Tuesday, January 4, 2011

Pending XMRV Study by Dr. Miller

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XMRV Global Action

Response from Dr Dusty Miller on pending XMRV study


By XMRV Global Action


Tuesday, 4 January 2011




As you may recall, we posted some preliminary
information on a possible XMRV study to be
conducted by Dr Dusty Miller at the Fred Hutchinson
Cancer Research Center in Seattle.

We emailed Dr Miller at his @fhcrc.org address.

Dr Miller responded today via email to our enquiry for
information.

Here is a summary, with the email appended below.
FYI Dr Miller also posted this information in the
discussion thread on the Niceguidelines Blog here:
http://bit.ly/ikoZ4P




Summary:

     * Yes, Dr Miller will be conducting a study on
XMRV positive patients

     * It is not a neurological study

     * The study has NOT yet been formally announced
- it will be announced once IRB approval has
been received

     * Patients from Canada and the US who have
previously tested positive for XMRV will be
potentially eligible for the study



``````

NB: Dr Miller has specifically requested that
patients not contact him with questions about the
study
, and has indicated that Ecoclimber will be
assisting him with this.  Ecoclimber provided this
email address:  FHCRC_RESEARCH@hotmail.com

``````



Clearly patients need to do their own due diligence
about any study they participate in - we are merely
relaying Dr Miller's request.

That said, it might be argued that patients should
welcome the participation of another keen
retrovirologist in ME/CFS/XMRV research.

Do keep in mind that this study has not yet been
formally announced. It may well be that the formal
announcement will address many questions about
the study.


While it is interesting that Dr Miller will not be using
positive control samples from the labs of the WPI, or
elsewhere (eg. Dr Singh, Dr Alter etc), this might be
an astute move.

Given the power of the rumor mill on
*contamination*, by bypassing these labs and going
to the patients directly, Dr Miller might in effect
nullify concerns about the contaminated lab vector.

This argument might also hold if Dr Miller is
intentionally using different reagents etc. than the
WPI.

Patients who have tested positive through VIPDx,
the WPI, the FDA, or other venues might also
provide a voice to possible discrepancies if other
studies find them negative for XMRV/MRV's.

While there have been concerns raised about many
XMRV studies, the reality is that by participating in
multiple studies, patients might in fact provide a
"reality check" and informed voice on results
(particularly if their results are unblinded, and there
are discrepancies between multiple XMRV study
results).



What remains unanswered is which ME/CFS criteria
are being used to identify patients - and how the
fulfilment of these criteria will be confirmed via
long-distance.

Also unclear is the scope of the role which laymen
such as Cort and Ecoclimber will be playing in this
study.

There are multiple threads on the IAP issue that you
can read up on, at:  http://bit.ly/hxJA3S



What is potentially exciting is the prospect of an
independent lab confirming WPI, FDA, and/or other
labs' positive XMRV/MRV findings.

Bottom line, these are early days for this study, and
we'll post the formal announcement as soon as it's
available.





``````



   From: Miller, Dusty
      [mailto: dmiller@fhcrc.org ]

   Sent: 2011/Jan/03 10:46 AM

   To: (XMRV Global Action)

   Subject: Re: Request to confirm
      information: Is study of neurological
      sequelae in XMRV+ve patients "legit"?



   Thank you for your email.  Yes I am
      planning a study basically as described by
      Ecoclimber.  However, I don't plan any
      neurological studies at this point, as some
      postings imply.  I just posted the following
      on the Niceguidelines Blog summarizing the
      intent of the study:



  *adustymiller* is indeed Dr. A. Dusty
      Miller.  I have a lab at the Fred Hutchinson
      Cancer Research Center.



   Given all of the controversy surrounding
      the claims that XMRV and/or related
      retroviruses are present in humans, my lab
      members and I want to test for the
      presence of XMRV in samples freshly
      obtained from those most likely to carry
      the virus.  This includes those who have
      tested positive by PCR and/or virus
      assays performed by other labs.
      However, we have not currently set up
      formal arrangements with other labs,
      including the WPI, to obtain samples from
      people they have tested.  Instead, we
      plan to rely on volunteers from the
      CFS/ME community to provide small
      samples of blood for analysis.


``````````````````
   (XMRV GA's note: In other words, they
      ARE using positive controls, but are
      obtaining these samples directly from
      patients, not via the labs, to rule out
      potential for lab contamination)

``````````````````


   I have been in communication with
      Ecoclimber and Cort to refine the
      objectives and criteria for our study and to
      help with recruitment of subjects.  We
      understand that there is heated
      controversy over how the study should be
      done, but I hope my extensive experience
      in retrovirology provides some assurance
      that we can perform this study properly.



   Regarding the IAP issue, published
      results and our analysis indicate that PCR
      assay for mouse IAP sequences provides
      the best method to rule out mouse DNA
      contamination in our study.  One can find
      relatives of these sequences in the human
      genome, but they are not closely related
      and do not amplify with the published IAP
      primers.



   I want to assure the CFS/ME community
      that I have no hidden agenda, other than
      that I would like to apply our expertise in
      retrovirology to contribute to an
      understanding and possible treatment of
      CFS/ME.  This predisposes me to want to
      find the virus in humans, but I clearly
      understand that false positive results are
      not in anyone's best interests.



   Please pardon me if I can't address
      many questions raised on the various
      blogs.  I already spend way too much time
      in the lab! "



   I am waiting for Institutional Review
      Board approval of my study before
      beginning.  This should happen soon.



   And yes, I certainly would be
      interested in subjects from Canada
      proven to be XMRV+ by another group.



   Please don't have subjects contact me
      directly about participation in the study.
      Ecoclimber has volunteered to help me
      with this.  We will formally anounce the
      study when I obtain IRB approval.



   Sincerely,



   A. Dusty Miller, PhD

   Member

   Fred Hutchinson Cancer Research Center




``````





You can read our earlier post on this topic here:
http://on.fb.me/dWFtJJ

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