XMRV Buzz - Take a Deep Breath/the Big XMRV Meeting, Singh On XMRV, Sample prep?

[Sasha]

The Lipkin meeting was not about the BWG. [...]As far as the BWG phase 2 and why no information has been released, despite Dr. Glynnis's comments at the CFSAC meeting . . . . my thought is that maybe it is simply not finished and therefore cannot be released. Pretty much every stage of the BWG has been delayed and then released later than promised. [...] The BWG and NIH and Lipkin are very very aware that we are all on pins and needles waiting for results.

Thanks, Jenny - if they're two different things and the conclusion of BWG Phase II has been delayed, there's less of a mystery (though no less tension). I'm glad they know we're waiting!

Sorry your pain isn't very good today. You'll be needing one of these :headache:, apparently!

 

[CBS]

I hope this helps. If anyone has more questions, let me know. PM me if you like. I do my best to keep up with all the threads, but today's pain management visit didn't do much to help me manage today! :In bed:

ETA: Sasha said that the BWG needs to know we are waiting. Oh believe me, they do. The BWG and NIH and Lipkin are very very aware that we are all on pins and needles waiting for results.

Jennie,

Most excellent! Thanks so much for this summary, especially on a day that's not so great for you personally.

 

[Cort]

I do not have access to some of the information we so desperately want because access is restricted to participating members of the BWG or other task forces. So there are some questions I simply cannot get answers to. Having said that, I hope I can offer some clarifications:

• The Lipkin meeting was not about the BWG. It was about Lipkin's own study funded by NIAID. Obviously there is overlap between the BWG and people who went to the Lipkin meeting, but they are not one and the same.
• Why did Lipkin call the meeting? Because that is his process. The excerpt from "Microbe Hunters" earlier in this thread (I think??) sets out how he approaches these kinds of studies - he starts by bringing the stakeholders together.
• The discussions from the Lipkin meeting are embargoed - completely. No one who attended can/should talk about the protocols/study design/related issues or anything else that was discussed.
• Having said that, my understanding is that Lipkin believes in transparency and accountability as part of the process.
• As far as the BWG phase 2 and why no information has been released, despite Dr. Glynnis's comments at the CFSAC meeting . . . . my thought is that maybe it is simply not finished and therefore cannot be released. Pretty much every stage of the BWG has been delayed and then released later than promised. I don't think we can draw reliable conclusions from a promised date slipping again.
• Rumors abound. I try to avoid them! It just freaks me out and works me up. :worried:
• The CAA believes that information on each BWG phase and other federal efforts should be made public as soon as possible (i.e. when they are finished), and we advocate for that on the BWG and AABB Task Force and with NIH. And that's not limited to XMRV, it is across the board with funding and public education issues.
• We want this information as badly as everyone here! But we also want the science to be done right. Slipshod results help none of us, so I personally would rather wait a little longer if it means the science is being done correctly and we can rely on the results.

I hope this helps. If anyone has more questions, let me know. PM me if you like. I do my best to keep up with all the threads, but today's pain management visit didn't do much to help me manage today! :In bed:

ETA: Sasha said that the BWG needs to know we are waiting. Oh believe me, they do. The BWG and NIH and Lipkin are very very aware that we are all on pins and needles waiting for results.

I think our problem is that our or at least my understanding was that Ian Lipkin is/was going to use the protocols developed by the BWG for his sample collection, etc. Then we hear that he has gathered this group together to discuss how his study will proceed - which, of course, suggested that he has determined (a) how it will proceed and thus (b) has received the findings from the BWG. My understanding, which could be wrong, was that he will also be using the assays developed by the BWG as well (and hopefully others!)

The groups appear to be quite intertwined - they appear to be almost complementary steps of a long process but maybe that's not correct. Perhaps he just happened to bring this group together at just the time the BWG was due to release their findings and he was talking about the general thrust of his study. That is actually the most logical outcome given the state of things and we just got caught in the middle.

What did Dr. Lipkin think was going to happen, though? He has federal officials, researchers and advocacy reps meet with him in New York right in the midst of all this - allows that information to be posted in the press - and then embargoes everything about the meeting except that it is about future studies for CFS - which is a recipe for speculation. I don't think anybody would really care about that if not for the BWG issue.

The CAA is caught in the middle right now - not a comfortable place to be.

Sorry you're not feeling well! I recommend you try on this little cap here - I hear it works greats for the Scots :headache: when they're not feeling well.

I really appreciate you giving your insights. I hope you feel better soon.

 

[asleep]

• The discussions from the Lipkin meeting are embargoed - completely. No one who attended can/should talk about the protocols/study design/related issues or anything else that was discussed.
• Having said that, my understanding is that Lipkin believes in transparency and accountability as part of the process.

