RE: FDA approval

[Guest guest]

is correct. The FDA does not approve medical protocols. It approves

drugs. All of the drugs that are used at this time are all in any typical

formulary with the possible exception of Kutapressin because it is not a

commonly used drug. Kathy -NNY

[Guest guest]

Hi SM-

Just what part of the treatment are you thinking is not FDA

approved? I don't think the " protocol " requires FDA approval (I know

individual drugs require approval). My son has never received anything

that is not FDA approved and legal.

Just like everyone else, if I get a sinus infection, my doc starts the

rounds of various antibiotics and if there is a fungal infection too,

throws in the anti-fungal. I don't see how treatment is any

different. Maybe you are asking when the protocol will be recognized by

the establishment as legitimate treatment for children with the

(psychological) Dx of Autism? I guess I am confused about what you mean.

the Moghaddams wrote:

> Does any one have an idea when procedure would be approved by FDA

> in treatment of autism?

> Thanks

> S.M.

>

[Guest guest]

Hi all,

I know the approval date very well. It was May 2001.

I was enrolled in the Expanded Access Trial # 113. This trial was for those

patients who failed on Interferon. The trial terminated when Gleevec was FDA

approved. At that point in time I had 2 choices. 1. Pay for the drug or 2.

Find another trial. I was lucky to get into a trial in Canada.

At the time Gleevec was the fasted approved cancer drug.

Novartis applied in Feb 2001 and was granted approval in May 2001.

Zavie

Discoveries Leading to FDA Approval of STI571/Gleevec: Fact Sheet

1960: Nowell reported that patients with chronic myelogenous leukemia

(CML) consistently had an abnormally small chromosome 22, an alteration that

became known as the Philadelphia chromosome. Because of the consistency of

the finding, scientists speculated that this shortening might be related to

the cause of the leukemia.

1973: New staining techniques allowed researchers to see that, in addition

to the deletion in the long arm of chromosome 22, the long arm of chromosome

9 was lengthened by about the same amount in all the CML patients examined.

This suggested that pieces of each chromosome were exchanged or

translocated.

1982: One of the human cancer genes, the abl proto-oncogene, was shown to be

located on chromosome 9 in non-CML patients and translocated to the

Philadelphia chromosome in patients with CML. These findings raised the

prospect that the abl oncogene was activated by this translocation.

1984-1987: During this period, several labs played a role in discovering how

the translocation produces a cancer-causing protein. They found that in

cancer cells, the abl translocation to chromosome 22 leads to the formation

of an altered protein containing a piece of the Abl protein joined to a

piece of a second protein, BCR. It is this fused protein product, called

BCR-ABL, which is abnormally expressed in about 95 percent of CML patients.

1990: Several labs showed that bcr-abl alone causes leukemia in mice.

1993: The first laboratory studies of STI571 began when a scientist, now at

Oregon Health Sciences Center in Portland, approached Ciba-Geigy, now

Novartis Pharmaceuticals (Basel, Switzerland) requesting permission to test

various compounds that would be likely to block the abnormal protein,

BCR-ABL.

1996: One of these compounds, STI571, was shown to inhibit the growth of

BCR-ABL-expressing cells.

1998: STI571 was first tested in a small study in people to determine

whether it is safe. Doctors noticed that with higher doses, patients had

dramatic positive responses to the drug.

1999: The preliminary results of this early study showed that 31 out of 31

patients who received at least 300 milligrams daily had their blood counts

return to normal. In nine of the 20 patients who were treated for five

months or longer, no cells with the Philadelphia chromosome could be found.

2001: February: Novartis submitted the New Drug Application for STI571, now

known as Gleevec, to FDA for the treatment of the late phases of CML.

2001: April: Results of a larger study of STI571 in 83 patients were

reported in New England Journal of Medicine. In the 54 chronic-phrase CML

patients who were treated with doses of 300 milligrams or more, normal blood

counts were restored in 53, and in 29 of the 54 patients, the Philadelphia

chromosome disappeared. Most side effects were mild.

2001: May: U.S. Food and Drug Administration approved the sale of

STI571/Gleevec for CML.

Zavie (age 71)

67 Shoreham Avenue

Ottawa, Canada, K2G 3X3

dxd AUG/99

INF OCT/99 to FEB/00, CHF

No meds FEB/00 to JAN/01

Gleevec since MAR/27/01 (400 mg)

CCR SEP/01. #102 in Zero Club

2.8 log reduction Sep/05

3.0 log reduction Jan/06

2.9 log reduction Feb/07

3.6 log reduction Apr/08

3.6 log reduction Sep/08

3.7 log reduction Jan/09

3.8 log reduction May/09

e-mail: zmiller@...

