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MEAT TENDERIZERS=ESWT

Posted by Ed Davis, DPM on 1/02/02 at 23:26 (068500)

Okay folks--this is America, home of the free, land of the brave. The Bill of Rights protects free speach as long as their is not attempt to defame, slander, libel or intent to cause injury (the ACLU may argue with these exceptions though).

Then why can't we use the term 'Orba-sone' on this site. I can discuss Osama bin Ladin on this site--his name is not blocked but the name of a valuable therapeutic device that has helped thousands and has hurt nobody cannot be mentioned! Arghh! Just because the manufacturer pissed off some FDA 'pointy headed bureaucrats who can't part their bicycles straight.'
(Sorry for that quote--it came from former Alabama governor George C. Wallace in a speech about forced school busing--it sounded appropriate and sort of funny so I could not resist).

Again, I really wan't to be fair to the FDA. They are a very important agency with the responsibility to protect the public with a lot of good dedicated employees. I realize the 'Orba-sone' manufacturers tried to pull a fast one on them and really got someone mad but lets be realistic. There have probably been more people harmed by Aspartame, more complaints against that product with not enough action (to the best of my knowledge) than by by all the ESMT combined. ESMT=extracorporeal meat tenderizers which is what I will call ESWT until this dispute is resolved. I recently visited the Sonocur people in Vancouver, BC who termed the unit an 'expensive meat tenderizer.'

The potential for harm based on the European and Canadian experience does not warrant such an expensive, extensive and protracted review process. The net effect is patients not getting the treatment they need and treatments that are prohibitively expensive because of the process. Lets save a buck or two and take the Canadian review process into account and extend provisional approvals for the products. The Canadians are quite safety conscious so their process should be respected and utilized.
Ed

Re: did you say 0rbasone? :-)

elliott on 1/03/02 at 00:42 (068506)

Just use the zero symbol in place of the letter o. :-) It feels so good to beat the censors! It's like, illegal, man!

Can you please elaborate as to exactly how the 0rbasone people pissed off the FDA? Also, what's Scott's connection? Advertising? Of what?

-----

Re: It's all about money

alan k on 1/03/02 at 07:33 (068511)

One has to take into consideration the fact that heelspurs.com is a small time operation without a sea of money standing behind it should anything happen legally.

A company can file a lawsuit without merit if they have the money to pay for it, and if you can't put up matching funds you have to cave. Take the recent example of the Etoyz internet art group, from germany I think. They got sued by etoyz.com for infringement of trademark name, even though Etoyz art group was in operation years before there ever was an etoyz.com. The proper legal ruling is obvious in this case, but Etoyz art had to give up their long-standing name because they couldn't come up with the money to fight in court. Both sides, everyone in fact, knew who had the name first, but it didn't matter because legal battles take money.

etoyz.com then became a favorite target for hackers...

The government and FDA has unlimited funds, and is at the same time the one who makes the rules, so they have an even greater advantage over a little internet site.

Sometimes you have to bend a bit to stay upright.

Good luck continuing to use a zero instead of an O-- we'll see how long that lasts!

For those interested in the reference to the dangers of nutrasweet or aspartame, I have used it for years before finding out that it is a powerful neurotoxin with potentially dangerous effects on-- what was it?--something or other about memory or something.

alan k

Re: what is?

elliott on 1/03/02 at 09:23 (068526)

I'm not at all upset about it; I can't be, as I still don't get what's going on. Maybe I'm a little dense. If it's not so secret, can you elucidate or speculate as to what is heelspurs' connection or agreement with the FDA? Please respond before this thread is deleted and self-destructs in five seconds. :-)

Re: what is?

alan k on 1/03/02 at 10:43 (068539)

Oh, I don't know anything about any connection, just that it is quite easy and credible for either the FDA or other manufacturers, or some unholy alliance, to 'insist' that the big 'O' not be mentioned. So I'm just guessing that the website was 'insisted' and the prudent thing was to comply. Just guessing. I wouldn't assume there is any collusion. It's a legal matter probably, coming down to unequal access to money/power.

