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recovery time for second round ESWT

Posted by Rosemary T on 6/06/03 at 08:17 (121097)

Hi ,
I haven't posted in a while, after my first round of ESWT I would say I am about 60% improved. My doctor recommends another round. Here is my question for those of you who have had the treatment more than once. If at the beginning of the first treatment you are about 10% of your normal functioning - have the treatment, initially regress(post treatment sorness and healing process)- then improve to 50% normal functioning. If you have the treatment again, would you feel as bad post treatment as the first time or because you went into the treatment feeling better, you would naturally be functioning at a higher level post treatment right from the beginning. I hope I have been clear. Asking because I want to determine how much I will be able to do following this treatment. The first time I really needed to rest a lot - but I was almost unable to do anything prior to the treatment. REsponses and advice would be greatly appreciated. Thanks, R osemary

Re: recovery time for second round ESWT

SteveG on 6/06/03 at 09:40 (121114)

I had periods after the second treatment when the pain was similiar to what it was before the first treatment. The amount of pain you experience after treatment can vary quite a bit. I hope this makes sense and answers your question.

Re: recovery time for second round ESWT

Rosemary on 6/06/03 at 22:27 (121221)

Hi Steve,
As you can see I have decided to go ahead with another round. I know it is probably too early to tell, but do you feel like you have to rest after the second treatment as much as after the first. Thanks, it seems like I am following your path. did you have your first treatment around Jan or Feb. sometime - it seems like we have been through this before!

Re: recovery time for second round ESWT

Dr. Z on 6/06/03 at 22:59 (121228)

Alot of patients if they obtain at least 50% improvement from their 1st ESWT can obtain alot of relief from the 2nd . Whether it will be right away is like looking into the eight ball, but from my experience most will get a big quick boost of pain relief. immediately. Rest is very important . Refrain from high impact sports, walking for miles and long mall shopping. Good luck. I believe Steve is unique in that he had Sonocur and then high energy dornier. What type of energy level treatments have you ahd so far.

Re: recovery time for second round ESWT

Rosemary T on 6/07/03 at 11:14 (121250)

High energy - part of an FDA study. Any information out there re: on how many months after the first treatment one waits before the second in regard to overall improvement?

Re: recovery time for second round ESWT

Dr. Z on 6/07/03 at 11:20 (121251)

Hi

The Dornier High Energy FDA study had no re-treats done Excellence Shockwave Therapy Groups waits at least 16 weeks in our high energy treatment program. If there is none to no improvement then we consider a 2nd treatment

Re: recovery time for second round ESWT

SteveG on 6/07/03 at 11:23 (121252)

Rosemary - I did not rest much after the second treatment. Since I have a sedentary job, I am not forced to be on my feet much. In terms of my other activities, I have sort of let pain be my guide. If they started to bother me, I would take it easy. I had the first treatment at Christmas time (3 treatments). I had the high energy done on May 1st. I seems like they are getting better, but, as I noted, the discomfort can vary quite a bit during the course of the day.

Re: recovery time for second round ESWT

Pauline on 6/07/03 at 12:45 (121256)

Brian can probably provide you with some information. He check with some European doctors I believe who had done studies. Brian had the same decision to make before he went back for his second treatment.

Brian can you share what you found out with Rosemary?

Re: recovery time for second round ESWT

Jen L on 6/07/03 at 15:09 (121262)

One thing you may have to consider: time period between the 1st and 2nd treatment if needed mihgt be different with different machines, whether it's Dornier, Ossatron or Orbi... Besides, if it's a FDA study, don't they requre you to stay in it for a predetermined number of months or a year so that at each intervals they can get patients's feedback recorded?
Why don't you ask your treating doctor who should know your condition better, or do you want to try a different machine this time?

Re: To Dr. Z -recovery time for second round ESWT

Jen L on 6/07/03 at 15:36 (121263)

Dr. Z,

In one of your earlier post of this thread you said a lot of patients can get a lot of relief from the 2nd ESWT if they improved 50% or more from the 1st treatment. But in later post you said 'If there is none to no improvement then we consider a 2nd treatment.' Do you mean that you will not consider the 2nd ESWT as part of the PAID treatment plan for a patient who got 50% improvement with the 1st ESWT?

If the patient's pain level was 10 before the procedure, then the pain got down to 5 which is a lot better, but I would think it's still difficult to have a normal life.

Thanks for clarification.

Jen

Re: To Dr. Z -recovery time for second round ESWT

Dr. Z on 6/07/03 at 16:11 (121265)

No.All second treatment are included . If you have 50% reduction in pain and your time frame from the 1st treatment is within six months. Give it more to time to heal

Re: recovery time for second round ESWT

Patti R on 6/07/03 at 20:06 (121278)

Hello..This is my first time to this site. I live in Los Angeles and don't have lots of time for this therapy and that therapy. I think I want the ESWT therapy for PF and I'm willing to fly to Canada if I have to but I am unsure where to go. Can someone help me with this issue and let me know places and prices? Thanks!

Re: recovery time for second round ESWT

Dr. Z on 6/07/03 at 22:25 (121281)

Hi

ESWT is indicated for chronic heel pain /plantar fasciitis for a duration of six months. How long have you had your pf problem?

Re: recovery time for second round ESWT

Patti R on 6/08/03 at 07:37 (121284)

Thank you for responding. I have been suffering with this for about 18 months. The pain has increased to a 9 or 10. I am 50 years old, in good health, but have put on about 25 lbs in the past 2 years. I have had to stop playing tennis, walking my 2 miles a day, cleaning my own house and now the PF is midigating my work ability as I am the Director of a non-profit organization so my public relations skills have come to a halt. Thank you for any type of help you can provide.....Patti

Re: recovery time for second round ESWT

Peter R on 6/08/03 at 09:08 (121295)

Patti- call 888-835-0886 and ask for a list of podiatrists in your area who can provide ESWT treatment with the lastes equipment.

Re: recovery time for second round ESWT

Dr. Z on 6/08/03 at 09:49 (121296)

Hi

First you do need an evaluation to determine if ESWT will help you. I can arrange for an evaluation or recommend someone in your area if you would like that. Where do you live?

Re: recovery time for second round ESWT

Patti R on 6/08/03 at 09:57 (121297)

I live in Los Angeles. I don't think ESWT is available in the U.S. My podiatrist is a jerk but I am limited to physicians due to my HMO as well as treatment. I have no problem going to Canada for treatment as I understand it is less expensive. My podiatrist had recommended rest, ice and special made arch supports, but my HMO will only cover foot orthotics for members with diabetic foot disease. My primary doctor said I have had these 'spurs' for a very long time. I truly need the best and most effective treatment.

Re: recovery time for second round ESWT

Dr. Z on 6/08/03 at 10:06 (121298)

Hi,

ESWT is offered in the USA. We have used it for over four years with very effective pain relief. You are correct your HMO probaby won't cover the prcedure.
The price ranges, experience in the USA is going to differ from podiatrist to podiatrist.
Going to Canada may or may not be the best option for you . If time, is a factor staying local may be your best choice. .
Peter R. did list a name of a company called United Shockwave. They may or may not have an experienced podiatrist in your area. Try the number he gave you.
ESWT isn't an over nite cure so you are going to have to invest some resting time with this procedure

After seeing someone feel free to ask some additional questions once you have had your consultation. This is alot of information on this board about ESWT.

Re: recovery time for second round ESWT

Pauline on 6/08/03 at 12:33 (121307)

Patti,
My suggestion is you check prices here and compare them with Canada. If your close enough and travel expenses don't add up the the same cost in the U.S. go to Canada.

They have use ESWT for a longer time and are experienced. Sunny who posts here does ESWT at Bayshore Clinic in Canada near Toronto and he'd be the first to tell you how successful they have been. I'm sure you'd find good clinics in the Vancouver area as well. The bottom line is that you can get good treatment in many locations and the exchange rate in Canada can be helpful especially when insurance isn't picking up the tab.

