Re: ampligen

[Guest guest]

In a message dated 3/18/99 6:45:34 PM Eastern Standard Time, tab@...

writes:

> Info about Ampligen can be found at CFIDSME-Activistonelist

Hello Christie...I had clicked on the wrong part..but the archives are not

open to us...

Thanks...

Susy...

[Guest guest]

In a message dated 3/20/99 8:14:39 PM Eastern Standard Time,

oobadooba@... writes:

<< I feel like I may have started it >>

Tracey, you didn't start it. Don't feel bad. I started it by demanding the

truth and started by demanding the same thing. But, really, the

manufacturer's started it by promoting instead of protecting.

[Guest guest]

In a message dated 3/21/99 12:31:09 AM Eastern Standard Time,

cfsmail@... writes:

<< Unfortunately, since Mitch and are apparently working

together to get patients to take Ampligen by sending them unsolicited email

promotions, this means that Ampligen spammers now have some of our email

addresses and we may be hearing from them. >>

What do you mean by this?? I thought it was very difficult to get into a

Ampligen clinical trial.

Who is Mitch?

I have been on several of 's and 's lists off and on for years. I

have never gotten a email promotion for ampligen. Are you sure there is even

such a thing as ampligen email spammers? I am afraid maybe you are over

reacting?

Sydney

Poore5@...

[Guest guest]

Hi --

None of this is your fault -- on the contrary, you did a lot of good by

letting us know about this email promotion of Ampligen that's going on. And

it wasn't your contact with Mitch that started this -- it was one of our

listmembers who broke the list rules and sent posts from us to

Schweitzer. Unfortunately, since Mitch and are apparently working

together to get patients to take Ampligen by sending them unsolicited email

promotions, this means that Ampligen spammers now have some of our email

addresses and we may be hearing from them. This is the reason I asked

people not to forward posts to their friends, but instead to direct them to

the archives, where the posters' email addresses are deleted.

One of my first concerns about this list is to make sure nobody uses the

list to target patients for sales scams. It's probably impossible to

completely prevent it, but I'm doing the best I can. I do edit all the

digests in the archives to make sure no email addresses are posted there --

OneList is supposed to automatically edit them out, but sometimes they screw

up.

I've invited some of the posters who were banned to post their own

experiences on Ampligen without including propaganda or flames, but they

haven't done that, which I consider to be a great loss.

I do know a couple of patients who genuinely got better on Ampligen, whose

word I trust and who are not affiliated with Hemispherx in any way. I'll

try to get in touch with them and see if they would be willing to post to

the list about their experiences.

Take care, y'all,

Re: ampligen

From: " oobadooba " <oobadooba@...>

I am sorry. I feel like I may have started it when I asked about Mitch.

[Guest guest]

Thanks, I feel better.

Re: ampligen

>From: GAILRONDA@...

>

>In a message dated 3/20/99 8:14:39 PM Eastern Standard Time,

>oobadooba@... writes:

>

><< I feel like I may have started it >>

>Tracey, you didn't start it. Don't feel bad. I started it by demanding

the

>truth and started by demanding the same thing. But, really, the

>manufacturer's started it by promoting instead of protecting.

>

>------------------------------------------------------------------------

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>

>Onelist: ing connections and information exchange

>------------------------------------------------------------------------

>This list is intended for patients to share personal experiences with each

other, not to give medical advice. If you are interested in any treatment

discussed here, please consult your doctor.

>

[Guest guest]

In a message dated 3/25/99 2:29:00 PM Eastern Standard Time,

mgrahn@... writes:

<<

Now THIS makes me VERY uncomfortable! Are you saying that the compay

Hemispherx, or their representatives, or reporters are monitoring our personal

private chat for their own agenda???? I cannot

BELIEVE any reputable company would stoop so low. >>

This is one of the things that has been proven about the company. That's why

we so fervently want answers from the company and not from patients who have

done well or have not done well. If they do this, what else would they do?

We want to know to make sure they are not harming any patient. This,

unfortuately, has been misconstured as being anti-patient by some Ampligen

users and the company and stock-holders at large.

Gail

[Guest guest]

Marcia,

In theory, I definitely agree with you about a drug co. 'monitoring' a

patient list. However, I have recently heard information from a very

reliable source that the drug co. may be being 'attacked' in its efforts

to complete these clinical trials, which are in their final phase. What

I have heard was so awful that it makes me nervous, and that is why the

drug co. MAY be reading posts from this list, and for no other reason. I

don't even know for sure if they are, since everything is second hand.