Tel: 613-726-1117

Fax: 613-482-4801

Cell: 613-282-0204

ID: zaviem

YM: zaviemiller

Skype: Zavie

_____

From: [mailto: ] On Behalf Of Lottie

Duthu

Sent: August 20, 2009 12:54 AM

CML

Subject: [ ] FDA approval

Dear Bobby,

You are right, Gleevec was approved in 2001, that's when I got off my

Inteferon horse. I remember Gleevec trial talk on ACOR right after I was

diagnosed, so I think it was longer than that. Zavie would know. Just

reading about it and thinking about it kept me going until I could make the

switch. Inteferon was a witch, but for some it was all we had, except for

Hydrea and Busulfan. I was on Hydrea for 4 years and on Gleevec 4 years as

well. Hard to believe all the drugs we were on. As of now, I count 7 total.

xoxoxox

Lottie Duthu

[Guest guest]

I was in trial right around the same time as Zavie, and I will never forget it

was May 2001, because I used to travel back and forth to NY for the Trial. I

went in April of 2001, and they told me it would be my last appointment in NY,

and that I could start seeing my Oncologist in NJ due to the FDA Approval in

May. What a relief that was.

[Guest guest]

I`m sorry but I`m a little horrified at this kind of attitude. When I go with my husband to his neuro appointments once a year, we sit in the waiting room and I could cry when I see the state some people are in. I know they all have MS. Some cant talk anymore, most cant walk without aid. Am I supposed to sit there and think that these people dont deserve to know about LDN because they didnt find it yet? Or dont use a computer? I don`t think we have any right to try to keep this "our little secret", that would be a horrible selfish attitude.

I would not have found out about LDN 7 years ago had someone not "paid it forward' and put their findings on the internet. Then maybe my husband would be one of those poor people in the waiting room instead of a man who still works each day.Be

low dose naltrexone From: oldglory@...Date: Thu, 10 Mar 2011 15:31:29 -0600Subject: [low dose naltrexone] FDA approval

Hi,I agree. Trialing would be right down their alley. You would not be able to afford it, nor find doctors to prescribe it. Leave It ALONE! It belongs to the people and once you give it up, it won’t come back around. We don’t want their approval!!!!! Jean

From: <bicyclenutmail-ldn@...>Reply-<bicyclenutmail-ldn@...>Date: Thu, 10 Mar 2011 06:51:54 -0800 (PST)Pat O'Mara <nypatandgeorge@...>, <low dose naltrexone >Subject: RE: [low dose naltrexone] FDA approvalYou said that "It cost pennies now and the increase would be minimal." You are either very naive or you are connected to the drug companies. Dr Skips example, I have forgotten the name of the drug, was a very old drug that was very cheap, the FDA offered a drug company to trial the drug and they would have an exclusive on it. The price went up something like 1000 times, hardly minimal.Sterling

From: Pat O'Mara <nypatandgeorge@...>Subject: RE: [low dose naltrexone] FDA approvalbicyclenutmail-ldn@...Date: Thursday, March 10, 2011, 4:04 AMSo what if the FDA approves it for lower doses and the price goes up... isn't FDA approval what everyone is fighting for? Isn't this the reason doctors won't prescribe it? Don't we all want this available to every patient who needs it? It would be the BEST thing to happen! It cost pennies now and the increase would be minimal. It would be nice to see it on the news as the best thing in 50 years and it would hurt companies who make lousy expensive drugs that don't work and make patients sick. Millions could benefit!

low dose naltrexone From: bicyclenutmail-ldn@...Date: Wed, 9 Mar 2011 22:43:15 -0800Subject: [low dose naltrexone] FDA approval I too am concerned that FDA approval will mean higher prices for LDN. Are we cutting our own throat by promoting LDN? I hate to think that. However, Dr Skips example and other similar examples, it looks like LDN might just be ours and nobody else. What an awful position.Sterling

[Guest guest]

I am almost afraid to have the FDA do anything. I just read an article that they gave the nod for a progesterone shot that helps women keep from having miscarrying. They used to have to have it compounded for about $10 – $40 per shot. Now that the FDA has approved it for this reason it will now cost $1,500 per shot which means it could end up costing $30,000 for a woman to keep her baby. Scary thought.

Theresa

Attachment: vcard [not shown]

[Guest guest]

My wife has Crohn's and the doctor prescribed Entocort at $800.00 per month and if that did not work he wanted to "TRY" Remicade at who knows how much, I have heard $6000.00 per infusion. She in now on LDN and has good results at a very small price in a relatively short time (2 months)SterlingAnd thank you Dr Skip for all you have doneFrom: slenzrph@... <slenzrph@...>Subject: RE: [low dose naltrexone] FDA approvallow dose naltrexone Date: Friday, March 11, 2011, 11:52 AM

I sent this to Jayne, and the group but must have been misplaced.

I am one of those who does not want LDN to be approved by the US FDA. Let me point out what happened to 4 aminopyridine when .Ampyra was approved. We sell 4-ap 10mg for less than 40 dollars per month. Ampyra as of just a few minutes ago was wholesaling for over 1000 dollars for a month's supply. Same drug different delivery system. Our stuff you have to take three times a day, their stuff you take twice a day. So for 960 dollars you have the luxury of reducing your dose by one per day. Now, we have dispensed this for over 10 years now. Not once did I ever have anyone complain that they were inconvienced by the extra tab and for close to a thousand dollars.

