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Dr Z...a question about the different machines

Posted by Jen R on 12/29/01 at 07:20 (068056)

Hey Dr. Z,

I was just wondering...now that different machines are starting to be approved by the FDA for ESWT, is there any evidence or have you found that any protocol and/or machine is better than others? Isn't the Dornier a lower voltage machine that normally is administered several times right from the start while the Ossatron is more like your Orbie machine which starts with just one treatment and then with follow-ups, if necessary?

Despite the fact that your machine didn't help me...any chance a different machine such as the Dornier could have a better result??

Thanks,

Jen R

Re: Dr Z...a question about the different machines

DR Zuckerman on 12/29/01 at 09:37 (068059)

Boy this is the question that everyone wants to know . The dornier is a lower energy machine that will probaby need anesthesia local. I am waiting for the FDA trial studies results in hopes that they will give some insight as to whether they got better results. The FDA results for the ossatron was 62% but other studies have shown higher. The big O has been giving very good results in about 80% of the chronic pf cases.

I have a feeling that we will never know which machine is the one

Re: Dr Z...a question about the different machines

Jen R on 12/29/01 at 09:45 (068061)

When I initially did my ESWT research I remember that there were machines (maybe the Sonocur) which were being used in Canada. The facility wanted me to have treatments like 5 days in a row or something like that which meant staying there for a week. Do you know if that is the typical protocol for the Dornier as well? Does lower voltage mean that you need more treatments? How about the Ossatron?

Re: Dr Z...a question about the different machines

DR Zuckerman on 12/29/01 at 12:22 (068080)

Not sure if there is a treatment protocol. I have been in contact with them and will have the treatment recommendation very shortly. My guess is that it will take two treatments on the average

Re: Dr Z...a question about the different machines

Nicole K. on 12/29/01 at 14:08 (068086)

Dr. Z,
I'm just wondering if you and others in the US are still using the big O machine even though it wasn't FDA approved? Does FDA approval mean anything to the consumer other than possible insurance payment; or lack of?

Re: Dr Z...a question about the different machines

DR. Z on 12/29/01 at 15:18 (068090)

Hi,

It was approved for soft tissue pain management when it was first marketed and reviewed by the FDA. Now it has to go thru a class three review as well all ESWT machine will now and in the future. The big O is has been used in the USA for the past two years and in my opinion has a very safe track record.

Nothing else I can tell you about the machine. I just wish that the classfication system will change so that joe public won't have to pay five tthousand plus to get ESWT.
ESWT has been used in Canada and Europe for many years, as you already know.

Re: Insurance payment

DR. Z on 12/29/01 at 15:22 (068091)

The reason there is lack of insurance payment for ESWT is due to the
very expensive charges to the insurances for this treatment. Until there is a re-classification of these machine the charge to have the machine will be sky high. Why it needs to be this way is beyond all common sense
Why do you think the fee is much lower in Canada. Same machince different
country and three times the price

Re: Insurance payment

Jen R on 12/29/01 at 17:45 (068098)

I assume that Canada does not have to adhere to FDA Regulations since I believe that FDA is a US Federal organization. Is that a correct assumption? If so...is there any organization similar to our FDA that monitors and approves medical equipment and/or treatments? I found that the treatment was much cheaper too but the facility I spoke to wanted to do like 5 treatments and wanted me to stay about a week for my first set of treatments so on top of the treatment you have additional hotel and travel expenses to consider. But...as far as I am concerned...I would pay any amount to put an end to this miserable foot pain I've had for the past 4 years. And just like people having the lasik eye surgery are starting to find out...cheaper is not always better!

Re: To Jen

Pauline on 12/29/01 at 22:01 (068110)

Jen,
If I remember correctly Orbie didn't begin it's life in the U.S. being used as a low power machine with several follow up treatments being given. In it's earlier life, a total foot block was used and the machine was used as a high power machine. I'm not sure that all 6 physicians that currently own the machine use it the same way even today. When Dr. Z changed the way he delivered his treatment, Dr. Weil was still using it the
original way it was presented. Dr. Z indicated early on that there was no manual for the machine and without FDA approval or FDA studies no protocol
was ever set for this machine to be use as either a high power or low power ESWT machine because it wasn't approved as an ESWT machine at all. It was approved only a Theraputic Vibrator in the Class I catagory. High or low power made no difference classed as a Vibrator.

I personally feel that the success ratings for any machine must come from double blind studies required by the FDA, using the same set of standardized protocol in various independent locations before they can be accurately measured and given percentages. Without this type of testing any manufacturer could simply treat their office personal and report any results they want. Scientific results require controlled studies.

The Orbie had a labeling problem with the FDA, because Norland Medical's application called it a Theraputic Vibrator, but was marketing to physicians as an ESWT machine. That's a big no no especially when Healthronics had gone through the FDA Class III approval for it's ESWT machine at the same time. Healthronics approval took much longer and cost lots more money. The FDA didn't take kindly to Norland Medical's approval and switch deal so they forced Norland to stop marketing their machine and put the Orbie on their Automatic Detention list to stop all inporting of it where it still remains today. No more Orbie sales until they meet the FDA classification requirements.

When and if more insurance coverage becomes available for all FDA approved ESWT machines, like everything else people will not be concerned with the cost because they think someone else is paying for the treatment, namely their insurance companies. Unless the Orbie get's that FDA approval as a legitimate ESWT machine it's going to miss out on insurance coverage unless coded as something other than ESWt treatment. They could design a code for a Theraputic Vibrator treatment, but I don't think they could bill $5,000 or $6,000 dollars for it like the Ossatron or others that receive approval in the U.S. It will be interesting to see the cost Dornier puts on their machine and treatment and where they intend to locate them.

These companies have been down this FDA approval many times before and they wouldn't have taken their ESWT machines on this FDA ride and at the cost involved if they didn't think for one minute they wouldn't get some of it back. I think they are banking on insurance coverage and will get it.

Re: To Jen

DR. Z on 12/30/01 at 09:25 (068124)

HI,
I never stated that the orbie didn't have FDA approval as a pain management system. I use it exactly the way I was taught and still do ttill this day. Low energy to high . I just don't automatically use a local anesthesia on every patient.

What makes you think that Norland Medical did any switching. I don't think they would appreciate that accusation Let's let Norland and the FDA resolve this and that all I am going to say about this.

Insurance is something that I am expert in . This isn't about insurance its about stock value period.

