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Newly refined test from the Whittemore Peterson Institute

Abraxas

Senior Member
Messages
129
Not sure if this has been posted anywhere here yet, but the Whittemore Peterson Institute have issued a press release today regarding availability of an updated XMRV test.

From their Facebook account: http://www.facebook.com/notes/whitt...om-whittemore-peterson-institute/249958073025

Press Release from Whittemore Peterson Institute Today at 10:15am

FOR IMMEDIATE RELEASE

Frankie Vigil
R&R Partners for
Whittemore Peterson Institute 775-336-4555

frankie.vigil@rrpartners.com

Whittemore Peterson Institute Announces Availability of Updated XMRV Testing Reno, Nev. -

In October 2009, together with the Cleveland Clinic and National Cancer Institute, the Whittemore Peterson Institute published findings in Science regarding the discovery ofXMRV in the blood of Chronic Fatigue Syndrome (CFS) patients.

The testing method, validated in multiple other labs using positive control samples, uses a unique process that was extensively peer reviewed before publication and provides the most accurate results available.

This virus culture test is the same method used in the Science publication, and the only scientifically validated methodology to find XMRV. Some labs, including the recent study published in the U.K., have used non-validated PCR and whole blood PCR assays. At this time no single PCR or whole blood assay alone has been validated as accurately detecting XMRV, and is therefore not an appropriate way to study or diagnose the presence of the virus.

WPI has licensed the latest version of the test to Viral Immune Pathways Diagnostic Laboratories (VIP Dx) in Reno, Nev. The non-exclusive license allows patients and their doctors access to a reliable diagnostic tool. The newly refined test uses a virus culture methodology that yields more reliable results in one test at a lower cost to patients.

Our mission at WPI is to discover bio markers of disease and translate those discoveries into accurate diagnostics and effective treatments for patients, said WPI Founder and President Annette Whittemore. We continue to talk to other clinical laboratory companies, both nationally and internationally, in order to make the test available to a wider audience.

WPI Research Scientist and co-author of the Science paper, Dr. Vincent Lombardi, is providing technical assistance and oversight of the VIP Dx testing. In exchange for the non-exclusive license, VIP Dx will pay a royalty to WPI for each test it conducts.

We structured the licensing contract to be sure that any and all profits that might emerge at VIPDx from XMRV testing come directly back to WPI to benefit the research program said Whittemore. Dr. Lombardi is an employee of WPI, and has no personal financial interest in VIP Dx. Likewise, the Whittemore family put their interest in VIP Dx into a trust to benefit WPI.

The availability of these tests has a dramatic impact to the CFS/ME community. These tests allow licensed laboratories to begin answering important questions about XMRVs incidence in disease and prevalence in the world. WPI hopes that this will generate further research related to XMRV. "The institutes driving goal continues to be the translation of research to meaningful results for patients, explained Whittemore.

It is still unknown exactly how XMRV impacts humans. Scientists who understand the potential ramifications of human infection with retroviruses take the study of XMRV seriously. WPI researchers along with many other scientists around the world are actively engaged in advancing research in this field.

The Whittemore Peterson Institute for Neuro-Immune Disease exists to bring discovery, knowledge, and effective treatments to patients with illnesses that are caused by acquired dysregulation of the immune system and the nervous system, often resulting in lifelong disease and disability.

The WPI is the first institute in the world dedicated to X associated neuro-immune disease (XAND), and other X associated diseases, integrating patient treatment, basic and clinical research and medical education.



This also explains why the VIP Dx site is being updated :rolleyes:
 

anne_likes_red

Senior Member
Messages
1,103
Not sure if this has been posted anywhere here yet, but the Whittemore Peterson Institute have issued a press release today regarding availability of an updated XMRV test.

From their Facebook account: http://www.facebook.com/notes/whitt...om-whittemore-peterson-institute/249958073025

This also explains why the VIP Dx site is being updated :rolleyes:


Good news.


Has VIPdx held onto blood samples so previously tested people can get an "upgraded" result?
Or do they need to provide samples again?
 

Abraxas

Senior Member
Messages
129
Has VIPdx held onto blood samples so previously tested people can get an "upgraded" result?
Or do they need to provide samples again?

Good point, but I have no idea sorry. Perhaps someone else might know more?
 
D

DysautonomiaXMRV

Guest
I would imagine not.

Still, it gives some hope for those who tested negative I guess.
 

kurt

Senior Member
Messages
1,186
Location
USA
Thanks for posting that.

Here are some observations. Note that I am not pro or con WPI, and am trying to be an objective observer of the science (not the politics) of XMRV.