Next is progesterone injection to prevent spontaneous abortion. We have sold literally gallons of this stuff in 10 ml sizes. Price was 39.95/10 mls. New company gets an orphan approval and is now selling it for 1500 dollars.

I can go on, but sufficive to say that these bottom feeding pieces of bovine feces will feed on MS patients at every opportunity they can get. Just look at the average cost of the crap drugs, opps I mean crabs. > 30,000 dollars per year. For what, an average decrease of 38% for exacerbations. It goes on and on, how about Prokarin for 250 dollars, the zapper for 199 dollars, dr barefoots super duper pooper scoper calcium carbonate for 49 dollars. All approved all junk but MS patients will jump because this crap might help.

So no I don't support the approval of LDN. I will challenge the applications with a patient petition as soon as I learned about it.

I have spent the last 10 years selling LDN for a pittance. Why, because it is one of the most significant drugs I have seen in the last almost 40 years. I believe that people should have access to it no matter how much money they make. You get this approved and all bets are off.

Answer me this, was I a fool for making it available to a large number of people, or should I have charged 50-60-up to 90 dollars per month.

Okay, I will get off my high horse now. Friends can disagree.

Skip

[Guest guest]

Count me in, too. No price increase for LDN and no profits for big

pharmaceutical companies, the government, the NMSS and other useless groups.

They didn't care about us before, no reason to care about us now.

Art

--

>

> Thank you, Dr. Skip. I don't know how it all works, but if appropriate, I

> will sign on to your patient petition in a heartbeat.

>

> --

>

>

> >I sent this to Jayne, and the group but must have been misplaced.

> >I am one of those who does not want LDN to be approved by the US FDA. Let

> >me point out what happened to 4 aminopyridine when .Ampyra was

> >approved. We sell 4-ap 10mg for less than 40 dollars per month. Ampyra

> >as of just a few minutes ago was wholesaling for over 1000 dollars for a

> >month's supply. Same drug different delivery system. Our stuff you have

> >to take three times a day, their stuff you take twice a day. So for 960

> >dollars you have the luxury of reducing your dose by one per day. Now, we

> >have dispensed this for over 10 years now. Not once did I ever have

> >anyone complain that they were inconvienced by the extra tab and for close

> >to a thousand dollars.

> >Next is progesterone injection to prevent spontaneous abortion. We have

> >sold literally gallons of this stuff in 10 ml sizes. Price was 39.95/10

> >mls. New company gets an orphan approval and is now selling it for 1500

> >dollars.

> >I can go on, but sufficive to say that these bottom feeding pieces of

> >bovine feces will feed on MS patients at every opportunity they can

> >get. Just look at the average cost of the crap drugs, opps I mean

> >crabs. > 30,000 dollars per year. For what, an average decrease of 38%

> >for exacerbations. It goes on and on, how about Prokarin for 250 dollars,

> >the zapper for 199 dollars, dr barefoots super duper pooper scoper calcium

> >carbonate for 49 dollars. All approved all junk but MS patients will jump

> >because this crap might help.

> >So no I don't support the approval of LDN. I will challenge the

> >applications with a patient petition as soon as I learned about it.

> >I have spent the last 10 years selling LDN for a pittance. Why, because

> >it is one of the most significant drugs I have seen in the last almost 40

> >years. I believe that people should have access to it no matter how much

> >money they make. You get this approved and all bets are off.

> >Answer me this, was I a fool for making it available to a large number of

> >people, or should I have charged 50-60-up to 90 dollars per month.

> >Okay, I will get off my high horse now. Friends can disagree.

> >Skip

> >

> >

> >

>

>

> ~~~ There is no way to peace; peace is the way ~~~~

> --A.J. Muste

>

[Guest guest]

Skip - were both of those slightly altered for a new patent?  JaxiOn Fri, Mar 11, 2011 at 1:52 PM, <slenzrph@...> wrote:

I sent this to Jayne, and the group but must have been misplaced.

I am one of those who does not want LDN to be approved by the US FDA.  Let me point out what happened to 4 aminopyridine when .Ampyra was approved.   We sell 4-ap 10mg  for less than 40 dollars per month.  Ampyra as of just a few minutes ago was wholesaling for over 1000 dollars for a month's supply.  Same drug different delivery system.  Our stuff you have to take three times a day, their stuff you take twice a day.  So for 960 dollars you have the luxury of reducing your dose by one per day.  Now, we have dispensed this for over 10 years now.  Not once did I ever have anyone complain that they were inconvienced by the extra tab and for close to a thousand dollars.

Next is progesterone injection to prevent spontaneous abortion.  We have sold literally  gallons of this stuff in 10 ml sizes.  Price was 39.95/10 mls.  New company gets an orphan approval and is now selling it for 1500 dollars. 

I can go on, but sufficive to say that these bottom feeding pieces of bovine feces will feed on MS patients at every opportunity they can get.  Just look at the average cost of the crap drugs, opps I mean crabs.  > 30,000 dollars per year.  For what, an average decrease of 38% for exacerbations.  It goes on and on, how about Prokarin for 250 dollars, the zapper for 199 dollars, dr barefoots super duper pooper scoper calcium carbonate for 49 dollars.  All approved all junk but MS patients will jump because this crap might help.

