Discussion in 'XMRV Testing, Treatment and Transmission' started by Kati, Feb 4, 2010.
Sorry julius - too late. I already sent one addendum.
Wow this is all soooo interesting.
You know I do think our efforts as a community are clearly having an effect.
Whether it's a good or a bad effect I don't yet know, but clearly they are responding to us.
That is a common issue in research and usually means that tests will only be available for research projects approved by a 'human subjects committe' (or whatever they are called in the UK) charged with ensuring patient safety.
Shortly after I had published the Notice from the Imperial College website (and established that they had taken down all pages relating to the offer of this test for referring doctors and hospital clinicians) I gave Tony Britton (MEA Press and Publicity) a heads up.
This afternoon, the ME Association has published the following:
Imperial College say who's NOT eligible for their XMRV tests
Monday, 08 February 2010 12:30
As expected, Imperial College London posted new information on their website this morning to clarify a misunderstanding about eligibility for their XMRV test.
Their statement reads:
"We wish to apologise for any confusion concerning the availability of this test and would like to clarify that it is only available as part of an ethically approved research project. We emphasise that our laboratory does not deal directly with patients and we are not advising people who are concerned that they might have CFS, or who have been diagnosed with CFS, to request this test.
This entire business is weird and getting weirder by the day...
Sorry you missed the boat for Kim's FOI.
I would be happy to submit that question, tomorrow, as a separate request or would you prefer to do it yourself?
I will do it. I assume it's ok for foreigners to make such a request (I'm Canadian, living in Canada). If not, then it would be great if one of you locals could do it.
Also if anyone has any ideas on how best to ask the question I would appreciate input.
julius, Suzy says it's okay if we're not in the UK. Here is are the basic elements for your email:
Here's a line from my email that you can use as an introduction to your question if you like:
It's my understanding that requests for information from outside the UK are processed the same as for UK residents.
As a rule, I always include full contact details plus phone number but on the odd occasion when I have submitted a request under FOI, with email address only, omitting my street address, I have still received a response - so if you are happy to submit the question, please do.
When it's ready, I'd appreciate a copy of your question for the collection and a copy of the response you receive and whether you would be happy for me to publish both on my site, redacted of any personal details you would not want placed in the public domain.
Don't forget to ask for an acknowledgement of receipt and also CC yourself into all correspondence.
Erlwein O, Kaye S, McClure MO, Weber J, Wills G, Collier D, Wessely S, Cleare A. (2010) Failure to detect the novel retrovirus XMRV in chronic fatigue syndrome. PLoS One. 2010; 5: e8519
PCR detection of XMRV and MLV sequences.DNA was extracted from EDTA whole blood using a standard phenol-based organic deproteinisation procedure . DNA concentrations were determined by absorbance at 260 nm (A260). Each sample was amplified in three nested PCRs using primers targeted to an XMRV-specific sequence, to a sequence conserved amongst most MLV and, as a control for sample addition and PCR-inhibition, to a human beta-globin (hBG) sequence (Table 1). Each first-round reaction was performed in a 25 l volume containing 0.5 units TaqGold (Applied BioSystems, Warrington, UK), 1 x TaqGold reaction buffer (Applied BioSystems), 1.5 mM Mg2+, 200 mM each dNTP, 2.5 pmol each primer to which 5 l DNA extract or control was added. Reaction conditions were one cycle of 94C, 8 minutes, 35 cycles of 94C 30 seconds, 55C 30 seconds, 72C 30 seconds and one cycle 0f 72C, 7 minutes. Second round reaction mixes were identical to the first round and the sample was a 1 l transfer from the first round reactions. Second round reaction conditions were as for the first round over 30 cycles. PCR amplicons were visualised on a 1% agarose gel stained with ethidium bromide. Each PCR run consisted of test samples, six negative (water) and two positive controls. The positive control was a dilution of a plasmid with a full-length XMRV (isolate VP62) insert, generously gifted by Dr R. Silverman. To validate the sensitivity of the PCR, an end-point dilution of the plasmid was performed. To determine specificity of the PCR, a sample of human DNA from the LNCaP prostate cancer cell line (American Type Culture Collection, code CRL-1740) was amplified with the XMRV and MLV primer sets. To ensure integrity of the DNA extracts, three randomly selected samples were titrated to end-point using the hBG PCR to determine if the PCR copy number equated with the A260. To determine if the DNA extracts exhibited low level non-specific inhibition of PCR, 10 samples were subjected to 30 cycles of the first round hBG PCR (reaction mix and conditions as above) followed by 40 cycles of a nested real-time SYBR-green PCR using the SYBR-green Fast PCR kit (Roche, Lewes UK) according to the manufacturer's instructions.
