Dr Enlander Proposes Large Multi-lab Study

Cort

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We've all heard about the need to for different labs to look at the same samples. Now Dr. Enlander is proposing a large double blinded multi-lab study that he believes will tell us whether the problem is in the different methodologies or the different patients. There is no breakthru in laboratory procedures here; this is simply a chance for a number of CFS labs to test exactly the same patients and see where they disagree or agree. Dr. Enlander would be coordinating the study. It would take about $10,000 on his side to bring it off.

Proposal to test the presence or absence of XMRV virus in the CFS in a double-blind trial using replicant patient specimens in five different labs.

Preamble The presence of XMRV virus in that CFS patients was reported in the Science in October 2009. This caused great excitement in the scientific world, as an infective organism was suggested as the etiology of CFS. The excitement abated as other labs attempted to replicate the result. Papers were soon published denying the presence of the XMRV virus in the CFS patients. Discussion then opened with various researchers debating the possibility of poor storage of specimens, poor selection of CFS patients without proper criteria, different methodology in the determining the presence of the virus, and other aspects in the research methods. Patients and physicians were then left in a quandary whether the original research gave us insight into a viral etiology. Indeed the picture became more blurred.

We will attempt to determine whether testing methods or patient selection were different or faulty. We propose to replicate a study in the five labs that were prominent in the disputed discussion, by replicating patient and control specimens in divided aliquots in a double-blind trial.

Method 100 patients , who have been diagnosed by the Fukuda and Canadian criteria for CFS, and 100 matched controls will have 15 ML blood drawn (two vials) . The 15 ML blood specimens will be combined into a single tube and will be centrifuged . The supernatants will be refrigerated. Each patient or control specimen will be numbered randomly and blindly 1 to 200, each specimen will then be divided into five aliquots and labeled A,B,C,D and E . We will thus have 1000 test aliquots to be divided between five viral test labs.

We will send 200 aliquots in frozen containers to five virus testing laboratories; A) Whitmore Peterson Institute in Reno Nevada, B) Jonathan Kerr in London, C) Simon Wessley group in London, D) Gow in Glasgow, and E) de MeirLeir in Brussels The selection of these labs does not mean that we recommend their methods. These labs have not replicated the original thesis. Perhaps, the comparison of duplicate specimens in a double blind trial can be revealing.

Results The test results will be sent to Dr. Enlander in New York, where the blind will be opened and the results tabulated. As each lab has received the same patient and control aliquots, we can attempt to correlate differences in testing method without the problem of bias in patient selection.

http://www.enlander.com/main.html
 

VillageLife

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(I dont want to sound negative) but I dont think some of the labs will want to take part in this study.

Myra Mcclure said she will not do anymore CFS studies she said its up to the CDC to find the answers to CFS and XMRV....and Johnathan Kerr says he is not doing anymore XMRV research.
 
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Cort
With McClure saying she wouldn't be doing any more CFS research, do you think she will change her mind? I think it's a possibility.
 

Nielk

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Hi Cort,

I am a patient of Dr. enlander.
Where did you get this information?

By the way, I really like your quote of Oliver Wendell Homes but, it is assuming that we CAN stand and that we CAN walk! (just joking with you)
 

ukxmrv

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Dr Kerr pulled out of a study with Invest in ME but has he said that he would not do further XMRV research?
 

omerbasket

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First of all, this is a great idea.
Second of all - Dr. Enlander left a talkback in the blog of the ME/CFS advocate, saying that he sent samples of his patient to Dr. Kerr to test for XMRV - and that might mean that Dr. Kerr still tests patients for XMRV.
However, I'm arfraid it will be difficult to make these different labs to particiapte here. I think that the WPI would agree to do so, but that other, such as Wessely group and Van der Meer group would not agree.

And after all of that had been said, I think there is a fatal mistake in the suggestion Dr. Enlander is making regarding the quantity of blood in the tubes. 15ml divided into five, which means 3ml for each lab?! Correct me if I'm wrong, but I think that the WPI had said before that you're gonna need 20ml of blood from a patient (and if I'm not mistaken, they said that you need 4 smaples that were taken at different time).
 
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I agree Villagelife, he's a good guy.
As others have said, it should be the same method, no frozen blood etc.
 

parvofighter

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In an ideal world

In an ideal world, I think this would be a great idea. In practice however, why in heavens would one turn to a a psychiatry-infused team replete with moral hazard and conflict-of-interest, for a credible retrovirology answer? Far better to send samples to independent third parties that are indeed retrovirology-based. The more we keep asking for the psycholobby's opinion, the longer the waters will be muddied. This question should never have been in their hands. It is simply because of the the stark and impoverished medical history of this disease that Wessley et al are even being potentially consulted.

Time to cut them out of the equation. The criteria for a credible evaluation of blood samples should be:

  • Are these potential labs world-renowned in retrovirology and appropriate assays?
  • Are they politically motivated to snuff out findings of a retrovirus in ME/CFS patients?
What we are observing is the morphing of what it means to be an "expert in ME/CFS". The old definition - i.e. to be a psychiatrist looking at false illness beliefs - needs to go the way of the dinosaur. WHY in heaven's name cultivate their opinion?

It's time for science, not politics and archaic public policy, to dictate who is an "expert" on ME/CFS. And there is abundant evidence that we should be looking at molecular biologists, virologists, retrovirologists. Not psychiatrists.
 
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So true parvo.

I always refer to them as a small group of psychiatrists, and then refer to those like Peterson, Chia, etc. As experts. Let's write them out.
 
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Cort, uhhhh, wasn't the Emory group / blood study group doing the same thing as far as tests, seeing which one is accurate?