The cognitive dissonance: it burns! How is one supposed to reconcile these two points?

Edit: Sounds like typical "government transparency," where transparency extends to talk about transparency and nothing more.

 

[Cort]

The cognitive dissonance: it burns! How is one supposed to reconcile these two points?

Edit: Sounds like typical "government transparency," where transparency extends to talk about transparency and nothing more.

That's interesting because as I read that - which is what I was thinking - I just realized that Jennie's statements are not irreconciliable. Dr. Lipkin does believe in transparency - he did after all bring all those groups together - probably to introduce transparency into the process and get them all on the same page He just doesn't believe in transparency with us. - the unwashed masses

Now I do need my Tam
:headache::headache::headache::headache::headache:​

 

[Cort]

Here was my summary on the Buzz Page

The Patient Community Twists and Turns and the Blood Working Group Remains Mum - A month earlier Dr. Glynnis at the CFSAC panel Oct 14th (1:45:28) stated

"We hope we'll be able to have results of this ongoing study by early November and it is our plan certainly to immediately release the results because we think they will be extremely important to the scientific community ....so that the optimal preparations of the samples will be known."

Amy Dockser Marcus's blog in the WSJ stating that Dr. Lipkin, who is reportedly going to use BWG findings for his study, met with federal officials, researchers and advocacy reps to discuss how his study will now proceed, of course, set off a firestorm of speculation. Was the BWG done? Why have a meeting if it wasn't? If it was, why not release the results?

That the details of that meeting were embargoed meant what? Speculation raged...was this good news or bad news? CAA Board Member Jennie Spotila was willing to jump in and state that, while she wasn't privy to all the information, she thought the BWG findings had nothing to do with Lipkin's meeting.

The only thing certain is that the federal officials have once again allowed events to spin out of control in the patient community, leading to more and more speculation and, of course, anxiety. The CAA is caught in the middle between their promise to keep the information embargoed and a community that would like to know what's going on.

The BWG could easily clear up the confusion but repeated emails to the BWG co-chairs have been ignored. Perhaps the most logical assumption to make at this point is that Dr. Lipkin just happened to call his meeting about the time that the BWG was to release their results and that the BWG, as have most groups in the past, is just taking longer than expected to finish up their study.....and that they're simply inept at dealing with a curious and informed patient population.

 

[pictureofhealth]

I think you're right Cort - judging from Dr Glynnis comment (in italics) above, and as you said earlier, 'our plan .. to immediately release the results' for optimal sample preparation, didn't necessarily mean immediately releasing them to us/the patients, perhaps only to interested scientists.

Ah well, but we will get there in the end, once its all sorted out on high.

Wonder if its possible to sleep with one of these :headache: on your head?

 

[Sasha]

Now I do need my Tam
:headache::headache::headache::headache::headache:​

You've ended up with five heads, Cort! The very epitome of co-morbidity.

 

[Navid]

Very Dada! Like it!

:headache::Green hat:each:

sasha:

glad u like it...i'm a mama so i like to get in touch with my dada side sometimes. (ouch bad humour can be painful)...where's my darn tam o shanter:headache:

actually i threw the peach in there because it's just as weird an icon as the tam o shanter- ice pack, green faced businessman.........and then the peach?!!?!?!

what does the peach mean...does it have some deep mystical powers?

Since the Allman Bros once titled a great album: Eat a Peach....maybe it will make us happy, get us singing and give us super-magical powers of patience.each:

bye sasha!!!!!

 

[Sasha]

Yes, shebacat - the peach is indeed weird, and strange in its realism compared to the other things. Yes, what does it mean??? Must be very deep, very deep...

 

[jspotila]

I think our problem is that our or at least my understanding was that Ian Lipkin is/was going to use the protocols developed by the BWG for his sample collection, etc. Then we hear that he has gathered this group together to discuss how his study will proceed - which, of course, suggested that he has determined (a) how it will proceed and thus (b) has received the findings from the BWG. My understanding, which could be wrong, was that he will also be using the assays developed by the BWG as well (and hopefully others!)

Phase 2 of the BWG is standardizing the assay, right? But there is so much more than the assay involved in designing Lipkin's study. Patient selection, size of cohorts, labs who will participate, and so on. Lipkin will need IRB approval, and my recollection from the CFSAC is that NIAID was working on writing (or approving) protocols for the Lipkin study. So even if he does use the BWG assay, there is waaaaaaaaayyyy more to it than that.

