Re: Who gives Information to FDA?

[Guest guest]

it has to have rigorous clinical trials (costing thousands of $) in order

for it to be approved by the FDA. Typically drug companies fund these

since they are the ones who receive the billions in profit later on. Merck

is the company who sells Naltrexone and since this is given in such low

doses to us (~$30/month), it is doubtful they'd be willing to invest the $

to do the trials... it's a Catch-22, isn't it?

So what can we all do? Try this drug (help each other find an MD to

prescribe it if necessary) and keep the volume turned up to our PCP and

neuro on our " anecdotal " data. We have the power to do that part, and it

may change things. Grass roots, ground swells have worked in the past,

they can work now...

On Tue, 13 May 2003, mymisspriss19472000 wrote:

> If we want low dose Naltrexone (fast-acting) to get FDA approval who

> sends the information to them? I am sure my doctor is keeping

> records of my usage, but how does this get to back to the Federal

> Drug Administration? Or does the studies have to promoted by FDA?

> Does anyone have any idea of when it will be ready to be prescribed

> like most other drugs? Many people are not willing to try the drug

> because of this glitch, this drug, not being FDA approved.

>

>

>

>

[Guest guest]

I was thinking about that last night. I notice they are checking into 10X

dosage on Lipitor to help MS (who knows what that will do to your cholesterol

levels... you may not have vein walls left, but your MS will be helped?)....

BUT they won't check out LDN. There's MONEY in Lipitor prescriptions. NO

profits in LDN... why HELP people if there's no money in it? Thank <whomever>

for Dr. Bihari!

----- Original Message -----

From: " G. Harding " <philh@...>

" mymisspriss19472000 " <mymisspriss19472000@...>

Cc: <low dose naltrexone >

Sent: Wednesday, May 14, 2003 07:22

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

> it has to have rigorous clinical trials (costing thousands of $) in order

> for it to be approved by the FDA. Typically drug companies fund these

> since they are the ones who receive the billions in profit later on. Merck

> is the company who sells Naltrexone and since this is given in such low

> doses to us (~$30/month), it is doubtful they'd be willing to invest the $

> to do the trials... it's a Catch-22, isn't it?

> So what can we all do? Try this drug (help each other find an MD to

> prescribe it if necessary) and keep the volume turned up to our PCP and

> neuro on our " anecdotal " data. We have the power to do that part, and it

> may change things. Grass roots, ground swells have worked in the past,

> they can work now...

>

>

> On Tue, 13 May 2003, mymisspriss19472000 wrote:

>

> > If we want low dose Naltrexone (fast-acting) to get FDA approval who

> > sends the information to them? I am sure my doctor is keeping

> > records of my usage, but how does this get to back to the Federal

> > Drug Administration? Or does the studies have to promoted by FDA?

> > Does anyone have any idea of when it will be ready to be prescribed

> > like most other drugs? Many people are not willing to try the drug

> > because of this glitch, this drug, not being FDA approved.

>

[Guest guest]

I hate to be negative but something tells me this drug will never be

clinically tested for MS. It's all a money game and there is no money in

this drug so to speak. The big money is to be had with a patent and there is

no hope for one with this drug since it's been in use almost 20 years

already. Maybe someone could put it into a patentable combo or

something...not sure. No one will put out the millions on it cuz once it

becomes proven to be something that can be used to halt the progression of

MS they will all get on the bandwagon and the ones that shelled out the

millions to test it will be left in the lurch. That is how this all works so

that is why I am not optomistic about it happening in my life time. It is

what makes all this so hard to spread the news about too. I was in an MSN

chatroom for MS and started to talk about LDN, can't stop myself from doing

that. Well when I posted the website addy for LDN they booted me out. They

asked me if I was some kind of representative for the drug or something.They

just don't trust the fact that it is not something the docs won't prescribe.

So so frustrating but I will continue to try to spread the news because I

think it is the only right thing to do. I feel obligated to let as many

people know about this as I possibly can.

I would love to see some talk show feature something like this..what better

way to spread the news? Pipe dream I guess...:-) Joyce.

>From: " G. Harding " <philh@...>

>mymisspriss19472000 <mymisspriss19472000@...>

>CC: low dose naltrexone

>Subject: Re: [low dose naltrexone] Who gives Information to FDA?

>Date: Wed, 14 May 2003 07:22:50 -0400 (EDT)

>

>it has to have rigorous clinical trials (costing thousands of $) in order

>for it to be approved by the FDA. Typically drug companies fund these

>since they are the ones who receive the billions in profit later on. Merck

>is the company who sells Naltrexone and since this is given in such low

>doses to us (~$30/month), it is doubtful they'd be willing to invest the $

>to do the trials... it's a Catch-22, isn't it?

>So what can we all do? Try this drug (help each other find an MD to

>prescribe it if necessary) and keep the volume turned up to our PCP and

>neuro on our " anecdotal " data. We have the power to do that part, and it

>may change things. Grass roots, ground swells have worked in the past,

>they can work now...

