Re: HHV6 and Ampligen to new kid

[Guest guest]

In a message dated 10/30/99 4:21:37 PM Eastern Daylight Time,

elsbeth@... writes:

<< I joined this list because I am interested in therapies/theories related to

NK cell function, HHV-6 and anti-thyroid antibodies. >>

There are many things that inhibit HHV6A. Kutapressin and Ampligen are just

two. There is nothing YET that kills it. Drs. Knox and Carrigan were funded

by The National CFIDS Foundation to try to find one non-toxic drug that would

ill HHV6A. They did. It is called Dicosonal. However, even though

Diconsonal went through three phases of the FDA, they did not approve it and

gave no reason why. These researchers are, however, looking at another

promising non-toxic remedy and the results, we hope, will be ready for our

winter edition. As for Ampligen, you may want to read one of the four front

page stories in the present edition of The National Forum:

(FRONT PAGE)

AMPLIGEN REPORT EXPOSED:

PATIENTS DUPED

By Gail Kansky and Cheryl Tai

The purpose of giving this much-abbreviated report that was based on

patient

interviews of former and current Ampligen patients was twofold. The original

and lengthy

document was to asses the information in order to identify new avenues of

investigation

and the second was to create a document that could be sent to the FDA

(Federal Drug

Administration) to facilitate the agency’s Ampligen investigation truthfully.

Two facts are apparent from the information given to The National CFIDS

Foundation: Some patients with CFIDS/ME have been seriously harmed by

Ampligen and

no patient ever recovered completely or was able to return to full-time work.

These facts

are important because Hemispherx Biophrama has and continues to conduct a

promotional

campaign that is blatantly dishonest as well as one that is illegal. (It is

not legal to

promote a drug still in testing to patients according to the FDA.) Because

of the

company’s dishonesty, CFIDS/ME patients are led to believe they have a high

probability

of complete recovery and are in little to no danger of any significant

adverse reactions.

“CFS Radio” has reported on several occasions that Ampligen is a “cure.” No

follow-up

has ever been done on patients that experienced adverse effects from the

drug. Former

patients have been denied adequate follow-up medical care. Future patients

remain

ignorant about the truthful outcomes of the trials. Information has been

taken from

patients in former Ampligen trials as well as from those on cost-recovery.

Tape recorded telephone interviews, essays, personal correspondence, and

e-mail were

used to gather the information we summarize below as well as questionnaires.

One patient

had a telephone interview scheduled three times but the former Ampligen

patient’s health

had deteriorated so much that she has been prevented from responding to date.

One

group that has participated in trials from 1997 to the present has been

omitted since there

is sufficient evidence of untruthfulness in their answers. This group, who

are from the

Incline Village site of Dr. , include Lang, a board

member of The

CFIDS Association who is regarded by some fellow board members as an advocate

for

Hemispherx and has signed e-mail that clearly came from that company trying

to persuade

patients not to sue, Barossi, Anita Patton, who is married to Bob

Patton, a publicist

for Hemispherx, Rich ll, who said on “CFS Radio” that Ampligen is “as

harmless

as chicken soup, and others from that area who seem to have been pressured or

coerced

to exaggerate Ampligen’s positive effects.

This report is based on 17 patients. Two of the 17 patients are still

on the treatment

and feel they have had some cognitive improvement:

8=imporved stamina

8=pain reduction

1=seizures subsided

8=increased fatigue

7=increased pain

14=put on Demerol or Morphine during trial

6=continue on pain meds (above) today, 1-5 years after termination

of treatment

6=pain has not decreased

3=elevated liver enzymes

2=dpression not felt before

3=infections (kidney, pneumonia, etc.)

2=mentrual irregularities*(several had hysterectomies prior to

treatment/some male)

1=cardiac arrythmias, tachycardia, gastrointestinal problems,

thyroid abnormalities

(verified with blood tests)

5=increased headaches

5=burning sensation in spine and/or back

5=burning sensation in legs and/or feet

2=fevers not previously experienced

2=thought to having “heart attacks” during first infusion

(breathing problems, cold,

sweaty, etc.)