But the person(s) supposedly attempting to make life difficult for the

drug co. also have CFIDS, and I will never begin to understand why they

would try to disturb a study in progress. So that is what I meant. In

the absence of these things 'going on', if they are, I sincerely doubt

that a drug co. would care at all about a patient list that is really a

'support group', and a helpful one at that. I hope this addresses your

concern and explains what I wrote. And thanks for your other comments

also.

Marcia Grahn wrote:

>

> From: Marcia Grahn <mgrahn@...>

>

> and Bob wrote:

>

> > I have seen various items discussed on this list since joining,

> > including Florinef, glyconutrients, various pain medications, sleep

> > medications, oral interferon, etc. I am not posting this to tout

> > Ampligen and clearly, everyone has to make their own informed choices

> > about what treatment approaches and regimens are right for them. And

> > what is right for one person is not necessarily right for someone else.

> > Ampligen, reportedly, will not help all CFIDS patients; however, there

> > are immunological and other specific tests to help determine those whom

> > it may have a better chance of helping. I am writing to put my two cents

> > worth into the fray, as it seems to have gotten out of hand.

>

> ,

>

> Thats good news that you have found a treatment that works for you and are

doing well on Ampligen. We all know the suffering CFS/FMS causes and are

relieved and happy to hear when a fellow

> sufferer finds relief.

>

> You are right, we all want/need the right to hear ALL of the truth and make

our own personal choices because there are so many risks involved with many

treatments and we all react differently to a

> given treatment.

>

> Thats why we enjoy this list so much, because we can throw out ideas and try

to get the benefit of experience, knowlege, and support from the other

listmembers. I don't tell anyone else what to

> take and I don't expect them to tell me what to take either. None of us are

Drs.

>

> > I do not

> > know anyone at Hemispherx, the company that produces Ampligen. I do

> > understand why they might monitor this list however, given all the

> > difficulties there have been in discussing this drug.

>

> Now THIS makes me VERY uncomfortable! Are you saying that the compay

Hemispherx, or their representatives, or reporters are monitoring our personal

private chat for their own agenda???? I cannot

> BELIEVE any reputable company would stoop so low. What would they care about

a bunch of sick people trying to share some information and comfort and

encouragement to keep us going through such a

> devastating illness? THIS is unbelievable to me that we now have to worry

about sharing our innermost thoughts, fears, struggles and treatments and having

our private information being sent on to

> a DRUG COMPANY????

>

> Does anyone else have concerns about this?????

>

> Marcia

>

> >

>

> ------------------------------------------------------------------------

> Ta Da! Come see our new web site!

>

> Onelist: A free email community service

> ------------------------------------------------------------------------

> This list is intended for patients to share personal experiences with each

other, not to give medical advice. If you are interested in any treatment

discussed here, please consult your doctor.

[Guest guest]

and Bob wrote:

> I have seen various items discussed on this list since joining,

> including Florinef, glyconutrients, various pain medications, sleep

> medications, oral interferon, etc. I am not posting this to tout

> Ampligen and clearly, everyone has to make their own informed choices

> about what treatment approaches and regimens are right for them. And

> what is right for one person is not necessarily right for someone else.

> Ampligen, reportedly, will not help all CFIDS patients; however, there

> are immunological and other specific tests to help determine those whom

> it may have a better chance of helping. I am writing to put my two cents

> worth into the fray, as it seems to have gotten out of hand.

,

Thats good news that you have found a treatment that works for you and are doing

well on Ampligen. We all know the suffering CFS/FMS causes and are relieved and

happy to hear when a fellow

sufferer finds relief.

You are right, we all want/need the right to hear ALL of the truth and make our

own personal choices because there are so many risks involved with many

treatments and we all react differently to a

given treatment.

Thats why we enjoy this list so much, because we can throw out ideas and try to

get the benefit of experience, knowlege, and support from the other listmembers.

I don't tell anyone else what to

take and I don't expect them to tell me what to take either. None of us are

Drs.

> I do not

> know anyone at Hemispherx, the company that produces Ampligen. I do

> understand why they might monitor this list however, given all the

> difficulties there have been in discussing this drug.

