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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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    This is no doubt an accurate summation of the contract law as would be currently understood by the legal codes of most developed nations. However it does not take into account the differing Regulatory regimes that govern medical practice in every country; specifically in the UK, the burden on doctors is unequivocal and reference to the case of Dr Andrew Wright held earlier this year makes this very clear. Wright was held to have ordered tests which were of no medical value, and order tests from a (US) laboratory which had no competence to deliver medical tests as deemed appropriate to the standard required by UK medical authority.

    If VIPdx required that all tests were ordered via a doctor, then any doctor on the UK register who ordered such a test would patently have failed in the professional duty as defined by the GMC (and now MPTS ). Of course if VIPdx were actually accepting orders direct from patients, or if some non UK based doctors were merely acting as order agents for a fee that would be a different issue. The role of R.E.D Labs (Belgium) becomes relevant in the latter case because they acted as a European agent for VIPdx, and it is therefore reasonable to ask whether any of the doctors (Profit and Loss ) associated with R.E.D labs participated in a ‘sign off’ service, something which might be considered unethical.


    The protections in a genuine research project are very different from that which applies in the case of day to day testing, specifically the ethical basis of the study would (or at least should ) be independently assessed, and this would (or should) include full provision for specialist advice to participants on interpretation of the results. One of the dubious aspects of the WPI work is that there appeared to be no provision for any referral of patients to medical specialists qualified to interpret the results provided by WPI. And even more worrying was the rhetoric from WPI at one stage, that the results of commercially sold tests would be used for research, when there was no provision for any ethical protection in place to govern how the test results were used.
    IVI
     
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  2. jace

    jace Off the fence

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    I don't remember rhetoric from the WPI that the results of the commercial tests would be used in research, but I do remember. Mikovits never said the REDLABS tests were clinically validated, in fact she questioned that, as shown in the OP
    On the other hand, the WPI definitely did, here
     
  3. In Vitro Infidelium

    In Vitro Infidelium Guest

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    Mikovits’ position is not as immaculate as this would suggest. Even if it is allowed that in the original study Dr Peterson (as the sampling source) was an appropriate physician to advise participants on the interpretation of their individual results (an independent specialist would have been a better choice), there was absolutely no provision made for specialist support to the UK participants of the proposed later study for which bloods were collected. Mikovits was the study designer and physician support in medical research is a clear ethical necessity. Had Mikovits paid attention to this aspect, the issue of what validity any test whether (as Mikovits claims), the uniquely effective WPI test or any other commercial test, would have to have been established between the independent physician and Mikovits herself. Basically someone would have asked ‘what does positive or negative mean ? and a clinically relevant answer would have to have been agreed, before any test was done. As Dr Bell is quoted in this contemporary blog Newly Nerfed “I am reluctant to suggest to anyone that they spend big bucks for a commercial test now. We do not know if a particular test is accurate, and even if it is accurate we do not know what it means, and even if we did know what it meant we would not know what to do with it.”

    To keep repeating the issue of ‘clinical validation’ is to keep avoiding the harsh truth – clinical validation could never have happened without the results of Lombardi et al 2009 being demonstrated as unequivocally reproducible. Until at least one other research group, independent of the originally published work, demonstrated that XMRV was in the blood of a percentage of CFS patients and a percentage of controls, in some proportion comparable to that shown by Lombardi et al, no process of clinical validation could even begin. Whatever the WPI/Lombardi had to say about clinical validation of the VIPdx tests, and no matter how flawed their statements were, that doesn’t make the testing used in Lombardi et al 2009 competent as a test. The VIPdx tests may not have been fit for purpose, but in any meaningful sense, neither were the tests used in the research upon which the VIPdx tests were based.

