Wednesday, December 15, 2010

"XRMV and CSF" - FDA Blood Study Advisory meeting

The Patient Advocate went with his son Nicholas to the FDA Blood Study Advisory meeting in Gaithersburg MD on December 14, 2010. This committee meets every six months to consider issues regarding the blood supply in the United States. They operate as an advisory committee, hear issues and vote on specific questions that are then passed on to the FDA itself. In most cases the FDA accepts the recommendations of the advisory committee.

In early December the Patient Advocate wrote an account of what was going to happen at this committee meeting, and this description foretells quite accurately what occurred on Dec 14th – with one major exception. With this particular committee there seemed to be no one in charge, no one running the show. Certainly it was not the appointed head of the committee - Dr. Blaine Hollinger - but surprisingly it was no one else either. In the PA’s experience this is unusual. This fact, this shortcoming, heightened the unmoored and discombobulated sense of the day’s presentations, and particularly the vote on one question – a very significant question – at the end.

In no sense did this committee, with a few exceptions, project the sense that they had ever heard anything about XMRV, or CFS before - even though there had been at least one earlier meeting on this subject - and maybe two. A number of the committee members invented their own illness acronym - CSF and XRMV - and used them repeatedly. The bottom line was that at the end of the day – after listening (or not listening) to the days’ presentation - the committee, during their discussion, seemed totally unmoored, unable to recognize what they were voting for, what the implications were, or even, most absurdly, what a yes or no vote actually meant. The discussion was stunning in its absurdity, the greatest sense of unreality that the PA has ever seen – and this is really saying something. The Patient Advocate was certain that he knew what was going to happen, but, for a few moments, the PA panicked with the realization that this group of “experts” was so lost and so self-absorbed that the issue could not be clarified and that the committee would not be able to do the task at hand.

So it was with some trepidation that the Patient Advocate watched the unfolding of the committee vote. The PA himself had been confused by the committee chair as to what the vote was actually about, what the main issue actually was - although the PA had not previously suffered from this “not knowing”. The 13 members voted with their little silent push buttons and suddenly the audience could see the result on the screen. The vote was 9-4 with the committee voting to restrict the participation of CFS patients in giving blood. Or that was the Patient Advocate thought after the committee confusions and this was shortly confirmed by reality - although Dr. Ruschetti also was unsure what the committee had voted for. It is the PA’s belief that some members voted no meaning to vote yes and some members voted yes meaning to vote no. Fortunately it worked out in the end - and this is how great victories are achieved in this modern world of ours.

The misdirection and confusion of this committee was stunning and took away, at least momentarily, the profound importance of their vote. This was a great day for ME/CFS patients - as the government recognized for the first time in history that ME/CFS was an infectious disease, and that it should be kept out of the blood supply. The Patient Advocate had a sense that the committee had no idea of the implications of their vote, either now or will in the future. Without their knowing, or seemingly even caring, this committee’s vote confirmed for the first time ever that the federal government is complicit in the neglect and abuse of ME/CFS patients. At a minimum it sets a date where the government is on record as acknowledging that they have some awareness –something to lose - that a new retrovirus or two or three are loose in the blood supply, and that it might have consequences. Hence the clock has been started for future liabilities for blood transfusions. The government had been wanting to push this date back forever, but events have descended upon them.

This was a very important day for ME/CFS.

From the beginning to the end it was a day of great strangeness.

The Patient Advocate will not enumerate the specific presentations of the day, preferring as usual, to give his “take” on the day (highlights and lowlights) and to try to project the general weirdness of it all.

Two new voting members were attached to this committee. They were Dr. Nancy Klimas and Dr. John Coffin. Late in the day, as the committee lurched uncertainly sideways, about to pitch themselves headfirst into the ditch, two presentations saved the day. One was more unexpected than the other. The first was that Dr. Klimas, at a critical moment, articulated the problem of patients with this illness and the danger to the blood supply - something that many could do, including the PA – but it was Dr. Klimas who was there at crunch time - and this needs to be noted. Dr. Klimas was great. Thank heavens that Dr. Klimas had been placed on this committee for this day, and that she was able to stroll in with her little rolling bag and do her thing. Otherwise the day would have been sunk.

