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lowest ESWT prices in U.S. - St Louis

Posted by scott r on 10/25/02 at 04:09 (098320)

Dr. Daniel Adamovsky in St. Louis, Missouri is offering the lowest-priced ESWT in the U.S.

Re: lowest ESWT prices in U.S. - St Louis

rob a on 10/25/02 at 09:20 (098324)

Just so we are clear. That cost is the total amount or just the doctor's fee? I just want to make sure that there are no facility, anesthesia or other surprise bills. Does he do it in his office or as an outpatient procedure? By the way, good to hear from you Scott.

Re: lowest ESWT prices in U.S. - St Louis

scott r on 10/25/02 at 10:22 (098337)

It's always good to see you around too Rob. It's the total amount. If someone finds out that it isn't then I need to know ASAP.

Re: lowest ESWT prices in U.S. - St Louis

scott r on 10/25/02 at 11:42 (098348)

hmmm, i guess that bug in the message board program isn't out yet for when people make a post within a second of each other, so my last post got deleted. Anyway, it's good to hear from you too Rob. Yes, it's the total cost.

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/25/02 at 22:27 (098359)

Scott:

I think it is important that you differentiate an advertisement from a statement of fact. I charge less than this doctor for ESWT at about $1470 per foot for 3 Sonocur treatments, with additional discounts available so one certainly cannot claim that the doctor in St. Louis has the 'lowest-priced ESWT in the US.'

Ed

Re: Is this an advertisement or a statement of fact?

scott r on 10/25/02 at 22:39 (098362)

Oh, sorry Dr Davis. Then I have to modify it to say 'lowest-priced FDA-approved ESWT machine for heel pain'

Scott

Re: Is this an advertisement or a statement of fact?

john h on 10/28/02 at 12:10 (098487)

Dr. Ed: I thought you were sending your patients to Canada for treatment. Have you acquired a Sonocur machine? What is the spacing between your treatments?

Re: and let's not forget...

elliott on 10/28/02 at 13:12 (098490)

what are your observed success rates, Dr. Ed? Since you've just started, we'll accept the 3-month benchmark. :-)

[]

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/28/02 at 14:59 (098501)

John:

I sent primarily patients without ESWT coverage to Canada. I have been using the Ossatron primarily for patients with insurance coverage although the treatment cost has come down substantially for those without coverage this summer.

The Sonocur was approved this July and I introduced a unit in my office about 3 weeks ago.

It is my intention to use both the Ossatron and the Sonocur.
Ed

Re: and let's not forget...

Ed Davis, DPM on 10/28/02 at 15:04 (098502)

Elliott:

I would like to get some decent numbers of treatments on the Sonocur before comparing it to the Ossatron. I have used the Ossatron for about a year.

One interesting observation: I am seeing two distinct groups of individuals for ESWT treatment (something I did not quite expect).
The first group are those individuals whom have not been helped by conservative treatment so ESWT is an alternative to surgery.
The second group of patients are individuals who have gotten much better with conservative treatment but not completely cured. This group gets through the day okay but has to rest upon getting home at night and would like to get up to full function.
Ed

Re: Sonocur approved by FDA for PF treatment?

BrianG on 10/28/02 at 21:55 (098522)

Hi Dr. Ed,

Are you using the Sonocur, in your office, to treat PF? I hadn't heard where it was approved for PF.

Regards
BrianG

Re: Is this an advertisement or a statement of fact?

john h on 10/29/02 at 09:13 (098543)

Dr. Ed: You have seen me post this before but Dr. Gordon in Canada who consults with Bayshore told me he uses the Ossatron on a foot that has had previous surgery and the Sonocur on other feet. Have you used the Ossatron on a foot that had previous surgery? We just got an Ossatron in Little Rock with a large orthopedic group. They could not even give me a price and had patients fill out forms which they forward on to Healthtronics to see if you qualify for treatment. This orthopedic group was far less knowledgable about ESWT for PF than me and could not answer the basic questions about number of pulses, the general protocol after treatment,etc. Is Healthtronics just determining whether the patient is able to qualify for insurance coverage or are they making the medical decision as to whether a patient qualifies for treatment? Do they set the price?

Re: Is this an advertisement or a statement of fact?

john h on 10/29/02 at 09:15 (098544)

Dr. Ed: Another question? How far apart do you space your Sonocur treatments assuming you are using a three treatment protocol?

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 11:50 (098558)

It is against the law to advertise the use of the Sonocur
for the treatment of plantar faciitis! The machine is not
FDA approved for that indication and no company or person
can advertise its use for that purpose. If you doubt it
contact the enforcement division of the FDA. They are
investigating anyone who advertises the use of the
Sonocur for the treatment of plantar faciitis.

Please follow the law.

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 11:52 (098559)

The Sonocur is not FDA approved for the treatment of
plantar faciitis! Do not advertise it or you will be the
subject of an FDA enforcement action!

Re: Sonocur approved by FDA for PF treatment?

Bill on 10/29/02 at 11:53 (098560)

It is not approved and it is illegal to advertise
its use.

Re: Is this an advertisement or a statement of fact?

David L on 10/29/02 at 12:26 (098561)

Bill,
You are correct that there are restrictions on the advertising of a device for off-label purposes; however, as for the use, please refer to the section of the Food & Drug Act below:

SEC. 906 PRACTICE OF MEDICINE. --

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: Is this an advertisement or a statement of fact?

Dr. Zuckerman on 10/29/02 at 12:28 (098562)

Can a podiatrist purchase a soncur machine for pain management?

Re: Is this an advertisement or a statement of fact?

john h on 10/29/02 at 13:48 (098570)

Bill you may be correct but it is sure not illegal in Canada or Europe and been used for that purpose for many years. If you have ever had a severe case of PF with the accompanying pain you may take a differnt view on this subject..

Re: Is this an advertisement or a statement of fact?

elliott on 10/29/02 at 13:57 (098572)

Bill, just wondering if Dr. Ed's post is called advertising. What exactly are the guidelines? In neither post did Dr. Ed leave an address or phone, nor did he mention PF (whew, lucky there! :-)). He only said he's charging $1470 per foot. No doubt he meant rental rates for the floor space. :-) Is just saying very generally that one is gonna use a Sonocur, but not for what, as he did in his second post which got a warning, considered a violation? Also, what's your angle in this? Are you a watchdog for the FDA? Thanks.

Re: Is this an advertisement or a statement of fact?

Dr. Zuckerman on 10/29/02 at 15:16 (098584)

I can say the word Orbasone now. Boy did that feel good. Long live the Orbasone !!

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 18:03 (098603)

No because it is only FDA approved to treat tennis
elbow and podiatrists are not licensed to treat tennis
elbow. A doctor who is licensed to treat tennis elbow
can use it off-label to treat his patients within his
rights as a doctor but he cannot market it for off-label uses.
There is no questions that marketing for off-label use
is against the law and is the responsibility of enforcement
division of the FDA.

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 18:15 (098604)

Marketing means that you cannot make it generally known that
you use the Sonocur to treat plantar faciitis. You cannot advertise
in the newspaper in a manner designed to get patients asking
for the non-invasive treatment and then offer the Sonocur.

I know that you think that the above rule gives physicians the
right to use the Sonocur to treat plantar faciitis but it is
not that simple and I believe that many physicians and podiatrists
are breaking the law.

Just imagine, a class 3 medical device is the most dangerous device
approved by the FDA. The Sonocur is a class 3 medical device. It
required a clinical study in order to market the device for tennis
elbow. The clinical stuy was designed to test the safety and then
the effectiveness of the treatment. It took a significant amount
of time and was reviewed by many scientists. After many years they
got approval to treat tennis elbow.

The Sonocur is not approved for plantar faciitis. It has not been
shown to be safe or effective and it is not proper or ethical to
use the Sonocur to treat plantar faciitis without FDA approval when
FDA approved devices exist.

What do you think would be the result of a liability lawsuit if a
patient was injured by the device? What would be the podiatrist's
defense? (I used the Sonocur because I could make more money and
I know that they use it in Canada. I don't think that defense would
work in a jury trial)

The FDA has rules to protect the public. If a podiatrist or orthopedic
surgeon hurts a patient using the Sonocur to treat plantar faciitis
before it is approved then God help him. He will not survive the lawsuit.
He will not be able to get liability insurance because not insurance
company would trust him. I don't think that it is worth the risk and
I can't imagine a professional taking such a risk.

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 18:17 (098605)

Correct. The FDA only controls the safety of medical devices
in the US.

I would not take a different view. I would asked to be treated
on a machine that was FDA approved. I would not risk the possibility of
a sham treatment, or worse, being injured by a machine that
has not passed FDA regulations.

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 18:20 (098606)

You can say what you want. You cannot market an
off label use. You cannot solicit patients for
off-label uses unless it is part of a IRB approved
study which is conducted according to FDA guidelines.

Using the Sonocur to treat plantar faciitis in the US
is experimenting on patients and all patient experimentation
is strictly controlled by the government.

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 18:33 (098607)

I think that it is advertising. He indicated that he uses the
machine to treat plantar faciitis and that his charge is XXXX
It is reasonable to assume that he will be contacted by prospective
patients wanting to save money and that they will ask about
the Sonocur. This forum is both a way to exchange ideas and a
way to locate podiatrists so messages are a type of advertising.

I think he should be careful. I think that he is taking on a
significant liability risk using the machine and he will have no
defense if one of his patients gets injured by the treatment.

I can say with some certainty that he will not be able to rely
on the consent form signed by the patient because he cannot truly
say that the patient knew the risks. The best protection would be
to initiate a study and get approval of a hospital IRB. The IRB
will review the documents and make sure that he is following FDA
protocol.

Re: Is this an advertisement or a statement of fact?

elliott on 10/29/02 at 21:14 (098618)

Bill, please answer my other question: Are you some sort of watchdog for the FDA or other gov't agency or working on their behalf?

Re: Is this an advertisement or a statement of fact?

john h on 10/29/02 at 21:54 (098627)

You got all the keywords in your post Bill: Sue,liability lawsuit,defense, FDA approval, breaking the law, after many years they got approval to treat tennis elbow, survive,etc.

This is the same FDA I assume that approves a full release of the fascia for treatment of plantar fasciaitis. The FDA is a necessary but certainly not a flawless agency.

Re: Is this an advertisement or a statement of fact?

elliott on 10/29/02 at 22:02 (098628)

A Boy Named Sue. :-)

[]

Re: Is this an advertisement or a statement of fact?

john h on 10/29/02 at 22:03 (098629)

Elliott: I am with you in that I would like to know from what platform Bill is speaking and who he represents. If he represents the FDA and is being paid with tax payer funds I would like to know so I can express my feelings to my Senate and House Represenatives about his scare tactics on this board. We have people here who are suffering daily, have lost their jobs and some in wheel chairs. They are looking for help amd Bill's post provides nothing but fear. If he is just another poster then have at it.

Re: OK Bill. Who are you, and who do you represent?

Julie on 10/30/02 at 02:15 (098643)

No message.

Re: Is this an advertisement or a statement of fact?

nancy s. on 10/30/02 at 06:10 (098647)

i'm with you on this, john, all the way. you are right about the fda: the need for it, but also its many serious flaws. and i have the same question as you and elliott do: who is this fearmonger? bill, be honest and tell people who you are. you can't have a hope of being taken seriously unless you do. your threats could affect not people looking for some fun party to go to but people who are seriously suffering, whose lives have come to a screeching halt, and who need all the helpful options that people, most of all professionals, can offer them.
nancy
.

Re: It shouldn't matter

BrianG on 10/30/02 at 10:59 (098666)

who Bill is. The fact that he is possibly saving Dr. Ed from a whole passle of legal trouble from the FDA should have people thanking him. Just because someone comes to the board, with new information, should not mean that certain long time readers gang up on him. I look at him as someone who has done his home work, knows the laws, and is having his say. Do you really want to drive people like Bill away ????

Regards
BrianG

Re: It shouldn't matter

nancy s. on 10/30/02 at 11:40 (098669)

nope, brian, not at all -- just want to know who he is and what's his interest. that's the usual courtesy around here, and not too much to ask, in my opinion.

Re: It shouldn't matter

john h on 10/30/02 at 11:48 (098672)

Bill wrote very much in the manner of a Lawyer which he well may be. He could represent the FDA or he could represent an ESWT competitor of Sonocur with an obvious goal in mind. If he is with the FDA then he should have no problem identifying himself as such. Dr. Ed has always been very good with providing helpful information and has been one in particular who I would say does not advertise or seek patients to come to his facility. All I know is he is somewhere in the Northwest. Scott your post is well taken because as a small entrapeneur you cannot deal with federal agenices with unlimited amounts of money and lawyers. You have also been careful to keep us all informed of what is appropriate and not appropriate. . This board provides an informative and most helpful servie to all who suffer from PF. Probably more so than any other source in the land. When I see threats such as Bill post (be he right or wrong) my hair stands on end. If he represents our government and is paid by our tax money I want to know what agency he represents so I can make my feelings as a patient be known to the agecny and my elected representatives. If he represents a competitor of one or more of the ESWT manufacturers then shame on you Bill. People on this board know who I am, where I am, what I do and a lot of my personal history. I am not always right but I always have compassion for my fellow PF sufferers. I respect Bill's right to post and if he intended to scare some Doctors who have helped us all then he probably succeeded.but you really did not help us with PF Bill which has been the purpose of the board from the begining.

Re: It shouldn't matter

Carole C in NOLA on 10/30/02 at 12:16 (098677)

A federal employee working for an agency such as the FDA cannot speak for that agency unless he is authorized to do so, in this forum, and has it approved and so on. At least, that is the case in my agency (a different one).

We are specifically cautioned to be careful about message board participation. You may have noticed that as proud as I am of my agency and the work we do, I don't talk about or give specifics about my agency here, and I try not to say anything that would be an attempt to represent my agency or that would reflect poorly on my agency.

Carole C

Re: It shouldn't matter

BrianG on 10/30/02 at 18:20 (098700)

Hi John,

I really hate to argue with you, but can you tell me where Bill made any threats? I realize he may sound like a lawyer, or other professional in the field, but I really think that if he was out to hurt Dr. Ed, or anyone else, he would have already done it. Instead he came to the forum with some facts. I see no reason to think he is anyone other than an educated consumer.