>

>

>On Tue, 13 May 2003, mymisspriss19472000 wrote:

>

> > If we want low dose Naltrexone (fast-acting) to get FDA approval who

> > sends the information to them? I am sure my doctor is keeping

> > records of my usage, but how does this get to back to the Federal

> > Drug Administration? Or does the studies have to promoted by FDA?

> > Does anyone have any idea of when it will be ready to be prescribed

> > like most other drugs? Many people are not willing to try the drug

> > because of this glitch, this drug, not being FDA approved.

> >

> >

> >

> >

[Guest guest]

one correction: Ian Zagon, who is mentioned on the LDN site, is at Penn

State and he told me he holds the patent for naltrexone. He " discovered "

this drug and published papers on it's opiate-blocking properties 20 years

ago.

(http://www.hmc.psu.edu/depts/old%20pages-kms%20save/neuro/faculty/zagon.htm)

No one has a patent on LDN for MS use or otherwise.

Ian also told me that since this research was done at a state-funded

university, he has received NO profits from having the patent. Evidently

Dr. Bihari read these papers years ago and started using LDN (low doses

i.e) for MS, HIV, and cancer patients due to their common problem: immuno

deficiency; iow's an immune system that is malfunctioning. Ian talks about

the OGF (opiod growth factor) correcting this and that's why it works in

patients with a wide variety of diseases. So you might say Dr. Bihari

" discovered " LDN -- however it's very difficult (impossible?) to patent a

dosage...

On Wed, 14 May 2003, wkendz 32 wrote:

> I hate to be negative but something tells me this drug will never be

> clinically tested for MS. It's all a money game and there is no money in

> this drug so to speak. The big money is to be had with a patent and there is

> no hope for one with this drug since it's been in use almost 20 years

> already. Maybe someone could put it into a patentable combo or

> something...not sure. No one will put out the millions on it cuz once it

> becomes proven to be something that can be used to halt the progression of

> MS they will all get on the bandwagon and the ones that shelled out the

> millions to test it will be left in the lurch. That is how this all works so

> that is why I am not optomistic about it happening in my life time. It is

> what makes all this so hard to spread the news about too. I was in an MSN

> chatroom for MS and started to talk about LDN, can't stop myself from doing

> that. Well when I posted the website addy for LDN they booted me out. They

> asked me if I was some kind of representative for the drug or something.They

> just don't trust the fact that it is not something the docs won't prescribe.

> So so frustrating but I will continue to try to spread the news because I

> think it is the only right thing to do. I feel obligated to let as many

> people know about this as I possibly can.

> I would love to see some talk show feature something like this..what better

> way to spread the news? Pipe dream I guess...:-) Joyce.

>

> >From: " G. Harding " <philh@...>

> >mymisspriss19472000 <mymisspriss19472000@...>

> >CC: low dose naltrexone

> >Subject: Re: [low dose naltrexone] Who gives Information to FDA?

> >Date: Wed, 14 May 2003 07:22:50 -0400 (EDT)

> >

> >it has to have rigorous clinical trials (costing thousands of $) in order

> >for it to be approved by the FDA. Typically drug companies fund these

> >since they are the ones who receive the billions in profit later on. Merck

> >is the company who sells Naltrexone and since this is given in such low

> >doses to us (~$30/month), it is doubtful they'd be willing to invest the $

> >to do the trials... it's a Catch-22, isn't it?

> >So what can we all do? Try this drug (help each other find an MD to

> >prescribe it if necessary) and keep the volume turned up to our PCP and

> >neuro on our " anecdotal " data. We have the power to do that part, and it

> >may change things. Grass roots, ground swells have worked in the past,

> >they can work now...

> >

> >

> >On Tue, 13 May 2003, mymisspriss19472000 wrote:

> >

> > > If we want low dose Naltrexone (fast-acting) to get FDA approval who

> > > sends the information to them? I am sure my doctor is keeping

> > > records of my usage, but how does this get to back to the Federal

> > > Drug Administration? Or does the studies have to promoted by FDA?

> > > Does anyone have any idea of when it will be ready to be prescribed

> > > like most other drugs? Many people are not willing to try the drug

> > > because of this glitch, this drug, not being FDA approved.

> > >

> > >

> > >

> > >

[Guest guest]

Hi there ,

Yes I am using the LDN in the 4.5mg dosage. Have been on it nearly a year

now. I have not had such a bad case with my MS. Not sure if my exercise

routine over the years had something to do with that. I am pretty convinced

that was the case now that I know how the LDN works. It causes the body to

produce endorphins probably the same way vigorous exercise does. That

certainly makes sense to me cuz I used to practically live at the health

club for the last 10 years or so before I started to slack off and I started

to decline. Never put two and two together before now.

Anyway, sure I can help you...whatever you want to know about it, I will try

and help answer your questions. How did you hear of the LDN?

