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9 weeks and praying for a miracle

Posted by Connie Moody on 11/05/04 at 21:08 (163061)

Not sure where you are located, Dr. Z. Would appreciate a private email
Thanks
Connie M
(email removed)

Re: 9 weeks and praying for a miracle

vince on 11/06/04 at 08:47 (163079)

The best course for you, from my own experience with low energy ESWT, is to get your PF treated with the Dornier Epos,stretch your calf, achilles and PF 2x a day, don't go barefoot, no antiinflamatory meds, and probably most important a proper fitting pair of orthotics that addresses any bio-mechanical problems that your feet may have. I have a problem in the way my big toe on both feet moves as I walk and I was told that this can cause a extra load on the PF where it hooks up with the heel. My orthotics were made to help the toe move properly and in short order, after the High Energy ESWT, I was dancing as I walked. According to my podiatrist it's best to make the cast for orthotics when your foot is not weight bearing and he doesn't use the step in casting mold that is a foam in a box. It's a bit of getting lucky with orthotics between getting a mold made right and having them made properly by the shop that makes the orthotic. I also used a boot that stretched my feet for a couple of hours a day in the evening before I went to sleep. I was supposed to wear them all night but I couldn't sleep with them.
Good luck

Re: 9 weeks and praying for a miracle

Connie Moody on 11/06/04 at 18:43 (163110)

Thanks, Vince. I have worked with each method you have described except the Dornier Epos (?) and the high energy ESWT. I have suffered with this over 10 years...have had all traditional treatments to include surgey on one foot (to no avail) 4 years ago. All the anti-inflammatories you can name...4 sets of professionally made orthotics - 3 of which were made when I was non-wt bearing(of which all seem to worsen the condition....a closet full of every shoe that has ever been recommended...cortisone injections, night splints, exercises, have not gone barefoot in YEARS!
Where did you have your ESWT tx? How long ago was that and how long did you suffer with PF prior to ESWT?
Thanks for any help you might offer
Connie

Re: 9 weeks and praying for a miracle

vince on 11/06/04 at 19:15 (163113)

I was treated in the New England area. Who did it isn't important. Any podiatrist that uses the Dornier Epos according to the FDA high energy method will give you the best chances for relief. If you have pf that's not complicated by other things wrong in your feet it should work real well for you. In had pf for about 5-6 years on and off. Good luck

Re: 9 weeks and praying for a miracle

Pauline on 11/06/04 at 19:28 (163115)

Vince,
I can't remember did you have surgery like Connie did prior to your ESWT?

Re: 9 weeks and praying for a miracle

vince on 11/06/04 at 19:45 (163116)

No surgery- just failed 3 low energy treatments- I think I'll ask the doctor for my money back and take him to small claims court if he doesn't give it back to me. I wasn't told that the low energy wasn't FDA approved- He just said it works but the insurance doesn't cover it- I didn't check on the treatment and I just paid him 3 times.It wasn't until later on that I did some looking and finaly went to someone else. Don't anybody ask who- what- where- when- or how much- I won't give out info like that.

Re: 9 weeks and praying for a miracle

Pauline on 11/06/04 at 20:25 (163118)

Vince,
When you begin to give fair warning about who, what, where, when or how much, unfortunately you lose a bit of credibility with me, but that's just me. I tend to view things a little differently.

The first question I'd ask you, is did you file a written complaint against the doctor with the state Medical Board, the FDA, any of his professional societies, and have you personally written him a letter.
To me this is far more important and if you haven't done so I would consider doing this documention soon. Other than telling us it doesn't sound like you've taken your complaint to any governing medical or licensing boards yet.

It should make for an interesting case should you take the doc to court.
I have a hunch that if you do anything you may ask for your money back, but court I have my doubts. Keep us posted, as I say it would make for an interesting case.

Re: 9 weeks and praying for a miracle

vince on 11/06/04 at 20:31 (163119)

Lose credibility with you?? LIke that really means a whole hill of beans. When were you appointed chief of the credibility police- and or the czar of advice oversite? Please don't ask me any questions- I have read your posts that time after time are like someone picking at a wound. I would appreciate if you would totaly ignore my chat postings

Re: 9 weeks and praying for a miracle

Pauline on 11/06/04 at 20:40 (163120)

Vince,
Your last post prior to this one was 'your' response to my post.