Hey did you get my post on Dr. Marc Feldman from Miami Florida?

Re: To Dr. Z

Pauline on 12/30/01 at 16:27 (068140)

Hi Dr. Z.,
Making application for FDA approval as a Class 1 medical device, calling it's Orbie a Theraputic Vibrator and labeling it as such, but marketing it to physicians as an ESWT machine is not exactly a smart thing to do and the FDA obviously didn't like it.

In your thread posted on 4/17/01 you state 'There has never been an indication by the FDA that the machine itself is a problem. The problem has been with the way Norland Medical has been marketing the Orbie to doctors.'

Your statement was correct. There was never anything wrong with the machine itself, but they sold it to the FDA as one thing, a Theraputic Vibrator seeking pre market approval as a Class I medical device to be used strictly for such things as relaxing muscles and relieving minor aches and pains, but they marketed it to physicians as an ESWT machine to treat specific soft tissue problems like Plantar Fascittis a purpose for which it was never approved. That's similar to Marketing 101's Bait and Switch sales technique. My own theory is that Norland was rushing because it knew it had physicians waiting to purchase the product and the fastest and cheapest way through approval was to seek it in Class 1. They got caught simply because of other machines were going through the system at the same time.

Got your information about Dr. Feldman a little late, but Dr.Reid provided
a lead on the new replacement device. We're moveing on it slowly because it's a big decision for her. She would prefer it done only one time and I think that's a reasonable expection. She's spending the holidays with her children right now.

P.S. Saying your an expert in insurance may be an understatement, but I don't know a descriptive term that would be higher except maybe Resident Expert but your on top when it comes to insurance.

Re: To Dr. Z

nancy s. on 12/30/01 at 17:29 (068142)

i wish i had the faith in the FDA that you do, pauline. FDA approval is not any kind of guarantee, and FDA lack of approval doesn't necessarily mean anything either. when it comes to many government agencies/bureaucracies, i believe a broader vision and not tunnel vision is probably the wisest approach.
nancy

Re: The FDA and Thalidomide

BrianG on 12/30/01 at 18:28 (068150)

I think I'll put my faith in the FDA. Take Thalidomide for instance. It was developed in Germany in 1954. By 1958 it was in quite wide use through out Europe, causing up to 10,000 birth defects. If it were not for the FDA, taking it's time to do things right, we would have had the same problems here in the US. Finally in the late 60's the FDA had enough information to ban the drug here. With other countries soon following.

How many other Thalidomides would we have it were not for the FDA and it's studies ???? I'm not saying I'm a little imapatient for some more of these ESWT machines to be approved. I just want to make damn sure it's not something else I have to worry about in the future.

BCG

Re: To Nancy

Pauline on 12/30/01 at 18:38 (068151)

I never said I had any faith in the way the FDA chooses to operate, but we are a country governed by laws and the FDA was set up for protective purposes, besides income so under those conditions companies choosing to market their products got to play the game and follow the FDA's rules if they need their approval to market their product.

If they didn't need the approval believe me they wouldn't go that route.

The public itself is very fickle when it comes to the FDA. They like the idea of protection to some degree, but they want the goods to reach them faster. If their injured because of a product or medication or procedure
they can't run fast enough to their attorney to sue they were not protected enough.

Like every other Government Agency it needs to be re-evaluated and maybe revamped from time to time to see how it's meeting the needs of the public that it's suppose to be protecting, but it never happens they just hire more individuals and make new layers within the departments. Government agencies are really good with the Peter Principle and life goes on as usual.

Re: To Dr. Z

Pauline on 12/30/01 at 19:40 (068155)

Dr. Z, your correct again the stock value for their machine can't go up if they can't market the product. In this case, FDA Approval means Marketing which will provide their Earnings. If they don't comply no Earnings from Orbie.

The insurance coverage also means some earnings as well, because insurance coverage may not be approved for machines that do not carry FDA approval for the specific treatments given. Given a choice patients will usually choose for their insurance companies to cover their treatment cost instead of paying out of pocket. Every time that machine is used and paid for the company and physician profit.

Re: The FDA and Thalidomide

DR Zuckerman on 12/30/01 at 19:54 (068157)

I am 100% in agreement with safey and proof that something is safe. There should a requirment via animal studies for ESWT that it is safe. Only one machine that I know that did this study it's name is Orbie. I know of no FDA requirement that you need animal studies for ESWT . Please show me I am wrong

Re: To Dr. Z

DR Zuckerman on 12/30/01 at 20:01 (068159)

I agree but here is exactly what I meant . How about companies getting some insurance coverage here and there and then talk about how they are going to get insurance coverage in future . The company is never very specific as to who they are talking with or what insurance company . It is the future promise that makes stock prices go up. The company really never has to reach the promise and talk about that promise. And maybe they can even sell their company to someone who believes in their promise in the future.

I still can't see how an insurance company can afford to pay for ESWT at the currect rate. I have been told that Dornier may be different only time will time but then again this all about stock and stock prices.

Re: To Nancy / to pauline

nancy s. on 12/30/01 at 20:10 (068160)

i agree with everything you say here, pauline. the peter principle does too often ruin the best of intentions. and the layers of bureaucracy within bureaucracy can make for major distortions. i wish it weren't so.

i noticed the fda misinterpreted and warped the ossatron data quite badly, making the trial's results look much less successful than they actually were. (i've never had eswt myself -- just interested on behalf of others, as are you, i know.)

nancy

Re: To Nancy / to pauline

Jen R on 12/30/01 at 20:18 (068161)

I know that the insurance issue is a big deal. I am lucky enough to have been able to afford ESWT. Unfortunately, I didn't work for me. However, I started this post to find out information about the results being obtained by the different machines. I am a former basketball player and then remained extremely active being almost a fanatic when it came to exercising. I hate the fact that I can no longer exercise let alone stand or walk for more than 15 or 20 minutes at a time. All I want to know is whether the machine could make a difference. Maybe the procedure is just too recent to have that kind of information yet.

Re: To Dr. Z

Pauline on 12/30/01 at 21:39 (068166)

Dr. Z,
Suppose Dornier is different as you suggest, they charge less and insurance companies readily decide to pay for the treatment and these same companies including medicare will only pay the same amount if the Ossatron is being used. Do you think Ossatron will continue to lose money on every treatment or will they lower the cost and accept the coverage given?