I will try and help you with how to obtain it and the story behind it all. I

think it would really be helpful if we could draw up an outline that could

be posted somewhere on the site whereby we would not have to keep repeating

ourselves with a lot of this stuff too. There is just so much to say about

it. I'll try my darndest to help though. ...*S*. Joyce.

>From: Braun Doherty <lindabd@...>

>wkendz 32 <wkendz32@...>

>Subject: Re: [low dose naltrexone] Who gives Information to FDA?

>Date: Wed, 14 May 2003 09:21:30 -0400

>

>Joyce-

>I saw your posting about LDN and am interested to know if you use this

>drug. I

>just heard about LDN for the first time yesterday and am hopeful it will be

>good

>for my MS. Any info you have would be greatly appreciated.

>

>Thanks,

>

>

>

>wkendz 32 wrote:

>

> > I hate to be negative but something tells me this drug will never be

> > clinically tested for MS. It's all a money game and there is no money in

> > this drug so to speak. The big money is to be had with a patent and

>there is

> > no hope for one with this drug since it's been in use almost 20 years

> > already. Maybe someone could put it into a patentable combo or

> > something...not sure. No one will put out the millions on it cuz once

>it

> > becomes proven to be something that can be used to halt the progression

>of

> > MS they will all get on the bandwagon and the ones that shelled out the

> > millions to test it will be left in the lurch. That is how this all

>works so

> > that is why I am not optomistic about it happening in my life time. It

>is

> > what makes all this so hard to spread the news about too. I was in an

>MSN

> > chatroom for MS and started to talk about LDN, can't stop myself from

>doing

> > that. Well when I posted the website addy for LDN they booted me out.

>They

> > asked me if I was some kind of representative for the drug or

>something.They

> > just don't trust the fact that it is not something the docs won't

>prescribe.

> > So so frustrating but I will continue to try to spread the news

>because I

> > think it is the only right thing to do. I feel obligated to let as many

> > people know about this as I possibly can.

> > I would love to see some talk show feature something like this..what

>better

> > way to spread the news? Pipe dream I guess...:-) Joyce.

> >

> > >From: " G. Harding " <philh@...>

> > >mymisspriss19472000 <mymisspriss19472000@...>

> > >CC: low dose naltrexone

> > >Subject: Re: [low dose naltrexone] Who gives Information to FDA?

> > >Date: Wed, 14 May 2003 07:22:50 -0400 (EDT)

> > >

> > >it has to have rigorous clinical trials (costing thousands of $) in

>order

> > >for it to be approved by the FDA. Typically drug companies fund these

> > >since they are the ones who receive the billions in profit later on.

>Merck

> > >is the company who sells Naltrexone and since this is given in such low

> > >doses to us (~$30/month), it is doubtful they'd be willing to invest

>the $

> > >to do the trials... it's a Catch-22, isn't it?

> > >So what can we all do? Try this drug (help each other find an MD to

> > >prescribe it if necessary) and keep the volume turned up to our PCP and

> > >neuro on our " anecdotal " data. We have the power to do that part, and

>it

> > >may change things. Grass roots, ground swells have worked in the past,

> > >they can work now...

> > >

> > >

> > >On Tue, 13 May 2003, mymisspriss19472000 wrote:

> > >

> > > > If we want low dose Naltrexone (fast-acting) to get FDA approval who

> > > > sends the information to them? I am sure my doctor is keeping

> > > > records of my usage, but how does this get to back to the Federal

> > > > Drug Administration? Or does the studies have to promoted by FDA?

> > > > Does anyone have any idea of when it will be ready to be prescribed

> > > > like most other drugs? Many people are not willing to try the drug

> > > > because of this glitch, this drug, not being FDA approved.

> > > >

> > > >

> > > >

> > > >

[Guest guest]

you know Joyce, we've talked about this before but I do believe it has

something to do with exercise producing endorphins and that can be

enough to keep symptoms at bay. My story is that I never experienced my

balance/walking problems as badly as I did until AFTER my knee surgery.

Before that 6 months of recuperation, I worked out strenuously (I did

Aikido, a martial art, for about 12 years, running, yoga along with

that). and even though I feel I've had MS since my 30's, it never

appeared on my radar screen BECAUSE MY ENDORPHIN LEVEL WAS HIGH (

Looking back with these new MS-glasses, I recognise now that I had MS

symptoms I could not attribute to anything at the time). After I

slacked off exercise due to my knee, my symptoms increased... makes

sense, doesn't it?

LDN increases one's endorphin level by initially blocking uptake, hence

your body responds by flooding it with them... mmmm, very interesting.

I'm going to keep exercising at the gym (I can't do Aikido or running

anymore -- no balance) and keep taking LDN (3mg/day). It's only been 2

weeks and I feel great.

I encourage anyone who is on the fence about trying this

no-side-effects drug to start on it asap... nothing to lose, everything

to gain... at $30/month!

