RE: Re: Nexavir - Is this safe?

[Guest guest]

----Original Message Follows----

From: michelle and daron freedberg <mdfreedberg@...>

>Sorry I have not been clearer.

>The purpose of the post is to confirm what Dr. Goldberg has been saying.

Once in a while us parents with limited brain cells have a few that spark.

It's disingenuous to raise these points and concerns now if they weren't

being raised previously.

>THERE IS NO FDA APPROVED IMMUNOMODULATOR.

I think any parent who's been around a while has read the descriptions on

the old, indirect, and potentially new ways to modulate the immune system.

The type of agents Dr. G has discussed as immune modulators are in clinical

trials. I've posted quite a bit on the VIP related agents.

The ironic thing is that the proprietary neuroprotective technology

originated from studies by scientists at Tel Aviv University and the U.S.

National Institutes of Health. A Canadian biotechnology company has licensed

exclusive worldwide rights.

Cheryl

[Guest guest]

>

>

> THERE IS NO FDA APPROVED IMMUNOMODULATOR.

You mean, for the treatment of autism? There are plenty of

immunomodulators that have been around a long time, and

are FDA approved. (not that they'd be appropriate for use

with autism).

[Guest guest]

I hope this email will end the back-and-forth about nexavir.

My intention was to inform, not depress people. I have great hope

for new therapies; I research and regulate new therapies at the FDA.

On the other hand, I cannot let things get perpetuated when I KNOW

they are not true.

To sum up, neither Nexavir nor kutapressin are nowhere on the FDA's

list that I can find. Perhaps there are secret clinical trials, but

I don't know about them. In any case, the label for kutapressin that

I found online, looks like an old one from the 1960's. Maybe

kutapressin was used back then, but there are few current

peer-reviewed articles about it or nexavir. Press releases DON'T

count when it comes to good science. Just because a company thinks

they have the next magic bullet doesn't qualify it as a good

therapeutic. What I am trying to say is that Clinical trials are the

gold standard. Data from these are published in scientific/medical

journals. I don't see evidence of that (and a label on a website -

bad press about the FDA fining a company etc... don't count)

I would like to see Nexavir approved, but there is nothing submitted

to the FDA at the present time. That is not to say that it won't be

approved if it is submitted for approval. I simply think that the

companies who are telling people that Nexavir will soon be approved

are being disingenuous.

I am not sure why it would be disingenuous to raise these points now.

If you are referring to the latest requirements by the FDA not

matching the old ones, I would say that we know a whole lot more now

then we did in the 60's, 70's, 80's and 90's. There are new viruses

(AIDS, Ebola, SARS, Hepatitis C and others) that we need to make sure

are not present in pig livers. In addition, there are issues with

pig retroviruses: They can infect humans. I don't think anyone

wants that. There are other issues as well, and I won't bore the list

with those.

I apologize for the incorrect comment saying there is no FDA approved

immunomodulator. That is clearly wrong. But it is true that they

are not approved for use in autism therapy. Nothing is, really. We

need to alert the pharmaceutical companies that new squeaky clean

therapies are needed to treat our children.

I won't be writing any more on this topic - Enjoy your discussions,

Daron

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

>From: michelle and daron freedberg <mdfreedberg@...>

>>Sorry I have not been clearer.

>

>>The purpose of the post is to confirm what Dr. Goldberg has been saying.

>

>Once in a while us parents with limited brain cells have a few that spark.

>

>It's disingenuous to raise these points and concerns now if they weren't

>being raised previously.

>

>>THERE IS NO FDA APPROVED IMMUNOMODULATOR.

>

>I think any parent who's been around a while has read the descriptions on

>the old, indirect, and potentially new ways to modulate the immune system.

>

>The type of agents Dr. G has discussed as immune modulators are in clinical

>trials. I've posted quite a bit on the VIP related agents.

>

>The ironic thing is that the proprietary neuroprotective technology

>originated from studies by scientists at Tel Aviv University and the U.S.

>National Institutes of Health. A Canadian biotechnology company has licensed

>exclusive worldwide rights.

>Cheryl

>

>

>

>

>Responsibility for the content of this message lies strictly with

>the original author(s), and is not necessarily endorsed by or the

>opinion of the Research Institute and/or the Parent Coalition.

>

>

>

>

[Guest guest]

Hi Cheryl -

I wanted to ask what that means to us w/ the biotech

co licensing the rights... does that restrict us from

having access?

If I remember right? (I certainly wouldn't trust my

memory a fraction from the last two years of brain

fog)... Were there some trials in CFS that were in

later stages that were going well? I'll have to look

back thru all the TONS of posts I saved, but I still

have trouble processing new things that I read right

now so I don't know that my brain will grasp them.

Thanks as always for info... I look forward to

re-reading the last two years of Raptor posts as my

brain is beginning to function again. lol

--- Cheryl B <clbro66@...> wrote:

> The ironic thing is that the proprietary

> neuroprotective technology

> originated from studies by scientists at Tel Aviv

> University and the U.S.

> National Institutes of Health. A Canadian

> biotechnology company has licensed

> exclusive worldwide rights.

> Cheryl

>

>

>

__________________________________________________

[Guest guest]

Daron,

This might surprise you but I actually agree with much of what you wrote.

Many of Dr. G's patients (my younger son included) were on Kutapressin in

the 90's and early 2000's as just one piece of their regimen. I realize

that it came on the market before stricter regulations were in place.

My disingenuous comment has to do with the questions directed at Nexavir but

not Kutapressin. Dr. Goldberg raised concerns about PERVs, prions, etc.

when other doctors were prescribing secretin, but when asked about

Kutapressin he assured us it was a much safer, purer product due to the way

it's processed . I certainly believed it was pretty safe.