Right now Ossatron is the only FDA game in town, when others come on board coverage and costs may change dramaticly. Only time will tell. Can you really see the big guys like Mass General etc having a Dornier or any other brand of machine there only to collect dust? They need money from that machine and the only way they are going to get it is with insurance coverage. They got to keep it up and running. Remember they own a piece of the rock too.

Re: Animal testing

Pauline on 12/30/01 at 21:52 (068167)

Dr. Z,
Animal activist fight against this daily. Most products today carry labels stating 'no animal testing' and they are very proud of it. I don't know how this fact would play to the general public today.

Re: To Dr. Z

DR Zuckerman on 12/30/01 at 22:27 (068168)

I agree that the institutions like Mass General will want to be involved. In fact we need them involved for increased credibility for ESWT The answer in my opinion is to keep it out of the surgical centers and use local anesthesia unless there is an individual need for IV sedation. Now that would take off about $4000 bucks off the treatment costs. The insurance companies may be very interested in paying for that setup.

Re: To Dr. Z

DR Zuckerman on 12/30/01 at 22:33 (068169)

I one last thing . We really don't know how norland presented the orbie for pre-market approval to the FDA. I will think that a picture or the diagram of how the machine works would be a part of the application, or at least an explanation of exactly how the machine works and what the conponents are. Boy what would you think if they would told that this a was spark gap machine and that it used spark plugs and that produced certain mpa or mj/mm2 at the F2. and that each treatment has 3000 shocks.
hmm. You never know what goes on in this world. I really would like to see the application

Re: Animal testing

DR Zuckerman on 12/30/01 at 22:34 (068170)

I love my dog and I love animals but how do we test the safey of shockwaves going into a human foot.

Re: To Jen

Pauline on 12/30/01 at 22:56 (068171)

Jen,
In answer to you question about results from different machines you would get the best information in my opinion from Dr. Jan Rompe. He is by far the best expert on ESWt and has been testing and studing it for years in Europe. His e-mail address is (email removed). Name the machines your interested in and he will reply. He will either supply you with the information or direct you to it.

The only studies done in the U.S. are those that were required by the FDA for the Ossatron and now Dornier. They become more available to the public after the approval is given. Rompe is your best bet on all the machines. Tell him the ESWT treatment you already had and ask his opinion as to whether he thinks another machine would or could help your condition. The man is very nice and will provide you with accurate information. If anyone know ESWT it's Dr. Rompe.
Good luck.

P.S. Since we only have Ossatron and Dornier approved you might want to see if he would suggest one over the other. There is also the other one in Canada. Not sure of the spelling but it's somethng like Sonocur. Sorry about the spelling. Hope this information will help you.

Re: To Dr. Z

Pauline on 12/30/01 at 23:08 (068172)

I think in one of your earlier posts you said you did see the original application along with all the research that was turned in. I could be wrong, but there was a lot of this type of dialog when you and the Healthronics guy went a few rounds very early on.

You purchased it from Norland and should be on pretty good terms with them, why not ask them to show it to you. As an owner, you certainly have an interest where they go with this.

Re: Animal testing

Pauline on 12/30/01 at 23:10 (068173)

We let them do it in Europe. What are their names your dog and cat?

Re: To Dr. Z

Pauline on 12/30/01 at 23:22 (068174)

The Dornier at Henry Ford is in their Center for Sport's Medicine. Sort of a physicians office setting, but it's really part of the Medical Center. My doctor said he when he ran the test for Dornier it's done using local anesthesia.

Under these conditions I think it will run less than the Ossatron. Where it is located all the physicians Orthos associated with the medical center could use it although I think they would probably refer to only a few.

He indicated since he also worked and had offices at another large medical center he planned on getting the machine there as well.

Both medical centers have satellites so like mammogram machines if the price is right they may show up in these centers as well.

Re: To Dr. Z

DR Zuckerman on 12/31/01 at 07:11 (068184)

What I saw was the ok from the FDA to market the orbie and the animal studies showing that the machine had no adverse effects on bone . I was also told by the FDA that it was ok to market the orbie for soft tissue pain. IF the FDA states that yes they have market approval for soft tissue pain and you see the letter stating this what else can you do .

Re: Animal testing

DR Zuckerman on 12/31/01 at 07:12 (068185)

I have a yorkie named molly.

Re: Animal testing

Pauline on 12/31/01 at 09:01 (068198)

Sounds like a really cute dog. I'm a dog lover, but ours passed away so we are now left with a nasty cat. The dog kept the cat in line, but with it's passing the cat gets away with a lot.

I know not all cat's are like the gem we have, but I tell you this one would make you think real hard before you selected another.

In answer to your other question about what can you do. If you were contacted when it's advertising and marketing were suddenly halted. All anyone can do under those circumstances is follow the directives you were given at that time if any were given at all.

You could also contact Norland if you really want to see where they are with the FDA, but I don't think that is really a concern to you at this time unless you wanted to purchase another machine. What will be will be as long as you can continue to use it why remind them.

Scott has said many times before the FDA knows there out there, but from that letter he posted about, something must have happened. Maybe they put more pressure on Norland to comply.

Have a wonderful New Year and party tonight.

Re: Animal testing

Dr. Zuckerman on 12/31/01 at 10:16 (068206)

Wishing you a happy and healthy new year. We are getting old because we have a nice dinner at home with friends and family. I never was the Times
Square partying type and Of course my yorkie has to be with us where ever we go.

This will be the two year anniversity of the orbie. Dam time flies

Re: To Dr. Z

Pauline on 12/31/01 at 12:06 (068219)

The machine you say is 2 years old and you did over 200 treatments it's paid your initial investment back already---clear profit from here except for upkeep, but that's pocket change if spread between all the physicians in the group now using it. Dr. Wishnie made reference to the group back in September and you indicated that because of this new arrangement your cost per treatment had to go up. All things factured in, I don't think your loosing money on it and your providing treatment. I'd say that's a good deal.

Luckly the medical industry doesn't change as rapidly as the computer field. It will probably serve you well into your senior years without having to purchase a newer, faster model.

Today some husband's can't even say that about their wives nor wives about their husband's. That's society for you.

Re: To Dr. Z

BrianG on 12/31/01 at 18:04 (068269)

I know that the MGH trials were also done with a local, and from what I remember, all the rials were done with a local. Now, maybe it would have been better to do half with the local, and half without. I would imagine that Dornier would now like to know the results of ESWT treatments 'without' a local. How would they go about this, without starting a whole new round of trials? I have written to Dornier, without a reply. I'd bet there is a lot of scrambling going on behind the scenes. I'm hoping we will know much more, by this time next year.