As I understand it, the unmentionable 'O' snuck in the back door and avoided certain FDA trials and perhaps there is some merit that that was not fair, or perhaps there is some merit to the argument that patients need their treatment now, not later. I don't have a firm opinion, but if there is any censorhip it is due to this problem, and one of the parties insisting that heelspurs.com not be implicated, or so I guess.

I think you are underestimating Scott's sense of humor about all this. I doubt our messages will disappear.

alan k

Re: also/ lots more on FDA and the unmentionable

alan k on 1/03/02 at 11:09 (068542)

Also we should appreciate that the FDA protects us from so many things and so many aggressive entrepreneurs that would cheat us or harm us for money. Many of us would already be dead if it were not for the FDA. Long live the FDA.*

Also, at the same time it does often interfere and meddle in things due to its bureacratic proceedures in ways that hurt people. For instance, denying AIDS patients in the US access to effective medicines available in Europe. So what happened? Activists got the laws relaxed. The general trend is that democratic processes are working to adjust the sometimes heavy handed tactics of the FDA. But it is not the just the FDA that needs to be reformed: Take the celebrated case of the phen-phen deaths (wrong spelling I know). This diet drug combination was very effective in reducing serious obesity, and at a risk that was reasonably ruled worth it-- for the really obese in big trouble, and who have normal liver and renal function (which is not the case in many obese people, but some). So the FDA ruled the drug was safe for this particular population. But DOCTORS abused the conditions under which the ruling was made and gave the drug to people for whom it was dangerous, so people died. Perhaps the risks may have been 'underestimated' due to influences of big money on the FDA, as some think, but doctors have to take some blame too.

The most important thing is patients being informed, and doctors with high ethical standards. In the heelspurs.com case, we have well-informed patients talking with doctors of the highest ethical caliber, openly, critically, in dialogue and argument, about a machine that really should have been available years ago, from a company that may not have had the money to put up for trials, and which offered hope and real success to people in seriously disabling condition. There are now probably hundreds of individuals who have their lives back due to this unmentionable thing, and everyone involved has no regrets.

However, the website, like the FDA, must go on. We have to continue to develop our democracy so that information keeps flowing while safety is still assured. You can't put it all on the shoulders of one person working out of their living room.

alan k

*I am not and never have been a member of the FDA. However, should the FDA be interested in hiring a paid secret spokesman, I'm sure they know were to find me.

Re: what is?

Scott R on 1/03/02 at 17:18 (068574)

The FDA said I was in violation of the law for promoting the 'big O', but they didn't specify I had violated any regulations. They quoted regulations that applied to others, but none that appeared to apply to me. They didn't tell me to do anything but wanted a written response describing how I intended 'to comply with the Act' (FDA's regulations). They said I was making a false and misleading statement by quoting the most recent big O letter on their website, but altered my statement to hide the fact that I was quoting their letter (they removed my quotes and thereby claimed I made the statement, rather than saying something like 'You're quoting an outdated letter of ours - here is our most recent position'). They stated if I had any questions I should call or email, but they have not responded to my only important question. It was clear to me that they are not going to stay within the boundaries of their regulations in trying to suppress the 'big O'. They did not specify I should take any specific actions, so I took the conservative approach and removed all reference to it from the website and stated I had done so. By making the statement I'm required to adhere to it lest they later use my not doing as I stated against me. They are paid to take legal action against others and since I don't get paid to let people know about the big O, there isn't any reason I should argue against them other than merely wanting to help people save $5,000 each. The FDA has a long and rich history of shutting businesses down for not doing as they're told and I don't want to be one of them. Some people think this is about the law, but it is not: the FDA has always been above the law unless you have enough money to take them to court. Without warning they can bust your door down with guns drawn, sieze all computers and records, and padlock your business door. The most famous and notorious example was about 10 years ago when they busted a doctor and his office staff this way for dispensing vitamins. He eventually won in court, but I'm sure he lost a bundle and they got their point across. http://www.lef.org is one of the few companies that has survived their attacks and is still able to publish negative stuff about them. Welcome to the U.S.A.

Re: what is?

Scott R on 1/03/02 at 17:30 (068577)

Here's some stuff about the FDA: http://www.lef.org/shop/fda2.htm

Re: what is?

Scott R on 1/03/02 at 17:50 (068580)

The question I've asked but they haven't answered is this: am I required to kick you people out of the message board for getting around my blocks and discussing the O? If anyone wants to set up their own O website they can, it just ain't going to be me.