So no I don't support the approval of LDN.  I will challenge the applications with a patient petition as soon as I learned about it. 

I have spent the last 10 years selling LDN for a pittance.  Why, because it is one of the most significant drugs I have seen in the last almost 40 years.  I believe that people should have access to it no matter how much money they make.  You get this approved and all bets are off. 

Answer me this, was I a fool for making it available to a large number of people, or should I have charged 50-60-up to 90 dollars per month. 

Okay, I will get off my high horse now.  Friends can disagree.

Skip

[Guest guest]

sadly, that's how it is and i'm with you.

thanks for posting this... maybe it will give due pause to some well-intended exuberance.

you're only a fool in the eyes of predators deserving of contempt, near as i can figger.

From: low dose naltrexone [mailto:low dose naltrexone ] On Behalf Of slenzrph@...Sent: Friday, March 11, 2011 11:52 AMlow dose naltrexone Subject: RE: [low dose naltrexone] FDA approval

I sent this to Jayne, and the group but must have been misplaced.

I am one of those who does not want LDN to be approved by the US FDA.

Answer me this, was I a fool for making it available to a large number of people, or should I have charged 50-60-up to 90 dollars per month.

Okay, I will get off my high horse now. Friends can disagree.

Skip

[Guest guest]

Healthcare should not be "for sale to the highest bidder" .... it's a tragedy of monumental proportion that powerful companies prey on those who are ill. I'm with Skip on this one, I think LDN should be made available to everyone & I surely wouldn't mind if it cost me $10 more but, if is going to cost me hundreds/thousands more for this to happen, I won't be able to afford it for my daughter. Something is seriously wrong with "the system".

RE: [low dose naltrexone] FDA approval

I sent this to Jayne, and the group but must have been misplaced.

I am one of those who does not want LDN to be approved by the US FDA.

Answer me this, was I a fool for making it available to a large number of people, or should I have charged 50-60-up to 90 dollars per month.

Okay, I will get off my high horse now. Friends can disagree.

Skip

[Guest guest]

From what I understand,

LDN can be tweeked (same drug but something added) and walla, you have a "new" patented drug. Skip, Am I right?

RE: [low dose naltrexone] FDA approval

I sent this to Jayne, and the group but must have been misplaced.

I am one of those who does not want LDN to be approved by the US FDA.

Answer me this, was I a fool for making it available to a large number of people, or should I have charged 50-60-up to 90 dollars per month.

Okay, I will get off my high horse now. Friends can disagree.

Skip

[Guest guest]

IMHO - - Dr. Skip's remarks and his often unheralded support of this group are excellent reasons why anyone that has a prescription for LDN should use his services exclusively.

[Guest guest]