1. This means that WPI has packaged their culture test which includes an MuLV antibody test. They continue to call this an XMRV test which is not completely accurate. Culturing will grow whatever is there, and MuLV is known to cross-react with HERVs which are known to be activated in PWC. Still, a positive finding on this test does illustrate that a person has some history of an MuLV type antigen in their blood, which certainly IS a real finding, assuming it is not a testing artifact (false positive).

2. The statement that no outside PCR test has been validated is unfounded, as WPI is not any kind of standards agency. Also, validation and replication are two separate issues. Replication has been accomplished for the WPI test based on the Cleveland Clinic and NCI confirmation studies. That means that other labs running the WPI PCR test precisely as WPI did (which is probably an NCI test originally, used in prostate cancer studies) will get the same result. Unfortunately this is not validation for the XMRV hypothesis. To validate a finding like this the DNA for XMRV must be found several different ways. That would prove that the positive WPI finding is not a false positive, some type of testing artifact. Culture and antibody studies are supportive, but not confirmation as positives can result from cross-reactions.

This statement may be an attempt to distance WPI from negative PCR findings in validation/confirmation studies that have and are soon to be reported. I can understand that, but they are not mentioning that the standard process for proving something like XMRV is pathogenic in CFS usually includes finding the virus different ways, and that has NOT happened yet. They are acting like their test is a gold standard, and that is highly premature, even if they are correct.

Also, WPI is insinuating here that outside PCR tests are not capable of getting positive hits on XMRV. That may be true for some cases, but is unlikely for all replication/validation study efforts. If a PCR test can get a hit on a known positive at a comparable dilution to the WPI test, then it is capable of getting positive XMRV findings. And I am sure most if not all the outside replication/validation researchers realize that and will not run their tests on large samples until they know they can get hits on known positive samples (such as prostate cancer XMRV positives). OF COURSE outside labs will calibrate their tests this way, I am sure that is what WPI did themselves. So that statement is basically saying that WPI does not believe anyone but them can calibrate PCR correctly, which is unlikely.

3. WPI has finally revealed a conflict of interest in the commercial testing of VIP Dx. I can only assume that someone outside has finally reported the fact that the Whittimores own a majority interest or major share of VIP Dx, that would be a matter of public record. This was a nice piece of spin-doctoring, the way they said this I almost want them to own VIP Dx so that the profits go back to CFS research. Well done, but a little late, that should have been revealed as soon as tests were sold by VIP Dx. I do trust WPI's motives, am not bashing them, but just do not like that they withheld this piece of information, that was a poor business practice in this type of science where people's illness is being used for financial profits, even if those profits do go to benefit CFS at the present time.

4. As with the prior XMRV tests, there is no real guidance for patient or physician. What does one do with the results of this test? Since WPI is selling so many XMRV tests, what do they expect people to learn, how will this help my ME/CFS? I think that small problem is being ignored in all the excitement. Again, if WPI wants to be a CFS advocacy company, then please advise us of the reason we need to be tested for XMRV at this time.

5. I realize I have just raised some questions and issues, and given that so many on this forum are optimistic about XMRV, here is one positive. I think this is the best move WPI has made yet related to XMRV, offering to license what they believe is the most affordable and useful test. I do hope some outside labs license the WPI culture-antibody test, might be interesting to see what happens if a lab that is getting negative PCR results has that to look at and think about. There is still so much to learn.

6. Finally, WPI continues to position themselves as the group bringing us validation. They say this test will have a dramatic impact on CFS, and have stated this before. This is probably what they hope. Personally, I don't need to be validated by WPI in any way, my CFS is very real and many different tests can prove that I am sick. I think we need to be careful, collectively speaking, when any group says we need validation. That ignores the mountain of research that has already validated CFS as a very real biological problem. Certainly Dr Peterson knows that well, in fact in 2008 he said that HHV6 findings validated CFS. We are validated already, without XMRV. We do have massive political problems with governments and uninformed medical professionals, but there is already adequate evidence for CFS, political battles need to be fought, but political-medical validation is a separate issue from the detailed scientific search for answers about CFS.

My request to WPI, please focus on finding some answers, others can fight the political battles. Also, please do not promote the idea that your test somehow will solve our medical-political validation problems. People should get tested when the test can be helpful in diagnosis and treatment, and not because they are seeking validation for their illness, at least at this early stage of the scientific process. I believe that equating XMRV with validation of CFS will cause a lot of distress in the vulnerable CFS community over the coming years as researchers debate the issues surrounding XMRV in CFS.
 
G

George

Guest
Well thought out Kurt

A very well thought out and laid out post on this recent information Kurt.