Regards
BrianG

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/30/02 at 20:58 (098728)

John:

The theory is that a foot that has had prior surgery has a lot of scar tissue so high energy would have an advantage in that scenario. It sounds logical although I do not believe we have studies to back that up.
Ed

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/30/02 at 21:00 (098730)

John:

We use the protocol that has been used by the Sonocur treatment centers in Canada -- 3 low energy treatments spaced one week apart.
Ed

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/30/02 at 21:02 (098731)

Bill:

The FDA does not have to approve all medical treatment in the US. It is perfectly legal and ethical to use devices and drugs 'off label.'
Ed

Re: Sonocur approved by FDA for PF treatment?

Ed Davis, DPM on 10/30/02 at 21:11 (098734)

Wow, Bill, lighten up! Nobody is marketing the Sonocur for plantar fasciitis in the United States. A number of us use more than one machine -- I use the Ossatron and the Sonorex. We let the public know that we offer ESWT and they have the choice of protocols with the Ossatron which is 'on' label and Sonorex which is 'off' label.
Ed

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/30/02 at 21:19 (098738)

Bill:

I let the public know that I treat the diabetic foot. A diabetic who suffers from painful diabetic neuropathy often obtains the best relief from a number of non-FDA approved compounded medications that I may subscribe. Using your logic, I cannot legally advertise myself as a doctor who treats diabetic foot problems because I may prescribe an off label medication.
Ed

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/30/02 at 21:25 (098739)

John:

I would love to know more about Bill's background. He comes across as an attorney taking a very narrow legal interpretation of agency law.

My first duty as a physician is to heal. It is part of the Hippocratic Oath as well as a moral and ethical duty. The FDA was designed to protect and enhance the health of the public so I have difficulty with any interpretation that does not support that mission.

Ed

Re: Excellent question, Julie!

Ed Davis, DPM on 10/30/02 at 21:27 (098740)

Excellent question, Julie!
Ed

Re: marketing vs. advertising

Ed Davis, DPM on 10/30/02 at 21:37 (098742)

Brian:

Considering Bill's ardent position, I think we really need to know where he is coming from and whom he represents.

The legal 'advice' is appreciated and I have refrained and intend to refrain from 'formally' marketing the Sonocur. How one defines marketing can be problematic though. I am a part time teacher and I just completed a lecture on heel pain to family practice residents in Tacoma. It certainly was an ethical obligation on my part to inform them of all the modalities to treat heel pain. They will be the referring family doctors of the near future and I emphasized that plantar fascial release surgery should rarely be performed due to the availability of ESWT. I discussed how ESWT works, the different machines and protocols. Yes, this, in a way, could be construed as a means of marketing as some of those residents who will remain to practice in this community may refer heel pain patients to me.

Perhaps we should state that such devices not be advertised as opposed to not 'marketed.'
Ed

Re: Sorry Bill but "off label" use of any modality is NOT the same as experimenting--Bill you are stepping way over the line!

Ed Davis, DPM on 10/30/02 at 21:46 (098743)

Off label use of any modality whether it is a drug (eg. Neurontin is probably used more off label by doctors than it is used on label) or device is NOT experimentation. Patient experimentation is regulated, not controlled by the government.
Ed

Re: Bill, take a deep breath and go read the Bill of Rights

Ed Davis, DPM on 10/30/02 at 21:52 (098744)

Bill:

Implying that the FDA is the sole authority and arbiter of patient benefit and safety is assigning duties to a government agency that no reasonable individual could imagine. Do you believe that any such agency can have such extraordinary powers and insights. Do you believe that similar agencies in Canada and Europe have no veracity or credibility?
Ed

Re: It shouldn't matter

john h on 10/31/02 at 09:28 (098792)

Brian buddy: Bill did not make direct threats but I think you could reasonablly imply their were veiled threats in that the implacation is if the Doctors advertise Son----- as a treatment for PF the FDA will come down on them with a hammer and patients might sue them for all they are worth. The end result of this will be that some of our Doctors may just leave the board and offer no advice at all. They are probably at risk every time they give us information on anything. Bill's post may have the chilling effect of all of us receiving less information than we now have. Without this board I would know nothing of ESWT, the dangers of PF surgery, and all the various things we can do to treat PF. Semantically speaking you may be correct but you like I are result oriented and the results of Bill's post could possible scare some people from ever considering ESWT either approved or not approved. Those people who are informed and think low energy treatment may be the treatment of choice will just move on to Canada or elsewhere. Bill would not identify himself so I can only assume (as Carole properly pointed out) that he is probably not from the FDA but in my estimation a representative of a manufacturer of another ESWT machine. I would guess tha Siemens will proceed to have this machine approved for PF at some point and all this will be moot. Does anyone among us believe that ESWT for PF with any machine poses the dangers of the 'approved' fascia release some of which are complete release of the fascia. Do we know anyone in a wheelchair as a result of ESWT? There are sure some who have shown up on this board that are as a result of surgery. Government agencies such as the FDA are necessary but never think they are perfect and are the final answer. We continually see FDA approved devices and drugs pulled off the market ater they failed in the general population..No one cares more about your health than you do. You can bet that people on this board care more about your health than Bill or the FDA Brian. I know I do. Bill may have presented a great legal argument and be 100% correct but none of us are beter for it. Hey Brian how are you doing? Has Bill asked you that lately?. .

Re: Is this an advertisement or a statement of fact?

john h on 10/31/02 at 09:49 (098794)

Ed: That is very much what Dr. Gordon in Canada told me. He also stated at the time he was doing a study on high energy vs low energy but not a study on feet that had previous surgery.

Re: It shouldn't matter

Dr. Zuckerman on 10/31/02 at 12:01 (098811)

Ok Here is my take from someone who has been down this road already. This is all about money. Due to Healtronics applying for a class three device for the ossatron we all are going to pay whether it be in machine price or patient treatment costs.

When I used the Orbasone years ago. Healthronics led the way to have this pain managment device removed from the market. All ESWT machines for plantar fasciitis are going to have to apply for class three use.

So what does this means. Prices will increase and so will costs. I am not making judgements but this is what will and has happened. This is part of the reason why ESWT costs are reduced in Canada and increased in USA.

There is no way that this will changes. Bill makes alot of points that is the policy of the FDA. So my guess is he is some FDA consultant to one of the big ESWT companies already selling units in the USA

So if I get this right Bill do I get a free ESWT machine or a discount . Just joking. But I will tell you the FDA will send letters to you telling any podiatrist to stop using the soncur or face the electric chair

IF I wanted to use the soncur what I would do is buy the machine with a physician who treats elbows and then use the machine off-label. Just my thoughts

Re: Trials should be done on surgical patients

BrianG on 10/31/02 at 16:44 (098831)

John,

Since there are so many of us that have been cut, it would seem only right that the FDA visit this. They should have at least one of the ESWT makers perform trials on patients who have had surgery. I know the Dornier trials did not allow anyone who had surgery to participate. This seems to be a pretty big oversight, don't you think?

Does anyone know if these type of trials have happened in Europe? I wonder where we could go to see if 'anyone' has performed this type of trial? Any ideas?

Regards
BrianG

Re: Trials should be done on surgical patients

Ed DAvis, DPM on 10/31/02 at 20:01 (098845)

Brian:

I am not sure that the FDA would need to approve a trial for such a specific purpose. It is an excellent idea for a research paper -- of course, someone needs to take the lead.
Ed

Re: Sonocur IS an FDA approved device

Ed DAvis, DPM on 10/31/02 at 20:22 (098846)

Bill sounds like he may be working for a competitor, perhaps with a legal background. I really think he may be hurting his cause more than helping it by taking such an aggressive legalistic view. A lot of law is open for interpretation and there are a number of things Bill has stated that are
not completely accurate or may represent very narrow legal interpretations.

First of all, he does not have a good understanding of the rights to physicians to use off label devices and drugs. I like to use the Neurontin example because a lot of posters here know of the drug. Neurontin is an FDA aproved drug. Approval means not just that it is efficacious for its primary indication but that the drug is relatively safe. There are probably more off label uses of Neurontin by doctors than on label uses. That said, the drug company that manufactures Neurontin can only detail (market) the on label uses to doctors of the drug.

The Siemans Sonocor is an FDA approved device-- period! Approval means not just that the machine is efficacious for its primary indication but that it is relatively safe. Currently it only has approval for usage in one indication, lateral epicondylitis (tennis elbow). It does not have official approval for medial epicondylitis (golf elbow) so that would be an 'off label' use just as is its use for PF. That said, the company that manufactures the Sonocur can only market it for use on lateral epicondylitis in the United States. Any qualified doctor, including podiatric physicians can obtain a machine. The Sonorex people cannot advertise use of the Sonocur for PF in a podiatry trade journal. The APMA National Convention was here in Seattle this year, only a couple hours from Dave Lowy's home base of Vancouver, BC. I asked him to represent his company at that convention and he had to turn me down.

The other error Bill made was his ridiculous claim that off label uses of devices/medication is the same as experimenting on patients. I assumed, after that injudicious statement, that he probably is not an attorney.
Ed

Re: Sonocur approved by FDA for PF treatment?

Bill on 10/31/02 at 20:47 (098851)

Ed,

You just marketed your service. I suggest that you contact the
FDA enforcement division and ask what they think. You might
be surprised.

Re: Sonocur approved by FDA for PF treatment?

Bill on 10/31/02 at 20:49 (098852)

Ed,

You just advertised your service again. You might want to
call the FDA enforcement division and see if you have the
right to use the Sonorex. You might be surprised at what
you discover.

The FDA is there to protect the public. Just because you
don't like the laws, does not give you the right to violate
them.

You talk about higher levels but are using the Sonorex
because it is cheaper than the Dornier? Maybe the Sonorex
is cheaper because it is not FDA approved for PF.

Re: Sonocur IS an FDA approved device

Bill on 10/31/02 at 21:02 (098855)

Ed,

The Sonocour is not FDA approved for the treatment of PF! I don't work for the competitor. I am concerned by your disregard for FDA regulations and I am surprised by your responses. I am also quite sure that Dave Lowy and his lawyers talked to you about off-label uses before you signed your lease agreement.

If you really feel so strongly, then good luck. However, you might want to ask your liability insurance company their opinion of your off-label use of the Sonocur. They might surprise you.

In fact, you know, as do other people who read this board, that the Sonocur is not FDA approved to treat PF. You know that you cannot advertise the treatment of PF using the Sonocur. You know that there are FDA regulations that we all live by.

The FDA does not want to prevent effective treatment from making it to market. They just want to make sure that you are not selling snake oil. Without a carefully designed study, how do you know that the low power treatments of the Sonocur work? Are you all knowing?

Re: Bill

Julie on 11/01/02 at 02:23 (098865)

I must ask again. Who are you, and whom do you represent?

Re: Trials should be done on surgical patients

elliott on 11/01/02 at 07:52 (098881)

BrianG, I don't fault them for excluding failed surgical patients in the initial study, as it introduces yet another--certainly large--dimension of variability. Also, if the studies are so successful without them, this would in future establish the wisdom that ESWT always be tried first, so the surgery-first group would be a closed 'dying' group.

As Dr. Ed said, there can always be a (possibly not FDA-approved) study on just failed surgical cases. No doubt some company's machine will find success rates comparable to the 90% published for PF releases. :-)

[]

Re: Trials should be done on surgical patients

john h on 11/01/02 at 09:50 (098891)

Brian: I very much agree with you that there has been no studies on ESWT for people who have had previous surgery, In fact, I think these people have been eliminated from the studies?? Dr. Gordon who I spoke with in Canada has done many procedures with ESWT. He did Scott' and others in the Ossatron Gang. He told me that he would recommed the Ossatron on a foot that had previous surgery because of it's power and the fact that you had scar tissue. Dr. Gordon also uses low power equipment and chares the same thing so he should be non-biased in this situation. Some of the general data I have read is tht the success rate with ESWT among those who had previous surgery was less than those who had not had surgery. Do a search on this board under 'Mohez'. His last post some many months ago he talked about having treatments with three different machines and as best I could determine had 11 treatments. I think he thouhgt the Ossatron put him over the top but with so many treatments and different machines who really knows. Anyway he seems to be doing everything he wants to after many years of PF. As Rob posted I think in the near future we will have multiple machines approved by the FDA for use with PF. I think that is when we will start to see a drop in price. I think even now some of the machines cost significantly less than the others which makes treatment with them much less than the more expensive equipment. Ultimately the market place will drive the cost down and when we look back at some of those who paid $5000 for an Ossatron treatment in the begining we will be amazed..

Re: It shouldn't matter

Bill on 11/01/02 at 09:57 (098892)

What value is advice to use a device that is not approved to treat PF?

Thought you might be interested in what the FDA says is a Class 3
device.

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance.

PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. The PMA owner, however, can authorize use of its data by another.

The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. The applicant is often the inventor/developer and ultimately the manufacturer.

FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide FDA with the committee's recommendation on whether FDA should approve the submission. After FDA notifies the applicant that the PMA has been approved or denied, a notice is published on the Internet (1) announcing the data on which the decision is based, and (2) providing interested persons an opportunity to petition FDA within 30 days for reconsideration of the decision.

The regulation governing premarket approval is located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval. A class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act and cannot be marketed.

Re: Sonocur IS an FDA approved device

john h on 11/01/02 at 10:21 (098895)

For a moment Bill forget the legal problems you bring up and think like a patient. I have had PF for eight years. It has effected my life in ways only another PF patient can begin to understand. I am intelligent enough to know that the Sonocur has been used to treat PF in many countries for many years. I have read data of the effectiveness of this equipment and also data concerning the chances of it injuring me. My only options are ESWT or a very risky surgery as I have tried all other known treatments. I know all these machines approved and not approved operate on the very same principal. The differences are for the most part like the difference between a Chevy and a Ford. One may have a bigger engine. As a matter of fact the Sonocur has the smaller engine compared to the Epos so it is very likely the Sonocur is less likely to injure me. This equipment may be a Class III device but the associated risk is not like a new heart valve or pace maker. In the real world of pain and suffering the FDA needs to get it's act together and start moving on this equipment. This is a case where I would argue with them or testify before them or any congressional panel about the complete absurdity of the problems you identify. There is equipment out there that has been proven over and over again to help wtih PF. Germany,England,Australia, and other countries are not 3rd world nations and why do we not look at some of their data and test rather than pretend we are the first ones who have ever tested this equipment. I am still wondering why our FDA came up with a protocol of one Epos treatment for PF when other countries have a protocol of three treatments for PF and have been using the same equipment for many years. Did they completely ignore the data in front of their eyes. I have personally had three treatments with the now discarded Orby. The treatments helped. I am not an engineer but can easily grasp how these machines work and how the feel on treatment and after treatment. ESWT for the foot is not brain surgery and it should not take millions of dollars and years to get such treatment approved for PF. It cost patients to much money and delays treatment for thousands who suffer. As you may know their are estimates of around 6 million new cases of PF each year in this country.