Now THIS makes me VERY uncomfortable! Are you saying that the compay

Hemispherx, or their representatives, or reporters are monitoring our personal

private chat for their own agenda???? I cannot

BELIEVE any reputable company would stoop so low. What would they care about a

bunch of sick people trying to share some information and comfort and

encouragement to keep us going through such a

devastating illness? THIS is unbelievable to me that we now have to worry about

sharing our innermost thoughts, fears, struggles and treatments and having our

private information being sent on to

a DRUG COMPANY????

Does anyone else have concerns about this?????

Marcia

>

[Guest guest]

In a message dated 6/4/99 1:45:14 PM Eastern Daylight Time,

mgrahn@... writes:

<< I must admit I am confused. >>

There will be, we fervently hope, a first organizational meeting of a

Citizens Advisory Board in either July or August. is the organizer of

that meeting and I am on the Interim Steering Committee. Until the official

CAB takes over, I'm not allowed to speak publicly on the subject nor is

. The story going into our next issue even had to be written by other

members of our staff! I didn't realize that when I first posted as I never

made it to the meeting where this was agreed (my plane never left the

ground). But, eventually, there will be answers and, eventually, this " two

weeks " of taking over as moderator (that's now been about 2 months and going,

going, going!!!) will dome to an end! And I'll celebrate with a virtual

cocktail (it has to be virutal since I can't drink!).

Gail

[Guest guest]

Gail and Els, and all,

I must admit I am confused. In the past everyone on Ampligen who tried to speak

on this list about their positive experience has been banned from the list.

Gail says the rules are no one can

speak about Ampligen unless its about their own experience. Yet we keep hearing

these vaugue reports about all the lives Ampligen has destroyed. I have not yet

encountered ANY of these people or

stories except secondhand on this list and I too would be interested in hearing

from these people about their Ampligen experience. We were told NOT to even

mention Ampligen until mid May when

would reveal the smoking gun against Ampligen. Now we find out she has

formed a committee to monitor the trials and fast track the drug. Am I the only

one who is confused here??????

I don't think any of us expects Ampligen to be a magic bullet to cure us all,

but if it could be a viable treatment for some of us and relieve our suffering

and give us some life, like has

experienced (to our joy) with the interferon, I for one feel a need to learn

more about it. If its soon to be approved as a treatment for CFS, it seems it

would be a VERY important part of our

knowledge base to discuss with our Doctors, and weigh the risks and benefits of

such treatment.

Gail, it would be interesting if we could hear from these people you mentioned

that took the drug so we could find out more about the testing and treatment,

that would be great.

Marcia

Els Thiebaut wrote:

> From: Els Thiebaut <bruno.vandenmeerschaut@...>

>

> Gail,

>

> I'm trying to learn about Ampligen and I know of many people here and

> abroad having real benefits from this treatment. I know that, as goes

> for ANY medication, people react individually and anyone going on

> medication never has any guarantee on how he will respond.

>

> That is why I really as well want to know about people with a positive

> LMW RNase-L test having negative experiences with this treatment. As I

> assume you know these men: could you ask these men to get to me

> eventually backchannel? I'm sure they would want to share this with

> fellow pwc's, who are considering treatment (I would..) and I need all

> the info I can get. As far as I know the suicide of this poor man was

> not due to Ampligen treatment. One man only had a few months of

> treatment and went back to the states and the third one did improve and

> went back to the states for further treatment.

>

> Do you know for certain that they had a positive RNase-L test before

> treatment? As far as I know these were only routinely done from March

> 1998.

> Els

>

> Gail posted:

> >ELS, the three patients that I know that went to Belguim last year for

> >the Ampligen trials were not helped. All were male. All tested

> >positive to the RNase-L. One took his own life while there due to the

> >pain he experienced. The others are now feeling worse. Both of them

> >are on morphine to try to diminish the pain that resulted.

> >Gail

>

[Guest guest]

GAILRONDA@... wrote:

> But, eventually, there will be answers and, eventually, this " two

> weeks " of taking over as moderator (that's now been about 2 months and going,

> going, going!!!) will dome to an end! And I'll celebrate with a virtual

> cocktail (it has to be virutal since I can't drink!).

> Gail

Gail,

Sounds like 2 weeks Cfids time! LOL

Marcia

[Guest guest]

Marcia,

Yes, that is why I was so confused as well. Thank you for sharing your

view on this. Gail spoke about experiences of other people, where I only

asked if someone know about the hypothesis of Dr. Cheney and where

Ampligen could help. Then the story about these 3 men, and I asked Gail

to ask these men to eventually backchannel to me as I feel, she cannot

speak for someone else, and as matter of fact, I cannot veryfy this. If

she would have talked from her own experience, this would be very much

different.