I am hoping that the new test and licensing choices are being made because the WPI is in the know on other studies and, that they are confident of enough validation as well as replications studies to move up to this level of commercialism. :sofa:
 

Lesley

Senior Member
Messages
188
Location
Southeastern US
Kurt,

Regarding the conflict of interest, when I heard it mentioned in connection with the UK study I felt like it was something I was already aware of, and I am not privy to any inside info. The Whittemores' connection to VIPdx was disclosed in the WPI press release announcing the availability of original test. The nature of their interest may have been unclear because they referred to "supporting" the lab, rather than investing in it, but as a former corporate lawyer, it was clear to me what they meant. All that to say I don't think they are revealing something, just clarifying it. Still, placing their interest in trust for WPI and clarifying Lombardi's role will remove an obstacle to a discussion of the science.

My sense is that the Whittemores invested in VIPdx for the same reasons they founded the WPI, and never expected their motives to be questioned. Unfortunately, the politics of the situation make everyone's motives suspect.

The press release is here: http://www.wpinstitute.org/news/docs/WPI Release Diagnostic Test.pdf
 

MEKoan

Senior Member
Messages
2,630
My sense is that the Whittemores invested in VIPdx for the same reasons they founded the WPI, and never expected their motives to be questioned. Unfortunately, the politics of the situation make everyone's motives suspect.

Well said, Lesley, I could not agree more.
 
D

DysautonomiaXMRV

Guest
i know they kept my blood..i contacted them.

Hi. Did you by chance send 3 blood tubes for the XMRV test do you know, or maybe more?
From memory there were 4 in the kit, but I got told to send only 3.
Yet this week I hear of someone saying they sent 6.

Thanks.
 

bullybeef

Senior Member
Messages
488
Location
North West, England, UK
The problem we have here in the UK is our ’free’ health service. Lauded around the world, but in terms of new research, validation, or rather prevalence, is the only way the UK scientific community will take serious notice of XMRV. The people in the UK who have paid for their tests, something we are not predisposed to here the UK, is quite brave. The irony, nobody wants to be told they have a retrovirus, but such is the lack of perception and awareness here in the UK, these people are pioneers, opening doors that may have remained shut, at least for the time being. Only last week a national newspaper ran a poll asking the British public if ME wasn't a real illness. And 20% said it wasn't! Has that ever happened in the US? I doubt it.

Prof Weesleys’ paid to print research says everything that is murky about ME/CFS here in the UK and the lengths some with go to refute XMRV. WPI initial US figures need to stand up internationally, or be as close as possible. People in the US pay for their treatment and can demand specific tests to validate their condition. In the UK, the NHS aren’t very forthcoming in helping us investigate our bodies and even if we do pay for private tests, not all are available and many cannot afford it. My wife pays over 100 ($163) per month towards her national insurance (NHS costs) and we pay them whether we see a doctor 100 times a year or never! These costs are compulsory.

So we have to rely on XMRV being validated, globally, otherwise we could be left behind.
 
Messages
13,774
Thanks for posting that.

Here are some observations. Note that I am not pro or con WPI, and am trying to be an objective observer of the science (not the politics) of XMRV.

1. This means that WPI has packaged their culture test which includes an MuLV antibody test. They continue to call this an XMRV test which is not completely accurate. Culturing will grow whatever is there, and MuLV is known to cross-react with HERVs which are known to be activated in PWC. Still, a positive finding on this test does illustrate that a person has some history of an MuLV type antigen in their blood, which certainly IS a real finding, assuming it is not a testing artifact (false positive).

2. The statement that no outside PCR test has been validated is unfounded, as WPI is not any kind of standards agency. Also, validation and replication are two separate issues. Replication has been accomplished for the WPI test based on the Cleveland Clinic and NCI confirmation studies. That means that other labs running the WPI PCR test precisely as WPI did (which is probably an NCI test originally, used in prostate cancer studies) will get the same result. Unfortunately this is not validation for the XMRV hypothesis. To validate a finding like this the DNA for XMRV must be found several different ways. That would prove that the positive WPI finding is not a false positive, some type of testing artifact. Culture and antibody studies are supportive, but not confirmation as positives can result from cross-reactions.

This statement may be an attempt to distance WPI from negative PCR findings in validation/confirmation studies that have and are soon to be reported. I can understand that, but they are not mentioning that the standard process for proving something like XMRV is pathogenic in CFS usually includes finding the virus different ways, and that has NOT happened yet. They are acting like their test is a gold standard, and that is highly premature, even if they are correct.