Re: recovery time for second round ESWT

Dr. Z on 6/08/03 at 14:31 (121312)

I agree she should check with different sites. There is one correction to your statement. The experience of high ESWT one time treatment is much greater in the USA. The have been thousands of high energy treatment done in the USA. High energy is the only FDA approved ESWT procedure in the USA for Plantar Fasciitis.
High Energy for Plantar fasciitis is the only treatment that has undergo strict randonized double blind Studies at major universities in the the USA. Some of the centers are Harvard, Emory and Henry Ford University
Canada has been using low energy for some time and they claim their sucess rate to be very good, however there are no FDA studies for low energy in either the USA and or Canada for chronic plantar fasciitis .. If FDA approval is important to you then this informaton should be part of your decision process.
I am not saying that Canada doesn't have excellent clinic I am just trying to allow you to compare apples with apples. ESWT isn't ESWT there are different types, different machines. different physician experiencs, and different approval standards.

Re: recovery time for second round ESWT

Peter R on 6/08/03 at 15:11 (121314)

**= Well said Dr. Z. Although I have not agreed with every aspect of some of your postings, this time you on on 100%. People who look for the cheap way usually get just what they pay for. I'm sure that, in the not too distant future, we will be seeing studies that show that the higher energy ESWT treatments have a higher rate of effectivness than low energy. Mulitple trips to Canada, transpotation, meals, lost time etc- this does not sound to me like it adds up to a lower cost overall.

Re: recovery time for second round ESWT

Dr. Z on 6/08/03 at 16:35 (121315)

We even had difference in treatment experience in the USA as well. Patient needs to do their homework and the most important aspect of ESWT treatment is the evaluation, diagnosis and the experience of the doctor in treating heel pain period.
Would you let your family doctor do plastic surgery on your face, this is the same analogy for ESWT. If your local podiatrist never did surgery or doesn't treat alot of plantar fasciitis do you want him or her doing ESWT on your feet.
You are going to find that the low ball fees out there are due to lack of experience and doctors trying to find patients.
Who would you go to the lasik surgeon who charges $500 or the lasik surgeon who charges $3000 . Well I would go to the lasik surgeon with the experience to do the procedure and treat other foot pathology that may or may not co-exist for plantar fasciitis. We all know that ESWT doesn't work at all in the wrong patient. So make sure your ESWT doctor knows how to diagnosis your foot problem in the first place

This board is full of stories that podiatrist, orthopedic surgeon doesn't understand my problem or can't find out what is wrong with me. Well don't fool yourselve into thinking that this doesn't extend to the next level that my ESWT doctor didn't know if I was a good candidate or wasn't sure of if it would work. ESWT is a very good procedure in the right hands, in the person and both with thre correct goals in mind.

Re: recovery time for second round ESWT

Pauline on 6/08/03 at 21:05 (121329)

There are high energy machines available in Canada as well as the U.S. and to think someone like Dr. Gordon M.D. who uses the Ossatron or other Orthopedic Surgeons in Canada like Dr. Kado who uses the Dornier Espos along with other would not provide adequate or proper treatment is pure nonsense.

I have to laugh Dr. Z when you talk about FDA approval and it's importance. Some of us have been around long enough to remember that FDA approval didn't mean a hill of beans to you a while back. Sorry it's just funny when I see you climb on the back of the FDA now. You made me laugh again tonight:*

Re: recovery time for second round ESWT

BrianG on 6/08/03 at 21:33 (121334)

Hi Rosemary,

I did check with a couple of doctors from the IMST group in Europe when I was thinking about getting a second Dornier treatment. What they suggested, is that since the full effects of the ESWT can be seen for up to a whole year, that I wait the year before a second treatment. The IMST group seems to use mostly low energy machines, but they did say the year would be good for high, or low, energy ESWT.

With that information, I decided to wait the year. Unfortunatly the first treatment didn't help me. I had the 2nd treatment (Dornier, from Dr Z) about 5 weeks ago. I had some initial discomfert after both treatments, but it didn't take long for that to disappear. This second time I had even less pain. So far, I haven't seen any improvement, but that could be for a variety of reasons. I know that I still have a month or two before seeing some improvement this time around.

I would advise you to listen to your feet. Take it easy for a couple of weeks. After that, slowley spend more time on your feet. If you use them too much one day, rest the next, if possible. Since I have had almost debilitating chronic pain for about 9 years, I honestly think it's going to be harder to heal me, than most people with PF. I think there is a lot more going on with the brain, and pain receptors, then most doctors are looking at. Thank god there is some research going on, as it may be my only way to turn off this pain.

I've done just about everything, to heal this pain, which leads me to believe there is something else going on besides PF, that could be related to how my brain precieves this pain!!!

Good luck
BrianG

Re: recovery time for second round ESWT

Dr. Z on 6/08/03 at 21:46 (121337)

I know that Dr. Gordon uses the ossatron. Not sure who Dr. Kadois is . I guess this is Kessler Kennedy. I am correct.? This still does change the fact that the experience of high energy is superior in the USA compared to the Canadian experience. Numbers are numbers

I knew you would bring up the FDA and my previous position but that doesn't change the fact that the FDA controls the safe and efficiency of All ESWT machines in the USA. When I spoke of FDA approval I was talking about difference in Classifications. The Big O was the only machine that showed the FDA safefy even before it applied for FDA Class one approval.
What makes me laugh is how at one time you though it was so important and now fail to mention it when you refer patients to Canada with your only concern price and you mention nothing about why the price is different in the USA. I am happy that I did make you laugh because laugher is the best medicine in the world.

Re: recovery time for second round ESWT

Dr. Z on 6/08/03 at 21:51 (121339)

One more comment Pauline. How many high energy machine are there in Canada and where are they located?. I know of the one ossatron and I believe there is one dornier that the last time I checked was used maybe once per month at Kessler-Kennedy. Could you tell us where are all the high energy machine in Canada. Just curious.

Re: recovery time for second round ESWT

Patti R on 6/08/03 at 22:37 (121344)

Ok Folks, U have this little ole L.A. girl totally confused. What is the difference between high energy and low energy? I thought that the FDA had not approved ESWT in the U.S. Is my information incorrect? However, I noted that there are clinics back east in the US. that provide this kind of service. I had also heard that ESWT costs about $5K for both feet in the U.S. and about $1,000 per foot in Canada. Living in the Big City, one would think that L.A. would have lots of clinics that cater to PF due to the sports oriented aspect of California. I really just want to find a place that will help me get back on my active feet. If I can save $3K I will go to Canada (Vancouver, hopefully) as my husband is having dental implants done there this summer. He is looking at a savings of $6K. Since our HMO is useless, we are going to foot the medical/dental bills ourself. If we can save $7K we will still come out more fianacially viable and get outstanding medical/dental care even with air fare, hotels, rental cars, etc. Can anyone out there lead me in the right direction?

Re: recovery time for second round ESWT

Mark S. on 6/09/03 at 10:50 (121373)

Hi Patti. Here's the websight for one of the clinics in Canada. I believe it's just north of Niagra Falls. http://www.eswt.bayshore.ca
Mark

Re: recovery time for second round ESWT

David L on 6/09/03 at 11:31 (121377)

Mark....Niagara Falls is a 5 hour flight east of Vancouver. It is like the distance between Seattle & Buffalo. The only ESWT device in Vancouver is at our clinic.....tel. 1 877 766-6287. For a listing of locations in southern California, see http://www.sonorex.com

Re: To David.

Pauline on 6/09/03 at 12:38 (121380)

David,
Since the FDA approved Sonocur for treating tennis elbow are U.S. doctors allowed to use it for treating Plantar Fasciitis as well?

My guess is that they are allowed to use if off label without a problem.
Can you tell us so there will not be any confusion about this?

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/09/03 at 14:35 (121386)

Patti:

There is a specific amount of energy which, when delivered to the tissue provides the desired effect. It can be via machines that deliver fewer shocks with a higher power or machines that deliver a large number of shocks with a lower power. There is no conclusive evidence whatsoever that one protocol is superior to the other.

I would imagine that a city the size of LA would have availability of this modality. Despite the size of the area, HMOs can place quite a limitation on care.