Re: Trials should be done on surgical patients

john h on 11/01/02 at 10:30 (098897)

Elliott I agree with you that the initial trials should not be on a foot with previous surgery. But a trial someday along the way could make sense because so many of the failed surgeries are the people in the worst pain. Since I have bi-laterial PF I would be a good case to look at. In considering Bayshore and talking to Dr. Gordon I could have the Ossatron on the surgically treated foot and their other machine on the other foot.Most people who have had surgery have had one of several types of relases but as you know I had a Baxter Procedure which is not a true fascia release and probably do not have as much scar tissue.

Re: Bill, you obviously have a hidden agenda and you are not listening to what I am saying -- what gives?

Ed Davis, DPM on 11/01/02 at 10:30 (098898)

Bill or whatever your real name is:

Read the various posts about 'off label' uses of drugs and equipment then respond again.

Snake oil? So you really think all of the studies on low energy ESWT done in Europe are not valid. Is European plantar fascia that different than American plantar fascia? Most countries have an equivalent of the FDA including Germany, Great Britain and Canada -- all of whom have approved the Sonocur for use on plantar fasciitis. Do you think our FDA is so far superior to those agencies that their approval has no validity? It sounds like you are the one who is 'all knowing' -- the problem is what you think you know and your obvious lack of respect for information that does not coincide with your narrow opinions.

Devices are approved for use but only get approval for specific indications if a formal application has been made. The fact that that process is not complete hardly invalidates the benefit of a significant modality and certainly does not make something 'snake oil.'
Ed

Re: It shouldn't matter

Ed Davis, DPM on 11/01/02 at 10:33 (098899)

There is a big difference between a device that 'fails' to meet PMA and one that has not gone through the formal process.
Ed

Re: Sonocur IS an FDA approved device

Bill on 11/01/02 at 10:44 (098906)

Its interesting you mention Germany. The German government discontinued the use of ESWT until they received results from FDA studies proving effectiveness. They suspended all treatments because of over use and abuse.

There is a high placebo effect with ESWT treatments. The Ossatron and EPOS studies show that they are safe and effective. These studies show that some patients treated with these machines experience relief. Why would you pay good money for a treatment on a machine that has not been shown to be effective?

If you are concerned about cost, doesn't it bother you that podiatrists who use the Soncur are charging too much. After all, they get unrestricted use of the machine for $1,500 per month. How do they justify their high price? One patient a month makes the payment and the rest is profit. Doesn't that bother you? It sure bothers me.

I think it is in everybody's interest to have these treatments performed as indicated, on approved machines, and not be overused. The risk is that the procedure becomes discredited and then stops being available.

In terms of how these machines work, I don't think it is obvious which therapy is the best. We see FDA studies showing success with high energy or high intensity treatments using the Ossatron and Epos. We see a JAMA article suggesting that low intensity does not work. If you look at the European studies you will find that most of them are not peer reviewed.

Don't you think it is interesting that the Sonocur is approved for tennis elbow and the Ossatron is not? You have to believe that Healthtronics submitted their study at the same time as Seimans. Maybe the FDA scientists are concerned about high power hitting the structures of the elbow? I really don't know. If it was easy and obvious then the FDA scientists would not waste their time. You have to believe that these people take pride in their work like the rest of us.

Re: Sonocur IS an FDA approved device

elliott on 11/01/02 at 11:16 (098907)

john h, I wish you, and others for that matter, would direct to Dr. Z the same question you just asked:

'I am still wondering why our FDA came up with a protocol of one Epos treatment for PF when other countries have a protocol of three treatments for PF and have been using the same equipment for many years. Did they completely ignore the data in front of their eyes.'

I have asked Dr. Z this same question, but he apparently doesn't know. I'm not trying to create a ruckus here, I wish the mainstream PC crowd would also ask such questions, but they just never do, and so the few who do bother to ask come out shouldering the burden of looking negative.

It is a fair question, given the European history, to ask why the FDA chose to give its blessing to one high-level treatment. Not sure why you brought it up in the context of Bill; it's more relevant to Dr. Z since he constantly lauds its virtues here, is unquestioning of the study, and has an interest. Rather than respond with 'you go fetch and find out if you want to', unlike us it is he who is in the best position to find out if he really wants to (e.g. by asking Dornier), and pass that on to us. I'm willing to be persuaded the more persuasive the evidence. So Dr. Z, I wish you'd be a bit more proactive (yuck--hate that word) in this regard and help make your case.

[]

Re: It shouldn't matter

Bill on 11/01/02 at 11:27 (098909)

Are you serious? Are you suggesting that any device that does not go through the formal process but has been used in other countries should be used in the US? Imagine, for a moment, the consequences of this logic. I distribute my machine in another country. I pay podiatrists to use it and write articles saying that it works. I get the articles published in conferences and other venues that do not require peer review. I bring my machine to this country and start marketing it. I am ok as long as I do not test it because it hasn't failed to meet a PMA.

I think that everybody needs to take a breath. Nobody is saying that ESWT should not be performed. I think that current prices are too high and I think that they will come down when there is legitimate compeition. We need to encourage competition by getting insurance companies to pay for the procedure. It doesn't make sense to use machines that have not been shown effective because they may result in treatment failures and high treatment failures will discredit the procedure. Once the procedure has been discredited then insurance companies might stop covering the procedure for all equipment.

Dr. Davis, I know that you have a financial interest and I also believe that you have good intentions, but you really don't have any peer reviewed studies that show the Sonocur works and you could get the same results with the EPOS on its low setting. You could afford to charge the same price to your patients if you used the EPOS but you decided to use the Sonocur because it was cheaper. My point is, your financial interests, and not your clinical interests, helped make your decision.

Re: Bill, you obviously have a hidden agenda and you are not listening to what I am saying -- what gives?

Bill on 11/01/02 at 11:40 (098910)

Sorry for the snake-oil comment. I see it got you upset.

Really, the argument is simple. It is not FDA approved. Until it is FDA approved, it cannot be marketed for the treatment of PF. The reason it cannot be marketed is that it has not been shown to be safe and effective.

There are two FDA approved machines that have been proven safe and effective and they can be used to treat your patients. If you chose to treat with a device that is not FDA approved to treat PF then you are chosing to use that machine off-label. Your choice to use the machine off- label seems to be financial and not clinical. Since you can get the same clinical results with the EPOS.

Again, you can offer economical treatment of PF with ESWT by using an approved machine. You might not make as much money, but you can use an approved device and still make a living.

As for the studies, are you chosing the ones that you believe or the ones that are conducted according to rigorous scientific method. The FDA studies are the most respected. Peer reviewed articles are also respected. Look at the Weil article. It was peer reviewed. Look at the Rompe study. It was peer reviewed. Many of the other articles are not.

Re: The agenda is not hidden

Bill on 11/01/02 at 11:53 (098912)

In terms of a hidden agenda. I don't think its hidden.

My agenda is to explain that the Sonocur is not FDA approved to treat PF. It has not been shown to be safe and effective. I want to make it clear that it is illegal to advertise or market the Sonocur for a non FDA approved use.

I object to the flexibility with the law that you and other seem to have and I believe this flexibility is motivated by your financial interests as much as true clinical outcomes.

Finally, I do not understand why you feel the need to risk your license using the Sonocur. Will you make that much more money? Talk to a healthcare lawyer and get their take on it. Or better yet, talk to Neil Ogden at the FDA. He reviewed the clinical studies presented by Siemans in support of their PMA application for the Sonocur. He can tell you more. Do your homework.

Do you have any studies that show that the Sonocur does a better job treating PF than the Ossatron or the EPOS? I don't think that any such studies exist.

Re: European studies

Ed Davis, DPM on 11/01/02 at 13:14 (098918)

Bill:

You are implying that the numerous European studies are not peer reviewed and are somehow inferior. Beleive that if you will if you insist on only looking at those that support your point of view. I am not picking and choosing but looking at the aggreagate of studies and evidence. Please do not accuse me of doing what you are doing.

I use both the Ossatron and the Sonocur. I make more money when I use the Ossatron because I do not make lease payments on that machine. Your statement that I use Sonocur for my financial advantage is wrong and is a rotten accusation that only a coward who will not identify him or herself would make.

The current dilemna facing patients is the poor availability of this modality -- either due to geographic or financial reasons. I have provided some patients with Sonocur treatment at my cost price because that is all they can afford. I am a doctor -- I treat some people for free, some for reduced cost.... Something that people of your ilk just will never understand.
Ed

Re: Bill

elliott on 11/01/02 at 13:36 (098920)

Bill, I don't doubt, as you say, that many of the ESWT studies on PF were not done as carefully as they could have been. You then mention Rompe as one of those respected and whose studies are considered to have been done carefully. You also say that high-energy ESWT has more credibility than low-energy since an FDA study gave its approval. But Rompe did a *low-energy* study finding ESWT success. How do you explain that?

I'll add that Dr. Ed does have a point about Neurontin. The FDA never approved its use for pain associated with peripheral neuropathy, yet many are using it for this, with strong anecdotal evidence that it works for some.

[]

Re: The agenda is not hidden-- I think it is!

Ed Davis, DPM on 11/01/02 at 13:48 (098921)

Bill:
You keep repeating that Sonocur has not been FDA approved for the PF indication over and over again. I have acknowledged this fact over and over again. I will not let you distort the meaning of FDA approval with claims of snake oil, human experimentation, financial gain, etc. which you insist on doing.

You keep repeating that one cannot market the Sonocur for PF treatment and I keep acknowledging this fact.

I will acknowledge the above every time you insist on repeating them. Perhaps you should try hitting 'send' multiple times if you think that repetition somehow will make your position more credible.

The bottom line is that it is my duty to give patients the best treatment available, placing financial gain second. You are basically maligning my reputation and motives here as my identity is known and yours is not.
Ed

Re: The agenda is not hidden-- I think it is!

Bill on 11/01/02 at 13:59 (098922)

I'm not maligning your reputation. What is the basis for your claim that you are giving your patients the best treatment available? What studies are you following? Is it that simple.

Alternatively, how many patients have you treated? Are you saying that the success with this machine is better than the currently approved machines? Are you really placing financial gain second?

If you can't give a basis for your claim then its brings into question you motives and since you have a financial gain. You have already have a conflict of interest. You make more money treating with the Sonocur.

Re: European studies

Bill on 11/01/02 at 14:09 (098923)

Ed:

It is hard to let this one go. You say that you are providing the Sonocur treatment at cost. Are you serious. It costs you $1,500 per month and around $150 per patient treatment. How many patients are you treating each month. If the number is less than four then I agree with your math. If you treat five or more then I don't agree.

Of course you make more money on the Ossatron. Healthtronics does global billing and pays you. They charge a very high price to insurance companies and then turn around and overpay the podiatrists for their services. The idea is that it will be more financially beneficial to treat on the Ossatron than other machines. In addition, many physicians are investors with Healthtronics and receive a dividend check that is many times their initial investment. Are you an investor too?

In terms of the studies, numerous poorly executed studies do not prove a result. I do not know if the European studies are poorly conducted because they have not been peer reviewed. The peer review process helps ensure the integrety of the system.

Are there numerous studies on the Sonocur or just numerous studies on ESWT? Numerous studies on ESWT do not imply that the Sonocur works?

Re: It shouldn't matter

Ed Davis, DPM on 11/01/02 at 14:20 (098926)

Sorry Bill but office based ESWT is cheaper than surgicenter or hosptital based ESWT. I can give patients Sonocur treatments for free if I want to but not true when an anesthesiologist, surgicenter and limited partnership needs to be paind as with high energy units.

One of the larget problems our citizens are facing and will have to face is medications and treatments being priced out of availablity. There is a reasonable balance that needs to exist between public safety and making treatment affordable. Canada is not without fault but has done a much better job than the US in this specific area. I deal with this problem every day in my practice. Some of my patients travel to Mexico to get meds because they cannot afford the prices.

I am not saying that ANY device that does not go through the formal FDA process is appropriate for use -- do not distort what I say but take my statments literally. Low energy ESWT has not only been extensively studied but has a number of years of successful and safe experience on use on real people to show it to be a safe and efficacious modality. Formal FDA approval is just a matter of time at this point.
Ed

Re: yes I am serious

Ed Davis, DPM on 11/01/02 at 14:30 (098927)

Bill:

I do what most doctors do -- you seem to have a lot of misconceptions.
We treat some patients at full price, some at discounts and some for free.
This is not unusual.

I am not an investor in Healthtronics. I recieve no dividend checks from Healthtronics. Healthtronics does NOT do global billing for my patients-- I bill insurance directly.

Why do you take such strong view if you admit to not knowing about the quality of the European studies? Why do you assume they are not peer reviewed? We are looking primarily at studies of low energy ESWT as opposed to those done using the Sonocur. There is overwhelming evidence that low energy ESWT works. One issue is... which works better low energy or high energy ESWT -- not enough info. on this one. You also cannot ignore the collective experiences of patients and practitioners using this modality throughout the last few years. Keep in mind that these are patients with intractable PF-- there is little room for a placebo effect.
Ed

Re: The agenda is not hidden-- I think it is!

Ed Davis, DPM on 11/01/02 at 14:39 (098928)

Bill:
I can make more money by treating all the patients who need treatment with the Ossatron.
No one can say, at this point, whether high or low energy is superior. I make no such claims but you want to make this a major issue here. My claim is simply that low and high energy ESWT work for intractable PF and that we do not know which works better.
Your statements are part of a permanent electronic record so I think any reasonable reader can see that your accusations of experimentation, seemingly improper financial gain are apparent. AGAIN, WHY WILL YOU NOT REVEAL WHO YOU ARE?
Ed

Re: OK Bill. Who are you, and who do you represent?