Re: another FDA link

Scott R on 1/03/02 at 17:59 (068581)

Do a search on the FDA at this website:
http://www.drwhitaker.com/

Re: what is?

wendyn on 1/03/02 at 18:13 (068583)

Scott - you probably know that I have little interest in the ESWT machines...but this whole thing really sounds like some iron curtain type of censorship.

How can they forbid people from discussing something in a public forum?

Re: what is?

DR Zuckerman on 1/03/02 at 18:28 (068585)

Hi Scott,

Why don't we get rid of any and all ESWT on this board. There are some major companies that could be paying you some bucks for the use of this board. I never could figure out why you list treatment center for free when they could be paying for them.

Re: what is?

Scott R on 1/03/02 at 18:30 (068586)

Wendy, they can stop us from discussing the O in the same way they made me take it off the website: by threatening me again.

Re: what is?

Ed Davis, DPM on 1/03/02 at 21:18 (068598)

What a sad state of affairs--when we have to fear our own government.
Ed

Re: also/ lots more on FDA and the unmentionable

Ed Davis, DPM on 1/03/02 at 21:22 (068599)

A lot of good points. The drug companies have the big bucks to spend on the approval process--more than other industries. Drugs have more potential for harm than a many medical devices so perhaps a different burden of proof of safety needs to exist for different helath industries. That said, the price of many of the drugs that have come out in the last few year, many of them good drugs, has been exorbitatant. Patients have a hard time affording the drugs and insurance companies are often refusing to pay for the latest generation of drugs--a lose-lose situation. Something needs to change.
Ed

Re: did you say 0rbasone? :-)

Ed Davis, DPM on 1/03/02 at 21:27 (068601)

Elliott, apparently the Orbas0ne people were able to get approval for their device by classifying it as a therapeutic massager to the FDA, while marketing it to the medical community as ESWT. Not honest---but I need to look at some comparative culpability. Who did more harm--the Orbas0ne people or the FDA via their problematic review process.
Ed

Re: what is?

Ed Davis, DPM on 1/03/02 at 21:31 (068603)

Dr. Z---This board is about heel pain and ESWT is just too important a modality not to be discussed, let alone censored. Scott, potentially could take advertisements for ESWT centers but as long as he identifies them as paid ads he is being honest.
Ed

Re: what is?

Scott R on 1/03/02 at 21:35 (068604)

The irony is that what they made me take off my website, is still the only letter on their website. I doubt they sent a notice of violation to their own webmasters.

Re: also/ lots more on FDA and the unmentionable

Ed Davis, DPM on 1/03/02 at 21:43 (068606)

One more thing. Don't you think it is sad that the FDA appears to be able or at least trying to limit free speech on this forum? I don't know--maybe Scott is over-reacting to his contact with the FDA. Nevertheless, the net effect is a restriction of free speach guaranteed by our Bill of Rights. Is that an FDA that you can admire?
Ed

Re: MEAT TENDERIZERS=ESWT

BrianG on 1/03/02 at 21:58 (068612)

Hi Dr. Ed,

I admit I don't know much about the Canadian trials on machines like ESWT, or their insurance programs. I think thint what ever country we may try to follow, should have enough information for our insurance companies to do their part. It's not just good enough for the FDA to approve something, if the majority of the people cannot afford it.
It's very important the insurance companies are brought on board from the begnning.

BCG

Re: did you say 0rbasone? :-)

DR Zuckerman on 1/03/02 at 21:59 (068614)

I still think the FDA knew that the orbsore was an ESWT machine at the intial process and approved the machine for pain relief. Norland Medical has taken over thirty five products by the FDA . So I think they understand the process. Only after another very competitive company didn't like the fact that they were beaten did this problem arrive. The first company to go thru the controls the classification .

Let look at this another way . Lets just saw this other company was wrong with the way they went thru the classification process boy would it cost the stock holders. May even put the company out of business. Now would you do anything you could to get rid of of this seond company who juwt may be smarter but not in the same money league.

Re: what is?

DR Zuckerman on 1/03/02 at 22:02 (068615)

I have always told you do what makes you feel safe and comfortable. and what in your mind is right. No one can walk in your shoes. Now if you start to censor the anme Scott I would get alittle worried my friend.

