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XMRV testing: The REDLABS, trading as VIP Dx, WPI connection

Discussion in 'XMRV Testing, Treatment and Transmission' started by jace, Aug 9, 2012.

  1. In Vitro Infidelium

    In Vitro Infidelium Guest

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    No offence to me personally, but I strongly dislike any proposition that there exists a cognicenti of patients who at some previous time were able to establish an absolute truth. From WPI statements (no longer online), plus extrapolationg from income declared in the WPI F990s, it seemed that by mid 20011 some $1 million worth of tests had been sold - I don't think a converstion between a few people on PR two years ago is representative of what patients knew, what the believed they knew, nor what was actually being told to them by WPI.
    So the issue of clinical validation as raised in the article which is the focus of this thread, is a red herring ?

    I've not commented in anyway about "patients experiences", the premise of this thread, appeared to be that there were issues of fact that could/should be established and much of the previous discussions in earlier threads have been littered with false premises. These premises are not flawed because I disagee with them, but flawed on the basis of fact - which is what my understanding is of what his thread was to be concerned with. Publication of sample documentation would certainly add to the potential for establishing fact rather than annecdote which we've aleady had an over abundance of.

    Overtesting is major problem and has been widely discussed in the last couple of years, however it's important to distinguish between tests that are unnecessary but clinically valid, and tests which lacking any standard of validation can have no benefit to the patient under any forseeable circumstance. Unnecessary testing in private medicine is part of the territory, just because it happens doesn't make it acceptable, nor under the UK regulatory system does it remove the doctor from liability; any patient who feels (as in the Andrew Wright case) that they have been subject to unnecessary testing, can (and in my view absolutely should) complain to the GMC. And to be clear, I'm not interested in old discussions - I'm interested in documentation and argumentation that follows from documentation, going back to discussions that took place before the BWG or the Whittemore/Seeno legal battle makes no sense because the context was materially changed by the material that both provided.

    IVI
  2. In Vitro Infidelium

    In Vitro Infidelium Guest

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    Why should what has been said before have relevance given that material that wasn't available to inform the earlier discussion is now in the public domain ? Reading old forum threads is as about as enllightening as divining meaning in a bowl of porridge.
    So, you post an article which is about past events, which article raises questions of fact - the answers to which patently and axiomatically are suggested not to have been previously provided, and then when someone offers factual response (Redlabs ownership etc) and poses questions that are pertinent to obtain the answers that the OP article defines as relevant, or to provide facts that are at variance with the OP article proposition - your response is that the only point of reference should be passed discussions.
    Having viewed the forum over the last two and half years, including using the search facility many times - I'm pretty confident that there is no substantive documentation related to the claim of VIPdx tests being promoted as experimental - there's not even any obvious statements from those saying they purchased the rests actually having that view. What I now think actually happend (though I can't be sure) is that some people read Annette Whittemore's announcement that the VIPdx licence would ensure funds came back to help WPI research, as meaning that the VIPdx test "would help research" and somewhere along the way the notion of trialling a test and the licence arrangment got conflated in people's 'belief' - but not in fact.

    Anyway, all that still leaves the question of the relevance of the OP article - if purchasers of the tests believed that the tests were experimental, why would anyone now raise (as the article does) the question of whether the tests were clinically validated ? If the tests were experimental, they could not possibly have been clinically validated. And if test purchasers knew the tests were experimental how could VIPdx or WPI be at fault for marketing an unsuitable test ? And why would anyone place medical certainty on an experimental test ? Such a test would in individual terms be meaningless, so why would anyone pay $650 for one ? As far as I can tell there is nothing in the archives of this forum that answers these questions.

    IVI
  3. jace

    jace Off the fence

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    I had a peek using the search term XMRV testing in titles and posts only. It returned only 2 pages. Interestingly apparently there was XMRV testing by Molecular Diagnostics Unit, Imperial College, London - haven't explored that yet - here's some more
    There's heaps more, of course. But then I was there.
  4. Mula

    Mula Senior Member

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    Why do you deflect from the liability of the laboratory or licensor?