Re: 9 weeks and praying for a miracle

Dr. Z on 11/06/04 at 20:52 (163121)

Vince,
It is very serious if your doctor never told you that it wasn't FDA approved. It is very possible that maybe he was never told. I teach, train doctors ESWT and there are many cases where the doctors were never really explained that low energy is off label and not FDA approved with plantar fascia treatment. There is a compnay that use direct mail ESWT information to try and sign up doctors in my area that would state in WRITING that the Sonocur was an FDA approved equipment when in fact it is FDA approved for elbows and not plantar fascia. If you want additional informational about this just e-mail Dr. Z at (email removed) and I will give you very specific information that will help you get your money back

Re: 9 weeks and praying for a miracle

john on 11/07/04 at 07:21 (163128)

Vince,

I agree with Pauline. You need to file a complaint with the State Medical Board. You podiatrist is probably guilty of an ethics violation, at the minimum, for failing to disclose that he was prescribing low energy ESWT off label.

Re: 9 weeks and praying for a miracle

Pauline on 11/07/04 at 12:03 (163153)

I think Dr. Ed would know what is required in the way of disclosure if a doctor is going to use low energy for P.F. I believe he owns a low power machine.

Re: 9 weeks and praying for a miracle

Pauline on 11/07/04 at 12:22 (163154)

Dr. Z,
Since doctors are given quite a bit of discretion when it comes to using many items off label, including RX drugs, why would using the Sonocur off label be any different unless in fact the doctor himself was sold a bill of goods. If that indeed were the case, wouldn't that have to be proved too?

If a doctor orders an off label treatment RX for a patient does he have to disclose that fact to the patient as well?

My guess is a well written letter on an attorneys letter head with a copy sent to the FDA complaint dept. would get Vince his money back fairly quickly.

I don't think Vince realized the FDA does have a complaint dept. and is interested in hearing from patients who feel they have been mistreated, or misinformed about their medical treatments. I think they would like to hear from him.

Re: 9 weeks and praying for a miracle

Ed Davis,DPM on 11/07/04 at 12:49 (163156)

Pauline:
Off label use often exceeds 'on label' use. A good case in point is Neurontin and related drugs. Neurontin is ONLY approved by the FDA for use in the pervention of seizures. I would be amazed if 20% of the time it is used, it is used for THAT purpose.
Ed

Re: 9 weeks and praying for a miracle

Ed Davis,DPM on 11/07/04 at 12:59 (163157)

john:

Would you take a doctor to court who used a drug off label? Many drugs are used off label more than on label.

By the way,what would you say to all the patients who found no help until they saw Sunny Jacob for Sonocur Plus treatments at Bayshore, later Pain Free clinics andthe thousands of patient with PF cured at the Sonorex Treatment Centerin Vancouver by David Lowy?

Again, one cannot take one individual experience and extrapolate it to a whole population. High energy worked better for Vince but I can show you thousands for whom lowenergy worked better.

The other thing that Vince may not see is that there tends to be a cumulative effect of ESWT. When a certain threshold is reached, effectiveness occurs. It may be, in Vince's case, that the final treatment which was high energy was the treatment that crossed the threshold for a therapeutic effect and could have happened with any machine.

I had a patient, before I started with Sonorex, who had the recommendeations for surgery by four podiatrists after 9 years of intractable PF. It took at total of 4 sets of 3 low energy applications in Vancouver , BC but she was cured in 4 months, after 9 years of suffering.
Ed

Re: 9 weeks and praying for a miracle

Pauline on 11/07/04 at 13:13 (163159)

Dr. Ed,
I realize that and that is why I wondered how anyone could take a doctor to court simply for using something off label. It's done all the time. Case in point Neurontin as you rightly pointed out.

Re: 9 weeks and praying for a miracle

Dr. Z on 11/07/04 at 14:22 (163161)

The use of the sonocur off label isn't illegal. If is my opinion that the doctor should disclose that his use of a treatment or product is off label. You would have to ask the medical board or an attorney as to what violation is involved when there is no disclosure

Re: 9 weeks and praying for a miracle

john on 11/07/04 at 14:28 (163162)

Dr Davis,

The situation here is quite different than with off label use of drugs. Here the podiatrist requested money for a treatment that was not considered standard of care. The treatment was performed on a machine that was not FDA approved for plantar fasciitis. The patient was required to pay out-of-pocket. At a minimum, the podiatrist should have told the patient that one of the reasons that an out-of-pocket payment was necessary was because the treatment lacked FDA approval and insurance companies are hesitant to pay for experimental procedures.

Of course, the podiatrist would be free to relate his experience with low energy ESWT. He could make statements like yours regarding its efficacy. However, the podiatrist should have told the patient that there were two FDA approved machines and given the patient the choice to take the low energy treatment or seek high energy treatment on an approved machine.

Your comments about Sunny Jacob don't really apply since anyone going to Bayshore would already know that they are seeking a treatment that is not FDA approved.

Finally, there are no studies about the cumulative effect of ESWT. I'm glad to hear about your patient who was cured with 12 treatments of low energy ESWT. It is amazing that she was treated almost every week for four months. Are there podiatrists who perform low energy ESWT each week until the patient is cured? Are there any research articles that suggest when to stop giving low energy ESWT?