Julie on 11/01/02 at 15:11 (098930)

I'll try again.

Bill, it is time you told us who you are, who you represent, and what is your agenda (you obviously have one, and I think it IS hidden).

You have been asked many times, by several of us, to identify yourself and to tell us whom you represent. You have ignored all our requests. You continue to malign one of the most honourable people on this website, Dr Ed Davis. You have continued to impute dishonourable, mercenary motives to him. None of us who knows him believes your imputations to have any relevance to the doctor we know.

I strongly object to your attitude to him, and to us.

It is time for you to stand up and reveal yourself. Please do so now.

Re: LIES

Ed Davis, DPM on 11/01/02 at 15:13 (098931)

Physicians DO NOT get unrestricted use of Sonorex for $1500 per month.
There is NOT a high placebo effect with ESWT.
Where does 'Bill' get his information to back up the accusation that 'podiatrists who use the Sonocur are charging too much'?
'One patient per month makes the payment and the rest is profit'--Liar liar, pants on fire--- it takes more than that.
Ed

Re: yes I am serious

Bill on 11/01/02 at 15:16 (098932)

Ed,

I am glad to hear that you are not invested in the local venture offering the Ossatron and that you are billing separately for your services. I think that Healthtronics has done us all a dis-service as their greed has unnecessarily delayed acceptence of this procedure by insurance providers.

I agree that there are many good studies showing positive effects of low energy, e.g., Rompe et al. I'd like to see a careful study of low energy that is similar to the FDA studies. I don't think that all 'low energy' treatments are the same and that you can generalize between machines.

I have seen many European studies that are not worth the paper they are written on. The studies could just as easily been US studies but the treatment has not been in the US long enough. I was surprised to find so many articles published without peer review. I was even surprised to hear from this board that the JAMA article was not reviewed by podiatrists.
I would hate to have a poditrist rely on the JAMA sudy when evaluating ESWT because I have my doubts about the JAMA study.

I don't know about intractable PF. Did any of the patients in the FDA studies have intractable PF? Both FDA studies show a high placebo effect.

In terms of FDA only approving high energy, that is just a wrong idea. The manufacturer's decided to market the devices in the US using a high energy protocol. I don't know why they choose a high energy protocol but it was not an FDA decision it was a Dornier and Healthtronics decision.

Re: It shouldn't matter

Bill on 11/01/02 at 15:31 (098934)

Ed,

The Dornier EPOS is an office based ESWT and does not require an anesthesiologist or surgicenter. You could use this machine for free if you want without the extra costs that you attribute to the Ossatron.

I agree about physician owned limited partnerships. They distort the market and result in higher prices for everyone. I hope that they will be outlawed so that market forces will prevail.

I agree that new medicines are generally too expensive but the problem cannot be solved by us on this board. There are reasons for the prices and there are consequences to limiting the prices. I don't even want to start that discussion as it will take us very far afield.

For the life of me, I cannot understand why ESWT needs to be so expensive except that something is limiting competition. In the beginning, it was Healthtronics. Now I am worried about the casual use of the Sonocur. I worry about using this machine off-label. I worry that it may not be effective and that by the time my insurance company starts to think about covering the procedure that the failed Sonocur treatments will give them ammunition to reject covering ESWT.

You keep saying that low energy ESWT has been extensively studied for a number of years. Besides the Rompe studies, do you know of any other published studies that have been peer reviewed, that compare low energy treatments to sham treatments and demonstrate improvement?

I take your statements literally. Show me the money, or more appropriately, show me the peer reviewed studies, then I'll buy your arguments. Otherwise, you are quoting results from studies that may have flaws; flaws like the JAMA article.

Re: Charging too much.

Bill on 11/01/02 at 15:48 (098937)

Maybe you didn't get the discounted price. I understood the price to be $1500 per month plus $150 per treatment. Somewhere down the line you have to pay a maintenance fee. The lease is for five years and you never get to own the equipment. Is that about right?

The high placebo effect with ESWT is well documented. Look at the Healthronics studies. Look at the FDA studies. These studies show a small but measurable difference between the treated groups and the sham groups.

The JAMA article was even more direct. It cites the strong placebo effect in explaining its results. I don't believe the conclusions of the JAMA article but they certainly note the strong placebo effect.

Dr. Davis, look at the articles. There are many that talk about the high placebo effect.

In terms of charging too much, I would guess that you receive more dollars per hour performing ESWT than any other procedure you perform. I would guess that surgery requires more skill and pays less than ESWT. If my guess is true then I say that you are charging too much to ESWT. I object to paying a podiatrist over $150 per hour to perform ESWT. I strongly object to paying $1000 per hour.

Re: Permanent electronic record

Bill on 11/01/02 at 15:59 (098939)

Dr. Davis,

I am glad that you are not treating all of your patients with the Ossatron. I am not claiming that high energy is better. I am stating the fact that the Osstron and the EPOS are FDA approved for a high energy protocol and the Sonocur is not approved to treat PF. Do you have a medical preference for low energy treatments? What is the medical reason you prefer low energy?

Re: It shouldn't matter

Ed Davis, DPM on 11/01/02 at 16:11 (098942)

Bill:

Unfortunately, the Dornier unit is not available in my area and its costs are too high for most individual practitioners.

Limited partnerships are a way for physicians to get together and obtain equipment they could not afford as individual pracitices. There is good and bad in this concept -- something we may agree upon.

I am here on a voluntary unpaid basis so I do not have the time to look up all the references you need on low energy ESWT -- that is a project you will have to take on yourself.

Overutilization of ESWT is a minor concern compared to overutilization of surgical procedures for PF. Take some time to read the 'Surgery' board on this site.

I am astounded by your statement that 'I cannot understand why ESWT needs to be so expensive...' New drugs and devices face regulatory and legal hurdles that add billions to the cost of healthcare in the US. You seemed to support those hurdles in a big way based on most of your posts. Don't misconstrue this statement -- we all want government to provide us with reasonable protections. There needs to be a balance between public protection and costs of protection. It seems like Canada has struck a better balance in this area. Take some time to visit one of the Sonocur centers in Canada to see happy patients getting effective treatment at reasonable fees.
Ed

Re: It shouldn't matter

Ed Davis, DPM on 11/01/02 at 16:15 (098944)

PS David Lowy of the Vancouver, BC Sonocur center can send you a packet of research studies if you are really interested.
Ed

Re: Permanent electronic record

Ed Davis, DPM on 11/01/02 at 16:18 (098945)

Bill:

I really do not know if low energy or high energy ESWT is better and I do not have a preference from the standpoint of efficacy. It will take a few years before any of us know for sure. I do have a preference from the standpoint of patient cost, convenience and availability -- that is where the low energy units have the edge.
Ed

Re: yes I am serious

Ed Davis, DPM on 11/01/02 at 16:26 (098946)

Bill:
One of the big problems with the AMA study was that half of the patients had PF less than 6 months -- obviously not eligible for the study.

Keep in mind that the technology behind the Ossatron only allows for high energy usage so an application for low energy was not an option for them.
I think that it was the goal of Dornier to get a unit to market quickly so the fastest way was to ride in on the 'coattails' of Healthtronics with a similar protocol.

Bob pointed out a very important issue: it is not likely that FDA approvals will be based on a body region basis for much longer.

In theory, a machine such as the Dornier which has a fairly wide range of power output will be very practical when ESWT can be used for multiple body regions. It is hard to envision high power machines such as the Ossatron ever being appropriate for small tendons (lateral/medial epicondylitis) and the low power units will not be efficacious for treatment of non-unions.

Okay-- the tone of the discussion is getting better. How about telling us a little about your background if you do not want to tell us who you are?
Ed

Re: Sonocur IS an FDA approved device

Dr. Zuckerman on 11/01/02 at 16:27 (098947)

I don'tknow the answer but will give you my opinion. High energy is a one time treatment and maybe Dornier after market research determined that this is what the public wants and this is what the insurance companies will pay for in the long run. This just my opinion

Re: Charging too much.

Ed Davis, DPM on 11/01/02 at 16:39 (098949)

Bill:
It does not take a great deal of skill to apply ESWT. The price you are paying is more for the high aquisition costs of the units. One must sincerely compliment the Sonorex people for making their unit affordable to the average practitioner.

Okay, you modified your claim -- that is okay. It is not $1500 per month for unlimited use but $1500 plus $100 to $150 per application.
Now we can rationally discuss some arithmetic. Say, a doctor gives 10 treatments per month (I realize that is low but we have to start somewhere) then we have 1500 divided by 10 or $150 going toward the lease plus say an average of $125 going to Sonorex. So far we are up to $275 per treatment. Now, add in the rest of office overhead -- rent, salaries, insurance, staff, scheduling ... which adds about $175 per treatment to the cost for an average treatment cost of $450. Docs are charging from $490 to 600 per treatment (remember that it is 3 treatments per patient per foot). I think that is a reasonable profit margin. Higher volume cuts the lease cost so the margin goes up but not by a drastic amount.

The typical patient with intractable PF is frustrated, skeptical and generally not very susceptible to the placebo effect. I have seen patients come back a week after ESWT claiming benefit -- yes, that may be a placebo effect. If patients are seeing sa protracted benefit months later one would be hard pressed to assign a placebo effect to that and I would need to see how the study attempted to make that determination.
Ed

Re: Full Circle: Lower priced ESWT for PF by off-label use of the Sonocur!

Bill on 11/01/02 at 16:54 (098952)

Ed,

You understand about expensive ESWT and now we have come full circle.

Your solution to the price of ESWT is to use a machine that is not FDA approved for the treatment of PF. Your price is very reasonable and will hopefully start a trend. Your price could be charged by owners of the Ossatron and Epos. We already see a price of $1,800 using the Epos. They still make money at that price and could probably go lower.

Don't put the high price of ESWT procedures onto regulation. Regulation keeps us safe and guarantees that the claims made by others are true. The high price of ESWT is about market access and competition. As soon as competition takes hold, the price will drop.

I hope that you are right and the treatment works. Only time will tell.

Re: yes I am serious

Bill on 11/01/02 at 17:11 (098957)

I agree that the tone is getting better. I'd rather not discuss my background or my name since I think it is not important. My posts should stand or fall on their own merits and not on the merits of the author.

I also agree that it is unlikely that the Ossatron will get a blanket approval from the FDA. I think that Healthtronics would disagree with your statements and cite many European studies, and I am not putting your face in it. I truly believe that there are many European studies that show that the Ossatron works for all parts of the body. I just worry about that high energy hitting adjacent structures.

I am glad that the FDA is carefully reviewing each application to each region of the body and I look forward to the day when these machines can be evaluated without regard to treatment location. Until that day, I hope that the FDA continues to carefully review each application.

Re: Calling Dr. Z -- want to jump in?

Ed Davis, DPM on 11/01/02 at 20:21 (098970)

Bill:

Wait 6 to 12 months --- Siemans is a big company and will place a lot of machines. I certainly am not the pioneer in the use of the Sonocur for PF-- you will see lots of use.

I have to disagree with you about the cost of regulation in the US. I am in favor of reasonable levels of regulation and the best example of that is Canada. Drug and device costs in Canada are more reasonable yet their public, I feel, has a very good level of protection in this area. Regulatory agencies are often used as a political weapon to quash competition and provide advantages to certain companies and industries. Dr. Z is more familiar with some of the details of the politics surrounding ESWT since he went through the Orb-sone saga. One must question if ESWT devices should be considered class 3 devices and if that was not something done by the first company 'through the door' to slow the approval of competitive products. Obviously, the ill fated attempt by the Orb-sone people to speed approval of their device by obtaining a class 1 classification may have laid the groundwork for an 'over-reaction' by regulators at the FDA.
Ed

Re: But your background is important...

Julie on 11/02/02 at 01:15 (098984)

and it's ingenuous to say it isn't. If you have an interest, you should declare it. Your conversation is with Dr Ed Davis, I know, but this is a public message board and those who read what you say are entitled to know what your interest is so that your statements can be weighed accordingly.

Re: Calling Dr. Z -- want to jump in?

Drd. Z on 11/02/02 at 08:31 (098992)

Here is what I learned

The FDA can come directly to the doctor if the distribution company fails to remove any device that the FDA deems illegally placed in the USA market.
The FDA calls any device that is legally marketed experimental and dangerious regardless of what we know and thinks.

As John Warlick from Healthronics once told me don't worry by the time the FDA decides on a course of action your machine will need new parts. It took the FDA over two years to resolve the O situation.

The FDA can and will make mistake but it doesn't matter the can correct them and ask for the machine back regardless of the time and regardless of whether they made the mistake or not. They will even admit hey we made a mistake sorry

Re: OK Bill. Who are you, and who do you represent?

rob a on 11/02/02 at 09:31 (099006)

Can we end this now? I believe that we are beating a dead horse and Bill has no intentions of offering any info about himself or his motives other then what he has previously stated. Sorry if I sound arrogant but this thread has become too repetitive and clearly, Bill is not about to change his position.

Re: Sonocur approved by FDA for PF treatment?

Ed Davis, DPM on 11/02/02 at 10:59 (099030)

Bill:
This comes down to the difference between marketing and advertising. Virtually any conversation, message board, etc. can be construed as 'marketing.' Are you sure you were not a commissar in the old Soviet Union?
Ed

Re: Sonocur approved by FDA for PF treatment?

john h on 11/02/02 at 13:43 (099039)

Long live the borad, long live bill, and down with PF.

Re: regarding how Dornier decided to use high energy for the FDA study

elliott on 11/02/02 at 18:44 (099090)

Dr. Z, couldn't you just contact Dornier and, like, ask them? It's an important question. What the public wants isn't necessarily what works the best, even if by luck it may have turned out that way. I just can't believe they went through the process of a double-blind placebo-controlled, FDA-approved, etc., etc., study without something to back it up.

Re: regarding how Dornier decided to use high energy for the FDA study

Dr. Z on 11/03/02 at 16:21 (099183)

I could . You tell you specifically who I should asked this question to at dornier.

Re: yes I am serious

JudyS on 11/04/02 at 12:43 (099282)

Bill, given your obvious in-depth knowledge of ESWT machines and treatments, I'm surprised that we've not heard from you before. The subject (ESWT) is of great and ongoing importance to us here. Have you done all your research on your own as a result of Plantar Fasciitis? Or is your expertise based on your own work with ESWT?