    IVI
     
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  4. Mula

    Mula Senior Member

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    When a test that has previously been used for research is marketed to patients as clinically validated then the laboratory selling is liable along with the licensor, including all modifications of the test under a new license. If a test was brought by a person in the UK through a doctor, then the NHS is liable unless the person went directly to laboratory selling the test and then the liability would be the same as for US citizens and returns the lab selling the test and the licensor. If it is found that the clinical validation was not established damages could run into the millions. There is no interpretation for a physician to make as a sold test is provided as a service and would be expect to meet the standards advertised. Arrangements with other laboratories by the licensor would need to be reviewed separately. Research testing would have nothing to do with this.

    Your bold statements about research tests could be given more credence if they were reproducible examined and published. False negatives too are not a rarity even in FDA approved tests.
     
  5. ukxmrv

    ukxmrv Senior Member

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    We UK patients aren't given any specialist support for research projects with other tests though are we, IVI?

    I've participated in UK CFS and other research where my bloods have been taken either through a doctor working for a NHS clinic or through my own GP. In these cases I've been offered no support of any kind with regards to these studies.

    I've even participated in a clinical trial (not ME related) and not received support.
     
  6. Firestormm

    Firestormm Guest

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    Are they 'for research purposes only' tests? Do they contain the 'clause' that doctors are responsible for the test result interpretation thereby seeking to exonerate the laboratory of responsibility not only for the efficacy of the test itself, but also any specific treatment that might be prescribed subsequently?

    I do not personally have any knowledge of what you say being true or otherwise. If true then a doctor cannot escape their responsibility to their patients by 'blaming' it on the test result.

    That people with ME are having 'tests' applied to them that originate abroad or in this country, and thereafter being prescribed treatments, just reinforces in my own mind how arbitrarily treatment for ME is applied.

    There is nothing in the NICE Guideline (or any other guideline or regulation) that applies to us that allows for 'testing' originating abroad.

    A doctor I am sure will do whatever he/she thinks appropriate to better understand what is happening and what might be contributing to their patient's distress.

    They cannot however, seek to shift responsibility. This was about the XMRV 'test' specifically and not more general practices.

    But, I cannot see any reason why a doctor in this country faced with a patient with this diagnosis would want or feel the need to seek a test from abroad.

    Edit:

    If you want to talk about any specific test that you might be referring to such as those originating in KDM's laboratory, or any other, I'd be happy to do so.
     
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  7. Firestormm

    Firestormm Guest

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    What has interested me Mula, is that neither you or anyone else has even attempted to establish whether or not you have a case for seeking damages.

    I mean doesn't the whole debacle surrounding these commercial tests make you want to get to the bottom of it? Gods if I had been persuaded to pay for this test by all of the speculation surrounding the issue I would have sought legal advice earlier this year.

    And I don't mean if I had involved specifically the NHS either - I would rather have gone direct to VIPdx under legal advisement and asked my legal counsel to consider all the hype that had coerced me into believing I needed to know if I was 'infected'.

    However, I suspect that the reasons why this has not happened (or even been openly been discussed or revealed as having happened), is because for some the notion that it wasn't really about 'XMRV', that the 'test' hadn't replicated what Mikovits' actually is alleged now to have 'discovered' i.e. not XMRV, allow you to continue to believe; but more probably - it is embarrassment mixed an acceptance of personal responsibility.

    It is to me quite incredible that - when you look back at all that hype surrounding how potentially 'dangerous' this infection was to humans, that it could be transmitted 'sexually', or by 'aerosol' and the comparisons made to HIV, and how anti-retrovirals were the 'only' answer etc. - all the fear and concern it generated - substantiated and even endorsed by those bloody test results - why people are not hopping bloody mad.

    The USA is a country where - we hear - every little thing is open to legal contest - WHY hasn't anyone hit back at Mikovits, WPI, and/or VIPdx? It sometimes makes no sense to me at all. Even if there is no legal case - people are still defending these 'tests'.

    Unapproved testing, commercially sold, especially with the disclaimer of them being some sort of 'research only' ones, need to be closed down. Period.

    Desperate people - including those who think they know more than others - will always fall foul of exploitation. And even with what I remain certain were in this case genuine motivations to help - this entire episode has been one of exploitation.