I agree, in the US, approval would be devastating to price, but if we got the socialist system in the UK to do the work (trials), then it would not be Big Pharma driving the case and you would not see the price rises, you would just see it in use.  The British Govt would not be interested in making huge profits out of it, like some of our pharmacists currently do.  This to me is unacceptable and those pharmacists charging the NHS 10 times the amount Dicksons do need to be put out of business.  Unfortunately when prescribing ‘specials’ here in the UK, it is perfectly legal (not ethical, but legal).  As I pointed out to another post, our so-called Dept of Health needs to get a handle on this and stop it.  I believe this is currently being looked into. Re your ‘bottom line’ – any Dr can prescribe LDN off label in the UK too, but the risk of them being reported to our General Medical Council for doing so, is, a huge risk, one which could result in them losing their licence to practise for 12 months.  Already one of our LDN prescribing Drs has been reported but thankfully won his case.  This in itself is not acceptable - Drs fearing to prescribe LDN.  It isn’t a case of if they don’t believe some study when you show it to them, they never will, it really is a case of “what have I got to lose by prescribing LDN†and I’m sad to say that in the UK, it’s a heck of a lot.  We are therefore campaigning to get it approved so Drs have the confidence and the comfort to prescribe it without any libel action. We want the patients not the drug companies to get this approval.  If the charities aren’t interested or can’t raise the funds, the drug companies aren’t interested, the academics aren’t interested, but the patients are, we need to be able to get the clinical trial and the approval using public money.  These systems don’t exist yet but this is what we are fighting for.  Personally I don’t favour any trials especially when a drug is already approved at a certain dose and we only want it recognised as a treatment in lower doses for various conditions.  There’s no logic or easy solution but when I read more often than not people are now considering LDN as everything else has ‘failed’ it makes me furious knowing what damage they have endured which they can’t regain and not having the option or being told about a non toxic harmless drug like LDN. Jayne Crocker www.LDNNow.comImportant! Please sign our LDN petition to the European Parliament by clicking heretel: +44 (0) 7877 492 669Dr Steele MBE, talking about LDNLDNNow are a political/pressure group of individuals dedicated to getting Low Dose Naltrexone (LDN) accepted into modern medicine and trialled for the myriad of uses it shows benefit for. . From: SLenzrph@... [mailto:SLenzrph@...] Sent: 11 March 2011 15:07jaynelcrocker@...Subject: Re: [low dose naltrexone] FDA approval I am one of those who is against taking this to the FDA. Need I point out what happened to 4 aminopyridine, or progesterone inject, or dilt cream. Each of these drugs were taken throu the FDA process and have increases in price one to two magnitudes. These drugs have been trialed over and over and over again. They work. If a physician doesn't choose to believe these studies, they won't believe anything. Lets get to the bottom line, docs in the US can prescribe off label. They have always been able to. One of the requirements is to have data that supports the off label use. The Italian studies are well designed studies that support the use of LDN in ms. The real issue is who pays for it. The UK system, correct me if I am wrong, has the government paying the bill. Last week we saw how some pharmacist are already gouging the government, was it 200 dollars or 200 pounds. Either case that is highway robbery and those pharmacist should be shot. I do not begrudge anyone a profit, but this is outrageous. Now if we get approval, you will see that drug companies go crazy and charge that type of money. So do we keep this " unapproved " (not quite true) and let the masses enjoy the benefits or do we let the bottom dwelling leach like big pharma get ahold of this and then only people with insurance or plenty of money be the beneficaries. My vote now, 10 years ago and 10 years from now is lets continue studying but never, never, never let it be " approved " . As a matter of fact, I feel so strongly about this, I would file a people's complaint against approval here in the US. If that didn't work, I would harken to the call of off shore piracy, methinks. Arrgh, all power to the people.Dr.Skip In a message dated 3/11/2011 6:30:19 A.M. Eastern Standard Time, jaynelcrocker@... writes: Very well said Bev! I can’t think of anyone I don’t know who doesn’t know someone who could benefit from using LDN. This attitude is intolerable.May I suggest that for those who feel this strongly about not having this drug trialled so it can be available as a front line option treatment by the medical profession to ALL, kindly email Dr Zagon, Dr McCandless, Professor Jill , Dr Gluck, Dr Jarred Younger, Dr Gironi, Dr Bruce Cree, and ask them WHY they are pursuing down this line?You might ac tually learn something!!Jayne Crockerwww.LDNNow.comImportant! Please sign our LDN pet ition to the European Parliament by clicking heretel: +44 (0) 7877 492 669Dr Steele MBE, talking about LDNLDNNow are a political/pressure group of individuals dedicated to getting Low Dose Naltrexone (LDN) accepted into modern medicine and trialled for the myriad of uses it shows benefit for. .From: low dose naltrexone [mailto:low dose naltrexone ] On Behalf Of Bev KeanSent: 11 March 2011 01:46oldglory@...; low dose naltrexone Subject: RE: [low dose naltrexone] FDA approval I`m sorry but I`m a little horrified at this kind of attitude. When I go with my husband to his neuro appointments once a year, we sit in the waiting room and I could cry when I see the state some people are in. I know they all have MS. Some cant talk anymore, most cant walk without aid. Am I supposed to sit there and think that these people dont deserve to know about LDN because they didnt find it yet? Or dont use a computer? I don`t think we have any right to try to keep this " our little secret " , that would be a horrible selfish attitude.I would not have found out about LDN 7 years ago had someone not " paid it forward' and put their findings on the internet. Then maybe my husband would be one of those poor people in the waiting room instead of a man who still works each day.Be low dose naltrexone From: oldglory@...Date: Thu, 10 Mar 2011 15:31:29 -0600Subject: [low dose naltrexone] FDA approval Hi,I agree. Trialing would be right down their alley. You would not be able to afford it, nor find doctors to prescribe it. Leave It ALONE! It belongs to the people and once you give it up, it won’t come back around. We don’t want their approval!!!!! JeanFrom: <bicyclenutmail-ldn@...>Reply-<bicyclenutmail-ldn@...>Date: Thu, 10 Mar 2011 06:51:54 -0800 (PST)Pat O'Mara <nypatandgeorge@...>, <low dose naltrexone >Subject: RE: [low dose naltrexone] FDA approvalYou said that " It cost pennies now and the increase would be minimal. " You are either very naive or you are connected to the drug companies. Dr Skips example, I have forgotten the name of the drug, was a very old drug that was very cheap, the FDA offered a drug company to trial the drug and they would have an exclusive on it. The price went up something like 1000 times, hardly minimal.SterlingFrom: Pat O'Mara <nypat andgeorge@...>Subject: RE: [low dose naltrexone] FDA approvalbicyclenutmail-ldn@...Date: Thursday, March 10, 2011, 4:04 AMSo what if the FDA approves it for lower doses and the price goes up... isn't FDA approval what everyone is fighting for? Isn't this the reason doctors won't prescribe it? Don't we all want this available to every patient who needs it? It would be the BEST thing to happen! It cost pennies now and the increase would be minimal. It would be nice to see it on the news as the best thing in 50 years and it would hurt companies who make lousy expensive drugs that don't work and make patients sick. Millions could benefit!low dose naltrexone From: bicyclenutmail-ldn@...Date: Wed, 9 Mar 2011 22:43:15 -0800Subject: [low dose naltrexone] FDA approval I too am concerned that FDA approval will mean higher prices for LDN. Are we cutting our own throat by promoting LDN? I hate to think that. However, Dr Skips example and other similar examples, it looks like LDN might just be ours and nobody else. What an awful position.Sterling

[Guest guest]

Dear Sr Skip,I must say you are absolutely right. Something available readily and within reach of ordinary people like us will become highly priced and gaurded once the attention is drawn by agencies like FDA etc.So let it be as it is. It is helping so many whether some agency approves it or not.RajeevIndiaFrom: "slenzrph@..."