Also, WPI is insinuating here that outside PCR tests are not capable of getting positive hits on XMRV. That may be true for some cases, but is unlikely for all replication/validation study efforts. If a PCR test can get a hit on a known positive at a comparable dilution to the WPI test, then it is capable of getting positive XMRV findings. And I am sure most if not all the outside replication/validation researchers realize that and will not run their tests on large samples until they know they can get hits on known positive samples (such as prostate cancer XMRV positives). OF COURSE outside labs will calibrate their tests this way, I am sure that is what WPI did themselves. So that statement is basically saying that WPI does not believe anyone but them can calibrate PCR correctly, which is unlikely.

3. WPI has finally revealed a conflict of interest in the commercial testing of VIP Dx. I can only assume that someone outside has finally reported the fact that the Whittimores own a majority interest or major share of VIP Dx, that would be a matter of public record. This was a nice piece of spin-doctoring, the way they said this I almost want them to own VIP Dx so that the profits go back to CFS research. Well done, but a little late, that should have been revealed as soon as tests were sold by VIP Dx. I do trust WPI's motives, am not bashing them, but just do not like that they withheld this piece of information, that was a poor business practice in this type of science where people's illness is being used for financial profits, even if those profits do go to benefit CFS at the present time.

4. As with the prior XMRV tests, there is no real guidance for patient or physician. What does one do with the results of this test? Since WPI is selling so many XMRV tests, what do they expect people to learn, how will this help my ME/CFS? I think that small problem is being ignored in all the excitement. Again, if WPI wants to be a CFS advocacy company, then please advise us of the reason we need to be tested for XMRV at this time.

5. I realize I have just raised some questions and issues, and given that so many on this forum are optimistic about XMRV, here is one positive. I think this is the best move WPI has made yet related to XMRV, offering to license what they believe is the most affordable and useful test. I do hope some outside labs license the WPI culture-antibody test, might be interesting to see what happens if a lab that is getting negative PCR results has that to look at and think about. There is still so much to learn.

6. Finally, WPI continues to position themselves as the group bringing us validation. They say this test will have a dramatic impact on CFS, and have stated this before. This is probably what they hope. Personally, I don't need to be validated by WPI in any way, my CFS is very real and many different tests can prove that I am sick. I think we need to be careful, collectively speaking, when any group says we need validation. That ignores the mountain of research that has already validated CFS as a very real biological problem. Certainly Dr Peterson knows that well, in fact in 2008 he said that HHV6 findings validated CFS. We are validated already, without XMRV. We do have massive political problems with governments and uninformed medical professionals, but there is already adequate evidence for CFS, political battles need to be fought, but political-medical validation is a separate issue from the detailed scientific search for answers about CFS.

My request to WPI, please focus on finding some answers, others can fight the political battles. Also, please do not promote the idea that your test somehow will solve our medical-political validation problems. People should get tested when the test can be helpful in diagnosis and treatment, and not because they are seeking validation for their illness, at least at this early stage of the scientific process. I believe that equating XMRV with validation of CFS will cause a lot of distress in the vulnerable CFS community over the coming years as researchers debate the issues surrounding XMRV in CFS.

Thanks Kurt.

re point 2, is describing their test as the only one which as been scientifically validated really just spin then? It stood out to me as a strange thing to say at this point - how does a test get 'scietifically validated? I'm worried that other scientists might be getting antsy about some of the loose use of language that seems to be coming from the WPI. Would most scientists accept these sorts of claims as a normal part of promoting your own data, or might it seem odd?

Does anyone have any contacts with the WPI who might know why they're choosing to take this approach to PR? I find it all a bit unsettling.
 

anne_likes_red

Senior Member
Messages
1,103
The problem we have here in the UK is our free health service. Lauded around the world, but in terms of new research, validation, or rather prevalence, is the only way the UK scientific community will take serious notice of XMRV. The people in the UK who have paid for their tests, something we are not predisposed to here the UK, is quite brave. The irony, nobody wants to be told they have a retrovirus, but such is the lack of perception and awareness here in the UK, these people are pioneers, opening doors that may have remained shut, at least for the time being. Only last week a national newspaper ran a poll asking the British public if ME wasn't a real illness. And 20% said it wasn't! Has that ever happened in the US? I doubt it.

Prof Weesleys paid to print research says everything that is murky about ME/CFS here in the UK and the lengths some with go to refute XMRV. WPI initial US figures need to stand up internationally, or be as close as possible. People in the US pay for their treatment and can demand specific tests to validate their condition. In the UK, the NHS arent very forthcoming in helping us investigate our bodies and even if we do pay for private tests, not all are available and many cannot afford it. My wife pays over 100 ($163) per month towards her national insurance (NHS costs) and we pay them whether we see a doctor 100 times a year or never! These costs are compulsory.

So we have to rely on XMRV being validated, globally, otherwise we could be left behind.

