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

[Firestormm]

You mean a clinical trial of a drug, Jace? Based on what hypothesis exactly?

 

[Firestormm]

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.

V99 herself finally now questioning the 'clinical validity' statement: http://peoplewithme.com/thread-1531.html

 

[In Vitro Infidelium]

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.

I'm unclear what you then would mean by: "just that it [retroviral hypothesis] seems a likely cause, but is not yet either proven or disproven. [and is] accepted as a working hypothesis". Who accepts this as a working hypothesis ? As an hypothesis a retroviral cause/involvement in M.E/CFS remains unfalsified, but that hardly elevates it to 'working', in the sense that it commands significant research effort. M.E/CFS has never been short of explantory hypotheses - yet few have had the power to drive consistent research.

I understand the difficulty of responding in detail - but I think if people are going to post articles that are critical of specific scientific research, and then defend that criticism, that there is an inherent responsibility on the defenders to respond to questions and opposing views in a precise and full way that reflects the science involved.

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.

Who is 'we' ? Are you invoking the collective will of all M.E/CFS affected people, or are you referring to a specific group who share an expressed perspective ? And how could any clinical trial proceed without identification of a target ? Even if specualtive use of an anti retroviral drug could get past ethical considerations, without an identified target pathogen such a trial would not be a test of the hypothesis you are promoting - any positive effective of the drug employed might be the result of of numerous biological actions, none of which may involve anti retroviral activity.

IVI

 

[Firestormm]

I loathe this collective terminology that gets used. I mean sometimes, occasionally, fine but it's like when people start claiming their views reflect 'most' people's opinions. It's not hard for folk claiming to be 'advocates' to identify themselves and those whose opinions they are representing.

Anyway, what you've said above IVI about clinical trials similarly concerns be about Rituximab. I understand that this was originally an unintentional association, and I think they are proceeding with caution - but still. It remains a concern because even if the results are deemed positive - that positive cannot possibly apply to everyone with the condition.

I would like to have seen more identified in terms of who exactly is likely to have benefitted from this treatment and precisely why e.g. what biological deficiencies did they have prior to and post treatment. I mean depending on the results we could after all be looking at some sort of biomarker.

Bottom line though is that I suspect for some the example of Rituximab i.e. proceeding to clinical trial without the necessary preceding scientific hypothesis - will be used as some sort of justification for trying any old thing on the market.

 

[Adamskitutu]

I think we are falling into a quagmire of semantics now. There are enough people in this community and elsewhere who feel the POSSIBLE retroviral link has not been explored adequately, and that there are big problems with the way the issue has been treated by the various scientists claiming to be the authority on this issue. These has been talked about at length on patient boards. Jace or anyone else does not need to quantify that, AGAIN. The hypothesis is that there is a retroviral cause (HGRV - NOT MLV or XMRV remember) and that certain Anti-retrovirals might cure or improve. People would like to see that avenue of scientific enquiry explored with the development of clinical trials. It's pretty simple and not an unreasonable wish.

 

[In Vitro Infidelium]

I think we are falling into a quagmire of semantics now.

Semantics is no less valuable an area of investigation than any other – no need for it to be a quagmire, it merely requires clear reference to intended meaning.

There are enough people in this community and elsewhere who feel the POSSIBLE retroviral link has not been explored adequately, and that there are big problems with the way the issue has been treated by the various scientists claiming to be the authority on this issue.

Isn’t that just argumentum ad populum ? This thread is about an article that contends inadequate science has taken place, requiring some demonstration of the substance of the claim ‘in scientific terms’ rather than accepting the contention uncritically, is not unreasonable. The fact that a particular hypothesis is liked by a number of people doesn’t give strength to that hypothesis or in anyway command scientific priority for the testing of the hypothesis.

These has been talked about at length on patient boards. Jace or anyone else does not need to quantify that, AGAIN. The hypothesis is that there is a retroviral cause (HGRV - NOT MLV or XMRV remember) and that certain Anti-retrovirals might cure or improve. People would like to see that avenue of scientific enquiry explored with the development of clinical trials. It's pretty simple and not an unreasonable wish.