The second surprising moment occurred when Dr. Harvey Alter, in no official role, stepped to the microphone and in a very short presentation articulated the main issues regarding the science of XMRV, set aside the notion of contaminations and basically framed what the committee needed to do. He also presented a spirited defense of the WPI research and Dr. Mikovits in particular.

The following is the near verbatim transcription of Alter’s short statement transcribed by Valerie in real time. The PA borrowed it from the ME/CFS forums. The Patient Advocate was sitting next to Valerie and he watched in disbelief as she rattled along typing up these lectures. How she does this the PA does not know, but the rest of us owe her a great sense of gratitude.

“When a group finds a new agent, become biased that it’s real. When it’s not found by another group, they become even more biased it’s unreal. Our goal should be to find the truth. The truth will out over the next year. I concur we have no evidence for causality, especially when we’re at the LoD and assay performance is so critical

But I still want to counter by saying that the current evidence for disease association is very strong that XMRV or MLV is strongly associated with CFS. In those labs who do find the agent, it's very reproducible. Year after year, same patients test positive. Confirmed by sequencing, reproducible over time. Dr. Hanson has demonstrated how critical the assays are. When tweaked assays, the findings are identical to Lo lab.

Diversity of XMRV/MLV being confirmed in WPI lab, so XMRV is the not only agent being confirmed there. In hundreds of negative controls in same lab (Lo’s) all results were negative, Lo has done what Coffin recommended to test for contamination, Always negative for contamination. It isn't logical to suggest otherwise. Stoye used single-case anecdotal information to try to make a case. Simply because it has happened in the past isn't valid to negate reproducible data from 4 different laboratories.

I'm not a CFS Dr, but have learned alot in last 6 months. Absolutely convinced when you define this by proper criteria, it's a very serious, medical disease. Characteristics of a viral disease. If it's NOT XMRV, we must continue the research to find out what is''.

Meanwhile, during this final discussion leading to a vote (and actually for the entire day), the other newcomer to the committee, Dr. John Coffin was doing his very best to confuse the issues. This behavior involved his usual obnoxious grandstanding and self-preening - trying to display his superior intellect in parsing these issues. Dr. John Coffin is immediately recognizable to the Patient Advocate as a person of the PA’s generation and the PA is embarrassed that he shares this man's culture. Dr. Coffin is a leading light of “The Stupidest Generation” (in the history of the world). This self-pleasuring has been evident since the Patient Advocate first saw this fellow at the CFSAC meeting in October 2009 . Dr. Coffin is a slippery adversary, and should not be trusted in any situation.

The Patient Advocate watches this old dilapidated codger (Coffin) and the others of my generation on the committee, and the PA wonders what they think of Dr. Judy Mikovits? The PA wonders if they see in her the extraordinary qualities that the PA sees? The PA would have to say – no, no, these fellows don’t see it. They are true to their generation, eaten up by their fear of being unseated by younger women who are much smarter than they are – and they are unable to get their minds around this and it coagulates them into a malleable jelly-like substance without any spine.

The day was a triumph for ME/CFS research. It is clear to the Patient Advocate that in spite of actually being able to execute the vote, the committee and the federal government that they represent is no longer in control of this issue. This was best highlighted by the presentation and comments of Judy Mikovits. While Dr. Mikovits presented nothing new, her acuity and intellect are so much more elevated than the others in the room that it is almost painful to watch. While she took her usual bashing, there was a sense in the room that she and other scientists are now in control of ME/CFS issue. The government is in the way and must move aside. Dr. Ian Lipkin should be given another job.

The presentation of Dr. Stoye was a curious one. For some reason Dr. Stoye, a UK virologist, was given a prominent place in this discussion - and he took full advantage of it. His assignment was to give an “overview” of the current research into retroviruses and ME/CFS. Why he was chosen for this task is hard to understand. Dr. Stoye, whatever his virtues are, has demonstrated that he does not do well on the open field. Dr. Stoye failed miserably at this overview task, instead giving a magnificent “underview” and quickly descending into a haphazard, lackadaisical, offhand, slipshod set of opinions and anecdotal assessments that bordered on the unprofessional. Dr. Stoye tried his best to reenter the contamination issue but, by the end of the day, this had been buried (at least for this day), primarily through the aforementioned summary of Dr. Alter. In other ways Dr. Stoye tried to shift the momentum against the validity of any association of MLV-related viruses with ME/CFS. As the committee vote revealed, Dr. Stoye’s contribution was ignored and did not take hold.