But, you also have to rely on their test being scientifcally validated before the NHS will offer it.


Thanks for clarifying replication and validation further Kurt.
 

Kati

Patient in training
Messages
5,497
Thanks for posting that.

3. WPI has finally revealed a conflict of interest in the commercial testing of VIP Dx. I can only assume that someone outside has finally reported the fact that the Whittimores own a majority interest or major share of VIP Dx, that would be a matter of public record. This was a nice piece of spin-doctoring, the way they said this I almost want them to own VIP Dx so that the profits go back to CFS research. Well done, but a little late, that should have been revealed as soon as tests were sold by VIP Dx. I do trust WPI's motives, am not bashing them, but just do not like that they withheld this piece of information, that was a poor business practice in this type of science where people's illness is being used for financial profits, even if those profits do go to benefit CFS at the present time.

.



Kurt, it was announced before that all profits of the XMRV testing would be transferred back to WPI research- I don't think it was a secret kept from anybody. So the message they sent out was a clarification.

It was also "commercialized" because lots pf peiople from the public, including me, wants their disease legitimized and validated. Lots of people think that it was worth the 650$ even with the knowledge that false negatives are possible.
 

Alice Band

PWME - ME by Ramsay
Messages
175
Location
UK
How is this new test different from the old Culture test?

Kurt - do you mean "repackage" the existing culture test?
 

Kati

Patient in training
Messages
5,497
Hi. Did you by chance send 3 blood tubes for the XMRV test do you know, or maybe more?
From memory there were 4 in the kit, but I got told to send only 3.
Yet this week I hear of someone saying they sent 6.

Thanks.

Hi there, I phoned last week adn they needed 15-20 ml of the green top tube and 1 small lavender tube. This may have changed since they don't do PCR anymore- I have just sent my samples today and likely sent too much blood but better too much than not enough.
 
G

gerwyn morris

Guest
reply to Kurt re observations

Thanks for posting that.Thank to be virus specifics for your posting>there are a number of things that i take issue with

A culture will not neccesserily grow what is the media have to be specifically constructed to be virus specific-if the amplification protocols are inadequate you wont be able to detect low tires especially in whole blood samples.The work of the WPI can only be validated using exactly the same protocol that,s why scientific papers are constructed in the way they are.\Any attempt at validation using different assay protocols and patient selection criterea are scientifically unvalid if one sticks rigidly to the scientific method.
I dont know how the WPI can be accused of of politics .Anwering the specific criticisms of Wesselly et al was neccessary to AVOID political dominace by psychiatrists with their own(but undeclared vested interests and using hand picked patients ffrom the clinic of one man-again scientifically inappropiate because this should have been declared.
If you want to complain about doctors engaging in politics I suggest that you direct your fire towards this side of the pond.In the real world money power and politics always win with science coming a poor last.Disengaging from the politics would be suicide and play right into the hands of those with vested interests in branding the illness as psychological.

Finally you can only detect what you are looking for ,other tests look for retroviradae not swpecifically for the unique dna sequence of XMRV.REtroviruses in my day were often called stealth viruses and are very difficult to detect if they replicate slowly. Adapting currently available tests is at best crude.As things stand The WPI test detects XMRV if present(for whatever reason.Thus far other tests have not shown any ablity to do so they therefore need to be validated against samples containing known positives.The WPI test has also been validated by replication and thus also established its reliability.Cross reactions are a possibility but rendered less likely by multiple sampling points, patients meeting the canadian criterea for me/cfs and having two seperate genomically inserted or actively replicating retroviruses would be truly unfortunate.The test would of course be less specific in non cfs patients.
The quality and design of previous biomedical research in this area is poor mainly because of study design and low numbers so the results have been inadequately powered and hence not generalisable.Statistical treatment has been almost absent so the results have easily been refuted.Correlation can equal causation if the f value approaches 1 for example.Serious clinicians look for the confidence intervals of data p values and so forth.Most if not all studies into the biomedical area are examples of pilot enquiry which have never been followed up by properly designed trials.The Trials which have refuted the initial work wern,t carried out properly either and were equally meaningless

Here are some observations. Note that I am not pro or con WPI, and am trying to be an objective observer of the science (not the politics) of XMRV.

1. This means that WPI has packaged their culture test which includes an MuLV antibody test. They continue to call this an XMRV test which is not completely accurate. Culturing will grow whatever is there, and MuLV is known to cross-react with HERVs which are known to be activated in PWC. Still, a positive finding on this test does illustrate that a person has some history of an MuLV type antigen in their blood, which certainly IS a real finding, assuming it is not a testing artifact (false positive).