Okay, so maybe having that page up for two weeks was an uncharacteristic mistake, even if by a group that includes someone who rarely if ever seems to be held accountable--for mistakes, malpractice, or worse. It seems a bit odd to look upon it as part of a planned strategy, not that anyone should underestimate these people. Even if it's remarkably strange that Wessely would address it in an email.
There are other possibilities, but guessing probably doesn't help. And whatever the case, even if it was just a mistake, this is a public board & as weird and/or foolish as it may look on their part, they hold most of the cards. Especially since we aren't privy to their thoughts and plans, but, at the risk of sounding paranoid, they possess the capability to view plenty of ours.
Thanks for all the info,
Was having a nap so didn't read it till now. I will get on it asap.
Since this thread has become something of an advocacy thread, I recommend everybody go to this article.
And here's a thread about it on this forum,
Even if you don't have time to read the article, open it up to give this guy lots of traffic.....hell, do it a few times a day!
Lily, that's a very good point. Being a nurse, I know that all the projects involving patients MUST be reviewed by the ethics department that is INDEPENDENT of the research team. You would not get research funds if the ethics comitee (sp) has a problem with your study.
I think they're trying to impress us with their words.
I won't have any time today to spare but someone might like to have a poke around at these links:
Unique identification scheme
Kim's FOI covers Ethics approval and requests any reference numbers attached to this approval.
I'm not making any assumptions, myself, about what might be going on, here.
The test was advertised for a few weeks, then withdrawn on the (apparent) basis that the test is part of a research trial.
But the specific diseases/conditions/study domains for which the patient samples are to be collected remains unconfirmed.
In the absence of further clarification by Imperial College, I am not prepared to accept the MEA's, unverified source explanation that the test applies to "prostate cancer" patients only.
So we now have two stories:
1] The ME Association and its unamed source: that it is an XMRV test "only for referring doctors who are dealing with cases of prostate cancer."
2] Imperial College: that the test is "only available as part of an ethically approved research project" (project unspecified, diseases/conditions/study domains unspecified).
In order to set a price for the test (stated twice in the website text to be accessible only to referring GPs and hospital doctors and not to patient self referrals) someone would have to have determined a price, possibly had that price approved, written the User instructions, prepared the text for the webmaster etc.
So if it had been the case that the test should never have been advertised because it was part of research project and not a new commercial service being offered by the Molecular Diagnostic Unit for NHS clinician use, how come somewhere along the line management chain, this did not get picked up - or not picked up by Dr Steve Kaye, who heads up the Molecular Diagnostic Unit?
I do not think it was part of a planned strategy, though something has evidently gone wrong.
I don't want to be picky but you've said:
"...even if by a group that includes someone who rarely if ever seems to be held accountable."
I'm not sure what you mean, here.
Wessely was one of a number of a collaborators in the PLoS One paper study (providing samples for the study from a previously deployed cohort from King's College London) he is employed by the Insititute of Psychiatry, under which King's comes.
He is not employed by Imperial College. And the test was being offered by the Imperial College Faculty of Medicine, Molecular Diagnostic Unit, not by IoP or King's.