Despite the asinine aspect of this committee meeting and the ensuing confusion, this was a banner day for science and research relating to ME/CFS. The government will continue in its silly ineffectual way, but now they are strapped to the serious science being done at the WPI and other places and we are better for this. The good guys won the vote and the bad guys took a beating. Now it is time to move on.

22 comments:

  1. "The day was a triumph for ME/CFS research. It is clear to the Patient Advocate that in spite of actually being able to execute the vote, the committee and the federal government that they represent is no longer in control of this issue."

    Thank you, Patient Advocate. Once again, you have given us a clear description of what happened, along with your vivid impressions. Since I am homebound, I am most grateful to you for being my window on the ME research world. And I am very happy that the government which has covered up this disease for the last 25 years is no longer in control.

    Patricia Carter
    XMRV+, 24 years ME
    www.mecfsforums.com

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  2. Thank you so much Chris for this report. I hope they listen.

    Of course let's pretend they haven't.

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  3. Thank your for this first-hand report. Talk about from the sublime (Alter) to the ridiculous (Stoye).

    This portion of Dr. Alter's statement brought tears to my eyes.

    "I'm not a CFS Dr, but have learned alot in last 6 months. Absolutely convinced when you define this by proper criteria, it's a very serious, medical disease. Characteristics of a viral disease. If it's NOT XMRV, we must continue the research to find out what is."

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  4. Hi PA,

    Always look forward to your colorful commentary! Thanks again for your time and insight.

    Andrew

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  5. I always look forward to reading your posts.Thank you for the account, and for the laugh! Both are much appreciated.
    Ginette, Montreal

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  6. I would choose Coffin as my first choice to lead a search for retroviruses in CFS and I'm glad he's making his expertise available. The questions Coffin, Stoye and others ask are not mere formalities nor are they trivial. They are necessary to the advancement of the field. A lot of CFS patients are content to take certain individuals words on things, but science doesn't rely on quoteable quotes, no matter how well-intentioned the individual giving the presentation.

    I would also pay special attention to what Dr. Coffin says as certain US patient organizations have been cowed by an angry constituancy into not vocalizing these same questions even though they might share them, which in my opinion is not in the best interest of the patients. Since they are an honest, these patient organizations can't help but voice their concerns, but since they have been cowed they do so in a seemingly catty, backhanded manner, which only serves to further increase the ire of patients. The patient org's in question need to just say what they need to say and get it over with and let the chips fall where they may, kind of along the lines of the UK's MEAssociation, who have been bluntly honest in their assessment which can be basically summed up as 'We don't know; we're just not sure'.

    Remember, "the role of scientist is to question everything with great glee"- the emphasis here is on everything, not just what you like or don't like. Everything.

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  7. PA - As always, thank you. I had the pleasure of being on the reading end of Val's amazing feats of transcription and have been reveling in Dr. Alter's words all day. One wonders if he would like to be a CFS doc.

    I believe I heard Dr. Coffin mention (at the beginning of the 1st International XMRV Conference Q&A) that Dr. Stoye was his mentee and designated grabber of microphones. It appears Stoye (or Le Grice in a pinch) is Dr. Coffin's means of sewing doubt, confusion and the dreaded Contamination Accusation into any scientific gathering. It also appears the apple doesn't fall too far from the tree. So long as rolling doesn't count.

    From the truth is waaaay stranger than fiction category comes (after a nude statue) a truly horrifying photo of Dr. Stoye sniffing Dr. Coffin's Tootsie Roll in some bizarre display of scientific reverance. http://schaechter.asmblog.org/schaechter/2008/09/the-view-from-2.html

    I would like to ask, if anyone were in charge TO ASK: "Why is a British national is brought in to do a research underview (and disparage the work of good researchers in the bargain) in a FDA forum determining the blood policy of the United States"?

