Article: NIH Steps Up to the Plate - Picks Pathogen Ace to Lead Major XMRV/CFS Study
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From Amy Dockser Marcus :
"The new study, Lipkin says, will involve fresh blood samples from 100 CFS patients and 100 similar, but healthy people — 25 of each group from four different sites around the country, to provide geographic diversity. The samples will be processed, blinded and sent to the FDA, the CDC and the Whittemore Peterson Institute, which led the team that published the original Science paper. If a lab finds a sample is positive for XMRV, further tests will be needed to confirm the result. If one lab finds a positive sample but another lab doesn’t, the same samples can be shipped again, with a new blinded code, to be tested again. “If you get the same result, it is valid,” Lipkin says.
He adds that it may turn out that certain labs are simply more proficient than others at finding XMRV and related viruses. And he says he’s open to whatever the outcome is, which is one reason why NIAID asked his group to run the study. “We have no horse in this race,” he says."
I'm all for impartiality and getting to the truth, but the fact is you just can't 'split the difference' between a disease paradigm that favours a psychological aetiology and one that posits a viral one.
Which brings us back again to the cohorts and patient selection.
To find/confirm the virus you need to start from the assumption that a (retro)virus is to blame and is causing the neuroimmune damage seen in ME/CFS patients - but not universally accepted. The symptomology (for which read case definitions) will determine which patients are chosen for the study.
Lipkin has the background to appreciate how a retovirus could produce the symptoms seen in ME/CFS. But what patient description will he be given? Will be be allowed to use the CCD case definition which is presently for clinical use only or will he be required to use Fukada or Fukada-lite for reasons of comparability and research publication?
I'm afraid I'm reserving judgement until the cohort criteria are clarified.
"The new study, Lipkin says, will involve fresh blood samples from 100 CFS patients and 100 similar, but healthy people — 25 of each group from four different sites around the country, to provide geographic diversity. The samples will be processed, blinded and sent to the FDA, the CDC and the Whittemore Peterson Institute, which led the team that published the original Science paper. If a lab finds a sample is positive for XMRV, further tests will be needed to confirm the result. If one lab finds a positive sample but another lab doesn’t, the same samples can be shipped again, with a new blinded code, to be tested again. “If you get the same result, it is valid,” Lipkin says.
He adds that it may turn out that certain labs are simply more proficient than others at finding XMRV and related viruses. And he says he’s open to whatever the outcome is, which is one reason why NIAID asked his group to run the study. “We have no horse in this race,” he says."
I'm all for impartiality and getting to the truth, but the fact is you just can't 'split the difference' between a disease paradigm that favours a psychological aetiology and one that posits a viral one.
Which brings us back again to the cohorts and patient selection.
To find/confirm the virus you need to start from the assumption that a (retro)virus is to blame and is causing the neuroimmune damage seen in ME/CFS patients - but not universally accepted. The symptomology (for which read case definitions) will determine which patients are chosen for the study.
Lipkin has the background to appreciate how a retovirus could produce the symptoms seen in ME/CFS. But what patient description will he be given? Will be be allowed to use the CCD case definition which is presently for clinical use only or will he be required to use Fukada or Fukada-lite for reasons of comparability and research publication?
I'm afraid I'm reserving judgement until the cohort criteria are clarified.
Yes, I think I was jumping the gun a bit in my previous post...
If the patient cohorts are watered down with the CDC's phone-survey patients, then that doesn't help us at all...
We need to have legitimate ME patient samples used for this research...
This is an issue that I think we need to keep our collective eyes on... and kick up a storm of protest if the CDC gets its way.
Lipkin wants results! We'll have to see but I would think that he's smart enough to make sure to get a patient cohort that might give him those results. In any case, this is the NIH not the CDC and they reportedly hate each other! So I would be surprised if they used any CDC samples. I would be surprised if they didn't get them from the WPI, actually. The Blood WOrking group is using ALL WPI samples I believe.
Cort, i know you want to stay positive but "The U.S. Centers for Disease Control and Prevention (CDC) named W. Ian Lipkin, MD, co-chair of its National Biosurveillance Advisory Subcommittee (NBAS). As the subcommittee to the CDC, NBAS provides counsel to the federal government on the broad range of issues impacting the development and implementation of a nationwide biosurveillance strategy for human health.
Appointed to this job, just when the CDC published their negative paper and but put hold the Alter and Lo paper, on the 15. July, by the CDC appointed !