If I had been making enquiries myself about the purpose of this test (I already understood that the test was doctor referral and not for patient referral) I would have addressed my enquiries direct to Imperial College or their Molecular Diagnostic Unit.
I would not have gone to Wessely, since this is not his purview and I am surprised that he took it upon himself to field queries about this test. I consider that he should have referred the enquirer (whose exchanges with Wessely were kindly made available to me for publishing in full) to Imperial College.
You will note that Wessely does not comment on any of the points of concern that Fiona raised, he only seeks to offer a clarification on the purpose of the test on behalf of another institution.
OK, he was a collaborator in and a co-author of a published paper which used an Imperial College blood test for detection of XMRV in a KCL CFS patient cohort - but he does not run the Molecular Diagnostic Unit of Imperial College, nor is he employed by Imperial College so why does he elect to act in the role of spokesperson for Imperial College?
The fact that the ME Association is unwilling to confirm from whom it got its information that the test was intended not for CFS patients but for "prostate cancer patients" suggests to me that its "late [Friday] night source" is not a member of staff at Imperial College.
A full and formal clarification needed to come direct from a spokesperson from Imperial College (even if we had to wait several days for it) not presented by the ME Association to the ME community as though their Press and Publicity guy, Tony Britton, had received a tip off in a bar round the corner from St Mary's.
Then when the "full clarification" is issued by Imperial College - it fails to confirm the "prostate cancer" story that was conveyed to Shepherd/Britton "late [Friday] night" by a source who cannot be "revealed" to mollify a confused and indignant patient population.
It will all be unravelled in the end and it will be most interesting to observe the unravelling.
These are the pertinent bits of the three "clarifications" in timeline order:
Simon Wessely: Thank you for your inquiry re the announcement from Imperial College that they are offering a diagnostic test for XMRV; I understand that this is not intended for people who know they have CFS or are concerned they might have CFS
ME Association: The ME Association was informed that this announcement about XMRV testing does not apply to people with ME/CFS, or suspected ME/CFS. It only relates to the availability of the Imperial College XMRV test to referring doctors who are dealing with cases of prostate cancer.
Imperial College: We wish to apologise for any confusion concerning the availability of this test and would like to clarify that it is only available as part of an ethically approved research project. We emphasis that our laboratory does not deal directly with patients and we are not advising people who are concerned that they might have CFS, or who have been diagnosed with CFS, to request this test.
Ok, finally got it done.
Suzy, feel free to post this or anything else I post anywhere you like. I will post the response as soon as I get it.
To: Imperial College London
Freedom of Information Officer
Re: Request for information under FOIA in respect of Molecular Diagnostic Unit XMRV Test
Please acknowledge receipt of this request along with a Reference Number, and the date by which a response will be provided.
From 27 Jan 2010 until 8 Feb 2010, XMRV Detection Testing was offered for
200 by the Molecular Diagnostic Unit via the Imperial College London
Please provide information regarding the exact testing methods employed in the test offered including, but not limited to the following:
1) blood sample volumes and processing
2) does the test use a molecular plasmid control in water or a positive blood sample
3) primer sequences and amplification protocol used
I got a response from IC. I'm new to this letter writing thing so i wonder if any of you could offer me some pointers.
1) I will post the response here, but I'm just not sure if I should do that without permission,
2) in the response they acknowledged my 2nd request under the FOI. But it is only my first request. I'm thinking maybe they think it is the same request as Kim's, not really sure. Should I write again to clarify or not bother?
julius, I got 2 acknowledgements, but neither contained a reference number as I requested. I don't think it's necessary to post these here, but I did forward them to Suzy.
My guess is that since our requests arrived on the same day about the same issue, the email you got may have been a cut/pasted from mine.
I intend to write back and ask again for the reference number(s).
can we find out about the aims of the study from the ethics committee
The FOI request that I sent IC asked about the aims of the study.
The XMRV testing page on the IC website has been updated again to include the first paragraph below:
You can also try a Google Site Search
Separate names with a comma.