Thank you Marcia for sharing your feeling with the list, you are not the

only one being confused. As for me, as I tested RNase-L positive, I

assume that I might benefit from this drug, as it seems that patients

who test positive for the defective 37kDa RnaseL are the ones who seem

to do the best. Are we not all trying to find out about possibilies to

get our lives back? Some do benefit from certain medication, others

don't, that goes for all of us. Isn't this list about sharing our

experiences, without forcing a point of view? I thought that even bad

individual experiences could be shared?

As you said Marcia: " If its soon to be approved as a treatment for CFS,

it seems it would be a VERY important part of our knowledge base to

discuss with our Doctors, and weigh the risks and benefits of such

treatment. "

Gail,

you backchanelled me on this and I really don't understand why you

cannot share this on this list, it should'nt have to be so secret.

If you promised not to talk about it until the CAB can get reliable

answers, then I think you should'nt have talked about these three men in

the first place, because they are not speaking for themselves. I'm sorry

to see this is happening.

Gail, thank you anyway for your concern, but what I need is info from

personal experiences, and not from 'having heard', so could you please

ask this one man if he would like to get in touch with me as I cannot do

that myself, not knowing him and as I would intrude in his privacy by

means of an emailaddress given to me. I'll backchannel you regarding

your message.

Gail, please understand, and I don't intend to offend you: it is

important that we can discuss Ampligen on this list as any other drug.

You don't NEED to reply to messages sent, if that makes you feel

uneasy. I feel that you are feeling negative about Ampligen and it

certainly is your right. But please don't shut out people like me who

have a different view on this, as I am eager to learn about a probable

cure for me.

I do know that many people respond positively to Ampligen and yes, there

are people who are not being helped with the drug, whatever the reason

is. But, don't we all react differenty? If people talk about their

individual experience, whether either positive or negative, I do know

how to make my own decision by 'weighing pro's and con's' regarding my

options.

And as a matter of fact, as I said in my previous email, I do live in

Belgium and have found information on what you wrote about these men

from a very reliable source.

>Message: 12

> Date: Fri, 04 Jun 1999 10:43:14 -0800

> From: Marcia Grahn <mgrahn@...>

>Subject: Re: Ampligen

>Gail and Els, and all,

>I must admit I am confused. In the past everyone on Ampligen who tried

>to speak on this list about their positive experience has been banned

>from the list. Gail says the rules are no one can speak about

>Ampligen unless its about their own experience. Yet we keep hearing

>these vaugue reports about all the lives Ampligen has destroyed. I

>have not yet encountered ANY of these people or stories except

>secondhand on this list and I too would be interested in hearing from

>these people about their Ampligen experience. We were told NOT to even

>mention Ampligen until mid May when would reveal the smoking gun

>against Ampligen. Now we find out she has formed a committee to

>monitor the trials and fast track the drug. Am I the only one who is

>onfused here??????

>I don't think any of us expects Ampligen to be a magic bullet to cure

>us all, but if it could be a viable treatment for some of us and

>relieve our suffering and give us some life, like has experienced

>(to our joy) with the interferon, I for one feel a need to learn more

>about it.

>If its soon to be approved as a treatment for CFS, it seems it would be

>a VERY important part of our knowledge base to discuss with our

>Doctors, and weigh the risks and benefits of such treatment.

>Gail, it would be interesting if we could hear from these people you

>mentioned that took the drug so we could find out more about the

>testing and treatment, that would be great.

>Marcia

Els Thiebaut wrote:

> From: Els Thiebaut <bruno.vandenmeerschaut@...>

>

> Gail,

> I'm trying to learn about Ampligen and I know of many people here and

> abroad having real benefits from this treatment. I know that, as goes

> for ANY medication, people react individually and anyone going on

> medication never has any guarantee on how he will respond.

>

> That is why I really as well want to know about people with a positive

> LMW RNase-L test having negative experiences with this treatment. As > I

assume you know these men: could you ask these men to get to me

> eventually backchannel? I'm sure they would want to share this with

> fellow pwc's, who are considering treatment (I would..) and I need all

> the info I can get. As far as I know the suicide of this poor man was

> not due to Ampligen treatment. One man only had a few months of

> treatment and went back to the states and the third one did improve

> and went back to the states for further treatment.