The Sonorex treatment center in Vancouver, B.C. can provide excellent care
at a favorable price.

Take some time to read Scott's Heel Pain Book to make sure you really have had all of the necessary care for your condition.

If the Seattle area is convenient, I use the Sonocur in my office at a cost of $390 per ptreatment per foot or a total of $1270 per foot.

Ed

Re: To David.

Ed Davis, DPM on 6/09/03 at 14:43 (121388)

Pauline:

Yes. US doctors can and do use the machine off label for plantar fasciitis. David cannot market it for off label use. I had to come to him to request a machine. My research on the modality and my visit to his clinic convinced me that Sonocur was the most cost effective way to get as many patients who need the treatment access as possible.

'On label' use is for lateral epicondylits (tennis elbow) but it would be off label for medial epicondylitis (golf elbow). Somehow this strikes me as silly but I sure as heck would use it on my elbow if I had medial epicondylitis.

Ed

Re: To Dr. Ed

Pauline on 6/09/03 at 16:14 (121393)

Thank you Dr. Ed. for answering my question and for taking the mystery out of Sonocur's use by U.S. doctors.

Re: recovery time for second round ESWT

elliott on 6/09/03 at 16:51 (121396)

Dr. Ed, you're basically disagreeing with Dr. Z, right? Can I quote you on that? :-)

[]

Re: To Dr. Ed

David L on 6/09/03 at 18:39 (121402)

Pauline....in answer to your question, section 906 of the Food & Drug Act states the following. Regards.....David

'Nothing in this Act shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unap- proved uses oflegally marketed devices. '

Re: recovery time for second round ESWT

Patti R on 6/09/03 at 18:49 (121403)

Ed,
Thank you for responding. As a matter of fact, I lived in Bellevue, WA 2 years ago so Seattle may be a good option for me. My podiatrit, in Pasadena, is totally clueless, but I think he is aobut 22 years old and maybe not in the loop. He advised me to consult with my Primary Physician to see if another podiatrist can help me as orthotics were my only hope! Can U believe that? Wonder why he didn't mention surgery... Anyway, what information do I need from you and how can I contact you yadda,yadda,yadda. What is my downtime? When can this be done? How long do I stay in Seattle? I'm am ready to forget my HMO & just pay cash. I thought about going with a PPO but I just missed the enrollment month. By the way, are you an M.D.?
Regards,
Patti

Re: To Dr. Ed

Pauline on 6/09/03 at 18:58 (121404)

Thanks David. I greatly appreciate your posting the FDA act that covers this.

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/09/03 at 19:50 (121406)

Patti:

There is no downtime after low energy ESWT. You simply make an appointment and the procedure is performed: 252-841-3668.

It is preferable to perform 3 treatments, one week apart but for travelers, we perform two treatments on consecutive days followed by the third one, one week from the initial one.

Ed

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/09/03 at 19:51 (121407)

Elliott:

I am unsure on what point you feel that I disagree with Dr. Z.

Ed

Re: correction

Ed Davis, DPM on 6/09/03 at 19:53 (121408)

253-841-3668

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/09/03 at 20:01 (121410)

Peter:

What future studies are you thinking about and what is the basis for your prediction? The Europeans and Canadians have had a lot more experience than us in the US. They have already gone the high energy route and have had time to compare. Why do you think HMT, the manufacturer of the high energy Ossatron is now primarily marketing its low energy Reflectron? There is a big difference between 'cheap' and 'cost effective.'

Ed

Re: To Dr. Ed

Dr. Z on 6/09/03 at 22:57 (121419)

I find this act very confusing. Could some one explain to Dr. Z what this means and if it is ok to market the Soncur to podiatrist just for plantar fasciitis. In reality that is all a podiatrist can treat with the Sonocur.
Just asking. I find that the FDA can say one thing and then the next day change their mind. I do know that there are two companies dornier and Healathronis that don't agree that the Soncur is legally allowed to market
this device for plantar fasciits or is any doctor allowed to market the soncur for plantar fasciitis. What happens in the future is going to be very interesting

Re: To Dr. Ed

Dr. Z on 6/09/03 at 23:10 (121422)

Pauline,

What has your reseach revealed ?

Re: To Dr. Ed

Scott D. on 6/10/03 at 07:48 (121430)

Dr. Z,

Don't you market your device for off-label uses? The picture of your truck on your website says 'Do you suffer from Heel Spurs * Achilles Tendonitis * Plantar Fasciitis * Patella Tendonitis....' How is that different? Do you have orthopedic surgeons on staff to do the patella tendonitis? I only saw DPM's listed.

Re: To Dr. Ed

Dr. Z on 6/10/03 at 08:51 (121431)

Like I said it is very confusing the rules. The FDA will eventually resolve the off label SALE of ESWT machines to podiatrists
in the future. I do have relationships with orthopedic surgeon that treat the knees,

Re: recovery time for second round ESWT

elliott on 6/10/03 at 08:57 (121432)

Dr. Ed, I'm talking about your statement, 'There is no conclusive evidence whatsoever that one protocol is superior to the other.'

[]

Re: To Dr. Z.

Pauline on 6/10/03 at 09:43 (121434)

Why don't you use their name on your trailer along with the DPM's. or advertise that an Orthopedic Surgeon would be treating knee patients?

Don't you feel your a little disingenous to potiental patients if you are allowing them believe Pod's are treating petella problems? Wouldn't it be better to add the doctors names or remove the treatment availability from your trailer advertisement?

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/10/03 at 12:37 (121455)

Elliott:

I absolutely stand by that statement. I have commented on numerous posts that it will take quite a bit of time, perhaps 5 to 10 years before we can state with any reasonable certainty what the optimal protocols are for treatment of various tendinopathies via ESWT.

High energy treatment preceded low energy and, as such, there is more domestic data supporting that. The European research and experience demonstrates that low energy is very effective and have, largely, been moving away from high energy to low energy protocols. Unquestionably, there must be some minimum level of energy for the treatment to work but I have not seen any of the protocols or existing machines running into a problem in that area.

I am all for research in this area but feel that the research now needs to be aimed at refining protocols. I think we are well beyond the stage where further proof of ESWT efficacy exists.

Ed

Re: To Dr. Z.

Ed Davis, DPM on 6/10/03 at 12:43 (121457)

Pauline, Scott, DR. Z:

Please don't get too wrapped up in the intricacies of the FDA -- that is not how we practice medicine.

Obviously, we must follow FDA regs. On the other hand the FDA must be careful not to violate our basic freedoms such as freedom of speech and the doctor-patient relationship.

Ed

Re: To Dr. Z.

Dr. Z on 6/10/03 at 14:30 (121469)

I use to believe that was true until the FDA interfered with the orbie and my relationship with treating patients. The FDA plays a major role or interfere with the patient doctor relationship. I purchased an orbie at hugh expense with FDA approval. I even spoke with the FDA and made sure that the Orbie had the ok, two years later hey we were wrong and the orbie is a class three device and therefore you can't use this machine. I even had in writing from the FDA that the orbie could be used for plantar fasciitis. Money talks and again as I told you before there are major ESWT companies that spent alot of money going thru the Class three studies. Don't think they are going to sit back and watch the Soncur go around the process. Right or wrong this is just the facts

Re: To Dr. Z.

Pauline on 6/10/03 at 15:40 (121478)

We'll have to sit back and see if Healthronics and Dornier jump on them.

The biggest problem with Orbie was that it was pre marketed as a high power ESWT machine while labeled and presented to the FDA as simply a theraputic vibrator. Any approval it had, was rescinded and all marketing stopped. Even importation of it was stopped. It was sort of a wolf in sheep's clothing.

Sonocur never misrepresented it's product, and it's different it's a low power machine and as you've said yourself doctors have always used many different machines for off label treatments. They also use medications the same way.

Time will tell.

Re: recovery time for second round ESWT

Dr. Z on 6/10/03 at 15:47 (121482)

I agree that the word conclusive is the correct word at this stage of high and low energy treatments comparisons. High energy does have the lead due to the wider use in the USA at the present time but time will truely tells which is better, more important which will the public acceptance be better that is going to be a much better horse race. IF low energy was completely painless I believe that low energy will be the direction to go but it can be painful and Americans don't like to undergo multiple time consuming treatments.
There must be a feeling among the engineers that high energy is better due to the money spent on FDA approval processes . Dornier could of went either way high or low and they went for the high energy fDA approval process. The question is why.

