1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
9th Invest in ME International ME Conference, 2014 - Part 2: Pathogens and the Gut
Mark Berry continues his series of articles on the 9th Invest in ME International ME Conference in London, with the emphasis shifting from autoimmunity to pathogens and the gut ...
Discuss the article on the Forums.

Blood Products Advisory Committee Meeting Background Material

Discussion in 'XMRV Testing, Treatment and Transmission' started by ixchelkali, Jul 15, 2010.

  1. jspotila

    jspotila Senior Member

    Messages:
    1,069
    Likes:
    587
    No, the meeting will not be webcast. I contacted the Designated Federal Officer for the Blood Products Advisory committee and urged them to reconsider, offering the CFSAC meetings as an example. He referred me to FDALive.com (I think!?) where DVDs of meetings can be purchased.
  2. Eric Johnson from I&I

    Eric Johnson from I&I Senior Member

    Messages:
    337
    Likes:
    0
    Looks like they do sell a webcast and a DVD. The prices are... a little genteel.
  3. VillageLife

    VillageLife Senior Member

    Messages:
    674
    Likes:
    36
    United Kingdom
    oh well todays the day! fingers crossed everyone.
    Hope today works out.
  4. usedtobeperkytina

    usedtobeperkytina Senior Member

    Messages:
    1,384
    Likes:
    185
    Clay, Alabama
    So funny, I started reading this from the original post thinking it was put up today, knowing that today was the day. I didn't recognize it as something I had read before. I read the whole thing again. And I read the following posts, again, not recognizing that I had read it before. But when I got to the comment that FDA study and CDC aren't mentioned, I thought to myself, "The CDC one is, but the FDA one isn't."

    And then I read the next post, and sure enough, someone corrected that. And then I look, and it was me that corrected it. And only then did I realize this was not a new thread and I had read all of this before.

    Tina
  5. SOC

    SOC Moderator and Senior Member

    Messages:
    5,283
    Likes:
    6,254
    USA
    LOL! Oh, those ME/CFS moments! My family has finally gotten used to mine. Mostly.

    I can remember reading some post here and thinking, "Oh! Good thought, I wouldn't have thought of that" only to realize it was my own post. :rolleyes:

    Isn't it wonderful to have a place where you can talk about these things and people don't start edging away from you. ;)
  6. Rrrr

    Rrrr Senior Member

    Messages:
    1,397
    Likes:
    263
    no word on what happened yet?
  7. VillageLife

    VillageLife Senior Member

    Messages:
    674
    Likes:
    36
    United Kingdom
    2 hours ago CFIDS FACEBOOK, put a message up about the meeting, it said..........

    Dr. Mikovits responded to a question about testing multiply transfused individuals and she expressed concern about the CDC study but she did not make a formal presentation, although time was available during the public comment session.
  8. Rrrr

    Rrrr Senior Member

    Messages:
    1,397
    Likes:
    263
  9. VillageLife

    VillageLife Senior Member

    Messages:
    674
    Likes:
    36
    United Kingdom
    I have heard a little from someone that attended the meeting, i dont want to say to much because i dont have the permission but from what i can understand, it went as well as you could hope for, nothing outstandingly good but nothing terribly bad either!
  10. ukxmrv

    ukxmrv Senior Member

    Messages:
    3,384
    Likes:
    1,848
    London
  11. SOC

    SOC Moderator and Senior Member

    Messages:
    5,283
    Likes:
    6,254
    USA
  12. shrewsbury

    shrewsbury member

    Messages:
    1,540
    Likes:
    54
    Heidi Dunlap Bauer attended and wrote a great report. If you're tired - skip to the bottom & check-out the info from Stuart Le Grice's slide (*XMRV detected with SINGLE COPY sensitivity*XMRV detected in plasma and whole blood with 100% accuracy*No false positives or negatives)
    -----------------

    Informal Report from the FDA's Blood Safety Advisory Committee Meeting

    Its All About the Prostate, Folks.


