XMRV/ME/CFS How do we react to the recent events?

Discussion in 'Fibromyalgia Main Forum' started by karinaxx, Jul 26, 2010.

  1. karinaxx

    karinaxx New Member

    Since days and weeks I am on different boards reading about the topic of the day, XMRV and the controversy surrounding the hold on the FDA, Alter paper. While I was watching and listening I started to realize that most of the researchers and agencies working on XMRV/ME/CFS know shockingly really very little about ME/CFS and definitively nothing about the urgency for us patients, to get help and results. We, on the other hand, do know very little about these big agencies; how they work and think. (I am not talking about the few mentally retarded at the CDC. We know how they think, but they are not representative of all the agencies and researchers, although they had far too much influence on the politics surrounding ME/CFS. )
    I ask myself the question if we are doing a good job, the way we advocate for our "cause”?
    First thing, shouldn't we get to know who your dealing with.....?
    In the search for this answer i started searching and found this transcript covering the meeting of FDA EMERGING INFECTIOUS DISEASES CONFERENCE ....
    It is long and really boring, but it shows what is going on behind those doors and how these people work and think. Here just a few phrases which caught my eye:

    “From a public policy point of view, I think there's a lot of pressure, there's a lot of pressure particularly from people with CFS, which is a disease of considerable concern, and their belief is that if this is -- does have an infectious cause, and that's a very open question, shouldn't we be reducing the risk of transmitting this to other people. But the problem of transmission of XMRV if it is a problem, it's going to be very much bigger than I think CFS alone. “

    "In the context of XMRV, I think that there is an emergency, but it's a perceptual emergency. And I'm not as well versed in the tools of managing that, but I think that what we need to do is to manage people's reactions rather than people's safety at this point. "

    "Just a follow-up to the last comment that Roger made that I agree very much, and I think you touched the important point, is that I believe that we are going to confront this type of issues more and more frequently. It became a pattern with for instance, Gulf War syndrome, and all that where affinity groups as you called -- have adopted transfusion as a way of calling more resources to their issues.
    And in fairness to them, it's a very serious problem and they haven't gotten enough in attention and support. But I think that we have to be able to deal with the issue because it is going to become more frequent than it is now.
    MR. DODD: Thank you. I'm glad you said it, not I"

    DR. ALTER: "Yeah, well, I was going to say something very similar to Roger. I think this theoretical formula that I would have -- you can do the same by logic and eyeball (phonetic). But if you had a formula and you took XMRV we know a rough donor prevalence that we'd be okay there but we haven't yet proven it's blood transmissible. That information should probably be coming out soon. But we don't have a disease. So I think -- so that would turn your formula right now to zero but -- so that puts it into a very low priority based on science. That's where maybe perception would come in and then the perception would say well, maybe we should do something but something mild. You know, maybe ask a question or give more information to the donors. Those are mild interventions which are commensurate with the risk. If it turns out that it really causes chronic fatigue syndrome that it moves up the ladder on your priority list. "

    http://www.fda.gov/downloads/Biologi.../UCM214030.pdf

    I posted this train of thought on another board and someone on that board directed my attention to other agencies involved in the of ME/CFS.

    Here is what he said:
    There are those who know, and they don't want the blood supply issue to come up.

    You need to see who has been in charge of the NIAID at NIH for 26 years.

    http://oslersweb.com/blog.htm?post=693814

    RE-POST; ANTHONY FAUCI April 17, 2010

    http://oslersweb.com/blog.htm?post=635123

    I continue my train of thought and try to summarize:

    So, who do we have there at NIH ? Anthony Fauci .
    Seems he as well does not know ME/CFS, does not understand the urgency and it seems he is mainly interested in getting HIS research grants. (Do we know where this grants are really going?I mean now?)

    We have the FDA: does not know much about ME/CFS and they do not see the urgency in XMRV as long as the virus is not associated with a disease, but want further studies!
    They also want to control public reaction to the new retrovirus XMRV, rather than control the spread of the virus XMRV! (See text of conference above)

    The CDC has just revamp their website , they continue more than ever to propagate ME/CFS abnormalities are theoretical and experimental, even though all the experts and all of them use the Canadien Consesus Diagnostic Criteria and have accepted those test as part of the diagnostic process.


    So, where are we?

    The publication to the study which could prove the disease link of XMRV to a disease (Alter publ.), which according to the FDA is needed to upgradeXMRV to an emergency topic, has been halted.

    First international Workshop on XMRV has topic speakers wich are NOT ME/CFS speakers ! Micovits is getting side lined?