Re: To Dr. Z.

Dr. Z on 6/10/03 at 16:40 (121485)

The biggest problem with the orbie was that when I called the FDA and asked the FDA if the orbie was approved for pf treatment their answer was yes. That led me to purchase this machine. The FDA mislead Dr. Z and alot of other doctors, and they let the company off the hook

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/10/03 at 18:14 (121490)

Dr. Z:

One issue is simply that of logistics. When I schedule a high energy ESWT with Ossatron or Dornier, it is like scheduling surgery and I am away from the office. We schedule Sonocur just like any regular office visit as it takes about 15 minutes to do in the office. Few individual practitioners have a Dornier unit in their office but if that was the case and low energy was used with Dornier, it could be scheduled in a similar fashion. It is a time and expense to bring the Dornier or Ossatron to a location and would rather not have to do it three times.

I cannot speak for Dornier but one factor may have been the fact that they were riding in on the coat-tails of Healthtronics and did not want to get into something new with the FDA, which is understandable considering the time and money involved in the process. Considering the fact that they spent the extra money to make a machine with a broad range of deliverable energies, it appears that they were attempting to produce a product that can adapt to virtually any future protocol.

Siemen's side stepped the high vs. low energy issue by simply starting with a new protocol for the elbow. They do not market to podiatrists. Nevertheless, the Sonorex clinics in Canada treat a lot of plantar fasciitis successfully. They have an impressive list of celebrities they have treated. I had referred tough cases of PF to them and saw remarkable results -- Vancouver is only about 2 1/2 hours from Seattle. I felt that their protocol was the most cost effective way to provide good treatment to as many patients as possible. Eventually we are going to need 'body wide' indications and that will open the debate on which energy levels to use when and where.

Ed

Re: To Dr. Z.

Ed Davis, DPM on 6/10/03 at 19:25 (121492)

Dr. Z:

There may have been some problems with the way the manufacturer tried to pass the Orby through the FDA but cannot agree with the FDA's approach which effectively removed it from use.

The Sonocur people, unlike the situation with Orby, are basically playing by FDA rules so I don't expect a repeat of the situation. Also, and I don't know how big a difference this makes, but the Clintonista's are no longer in charge. Still vivid in the memory of my fellow Washingtonians is the event when FDA agents, arms drawn, burst into the Tahoma Clinic, run by Dr. Wright who is sort of a maverick MD who uses primarily herbal and natural remedies. The patients in the waiting room were made to lay face down on the floor, arms spread apart at gunpoint while FDA agents raided the clinic, seizing herbal medications and arresting the doctors.

While Bush's focus has been primarily on foreign policy I believe, and hope, the worst bureaucratic abuse of the Clinton years is behind us nad that we will have a 'kinder, gentler' FDA.

Ed

Re: FDA/ Jonathan Wright, MD

Ed Davis, DPM on 6/10/03 at 19:37 (121493)

The FDA's Raid Of The Tahoma Clinic

On May 6, 1992, the FDA sent its gun-toting agents to Kent, Washington to raid a medical clinic run by Dr. Jonathan Wright, a highly popular alternative medicine physician who has been successfully treating patients for many years. The FDA proceeded to seize large quantities of vitamin B-12 and other vitamins and minerals, as well as computer files, patient records, and personal property. Their alleged reason for staging this raid was stop Dr. Wright from treating with patients with 'contaminated' vitamins, but the FDA presented no evidence in support of this allegation.

The FDA's illegal raid of Dr. Wright's clinic, which was also obtained with perjured testimony, has put him out of business and has left hundreds of his patients without the medical care of their choice. It has also served as a brutal warning to other U.S. physicians that unless they toe the FDA's party line on how to practice medicine, the FDA will destroy them!

According to the law, the FDA is not supposed to have control over how physicians practice medicine in the United States. However, the FDA's illegal raid of Dr. Wright's clinic makes it clear that the agency will do whatever it takes to stop what 'heretics' from practicing medicine in this countray. Since the 'orthodox' medicine the FDA approves of has been shown to be incapable of treating millions of desperate Americans, their lives will hang in the balance as long as the FDA denies them access to effective alternative treatments!

COLUMBIAN, CLARK CO., VANCOUVER, WASHINGTON, JUNE 26, 1992

FDA's police-state tactics offer scary glimpse of socialized medicine

If the FDA continues to stifle innovation in health care, we may never get the cost-saving advances we've made in other industries. A bloated, inefficient and expensive health care system, will be the result.
By Jim Becker
A Libertarian's view

On Wednesday, May 6, the morning that the Tahoma Clinic in Kent, Wash., was raided by the Food and Drug Administration, clinic founder Jonathan Wright went on what he calls the 'FDA diet.' This is when the FDA breaks down your door and points a gun in your face, and you suddenly lose your appetite.

Syndicated columnist James J. Kilpatrick's June 16 column on the incident, 'With Kent raid, FDA shows its indifference to victims of illness' addressed a subject that heats too little debate in our current political discourse. Kilpatrick did, however, convey a few factual errors and leave out a few important facts.

The FDA break-in at the Tahoma Clinic was the culmination of a year-long struggle between the clinic and the agency. The struggle began last June, when the FDA seized the clinic's entire stock of L-tryptophan, an essential amino acid used in the treatment of depression and insomnia.

When it was discovered last spring that the Japanese supplier had left trace contaminants in the protein, the FDA began confiscating all supplies in the United States. The Tahoma Clinic had its supply tested and found no contaminants. The FDA seized their entire stock anyway.

Last September, the Tahoma clinic sued the FDA for return of the L-tryptophan. Though the contamination problem had been cleared up, the FDA continued to prohibit any sale of the protein in the United States.

According to agency documents, the FDA began searching the garbage of the Tahoma Clinic in late September. By this spring, the agency found something it could use against the clinic.

The clinic commonly treats patients with severe allergic reactions to many common chemicals. For this reason, it keeps on hand an assortment of pure vitamin supplements, which do not contain the fillers and preservatives found in all drug-store vitamin supplies. No major manufacturer in the United States or Japan sells vitamins in this form. Wright had obtained the vitamins through a small German company which specializes in such compounds.

The FDA raided the Clinic last month and seized all the vitamins on the grounds that the German company did not have proper FDA approval. The approval process costs millions of dollars, which the small company cannot afford.

Should the clinic manage to stay in operation, the L-tryptophan court case will begin in July.

Like most other libertarians, I've learned to stay away from such the grip of government. Disputes with various bureaucracies tend to be so costly and so unproductive that I try to keep my distance and maintain my dignity. This is probably why a large portion of the Libertarian membership works in one of the last unregulated businesses: the computer industry.

In this sense, Wright is a Libertarian with a difference. He provides his services in one of the most over-regulated endeavors known: the medical profession. He attempts to bring invention and innovation while navigating through an FDA-created minefield. At some point he inevitably faces a cruel choice: Does he break a government regulation or does he let his patient suffer?

Given that Wright's treatment is completely safe and that the regulation is counterproductive -- as they usually are -- he breaks the rule and treats his patient. Both the FDA structure and his duty as a doctor provide no alternative.

If you suspect I'm exaggerating the FDA's abuses, consider this: During the raid, agents seized three machines that Wright uses to detect allergic reactions in his patients. The machines work by detecting changes in the electrical resistance of the skin-identical in operation to a polygraph or lie-detector. The machines are completely safe; the FDA seized them because they have not been approved for this use. Had Wright been using them to test his patients' honesty, he could have kept them.

The FDA's action provides a glimpse of what life would be like under a system of socialized medicine. One critic has said that socialized medicine will provide 'the quality of the public school the timeliness of the post office and the cost controls of the Pentagon.' If the FDA continues to stifle innovation in health care, we may never get the cost-saving advances we've made in other industries. A bloated, inefficient and expensive health care system will he the result.

