FDA/NIH XMRV paper ON HOLD
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Which are the most powerful lobbies in the US and which groups would be most interested in suppressing an XMRV-CFS conection?
My initial thoughts are
1) insurance companies, which avoid payouts and economise massively by insisting it is psychological
2) blood transfusion agencies, this would open a can of worms for them. Are they commercial organisations or fully governemnt funded? If they had to ditch all their blood supplies would they lose money as well as be ing unable to save lives?
3) psychologists themselves, who make a handsome living out of their invented "science". XMRV would be career suicide here.
4) (THE SCARY ONE) The CDC itself, whose major role, it seems to me, is the promotion of vaccination programmes. The new head of the CDC is very into vaccination I've just read. The concept of XMRV being triggered by vaccines would basically leave the CDC as a purposeless organisation adn thus be career suicide for many top men.
My initial thoughts are
1) insurance companies, which avoid payouts and economise massively by insisting it is psychological
2) blood transfusion agencies, this would open a can of worms for them. Are they commercial organisations or fully governemnt funded? If they had to ditch all their blood supplies would they lose money as well as be ing unable to save lives?
3) psychologists themselves, who make a handsome living out of their invented "science". XMRV would be career suicide here.
4) (THE SCARY ONE) The CDC itself, whose major role, it seems to me, is the promotion of vaccination programmes. The new head of the CDC is very into vaccination I've just read. The concept of XMRV being triggered by vaccines would basically leave the CDC as a purposeless organisation adn thus be career suicide for many top men.
They may as well shut their doors, if this is the best they can do!!!!
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> I imagine they are institutional researchers employed directly by the DHHS.
Cort, yes, I'm certain they work in one of the NIH's research palaces, that is, they are "intramural." Virtually every prof at every american uni depends mostly on NIH money but they aren't referred to as "being NIH people." It's the intramural people who "are NIH."
I think the main palaces are Bethesda of course, and Rocky Mountain Labs in Montana. When you work there, your position and funding are perceived as more secure than some professor's at some uni. Accordingly, it's sort of understood that you should do slightly more risky, pioneering, potentially high impact work than the average prof.
The intramural joints are considered fun to work at. If you work at Bethesda you can get any deliriously rare reagent you want anytime, you can walk over and talk at any moment to some expert who is ungodly-hyperspecialized in exactly whatever it is you're wondering about.
Cort, yes, I'm certain they work in one of the NIH's research palaces, that is, they are "intramural." Virtually every prof at every american uni depends mostly on NIH money but they aren't referred to as "being NIH people." It's the intramural people who "are NIH."
I think the main palaces are Bethesda of course, and Rocky Mountain Labs in Montana. When you work there, your position and funding are perceived as more secure than some professor's at some uni. Accordingly, it's sort of understood that you should do slightly more risky, pioneering, potentially high impact work than the average prof.
The intramural joints are considered fun to work at. If you work at Bethesda you can get any deliriously rare reagent you want anytime, you can walk over and talk at any moment to some expert who is ungodly-hyperspecialized in exactly whatever it is you're wondering about.
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im just trying to get people to sign the petition...
http://healthcare.change.org/petitions/view/xmrv_allow_science_to_progress
http://healthcare.change.org/petitions/view/xmrv_allow_science_to_progress
Two different government agencies came to opposite and apparently exclusive conclusions. Obviously one of them got it wrong (of course we know which ones are right!!)
Before publishing them they probably want to find out which one is wrong. It seems like me to be a bit of a$$-covering, plus a little justifiable caution.
Before publishing them they probably want to find out which one is wrong. It seems like me to be a bit of a$$-covering, plus a little justifiable caution.
REPLAY - Dr Freitas
CDC had no problem with the negative studies being poublished.
They will be doing everything they can to dispute Dr. Alter's findings
Thank God Dr Alter had the courage to leak this out - be realistic what would have happened if it had not leaked out.
Why are studies hidden? Think about it.
