FDA and NIH confirm WPI XMRV findings (report of leaked presentation)

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Hi Tina

The drugs you refer to are existing drugs, and we could have them available in six to twelve months if the studies are fasttracked. Off-label they can be used now, but most insurance policies etc wont cover them.

New drugs arise from basic research. You have to find a candidate drug (usually by studying target molecules), test drugs in the lab and animals, run a series of clinical studies, then get official approval. This is a long process.

There is a halfway position however. There may be hundreds of drugs that were tested on HIV but didn't work. This drugs can be rapidly retested against XMRV, and if they work then this would significantly reduce the time to development.

Bye,
Alex

Alex, is that true even if the drug has already passed some phases of study, having been tested in HIV patients for safety?

I think I remember someone saying, was it Mikovits, that it will be even quicker because they just have to pull them off the shelf. No development, already tested for safety?

I just wonder if your figures took that into consideration.

Tina
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
HI Mark,

As usual I agree with most of what you said.

I have a though about related MLVs. XMRV may not be the only virus out there, and that is why they are trying to keep this quiet, until they can nail the research.

Bye
Alex

@cfs_since_1998: "What do they mean by related MLVs?" - There are minimum 6 known strains of XMRV, they have obviously branched further out on the phylogenetic tree of XMRV since then, and the related MLVs are not actually XMRV but part of the family. It also means: Lots of different types of us, lots of detail, there are differences between us but we are all connected; against everyone's expectations, the wastebasket has a lowest common denominator after all.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
HI bullybeef

That about sums it up. I have been trying to convince people of this risk since last october, and on these forums since May when I joined. Its not hard to do some math to show best and worst case scenarios, all this was predictable from the beginning.

Bye
Alex

XMRV: Scenarios for the future - page 37
•Completely unknown and essentially unpredictable
Range from irrelevant to doomsday
•Irrelevant
–Contamination, cross-reactivity, “normal viral flora”
–Possible models are TTV/SEN-V, HGV/GBV-C, SFV
•Doomsday:
–Virus causes dread disease(s)
–Extended incubation period
–Spreads rapidly via common routes
–Is already widespread
–(Perhaps after viral mutation event
)
 

Daffodil

Senior Member
Messages
5,885
XMRV is really nothing like HIV, other than them both being retroviruses. one of the co-founders of XMRV told me that in the future, XMRV will not turn out to be a serious, life-threatening infection, once treated. it is much less cytoxic than HIV and has none of the accessory proteins.

they will have a vaccine....maybe it won't be so bad.....:-/

maybe

ugh.
 

judderwocky

Senior Member
Messages
328
Hi Tina

The drugs you refer to are existing drugs, and we could have them available in six to twelve months if the studies are fasttracked. Off-label they can be used now, but most insurance policies etc wont cover them.

New drugs arise from basic research. You have to find a candidate drug (usually by studying target molecules), test drugs in the lab and animals, run a series of clinical studies, then get official approval. This is a long process.

There is a halfway position however. There may be hundreds of drugs that were tested on HIV but didn't work. This drugs can be rapidly retested against XMRV, and if they work then this would significantly reduce the time to development.

Bye,
Alex

well... see a lot of the early drugs for HIV were actually tested first against MLV's... so we probably already got a let up on that.... they were using MLV's for quite some time to learn how the more complicated lentiviruses worked...

MLV's have been studied extensively in animals and as models for other retroviruses (hiv included).... what is astounding to me, is that it took so long to realize their could be human infections... it was just always assumed that couldn't happen...

there are some important similarities... it is known that XMRV biapasses some of the same cellular defense systems as HIV, like HIV it is not restricted by Trim5Alpha... which is odd becaue most MLV's are...

Gammaretroviruses are usually much smaller and slower replicating...which might be advantageous to those with an infection,
They don't have all the bell's and whistles of an HIV infection, but the tropism is also significantly different, which poses additional risks... for instance... the fact that it may be able to reside in lymph tissue is very signifigant because hormones often times increase the replication rate of retroviruses... the ability to live in a hormonally rich environment changes the responsiveness of the virus to environmental changes considerably
 

jeffrez

Senior Member
Messages
1,112
Location
NY
@Mr Kite:[/B] "[/SIZE][/SIZE]I know if I went to any doctor with this information, they would still say the same thing: that there's nothing they can do because there is still no proof that XMRV causes CFS. Which is true. Then they would continue implying it was some kind of psychological malady or defect."
I didn't get where I am today by trusting doctors Mr Kite. :D Just because they say stuff doesn't mean you have to respect it. The point about non-mathematical "proof" being subject to interpretation is correct. This is not about proof, but about truth. The evidence is overwhelming. The ME/CFS literature has been begging the question as to why our T and NK cells are malfunctioning for some years, so a retrovirus known to selectively infect those cells and subvert their functioning sounds like a considerably more likely explanation for that behaviour than cosmic rays to me. Immune dysfunction is what retroviruses do. Immune dysfunction is what we have. XMRV infects the precise cells that are damaged in us. Occam's Razor does the rest.