    ADVISORY COMMITTEE BLOOD PRODUCTS MEETING does not list the FDA/Alter studies and goes into a Meeting without the results of the most important replication study on XMRV , which could prove disease association !

    The CDC denies any biological abnormalities are valid in ME/CFS, that it self endangers Micovits study to be seen as questionable and possible all other future studies, because we do not have a patient cohort criteria which is validated !


    All three Agencies seem to have one factor in common, although because of different reasons:
    All three agencies "seem" to plan to dissociate XMRV from ME/CFS !

    I ask myself the question if we are doing a good job, the way we advocate for our "cause”?
    What do we need to do to get results AND HOW DO WE REACT TO THE RECENT EVENTS
  2. quanked

    quanked Member

    I think we all feel frustration over how the "experts" are handling the XMRV issue. I do not think one needs to be an MD or Phd or whatever to quickly pick up on the inept handling of this issue.

    Your post is alarming and hope flattening when you quote the discussions between the "experts". To me, and I could be reading the message incorrectly, it seems like these people are struggling with how to deal with these problem patients with CFIDS. Too bad they just do not deal with XMRV and stop wasting their time on how to manage the CFIDS/ME population.

    I am not sure I have a reaction. To me it seems like, somedays, that all the kids and people I have known that put so much energy into avoiding doing certain things in their life (they could have saved themselves lots of time and energy if they had just did what needed to be done) have been hired to work by these agencies who do not seem to want to serve the needs of the public (even though that is what they are paid to do).

    There are enough of us to demand more and better. I just need to know who to target with my demand.
  3. karinaxx

    karinaxx New Member

    i agree , they are waisting so much resources for nothing.

    There are enough of us to demand , none of us know who to target with our demand!

    The world, researchers, docs, politicians, governments .......

    This has been posted on another board, spoken by a well known person at the Whittermore Peterson Institute :

    MAKE YOUR VOICE HEARD BY YOUR GOVERNMENT!

    • Ask why the NIAID is not allocating money for the more than 10 million Americans infected with XMRV while spending billions on the less than 1 million Americans infected with HIV.

    • Demand that NIAID immediately put resources into XMRV, an HIV-like virus that is destroying American families. After all, these are our tax dollars being allocated.

    • XMRV is real. Every infected individual and family deserves the same attention that an HIV infected individual or cancer patient receives.

    • XMRV is a new human infectious retrovirus which is in the blood and can infect anyone.

    • WPI, NCI and CC did the most rigorous research possible to show that XMRV is associated with CFS. As taxpayers, we need to demand that our government not deny us for one more day!

    [This Message was Edited on 07/28/2010]
    [This Message was Edited on 07/28/2010]
    [This Message was Edited on 07/28/2010]
  4. simonedb

    simonedb Member

    secretary sebellius of dept health and human service may be a good one to write to

    more related breaking info:

    one highlight from below article--Dr. Silverman with NCI (one of the "good guys") said: "XMRV is associated with prostate cancer and CSF in humans in some, but not all, studies. All individuals are at risk, regardless of the RNA cell genotype. XMRV establishes both acute and chronic persistent disseminated infection in primates — the prostate epithelium is an early target, the stroma a late target, CD4 and other blood cell types are infected," he told the panel.
    In addition, "XMRV growth is fueled by androgen, which is a possible oncogenic mechanism, XMRV might be transmitted by blood transfusion, and there is now donor deferral for people with CFS in 3 countries," he said.

    full article:
    ------------------------------
    Medscape - Blood Products Advisory Committee Mulls XMRV Information
    http://www.medscape.com/viewarticle/725820

    July 27, 2010 — The US Food and Drug Administration (FDA) Blood Products Advisory Committee yesterday heard briefings from a number of public health agencies and other experts on whether the recently discovered human retrovirus xenotropic murine leukemia virus–related virus (XMRV) poses a threat to the nation's blood supply.

    The committee also heard how laboratories from the National Cancer Institute (NCI), the Centers for Disease Control and Prevention (CDC), the Blood Systems Research Institute, and the FDA are working to develop state-of-the-art assays to speed recognition of the virus and facilitate screening of potential blood donors.

    The panel was treated to a rehash of conflicting studies — some showing an association with XMRV and prostate cancer and chronic fatigue syndrome (CFS), and others showing zero association between the gammaretrovirus and these diseases.

    Indira Hewlett, PhD, from the FDA's Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, briefed the panel on the conflicting studies that linked — or did not link — XMRV with prostate cancer and CFS.