>

> Do you know for certain that they had a positive RNase-L test before

> treatment? As far as I know these were only routinely done from March

> 1998.

> Els

>

> Gail posted:

> >ELS, the three patients that I know that went to Belguim last year

> >for the Ampligen trials were not helped. All were male. All tested

> >positive to the RNase-L. One took his own life while there due to

> >the pain he experienced. The others are now feeling worse. Both of

> >them are on morphine to try to diminish the pain that resulted.

> >Gail

[Guest guest]

another thing to add....Dr. Dianna on was at the meeting in

Philadelphia as an AIDS activist. She was told that fast-tracking it for

AIDS would not help the CFS patient as we wouldn't be able to get it the way

AIDS patients can get anuything approved for another disease. Originally,

she was going to go for AIDS fastracking it but decided to wait and see if

CFIDS patients could do it without looking too closely at safety of

efficicacy. The CFIDS community has been misinformed about Ampligen. Right

now, it is not safe for CFIDS patients. The majority who have tried it are

now suffering horribly. The company won't even return their calls. I'm all

for seeing a good drug passed quickly, but if it harms a patient to the

extent that they are in so much pain that they take their own lives, I won't

be part of it and that's why I left the committee pushing for a CAB. The

ones in power, put there by nominations by , are ones that need it

fastracked to have their insurance companies. I can't help promote something

that may eventually bring on such adverse reaction that a person has to take

their own life. While I wouldn't be able to live with that, there are,

obviously, others that have no qualms about it if it helps them personally.

Gail

[Guest guest]

In a message dated 6/22/99 9:50:59 AM Pacific Daylight Time,

GAILRONDA@... writes:

> The CFIDS community has been misinformed about Ampligen. Right

> now, it is not safe for CFIDS patients. The majority who have tried it

are

> now suffering horribly. The company won't even return their calls.

Where are you getting your information? This goes against both the anecdotal

and the hard evidence that I have gathered. Why would the FDA approve it for

Phase III trials if it was an unsafe drug? I think you should have to back

up your assertions with evidence. Wasn't that a rule created for this list

not so long ago?

Asensio, is that you?

in Los Angeles

[Guest guest]

In a message dated 6/22/99 1:21:17 PM Eastern Daylight Time,

MissCluey@... writes:

<< Where are you getting your information? This goes against both the

anecdotal

and the hard evidence that I have gathered. Why would the FDA approve it

for

Phase III trials if it was an unsafe drug? I think you should have to back

up your assertions with evidence. Wasn't that a rule created for this list

not so long ago?

Asensio, is that you?

>>

Both and are not CFIDS patients but are stockholders in the

company. they've both been removed from the list.

the information, BTW, comes directly from patients who have been and are

suffering to this day. Asensio is a stockbroker who has been attacking

Hemispherx to bring them low and buy up the stock...a manuever done often in

the big world. He has, in addition to printing a lot of truths about

Ampligen, also said there's no such thing as CFIDS and we're all nutty, so I

don't have anything to do with him either!

[Guest guest]

I think folks on this list should start on Ampligen as a few of us have on

the Interferon and lets see for ourselves! No offense to the " pro " or " con "

Ampligen sides intended.........just would like to follow " 1st hand " !

Ps.......My decision was to go for the Interferon over the Ampligen based on

what my personal understanding is re: Ampligen.

[Guest guest]

I agree that the ampligen have overstated their case. However are you sure

you can stand by the statement: " Right now, it is not safe for CFIDS

patients. The majority who have tried it are

now suffering horribly. " I think that your heart is in the right place but

does anyone really know the outcome of the MAJORITY of cases. If you say

" the majority of those I have talked to " I see no problem with that. It is

just that the consumer community should not engage in the same type of over

statements that this particular drug maker has engaged in.

I admire your work in this area so please do not take offense.

Thanks

Steve

[Guest guest]

No offense taken, Steve. But the majority in the US have been contacted

except for those who ended up taking their own lives. ALL experienced a form

of hell when they went off. Right now, only those in Incline Village and a

few in Philadephia are having some success. All the others have either felt

nothing or have gotten so much worse that they wish they weren't alive. It's

obvious to me that the drug, as Dr. stated, " helps a small subset. "

I'd like to know how he identifies that subset. They certainly aren't the

sickest patients and he tells them if they're a candidate. One woman was

chosen but her young son (just turning 20) was not eligible. Yet he was

worse!