    Redlabs and the WPI as licensor would be liable for tests brought directly by patients in the UK from the US laboratory or through a private doctor if the tests were clinically unvalidated as this was not how they had been advertised. Patients and doctors were told by Redlabs and the WPI licensor that the tests were those used in the Lombardi paper and that those had been clinically validated along with subsequent modifications which they had then sold. Nevada state may also be liable if these assays are not as they were advertised.

    The original research assays which are not required to be clinically validated were devised by Dr Ruscetti and Dr Mikovits using the techniques that isolated HTLV1 and they used the nested PCR protocol developed by Dr Silverman but modified to make the test more sensitive for detecting low number and sequence variants, making this anything but an experimental test.

    If an NHS test is faulty or the laboratory errors the liability belongs to the NHS trust, but only the NHS validates NHS tests so why is this being discussed?

    This so far has focussed on Redlabs in the US, but patients may want to know the status of the tests in Beligium where there is no worry over validation. In this scenario the liability if the tests are not as advertised would belong to the laboratory and the WPI as licensor.
  5. In Vitro Infidelium

    In Vitro Infidelium Guest

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    What deflection ? The starting point of this thread is the claim and proposition of the article given in the original post (OP) - so that's what this thread is about - of course we can use the discussion to seek to accurately describe both the specific historic situation (2009-2010) and the general legal position as it is now, but posters need to make it clear where they are abandoning defence/criticism of the OP and moving to some other reference point. Jace has already introduced an argument that directly contradicts her support of the article she posted, I can not see where the issue of general liability of laboratories addresses the issues raised in the OP, perhaps Mula you could make that link clearer ?

    VIPdx claimed (documented) that it only took orders from physicians, who were resonsible for interpreting tests. If in fact VIPdx sold tests directly to patients, then VIPdx lied about its practices - this would be very significnt information because the name in which the VIPdx statement was made, was that of the (now) Primary Investigator at a research institute. Sale of tests directly to patients should be easily demonstrable through sales/ordering documentation - so the answers lie with those who purchased tests - I've already suggested someone might care to scan and post such documents.

    A specific situation applies to UK patients who did acquire a VIPdx XMRV test via an ordering doctor - that is the doctor has an unquival responsibility which can be tested in a professional complaint against that doctor - so we have a second line of exposure of the 'truth' - that is either there is available documentation to show patients bought tests direct, or there is professionable liability of UK doctors. The testing of the liability of UK doctor would be a far easier opton for a UK patient than bringing a legal case in US court against a business entity that appears to have been moribund for over a year and whose legal owners are highly litigeous.

    There are two competing claims being made on this thread about the status of the VIPdx XMRV tests:

    1. Patients knew the tests were experimental (and therefore could not have been clinically validated.)

    2. VIPdx marketed the tests as though they were clinically validated.

    There has been no evidence presented that point 1. has any substance, however the evidence for point 2. appears limited to an after the fact statement from VIPdx - that is from a time when the tests were no longer available. So it appears possible that purchasers of the test could have believed almost anything based on rumour and/or misunderstanding. Resolving liabilty in such a case, where there is a dearth of documentation, is hardly straight forward, although one could certainly conclude that WPI and VIPdx were grossly irresponsible in not stating what the limitations of the test actually were while encouraging patients to make the purchase.

    The point about the Belgian tests is certainly relevant (although denied by the article in the OP), in that case the issue of physician and laboratory liability is conflated (see: To Get Tested For XMRV-MLV Or Not. That’s Still The Question.) and raises conflict of interest questions that should be of contiuing concern (see: Profit and Loss ). As far as the UK is concerned, there could be no libility issue related to XMRV testing, other than in the highly improbable circumstance the NHS was billed for an XMRV test, the ordering doctor would be guilty of fraud.

    IVI
  6. jace

    jace Off the fence

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    Impossible, not improbable.