I guess this proposed study is looking at prevalence in CFS, which is different question. But seems to me, once those other folks find the right test, the problem of different assays will be gone.

Just use the accepted test for CFSers, and answer given. I think while there are different testing methods being used, I don't think any study looking into the prevalence will resolve the issue, whether samples are exchanged or not. All switching samples will prove now is which testing method is right, which is what the other study is looking at.

Help me out where I am wrong.

tina
 

citybug

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Dr. Enlander suggested this a while ago when the studies came out. He sent blood to Dr. Kerr for his study earlier in the year.
I think there should be a comparison when labs say they have a test. I'd like to know if Emory wants any blood, or how ARUP is doing.
 

garcia

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Dr. Enlander suggested this a while ago when the studies came out. He sent blood to Dr. Kerr for his study earlier in the year.
The question is why didn't Kerr test any of Enlander's samples (according to the blog post earlier). Presumably because he knew they would test negative by his existing methods?
 
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I wonder if Kerr was going to use these in a follow up study. Kerr's group couldn't find it, so now perhaps, I hope, he is waiting for the FDA approved test. It may be that he cannot get funding for this right now. A replication study may change that.

Making lots of guesses right now, just don't really believe Kerr is ignoring this.
 

free at last

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At first glance i thought this was a great idea, removing the question of cohorts ect, but surely if testing procedure is in question as has been suggested by many, ( and Tina here ) Then there could arise a situation where the wpi find it ( xmrv ) but no else will, I dont see what this would achieve, wouldnt it be better to agree on a standardized testing method, that all partys use and agree on. Then do this study. This would at least remove the question of inadequate storage and testing.

What it would not unfortunately do is prove trust worthyness. As im sure im not the only one who doesnt trust certain individuals and clinics to be involved in this. The idea is a good one. But instead of having the likes of imperial college london involved ect. Wouldnt it be illuminating to do this study, with unbiased, completely free from involvement of CFS ME research Labs, that could be carefully chosen. with the same trusted standardized test. I guess to be fair this might also exclude the WPI from the study. As some will argue they are biased. Also thought i remember Dr kilmas saying they tried something similar to this with very confusing data becoming apparent ? What a mess folks, Hasnt it always been like this.
 

Cort

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ifDr. Enlander sent that to me as an e-mail. I agree that the choice of the labs is somewhat problematic. I think he chose most of them because they had already published studies. It would be more interesting to me if you sent the samples to ARUP or Emory or Gallo's lab. I don't think anybody thinks the retrovirologists associated with the psych groups would falsify their results; that would up making them look like idiots in the long run, but having the best retrovirologists in the world involved would, of course, be very helpful.

I don't know if he's received promises from those groups to do the study. The biggest problem for me is that, outside of the WPI, nobody's been able to find any XMRV - so we don't know if anybody can find it anyway. I imagine this study would definitively demonstrate that the problem is in the labs not in the types of patients each one is studying; I imagine that the WPI would be able to find it in substantial numbers of patients and nobody else would. This study, at least, would clear that lingering question up.
 

free at last

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ifDr. Enlander sent that to me as an e-mail. I agree that the choice of the labs is somewhat problematic. I think he chose most of them because they had already published studies. It would be more interesting to me if you sent the samples to ARUP or Emory or Gallo's lab. I don't think anybody thinks the retrovirologists associated with the psych groups would falsify their results; that would up making them look like idiots in the long run, but having the best retrovirologists in the world involved would, of course, be very helpful.

I don't know if he's received promises from those groups to do the study. The biggest problem for me is that, outside of the WPI, nobody's been able to find any XMRV - so we don't know if anybody can find it anyway. I imagine this study would definitively demonstrate that the problem is in the labs not in the types of patients each one is studying; I imagine that the WPI would be able to find it in substantial numbers of patients and nobody else would. This study, at least, would clear that lingering question up.
Hi Cort, Yes i dont think the Dutch group or imperial college could go as far as to falsify the tests, But certainly wouldnt put it past them to want to do there own standardized testing, Producing results that we have seen already. So unless a standardized test was used by all, that has been shown to be the most reliable. I certainly wouldnt trust there methods. and by default there intentions. I must admit i get parenoid about these phsychiatric groups, probably irrationally so. But after seeing the likes of Wessley seem to pick and choose certain types of evidence to back up there viewpoint. I find it hard to trust them full stop. I know many others feel the same

I think i would trust them with a agreed reliable standardized test, But then again. Just felt a twinge when i said that, here comes the parenoid feeling again. Actually just the thought of them being involved bothers the hell out of me, More irrational thoughts. Its not easy when i know he ( Wessley ) probably ignored 90% of what i was telling him, as a very sick young man. And focussed on the leading questions

Do you cry, Ahh there you go, your just depessed. No Simon i cry because i know how ill im going to get when the symptoms start with a temperature. Sorry i didnt hear you what was that, I SAID TEMPE----------- Sorry the sessions over we will have to re book. Its hard to trust this Guy Cort and others like him. Irrational and parenoid comes easy with imperial college. Although i understand Wessley wouldnt be doing the testing, just hes prescence around those that would be bothers me,
Im glad Dr enlander is thinking along these lines Cort. But i really dont think if theres a chance this mess will get sorted, ( especially if the odds are in favour of xmrv being found ) that they will do the study. Again especially as whats happend since the science paper was published, with all the negative studys, Must suit them just to stay out of it now, and wait and see if Judy M sinks or swims
 
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I would echo your thoughts free and last, and add that Wessely says it's not in the UK, without evidence, and the Dutch group with held significant information. They are both not worthy to continue this research. I don't say McClure, as personally I don't think they were her words.