2=symptoms worsened after infusions

The following group is based on 14 patients following treatments with

Ampligen. The

above 17 combined both past and present Ampligen users.

3=patients who feel they are better than they were before Ampligen

treatment

8=patients who feel they are worse than before Ampligen treatment

3=feel they are no worse or better since Ampligen treatment

6=crashed badly after stopping treatment

7=became more severe during and continued to deteriorate after

treatment

3=diagnosed with an additional autoimmune disease following

treatment

2=cardiac problems following treatment

2=depression diagnosed following treatment

Some patients saw repeated infections at the site of infusion and there were,

within their

group, reports of abnormalities following treatments that included elevated

liver enzymes,

uterine hemorrhage and homonal abnormalities.

No pharmaceutical undergoing FDA trials is allowed to promote their

product as “safe

and effective.” Hemispherx received at least one letter from the FDA warning

them of this

breach which served to silence them for only two years. They promote their

product on

their website, in PR releases, radio programs, online guest appearances, and

at medical

conferences. In 1994, an AACFS conference was held in Fort Lauderdale,

Florida where

a representative of Hemispherx reported that 80% of patients on a Belgium

trial made a

complete recovery. To date, no actual data from this trial has been shown,

yet

presentations at medical conferences, including one AACFS conference in San

Francisco

and another in Boston cited this same “80 percent recovery.” Both the

company and the

investigating physicians repeatedly cite this “80% recovery” to patients

including 16 of the

17 interviewed for this document. In 1998, data was shown at the Boston AACFS

conference on slides that were changed so quickly that nobody present could

read them

and the abstract itself was vaguely worded.

Hemispherx also makes claims that effectiveness for Hepatitis B and for

HIV/AIDS

patients. One article entitled “CFS Advocacy Group Says Ampligen Works and

is Needed

Immediately” was actually put out by just one patient on cost recovery who

had suffered a

stroke while on the drug. She is not on the board of the group that was

cited and the

group is now in the process of suing her. Her husband is now listed on the

board for the

CAB development (Citizens Advisory Committee) along with all but one of the

formally

named Incline Village patients.

Potential Ampligen patients are told to expect “recovery” after 6

months. When the 6

months elapse with no recovery, they are then told it will take at least a

year to see if

Ampligen will help them. In the 1900-1991 U.S. double-blind trial, the FDA

found in

nearly one third of the patients “deterioration of Activity of Daily Living

(ADL) scores

during...treatment.” Yet guest on “CFS Radio” continue to state promotional

themes.

These transcripts are available on Dr. Mazlen’s website and posted on

several other

sites. Nowhere is it indicated that Hemispherx Biopharma is funding these

broadcasts.

Dr. Mazlen is now testing patients for RED (Rnase-L Enzyme Detection) whose

laboratories are associated with Hemispherx. The owner of RED Laboratories,

C.V.

Herst, is a former board member of Hemispherx. Dr. Dharem Ablashi stated

that he

couldn’t find HHV6 in the patients following Ampligen but did not explain

that is often

does not show up in blood tests. Dave , the AIDS activist who has led

Clement and the CFIDS Ampligen trials down the road of prejudice, was also

featured on

the show and called “Dr. .” (Dave is neither a medical doctor or a

Ph.D.) Dave

claimed the only side effects of Ampligen is “a little hair loss.” Although

the FDA has

been sent transcripts of these shows that clearly breaks their rules, they

have remained

silent.

In the CFIDS Chronicle, Hemispherx’s Dr. Strayer said that long-term

follow-up data

were favorable and presented at the 1998 AACFS conference. We have not yet

been able

to locate any Ampligen patient who was ever contacted for a follow-up study.

The

patients interviewed, who have stayed in touch with others from their study

group, never

heard of any patients who were contacted. Only 2 of the 17 interviewed

“retained any

improvement” in their health following Ampligen treatment.