Gail

p.s. there really haven't been all that many patients in the US, you know. A

lot of hype, yes, but really few patients and no long term follow-up even

though the first ones on it welcome a follow-up.

[Guest guest]

Jerry, the CAB isn't even formed yet. To stick with it would have meant we

had to add to the corruption and, therefore, add to it. I hate politics and

couldn't deal with disregarding the patients I have been in touch with who

are so horribly and intensely ill. I had a choice of being in the limelight

or letting people know the truth. The five who quit have plans, but ones

that can't be discussed now, but quitting is something we did to the

committee, not the patient community.

Gail

[Guest guest]

In a message dated 6/22/99 5:37:57 PM Eastern Daylight Time,

SWNGDABOAT@... writes:

<< I think folks on this list should start on Ampligen as a few of us have on

the Interferon and lets see for ourselves >>

you first!

[Guest guest]

So now that the CAB is corrupt, where do we go for answers? Why didn't the

people who quit stick with it if only just to monitor the corruption?

Jerry

[Guest guest]

At least I know you'll be looking out for us. ;-)

Jerry

Re: Ampligen

>From: GAILRONDA@...

>

>Jerry, the CAB isn't even formed yet. To stick with it would have meant we

>had to add to the corruption and, therefore, add to it. I hate politics

and

>couldn't deal with disregarding the patients I have been in touch with who

>are so horribly and intensely ill. I had a choice of being in the

limelight

>or letting people know the truth. The five who quit have plans, but ones

>that can't be discussed now, but quitting is something we did to the

>committee, not the patient community.

>Gail

>

>---------------------------

[Guest guest]

In a message dated 6/22/99 8:12:46 PM Eastern Daylight Time,

GAILRONDA@... writes:

> The five who quit have plans, but ones

> that can't be discussed now, but quitting is something we did to the

> committee, not the patient community.

I just knew that one, has been sitting under those Cherry Trees for

years for all of us and the others have done so much !

Thank you so much to the Five Elite ! In my Book Hats Off to You !

[Guest guest]

In (wordy, sorry) response to Steve 's questions:

> What is the bottom line on amplegen?

After years of raising enough capital to be able to pull it off,

Hemispherx (the small company that makes Ampligen, which is basically

their only marketed product) is in the middle of conducting what are

called " Phase III " or " double-blind " studies -- and in this particular

case, are called the " Ampligen 516 " studies.

In a double blind study, half the patients receive the treatment and

half don't -- but neither the patient, nor the doctor treating the

patient, knows which is which. Since Ampligen is delivered by IV, that

means that the people on the placebo are being given IV " s of simple

saline solution. The current plans are for the double blind to go on

for as long as 40 weeks at some sites -- that's a very very long time

for a person sick with CFS/M.E. to have to go to a doctor's office and

have an IV stuck in their veins twice a week, for NOTHING. (Even worse

if some patients end up having to have a permanent port put in for the

IV's, because as part of our disease, our veins are really flat.) I

think the whole thing is immoral myself -- surely there are better ways

to find out if it's effective than to have to put patients through this

ugly process. (They don't do it in Europe any more.) But, right now,

that's the way things stand.

In the normal course of things, we would all have to wait for the

double blind to be completed and the statistics compiled, and Hemispherx

to file a report and a request for approval to the next stage.

According to folks who should know, it can take two years to go from the

successful completion of the double blind study to the FDA's provisional

approval of the drug -- the stage we need to get to. Paperwork,

paperwork, paperwork; bureaucracy, bureaucracy, bureaucracy. (And,

rumor hath, payola.)

But in the fall of 1997 Congress passed the FDA Modernization Act, which

calls for " fast tracking " drugs that meet three criteria: (1) the

disease is life threatening or substantially life altering; (2) there

are few or none alternatives; and (3) there is no evidence of major

toxicity. With fast tracking, doctors can prescribe the drug BEFORE the

double-blind is completed -- with the understanding that if the double

blind turns up major toxicities or fails in some other way, approval may

be revoked.

During the hearings, patients testified about drugs for three diseases

-- cancer, AIDS -- and CFS!!! There it was on ABC's evening news --

Sara Milliner's husband testifying about needing Ampligen for CFS! So

this combination was even part of the reason that Congress created

fast-tracking!

