled and marketed incorrectly not because it received FDA approval for use to treat Plantar Fasciitis. Healthronics OssaTron was the first ESWT given full FDA approval to be sold and marketed for the treatment of specific soft tissue diseases. Other manufacturers wanting to provide the same type of treatment will have to be approved by the FDA in the same classification catagory.

No doubt the Orbasone will reapply and provide the FDA with the documentation it is requiring if it wants to get it's Orbasone off the
FDA's Automatic Detention list. The FDA is using this to bring Norland into complience with its regulations.

If anyone is interested in the ins and outs of the FDA's Regulations on Medical Devices you can go to this web site. It puts it in a nut shell and has additional links.

http://www.qrasupport.com/FDA_MED_DEVICE.html

There is a big difference between Classifications Applications and some Physical Therapy devices which might be in Class I certainly don't carry the same risk according to the FDA as devices in Class II and Class III.

I don't think they would go for a manufacturer of a Heart Massager applying for FDA clearance as a Class I device then labeling and marketing it to Heart Surgeons as a Pace Maker. We're in the U.S. and the companies have to play by the FDA's rules. The rules in Canada and Europe don't seem to apply here.

Re: Valerie be sure you let your Pod know there are differences!

Dr. Zuckerman on 4/17/01 at 12:49 (044837)

Hi Pauline,

Well here is what we do know . Ultrasound devices have the potential to cause burning, nerve damage, etc. There are even FDA class one approved focused ultra sound devices that can cause alot of damage.

So tell me why you can market a new renal device lithrotripsy device,file a form and off to the USA market. In fact it is in the class two area.

Again I am not trying to defend any company. Rules are rules. But if you follow rules they you shouldn't have them be changed in the middle of the road.

Now why would anyone want to treat plantar fasciitis that doesn't have pain.

The reason any and all pf is treated for ESWT is pain. Did you know that none of the current ESWT machines out there are producing shockwaves or using a true lithotripter device, except the ossatron.

I have received an education in the use of Shockwaves and I still can't believe that one company determined the classification.

Did you know that there is an ESWT machine used right now in the USA distributed by Norland medical and made by MIP. Same technology but in class two. This is because it is used for blasting of kidney stones. not the treatment of pain for soft tissue. In theory I can buy this present machine use the machine for pf pain and that is that.

So how would you feel as a doctor to see an approval form from the FDA that knows about the orbasone and knows about the ossatron and ok's the use of the orbasone and then in the middle of the road decides that wrong form wrong application. I could understand mistakes what I can't understand is a mistake when you know the machines and know the technology

I would think that your concern would be toward the govt agency that is changing decision and interfering with the free market and the treatment of patients. I would think that you would be concern that the FDA could review and determine that there should be different classification for all of these devices. If is ok to use European site for testing. This was done for the ossatron and for the Dornier. The public should have a say in FDA policy or FDA change of policy. Yes protection of the public is important but it isn't important to protect the market for one company . Did you know that there are public representation within the FDA. The proof for ESWT is out there and duplication shouldn't be necessary at this time . We don't need any more medical competition between companies.

The analogy about the heart doesn't apply here.

So PAuline I hope that you re-consider your attack against the MIP and Norland. Maybe it should be directed toward the policies that are at present time helping to control the market.

What more do you want from a company supplying dog killing studies that prove that the orbasone can't damage bone. What more do you need if you have hundred of pateints that have had ESWT by the orbasone and the patients are pain free. What do you Pauline want.

Remember that you have pf and remember that you know what the pain is like. Now remember that there are pateints that can't affored the present cost of ESWT in the ASC. Think about the poor pf suffering patient. Now take a look at the classifcations for ESWT . Please try to re-think your though process.

Thanks you.

Re: Hi Pauline .- I would like to talk to you on the phone.

Dr. Zuckerman on 4/17/01 at 13:04 (044840)

Hi Pauline,

I really would like to talk to you over the phone . Sometimes I don't express the information that I know very well. There is some information that I would love to run by you for your opinion. I believe that your goal is for the benefit of the public and the pf suffering patients. So how about us talking over the phone. My phone number is 1-856-848-338. If you call collect it is ok. If I am with a patient they will aceept your call and I will then call you back.

Thanks.

Dr. Z

Re: Valerie be sure you let your Pod know there are differences!

Pauline on 4/17/01 at 13:11 (044842)

Dr. Z,
I can see the red in your eyes and the steam comming from your ears, but you know I didn't make the rules. Norland, Healthronics, Dornier etc. etc. are all grown up companies who have on more than one occassion applied for some type of FDA approval. They know the rules and regulations and know how to play the games the Government requires. They even hire other companies to help them play the games well.

Your anger would be better served at Norland for messing up their great opportunity. There is no doubt in my mind that they will meet compliances and all will be right with the world once again. Keep the faith.

Re: Valerie be sure you let your Pod know there are differences!

Kim B. on 4/17/01 at hrmin (044845)

Dr. Zuckerman,

I have legitimate concerns and some of them come from the 'Warning Letter' that was sent to Mr. Terry Schwalenberg, the Director of Quality Assurance and Regulatory Affairs at Norland Medical, the manufacture of the Orbasone, the machine that you use in giving ESWT treatments.

The letter states strong language that, in my opinion, gives any PF consumer who is considering your treatment cause for concern. It specifically states that the Orbasone can only be marketed for general pain relief without reference to specific sites on the body. The OssaTron ESWT however, is PF and heelpain specific and is further, proven safe and effective in the treatment of heel pain and PF. Still you insist that the machines are basically equal in their ability. I take issue with any company, or any individual, that does not abide by the law of this land and respect that the FDA has set certain limits in place.