Kaiser, the first CFIDS/ME patient to try Ampligen treatment and

who was on

it for several years, was often coerced into promoting the drug during

treatment with

threats of having the drug taken away if she did not cooperate. She was

introduced as a

“recovered” patient although she always corrected that statement as being

untrue. In

1998 and 1999, one Ampligen investigator who gives numerous patient lectures

has

evoked her name and said she “has returned to work and a weekly round of

golf.” That is

completely , although wished it were the truth. Lang, who

circulated the

rumor that Dr. Jonna Lannert was suicidally depressed before she took

Ampligen are was

that same way when she died, was telling a story adamantly denied by all

close friends of

Dr. Lannert, her family, and even her physician. It was also false that Dr.

Lannert asked

to be taken off the drug. The company, without a word, just ceased supplying

Ampligen

to her.

During an investigation done for The CFIDS Chronicle (for an article

they refused,

ultimately, to publish) there were three suicides attributed to the

horrendous adverse

reactions of Ampligen. The National CFIDS Foundation has located a fourth

one who

had traveled to Belgium to receive the drug over the objections of his

physician, Dr.

Klimas. Desperate and, evidently believing the hype and falsehoods

promoted by

Hemispherx, he took the drug for many months before he took his own life in

France.

At a CAB develop meeting held in Philadelphia earlier this year, Dr.

,

CEO of Hemispherx, singled out The National Forum when he asked for no further

negative information on Ampligen until the CAB was up and running and called

the

Forum a “scandal sheet.” Our staff was particularly pleased with his comment

in light of

how knowledgeable people view both him and his company. If we convince just

one

CFIDS/ME patient of the dangers of the drug, Ampligen, we consider our

efforts well

worth the time spent. If you are considering a trial of the drug, the NCF

will be happy to

put you in touch with former Ampligen patients who can report to you as they

have to us,

“The day after Ampligen (injections) was pure hell.” While we’d love to

believe the CAB

will find the truth, with Lang and other Ampligen patients leading the

effort, we see

no reason to expect truthfulness. If you know of any CFIDS/ME patient

considering the

drug, please ask them to contact us. They are welcome to reverse the charges.

[Guest guest]

Gail,

Another can of worms. Thanks for the information on Ampligen trials.

beth

Re: HHV6 and Ampligen to " new kid "

> From: GAILRONDA@...

>

[Guest guest]

In a message dated 10/31/99 11:45:27 AM Eastern Standard Time,

bgrommes@... writes:

<<

From your description, Disconsonal sounds as if it was more effective and

less dangerous than Ampligen >>

I'm hoping that the AIDS community will jump on this and have a list to begin

alerting them to these facts. They're much stronger and have more money to

do this. Discosonal was manufactured by Avanir Pharmaceuticals and the third

phase ended in 1999 and was brought to the FDA for approval in September.

The researchers got no reason for it's denial and were so frustrated that

they went to Japan to distribute it in cream form (but we need the oral). It

was not tested for HIV or for CFS.

We're now having Drs. Knox and Carrigan test another non-toxic product (with

probably the first IOU to researchers in history!) and, hopefully, it will be

as effective. Even better, if it is, it is not considered one that must be

prescribed.

If you can reach Danya, she may be able to send you the file that I was

working with for the recent article. She has the original.

I do know that Bristol-Squibb-Meyers was going to buy out Avanir after the

approval, but this was mute, of course. Avanir Pahmaceuticals were using it

under the trade name of " Lidakol " and it acts similar to a virucide to alter

the lipid envelope of the virus. It inhibits the HHV-6A/GS (CFS strain of

HHV6A) with very low toxicity and nobody on the trials had any adverse

reactions, so it actually went far beyond Ampligen.

Gail

[Guest guest]

Sorry, that last post was meant to be private. Goofed again!

Gail

[Guest guest]

Re: HHV6 and Ampligen to " new kid "

>Drs. Knox and Carrigan were funded

>by The National CFIDS Foundation to try to find one non-toxic drug that

would

>ill HHV6A. They did. It is called Dicosonal. However, even though

>Diconsonal went through three phases of the FDA, they did not approve it

and

>gave no reason why.

