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FOI responses: XMRV testing by Molecular Diagnostics Unit, Imperial College, London

Discussion in 'XMRV Research and Replication Studies' started by Dx Revision Watch, Mar 8, 2010.

  1. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

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    [The forum search engine and the ability to locate previous posts are not working for me this evening so I cannot find the original thread that this relates to. I will park the post, here, until the original thread can be located.]


    *Edit: Query with ICL taken up 09 March

    FOI responses: XMRV testing by Molecular Diagnostics Unit, Imperial College, London

    Shortlink to post on ME agenda site: http://wp.me/p5foE-2Pr

    This mailing may be reposted provided it is published in full, unedited and http://meagenda.wordpress.com is credited as the source.

    08 March 2010

    In order to obtain clarification in relation to the advertising of XMRV testing by the Molecular Diagnostics Unit, Imperial College, London, three advocates submitted requests for information under the Freedom of Information Act (FOIA), in February.

    Responses were fulfilled for all three on 08 March and are reproduced with kind consent of the recipients.

    A copy of the complete text of the Molecular Diagnostics Unit, Imperial College, London XMRV Detection Testing web pages, which were taken offline on Monday, 8 February, has been archived on ME agenda site at this posting

    R = Response by Imperial College, London Freedom of Information Office foi@imperial.ac.uk

    [1] Request for information under FOIA by Suzy Chapman, UK:

    To: Imperial College London, Freedom of Information Office
    Date: 21 February 2010
    Subject: XMRV testing available via ICL Molecular Diagnostics Unit (MDU)


    A revised notice on the website for the MDU states:

    The MDU offers XMRV testing for research purposes only. If you are a researcher who is interested in XMRV testing, please contact the unit with an outline of your requirements.

    There has been some confusion around the availability of the XMRV test, for which we apologise. We 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.


    On 6 February, The ME Association had published a notice on its website stating that it had been informed that an earlier announcement about XMRV testing on the MDU website:

    did not apply to people with ME/CFS, or suspected ME/CFS

    and that the test related only to:

    the availability of the Imperial College XMRV test to referring doctors who are dealing with cases of prostate cancer. A full clarification will appear on the Imperial College website on Monday.

    Although it has since been clarified by ICL that the XMRV testing being made available through the MDU is for researchers only, confusion persists over which diseases/conditions this test is being offered for.

    I request the following information under the FOI Act:

    1] For what diseases/conditions/study domains is the XMRV test being made available to researchers?

    R: Further to your request for information regarding the diseases/conditions/study domains for which the XMRV test was made available to researchers (below) which was received by us on 22 February 2010, any physician or laboratory scientist can request the test for any disease or condition* as part of an ethically approved research study. Our group at Imperial College London is currently focused on neoplasms of the genital tract but the clinical implications of XMRV infection are not yet fully understood. Our group is no longer studying CFS.


    [2] Request for information under FOIA by Kim LeMoon, USA:

    From: foi@imperial.ac.uk
    Date: 08 March 2010
    Subject: RE: Request for Information XMRV Research


    R: Further to your request for information received by us on 8 February 2010, please find below the Colleges response to your questions.

    Request for information under FOIA in respect of all ongoing research projects or scheduled research projects relating to XMRV (Xenotropic murine leukemia virus-related virus) detection via blood samples, tissue samples or any other methods of detection

    I should be pleased if receipt of this request for information could be acknowledged, together with the date by which a response will be provided.


    Project Supervisors:

    R: Professor Myra O McClure, Dr Steve Kaye, Professor Jonathan Weber

    Project title:

    R: XMRV and its association with Prostate cancer

    Laboratory supervisor:

    R: Dr Steve Kaye

    Clinical supervisor:

    R: Dr Anup Patel

    1] Any Identification or Reference code assigned to Project:

    R: n/a

    2] Projects Public Title; Projects Scientific Title:


    R: XMRV and its association with Prostate cancer

    3] Study hypothesis/rationale (where applicable):

    R: n/a

    4] Ethics approval and any reference numbers attached to this approval:

    R: Tissue bank ethics number 98CC141. A study to collect blood & urine specimens, prostate tissue &/bone marrow specimens to help establish methods for diagnosing and treating prostatic cancer.