From what I am able to understand, the only reason you currently have your Orbasone is that the FDA goofed and let six (6) of the machines into the U.S. When they realized their mistake, they put them on a detention list pending proper FDA approval. They did not recall the machines, but they did put limit on the way that the six doctors that already had them would be allowed to use them, pending proper approval. They were trying to make the best of the situation for all involved, including the six doctors that already had the machines.

I know the 6 doctors that bought the machines, you included, are at a disadvantage in this whole situation, but however, that doesn't make it okay for you to pass the product off as safe and reliable until it actually has our Government's stamp of approval. A gold standard keeps me and many other people in this country safe. You choose to continue sighting Europe's success with the Orbasone. That is good enough for you because you have invested a lot of money in the machine, but until it has the US. Stamp of approval, it is substandard in my book, and possibly the book of many others if the information was not so buried beneath all the spin that is being put on the almost generic name 'ESWT.' If people have all the facts presented to them and still chose what you are offering, I totally respect their choice.

For those who are interested, this is where they can find the 'Warning Letter' that has given me some of my concerns. You will need 'Acrobat Reader' to open it, and in addition, I had to print it out to be able to read it. It is rather jagged. If for some reason this like does not work, let me know, I will try to fix what is wrong. http://www.heelspurs.com/ ESWT/fda_letter_on_orbasone.pdf

Here are a few of my main concerns: The people that buy your treatments have a right to know that for now, they are buying a service that is not the 'ESWT' that is being raved about in the media. Even the people that win your lottery have a right to know that there are many questions still unanswered about the machine that you will be using on their bodies. Many people are scraping money together for the airfare and hotel expenses to come and see you. It may seem like small money to you, but for many, like me, it is a lot of money. They need to know that the machine you will be using is not the same as the one that provides relief in one treatment, such as the OssaTron does. They need to know that they will probably need multiple treatments to improve their chances of getting the same results that can be obtained with one treatment from the OssaTron. Moreover, they need to factor these aspects in to the overall cost. This is another example of how the machines are not comparable, the first one because one is approved and proven safe and effective by the FDA for treatment of Heelpain and PF and the other is not.

Dr. Z. it seems to me, that too many facts are being swept under the rug, and too many of half-truths are being treated as fact. If it were not for the fact that I have obtained temporary relief from my PF torture with the use of Methadone, I would still be just as desperate as many of the others that show up at this site looking for clear and unbiased information. This is a vulnerable group. I do not want to see them taken advantage of. Unfortunately, I am being made to look like a troublemaker, when in fact; I just want all the cards to be showing so that EVERYTHING is on the up and up. There is a cloud over this topic and we are not being allowed to discuss ESWT freely. Some people here want to put gag orders on everyone that has an opinion that is different from yours. That just is not fair!

I sense that you are in such a hurry to promote your own agenda, that you are failing to inform the people of what exactly you are selling them. Maybe you want to make a lot of money with the machine while you can, because maybe they are going to recall it. I am just guessing here. I really do not know, I just know that so many things are not adding up.

Many people who have already been treated by you may have no idea that your machine was detained because it lacked FDA approval. Did you reveal this to them in advance of using the Orbasone on them? Don't you think you should? Why don't you go one step further and tell them before they spend all the time and money to come to New Jersey to see you? I am so curious about how you can perpetuate the myth that everything you are doing is on the up and up. I have so many questions to ask you if you were up to answering them. For example, do you require that the people you treat for 'free' sign a disclaimer of any sort? Do you inform them of the controversies surrounding it before you use the machine in them? I also have concerns about the long-term outcome of using a machine that seems to be unregulated because it is unapproved in the first place.

Right or wrong, I get the impression that since it is illegal for you to market your product for use as a PF and Heelspur Treatments at you own site, you are doing it here to a huge number of a very select audience of desperately ill and trusting people. It's a little like letting the fox in to the chicken coop. It's hard for you to be unbiased because you have so much money tied up in the Orbasone machine that you purchased, in advance of it being approved for use on PF and Heel pain.

The device is labeled as a 'Therapeutic Vibrator' intended for various uses such as RELAXING MUSCLES AND RELIEVING MINOR ACHES AND PAINS. When someone is scraping together the airfare to come to you for a treatment, do they, or do they not, have a right to know what they are spending their money on? Or are you concerned that when they know all the facts, they may choose to put that money toward OssaTron, or wait until is the OssaTron or a another truly comparable machine is covered by health insurance? Don't you think it is true that when health insurance starts to pay for ESWT it will not be paying for the milder versions of ESWT that the machine you currently use provides? Is that why you are so anxious to make as much money as you can before that action takes place? Because your machine might be of little or no use after that?

Another concern I have it that I think many patients are lulled into believe they are getting, or at least that the treatment you are going to give them is equivalent to the OssaTron. I would admire your 'Free treatment lottery' so much more if the facts regarding what you are actually giving them were laid out on the table. This is true even more so, for the people that are paying full price.