That's interesting because as I read that - which is what I was thinking - I just realized that Jennie's statements are not irreconciliable. Dr. Lipkin does believe in transparency - he did after all bring all those groups together - probably to introduce transparency into the process and get them all on the same page He just doesn't believe in transparency with us. - the unwashed masses

We all want immediate transparency. I wish I was at every meeting and on every conference call (easy for me to say: it would probably require more :headache. But the reality is that we - regardless of our washed or unwashed state - are just not going to get all the information on the same timeline as government and scientific representatives. We're just not. Sometimes, the lack of transparency is something to rage against, but other times it's just a matter of things not being ready for prime time. It's hard to discern the difference sometimes, especially when we have all spent more than a year walking around like this:


Thanks for all the well wishes, friends. Which one of you is bringing my cuppa to go with my tam?

 

[George]

Dang JSpot there isn't a cuppa icon or I'd serve ya up one. (big grins) I know how bad some days can be so relax with a REAL nice cuppa.

I'd like to address some points and put forth an action plan that will make a point without upsetting the apple cart, just give it a tiny little tilt to get some attention.

Cort you and I have the same information set it appears.
The BWG would;

1) finish the phase II trial showing how to consistently find XMRV in (wild) patient samples. This would be a research only test but it would allow for two things.

a) Those wishing to pursue "novel" assays for patent purposes would have a standard test to check results against.

b) Those researchers wishing to work with patient/population based research would have a "gold" standard to work with providing good statistical analysis.

c) Allow for the beginning of Phase III to check the blood supply and Phase IV to look at population prevalence studies.

Dr. Lipkin was brought in to act as an independent arbitrator and to establish if a "link" between CFS actually exists. (why he doesn't have to establish a link between XMRV and prostate cancer chaps my little doggy butt but we will leave that for now) Dr. Lipkin per Dr. Glinnis would use the "gold" standard developed in phase II as a check method for the following portions of the study.

1) Dr. Lipkin would choose the patient's so there was no question about politics affecting patient selection.

2) Dr. Lipkin would choose the healthy controls so that the patients matched in age, area and gender.

3) Dr. Lipkin would oversee the careful blood draw and handling of patient and controls so that improper handling could not be an issue.

4) Dr. Lipkin would use the BWG Phase II "gold" standard to test all samples.

5) the samples would then be blinded and identical sets sent to 4 labs, WPI two in the FDA and the CDC
a) the individual groups would test the samples using the gold standard and any novel assays that they cared to use
b) the individual groups would send the result back to Dr. Lipkin

6) Dr. Lipkin would unblind the results and then pull the statistic together showing which labs were able to detect XMRV, what percentage they got right/wrong, possible contamination if all turn out positive or a higher percent, possible problems if the incorrect proportions turn out negative.

No word on if this would be published but per one of the panel members (sorry memory lapse there) stated that the information would/should be available by the April NIH conference.

Now there is no reason for the NIH BWG to with hold the Phase II results from the patient population. There isn't anything that will cause a ruckus on the public level in simply understanding how to find a virus that may or may not be in the population and may or may not make people ill depending on a dozen different things.

I think it is important for the NIH and for any organization that works with ME/CFS patients to understand that we have be ignore and abused in many ways for many years and are willing to put the weight of our numbers against them and insist on transparency where transparency is warranted.

I'd propose a small act/demonstration of that power.

1) Let them know what we want - the information regarding the Phase II trial (we are not trying to influence the Lipkin trial in any way nor are we asking for any information that would compromise that trial) Just the results from the Phase II trial that establish the correct protocol.

2) Let them know how they can deliver the information via website, email to an advocacy group.

3) Let's just pick one group like the International ME/CFS group and leave the CAA out of this since they are going the route of research and this could compromise that aim.

4) Give them a time line to deliver the information such as by November 30th. Then even if they have only now completed the information it will be available in time.(There were hints from both conferences that the problem was solved so I don't think this is a head scratcher)

By emailing each of the persons involved which I would say all members of the BWG plus Collins, Faucci and Sebblius each day with a very short e-mail stating those points above by as many people as possible it should get the point across.

What's the point we are making

1)Don't say that you want to be in touch with the patient community and then go silent

2)Don't provide and advocate who picks and chooses how he answers the community and what information he delivers

3) Provide thoughtful, sincere and honest information, If a time line moves let us know and if information must be withheld or is going to be unavailable then let us know that.

4) We deserve to be treated not only as adults but as intelligent patients who have educated themselves to a very high level and we deserve to be respected for that intelligence.

We can help these guys NOT make the mistakes they have made with other patient populations in the past by providing them with the same level of respect, honesty and communication that we expect in return. The 'What have you done for ME NIH' campaign did the same thing it provided an important conduit for the NIH to talk to the patient population. We can continue shaping that dialogue into the future if we apply the right pressure at the right time to the right people and do it with the same respect we ask for ourselves.