Re: lowest ESWT prices in U.S. - St Louis

rob a on 10/25/02 at 09:20 (098324)

Just so we are clear. That cost is the total amount or just the doctor's fee? I just want to make sure that there are no facility, anesthesia or other surprise bills. Does he do it in his office or as an outpatient procedure? By the way, good to hear from you Scott.

Re: lowest ESWT prices in U.S. - St Louis

scott r on 10/25/02 at 10:22 (098337)

It's always good to see you around too Rob. It's the total amount. If someone finds out that it isn't then I need to know ASAP.

Re: lowest ESWT prices in U.S. - St Louis

scott r on 10/25/02 at 11:42 (098348)

hmmm, i guess that bug in the message board program isn't out yet for when people make a post within a second of each other, so my last post got deleted. Anyway, it's good to hear from you too Rob. Yes, it's the total cost.

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/25/02 at 22:27 (098359)

Scott:

I think it is important that you differentiate an advertisement from a statement of fact. I charge less than this doctor for ESWT at about $1470 per foot for 3 Sonocur treatments, with additional discounts available so one certainly cannot claim that the doctor in St. Louis has the 'lowest-priced ESWT in the US.'

Ed

Re: Is this an advertisement or a statement of fact?

scott r on 10/25/02 at 22:39 (098362)

Oh, sorry Dr Davis. Then I have to modify it to say 'lowest-priced FDA-approved ESWT machine for heel pain'

Scott

Re: Is this an advertisement or a statement of fact?

john h on 10/28/02 at 12:10 (098487)

Dr. Ed: I thought you were sending your patients to Canada for treatment. Have you acquired a Sonocur machine? What is the spacing between your treatments?

Re: and let's not forget...

elliott on 10/28/02 at 13:12 (098490)

what are your observed success rates, Dr. Ed? Since you've just started, we'll accept the 3-month benchmark. :-)

[]

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/28/02 at 14:59 (098501)

John:

I sent primarily patients without ESWT coverage to Canada. I have been using the Ossatron primarily for patients with insurance coverage although the treatment cost has come down substantially for those without coverage this summer.

The Sonocur was approved this July and I introduced a unit in my office about 3 weeks ago.

It is my intention to use both the Ossatron and the Sonocur.
Ed

Re: and let's not forget...

Ed Davis, DPM on 10/28/02 at 15:04 (098502)

Elliott:

I would like to get some decent numbers of treatments on the Sonocur before comparing it to the Ossatron. I have used the Ossatron for about a year.

One interesting observation: I am seeing two distinct groups of individuals for ESWT treatment (something I did not quite expect).
The first group are those individuals whom have not been helped by conservative treatment so ESWT is an alternative to surgery.
The second group of patients are individuals who have gotten much better with conservative treatment but not completely cured. This group gets through the day okay but has to rest upon getting home at night and would like to get up to full function.
Ed

Re: Sonocur approved by FDA for PF treatment?

BrianG on 10/28/02 at 21:55 (098522)

Hi Dr. Ed,

Are you using the Sonocur, in your office, to treat PF? I hadn't heard where it was approved for PF.

Regards
BrianG

Re: Is this an advertisement or a statement of fact?

john h on 10/29/02 at 09:13 (098543)

Dr. Ed: You have seen me post this before but Dr. Gordon in Canada who consults with Bayshore told me he uses the Ossatron on a foot that has had previous surgery and the Sonocur on other feet. Have you used the Ossatron on a foot that had previous surgery? We just got an Ossatron in Little Rock with a large orthopedic group. They could not even give me a price and had patients fill out forms which they forward on to Healthtronics to see if you qualify for treatment. This orthopedic group was far less knowledgable about ESWT for PF than me and could not answer the basic questions about number of pulses, the general protocol after treatment,etc. Is Healthtronics just determining whether the patient is able to qualify for insurance coverage or are they making the medical decision as to whether a patient qualifies for treatment? Do they set the price?

Re: Is this an advertisement or a statement of fact?

john h on 10/29/02 at 09:15 (098544)

Dr. Ed: Another question? How far apart do you space your Sonocur treatments assuming you are using a three treatment protocol?

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 11:50 (098558)

It is against the law to advertise the use of the Sonocur
for the treatment of plantar faciitis! The machine is not
FDA approved for that indication and no company or person
can advertise its use for that purpose. If you doubt it
contact the enforcement division of the FDA. They are
investigating anyone who advertises the use of the
Sonocur for the treatment of plantar faciitis.

Please follow the law.

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 11:52 (098559)

The Sonocur is not FDA approved for the treatment of
plantar faciitis! Do not advertise it or you will be the
subject of an FDA enforcement action!

Re: Sonocur approved by FDA for PF treatment?

Bill on 10/29/02 at 11:53 (098560)

It is not approved and it is illegal to advertise
its use.

Re: Is this an advertisement or a statement of fact?

David L on 10/29/02 at 12:26 (098561)

Bill,
You are correct that there are restrictions on the advertising of a device for off-label purposes; however, as for the use, please refer to the section of the Food & Drug Act below:

SEC. 906 PRACTICE OF MEDICINE. --

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: Is this an advertisement or a statement of fact?

Dr. Zuckerman on 10/29/02 at 12:28 (098562)

Can a podiatrist purchase a soncur machine for pain management?

Re: Is this an advertisement or a statement of fact?

john h on 10/29/02 at 13:48 (098570)

Bill you may be correct but it is sure not illegal in Canada or Europe and been used for that purpose for many years. If you have ever had a severe case of PF with the accompanying pain you may take a differnt view on this subject..

Re: Is this an advertisement or a statement of fact?

elliott on 10/29/02 at 13:57 (098572)

Bill, just wondering if Dr. Ed's post is called advertising. What exactly are the guidelines? In neither post did Dr. Ed leave an address or phone, nor did he mention PF (whew, lucky there! :-)). He only said he's charging $1470 per foot. No doubt he meant rental rates for the floor space. :-) Is just saying very generally that one is gonna use a Sonocur, but not for what, as he did in his second post which got a warning, considered a violation? Also, what's your angle in this? Are you a watchdog for the FDA? Thanks.

Re: Is this an advertisement or a statement of fact?

Dr. Zuckerman on 10/29/02 at 15:16 (098584)

I can say the word Orbasone now. Boy did that feel good. Long live the Orbasone !!

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 18:03 (098603)

No because it is only FDA approved to treat tennis
elbow and podiatrists are not licensed to treat tennis
elbow. A doctor who is licensed to treat tennis elbow
can use it off-label to treat his patients within his
rights as a doctor but he cannot market it for off-label uses.
There is no questions that marketing for off-label use
is against the law and is the responsibility of enforcement
division of the FDA.

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 18:15 (098604)

Marketing means that you cannot make it generally known that
you use the Sonocur to treat plantar faciitis. You cannot advertise
in the newspaper in a manner designed to get patients asking
for the non-invasive treatment and then offer the Sonocur.

I know that you think that the above rule gives physicians the
right to use the Sonocur to treat plantar faciitis but it is
not that simple and I believe that many physicians and podiatrists
are breaking the law.

Just imagine, a class 3 medical device is the most dangerous device
approved by the FDA. The Sonocur is a class 3 medical device. It
required a clinical study in order to market the device for tennis
elbow. The clinical stuy was designed to test the safety and then
the effectiveness of the treatment. It took a significant amount
of time and was reviewed by many scientists. After many years they
got approval to treat tennis elbow.

The Sonocur is not approved for plantar faciitis. It has not been
shown to be safe or effective and it is not proper or ethical to
use the Sonocur to treat plantar faciitis without FDA approval when
FDA approved devices exist.

What do you think would be the result of a liability lawsuit if a
patient was injured by the device? What would be the podiatrist's
defense? (I used the Sonocur because I could make more money and
I know that they use it in Canada. I don't think that defense would
work in a jury trial)

The FDA has rules to protect the public. If a podiatrist or orthopedic
surgeon hurts a patient using the Sonocur to treat plantar faciitis
before it is approved then God help him. He will not survive the lawsuit.
He will not be able to get liability insurance because not insurance
company would trust him. I don't think that it is worth the risk and
I can't imagine a professional taking such a risk.

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 18:17 (098605)

Correct. The FDA only controls the safety of medical devices
in the US.

I would not take a different view. I would asked to be treated
on a machine that was FDA approved. I would not risk the possibility of
a sham treatment, or worse, being injured by a machine that
has not passed FDA regulations.

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 18:20 (098606)

You can say what you want. You cannot market an
off label use. You cannot solicit patients for
off-label uses unless it is part of a IRB approved
study which is conducted according to FDA guidelines.

Using the Sonocur to treat plantar faciitis in the US
is experimenting on patients and all patient experimentation
is strictly controlled by the government.

Re: Is this an advertisement or a statement of fact?

Bill on 10/29/02 at 18:33 (098607)

I think that it is advertising. He indicated that he uses the
machine to treat plantar faciitis and that his charge is XXXX
It is reasonable to assume that he will be contacted by prospective
patients wanting to save money and that they will ask about
the Sonocur. This forum is both a way to exchange ideas and a
way to locate podiatrists so messages are a type of advertising.

I think he should be careful. I think that he is taking on a
significant liability risk using the machine and he will have no
defense if one of his patients gets injured by the treatment.

I can say with some certainty that he will not be able to rely
on the consent form signed by the patient because he cannot truly
say that the patient knew the risks. The best protection would be
to initiate a study and get approval of a hospital IRB. The IRB
will review the documents and make sure that he is following FDA
protocol.

Re: Is this an advertisement or a statement of fact?

elliott on 10/29/02 at 21:14 (098618)

Bill, please answer my other question: Are you some sort of watchdog for the FDA or other gov't agency or working on their behalf?

Re: Is this an advertisement or a statement of fact?

john h on 10/29/02 at 21:54 (098627)

You got all the keywords in your post Bill: Sue,liability lawsuit,defense, FDA approval, breaking the law, after many years they got approval to treat tennis elbow, survive,etc.

This is the same FDA I assume that approves a full release of the fascia for treatment of plantar fasciaitis. The FDA is a necessary but certainly not a flawless agency.

Re: Is this an advertisement or a statement of fact?

elliott on 10/29/02 at 22:02 (098628)

A Boy Named Sue. :-)

[]

Re: Is this an advertisement or a statement of fact?

john h on 10/29/02 at 22:03 (098629)

Elliott: I am with you in that I would like to know from what platform Bill is speaking and who he represents. If he represents the FDA and is being paid with tax payer funds I would like to know so I can express my feelings to my Senate and House Represenatives about his scare tactics on this board. We have people here who are suffering daily, have lost their jobs and some in wheel chairs. They are looking for help amd Bill's post provides nothing but fear. If he is just another poster then have at it.

Re: OK Bill. Who are you, and who do you represent?

Julie on 10/30/02 at 02:15 (098643)

No message.

Re: Is this an advertisement or a statement of fact?

nancy s. on 10/30/02 at 06:10 (098647)

i'm with you on this, john, all the way. you are right about the fda: the need for it, but also its many serious flaws. and i have the same question as you and elliott do: who is this fearmonger? bill, be honest and tell people who you are. you can't have a hope of being taken seriously unless you do. your threats could affect not people looking for some fun party to go to but people who are seriously suffering, whose lives have come to a screeching halt, and who need all the helpful options that people, most of all professionals, can offer them.
nancy
.

Re: It shouldn't matter

BrianG on 10/30/02 at 10:59 (098666)

who Bill is. The fact that he is possibly saving Dr. Ed from a whole passle of legal trouble from the FDA should have people thanking him. Just because someone comes to the board, with new information, should not mean that certain long time readers gang up on him. I look at him as someone who has done his home work, knows the laws, and is having his say. Do you really want to drive people like Bill away ????

Regards
BrianG

Re: It shouldn't matter

nancy s. on 10/30/02 at 11:40 (098669)

nope, brian, not at all -- just want to know who he is and what's his interest. that's the usual courtesy around here, and not too much to ask, in my opinion.

Re: It shouldn't matter

john h on 10/30/02 at 11:48 (098672)

Bill wrote very much in the manner of a Lawyer which he well may be. He could represent the FDA or he could represent an ESWT competitor of Sonocur with an obvious goal in mind. If he is with the FDA then he should have no problem identifying himself as such. Dr. Ed has always been very good with providing helpful information and has been one in particular who I would say does not advertise or seek patients to come to his facility. All I know is he is somewhere in the Northwest. Scott your post is well taken because as a small entrapeneur you cannot deal with federal agenices with unlimited amounts of money and lawyers. You have also been careful to keep us all informed of what is appropriate and not appropriate. . This board provides an informative and most helpful servie to all who suffer from PF. Probably more so than any other source in the land. When I see threats such as Bill post (be he right or wrong) my hair stands on end. If he represents our government and is paid by our tax money I want to know what agency he represents so I can make my feelings as a patient be known to the agecny and my elected representatives. If he represents a competitor of one or more of the ESWT manufacturers then shame on you Bill. People on this board know who I am, where I am, what I do and a lot of my personal history. I am not always right but I always have compassion for my fellow PF sufferers. I respect Bill's right to post and if he intended to scare some Doctors who have helped us all then he probably succeeded.but you really did not help us with PF Bill which has been the purpose of the board from the begining.

Re: It shouldn't matter

Carole C in NOLA on 10/30/02 at 12:16 (098677)

A federal employee working for an agency such as the FDA cannot speak for that agency unless he is authorized to do so, in this forum, and has it approved and so on. At least, that is the case in my agency (a different one).

We are specifically cautioned to be careful about message board participation. You may have noticed that as proud as I am of my agency and the work we do, I don't talk about or give specifics about my agency here, and I try not to say anything that would be an attempt to represent my agency or that would reflect poorly on my agency.

Carole C

Re: It shouldn't matter

BrianG on 10/30/02 at 18:20 (098700)

Hi John,

I really hate to argue with you, but can you tell me where Bill made any threats? I realize he may sound like a lawyer, or other professional in the field, but I really think that if he was out to hurt Dr. Ed, or anyone else, he would have already done it. Instead he came to the forum with some facts. I see no reason to think he is anyone other than an educated consumer.