    Personal choice? Well. You tell me. If you are a patient with ME who has been able to keep up with all that occurred*, all that hype and argument, and you believed in what the key players had to say - that they were your only real hope and that they had the answer that could lead to an effective treatment (incl. Autism) - are you in any position really - NOT to be coerced?

    Thank the Gods that so relatively few were sucked into it. And don't get me wrong. I don't blame anyone who paid for the 'tests' not really. I know what I place the blame and it isn't with them.

    In my opinion and for what ever that is worth.

    (*Imagine if you were so ill that you'd only been able to keep up with snippets. That could even be worse. If someone truly believed that based on that 'test' their doctor was refusing them effective treatment - on the NHS - I can only begin to imagine what stress that could place them under. And now we have a situation when some people are claiming that the 'test' result might not have been accurate. That they still might in fact be carrying a retrovirus!!)
     
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  8. jace

    jace Off the fence

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    Firestormm said
    Quite simply, because it has not been disproved. I now have two more family members with the illness. No-one said it was infectious as flu, but it has not been proved that it is not infectious at all.
    Indeed, the existence of outbreaks (though information on that has been suppressed in recent years) rather confirms that suspicion. We need more transparency of information and study.

    IVI said
    I was one of those, and I had a lovely letter along with my results, with an offer of help, from Dr Judy Mikovits. I did not take up the offer, because I'd rather she focussed on her core work. I'm sure I was not singled out for special treatment.
     
  9. In Vitro Infidelium

    In Vitro Infidelium Guest

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    Agreed - in contract law that's (with circumstantial caveats) unequivocal.


    That does not accurately represent the patient/doctor/provider relationship in the NHS. The ordering doctor is under a distinct ethical and regulatory burden. A practical difference operates between GP (primary care) and (the majority of)hospital based provision. GPs operate as private contractors to the NHS (a weird artefact of the NHS creation) while most hospitals are NHS operated and staff are direct NHS employees.


    This conflates two separate issues. Firstly the UK regulatory conditions, places a burden on the ordering doctor to ensure that any test ordered is both necessary to the patients needs, and meets an appropriate standard. This is an inescapable responsibility of the doctor. In practice, within the NHS the whole process of testing is strictly managed and audited, with most testing done by NHS run facilities or through strictly monitored contracts. The concern for patients is therefore primarily with doctors operating a Private service outside any NHS contract.

    Secondly and specific to the WPI/VIPdx XMRV tests – the document on which this thread is focussed and Jace’s subsequent comments, involve an implication that the problem with the VIPdx tests is that they were not ‘clinically validated’, but the point is the tests could never have been clinically validated in the absence of any demonstration of reproducibility (via independent replication studies) . WPI should not have licensed for sale, nor VIPdx have marketed the tests, not because of the lack of clinical validation, but because clinical validation was never going to be achievable without independent replication of the research on which the licensing was based. This is of more than just academic relevance because anyone who followed the research, including (one must assume) those doctors who signed off on ordering tests from VIPdx, knew that the supportive science wasn’t there – i.e the tests were scientifically and medically meaningless.

    I’m not sure I understand ? In broad terms that appears to make sense but it doesn’t seem to take account of the discussion in this thread.

    IVI
     
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  10. Firestormm

    Firestormm Guest

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    Gods. How many other reasons might there be for familial diagnosis with this condition? Even before you consider specific opinion about any cause or influencing factor spouted by 'experts' or medical opinion.

    I mean here we are today, I believe my own was triggered by a diagnosed virus. I can be as wrong about that being a direct contributory cause as some who believes it was a vaccine.

    I, like many other people I suspect thought 'Well I had this virus and in incapacitated me, led to PVFS, which led to ME being diagnosed'. Similarly, 'Well I had this vaccination, and I never felt well again'.

    Difference is that I have always realised that my association was simply that. It was my own applied 'logic'. I didn't cling to this notion and think that the only answer was anti-virals. I don't honestly believe that the majority of people with my diagnosis do anything different.

    There is absolutely no reason to cling to the idea that XMRV or MLVs or retroviruses are the cause of your suffering, or my own.