Its much easier to sweep a possitive study under the table when no one knows of them, be it negative we will all know. Many have suffered with Dr. Freistas retrovirus
They don,t want any new illnesses
Please people do not keep quiet on this one
Think of the recent negative study published, there was no problem even when it was found out that WPI found possitvie samples in their negative samples
Lets keep our eyes open, it is so very hard to see the real harm being done here, its unbelievable so very difficult to accept what they are REALLY doing
glen
Current statuc check
"According to sources that can't be named right now" the current state of play looks something like this. . .
There are 5 negitive studies that do not correlate CFS and XMRV
1- Erlwein O, Kaye S, McClure MO, Weber J, Wills G, Collier D, Wessely S, Cleare A.
PLoS One. 2010 Jan 6 Total 0 CFS 0 HC
2-Groom HC, Boucherit VC, Makinson K, Randal E, Baptista S, Hagan S, Gow JW, Mattes FM, Breuer J, Kerr JR, Stoye JP, Bishop KN.
Retrovirology. 2010 Feb 15 Total 1 CFS and 4 HC
3-van Kuppeveld FJ, de Jong AS, Lanke KH, Verhaegh GW, Melchers WJ, Swanink CM, Bleijenberg G, Netea MG, Galama JM, van der Meer JW.
BMJ. 2010 Feb 25 Total 0 CFS and 0 HC *
(*caveat is that WPI found 2 XMRV positive from 10 samples sent to them by Van Kupperveld which was omitted from the original paper)
4-The Hubner study which has not been published at this time but which was leaked by Dr. Hubner and is reportedly a zero/zero study
5- The CDC paper which was completed early on and is reportedly a zero/zero study as well
Now the THREE positive studies are. .
1-Lombardi VC, Ruscetti FW, Das Gupta J, Pfost MA, Hagen KS, Peterson DL, Ruscetti SK, Bagni RK, Petrow-Sadowski C, Gold B, Dean M, Silverman RH, Mikovits JA.
Science. 2009 Oct 23;326(5952):585-9. Epub 2009 Oct 8. Total 68 CFS 8 HC **
(There are two additional studies often referenced by Dr. Mikovitz in talks reporting numbers in FAMILIAL illnesses including CFS families with members who have Autisum, MS, and Fibromyalgia this paper has been ready for publication and passed peer review, according to Dr. Mikovitz since February and a second study that uses the same Science cohort that reports a 98% incidence of XMRV in CFS patients that has also been review and ready to be publish since February)
2- The second study was reportedly completed by the FDA in April and rumors have the numbers anywhere from 80% CFS to 99% CFS and HC from 3% to 10%. Until this study is published we just don't know. But per the source that can not be named the FDA study is a unique stand alone study not associated with the NIH study. Totals unknown
3-Which brings us to the third study that is also being held up and that's the NIH study. Again rumors abound and I've read "reliable" reports of 80 to 95% in CFS patients and 3 to 7% of HC*** (This number seems to come from the slide given at the IPFA/PEI 17th Workshop on 'Surveillance and screening of Blood Borne Pathogens' in Zagreb. The slide states that XMRV and MLV's are present in the blood supply at 3 to 7% so those numbers are ambiguous at best) Totals unknown
The fact that there are THREE positive studies was stated in the videos, for some reason people keep making the FDA/NIH into one study. Incorrect.
_________________________________________________________________________________
In addition to this the Dr.'s Light study on Interferon and PEM which added an XMRV study to the end of it has never been published and we know from anecdotal evidence that an additional study was executed by the Dr.'s Light in April (is that correct CBS?) of this year.
And the Glaxo-Smith-Klien study that was started end of March or 1st of April.
Also data presented at the Prague CROI has yet to surface as well as the Cold Harbor Springs Conference which is referenced in our non-referenceable reference. (big grins)
Another extremely important point gleaned from our unnamed sources is why the various papers have come up negative. If you read the negative papers that are published you will find that all three used the ENV portion of the XMRV virus rather than the GAG portion. Turns out and this is a very important piece of information that the ENV is the area of change. We also know that being off just a little will cause zero results. We won't know for a fact until the Huebner and CDC studies are published that they in fact looked at ENV instead of GAG but most likely this is the case.
___________________________________________________________________
In addition to this information it's known that recruiting has started in the area of research to look at the disease mechanism for XMRV in Chronic Fatigue Syndrome. This is several steps ahead from just "linking" the virus in a Koch's Postulate kinda way to the illness. This is "hey we're pretty sure we got the what now we need to look for the how" area of study.