 

[Sasha]

Which one of you is bringing my cuppa to go with my tam?

I don't know how to post a picture so I tried to build you a cuppa out of emoticons but the result was, frankly, disturbing...

 

[Otis]

Otis you are a truly lovely avatar in my life! Would you be up to coordinating the blog/website thing - what about XMRV global action??? Would they be interested you think? I didn't get into blogging before I got sick and now I'm too stupid to learn but I can e-mail up a storm. I've been e-mailing and posting since the days of the BB's and Lynx. (grins)

I love the Todd Rungran refrence and your are exactly right we knocked politely now we need bang the Gong! (grins)

It's totally in my nature to try to spearhead Project Bang a Gong (Let's Get it On) but I'm in a crash and have to travel next week which means lots of prep and preemptive rest which ain't working because I am not sleeping.

All we need a blog page here or elsewhere with instructions. Suggest using what was done for what have you done ME/CFS today as a model.

Then we just have to slap links to the instructions everywhere. I'll take care of twitter blasting and my little facebook world.

Who put the little red car on my head? :headache: That hurts man.

 

[Otis]

My ideas right now

a) it's not that they discovered a contaminant - that information they could release. Its been a week now...they've had plenty of time.
b) it's not about blood storage or prep or whatever - that would have been released immediately
c) they have found SOMETHING; it could be a contaminant or something else - but they need more evidence; they need to dig deeper before they release it - so Lipkin's lab is doing that.
d) They're just being stupidly secretive - which I don't think is happening. Dr. Glynnis said 'we plan to release the info ...so she left the option open for something that could happen that would make them not want to release the info. I assume that's what happened and, whatever is going on, it's of a signficant enough nature that Lipkin felt he wanted to speak to everyone personally.
e) fill in the blank

I'll take a variation on c. If LeGrice though they'd settle contamination then I expect he thinks it is contamination (otherwise HE wasted a lot of hot air at the CFSAC) and there is a serious rift on how to read the science, still.

I think yelling Contamination in a crowded room is a really good delay tactic. I trust Le Grice's motives as far as I can throw my car and not the little one on my head. :headache:

Lipkin may be running a 'I'm in charge and everybody get in line' show, but the BWG is a damn committee.

OK, I've thrown Le Grice under my imaginary bus, I feel all better.

I'm climbing in my 3? poster bed.... :In bed: That one in the middle is piercing my brain.

 

[Valb626]

Bravo, Otis. It's TIME for new info.

 

[OverTheHills]

Have a hug and a kiss ...MWA (sound effects only (no smiley)) from me Otis, you make me giggle.

OTH

 

[George]

I like Otis's tata's. . . er umbrellas. (grins) So true Otis about the BWG being a committee and all they have to do is give the CAA or the WPI or the AABB permission to post the information on one of their sites and tada, no problems. (grins)

sounds like a deal Otis on the set up I'll see if I can get someone to do the blog part. . . maybe Bob?

 

[Sean]

Honestly, I think some here are reading too much into these delays, such as they are. This is all standard stuff for anything involving large bureaucracies, multiple stakeholders with sometimes conflicting views, difficult technical & policy issues, etc.

Not saying that they couldn't do better, things can always be done better. But I see nothing yet to give me serious concern about this process so far. I certainly don't feel the need to be instantly updated with every tiny little admin, political, and technical detail.

Don't leap at shadows. Don't sweat the small stuff.

 

[Cort]

We all want immediate transparency. I wish I was at every meeting and on every conference call (easy for me to say: it would probably require more :headache. But the reality is that we - regardless of our washed or unwashed state - are just not going to get all the information on the same timeline as government and scientific representatives. We're just not. Sometimes, the lack of transparency is something to rage against, but other times it's just a matter of things not being ready for prime time. It's hard to discern the difference sometimes, especially when we have all spent more than a year walking around like this:


Thanks for all the well wishes, friends. Which one of you is bringing my cuppa to go with my tam?

I don't think we're asking for immediate transparency..... I think we had expectations based on what federal officials said and we had real reasons to believe that X, Y or Z had occurred and all we asked for was some information on whether or not they had occurred and we couldn't even get an answer to that. A simple answer to the questions - like was the BWG done? If not when do you believe it will done with its work? weren't even forthcoming. We weren't asking for the answer - we were simply asking for a status report! Those aren't questions from a demanding patient community that can't sit still. They're just reasonable questions given the situation - we're not asking for alot.

They're doing what they do - they're off in their world concentrating on their own stuff. We've been stewing about this for over a week and you are first person to say anything even semi-official which I personally, am thankful for. I'm thinking we should protest just so that they know we matter and that when they do things that end up being confusing, whether its their fault or not, they have something of obligation to cool the fires.