Re: Process for FDA approval - Change off label use

[Guest guest]

This is why I believe a focus of this group and the various

Societies should be lobbying to change the rules and laws associated

with prescribing and taking " Approved " drugs for Off Label (meaning

not currently approved and on the label) conditions.

Since an " approved " drug has already been " tested " for treating

something, and found " safe " (presumably for most people subject to

the warning on the label),focusing on use of that drug in the

approved (or in the case of things like LDN) or less than approved

dose should be one of the things we are targeting and discussing.

The bigger issue of Off Label use is typically similiar to the LDN

story, where the drug is out of patent protection and the economics

end up putting it into limbo with respect to off label use. The big

issue for prescribing it is often fear of liability (getting sued).

I had one Neuro say that to me (in a general and vague way - but the

message was clear).

Focusing on allowing patients and Doctors to use and

prescribe " approved " drugs would probably mean the patient signing

some releases so that all the folks worried about getting sued are

covered. No doubt this would require the " buyer to beware " , but with

drugs like LDN, given its history (safe use) and Low dose it seems a

prime candidate for exmplifying the bigger issue of Off Label use.

This may well be the " Back Door " some have mentioned previously on

this site.

Just my thoughts!

Alan

> Now we can understand the complexity of getting LDN approved!

>

>

[Guest guest]

Aegis thinks, What we need is a trial, if LDN works, the FDA will

approve LDN for the new indication MS. If it does not, changing the

rules will not change anything, unless the new rules are to approve

drugs based on anecdotal data.

> > Now we can understand the complexity of getting LDN approved!

> >

> >

[Guest guest]

>Aegis wrote....

>Aegis thinks, What we need is a trial, if LDN works, the FDA will

approve LDN for the new indication MS.....

Respectfully, and with no offense of any kind intended - Aegis can

think what he or she likes, but I for one don't completely agree!

I am trying to keep focused on the " Goal " , which I believe to be:

Easy and reliable (consistent dosage) access to LDN for MSers (and

all the others suffering from conditions it might help), NOW!

Being " new " to MS, having been dx in Feb. and on LDN for over 60

days, the first thing I noticed when looking into LDN was the

difficulties many were encountering, and continue to encounter

today, when simply trying to get their hands on an RX for LDN, and

getting it filled properly.

Although I would love to see Clinical Trials, for several reasons

(not the least of which is being testing oriented given my

Engineering background), I believe we should all be thinking about,

and supporting options that have the potential to make LDN available

ASAP. Far too many MSers (and others) continue to progress when LDN

might help. This is true of other potential Off Label drugs as well!

As we all know, the name of the game for us MSers is slowing down or

halting progression. At best, Trials will take years to yield

tangible results for MSers waiting for " official " approval for LDN

use for MS. Even with trials, it will be an uphill fight because LDN

is cheap and beyond patent protection as the rules stand today!

I see no harm, and much potential gain, in prioritizing both

Clinical Trials and changes to Off Label use retrictions, even if

that means waivers or new patent protections. If we do get some

serious news media interested, the Off Label use " angle " may be as,

or more interesting to the media, given their focus on short term

sensationalism. Trials are a longterm deal, especially for those

still progressing! Off Label use may not be a subject to bring up

with folks considering doing, or otherwise interested in a trial,

but I have contacted several media people and seem to be getting a

better response to the concept of approved drugs being used for

other, so far unapproved " conditions (Off Label Use), versus

Clinical Trials for LDN.

Although we need to focus our efforts, we also need to keep

the " goal " (or at least I think it's ours, it's certainly my goal as

noted above) in front of us, and not necessarily keep all our eggs

in the " Clinical Trials " basket. If life was perfect Trials would be

the way to go, but if life was perfect we wouldn't need LDN!

This is just my opinion, Aegis and others are certainly welcome to

theirs.

Comments?

Best, Alan

>Aegis wrote....

>Aegis thinks, What we need is a trial, if LDN works, the FDA will

approve LDN for the new indication MS. If it does not, changing the

> rules will not change anything, unless the new rules are to

approve

> drugs based on anecdotal data.

" alanms1579 " ......> wrote:

> > This is why I believe a focus of this group and the various

> > Societies should be lobbying to change the rules and laws

> associated

> > with prescribing and taking " Approved " drugs for Off Label

(meaning

> > not currently approved and on the label) conditions.

> >

> > Since an " approved " drug has already been " tested " for treating

> > something, and found " safe " (presumably for most people subject

to

> > the warning on the label),focusing on use of that drug in the

> > approved (or in the case of things like LDN) or less than

approved

> > dose should be one of the things we are targeting and

discussing.