Beyond all this lies a larger question: Do we live in an enlightened society? Liberals would say it depends on the morality we enforce on the population. As a Libertarian, I have a different measure: Our enlightenment is dependent on how we treat our visionaries. If people have new ideas or outlooks, do we harass them and fear the changes they bring? Or do we let them freely prove their worth?

We have a mixed score on this measure, I think. In the computer industry, we let Steve Jobs and Alan Kay have free rein. They proceeded to revolutionize their work and much of our society as well. In the medical profession our visionaries are Jonathan Wright, Linus Pauling and Julian Whittaker. They have the insight and the skill to revolutionize much of modern medicine. For these people, our government seems to have nothing but scorn and harassment. The costs for these actions will be large, and they will fall on all of us.

Back To Suppressed News Index Of Articles (PIPE) Home Page (PIPE) Back To Top

Re: FDA/ Jonathan Wright, MD

Dr. Z on 6/10/03 at 20:11 (121494)

Ok here is one for you.

There are USA companies that are buying Soncur's from I guess Sonnex or Siemans. The companies are mass marketing the use of the Soncur to podiatrists via mail, broadcast faxing. The literature that they send out states that the Soncur is an FDA approved machine and talks about elbows, shoulders, plantar fasciitis. There is no explanation that it is only FDA approved for Elbows
The company called orthoshockwave consultants is marketing directly to podiatry. They are marketing to insurance companies that they are FDA approved for plantar fasciitis.
Trust me you are going to see Machine seizures taking place . How many,where, who is behind this I have no idea. The position of orthoshock wave consultants is that they aren't the manufactor and therefore they can market to Podiatry and to the public regardless of FDA approval
I have no idea how wide spread this is in the USA but on the East Coast they claim that there are over two hundred podiatrists already trained.
Ed. I believe you when you say that Sieman's isn't marketing to podiatry but I know for a fact they forget to let you in on the master plan.
Its ashame that we are going to get more bad press when the blank hits the fan.
This specific company told me that they will use the Soncur in the presence of an implanted pacemaker without any hesitation or any medical and or manufactor person involved in the procedure.
This is just the tip of the ice berg.

Re: FDA/ Jonathan Wright, MD

Ed Davis, DPM on 6/10/03 at 20:29 (121496)

Dr. Z:

I have no idea who 'orthoshockwave consultants' are. Their marketing tactics will place them at odds with the FDA. They do not, as far as I can tell, represent Siemens and I would need to see some evidence that would show otherwise.

The Sonorex people are the 'official' placement people for the Siemen's Sonocur and it was my understanding that they had exclusivity.

Ed

Re: FDA/ Jonathan Wright, MD

Dr. Z on 6/10/03 at 20:59 (121500)

Ed,
That was my understanding also that are the official placement people for the Sieman's Sonocur. I have no evidence or idea who they represent. I do know that they are pushing the sonocur into the podiatry market on the east coast. which is New York, New Jersey,Conn. etc. It is going to be very interesting to see how the FDA handle this. It is going to bring the bright lighs into the eyes of Siemans if they don't control the clients they sell the sonocur too.

Re: FDA/ Jonathan Wright, MD

Dorothy C. on 6/10/03 at 21:06 (121503)

We do need solid science-based oversight of medical devices and treatments, but it needs to be fairly and justly applied. Yes, there are many charlatans out there eager to relieve desperate people of their money. Greedy profiteering occurs in the prescription world as well as in the OTC supplement world.
Fair application of oversight and enforcement would see that prescription drugs receive the same kind of critical evaluation that OTC supplements do. L-tryptophan was a good example. If you compare the lethality of apparently just one batch of L-tryptophan to the lethality of so many prescription drugs that have been available on the RX market without any interruption, the (seemingly) permanent ban of that supplement seems irrational. The same is true of L-Tryptophan compared to many other OTC supplements. It is bizarre how that supplement was banned, and continues to be banned, even though it is pretty generally accepted that it was one batch from Japan contaminated in the processing. If other drugs contaminated in the processing were banned for life, then many currently available drugs would be off the market! I have no particular interest in L-tryptophan or any other drug, but if I wanted to use L-Tryptophan and were well-informed about it, I would want it to be available to me. The uneven application of 'justice' in the RX versus OTC areas causes people to believe in all sorts of ideas like the 'conspiracy theories' that abound about the FDA and collusion with drug companies or the suppression of 'miracle' cures because of some profit motive. I prefer to think that the FDA means well for us, but that maybe some hybrid of the FDA and Commerce and Public Health needs to evolve that will better serve the needs of all citizens. I think prudence and caution by the FDA are wise and desirable, but prudence and caution applied evenhandedly, and a requirement to re-evaluate all bannings periodically to see if they should still be in effect. I think that MANY of the RX drugs should be OTC, but only once we have single-payer universal health care - otherwise, moving RX to OTC simply becomes a means for insurance companies not to cover more drugs that were previously covered as a prescription (RX) drug. And we need to be assured that the FDA is watching out for US, not for the interests of prescription drug companies' bottom lines.

Re: FDA/ Jonathan Wright, MD

BrianG on 6/10/03 at 21:07 (121504)

Dr. Ed,

May I ask where you got this information from.

Thanks
BrianG

Re: Heres the relationship between Sonnex/orthoshockwave

Dr. Z on 6/10/03 at 22:16 (121507)

Ed,
Here is the relationship and here is the marketing to a podiatrist named Dr. Z. I have many more e-mail from this group including mailings, broadcast fax. This is an overt FDA violation for marketing the Sonocur to podiatrists. Looks like orthoshockwave is a frontman for someone. Come on Pauline the master of research and you didn't come up with this.

Name:: Mr. Jonty Yamisha

Company:: Ortho Shock Wave Consultants

Street Address:: 662 Goffle Road

City:: Hawthorne

State:: NJ

Zip:: 07506

Phone Number:: 973-238-9560

Comments:: Hi, my name is Mr. Jonty Yamisha. I work closely with Sonorex
(www.sonorex.com) and Ortho Shock Wave Consultants
(www.orthoshockwaveconsultants.com) and Siemens to offer low-energy
Extracorporeal Shock Wave Therapy (ESWT) for chronic plantar fasciitis. Ours
is a mobile, turn-key business model that has been well received by
podiatrists and patients alike.

We currently work with several hundred podiatrists in the states of New York
and New Jersey, Ohio & Pennsylvania.

I found your practice's web site on the Internet, and it looks like you
operate in one of our areas. (Please correct me if I am mistaken.) I was
wondering whether you have any interest in offering low-energy ESWT
treatment in your office.

We offer a turn-key solution. We provide you with the state-of-the-art
equipment, insurance verification/authorization and billing services
necessary to offer ESWT treatment in your office. With few as 10 patients a
month, you can generate more than $100,000 in additional revenue.

The machine we utilize is the SONOCUR Basic from Siemens, and Ortho Shock
Wave Consultants is the only provider of this machine in many areas.

Please feel free to contact me should you be interested in learning more
about our program. My DIRECT phone number is 973-238-9560. Alternativey, you
may also email me by responding to this email.

Sincerely,

Mr. Jonty Yamisha

Submit: Submit

Re: Heres the relationship between Sonnex/orthoshockwave

Dr. Z on 6/10/03 at 22:18 (121508)

Hi

Sure where is the meeting.

Dr. Zuckerman

-----Original Message-----
From: Jonty Yamisha [mailto:(email removed)]
Sent: Saturday, May 24, 2003 10:46 PM
To: David Zuckerman
Subject: June 18, 2003

Dr. Zuckerman, I also wanted to let you know that Ortho Shock Wave
Consultants is going to be holding a Sonocur certification class on
Wednesday, June 18, 2003.

This class will be attended mostly by New Jersey and Manhattan DPMs. It
would provide you with an opportunity to see the Sonocur in action, meet w/
colleagues using the device, and/or interested in using the device, as well
as members of our management team.

If you are interested in attending, I will email you the details. Please let
me know.