The actual studies themselves aren't really noteworthy at this time because they are shot's in the dark more or less. There are hundreds of MLV mouse studies that have been preformed over the last four decades. Researchers are currently trying to match up possible models that have been studied to what's known about the CFS disease model today. It will be a while before we get anything in that are nailed down.
"According to sources that can't be named right now" the current state of play looks something like this. . .
There are 5 negitive studies that do not correlate CFS and XMRV
1- Erlwein O, Kaye S, McClure MO, Weber J, Wills G, Collier D, Wessely S, Cleare A.
PLoS One. 2010 Jan 6 Total 0 CFS 0 HC
2-Groom HC, Boucherit VC, Makinson K, Randal E, Baptista S, Hagan S, Gow JW, Mattes FM, Breuer J, Kerr JR, Stoye JP, Bishop KN.
Retrovirology. 2010 Feb 15 Total 1 CFS and 4 HC
3-van Kuppeveld FJ, de Jong AS, Lanke KH, Verhaegh GW, Melchers WJ, Swanink CM, Bleijenberg G, Netea MG, Galama JM, van der Meer JW.
BMJ. 2010 Feb 25 Total 0 CFS and 0 HC *
(*caveat is that WPI found 2 XMRV positive from 10 samples sent to them by Van Kupperveld which was omitted from the original paper)
4-The Hubner study which has not been published at this time but which was leaked by Dr. Hubner and is reportedly a zero/zero study
5- The CDC paper which was completed early on and is reportedly a zero/zero study as well
Now the THREE positive studies are. .
1-Lombardi VC, Ruscetti FW, Das Gupta J, Pfost MA, Hagen KS, Peterson DL, Ruscetti SK, Bagni RK, Petrow-Sadowski C, Gold B, Dean M, Silverman RH, Mikovits JA.
Science. 2009 Oct 23;326(5952):585-9. Epub 2009 Oct 8. Total 68 CFS 8 HC **
(There are two additional studies often referenced by Dr. Mikovitz in talks reporting numbers in FAMILIAL illnesses including CFS families with members who have Autisum, MS, and Fibromyalgia this paper has been ready for publication and passed peer review, according to Dr. Mikovitz since February and a second study that uses the same Science cohort that reports a 98% incidence of XMRV in CFS patients that has also been review and ready to be publish since February)
2- The second study was reportedly completed by the FDA in April and rumors have the numbers anywhere from 80% CFS to 99% CFS and HC from 3% to 10%. Until this study is published we just don't know. But per the source that can not be named the FDA study is a unique stand alone study not associated with the NIH study. Totals unknown
3-Which brings us to the third study that is also being held up and that's the NIH study. Again rumors abound and I've read "reliable" reports of 80 to 95% in CFS patients and 3 to 7% of HC*** (This number seems to come from the slide given at the IPFA/PEI 17th Workshop on 'Surveillance and screening of Blood Borne Pathogens' in Zagreb. The slide states that XMRV and MLV's are present in the blood supply at 3 to 7% so those numbers are ambiguous at best) Totals unknown
The fact that there are THREE positive studies was stated in the videos, for some reason people keep making the FDA/NIH into one study. Incorrect.
_________________________________________________________________________________
In addition to this the Dr.'s Light study on Interferon and PEM which added an XMRV study to the end of it has never been published and we know from anecdotal evidence that an additional study was executed by the Dr.'s Light in April (is that correct CBS?) of this year.
And the Glaxo-Smith-Klien study that was started end of March or 1st of April.
Also data presented at the Prague CROI has yet to surface as well as the Cold Harbor Springs Conference which is referenced in our non-referenceable reference. (big grins)
Another extremely important point gleaned from our unnamed sources is why the various papers have come up negative. If you read the negative papers that are published you will find that all three used the ENV portion of the XMRV virus rather than the GAG portion. Turns out and this is a very important piece of information that the ENV is the area of change. We also know that being off just a little will cause zero results. We won't know for a fact until the Huebner and CDC studies are published that they in fact looked at ENV instead of GAG but most likely this is the case.