Re: 9 weeks and praying for a miracle

john on 11/07/04 at 14:35 (163163)

Pauline,

I can imagine that if a podiatrist treats using low energy ESWT and convinces the patient to pay him out-of-pocket without providing the proper disclosures would be liable to the patient.

It's not really the same as with off-label drug use since the argument would hinge on standard-of-care. In the case of the drug, it would be standard-of-care. In the case of low energy ESWT, it would be experimental. The argument would note that the APMA only endorses high energy ESWT and there is considerable controversy as to whether low energy ESWT works. The podiatrist could not argue that low energy ESWT was stardard-of-care.

Re: 9 weeks and praying for a miracle

Pauline on 11/07/04 at 15:20 (163165)

John,
I'm not an attorney and we have only heard one side of the story. I think if Vince wants to pursue this, he needs to use the legal system that is available to him. That is why I suggested that he put things in writing and documment his complaint to the proper authorities. These things are important if one is really serious about going to court.

You saw the response that I got from simply trying to point this out.

What ever Vince decides to do is fine with me. His case will be discussed here, but ultimately not resolved here.

Re: 9 weeks and praying for a miracle

Dr. Z on 11/07/04 at 15:20 (163166)

The bottom line is all you have to do is just tell the patient that the low energy treatment is off label in the USA. Plain and Simple. It no big deal to just tell your patients

Re: 9 weeks and praying for a miracle

Pauline on 11/07/04 at 15:29 (163168)

Dr. Z,
This is just my opinion, but I don't think most patients understand 'off label' usage of anything. Even if told without something that they sign it would be the doctors word against the patient as to whether they, the patient, were not only informed but fully understood the what, how and why they were being treated using a machine that was off label.

Not knowing all the ramificatons of the law on such an issue really lends itself to mere guessing on our part.

Re: 9 weeks and praying for a miracle

Dr. Z on 11/07/04 at 17:30 (163172)

Pauline,
I agree most patients probaby don't understand off Label. The patient shold sign a consent form before ESWT and if the procedure is off label should sign an explanation of what off label is and that insurance doesn't cover off labal procedure. I think that you will probaby start to see some legal issues with ESWT and off label use due to the volume of off label procedures being done.

Re: 9 weeks and praying for a miracle

Pauline on 11/07/04 at 20:22 (163184)

Unless required by State or Federal law, I don't think a doctor is required to have patients do any of this unless he is trying to protect himself. Then the question would still be is it binding and the answer may still be no depending on who is interpreting the law, the case at hand and of course the judge.

Re: 9 weeks and praying for a miracle

Dr. Z on 11/07/04 at 21:02 (163188)

There are state laws that deal with this issue. There is also lack of inform consent which is dependent state by state. Anyway I am not a lawyer, I am not prepared to go into detail as to which law or what is lack of inform consent.

Re: 9 weeks and praying for a miracle

Ed Davis,DPM on 11/07/04 at 21:13 (163189)

John: So you have taken it upon yourself to determine what 'the' standard of care be? Is the excellent care provided by Sunny Jacob, David Lowy, Sonorex, not to mention hundreds of providers providing successful low energy ESWT not meet the 'standard of care' that you have defined? Is surgical treatment the 'standard of care' with a 60% success rate and large complication rate? Does the FDA determine the standard of care? How is the off label use of drugs different different that off label use of devices in your eyes?
Ed

Re: 9 weeks and praying for a miracle

Ed Davis,DPM on 11/07/04 at 21:15 (163190)

Pauline:
Vince certainly has access to the legal system. I wonder if he would have the same problem with his care if he had failed plantar fascial release surgery?
Ed

Re: 9 weeks and praying for a miracle

Ed Davis,DPM on 11/07/04 at 21:20 (163191)

John:
Low energy is not experimental when it has cured thousands of patients worldwide and literally never led to harm. That cannot be said about off label drug use nor surgical treatment.

By the way John, I think it is time to divulge WHICH high energy ESWT company you work for or have an interest in. Of course, we can only ask you to do so but it is very apparent from your posts that you are far from a casual observor of ESWT.
Ed

Re: 9 weeks and praying for a miracle

Dr. Z on 11/07/04 at 22:14 (163193)

Ed,
You bring up a interesting concept of standard of care. I have found that the standard of care is a legal term that only takes place in a court room or in a disability case I do believe that the lack of FDA approval for Low energy ESWT for plantar fasciitis would be a very tough hurdle to over come in a court of law but I really don't ever see this happening unless it is maybe an anti-trust suit
I am not aware of any anti-trust suits filed against Siemans or any local distributors for the Sonorex in the USA.