Who knows, someday I may be forced to go on an ABC drug, but for now I

am a firm believer in LDN to slow/halt the progression of this

disease....

phil

On Wednesday, May 14, 2003, at 03:20 PM, wkendz 32 wrote:

> Hi there ,

> Yes I am using the LDN in the 4.5mg dosage. Have been on it nearly a

> year

> now. I have not had such a bad case with my MS. Not sure if my exercise

> routine over the years had something to do with that. I am pretty

> convinced

> that was the case now that I know how the LDN works. It causes the

> body to

> produce endorphins probably the same way vigorous exercise does. That

> certainly makes sense to me cuz I used to practically live at the

> health

> club for the last 10 years or so before I started to slack off and I

> started

> to decline. Never put two and two together before now.

> Anyway, sure I can help you...whatever you want to know about it, I

> will try

> and help answer your questions. How did you hear of the LDN?

> I will try and help you with how to obtain it and the story behind it

> all. I

> think it would really be helpful if we could draw up an outline that

> could

> be posted somewhere on the site whereby we would not have to keep

> repeating

> ourselves with a lot of this stuff too. There is just so much to say

> about

> it. I'll try my darndest to help though. ...*S*. Joyce.

>

>

>> From: Braun Doherty <lindabd@...>

>> wkendz 32 <wkendz32@...>

>> Subject: Re: [low dose naltrexone] Who gives Information to FDA?

>> Date: Wed, 14 May 2003 09:21:30 -0400

>>

>> Joyce-

>> I saw your posting about LDN and am interested to know if you use this

>> drug. I

>> just heard about LDN for the first time yesterday and am hopeful it

>> will be

>> good

>> for my MS. Any info you have would be greatly appreciated.

>>

>> Thanks,

>>

>>

>>

>> wkendz 32 wrote:

>>

>>> I hate to be negative but something tells me this drug will never be

>>> clinically tested for MS. It's all a money game and there is no

>>> money in

>>> this drug so to speak. The big money is to be had with a patent and

>> there is

>>> no hope for one with this drug since it's been in use almost 20 years

>>> already. Maybe someone could put it into a patentable combo or

>>> something...not sure. No one will put out the millions on it cuz

>>> once

>> it

>>> becomes proven to be something that can be used to halt the

>>> progression

>> of

>>> MS they will all get on the bandwagon and the ones that shelled out

>>> the

>>> millions to test it will be left in the lurch. That is how this all

>> works so

>>> that is why I am not optomistic about it happening in my life time.

>>> It

>> is

>>> what makes all this so hard to spread the news about too. I was in an

>> MSN

>>> chatroom for MS and started to talk about LDN, can't stop myself from

>> doing

>>> that. Well when I posted the website addy for LDN they booted me out.

>> They

>>> asked me if I was some kind of representative for the drug or

>> something.They

>>> just don't trust the fact that it is not something the docs won't

>> prescribe.

>>> So so frustrating but I will continue to try to spread the news

>> because I

>>> think it is the only right thing to do. I feel obligated to let as

>>> many

>>> people know about this as I possibly can.

>>> I would love to see some talk show feature something like this..what

>> better

>>> way to spread the news? Pipe dream I guess...:-) Joyce.

>>>

>>>> From: " G. Harding " <philh@...>

>>>> mymisspriss19472000 <mymisspriss19472000@...>

>>>> CC: low dose naltrexone

>>>> Subject: Re: [low dose naltrexone] Who gives Information to FDA?

>>>> Date: Wed, 14 May 2003 07:22:50 -0400 (EDT)

>>>>

>>>> it has to have rigorous clinical trials (costing thousands of $) in

>> order

>>>> for it to be approved by the FDA. Typically drug companies fund

>>>> these

>>>> since they are the ones who receive the billions in profit later on.

>> Merck

>>>> is the company who sells Naltrexone and since this is given in such

>>>> low

>>>> doses to us (~$30/month), it is doubtful they'd be willing to invest

>> the $

>>>> to do the trials... it's a Catch-22, isn't it?

>>>> So what can we all do? Try this drug (help each other find an MD to

>>>> prescribe it if necessary) and keep the volume turned up to our PCP

>>>> and

>>>> neuro on our " anecdotal " data. We have the power to do that part,

>>>> and

>> it

>>>> may change things. Grass roots, ground swells have worked in the

>>>> past,

>>>> they can work now...

>>>>

>>>>

>>>> On Tue, 13 May 2003, mymisspriss19472000 wrote:

>>>>

>>>>> If we want low dose Naltrexone (fast-acting) to get FDA approval

>>>>> who

>>>>> sends the information to them? I am sure my doctor is keeping

>>>>> records of my usage, but how does this get to back to the Federal

>>>>> Drug Administration? Or does the studies have to promoted by FDA?

>>>>> Does anyone have any idea of when it will be ready to be prescribed

>>>>> like most other drugs? Many people are not willing to try the drug

>>>>> because of this glitch, this drug, not being FDA approved.