___________________________________________________________________
In addition to this information it's known that recruiting has started in the area of research to look at the disease mechanism for XMRV in Chronic Fatigue Syndrome. This is several steps ahead from just "linking" the virus in a Koch's Postulate kinda way to the illness. This is "hey we're pretty sure we got the what now we need to look for the how" area of study.
The actual studies themselves aren't really noteworthy at this time because they are shot's in the dark more or less. There are hundreds of MLV mouse studies that have been preformed over the last four decades. Researchers are currently trying to match up possible models that have been studied to what's known about the CFS disease model today. It will be a while before we get anything in that are nailed down.
Act now, figure the rest out later
Hi Lesley
I think the main problem with governments everywhere is that despite more than a years warning (wasn't there an emergency conference in May of last year?), everybody has been caught flat footed - they don't know what to do. Many voices are probably screaming many things that have to be done, but the agency bosses are in panic mode and playing for time. This involves policy that will effect every level of government and the economy. In the US this will involve the President, who has either been briefed or will be shortly. This involves the WHO. This involves every government in the world. Even a weeks delay will give them time to make policy on the run. I am about to hit the Australian minister for health with a question about how the policy formulation and planning I requested be undertaken is coming along, as XMRV is all but officially confirmed as a major public health risk. I intend to make this public (as is my policy) and will cc every health minister and shadow health minister in Australia, as well as many media outlets. I have been waiting for published confirmation of XMRV, but this delay is politial interference not science, and cannot be tolerated.
Bye
Alex
Hi Lesley
I think the main problem with governments everywhere is that despite more than a years warning (wasn't there an emergency conference in May of last year?), everybody has been caught flat footed - they don't know what to do. Many voices are probably screaming many things that have to be done, but the agency bosses are in panic mode and playing for time. This involves policy that will effect every level of government and the economy. In the US this will involve the President, who has either been briefed or will be shortly. This involves the WHO. This involves every government in the world. Even a weeks delay will give them time to make policy on the run. I am about to hit the Australian minister for health with a question about how the policy formulation and planning I requested be undertaken is coming along, as XMRV is all but officially confirmed as a major public health risk. I intend to make this public (as is my policy) and will cc every health minister and shadow health minister in Australia, as well as many media outlets. I have been waiting for published confirmation of XMRV, but this delay is politial interference not science, and cannot be tolerated.
Bye
Alex
Athene,
I agree there are a lot of powerful interests involved here. You left our the one that I feel is our trump card, Big Pharma.
I'm not the least surprised that the soon to not be released study was (partially?) authored by the Food and DRUG Administration. It is easy to imagine a scenario where the CDC took one look and said "Huh, nothing there. Move along folks, nothing to see here." and the folks with the connections/background in the pharmaceutical industry looked repeatedly, following any small lead or marginal results until they had something definitive. I can't help but think that the difference was probably that the FDA/NIH group just looked harder and longer. It looks like the CDC simply confirmed their biases and broke out the typewriters.
My bet is on the drug companies now. As has been stated before;
"Yeah! Someone finally wants to exploit us." :victory:
I agree there are a lot of powerful interests involved here. You left our the one that I feel is our trump card, Big Pharma.
I'm not the least surprised that the soon to not be released study was (partially?) authored by the Food and DRUG Administration. It is easy to imagine a scenario where the CDC took one look and said "Huh, nothing there. Move along folks, nothing to see here." and the folks with the connections/background in the pharmaceutical industry looked repeatedly, following any small lead or marginal results until they had something definitive. I can't help but think that the difference was probably that the FDA/NIH group just looked harder and longer. It looks like the CDC simply confirmed their biases and broke out the typewriters.
My bet is on the drug companies now. As has been stated before;
"Yeah! Someone finally wants to exploit us." :victory:
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I have changed the petition to go out to the heads of the NIH, CDC, and FDA as well as elected officials.
It is my understanding that Drs. Light, Light, Sighn and Bateman have been working on two studies. The first was the addition of an XMRV component to the original Exercise Study participants (original patient group had and n=32; original study - J of Pain, Nov, '09?). The second study involved 100 CFS patients and 200 controls. This was in late March (I gave blood samples on 3/23). As for what was found or when to expect publication, I don't know.