Re: also/ lots more on FDA and the unmentionable

nancy s. on 1/03/02 at 22:09 (068619)

i agree with you, dr. ed.; this impingement on free speech is sad. i'm rather amazed that the fda can do or cause this kind of thing. let's face it -- it's undemocratic and unamerican. i don't understand it. anyone know someone with clout to write to about this?

Re: also/ lots more on FDA and the unmentionable

Scott R on 1/03/02 at 22:21 (068624)

I was just thinking there are several alternative magazines that would love to get a hold of this story. lef.org already wanted to do a profile on me but I refused because I didn't like the way their 3-page articles were laid out. The Wall Street Journal also likes to talk about the FDA, web pages, and individuals involved with either.

Re: big "o" and big bro

elliott on 1/03/02 at 22:56 (068628)

One more question: Do you ask the FDA for rulings, or are they spying on this site to make sure you comply? If the former, sometimes it's better not to ask.

Re: thanks; that clears things up (nm)

elliott on 1/03/02 at 22:58 (068629)

.

Re: big "o" and big bro

Scott R on 1/03/02 at 22:59 (068631)

To quote:

'Hello Scott,
Thank you for your prompt reply. When your letter gets here, we will review it and your website, then get back to you with a written response.'

Re: big "o" and big bro

Pauline on 1/03/02 at 23:26 (068636)

Scott, I say do what ever you can. Go for it. If the Wall Street Journal
is interested and it's in the public's best interest ring them up and get your story told. No harm done to anyone and heelspurs gets more publicity. Could be a win, win situation.

Re: yeah, but if Scott loses and they shut this place down...

elliott on 1/03/02 at 23:29 (068637)

there's gonna be a lot of weeping heelspurs members without their support group.

---

Re: what is?

wendyn on 1/03/02 at 23:29 (068638)

It's really sad though....I suppose I can understand telling you to take it off the site as some type of 'promotion' or 'advertisement'....but as far as discussion.....

Seems absurd that people can go into all kinds of sex sites dealing with all kinds of bizarre, perverse, and at times even illegal things - but here we are forbidden from mentioning the name of a machine. Other sites will tell you how to manufacture bombs or anthrax...but some government agency is worried about YOU?

Bizarre.

Re: so if I say 0rbasone

elliott on 1/03/02 at 23:31 (068639)

can they give me a foul and bombard me with a thousand unwanted junk emails? If not, you're more powerful than they are. :-)

-----

Re: you wouldn't understand

elliott on 1/03/02 at 23:32 (068640)

You live in Canada.

HAHAHAHAHAHAHAHAHAHAHA!!!!!!!!!!!!!!!

----

Re: what is?

john h on 1/04/02 at 13:14 (068687)

Scott: I would suspect that someone complained to the FDA to bring it to their attention. I was recently threatened by Microsoft because I offered a computer for sale on Ebay and noted that it had Microsoft Office installed on it. As a matter of fact I purchased the computer new from MacWarehouse and it came with Microsoft Office on it and I had the Software with Microsoft Serial Number on it which would have gone with the computer. So why could I not sell a computer just like I bought it? I am not in a position to go to court with Bill Gates so I lose. By the way Ebay advised me they were forced to remove my computer listing from the board. Microsoft quoted me the laws and were nice enough but they carry a big stick and apparently monitor the internet to make sure people are not pirating their software.

Re: did you say 0rbasone? :-)

Ed Davis, DPM on 1/04/02 at 14:47 (068705)

I am not upset with the Orbas0ne people. If they did anything wrong, I think it was very minor and, as you said, a big factor may have been the competition.
Ed

Re: MEAT TENDERIZERS=ESWT

Camilla on 1/04/02 at 17:23 (068735)

I have been away from the board for awhile and just finished reading this discussion.

We, as contributors to this discussion, come from many states. Has anyone called their representative to report this unacceptable situation? I know I have not. It will be the first thing on my 'to do list' Monday morning. Someone 'up there' makes the rules the FDA follows.