2. The statement that no outside PCR test has been validated is unfounded, as WPI is not any kind of standards agency. Also, validation and replication are two separate issues. Replication has been accomplished for the WPI test based on the Cleveland Clinic and NCI confirmation studies. That means that other labs running the WPI PCR test precisely as WPI did (which is probably an NCI test originally, used in prostate cancer studies) will get the same result. Unfortunately this is not validation for the XMRV hypothesis. To validate a finding like this the DNA for XMRV must be found several different ways. That would prove that the positive WPI finding is not a false positive, some type of testing artifact. Culture and antibody studies are supportive, but not confirmation as positives can result from cross-reactions.

This statement may be an attempt to distance WPI from negative PCR findings in validation/confirmation studies that have and are soon to be reported. I can understand that, but they are not mentioning that the standard process for proving something like XMRV is pathogenic in CFS usually includes finding the virus different ways, and that has NOT happened yet. They are acting like their test is a gold standard, and that is highly premature, even if they are correct.

Also, WPI is insinuating here that outside PCR tests are not capable of getting positive hits on XMRV. That may be true for some cases, but is unlikely for all replication/validation study efforts. If a PCR test can get a hit on a known positive at a comparable dilution to the WPI test, then it is capable of getting positive XMRV findings. And I am sure most if not all the outside replication/validation researchers realize that and will not run their tests on large samples until they know they can get hits on known positive samples (such as prostate cancer XMRV positives). OF COURSE outside labs will calibrate their tests this way, I am sure that is what WPI did themselves. So that statement is basically saying that WPI does not believe anyone but them can calibrate PCR correctly, which is unlikely.

3. WPI has finally revealed a conflict of interest in the commercial testing of VIP Dx. I can only assume that someone outside has finally reported the fact that the Whittimores own a majority interest or major share of VIP Dx, that would be a matter of public record. This was a nice piece of spin-doctoring, the way they said this I almost want them to own VIP Dx so that the profits go back to CFS research. Well done, but a little late, that should have been revealed as soon as tests were sold by VIP Dx. I do trust WPI's motives, am not bashing them, but just do not like that they withheld this piece of information, that was a poor business practice in this type of science where people's illness is being used for financial profits, even if those profits do go to benefit CFS at the present time.

4. As with the prior XMRV tests, there is no real guidance for patient or physician. What does one do with the results of this test? Since WPI is selling so many XMRV tests, what do they expect people to learn, how will this help my ME/CFS? I think that small problem is being ignored in all the excitement. Again, if WPI wants to be a CFS advocacy company, then please advise us of the reason we need to be tested for XMRV at this time.

5. I realize I have just raised some questions and issues, and given that so many on this forum are optimistic about XMRV, here is one positive. I think this is the best move WPI has made yet related to XMRV, offering to license what they believe is the most affordable and useful test. I do hope some outside labs license the WPI culture-antibody test, might be interesting to see what happens if a lab that is getting negative PCR results has that to look at and think about. There is still so much to learn.

6. Finally, WPI continues to position themselves as the group bringing us validation. They say this test will have a dramatic impact on CFS, and have stated this before. This is probably what they hope. Personally, I don't need to be validated by WPI in any way, my CFS is very real and many different tests can prove that I am sick. I think we need to be careful, collectively speaking, when any group says we need validation. That ignores the mountain of research that has already validated CFS as a very real biological problem. Certainly Dr Peterson knows that well, in fact in 2008 he said that HHV6 findings validated CFS. We are validated already, without XMRV. We do have massive political problems with governments and uninformed medical professionals, but there is already adequate evidence for CFS, political battles need to be fought, but political-medical validation is a separate issue from the detailed scientific search for answers about CFS.

My request to WPI, please focus on finding some answers, others can fight the political battles. Also, please do not promote the idea that your test somehow will solve our medical-political validation problems. People should get tested when the test can be helpful in diagnosis and treatment, and not because they are seeking validation for their illness, at least at this early stage of the scientific process. I believe that equating XMRV with validation of CFS will cause a lot of distress in the vulnerable CFS community over the coming years as researchers debate the issues surrounding XMRV in CFS.[/QUOTE]
 

kurt

Senior Member
Messages
1,186
Location
USA
Kurt,
Regarding the conflict of interest, when I heard it mentioned in connection with the UK study I felt like it was something I was already aware of, and I am not privy to any inside info. The Whittemores' connection to VIPdx was disclosed in the WPI press release announcing the availability of original test. The nature of their interest may have been unclear because they referred to "supporting" the lab, rather than investing in it, but as a former corporate lawyer, it was clear to me what they meant. All that to say I don't think they are revealing something, just clarifying it. Still, placing their interest in trust for WPI and clarifying Lombardi's role will remove an obstacle to a discussion of the science.