Where someone posts an extensive article that makes numerous presentations of fact, it is not unreasonable to expect that the poster would make the effort to engaged with criticism of the article and to explain points of inadequacy. It’s not as though in this case the OP has just given a link and said “looks interesting”, but rather has posted the article in full (on PR and elsewhere) and then responded to replies with defences of the article. Further the only relevant hypotheses that follow from the posted article are those that formed the basis of the Lombardi et al 2009 paper and the BWG study. If some other hypothesis is now being introduced – someone needs to explain the relevance, not merely expect the discussion to go ahead as though all this has been established by some definitive debate that occurred at some unspecified time in the past adjudicated over by some unspecified but uniquely qualified persons.
What ‘people’ (who ?) may like, is no basis on which to command a direction in scientific enquiry, and it doesn’t matter how much a ‘populist’ notion is propounded – it will never translate into effective science without a sound basis for investigation being established.

Without an identifiable target, clinical trials of retroviral drugs would face exceptional ethical hurdles. It may be that such things as HGRVs actually exist, it may be that such things could be pathogenic, it could be that such pathogenic action could be integral to some or even all illness that is currently described as M.E/CFS/M.E(etc) but blindly throwing expensive, not to mention toxic drugs at M.E/CFS patients without any grasp of what dosage might be effective, what duration of treatment might be effective or what effect the development of resistance might have would be crazy. Suppose there is an RV present in an M.E sufferer, that the RV is broadly held in check but not eliminated by the immune system, that treatment with an ARV causes rapid resistance and selects for greater virulence, and that no other treatment is available – the researchers would have turned a chronic condition into a lethal one. Personally I doubt that such a scenario is probable but scientists have to consider such issues. For the present HGRVs are hypothetical and until such time as there is repeatable observation of active HGRVs , clinical trials ‘treating’ such things would involve the error of stacking one hypothesis on another – not a sound way fro research to proceed.
IVI

 

[Adamskitutu]

No, IVI, it's not 'argument ad populum'. It's pointing out that these issues are debated, time and time again, on these forums, and it's a generalisation that needs to be made, in order to establish what some people are thinking would be a good example of scientific progress. Without establishing some generalities of what some people are asking for, we are forever doomed to be arguing semantics.

It also concerns me you undertake to tell others here what 'scientists' are thinking, as this in itself is a gross generalisation. It also concerns me that you adopt a position of 'educating the rabble' here about what scientists 'have to' do, as if you have a special insight and authority to talk for all scientists, as you have done above. Clearly you do not. That's not a personal attack by the way, it is merely pointing out that you are not a supreme arbiter for what scientists 'have to do', no more than anyone else here, for example.

Treatment trials have proceeded on hypothesis of causation only MANY times: the PACE trial being just one case in point from what I understand!

 

[barbc56]

No, IVI, it's not 'argument ad populum'. It's pointing out that these issues are debated, time and time again, on these forums, and it's a generalisation that needs to be made, in order to establish what some people are thinking would be a good example of scientific progress. Without establishing some generalities of what some people are asking for, we are forever doomed to be arguing semantics.

It also concerns me you undertake to tell others here what 'scientists' are thinking, as this in itself is a gross generalisation. It also concerns me that you adopt a position of 'educating the rabble' here about what scientists 'have to' do, as if you have a special insight and authority to talk for all scientists, as you have done above. Clearly you do not. That's not a personal attack by the way, it is merely pointing out that you are not a supreme arbiter for what scientists 'have to do', no more than anyone else here, for example.

Treatment trials have proceeded on hypothesis of causation only MANY times: the PACE trial being just one case in point from what I understand!

How are you applying the term "generalities".in your above post? I may be reading incorrectly, but it seems that you are saying in your first paragraph that generalizations need to be made for scientific progress, yet in one of the following paragraphs, you don't like IVI making generalizations about scientists?

Yes there are treatment trials conducted where only causation is considered as the major factor but these studies are not as robust as ones that look at the broader picture. To use your example, the PACE trial, includes several flaws.

I find all posts, and that includes IVI, to be illuminating even if I don't agree with the poster. It's easy to become so immersed in our views that we interpret another view as criticism directed towards ourselves taking a defensive stance when it's not necessary as that may not be the intention of the other poster.We have all done this at one time or another as we are only human. I have read posts that contain views I do not agree with and TBH, sometimes my first reaction might be to take the post personally. However, it's prudent to step back a bit and realize that different views are not necessary negative and are an important/necessary process in debate as well as an excellent way to learn information about a topic.

IMHO
Barb C.:>)

 

[Adamskitutu]

Barb, generalisations need to be made on FORUMS, sometimes, for the purposes of coherent discussion, as one does on everyday discourse and engagement. We do not live in a world where generalities are NEVER permitted. We'd never get through the day if we had to defend every rule of thumb or description of tendency we work to.