    In one study, XMRV was detected in 7 of 11 prostate cancer patients with a genetic predisposition for prostate cancer; in another, 6% of 334 prostate cancer patients were found to be positive for XMRV by polymerase chain reaction (PCR), and 23% were found to be positive for XMRV by immunohistochemistry. "Taken together, these findings suggest an association of XMRV with prostate cancer," Dr. Hewlett said.

    In CFS, one study (Science. 2009;326:585-589) showed that XMRV could be detected in 67% of patients with CFS vs 3.7% of healthy control patients, using PCR and serology testing.

    Horns of a Dilemma

    However, other studies have yielded negative results for both prostate cancer and CFS, and these have placed researchers and policy makers on the horns of a dilemma.

    The possibility of potential transfusion transmission of XMRV comes from experiments with rhesus macaque monkeys — intravenous inoculation showed disseminated infection and low but detectable transient viremia between 4 and 14 days, Dr. Hewlett told the committee. Seroconversion occurred between 11 and 14 days, with titers peaking around day 95. In addition, XMRV was isolated from lymphoid cells, reproductive tissue, and a number of organs.

    "These findings lend support to potential transfusion transmission of XMRV and suggests that there is a need for additional studies using well-standardized assays," Dr. Hewlett said.

    Because of the potential for transmission of XMRV during blood transfusions, the Canadian government has decided to err on the side of caution by mandating that all patients with CFS refrain from donating blood, Peter Ganz, MD, from Health Canada, Ottawa, told the panel.

    Caution in Canada

    The Canadians have been ultracautious ever since the "tainted blood" scandal of the mid-1980s, which saw a number of people become infected with HIV through blood transfusions, Dr. Ganz said.

    Blood from donors with CFS who were asymptomatic was accepted in Canada until April 2010, but now 90% of these would-be donors are indefinitely referred. The remaining 10% are from the province of Quebec, which still allows donors to give blood as long as they feel well.

    "In Canada, one of our overarching guiding principles with regard to blood safety is the precautionary principle, which means that authorities must act, even if there is only a theoretical risk of harm," he said.

    Robert Silverman, PhD, who was part of the team that first reported the potential link between XMRV and prostate cancer and CFS, presented those data again and also told the panel about possible ways that the virus infects humans.

    Dr. Silverman told the panel that XMRV is found in semen and that its infectivity is enhanced by androgen and inhibited by antiandrogens.

    Evidence Mixed for Disease Links

    Of the 12 studies on XMRV and prostate cancer, 9 found evidence of the virus at some level. In CFS, the evidence has been less: Only 1 study of the 5 that have been done found a link between XMRV and this debilitating disease.

    Dr. Silverman suggested that laboratory contamination, geographical distribution, sequence variants, clinical criteria for patient selection (particularly with CFS), and lack of standardized screening methods and positive control human participants are factors that could be responsible for large differences in the detection rate.

    "XMRV is associated with prostate cancer and CSF in humans in some, but not all, studies. All individuals are at risk, regardless of the RNA cell genotype. XMRV establishes both acute and chronic persistent disseminated infection in primates — the prostate epithelium is an early target, the stroma a late target, CD4 and other blood cell types are infected," he told the panel.

    In addition, "XMRV growth is fueled by androgen, which is a possible oncogenic mechanism, XMRV might be transmitted by blood transfusion, and there is now donor deferral for people with CFS in 3 countries," he said.

    Knowledge Still Emerging

    In spite of these observations, Dr. Silverman cautioned that knowledge about the infectious nature of XMRV is still emerging. "We need to let science do its work. Any causal link to human disease remains to be established."

    R. Michael Hendry, DSC, from the CDC in Atlanta, Georgia, followed Dr. Silverman's presentation. He told the panel that, in direct and complete contrast to Dr. Silverman's experience, the CDC was unable to find any evidence of infection with XMRV in their population of CFS patients by any means, including using Western blot or ultrasensitive PCR assays.

    "Many people have alluded to differences in patient population, complexities of defining [CFS], lab methods, and strain differences, to explain the contrasting results; however, our results do not support an association of XMRV with the majority of [CFS] patients," he said.

    Stuart Le Grice, PhD, from the NCI Frederick Laboratory, Frederick, Maryland, described how he and his colleagues have been working to develop a single-copy assay for XMRV DNA, RNA, and serology, based on the assay that was developed for HIV.

    "The HIV single copy that was developed at the NCI is regarded as the gold standard assay. We now believe that we have an equivalent assay for XMRV."