You seem to represent your product as the same thing for a fraction of the cost. Considering the differences I have sited for you here, how can you represent what you are providing as comparable? I am concerned about this. I have no financial ties what so ever to ESWT in any way, except for the fact that it may someday be part o my personal treatment plan. That is the only reason I began researching this topic as much as I have so far. Some here may remember that at one time, just before the idea of the lotto came to be, you offered to treat ME for FREE, and I would only have to pay you if it worked for me, because you wanted to see if your machine was effective on 'Fibromyalgia of the feet.' I could have already been there getting a possibly free treatment, so this is not sour grapes about me not having won the lotto. For the record, I am not even entered in the lotto. I started researching the differences in machines when you made your generous offer, and that is when all these tidbits of information started interesting me so much. I too wanted to weigh the possibility of whether I should scrounge up the travel expenses and take you up on your offer. As for me, I came us with a NO; I will wait for Insurance to help me get the 'real deal.' If you offered everyone the same money back guarantee you offered me, I think what you are offering would be a lot more fair. Then my only concern would be that the buyer beware that the machine is unregulated at this moment, because it is unapproved for use in the specific capacity that you are offering it. There should be no disclaimers signed, because, Lord forbid, if something goes wrong, they would have no recourse what so ever.

I more than welcome any truthful enlightenment that you can offer. I admit that I don't understand all that is going on with this sorted mess. I am still learning. I apologize if I have offended you in reporting my concerns to the group. I have tried to present my perspective for the sake of others like me, without specifically referencing you when it is possible. But, it's hard to talk about this subject truthfully without mentioning names at all. That is what we do here, we try to inform and support each other. I am bonded to those who have the severe pain and discomfort of chronic PF. I am loyal to them first; even though some here choose t make me look like a bad guy. I know in my heart that I am doing it for the right reasons.
Regards, Kim B.

Re: Valerie be sure you let your Pod know there are differences!

Dr. Zuckerman on 4/17/01 at 15:25 (044852)

Kim

The FDA never stated that any of the doctors including Dr. Z has to stop using the orbasone for the treatment of pf. I can market the use of the orbasone for the treatment of pf. This long letter is about the people selling the machines to the doctors. Not the doctors using the machine to the public.

The orbasone is a safe and effective machine that is and can be used by the six doctors. I can and will use it for the treatment for the pain in the foot . I will and and can use it for the treatment of pf pain.

You talk about Methadone and the treatment for pf. Now I am not making any judgement but this is something that is also under the direction of the FDA . The reason that your doctor can use this is probaby due to his or her having the freedom to determine how it should be used. To my knowledge I didn't even know that methadone was legal. So if I would talk off the top of my head I would conclude that your doctor is using methadone against FDA regulations and orders. But I do know that the doctor probaby has the ability to use if off label. If I just talked off the top of my head I would conclude that the use of methadone for pf is illegal and should be reported to the FDA. But I won't make these statements because I don't know all of the facts. The fact is that Dr. Z and the six doctors using the orbasone are using the orbasone because not only is it very safe and effective it is the best priced machine in the world. The cost to have this done is fair. I could stop within the next six weeks stitch to the ossatron charge everyone up the $%$%$#%#$ and forget that these are people.

Yes people need to be informed and the fact is the doctors using the orbasone are using an effective and safe treatment that has stood the test of time in both Europe and the USA. The FDA knows this and I hope that you will stop with all this .

Re: Valerie be sure you let your Pod know there are differences!

Nancy N on 4/17/01 at 16:00 (044857)

Am I the only one who's read Dr. Z's posts about how he now has access to an OssaTron and will be able to offer it to his patients in the near future? I hardly think that's the behavior or a self-centered, money-hungry doctor. I don't know where this desire to attack came from lately, but I think it's unfounded and needs to stop. If the problem is with the machine, and what the company did or didn't do as far as the FDA is concerned, fine. But don't take it out on the doctor who's caught in the middle just because he was on the ball enough to be aware of a new treatment, and saw an opportunity to end his patients' suffering.

The Orbasone and other ESWT machiens have been used safely in plenty of other countries for a decade now--that's plenty of time for any side effects to appear--while we've waited, cluelessly, on the other side of the Atlantic, having surgeries that only made us worse or just suffering in silence and despair. In fact, if the FDA weren't being stubborn about going through the whole process again and delaying approvals for a few more years, we wouldn't be having this discussion now, because they'd have their data, the machines would have their approval, and the insurance companies would be covering it. I think that's at least as ridiculous as the current situation surrounding the Orbasone, which is why it's important to take the information Brian posted and contact the FDA to tell them to quit dragging their feet.

Re: Number of treatments per machine

Nancy N on 4/17/01 at 16:56 (044863)

I forgot to mention earlier that the number of treatments required for ESWT varies by machine. The OssaTron often, but not always (according to information OssaTron patients and docs have posted on this site) requires only one treatment. Rose L posted the other day that her treatment in Canada, which I believe was a Sonocur treatment, was four treatments a few days apart from each other. The OrthoWave machine, whose FDA trial I was involved in, used two treatments, two weeks apart. I vaguely seem to recall someone posting that the Dornier machine also used multiple treatments, but I don't recall the details on that one.

My point is that the number of treatments is going to vary by machine, and the machines vary by philosophy as far as high- or low- energy and duration of the treatment, which is probably how they determine how many treatments are needed and at what interval. I don't think it's fair, then, or even a good argument to base the quality of a machine on the number of treatments required. Also, as we all know on this board, some treatments work for some people, and some do not. PF is a highly individual condition, so it is reasonable to expect that some people may respond differently to the treatment, and some may require fewer treatments than others (though this also depends on the machine and the logic behind the treatment schedule). Considering that the European literature on ESWT, which is based on ten years of study, says that multiple treatments are beneficial, I'm not surprised that so many of these machines make use of the multiple treatment philosophy. In fact, it's rather more surprising that the OssaTron seems to be the only one that doesn't.