Regards
BrianG

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/30/02 at 20:58 (098728)

John:

The theory is that a foot that has had prior surgery has a lot of scar tissue so high energy would have an advantage in that scenario. It sounds logical although I do not believe we have studies to back that up.
Ed

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/30/02 at 21:00 (098730)

John:

We use the protocol that has been used by the Sonocur treatment centers in Canada -- 3 low energy treatments spaced one week apart.
Ed

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/30/02 at 21:02 (098731)

Bill:

The FDA does not have to approve all medical treatment in the US. It is perfectly legal and ethical to use devices and drugs 'off label.'
Ed

Re: Sonocur approved by FDA for PF treatment?

Ed Davis, DPM on 10/30/02 at 21:11 (098734)

Wow, Bill, lighten up! Nobody is marketing the Sonocur for plantar fasciitis in the United States. A number of us use more than one machine -- I use the Ossatron and the Sonorex. We let the public know that we offer ESWT and they have the choice of protocols with the Ossatron which is 'on' label and Sonorex which is 'off' label.
Ed

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/30/02 at 21:19 (098738)

Bill:

I let the public know that I treat the diabetic foot. A diabetic who suffers from painful diabetic neuropathy often obtains the best relief from a number of non-FDA approved compounded medications that I may subscribe. Using your logic, I cannot legally advertise myself as a doctor who treats diabetic foot problems because I may prescribe an off label medication.
Ed

Re: Is this an advertisement or a statement of fact?

Ed Davis, DPM on 10/30/02 at 21:25 (098739)

John:

I would love to know more about Bill's background. He comes across as an attorney taking a very narrow legal interpretation of agency law.

My first duty as a physician is to heal. It is part of the Hippocratic Oath as well as a moral and ethical duty. The FDA was designed to protect and enhance the health of the public so I have difficulty with any interpretation that does not support that mission.

Ed

Re: Excellent question, Julie!

Ed Davis, DPM on 10/30/02 at 21:27 (098740)

Excellent question, Julie!
Ed

Re: marketing vs. advertising

Ed Davis, DPM on 10/30/02 at 21:37 (098742)

Brian:

Considering Bill's ardent position, I think we really need to know where he is coming from and whom he represents.

The legal 'advice' is appreciated and I have refrained and intend to refrain from 'formally' marketing the Sonocur. How one defines marketing can be problematic though. I am a part time teacher and I just completed a lecture on heel pain to family practice residents in Tacoma. It certainly was an ethical obligation on my part to inform them of all the modalities to treat heel pain. They will be the referring family doctors of the near future and I emphasized that plantar fascial release surgery should rarely be performed due to the availability of ESWT. I discussed how ESWT works, the different machines and protocols. Yes, this, in a way, could be construed as a means of marketing as some of those residents who will remain to practice in this community may refer heel pain patients to me.

Perhaps we should state that such devices not be advertised as opposed to not 'marketed.'
Ed

Re: Sorry Bill but "off label" use of any modality is NOT the same as experimenting--Bill you are stepping way over the line!

Ed Davis, DPM on 10/30/02 at 21:46 (098743)

Off label use of any modality whether it is a drug (eg. Neurontin is probably used more off label by doctors than it is used on label) or device is NOT experimentation. Patient experimentation is regulated, not controlled by the government.
Ed

Re: Bill, take a deep breath and go read the Bill of Rights

Ed Davis, DPM on 10/30/02 at 21:52 (098744)

Bill:

Implying that the FDA is the sole authority and arbiter of patient benefit and safety is assigning duties to a government agency that no reasonable individual could imagine. Do you believe that any such agency can have such extraordinary powers and insights. Do you believe that similar agencies in Canada and Europe have no veracity or credibility?
Ed

Re: It shouldn't matter

john h on 10/31/02 at 09:28 (098792)

Brian buddy: Bill did not make direct threats but I think you could reasonablly imply their were veiled threats in that the implacation is if the Doctors advertise Son----- as a treatment for PF the FDA will come down on them with a hammer and patients might sue them for all they are worth. The end result of this will be that some of our Doctors may just leave the board and offer no advice at all. They are probably at risk every time they give us information on anything. Bill's post may have the chilling effect of all of us receiving less information than we now have. Without this board I would know nothing of ESWT, the dangers of PF surgery, and all the various things we can do to treat PF. Semantically speaking you may be correct but you like I are result oriented and the results of Bill's post could possible scare some people from ever considering ESWT either approved or not approved. Those people who are informed and think low energy treatment may be the treatment of choice will just move on to Canada or elsewhere. Bill would not identify himself so I can only assume (as Carole properly pointed out) that he is probably not from the FDA but in my estimation a representative of a manufacturer of another ESWT machine. I would guess tha Siemens will proceed to have this machine approved for PF at some point and all this will be moot. Does anyone among us believe that ESWT for PF with any machine poses the dangers of the 'approved' fascia release some of which are complete release of the fascia. Do we know anyone in a wheelchair as a result of ESWT? There are sure some who have shown up on this board that are as a result of surgery. Government agencies such as the FDA are necessary but never think they are perfect and are the final answer. We continually see FDA approved devices and drugs pulled off the market ater they failed in the general population..No one cares more about your health than you do. You can bet that people on this board care more about your health than Bill or the FDA Brian. I know I do. Bill may have presented a great legal argument and be 100% correct but none of us are beter for it. Hey Brian how are you doing? Has Bill asked you that lately?. .

Re: Is this an advertisement or a statement of fact?

john h on 10/31/02 at 09:49 (098794)

Ed: That is very much what Dr. Gordon in Canada told me. He also stated at the time he was doing a study on high energy vs low energy but not a study on feet that had previous surgery.

Re: It shouldn't matter

Dr. Zuckerman on 10/31/02 at 12:01 (098811)

Ok Here is my take from someone who has been down this road already. This is all about money. Due to Healtronics applying for a class three device for the ossatron we all are going to pay whether it be in machine price or patient treatment costs.

When I used the Orbasone years ago. Healthronics led the way to have this pain managment device removed from the market. All ESWT machines for plantar fasciitis are going to have to apply for class three use.

So what does this means. Prices will increase and so will costs. I am not making judgements but this is what will and has happened. This is part of the reason why ESWT costs are reduced in Canada and increased in USA.

There is no way that this will changes. Bill makes alot of points that is the policy of the FDA. So my guess is he is some FDA consultant to one of the big ESWT companies already selling units in the USA

So if I get this right Bill do I get a free ESWT machine or a discount . Just joking. But I will tell you the FDA will send letters to you telling any podiatrist to stop using the soncur or face the electric chair

IF I wanted to use the soncur what I would do is buy the machine with a physician who treats elbows and then use the machine off-label. Just my thoughts

Re: Trials should be done on surgical patients

BrianG on 10/31/02 at 16:44 (098831)

John,

Since there are so many of us that have been cut, it would seem only right that the FDA visit this. They should have at least one of the ESWT makers perform trials on patients who have had surgery. I know the Dornier trials did not allow anyone who had surgery to participate. This seems to be a pretty big oversight, don't you think?

Does anyone know if these type of trials have happened in Europe? I wonder where we could go to see if 'anyone' has performed this type of trial? Any ideas?

Regards
BrianG

Re: Trials should be done on surgical patients

Ed DAvis, DPM on 10/31/02 at 20:01 (098845)

Brian:

I am not sure that the FDA would need to approve a trial for such a specific purpose. It is an excellent idea for a research paper -- of course, someone needs to take the lead.
Ed

Re: Sonocur IS an FDA approved device

Ed DAvis, DPM on 10/31/02 at 20:22 (098846)

Bill sounds like he may be working for a competitor, perhaps with a legal background. I really think he may be hurting his cause more than helping it by taking such an aggressive legalistic view. A lot of law is open for interpretation and there are a number of things Bill has stated that are
not completely accurate or may represent very narrow legal interpretations.

First of all, he does not have a good understanding of the rights to physicians to use off label devices and drugs. I like to use the Neurontin example because a lot of posters here know of the drug. Neurontin is an FDA aproved drug. Approval means not just that it is efficacious for its primary indication but that the drug is relatively safe. There are probably more off label uses of Neurontin by doctors than on label uses. That said, the drug company that manufactures Neurontin can only detail (market) the on label uses to doctors of the drug.

The Siemans Sonocor is an FDA approved device-- period! Approval means not just that the machine is efficacious for its primary indication but that it is relatively safe. Currently it only has approval for usage in one indication, lateral epicondylitis (tennis elbow). It does not have official approval for medial epicondylitis (golf elbow) so that would be an 'off label' use just as is its use for PF. That said, the company that manufactures the Sonocur can only market it for use on lateral epicondylitis in the United States. Any qualified doctor, including podiatric physicians can obtain a machine. The Sonorex people cannot advertise use of the Sonocur for PF in a podiatry trade journal. The APMA National Convention was here in Seattle this year, only a couple hours from Dave Lowy's home base of Vancouver, BC. I asked him to represent his company at that convention and he had to turn me down.

The other error Bill made was his ridiculous claim that off label uses of devices/medication is the same as experimenting on patients. I assumed, after that injudicious statement, that he probably is not an attorney.
Ed

Re: Sonocur approved by FDA for PF treatment?

Bill on 10/31/02 at 20:47 (098851)

Ed,

You just marketed your service. I suggest that you contact the
FDA enforcement division and ask what they think. You might
be surprised.

Re: Sonocur approved by FDA for PF treatment?

Bill on 10/31/02 at 20:49 (098852)

Ed,

You just advertised your service again. You might want to
call the FDA enforcement division and see if you have the
right to use the Sonorex. You might be surprised at what
you discover.

The FDA is there to protect the public. Just because you
don't like the laws, does not give you the right to violate
them.

You talk about higher levels but are using the Sonorex
because it is cheaper than the Dornier? Maybe the Sonorex
is cheaper because it is not FDA approved for PF.

Re: Sonocur IS an FDA approved device

Bill on 10/31/02 at 21:02 (098855)

Ed,

The Sonocour is not FDA approved for the treatment of PF! I don't work for the competitor. I am concerned by your disregard for FDA regulations and I am surprised by your responses. I am also quite sure that Dave Lowy and his lawyers talked to you about off-label uses before you signed your lease agreement.

If you really feel so strongly, then good luck. However, you might want to ask your liability insurance company their opinion of your off-label use of the Sonocur. They might surprise you.

In fact, you know, as do other people who read this board, that the Sonocur is not FDA approved to treat PF. You know that you cannot advertise the treatment of PF using the Sonocur. You know that there are FDA regulations that we all live by.

The FDA does not want to prevent effective treatment from making it to market. They just want to make sure that you are not selling snake oil. Without a carefully designed study, how do you know that the low power treatments of the Sonocur work? Are you all knowing?

Re: Bill

Julie on 11/01/02 at 02:23 (098865)

I must ask again. Who are you, and whom do you represent?

Re: Trials should be done on surgical patients

elliott on 11/01/02 at 07:52 (098881)

BrianG, I don't fault them for excluding failed surgical patients in the initial study, as it introduces yet another--certainly large--dimension of variability. Also, if the studies are so successful without them, this would in future establish the wisdom that ESWT always be tried first, so the surgery-first group would be a closed 'dying' group.

As Dr. Ed said, there can always be a (possibly not FDA-approved) study on just failed surgical cases. No doubt some company's machine will find success rates comparable to the 90% published for PF releases. :-)

[]

Re: Trials should be done on surgical patients

john h on 11/01/02 at 09:50 (098891)

Brian: I very much agree with you that there has been no studies on ESWT for people who have had previous surgery, In fact, I think these people have been eliminated from the studies?? Dr. Gordon who I spoke with in Canada has done many procedures with ESWT. He did Scott' and others in the Ossatron Gang. He told me that he would recommed the Ossatron on a foot that had previous surgery because of it's power and the fact that you had scar tissue. Dr. Gordon also uses low power equipment and chares the same thing so he should be non-biased in this situation. Some of the general data I have read is tht the success rate with ESWT among those who had previous surgery was less than those who had not had surgery. Do a search on this board under 'Mohez'. His last post some many months ago he talked about having treatments with three different machines and as best I could determine had 11 treatments. I think he thouhgt the Ossatron put him over the top but with so many treatments and different machines who really knows. Anyway he seems to be doing everything he wants to after many years of PF. As Rob posted I think in the near future we will have multiple machines approved by the FDA for use with PF. I think that is when we will start to see a drop in price. I think even now some of the machines cost significantly less than the others which makes treatment with them much less than the more expensive equipment. Ultimately the market place will drive the cost down and when we look back at some of those who paid $5000 for an Ossatron treatment in the begining we will be amazed..

Re: It shouldn't matter

Bill on 11/01/02 at 09:57 (098892)

What value is advice to use a device that is not approved to treat PF?

Thought you might be interested in what the FDA says is a Class 3
device.

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance.

PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. The PMA owner, however, can authorize use of its data by another.

The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. The applicant is often the inventor/developer and ultimately the manufacturer.

FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide FDA with the committee's recommendation on whether FDA should approve the submission. After FDA notifies the applicant that the PMA has been approved or denied, a notice is published on the Internet (1) announcing the data on which the decision is based, and (2) providing interested persons an opportunity to petition FDA within 30 days for reconsideration of the decision.

The regulation governing premarket approval is located in Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval. A class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act and cannot be marketed.

Re: Sonocur IS an FDA approved device

john h on 11/01/02 at 10:21 (098895)

For a moment Bill forget the legal problems you bring up and think like a patient. I have had PF for eight years. It has effected my life in ways only another PF patient can begin to understand. I am intelligent enough to know that the Sonocur has been used to treat PF in many countries for many years. I have read data of the effectiveness of this equipment and also data concerning the chances of it injuring me. My only options are ESWT or a very risky surgery as I have tried all other known treatments. I know all these machines approved and not approved operate on the very same principal. The differences are for the most part like the difference between a Chevy and a Ford. One may have a bigger engine. As a matter of fact the Sonocur has the smaller engine compared to the Epos so it is very likely the Sonocur is less likely to injure me. This equipment may be a Class III device but the associated risk is not like a new heart valve or pace maker. In the real world of pain and suffering the FDA needs to get it's act together and start moving on this equipment. This is a case where I would argue with them or testify before them or any congressional panel about the complete absurdity of the problems you identify. There is equipment out there that has been proven over and over again to help wtih PF. Germany,England,Australia, and other countries are not 3rd world nations and why do we not look at some of their data and test rather than pretend we are the first ones who have ever tested this equipment. I am still wondering why our FDA came up with a protocol of one Epos treatment for PF when other countries have a protocol of three treatments for PF and have been using the same equipment for many years. Did they completely ignore the data in front of their eyes. I have personally had three treatments with the now discarded Orby. The treatments helped. I am not an engineer but can easily grasp how these machines work and how the feel on treatment and after treatment. ESWT for the foot is not brain surgery and it should not take millions of dollars and years to get such treatment approved for PF. It cost patients to much money and delays treatment for thousands who suffer. As you may know their are estimates of around 6 million new cases of PF each year in this country.