This is not the same issue as the scientific method, though that is another subject which the topic of generalising applies to, but that is off this thread's topic.

I'm very glad you understand that PACE has several flaws. But there are MANY treatment trials throughout medicine that work on untested hypothesis only. The interesting thing is why the HGRV 'hypothesis' is discarded when, for example, trials based on the massively unsafe hypothesis of deconditioning and catastrophisation, or child trauma! get trialled extremely frequently - with millions of pounds/dollars wasted. That is what people are concerned about, among other things.

I'm glad you find IVI educating. I don't - no offence to either you or him. He has no special or privileged expertise to claim to need to 'educate' anyone here, no special educating role to fill. Your advice to me to 'step back a bit' applies to you as much as anyone, and indeed to him. I don't think, to be honest, you need to educate me on what is negative or not, or what my opportunities for learning need to be. I am only responding to some assertions and disagreeing, as an equal participant on a forum.

 

[Mula]

If an NHS doctor ordered a test not approved by the NHS and the test was faulty, then the NHS trust would be liable and the doctor would probably be disciplined. When a UK doctor in private practice orders a test from abroad, if that test is faulty then the doctor could be sued as well as the laboratory who provided that test. In the situation discussed here most patients brought directly from the laboratory and will be from different countries, but I will include the details for NHS. If an NHS test is faulty the NHS trust is liable.

In the rare event that an NHS doctor ordered a test then this site is applicable.

NHS bodies owe a duty of care to healthy volunteers or patients treated or undergoing tests which they administer.

http://www.nhsla.com/Claims/

A doctor can only relies on the figures they are provided with by the testing laboratory. If those are inaccurate due to a faulty test the liability is as described. A doctor is not expected to know a test is faulty and they don't interpret but are provided with what they trust is accurate information.

Here the licensor and laboratory presented to the public a test they claimed was clinically validated test. The onus on ensuring that test was clinically validated would rest with the laboratory selling the test and the licensor would be required to ensure the test met this standard. The burden would not be for researchers who initially developed the test as they would have no requirement to clinically validate that test. They were not the licensor or the seller.

The WPI research using UK participants was NIH funded. Every detail would have been approved and passed their regulatory system. Research testing is regulated by ethics but there is no burden of validity when testing patients or all other research studies would have claims made against them.

 

[barbc56]

G

Barb, generalisations need to be made on FORUMS, sometimes, for the purposes of coherent discussion, as one does on everyday discourse and engagement. We do not live in a world where generalities are NEVER permitted. We'd never get through the day if we had to defend every rule of thumb or description of tendency we work to.

This is not the same issue as the scientific method, though that is another subject which the topic of generalising applies to, but that is off this thread's topic.

I'm very glad you understand that PACE has several flaws. But there are MANY treatment trials throughout medicine that work on untested hypothesis only. The interesting thing is why the HGRV 'hypothesis' is discarded when, for example, trials based on the massively unsafe hypothesis of deconditioning and catastrophisation, or child trauma! get trialled extremely frequently - with millions of pounds/dollars wasted. That is what people are concerned about, among other things.

I'm glad you find IVI educating. I don't - no offence to either you or him. He has no special or privileged expertise to claim to need to 'educate' anyone here, no special educating role to fill. Your advice to me to 'step back a bit' applies to you as much as anyone, and indeed to him. I don't think, to be honest, you need to educate me on what is negative or not, or what my opportunities for learning need to be. I am only responding to some assertions and disagreeing, as an equal participant on a forum.

I guess I just don't understand your point but that could be my misunderstanding and not yours. I think it's best to move on and get back on topic.

I'm sorry if you thought the stepping back comment was directed at you as that was not my intention. When you read my post, I said there are times that we have all done this and it's something to consider when posting.

Last time I looked we are all allowed to express our point of view as long as we post appropriately and IMHO, this includes debating the topic and not the person writing a post.

Barb C.:>)

 

[Adamskitutu]

Barb I agree about this not being about debating a person. Nevertheless, a person's argument (whether immediate or one they make long term), can be debated, and sometimes that involves having to mention the person, or addressing them directly. I'm presuming that you understand that I am not 'debating the person' here, and therefore you are just making a 'general comment' not related to me?

 

[Firestormm]

Mula, how would someone in the UK have arranged for their blood to be drawn (assuming no doctor had been involved) and who would have interpreted the results once the result from VIPdx was received?

