Treatment
Most Exciting Treatment Trial – After years of treating FM patients, Dr. ‘Skip’ Pridgen raises over $3 million dollars to begin a multi-center treatment trial combining Valtrex and Celebrex
Most Out of the Blue Treatment Possibility – citing the work of some Italian doctors, Karen Lee Richards experiments with and does well with Vit B1 – setting the stage for a massive exploration of this affordable option
Best Chance To Provide New Treatment Options NOW – the OMI’s crowdfund attempt to produce a study showing ME/CFS patients with MTHFR mutations respond VERY WELL to B-12/folate supplementation could provide new treatment options for many.
The Most Flagrant, Save-Our-Skin, We’ve Gotta Make This Treatment Work Somehow, Changes to a Study – the authors of the PACE study, trying to save their $8 million dollar study, institute major changes to the study in order to make it look like people actually recovered. (Thank god no-one noticed. Whew!) (See Tom Kindlon’s comment below for more).
Biggest Movement By an Alternative Treatment – studies suggest that Low Dose Naltrexone, which drug companies cannot make money off, may be helpful in FM. Dr. Klimas reports LDN is her first drug for pain in her FM/ME/CFS patients.
Research
Most Exciting Hypothesis – the Vagus Nerve Infection Hypothesis could explain many of the puzzles of ME/CFS including how an infection triggers the disorder and seemingly disappears.
Most Exciting Research Advance – Fibromyalgia -Two small fiber nerve studies suggest that small nerve fibers controlling the autonomic nervous system, blood flows and sensory impulses could be damaged in many people with FM (and perhaps ME/CFS) – opening an entirely new field of investigation
Best Grant Achieved – The Open Medicine Institute scores major grant to study a promising but little studied field in ME/CFS – the HLA genes
Biggest déjà vu Moment – Just after Dr. Julia Newton comes out with a study indicating blood vessel problems in the brain may cause ME/CFS, a researcher at an Autonomic Nervous System conference reports exactly same findings in POTS – making one wonder if the two disorders are simply different variations of the same theme.
Most Confounding Result – The Chronic Fatigue Initiatives Lipkin pathogen study finds almost no viruses (except for Anelloviruses) in the blood of patients, a good subset of which do respond to antivirals.
The Most Overlooked Result – the Lipkin study does find quite a few Anelloviruses – more on that later.
Most Intriguing Grant Not Yet Fully Funded – Forget the viruses…Simmaron Research Institutes becomes the only group to get access to the NIH’s samples for a study to see if tick-borne (hmm- Lyme?) or mosquito-borne (hmm- encephalitis?) illnesses contribute to ME/CFS
Most Dismaying Finding – Research finding suggests that the immunoperoxidase test Dr. Chia used might not always be picking up enteroviruses.
Most Welcome Movement at a Major University – demonstrating that he really is making inroads at Stanford, Dr. Montoya not only gets the University to support the IACFS/ME Biannual Conference, but produces a Symposium on ME/CFS dominated by Stanford researchers
FEDS
Seemingly Sneakiest Move and Biggest Kerfuffle – The DHHS, without informing anyone, including their own experts, contracts with the IOM to produce a clinical definition for Chronic Fatigue Syndrome. The community unites in dismay like it never has before.
Biggest What’s Wrong with This Picture Situation – while the Norwegian government devotes a considerable amount of its research budget to funding a Rituximab trial, the mighty United States – despite study evidence indicating Rituximab can be effective in ME/CFS – sits on its hands.
National Institutes of Health
Worst Move By a Federal Agency – after an extremely critical hearing the FDA panel in confusing fashion votes that Ampligen is a safe enough for ME/CFS patients to try, but has not been proved effective – so the only drug under review for ME/CFS at the FDA is rejected.
Second Biggest Opportunity Missed – citing several strange reasons, the CDC decides not to include repeat exercise testing in their multi-site study, thus missing the opportunity to prove a metabolic dysfunction underlies the exercise problems in ME/CFS. Dr. Unger takes the hit from the patient community, but some reports suggest the doctors simply weren’t on board.
Biggest Flunk by a Federal Agency Over Time – An analysis indicates that the NIH is spending about as much on chronic fatigue syndrome as it did in 1993.
Best Move By a Federal Agency – The FDA’s ‘Voice of the Patient’ document accurately portrays the voice of the ME/CFS Community
Biggest Turnaround by a Government – approximately six months after the Norwegian government declines to fund a Rituximab trial, they decide to fund one – proving that advocacy and outcries do work.
Best Presentation Before Parliament 🙂 – Dr. Peterson gets down to brass tacks as he addresses the Swedish Parliament on ME/CFS. Meanwhile the Dutch wind up years of effort as they present Parliament with a petition – and a decision to make – as they demand ME/CFS be accepted as a biological disease.