    Be Well

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  8. Yes, it's a good thing someone was there to make sure the opinion was heard that the WPI's paper in Science and the Lo et al paper in PNAS should be viewed as two different events, and in any case we still can't rule out contamination. We haven't heard this enough times. What, LeGrice wasn't available?

    Coffin's position has been sufficiently non-committal. This is understandable, to a point (although if Lo's comment that 'we did what you suggested' was directed at Coffin...maybe he's less non-committal than he's seemed up to this point, at least publically?). But there's a different tone now, and Stoye seems far more skeptical. Why wouldn't he be? He is co-author on a negative study, after all--but between the NIH Q&A and this meeting, he seems increasingly defensive. Hmmm. He felt it necessary to articulate that he didn't come into this looking for a negative result? Shouldn't that be so obvious, that a researcher should never have to utter such a statement?

    Meanwhile...I wonder if Coffin's stance is based in any part on how he feels research funding may be doled out on this. I'm guessing that plays no small role in his attention to this issue.

    I wonder how these guys feel about Mikovits being the one speaking with Lipkin in March.

    I have an idea.

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  9. I know I should noy be LOL, but I could not help it. Your dissertation kept reminding me of the three stooges....Thanks to Klimas....the day was saved. An interesting commando thought here.....I believe we need to have someone videotaping these so called panels and discussions. These are going to make great footage for the Documentary on whos on first; the CFIDS Malfunction, Paid for in full by The United States Government.Anyone willing to start making a movie? These sessions have GOT to be tased for the people, by the people of the people.

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  10. I, too, have wondered why Stoye is included in all the U.S. panels. The UK should never, ever have a vote on anything the U.S. is deciding about ME/CFS.

    Thanks the stars and heavens for the 'light' of Drs Nancy Klimas and Judy Mikovits!

    Thanks to Val for her stupendous performance in keeping us up to the minute on this day <3

    Thank you, Chris, for your powerful ability to read people so well, and between the lines so prolifically. You're so special.

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  11. @Anon:
    The somatisation theory of ME/CFS has reigned supreme since the late 1980s. As it's essentially unproveable, you would expect scientists to be far more skeptical about it than they are for infection theory. They aren't. What's your explanation for the widespread acceptance of a pseudotheory by those whose 'role ... is to question everything'?

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  12. "I would choose Coffin as my first choice to lead a search for retroviruses in CFS and I'm glad he's making his expertise available. " Anonymous

    If MLV-related retroviruses are associated with ME, and the evidence for that is strong. Then Coffin is obviously not the person to be leading the search, simply because he cannot find the virus. It is Mikovits, Ruscetti, Hanson, Lo, Alter, who are. do not be fouled be credentials, they don't always count.

    "I would also pay special attention to what Dr. Coffin says as certain US patient organizations have been cowed by an angry constituancy into not vocalizing these same questions even though they might share them, which in my opinion is not in the best interest of the patients. "

    That is blatantly untrue. Those organisations do not speak up because they don't know how to. It's what they believe is a good strategy, but it's never worked, and never will.

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  13. Thanks so much for giving us the inside view, Chris. Great job, as usual!

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  14. Brilliant PA, really helpful to those of us who couldn't attend...I love the way you write and am very grateful.

    Re Coffin/Stoye, yes questioning science is good, it makes for more robust science, but when those who are questioned do what is asked...and then still get accused of their science being contamination, you start to wonder what Coffin/Stoye are up to.

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  15. I recognized Stoye as a member of GOBSARTT (Good Ole Boys Sitting Around a Table Talking) long ago, but the revelation that he is/was Coffin's "mentor" explains a lot. I recall Coffin's editorial right after the WPI Science study came out: "A New Virus for Old Diseases?" or something like that. Then I saw a recording of him saying something like the only way to find out if XMRV causes ME/CFS is to treat the patients with ARV drugs and if they get better, that's the proof.