    5] Study design:

    R: Molecular and serological methods

    6] Countries of recruitment:

    R: UK.

    Centres of recruitment:

    R: Imperial College Healthcare Trust.

    Other methods of Recruitment:

    R: n/a

    * Through what means will prospective participants be recruited?

    R: Signed consent to use biopsy tissue for retroviral analysis. Not yet underway.

    7] For what diseases/conditions/study domains are patient samples to be collected?

    R: Prostate cancer

    * Through what means will control samples be assembled?

    R: Not being assembled currently

    8] Participants inclusion criteria:

    R: Participants will be restricted to those patients who are having a prostate biopsy for diagnostic purposes and have given consent for a small (10 micron) slice of their biopsy tissue to be used for research purposes.

    9] Participants exclusion criteria:

    R: n/a

    10] Target number of participants:

    R: Open

    11] Patient information material: please provide copies of any patient information material:

    R: n/a

    12] Anticipated start date:

    R: January 2010

    13] Anticipated project completion date:

    R: December 2010

    14] Sources of funding:

    R: BRC [Ed: This response has been referred back to ICL for additional clarificiation by Kim as SC questions whether it should have read "MRC".]

    15] Sponsor details:

    R: None



    [3] Additional Request for information under FOIA by Kim LeMoon, USA:

    R: Further to the addendum to your request for information which was received by us on 8 February 2010, please find below the Colleges response to your questions.

    In addition to the earlier request that was made today, I request the following information under the Act

    1] Principal Investigator(s):

    R: Dr Otto Erlwein, Dr Steve Kaye, Professor Myra O McClure, Professor Jonathan Weber.

    2] Names of Project Collaborator(s):

    R: Dr Anup Patel

    3] Names of Collaborating Institution(s):

    R: Imperial College Healthcare Trust

    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 website. On 8 Feb 2010, the information was removed from the website and replaced with this notification:

    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.

    Please provide answers to the following questions:

    4] Why was the Molecular Diagnostic Unit charging 200 if the XMRV Diagnostic Testing is to be carried out as part of an ethically approved research study?

    R: There are costs associated with providing this test. Therefore, if we are contacted by individuals from organisations outside Imperial requesting this test for a research study, we will charge them to test their samples.

    5] Why was the XMRV Diagnostic Test being advertised to referring medical practitioners (GPs or hospital doctors) if the testing is being carried out as part of an ethically approved research study?


    R: Medical practitioners such as GPs and hospital doctors are involved in research studies and we would expect any referring medical practitioner to be requesting samples as part of an ethically approved research study. We do not deal directly with patients.

    6] If the XMVR Diagnostic Test was not being offered for people who are concerned that they might have CFS, or who have been diagnosed with CFS, what patient population was the test intended for?

    R: Clinicians and clinical research scientists who are interested in the association of XMRV with prostate cancer*.


    [4] Request for information under the FOI Act 4 by Julius, Canada

    To: Imperial College London, Freedom of Information Office
    Date: 09 February 2010
    Subject: 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 website.

    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


    R: Further to your request for information dated 9 February 2010 regarding the exact testing methods employed in XMRV testing carried out at the College (below) technical details associated with testing CFS tissue for the presence of XMRV are published in PLoS 1 January 6th 2010. Modifications of the assay for prostate cancer are not yet published and are not available to the public. The College hopes to publish this information before the end of the year.

    [Responses end]
     
  2. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

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    Note that my response from ICL was not consistent with Kim's response:

    "Further to your request for information regarding the diseases/ conditions/ study domains for which the XMRV test was made available to researchers (below) which was received by us on 22 February 2010, any physician or laboratory scientist can request the test for any disease or condition as part of an ethically approved research study."

    cf with

    6] If the XMVR Diagnostic Test was not being offered for people who are concerned that they might have CFS, or who have been diagnosed with CFS,what patient population was the test intended for?