Re: Trials should be done on surgical patients

john h on 11/01/02 at 10:30 (098897)

Elliott I agree with you that the initial trials should not be on a foot with previous surgery. But a trial someday along the way could make sense because so many of the failed surgeries are the people in the worst pain. Since I have bi-laterial PF I would be a good case to look at. In considering Bayshore and talking to Dr. Gordon I could have the Ossatron on the surgically treated foot and their other machine on the other foot.Most people who have had surgery have had one of several types of relases but as you know I had a Baxter Procedure which is not a true fascia release and probably do not have as much scar tissue.

Re: Bill, you obviously have a hidden agenda and you are not listening to what I am saying -- what gives?

Ed Davis, DPM on 11/01/02 at 10:30 (098898)

Bill or whatever your real name is:

Read the various posts about 'off label' uses of drugs and equipment then respond again.

Snake oil? So you really think all of the studies on low energy ESWT done in Europe are not valid. Is European plantar fascia that different than American plantar fascia? Most countries have an equivalent of the FDA including Germany, Great Britain and Canada -- all of whom have approved the Sonocur for use on plantar fasciitis. Do you think our FDA is so far superior to those agencies that their approval has no validity? It sounds like you are the one who is 'all knowing' -- the problem is what you think you know and your obvious lack of respect for information that does not coincide with your narrow opinions.

Devices are approved for use but only get approval for specific indications if a formal application has been made. The fact that that process is not complete hardly invalidates the benefit of a significant modality and certainly does not make something 'snake oil.'
Ed

Re: It shouldn't matter

Ed Davis, DPM on 11/01/02 at 10:33 (098899)

There is a big difference between a device that 'fails' to meet PMA and one that has not gone through the formal process.
Ed

Re: Sonocur IS an FDA approved device

Bill on 11/01/02 at 10:44 (098906)

Its interesting you mention Germany. The German government discontinued the use of ESWT until they received results from FDA studies proving effectiveness. They suspended all treatments because of over use and abuse.

There is a high placebo effect with ESWT treatments. The Ossatron and EPOS studies show that they are safe and effective. These studies show that some patients treated with these machines experience relief. Why would you pay good money for a treatment on a machine that has not been shown to be effective?

If you are concerned about cost, doesn't it bother you that podiatrists who use the Soncur are charging too much. After all, they get unrestricted use of the machine for $1,500 per month. How do they justify their high price? One patient a month makes the payment and the rest is profit. Doesn't that bother you? It sure bothers me.

I think it is in everybody's interest to have these treatments performed as indicated, on approved machines, and not be overused. The risk is that the procedure becomes discredited and then stops being available.

In terms of how these machines work, I don't think it is obvious which therapy is the best. We see FDA studies showing success with high energy or high intensity treatments using the Ossatron and Epos. We see a JAMA article suggesting that low intensity does not work. If you look at the European studies you will find that most of them are not peer reviewed.

Don't you think it is interesting that the Sonocur is approved for tennis elbow and the Ossatron is not? You have to believe that Healthtronics submitted their study at the same time as Seimans. Maybe the FDA scientists are concerned about high power hitting the structures of the elbow? I really don't know. If it was easy and obvious then the FDA scientists would not waste their time. You have to believe that these people take pride in their work like the rest of us.

Re: Sonocur IS an FDA approved device

elliott on 11/01/02 at 11:16 (098907)

john h, I wish you, and others for that matter, would direct to Dr. Z the same question you just asked:

'I am still wondering why our FDA came up with a protocol of one Epos treatment for PF when other countries have a protocol of three treatments for PF and have been using the same equipment for many years. Did they completely ignore the data in front of their eyes.'

I have asked Dr. Z this same question, but he apparently doesn't know. I'm not trying to create a ruckus here, I wish the mainstream PC crowd would also ask such questions, but they just never do, and so the few who do bother to ask come out shouldering the burden of looking negative.

It is a fair question, given the European history, to ask why the FDA chose to give its blessing to one high-level treatment. Not sure why you brought it up in the context of Bill; it's more relevant to Dr. Z since he constantly lauds its virtues here, is unquestioning of the study, and has an interest. Rather than respond with 'you go fetch and find out if you want to', unlike us it is he who is in the best position to find out if he really wants to (e.g. by asking Dornier), and pass that on to us. I'm willing to be persuaded the more persuasive the evidence. So Dr. Z, I wish you'd be a bit more proactive (yuck--hate that word) in this regard and help make your case.

[]

Re: It shouldn't matter

Bill on 11/01/02 at 11:27 (098909)

Are you serious? Are you suggesting that any device that does not go through the formal process but has been used in other countries should be used in the US? Imagine, for a moment, the consequences of this logic. I distribute my machine in another country. I pay podiatrists to use it and write articles saying that it works. I get the articles published in conferences and other venues that do not require peer review. I bring my machine to this country and start marketing it. I am ok as long as I do not test it because it hasn't failed to meet a PMA.

I think that everybody needs to take a breath. Nobody is saying that ESWT should not be performed. I think that current prices are too high and I think that they will come down when there is legitimate compeition. We need to encourage competition by getting insurance companies to pay for the procedure. It doesn't make sense to use machines that have not been shown effective because they may result in treatment failures and high treatment failures will discredit the procedure. Once the procedure has been discredited then insurance companies might stop covering the procedure for all equipment.

Dr. Davis, I know that you have a financial interest and I also believe that you have good intentions, but you really don't have any peer reviewed studies that show the Sonocur works and you could get the same results with the EPOS on its low setting. You could afford to charge the same price to your patients if you used the EPOS but you decided to use the Sonocur because it was cheaper. My point is, your financial interests, and not your clinical interests, helped make your decision.

Re: Bill, you obviously have a hidden agenda and you are not listening to what I am saying -- what gives?

Bill on 11/01/02 at 11:40 (098910)

Sorry for the snake-oil comment. I see it got you upset.

Really, the argument is simple. It is not FDA approved. Until it is FDA approved, it cannot be marketed for the treatment of PF. The reason it cannot be marketed is that it has not been shown to be safe and effective.

There are two FDA approved machines that have been proven safe and effective and they can be used to treat your patients. If you chose to treat with a device that is not FDA approved to treat PF then you are chosing to use that machine off-label. Your choice to use the machine off- label seems to be financial and not clinical. Since you can get the same clinical results with the EPOS.

Again, you can offer economical treatment of PF with ESWT by using an approved machine. You might not make as much money, but you can use an approved device and still make a living.

As for the studies, are you chosing the ones that you believe or the ones that are conducted according to rigorous scientific method. The FDA studies are the most respected. Peer reviewed articles are also respected. Look at the Weil article. It was peer reviewed. Look at the Rompe study. It was peer reviewed. Many of the other articles are not.

Re: The agenda is not hidden

Bill on 11/01/02 at 11:53 (098912)

In terms of a hidden agenda. I don't think its hidden.

My agenda is to explain that the Sonocur is not FDA approved to treat PF. It has not been shown to be safe and effective. I want to make it clear that it is illegal to advertise or market the Sonocur for a non FDA approved use.

I object to the flexibility with the law that you and other seem to have and I believe this flexibility is motivated by your financial interests as much as true clinical outcomes.

Finally, I do not understand why you feel the need to risk your license using the Sonocur. Will you make that much more money? Talk to a healthcare lawyer and get their take on it. Or better yet, talk to Neil Ogden at the FDA. He reviewed the clinical studies presented by Siemans in support of their PMA application for the Sonocur. He can tell you more. Do your homework.

Do you have any studies that show that the Sonocur does a better job treating PF than the Ossatron or the EPOS? I don't think that any such studies exist.

Re: European studies

Ed Davis, DPM on 11/01/02 at 13:14 (098918)

Bill:

You are implying that the numerous European studies are not peer reviewed and are somehow inferior. Beleive that if you will if you insist on only looking at those that support your point of view. I am not picking and choosing but looking at the aggreagate of studies and evidence. Please do not accuse me of doing what you are doing.

I use both the Ossatron and the Sonocur. I make more money when I use the Ossatron because I do not make lease payments on that machine. Your statement that I use Sonocur for my financial advantage is wrong and is a rotten accusation that only a coward who will not identify him or herself would make.

The current dilemna facing patients is the poor availability of this modality -- either due to geographic or financial reasons. I have provided some patients with Sonocur treatment at my cost price because that is all they can afford. I am a doctor -- I treat some people for free, some for reduced cost.... Something that people of your ilk just will never understand.
Ed

Re: Bill

elliott on 11/01/02 at 13:36 (098920)

Bill, I don't doubt, as you say, that many of the ESWT studies on PF were not done as carefully as they could have been. You then mention Rompe as one of those respected and whose studies are considered to have been done carefully. You also say that high-energy ESWT has more credibility than low-energy since an FDA study gave its approval. But Rompe did a *low-energy* study finding ESWT success. How do you explain that?

I'll add that Dr. Ed does have a point about Neurontin. The FDA never approved its use for pain associated with peripheral neuropathy, yet many are using it for this, with strong anecdotal evidence that it works for some.

[]

Re: The agenda is not hidden-- I think it is!

Ed Davis, DPM on 11/01/02 at 13:48 (098921)

Bill:
You keep repeating that Sonocur has not been FDA approved for the PF indication over and over again. I have acknowledged this fact over and over again. I will not let you distort the meaning of FDA approval with claims of snake oil, human experimentation, financial gain, etc. which you insist on doing.

You keep repeating that one cannot market the Sonocur for PF treatment and I keep acknowledging this fact.

I will acknowledge the above every time you insist on repeating them. Perhaps you should try hitting 'send' multiple times if you think that repetition somehow will make your position more credible.

The bottom line is that it is my duty to give patients the best treatment available, placing financial gain second. You are basically maligning my reputation and motives here as my identity is known and yours is not.
Ed

Re: The agenda is not hidden-- I think it is!

Bill on 11/01/02 at 13:59 (098922)

I'm not maligning your reputation. What is the basis for your claim that you are giving your patients the best treatment available? What studies are you following? Is it that simple.

Alternatively, how many patients have you treated? Are you saying that the success with this machine is better than the currently approved machines? Are you really placing financial gain second?

If you can't give a basis for your claim then its brings into question you motives and since you have a financial gain. You have already have a conflict of interest. You make more money treating with the Sonocur.

Re: European studies

Bill on 11/01/02 at 14:09 (098923)

Ed:

It is hard to let this one go. You say that you are providing the Sonocur treatment at cost. Are you serious. It costs you $1,500 per month and around $150 per patient treatment. How many patients are you treating each month. If the number is less than four then I agree with your math. If you treat five or more then I don't agree.

Of course you make more money on the Ossatron. Healthtronics does global billing and pays you. They charge a very high price to insurance companies and then turn around and overpay the podiatrists for their services. The idea is that it will be more financially beneficial to treat on the Ossatron than other machines. In addition, many physicians are investors with Healthtronics and receive a dividend check that is many times their initial investment. Are you an investor too?

In terms of the studies, numerous poorly executed studies do not prove a result. I do not know if the European studies are poorly conducted because they have not been peer reviewed. The peer review process helps ensure the integrety of the system.

Are there numerous studies on the Sonocur or just numerous studies on ESWT? Numerous studies on ESWT do not imply that the Sonocur works?

Re: It shouldn't matter

Ed Davis, DPM on 11/01/02 at 14:20 (098926)

Sorry Bill but office based ESWT is cheaper than surgicenter or hosptital based ESWT. I can give patients Sonocur treatments for free if I want to but not true when an anesthesiologist, surgicenter and limited partnership needs to be paind as with high energy units.

One of the larget problems our citizens are facing and will have to face is medications and treatments being priced out of availablity. There is a reasonable balance that needs to exist between public safety and making treatment affordable. Canada is not without fault but has done a much better job than the US in this specific area. I deal with this problem every day in my practice. Some of my patients travel to Mexico to get meds because they cannot afford the prices.

I am not saying that ANY device that does not go through the formal FDA process is appropriate for use -- do not distort what I say but take my statments literally. Low energy ESWT has not only been extensively studied but has a number of years of successful and safe experience on use on real people to show it to be a safe and efficacious modality. Formal FDA approval is just a matter of time at this point.
Ed

Re: yes I am serious

Ed Davis, DPM on 11/01/02 at 14:30 (098927)

Bill:

I do what most doctors do -- you seem to have a lot of misconceptions.
We treat some patients at full price, some at discounts and some for free.
This is not unusual.

I am not an investor in Healthtronics. I recieve no dividend checks from Healthtronics. Healthtronics does NOT do global billing for my patients-- I bill insurance directly.

Why do you take such strong view if you admit to not knowing about the quality of the European studies? Why do you assume they are not peer reviewed? We are looking primarily at studies of low energy ESWT as opposed to those done using the Sonocur. There is overwhelming evidence that low energy ESWT works. One issue is... which works better low energy or high energy ESWT -- not enough info. on this one. You also cannot ignore the collective experiences of patients and practitioners using this modality throughout the last few years. Keep in mind that these are patients with intractable PF-- there is little room for a placebo effect.
Ed

Re: The agenda is not hidden-- I think it is!

Ed Davis, DPM on 11/01/02 at 14:39 (098928)

Bill:
I can make more money by treating all the patients who need treatment with the Ossatron.
No one can say, at this point, whether high or low energy is superior. I make no such claims but you want to make this a major issue here. My claim is simply that low and high energy ESWT work for intractable PF and that we do not know which works better.
Your statements are part of a permanent electronic record so I think any reasonable reader can see that your accusations of experimentation, seemingly improper financial gain are apparent. AGAIN, WHY WILL YOU NOT REVEAL WHO YOU ARE?
Ed

Re: OK Bill. Who are you, and who do you represent?