People and Community
Saddest Loss – Tom Hennessey commits suicide ending decades of suffering and a once promising life by a gifted person
Biggest Vision – the Open Medicine Institute brings experts together to agree ME/CFS research and treatment goals, convinces the CDC to upgrade their multi-site experts study, snags a big grant and is building a online system to gather BIG data from ME/CFS patients. It’s all part of the the biggest plan to move ME/CFS and FM forward yet generated.
Most Amazing Recovery Story – Lauren Stiles sudden collapse leads to years of dead ends until she finally finds the right doctor who does the right test and finds the right treatment. After being diagnosed with FM, ME/CFS and multiple other disorders it turns out she has Sjogren’s Syndrome. IVIG does not return her to health, but she does improve greatly.
Most Surprisingly Resignation – Citing family changes, Kim McCleary, the head of the CFIDS Association of America for just about ever, resigns. She quickly lands on her feet and becomes the Director of Strategic Initiatives at FasterCures focused on improving the medical research system to develop faster cures.
Most Disappointing Performance By ME/CFS Professionals – While Dr. Komaroff votes three times to reject Ampligen, several other professionals with no ties to ME/CFS vote to approve the drug. Dr. Unger’s no votes on two of the questions make one wonder what use having ME/CFS professionals on a federal panel is.
Most Incredible Show of Support from the ME/CFS Community – the Canary in a Coal Mine fundraiser for a film on ME/CFS raises an incredible $200,000 in less than a month
Best Hire – Dr. DeMeirleir becomes Medical Director of the Whittemore-Peterson Institute, putting a well known ME/CFS physician and researcher at the helm of an important Institute in the ME/CFS universe.
Most Exciting Advocacy Event – Bob Miller skydives for ME/CFS
Scariest Advocacy Event – Bob Miller goes on a hunger strike for Ampligen approval
Blogs and Books
Most Popular Blogs (on Health Rising) (Page Views)
- Successful Low Dose Naltrexone Fibromyalgia Trial – 12,768
- Changing the Gut Flora through Diet (Ken Lassesen)– 11,465
- Small Nerve Fiber Study in Fibromyalgia – 10,698
- Glutamate -One More Piece of the Puzzle in ME/CFS (Marco) – 10,151
- Are Oxygen Starved Tissues Causing Problems in ME/CFS and FM – 8,593
- B-1 Treatment for Fibromyalgia and Chronic Fatigue Syndrome – 8,346
- Best Diet for Chronic Fatigue Syndrome? (Mediterranean Diet) – 7,883
- Deconditioning, Exercise and Recovery -the CDC Talk by Dr. Klimas – 7,713
- Single Cause for ME/CFS (Dan Neuffler) – 7,582
- Not Fatigue After All (Sensory Gating – Marco) – 7,487
- Lipkin Study Results (Simmaron Rising) – @7,000
Best Blog Series -Tie: Neuroinflammatory Series by Marco, and Carol Lefelt’s series “A Chronic Fatigue Syndrome Chronicle”
Best New Book – Erica Verillo’s massive compedium of ME/CFS treatments (available for download at a cheap price).
Thanks for this wonderful concise summary Cort.
Thanks Cort.
I think the PACE Trial recovery paper deserves a mention.
The investigators published a protocol for this £5 million trial. The recovery outcome measure had 4 elements. In the final paper, three of this were changed. These weren’t small changes e.g. protocol definition required a score of 85+ on the SF-36 physical functioning scale. With the changed criteria, one could be recovered with a score of 60! This means one could even deteriorate from the initial score (entry threshold was 65 or less) and be counted as recovery.
There has been a lot of talk about the PACE Trial over the years and some people may have switched of a bit, but these changes were probably the biggest, most flagrant questionnable move.
Oops, apologies for typos
Thanks Tom –
Added – The Most Flagrant, Save-Our-Skin, We’ve Gotta Make This Treatment Work Somehow, Changes to a Study – the authors of the PACE study, trying to save their $5 million dollar study, institute major changes to the study in order to make it look like people actually recovered. (Thank god no-one noticed. Whew!) (See Tom Kindlon’s comment below for more).
Cheers Cort.
Perhaps you could change it to $8 million or $8.2 million as it cost 5 million UK pounds (Xe.com converts it to 8,223,189.90 US dollars). Thanks.
Wow…$8 million dollars; these guys were serious!
Dearest Cort, thanks so much for all the info you provide all year long, it has given me such hope that at least there are the small few who are doing something in the field, terrifying that it is that the more we learn the less we know, in particular all the bemusing ‘leads’ that have been investigated this year. Thanks for this article in particular, I will have great fun going through it at length over the next while. Blessings for the new year, may it be a pain-free, copious amounts of energy and fog-be-gone one!