"Lipkin has been 'called on' to investigate a viral association with CFS; he authored a negative study on the link between Borna disease virus (BDV) and CFS in 1999." "in a classical example of the pitfalls of PCR diagnostics, particularly using nesting methods, BDV was implicated in a wide variety of disorders that included major depressive disorder, bipolar disorder, schizophrenia, chronic fatigue syndrome (CFS), AIDS encephalopathy, multiple sclerosis, motor neuron disease, and brain tumors (glioblastoma multiforme) (75). Following a report of BDV RNA in the blood of more than 50% of CFS subjects, which raised concerns for blood product safety (87, 88), we were recruited to pursue a replication study. We found no BDV nucleic acid or specific immunoreactivity in a blinded analysis of well-characterized CFS subjects. At the time of this writing, there is no conclusive evidence that BDV infects humans. However, new highly divergent strains of BDV were recently identified...Thus, it is conceivable that there are human strains yet to be found."
As some smart person remarked on another forum :[Another rather uncomfortable similarity: he mentions that although unpopular, publishing negative/ refuting studies can be a community service, including in the sense that it can "prevent the inappropriate or unnecessary use of drugs that are toxic or in short supply".]
There is certainly a lot of good to be said about him as a top virus hunter, but adding all this facts, especially that he works for a subcommittee of the CDC, i think it is naive to think this study will be in the interest of us patients ! One can always hope for miracles, but the CDC has not and will not change it's policies, unless they are forced to !
Aruschima
Appointed to this job, just when the CDC published their negative paper and but put hold the Alter and Lo paper, on the 15. July, by the CDC appointed !
"Lipkin has been 'called on' to investigate a viral association with CFS; he authored a negative study on the link between Borna disease virus (BDV) and CFS in 1999." "in a classical example of the pitfalls of PCR diagnostics, particularly using nesting methods, BDV was implicated in a wide variety of disorders that included major depressive disorder, bipolar disorder, schizophrenia, chronic fatigue syndrome (CFS), AIDS encephalopathy, multiple sclerosis, motor neuron disease, and brain tumors (glioblastoma multiforme) (75). Following a report of BDV RNA in the blood of more than 50% of CFS subjects, which raised concerns for blood product safety (87, 88), we were recruited to pursue a replication study. We found no BDV nucleic acid or specific immunoreactivity in a blinded analysis of well-characterized CFS subjects. At the time of this writing, there is no conclusive evidence that BDV infects humans. However, new highly divergent strains of BDV were recently identified...Thus, it is conceivable that there are human strains yet to be found."
As some smart person remarked on another forum :[Another rather uncomfortable similarity: he mentions that although unpopular, publishing negative/ refuting studies can be a community service, including in the sense that it can "prevent the inappropriate or unnecessary use of drugs that are toxic or in short supply".]
There is certainly a lot of good to be said about him as a top virus hunter, but adding all this facts, especially that he works for a subcommittee of the CDC, i think it is naive to think this study will be in the interest of us patients ! One can always hope for miracles, but the CDC has not and will not change it's policies, unless they are forced to !
Aruschima
I agree Arushima.. the whole thing is a real worry about his connection to the CDC.
Im not going to feel comfortable till i end up hearing more about the study he does.. the cohorts and the results.
They may of just had to get someone very good involved to "settle" things down, if they didnt want this all out. No scientists will probably doubt any result he comes up with as he's so high.
I are hoping for the best and no idea what is going to happen next. Time will tell.
(and yeah if what we have has mutated into that aweful thing that is apparently killing people fast in china which is currently being hidden... there would be good cause that they want to hush things up to avoid public panic).
Im not going to feel comfortable till i end up hearing more about the study he does.. the cohorts and the results.
They may of just had to get someone very good involved to "settle" things down, if they didnt want this all out. No scientists will probably doubt any result he comes up with as he's so high.
I are hoping for the best and no idea what is going to happen next. Time will tell.
(and yeah if what we have has mutated into that aweful thing that is apparently killing people fast in china which is currently being hidden... there would be good cause that they want to hush things up to avoid public panic).
Look, this guy is a celebrity in the medical world, on a personal level this guy would not want to get involved unless he thought he can reach a definative answer, one way or the other.
He has both the CDC who have not found it, and the WPI who have found it, involved in the new study. Which he should if he wants an answer which the majority of people will accept one way or the other.
The WPI wouldnt be involved unless the cohorts are acceptable to them. So that fact they are involved, means this guy genuinely believes they might find the virus.