<slenzrph@...>low dose naltrexone Sent: Fri, March 11, 2011 11:52:12 AMSubject: RE: [low dose naltrexone] FDA approval

I sent this to Jayne, and the group but must have been misplaced.

I am one of those who does not want LDN to be approved by the US FDA. Let me point out what happened to 4 aminopyridine when .Ampyra was approved. We sell 4-ap 10mg for less than 40 dollars per month. Ampyra as of just a few minutes ago was wholesaling for over 1000 dollars for a month's supply. Same drug different delivery system. Our stuff you have to take three times a day, their stuff you take twice a day. So for 960 dollars you have the luxury of reducing your dose by one per day. Now, we have dispensed this for over 10 years now. Not once did I ever have anyone complain that they were inconvienced by the extra tab and for close to a thousand dollars.

Next is progesterone injection to prevent spontaneous abortion. We have sold literally gallons of this stuff in 10 ml sizes. Price was 39.95/10 mls. New company gets an orphan approval and is now selling it for 1500 dollars.

I can go on, but sufficive to say that these bottom feeding pieces of bovine feces will feed on MS patients at every opportunity they can get. Just look at the average cost of the crap drugs, opps I mean crabs. > 30,000 dollars per year. For what, an average decrease of 38% for exacerbations. It goes on and on, how about Prokarin for 250 dollars, the zapper for 199 dollars, dr barefoots super duper pooper scoper calcium carbonate for 49 dollars. All approved all junk but MS patients will jump because this crap might help.

So no I don't support the approval of LDN. I will challenge the applications with a patient petition as soon as I learned about it.

I have spent the last 10 years selling LDN for a pittance. Why, because it is one of the most significant drugs I have seen in the last almost 40 years. I believe that people should have access to it no matter how much money they make. You get this approved and all bets are off.

Answer me this, was I a fool for making it available to a large number of people, or should I have charged 50-60-up to 90 dollars per month.

Okay, I will get off my high horse now. Friends can disagree.

Skip

[Guest guest]

Yes Rajeev, I understand the arguments but Dr Skip will not prescribe LDN without a Drs prescription.  Just like our Drs won’t prescribe LDN without the Govt’s approval.  As a result, there are a lot of people out there that are not being given the ‘first do no harm’ treatment option.  I believe it’s a worldwide problem and like everywhere else, there are plenty of Drs in the USA that won’t prescribe LDN because it is not FDA approved. There is no reason why it shouldn’t be approved seeing as Naltrexone is already an FDA approved drug.  We just need the stamp of approval for it to be used in ‘low doses’. I have to take my hat off to Dr Skip for coming on these forums and helping as much as he does.  Those who get their LDN from Skips have the comfort knowing that if you get your LDN from his pharmacy it will be of the highest quality.  Should anyone have any problems I know his staff are a very knowledgeable and helpful group of people re  LDN who you can discuss any issues you may have – be it the filler, dosage, etc., and are only too happy to work with you.  This service doesn’t exist to those who purchase it without a script but at least they have this forum where they can be helped by others who share their views and experiences. I do think it’s important to work with your Dr as much as possible and even if he won’t prescribe LDN it wouldn’t hurt to ask him to monitor your progress with blood tests during your time on LDN.  Jayne Crocker www.LDNNow.comImportant! Please sign our LDN petition to the European Parliament by clicking heretel: +44 (0) 7877 492 669Dr Steele MBE, talking about LDNLDNNow are a political/pressure group of individuals dedicated to getting Low Dose Naltrexone (LDN) accepted into modern medicine and trialled for the myriad of uses it shows benefit for. . From: low dose naltrexone [mailto:low dose naltrexone ] On Behalf Of Rajeev AgarwalSent: 03 April 2011 12:17slenzrph@...; low dose naltrexone Subject: Re: [low dose naltrexone] FDA approval Dear Sr Skip, I must say you are absolutely right. Something available readily and within reach of ordinary people like us will become highly priced and gaurded once the attention is drawn by agencies like FDA etc. So let it be as it is. It is helping so many whether some agency approves it or not. RajeevIndia From: " slenzrph@... " <slenzrph@...>low dose naltrexone Sent: Fri, March 11, 2011 11:52:12 AMSubject: RE: [low dose naltrexone] FDA approval I sent this to Jayne, and the group but must have been misplaced.I am one of those who does not want LDN to be approved by the US FDA. Let me point out what happened to 4 aminopyridine when .Ampyra was approved. We sell 4-ap 10mg for less than 40 dollars per month. Ampyra as of just a few minutes ago was wholesaling for over 1000 dollars for a month's supply. Same drug different delivery system. Our stuff you have to take three times a day, their stuff you take twice a day. So for 960 dollars you have the luxury of reducing your dose by one per day. Now, we have dispensed this for over 10 years now. Not once did I ever have anyone complain that they were inconvienced by the extra tab and for close to a thousand dollars.Next is progesterone injection to prevent spontaneous abortion. We have sold literally gallons of this stuff in 10 ml sizes. Price was 39.95/10 mls. New company gets an orphan approval and is now selling it for 1500 dollars. I can go on, but sufficive to say that these bottom feeding pieces of bovine feces will feed on MS patients at every opportunity they can get. Just look at the average cost of the crap drugs, opps I mean crabs. > 30,000 dollars per year. For what, an average decrease of 38% for exacerbations. It goes on and on, how about Prokarin for 250 dollars, the zapper for 199 dollars, dr barefoots super duper pooper scoper calcium carbonate for 49 dollars. All approved all junk but MS patients will jump because this crap might help.So no I don't support the approval of LDN. I will challenge the applications with a patient petition as soon as I learned about it. I have spent the last 10 years selling LDN for a pittance. Why, because it is one of the most significant drugs I have seen in the last almost 40 years. I believe that people should have access to it no matter how much money they make. You get this approved and all bets are off. Answer me this, was I a fool for making it available to a large number of people, or should I have charged 50-60-up to 90 dollars per month. Okay, I will get off my high horse now. Friends can disagree.Skip