Re: Number of treatments per machine

Dr. Zuckerman on 4/17/01 at 19:03 (044888)

Hi,

In Europe the Ossatron study for heel spur had about a 20% second treatment rate. I don't see the big deal with 2nd or even 3rd treatments.

The one shot treatment may or may not be in the best interest of the patients. I only though one treatment in the beginning but my though process is open to make the treatment program specific to the patient and the patients specific needs. This would mean activity, travel time, expense
and just don't want to go to sleep or have a needle placed into the foot.

Everyone is different so every treat must be though out for each different patients. Choice is the word that I like to use when discussing treatments

Re: Dr. Z, FYI

Kim B. on 4/17/01 at hrmin (044915)

Dr. Z.,
Respectfully, I must still stand on all of the statements in my previous post. I did my homework, and from what I read in the letter, the facts STILL remain the same. This is a good expample of half-truths Doc. Yes, it is true that the letter was to Norland Mecial about how they market the machine, but the jest of the letter was that the marketing was being handled incorrectly and that by marketing it incorrectly in the first place to the doctors who would buy it, it would cause it to be mis-marketed in the same way, by the Doctors. As we see, it rings true in your situation. Anyone who reads the letter can see that it is more than clear what the author was trying to put a stop to. Do you mean to tell me that you read that letter and don't agree that the message in it applies to YOU? Please.

In addition, if you had done you homework on my situation you would see the numerous postings I've made regarding my success with Methadone. In those post, I explained that I was given Methadone to treat my long term case of Fibromyalgia. The fact that it also benefited my feet was an unexpected side benefit!! I posted that to this group, and went on to encourage the doctors here to consider whether Metadone may also be indicated for others who have severe PF that has not responded to any other treatments. I even pointed out that as another side benefit, I have lost weight without even trying, because my metabollism is up, my pain is down, and I am much more active. Doctors are so quick to site weight problems as a PF aggravator, I thought you docs MIGHT be thrilled that something so inexpensive is readily avialible and may be yet another tool that could be added to the doctors arsonal. But you know, I got no response from the docs about that. Docs don't make money off of prescriptions that are available in generic equivelients.

'Talking off the top of your head', is no good. You are incorrect. My doctor is completely within the law by prescibing Methadone for my chronic pain issue. You have wrongfully accuses me and my doctor of illegally using drugs. Homework, Dr.Zuckerman, Do your homework first.

Kim B.

Re: To Kim

Pauline on 4/18/01 at 13:09 (044984)

Kim,
I'm changing the subject but do you know if Methadone is used to help the pain of Pancreatitis? I have a friend who suffered daily with chronic
pain. She is on multiple narcotics. I had to pick up her perscription
one day and I felt like a criminal. The perscriptions have to be filled in 24 hrs. Scrips pickup in person. She goes to a pain clinic and has had some kind of blocks done too. I feel so sorry for her.

Re: Dr. Z, FYI

denisea on 4/23/01 at hrmin (045417)

Hi Kim,

I was going to just read and listen because you obviously know I work with Dr. Zuckerman. I also believe you have the right to raise questions so that you can hear the answers and make your own decisions. In this instance though I would like to make just one comment.

Dr. Zuckerman wasn't accusing you or your doctor of illegally using drugs. He was saying that the Dr. was probably using the prescription with 'off label' use. His comment was that he COULD make a comment off the top of his head that the use was illegal, but that the truth was he was using the product 'off label.' That's how I took it. Dr. Zuckerman can correct me if I'm wrong but I don't think he meant disrespect to either of you.

Denise

Re: Valerie be sure you let your Pod know there are differences!

Kim B. on 4/16/01 at hrmin (044748)

Hi Valerie,

I would recommend that you help your Pod understand that there are huge differnces between ESWT machines. The Orbasone is carrying a cloud of doubt over it's head at this time. Where as the OssaTron is not. The last thing you want is for him to hear the bad information first and then throw the baby out with the bathwater.

It is my understanding that The Orbasone is basically a 'Theraputic Vibrator' and is NOT currently approved by the FDA as a machine that is to be marketed for Heel Pain. The OssaTron on the other hand is.

Be sure he understands they are very different machines that come with different capabilities. If your pod was to just read about the things going on with the Orbasone, he may conclude that all ESWT is currently under dention by the department of Health and human services.

If you want him to pursue the more successful EWST route, You'll want to be sure that he hears the Good News about the OssaTron and/or other FDA APPROVED devices that will be entering the market soon.

Good luck! Like you, I want every Podiatrist, surgeon and Orthopedic Specialist in the U.S. to become educated about ESWT. The good machines that are FDA APPROVED for heel pain. NOT the machine that is currently under detention, due to it's manufacture failing to prove it safe and effective.

Regards, Kim B.

Re: My Pod just recommended ESWT!

Steve P on 4/16/01 at 18:44 (044766)

Hi Val -- Good for you!

The ESWT Locations database shows a treatment center in Birmingham, Mich. I don't know how far that is from Grand Rapids. ????? There are also several in the Chicago area, including Dr. Marlene Reid's practice. (She is a frequent poster on this board.)

Also, there is Heidi Brunner in the Toronto area (whom Rose from our board recently visited & posted about). So there are a lot of choices.

You might want to make your first phone call to Dr. Z, just to get his feeling on whether you are a candidate for ESWT & any recommendations he may have.

I don't share the view that one machine is clearly better than the others. Scott's database shows remarkably similar results for all 3 machines based on data gathered to date.

Good luck............Steve

Re: Valerie be sure you let your Pod know there are differences!