    REDLABS Nevada is not connected to RedLabs Belgium.
  7. Firestormm

    Firestormm Senior Member

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    Hmmm... Belgium and it's labs deserve a whole separate thread methinks...
  8. In Vitro Infidelium

    In Vitro Infidelium Guest

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    Not strictly true, see (as previously given): Profit and Loss, but the connection to WPI is anyway the significant thing given that R.E.Dlabs was part of the licensing deal and through that at some point seems to have been sending bloods to VIPdx - http://esme-eu.com/news/redlabs-serology-test-will-be-done-at-vipdx-labs-article416-7.html ; also an interesting statement reported (if in somewhat garbled language) on esme, regarding Mikovits confirmation of the clinical validity of the VIPdx XMRV tests dated 15th September 2010 http://esme-eu.com/news/xmrv-an-mlv...planation-vipdx-and-redlabs-article413-7.html if correct Mikovits could not, as she claimed, have been questioning the validity of the VIPdx tests for nearly two years, in August 2011.

    Jace, you keep making absolute statments, but not providing any references to support these - if there are issues of fact that are not easily obvious to the interested observer, some documentary evidence would help your case. Given that the question over clinical validation is key to this thread, and you yourself seem to be at odds with the article you posted as well as the view of other posters here, could you provide some explantion for the source of the proposition that patients understood that the VIPdx tests were experimental, and therefore not clinically validated ? Could you also say in your experince, whether or not UK patients were able to order tests from VIPdx, without the involvement of a doctor ? These don't seem onerous questions and would help move the debate (as initiated by you) along in a positive direction.

    IVI
  9. jace

    jace Off the fence

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    References were given earlier in the thread. You keep insisting I 'debate' according to your agenda. A case of pots calling kettles black?
  10. In Vitro Infidelium

    In Vitro Infidelium Guest

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    I'm entirely happy to seek to debate within your chosen terms, if you could be explicit about your agenda. My agenda (to avoid others mischaracterising it), as a general point, is to condisider M.E/CFS (or whatever prefered term) within the context of scientific enquiry as that is commonly understood; and in this particular case to examine the facts of the history of the WPI/Redlabs XMRV saga as prefigured by the article at the begining of this thread. To that end the references (such as they are) that have been provided are not adequate to establish the full facts, nor are the adequate to elucidate the various perspectives that are being argued from. Asking for an explanation of why someone is arguing from a particular perspective when there is no common knowledge or particular reference available to support a proposition, is not unreasonable.

    We still have no documentary basis to resolve the question "Were VIPdx tests sold as experimental, or were purchasers led to expect that the tests were clinically validated ?" References that help answer this would be helpful to anyone concerned with that question.

    IVI
  11. jace

    jace Off the fence

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    We don't have the evidence, that's true. That's why the op was full of question marks. We, as I remember, were promised validation data but it never materialised. As you know, Mikovits tried to get information about the VIP Dx/REDLABS tests for two years. She drew a blank to, indeed, she was fired for her pains.

    Whistleblowers are never popular with the object of their revelations.

    ETA that second ESME link you posted is full of manure. Mikovits never worked at VIP Dx, and as I said, we never did get site of any validation data, that I am aware.
  12. Mula

    Mula Senior Member

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    The questions under discussion are not of science but fact. The WPI licensed tests to Redlabs and at various times both have made claims that those tests were clinical validated, which has a precise meaning.

    If a test is not as advertise patients in the UK or US who brought those privately can pursue legal action against the testing laboratory who is responsible for the validation process and the licensor. They could do so to simply obtained the evidence if they are withholding the validation status.

    I see that you are again deflecting from those who would be held responsible by your fixation over a single mention of experimental, which is not consistent with the facts. The tests were advertised as clinically validated and the original tests cannot be characterized as experimental as they had been adapted from HTLV1 and xmrv methods. You have also tried to deflect attention by attempting to implicate Dr Mikovits who at no point worked for the clinical laboratory or licensed tests. Redlabs may have said Dr Mikovits would provide a confirmation but it certainly never occurred and I would think she would be unaware of statements posted by this commercial laboratory.