    Dr. Le Grice and his team have also developed a cell line, dubbed the Derse cell line, which can detect XMRV in as little as 3 days.

    He said that the XMRV assay that his lab has developed has been transferred to labs in Sweden, Australia, Vietnam, and South Africa to prove its utility. "Developing an assay is one thing, but transferring it to a laboratory where it can be reproduced is clearly important when we are talking about single copy assay. Contamination is a huge problem, and the ability to transfer these reagents is very important," he noted.

    Dr. Le Grice added that the aim of the NCI is to make sure that the assays they have developed are as valid as possible. "Our goal is to develop a series of assays that we feel confident in and to test those head to head with other assays. I think that is really important at the moment. We should start with 6 assays in house, and if we have a problem, I think it is important to sit amongst ourselves and try to understand where those problems are before we disagree with anybody else's assay."
  5. quanked

    quanked Member

    Who is our spokesperson? It seems like the public response to XMRV is so diffuse, unfocused, sometimes angry (which is not a bad thing if the energy is focused in a constuctive way), etc.

    I have been coming to this site for a number o f years now. If I were asked who speaks for us I would not know what to say.

    The WPI has its own agendas. We need a spokesperson who can speak for us, argue for us, not these various institutions with their own agendas that are not necessarily taking in to consideration our needs, opinions, desires, etc. when making funding, treatment, policy, future plans, etc., etc decisions.

    Of course, the obvious problem is how are we going to find someone who understands these dd's other than a vicitm of CFIDS/ME? I do not even understand my own disease. And I am too damned tired and befuddled a great deal of the time just like so many others. Like now.

    On some levels this is a most hilarious conundrum--we desperately need a strong, energetic, intelligent, assertive, quick minded individual to advocate for us--the unwell, unenergetic, brain fogged, tired, tired, tired population. I mean, on a good day, I could have endless laughter poking fun at this stiuation.

    I love advocacy. And I was very good at it in my other life. But who could trust this person?---I have been noticing these ads on tv for a sleeping aid, Alteril. I have been thinking that when I can get myself to the store I might buy some and give it a try--I very much need help with my sleep. A little while ago I was in a cupboard and looked up on the top shelf and WHOA! I spotted a box of Alteril! I have no memory of buying this and I do not know how long it has been there. Clearly, I cannot get back into the advocacy business. Who of us can?

    How do we mobilize, organize, apply social and political pressue, educate the public and so much more? Where is power base?

    I ponder these things often.

  6. Tizz

    Tizz New Member

    "...I think that what we need to do is to manage people's reactions rather than people's safety at this point. "

    They are playing politics with our health.

    Tizz
  7. karinaxx

    karinaxx New Member

    your right, we do not have a spokes person. The fact is that so many tried and got chewed up for doing so . Cannot blame people for wanting to stay away from this topic and another Mother Theresa would be needed to accept such a cross to carry !

    Yes, i thought too , it was and is scary to see with what disregard and nonchalance the topic of XMRV and CFS has been handled.

    We do need some PR persons who tries to get the urgency of our situation out there.

    Again, like so many times said, we are just too sick and involved in survival struggles for actively advocating, and as in all political struggles it is hard to get folks agree ...... and work out the details, let alone start a world wide coordinated action !

  8. skeptik2

    skeptik2 Member

    Check out Debbie Anderson's FB page; she is sending out the Petition to Recognize M.E., (with 8,700 signatures), along with a cover letter and the Memorial List of PWMEs who have died.

    She is also sending all of the above to every class action lawsuit attorney she can find,
    and to the Sec., Kathleen Sebelius, First Lady, Second Lady, Sec. of State, and many other government officials.

    She is sending all this to Erin Brokovich and Michael Moore, also.

    Every packet costs money to send; postage, paper, printer ink. It is a massive package!
    If you want to help, go to her profile and find her yahoo link that has a paypal way to send her $5, $10, whatever you can afford.

    She started this on her own; her cover letters and responses from the various people and her replies back to them are concise and well written, always mentioning the fact that lawyers are being approached constantly.

    The only thing that will get this ball rolling will be either a class action suit or a congressional inquiry! until then, lying and pacification will be the rule of the day.

    Get involved with XMRV Global Action, XMRV Press Releases; send money to the WPI at wpinstitute.org, too! Every dollar counts, my fellow patients. Make WPI your "cause", and make any donation amount you can afford. I pledged a small amount each month,
    and that adds up quickly, and so can yours!

