I agree with Cort and George that it seems some appropriate co-ordinated pressure is well in order - and sustained pressure, until sufficient information is released. Ian Lipkin himself, and Francis Collins, seem to me to be the people to petition. All those who made promises, or who implied some kind of new listening-to-patients was going to go on, and used words like transparency, should be hassled for statements.
Even if there were no information ready to release, the BWG could still release a statement to that effect - eg: "the phase II results are inconclusive and the assay is still in dispute / in the final stages of standardisation and these are expected to be finished in 2 weeks".
But there clearly IS information that
could be released, or is immenently ready for release, or has perhaps been deemed not suitable for release, because a significant meeting was held over a week ago and no information has been forthcoming. That information is not being shared - we could at least be told a date when further information will be released, that I could perhaps understand, but to be told nothing, even when asked directly what is going on, seems to be the very opposite of the transparency we were led to expect from this group.
It is quite obvious that any information pertinent to the resolution of questions about contamination, XMRV assay standardisation, and methodology for the study of XMRV, would be hugely beneficial to the worldwide community of researchers investigating XMRV, and that information, whatever it may be, has the potential to speed up worldiwde XMRV research greatly.
So what possible reason or excuse can there be for keeping such information from the public?
Such official secrecy has been a recurrent theme of XMRV/CFS research, and I doubt the assertion that all this really is just the norm. Already we've seen a key paper - Lo/Alter - delayed in an unprecedented manner, and leaked from a private conference and then eventually published with a less obviously confirmatory headline.
Before that we we had seen a rapid negative study (McClure/Wessely) undertaken without any prior public announcement of its existence - despite questions in the House of Commons and via FOI requests aimed at determining what studies were being undertaken - this controversial but key negative study nevertheless being published months ahead of any of the other, publicly announced replication studies.
And still now, the WPI and others have completed multiple studies, which remain unpublished - remember that a year ago we were expecting to have seen 6 or 7 published studies by now, and many of those seem to have completed, and we have heard elements of their positive conclusions, and yet still nothing is published, by any of the planned studies nor by any of the groups who have given poster presentations about their positive studies - all the positive information remains unpublished, and random negative studies from people who can't detect XMRV continue to pop up as if from nowhere.
And it is not a small point George makes when wondering why the prostate cancer controversy - which appears to be the identical problem that some researchers are detecting XMRV successfully, whilst others cannot detect anything - this same 'controversy' in the prostate cancer field is somehow being treated separately from CFS. There seems to be no logic to that separation. It seems a worryingly political separation rather than one based on scientific evidence.
Anyway: the bottom line is that we can't afford to ignore that information is being withheld from us. We are only asking for at least the courtesy of some kind of statement, something like even "we will make a further statement within 2 weeks", or whatever. With the Lo/Alter paper, crucial positive information was held back for over 3 months. That delay, at least, was an exceptional case, worthy of an explanatory editorial in PNAS regarding the delay and the leak. Whether the BWG's delay and their secrecy over the Phase II trials are unusual practices or not, I don't know, but I think this sort of secrecy, this lack of government transparency, and this sort of delay to the open scientific process, should be seen as being unacceptable.
And so it seems like a polite but persitent petitioning of the Relevant Individuals is in order...
As per George...
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.
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