Monday, October 24, 2011

Rituximab and the Press

Recent events have reminded me of Dr. Marcus Conant's admonition "Do not trust the press. They are not your friends". According to Dr. Conant, a veteran (and great, selfless hero) of the wars on AIDS, the press has their own agenda - and they do not have our interests in mind.

At this moment we have to ask ourselves a question. Why has there been so little mainstream news coverage of the Norwegian rituximab study and ME? In the last few days, the Norwegian rituximab study with ME is seeping very slowly into the mainstream. But it is small potatoes compared to the flood of crap vomited worldwide in the supposed demise of a retroviral involvement in ME. (Incidentally this retroviral story is not over. Dr Mikovits and others will resurface and continue their research into HGRVs. And it is worth remembering that Dr. Mikovits was early on in Norway trying to find out about these cancer scientists and Rituximab. Dr. Mikovits has always been open to suggestion.)

It is one thing for the press to ignore a story. It is quite another to frame out a story incorrectly - especially if it masquerades in the same phony guise that ME has been characterized for the last 25 years. This becomes tiresome - and disingenuous. These hapless press stories of the past two years lead nowhere. They can just be heaped up with all the other ME dodges of the past.

It is not true that any press is better than no press. A truthful story line is important. I wrote a post on this subject some months ago called The Story Line.

In the last year, four mainstream journalists - Amy Marcus, David Tuller, Trine Tsouderos, and Michelle Fay Cortez - have decided to get involved with the retroviral association to ME story - each for "their own reasons". All of them have developed the sometime habit of writing about ME. Each goes in a different direction, each with no cohesion of story. Why is this so, Marvin Macy? For the rest of us the reason for these disconnects is especially unclear right now. The neglect in covering the Rituximab study with ME calls into question all these journalists' previous motivations. It makes us suspect. What was their agenda? What were they really interested in?

In the last few years something quite different (than what is depicted in the press) has been going on in the research and treatment world of ME. In the last few months, amidst the worldwide , hyperbolic "take out" of retroviral research into ME, various other researchers have been plugging along - and expanding their interests. These include Dr. Jose Montoya at Stanford (in collaboration with Dr. Ian Lipkin at Columbia), the newly announced Chronic Fatigue Initiative at Harvard, Columbia (again Lipkin) and Duke, financed by the Hutchins Foundation, the impending opening of a treatment and research center at Mount Sinai in NY with Dr. Derek Enlander as one of the clinicians, the Simmaron research group of Dr. Daniel Peterson and associates in alliance with Bond University in Australia - to name just a few. To this, we might mention the ongoing research of Dr. John Chia into enteroviral involvement in ME, the disciplined, longstanding work of Dr. Nancy Klimas in Miami, the Lights in Utah, Dr. A. Martin Lerner in MI, and Dr. Kenny de Meirleir in Belgium. And we do not want to forget the WPI, which will reconstitute itself and make important additional contributions. This list goes on, and apologies to those left off. It is an exciting time. A great consolidation is taking place. Does anyone get the idea that the press is trying to tell this story - to explain or sell this consolidation? In no instance are they "on this story".

And now comes the Rituximab study - seemingly from out of the blue. This is a major story in ME, perhaps the major story. The picture is best expressed by Dr. David Bell in this short youtube clip. Meanwhile, where are our "friends" in the press? Are we to accept and believe the lame excuse that mainstream journals do not cover small phase II trials? Are you kidding me? I would surmise that Dr. Bell would trade in all the "human interest" stories on ME for one decent accounting of the current research into this illness - especially regarding this Rituximab study.

Over the years there has been so little consolidated research in ME. One of the big hopes is that something will "slop over" from another drug study in another disease. This appears to be what has happened here - pure serendipity (combined with the observations of two very insightful cancer researchers). Perhaps we can expect more of this in the future? Let us hope so. In the meantime, this Fluge/Mella study, and many other items, convince us that certain scientists have fantastic minds for making unexpected connections.

