Thursday, December 2, 2010
Crunch Time - FDA Blood Advisory Committee, December 14, 2010
It has been a long three months since the 1st XMRV conference and there has been very little information released by the Federal Government regarding what they plan to do about a number of XMRV-related subjects - most importantly what they plan to do about XMRV and the blood supply
This is about to change. The FDA is trapped by their own agenda, and they will have to say something on December 14th. On that day, the FDA is seeking advice from the Blood Products Advisory Committee in an afternoon meeting in Gaithersburg MD. Background information, discussion and summary of this meeting is provided here.
The FDA Blood Products Advisory Committee meets every six months to discuss various issues related to the blood supply. The committee's charge is here. More information is provided here. The December 14th agenda is provided here, and the presentation regarding XMRV takes place in the afternoon from 1-5:30.
An assessment of the current research into XMRV and its association with illness will be given by Jonathan Stoye. We last saw Dr. Stoye doing a haplessly weak job refereering at the Q&A of the 1st annual XMRV conference. This fellow morphs together in the Patient Advocate's mind with that other fellow, what's his name, whom the PA saw also give an XMRV research assessment at the CFSAC meeting in October. Do not expect much, except misdirection and inept sandbagging, from this UK virologist.
Following this, short presentations will be given by Shyh-Ching Lo, co-author of the FDA/NIH paper, Maureen Hanson, co-author of the 10-10-10 study (with David Bell), and Judy Mikovits.
An XMRV blood working group update will be given by Graham Simpson of Blood System Research Institute (SSRI). Dr. Simpson's name was on the CDC XMRV paper. The XMRV blood working group was formed by the HHS in 2009 to investigate XMRV presence in the blood supply. (The PA sees it as a sub-committee of the Blood Study Advisory Committee.) Their plan is to study XMRV and the blood supply problem in four phases. A report of the first stage is given here. The second phase is to determine a diagnostic protocol for XMRV testing that will allow for broader examination of the blood supply. The report of the second stage was scheduled to be released in early November, but this release has been delayed without explanation. The PA imagines that something concrete will be presented at the December 14th meeting.
Indira Hewlett, Francois Villinger, Micheal Busch and Rachel Bagni will also give presentations.
Following the presentations there will be both an open public hearing and an open committee discussion. As usual it is here where things are apt to get interesting.
The Patient Advocate has attended a number of these FDA advice or recommendation panels - mostly regarding diagnostic tools for diabetes. These panels are composed of various government scientists along with a healthy dose of academics. The dynamics of the public forum are always the same. Very articulate but powerless patients or advocates stand up and in a very compressed time period argue their points to indifferent and ignorant functionaries. Many of the panel members, half asleep, are hearing the information for the first time, and nod off under the pressure of their ignorance. They will be called upon to cast their votes at the end of the day. Often these committees are in the grips of two or three "important people" whose guiding principle is "answers first, questions later". This process leads to one recommendation absurdity after another in an endless array.
The "discrepancies" between the advocates and the committee members couldn't be greater. For the objective observer, the situation challenges any known form of reality, and one is apt to become unmoored by the absurdity of it all. It has always been the PA's opinion that these two groups should trade places - allowing for real change.
The open committee meeting is even worse. With an exception or two, each panel member tries to position themselves, with a mixture of confidence and imbecility, with the majority - or with what they perceive to be the majority. This "territory" can be shifting and dangerous at times. Often there are palpable and anxious vibes of members desperately trying to figure which way the wind is blowing while at the same time trying to cover their asses. These folks are real professionals with a capital P- and are to be deeply admired for their detachment.
The stated purpose of this meeting is thus: the FDA is seeking advice. In this case the Patient Advocate thinks that they will get it. What they do with the advice is another matter. One thing is clear. The FDA will ban CFS patients from giving blood in the US. (ME/CFS patients blood donations have already been banned in the UK, Canada, NZ, and Australia.)
While taking this step the FDA will reassure the public that all is well (in spite of the fact that at least two new retroviruses are in the blood supply and maybe as many as four), that this is just a prudent and precautionary step, necessary to protect ME/CFS patients from themselves. Later the full extent on the presence of these viruses will be determined, but the FDA and HHS will try to take their time with this. The pertinent question is whether the government can really get on top of this situation at the moment - or whether their fatal errors of the past condemn them to always being behind in managing the situation. The Patient Advocate would put his money on the latter.
The good news is that circumstances, i.e. reality, has taken over and the situation is driving itself. The only question is how to speed it up.