The FDA has admitted at the CFSCC meetings that Ampligen meets all three

criteria for fast tracking. But they are doing nothing. We're not the

only ones -- apparently the only drugs that have been fast tracked are

those that are pushed by major pharmaceuticals (like Viagra ...) To

gain some perspective here, they held up the major component of the AIDS

cocktail for ten years; right now they're holding up a type of

heart-valve replacement (how do you do a placebo on that? why would you

even want to?) So we are not the Lone Rangers. Everything is stuck in

the bureaucratic maze.

Legally, Ampligen could be fast-tracked and available to your doctor

tomorrow. IF the FDA WANTED to.

If it isn't fast-tracked, it will be probably take up to the year 2003

before it is available on the next level.

> When it become avaiable will it be through

> infectious disease drs. or any doc who want

> to try it?

Once it passes the Phase III, any doctor who believes his/her patient

can benefit from the drug will be able to prescribe it -- just like they

are free to prescribe anything else. HOWEVER, they must sit down with

the patient and explain that this is still experimental. But this means

that you wouldn't have to travel to some far-off location. And it also

means that MEDICARE and private health insurance plans would have to pay

for it (right now they don't have to, so they won't even consider it).

Since the bulk of the cost is the infusions, this would make the drug

financially available to far more patients (and those of us currently

paying out-of-pocket won't have to go any further into debt ...)

Also, once the next level has been reached and insurance will pay

for most people, Hemispherx has promised that they will offer Ampligen

on a compassionate care basis to patients who are very sick and can't

afford it.

> Is it now available through extrordinary means but not

> available to the general population? Does

> amplegen have FDA approval for any disease?

It's available in the United States two ways: the 511 study (which is

what I am on) -- also known as a " cost recovery " study. This is a new

category that was created a few years back for cancer and AIDS patients

so people in desperate shape could get a drug before approval. But the

deal with the devil, sort of, is that we can't ask insurance to pay for

any of it. So ... makes you kinda wonder just who is being protected

here ...

The other way you can get it in the United States is the 516

double-blind study. Then it's free -- the " cost " is the risk that what

you get for the first 10 months is IV saline and not Ampligen.

Hemispherx has promised that patients who received the placebo (the IV

saline) will get six months of Ampligen for free. But six months is not

enough for permanent effects. This is another reason that we need the

drug fast-tracked. We need it approved by the time those patients

start going off their free six months, because few are going to be able

to pay for it (and if it isn't approved yet, Hemispherx can't afford to

keep footing the bill either -- they are required by law to foot the

whole bill for the 516 trials right now, and it involves 220 patients.)

The FDA doesn't like the cost-recovery studies and they have only

permitted a very very few. I think right now fewer than 75 patients

have been able to participate in the 511. There are a couple of

openings in a couple of places -- Dr. Mazlen has some openings, and

there are some openings down in Hollywood, Florida. But in general the

511 is very hard to get into.

If you want your OWN doctor to participate in the 511, the doctor has to

actually design a study that would include you, and get that specific

study proposal approved by the FDA. This is a total hassle and takes a

lot of precious time away from other patients. So you can see that few

doctors are willing to go to all this trouble just to put a single

patient on the 511. My own doctor participated for a while in the 511,

but finally had to quit because her partners thought it was just too

expensive (i.e., she spent too much time with her 511 patient and not

enough time making money for the practice ...) I was supposed to get

the 511 through Marsha, and when she had to bow out, I was frantic to

find a substitute; very fortunate that Dr. Bellesorte (who is actually

closer to where I live), had two spots open (the other spot went to a

teenager who was also a Wallace patient).

If Ampligen had approval for OTHER diseases, then all this would be

much easier -- your doctor could try it out on an " off-label " basis.

(That's what's going on with the Interferon-A studies for fibromyalgia

-- it's off-label, so your doctor can prescribe it if he/she wants to --

but both you and your dotor must understand it's experimental.)

Insurance would not pay for it, but at least you could get it.

Ampligen isn't approved for any illness. Until recently, it was

only in the FDA's approval track for CFS/M.E.; they filed for approval

for AIDS patients some time this summer, I think.

AIDS activist groups are now trying to get approval for Ampligen,

but we're further along in the approval process (however, they're much

better organized!) If it is fast-tracked for AIDS, it won't be

fast-tracked for CFS/M.E. (I don't know why but it's in the rules) -- we

can get it off-label, but will still probably have to pay for it

ourselves, depending on your insurance.

