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.


  1. As always, the Patient Advocate gives honest insight into the FDA Blood Advisory Committee, and what can be expected from it. The FDA will ban CFS patients from giving blood in the U.S. but will not admit that retroviruses are in the blood and will try to stall more, in spite of the facts.

    Patricia Carter

  2. This is all reminiscent of the early days of HIV, prior to the FDA requiring blood screening for all blood supplies. It would be prudent to get the advisory committee to recommend screening all the blood supply as we know from data from Ruschetti's lab from the NCI has identified XMRV in samples as far back as 1984 stored plasma. The retrovirus is most likely already in the blood supply.

  3. I have sent this to a couple gov. officials. I know this site has a lot of traffic. If you feel like I do, feel free to copy and send to officials of your choosing. CFS people unite!

    I protest the disproportionate diversion of resources to national security, drawing away from other deadly issues like food, water and disease. The FDA, CDC, NIH and nongovernmental organizations including the AMA are ineffective bureaucracies that have become impotent and highly political. Failing to disband these organizations will likely cause such a drain on resources; proportional to contributions, society will collapse down to a less advanced form, weakening civilization. Simple minded over-commitment of resources to Military Might ignores other serious, but far more deadly threats to existence. In fact, the vast majority of people die from causes other than war or violence. Currently my life’s value is nothing even close to a violent persons’ who receives unlimited Gov. Funds, for example, bin Laden; absurd.

    Presently a perverted motivation exists globally to exterminate others that are not like minded. Those of us stricken by chronic illness have been betrayed by our fellow citizens. The minority members of the world; violent, angry and dogmatic are SOCIOPATHIC MANIACS bent on dominating and controlling everyone worldwide. Society at large is behaving like mindless Lemmings, allowing the agenda of the Fear/Defense complex to dictate the direction of society. Disproportionately allocating resources to the Science of Killing rather than the Science of Advancing Humanity.

    Spending for defense in 2009 was $494 Billion, AIDS research spending was $3 Billion, and spending on my type illness, Chronic Fatigue, research was $3 Million! As this catastrophic illness gains understanding, the affected population is predicted to be much larger than HIV, but comparatively only receives one tenth of one percent (%.1) in research spending. It is predicted to be a much larger killer than previously realized (implicated in heart failure and numerous other energy related illnesses) killing considerably more people than war, yet funding for stopping this killer is so miniscule it cannot be compared to defense spending (six ten thousandths of one percent, %.0006), paltry insurance.

    Millions are being killed outright by this sociopathic agenda, and billions are dying from willful disregard. There are only two classes in this issue; those killed outright because of Mass Paranoia and those killed by neglect, like me. This is an ignorant misallocation of resources. People killed by accidents, age, or disease would all benefit by better medical knowledge, treatment, and equipment. Human misery would be eased by science focusing on easing suffering rather than inflicting it!

    I believe history will compare this era to that of the Middle Ages and numerous other eras of social darkness. (Provided the WAR MACHINE does not destroy ALL life.) Socially we are inarguably regressing; this catastrophic inability to distinguish socially constructive investments, verses socially destructive investments has likely caused most civilizational collapses. From the Inca Empire, to the Egyptians, and more recently the Roman Empire. The dangers of the current social path are too cataclysmic to ignore.

    Judging from this stunning lack of hindsight/foresight, perhaps more Empire Failures are inevitable.

    PARANOIA is a Psychosis!

    Participants need to be treated as Mentally Ill! NOT allowed to dictate national agendas!

    Our leaders are leading us into Hell!

  4. I worry as time goes by, days become weeks, weeks become months and months will become years. At the Agenda the 29th of March in New York, Mikovits and Lipkin. It sounds stupid, but in my case I have no choice, I look forward to this date. Just like I looked forward to the 14th of December. What will be next? A date somewhere in July or September. I wait while my life is passing by.

  5. One question I wish I could ask the committee members is which one of them is next for this disease? because we (the patients) cannot stop this alone.

  6. I feel there is one big difference between XMRV and HIV: we are not dying. This seems to me one big reason why all this terrible stalling is possible...


  8. We simply adore you dear Patient Advocate...

  9. Ackuity. U has it.

    LOLCFS, "I can hab integritty".