We can all make up our excuses why this trial means nothing - it is "too early", it is "too small", the researchers are Norwegians, the drug is really dangerous, we don't know the mechanism, it is better to wait for more trials, how could ME be an autoimmune disease - the list of negative thinking goes on and on. It is worth mentioning again, at this point, Dr. Bell's startling statement: "I have not seen results like this in any medical study in the twenty-five years I have been in the field. These are extraordinary results".

Meanwhile Fluge and Mella move on to larger and more specific trials. A new trial will test Rituximab on four of the most severely ill ME patients. (If you need to be educated on this patient group, watch the powerful film "Voices from the Shadows".) These two Norwegian researchers have been backed by the Kavli foundation to find a blood test marker for ME. We can expect this research to continue and grow, most likely extending into Sweden. Several clinicians in the United States have their eye on trials with Rituximab.

The story of ME, in all its sordid reality, lies there at our feet, ready to be told. Who will tell it? What journalist has the courage to tell it? There is no longer any uncertainty. ME is a nasty and dangerous disease. The patients with ME and their caregivers have been abused for years. This study tells us that this serious disease may need a serious drug. ME is most likely viral in origin involving various immune abnormalities. It is very possibly communicable. This Rituximab study opens additional doors to research. The urgency is now. Too many patients have already gone down the tubes with astonishing neglect.

Even "the end of the story" is provided now (for journalists). They no longer have to speculate and fall back on their threadbare notions. Consider the amazing admission of the Norwegian Directorate of Health in the wake of the published study on Rituximab.

"I think that we have not cared for people with ME to a great enough extent. I think it is correct to say that we have not established proper health care services for these people, and I regret that."

"Such a public apology from a governmental health agency has never occurred before."

How long do we, in the United States, have to wait for our story to be told, for our apology?

Wednesday, October 19, 2011


The long-awaited Norwegian study on Rituximab and ME was finally published today. This story is here. This is a very big deal. It will be interesting if this is picked up by the mainstream media, and this reality will be a key to determining if ME has reached a higher level in the the consciousness of "Important People". Where are Amy Dockser Marcus and David Tuller when we need them, when there is a real thread or story to be followed? I mean it is not like they didn't know this was coming?

Many who had seen the presentation by the two Norwegian cancer researchers, Drs. Fluge and Mella, at the InvestinME conference in May in London, or had seen the subsequent DVD lecture, knew what was coming - and awaited the official publication with excitement. This is going to open up an entire potential new branch of investigation of ME as an autoimmune illness characterized by immune disregulations. This association, which needs further study, potentially puts ME a step closer to an acquired immune deficiency. Another door has been opened into research and treatment - but many new questions can now be asked.

These two Norwegian cancer researchers stumbled upon the association of Rituximab and ME by serendipity. However they immediately realized they had struck upon something interesting, and aggressively pursued a double-blind, placebo-controlled trial with thirty patients. While the trial was small, the results were impressive.

A larger trial is underway, and we can be assured that these two researchers will continue to pursue and investigate this treatment - even though it is a side-light to their main cancer work. Both these researchers give the impression of being extremely serious in their studies - and they make no false claims. They are both cautious and optimistic.

Other clinician/researchers will also pick up on this study and build on it. Further studies investigating treatment protocols, involving dosage and timing, with Rituximab or with upcoming drugs in this class will now also occur. A ball has started rolling here. Clinician/researchers in the United States and perhaps elsewhere will explore the use of Rituximab off-label in ME. Kogelnick in CA is rumored to be doing a trial with Rituximab. Peterson is known to have interest in this drug. One can imagine the WPI or the new Mount Sinai ME/CFS research and treatment center giving Rituximab a try.

The most interesting thing about Rituximab is that it is an existing drug that is heavily used world-wide. Rituximab is not without side effects, but future drugs in the same class promise to be more tolerable and safe.

Cort Johnson has written an excellent essay of Rituximab in December 2010 and I refer you to that here.