    Response "Clinicians and clinical research scientists who are interested in the association of XMRV with prostate cancer."

    So now that we have all three responses fulfilled, this inconsistancy is going to have to be queried.

    Suzy
     
  3. shrewsbury

    shrewsbury member

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    please forgive my frivolousness, but

    go -Suzy & Kim -go:victory:
     
  4. Gerwyn

    Gerwyn Guest

    I am now totally convinced that they are trying to develop a test that they will claim detects xmrv generally--it wont of course but they will use the "negatives" to try and bury xmrv in the uk.It will be ready sooner than Dec!
     
  5. Robin

    Robin Guest

    Good job, ladies!

    Did they ever establish that they could find XMRV in human blood or tissue? (Another inconsistency! :tear:)
     
  6. gracenote

    gracenote All shall be well . . .

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    Is this a different method than what they used for CFS? They will be using serological methods for testing prostate cancer patients, and other "modifications of the assay" that are "not yet published."

    I wonder (not) if they will go back and check their CFS samples using these newer methods.

    Or am I reading more into this than there is?
     
  7. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

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    Robin wrote:

    Don't forget Julius!

    And yes, it's all about as clear as mud.

    Suzy
     
  8. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

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    Additional text:

    The text in brown was omitted from the ICL response as received by Kim. For context I have inserted it this morning to my original post.

    [2] Request for information under FOIA by Kim LeMoon, USA:


    From: foi@imperial.ac.uk
    Date: 08 March 2010
    Subject: RE: Request for Information XMRV Research


    R: Further to your request for information received by us on 8 February 2010, please find below the Colleges response to your questions.

    Request for information under FOIA in respect of all ongoing research projects or scheduled research projects relating to XMRV (Xenotropic murine leukemia virus-related virus) detection via blood samples, tissue samples or any other methods of detection

    I should be pleased if receipt of this request for information could be acknowledged, together with the date by which a response will be provided.



    Project Supervisors:

    R: Professor Myra O McClure, Dr Steve Kaye, Professor Jonathan Weber

    etc.
     
  9. natasa778

    natasa778 Senior Member

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    Is there a possibility they could end up being an "NHS-approved" lab?
     
  10. bullybeef

    bullybeef Senior Member

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    The scary thing and unethical picture here is if they are testing prostate cancer patients, they would have to use the correct method to find XMRV. If they attempt to purposely bury XMRV and literally lie to cancer patients that they are not carriers, it should surely have huge repercussions if and when the test is refined elsewhere and the same patients test XMRV+ in the future.

    The way I see it is, they have found XMRV in prostate cancer. On the original wessely study, McClure simply says they have not found XMRV in CFS patients, but she didn't mention cancer. So is Wessely thinking if we definitively find XMRV in cancer and go on to report this study, we'll be lauded. But, if and when the majority of ME patients have tested XMRV+, I wouldn't put it past wessley to say, will they must have a pre-cancerous virus, not ME!
     
  11. maryb

    maryb iherb code TAK122

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  12. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

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    The more questions put to ICL, the murkier it becomes...

    ...perhaps someone who's been following the science more closely than I have had time to and with a better understanding than I have, might consider drawing up another batch of questions for submission under the FOIA. One does not need to be a UK resident and all that is required is to set the questions out clearly and request a response under the FOIA. But I will be querying the inconsistency between Kim's response and mine to the question about which disease domains the XMRV test is for, today.

    Edit: Query with ICL taken up 09 March

    The following has probably been flagged up elsewhere, but I'll slip it in here:

    Last week's edition of the BMJ was stuffed full of CFS and XMRV related items. There is a PodCast here which can be played in situ or downloaded:

    http://podcasts.bmj.com/bmj/2010/03/05/chronic-fatigue-syndrome/

    Around 25 mins long. The CFS, XMRV and Wessely section starts 4.25 mins in from the start.