    Write all your state congress critters! Don't stop at one letter; send one a month to each of them! Sober, concise arguments with brief capsule of your illness...hand written is
    really great, too! President Obama reads handwritten ones everyday, also!

    Heidi Bauer on FB wrote up a report of her visit to the Blood Group; she was able to sit right next to Judy Mikovits and her report is outstanding.

    Andrea Pring on FB also has motivation, reporting, and links for you to get involved.

    Check them out...do what you can without getting too tired...slow and steady will do
    the trick eventually, believe it. The way XMRV is spreading thru the country and world, everyone will know someone affected some day soon, and the ones in power will then ACT.

    See Tom Hennessey's Rescind dot org page; he's baaack, and posting lots of new
    stuff on his site, too.

    If we do our part, we will have HOPE.

    skeptik2
  9. karinaxx

    karinaxx New Member

    well done and many good suggestions.

    Though i have to say, i am not sure that it is wise to follow the notion on some of this sites to separate M.E. / CFS right now?

    XMRV research now and a progress for us, depends in proving the association of XMRV to a disease ! This is what the FDA study has been all about and this is what will bring changes, recognition and more funding for further research into XMRV and ME/CFS.

    Check out the section of the meeting where Alter talks about the disease association and its implications.

    This is why the study was halted, because this study proved it and would have caused the big bang we need, but the CDC and other agencies are afraid off!

    Food for thought

    k.
  10. karinaxx

    karinaxx New Member

    well done and many good suggestions.

    Though i have to say, i am not sure that it is wise to follow the notion on some of this sites to separate M.E. / CFS right now?

    XMRV research now and a progress for us, depends in proving the association of XMRV to a disease ! This is what the FDA study has been all about and this is what will bring changes, recognition and more funding for further research into XMRV and ME/CFS.

    Check out the section of the meeting where Alter talks about the disease association and its implications.

    This is why the study was halted, because this study proved it and would have caused the big bang we need, but the CDC and other agencies are afraid off!

    Food for thought

    k.
  11. karinaxx

    karinaxx New Member

    Can you explain to me, what the "Senate Appropriations Bill Report Language for FY2011" is ?
    I am not from the states and do not understand the whole Us political arena.

    thxs
    [This Message was Edited on 07/31/2010]
  12. skeptik2

    skeptik2 Member

    Hi, harinaxx! You know, I debated with Debbie Anderson about the
    problem of using M.E., and she has very convincing arguments:

    First, the CDC knew it was M.E. when they first studied the illness
    and against 3 prominent virologist's reasoning, decided to call it
    CFS;

    Secondly, if one reads the Canadian Definition, and you fit it, you
    have M.E., not CFS. Byron Hyde clearly tells how to find M.E., or
    any other disease you may have that mimics it.

    Finally, if M.E. is separated away from CFS, except in research,
    because now they are so intertwined, then, those left over will be
    able to get a handle on what is causing their fatigue: depression,
    thyroid, adrenals, cancer, etc.

    The CDC has steadily and purposefully diluted CFS to mean
    "unwell", and it has steadily and surely hurt hundreds of people
    because then the truly sick from ME patients are lumped in
    with other patients for which there is only CBT and GET.
    ...well, and major antidepressant therapy.

    I'm not the best person for making a case; somewhere along
    the past 22 years I have lost my logic, but I know I don't have
    Reeves' Empirical Definition at all, at all.

    XMRV will probably change the whole equation, if the U.S.
    gov't allows it to be known to the general public; until then,
    I want to be a part of having M.E. restored to the U.S. medical
    codes and physician training, as is covered by the WHO's code
    of 93.3. That's why I'm supporting and cheering Debbie ON.

    skeptik2

    @ out of step: thank you so much for the info posted; do
    you have a link to this? Thanks....[This Message was Edited on 07/31/2010]
  13. skeptik2

    skeptik2 Member

    I don't even visit CAA's site; I don't want to be "counted" by them as a
    visitor even!

    I supported them heavily from 92-about 2000, but gave it up when I
    couldn't find their advocacy except "Faces of CFS" which made me
    puke.

    skeptik2
  14. karinaxx

    karinaxx New Member

    thanks , know i understand one more thing about American Politics.

    I am a bit surprised about the strong feeling against CCA at some boards here.

    Wonder if this is gonna help our cause?

    Anyway, just heard that the FDA study will be released about September.

    I hope it will bring the so much needed changes , but it looks like the NIH has planned some studies and further big studies all over the world are on going. I am a bit more positive..... with caution.