Monday, April 29, 2013

Fish or Cut Bait

Regarding the April 25-26th FDA meeting, this much can be said. There is the real world - and then there is the world of the government. These two worlds do not intersect at any point.

In the real world of ME/CFS, research and treatment are moving along, government or no government. There are hints and suggestions that a certain dynamism is occurring - perhaps for the first time ever.

One extremely bright spot is the upcoming InvestinME conference in London on May 31, 2013. I cannot say enough positive things about this conference, and the reader can access my previous posts about this conference. This is the sixth year I have attended this conference. Thanks (in abundance) goes to Pia and Richard Simpson (and their friends), the organizers of this 8th annual InvestinME conference. The title of this year's conference is: "Infection, Immunity and Myalgic Encephalomyelitis - Mainstreaming Research into ME". I cannot imagine a more apt title to describe where this conference is headed this year.

This conference is an intense, compact, knockout set of presentations, entirely directed towards biological research into ME/CFS. There is no bullshit here, no fluff, no pandering - and the day is long and difficult. But it is also enthralling. The organizers tailor the presentations to provide a strong research thread from the past, while, at the same time, offering new research avenues to a broadening understanding of this illness.

The conference Chair this year is Dr. Ian Gibson. In this tight-packed day, this job takes on a heightened importance, requiring the chair to forge links between research threads, and to guide speakers along in a commonly focussed direction - so that the entirety takes on some cohesion. I personally am a great admirer of the skills, nudging abilities and humor of Professor Malcolm Hooper, who has done this task at a number of these conferences.

Dr. Andy Kolgenik will return for the third year in a row. Dr. Kolgenik's research and treatment is ever expanding with more clinical data. Most likely Dr. Kogelnik will present updated ideas coming out of his Open Medicine Institute. (It is generally known that Dr. Kogelnik and Dr. Dan Peterson have a close and strong working relationship. Dr. Peterson is a regular attendee at this conference and has lectured here on a number of occasions. (Dr. Peterson will be attending this year's conference.) Dr. Peterson recently presented a retrospective study of infused Vistide in ME/CFS patients. The results, generated by his research institute, Simmaron, were impressive - and give further weight to the reality that here are existing treatments for this illness, a reality that the CDC has completely ignored. Cort Johnson reports on this study here. Not only does the study encourage broader use of Vistide but it also points with some optimism to the future use of an analogue of Vistide, CMX001, now in clinical trials.

Dr Sonya Marshall-Gradnisdik will return, presenting further her work on NK cells. This research is very promising for a marker or markers, and perhaps clinical tracking for this illness. (Incidentally Dr. Jose Montoya indicated to me at the FDA meeting that he was working hard on a cytokine signature for this illness and should have some results in the next six months or year. Dr. Montoya does not want to be rushed and wants to "get it right".)

Dr. Fluge and Dr. Mella will also be returning, perhaps with new information about their follow-up treatment on the original Rituximab patient cohort and perhaps on their trial of Enbrel. (Some might remember that Dr. Jonathan Kerr proposed a study on Enbrel in 2007, but he was turned down in his funding application.) Hopefully the momemtum on Rituximab treatment options in ME/CFS will gain some traction.

New researchers this year include Dr. Mady Hornig from Columbia. She promises to describe some results of the pathogens study under the aegis of the Chronic Fatigue Initiative, financed by the Hutchins Family Foundation and directed by Dr. Ian Lipkin.

Two new immunologists will speak - Dr. Carmen Shelbenbogen from the Berlin Charitie and Dr. Amolak Bansal from Epsom and St. Helena University Hospitals in Surrey. Professor Greg Towers, a virologist from the University College London will also speak.

This year's conference promises to yield more and deeper collaborative efforts between researchers and clinicians as bonds are formed among individuals who have a certain like-mindedness. More importantly, these individuals are not confused about whether this illness exists, nor are they disbelieving of the serious nature of this illness. None of these presenters have to be convinced that these patients are seriously ill and debilitated with measurable immunological abnormalities.

Dr. James Baraniuk will not be able to return this year - as he has a conflicting engagement. I was able to speak at some length with Dr. Baraniuk at the FDA. His brain research is terrifically exciting. In presentation, Dr Baraniuk generates a certain confidence and clarity. I have long felt that Dr. Baraniuk's research is going to have a profound impact in the field. His most recent study can be read here. I understand that other papers will be forthcoming. His NIH grants are continuing at a sufficient level where his research can be ongoing.

Fortunately Dr. Baraniuk's colleague Dr. Rakib Rayhan will be making a presentation at the InvestinME conference. From the InvestinME website: "Dr. Rayhan's desire is to identify potential biomarkers that provide objective support to disease criteria and that are translated into new and affordable therapies leading to a better quality of life for patients."

Last year InvestinME introduced a pre-conference, invitational roundtable (with the same subject as the conference). The roundtable took place on the day before the conference. Last year's subject was autoimmunity and featured a number of researchers from potentially allied autoimmune illnesses. The invited guests, including the conference speakers, spent a full day exchanging ideas. This exchange has proven to be very effective in forging new and sometimes unexpected alliances. What could be better? There are various ways in which to encourage exchanges between experts inside and outside the field and all conferences and university research facilities should be exploring ways to do this. The Ratna Ling model, ending in 2008, sets a nice example.