JudyS on 4/16/01 at 20:46 (044776)

Is it not true that the Orbasone has indeed been approved, generally, for the 'treatment of pain.....'? Does not having 2 certain forms on file with the FDA mean, specifically, that Norland has 'failed to prove it's safe and effective...' Is that the specific language of the FDA?
I happily applaud any member of this board wanting to provide as much information as possible about ANY tool used for PF. And I especially appreciate the research that some have done for the benefit of all. What I'm confused about is the seemingly secretive nature of FDA information and what seems to be a determination to discredit Dr. Z's use of the Orbasone.
Scott, is it possible for this documentation to be posted here so we can all evaluate it and, as with all else here, make our own conclusions?

Re: Valerie be sure you let your Pod know there are differences!

Dr. Zuckerman on 4/17/01 at 09:07 (044803)

Kim,

There is over four hundred pages of proof for the safey and effectiveness for the orbasone machine. Much of this in on file with the FDA.

The safety of the orbasone was determined and proven in the orginal application to the FDA.

The orbasone has a long and proven track record in the treatment of pain in the USA and European. In fact the orbasone has been used in more patients then any other ESWT machine in the USA.

There has never been an indication by the FDA that the machine itself is a problem . The problem has been with the way Norland Medical has been marketing the orbasone to doctors.

Now go take a look at the FDA studies for the ossatron and you tell me it they proved that the machine is effective. Scott has pointed out the the control was 48% and the treating patients was 62%

Re: Valerie be sure you let your Pod know there are differences!

Pauline on 4/17/01 at 10:47 (044817)

DR, Z,
Dr Z, You are correct in everything you said. Indeed the Orbasone machine has proof for the safety and effectiveness in the device classification,
Class I, in accordance with it's original application.

The FDA never indicated it had a problem with the machine itself, it simply said that the machine in order to be used to treat soft tissue diseases (ie PF) it needs to provide much more documentation and be reclassified with similar machines and cannot be marketed as it is currently classified. Norland Medical, cannot apply for one type of clearance then label and market it machine for a different purpose.

Its been used the longest in the U.S. simply because it was labeled and marketed incorrectly not because it received FDA approval for use to treat Plantar Fasciitis. Healthronics OssaTron was the first ESWT given full FDA approval to be sold and marketed for the treatment of specific soft tissue diseases. Other manufacturers wanting to provide the same type of treatment will have to be approved by the FDA in the same classification catagory.

No doubt the Orbasone will reapply and provide the FDA with the documentation it is requiring if it wants to get it's Orbasone off the
FDA's Automatic Detention list. The FDA is using this to bring Norland into complience with its regulations.

If anyone is interested in the ins and outs of the FDA's Regulations on Medical Devices you can go to this web site. It puts it in a nut shell and has additional links.

http://www.qrasupport.com/FDA_MED_DEVICE.html

There is a big difference between Classifications Applications and some Physical Therapy devices which might be in Class I certainly don't carry the same risk according to the FDA as devices in Class II and Class III.

I don't think they would go for a manufacturer of a Heart Massager applying for FDA clearance as a Class I device then labeling and marketing it to Heart Surgeons as a Pace Maker. We're in the U.S. and the companies have to play by the FDA's rules. The rules in Canada and Europe don't seem to apply here.

Re: Valerie be sure you let your Pod know there are differences!

Dr. Zuckerman on 4/17/01 at 12:49 (044837)

Hi Pauline,

Well here is what we do know . Ultrasound devices have the potential to cause burning, nerve damage, etc. There are even FDA class one approved focused ultra sound devices that can cause alot of damage.

So tell me why you can market a new renal device lithrotripsy device,file a form and off to the USA market. In fact it is in the class two area.

Again I am not trying to defend any company. Rules are rules. But if you follow rules they you shouldn't have them be changed in the middle of the road.

Now why would anyone want to treat plantar fasciitis that doesn't have pain.

The reason any and all pf is treated for ESWT is pain. Did you know that none of the current ESWT machines out there are producing shockwaves or using a true lithotripter device, except the ossatron.

I have received an education in the use of Shockwaves and I still can't believe that one company determined the classification.

Did you know that there is an ESWT machine used right now in the USA distributed by Norland medical and made by MIP. Same technology but in class two. This is because it is used for blasting of kidney stones. not the treatment of pain for soft tissue. In theory I can buy this present machine use the machine for pf pain and that is that.

So how would you feel as a doctor to see an approval form from the FDA that knows about the orbasone and knows about the ossatron and ok's the use of the orbasone and then in the middle of the road decides that wrong form wrong application. I could understand mistakes what I can't understand is a mistake when you know the machines and know the technology

I would think that your concern would be toward the govt agency that is changing decision and interfering with the free market and the treatment of patients. I would think that you would be concern that the FDA could review and determine that there should be different classification for all of these devices. If is ok to use European site for testing. This was done for the ossatron and for the Dornier. The public should have a say in FDA policy or FDA change of policy. Yes protection of the public is important but it isn't important to protect the market for one company . Did you know that there are public representation within the FDA. The proof for ESWT is out there and duplication shouldn't be necessary at this time . We don't need any more medical competition between companies.

The analogy about the heart doesn't apply here.

So PAuline I hope that you re-consider your attack against the MIP and Norland. Maybe it should be directed toward the policies that are at present time helping to control the market.

What more do you want from a company supplying dog killing studies that prove that the orbasone can't damage bone. What more do you need if you have hundred of pateints that have had ESWT by the orbasone and the patients are pain free. What do you Pauline want.