Julie on 11/01/02 at 15:11 (098930)

I'll try again.

Bill, it is time you told us who you are, who you represent, and what is your agenda (you obviously have one, and I think it IS hidden).

You have been asked many times, by several of us, to identify yourself and to tell us whom you represent. You have ignored all our requests. You continue to malign one of the most honourable people on this website, Dr Ed Davis. You have continued to impute dishonourable, mercenary motives to him. None of us who knows him believes your imputations to have any relevance to the doctor we know.

I strongly object to your attitude to him, and to us.

It is time for you to stand up and reveal yourself. Please do so now.

Re: LIES

Ed Davis, DPM on 11/01/02 at 15:13 (098931)

Physicians DO NOT get unrestricted use of Sonorex for $1500 per month.
There is NOT a high placebo effect with ESWT.
Where does 'Bill' get his information to back up the accusation that 'podiatrists who use the Sonocur are charging too much'?
'One patient per month makes the payment and the rest is profit'--Liar liar, pants on fire--- it takes more than that.
Ed

Re: yes I am serious

Bill on 11/01/02 at 15:16 (098932)

Ed,

I am glad to hear that you are not invested in the local venture offering the Ossatron and that you are billing separately for your services. I think that Healthtronics has done us all a dis-service as their greed has unnecessarily delayed acceptence of this procedure by insurance providers.

I agree that there are many good studies showing positive effects of low energy, e.g., Rompe et al. I'd like to see a careful study of low energy that is similar to the FDA studies. I don't think that all 'low energy' treatments are the same and that you can generalize between machines.

I have seen many European studies that are not worth the paper they are written on. The studies could just as easily been US studies but the treatment has not been in the US long enough. I was surprised to find so many articles published without peer review. I was even surprised to hear from this board that the JAMA article was not reviewed by podiatrists.
I would hate to have a poditrist rely on the JAMA sudy when evaluating ESWT because I have my doubts about the JAMA study.

I don't know about intractable PF. Did any of the patients in the FDA studies have intractable PF? Both FDA studies show a high placebo effect.

In terms of FDA only approving high energy, that is just a wrong idea. The manufacturer's decided to market the devices in the US using a high energy protocol. I don't know why they choose a high energy protocol but it was not an FDA decision it was a Dornier and Healthtronics decision.

Re: It shouldn't matter

Bill on 11/01/02 at 15:31 (098934)

Ed,

The Dornier EPOS is an office based ESWT and does not require an anesthesiologist or surgicenter. You could use this machine for free if you want without the extra costs that you attribute to the Ossatron.

I agree about physician owned limited partnerships. They distort the market and result in higher prices for everyone. I hope that they will be outlawed so that market forces will prevail.

I agree that new medicines are generally too expensive but the problem cannot be solved by us on this board. There are reasons for the prices and there are consequences to limiting the prices. I don't even want to start that discussion as it will take us very far afield.

For the life of me, I cannot understand why ESWT needs to be so expensive except that something is limiting competition. In the beginning, it was Healthtronics. Now I am worried about the casual use of the Sonocur. I worry about using this machine off-label. I worry that it may not be effective and that by the time my insurance company starts to think about covering the procedure that the failed Sonocur treatments will give them ammunition to reject covering ESWT.

You keep saying that low energy ESWT has been extensively studied for a number of years. Besides the Rompe studies, do you know of any other published studies that have been peer reviewed, that compare low energy treatments to sham treatments and demonstrate improvement?

I take your statements literally. Show me the money, or more appropriately, show me the peer reviewed studies, then I'll buy your arguments. Otherwise, you are quoting results from studies that may have flaws; flaws like the JAMA article.

Re: Charging too much.

Bill on 11/01/02 at 15:48 (098937)

Maybe you didn't get the discounted price. I understood the price to be $1500 per month plus $150 per treatment. Somewhere down the line you have to pay a maintenance fee. The lease is for five years and you never get to own the equipment. Is that about right?

The high placebo effect with ESWT is well documented. Look at the Healthronics studies. Look at the FDA studies. These studies show a small but measurable difference between the treated groups and the sham groups.

The JAMA article was even more direct. It cites the strong placebo effect in explaining its results. I don't believe the conclusions of the JAMA article but they certainly note the strong placebo effect.

Dr. Davis, look at the articles. There are many that talk about the high placebo effect.

In terms of charging too much, I would guess that you receive more dollars per hour performing ESWT than any other procedure you perform. I would guess that surgery requires more skill and pays less than ESWT. If my guess is true then I say that you are charging too much to ESWT. I object to paying a podiatrist over $150 per hour to perform ESWT. I strongly object to paying $1000 per hour.

Re: Permanent electronic record

Bill on 11/01/02 at 15:59 (098939)

Dr. Davis,

I am glad that you are not treating all of your patients with the Ossatron. I am not claiming that high energy is better. I am stating the fact that the Osstron and the EPOS are FDA approved for a high energy protocol and the Sonocur is not approved to treat PF. Do you have a medical preference for low energy treatments? What is the medical reason you prefer low energy?

Re: It shouldn't matter

Ed Davis, DPM on 11/01/02 at 16:11 (098942)

Bill:

Unfortunately, the Dornier unit is not available in my area and its costs are too high for most individual practitioners.

Limited partnerships are a way for physicians to get together and obtain equipment they could not afford as individual pracitices. There is good and bad in this concept -- something we may agree upon.

I am here on a voluntary unpaid basis so I do not have the time to look up all the references you need on low energy ESWT -- that is a project you will have to take on yourself.

Overutilization of ESWT is a minor concern compared to overutilization of surgical procedures for PF. Take some time to read the 'Surgery' board on this site.

I am astounded by your statement that 'I cannot understand why ESWT needs to be so expensive...' New drugs and devices face regulatory and legal hurdles that add billions to the cost of healthcare in the US. You seemed to support those hurdles in a big way based on most of your posts. Don't misconstrue this statement -- we all want government to provide us with reasonable protections. There needs to be a balance between public protection and costs of protection. It seems like Canada has struck a better balance in this area. Take some time to visit one of the Sonocur centers in Canada to see happy patients getting effective treatment at reasonable fees.
Ed

Re: It shouldn't matter

Ed Davis, DPM on 11/01/02 at 16:15 (098944)

PS David Lowy of the Vancouver, BC Sonocur center can send you a packet of research studies if you are really interested.
Ed

Re: Permanent electronic record

Ed Davis, DPM on 11/01/02 at 16:18 (098945)

Bill:

I really do not know if low energy or high energy ESWT is better and I do not have a preference from the standpoint of efficacy. It will take a few years before any of us know for sure. I do have a preference from the standpoint of patient cost, convenience and availability -- that is where the low energy units have the edge.
Ed

Re: yes I am serious

Ed Davis, DPM on 11/01/02 at 16:26 (098946)

Bill:
One of the big problems with the AMA study was that half of the patients had PF less than 6 months -- obviously not eligible for the study.

Keep in mind that the technology behind the Ossatron only allows for high energy usage so an application for low energy was not an option for them.
I think that it was the goal of Dornier to get a unit to market quickly so the fastest way was to ride in on the 'coattails' of Healthtronics with a similar protocol.

Bob pointed out a very important issue: it is not likely that FDA approvals will be based on a body region basis for much longer.

In theory, a machine such as the Dornier which has a fairly wide range of power output will be very practical when ESWT can be used for multiple body regions. It is hard to envision high power machines such as the Ossatron ever being appropriate for small tendons (lateral/medial epicondylitis) and the low power units will not be efficacious for treatment of non-unions.

Okay-- the tone of the discussion is getting better. How about telling us a little about your background if you do not want to tell us who you are?
Ed

Re: Sonocur IS an FDA approved device

Dr. Zuckerman on 11/01/02 at 16:27 (098947)

I don'tknow the answer but will give you my opinion. High energy is a one time treatment and maybe Dornier after market research determined that this is what the public wants and this is what the insurance companies will pay for in the long run. This just my opinion

Re: Charging too much.

Ed Davis, DPM on 11/01/02 at 16:39 (098949)

Bill:
It does not take a great deal of skill to apply ESWT. The price you are paying is more for the high aquisition costs of the units. One must sincerely compliment the Sonorex people for making their unit affordable to the average practitioner.

Okay, you modified your claim -- that is okay. It is not $1500 per month for unlimited use but $1500 plus $100 to $150 per application.
Now we can rationally discuss some arithmetic. Say, a doctor gives 10 treatments per month (I realize that is low but we have to start somewhere) then we have 1500 divided by 10 or $150 going toward the lease plus say an average of $125 going to Sonorex. So far we are up to $275 per treatment. Now, add in the rest of office overhead -- rent, salaries, insurance, staff, scheduling ... which adds about $175 per treatment to the cost for an average treatment cost of $450. Docs are charging from $490 to 600 per treatment (remember that it is 3 treatments per patient per foot). I think that is a reasonable profit margin. Higher volume cuts the lease cost so the margin goes up but not by a drastic amount.

The typical patient with intractable PF is frustrated, skeptical and generally not very susceptible to the placebo effect. I have seen patients come back a week after ESWT claiming benefit -- yes, that may be a placebo effect. If patients are seeing sa protracted benefit months later one would be hard pressed to assign a placebo effect to that and I would need to see how the study attempted to make that determination.
Ed

Re: Full Circle: Lower priced ESWT for PF by off-label use of the Sonocur!

Bill on 11/01/02 at 16:54 (098952)

Ed,

You understand about expensive ESWT and now we have come full circle.

Your solution to the price of ESWT is to use a machine that is not FDA approved for the treatment of PF. Your price is very reasonable and will hopefully start a trend. Your price could be charged by owners of the Ossatron and Epos. We already see a price of $1,800 using the Epos. They still make money at that price and could probably go lower.

Don't put the high price of ESWT procedures onto regulation. Regulation keeps us safe and guarantees that the claims made by others are true. The high price of ESWT is about market access and competition. As soon as competition takes hold, the price will drop.

I hope that you are right and the treatment works. Only time will tell.

Re: yes I am serious

Bill on 11/01/02 at 17:11 (098957)

I agree that the tone is getting better. I'd rather not discuss my background or my name since I think it is not important. My posts should stand or fall on their own merits and not on the merits of the author.

I also agree that it is unlikely that the Ossatron will get a blanket approval from the FDA. I think that Healthtronics would disagree with your statements and cite many European studies, and I am not putting your face in it. I truly believe that there are many European studies that show that the Ossatron works for all parts of the body. I just worry about that high energy hitting adjacent structures.

I am glad that the FDA is carefully reviewing each application to each region of the body and I look forward to the day when these machines can be evaluated without regard to treatment location. Until that day, I hope that the FDA continues to carefully review each application.

Re: Calling Dr. Z -- want to jump in?

Ed Davis, DPM on 11/01/02 at 20:21 (098970)

Bill:

Wait 6 to 12 months --- Siemans is a big company and will place a lot of machines. I certainly am not the pioneer in the use of the Sonocur for PF-- you will see lots of use.

I have to disagree with you about the cost of regulation in the US. I am in favor of reasonable levels of regulation and the best example of that is Canada. Drug and device costs in Canada are more reasonable yet their public, I feel, has a very good level of protection in this area. Regulatory agencies are often used as a political weapon to quash competition and provide advantages to certain companies and industries. Dr. Z is more familiar with some of the details of the politics surrounding ESWT since he went through the Orb-sone saga. One must question if ESWT devices should be considered class 3 devices and if that was not something done by the first company 'through the door' to slow the approval of competitive products. Obviously, the ill fated attempt by the Orb-sone people to speed approval of their device by obtaining a class 1 classification may have laid the groundwork for an 'over-reaction' by regulators at the FDA.
Ed

Re: But your background is important...

Julie on 11/02/02 at 01:15 (098984)

and it's ingenuous to say it isn't. If you have an interest, you should declare it. Your conversation is with Dr Ed Davis, I know, but this is a public message board and those who read what you say are entitled to know what your interest is so that your statements can be weighed accordingly.

Re: Calling Dr. Z -- want to jump in?

Drd. Z on 11/02/02 at 08:31 (098992)

Here is what I learned

The FDA can come directly to the doctor if the distribution company fails to remove any device that the FDA deems illegally placed in the USA market.
The FDA calls any device that is legally marketed experimental and dangerious regardless of what we know and thinks.

As John Warlick from Healthronics once told me don't worry by the time the FDA decides on a course of action your machine will need new parts. It took the FDA over two years to resolve the O situation.

The FDA can and will make mistake but it doesn't matter the can correct them and ask for the machine back regardless of the time and regardless of whether they made the mistake or not. They will even admit hey we made a mistake sorry

Re: OK Bill. Who are you, and who do you represent?

rob a on 11/02/02 at 09:31 (099006)

Can we end this now? I believe that we are beating a dead horse and Bill has no intentions of offering any info about himself or his motives other then what he has previously stated. Sorry if I sound arrogant but this thread has become too repetitive and clearly, Bill is not about to change his position.

Re: Sonocur approved by FDA for PF treatment?

Ed Davis, DPM on 11/02/02 at 10:59 (099030)

Bill:
This comes down to the difference between marketing and advertising. Virtually any conversation, message board, etc. can be construed as 'marketing.' Are you sure you were not a commissar in the old Soviet Union?
Ed

Re: Sonocur approved by FDA for PF treatment?

john h on 11/02/02 at 13:43 (099039)

Long live the borad, long live bill, and down with PF.

Re: regarding how Dornier decided to use high energy for the FDA study

elliott on 11/02/02 at 18:44 (099090)

Dr. Z, couldn't you just contact Dornier and, like, ask them? It's an important question. What the public wants isn't necessarily what works the best, even if by luck it may have turned out that way. I just can't believe they went through the process of a double-blind placebo-controlled, FDA-approved, etc., etc., study without something to back it up.

Re: regarding how Dornier decided to use high energy for the FDA study

Dr. Z on 11/03/02 at 16:21 (099183)

I could . You tell you specifically who I should asked this question to at dornier.

Re: yes I am serious

JudyS on 11/04/02 at 12:43 (099282)

Bill, given your obvious in-depth knowledge of ESWT machines and treatments, I'm surprised that we've not heard from you before. The subject (ESWT) is of great and ongoing importance to us here. Have you done all your research on your own as a result of Plantar Fasciitis? Or is your expertise based on your own work with ESWT?