Thursday, October 6, 2011

IACFSME Conference - Ottawa

I imagine that the organizers of the recent IACFSME meeting in Ottawa were surprised when they stepped out of their cabs on Wednesday, September 21st, and found the conference site, the Delta Hotel, was "under construction". For weeks the hotel website indicated that this was in the process of happening. This reality made for a shoddy start for what was billed as "an important conference". The flighty title of the conference was "Translating Evidence into Practice".

At first blush it was difficult not to see this "construction thing" as a symbol - a symbol of the current state surrounding this illness, and particularly of this conference and its organizers. This was not a good start. The hotel employees were quite cheerful about it all, happy I suppose to have this group show up. Somebody has to keep the hotel going, and it might as well be unwitting IACFSME conference attendees.

The consequence of this renovation was that fully one third of the ground floor and first floor of the hotel was unavailable for the conference. Most people are aware that 83.3% of meaningful interaction at conferences takes place in "informal settings". Researchers and clinicians find places in the lobby to meet and exchange ideas - and at all times of the day. Insomniacs stumble through the lobby and have fascinating conversations with strangers from half-way around the world. This is what hotel lobbies are designed for - the random meetings of people under relaxed circumstances. This is where shit happens. In this case, this part of the conference was canceled, and, not surprisingly, it had a negative effect on the atmosphere. There was no place to sit down - except for a ground floor bar. Outside of the conference room itself there was no place to sit and watch people come and go. Upstairs there was a room for patients to rest - but otherwise patients also had no place to sit, rest and enjoy the atmosphere.

The interior itself was very claustrophobic with the hallway spaces constricted with newly installed sheetrock and plastic drapes. The entire front part of building smelled of mold, dust and debris. Various fans were set up in the hallways to "circulate" air or to "filter" air, but from what or to what? None of the fans were vented outside, either for intake or outtake. It was difficult to determine what these fans were actually doing. One had a label of "Hepa" but every vacuum cleaner and fan in the world has the label "Hepa" on it. On the last day of the conference, the fans were shut off, and the side doors to the outside were open. This was the one moment with an "inside-outside" experience, where one did not feel quite so entombed. I wonder how many people besides me got sick in this building?

The first day was the Patients Conference. This set of lectures painted in broad strokes the nature of this illness and the research into it. Comments from patients ranged from it being "a massive overload of information" to "not presenting anything new". The bottom line is that this day performed its function very well, particularly to those new to the illness. They got to see Byron Hyde, Nancy Klimas, Annette Whittemore, Alison Bested, Leonard Jason and Anthony Komaroff. What could be better? To the newcomers, all of this is incredibly fascinating - and this day was very important for them.

The second day featured a bit of grandstanding by the conference organizers. They made a weak attempt to recreate the "lightning in a bottle" of the April NIH confrontation between Coffin and Mikovits - a day that seems so far away now. In spite of the build-up, this was not "the biggest presentation of Mikovits' life". That day occurred in July 2009. There was an aspect of "a chronicle foretold", and the struggle over a gamma retrovirus involvement in ME will continue. Dr. Mikovits' slides can be seen on Dr. Deckoff-Jones' blog here. Dr. Coffin seemed a bit subdued and meandered on his way, with his little bag, presumably back to Boston to see his Red Sox get smushed.

Shortly before this encounter, the audience was treated to an excellent lecture by Dr. Maureen Hanson. This woman has a fine way of delivering a lecture, presenting information in a clear and palatable form, with just enough humor and tantalizing possibilities to keep the listener riveted. Dr. Hanson gave perhaps the best lecture with a cadence and delivery of someone in touch with and at ease with her subject.

The poster papers went up on the morning of the second day - the beginning of the "Professional" conference. I never have been able to understand why the "first day" patients are not privy to this information. Many of the most interesting research items are presented at the poster sessions. Here again there were no chairs to sit down - no chairs for patients who might be in attendance. I assume that these poster papers will be made available on the internet - but you never know with "these people". They sell a DVD set for three hundred dollars, very much beyond the reach of most people. Perhaps the poster papers will be in the DVD but I would prefer to see them online for nothing. InvestinME does something quite different. They sell their DVD for $20, or, if you can't afford it, they give it to you.

There were about 50 poster presentations. The common denominator was that all were underfunded. I took special note of the posters on GcMAF. There were several of them. Dr.Cheney presented the results of a MAF 314 trial in August in collaboration with Dr. Marco Ruggiero. Marc Fremont presented an interesting poster on Redlabs new Metagenomics fecal analyis, which promises to link up with GcMAF treatment in a useful way. Dr. Shoemaker presented a paper on a small trial with VIP. There were several presentations on low NK cell function, as well as various papers on the working of various diagnostic markers. A Japanese team, working with rats, found the bioflavanoid resveratrol regenerated the atrophied hippocampus. (I immediately reached for my bottle.) Rich van Konynenburg had an update of his independent and crucial research. Recently Rich went to Sweden to give a lecture and his three hour presentation can be viewed here. Here the viewer will find "Everything one wants to know about glutathione - and more". Check it out.

There were many other worthy poster presentations that are not mentioned here.

The third and fourth days were filled with a dizzying array of lectures on various subjects. As usual, it was difficult to find the thread. For a full accounting of the research presentations on these days, I direct you to Cort Johnson's site. Currently there are "quick hits", but soon will be more extensive and detailed examination of the presentations. Cort does an amazing job of summing things up and of finding a coherence to the various threads of research that were presented. I noticed that Cort "takes notes". To me, this seems like cheating. No wonder he can put together all this information in a coherent fashion.

Saturday night's banquet featured a talk by Dr. Byron Hyde, the Canadian veteran ME clinician. He gave a presentation on the history of ME outbreaks. Various well-deserved awards were made - to Leonard Jason, Mary Ann Fletcher, Lydia Neilson, Ekua Brenu and Ellen Piro, The winner of the researcher of the year was Nancy Klimas. This was a nice choice, but could there have been a better one, a more fitting one? Yes, there could have. The IACFS could have given it to Dr. A. Martin Lerner. What were they thinking of - to not have done this? (I ran into Dr. Lerner in the elevator on the first day. He was his usual friendly and enthusiastic self - and said that he had a very exciting announcement - ME/CFS is definitely a heart problem - and that he has Holter monitor, and Echo data to prove it. )

The conference was attended by many familiar faces, Klimas, Fletcher, Broderick, Cheney, de Meirleir, Fremont, Lerner, Mikovits, Baraniuk, Hyde, and so forth. However, this conference was also defined by who was not there. Notable figures were missing - for various reasons, some bordering on the absurd. For instance, Dr. Enlander was not in attendance, nor was Dr. Brewer or Dr. Levine, or Dr. Guyer or Dr. Shoemaker or Dr. Natelson or any of the UK physicians. I had hoped to see Dr. Michael Dean or Dr Theoharis C. Theoharides, both of whom attended the NIH conference. No one from the CAA attended. What was that all about? One wonders why so many people did not show up? Some would say that these "absences" had no effect on the success of the meeting, but I would beg to differ.

I tend to focus on clinician/researchers. I suppose this comes from my own sense of urgency - of wanting to get on to treatments. Personally I would like to see a small clinician/researcher-driven conference, more in line with the InvestinME conference. I would like to see more concentrated discussion of treatment options and focused discussions among doctors and researchers who understand this illness and/or have clinical experience. I would like to see more coordinated, structured talks on biomarkers, and a broader, focused discussion of options for treatment trials. The time to do this is now. The Ratna Ling group and the InvestinME conference give us the examples to follow. I would like to lock in a room various people - Brewer, Cheney, de Meirleir, Guyer, Klimas, Bell, Enlander, Myhill, Levine, Peterson, and Montoya - and not let them out until they agreed on something in regards to diagnostics and treatment. I know it is there. Why can't this happen?

There are other important things on which to focus. Many are intent on continuing the search for a viral or retroviral insult with this illness. More are convinced of this now than at any time in history. This is not 1992. The question is how to deal with this, how to move forward with existing or new therapies. Those who think that the final pounding has occurred with HGRV had better think again. Retroviral drugs, in a few people, are working against something. Most likely they are the wrong drugs and the wrong dosage, but there are possibilities in this direction.

I spoke to Dr. Peterson while we were waiting to board a plane in Ottawa. He emphasized that there were now three options for treatment - Ampligen, Rituximab (Rituxan) and anti-virals. (I don't think he was including anti-retrovirals.) And there are other options that he did not mention.

Meanwhile the Hutchins foundation has pledged ten million to study viruses in this illness. Leading their study is the ever-present Ian Lipkin, who has a powerful idea about himself. He certainly has the equipment and the lab to probe deeper into the viral cause. The question is, will he build on recent experience and find what already has been found? I think many people would be perfectly happy if he did this.

Further information:
It looks like the Chronic Fatigue Initiative (despite its terrible name) is going to do some of the studies that the CDC should have done years ago. They’re using both the Canadian Consensus Definition and the CDC’s “empiric” definition. This seems to be a mistake at first glance, but, if they analyze the two groups separately and show that the “empiric” definition doesn’t really define anything, it could be useful.

Specifically, the CFI is funding some important epidemiological research at Harvard. Researchers there will look at a large group of nurses and health professionals that already have been followed for many years to see who develops “CFS” and what happens to them over time. Hopefully, this will provide the longitudinal picture of the disease that has been lacking up to now, as well as insights into predisposing factors. They will examine a large sample of men and women with “CFS” to determine what environmental exposures they have had. This, too, has been poorly understood. Hopefully, they will be able to begin to understand whether viral infections lead to environmental sensitivities or vice versa (i.e., environmental exposures adversely affect the immune system which makes patients prone to re-activation of old viral infections or acquisition of new ones). This population of patients, as well as the group of nurses, apparently has blood available from both before and after becoming ill, so there is the potential to look at what specific triggers do to various blood tests. This could enhance our understanding considerably. One hopes that they will also be looking at geographic and family clusters--if not now, soon.

CFI is also hoping to clarify pathogenesis by recruiting 200 well-characterized “CFS” patients with the help of Drs. Klimas, Bateman, Peterson and Montoya, as well as 200 healthy matched controls. They will collect clinical data and biological samples from the two groups, looking for clues about what causes the disease. They will store the biological samples in a centralized biobank at Duke University. The samples will be available to other researchers for study. Once this database is complete Dr. Ian Lipkin and Dr. Mady Hornig will be using the samples to look for novel viruses or other pathogens. Again, this is a long-delayed effort that is sorely needed and has the potential to be very productive.

Finally, the CFI is establishing a program called Mechanism of Illness that will provide grants for research looking for the mechanisms involved in “CFS”. The first grant is funding a Fellow in Infectious Diseases at the New York Presbyterian/Columbia University Medical Center. It is important to train new clinicians and researchers who will spend their careers studying and treating ME/CFS. We can hope that other grants under this program will advance the understanding of ME/CFS.

The CFI states that its aim is to fund programs which will stimulate interest in “CFS” and result in increasing commitments by other institutions to research. Certainly, the efforts of the WPI over the past two years have done that. We can certainly hope that the CFI will help to continue that momentum.

Online screening: Voices from the Shadows

Natalie Boulton and Josh Biggs' ME film "Voices from the Shadows" will be available for people in the USA and Canada to watch free of charge online - during the Mill Valley film festival, where the film is being premiered. The film festival runs from October 6th-16th and the free screening will be extended to October 30th. The film will be able to be accessed for streaming at It will not be downloadable.

This screening is available through a Mill Valley/MUBI collaboration. The will be more information on the website:

This is a timely event. Today is a very good day to reflect on the serious nature of this illness, Myalgic Encephalomyelistis - and to expand the knowledge base of information so that necessary research and treatment can move forward for these neglected and abused patients.

This is a must-see film.