    Im sure there will be much more reporting regarding the FDA Blood Products Advisory Committee meeting from today, but since I did make the effort to attend, I thought I would try to report as best as I can from my experience. My plan was first to tape Dr. Judy Mikovits speaking. I was under the impression that she would be allowed to speak somehow at the last minute. I had planned on taking a camcorder, but decided against it and took a voice recorder instead. I didnt even use that though because all slides were copied onto handouts to be picked up at the door. The room was huge and filled with scientists, press and very few patient advocates, or at least very few who used the public time to speak. Kim McCleary was there, but I recognized few familiar faces aside from Wanda Jones. Even in the fourth row back from front, I was half a room away from the committee. This was far different than the CFSAC meetings Ive attended with their cozy, cramped storage rooms. I was fortunate enough to see Dr. Mikovits enter and forced myself over to greet her and introduce myself. She graciously allowed me to glue myself to her for support, meaning she allowed me to sit with her during the meeting. I found out quickly that there were no accommodations made last minute for her to speak. She was sent to be a presence in the audience, and I hoped, a reminder that the good guys are still vigilant about our government finally getting this right.

    The chair, Blaine Hollinger, M.D., opened with a statement I had previously read in an email. He stressed that the XMRV portion was information only and no recommendations or decisions would be made during this meeting. This seemed reasonable given that it was being videoed by the FDA along with a transcript being released eventually. My general impression afterwards is that this was simply a show for the public, a nice, safe, production meant to dispel public panic and focus almost solely on Prostate Cancer when XMRV was mentioned. To me, it is still reprehensible that prostate cancer (PC) receives respectful nods of approval and NIH funding when they have at best a 23% positive XMRV rate, and they only have found that in a highly specific type of PC that affects young men with a particularly aggressive form of PC. Add to that not even one replication study that backs those figures up (plus a couple negative studies) and they are in a worse situation than the Science study, which had a 67% positive rate, 95% with improved assays, and has a positive replication study pending publication. Yet, it is all about the prostate.

    First up was Dr. Indira Hewlett. She presented an overview of the upcoming speakers and topics - three positive studies, including the Science paper, Silvermans work and the German study, which found XMRV in respiratory secretions. Then the several negative papers are mentioned. As scientific courtesy dictates, the possible reasons for discrepant findings were listed, including the study populations, geographic differences, and other unknown factors. I mentally inserted, power, money, and politics as the unknown factors.

    Dr. Silverman spoke next and disclosed his affiliations with Abbott Laboratories as both his research support and patent licensing and consulting. Im going to move on past this one since there was nothing new presented here. I have read about that paper much too often. Im starting to think Ive read too much in general, because over 50% of the topics and slides were familiar information to me. Next, was Dr. Peter Ganz of Health Canada. Overall, they are not convinced that XMRV is the cause of ME/CFS, but they have employed what he called Regulatory Perspectives meaning Lack of consensus does not require adherence to the status quo and What are the potential risks to blood recipients? He called for further studies to establish XMRV as the underlying cause of human diseases in infected individuals. Hear, hear! Get the assays right, fund the studies and get on with it already. Prove the causative aspect so we can move on to answering the dozens of other questions this discovery brings about. How about - How is it transmitted exactly? How does it reach the brain? Is one person more at risk than another? What determines severity? All I could think of is what a waste of time this all is when researchers could, and SHOULD, already be in their labs, well funded, to hammer out the details. And, give the majority of the money to the WPI while Im making my wish list. If anyone can pull a miracle out of a shoestring budget, they can. Theyve done it before.

    Dr. Michael Hendry from the CDC study was up next. We all know the paper. We all know the Publishers Clearing House manner of patient selection used. If my cat could speak and answer a phone in Georgia or Kansas, Im sure he would have been chosen for the study, providing that he could also pull off being female. Sometimes Im surprised its the mouse and not the cat that XMRV derives from. Cats seem to naturally have the CDC version of a fatiguing illness. I was happy to see Dr. Suzanne Vernon pull the CDC paper apart quite well with a critical blow toward the CDC assuring patients this was a study designed NOT to find XMRV. No one expected anything other than that, of course. At least, no one with both eyes open. Dr. Vernons emphatic statement also leads me to believe the tides are changing. Compared to the harsh, critical blows Dr. Vernon gave to the Science paper early on, none of which could find fault with the virology, only a harping on the need for more patient information, her attack of the CDC paper at least momentarily could lead one to believe she is aligning herself with the burgeoning group of believers that XMRV is strongly linked with ME/CFS and is likely causative.