Re: 9 weeks and praying for a miracle

Ed Davis, DPM on 11/07/04 at 22:26 (163194)

Dr. Z:
Good points. I think given John's strong opinions, it is time for him to identify himself.
Ed

Re: 9 weeks and praying for a miracle

john on 11/08/04 at 06:54 (163199)

Dr Davis,

I do not determine stardard of care any more than you determine standard of care.

The term standard-of-care is well defined in the medical community. Surgical treatment of plantar fasciitis is standard-of-care. ESWT is an emerging technology. Many insurance companies consider all ESWT experimental. Most insurance companies consider low energy ESWT experimental.

The FDA does not determine stardard of care. However, using a medical device in a non-FDA approved manner is typically considered experimental.

Off-label drug use if different for the reasons that I stated previously.

Re: 9 weeks and praying for a miracle

john on 11/08/04 at 06:58 (163200)

Dr Davis,

I am not sure that Vince can get help from the legal ssytem. However, he can probably get help from the State Medical Board. I believe that his podiatrist committed an ethics violation by failing to disclose that low energy ESWT was not FDA approved for treating plantar fasciitis and that the FDA had approved high energy ESWT. The patient should have been informed. That's all.

The podiatrist would be free to give all of the reasons that he believed that low energy ESWT works.

Don't miss the point, the podiatrist had an ethical obligation to inform the patient. That's all. After than point, the patient has to decide whether to proceed or get a second opinion.

Re: 9 weeks and praying for a miracle

Pauline on 11/08/04 at 08:00 (163204)

I agree that Vince may get help from the State Medical Board and I'd add the complaint Dept. of the FDA for Medical Devices, but this means that he would have to document and make the contacts with these medical oversite groups for that help.

Does he have the will to do this? We really don't know, but the discussion on the subject is an interesting one whether real or for promotion of high energy ESWT.

It would be interesting to see what a State Medical Board would do with this or even a judge. I'd also be interested in seeing what the FDA would do if they recieve multiple complaints from many patients following off label treatment of P.F. using Sononcur? That one would be most interesting.

Re: 9 weeks and praying for a miracle

Ed Davis, DPM on 11/08/04 at 10:00 (163211)

john:
Again, you have taken it upon yourself to define what a 'standard of care' and what is 'experimental.' Wheat criteria are you using for your definitions? What is you role in the ESWT industry?
Ed

Re: 9 weeks and praying for a miracle

Dr. Z on 11/08/04 at 11:09 (163221)

Ed,

I use the term experimental when a products needs to undergo FDA approval of some kind in order to market the product. So experimental would mean that it hasn't undergone and or is in the process of FDA approval. So low energy ESWT for pf would be experimental and low energy for tennis elbow wouldn't be experimental. Let me also point out that this is all crap and the FDA in this specific area has caused more harm, force more patients to undergo foot surgery due to lack of a process that protects the public and at the same time allows the procedure to be get to the public at a fair price.
I still don't understand why Siemans didn't follow the market and get FDA low energy approval for PF. In my opinion if they had they would have had a opportunity to provide treatment that is very cost effective. The Siemans leasing model on the surface sounds very attractive.

Re: Re:Question to anyone

Pauline on 11/08/04 at 11:09 (163222)

Perhaps this enters into 'standard of care' a bit. If we are to believe that low Energy ESWT is a sham treatment whether it's used off label or on for treating P.F. as in Canada, are we then to believe that the Canadian Dept. Of Health and European countries that use it for treating P.F have chosen to provide their own Citizens with a form of ESWT that they know will not work?

This brings us back to the all enclusive statement that we are hearing and that is low energy just doesn't work for P.F. One then has to begin to wonder why developed countries such as Canada would scam their own citizens. Doesn't it seem that after hundreds or perhaps thousands of treated cases that 'the word' would get out just by those patients who were treated.

How do you scam and entire country?

Re: Re:Question to anyone

Dr. Z on 11/08/04 at 11:24 (163225)

Pauline,
You bring up an interesting question however I am not sure why you call low energy treatment a scam. I don't recall any authority in the USA, Canada or the world describing low energy ESWT as a sham. The real question is what protocol was used to authorize low energy in Canada or in Europe. Was there a double blind, randonized placebo driven study performed or submitted by the manufactors in Canada, Europe, Asia as was REQUIRED in the USA. What study was required if any at all by the manufactors.
Pauline you are the investigator why don't you call and or research exactly what is required by the Canadian Dept of Health to allow the use of high, low energy treatment to be performed. This information could be interesting and at the same time properly inform posters if we are the FDA in the USA standards for approving ESWT as the same as in Canada. Let me note before we even get into this are. Different does mean better but lets see what you come up with.