[Guest guest]

jaynei totally understand what you are saying here- i've been back working in mainstream medicine for over a year after being absent for about 8 years. i've called doctors and asked if they could order a thyroid study on a totally lethargic patient -- i've had patients that i knew had fibromyalgia and asked if they could look at that - i could go on and on - when i can't get a dr to prescribe cymbalta for someone who is depressed and a diabetic when we have studies to support the relationship between diabetes and depression then fda approval is not going to help- sorry to say - we need to support those physicians a new generation of physician who practice complimentary medicine and continue to educate the ones willing to listen on ldn.cyndiOn Apr 3, 2011, at 10:10 AM, jaynelcrocker wrote:Yes Rajeev, I understand the arguments but Dr Skip will not prescribe LDN without a Drs prescription. Just like our Drs won’t prescribe LDN without the Govt’s approval. As a result, there are a lot of people out there that are not being given the ‘first do no harm’ treatment option. I believe it’s a worldwide problem and like everywhere else, there are plenty of Drs in the USA that won’t prescribe LDN because it is not FDA approved. There is no reason why it shouldn’t be approved seeing as Naltrexone is already an FDA approved drug. We just need the stamp of approval for it to be used in ‘low doses’. I have to take my hat off to Dr Skip for coming on these forums and helping as much as he does. Those who get their LDN from Skips have the comfort knowing that if you get your LDN from his pharmacy it will be of the highest quality. Should anyone have any problems I know his staff are a very knowledgeable and helpful group of people re LDN who you can discuss any issues you may have – be it the filler, dosage, etc., and are only too happy to work with you. This service doesn’t exist to those who purchase it without a script but at least they have this forum where they can be helped by others who share their views and experiences. I do think it’s important to work with your Dr as much as possible and even if he won’t prescribe LDN it wouldn’t hurt to ask him to monitor your progress with blood tests during your time on LDN. Jayne Crocker<image002.jpg> www.LDNNow.comImportant! Please sign our LDN petition to the European Parliament by clicking heretel: +44 (0) 7877 492 669Dr Steele MBE, talking about LDNLDNNow are a political/pressure group of individuals dedicated to getting Low Dose Naltrexone (LDN) accepted into modern medicine and trialled for the myriad of uses it shows benefit for.. From: low dose naltrexone [mailto:low dose naltrexone ] On Behalf Of Rajeev AgarwalSent: 03 April 2011 12:17slenzrph@...; low dose naltrexone Subject: Re: [low dose naltrexone] FDA approval Dear Sr Skip, I must say you are absolutely right. Something available readily and within reach of ordinary people like us will become highly priced and gaurded once the attention is drawn by agencies like FDA etc. So let it be as it is. It is helping so many whether some agency approves it or not. RajeevIndia From: "slenzrph@..." <slenzrph@...>low dose naltrexone Sent: Fri, March 11, 2011 11:52:12 AMSubject: RE: [low dose naltrexone] FDA approval I sent this to Jayne, and the group but must have been misplaced.I am one of those who does not want LDN to be approved by the US FDA. Let me point out what happened to 4 aminopyridine when .Ampyra was approved. We sell 4-ap 10mg for less than 40 dollars per month. Ampyra as of just a few minutes ago was wholesaling for over 1000 dollars for a month's supply. Same drug different delivery system. Our stuff you have to take three times a day, their stuff you take twice a day. So for 960 dollars you have the luxury of reducing your dose by one per day. Now, we have dispensed this for over 10 years now. Not once did I ever have anyone complain that they were inconvienced by the extra tab and for close to a thousand dollars.Next is progesterone injection to prevent spontaneous abortion. We have sold literally gallons of this stuff in 10 ml sizes. Price was 39.95/10 mls. New company gets an orphan approval and is now selling it for 1500 dollars. I can go on, but sufficive to say that these bottom feeding pieces of bovine feces will feed on MS patients at every opportunity they can get. Just look at the average cost of the crap drugs, opps I mean crabs. > 30,000 dollars per year. For what, an average decrease of 38% for exacerbations. It goes on and on, how about Prokarin for 250 dollars, the zapper for 199 dollars, dr barefoots super duper pooper scoper calcium carbonate for 49 dollars. All approved all junk but MS patients will jump because this crap might help.So no I don't support the approval of LDN. I will challenge the applications with a patient petition as soon as I learned about it. I have spent the last 10 years selling LDN for a pittance. Why, because it is one of the most significant drugs I have seen in the last almost 40 years. I believe that people should have access to it no matter how much money they make. You get this approved and all bets are off. Answer me this, was I a fool for making it available to a large number of people, or should I have charged 50-60-up to 90 dollars per month. Okay, I will get off my high horse now. Friends can disagree.Skip