    The worst part of Dr. Hendrys presentation for me was after it was over. We are used to the lying, the manipulation and the sheer audacity to give false information as though they are facts. But, when asked by Dr. Hollinger if the PCR gag was the same as the Lombardi study, he said Yes. A bold faced lie. Its one thing to read about these moments, but its quite another to see the lying in person, not to mention the slight swagger of Dr. Hendry as he walked back to his seat. It was during the questioning that Dr. Mikovits rose up to answer a question that I unfortunately missed. Dr. Hendrys one slide had written on it Developed sensitive mouse sequence specific qPCR to detect contamination with mouse DNA. XMRV positive DNA samples tested for mouse contamination. Dr. Mikovits stood up and made sure everyone knew that these were sequenced and isolated. All 20 samples sent by the WPI were confirmed positives. It was hard to judge by body language what the reaction was. I kept looking over at Coffin though, who is so easy to pick out with the beard, hoping hed ask a question or get involved. This meeting seemed to be about keeping things stiff and calm though. I half expected the Queen of England to show up with that much composure to go around. But, the only one deserving of a royal title in my book is Dr. Mikovits and she wasnt even invited to speak. I was happy she was there as a reminder to all who the queen bee really is in the XMRV game.

    And, so we continue and see Dr. Hewlett appear again with information on the assays they are using. I really need to sit down and talk with someone soon about assay development to understand that all better. Right now, I simply trust that Dr. Mikovits and Dr. Frank Ruscetti know what they are doing better than anyone else in the world, because as of yet, good assays seem to be eluding most scientists. I kept thinking, Judys made this insanely easy for them. She says here, try this. It will work. They say, no. Well do it our way hoping we can trump you. So, basically, there is still a problem with assays. Period. Then why, please, would Dr. Hewlett want to examine HIV patients in Cameroon and Uganda with an assay that has yet to be proven? Why would the other study that searched for XMRV in over 560 HIV+ patients in Chicago use an ineffective assay as well? Not one HIV+ patient in either study had XMRV. Im fine with that if that is true. An HIV patient doesnt need another hit like XMRV. However, with 4% of the healthy population carrying XMRV, does it not seem likely that at least a few HIV patients would be able to contract it as well? Im not a scientist though, but Id like to make sure my tax money goes to the right place to find those answers out. In my dreams I think of filling out my next tax form and seeing a place that says, Would you like to donate $3 to WPI?

    Next up was the Blood XMRV Scientific Research Working Group report by Graham Simmons. This group has just about all the names we are familiar with and then some: Harvey Alter, Jerry Holmberg, Frank Ruscetti, Roger Dodd (you remember him from the May transcripts referring to the perception of an XMRV emergency rather than a real emergency), Suzanne Vernon, Judy Mikovits, John Coffin, Shyh-Ching Lo, Bill Switzer, etc. Presently, the main thrust of this group seems to be to find agreement on an effective assay. Graham Simmons concluded that the study was too small to conduct meaningful statistical comparisons and more work on analytical panel development will need to be performed. The main labs in this group are WPI, FDA (Lo), FDA (Hewlett), NCI and BSRI.

    Last up and the most interesting to me was the man with the Scottish accent, Dr. Stuart Le Grice. He said their goal is to create a group of 6 assays (Viral, DNA, RNA, Western blot serological (antibodies), serological (antibodies) and immunihistochemistry) that they are completely satisfied with and then go head to head with other assays to compare. If Im not mistaken, he talked about a need to find XMRV directly from the sample as opposed to growing it in a cell line. I might have to wait for the transcripts to make sure of that one, but that seems like a fairly important leap in assay development.

    I was impressed by one of his first slides:

    X-SCA: Single Copy XMRV DNA or RNA Detection HIV DRP

    Current status:

    72 blinded samples of donor plasma, spiked with known quantities of XMRV DNA or RNA were tested using the X-SCA assay

    *XMRV detected with SINGLE COPY sensitivity
    *XMRV detected in plasma and whole blood with 100% accuracy
    *No false positives or negatives

    Its good to hear someone finally say they can find XMRV with this sort of accuracy. I often feel scientists are playing hide and seek for XMRV with their hands over their eyes saying, I cant find you. In regards to a viral assay, which I believe looks for viral load, they have reduced the time on this to 3 days, and announced that there is information coming down the pipeline that it is now 1-2 days. The name of this assay is Viral DERSE (der-see). All I could say is, Wow! I pictured the future where patients go to the doctor to find out if the retroviral is working and the test they got two days ago, covered by insurance (I dream big), gives an accurate picture for the doctor to consider. Im not sure if Im right or wrong on being impressed, but I caught Dr. Mikovits nodding quite a lot, so I must not be too far off.