> >

> > The bigger issue of Off Label use is typically similiar to the

LDN

> > story, where the drug is out of patent protection and the

economics

> > end up putting it into limbo with respect to off label use. The

big

> > issue for prescribing it is often fear of liability (getting

sued).

> > I had one Neuro say that to me (in a general and vague way - but

> the

> > message was clear).

> >

> > Focusing on allowing patients and Doctors to use and

> > prescribe " approved " drugs would probably mean the patient

signing

> > some releases so that all the folks worried about getting sued

are

> > covered. No doubt this would require the " buyer to beware " , but

> with

> > drugs like LDN, given its history (safe use) and Low dose it

seems

> a

> > prime candidate for exmplifying the bigger issue of Off Label

use.

> >

> > This may well be the " Back Door " some have mentioned previously

on

> > this site.

> >

> > Just my thoughts!

> > Alan

> >

> > > Now we can understand the complexity of getting LDN approved!

[Guest guest]

Aegis is not big or smart enough to convince the FDA or the neuros

to approve LDN for MS without any supporting data (i.e. trial).

Anybody who claims this can be done is setting themselves and others

for a big disappointment. Alan is essentially asking the govt. hey

we desperately need engineers, can he graduate as an engineer

without going to college?. I rest my case.

> > > > Now we can understand the complexity of getting LDN approved!

[Guest guest]

Hi Alan,

I thought that your observations & suggestions re. the question of Off Label

use of LDN were interesting & to the point!

-From the somewhat judgemental & dismissive tone of their messages, it would

seem that some of us are pretty much convinced that we are the only ones

that know what`s going on (or SHOULD be going on) around here! -Personally,

I reckon that in this incredibly speedy,chaotic & crazy world in which we

find ourselves, a little more relaxed, friendly & unhurried consideration of

the various options that may be open to us would probably be a very good

idea!

Re. Off Label use, was there not a message fairly recently which stated

something like, that in the area of treatment of heart disease conditions,

the " off label " use of medications is so extensive that, it is a normal and

essential part of effective treatment? If this is indeed the case, perhaps

it would be helpful to try & learn the " whys & wherefores " of how this

situation came to be the norm?

By the way , I`m sure that a great many of us would have liked to have

started LDN so very close to our initial diagnosis! (it took me over 13

years to find it!) -In this sense at least, you seem to have been very

fortunate!......Nice one!!!

As this is such a vibrant & lively site, with the only definite common

interest being LDN, it seems pretty much inevitable that there will continue

to be an abundance of differing views! For our own comfort & ease as well as

lessening the potential alienation of newcomers, perhaps it would helpful if

occasionally we reflected on thoughts such as Luther King`s " Either

we learn to live together like brothers & sisters on this planet, or we

perish together as fools. " !

Finally, I would like to thank those of you who took the time to respond to

my recent spate of messages for your comments! - I don`t spend all day at

the computer, so with the recent heavy flow of messages here, & my being a

VERY slow typist, I regret that I have been unable to reply to as many as I

might have liked!

I think that this is a great site.

May we all be well & happy!

Gerald

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

From: " alanms1579 " <alanms@...>

<low dose naltrexone >

Sent: Friday, May 28, 2004 5:10 AM

Subject: [low dose naltrexone] Re: Process for FDA approval - Change off label

use

> >Aegis wrote....

> >Aegis thinks, What we need is a trial, if LDN works, the FDA will

> approve LDN for the new indication MS.....

>

> Respectfully, and with no offense of any kind intended - Aegis can

> think what he or she likes, but I for one don't completely agree!

>

> I am trying to keep focused on the " Goal " , which I believe to be:

>

> Easy and reliable (consistent dosage) access to LDN for MSers (and

> all the others suffering from conditions it might help), NOW!

>

> Being " new " to MS, having been dx in Feb. and on LDN for over 60

> days, the first thing I noticed when looking into LDN was the

> difficulties many were encountering, and continue to encounter

> today, when simply trying to get their hands on an RX for LDN, and

> getting it filled properly.

>

> Although I would love to see Clinical Trials, for several reasons

> (not the least of which is being testing oriented given my

> Engineering background), I believe we should all be thinking about,

> and supporting options that have the potential to make LDN available

> ASAP. Far too many MSers (and others) continue to progress when LDN

> might help. This is true of other potential Off Label drugs as well!

>

> As we all know, the name of the game for us MSers is slowing down or

> halting progression. At best, Trials will take years to yield

> tangible results for MSers waiting for " official " approval for LDN

> use for MS. Even with trials, it will be an uphill fight because LDN

> is cheap and beyond patent protection as the rules stand today!