I will check your link later. Thanks.

 

[In Vitro Infidelium]

If an NHS doctor ordered a test not approved by the NHS and the test was faulty, then the NHS trust would be liable and the doctor would probably be disciplined. When a UK doctor in private practice orders a test from abroad, if that test is faulty then the doctor could be sued as well as the laboratory who provided that test. In the situation discussed here most patients brought directly from the laboratory and will be from different countries, but I will include the details for NHS. If an NHS test is faulty the NHS trust is liable.

I’m afraid that still mixes things up. GPs seeing patients under an NHS contract are not part of a Trust structure, they are operating a private business contracted to the NHS (yes it’s clumsy and weird, but that’s the way it is). There would be no way for a Trust (hospital based) doctor to order tests outside the institutional level contract, nor would a GP be able to order non approved/contract agreed testing under his/her contract with the NHS without accounting oversight being raised.
What we have in the case of Dr Wright (case linked in earlier post) is a GP who in addition to his NHS contract, saw patients privately, and in that context he has been found professionally unfit on the basis of his ordering tests which he knew (or should have known) could not benefit his patients. This would have been exactly the case if UK patients were to have had tests from VIPdx should VIPdx have abided by their claim to only have supplied tests to ordering physicians. So in the case of UK patients, either VIPdx supplied tests without a doctor being involved, or UK patients were assisted by some non UK based doctors providing a ‘signing off’ service. Or there are UK doctors who acted in ways that implicate significant professional impropriety.

 

[Firestormm]

This forum is not conducive to font size

 

[In Vitro Infidelium]

No, IVI, it's not 'argument ad populum'. It's pointing out that these issues are debated, time and time again, on these forums, and it's a generalisation that needs to be made, in order to establish what some people are thinking would be a good example of scientific progress. Without establishing some generalities of what some people are asking for, we are forever doomed to be arguing semantics.

Who are these some people ? Really that is just an argument for validation of belief without any reference to the real world in which science takes place. Fine if the concern is to give an equality of position to every minor sectarian belief system, but nonsensical in terms of actually dealing with science as it is practised, funded and published.

It also concerns me you undertake to tell others here what 'scientists' are thinking, as this in itself is a gross generalisation. It also concerns me that you adopt a position of 'educating the rabble' here about what scientists 'have to' do, as if you have a special insight and authority to talk for all scientists, as you have done above. Clearly you do not. That's not a personal attack by the way, it is merely pointing out that you are not a supreme arbiter for what scientists 'have to do', no more than anyone else here, for example.

‘Personal attack’ it may not be, but it’s still an appeal to the ad hominem fallacy. On that reasoning I’m also an arbiter of the direction the sun rises and the correct spelling of marmalade. I find it absurd that it should be necessary to have to reprise statements about the most basic tenets of modern scientific practice, it is the equivalent of having to repeatedly restate Newtonian Laws and etymology of both the words East and the English noun for a conserve of oranges and sugar. But the issue is not semantics – it is about the way the science operates. You and others may wish it to be different, but if the basis of criticism of current science, is current science itself – wish fulfilment hardly makes for sensible argument.

Treatment trials have proceeded on hypothesis of causation only MANY times: the PACE trial being just one case in point from what I understand!

Not that PACE is relevant but causation was not necessary to the founding hypothesis, which was that CBT and GET were safe and effective treatments for CFS/M.E (author term). My take is that the PACE study was highly successful and clearly demonstrated that CBT and GET are ineffective treatments for M.E/CFS (or CFS/M.E), which should have been the end of the issue – and yes there are considerable problems in the NHS that allow resources to be committed to supporting a demonstrably non cost effective intervention to be promoted as though it were. None of which has anything to do with the principles scientific investigation.

Testing an hypothesis that states “ Pathogen X is causative of illness state Y, it is therefore hypothesised that treatment with antipathogen medication Z will cure illness state Y”, is not what has been argued for in this thread. There is no identified pathogen, there are no characteristics described of this hypothetical pathogen (other than it is retroviral in character), there are no defined pathways of disease causation, nor any means to distinguish the effects of this near mythical entity from any co-morbid condition. Under those conditions, as I elaborated upon above, any clinical trial with would be ethically and scientifically dubious. Of course anyone is free to believe otherwise – but will not change how the majority of researchers, medical professionals and funders view the situation.