    And, so ended my four hour stay in Gaithersburg. After two brief public comments, one by an HIV patient and another by a CFS patient who calmly took 30 seconds to ask that the Alter paper be released, we were let go for lunch. I had no interest in their talk on Babesia. I hope it went well. At least this time the agenda didnt have it pitted against XMRV as though it has to be a choice. Im unsure if I will return to another FDA Blood Advisory meeting, but I am happy I went this time. I appreciate the friends who wished me well and wanted to hear my report. Thank you for reading and your continued support through this journey were all on. We strengthen each other every day just by being available. I hope we all continue to spread that support to the WPI and specifically to Judy and Annette, women we have assumed a first name basis with because of our appreciation for their sacrifice and dedication to ending our suffering. They are truly women of truth and integrity, and they deserve so much better than what they have received at the hands of the media, science and our government. They will win though. Its imminent.

    http://www.facebook.com/notes/heidi...afety-advisory-committee-meeting/418605229227
  13. George

    George waitin' fer rabbits

    Messages:
    846
    Likes:
    44
    South Texas
    This is excellent news now they have no reason not to be able to detect XMRV in both patient and general population. This means that a meaningful study of the true numbers and the correlation with XMRV + with illness of any type can be accomplished in a matter of months. Like by December, o.k. o.k. this IS the gov'ment let's say early in the spring of 2011. (big grins)

    P.S. thanks Shrews for posting this!
  14. V99

    V99 *****

    Messages:
    1,471
    Likes:
    1
    UK
    What's that in doggy years?
  15. guest

    guest Guest

    Messages:
    320
    Likes:
    5
    Do you think we will have a definitive answer then?
  16. George

    George waitin' fer rabbits

    Messages:
    846
    Likes:
    44
    South Texas
    Oh man in doggie years the report would have come in yesterday!
  17. George

    George waitin' fer rabbits

    Messages:
    846
    Likes:
    44
    South Texas
    He D (love your sig, so true, so true)
    With a bonafid serology test, they will need to "verify" it. (big grins) Which sound like Le Grice has already started that process by sending to other labs to confirm. But with a serology test all they have to do is draw the blood and test it. They should get definitive positive and negatives. Testing 500 or 5000 or even 50,000 is just a matter of having the necessary lab facility and the people to staff it. With existing labs the "400" person patient study that was outlined by the Working Group could be finish in a matter of days.

    Plus, seeing that 95% of this group of ill persons (say CFS/ME), and 14% of that ill group (say atypical MS) or 4% of this group (say "Otherwise Healthy) could be whipped out and correlated in a couple of months. You've got time to "design" the study, time to fight about who get's to put their name on the study, (grins) time to do the dang study, time for some dweeb to write up the dang study. Whew, then time for some Gov'ment official to pressure some publication to print the dang study.

    So that will give good correlations about who's got what and how much but it still won't tell ya "scientifically" that XMRV actually Causes anything. (grins) got to have more studies for that. (wink)
  18. VillageLife

    VillageLife Senior Member

    Messages:
    674
    Likes:
    36
    United Kingdom
    once they got the 100% perfect test, there be no stoppin them!
  19. acer2000

    acer2000 Senior Member

    Messages:
    574
    Likes:
    203
    Are these positive controls that they sent to all these labs from CFS patients?
  20. SOC

    SOC Moderator and Senior Member

    Messages:
    5,283
    Likes:
    6,254
    USA
    Thanks, shrewsbury! I managed to struggle through the whole thing. :headache: How I miss my brain. :sad: You're right, the Dr LeGrice was the best.

    More out of spitefulness than any genuine scientific interest, I'd love to know more about the Hendry and PCR gag bit.

    Cheers for Dr Vernon and Dr Mikovits, as usual. :victory:

See more popular forum discussions.

Share This Page