This guy, if he finds it, will go down in history as the guy who led the study which settled the matter. Because he is also part of the CDC its ideal for them because the CDC dont loose too much face having failed to find it the first time, they can say yeah, but they found it the second time, or at least were invovled in the study which did.
On a personal level this guy wants to get on the bandwagon and get credit for this. At the end of the day if this virus does exist and gets found, and we finally get recognition of the reality of this brutal disease, and treatment then this guy will at the very least get this on his CV with him a major player. This combined with other things he has done, might well win him a nobel peace prize one day, so there is plenty reason for him to want to find it.
Also, dont forget if he doenst find it and someone else does later then he ends up with egg on his face.
To summarise, If its there to be found, he will find it in this study.
He has both the CDC who have not found it, and the WPI who have found it, involved in the new study. Which he should if he wants an answer which the majority of people will accept one way or the other.
The WPI wouldnt be involved unless the cohorts are acceptable to them. So that fact they are involved, means this guy genuinely believes they might find the virus.
This guy, if he finds it, will go down in history as the guy who led the study which settled the matter. Because he is also part of the CDC its ideal for them because the CDC dont loose too much face having failed to find it the first time, they can say yeah, but they found it the second time, or at least were invovled in the study which did.
On a personal level this guy wants to get on the bandwagon and get credit for this. At the end of the day if this virus does exist and gets found, and we finally get recognition of the reality of this brutal disease, and treatment then this guy will at the very least get this on his CV with him a major player. This combined with other things he has done, might well win him a nobel peace prize one day, so there is plenty reason for him to want to find it.
Also, dont forget if he doenst find it and someone else does later then he ends up with egg on his face.
To summarise, If its there to be found, he will find it in this study.
hi snowathlete, you make a good case for us to be optimistic at the moment...
I think that I am so used to things not going our way, that I can't quite believe what is happening at the moment...
We're just not used to the biggest names in science being on our side!
And we are not used to rigorous science being carried out by the establishment for the benefit of the ME community.
This is a completely new and unique situation for our community.
I still have a concern about the CDC... If the ME/CFS department of the CDC gets their way and present the virologists with the CDC's pseudo-ME patient cohort to test,
then the HMRV-positive samples could be watered down to anything between about 8% and 80% positive...
This might have the result of taking the focus away from ME/CFS, as they might then be able to say that ME/CFS patients are not disproportionately infected with HMRV's, even if HMRV is proven to cause a disease.
This could completely shift the focus away from the ME/CFS community.
I think this is something that we, as a community, need to be vigilant about.
I think that I am so used to things not going our way, that I can't quite believe what is happening at the moment...
We're just not used to the biggest names in science being on our side!
And we are not used to rigorous science being carried out by the establishment for the benefit of the ME community.
This is a completely new and unique situation for our community.
I still have a concern about the CDC... If the ME/CFS department of the CDC gets their way and present the virologists with the CDC's pseudo-ME patient cohort to test,
then the HMRV-positive samples could be watered down to anything between about 8% and 80% positive...
This might have the result of taking the focus away from ME/CFS, as they might then be able to say that ME/CFS patients are not disproportionately infected with HMRV's, even if HMRV is proven to cause a disease.
This could completely shift the focus away from the ME/CFS community.
I think this is something that we, as a community, need to be vigilant about.
Aruschima, I know we're worried about the CDC but I disagree with you. We tend to think of the CDC through the lens of the CFS Research Group but the CDC research group is a little, inconsequential pinprick relative to the other programs in the CDC. They have no power - they have a dinky little budget that declines almost every year - to think that they could somehow influence the HIV/AIDS division seems wild to me. Why the HIV/AIDS division would try and dismiss a virus they could work on for years - just because the little CFS Research division didn't believe in it - just doesn't make sense to me.
What does it mean that Lipkin was appointed to a committee about the time when the CDC paper was released? That doesn't mean anything! They had been working on that paper for months! He had nothing to do with it.....The CDC is a HUGE organization - a 16 billion dollar budget, when last I heard. If you're going to start questioning people's focus because they serve on subcommittees then you're going to have get rid of Lenny Jason, Nancy Klimas, Dr. Komaroff and many others.
I don't think a researcher's commitment to CFS patients can be measured by whether or not a CFS study has a positive finding! Requiring that they do rigorous and excellent work that elucidates what is actually present in CFS -irrespective of what we want to be there - is, I think, a far better standard.