My ESWT was denied last February by a local HMO in St. Louis. I was told by a supervisor that I should not feel 'singled out'...they had denied 1200 other policy holders for ESWT since the first of the year. They sited the fact that ESWT was still 'experimental' and not enough literature was available. I offered to find someone to interupt German...not a well received suggestion. There are alot of us in the same situation. Let's flood our senators and congressmens' telephone lines.

Scott, I know it is easy for us to say 'go for the publicitity'. You seem to be the person they want to control. Search your soul snd consider it. Articles in the Wall Streer are noticed and when THOSE THAT MAKE THE LAW find that there are so many unhappy constituates; I'd hope that they would investigate.

Re: I have the name of the person who rrepresents us in front of the FDA

DR Zuckerman on 1/04/02 at 21:01 (068763)

I have spoken in person with the FDA about the machine approval process.
The way the process is at this moment the cost of the treatment is too high
I have the fax number and name of the person that represents the public's interest with FDA matters. I would post this on Monday .

Re: did you say 0rbasone? :-)

elliott on 1/03/02 at 00:42 (068506)

Just use the zero symbol in place of the letter o. :-) It feels so good to beat the censors! It's like, illegal, man!

Can you please elaborate as to exactly how the 0rbasone people pissed off the FDA? Also, what's Scott's connection? Advertising? Of what?

-----

Re: It's all about money

alan k on 1/03/02 at 07:33 (068511)

One has to take into consideration the fact that heelspurs.com is a small time operation without a sea of money standing behind it should anything happen legally.

A company can file a lawsuit without merit if they have the money to pay for it, and if you can't put up matching funds you have to cave. Take the recent example of the Etoyz internet art group, from germany I think. They got sued by etoyz.com for infringement of trademark name, even though Etoyz art group was in operation years before there ever was an etoyz.com. The proper legal ruling is obvious in this case, but Etoyz art had to give up their long-standing name because they couldn't come up with the money to fight in court. Both sides, everyone in fact, knew who had the name first, but it didn't matter because legal battles take money.

etoyz.com then became a favorite target for hackers...

The government and FDA has unlimited funds, and is at the same time the one who makes the rules, so they have an even greater advantage over a little internet site.

Sometimes you have to bend a bit to stay upright.

Good luck continuing to use a zero instead of an O-- we'll see how long that lasts!

For those interested in the reference to the dangers of nutrasweet or aspartame, I have used it for years before finding out that it is a powerful neurotoxin with potentially dangerous effects on-- what was it?--something or other about memory or something.

alan k

Re: what is?

elliott on 1/03/02 at 09:23 (068526)

I'm not at all upset about it; I can't be, as I still don't get what's going on. Maybe I'm a little dense. If it's not so secret, can you elucidate or speculate as to what is heelspurs' connection or agreement with the FDA? Please respond before this thread is deleted and self-destructs in five seconds. :-)

Re: what is?

alan k on 1/03/02 at 10:43 (068539)

Oh, I don't know anything about any connection, just that it is quite easy and credible for either the FDA or other manufacturers, or some unholy alliance, to 'insist' that the big 'O' not be mentioned. So I'm just guessing that the website was 'insisted' and the prudent thing was to comply. Just guessing. I wouldn't assume there is any collusion. It's a legal matter probably, coming down to unequal access to money/power.

As I understand it, the unmentionable 'O' snuck in the back door and avoided certain FDA trials and perhaps there is some merit that that was not fair, or perhaps there is some merit to the argument that patients need their treatment now, not later. I don't have a firm opinion, but if there is any censorhip it is due to this problem, and one of the parties insisting that heelspurs.com not be implicated, or so I guess.

I think you are underestimating Scott's sense of humor about all this. I doubt our messages will disappear.

alan k

Re: also/ lots more on FDA and the unmentionable

alan k on 1/03/02 at 11:09 (068542)

Also we should appreciate that the FDA protects us from so many things and so many aggressive entrepreneurs that would cheat us or harm us for money. Many of us would already be dead if it were not for the FDA. Long live the FDA.*

Also, at the same time it does often interfere and meddle in things due to its bureacratic proceedures in ways that hurt people. For instance, denying AIDS patients in the US access to effective medicines available in Europe. So what happened? Activists got the laws relaxed. The general trend is that democratic processes are working to adjust the sometimes heavy handed tactics of the FDA. But it is not the just the FDA that needs to be reformed: Take the celebrated case of the phen-phen deaths (wrong spelling I know). This diet drug combination was very effective in reducing serious obesity, and at a risk that was reasonably ruled worth it-- for the really obese in big trouble, and who have normal liver and renal function (which is not the case in many obese people, but some). So the FDA ruled the drug was safe for this particular population. But DOCTORS abused the conditions under which the ruling was made and gave the drug to people for whom it was dangerous, so people died. Perhaps the risks may have been 'underestimated' due to influences of big money on the FDA, as some think, but doctors have to take some blame too.