I don't really think so. You're bandying words around like "truth" and "interpretation," but the point is that none of what you say proves anything causal. It's poor reasoning to say that just because XMRV is present, it therefore must be causing those things. "Begging the question" is actually a logical fallacy that means assuming the truth of your premise before you even start, which ironically is what you're doing by reasoning backward from your assumed premise to your unfounded conclusion. Parsimony has nothing to do with it. If anything, it's more parsimonius at this point to say that we contracted XMRV because of a preexisting immune dysfunction, not the other way around.

Mr Kite, you may be going to the wrong doctors. One of my telephone contacts just told me last week he went to a doctor that specializes in AIDS treatment (a major player) for the first time to discuss XRMR and anti-retrovial treatment for ME/CFS. The doctor was well aware of XMRV and the three AVRs that have been proposed for treatment. The doctor said he would have no problem treating the person with the AVRs because he has believed ME/CFS was caused by a retrovirus for a long time. The doctor doesn't want his name mentioned because he knows he would be swamped with calls. Some doctors are out there and they're ready for us.

Yes, if XMRV proves to be the cause, HIV/AIDS doctors might be the best ones for us to start seeing. Then perhaps there would be some way to start initiating legal action against those doctors who for years labeled us hypochrondriacs, somatizers, etc., especially if they now keep doing it. It's clearly malpractice, which we have known for years. But with a proven cause it should be much easier for the general public to appreciate the extent to which we have been marginalized and harmed by the medical profession.
 

muffin

Senior Member
Messages
940
Stigma from XMRV?

I don't think there will be the same horrible type and level of stigma directed at those of us with XMRV/CFIDS as there was initially with the poor AIDS/HIV gay men. XMRV and CFIDS/ME strikes children and very young and they don't have sex or engage in other nefarious activities that could be "blamed" for contracting/spreading XMRV.

If the whole XMRV thing turns out to be solid, then XMRV will probably be viewed as other viruses are in the way that they are spread. I really dare someone to point a finger at a child with CFIDS (and XMRV) and damn them.

I do suspect that the majority of us were just killing ourselves working, dealing with stress and damaging our immune systems such that we compromised them to the point of getting viruses - including XMRV. I wasn't having "fun" or playing games pre-CFIDS, I was killing myself in all areas and then got sick. If I ever hear one comment directed at me that I did something to "deserve" this virus I will knock that person in the mouth.
 

muffin

Senior Member
Messages
940
Anyone heard any comments from the CDC/Reeves or the UK/Weasel yet? Let's see how they twist this one.
 

natasa778

Senior Member
Messages
1,774
The last pdf is a summary of most interesting bits - someone was taking notes and writing down stuff that is not in presentations themselves. Sadly nothing much on Alter's presentation.
http://www.sanquin.nl/ipfa/Upcoming...cc818c125706600483652!OpenDocument&AutoFramed <http://www.sanquin.nl/ipfa/Upcoming_Events.nsf/Web%20Body?OpenFrameSet&amp;Frame=Body&amp;Src=%2Fipfa%2FUpcoming_Events.nsf%2F0%2Fcbfb86b6bbdcc818c125706600483652%21OpenDocument%26AutoFramed>




from Van der Poel's summary pdf:




Dr. Dodd (ARC, USA)

Of mice and men: XMRV a virus searching for diseaseand CFS a disease searching for a virus
Association with PC and CFS not established
Donor prevalence up to 3,7 % (NAT)
Blood Txma theoretical risk(where did we hear that before?)
A causal role of XMRV in CFS is an intriguing


Round table

Look for Coxiellapartitioning in blood
Coming next in this theatre: Does EU have XMRV?
MSM (men having sex with men) no risk group for XMRV (in Amsterdam)
XMRV disease after blood Txm?


Dr. Linnen(Gen-Probe)
B19/HAV in development, XMRV prototype, Dengue in Brazil studies planned
Panther instrument
[XMRV 0/1435 ARC donors, no XMRV in HIV+ samples

(is ARC = Abbotts? or something else?)