My sense is that the Whittemores invested in VIPdx for the same reasons they founded the WPI, and never expected their motives to be questioned. Unfortunately, the politics of the situation make everyone's motives suspect.

The press release is here: http://www.wpinstitute.org/news/docs/WPI Release Diagnostic Test.pdf

Thanks for that Lesley, I had not seen that original PR. However, you are making my point in a round-about way. Yes, a corporate lawyer might pick up the nuances of what is really being said. The same is true for much of the science in the studies, a researcher will realize that the XMRV study in the Science article was very early-stage research. Dr Coffin said so directly at CFSAC and he knows retrovirus research. But WPI is selling this to PWC as more than just tentative, setting themselves up as a type of standard. WPI is pretty skilled at PR for ME/CFS, but I personally feel that takes some advantage of PWC who trust the obvious meanings of the words and just send their money for tests, not realizing some of the finer details.

Also, the Whittimore family clearly owned VIP Dx years before WPI was founded, so their statements early in the XMRV announcements were more than a little misleading. They just said they had licensed their test to a local lab.

Thanks Kurt.
re point 2, is describing their test as the only one which as been scientifically validated really just spin then? It stood out to me as a strange thing to say at this point - how does a test get 'scientifically validated? I'm worried that other scientists might be getting antsy about some of the loose use of language that seems to be coming from the WPI. Would most scientists accept these sorts of claims as a normal part of promoting your own data, or might it seem odd?

Does anyone have any contacts with the WPI who might know why they're choosing to take this approach to PR? I find it all a bit unsettling.

Yes, that is just spin. But not all that uncommon in medical research. There are a lot of sharks in these medical markets and the small fish must swim fast.

Scientific validation for this type of finding should include multiple independent labs (not affiliated with WPI) running a variety of tests, all able to demonstrate the presence of XMRV in ME/CFS samples. And that has to be replicated many times, so a consensus opinion can emerge in the field. This usually takes years, particularly if there are conflicting findings. There is often some learning curve involved for the more difficult bugs such as HIV, but for something simple like XMRV this should be relatively simple once people know where the virus is found and how to get to it's RNA.

I think the odds are low that WPI will succeed, given the history of retroviral hunts for other diseases. But who knows, they did find something that reacts to MuLV antibodies, and they did a partial sequence so they found something. But WPI has not seriously addressed HERV contamination or explained how they controlled for that, and it is HERVs that usually kill this type of finding.

Kur, it was announced before that all profits of the XMRV testing would be transferred back to WPI research- I don't think it was a secret kept from anybody. So the message they sent out was a clarification. It was also "commercialized" because lots pf people from the public, including me, wants their disease legitimized and validated. Lots of people think that it was worth the 650$ even with the knowledge that false negatives are possible.

EXACTLY my point, many of these people are paying a lot of money for 'validation' of their illness. That is not what viral testing is designed for, and it is a poor gamble if that is the goal given that XMRV has not been proven to cause any disease or disability condition.

The conflict of interest issue can be very serious in science. Yes, for now profits are promised to flow back to WPI. But there is still a conflict, the problem is that this type of relationship can prejudice the science, put pressure on scientists to produce profitable findings over accurate findings. I am NOT saying that is happening, just that this is the risk, and the reason that conflicts of interest are important. The medical testing market potential for XMRV, if it is as pathogenic as WPI believes, is worth $billions. No matter how charitable someone says they are, when the numbers get high enough people change, organizations change, and conflicts of interest become serious problems. Still, I agree that WPI did the right thing in disclosing this, just am pointing out that it is a little late in the game to be clear about what is happening.

How is this new test different from the old Culture test?

Kurt - do you mean "repackage" the existing culture test?

That appears to be what happened, they said it was the original Science study ttest. So it is repackaged.
 

kurt

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Thanks for posting that.Thank to be virus specifics for your posting>there are a number of things that i take issue with

A culture will not neccesserily grow what is the media have to be specifically constructed to be virus specific-if the amplification protocols are inadequate you wont be able to detect low tires especially in whole blood samples.

Yes, I realized after I wrote that comment someone might point that out, good catch! However, if a contaminant virus is also amplified by the same protocol as the target antigen, then you could have a very high cross-reacting concentration for the eventual WP antibody test. And that is the problem with retroviral hunts, because the HERVs can be very, very similar to the target retrovirus and often cross react.