In the evening of this roundtable day, there is a dinner where further, important exchanges occur.

It is my hope that various clinicians, researchers, advocates (and perhaps a few semi-well or partially recovered or recovered patients) from the United States can go to this conference. This conference has always been woefully underattended by Americans (except for presenters). It is a black hole in the United States. This makes no sense. Shit happens at this conference, and more American "doers and thinkers" should just suck it up and go.

There should be two of these conferences per year - with the other one taking place in the United States. Someone in the US should "look and learn". The current US model for an ME/CFS  conference - a four-day biannual conference for "Professionals of all stripes" - really sucks.

By the way, the FDA should fish or cut bait. After this two-day FDA conference on April 25th and 26th, the FDA can no longer plead ignorance about the true nature of this illness. They have an opportunity now to "send a signal". They should start with a significant move to get Ampligen approved for this patient population. What has happened with Ampligen is a first-rate travesty.


  1. The conference sounds great, Chris. I wish I was well enough to attend. They usually put out a DVD of it which they sell to raise research funds. It sounds like a fantastic programme.

    I like your idea for two conferences a year - one in the US, one in the UK. Lots of international academic societies do a similar thing - e.g. alternate years in the US and Europe or wherever, depending on where most of the researchers are based.

    Given the state of the science (scarce), we can't afford not to have our scientists not regularly meeting up in the same room.

  2. Many of us in the United States would dearly love to attend the Invest in ME Conference and spend a few days in London. However, the fact that I am much too ill to travel excludes the possibility possibility of my attending. In addition, of course, being much too ill to work has had a considerable negative impact on my financial situation, and a trip to London is prohibitively expensive for many people. Please remember that many of us do not have the health or the resources for such attendance.

    I greatly appreciate your attendance of these conferences and reporting on them to us, since many of us are unable to attend.

    I, too, am most grateful to Pia and Richard Simpson (and their friends), the organizers of this 8th annual InvestinME conference. I am even more grateful to them for recording the conference sessions and making the recordings available to those of us who are unable to attend.


  3. For so long as researchers refuse to look at the phenomenon for which Dr Peterson called the CDC for help with in 1985, leading to the CDC investigation and subsequent creation of the Holmes CFS criteria, they will not be looking at the phenomenon that started CFS.

    I don't give a damn who they think they are, what they are studying, or what fine credentials they have. No interest in the entity that CFS was based on, equals no interest in the reasons there IS a Chronic Fatigue Syndrome.

    These fine so-called "CFS researchers" would never have helped us with this phenomenon any more than the CDC "didn't"

    Given their refusal, they really have no right to speak about CFS at all.


  4. The FDA did not make any attempt to deny the illness, and it is not up to them to "Step up" and do so.
    Identifying epidemics and elucidating etiologies is not part of their job description.

    My take on this meeting was that a chance was given to the CFS community to "make their case" in a public forum.

    And the case the CFS community made is that regardless of what "ME and CFS" may be, the condition is far too "Heterogeneous" to be thought of as discrete, or even coherent entities that can be effectively diagnosed.

    The "select CFS panel" made their case, again and again. The suffering is terrible, but the illness can be "caused" by just about anything from a virus or bacteria, to potentially driven by maladaptive behaviors.

    The minimum requirements for drug-testing can not possibly be met.

    The way the CFS community portrayed CFS
    (and ME) makes it impossible.

    Considering the way Ashley Slagles statement reiterating the reasons for denial seemed to have been previously prepared, it seems plain that they knew beforehand that the CFS community was going to do exactly what they did.

  5. Thanks to CFS Patient Advocate for "failure to delete" an Incline Village survivor for speaking his mind.
    A rare thing.

    It gives me hope for a few more honest people, though they be few and far between, scarcely to be seen.

    Here is something I want to say to the mob-rabble self-destructive "CFS Dis-unity".

    I don't want to hear any more trash-talking complaints about the CDC's "Failure to Respond"

    NOT when CFS groups are WORSE.

    If "CFS groups" refuse take an interest in the circumstances that started the syndrome. but rather, censor, delete, moving only to strike me down and crush clues, or simply make their concerted-indifference clear by sheer silence,
    their brazen hostility and hypocrisy towards the Tahoe outbreak are a million times WORSE than the very accusations they make of the CDC.

    It is the mindless mob CFS-Disunity crowd that needs to cut the hypocritical crap.... or get off the pot.

  6. The CFS community has made its decision.

    It is total hostility and all-out war on the evidence that started CFS.

    As an Incline Village survivor and original prottype for the syndrome, I declare "CFS" to be null and void. Self-destructed by its own "constituency".

    You better believe I can prove it!

    "Let me make something perfectly clear. The illness entity known as CFS, based on an outbreak of ME Plus, has never been fully investigated by
    anyone. Not one researcher has examined all of the evidence that caused the creation of this syndrome. NOT A SINGLE ONE. After nearly 30
    years. This is a disgrace of epic proportions. A disease that has brought brutal,relentless suffering to now millions of people and yet we have
    evidence that has been around since the inception of the syndrome that has never been examined."
    -Jeri McClure Kurre