BCG

PS A quarter milion dollar machine is not all that much these days. If they can utilze it without a local, it should be with in everyone's reach. I am still hoping that it will be used in some type of medical setting.

Re: To Pauline

Jen R on 1/01/02 at 18:47 (068384)

Pauline,

Hi. Thanks for the info. I really appreciate you taking the time to give me such thorough information.

I may just get in touch with Dr. Rompe to get some additional information about the machines.

Thanks again.

Jen R

Re: To Dr. Z

Ed Davis, DPM on 1/02/02 at 22:58 (068497)

Pauline:

I agree that the Orba-sone people (sorry for the mis-spelling) tried to pull a 'fast one' on the FDA. What they did was wrong from the standpoint of attempting to sidestep bureaucratic regulations but what the FDA has done, in my opinion, is morally wrong in creating a very difficult, protracted approval process--a process that may ignore that data and experience in Europe and will result in the price of treatment being prohibitively high for many patients. Check the posts asking why the treatment costs so much--people are getting frustrated with those aspects of our healthcare system driving costs up prohibitively. Doctors are in the front line hearing such frustrations on a daily basis. This is not that complicated a piece of equipment. One of the people at the Sonocur clinic in Vancouver, BC which I visited recently termed the unit a 'meat tenderizer.'
Ed

Re: To Dr. Z

DR Zuckerman on 1/03/02 at 06:54 (068509)

We really don't know if the obor-sone people didn't anything wrong. There are always two sides to a story. I would have to see an application with all the details that were involved to make that decision. If won't be the first time that our govt agencies just plain screwed up the process

Re: To Dr. Davis

Pauline on 1/03/02 at 17:35 (068578)

The way I see it, you either live in the U.S. or else where. If you live and earn your living in America regardless of it's rules and regulations they have to be followed or we would be a land of vigilanties.

Certainly one can disagree with the regulations set up by the FDA and I'm sure it's happened on more than one occassion by several companies as well as individuals, but when all is said and done some agreement is reached and the company usually meets the FDA requirements regardless of it's arguements.

In the case of this ESWT machine the 6 physicians that own it don't seem to be making much of an out cry directly to the FDA only here on this site.

We don't see these physicians, who have a direct interest in the machine, contacting Norland to check on the situation, their certainly not going public with their outrage asking their patients to sign petitions, nor are they storming the FDA office, We see no signs in their office window telling their patients to write their congressmen or the FDA demanding the release of the machine that's being held hostage or to change its regulations and standards concerning medical devices. None of this is happening.

My take on it is that as long as they can continue to use the machine and it is making them some income don't rock the boat except on guarded sites.

It sounds good, it gains some sympathy, but it really doesn't accomplish a whole lot to change things or make a difference in patients lives.

I personally believe if their was enough personal concern amoung the physicians, they would gather the forces of their professional organizations and start a social movement toward changing the rules and regulations set forth by the FDA. Until I see that movement happening I have to believe their postings are from their hearts, but mostly for show. Unity + Money and Action = Change.

Re: To Dr. Davis

DR Zuckerman on 1/03/02 at 18:18 (068584)

Dear Pauline.

How do you know that there aren't letters written to the FDA. How do you know I haven't visited the FDA myself on behalf of patients. How do you know that Norland medical isn't in contact with the FDA and is still working this out.

In case you don't know and I have stated this many times on this site. The patient is the one that will change the rules not the physician. Just look at the hmo situation

Dr. Davis is one clear thinking man and is just telling it like it is.
ESWT is so new to the medical community that they have no interest at this stage to get involve.

This will turn into a treatment that only the rich will be able to pay for
cause there is going to be a time when the price is going to go up and up and up without the big O machines in this country you will pay 5,000 plus

The only way to change this is for the patient to write to the FDA to change the approval process.

Can you believe that ESWL is a class two and that anyone in the world can
bring an ESWL machine into this country and sell it. Just think you can send shock waves right pass the kidneys liver and lungs but not the feet without double bind multicenter studies.

Re: The FDA and Thalidomide

Ed Davis, DPM on 1/03/02 at 21:39 (068605)

Brian:
The FDA has done some admirable work with the case in point you discussed being an excellent example. There are counter examples where drugs used in the US were banned in Europe and it took us a while to catch up. Please don't assume that just because we do the testing in the US that we are always superior to the work done in other countries.

The FDA of the 1960's through early 1980's probably struck a good balance between safety and product accessibility. Unfortunately, the pendulum swung too far to one side in the last 15 years in which the US is no longer an innovator in health care. Why do you think that no ESWT machines are even made by a US company (to this point)? Our drug costs have become astronomical to the point that many people cannot afford them and insurers are refusing to pay for the latest generation of drugs. Like with all things, there needs to be a healthy balance.
Ed

Re: To Dr. Davis

Ed Davis, DPM on 1/03/02 at 21:49 (068607)

Pauline;
Physicians. believe me, are heavily involved in the process. Nevertheless, they are considered a special interest group by the government so the impetus for change must come from the general public.
Most doctors I know are working 70 to 90 hour work weeks so they have little free time to be crusaders.
Ed

Re: To Dr. Davis

Pauline on 1/03/02 at 23:41 (068641)

Dr. Davis,
Seems to me special interest groups get a lot done in Washington. In fact I'd say special interest groups and lobbyist have a much louder voice than
Mr. & Mrs. Taxpayer.

The process revolves around money so you have to follow the money trail and ask who gains and who loses based on income, not treatment provided.

Re: To Dr. Z

Pauline on 1/04/02 at 00:08 (068646)

Your right Dr. Z. You never told us you took any personal actions. How could anyone know? What actions have you personally taken and how many other physicians have joined you to march to the FDA office?

In our community, many patients were dropped by their HMO's when the rules changed. The letters hit their homes pretty fast.

Re: To Dr. Davis

Ed Davis, DPM on 1/04/02 at 20:59 (068762)

More people, including 'Mr. and Mrs. Taxpayer' make up the special interest groups than you can imagine. For example, AARP, an organization that represents seniors is one of the most powerful lobbying organizations on capitol hill--they have been effective in shifting health care costs away from seniors to working people. They have done some good things too so I am not here to bash them. Labor unions, of which many working people are members, have been a powerful lobbying organization, sometimes for good but they have resisted changes in problematic laws such as ERISA, loopholes in which have caused many individuals denial of healthcare benefits. You may belong to a trade organization which has lobbyists in D.C.