They started out thinkning of Ampligen as an AIDS drug, by the

way. But a study with AIDS patients conducted by DuPont was screwd up

because DuPont ignored Hemispherx's instructions to use GLASS bottles.

Naturally, DuPont wanted to use PLASTIC bags -- but the product binds

with plastic -- and so the study was useless. There was a whole lawsuit

about it, which DuPont lost. But that was pretty much the end of the

testing for AIDS until recently.

I'm told by financial experts that although the myth is that if

it's " worthwhile " a big pharmaceutical will pick it up, in practice

there are hundreds of these products out there, each developed by

venture capital surrounding somebody's invention -- the pharmaceuticals

don't need them. If the company dissolves before the product passes the

Phase III, well, that's that. No skin off any of the Big Boys' noses.

(And there are cases where the Big Pharmaceuticals have actually FOUGHT

approval of potential competitors!) With these new biotech drugs, which

are very expensive to push through the Phase III, the Big Boys won't

touch it until it's past that stage. This is the OTHER reason that it

would be advanrtageous to get Ampligen past the Phase III -- THEN, major

pharmaceuticals would suddenly get interested -- and perhaps get

interested in the CFS/M.E. market as a whole.

It is frankly scary to be dependent on something that could

disappear tomorrow (just like it could be approved tomorrow); it is

traded on AMEX (now NASDAQ) and it was targeted a year ago by a

professional short-seller who takes pride in bankrupting these little

techie companies. He issued a slew of press releases about how the

disease was bogus so the product must be a hoax -- and he used the NIH's

and FDA's grossly outdated websites to back his statements up

(conveniently didn't notice the CDC)! The stock plummeted from 13 to 5

over one weekend. So once again the government's lax attitude about

the disease has an impact in the real world. It bottomed out at 5,

currently runs around 6 or 7, so he didn't succeed in totally

bankrupting Hemispherx (which is his announced goal!) -- but he's still

trying to do it.

I think this is one helluva back-assed way to run medical innovation!

They regulate banks better than they regulate our health care. (The

money supply, of course, is " important. " )

> When it become avaiable will it be through

> infectious disease drs. or any doc who want to try it?

When it hits the next stage, it will still be considered experimental,

but ANY DOCTOR WITH A LICENSE can prescribe it just like they can

prescribe anything else. All they have to do is give you a lecture on

how it is experimental. And it may take a lawsuit, but thus far the

courts have been consistent in insisting that a Phase IV experimental

drug has to be covered like anything else by insurance -- both private

and Medicare.

Some of us wonder if that's what's holding the whole thing up -- the

health care industry does NOT want to have to pay for this! (nobody

wants to pay for it). If they could figure out how to make it work in a

pill, odds are that we'd have no more problems with approval ...

Bottom line: unless Hemispherx goes belly up between now and then, I

think that Ampligen will be available via your own doctor (and

chargeable to insurance or Medicare) sometime in the year 2002. Unless,

of course, we are successful in pushing the FDA to approve it earlier.

If the AIDS community can get it approved earlier, then you can access

it via your own doctor, but insurance won't have to pay for it until

full approval (which again probably won't come for another 3 years).

Schweitzer

mailto:schweit2@...

thanks

[Guest guest]

In a message dated 10/16/99 11:27:14 AM Eastern Daylight Time,

schweit2@... writes:

<< What is the bottom line on amplegen? >>

I didn't have the time to read all of 's post, but it should include that

no long term studies have ever been done on the Ampligen. Of the first 15

patients in the United States, one is no longer alive, two have serious

cancers (two different types) and none are well. Most are severely ill. Dr.

and many others from Hemispherx love to tell stories about how much

the first patient, " patient 00 " was helped. In fact, Dr. had a patent

approved just last month that again mentioned her success. She is, however,

never, never, never been well and has gotten progressively worse. Those

physicians that speak of her, and I've heard one lead investigator speak of

her while I was present, say she's out playing golf again and living her life

happily. It is a total fabrication but Patient 00, whose name is

Kaiser, wishes it were so. She just went to a new physician well known in

this field. When she showed up for her appointment, the physician

immediately hospitalized her. Long term follow-up studies are not costly nor

are they difficult and yet have never been done. I remain very wary of the

drug and want much more information that are based on actual studies that can

be proven. The data is not yet there. An ME specialist in England, as well

as a patient and the advisor to the largest national suppport group in that

country has said he would not take the drug nor give anyone else the drug

until much more data has been disclosed. (Dr. Shepard.)

Gail