The most important thing is patients being informed, and doctors with high ethical standards. In the heelspurs.com case, we have well-informed patients talking with doctors of the highest ethical caliber, openly, critically, in dialogue and argument, about a machine that really should have been available years ago, from a company that may not have had the money to put up for trials, and which offered hope and real success to people in seriously disabling condition. There are now probably hundreds of individuals who have their lives back due to this unmentionable thing, and everyone involved has no regrets.

However, the website, like the FDA, must go on. We have to continue to develop our democracy so that information keeps flowing while safety is still assured. You can't put it all on the shoulders of one person working out of their living room.

alan k

*I am not and never have been a member of the FDA. However, should the FDA be interested in hiring a paid secret spokesman, I'm sure they know were to find me.

Re: what is?

Scott R on 1/03/02 at 17:18 (068574)

The FDA said I was in violation of the law for promoting the 'big O', but they didn't specify I had violated any regulations. They quoted regulations that applied to others, but none that appeared to apply to me. They didn't tell me to do anything but wanted a written response describing how I intended 'to comply with the Act' (FDA's regulations). They said I was making a false and misleading statement by quoting the most recent big O letter on their website, but altered my statement to hide the fact that I was quoting their letter (they removed my quotes and thereby claimed I made the statement, rather than saying something like 'You're quoting an outdated letter of ours - here is our most recent position'). They stated if I had any questions I should call or email, but they have not responded to my only important question. It was clear to me that they are not going to stay within the boundaries of their regulations in trying to suppress the 'big O'. They did not specify I should take any specific actions, so I took the conservative approach and removed all reference to it from the website and stated I had done so. By making the statement I'm required to adhere to it lest they later use my not doing as I stated against me. They are paid to take legal action against others and since I don't get paid to let people know about the big O, there isn't any reason I should argue against them other than merely wanting to help people save $5,000 each. The FDA has a long and rich history of shutting businesses down for not doing as they're told and I don't want to be one of them. Some people think this is about the law, but it is not: the FDA has always been above the law unless you have enough money to take them to court. Without warning they can bust your door down with guns drawn, sieze all computers and records, and padlock your business door. The most famous and notorious example was about 10 years ago when they busted a doctor and his office staff this way for dispensing vitamins. He eventually won in court, but I'm sure he lost a bundle and they got their point across. http://www.lef.org is one of the few companies that has survived their attacks and is still able to publish negative stuff about them. Welcome to the U.S.A.

Re: what is?

Scott R on 1/03/02 at 17:30 (068577)

Here's some stuff about the FDA: http://www.lef.org/shop/fda2.htm

Re: what is?

Scott R on 1/03/02 at 17:50 (068580)

The question I've asked but they haven't answered is this: am I required to kick you people out of the message board for getting around my blocks and discussing the O? If anyone wants to set up their own O website they can, it just ain't going to be me.

Re: another FDA link

Scott R on 1/03/02 at 17:59 (068581)

Do a search on the FDA at this website:
http://www.drwhitaker.com/

Re: what is?

wendyn on 1/03/02 at 18:13 (068583)

Scott - you probably know that I have little interest in the ESWT machines...but this whole thing really sounds like some iron curtain type of censorship.

How can they forbid people from discussing something in a public forum?

Re: what is?

DR Zuckerman on 1/03/02 at 18:28 (068585)

Hi Scott,

Why don't we get rid of any and all ESWT on this board. There are some major companies that could be paying you some bucks for the use of this board. I never could figure out why you list treatment center for free when they could be paying for them.

Re: what is?