I have been a member of the National Federation of Independent Business, a group that does a lot of good things in terms of the promotion of the interests of small business on capitol hill. Unfortunately they often oppose meaningful healthcare reform and patient's bill of rights.
Ed

Re: Dr Z...a question about the different machines

DR Zuckerman on 12/29/01 at 09:37 (068059)

Boy this is the question that everyone wants to know . The dornier is a lower energy machine that will probaby need anesthesia local. I am waiting for the FDA trial studies results in hopes that they will give some insight as to whether they got better results. The FDA results for the ossatron was 62% but other studies have shown higher. The big O has been giving very good results in about 80% of the chronic pf cases.

I have a feeling that we will never know which machine is the one

Re: Dr Z...a question about the different machines

Jen R on 12/29/01 at 09:45 (068061)

When I initially did my ESWT research I remember that there were machines (maybe the Sonocur) which were being used in Canada. The facility wanted me to have treatments like 5 days in a row or something like that which meant staying there for a week. Do you know if that is the typical protocol for the Dornier as well? Does lower voltage mean that you need more treatments? How about the Ossatron?

Re: Dr Z...a question about the different machines

DR Zuckerman on 12/29/01 at 12:22 (068080)

Not sure if there is a treatment protocol. I have been in contact with them and will have the treatment recommendation very shortly. My guess is that it will take two treatments on the average

Re: Dr Z...a question about the different machines

Nicole K. on 12/29/01 at 14:08 (068086)

Dr. Z,
I'm just wondering if you and others in the US are still using the big O machine even though it wasn't FDA approved? Does FDA approval mean anything to the consumer other than possible insurance payment; or lack of?

Re: Dr Z...a question about the different machines

DR. Z on 12/29/01 at 15:18 (068090)

Hi,

It was approved for soft tissue pain management when it was first marketed and reviewed by the FDA. Now it has to go thru a class three review as well all ESWT machine will now and in the future. The big O is has been used in the USA for the past two years and in my opinion has a very safe track record.

Nothing else I can tell you about the machine. I just wish that the classfication system will change so that joe public won't have to pay five tthousand plus to get ESWT.
ESWT has been used in Canada and Europe for many years, as you already know.

Re: Insurance payment

DR. Z on 12/29/01 at 15:22 (068091)

The reason there is lack of insurance payment for ESWT is due to the
very expensive charges to the insurances for this treatment. Until there is a re-classification of these machine the charge to have the machine will be sky high. Why it needs to be this way is beyond all common sense
Why do you think the fee is much lower in Canada. Same machince different
country and three times the price

Re: Insurance payment

Jen R on 12/29/01 at 17:45 (068098)

I assume that Canada does not have to adhere to FDA Regulations since I believe that FDA is a US Federal organization. Is that a correct assumption? If so...is there any organization similar to our FDA that monitors and approves medical equipment and/or treatments? I found that the treatment was much cheaper too but the facility I spoke to wanted to do like 5 treatments and wanted me to stay about a week for my first set of treatments so on top of the treatment you have additional hotel and travel expenses to consider. But...as far as I am concerned...I would pay any amount to put an end to this miserable foot pain I've had for the past 4 years. And just like people having the lasik eye surgery are starting to find out...cheaper is not always better!

Re: To Jen

Pauline on 12/29/01 at 22:01 (068110)

Jen,
If I remember correctly Orbie didn't begin it's life in the U.S. being used as a low power machine with several follow up treatments being given. In it's earlier life, a total foot block was used and the machine was used as a high power machine. I'm not sure that all 6 physicians that currently own the machine use it the same way even today. When Dr. Z changed the way he delivered his treatment, Dr. Weil was still using it the
original way it was presented. Dr. Z indicated early on that there was no manual for the machine and without FDA approval or FDA studies no protocol
was ever set for this machine to be use as either a high power or low power ESWT machine because it wasn't approved as an ESWT machine at all. It was approved only a Theraputic Vibrator in the Class I catagory. High or low power made no difference classed as a Vibrator.

I personally feel that the success ratings for any machine must come from double blind studies required by the FDA, using the same set of standardized protocol in various independent locations before they can be accurately measured and given percentages. Without this type of testing any manufacturer could simply treat their office personal and report any results they want. Scientific results require controlled studies.

The Orbie had a labeling problem with the FDA, because Norland Medical's application called it a Theraputic Vibrator, but was marketing to physicians as an ESWT machine. That's a big no no especially when Healthronics had gone through the FDA Class III approval for it's ESWT machine at the same time. Healthronics approval took much longer and cost lots more money. The FDA didn't take kindly to Norland Medical's approval and switch deal so they forced Norland to stop marketing their machine and put the Orbie on their Automatic Detention list to stop all inporting of it where it still remains today. No more Orbie sales until they meet the FDA classification requirements.

When and if more insurance coverage becomes available for all FDA approved ESWT machines, like everything else people will not be concerned with the cost because they think someone else is paying for the treatment, namely their insurance companies. Unless the Orbie get's that FDA approval as a legitimate ESWT machine it's going to miss out on insurance coverage unless coded as something other than ESWt treatment. They could design a code for a Theraputic Vibrator treatment, but I don't think they could bill $5,000 or $6,000 dollars for it like the Ossatron or others that receive approval in the U.S. It will be interesting to see the cost Dornier puts on their machine and treatment and where they intend to locate them.

These companies have been down this FDA approval many times before and they wouldn't have taken their ESWT machines on this FDA ride and at the cost involved if they didn't think for one minute they wouldn't get some of it back. I think they are banking on insurance coverage and will get it.

Re: To Jen

DR. Z on 12/30/01 at 09:25 (068124)

HI,
I never stated that the orbie didn't have FDA approval as a pain management system. I use it exactly the way I was taught and still do ttill this day. Low energy to high . I just don't automatically use a local anesthesia on every patient.

What makes you think that Norland Medical did any switching. I don't think they would appreciate that accusation Let's let Norland and the FDA resolve this and that all I am going to say about this.

Insurance is something that I am expert in . This isn't about insurance its about stock value period.

Hey did you get my post on Dr. Marc Feldman from Miami Florida?

Re: To Dr. Z

Pauline on 12/30/01 at 16:27 (068140)

Hi Dr. Z.,
Making application for FDA approval as a Class 1 medical device, calling it's Orbie a Theraputic Vibrator and labeling it as such, but marketing it to physicians as an ESWT machine is not exactly a smart thing to do and the FDA obviously didn't like it.