>>>>>

>>>>>

>>>>>

>>>>>

[Guest guest]

Hmm, how very odd. Dr Bihari told me that *he* held the patent for LDN.

Very strange, and even a bit unsettling, given the previous posts.

----- Original Message -----

From: G. Harding

wkendz 32

Cc: low dose naltrexone

Sent: Wednesday, May 14, 2003 10:29 AM

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

one correction: Ian Zagon, who is mentioned on the LDN site, is at PennState and he told me he holds the patent for naltrexone. He "discovered"this drug and published papers on it's opiate-blocking properties 20 yearsago.(http://www.hmc.psu.edu/depts/old%20pages-kms%20save/neuro/faculty/zagon.htm)No one has a patent on LDN for MS use or otherwise.Ian also told me that since this research was done at a state-fundeduniversity, he has received NO profits from having the patent. EvidentlyDr. Bihari read these papers years ago and started using LDN (low dosesi.e) for MS, HIV, and cancer patients due to their common problem: immunodeficiency; iow's an immune system that is malfunctioning. Ian talks aboutthe OGF (opiod growth factor) correcting this and that's why it works inpatients with a wide variety of diseases. So you might say Dr. Bihari"discovered" LDN -- however it's very difficult (impossible?) to patent adosage...On Wed, 14 May 2003, wkendz 32 wrote:> I hate to be negative but something tells me this drug will never be> clinically tested for MS. It's all a money game and there is no money in> this drug so to speak. The big money is to be had with a patent and there is> no hope for one with this drug since it's been in use almost 20 years> already. Maybe someone could put it into a patentable combo or> something...not sure. No one will put out the millions on it cuz once it> becomes proven to be something that can be used to halt the progression of> MS they will all get on the bandwagon and the ones that shelled out the> millions to test it will be left in the lurch. That is how this all works so> that is why I am not optomistic about it happening in my life time. It is> what makes all this so hard to spread the news about too. I was in an MSN> chatroom for MS and started to talk about LDN, can't stop myself from doing> that. Well when I posted the website addy for LDN they booted me out. They> asked me if I was some kind of representative for the drug or something.They> just don't trust the fact that it is not something the docs won't prescribe.> So so frustrating but I will continue to try to spread the news because I> think it is the only right thing to do. I feel obligated to let as many> people know about this as I possibly can.> I would love to see some talk show feature something like this..what better> way to spread the news? Pipe dream I guess...:-) Joyce.>> >From: " G. Harding" <philh@...>> >mymisspriss19472000 <mymisspriss19472000@...>> >CC: low dose naltrexone > >Subject: Re: [low dose naltrexone] Who gives Information to FDA?> >Date: Wed, 14 May 2003 07:22:50 -0400 (EDT)> >> >it has to have rigorous clinical trials (costing thousands of $) in order> >for it to be approved by the FDA. Typically drug companies fund these> >since they are the ones who receive the billions in profit later on. Merck> >is the company who sells Naltrexone and since this is given in such low> >doses to us (~$30/month), it is doubtful they'd be willing to invest the $> >to do the trials... it's a Catch-22, isn't it?> >So what can we all do? Try this drug (help each other find an MD to> >prescribe it if necessary) and keep the volume turned up to our PCP and> >neuro on our "anecdotal" data. We have the power to do that part, and it> >may change things. Grass roots, ground swells have worked in the past,> >they can work now...> >> >> >On Tue, 13 May 2003, mymisspriss19472000 wrote:> >> > > If we want low dose Naltrexone (fast-acting) to get FDA approval who> > > sends the information to them? I am sure my doctor is keeping> > > records of my usage, but how does this get to back to the Federal> > > Drug Administration? Or does the studies have to promoted by FDA?> > > Does anyone have any idea of when it will be ready to be prescribed> > > like most other drugs? Many people are not willing to try the drug> > > because of this glitch, this drug, not being FDA approved.> > >> > >> > >> > >

[Guest guest]

No, Bihari read Zagon's scientific publication 20 years ago after

naltrexone was discovered at Penn State (you can still read that journal

article if you want). It was Bihari who started using low doses for

treating patients... he does not own the patent on it.

On Wed, 14 May 2003, Rabbit wrote:

> Hmm, how very odd. Dr Bihari told me that *he* held the patent for LDN.

> Very strange, and even a bit unsettling, given the previous posts.

> ----- Original Message -----

> From: G. Harding

> wkendz 32

> Cc: low dose naltrexone

> Sent: Wednesday, May 14, 2003 10:29 AM

> Subject: Re: [low dose naltrexone] Who gives Information to FDA?

>

>

> one correction: Ian Zagon, who is mentioned on the LDN site, is at Penn

> State and he told me he holds the patent for naltrexone. He " discovered "

> this drug and published papers on it's opiate-blocking properties 20 years

> ago.

>

(http://www.hmc.psu.edu/depts/old%20pages-kms%20save/neuro/faculty/zagon.htm)

> No one has a patent on LDN for MS use or otherwise.