    Simon Wessely on "CFS", XMRV and the Lombardi paper, UK XMRV studies, the most recent Dutch XMRV study, with one of the Dutch researchers contributing.

    There is emphasis placed in the podcast on the reporter's perception of a lack of information in the Science paper around the corhort and that the Lombardi cohort had come from "US outbreaks". But Dr Judy M had clarified to me, via email, in November, that "the patients came from all areas of the US including but NOT limited to reported outbreaks of CFS".

    In the BMJ print and online edition

    6 March 2010 (Vol 340, No 7745)

    http://www.bmj.com/current.dtl

    This week's edition of the British Medical Journal focuses on CFS and XMRV.

    There are seven XMRV and CFS related items inside:

    1 Editor's choice: 'Let's proceed with caution' by Fiona Godlee.
    Full text: http://www.bmj.com/cgi/content/full/340/mar04_1/c1266

    2 Editorial: 'Chronic fatigue syndrome and human retrovirus XMRV' by Simon Wessely and Myra McClure (p489)
    Full text: http://www.bmj.com/cgi/content/full/340/feb25_1/c1099

    3 Letter: 'More than defeatism greets patients with ME' from Stephanie Munn (p495)
    (Can't locate this online.)

    4 Letter: 'Severely affected, severely neglected' from Charles Shepherd (p495)
    (Can't locate this online.)

    5 Observations/Medicine and the media: Science, chronic fatigue syndrome, and ME by Cathie Sudlow(p510)
    Extract only: http://www.bmj.com/cgi/content/extract/340/mar03_3/c1260

    (But full copies are out there.)

    6 Research highlights: Chronic fatigue syndrome and XMRV - reasons why the BMJ fast tracked the Dutch XMRV study and critical comments about the media publicity that accompanied publication of the Science paper in October 2009 (p516)

    7 Fast Track Research: Prevalence of XMRV in patients with chronic fatigue syndrome in the Netherlands: retrospective analysis of samples from an established cohort (summary of key points on p520)

    Full free text: http://www.bmj.com/cgi/content/full/340/feb25_1/c1018
     
  13. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

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    ICL Clarifications 1 and 2

    Clarification 1:

    Yesterday, 9 March, Imperial College, London confirmed to Kim that the "BRC" given as funders of the project:

    XMRV and its association with Prostate cancer

    Project Supervisors: Professor Myra O McClure, Dr Steve Kaye, Professor Jonathan Weber; Laboratory supervisor: Dr Steve Kaye; Clinical supervisor: Dr Anup Patel

    stands for "Biomedical Research Centre" (see: http://www1.imperial.ac.uk/medicine/news/p61112_1/ ).


    Clarification 2:

    Quoting the two sets of questions and their responses, I asked for the following to be clarified, yesterday. I have received a response, today, 10 March:

    Could it please be confirmed whether the XMRV test being offered by ICL's Molecular Diagnostic Unit is for:

    a] Any disease or condition, as part of an ethically approved research study.

    or

    b] Only for Prostate cancer, as part of an ethically approved research study.​


    The response from Imperial College is:

    Thank you for your email. There is a slight distinction between the questions being asked and though it is the case that the test has been made available for researchers to test for any disease or condition, the patients for which the test is intended are those with prostate cancer, since it is the association of XMRV with this disease that the scientists are particularly interested in.​
     
  14. Gerwyn

    Gerwyn Guest

    yeah sure it is
     
  15. natasa778

    natasa778 Senior Member

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    They are offering a service here, a product, how/why they should be deciding what those that will be using the service will want it for.

    It is like someone selling a bowl and deciding that it is only to be used by those who buy it for serving side salad. Not soup. 'Cos it would leak.
     
  16. Gerwyn

    Gerwyn Guest

    they will use this test to claim that they are a lab capable of finding xmrv anyplace anytime for any condition .If they cant detect XMRV in 22rvi cell lines with the potential titres there then they would be totally useless
     

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