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.