> Ian also told me that since this research was done at a state-funded

> university, he has received NO profits from having the patent. Evidently

> Dr. Bihari read these papers years ago and started using LDN (low doses

> i.e) for MS, HIV, and cancer patients due to their common problem: immuno

> deficiency; iow's an immune system that is malfunctioning. Ian talks about

> the OGF (opiod growth factor) correcting this and that's why it works in

> patients with a wide variety of diseases. So you might say Dr. Bihari

> " discovered " LDN -- however it's very difficult (impossible?) to patent a

> dosage...

>

> On Wed, 14 May 2003, wkendz 32 wrote:

>

> > I hate to be negative but something tells me this drug will never be

> > clinically tested for MS. It's all a money game and there is no money in

> > this drug so to speak. The big money is to be had with a patent and there

is

> > no hope for one with this drug since it's been in use almost 20 years

> > already. Maybe someone could put it into a patentable combo or

> > something...not sure. No one will put out the millions on it cuz once it

> > becomes proven to be something that can be used to halt the progression of

> > MS they will all get on the bandwagon and the ones that shelled out the

> > millions to test it will be left in the lurch. That is how this all works

so

> > that is why I am not optomistic about it happening in my life time. It is

> > what makes all this so hard to spread the news about too. I was in an MSN

> > chatroom for MS and started to talk about LDN, can't stop myself from

doing

> > that. Well when I posted the website addy for LDN they booted me out. They

> > asked me if I was some kind of representative for the drug or

something.They

> > just don't trust the fact that it is not something the docs won't

prescribe.

> > So so frustrating but I will continue to try to spread the news because

I

> > think it is the only right thing to do. I feel obligated to let as many

> > people know about this as I possibly can.

> > I would love to see some talk show feature something like this..what

better

> > way to spread the news? Pipe dream I guess...:-) Joyce.

> >

> > >From: " G. Harding " <philh@...>

> > >mymisspriss19472000 <mymisspriss19472000@...>

> > >CC: low dose naltrexone

> > >Subject: Re: [low dose naltrexone] Who gives Information to FDA?

> > >Date: Wed, 14 May 2003 07:22:50 -0400 (EDT)

> > >

> > >it has to have rigorous clinical trials (costing thousands of $) in order

> > >for it to be approved by the FDA. Typically drug companies fund these

> > >since they are the ones who receive the billions in profit later on.

Merck

> > >is the company who sells Naltrexone and since this is given in such low

> > >doses to us (~$30/month), it is doubtful they'd be willing to invest the

$

> > >to do the trials... it's a Catch-22, isn't it?

> > >So what can we all do? Try this drug (help each other find an MD to

> > >prescribe it if necessary) and keep the volume turned up to our PCP and

> > >neuro on our " anecdotal " data. We have the power to do that part, and it

> > >may change things. Grass roots, ground swells have worked in the past,

> > >they can work now...

> > >

> > >

> > >On Tue, 13 May 2003, mymisspriss19472000 wrote:

> > >

> > > > If we want low dose Naltrexone (fast-acting) to get FDA approval who

> > > > sends the information to them? I am sure my doctor is keeping

> > > > records of my usage, but how does this get to back to the Federal

> > > > Drug Administration? Or does the studies have to promoted by FDA?

> > > > Does anyone have any idea of when it will be ready to be prescribed

> > > > like most other drugs? Many people are not willing to try the drug

> > > > because of this glitch, this drug, not being FDA approved.

> > > >

> > > >

> > > >

> > > >

[Guest guest]

I didn't mean to imply that I believe he did/does, only that it was odd and unsettling that he had claimed to.