    And specifically, Lombardi did nothing to establish a cause or an effect. But the hype surrounding this paper was enough to motivate some people straight to paying for a 'test' and (allegedly) into being prescribed or seeking anti-retrovirals.

    It was wrong. Totally and completely wrong to make a 'test' available commercially to anyone under the circumstances of a single paper like that.

    Judy Mikovits has absolutely no right to be offering help to anyone. She is a scientist. Unless she is offering to help you with vitamin supplements, or even if she is, what sort of help was she offering? Help to interpret the results? Help to know what to do next? You do realise that by saying what you have that it will only serve to endorse the view that Mikovits stepped well outside of her brief.
     
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  11. In Vitro Infidelium

    In Vitro Infidelium Guest

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    The number of things that have not been 'proved' is infinite, which is why science doesn't concern itself with 'proof'. Of course if the point of reference isn't science then of course there is likely an infinite variation of philosophical positions from which to argue from - but as the start of this thread appeared to be located (at least notionally) in a scientifically valued reference point, arguing about proof seems irrelevant.

    Mikovits is not an MD and as the research lead she was certainly in no position to give independent advice. It would be very interesting to see the content of such letters (devoid of any personal details). Was there anything that stated that the results should be treated with significant scepticism - or were patients encouraged to 'believe' the results were meaningful ?

    IVI
     
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  12. In Vitro Infidelium

    In Vitro Infidelium Guest

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    My expectation would be that:
    1. Recruitment into a trial was either by referral via the patient’s GP, or if by other route, then contact with the GP would be conditional on participation.

    2. Health history from the GP would be provided to the researchers, and would form a basis for selection to research participation or exclusion (co-morbidities, confounding issues etc).

    3. Prior to their participation, participants would be made aware whether or not, after the research was complete, that individual test results were to be unblinded and be available to the partipants.

    4. Where unblinding was planned, individual results would be passed to an independent specialist Consultant for interpretation.

    5. The Consultant would write (in the usual way) to the GP, with any comments and recommendations regarding treatment or actions that the GP should make, including referrals to specialist clinics etc.

    If none of that occurred in your experience, then I would be concerned. Of course currently in M.E/CFS there isn’t anything substantial at step 5. that could be recommended unless there was something identified in the research that was a clinically distinct issue for which there is an established treatment.
    IVI
     
  13. jace

    jace Off the fence

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    I find that rather insulting. I have never said I am clinging (implied desperation) to the retroviral hypothesis, just that it seems a likely cause, but is not yet either proven or disproven. You say people put the start of their illness down to viral infection or immunisation, I would add to those triggers physical trauma and physical and/or emotional stress of long standing, plus hormone surges such as occur in puberty and pregnancy. The hypothesis is that these immune insults allow the retrovirus to come out of latency and start replicating in tissues. It's a hypothesis that makes sense to me, and I've yet to see any convincing proof that it's not a possibility. You are allowed to think differently.

    I took it to mean she was offering further explanation and emotional support. Ye Gods, IVI, first you criticise the study by saying
    and then when one of the Ashford 50 pipes up and says 'But I got a really nice letter with an offer of support' (no idea what kind as I didn't take it up) you start off on the Mikovits is not an MD tack. We do kinda know this already.

    We volunteered for the study freely, as adults of sound mind with self-determination. I doubt any of us expected to move on, get treated, at least in the short term. One year to five years is the time-frame I remember imagining to be possible. Of course we hope that research will lead to effective treatment options. Don't you?

    We knew that the study was experimental. Scientific studies usually are.
     
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  14. Firestormm

    Firestormm Guest

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    At what point would you consider the hypothesis 'disproven'? Is it do you think a personal decision. I suppose it is at the end of the day. I think though we are generally talking about the science itself.

    What about this 'Lipkin Study'? Mikovits is onboard with that one too. Will it's outcome carry greater weight because she is participating do you think, than if she hadn't? Will it help (or does it have the potential to help) satisfy things in your own mind?
     