In your thread posted on 4/17/01 you state 'There has never been an indication by the FDA that the machine itself is a problem. The problem has been with the way Norland Medical has been marketing the Orbie to doctors.'

Your statement was correct. There was never anything wrong with the machine itself, but they sold it to the FDA as one thing, a Theraputic Vibrator seeking pre market approval as a Class I medical device to be used strictly for such things as relaxing muscles and relieving minor aches and pains, but they marketed it to physicians as an ESWT machine to treat specific soft tissue problems like Plantar Fascittis a purpose for which it was never approved. That's similar to Marketing 101's Bait and Switch sales technique. My own theory is that Norland was rushing because it knew it had physicians waiting to purchase the product and the fastest and cheapest way through approval was to seek it in Class 1. They got caught simply because of other machines were going through the system at the same time.

Got your information about Dr. Feldman a little late, but Dr.Reid provided
a lead on the new replacement device. We're moveing on it slowly because it's a big decision for her. She would prefer it done only one time and I think that's a reasonable expection. She's spending the holidays with her children right now.

P.S. Saying your an expert in insurance may be an understatement, but I don't know a descriptive term that would be higher except maybe Resident Expert but your on top when it comes to insurance.

Re: To Dr. Z

nancy s. on 12/30/01 at 17:29 (068142)

i wish i had the faith in the FDA that you do, pauline. FDA approval is not any kind of guarantee, and FDA lack of approval doesn't necessarily mean anything either. when it comes to many government agencies/bureaucracies, i believe a broader vision and not tunnel vision is probably the wisest approach.
nancy

Re: The FDA and Thalidomide

BrianG on 12/30/01 at 18:28 (068150)

I think I'll put my faith in the FDA. Take Thalidomide for instance. It was developed in Germany in 1954. By 1958 it was in quite wide use through out Europe, causing up to 10,000 birth defects. If it were not for the FDA, taking it's time to do things right, we would have had the same problems here in the US. Finally in the late 60's the FDA had enough information to ban the drug here. With other countries soon following.

How many other Thalidomides would we have it were not for the FDA and it's studies ???? I'm not saying I'm a little imapatient for some more of these ESWT machines to be approved. I just want to make damn sure it's not something else I have to worry about in the future.

BCG

Re: To Nancy

Pauline on 12/30/01 at 18:38 (068151)

I never said I had any faith in the way the FDA chooses to operate, but we are a country governed by laws and the FDA was set up for protective purposes, besides income so under those conditions companies choosing to market their products got to play the game and follow the FDA's rules if they need their approval to market their product.

If they didn't need the approval believe me they wouldn't go that route.

The public itself is very fickle when it comes to the FDA. They like the idea of protection to some degree, but they want the goods to reach them faster. If their injured because of a product or medication or procedure
they can't run fast enough to their attorney to sue they were not protected enough.

Like every other Government Agency it needs to be re-evaluated and maybe revamped from time to time to see how it's meeting the needs of the public that it's suppose to be protecting, but it never happens they just hire more individuals and make new layers within the departments. Government agencies are really good with the Peter Principle and life goes on as usual.

Re: To Dr. Z

Pauline on 12/30/01 at 19:40 (068155)

Dr. Z, your correct again the stock value for their machine can't go up if they can't market the product. In this case, FDA Approval means Marketing which will provide their Earnings. If they don't comply no Earnings from Orbie.

The insurance coverage also means some earnings as well, because insurance coverage may not be approved for machines that do not carry FDA approval for the specific treatments given. Given a choice patients will usually choose for their insurance companies to cover their treatment cost instead of paying out of pocket. Every time that machine is used and paid for the company and physician profit.

Re: The FDA and Thalidomide

DR Zuckerman on 12/30/01 at 19:54 (068157)

I am 100% in agreement with safey and proof that something is safe. There should a requirment via animal studies for ESWT that it is safe. Only one machine that I know that did this study it's name is Orbie. I know of no FDA requirement that you need animal studies for ESWT . Please show me I am wrong

Re: To Dr. Z

DR Zuckerman on 12/30/01 at 20:01 (068159)

I agree but here is exactly what I meant . How about companies getting some insurance coverage here and there and then talk about how they are going to get insurance coverage in future . The company is never very specific as to who they are talking with or what insurance company . It is the future promise that makes stock prices go up. The company really never has to reach the promise and talk about that promise. And maybe they can even sell their company to someone who believes in their promise in the future.

I still can't see how an insurance company can afford to pay for ESWT at the currect rate. I have been told that Dornier may be different only time will time but then again this all about stock and stock prices.

Re: To Nancy / to pauline

nancy s. on 12/30/01 at 20:10 (068160)

i agree with everything you say here, pauline. the peter principle does too often ruin the best of intentions. and the layers of bureaucracy within bureaucracy can make for major distortions. i wish it weren't so.

i noticed the fda misinterpreted and warped the ossatron data quite badly, making the trial's results look much less successful than they actually were. (i've never had eswt myself -- just interested on behalf of others, as are you, i know.)

nancy

Re: To Nancy / to pauline

Jen R on 12/30/01 at 20:18 (068161)

I know that the insurance issue is a big deal. I am lucky enough to have been able to afford ESWT. Unfortunately, I didn't work for me. However, I started this post to find out information about the results being obtained by the different machines. I am a former basketball player and then remained extremely active being almost a fanatic when it came to exercising. I hate the fact that I can no longer exercise let alone stand or walk for more than 15 or 20 minutes at a time. All I want to know is whether the machine could make a difference. Maybe the procedure is just too recent to have that kind of information yet.

Re: To Dr. Z

Pauline on 12/30/01 at 21:39 (068166)

Dr. Z,
Suppose Dornier is different as you suggest, they charge less and insurance companies readily decide to pay for the treatment and these same companies including medicare will only pay the same amount if the Ossatron is being used. Do you think Ossatron will continue to lose money on every treatment or will they lower the cost and accept the coverage given?

Right now Ossatron is the only FDA game in town, when others come on board coverage and costs may change dramaticly. Only time will tell. Can you really see the big guys like Mass General etc having a Dornier or any other brand of machine there only to collect dust? They need money from that machine and the only way they are going to get it is with insurance coverage. They got to keep it up and running. Remember they own a piece of the rock too.