Agreed….a lots of energy year!
The next report – things to look forward to in 2014 is going to be good 🙂
Hi Cort,
I did not hear this before: Most Dismaying Finding – Research finding suggests that the immunoperoxidase test Dr. Chia used might not always be picking up enteroviruses. Can you lead me to the research on that please or explain more on how to find this information?
Thanks for the summary. It was a busy year.
It is below. It doesn’t mean that Dr. Chia is not finding enteroviruses; it could mean that some of the positive results are not for enteroviruses but are picking up mitochondrial proteins. My understanding is that Dr. Chia was also able to find evidence for them in the blood – so there’s backup on his general findings.
This came to me in an email. Kristin Loomis of the HHV6 Foundation referred to it as well.
“John Chia has used immunoperoxidase staining for enterovirus enterovirus
capsid protein (VP1). The method uses antibodies to VP1.
Now a new study
has discovered cross-reactivity of these antibodies with mitochondrial
proteins: “Collectively, our data show that the clone 5-D8/1 detects two
human mitochondrial enzymes in addition to enteroviral VP1″. This means
that the immunoperoxidase staining technique used by John Chia may give
positive results for other things than only enterovirus.”
Sara F Hansson, Stella Korsgren, Fredrik Pontén, Olle Korsgren.
Enteroviruses and the pathogenesis of type 1 diabetes revisited:
cross-reactivity of enterovirus capsid protein (VP1) antibodies with
human mitochondrial proteins. The Journal of Pathology Volume 229, Issue 5, pages 719–728, April 2013
http://onlinelibrary.wiley.com/doi/10.1002/path.4166/abstract
Abstract
Current or recent enteroviral infections show an association with type 1
diabetes. However, evidence for this has mainly been generated using a
particular mouse monoclonal antibody (clone 5-D8/1) which binds the
viral capsid protein VP1.
Difficulty in confirming these findings using other independent methods has led to the concern that this might be
artefactual.
To address this, we examined the potential cross-reactivity
of clone 5-D8/1 with normal islet proteins. Western blotting,
two-dimensional gel electrophoresis, and mass spectrometry were used to
identify human islet proteins bound by the clone 5-D8/1. We found a
distinct reactivity with two mitochondrial proteins, creatine kinase
B-type and ATP synthase beta subunit.
Immunohistochemistry using the
clone 5-D8/1 revealed a granular cytoplasmic staining pattern in
mitochondria-rich cells, ie hepatocytes, ductal epithelial cells,
vascular endothelial cells, skeletal muscle cells, and the neoplastic
salivary gland oncocytoma cells, whereas connective tissue and
infiltrating immune cells were negative. Staining on islets of
Langerhans from subjects with recent-onset type 1 diabetes, but not on
isolated human islets infected in vitro with enteroviruses, could be
blocked after mixing the clone 5-D8/1 with the mitochondrial proteins.
Collectively, our data show that the clone 5-D8/1 detects two human
mitochondrial enzymes in addition to enteroviral VP1.
The notion that the previously reported VP1 positivity in islets of recent-onset type 1 diabetes patients could reflect cross-reactivity to native islet proteins and not the presence of EV is supported by difficulties in
demonstrating EV infection by independent techniques such as PCR or in
situ hybridization.
These findings call for revisiting the presence of
enteroviruses in pancreatic islets of patients with type 1 diabetes.
Thanks for the article, Cort
And for the news about the enterovirus issues. The initial findings has attracted a lot of attention and would be very high on my ‘desperately needs replicating’ list.
Agreed 🙂
Cort, next year please add this blog to one of the BEST for 2014! Thanks for the concise recap of the happenings in the 2013 world of ME/CFS
Thanks Polly! 🙂
Thank you, Cort, for bringing all this information together. Some of it is very encouraging and yet others are dismaying to say the least. But onward we go. And perhaps this is the year for big changes in all that concerns CFS. We can never give up hope. There is no alternative for us but to keep on getting back up every day.
Cort I understand the Norwegian Rituximab trial is starting soon , do you know when results are expected?
Can you stir up some US support for the UK campaign to raise funds for a UK Rituximab trial? I understand they have 78% of the funds required.
BTW, I’m going to start taking some Chinese herbs soon which are supposed to reduce microglial activation. I’ll let you know how I go.
Matthias
This may help explain why the first time I did the test I tested negative for VP1 but positive for dsRNA. After lengthy oxymatrine treatment, I tested negative for dsRNA but …. positive for VP1.
The VP1 could be explained by cross reactivity, but then why didn’t it test positive in teh first test ? And why did my small bowel sample test negative ? I would think the mitochondrial enzymes would always be stained.