XMRV in 3,7% of donors, but not at ARC.
Macaques have it in their genito-urinary tract but MSM not..

(screening diseases with a new test @ alpha = 0,05, will yield one in 20 chance of associateddisease)
 

jeffrez

Senior Member
Messages
1,112
Location
NY
I don't think there will be the same horrible type and level of stigma directed at those of us with XMRV/CFIDS as there was initially with the poor AIDS/HIV gay men. XMRV and CFIDS/ME strikes children and very young and they don't have sex or engage in other nefarious activities that could be "blamed" for contracting/spreading XMRV.

If the whole XMRV thing turns out to be solid, then XMRV will probably be viewed as other viruses are in the way that they are spread. I really dare someone to point a finger at a child with CFIDS (and XMRV) and damn them.

I think that will be true only as long as there is a remedy. Otherwise, I think there is a very big risk that in the minds of most people we go from "harmless loon" to "potentially dangerous carrier of a serious infectious disease who needs to be avoided at all costs." I think that's another reason why having patience and not getting ahead of the science is so important here.
 

coxy

Senior Member
Messages
174
I'm still puzzled as to how 2 of our children got ME/cfs (both aged 8yrs, 4 yrs apart), and i got it 2 yrs AFTER them?
 

Esther12

Senior Member
Messages
13,774
I'm still puzzled as to how 2 of our children got ME/cfs (both aged 8yrs, 4 yrs apart), and i got it 2 yrs AFTER them?

Retroviruses can be funny things.

When I was thinking XMRV would be like HIV, it made no sense for CFS - but it could act in a compeletely different way. We'll have to wait and see.
 

VillageLife

Senior Member
Messages
674
Location
United Kingdom
I think dr mikovits said she thinks xmrv could be passed with another pathogen. She mentioned this might explain out breaks in schools where perhaps a common tummy bug might of been involved.
I think it probably can be passed through blood, mother to child, breast milk and sex but even if you pass it on the other person may never get sick.
We deserve to know what's wrong with us. We deserve the truth, it's gonna be hard to take at times but i think we can get through this.
 

Rrrr

Senior Member
Messages
1,591
well... see a lot of the early drugs for HIV were actually tested first against MLV's... so we probably already got a let up on that.... they were using MLV's for quite some time to learn how the more complicated lentiviruses worked...

MLV's have been studied extensively in animals and as models for other retroviruses (hiv included).... what is astounding to me, is that it took so long to realize their could be human infections... it was just always assumed that couldn't happen...

there are some important similarities... it is known that XMRV biapasses some of the same cellular defense systems as HIV, like HIV it is not restricted by Trim5Alpha... which is odd becaue most MLV's are...

Gammaretroviruses are usually much smaller and slower replicating...which might be advantageous to those with an infection,
They don't have all the bell's and whistles of an HIV infection, but the tropism is also significantly different, which poses additional risks... for instance... the fact that it may be able to reside in lymph tissue is very signifigant because hormones often times increase the replication rate of retroviruses... the ability to live in a hormonally rich environment changes the responsiveness of the virus to environmental changes considerably

thank you for bringing yr science background to this forum!!!!! i love reading yr posts!

rrrr
 

muffin

Senior Member
Messages
940
Long incubation period for XMRV may explain long time periods between family members

Didn't they say somewhere that XMRV had a long incubation period? That may explain why family members don't get XMRV/CFIDS until years later. My husband got sick ten years after me. There he sits on the couch with all the CFIDS symptoms (except pain). I was super careful with him and the rest of my family about anything that went into my mouth (toothbrushes, spoons/forks, food, etc). I did NOT kiss anyone on the mouth. I was just too frightened from the beginnig that I had a virus since that's what started my ball rolling so I assumed that was what I had and could not get rid of. So, I was most careful about breathing on baby niece, sharing food with spouse, etc. I also could not allow anyone to sit close to me since the pain from that gentle touch was too much. Actually, a hard punch in my arm or leg hurt far less than the gentle but constant pressure from someone (or a dog/cat) laying up against me (odd,that). My guess is that XMRVCFIDS could possibly be airborne since I did knock myself out in all ways NOT to share/spread my virus in ANY physical capacity.
 

Adam

Senior Member
Messages
495
Location
Sheffield UK
Journalists certainly can’t quote the guy word for word, he could take them to court. And even if the FDA or NIH try to pull it now, the word, and quotes are out…we all know.