-Jonty Yamisha

-----Original Message-----
From: David Zuckerman [mailto:footcare@comcast.net]
Sent: Saturday, May 24, 2003 8:18 PM
To: jyamisha@medicalpartnersgroup.com
Subject: RE: The Foot Specialists Inquiry Results

Hi

I spoke with you the other day on the phone. The only concern I am having is
that low energy has no FDA approval for chronic insert ional plantar
fasciitis. I use the Dornier Epos at present and the company has told me
that there is a FDA investigation with the use of the Soncur without any
FDA approval. Can you explain how this is being handled.
Sincerely yours

Dr. Zuckerman

-----Original Message-----
From: jyamisha@medicalpartnersgroup.com
[mailto:jyamisha@medicalpartnersgroup.com]
Sent: Saturday, May 24, 2003 7:04 PM
To: info@thefootspecialist.com
Subject: The Foot Specialists Inquiry Results

Below is the result of your feedback form. It was submitted by
(jyamisha@medicalpartnersgroup.com) on Saturday, May 24, 2003 at 19:04:29
---------------------------------------------------------------------------

Name:: Mr. Jonty Yamisha

Company:: Ortho Shock Wave Consultants

Street Address:: 662 Goffle Road

City:: Hawthorne

State:: NJ

Zip:: 07506

Phone Number:: 973-238-9560

Comments:: Hi, my name is Mr. Jonty Yamisha. I work closely with Sonorex
(www.sonorex.com) and Ortho Shock Wave Consultants
(www.orthoshockwaveconsultants.com) and Siemens to offer low-energy
Extracorporeal Shock Wave Therapy (ESWT) for chronic plantar fasciitis. Ours
is a mobile, turn-key business model that has been well received by
podiatrists and patients alike.

We currently work with several hundred podiatrists in the states of New York
and New Jersey, Ohio & Pennsylvania.

I found your practice's web site on the Internet, and it looks like you
operate in one of our areas. (Please correct me if I am mistaken.) I was
wondering whether you have any interest in offering low-energy ESWT
treatment in your office.

We offer a turn-key solution. We provide you with the state-of-the-art
equipment, insurance verification/authorization and billing services
necessary to offer ESWT treatment in your office. With few as 10 patients a
month, you can generate more than $100,000 in additional revenue.

The machine we utilize is the SONOCUR Basic from Siemens, and Ortho Shock
Wave Consultants is the only provider of this machine in many areas.

Please feel free to contact me should you be interested in learning more
about our program. My DIRECT phone number is 973-238-9560. Alternativey, you
may also email me by responding to this email.

Sincerely,

Mr. Jonty Yamisha

Submit: Submit

---------------------------------------------------------------------------

Re: Heres the relationship between Sonnex/orthoshockwave

Pauline on 6/10/03 at 22:45 (121511)

I like this part the best. Who's kidding who about income from ESWT and costs?

'With few as 10 patients a
month, you can generate more than $100,000 in additional revenue.'

Re: To Dr. Z. Heres the relationship between Sonnex/orthoshockwave

Pauline on 6/10/03 at 23:03 (121512)

Since you have it in writing, along with posting this information here, why not send copies to the FDA unless your afraid of doing harm to you colleagues.

If you think this should be stopped, you should do something about it especially since you have been solicited.

My thought is that although your willing to post this material and cast doubt on Dr. Ed's legal use to treat P.F. and advertise his use of this machine you don't have the guts to go any farther with it.

Let's see you post the response letter you receive from the FDA when you complain to the folks that can actually do something. When that happens I'll be impressed.

They do respond in a timely fashion and certainly would respond to a complaint submitted by a doctor who is concerned about quality and safty of patients. They respond to all letters and e-mails.

Now is your chance to step up to the plate and protect the innocent patients that your concerned about, lets see what you do with it. My guess is your loyality lies with your colleagues and you will not mention this anywhere accept here. You won't even make noise at your convention, or in your professional new letter.

I challenge you to make the noise and take this matter to the FDA, but I won't hold my breath because I know it won't happen.

Re: To Dr. Z. Heres the relationship between Sonnex/orthoshockwave

Dr. Z on 6/10/03 at 23:13 (121513)

Pauline,
I may just may report you to the FDA as a danger to the public.

Re: recovery time for second round ESWT

Bill on 6/11/03 at 08:32 (121522)

Dr Davis,

I read your post and was surprised that you are marketing the off-label use of the Sonocur. It is against the law to market the off-label use of the Sonocur. For your reference, the FDA has opened an investigation into the off-label marketing of the Sonocur. They take their responsibilities seriously and I would hope that you would respect the law and stop off-label marketing.

As an aside, why hasn't Sonorex applied for FDA approval for plantar fasciitis? They have experience conducting the required studies. I wonder if the data from their studies is giving them trouble?

Bill

Re: To Dr. Z. Heres the relationship between Sonnex/orthoshockwave

Bill on 6/11/03 at 08:47 (121523)

Pauline,

Copies are being sent to the FDA to help in their investigation.

Bill

Re: Heres the relationship between Sonnex/orthoshockwave

Ed Davis, dPM on 6/11/03 at 10:57 (121532)

They are claiming that a relationship exists but would like to hear from Sonorex, perhaps David Lowy, to see if that really exists. Their marketing approach sets off some red lights in my view.
Ed

Re: recovery time for second round ESWT

Ed Davis, dPM on 6/11/03 at 11:03 (121534)

Bill:

David Lowy has quoted the specific regulations that allow the usage of off label modalities. Since you are rendering a legal opinion on this board, please back up your opinion with specifics and tell the readers who you are.

You, anonymously, are accusing me of doing something illegal and doing so in a public forum. Either identify yourself and/or back up your acusation with specifics or retrct this statement. I will insist, at this point, that Scott Roberts reveal your IP address or block your activities if you insist on defaming my character on this board.

Ed

Re: recovery time for second round ESWT

Dr. Z on 6/11/03 at 11:28 (121536)

Bill

I am on my way out the door and I want to respond to this posting from you. Dr. Davis isn't marketing the off-lable use of the Soncur for anything.
I have never read or heard of him doing any such thing. As for the sale of the sonocur unit to Podiatry for the off label use that is something that the FDA is investigating and I am sure that they will resolve this in the next fifty years. It took the FDA two years to resolve the orbie situaion. But to accuse Dr. Davis of breaking the law just isn't true or fair.

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/11/03 at 11:45 (121540)

Dr. Z:

Thank you for your comments. I have been accused of doing something illegal on a public forum. The accusation is false although it is time for Bill to be identified -- and it WILL be done via legal action if Scott Roberts does not come forward with the information. I do expect the posts to be removed yet the incident logged.

Ed

Re: FDA/ Jonathan Wright, MD

Ed Davis, DPM on 6/11/03 at 11:59 (121542)

Dorothy:

You are well read and your insights are remarkably thoughtful. I don't agree with all of your conclusions but would enjoy nothing more than to spend time chatting with you. Best wishes.

Ed

Re: FDA/ Jonathan Wright, MD

Ed Davis, DPM on 6/11/03 at 12:01 (121543)

Brian:

Dr. Wright is a local in my area so the information was in all the newspapers at the time and is public knowledge. One can still do a search on his name or on his clinic, the Tahoma Clinic and find a lot of archives and information. I will see if I can come up with something specific once I have dealt with the latest 'Bill' issue.

Ed

Re: recovery time for second round ESWT

Bill on 6/11/03 at 12:06 (121545)

Off-label use is different than off-label marketing. The key
is that you cannot market the device for a non-FDA approved use.
I beleive that saying in a public forum that you are offering
to use the Sonocur for plantar fasciitis and giving your
price is marketing.

It doesn't really matter what my name is. Off-label marketing
is illegal. Look it up. Off-label use is legal. The reference
was already provided.

Sorry Dr. Davis but you cannot market the use of the Sonocur
for plantar fasciitis.

Re: recovery time for second round ESWT

Bill on 6/11/03 at 12:22 (121546)

Dr. Davis,

I am not defaming your character and I am sorry if you took
it that way. I am just pointing out that it is illegal to
market the Sonocur for plantar fasciitis. You have the right
to use it off-label. You do not have the right to market its
off-label use.