Now you're starting to worry me. I wasn't before. Are you saying that Dr.

G might have been wrong? Should we be concerned that our children were

exposed to something? My son was on Kutapressin until 2001.

Below I've included an excerpt where Dr. G discusses the use of Kutapressin

Cheryl

Kutapressin is a mixture of agents prepared from pig liver. Dr's Steinbeck

and Hermann

defined this mixture in the early 1980's as about 20-25% " immune active " .

Kutapressin has been used for the last 40 years as therapy for a wide

variety of dermatologic conditions. Favorable response to administration of

Kutapressin in patients with acne vulgaris, Herpes Zoster, Poison Ivy

Dermatitis, Pityriasis Rosea, Seborrheic Dermatitis, Urticaria, Eczema,

Severe Sunburn, and cea has been reported in the past. Kutapressin has

seemed very helpful (antedotally) in my practice and that of others when

used as an immune modulator in treating CFIDS.

In a number of pharmacologic systems, researchers have been able to

demonstrate that the active peptides in Kutapressin potentiate the action of

bradykinin. Bradykinin is a vaso-active peptide generated by the blood

plasma-kinin system. Plasma-kinin and its role in the inflammatory process

has been a subject of great interest to researchers seeking novel

anti-inflammatory drugs. A proceeding of a research symposium, published in

the Federation Proceedings provides some insight into our present

understanding of the effect of plasma kinins in the inflammatory process.

Several investigators have independently shown the presence of bradykinin in

inflamed tissues., In animal models, Kutapressin produces significant change

in the capillary permeability to improve leukocyte migration. Kutapressin

peptides stimulate rapid multiplication of thymocytes in tissue cultures. It

drastically reduces edmma induced by carageen in animals. It maintains the

integrity of the cell structure as demonstrated by higher survival time of

cells in the tissue culture.

Despite its wide anecdotal use by clinicians across the country, the

manufacturer of

Kutapressin does not intend to invest in further studies to investigate its

potential use as an immune modulator at this time. As with all agents,

Kutapressin does not benefit every patient, but when it works, the results

can be dramatic. In fact, the objectionable need to administer it by

injection is tolerated surprising well by children and adults when they

experience pronounced improvement in their condition.

Perhaps the only significantly negative effect of Kutapressin is the

possible danger of allergy. The patient must be screened against possible

allergy to Kutapressin, which seems present in approximately one per cent of

patients. The course of therapy I generally follow is based on original

protocols by Dr's Steinbeck and Hermann; one 2cc (for adults) intramuscular

injection daily for one month, then 2cc every other day for a month,

followed by one injection 3x's a week for 6 - 7 months, then 2 x's a week,

tapering according to patient response. The many possible variations in the

use and dosage of this drug, coupled with patient heterogeneity explain, in

part, the contradictory reports of this agent's efficacy; along with the

fact that as noted, this author does not feel that any one agent is the full

answer to therapy at this time.

Duration of usage of Kutapressin varies widely among individuals. Unlike the

first protocols by Dr. Steinback and Dr. Herman, I do not assume therapy can

end at five or six months. Discontinuation of its use before the patient

feels " normal/well " often results in backsliding over time. Happily, many

patients in my practice have seemed to reach a state of complete recovery

after usage for a year or longer (usually in combination with other

therapies). Maintenance for longer periods is acceptable if indicated and

helpful. Whether " cured " (a word I would use cautiously) or in a " remission "

as a result of Kutapressin, the patient will generally be at a significantly

improved level of functioning within a 3 - 6 month period, with some

positive response expected within the first 4 - 12 weeks. Short of the

drawbacks regarding allergies, Kutapressin appears to be a very safe agent,

especially compared to some alternative treatments. I must strongly

reemphasize, when treating any chronic condition, an agent's ng term safety

and efficacy is of extreme importance, in adults as well as children. This

is true whether the treatment is a prescription drug, OTC, Herbal, or any

other agent.

Kutapressin has seemed of particular help to patients with neurocognitive

problems and/or patients with multiple viral elevated titers and an abnormal

NeuroSPECT scan. Generally. Generally, this author accepts elevated viral

titers as a reflection of an activated, dysregulated immune system, not

necessarily or usually an acute viral infection. Kutapressin's effectiveness

in children with cognitive problems is still diminished by the need to

administer it by injection. Otherwise, it seems an extremely safe and

frequently a very efficacious agent. In the past, I chose Kutapressin for

those patients with predominantly cognitive dysfunction, not for those

patients who suffered more with " fibromyalgia " symptomlogy, such as body

aches and muscle pains. (Antedotally, low-dose, oral interferon has seemed

better for these patients.)

I would readily speculate that Kutapressin, as well as other Immune

Modulators, are likely to have the ability to return the body to normal. I

would stress that this has generally been in the context of " combined "

therapy approaches, aimed at " normalization " of the body and relief of

symptoms. It has been my frustration to know for years of a number of

potential new " immune-modulating " agents that are unavailable to be used

because they lack appropriate evaluation and testing. Without a means of

accurately sub-defining a group of CFIDS patients, and lacking an

" incidence " reflecting its true frequency, pharmaceutical companies have

been reluctant to invest funds for testing these new agents for this

capacity. While there has been a number of " pure " agents developed, it is

urgent to create a means to bring these agents into

controlled tests now, not five or ten years from now.

http://neuroimmunedr.com/Articles/CFS_-_CFIDS/Chronic_Fatigue/chronic_fatigue.ht\

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