And the WPI wouldn’t post it on their FB page if it wasn’t true. Surely they would know if someone has used their methods…they would have had to show them first!!!

Agreed.

Leaks, as opposed to rumours, are vital to help keep the pressure up. Keep things moving.

More leaks please...oh and will someone pass me the carrotts please?
 

Cort

Phoenix Rising Founder
From my blog

Dutch Journalists have been all over the European XMRV Conferences. Now in a startling announcement two Dutch journalists from the Health Professionals Journal Ortho report that they were able to obtain a lecture from NIH official Dr. Harvey Alter at the Blood Transfusion workshop May 26/27th in Zagreb, stating that both the FDA and NIH had confirmed the WPIs original findings.

Dr. Harvey Alter is the Clinical Studies Chief at the Infectious Diseases and Immunogenetics Section of the Department of Transfusion Medicine at the NIH Clinical Center in Bethesda. The Dutch journalists report that Alters lecture stated The data in the Lombardi, et al Science manuscript are extremely strong and likely true, despite the controversy. The lecture also purportedly stated the association with CFS is very strong, but causality not proved. XMRV and related MLVs are in the donor supply with an early prevalence estimate of 3%‐7%. We (FDA & NIH) have independently confirmed the Lombardi group findings.

The Dutch report does not include rate of XMRV prevalence found in CFS but does report that the association with CFS is very strong which can only mean, if true, that it was found in a much higher percentage of CFS patients than healthy controls. Indeed the similarity between the FDA and NIH findings of XMRV in healthy controls and the WPIs findings suggest that prevalence rates in CFS may be similar as well(67%).

Note that the report indicated that two institutions have independently confirmed the Science reports original findings something that would presumably make their findings unassailable. Dr. Alter would not confirm or deny the report but did say a paper would be out soon.

Dr. Harvey Alter is a well known researcher (he has a bio in Wikipedia) whose work lead to the discovery of the hepatitis C virus. The chief of the infectious disease section and the associate director for research of the Department of Transfusion Medicine at the Warren Grant Magnuson Clinical Center in the National Institutes of Health (NIH), he received the distinguished Albert Lasker award in 2000. He has 300 citations to his name in PubMed.

Its hard to imagine that such a report coming from such reputable scientists working in such important institutions, would not quickly legitimize the original Science findings. Researchers around the world (and governments and physicians and, of course, patients) have been waiting for a definitive word on XMRV. If this report is from the FDA and the NIH (somewhere in the NIH?) then this may be the report that everyones been waiting for. Because its harder to find XMRV than not find it, any report that shows how to actually find it has the potential of negating all the negative studies before it.

Theres been a uptick of positive reports over the last month. Several weeks ago Dr. Klimas reported a positive paper was on the way; a finding a Phoenix Rising Forum member reported was originally from Dr. Suzanne Vernon. Today, Hillary Johnson reported in a blog that two researchers have contacted her in the last few weeks stating that a major research paper confirming the Science paper will be published shortly and that it could push positivity rates in ME/CFS even higher.

Its possible that the recent AABB announcement recommending that blood collection groups aggressively discourage blood donation by CFS patients, was prompted by these findings as well.

Some care should be noted. Until these findings are in printed in black in white in a medical journal they make little difference in the research world. If that occurs then an association with CFS will be established. Then will come the work of finding what, if any other diseases, the virus is associated with, and what role it plays in ME/CFS. It could be a passenger virus or it could a major factor in CFS (ie the Puppet Master).

In any case, the confirmation of the WPIs original findings would, in itself, unleash a large amount of funding devoted to further understanding the connection between XMRV and ME/CFS. A big win indeed ;)
 

Megan

Senior Member
Messages
233
Location
Australia

Hi all,

This is very exciting news!! I can't quite believe it!!

Just to help me know that I am not seeing things can anyone explain the weird photos that appear to be in the Alter lecture pdf download? CBS's avatar appears to be in there and a couple of weird photos of little kids. CBS did you take this out of the pdf? I would like to send a copy of this on to one or two people I know that woud be interested, but don't want to do so if there is some type of weird virus affecting my files (no pun intended!)

thanks,

Megan.
 

jeffrez

Senior Member
Messages
1,112
Location
NY
Cort, that's a very balanced and well-stated report, in my view. I can understand all the excitement around the apparent NIH/FDA findings, of course, but I think that kind of measured and conservative approach benefits us more in the long run. Anyway, thanks for putting it all in perspective.
 
Back