Re: 9 weeks and praying for a miracle

john on 11/08/04 at 11:28 (163227)

Dr Davis,

STANDARD OF CARE
I have not defined standard of care but here is the definition provided on http://www.medterms.com/

Standard of care: 1. A diagnostic and treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstance. Adjuvant chemotherapy for lung cancer is 'a new standard of care, but not necessarily the only standard of care.' (New England Journal of Medicine, 2004)
2. In legal terms, the level at which the average, prudent provider in a given community would practice. It is how similarly qualified practitioners would have managed the patient's care under the same or similar circumstances. The medical malpractice plaintiff must establish the appropriate standard of care and demonstrate that the standard of care has been breached.

I don't think that low energy ESWT fits this definition of standard of care for US practitioners. Here the community are all podiatrists and orthopedic surgeons practicing in the United States. It does not mean through out the world.

EXPERIMENTAL
In terms of experimental, Blue Cross North Carolina defines experimental as follows:

BCBSNC defines the terms 'investigational' or 'experimental' as the use of a service, procedure or supply that is not recognized by the Plan as standard medical care for the condition, disease, illness or injury being
treated. A service, procedure or supply includes, but is not limited to the diagnostic service, treatment, facility, equipment, drug or device. A service is considered investigational (experimental) if any of the following criteria are met:

1. The services, procedures or supplies requiring Federal or other Governmental body approval, such as drugs and devices, do not have unrestricted market approval from the Food and Drug Administration
(FDA) or final approval from any other governmental regulatory body for use in treatment of a specified condition. Any approval that is granted as an interim step in the regulatory process is not a substitute for final or unrestricted market approval.

2. There is insufficient or inconclusive medical and scientific evidence to permit the Plan to evaluate the therapeutic value of the service, procedure or supply. (Adequate evidence is defined as at least two documents of medical and scientific evidence that indicate that the proposed treatment is likely to be beneficial to the member.)

3. There is inconclusive medical and scientific evidence in peer-reviewed medical literature that the service, procedure or supply has a beneficial effect on health outcomes.

4. The service, procedure or supply under consideration is not as beneficial as any established alternatives.

5. There is insufficient information or inconclusive scientific evidence that, when used in a non-investigational setting, the service, procedure or supply has a beneficial effect on health outcomes or is as beneficial as any established alternatives.

Based on the above definition, low energy ESWT is investigational or experimental since it does not meet condition 1.

DEFINITIONS
Dr Davis, what are your definitions? Please cite external references!

Re: Re:Question to anyone

Pauline on 11/08/04 at 11:50 (163229)

Dr. Z,
The word scam was used for lack of a better term. Perhaps 'bogus' or 'empty' would have been better. You are correct I don't recall any 'authority' in the USA, Canada or the world describing low energy ESWT as anything but a legitimate for of treatment whether used on or off label.

What are we to believe when we have posters that suggest that they have had low energy ESWT and it doesn't work? Should we place any more importance on their statements than that of other posters who have have high power ESWT and had the same results?

I don't think there is any need to reinvent the wheel. My guess is that Sonny probably has the information that you are interested in knowing. He has worked with ESWT for some years, low power on his own and has connected with Dr. Gordon for information on high power usage.

He's a wealth of information I'm sure. Why not give him a call and let us know what he says?

Re: 9 weeks and praying for a miracle

Pauline on 11/08/04 at 11:58 (163230)

John,
Based on the definations of experimental that you posted and the fact that most insurance companies are not paying for any ESWT wouldn't high energy
ESWT fall into the same category? Isn't this what Burchbinder is saying in her journal article when she says there is no evidence that the treatment works?

Re: Re:Question to anyone

Dr. Z on 11/08/04 at 11:58 (163231)

Pauline,
What are we to believe? Any one that wishes to know exactly what criteria is used to approve ESWT in Canada can contact the Canadian Health Ministry or what ever they call the Canadian FDA. I have no idea if the approval was as strict or long as was in the USA but knowing the FDA it was probaby more difficult to get FDA appproval for ESWT in the USA then in Canada.

Re: Re:Question to anyone

Dr. Z on 11/08/04 at 12:02 (163233)

Pauline,
At first the same though came to my mind, however high energy ESWT meets all of the criteria that John has listed. Is there something that I missed please point it out to me

Re: Re:Question to anyone

Pauline on 11/08/04 at 12:02 (163234)

I don't see why not. People probably contact them all the time. Any citizen in the U.S. can contact and recieve a written response from our FDA.

In my dealings with various agencies in foreign countries I have found them most helpful and very 'express' in getting a response back. You have no idea how kind they are.

Re: Re:Question to anyone

Pauline on 11/08/04 at 12:22 (163237)

Dr. Z,
First I have to say I think these are great discussions. Lets see if my answer fits.

First of all the criteria that John listed is limited to BCBS of North Carolina so I'm not certain that we can generalize that the criteria that he posted holds true for each and every other insurance carriers descriptions of experimental. They would all have to be checked.

For the sake of discussion I'll pick on one: # 3. Hopefully we can continue to talk without rage or anger over any of this. Pure discussion only.