----- Original Message -----

From: G. Harding

Rabbit

Cc: wkendz 32 ; low dose naltrexone

Sent: Wednesday, May 14, 2003 11:19 PM

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

No, Bihari read Zagon's scientific publication 20 years ago afternaltrexone was discovered at Penn State (you can still read that journalarticle if you want). It was Bihari who started using low doses fortreating patients... he does not own the patent on it.On Wed, 14 May 2003, Rabbit wrote:> Hmm, how very odd. Dr Bihari told me that *he* held the patent for LDN.> Very strange, and even a bit unsettling, given the previous posts.> ----- Original Message -----> From: G. Harding> wkendz 32> Cc: low dose naltrexone > Sent: Wednesday, May 14, 2003 10:29 AM> Subject: Re: [low dose naltrexone] Who gives Information to FDA?>>> one correction: Ian Zagon, who is mentioned on the LDN site, is at Penn> State and he told me he holds the patent for naltrexone. He "discovered"> this drug and published papers on it's opiate-blocking properties 20 years> ago.> (http://www.hmc.psu.edu/depts/old%20pages-kms%20save/neuro/faculty/zagon.htm)> No one has a patent on LDN for MS use or otherwise.> Ian also told me that since this research was done at a state-funded> university, he has received NO profits from having the patent. Evidently> Dr. Bihari read these papers years ago and started using LDN (low doses> i.e) for MS, HIV, and cancer patients due to their common problem: immuno> deficiency; iow's an immune system that is malfunctioning. Ian talks about> the OGF (opiod growth factor) correcting this and that's why it works in> patients with a wide variety of diseases. So you might say Dr. Bihari> "discovered" LDN -- however it's very difficult (impossible?) to patent a> dosage...>> On Wed, 14 May 2003, wkendz 32 wrote:>> > I hate to be negative but something tells me this drug will never be> > clinically tested for MS. It's all a money game and there is no money in> > this drug so to speak. The big money is to be had with a patent and there is> > no hope for one with this drug since it's been in use almost 20 years> > already. Maybe someone could put it into a patentable combo or> > something...not sure. No one will put out the millions on it cuz once it> > becomes proven to be something that can be used to halt the progression of> > MS they will all get on the bandwagon and the ones that shelled out the> > millions to test it will be left in the lurch. That is how this all works so> > that is why I am not optomistic about it happening in my life time. It is> > what makes all this so hard to spread the news about too. I was in an MSN> > chatroom for MS and started to talk about LDN, can't stop myself from doing> > that. Well when I posted the website addy for LDN they booted me out. They> > asked me if I was some kind of representative for the drug or something.They> > just don't trust the fact that it is not something the docs won't prescribe.> > So so frustrating but I will continue to try to spread the news because I> > think it is the only right thing to do. I feel obligated to let as many> > people know about this as I possibly can.> > I would love to see some talk show feature something like this..what better> > way to spread the news? Pipe dream I guess...:-) Joyce.> >> > >From: " G. Harding" <philh@...>> > >mymisspriss19472000 <mymisspriss19472000@...>> > >CC: low dose naltrexone > > >Subject: Re: [low dose naltrexone] Who gives Information to FDA?> > >Date: Wed, 14 May 2003 07:22:50 -0400 (EDT)> > >> > >it has to have rigorous clinical trials (costing thousands of $) in order> > >for it to be approved by the FDA. Typically drug companies fund these> > >since they are the ones who receive the billions in profit later on. Merck> > >is the company who sells Naltrexone and since this is given in such low> > >doses to us (~$30/month), it is doubtful they'd be willing to invest the $> > >to do the trials... it's a Catch-22, isn't it?> > >So what can we all do? Try this drug (help each other find an MD to> > >prescribe it if necessary) and keep the volume turned up to our PCP and> > >neuro on our "anecdotal" data. We have the power to do that part, and it> > >may change things. Grass roots, ground swells have worked in the past,> > >they can work now...> > >> > >> > >On Tue, 13 May 2003, mymisspriss19472000 wrote:> > >> > > > If we want low dose Naltrexone (fast-acting) to get FDA approval who> > > > sends the information to them? I am sure my doctor is keeping> > > > records of my usage, but how does this get to back to the Federal> > > > Drug Administration? Or does the studies have to promoted by FDA?> > > > Does anyone have any idea of when it will be ready to be prescribed> > > > like most other drugs? Many people are not willing to try the drug> > > > because of this glitch, this drug, not being FDA approved.> > > >> > > >> > > >> > > >

[Guest guest]

Interesting, thanks for the link.

----- Original Message -----

From: LarryGC

LDN group

Sent: Sunday, May 18, 2003 11:31 AM

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/netahtml/search-bool.html & r=5 & f=G & l=50 & co1=AND & d=ptxt & s1=4,888,346 & OS=4,888,346 & RS=4,888,346

This is the patent that Dr. Bihari has for LDN treating chronic herpes, it also includes MS in this one. There are quite a few patents of Dr. Bihari's for LDN.

----- Original Message -----

From: Rabbit

G. Harding

Cc: wkendz 32 ; low dose naltrexone

Sent: Sunday, May 18, 2003 03:28

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

I didn't mean to imply that I believe he did/does, only that it was odd and unsettling that he had claimed to.

----- Original Message -----

From: G. Harding

Rabbit

Cc: wkendz 32 ; low dose naltrexone

Sent: Wednesday, May 14, 2003 11:19 PM

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

No, Bihari read Zagon's scientific publication 20 years ago afternaltrexone was discovered at Penn State (you can still read that journalarticle if you want). It was Bihari who started using low doses fortreating patients... he does not own the patent on it.On Wed, 14 May 2003, Rabbit wrote:> Hmm, how very odd. Dr Bihari told me that *he* held the patent for LDN.> Very strange, and even a bit unsettling, given the previous posts.>

[Guest guest]

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/netahtml/search-bool.html & r=5 & f=G & l=50 & co1=AND & d=ptxt & s1=4,888,346 & OS=4,888,346 & RS=4,888,346

This is the patent that Dr. Bihari has for LDN treating chronic herpes, it also includes MS in this one. There are quite a few patents of Dr. Bihari's for LDN.