    Redlabs Belgium have so far had none of these questions hanging over them, but if they had made similar claims it could be useful to researchers to have their clinical validation data confirmed.
  13. In Vitro Infidelium

    In Vitro Infidelium Guest

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    We do have some evidence, and we can also use deductive reasoning (as distinct from what happens in the scientific process) to provide likely answers or likely alternative answers to a number of the questions posed.

    Firstly we know that at the time WPI licensed the XMRV tests to VIPdx and subsequently to R.E.D Laboratories, there had been no substantive replication of Lombardi 2009. Clinical validation could therefore not have happened at that stage because there was no independent test of the validity of the founding research work, there was simply no external reference against which clinical validity could be measured.

    From this first point we come to an ‘unknown’ – which is: ‘What claims for clinical validation were made to the those ordering/purchasing the tests, by the suppliers of the XMRV tests, ? If any claims were made, then it is surprising that none of the thousand plus purchasers ( number deduced from licence income stated in WPI accounts) has chosen to make that documentation available. By contrast we do have a contemporary document ( esme) that states clearly that clinical validation had been achieved.

    We can say some definitive things about this ‘unknown’. Firstly that documentary evidence would have been available, either provided to patients as direct purchases, or to ordering physicians. Given the number of tests sold , it seems likely that a number of purchasers would have retained this documentation even two years on, so we have to ask why purchasers are reticent about making this documentation public ? Secondly both the ESME statement and the later statement by Dr Lombardi claiming that clinical validation had been achieved for the XMRV tests can not be true because no meaningful standard against which clinical validation could be set had been provided by replicatory studies. Either the term clinical validation was being used in a sense outside usual meaning, or deliberate misrepresentation was being employed or there was substantial miscommunication.

    The issue of purchaser reticence is significant because clearly there is a large body of individuals who might reasonably feel aggrieved about spending considerable sums on tests which were either represented to them as ‘clinically validated’ (when that could not have been the case), or they were led to believe that these commercial tests were directly contributing to research, (which would have been unethical) – excepting that purchasers of the tests were informed prior to purchase that the tests could have no informative value for individual health status.

    The assertions about Dr Mikovits role are unsupported, other than by Dr Mikovits’ own claims. Given the size of the licensing yield to the WPI from VIPdx and R.E.D Labs(Belgium) and the contribution these made to the financial viability of the WPI, Dr Mikovits’ concerns seem not to have interrupted her taking of an exceptional salary from the WPI, which some might consider makes her subsequent claims rather hollow. Mikovits could never have been in any doubt that the WPI licensed tests were NOT clinically validated (how could they be without confirmatory replication studies ?). What Mikovits seems to have been concerned with is establishing that there was some meaningful difference between the testing used in Lombardi et al 2009 and the VIPdx tests – but this is total non sequitur. Lombardi et al 2009 did not establish the testing used as having even research viability in terms of identifying XMRV in human blood, even if there was some meaningful difference between the research tests and the commercial tests – they were both dud, because no independent research had provided a reference point as a test of validity for either test.
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  14. In Vitro Infidelium

    In Vitro Infidelium Guest

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    How is possible to address the fact of clinical validation (or lack thereof) without considering a scientific process ?

    That is true, but doesn't address the claim of VIPdx, that tests were only sold to ordering physicians; neither does it recognise that the issue of validation status in the case of the XMRV test is not in doubt - no clinical validation can ever have taken place for reasons of scientific process. Of course in terms of building a legal case it would be very useful to have it on record from the suppling laboratory that it (the laboratory) had no evidence of clinical validation, or that its use in promotional material of the term 'clinically valid' was intended to mean something other than that required to achieve approval by the FDA.


    'Deflecting' and 'fixation', seem unnecessarily accusative. Firstly the claim of 'experimental' is made by the OP and is therefore material to thread - and as annecdote I also support the view that there were forum discussions that certainy showed that a number of people purchasing VIPdx tests belived those tests were part of research. I'm sure that belief was ill founded but it's material to deconstructing the XMRV fiasco. That tests were adapted from use on other targets doesn't make their use in searching for a novel entity (XMRV) in a novel medium (human blood) 'not experimental', in terms of scientific practice - the propostion remains merely hypothetical.