Gail, I understand that you are saying Diconsonal is essentially a dead

issue but am still curious to learn about it, what type of drug it was, how

the study was structured, etc. as the nature of this drug may hold

interesting clues. I can not find anything about this drug after consulting

several Internet search engines. It appears to be so thoroughly buried that

it's never been discussed by the media, is no longer on the FDA trial site,

etc. Can you suggest some references to consult? Also, during what year(s)

did the phase III study take place? What advocacy efforts did the CFIDS

community undertake at the time? Were any protests lodged with the FDA?

Who jumped on this, and who didn't?

From your description, Disconsonal sounds as if it was more effective and

less dangerous than Ampligen. Some people on this list have looked into or

even participated in the Ampligen study, so surely someone here did the same

for Disconsonal. I don't know how I missed it. Anyone have any info to

contribute? Sometimes ideas that medical science discards eventually turn

out to be helpful.

Thanks much,

--Bob Grommes

[Guest guest]

In a message dated 10/31/99 1:09:17 PM Eastern Standard Time,

bgrommes@... writes:

<< So even if the stuff was approved it may not have been useful

to PWCs. >>

The testing and the outcome of this is something that I can no longer discuss

on this list, but saying it may not have been useful is the most naive

statement you could make. The company doesn't even know that we have had it

throughly tested since they were uncooperative in even giving a sample of it

for research.

[Guest guest]

Re: HHV6 and Ampligen to " new kid "

> Discosonal was manufactured by Avanir Pharmaceuticals and the third

> phase ended in 1999 and was brought to the FDA for approval in September.

Ah, now I *was* able to find this company. The press releases at

http://www.prnewswire.com/gh/cnoc/comp/509050.html pretty much tell the

story. The reason I didn't find the drug was the spelling: it is

Docosanol, not Discosonal. It is being developed to treat cold sores and

they mention only a cream form. No mention of HHV6 in any of the literature

I have found. So even if the stuff was approved it may not have been useful

to PWCs.

Avanir sounds a lot like HBP ... a troubled history. Formerly known as

Lidak, they are suing their former CEO for breach of fiduciary duty, just

won a 2.3M judgement against him; a board member just quit; they are openly

admitting that they are having financial problems due to the FDA dragging

out the study and requesting a new one, etc. Their 8/99 SEC filing is at

http://f2./e/990816/avnr.html.

It's not hard to get the impression that no one is interested in the

treatment of herpes-type viruses except third-tier startups who are

systematically crushed by the system. Evidently this kind of research just

isn't sexy enough for the mainstream.

> We're now having Drs. Knox and Carrigan test another non-toxic product

(with

> probably the first IOU to researchers in history!) and, hopefully, it will

be

> as effective. Even better, if it is, it is not considered one that must

be prescribed.

That will sure be an exciting development if it comes to pass.

Thank you for the info, Gail.

--Bob Grommes

[Guest guest]

Re: HHV6 and Ampligen to " new kid "

> The testing and the outcome of this is something that I can no longer

discuss

> on this list, but saying it may not have been useful is the most naive

> statement you could make.

All I said was that it " *may* not have been useful. That isn't the same

thing as a blanket dismissal. I also envisioned that even if was promising,

an additional round of FDA-approved testing would be required to get the

drug in a form both useful to, and on-label for PWCs, and we all know the

likely timframe and dicey outcome of *that* process. And it is pretty clear

that the pharmaceutical company hasn't the funds to do it anyway now that

the FDA in its tender mercies has relieved them of all their resources.

I did not understand that the company developing the drug was not the

primary entity invovled in / sponsoring the CFIDS-relevant research on its

own drug, hence my cognitive dissonance in not being able to find and

evaluate this research. Thanks to your explanation, this is no longer a

question for me. It explains why no one knows anything about it but you and

the researchers. I applaud any effort to leave no stones unturned in

following up with possible treatments or cures.

As to your no longer being able to discuss it on the list, I'm not sure I

understand the reason for the cloak-and-dagger routine, but I guess it's a

moot point now anyway. I'll just wait to see what comes of the more

promising research you mentioned on the non-prescription substance.

--Bob Grommes