Scott R on 1/03/02 at 18:30 (068586)

Wendy, they can stop us from discussing the O in the same way they made me take it off the website: by threatening me again.

Re: what is?

Ed Davis, DPM on 1/03/02 at 21:18 (068598)

What a sad state of affairs--when we have to fear our own government.
Ed

Re: also/ lots more on FDA and the unmentionable

Ed Davis, DPM on 1/03/02 at 21:22 (068599)

A lot of good points. The drug companies have the big bucks to spend on the approval process--more than other industries. Drugs have more potential for harm than a many medical devices so perhaps a different burden of proof of safety needs to exist for different helath industries. That said, the price of many of the drugs that have come out in the last few year, many of them good drugs, has been exorbitatant. Patients have a hard time affording the drugs and insurance companies are often refusing to pay for the latest generation of drugs--a lose-lose situation. Something needs to change.
Ed

Re: did you say 0rbasone? :-)

Ed Davis, DPM on 1/03/02 at 21:27 (068601)

Elliott, apparently the Orbas0ne people were able to get approval for their device by classifying it as a therapeutic massager to the FDA, while marketing it to the medical community as ESWT. Not honest---but I need to look at some comparative culpability. Who did more harm--the Orbas0ne people or the FDA via their problematic review process.
Ed

Re: what is?

Ed Davis, DPM on 1/03/02 at 21:31 (068603)

Dr. Z---This board is about heel pain and ESWT is just too important a modality not to be discussed, let alone censored. Scott, potentially could take advertisements for ESWT centers but as long as he identifies them as paid ads he is being honest.
Ed

Re: what is?

Scott R on 1/03/02 at 21:35 (068604)

The irony is that what they made me take off my website, is still the only letter on their website. I doubt they sent a notice of violation to their own webmasters.

Re: also/ lots more on FDA and the unmentionable

Ed Davis, DPM on 1/03/02 at 21:43 (068606)

One more thing. Don't you think it is sad that the FDA appears to be able or at least trying to limit free speech on this forum? I don't know--maybe Scott is over-reacting to his contact with the FDA. Nevertheless, the net effect is a restriction of free speach guaranteed by our Bill of Rights. Is that an FDA that you can admire?
Ed

Re: MEAT TENDERIZERS=ESWT

BrianG on 1/03/02 at 21:58 (068612)

Hi Dr. Ed,

I admit I don't know much about the Canadian trials on machines like ESWT, or their insurance programs. I think thint what ever country we may try to follow, should have enough information for our insurance companies to do their part. It's not just good enough for the FDA to approve something, if the majority of the people cannot afford it.
It's very important the insurance companies are brought on board from the begnning.

BCG

Re: did you say 0rbasone? :-)

DR Zuckerman on 1/03/02 at 21:59 (068614)

I still think the FDA knew that the orbsore was an ESWT machine at the intial process and approved the machine for pain relief. Norland Medical has taken over thirty five products by the FDA . So I think they understand the process. Only after another very competitive company didn't like the fact that they were beaten did this problem arrive. The first company to go thru the controls the classification .

Let look at this another way . Lets just saw this other company was wrong with the way they went thru the classification process boy would it cost the stock holders. May even put the company out of business. Now would you do anything you could to get rid of of this seond company who juwt may be smarter but not in the same money league.

Re: what is?

DR Zuckerman on 1/03/02 at 22:02 (068615)

I have always told you do what makes you feel safe and comfortable. and what in your mind is right. No one can walk in your shoes. Now if you start to censor the anme Scott I would get alittle worried my friend.

Re: also/ lots more on FDA and the unmentionable

nancy s. on 1/03/02 at 22:09 (068619)

i agree with you, dr. ed.; this impingement on free speech is sad. i'm rather amazed that the fda can do or cause this kind of thing. let's face it -- it's undemocratic and unamerican. i don't understand it. anyone know someone with clout to write to about this?

Re: also/ lots more on FDA and the unmentionable

Scott R on 1/03/02 at 22:21 (068624)

I was just thinking there are several alternative magazines that would love to get a hold of this story. lef.org already wanted to do a profile on me but I refused because I didn't like the way their 3-page articles were laid out. The Wall Street Journal also likes to talk about the FDA, web pages, and individuals involved with either.