Re: Animal testing

Pauline on 12/30/01 at 21:52 (068167)

Dr. Z,
Animal activist fight against this daily. Most products today carry labels stating 'no animal testing' and they are very proud of it. I don't know how this fact would play to the general public today.

Re: To Dr. Z

DR Zuckerman on 12/30/01 at 22:27 (068168)

I agree that the institutions like Mass General will want to be involved. In fact we need them involved for increased credibility for ESWT The answer in my opinion is to keep it out of the surgical centers and use local anesthesia unless there is an individual need for IV sedation. Now that would take off about $4000 bucks off the treatment costs. The insurance companies may be very interested in paying for that setup.

Re: To Dr. Z

DR Zuckerman on 12/30/01 at 22:33 (068169)

I one last thing . We really don't know how norland presented the orbie for pre-market approval to the FDA. I will think that a picture or the diagram of how the machine works would be a part of the application, or at least an explanation of exactly how the machine works and what the conponents are. Boy what would you think if they would told that this a was spark gap machine and that it used spark plugs and that produced certain mpa or mj/mm2 at the F2. and that each treatment has 3000 shocks.
hmm. You never know what goes on in this world. I really would like to see the application

Re: Animal testing

DR Zuckerman on 12/30/01 at 22:34 (068170)

I love my dog and I love animals but how do we test the safey of shockwaves going into a human foot.

Re: To Jen

Pauline on 12/30/01 at 22:56 (068171)

Jen,
In answer to you question about results from different machines you would get the best information in my opinion from Dr. Jan Rompe. He is by far the best expert on ESWt and has been testing and studing it for years in Europe. His e-mail address is (email removed). Name the machines your interested in and he will reply. He will either supply you with the information or direct you to it.

The only studies done in the U.S. are those that were required by the FDA for the Ossatron and now Dornier. They become more available to the public after the approval is given. Rompe is your best bet on all the machines. Tell him the ESWT treatment you already had and ask his opinion as to whether he thinks another machine would or could help your condition. The man is very nice and will provide you with accurate information. If anyone know ESWT it's Dr. Rompe.
Good luck.

P.S. Since we only have Ossatron and Dornier approved you might want to see if he would suggest one over the other. There is also the other one in Canada. Not sure of the spelling but it's somethng like Sonocur. Sorry about the spelling. Hope this information will help you.

Re: To Dr. Z

Pauline on 12/30/01 at 23:08 (068172)

I think in one of your earlier posts you said you did see the original application along with all the research that was turned in. I could be wrong, but there was a lot of this type of dialog when you and the Healthronics guy went a few rounds very early on.

You purchased it from Norland and should be on pretty good terms with them, why not ask them to show it to you. As an owner, you certainly have an interest where they go with this.

Re: Animal testing

Pauline on 12/30/01 at 23:10 (068173)

We let them do it in Europe. What are their names your dog and cat?

Re: To Dr. Z

Pauline on 12/30/01 at 23:22 (068174)

The Dornier at Henry Ford is in their Center for Sport's Medicine. Sort of a physicians office setting, but it's really part of the Medical Center. My doctor said he when he ran the test for Dornier it's done using local anesthesia.

Under these conditions I think it will run less than the Ossatron. Where it is located all the physicians Orthos associated with the medical center could use it although I think they would probably refer to only a few.

He indicated since he also worked and had offices at another large medical center he planned on getting the machine there as well.

Both medical centers have satellites so like mammogram machines if the price is right they may show up in these centers as well.

Re: To Dr. Z

DR Zuckerman on 12/31/01 at 07:11 (068184)

What I saw was the ok from the FDA to market the orbie and the animal studies showing that the machine had no adverse effects on bone . I was also told by the FDA that it was ok to market the orbie for soft tissue pain. IF the FDA states that yes they have market approval for soft tissue pain and you see the letter stating this what else can you do .

Re: Animal testing

DR Zuckerman on 12/31/01 at 07:12 (068185)

I have a yorkie named molly.

Re: Animal testing

Pauline on 12/31/01 at 09:01 (068198)

Sounds like a really cute dog. I'm a dog lover, but ours passed away so we are now left with a nasty cat. The dog kept the cat in line, but with it's passing the cat gets away with a lot.

I know not all cat's are like the gem we have, but I tell you this one would make you think real hard before you selected another.

In answer to your other question about what can you do. If you were contacted when it's advertising and marketing were suddenly halted. All anyone can do under those circumstances is follow the directives you were given at that time if any were given at all.

You could also contact Norland if you really want to see where they are with the FDA, but I don't think that is really a concern to you at this time unless you wanted to purchase another machine. What will be will be as long as you can continue to use it why remind them.

Scott has said many times before the FDA knows there out there, but from that letter he posted about, something must have happened. Maybe they put more pressure on Norland to comply.

Have a wonderful New Year and party tonight.

Re: Animal testing

Dr. Zuckerman on 12/31/01 at 10:16 (068206)

Wishing you a happy and healthy new year. We are getting old because we have a nice dinner at home with friends and family. I never was the Times
Square partying type and Of course my yorkie has to be with us where ever we go.

This will be the two year anniversity of the orbie. Dam time flies

Re: To Dr. Z

Pauline on 12/31/01 at 12:06 (068219)

The machine you say is 2 years old and you did over 200 treatments it's paid your initial investment back already---clear profit from here except for upkeep, but that's pocket change if spread between all the physicians in the group now using it. Dr. Wishnie made reference to the group back in September and you indicated that because of this new arrangement your cost per treatment had to go up. All things factured in, I don't think your loosing money on it and your providing treatment. I'd say that's a good deal.

Luckly the medical industry doesn't change as rapidly as the computer field. It will probably serve you well into your senior years without having to purchase a newer, faster model.

Today some husband's can't even say that about their wives nor wives about their husband's. That's society for you.

Re: To Dr. Z

BrianG on 12/31/01 at 18:04 (068269)

I know that the MGH trials were also done with a local, and from what I remember, all the rials were done with a local. Now, maybe it would have been better to do half with the local, and half without. I would imagine that Dornier would now like to know the results of ESWT treatments 'without' a local. How would they go about this, without starting a whole new round of trials? I have written to Dornier, without a reply. I'd bet there is a lot of scrambling going on behind the scenes. I'm hoping we will know much more, by this time next year.

BCG

PS A quarter milion dollar machine is not all that much these days. If they can utilze it without a local, it should be with in everyone's reach. I am still hoping that it will be used in some type of medical setting.