Better to concentrate on the fact that he was one of the few researchers willing to do a CFS study. He obviously thought Bornavirus had a chance to be there so he spent the time and money to do the study.
I talked to Suzanne Vernon at the Offer Conference. She said that Lipkin, who she apparently knows pretty well, has been interested in CFS since the 1980's and has always believed it was due to an infection. He tried to prove that with bornavirus and that didn't work. Now he's trying with XMRV and the MLV's - hopefully this time he will succeed.
Aruschima,
I could not be more thrilled that Dr. Lipkin was chosen to head the efforts of the NIH to study XMRV. Dr. Lipkin has been working on XMRV with CFS patients for at least a year with Dr. Montoya (the Stanford XMRV/Virus/Pathogen study). They've been collecting samples for many months and I cannot believe that Dr. Lipkin would agree to head this study if for nearly a year he had found absolutely nothing of interest.
I spoke with Dr. Singh at the OFFER conference and Dr. Lipkin is a colleague at Columbia (while now in Utah, Dr. Singh still holds a faculty position at Columbia). She spoke very highly of Dr. Lipkin. Dr. Singh is clearly of the belief that MLV's play a role in CFS and that MLV's are a very exciting area of study. She's getting ready to publish her study on XMRV and MLV in human tissue (taken from cadavers while she was at Columbia - she's been working on this topic for years) and she is presently reviewing the results of her own large CFS/XMRV-MLV study which she expects to submit for publication soon, hopefully by the end of the year.
hi cbs : )
so lipkin is the guy working on all the blood samples montoya took from patients over the past several months....is there who dr. marcus conant went to NYC to work with also....conant is the prominent sf hiv/aids doc who left his practice to go work in ny on a retro-virus that may causes cfid's...if these puzzle pieces are all fitting together it cld be very good news...just hope it doesn't take too longggggggggggggggggggg.
Hi Shebacat,
There was a link to an article on Dr. Conant at CFS central a couple months ago. I don't know exactly where he went but I have wondered if Conant was hooking up with Lipkin and Goff. As I mentioned above, Dr. Singh has retained ties to Columbia as well. Lot's of very smart people all sharing information and giving out signals that they are finding something interesting. As for getting it right and getting it fast, I know that Dr. Montoya appreciates the real costs of everyday that passes without a treatment and talking with Dr. Singh gave me the same impression. She conveys a very real empathy for the patients. Both also appreciate the essential nature of getting this right. I imagine that the tension between those two very real demands is one of the harder parts of doing this research but as Dr. Singh told me, "there is no other way to do this."
Little Stevie Ray Straus is an alumni of Columbia and received their medal of honor as an alum on his deathbed.
The little known CFS Twin Study at University of Washington was headed by Dedra Buchwald, M.D. handpicked
by Straus. Check the first protest of the Science article on XMRV. It was co authored by Simone Wesseley,
Dedra Buchwald and one or two others. YIKES! (I'm a twin and was in the study). What a waste of
taxpayer money is an understatement.
I received an email from Doreen Chiatt, RN, MPH. Corrdinator of a NIH study I was in for low t-cells in 1992-1996. I sent
her an email "congratulating her boss, Fauci on his appointment to oversee XMRV". I said that those of us
who have been ill more than 20 years are very excited at this discovery. She replied that she had not
heard of XMRV before and hoped I was well.
I hope all these Columbia grads don't hang together for the sake of their alma mater. Singh wrote me that XMRV had
not been shown to cause CFS. (Which is true at this point).
It has been said before there is a struggle for power over this XMRV. I hope Truth prevails.
The little known CFS Twin Study at University of Washington was headed by Dedra Buchwald, M.D. handpicked
by Straus. Check the first protest of the Science article on XMRV. It was co authored by Simone Wesseley,
Dedra Buchwald and one or two others. YIKES! (I'm a twin and was in the study). What a waste of
taxpayer money is an understatement.
I received an email from Doreen Chiatt, RN, MPH. Corrdinator of a NIH study I was in for low t-cells in 1992-1996. I sent
her an email "congratulating her boss, Fauci on his appointment to oversee XMRV". I said that those of us
who have been ill more than 20 years are very excited at this discovery. She replied that she had not
heard of XMRV before and hoped I was well.
I hope all these Columbia grads don't hang together for the sake of their alma mater. Singh wrote me that XMRV had
not been shown to cause CFS. (Which is true at this point).
It has been said before there is a struggle for power over this XMRV. I hope Truth prevails.