There is also the Stanford/Columbia study. It was my impression that a first phase (patients not taking anti-virals) started in early 2010. A second phase (patients taking anti-virals) is getting started very soon (I've received my invitation to participate and they are now wading through/contacting a huge list of potential participants).
One of the interesting aspects of the Light and Stanford studies is that they are both separated into two phases. Would you test another group if you couldn't find anything in the first group? Wouldn't you keep testing the first set of samples (or invite the first group back to give more blood or tissue) before bringing in more participants?
There is also the Stanford/Columbia study. It was my impression that a first phase (patients not taking anti-virals) started in early 2010. A second phase (patients taking anti-virals) is getting started very soon (I've received my invitation to participate and they are now wading through/contacting a huge list of potential participants).
One of the interesting aspects of the Light and Stanford studies is that they are both separated into two phases. Would you test another group if you couldn't find anything in the first group? Wouldn't you keep testing the first set of samples (or invite the first group back to give more blood or tissue) before bringing in more participants?
Thanks for the clarification CBS I really appreciate that and the update.
(big grins)
(big grins)
Hi
People outside the USA cannot sign this. We need another petition.
Bye
Alex
People outside the USA cannot sign this. We need another petition.
Bye
Alex
I think a big question is; why did both groups submit their papers in the first case?
It appears that they submitted them and then almost immediately held them. It's possible that they did that to make it clear that they didn't intend to just bury this. By submitting them they make it official that there was indeed a study.
It appears that they submitted them and then almost immediately held them. It's possible that they did that to make it clear that they didn't intend to just bury this. By submitting them they make it official that there was indeed a study.
I imagine that none of them had a clue that the DHHS would step in like this and hold those papers up. I'd love to know if this has ever happened before
Why?
OK, I'm not big on conspiracy theories but I have sat through far too many government hearings and workgroups to be ignorant of the fact that the way to find out 'the why' is to follow the money. Not ALL public officials are driven by campaign contributions and public employees by job security but this accurately describes far too many. I simply cannot count the number of times I have heard industry described as "our customers" by the groups tasked with regulation (think BP and the MMS). The terms used to describe a pesky and persistent public can't be printed.
The whole "consensus" thing reeks of short hand for "interests other than that of the patients."
Some also suggested earlier that the economy may be having an impact. To that end I submit this from today's (6/30/10) NTY's:
Federal AIDS Drug Program Is Strained by Weak Economy
OK, I'm not big on conspiracy theories but I have sat through far too many government hearings and workgroups to be ignorant of the fact that the way to find out 'the why' is to follow the money. Not ALL public officials are driven by campaign contributions and public employees by job security but this accurately describes far too many. I simply cannot count the number of times I have heard industry described as "our customers" by the groups tasked with regulation (think BP and the MMS). The terms used to describe a pesky and persistent public can't be printed.
The whole "consensus" thing reeks of short hand for "interests other than that of the patients."
Some also suggested earlier that the economy may be having an impact. To that end I submit this from today's (6/30/10) NTY's:
Federal AIDS Drug Program Is Strained by Weak Economy
Titles aren't everything; it's more the experience and training of the person that counts. Also, most scientific work now is done in teams so I wouldn't be surprised if there are PhDs on the CDC team.
If the CDC tested blood from their Bibb County "1-month unwellness/ empiric definition" group or their past cohorts (one of which had people working an average of 40 hours a week), they might not be looking at the right population. Even if some subjects were the correct population, if XMRV is tricky to find, this might account for their negative results. Can't tell though without the paper being published.
This might be a time to write/ call your US Congressional rep/ Senators again. I find it concerning that they are holding both papers; possible that they are trying to work out the implications but I don't want to wait months and months without an answer.
If the CDC tested blood from their Bibb County "1-month unwellness/ empiric definition" group or their past cohorts (one of which had people working an average of 40 hours a week), they might not be looking at the right population. Even if some subjects were the correct population, if XMRV is tricky to find, this might account for their negative results. Can't tell though without the paper being published.
This might be a time to write/ call your US Congressional rep/ Senators again. I find it concerning that they are holding both papers; possible that they are trying to work out the implications but I don't want to wait months and months without an answer.