    It would be very helpful to see documentation (other than the ESME page, and Lombardi's after the fact claim) that VIPdx or anyone else marketed the tests as though they were clinically validated. I would encourage anyone with such documentation to post it online. Mikovits is relevant to the thread, because she's mentioned in the OP article, has been identified by the OP as having sought information about the VIPdx tests, and she is relevant to the science that failed to demostrate the of "XMRV is detectable in human blood" hypothesis.

    The only evidence re: R.E.DLabs is that it sent all saples for testing in to VIPdx - thus any concern over the quality of the VIPdx testing would refer back to R.E.Dlabs for anyone purchasing via the Belgian company. R.E.Dlabs acquired the th same license as VIPdx, which was based on an unreplicated study - there is therefore no way R.E.Dlabs could have achieved clnical validation where VIPdx did not.

    IVI
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  15. Ernie

    Ernie Senior Member

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    Lombardi claimed they were clinically validated,although I have no idea what "internally" is supposed to mean:
    The “XMRV test” offered by VIP Dx is clinically validated and performed under rigorous protocols to ensure the accuracy and reliability of the test results. XMRV testing was offered based upon the existing scientific knowledge at the time. The original assays for XMRV testing were based on the 2009 Science publication. Those assays, as well as all subsequent modifications, were internally validated prior to being used to process patients’ samples.“
    (Statement of Vincent Lombardi, Phd, Clinical Lab Director, VIP Dx, 14 October 2011) (11)
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  16. Mula

    Mula Senior Member

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    You should not encourage patients to post documents on the internet that may be used in future claims, as it may be prejudicial to any case.

    A laboratory can clinically validate their own tests if they follow the proper procedures and continue to maintain that process on a regular basis. No other lab need be involved. Where you are making your mistake is in pulling the Lombardi research paper into this commercial validation claim and in arguing that Dr Mikovits would be in any position to know what was happening in the laboratory of another company where she had no oversight.


    This too is a mistake. VIPDx is Redlabs. The Beligium laboratory is a completely separate company who will have made their own validation claims. There is nothing to suggest they have sold tests not to their claimed status except the association with the licensor who is embroiled in questions about tests they licensed to Redlabs. The WPI though have advertised that they were licensing clinically validated tests and as licensor would be liable if those tests were not as advertised. Redlabs also made this claim and would also be liable for unvalidated assays.

    Experimental is your word but it is not in the article.
  17. ukxmrv

    ukxmrv Senior Member

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    I'm guessing the purchasers have not made the documentation available or are not publicaly persuing claims because they understood that these were experimental tests or very early versions of tests or something like this.

    There exists as individuals large numbers of ME and CFS patients who pay for experimental, early or evolving tests. Also tests that may need to be repeated or judged with their other results. I've been one of these patients before. Threads on this forum are dedicated to experimental treatments and discussion of tests is public.

    Therefore we are dealing with something that is regretable for us but common. In that CFS and ME pateints are spending money on tests that we don't know are going to be useful or not in the long run.

    It's a personal decision to have these tests. Sometimes a doctor is involved and sometimes not.

    That seems to be true in other diseases. My experience with non-ME conditions showed that other patients are doing the same thing in the UK and in the USA.

    For examples of NHS tests, I had the NHS VP1 test in the 80's. It doesn't seem to be run now. I also saw the UK cardiologist Dr Nixon in the late 80's and was given his hyperventilation tests. My NHS medical records are full of tests that have become out of date or didn't lead to treatment for me.
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  18. In Vitro Infidelium

    In Vitro Infidelium Guest

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    That’s a doctrine of perpetual non disclosure – nobody will make the evidence public on the basis that someone somewhere might at some point maybe start a legal case. In the case of VIPdx it’s not even clear the company any longer exists and statute of limitation issues may in any case begin to have relevance. The reality is there are several hundred people who read this forum who are in a position to provide the answers to at least some of the questions raised by the article posted at the top of this thread – the question them becomes why is no one prepared to assist with the answers.