[Guest guest]

On Sun, 03 Apr 2011 10:10:05 -0400, jaynelcrocker

<jaynelcrocker@...> wrote:

> Yes Rajeev, I understand the arguments but Dr Skip will not prescribe

> LDN without a Drs prescription. Just like our Drs won’t prescribe LDN

> without the Govt’s approval. As a result, there are a lot of people out

> there that are not being given the ‘first do no harm’ treatment option.

> I believe it’s a worldwide problem and like everywhere else, there are

> plenty of Drs in the USA that won’t prescribe LDN because it is not FDA

> approved. There is no reason why it shouldn’t be approved seeing as

> Naltrexone is already an FDA approved drug. We just need the stamp of

> approval for it to be used in ‘low doses’.

I don't see that FDA approval will make any difference whatsoever in

whether doctor's will prescribe it or not for Crohn's. (And why approval

for just Crohn's. If approval at all, it needs approval for a whole host

of auto-immune syndromes/diseases. And all it will do is make it LESS

available because many people who get it now won't be able to afford it --

as has been said before.

Doctors simply need to get educated about LDN -- if that occurs from their

patients, that's fine; that IS likely how it will occur; I told my doctor

about it and he was open-minded enough to prescribe it for me after

reading a bit about it (in his office, while I was there); and because he

knows that I'm not an idiot and that I'm very aware of my own condition.

Word of mouth from patients, and advocacy groups -- but not advocacy in

terms of FDA approval -- is the best approach, IMO, to make LDN more and

more widely known. I suspect that many if not most of us here are

personally responsible for making others aware of it and getting at least

one or two (or more) other people to try it (with or without their

doctor's approval).

There's is not a problem -- legally -- with doctors prescribing off-label

drugs. It's just that some of them (apparently a lot of them) are wimps of

the first order. Or so arrogant that they don't want a patient telling

them something they don't know.

n

[Guest guest]

Should low dose naltrexone become fda approved and assigned to a drug company to do the study that company will require exclusivity. Once they own the LDN they can pressure other countries to not export. StirlingFrom: jaynelcrocker <jaynelcrocker@...>Subject: RE: [low dose naltrexone] FDA Approvallow dose naltrexone Date: Sunday, April 3, 2011, 4:12 PM

Thank you for picking up on a question I was asking! Somehow I don’t think it will as you’re still getting the 50mg tablet – that was my point. As Naltrexone is already an approved drug, I’m not understanding how by allowing it to be prescribed in low doses can hike the price up. I’m obviously missing something. To those who have managed to convince their Drs about prescribing

LDN because:- - they can see you’re not stupid (one responder said to me)- they have faith in you because they can see you’re a smart person- they know you know what you’re talking about- you took the time and trouble to really research about your condition and that’s how you found out about LDN, therefore anyone can The responses go on and all I can say is that is absolutely wonderful. I’m just the messenger here passing on what Dr Jill is doing. Jayne Crocker www.LDNNow.comImportant! Please sign our LDN petition to the European Parliament by clicking heretel: +44 (0) 7877 492 669Dr Steele MBE, talking about LDNLDNNow are a political/pressure group of individuals dedicated to getting Low Dose Naltrexone (LDN) accepted into modern medicine and trialled for the myriad of uses it shows benefit for. . From: low dose naltrexone [mailto:low dose naltrexone ] On Behalf Of Davey

Sent: 03 April 2011 23:50low dose naltrexone Subject: [low dose naltrexone] FDA Approval Ms Crocker has a valid point also. Now if LDN is approved by the FDA, and the price goes up a hundredfold, would we be able to purchase the 50mg Naltrexone from Allday Chemist or United Pharmacies at current prices?.