>

> I see no harm, and much potential gain, in prioritizing both

> Clinical Trials and changes to Off Label use retrictions, even if

> that means waivers or new patent protections. If we do get some

> serious news media interested, the Off Label use " angle " may be as,

> or more interesting to the media, given their focus on short term

> sensationalism. Trials are a longterm deal, especially for those

> still progressing! Off Label use may not be a subject to bring up

> with folks considering doing, or otherwise interested in a trial,

> but I have contacted several media people and seem to be getting a

> better response to the concept of approved drugs being used for

> other, so far unapproved " conditions (Off Label Use), versus

> Clinical Trials for LDN.

>

> Although we need to focus our efforts, we also need to keep

> the " goal " (or at least I think it's ours, it's certainly my goal as

> noted above) in front of us, and not necessarily keep all our eggs

> in the " Clinical Trials " basket. If life was perfect Trials would be

> the way to go, but if life was perfect we wouldn't need LDN!

>

> This is just my opinion, Aegis and others are certainly welcome to

> theirs.

>

> Comments?

> Best, Alan

>

> >Aegis wrote....

> >Aegis thinks, What we need is a trial, if LDN works, the FDA will

> approve LDN for the new indication MS. If it does not, changing the

> > rules will not change anything, unless the new rules are to

> approve

> > drugs based on anecdotal data.

>

> " alanms1579 " ......> wrote:

> > > This is why I believe a focus of this group and the various

> > > Societies should be lobbying to change the rules and laws

> > associated

> > > with prescribing and taking " Approved " drugs for Off Label

> (meaning

> > > not currently approved and on the label) conditions.

> > >

> > > Since an " approved " drug has already been " tested " for treating

> > > something, and found " safe " (presumably for most people subject

> to

> > > the warning on the label),focusing on use of that drug in the

> > > approved (or in the case of things like LDN) or less than

> approved

> > > dose should be one of the things we are targeting and

> discussing.

> > >

> > > The bigger issue of Off Label use is typically similiar to the

> LDN

> > > story, where the drug is out of patent protection and the

> economics

> > > end up putting it into limbo with respect to off label use. The

> big

> > > issue for prescribing it is often fear of liability (getting

> sued).

> > > I had one Neuro say that to me (in a general and vague way - but

> > the

> > > message was clear).

> > >

> > > Focusing on allowing patients and Doctors to use and

> > > prescribe " approved " drugs would probably mean the patient

> signing

> > > some releases so that all the folks worried about getting sued

> are

> > > covered. No doubt this would require the " buyer to beware " , but

> > with

> > > drugs like LDN, given its history (safe use) and Low dose it

> seems

> > a

> > > prime candidate for exmplifying the bigger issue of Off Label

> use.

> > >

> > > This may well be the " Back Door " some have mentioned previously

> on

> > > this site.

> > >

> > > Just my thoughts!

> > > Alan

>

> > >

> > > > Now we can understand the complexity of getting LDN approved!

>

>

>

>

>

>

>

[Guest guest]

Thanks for the kind words. Although I would love to see Clinical

trails, and hope we will soon, both you and Friday (and several

other choosing to email instead of post) are on target with the

issues you all noted with respect to Off Label use.

Although I don't know Aegis, I can understand his/her position. I

also like working " behind the scenes " and that has led me to

splitting my efforts between a Trial and Off Label stuff. Aegis has

been a valuable contributor here, from whom I've learned alot. We

are all entitled to our opinion, and mine is that the Off Label

angle has merit.

Just for the record, I was either the first or second person to

register for Aegis' LDNers site. Good idea, and I appreciate the

work it took.

I have been in contact with several Ontario (Canada) Newspapers and

have been able get some interest from a City Editor. Some interest

in LDN and Clinical Trials, but more interest in the Off Label Use

issue. Again, we not talking about getting " approval " for changing

the " label " of naltrexone without a Trial, but removing the

obstacles (legal, moral, mental, financial - perceived or otherwise)

so that Docs and patients have some level of comfort prescribing and

taking LDN (clearly most of us here need no official stamp - but

some do). Changing Patent laws and rules, and or adding some kind of

release of liability for Off LAbel use, doesn't seem so far fetched

to me. I am hoping people respond to Friday's request for a list of

popular Off LAbel drugs.

I hope to meet with this City Editor in the next several weeks. He

is currently on Holidays. I will post as I know more.

Best Regards

Alan

> > > > > Now we can understand the complexity of getting LDN

approved!

> >

> >

> >

> >

> >

> >

> >