Again, the FDA guidelines give you the right to prescribe off-label.
The FDA prohibits anyone from marketing the off-label use of a device.
I believe that your previous posting markets the off-label use
of the device. You obviously believe otherwise. It all comes down
to whether it was marketing or not.

Do you think that posting the price and availability of a service
in a public forum is marketing? DO you believe that your posting was
marketing?

Re: recovery time for second round ESWT

Pauline on 6/11/03 at 12:25 (121548)

Just for the record. Bill you do not know me and I do not know you. We are not one in the same person. My IP address is different than yours and we've never met or exchange words by phone calls, e-mail, Fax or Snail mail.

I have one question though, where were you when the Orbie, which we cannot call by it's real name hit this forum?

Re: recovery time for second round ESWT

Bill on 6/11/03 at 12:32 (121549)

Dr Z.

I felt that by posting the price and availability of the service he was marketing. As you know, I feel very strongly about this. I read his posting about the price per foot and the availability of sonocur treatments for plantar fasciitis as marketing. If its not marketing, then there is nothing wrong with it.

Here is the item that I objected to:

'If the Seattle area is convenient, I use the Sonocur in my office at a cost of $390 per ptreatment per foot or a total of $1270 per foot.'

That looks like marketing to me. It advertises a price and availability of Sonocur treatments for plantar fasciitis.

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/11/03 at 12:46 (121550)

Every offer of treatment whether it be on or off label can be construed as a form of marketing. Patients are informed that use of the Sonocur is an off label use for PF -- you certainly realize this by the various posts on the web site. What gives you the right to pass judgement on the legal issues and to do so in a public forum?

It is time that you reveal yourself. I will track you down.

Ed

Re: recovery time for second round ESWT

Alex on 6/11/03 at 13:35 (121555)

As a lurker (and a parent of two kids), I can say that both of you need a time out!

Ed, I think you're taking this a little seriously! Come on - saying you will track someone down is a little silly.. I know basic text can't get it across well, but 'chill out, dude!' :)

I feel comfortable saying that on behalf of all lurkers on the board that we really appreciate all of your input. Heck, you've even answered a couple of questions I've had --- so thanks!

Bill, I hear your point... I have no idea about any FDA rules or anything, but I can say pretty confidently that anyone reading this board has probably gotten a *ton* of info about ESWT and I wouldn't worry that someone mentioning their price of a service is suddenly going to make the masses rush in and get off label treatment. I have no idea about the rules, again, but I think we all realize that this is a public forum and that answers are typed hastily, so we shouldn't take every response as the word of God or anything.

Anyway, I am only posting to ask you guys to chill out. As I agonize over my lousy Achilles, I like reading the postings on the board to learn a little more about the procedure and folks experiences. To have your argument inflame so quickly just has me a bit concerned.

Re: FDA/ Jonathan Wright, MD

BrianG on 6/11/03 at 18:16 (121591)

Thats Ok Dr. Ed. I thought maybe it was in a journal of some type.

BrianG

PS: Sorry if this is the thread Scott didn't want us posting to. I just wanted Dr. Ed to know he didn't have to look up the FDA info.

PPS: Can't the thread in question be locked?

Re: recovery time for second round ESWT

Bill on 6/11/03 at 18:44 (121594)

Dr Davis,

This quote was from a legal analysis of the subject in question.
I think that is speaks for itself. Please feel free to verify
its validity.

'However, prior to being appointed commissioner of the FDA, David Kessler, who recently resigned as commissioner, said, 'Use of an approved device for an unapproved use in a nonemergency situation represents a complex legal issue..The FDA will intervene if the device is being commercially promoted for an unapproved use. If the device is to be used in part of a research endeavor, the FDA will require a formal investigation trial. However, a physician who uses a device in an unapproved manner to treat a particular patient, without promoting it for such use, is unlikely to be in violation of the statute.'

Re: recovery time for second round ESWT

Bill on 6/11/03 at 18:46 (121595)

Dr Davis,

The reference for the previous quote is given as:

Kessler DA, Pape SM, Sundwall DN. The federal regulation of medical devices. N Engl J Med 1987; 317:357-366.

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/11/03 at 21:47 (121608)

Bill:
You have already taken it upon yourself to make that determination. Any exercise of free speech can be construed as a form of marketing. I have directly responded to inquiries about availability and pricing of the modality and have not run ads on this site or anywhere else. The fact that I and other doctors answer questions on this site can be considered a form of marketing. Sonocur is not the only 'off label' treatment that I and other doctors provide. Another example is our use of Neurontin for peripheral neuropathy -- it is not indicated by the FDA for that.

You have been reticent for a while and perhaps my bringing up the story about Dr. Wright got you going. Were you one of the 'boys' who held a gun to an innocent patient's head while telling them that you were there to 'protect' them? You have revealed enough about yourself to lead me to believe that you represent what is wrong with the system.

Ed

Re: recovery time for second round ESWT

bgcped on 6/11/03 at 21:53 (121609)

So Bill, based on your assertion, it would be ok to apply ,say a sonocur 20 mm into a patients rectum and crank it up in the name of hemoroid treatment? Provided it wasnt 'commercially promoted'....can we agree on that or should we refer to counsel?

Re: recovery time for second round ESWT

Pauline on 6/11/03 at 23:13 (121614)

In the heat of things, I'd have to say this post is out of order. Hit back if you will, but at least do it with dignity, order, and jurisprudence.

If Bill's miss quoted the law then prove him wrong instead of taking to mob bashing. I haven't seen anyone yet provide a counter FDA description of the law that Bill quoted or legal jargon that would dispute what he has said. Instead we're seeing a gang type mentality emerge.

Where did the professionalism go?

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/11/03 at 23:53 (121615)

Pauline:

Bill quoted no law. He quoted an interpretation of FDA agency policy via a quote of then chairman Kessler. Bill has taken it upon himself to interpret agency regulation and render a judgement. If he is a federal judge he may do so. If he is not, then he needs to stick to his own opinions. He also plays fast and loose with his own interpretation of what constitutes 'marketing.' If free speech is the equivalent to marketing, then we need to consider shutting down this board (let alone the US Constitution). BG is simply pointing out the absurdity and innapropriateness of Bill's statements wtih his own brand of levity.

Ed

Re: To Dr. Z. Heres the relationship between Sonnex/orthoshockwave

Ed Davis, DPM on 6/11/03 at 23:57 (121616)

Bill:

Let me get this straight. Are you turning in a competitor?

Ed

Re: Bill's selective concern for FDA compliance

Ed Davis, DPM on 6/12/03 at 01:34 (121618)

I find it interesting that Bill is not concerned with the numerous times off label uses of Dornier are mentioned on this site. Why is discussion of that not 'marketing?'

Ed

Re: recovery time for second round ESWT

Ed Davis, DPM on 6/12/03 at 02:11 (121622)

Pauline:
I have to wonder if Bill is a retired bureaucrat now working for a manufacturer. The Kessler quotes are very old (1991/92) The rules were revised in 1997. Furthermore, most of the rules apply to the marketing of devices by MANUFACTURERS, NOT PROVIDERS!
Ed THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release
November 21, 1997
Today, President Clinton signed into law 'the FDA Modernization Act of 1997, critical legislation that will improve the regulation of food, medical products and cosmetics, and prepare the FDA for the 21st century. This new law represents the culmination of several years of effort by the Administration and Congress to reach common ground on how to amend the drug, device, and food laws. The Act, the first major food and medical products reform legislation in 35 years, includes numerous initiatives championed by the Clinton Administration that will ease the regulatory burden on industries, protect consumers, and cut red tape, making government operations faster and more efficient.

--------------------------------------------------------------------------------
STRENGTHENING FDA MODERNIZATION INITIATIVES.