----- Original Message -----

From: Rabbit

G. Harding

Cc: wkendz 32 ; low dose naltrexone

Sent: Sunday, May 18, 2003 03:28

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

I didn't mean to imply that I believe he did/does, only that it was odd and unsettling that he had claimed to.

----- Original Message -----

From: G. Harding

Rabbit

Cc: wkendz 32 ; low dose naltrexone

Sent: Wednesday, May 14, 2003 11:19 PM

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

No, Bihari read Zagon's scientific publication 20 years ago afternaltrexone was discovered at Penn State (you can still read that journalarticle if you want). It was Bihari who started using low doses fortreating patients... he does not own the patent on it.On Wed, 14 May 2003, Rabbit wrote:> Hmm, how very odd. Dr Bihari told me that *he* held the patent for LDN.> Very strange, and even a bit unsettling, given the previous posts.>

[Guest guest]

Someone on another system found Dr. Bihari's patent for using LDN for HIV/AIDS, and he apparently thought this was reason to not take LDN. So I looked at the other patents, was looking for his patent for MS. Didn't see any, so I started looking at ALL of them, and found that this one, the one for herpes, was where he included MS, it's a few paragraphs down.

After I read it, I thanked the person who tried to use it to get me to NOT take LDN. I told him NOW I know that I made the right choice to take it.

It's GREAT that he has a patent on it, that means biogen, teva, serono and the like can't "discover it" on their own, produce it and charge $100/bottle for it!

I also want to know about these MS Trials. What is needed/wanted/required for an LDN trial? How much money? How would one go about it? How many volunteers do you need? Trials are usually what, 2 sets of 26 or 28 people? 52 or 56? How does one go about running a trial?

----- Original Message -----

From: Rabbit

LarryGC ; LDN group

Sent: Sunday, May 18, 2003 11:31

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

Interesting, thanks for the link.

----- Original Message -----

From: LarryGC

LDN group

Sent: Sunday, May 18, 2003 11:31 AM

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/netahtml/search-bool.html & r=5 & f=G & l=50 & co1=AND & d=ptxt & s1=4,888,346 & OS=4,888,346 & RS=4,888,346

This is the patent that Dr. Bihari has for LDN treating chronic herpes, it also includes MS in this one. There are quite a few patents of Dr. Bihari's for LDN.

----- Original Message -----

From: Rabbit

G. Harding

Cc: wkendz 32 ; low dose naltrexone

Sent: Sunday, May 18, 2003 03:28

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

I didn't mean to imply that I believe he did/does, only that it was odd and unsettling that he had claimed to.

----- Original Message -----

From: G. Harding

Rabbit

Cc: wkendz 32 ; low dose naltrexone

Sent: Wednesday, May 14, 2003 11:19 PM

Subject: Re: [low dose naltrexone] Who gives Information to FDA?

No, Bihari read Zagon's scientific publication 20 years ago afternaltrexone was discovered at Penn State (you can still read that journalarticle if you want). It was Bihari who started using low doses fortreating patients... he does not own the patent on it.On Wed, 14 May 2003, Rabbit wrote:> Hmm, how very odd. Dr Bihari told me that *he* held the patent for LDN.> Very strange, and even a bit unsettling, given the previous posts.>

[Guest guest]

I apologize for the misinformation regarding LDN. I didn't realize that

dosage amounts of a FDA-approved drug could be patented.

Phil Harding

On Sun, 18 May 2003, LarryGC wrote:

>

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/netahtm\

l/search-bool.html & r=5 & f=G & l=50 & co1=AND & d=ptxt & s1=4,888,346 & OS=4,888,346 & RS=4,88\

8,346

>

>

> This is the patent that Dr. Bihari has for LDN treating chronic herpes, it

also includes MS in this one. There are quite a few patents of Dr. Bihari's for

LDN.

>

>

> ----- Original Message -----

> From: Rabbit

> G. Harding

> Cc: wkendz 32 ; low dose naltrexone

> Sent: Sunday, May 18, 2003 03:28

> Subject: Re: [low dose naltrexone] Who gives Information to FDA?

>

>

> I didn't mean to imply that I believe he did/does, only that it was odd and

unsettling that he had claimed to.

> ----- Original Message -----

> From: G. Harding

> Rabbit

> Cc: wkendz 32 ; low dose naltrexone

> Sent: Wednesday, May 14, 2003 11:19 PM

> Subject: Re: [low dose naltrexone] Who gives Information to FDA?

>

>

> No, Bihari read Zagon's scientific publication 20 years ago after

> naltrexone was discovered at Penn State (you can still read that journal

> article if you want). It was Bihari who started using low doses for

> treating patients... he does not own the patent on it.

>

> On Wed, 14 May 2003, Rabbit wrote:

>

> > Hmm, how very odd. Dr Bihari told me that *he* held the patent for LDN.

> > Very strange, and even a bit unsettling, given the previous posts.

> >