3. There is inconclusive medical and scientific evidence in peer-reviewed medical literature that the service, procedure or supply has a beneficial effect on health outcomes.

In respect to # 3, I'd have to say that the publication of Burchbinder's study would fall into the area of inconclusive medical and scientific evidence in peer-reviewed medical literature.

Re: Re:Question to anyone

Ed Davis, DPM on 11/08/04 at 12:45 (163242)

Pauline:
Not only do the Canadian health authorities approve of the use of low energy ESWT but most health 'authorities' in West Europe including Germany approve. There is quite a concensus concerning efficacy and safety. We have, in the US, the added dimension of healthcare politics.
One just cannot say that Canadian feet, German feet and so on are resposnding differently than American feet -- it just makes no sense.
Ed

Re: Re:Question to anyone

Pauline on 11/08/04 at 12:56 (163243)

I have to agree with you on that Dr.Ed. I think we've had our share of non responsive feet with both high and low energy machines.

It's very difficult for me to believe that the Ministries of Health in Canada and other countries would delibertly have doctors treating patients with something they know would injure them or provide no help. As you say it just doesn't make good sense not to mention the time, and money spent.

A thought just popped into my head. Feet in many other countries are actually used for walking. Lots of walking because Americans are sooo used to using autos for everything. Now could it be that German, Italian, Spanish, Russian, and East Indian feet etc are better conditioned and therefore respond better to low energy:*) Soooo many paths to consider, the mind is a wonderful object for ones imagination.

Re: 9 weeks and praying for a miracle

Ed Davis, DPM on 11/08/04 at 13:22 (163245)

Dr. Z:
I am dissapointed that Siemens did not jump through the FDA hoops and get approval. Keep in mind that there are quite a few manufacturers out there
that have not accessed the US market. Agreeably, the consequences of the approval process is more surgery and as such, I would think that the actions of the FDA has hurt than helped more people. I wonder what the numbers are for people getting PF release surgery in Europe and Canada?
Ed

Re: 9 weeks and praying for a miracle

Ed Davis, DPM on 11/08/04 at 13:27 (163246)

Pauline:
Very few, if any complaints exist. None in WA State to the best of my knowledge. The reason is that the first maxim of medicine is 'do no harm' and Siemen's Sonocur has followed that. Second, the success rate is very high so there are very few people out to complain. I can sympathize with Vince being in the small percentage that was not helped but nothing is 100%. Luckily, he did not opt for surgical treatment -- something that is not FDA approved nor has a high approval rating from peers in the podiatric and orthopedic profession.
Ed

Re: Re:Question to anyone

Ed Davis, DPM on 11/08/04 at 13:35 (163250)

Pauline:
Good thoughts Pauline.
One thing that I am learning is that the effects of ESWT tend to be cumulative. We, in the US, not only got FDA approval for 2 high energy treatments BUT, AT the insertion of the plantar fascia only AND if a small percentage of the population would benefit from, say, a third round, it would never be officially FDA approved via the current system because no one is going to jump through the hhoops again, do studies, etc. to prove that say, 5% of PF sufferers need that third round. The thing that Vince may never know is if he was cured for sure by high energy or simply the cumulative effect of repeated ESWT.
Ed

Re: Re:Question to anyone

Pauline on 11/08/04 at 13:59 (163251)

Another thing I don't think we know is if ESWT was used sooner than 6 months out would the effect be any different? Were there studies done on this?

Re: 9 weeks and praying for a miracle

Ed Davis, DPM on 11/08/04 at 13:59 (163252)

Pauline:
With all due respects to your requests that doctors identify themselves, we have someone, anonymously posting as 'John' who obviously is not an average reader of this board but is strongly involved in the industry based on his posts. The FDA and insurance industry are NOT the standard that the medical profession uses to define something as experimental; sorry John.

Pauline, this is the third time I am asking that John simply give us the courtesy of identifying himself. His refusal to so do, in my view, serves to detract from his credibility because he has an obvious and strong bias that premeates his posts and it would only be fair to readers here to have that revealed. He could be the 'Bill' of 18 months ago; who knows?
Ed

Re: Re:Question to anyone

Ed Davis, DPM on 11/08/04 at 14:03 (163253)

Pauline:
Not specifically. Since the studies use repetition of ESWT in 12 weeks, we have used that as a guideline. Interestingly, Rompe noted the actual thinning occurring on sonography, I beleive in 20 weeks so most are convinced that the effect of ESWT actually goes on for longer than 12 weeks.
Ed

Re: 9 weeks and praying for a miracle

Ed Davis, DPM on 11/08/04 at 14:07 (163254)

ps.
The joint statement by the ACFAS and APMA of December 2003 largely recognizes ESWT as a standard of care. The insurance industry has an inherent bias in utilizing FDA approvals or non-approvals to deny payment for services.
Ed