I suggest anyone interested in this issue read the paper available here: Human RNA "Rumor" Viruses: the Search for Novel Human Retroviruses in Chronic Disease

The work of the WPI can only be validated using exactly the same protocol that,s why scientific papers are constructed in the way they are.\Any attempt at validation using different assay protocols and patient selection criterea are scientifically unvalid if one sticks rigidly to the scientific method.

Did you read my comments on replication vs validation? The WPI study can only be replicated using the same protocol. In my experience as a researcher, validation is a different matter, and requires multiple viewpoints, different types of measures. Otherwise there is no way to know if the original measures are producing false positives (in this case perhaps HERV cross-reactions, contaminant PCR hits or DNA interaction artifacts). WPI clearly understands this idea as they tried to use an MuLV antibody and sequenced two antigens (without explaining the biomarkers they used to select them), as well as an EM study, as evidence for their PCR test. Also, the patient selection criteria is pretty broad given WPI's comments about 98% (hinting 100%) positive for CFS. They appear to be toning that percent down now though. Anyway, by any CFS selection criteria there should be some positives, if WPI finds XMRV in a high percent of samples.

I dont know how the WPI can be accused of of politics. Anwering the specific criticisms of Wesselly et al was neccessary to AVOID political dominace by psychiatrists with their own(but undeclared vested interests and using hand picked patients ffrom the clinic of one man-again scientifically inappropiate because this should have been declared.
If you want to complain about doctors engaging in politics I suggest that you direct your fire towards this side of the pond.In the real world money power and politics always win with science coming a poor last.Disengaging from the politics would be suicide and play right into the hands of those with vested interests in branding the illness as psychological.

I was referring to the politics of promoting the idea that the XMRV test somehow validates ME/CFS. The science has NOTHING to do with the politics of CFS, and merging them is a bad idea in my view. Those in the UK do have an issue with psychiatrists, clearly, but I think playing to that is very risky behavior, because XMRV could become discredited, and then where will that leave you? ME/CFS must stand on its own and there is already plenty of physical evidence. The case has just not been adequately made yet in the halls of power in the UK, or the US (in fact, pretty much every government).

Finally you can only detect what you are looking for ,other tests look for retroviradae not swpecifically for the unique dna sequence of XMRV.REtroviruses in my day were often called stealth viruses and are very difficult to detect if they replicate slowly. Adapting currently available tests is at best crude.As things stand The WPI test detects XMRV if present(for whatever reason.Thus far other tests have not shown any ablity to do so they therefore need to be validated against samples containing known positives.The WPI test has also been validated by replication and thus also established its reliability.Cross reactions are a possibility but rendered less likely by multiple sampling points, patients meeting the canadian criterea for me/cfs and having two seperate genomically inserted or actively replicating retroviruses would be truly unfortunate.The test would of course be less specific in non cfs patients.

I don't agree, even in PCR testing you can find something different than you are looking for, this happens with retroviral research due to endogenous forms. See the link above, over 500 citations in that article!

Anyway, this point goes two ways. The same scientific challenge that makes replication and validation difficult also creates risk in the original study. That is one of the reasons validation by different test designs, looking in the same places and at the same dilution, are important. WPI was looking for and trying to build a case for XMRV to begin with. So they have focused on supporting that contention, and have not been as objective perhaps as they might have. And if they made an error, it will be a costly one for them as a result.

Also, any researcher skilled enough to conduct a replication or validation study (two different types of studies as I explained above) should know how to run proper calibration testing with known positives.

The quality and design of previous biomedical research in this area is poor mainly because of study design and low numbers so the results have been inadequately powered and hence not generalisable.Statistical treatment has been almost absent so the results have easily been refuted.Correlation can equal causation if the f value approaches 1 for example.Serious clinicians look for the confidence intervals of data p values and so forth.Most if not all studies into the biomedical area are examples of pilot enquiry which have never been followed up by properly designed trials.The Trials which have refuted the initial work wern,t carried out properly either and were equally meaningless

I agree, statistical power is very weak in most ME/CFS research. But I think this case will be different. WPI has made some very bold claims. So they will be taken to task and made to prove it. Right now their behavior worries me because of some of the issues I have raised.

You raised the issue of people seeing what they want, finding what they are looking for rather than what is there. I am afraid that may be happening with the enthusiasm for XMRV in the ME/CFS world right now. People are so desperate for validation and treatment that they are accepting things uncritically. If I am wrong, then fine, that will be shown in time. But seeing so many people jumping on a bandwagon like this just reminds me too much of the past, so many false hopes with ME/CFS ...

And the big irony is that there was an earlier breakthrough by WPI from their virachip study, and that is being completely ignored right now, but it was a very promising new direction (the May presentation by Mikovitz).

Thanks Gerwyn, you did raise some issues that should be debated, and I hope I have done them justice.