IVI

 

[In Vitro Infidelium]

This forum is not conducive to font size

Ain't that the truth !

 

[Adamskitutu]

IVI, you said:

"Who are these some people ? Really that is just an argument for validation of belief without any reference to the real world in which science takes place. Fine if the concern is to give an equality of position to every minor sectarian belief system, but nonsensical in terms of actually dealing with science as it is practised, funded and published."

I'm sorry, but that is a ludicrous suggestion. You quite happily talk about 'what scientists do' or 'have to do' yourself here in this thread. You provide no evidence to support your generalisations whatsoever, just assume some privileged insight into a scientific process which others can see is not consistent (the so-called scientific process), hence the arguing.

You are consistently making what I see as false generalisations as regards to 'science - but you must surely understand there are fair and rational generalisations to be made in every-day life and other discourses. Otherwise I wonder how you get through the day. If I were to turn the argument back on you, I would be demanding "who are these people you call 'scientists' per se who follow you way of thinking, who are they?" which of course would be as ludicrous a proposition as the one you have just made above.

You said: ‘Personal attack’ it may not be, but it’s still an appeal to the ad hominem fallacy. On that reasoning I’m also an arbiter of the direction the sun rises and the correct spelling of marmalade. I find it absurd that it should be necessary to have to reprise statements about the most basic tenets of modern scientific practice, it is the equivalent of having to repeatedly restate Newtonian Laws and etymology of both the words East and the English noun for a conserve of oranges and sugar. But the issue is not semantics – it is about the way the science operates. You and others may wish it to be different, but if the basis of criticism of current science, is current science itself – wish fulfilment hardly makes for sensible argument."

Again, a ludicrous proposition, that complaining about a tendency you have in your arguments is somehow an ad hominem and leading me to claim you are an arbiter of everything. My problem is you are CLAIMING to be an arbiter of 'what scientists do': you are claiming a privileged insight into the 'workings of science' over those who disagree with you here. That is what I am arguing against. Newtonian Laws are not relevant to this argument either - you are using false analogies - as is the above discussion on marmalade and the sun. Again - you claim to have privileged insight into how science operates, and I and others are saying you don't because your assertions are not correct, and cannot be supported.

And yes - semantics ARE the problem here. Your defence of PACE as a reasonable, scientific study as opposed to ARV trials, by saying the hypothesis of 'it's safe' is reasonable, fails miserably. The same could be said for an ARV trial, for one thing, and GET/CBT can be argued to be unsafe.

You also said:

"Testing an hypothesis that states “ Pathogen X is causative of illness state Y, it is therefore hypothesised that treatment with antipathogen medication Z will cure illness state Y”, is not what has been argued for in this thread."

You are not actually the arbiter of this thread and what happens on it.

 

[Mula]

I’m afraid that still mixes things up. GPs seeing patients under an NHS contract are not part of a Trust structure, they are operating a private business contracted to the NHS (yes it’s clumsy and weird, but that’s the way it is). There would be no way for a Trust (hospital based) doctor to order tests outside the institutional level contract, nor would a GP be able to order non approved/contract agreed testing under his/her contract with the NHS without accounting oversight being raised.
What we have in the case of Dr Wright (case linked in earlier post) is a GP who in addition to his NHS contract, saw patients privately, and in that context he has been found professionally unfit on the basis of his ordering tests which he knew (or should have known) could not benefit his patients. This would have been exactly the case if UK patients were to have had tests from VIPdx should VIPdx have abided by their claim to only have supplied tests to ordering physicians. So in the case of UK patients, either VIPdx supplied tests without a doctor being involved, or UK patients were assisted by some non UK based doctors providing a ‘signing off’ service. Or there are UK doctors who acted in ways that implicate significant professional impropriety.

Dr Wright was subject to a hearing for having blood tested at an facility not licensed for clinical laboratory testing. Redlabs (Vipdx) was given a CLIA certificate for clinical laboratory testing. I have given the relevant information in my previous response.

NHS bodies owe a duty of care to healthy volunteers or patients treated or undergoing tests which they administer.

http://www.nhsla.com/Claims/

Why do you deflect from responsibilities of Redlabs and the licensor, WPI, in having marketed tests to patients?

 

[Mula]

Mula, how would someone in the UK have arranged for their blood to be drawn (assuming no doctor had been involved) and who would have interpreted the results once the result from VIPdx was received?

I will check your link later. Thanks.

A pathogen test is interpreted by the laboratory who perform the testing.