Remember that you have pf and remember that you know what the pain is like. Now remember that there are pateints that can't affored the present cost of ESWT in the ASC. Think about the poor pf suffering patient. Now take a look at the classifcations for ESWT . Please try to re-think your though process.

Thanks you.

Re: Hi Pauline .- I would like to talk to you on the phone.

Dr. Zuckerman on 4/17/01 at 13:04 (044840)

Hi Pauline,

I really would like to talk to you over the phone . Sometimes I don't express the information that I know very well. There is some information that I would love to run by you for your opinion. I believe that your goal is for the benefit of the public and the pf suffering patients. So how about us talking over the phone. My phone number is 1-856-848-338. If you call collect it is ok. If I am with a patient they will aceept your call and I will then call you back.

Thanks.

Dr. Z

Re: Valerie be sure you let your Pod know there are differences!

Pauline on 4/17/01 at 13:11 (044842)

Dr. Z,
I can see the red in your eyes and the steam comming from your ears, but you know I didn't make the rules. Norland, Healthronics, Dornier etc. etc. are all grown up companies who have on more than one occassion applied for some type of FDA approval. They know the rules and regulations and know how to play the games the Government requires. They even hire other companies to help them play the games well.

Your anger would be better served at Norland for messing up their great opportunity. There is no doubt in my mind that they will meet compliances and all will be right with the world once again. Keep the faith.

Re: Valerie be sure you let your Pod know there are differences!

Kim B. on 4/17/01 at hrmin (044845)

Dr. Zuckerman,

I have legitimate concerns and some of them come from the 'Warning Letter' that was sent to Mr. Terry Schwalenberg, the Director of Quality Assurance and Regulatory Affairs at Norland Medical, the manufacture of the Orbasone, the machine that you use in giving ESWT treatments.

The letter states strong language that, in my opinion, gives any PF consumer who is considering your treatment cause for concern. It specifically states that the Orbasone can only be marketed for general pain relief without reference to specific sites on the body. The OssaTron ESWT however, is PF and heelpain specific and is further, proven safe and effective in the treatment of heel pain and PF. Still you insist that the machines are basically equal in their ability. I take issue with any company, or any individual, that does not abide by the law of this land and respect that the FDA has set certain limits in place.

From what I am able to understand, the only reason you currently have your Orbasone is that the FDA goofed and let six (6) of the machines into the U.S. When they realized their mistake, they put them on a detention list pending proper FDA approval. They did not recall the machines, but they did put limit on the way that the six doctors that already had them would be allowed to use them, pending proper approval. They were trying to make the best of the situation for all involved, including the six doctors that already had the machines.

I know the 6 doctors that bought the machines, you included, are at a disadvantage in this whole situation, but however, that doesn't make it okay for you to pass the product off as safe and reliable until it actually has our Government's stamp of approval. A gold standard keeps me and many other people in this country safe. You choose to continue sighting Europe's success with the Orbasone. That is good enough for you because you have invested a lot of money in the machine, but until it has the US. Stamp of approval, it is substandard in my book, and possibly the book of many others if the information was not so buried beneath all the spin that is being put on the almost generic name 'ESWT.' If people have all the facts presented to them and still chose what you are offering, I totally respect their choice.

For those who are interested, this is where they can find the 'Warning Letter' that has given me some of my concerns. You will need 'Acrobat Reader' to open it, and in addition, I had to print it out to be able to read it. It is rather jagged. If for some reason this like does not work, let me know, I will try to fix what is wrong. http://www.heelspurs.com/ ESWT/fda_letter_on_orbasone.pdf

Here are a few of my main concerns: The people that buy your treatments have a right to know that for now, they are buying a service that is not the 'ESWT' that is being raved about in the media. Even the people that win your lottery have a right to know that there are many questions still unanswered about the machine that you will be using on their bodies. Many people are scraping money together for the airfare and hotel expenses to come and see you. It may seem like small money to you, but for many, like me, it is a lot of money. They need to know that the machine you will be using is not the same as the one that provides relief in one treatment, such as the OssaTron does. They need to know that they will probably need multiple treatments to improve their chances of getting the same results that can be obtained with one treatment from the OssaTron. Moreover, they need to factor these aspects in to the overall cost. This is another example of how the machines are not comparable, the first one because one is approved and proven safe and effective by the FDA for treatment of Heelpain and PF and the other is not.

Dr. Z. it seems to me, that too many facts are being swept under the rug, and too many of half-truths are being treated as fact. If it were not for the fact that I have obtained temporary relief from my PF torture with the use of Methadone, I would still be just as desperate as many of the others that show up at this site looking for clear and unbiased information. This is a vulnerable group. I do not want to see them taken advantage of. Unfortunately, I am being made to look like a troublemaker, when in fact; I just want all the cards to be showing so that EVERYTHING is on the up and up. There is a cloud over this topic and we are not being allowed to discuss ESWT freely. Some people here want to put gag orders on everyone that has an opinion that is different from yours. That just is not fair!

I sense that you are in such a hurry to promote your own agenda, that you are failing to inform the people of what exactly you are selling them. Maybe you want to make a lot of money with the machine while you can, because maybe they are going to recall it. I am just guessing here. I really do not know, I just know that so many things are not adding up.

Many people who have already been treated by you may have no idea that your machine was detained because it lacked FDA approval. Did you reveal this to them in advance of using the Orbasone on them? Don't you think you should? Why don't you go one step further and tell them before they spend all the time and money to come to New Jersey to see you? I am so curious about how you can perpetuate the myth that everything you are doing is on the up and up. I have so many questions to ask you if you were up to answering them. For example, do you require that the people you treat for 'free' sign a disclaimer of any sort? Do you inform them of the controversies surrounding it before you use the machine in them? I also have concerns about the long-term outcome of using a machine that seems to be unregulated because it is unapproved in the first place.