    That is not the argument I have made. Firstly we have a clear divergence in the use of the specificacity of the term clinical validation. The only meaningful sense of ‘clinically valid’ from a patient perspective is something that would confer information in a clinical setting – this is what would apply to an FDA approved test. The internal validation processes of a laboratory are matters of scientifically informed practice, but which are not capable of establishing (in any scientific sense) the fact of non falsification of an hypothesis. Were that to be the case no one need ever have a test approved by the FDA or other regulator – indeed medicine could simply proceed in every kitchen.

    So we then have a second issue – the fact that Lombardi et al could never have served as a basis of a clinically valid test. It is irrelevant whether or not Mikovits was involved with VIPdx, and Mikovits’ argument about the VIPdx test not following the protocols used in the Lombardi et al research is equally irrelevant. Mikovits was unavoidably aware that the founding hypothesis of Lombardi et al 2009 was for all scientific purposes demonstrated as falsified – that is the preponderance of evidence was (and remains) that XMRV as proposed by Lombardi et al is not identifiable in the blood of M.E/CFS patients. The fact of falsification renders impossible any test (for XMRV in human blood), derived from Lombardi et al 2009, from being of clinical value. Either Mikovits is painfully ignorant of clinical processes, or she is being disingenuous in her criticism.

    For the third time - XMRV an MLV`s Serology Testing explanation VIPdx and Redlabs http://esme-eu.com/news/xmrv-an-mlv-s-serology-testing-explanation-vipdx-and-redlabs-article413-7.html and REDLabs Serology test will be done at VIPdx Labs !!!! http://esme-eu.com/news/redlabs-serology-test-will-be-done-at-vipdx-labs-article416-7.html ESME has long been close to De Meirleir and and a link is given to the R.E.Dlabs(Belgium) website (although this is now dead and blocked from Internet Archive scans). The licence was on a protocol that could never provide clinical validation, even if R.E.Dlabs(Belgium) did their own internal validation, there is still no means (as has been argued here and elsewhere) that Belgium lab work was in some way clinically meaningful – in any event they appear to have contracted the work to VIPdx.

    No it’s Jace’s term actually, and as the person who started the thread, it would be pretty odd not to address her responses. Further you will see poster UKXMRV also give credence to the ‘experimental’ notion.

    IVI
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  19. In Vitro Infidelium

    In Vitro Infidelium Guest

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    Well Mula disagrees with this point, and we have no evidence that VIPdx ever stated that purchasing was on the basis of the test being experimental, nor can it explain how (at least in the UK) the tests could have been ordered by a doctor - other than that doctor was behaving with gross dereliction of professional standard.

    Let's be absolutely clear: selling tests which are part of research is wholly unethical and no researcher who participates in such a practice could or would ever be trusted to produce meaningful science.
    IVI
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  20. ukxmrv

    ukxmrv Senior Member

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    I'm happy for people to disagree. Different patients may well have thought different things. Sometimes the language we use isn't right. Mula makes some very good points.

    My guess is that you are talking generally here about selling of tests? I'm not aware of Dr Mikovits (for example) ever selling tests through VIP dx. In my conversations with her she kept strictly away from that. She made it clear to me that she had nothing to do with VIP dx and their tests.

    The most blatant attempt to part me with my money ever was from an NHS doctor. He had a private practise and used the NHS appointment we had to try and get me to go to that instead. It was sleep therapy with strong drugs. He got away with this for years.

    I'm not aware of any UK doctor ordering XMRV tests through VIP dx. I'm also not aware of any UK doctors ordering the test through Myra Mclures team in Paddington either.

    If you ever get to take a look at the link I posted a while back. The Doctors Laboratory you'll see a huge range of tests that UK private doctors order up every day. This is what happens in real life and real practise in the UK.

    http://www.tdlpathology.com/test-information/a-z-test-list/numbers
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