Re: big "o" and big bro

elliott on 1/03/02 at 22:56 (068628)

One more question: Do you ask the FDA for rulings, or are they spying on this site to make sure you comply? If the former, sometimes it's better not to ask.

Re: thanks; that clears things up (nm)

elliott on 1/03/02 at 22:58 (068629)

.

Re: big "o" and big bro

Scott R on 1/03/02 at 22:59 (068631)

To quote:

'Hello Scott,
Thank you for your prompt reply. When your letter gets here, we will review it and your website, then get back to you with a written response.'

Re: big "o" and big bro

Pauline on 1/03/02 at 23:26 (068636)

Scott, I say do what ever you can. Go for it. If the Wall Street Journal
is interested and it's in the public's best interest ring them up and get your story told. No harm done to anyone and heelspurs gets more publicity. Could be a win, win situation.

Re: yeah, but if Scott loses and they shut this place down...

elliott on 1/03/02 at 23:29 (068637)

there's gonna be a lot of weeping heelspurs members without their support group.

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Re: what is?

wendyn on 1/03/02 at 23:29 (068638)

It's really sad though....I suppose I can understand telling you to take it off the site as some type of 'promotion' or 'advertisement'....but as far as discussion.....

Seems absurd that people can go into all kinds of sex sites dealing with all kinds of bizarre, perverse, and at times even illegal things - but here we are forbidden from mentioning the name of a machine. Other sites will tell you how to manufacture bombs or anthrax...but some government agency is worried about YOU?

Bizarre.

Re: so if I say 0rbasone

elliott on 1/03/02 at 23:31 (068639)

can they give me a foul and bombard me with a thousand unwanted junk emails? If not, you're more powerful than they are. :-)

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Re: you wouldn't understand

elliott on 1/03/02 at 23:32 (068640)

You live in Canada.

HAHAHAHAHAHAHAHAHAHAHA!!!!!!!!!!!!!!!

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Re: what is?

john h on 1/04/02 at 13:14 (068687)

Scott: I would suspect that someone complained to the FDA to bring it to their attention. I was recently threatened by Microsoft because I offered a computer for sale on Ebay and noted that it had Microsoft Office installed on it. As a matter of fact I purchased the computer new from MacWarehouse and it came with Microsoft Office on it and I had the Software with Microsoft Serial Number on it which would have gone with the computer. So why could I not sell a computer just like I bought it? I am not in a position to go to court with Bill Gates so I lose. By the way Ebay advised me they were forced to remove my computer listing from the board. Microsoft quoted me the laws and were nice enough but they carry a big stick and apparently monitor the internet to make sure people are not pirating their software.

Re: did you say 0rbasone? :-)

Ed Davis, DPM on 1/04/02 at 14:47 (068705)

I am not upset with the Orbas0ne people. If they did anything wrong, I think it was very minor and, as you said, a big factor may have been the competition.
Ed

Re: MEAT TENDERIZERS=ESWT

Camilla on 1/04/02 at 17:23 (068735)

I have been away from the board for awhile and just finished reading this discussion.

We, as contributors to this discussion, come from many states. Has anyone called their representative to report this unacceptable situation? I know I have not. It will be the first thing on my 'to do list' Monday morning. Someone 'up there' makes the rules the FDA follows.

My ESWT was denied last February by a local HMO in St. Louis. I was told by a supervisor that I should not feel 'singled out'...they had denied 1200 other policy holders for ESWT since the first of the year. They sited the fact that ESWT was still 'experimental' and not enough literature was available. I offered to find someone to interupt German...not a well received suggestion. There are alot of us in the same situation. Let's flood our senators and congressmens' telephone lines.

Scott, I know it is easy for us to say 'go for the publicitity'. You seem to be the person they want to control. Search your soul snd consider it. Articles in the Wall Streer are noticed and when THOSE THAT MAKE THE LAW find that there are so many unhappy constituates; I'd hope that they would investigate.

Re: I have the name of the person who rrepresents us in front of the FDA

DR Zuckerman on 1/04/02 at 21:01 (068763)

I have spoken in person with the FDA about the machine approval process.
The way the process is at this moment the cost of the treatment is too high
I have the fax number and name of the person that represents the public's interest with FDA matters. I would post this on Monday .