    Since then Coffin has been backpedalling on all fronts, regurgitating the party line of dissembling, doubt, and denial. Sold to the highest bidder, apparently, whether for research money or ego strokes. To see him, Stoye and the other GOBs in pack behavior reminds me of dogs sniffing each other and marking their territory with urine. I get the impression they still think males are superior because they pee standing up. No girls allowed in this clubhouse!

    When you said "The PA would have to say – no, no, these fellows don’t see it. They are true to their generation, eaten up by their fear of being unseated by younger women who are much smarter than they are – and they are unable to get their minds around this and it coagulates them into a malleable jelly-like substance without any spine." I had the best laugh I've had in quite some time! It is so validating that you see what I see!

    These dinosaurs ought to retire and get out of the way. At the very least they have the moral and legal obligation to stop obstructing progress. To them, we who have ME/CFS are nothing but lab rats.


    Mikovits, Lombardi, the Ruscettis, Lo, Alter, Singh - these are the present and the future of MLV/XMRV research. They are able to see us as human beings with human rights such as the right to medical treatment NOW.

    Keep up the good work, PA. Your blog gives us something to look forward to. I am so grateful for you and people like you.

    Oerganix - (ME/CFS for 29 years; past the age that many who have ME/CFS die of the viral heart disease, rare cancers and suicide that comprise the top 3 causes of death in ME/CFS, the illness that cannot be acknowledged by the US & UK governments)

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  16. Thank you, PA! It's as though I was actually there in the meeting room watching it for myself. Although, since I have a foggy brain, I probably would have just been confused if I was sitting there. You have described the scene and its meaning with absolute clarity. Are you sure you're not a journo, as well as a sculptor? :)

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  17. "The somatisation theory of ME/CFS has reigned supreme since the late 1980s. As it's essentially unproveable, you would expect scientists to be far more skeptical about it than they are for infection theory. They aren't. What's your explanation for the widespread acceptance of a pseudotheory by those whose 'role ... is to question everything'?"

    Good point- it certainly shows what can happen when people don't question what they're being told, correct?

    Just because the role of scientist is to question, that doesn't mean everyone who claims the label fulfills the role.

    I myself don't know enough about the subject to critique either the arguments for or the arguments against XMRV/MLV/HGRV in CFS, which makes me very grateful that those who do, are.

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  18. Thanks, Chris, for being there. Ironic, if I'm not mistaken, that it was your Stupid Generation that first wanted to find a viral cause for cancer.

    I'm not surprised that few in the BPAC had a clue; it's by the nature of the beast and superiors' design. Nor do I believe Fauci, Collins, Reeves, Switzer, Wessley, White, Stoye, etc. are as compartmentalized as they'd like to present themselves.

    If you write Congress, you should include your impressions of this event.

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  19. your reporting -- and even (or especially) your editorializing -- is very appreciated. what a treasure you are to the me/cfs community.

    rivka

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  20. I would like to strongly suggest that EVERYONE send Dr Alter a polite concise Thank You Email for his kind Truthful comments that were VERY MUCH appreciated.. You may email him at

    halter@dtm.cc.nih.gov

    Thank You Chris for ALL you do.

    ME/CFS 23years, XMRV Positive+
    Angel Mac
    http://standup2me.blogspot.com

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  21. "The discussion was stunning in its absurdity, the greatest sense of unreality that the PA has ever seen – and this is really saying something."

    Boy, oh boy, I'll bet that is the truth. You must have seen more of this kind of unreality than most in your role. I laughed frequently reading your account, but must say that there is at the same moment of laughter a bitter taste: this is how our government has been responding to serious disease? And to the risk of contamination of our blood supply? By installing a rudderless committee?

    Your comments on your embarrassment about the men of your, and my, cohort, evincing their fear of younger, smart women taking away their pride and place was another of the many gems in this post. What is it about such men that they cannot welcome new thought, fresh ideas, nor recognize and admire brilliance when it wears a female face?

    Keep up the good work.

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  22. kathryn said...

    I, too, have wondered why Stoye is included in all the U.S. panels. The UK should never, ever have a vote on anything the U.S. is deciding about ME/CFS.


    That's because we are doing research as well you dullard, but then as American you think you lead the world on everything!

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