Right or wrong, I get the impression that since it is illegal for you to market your product for use as a PF and Heelspur Treatments at you own site, you are doing it here to a huge number of a very select audience of desperately ill and trusting people. It's a little like letting the fox in to the chicken coop. It's hard for you to be unbiased because you have so much money tied up in the Orbasone machine that you purchased, in advance of it being approved for use on PF and Heel pain.

The device is labeled as a 'Therapeutic Vibrator' intended for various uses such as RELAXING MUSCLES AND RELIEVING MINOR ACHES AND PAINS. When someone is scraping together the airfare to come to you for a treatment, do they, or do they not, have a right to know what they are spending their money on? Or are you concerned that when they know all the facts, they may choose to put that money toward OssaTron, or wait until is the OssaTron or a another truly comparable machine is covered by health insurance? Don't you think it is true that when health insurance starts to pay for ESWT it will not be paying for the milder versions of ESWT that the machine you currently use provides? Is that why you are so anxious to make as much money as you can before that action takes place? Because your machine might be of little or no use after that?

Another concern I have it that I think many patients are lulled into believe they are getting, or at least that the treatment you are going to give them is equivalent to the OssaTron. I would admire your 'Free treatment lottery' so much more if the facts regarding what you are actually giving them were laid out on the table. This is true even more so, for the people that are paying full price.

You seem to represent your product as the same thing for a fraction of the cost. Considering the differences I have sited for you here, how can you represent what you are providing as comparable? I am concerned about this. I have no financial ties what so ever to ESWT in any way, except for the fact that it may someday be part o my personal treatment plan. That is the only reason I began researching this topic as much as I have so far. Some here may remember that at one time, just before the idea of the lotto came to be, you offered to treat ME for FREE, and I would only have to pay you if it worked for me, because you wanted to see if your machine was effective on 'Fibromyalgia of the feet.' I could have already been there getting a possibly free treatment, so this is not sour grapes about me not having won the lotto. For the record, I am not even entered in the lotto. I started researching the differences in machines when you made your generous offer, and that is when all these tidbits of information started interesting me so much. I too wanted to weigh the possibility of whether I should scrounge up the travel expenses and take you up on your offer. As for me, I came us with a NO; I will wait for Insurance to help me get the 'real deal.' If you offered everyone the same money back guarantee you offered me, I think what you are offering would be a lot more fair. Then my only concern would be that the buyer beware that the machine is unregulated at this moment, because it is unapproved for use in the specific capacity that you are offering it. There should be no disclaimers signed, because, Lord forbid, if something goes wrong, they would have no recourse what so ever.

I more than welcome any truthful enlightenment that you can offer. I admit that I don't understand all that is going on with this sorted mess. I am still learning. I apologize if I have offended you in reporting my concerns to the group. I have tried to present my perspective for the sake of others like me, without specifically referencing you when it is possible. But, it's hard to talk about this subject truthfully without mentioning names at all. That is what we do here, we try to inform and support each other. I am bonded to those who have the severe pain and discomfort of chronic PF. I am loyal to them first; even though some here choose t make me look like a bad guy. I know in my heart that I am doing it for the right reasons.
Regards, Kim B.

Re: Valerie be sure you let your Pod know there are differences!

Dr. Zuckerman on 4/17/01 at 15:25 (044852)

Kim

The FDA never stated that any of the doctors including Dr. Z has to stop using the orbasone for the treatment of pf. I can market the use of the orbasone for the treatment of pf. This long letter is about the people selling the machines to the doctors. Not the doctors using the machine to the public.

The orbasone is a safe and effective machine that is and can be used by the six doctors. I can and will use it for the treatment for the pain in the foot . I will and and can use it for the treatment of pf pain.

You talk about Methadone and the treatment for pf. Now I am not making any judgement but this is something that is also under the direction of the FDA . The reason that your doctor can use this is probaby due to his or her having the freedom to determine how it should be used. To my knowledge I didn't even know that methadone was legal. So if I would talk off the top of my head I would conclude that your doctor is using methadone against FDA regulations and orders. But I do know that the doctor probaby has the ability to use if off label. If I just talked off the top of my head I would conclude that the use of methadone for pf is illegal and should be reported to the FDA. But I won't make these statements because I don't know all of the facts. The fact is that Dr. Z and the six doctors using the orbasone are using the orbasone because not only is it very safe and effective it is the best priced machine in the world. The cost to have this done is fair. I could stop within the next six weeks stitch to the ossatron charge everyone up the $%$%$#%#$ and forget that these are people.

Yes people need to be informed and the fact is the doctors using the orbasone are using an effective and safe treatment that has stood the test of time in both Europe and the USA. The FDA knows this and I hope that you will stop with all this .

Re: Valerie be sure you let your Pod know there are differences!

Nancy N on 4/17/01 at 16:00 (044857)

Am I the only one who's read Dr. Z's posts about how he now has access to an OssaTron and will be able to offer it to his patients in the near future? I hardly think that's the behavior or a self-centered, money-hungry doctor. I don't know where this desire to attack came from lately, but I think it's unfounded and needs to stop. If the problem is with the machine, and what the company did or didn't do as far as the FDA is concerned, fine. But don't take it out on the doctor who's caught in the middle just because he was on the ball enough to be aware of a new treatment, and saw an opportunity to end his patients' suffering.