Re: 9 weeks and praying for a miracle

Dr. Z on 11/08/04 at 14:42 (163255)

Ed,
Good article !!! Why is more pf surgery done in the USA then in Canada and Europe and it has nothing to do with the UN. Seriously the use of ESWT should be offered to all patients, not just those with insurance and or the money to pay for the ESWT service

Re: Re:Question to anyone

Dr. Z on 11/08/04 at 14:49 (163256)

Pauline,
I agree these discussions are great. At first I though it would turn negative but it has in my opinion turned somewhat educational and interesting.
My confusion is that #2 and #3 are contradictory. There are two peer reviewed journals that show positive outcome. One is the FDA ossatron study and the other is the FDA dornier study. There are others. I have a 70 page report that reviews all of the literature. By the way this is the literature I want to send you Dr. ED. Please e-mail me at (email removed) and I will sent it

Re: 9 weeks and praying for a miracle

Pauline on 11/08/04 at 14:51 (163257)

Dr. Ed,
I think we could tell from the beginning that John is not merely an ESWT patient.

Re: Re:Question to anyone

Pauline on 11/08/04 at 14:56 (163258)

Dr.Z,
I think this sentence holds the key in John's post.
'A service is considered investigational (experimental) if any of the following criteria are met:'

It's didn't say 'all' it says 'any'. Sort of that slippery slope that provides an out in any direction.

Re: 9 weeks and praying for a miracle

Ed Davis, DPM on 11/08/04 at 15:08 (163260)

Pauline:
Yes, but remember that you are a 'veteran' of this board. We must also think of the 'newbies' and those who read but don't post. They too must have a reasonable level of awareness of what and who is coming here with information that appears 'authoritative.' What ways can those individuals be made aware or is it simply up to us to try to point issues like this out? If you think that our efforts are sufficient then that may be okay but do you think there is a point where we should have the right to ask for or require identification be made?
Ed

Re: 9 weeks and praying for a miracle

Pauline on 11/08/04 at 15:31 (163263)

Dr. Ed,
This 'veteran' as you describe me you'll remember was possibly the first individual ever cyperstoned over the net on this site, has had hate mail, threats of every kind and called just about everything possible in print on the face of this board with who knows what via backboarding and you're asking me if our efforts are sufficient?

Re: 9 weeks and praying for a miracle

Pauline on 11/08/04 at 15:33 (163264)

I should have added I know mine are, but I'm not certain about anyone else.

Re: 9 weeks and praying for a miracle

Dr. Z on 11/08/04 at 16:02 (163265)

Ed, Pauline,
I don't understand or see why there is a concern of what John is stating or saying. He has an opinion that is backed up with documentation
that he provided. He hasn't been mean or nasty. So what is the beef with John. I have none so far. I do feel that that all posters should be made aware that low energy in the USA isn't FDA approved but is available and that there is High energy that is FDA approved and is also available

Re: 9 weeks and praying for a miracle

Pauline on 11/08/04 at 16:14 (163266)

Dr.Z,
I have no beef with John. I agree with Dr. Ed that he knows a lot more about ESWT than the average poster but until your post, no one has associated the words mean and nasty with John.

I for one do not care to take our current discussion in that direction.

Re: 9 weeks and praying for a miracle

Dr. Z on 11/08/04 at 16:20 (163268)

Pauline,
I wasn't associating those words with him. I do agree that John is very bright

Re: 9 weeks and praying for a miracle

john on 11/08/04 at 17:10 (163269)

Pauline,

Good question. High energy has FDA approval so it meets the requirements of criteria 1. Experimental does not mean whether insurance pays.

By the way, the criteron listed applies to all Blue Cross plans and is what was used by the Blue Cross Technical Evaluation Committee (TEC).

Re: 9 weeks and praying for a miracle

john on 11/08/04 at 17:24 (163271)

Dr Davis,

The joint statement by the ACFAS and APMA of December 2003 recognizes the contradictory results of current low energy studies.

The insurance industry does not have an inherent bias. They insist on properly conducted studies for all new technology. The same studies that the FDA requires for approval. It is not a conspiracy.

Would you have insurance companies paying for magnets just because we are told that they work? I don't think so. Neither would I. Provide properly conducted studies and they will pay.

Re: 9 weeks and praying for a miracle

john on 11/08/04 at 17:28 (163272)

Dr Z.

Thank you for your kind comments.

Re: 9 weeks and praying for a miracle

Dr. Z on 11/08/04 at 17:40 (163273)

John,

Here is the Summary from the APMA position statement. It only recognizes
high energy. What conclusion can we make from this?