The new law builds on FDA modernization efforts already underway which have reduced drug and medical device approval times to record lows while maintaining consumer protections. The new law also expands the resources available to the FDA to carry out its mission. Key provisions of the new law include:

Reauthorizing the Prescription Drug User Fee Act. The Act reauthorizes for five more years the Prescription Drug User Fee Act of 1992, under which the FDA uses fees from manufacturers to accelerate the review of new drugs and biological products. This user fee program, developed in close cooperation with the pharmaceutical industry and Congress, has cut the average drug review time in half -- from 30 months before user fees to 15 months today -- bringing safe and effective new medicines to patients much more quickly than ever before.
Reinventing Government. The law enacts many FDA initiatives undertaken in recent years under the Vice President's Reinventing Government program. The codified initiatives include measures to modernize and streamline the regulation of biological products; increase patient access to experimental drugs and medical devices; and accelerate review of important new medications.
Increasing Access to Experimental Therapies. The new law streamlines the filing and approval for new therapies for serious or life-threatening conditions. It also codifies current FDA regulations and practices designed to ensure patient access to therapies for serious and life-threatening conditions before they are approved for marketing. At the Administration's urging, the law provides for an expanded database on clinical trials of experimental treatments for serious and life-threatening conditions so that patients may have access to the results of important clinical studies.
Streamlining Medical Product Approval. The Act reduces requirements and simplifies the review process for manufacturers of pharmaceutical products and medical devices, while maintaining the FDA's high standards of consumer protection. The Act also protects consumers by specifying that the FDA may ban devices produced in a seriously deficient manner, and by giving the agency explicit authority to take preventive action if the technology of a device suggests that it is likely to be used 'off-label' for a potentially harmful, unapproved use.
Expanding Consumer Access to Information on Unapproved or 'Off-label' Drug Uses. This Act seeks to ensure that health care providers find out quickly about new uses for approved products by explicitly allowing manufacturers to distribute information about unapproved uses of drugs and medical devices. This provision will allow manufacturers to disseminate reliable information about off-label uses provided they commit to conducting appropriate research and to filing a supplemental application for approval of these uses so that this information is available in the official product labeling.
Strengthening Risk-Based Regulation of Medical Devices. The Act complements and builds on the FDA's recent measures to match the level of medical device regulations to the level of risk posed by the products. Under the Act, manufacturers are no longer required to alert the FDA before they market certain low-risk devices. The new law also expands a program under which low-risk products can be initially reviewed for safety and effectiveness by FDA-accredited outside experts. In terms of devices already on the market, the Act directs the FDA to focus on implantable, life-supporting, life-sustaining, and other types of high-risk devices.
Ensuring Accurate Food Labeling. The Act expands procedures under which the FDA can authorize health and nutrient content claims -- which link a health benefit to a particular food component -- without weakening the current requirement that the information be truthful and scientifically valid.

--------------------------------------------------------------------------------
BUILDING ON PREVIOUS CLINTON ADMINISTRATION INITIATIVES.

Under the Clinton Administration, the FDA has made significant progress in

Re: recovery time for second round ESWT

bgcped on 6/12/03 at 06:43 (121624)

I was just making a lighthearted funny to lighten the post. I dont know who Bill is I just question people that cant admit who they are. I dont mean home address and last name but at least his affiliation or profession. I stay away from the ESWT stuff

Re: Bill's selective concern for FDA compliance

Scott D. on 6/12/03 at 09:08 (121628)

Ed,

You're getting awfully carried away with this stuff don't you think? Discussions of uses for technology are not marketing, until someone offers them for sale.

v. mar·ket·ed, mar·ket·ing, mar·kets
v. tr.
To offer for sale.
To sell.

I think we can all agree that the statement ' If the Seattle area is convenient, I use the Sonocur in my office at a cost of $390 per ptreatment per foot or a total of $1270 per foot.

Ed' is an 'offer for sale' since it includes the product or service being sold, a price for the product or service, and where to obtain it.

If you want to debate Bill on the ability/inability of a medical service provider to market an off-label use for a Class 3 device according to the FDA and its guidelines/regulations, go for it! The debate shouldn't be whether the service was being marketed though, clearly it was.

Re: Bill's selective concern for FDA compliance

Pauline on 6/12/03 at 10:33 (121636)

Scott,
Very well said. Two issues, one conclusive the other not.

Re: Bill's selective concern for FDA compliance

elliott on 6/12/03 at 10:52 (121637)

Scott D, it can't be actual marketing since the math came out wrong. 3 x $390 = $1170, not $1270. :-)

[]

Re: Bill's selective concern for FDA compliance

Scott D. on 6/12/03 at 11:20 (121639)

LOL, didn't catch that Elliot!

Re: Bill's selective concern for FDA compliance

Pauline on 6/12/03 at 12:12 (121645)

Cute Elliott, I got it:*

Re: Bill's selective concern for FDA compliance

Ed Davis, DPM on 6/12/03 at 19:28 (121685)

Scott:

Did you expect me to deny that I use the Sonocur and refuse to tell the patient what my fee is? The purpose of this board is to provide information, not deny it to patients. You obviously, as a provider of ESWT, view yourself as a competitor and would prefer that patients not know that a better service exists at a lower price.

You and Bill can become the 'censors' of the board by threatening competitors but it will be obvious what your motives are. I, for one, have lost any respect for you.

Ed

Re: To Dr. Z. Heres the relationship between Sonnex/orthoshockwave

Ed Davis, DPM on 6/12/03 at 19:31 (121687)

No answer?
Ed

Re: Bill's selective concern for FDA compliance

Scott D. on 6/12/03 at 21:32 (121710)

Ed,

I don't recall anyone asking your fee, maybe I missed it?? I've never refused to tell a prospective patient our fee as you suggest. You're very good at finding information, maybe you can pull it up.. Do you know ANYTHING about what service we offer, since you have said you offer a better one?

As for being a competitor.. you are in Washington state? Hmmm, I'm in NY.. I don't get many patients from the West Coast Ed.. Do you get many from New England?? Maybe anyone who challenges your thoughts is a competitor? I have respect for you as a Dr based upon your advise here. I never give medical advice because I am not a physician, perhaps you should stick to being a Dr?

I also don't remember making any sort of threat. I pointed out that your debate with Bill should center on the merits of you marketing an off-label use, not whether you had or hadn't. It was obvious that you indeed had! I'm not going to debate legality nor deny your ability to do as you choose in developing your business. I really don't care to be honest. My post was more a statement that if you are going to debate Bill that maybe you should do so based on common sense and fact.

You've posted probably 20 times on YOUR interpretation of what the FDA is and does. Thou protesteth too much maybe?

Re: Bill's selective concern for FDA compliance

Ed Davis, DPM on 6/12/03 at 21:44 (121713)

Scott:

There are Sonorex treatment centers in your region and thus in competition with you. Keep in mind, that it was you who leveled the accusation against me, not the other way around.
Ed

Re: Bill's selective concern for FDA compliance

Scott D. on 6/12/03 at 22:04 (121716)

Ed,

You said... 'You obviously, as a provider of ESWT, view yourself as a competitor and would prefer that patients not know that a better service exists at a lower price.'

I don't view you as a competitor at all. Do you work for Sonorex??

Also, you have said you use 3 machines. Why do you use 2 inferior machines to the Sonorex since in your opinion it is the best one?

Re: Bill's selective concern for FDA compliance

Ed Davis, DPM on 6/12/03 at 23:01 (121720)

Scott:

I use the other machines often because third parties dictate their use. I view the Sonocur advantage due to its cost effectiveness. I have stated numerous times on this site that there is insufficient evidence to confer an advantage on one machine or protocol when it comes to efficacy. I feel that the ease of scheduling low energy treatments, combined with the low price is what results in the better service. For example, I have no doubts about the efficacy of the Ossatron but the cost and logistics of providing that service makes offering that service very difficult to patients in my area.

I do not work for Sonorex but, I am listed on their web site, as a provider. You can go to http://www.sonorex.com to find the machine closest to you.

Ed

Re: To David

Sunny Jacob on 6/15/03 at 08:42 (121906)

David,
Recently you wrote about 90 locations in the United States where Sonocur Basic is used. Someone on this message board did request the addresses of all these locations in the various states. I also would like to know about Sonorex's exclusivity for USA such as the sale of Sonocur to US hospitals.