The Orbasone and other ESWT machiens have been used safely in plenty of other countries for a decade now--that's plenty of time for any side effects to appear--while we've waited, cluelessly, on the other side of the Atlantic, having surgeries that only made us worse or just suffering in silence and despair. In fact, if the FDA weren't being stubborn about going through the whole process again and delaying approvals for a few more years, we wouldn't be having this discussion now, because they'd have their data, the machines would have their approval, and the insurance companies would be covering it. I think that's at least as ridiculous as the current situation surrounding the Orbasone, which is why it's important to take the information Brian posted and contact the FDA to tell them to quit dragging their feet.

Re: Number of treatments per machine

Nancy N on 4/17/01 at 16:56 (044863)

I forgot to mention earlier that the number of treatments required for ESWT varies by machine. The OssaTron often, but not always (according to information OssaTron patients and docs have posted on this site) requires only one treatment. Rose L posted the other day that her treatment in Canada, which I believe was a Sonocur treatment, was four treatments a few days apart from each other. The OrthoWave machine, whose FDA trial I was involved in, used two treatments, two weeks apart. I vaguely seem to recall someone posting that the Dornier machine also used multiple treatments, but I don't recall the details on that one.

My point is that the number of treatments is going to vary by machine, and the machines vary by philosophy as far as high- or low- energy and duration of the treatment, which is probably how they determine how many treatments are needed and at what interval. I don't think it's fair, then, or even a good argument to base the quality of a machine on the number of treatments required. Also, as we all know on this board, some treatments work for some people, and some do not. PF is a highly individual condition, so it is reasonable to expect that some people may respond differently to the treatment, and some may require fewer treatments than others (though this also depends on the machine and the logic behind the treatment schedule). Considering that the European literature on ESWT, which is based on ten years of study, says that multiple treatments are beneficial, I'm not surprised that so many of these machines make use of the multiple treatment philosophy. In fact, it's rather more surprising that the OssaTron seems to be the only one that doesn't.

Re: Number of treatments per machine

Dr. Zuckerman on 4/17/01 at 19:03 (044888)

Hi,

In Europe the Ossatron study for heel spur had about a 20% second treatment rate. I don't see the big deal with 2nd or even 3rd treatments.

The one shot treatment may or may not be in the best interest of the patients. I only though one treatment in the beginning but my though process is open to make the treatment program specific to the patient and the patients specific needs. This would mean activity, travel time, expense
and just don't want to go to sleep or have a needle placed into the foot.

Everyone is different so every treat must be though out for each different patients. Choice is the word that I like to use when discussing treatments

Re: Dr. Z, FYI

Kim B. on 4/17/01 at hrmin (044915)

Dr. Z.,
Respectfully, I must still stand on all of the statements in my previous post. I did my homework, and from what I read in the letter, the facts STILL remain the same. This is a good expample of half-truths Doc. Yes, it is true that the letter was to Norland Mecial about how they market the machine, but the jest of the letter was that the marketing was being handled incorrectly and that by marketing it incorrectly in the first place to the doctors who would buy it, it would cause it to be mis-marketed in the same way, by the Doctors. As we see, it rings true in your situation. Anyone who reads the letter can see that it is more than clear what the author was trying to put a stop to. Do you mean to tell me that you read that letter and don't agree that the message in it applies to YOU? Please.

In addition, if you had done you homework on my situation you would see the numerous postings I've made regarding my success with Methadone. In those post, I explained that I was given Methadone to treat my long term case of Fibromyalgia. The fact that it also benefited my feet was an unexpected side benefit!! I posted that to this group, and went on to encourage the doctors here to consider whether Metadone may also be indicated for others who have severe PF that has not responded to any other treatments. I even pointed out that as another side benefit, I have lost weight without even trying, because my metabollism is up, my pain is down, and I am much more active. Doctors are so quick to site weight problems as a PF aggravator, I thought you docs MIGHT be thrilled that something so inexpensive is readily avialible and may be yet another tool that could be added to the doctors arsonal. But you know, I got no response from the docs about that. Docs don't make money off of prescriptions that are available in generic equivelients.

'Talking off the top of your head', is no good. You are incorrect. My doctor is completely within the law by prescibing Methadone for my chronic pain issue. You have wrongfully accuses me and my doctor of illegally using drugs. Homework, Dr.Zuckerman, Do your homework first.

Kim B.

Re: To Kim

Pauline on 4/18/01 at 13:09 (044984)

Kim,
I'm changing the subject but do you know if Methadone is used to help the pain of Pancreatitis? I have a friend who suffered daily with chronic
pain. She is on multiple narcotics. I had to pick up her perscription
one day and I felt like a criminal. The perscriptions have to be filled in 24 hrs. Scrips pickup in person. She goes to a pain clinic and has had some kind of blocks done too. I feel so sorry for her.

Re: Dr. Z, FYI

denisea on 4/23/01 at hrmin (045417)

Hi Kim,

I was going to just read and listen because you obviously know I work with Dr. Zuckerman. I also believe you have the right to raise questions so that you can hear the answers and make your own decisions. In this instance though I would like to make just one comment.

Dr. Zuckerman wasn't accusing you or your doctor of illegally using drugs. He was saying that the Dr. was probably using the prescription with 'off label' use. His comment was that he COULD make a comment off the top of his head that the use was illegal, but that the truth was he was using the product 'off label.' That's how I took it. Dr. Zuckerman can correct me if I'm wrong but I don't think he meant disrespect to either of you.

Denise