Some rough notes on the webinar.
I don't think I've done the webinar justice, as there's so much info in it.
Please don't rely upon these notes for 100% accuracy. I couldn't spend any more time on this to triple-check the info. (It's a long video.)
For much of the research that I've listed below, no further substantial info was provided, unfortunately. So there isn't a great deal more detail in the video about the research projects.
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INIM - Institute for Neuro-Immune Medicine
NSU - Nova SouthEastern University
Computational models.
Gordon Broderick and team are using "chaos theory" to analyses data to attempt to find the homoeostasis of the illness.
They have access to huge computational resources.
They use their computational power to virtually model the illness, and they can insert drugs into the virtual model to see how they might intervene in the illness process.
When asked to run a potential drug through the virtual system, it takes four days to run the program on a super-computer. (I'm not certain I've got the time scale correct there.)
Funding & pilot studies.
Klimas focuses a lot on the struggle to obtain funding, and the huge amount of time that it takes to get grant applications through, even if successful.
She says that private donations are a huge help, because they allow her to start a pilot trial immediately, with no messing around. And if the pilot study is successful, then this makes it much easier to apply for a grant for funding for a larger study, as she is then able to convince the reviewers or pharma companies with hard data (sometimes in relation to radical research proposals using heavy-duty potentially toxic drugs).
Sharing data
Klimas is a firm believer in sharing her data with other researchers, and makes data available.
Gulf War Illness (GWI/GWS) & CFS
Klimas also treats Gulf War Illness patients. (25% of veterans returned from the first Gulf War with a chronic illness.)
ME/CFS patients benefit from her work with Gulf War Illness, because she uses CFS patients as controls in her GWS studies, and so she learns about CFS from her GWS research. Also, money for GWS improves her lab systems, such as her computational models, which benefits CFS.
Advocacy Efforts - Funding - VA, DoD & congress
@ 20 mins
$5m being spent a year on CFS.
For gulf war illness, the budget is $35-40m a year from the DoD + VA, inclusive, for gulf war illness research.
Lesson to be learned for ME advocates. The DoD money comes from a congressional directive. This requires the DoD to use this money for this purpose every year. Learn from the veterans about how to get congress to earmark money for CFS research.
The DoD is mandated to spend the money on specific diseases. The DoD is happy to spend the money once they have it, and they are great at directing research programs. She says the DoD money is well coordinated, because a general is in charge of it - and it's outcome focused. i.e. "let's solve this problem". When you put a general in charge of this stuff, they approach it from an efficient problem solving point of view. She also says that the VA has stepped up.
She says that this money was legislated for in congress, and recommends that ME/CFS advocates seek to get a congressional mandate for ongoing research funds.
I'm not sure if she's suggesting that we get CFS money directed to the DoD - she might be - she says they coordinate funding for a variety of diseases, including breast cancer. So I suppose that advocacy efforts might involve teaming up with veterans, or veteran-friendly groups.
She says that we should refer to ourselves as an "under-served population" and that there's special money available for "under-served populations". She didn't go into details, but she's referring to advocacy in the US.
DoD funded GWS Research
The DoD have funded Klimas' group $1m a year for 4 years to study gulf war illness using virtual computational system, culminating with a proper clinical trial guided by what they learn from the virtual model. It's not a CFS project, but Klimas says that the money strengthens their computational model which they can then use for CFS.
Research projects - current funded:
Chronic Fatigue Initiative studies - bio repository.
CDC studies. (Multicenter site studies.)
NIH studies.
DoD studies.
Pharma studies.
- KPAX immune trial (completed - to be published possibly April.)
- Ampligen an open label clinical trial in ME/CFS (some sort of association with FDA)
- Phase 1 study of autologous stem cells in ME/CFS
- CDC sponsored ME/CFS clinical subgroups study
- DoD translational research program for gulf war study
Translational Medicine Unit (funded by private donation)
- Autologous stem cells in ME/CFS (15 patients) "has helped several people in the practice"
- Targeted therapies based on the computational model: the INIM trials. (Some money has been received from NIH to carry out cell-based model in lab. Will pick out the best of 25 drugs/interventions to then test on patients in phase I trials. Some therapies may be toxic, so best to test on computational model, and on cells before testing on patients. Also testing combinations of interventions based on "generics" or "potent supplements" that enhance e.g. mitochondrial function. Avoiding patenting and avoiding creating intellectual property to speed up process to get it to patients as soon as possible.)
New (2015) donation and VA sponsored
- Environment medicine division and research focus (research related to toxic exposures)
- There is much more info about this @ 38.30 mins. It seems like quite a detailed and sophisticated program.
Biomarker discovery programs
- CDC longitudinal study. Biomarkers in ME/CFS - providing samples to CDC.
- CFI biorepository study. CFI microbiome study.
- NIH microbial translocation study (leaky gut) (Dr Fletcher & Discovery lab)
- Biomarker discovery: predictors of severity (Good Day Bad Day study)
- Epigenetic of ME/CFS (R15/Nathanson)
Computational biology: modelling the illnss (ME/CFS and GWI)
- Women with ME/CFS vs FM vs controls (NIH, Klimas)
- Gender differences Men with ME/CFS vs controls (NIH, Fletcher)
- Men with GWI vs GW era veteran controls (DoD CDMRP, Klimas)
- Gender differences Women with GWI vs GW ere controls (VA, Klimas)
Various Studies:
- (VA partner) NIH and DoD funded genomics project: Changes in gene expression with a dynamic challenge; gene expression and regulation in CFS/ME and GWI.
- Microbial Translocation study (NIH R21, Fletcher and Discovery lab)
- Biomarker discovery: predictors of severity (NIH R52, Good Day Bad Day study)
- CFI pathogen discovery project in collaboration with Colubmia, CFS/ME clinical investigators network (CFS sponsored)
- Epigenetics of ME/CFS (NIH R15, Nathanson PI)
@ 45 mins.
Drug Trials:
Wants to trial FDA approved drug (biological response modifier) that blocks IL-1 (cytokine). Computational data points towards blocking IL-1. Not able to get it past review board, because drug is toxic, and review boards don't appreciate the severity of ME. Lost 5 years due to not getting grant proposals past review boards. Requires phase I funding from private donors. Will, instead look at other less optimal drugs (used for rheumatoid arthritis?) which she expects to get through review boards, but frustrated that she can't test the drug she wants to.
CDC multi-site study:
Longitudinal database with huge number of patients, inc children.
Also fibromyalgia control group added.
Klimas anticipates that the one-day exercise study (with cognitive testing before and after) will provide clean and interesting data. She's content with one-day test - changing to a two-day test at this late stage would be extraordinarily difficult.
VA based studies.
Modeling chronic illness:
1. Women with FM, ME/CFS, healthy controls (NIH)
2. Men with ME/CFS, healthy controls (NIH)
3. Women with GWI, healthy GW era veteran controls (VA)
4. In vitro testing of drug candidates in GWI (VA)
5. Animal models and drug interventions in GWI (DoD NSU Consortia)
Biomarker discovery:
1. Men and women with GWI and GW ere controls (DoD, Boston Consortia)
Under review:
1. Testing the model a phase I/II placebo control study of liposomal glutathione vs curcumin in GWI (DoD)
2. In vitro testing of drug candidates in ME/CFS (NIH)
3. Developing a clinical trials network for GWI (VA)
:thumbdown: