Monday, June 10, 2013
“You can’t have a disease without a gut problem.”
“None of these other therapies will work unless you deal with the gut.”
Paul Cheney, M.D, 2009
Professor Simon Carding, from the University of East Anglia and the Institute of Food Research, gave a talk at the 2011 Invest in ME conference entitled : ‘A Gut-Brain Link for ME/CFS’. It can be viewed on the Invest in ME 2011 conference DVD. Prof. Carding studies the gastro-intestinal tract in an effort to understand the relationship between our immune response and gut function and, in particular, how the microbes that reside in the gut and environmental microbes cause disease. In his 2011 talk, Prof. Carding discussed a very interesting theory regarding the breakdown in tolerance of commensal gut bacteria and illnesses such as in inflammatory bowel disease, where the body’s immune system is activated because it can no longer ignore or tolerate these microbes. This work highlights the possibility of probiotic treatment for those with ME/CFS who are found to have this intolerance.
Dr. Carding regular attends the Invest in ME conference. He was present at the conference last week as part of the one-day invitational discussion on "Infections and Immunity in Myalgic Encephalomyelitis". He also was a contributor to the 2012 roundtable discussion on "Autoimmunity in ME/CFS".
Dr. Carding, along with Tom Wileman, Amolak Bansal and others, is conducting a study of gut ecology in ME/CFS. Information on the study can be found here. "This project will determine if alterations in intestinal barrier function and/or microbiota exist in ME/CFS patients, and whether microbe-driven inflammatory responses can provide an explanatation for the pathophysiology of ME." The study hopes to reveal dysregulation in the gut ecology of ME/CFS, perhaps an overabundance or underabundance of some bacteria - or perhaps something completely missing. It is a three-year study and will involve potential interventions as the study unfolds and things are learned. So one will not necessarily have to wait until the end of the study to find out what might be helpful or potentially helpful.
Here is a youtube video entitled A Journey through Simon Carding. We will watch with interest the work of Professor Carding.
Among other things, it is understood that many ME/CFS patients have low Bifidobacteria. They also show a major disruption between Firmicutes and Bacteroidetes. Additionally often ME/CFS patients have low secretory IgA. The question is, can these items be augmented, can they be increased or balanced using prebiotics or probiotics? Testing can be done at Metametrix or Redlabs BE. The time to start investigating this on an individual basis is now.
The gut microbiome is an area of intense scientific study. On June 12, 20013 researchers from around the world are gathering at the New York Academy of Sciences on this very subject. The conference is entitled "Prebiotics, Probiotics and the Host Microbiome: The Science of Translation". Information can be found here. Gregor Reid will be making a presentation.
Friday, June 7, 2013
Thank you to: Alison Hunter Memorial Foundation (Australia) and the Invest In ME (UK)!
There is a plan.
There is scientific agreement, well thought out by many scientists in this room.
Now we need to pool knowledge, data and financial resources to get this plan in motion.
The chances are small for a local or national focus; this is an International problem that needs an International focus.
To quote Helen Keller, “Alone we can do so little, together we can do so much”.
The theme is Collaboration and Hope to conquer ME/CFS, which I will call ME today.
For patients with chronic ME, what matters most is that research be translated swiftly into effective treatments.
For new patients that have no idea what is wrong with them, what matters most is an accurate diagnosis with specific biomarkers.
For the rest, what matters is not getting this horrible life-altering, debilitating disease in the first place.
Collaboration was missing 7 years ago, when our 16-year-old daughter was struck down suddenly at 8:20 in the morning on day while at school, with a mysterious illness that left her bedridden for a year.
As a desperate parent looking for answers, I attended several conferences and left the conferences without HOPE or any words spoken of working together, teamwork or partnerships.
Today, times have accelerated in the right direction and you, like me are part of this global effort to understand and find answer.
We all know that collaborative efforts and sharing data will shave years off the discovery and intervention required.
It is wonderful that there are many patient organizations and local support groups for the patient community and there are multiple institutions around the world doing research.
It is time to connect the dots. It is important to take this separated effort and share gathered knowledge and analyze the data collectively. We can all connect technologically to fight this disease. I am convinced these answers are readily available if we apply the best resources in a large-scale, collaborative effort.
I was asked to speak to you tonight to tell you about the collaboration that is already happening at the Open Medicine Institute and Foundation.
Last June, we had a phenomenal breakthrough. After a successful gathering of scientific experts in a 2 ½ day meeting NYC, the OMI-MERIT Initiative was born. The Open Medicine Institute-Myalgic Encephalomyelitis Roundtable in Immunology and Treatment. The meeting was directed by Andy Kogelnik of the Open Medicine Institute and the MERIT plan now includes 27 scientists from 11 different countries, many of whom are here today.
The result of the meeting was a Big Plan, a top TEN list of priority projects collectively decided upon by this International cohort, which we call the OMI-MERIT Initiative.
This agreed upon comprehensive Plan is by far, the best solution and the best chance in the history of this disease to move forward to address the underlying disease process in ME with an emphasis on the role of infection, genetics and immunology.
As I sat listening in the meeting, I had hope for the first time that something might come out of this to help my daughter. Since many of you are part of this, I am honored and thankful to you and encourage all others to join the team and the open platform.
As some of you already know, the MERIT Initiative includes:
· A 150-300 patient International Clinical Trial of Rituximab and Valgancyclovir.
· A Registry and Biobank including an unlimited international registry and detailed 1000 specimen survey.
· A Protein Panel study including over 250 patient samples to be run on a detailed array of protein platforms.
· Several Mono and Combination Treatment Pilots
· Two extensive Immunologic Biomarker Exploration Studies
· DNA Genetics Studies
· Measurements to begin to establish an understanding of the contribution of nutritional and environmental factors to ME.
· Comprehensive Viral Testing
· Pilots for Natural and Over-the-Counter Substances
More details of the projects are available in the IIME journal and on our website.
After the MERIT meeting, Andy Kogelnik said to me, now that we have this Plan, we have to raise the funds to do this; will you do this with me?
I said Yes, and last August we began.
We have the Big Plan; we have scientists that are already beginning some of this work and others that are ready to begin.
How can this giant step in understanding and cracking this disease be funded?
I will tell you where we are at so far. We are on our way.
We are grateful and excited to tell you about the specific projects that have been funded to date. Since grants have been given for specific projects, we will start those first and others as they are funded.
The Open Medicine Foundation has received an extremely generous grant from the Edward P. Evans Foundation to fund the most extensive exploration of genes and their contribution to this disease.
Using newly developed techniques never applied to ME and collaborating with Dr. Ron Davis, one of the top investigators in the field of molecular genomics, this grant will establish or refute a role for genetics in ME. The study will include investigations into the HLA regions of the genome, DNA methylation and other aspects as well as whole genome sequencing.
By the time the study is done approximately 1,000 ME patients will have taken part. The results will be available within the next 12 months or less.
Support has come from other donors in other fields as well. For diseases as complex as ME, we will heavily depend on IT support to collect, manage and analyze these huge amounts of data into actionable information.
Another grant that the OMF received this month was from the VMware Foundation; VMware is a global IT expert in cloud computing. VMware has provided an exciting grant of financial and consulting support to enable the Open Medicine Institute to enhance the information technology platform, created by Andy Kogelnik called OpenMedNet.
This grant will enable the OMI to collect, share, and analyze hundreds of thousands of data points on individual ME patients. This already powerful “Open-Architecture”, enables seamless sharing of patient data (compliant with privacy rules and with patient consent).
I know that many of you have piles and piles of medical data, like I still have for my daughter. Now you will be able to use the OpenMedNet platform for your own medical records and, if you choose, be part of research and allowing your data to be analyzed along with thousands of others.
The VMware grant will give the OMI the capacity to build a monumental registry.
Using OpenMedNet and funded by the CDC, Andy Kogelnik is continuing to collaborate with the top ME clinicians the US to look at patients in detail to see if and how diagnosing patients differed between clinics, to gather hard data to help address the issue of case definition, and to find the best ways of measuring this illness. In all 450 patients are in the study.
Another funded study that the OMI is setting up is a pilot study with an alternative therapy called Moringa oleifera. This was something that I instigated and funded through my personal nonprofit, Neuro-Immune Disease Alliance, NIDA. With a number of anecdotal stories of recovery with this substance, and the relatively low cost of doing a pilot, this will illustrate how low-budget science can also be beneficial in this field and needs to be done on candidate substances.
I came here to London to tell you about the global collaboration that began with the OMI-MERIT Initiative and I stand before you now, telling you that we have a chance to find serious solutions to help you and your loved ones get their lives back. For the first time ever, there is an Internationally agreed upon plan. There is hope.
What will it take to move this forward.
The MERIT projects are budgeted at $13.5 million American dollars plus overhead. We already have over a million dollars towards 3 projects, 10-15% of what we need to accomplish the entire initiative. Since the CDC estimates at least 8 million ME patients in the world, then all we need is $1.56 American dollars more from each patient to close the gap to fund MERIT.
In the meantime,
The OMI and the OMF are working hard to close the gap by applying for grants from government funds, industry, corporations, pharma, philanthropic and private foundations, the patient community along with patient advocates. Our website makes it easy for people to donate with just a credit card; we just had a college student donate $3,000 from a Volleyball tournament dedicated to her Aunt – an ME patient.
At the Open Medicine Foundation, we are working on a number of prospective large Foundations that often fund medical research. We are continuing to pursue all available avenues in our effort to find funds. All ideas are encouraged and welcome.
So what can you do Individually, with your patient organizations, scientific communities, friends, and family members.
There are two important ways you can help.
Number one, stand by us and join in raising funds to support this joint International effort. One BIG Initiative, One BIG Plan. Connect the Data on one platform. Let’s get the OMI-MERIT Initiative completed in less than 3 years and then see where it takes us next.
Number two and just as important, It is within your power to share your data, scientific and personal medical records. The system is free and will be fully functional in summer with an easy to use platform to enter your data and answer questions if you want to share it, with all privacy laws followed.
There is a flyer in the journal that gives the simple instructions on how to sign up and then you will be emailed when it is ready.
We ask you to share it with your members for those of you that are leaders of patient organizations.
We are encouraging as many people and organizations as possible to sign up to the OMF free e-newsletter or read it on line on our website, to give patients and loved ones HOPE on the progress of ME/CFS research, specifically, the OMI-MERIT Initiative and as projects come up, we will be able to reach out the patients and ask for their engagement if they choose to be part of the research, part of the solution.
The more data points, the faster the answers. Researchers sharing data, physicians sharing patient successes, patients sharing their history and organizations getting their members to join in the research effort as well as everyone doing what they can to help fund this world-wide effort, is the key to getting results in the shortest amount of time.
My personal greatest purpose and passion at this point in my life is to do whatever I can, to help find a cure, better yet, a prevention of ME.
I know that we all want this and am excited that I can leave this conference knowing that collaboration is underway.
Tuesday, June 4, 2013
Several friends have written to ask me: “How was the Invest in ME conference?” “Anything good?” I can answer them. It was good, - very good.
I started the conference day quite early with my usual long walk down to the conference site. It takes me down past Buckingham Palace, through St. James Park, past the Horse Guards and along Birdcage Walk. It was a fine enough morning although I was a little tired, not having gotten much sleep. (I am always anxious before this conference.) This part of London in the late spring is very beautiful and green - and quiet in the early morning. Along the way, I thought about my daughter and all the others who are so terribly limited by this illness.
Pia and Richard Simpson’s work to consolidate research in the field is beginning to pay off. Each year they carefully select a group of clinician/researchers to present their work, often bringing back certain key individuals year after year.
Such was the case with the opening speaker, Dr. Dan Peterson, who is working hard to create a legacy for his lifetime’s work. Dr. Peterson religiously attends this conference every year, whether he has a speaking slot or not. More clinician/researchers should be doing this - as a great deal of information is exchanged at this conference. I preach to whomever I can that this is "the place to be", but so far I have been unable to persuade any other Americans to take this trip. Americans are making a big mistake not going to this conference.
Dr. Peterson gave a quick overview of the current state of affairs in ME/CFS research, and also spoke of the recent FDA meeting. These ideas, presented in two minutes at the FDA, are written up by Cort Johnson here. Dr. Peterson’s broad collaborative research ideas, based on his many years of clinical practice, were a perfect lead-in to the rest of the day’s lectures.
This conference day had been preceded by a pre-conference roundtable discussion involving 39 researchers in ME/CFS and various other fields. Invest in ME tries to promote a broad-based research approach to this complex illness or set of illnesses by reaching out to researchers outside the field of ME/CFS. The key words are collaboration, inclusion, and expansion. Some collaboration has been very successful, others not so much. Regardless, if you get this many serious people in one room for an entire day discussing a focused theme – "Infection and Immunity in Myalgic Encephalomyelitis" – something is going to happen. The Invest in ME model – a day of private meetings and a day of public lectures – is a very strong format.
Next up was Dr. Andy Kogelnik of Open Medicine Institute. Dr. Kogelnik gave an overview of the work at Open Medicine Institute and its offshoot, the OMI-MERIT ongoing effort. He spoke less about clinical work and more about the larger picture in approaching this illness, involving collaboration, technology and data gathering. OMI-MERIT has a game plan and he presented it. He also spoke of the explosion of tracking and measuring devices, including an EEG for the Iphone. Later, Dr. Kogelnik mentioned to me that Dr. Eric Schadt of the ME/CFS Center at Mt. Sinai has joined the OMI-MERIT collaborative effort. This, to me, is very good news.
Dr. James Baraniuk is doing such important work on the brain and Gulf War syndrome. He was not able to make the conference this year. In his place was his colleague Rakib Rayhan. This was Dr. Rayhan’s first public presentation and he made it a good one, presenting information from a recent paper on Gulf Wall illness and indicating that there will be more papers to come - and an expansion of the research into ME/CFS patients. Rakim got a good taste of “scientific discourse” as a clinician in the audience tried to take apart his research. Rakim did a pretty good job at defending his work.
In an entirely separate incident I was surprised (in conversation) to hear Dr. Jonas Blomberg, a Swedish virologist from Uppsala, dispassionately challenge (or contest) Dr. John Chia’s work, work which I always held in such high regard. This is not really news to Dr. Chia, as the two of them have an ongoing discussion. The nice thing about having an open, collaborative discourse environment is that when you ask a question, you get an answer.
Mady Horning gave a fine talk, echoing the one she gave in Florida in January. That talk can be accessed here. She spoke of the terrain and genetic defects leading to ME/CFS - what variables contribute to getting ME/CFS. In a follow-up question she was asked what we all want to know. What information can she give about the ongoing CFI Lipkin study? She said that 80% of the blood work is done, but that much additional work needs to be done on saliva, feces and urine. She said that they had identified several promising pathogen “candidates” including a “novel pathogen” - but the work was still early and no conclusions can be drawn. I have heard the term “novel pathogen” somewhere before.
The policy of Invest in ME leans towards inclusion. This year they reached out to Dr. Clare Gerada, who is married to you-know-who. Dr. Gerada accepted the invitation, which might or might not have been a surprise. A person in this position, a high-level professional government figure, addressing a predictably hostile audience, has several means of handling this. Most would come and express their concern for the specific illness, promise to do what they can and answer a few questions, all the while maintaining a professional but friendly distance. Dr. Gerada chose a different approach that bordered on the bizarre. She chose to describe in detail her own job and the difficulties and unpleasantries that she suffers on a daily basis. Let me tell you about my problems. It was a surprising and confounding lecture to give to an audience of sick patients and their advocates. She reminded me of my mother. Enough about you, let’s talk about me. The message that she seemed to be delivering was if you think things are bad now (regarding the NHS), they are going to get worse. I kept saying to myself, "You have got to be kidding me. What is this?" I was astonished to hear her say that she would not know how to treat an ME patient. Perhaps she should be introduced to Dr. Irving Spurr. He would tell her - treat the ME patient with compassion, with understanding. He would explain the positive benefit of real doctoring - handholding, not handwringing. This is the very thing that I cannot get for my daughter in MN - a doctor who understands how to be a doctor and what it means.
Dr. Gerada took the audience into “wanting to shriek” territory. The moderator Ian Gibson put the lid on the situation in a rather heavy-handed fashion and attempted to guided the questions. Nevertheless, several extremely articulate patients (or advocates) were able to extract some acknowledgment from Dr. Gerada that ME was a serious illness, and some admissions that she might be able to help. The entirety had an unpleasant and disingenuous feeling to it. I always get worried when someone looks down or sits back as far as possible when answering a question. Psychologically speaking, Dr. Gerada's body language was not encouraging.
She left when she left - right away. There was no aftereffect. In this way she did us a favor - as an absurd counterpoint - an intermezzo really - to the serious conversations that were about to resume. Rest assured that this "bizarre episode" made no dent in the positive flow of the day. The only consequence of the extended question period with Dr. Gerada was that it impacted the next two lectures, which had to be presented in truncated versions. It was unfortunate that Professor Sonya Marshall-Gradisnik had to cancel at the last minute. She is doing important NK cell research and I was looking forward to her update. Her colleague Dr. Don Staines presented her research for her, as I said, in a somewhat truncated fashion.
Two new researchers attending this conference were Dr. Amolak Bansal of Epsom and St. Heller University Hospitals and Dr. Carmen Scheibenbogen of Berlin Charite. They both gave presentations that tied in in many ways with the ideas of others. Dr. Sheibenbogen works with EBV and is developing a peptide test that very well might help nail down the involvement of EBV reactivations in patients. This would be a very important realization, and she feels she might have something conclusive in six months. Dr. Bansal is another one of these focused and sympathetic newcomers, and it was great to talk with him. His recent study is here. In fact it was great to talk to a lot of these clinician/researchers - as this in itself speaks to the shared values emerging in the wider clinical/research world of ME/CFS.
Mella and Fluge did a split presentation, as they did last year. They provided additional trial information that they asked to not be distributed, pending publication. All I can say is that this research is ongoing, and it now has the feeling of inevitability to it. I spoke to Dr. Mella about using a Fitbit pedometer instead of using patient assessment, which in my estimation is a total waste of time. He indicated that he used a movement device, the same one that Kogelnik uses, but that it was too expensive to outfit each patient with the device. I told him the Fitbit was $100 and he was astonished. I am not sure he believed me, but I hope he hooks up all his patients long-term and gets some objective information on their progress. These guys and gals are very smart, but they do not know everything.
At the conclusion of the conference day the moderator Ian Gibson observed that the audience remained riveted the entire day, right up to the end. He repeated this to me later in the hallway.
Invest in ME sells a modestly priced DVD of the conference. Get ahold of it and look at it yourself.
What are my conclusions at the end of the day? It looks to me like Invest in ME has the ME/CFS collaborative research presentation firmly established and ongoing. The OMI-MERIT initiative, the CFI, Simmaron Research and the ME/CFS Center at Mt. Sinai all have continuing and expanding research. Next year’s conference should present some important results.
What is most urgently needed is a “Treatments Now” conference. Some will say that there are no existing treatments, but I beg to differ. A conference on this subject would result in the same kind of compression that comes out of the Invest in ME conference. One might have to knock some heads, but something very good and solid would come out of this. I will write more on this later.
Equally urgent would be a conference on Severe ME. This has been a long neglected topic - and efforts should be made to reverse this, and give consideration to the patients at the very core of the illness, patients whose blood, saliva, feces and urine could have a huge impact on understanding this illness or set of illnesses.
Dr. William Weir has posted his comments on the conference here.
Mark Berry writes on the conference here.