Re: To Pauline

Jen R on 1/01/02 at 18:47 (068384)

Pauline,

Hi. Thanks for the info. I really appreciate you taking the time to give me such thorough information.

I may just get in touch with Dr. Rompe to get some additional information about the machines.

Thanks again.

Jen R

Re: To Dr. Z

Ed Davis, DPM on 1/02/02 at 22:58 (068497)

Pauline:

I agree that the Orba-sone people (sorry for the mis-spelling) tried to pull a 'fast one' on the FDA. What they did was wrong from the standpoint of attempting to sidestep bureaucratic regulations but what the FDA has done, in my opinion, is morally wrong in creating a very difficult, protracted approval process--a process that may ignore that data and experience in Europe and will result in the price of treatment being prohibitively high for many patients. Check the posts asking why the treatment costs so much--people are getting frustrated with those aspects of our healthcare system driving costs up prohibitively. Doctors are in the front line hearing such frustrations on a daily basis. This is not that complicated a piece of equipment. One of the people at the Sonocur clinic in Vancouver, BC which I visited recently termed the unit a 'meat tenderizer.'
Ed

Re: To Dr. Z

DR Zuckerman on 1/03/02 at 06:54 (068509)

We really don't know if the obor-sone people didn't anything wrong. There are always two sides to a story. I would have to see an application with all the details that were involved to make that decision. If won't be the first time that our govt agencies just plain screwed up the process

Re: To Dr. Davis

Pauline on 1/03/02 at 17:35 (068578)

The way I see it, you either live in the U.S. or else where. If you live and earn your living in America regardless of it's rules and regulations they have to be followed or we would be a land of vigilanties.

Certainly one can disagree with the regulations set up by the FDA and I'm sure it's happened on more than one occassion by several companies as well as individuals, but when all is said and done some agreement is reached and the company usually meets the FDA requirements regardless of it's arguements.

In the case of this ESWT machine the 6 physicians that own it don't seem to be making much of an out cry directly to the FDA only here on this site.

We don't see these physicians, who have a direct interest in the machine, contacting Norland to check on the situation, their certainly not going public with their outrage asking their patients to sign petitions, nor are they storming the FDA office, We see no signs in their office window telling their patients to write their congressmen or the FDA demanding the release of the machine that's being held hostage or to change its regulations and standards concerning medical devices. None of this is happening.

My take on it is that as long as they can continue to use the machine and it is making them some income don't rock the boat except on guarded sites.

It sounds good, it gains some sympathy, but it really doesn't accomplish a whole lot to change things or make a difference in patients lives.

I personally believe if their was enough personal concern amoung the physicians, they would gather the forces of their professional organizations and start a social movement toward changing the rules and regulations set forth by the FDA. Until I see that movement happening I have to believe their postings are from their hearts, but mostly for show. Unity + Money and Action = Change.

Re: To Dr. Davis

DR Zuckerman on 1/03/02 at 18:18 (068584)

Dear Pauline.

How do you know that there aren't letters written to the FDA. How do you know I haven't visited the FDA myself on behalf of patients. How do you know that Norland medical isn't in contact with the FDA and is still working this out.

In case you don't know and I have stated this many times on this site. The patient is the one that will change the rules not the physician. Just look at the hmo situation

Dr. Davis is one clear thinking man and is just telling it like it is.
ESWT is so new to the medical community that they have no interest at this stage to get involve.

This will turn into a treatment that only the rich will be able to pay for
cause there is going to be a time when the price is going to go up and up and up without the big O machines in this country you will pay 5,000 plus

The only way to change this is for the patient to write to the FDA to change the approval process.

Can you believe that ESWL is a class two and that anyone in the world can
bring an ESWL machine into this country and sell it. Just think you can send shock waves right pass the kidneys liver and lungs but not the feet without double bind multicenter studies.

Re: The FDA and Thalidomide

Ed Davis, DPM on 1/03/02 at 21:39 (068605)

Brian:
The FDA has done some admirable work with the case in point you discussed being an excellent example. There are counter examples where drugs used in the US were banned in Europe and it took us a while to catch up. Please don't assume that just because we do the testing in the US that we are always superior to the work done in other countries.

The FDA of the 1960's through early 1980's probably struck a good balance between safety and product accessibility. Unfortunately, the pendulum swung too far to one side in the last 15 years in which the US is no longer an innovator in health care. Why do you think that no ESWT machines are even made by a US company (to this point)? Our drug costs have become astronomical to the point that many people cannot afford them and insurers are refusing to pay for the latest generation of drugs. Like with all things, there needs to be a healthy balance.
Ed

Re: To Dr. Davis

Ed Davis, DPM on 1/03/02 at 21:49 (068607)

Pauline;
Physicians. believe me, are heavily involved in the process. Nevertheless, they are considered a special interest group by the government so the impetus for change must come from the general public.
Most doctors I know are working 70 to 90 hour work weeks so they have little free time to be crusaders.
Ed

Re: To Dr. Davis

Pauline on 1/03/02 at 23:41 (068641)

Dr. Davis,
Seems to me special interest groups get a lot done in Washington. In fact I'd say special interest groups and lobbyist have a much louder voice than
Mr. & Mrs. Taxpayer.

The process revolves around money so you have to follow the money trail and ask who gains and who loses based on income, not treatment provided.

Re: To Dr. Z

Pauline on 1/04/02 at 00:08 (068646)

Your right Dr. Z. You never told us you took any personal actions. How could anyone know? What actions have you personally taken and how many other physicians have joined you to march to the FDA office?

In our community, many patients were dropped by their HMO's when the rules changed. The letters hit their homes pretty fast.

Re: To Dr. Davis

Ed Davis, DPM on 1/04/02 at 20:59 (068762)

More people, including 'Mr. and Mrs. Taxpayer' make up the special interest groups than you can imagine. For example, AARP, an organization that represents seniors is one of the most powerful lobbying organizations on capitol hill--they have been effective in shifting health care costs away from seniors to working people. They have done some good things too so I am not here to bash them. Labor unions, of which many working people are members, have been a powerful lobbying organization, sometimes for good but they have resisted changes in problematic laws such as ERISA, loopholes in which have caused many individuals denial of healthcare benefits. You may belong to a trade organization which has lobbyists in D.C.

I have been a member of the National Federation of Independent Business, a group that does a lot of good things in terms of the promotion of the interests of small business on capitol hill. Unfortunately they often oppose meaningful healthcare reform and patient's bill of rights.
Ed