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  15. In Vitro Infidelium

    In Vitro Infidelium Guest

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    If there had been the appropriate provision, there would surely be no doubt what kind of support was to be provided, because that would have been part of the study proposal. Having a nice letter from a non medic is no substitute for an independent interpretation of the meaning of the results from someone who is appropriately qualified. It is irrelevant what the participants were, or were not happy with - it remains a crap way of doing medical science. In this particular case it has led to all sorts of fanciful propositions about what the tests mean, without a single qualified specialist having any role in counselling those who were told by WPI that they have a retroviral infection.

    A properly conducted study should ensure that participants have a very clear understanding at the outset of what to expect - the outcomes are always of likely limited choice (rarely something very unusual turns up and the researchers have to be especially sensitive in such cases) and the options need to be specified to participants at the point of their recruitment. Again, the low expectations (if they were indeed shared by all 50) of those in Ashford study are not relevant - there is never a reason to accept low standards in research practice.The article that is at the start of this thread places a false distinction between the responsibilities of the WPI and/or VIPdx and the responsibilities of Dr Mikovits, the standards of practice that affected all parts of the WPI/VIPdx operations were low in many respects and Mikovits can't be excused on the basis that things were only wrong at VIPdx. Mikovits was the study designer and Primary Investigator - many of the bucks necessarily stop with her.

    IVI
     
  16. asleep

    asleep Senior Member

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    Speaking for myself, I will consider it "disproven" (or, more accurately, "improbable") when I see strong, solid data that lends substantively stronger support to an alternative explanation for the positive results. Speaking of the "science itself," there is currently very little actual evidence to support the alternative explanation of contamination, once all the assumptions and professional prejudices are factored out. And despite specious claims to the contrary, the original finding of evidence for HGRVs has been reproduced by multiple labs now. This is much stronger evidence than a whole spate of failed reproductions under novel conditions.

    Like everything else, it will all depend on the details and the rigorousness of the study, none of which is known at this point. As I've detailed elsewhere, there are a great many open questions for which the Lipkin study will likely provide little resolution. The weight and role of the study in this debate will have to be judged on purely empirical terms, not on its ability to garner media fanfare nor its inclusion of certain authors (who will inherently be at the mercy of the study's design as well as any elements not directly under their entire control).

    Lastly, jace is right about your use of certain phrases ("cling to the idea", "satisfy things in your own mind") being unnecessarily prejudicial in their implication of irrationality and recalcitrance for having the audacity to follow the data instead of the story.
     
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  17. jace

    jace Off the fence

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    We were given comprehensive information about the study, IVI. You're flogging a dead horse here. It seems to me you are holding the people you don't agree with to higher standards than the ones you see as 'authoratative'.

    Fire, it does depend on the science, of course. But so many of the negative studies, if not all (but I haven't studied all) have fatal flaws. We've been over this ground so often, I'm not prepared to go over it all again.

    I'll judge the Lipkin study when I see it - if we get sight of the full paper. If not, it will be impossible to judge. The devil is in the details.
     
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  18. In Vitro Infidelium

    In Vitro Infidelium Guest

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    The article you started this thread with seems concerned with a scientific approach to medicine - you've referred to proof several times - and I've pointed out above that proof has nothing to do with science, can you therefore explain how 'proof' is relevant here - is the context science, or something else ? Otherwise it seems very unlikely that the discussion can be at anything other than cross purposes.

    IVI
     
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  19. Adamskitutu

    Adamskitutu *****

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    IVI - lay people - and many 'skeptics' for that matter - use the word 'proof' frequently on these online forums. Explain why 'proof' is not a safe concept in science if you like - I think you should - but this is a minor issue and does not detract from the fair comments being made here.
     
  20. jace

    jace Off the fence

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    I perhaps should have said 'accepted as a working hypothesis' but as you can see, it takes rather more typing to put it that way.

    What we would love to see is a well-controlled clinical trial based on the retroviral hypothesis. I'm sure they'd have no trouble finding volunteers.
     
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