Throughout history, there have been numerous examples of improvements in medical care as a result of new technology. In fact, before the 1990s traditional surgery for heel pain required a more prolonged recovery that usually resulted in 2-6 weeks of non-weight bearing, followed by partial to full weight bearing. With traditional heel surgery, 15-20 % of the cases can result in complications, such as nerve entrapments, continued pain, or lateral column syndromes, which may lead to chronic pain. This prolonged recovery and potential for complications led to the need for an improved surgical technique. In the early 1990s the endoscopic plantar fasciotomy came into vogue. It was a much easier procedure to perform with fewer complications than traditional heel surgery. In October of 2000 the first device became available for extracorporeal shock wave therapy. This new technology is revolutionizing the treatment of chronic heel pain, much the same way the lithotriptor did for kidney stones in 1984. The ESWT procedure has few, if any, complications that are minor in comparison to previous types of heel surgeries.

The number of shock wave procedures being performed has greatly increased in the past year, primarily due to the effectiveness of the treatment, fewer complications, and the increase in availability of the technology. Based on a thorough review of the literature, ESWT appears to be an efficacious, FDA-approved non-surgical option in the treatment of chronic proximal plantar fasciitis

Re: 9 weeks and praying for a miracle

Ed Davis, DPM on 11/08/04 at 23:52 (163292)

John:

The magnet analogy is flawed as it is more of a 'folk medicine' type modality. Lets look at some other things. What do you think about insurance companies paying for chiropractic treatment. Many states require that insurers cover chiropractic. There are probably 100s of thousands of chirpractic visits, if not millions every year by Americans yet the FDA has no studies let alone meager studies and evidence from academia discussing its efficacy. At some point experiential data from professionals comes into play and the efficacy of chiropractic, despite some controversy is difficult to assign a mass placebo effect or a conspiracy of silence among those in that profession as to the efficacy of its treatment.

John, where did you hear and what evidence do you have that EPF has a lower complication rate than traditional PF release surgery. Most papers I have seen show that the success rate and complication rate among open, EPF and minimal incision plantar fascial releases to be very similar other than the minimal incision approach rarely leading to infection as a complication and seemiong to be less painful in the early stages of recovery. The FDA approve NO surgical procedures for plantar fascial release.

John, you seem to place a lot of stock in the FDA while ignoring its counterparts throughout the civilized world. My loyalty goes out to the good old USA but I certainly do not claim scientific superiority to the Germans nor the Canadians let alone the rest of Western Europe. If anything, I compliment the Canadians on an excellent level of objectivity unfettered by the politics that seems to abound at the FDA. The FDA has routinely approved drugs that later have been pulled off the market while delaying pain sparing and sometimes life sparing drugs. It simply fails to study a lot of important health issues concerning Americans. it simply has minimal impact on my decision making as an American healthcare provider as it should to most.
Ed

Re: 9 weeks and praying for a miracle

Ed Davis, DPM on 11/08/04 at 23:55 (163293)

Dr. Z:
John is presenting himself in an authoritative fashion, selectively chosing information that supports a specific modality, high energy ESWT. yet he refuses to reveal to readers who he is and what his interest is in the field. He, obviously, is an insider with a bias, and for the sake of fairness and decency should let readers know who he is.
Ed

Re: 9 weeks and praying for a miracle

Ed Davis, DPM on 11/09/04 at 00:00 (163295)

Pauline:
Understandable, but lets consider the big picture here. We have lots of readers who don't post. Setting our personal experiences aside, what obligation does this board have to let readers know who an individual who seems to be anonymously presenting selective information from a seeming position of authority? At some point, it seems that the decent thing to do is to reveal one's bias and role in the industry as John, who is courteous, yet has a strong agenda, needs to be honest and informative about his role in the industry.
Ed

Re: 9 weeks and praying for a miracle

john on 11/09/04 at 01:19 (163297)

Dr Davis,

Besides the personal attacks, I don't understand your comments about plantar fascia surgery. I never said anything about the efficacy of EPF. Are you saying that since the FDA does not evaluate surgical procedures it should not evaluate ESWT devices?

I am sorry that you only feel contempt for the FDA. I find it ironic that in one breath you critize the FDA for not approving ESWT fast enough but go on to critize the FDA for routinely approving drugs that are later pulled off the market. You can't have it both ways. The FDA needs to insist on the same level of testing for all drugs and medical devices. ESWT is no exception.

I find it hard to believe that the FDA is playing politics with ESWT. There simply is not enough money in ESWT for politics to get involved. The money involved in ESWT does not begin to approach the money involved in a block buster drug.

Re: 9 weeks and praying for a miracle

Pauline on 11/09/04 at 07:49 (163314)

John,
The money involved in ESWT will be made by the providers in the form of outstanding easy profit.

Re: 9 weeks and praying for a miracle

Dr. Z on 11/09/04 at 08:35 (163319)

Pauline,
Nothing is easy and everything has risk