Archive for November, 2015

Simmaron Powers Change in 2015 & You Power Simmaron!

Simmaron Powers Change in 2015

2015 marks a powerful turning point for ME/CFS patients,

and it’s all happening because of you!

“We are going to ramp this up.’”

Dr. Francis Collins, Director, National Institutes of Health

NIH Elevates ME/CFS Research!

On October 29, Dr. Francis Collins, Director of the National Institutes of Health, announced promising changes to the federal research program on ME/CFS. He moved leadership of the disease to the National Institute of Neurological Diseases and Strokes, will upgrade the Trans-NIH Working Group to institute decision-makers, and will initiate an in-depth study of patients at the NIH Clinical Center in early 2016. Dr. Collins’ personal quotes mark the change: “‘…we ought to be able to come up with an answer with the tools we have.”

Dr. Ian Lipkin, Columbia University

“…it means it’s moved toward the front of the stove.” Dr. Ian Lipkin

One important catalyst to NIH’s promising changes was publication of the Columbia study findings this Spring. Two publications – the CFI multi-site study and Simmaron’s spinal fluid study – document groundbreaking findings of immune abnormalities, and they coincided with game-changing recommendations from the prestigious Institute of Medicine and NIH Pathways to Prevention Program identifying the “urgent need” for ME/CFS research. Simmaron is a proud collaborator in multiple Columbia studies, including our signature spinal fluid studies which distinguish ME/CFS patients from those with Multiple Sclerosis. As we move the pace and quality of research up, our Columbia collaborations become even more important.

 

Obama and Courtney questionPatient advocates led the community’s work to move ME/CFS from the fringes into the NIH Director’s office. Robert Miller and his wife Courtney, who volunteers as Simmaron’s Board President, have worked with many people for years to engage patients in direct actions, email campaigns and high level federal meetings, even provoking a promise from President Obama to elevate research at NIH. Patients have sent thousands of emails to FDA, NIH, and Secretaries of Health in recent years, and engagement of patients and experts was critical to a strong outcome from both the IOM and P2P processes. Many patients and groups contributed so much to garner recognition, and we know there is still a long way to go. We congratulate all patients who are central collaborators in the scientific advancement and social movement that created this shift.

With your help, Simmaron will continue to advocate for a strong federal research program with an emphasis on immunological dysfunction and the need for treatments.

 

Help Us Continue Columbia Collaborations!

SR_Donate_6.9.14_1Help us continue collaboration with Columbia University’s Center for Infection & Immunity at the Mailman School of Public Health. Simmaron’s priority is pursuing the next generation of spinal fluid studies with Drs. Lipkin and Hornig, to generate more specific information so we can translate findings into potential diagnostics and treatments.

  • Luminex, Proteomic and Metabolomic Discovery in Cerebrospinal Fluid of Patients with CFS/ME, Phase 2: Begun in 2015, this 2-year study is phase 2 of the Columbia spinal fluid studies. Proteomics will be used for biomarker identification and metabolomics to study bacteria and fungi-produced chemicals that enter systemic The 2-year cost of this study is $425,000, of which $273,000 has been funded. These are expensive studies because of the technologies and broad scope of investigation, but their potential to change the focus of research nationally and contribute to future treatments is enormous. We need your help right now: our immediate goal is $32,000 to complete first year funding!

In addition, Simmaron is collaborating in the Columbia Microbiome study, which is moving into the analysis stage. Dr. Hornig visited Simmaron in August and talked about the continuum of our studies together. Cort Johnson wrote: “Dr. Hornig noted Dr. Peterson’s exceptional foresight at collecting cerebrospinal fluid samples over many years and his skill at characterizing them. Now she appeared almost dumbfounded at his ability to pluck out subsets in his patients.” (Read Cort’s full blog here ).

 

Data Extraction and Analysis: Now is the Time!

Simmaron Research | Give | Donate | Scientifically Redefining ME/CFSGiven the changes announced at the highest level of NIH, now is the time to provide the historical experience of one of the field’s most experienced clinicians to inform new approaches at NIH. Simmaron has a unique ability to work with Dr. Peterson to extract data from his richly characterized patient cohort, but we need your help to make it feasible.

  • Data Extraction and Analysis: Simmaron has unparalleled data from Dr. Peterson’s clinical experience monitoring immune testing and utilizing immune-based treatments. We seek funding to extract and statistically analyze clinical experience with treatments to publish and share data that will stimulate more clinical trials in ME/CFS. Cost: $100,000 for 2016.

 

Our Special Thanks to the Spearing Family

thank you clip artLast May, the Spearing Family spearheaded a fundraiser to promote scientific research to help their daughter Stephanie, who suffers from a severe case of ME/CFS. They honored Simmaron Research by urging friends, family and others to support our research work. Dad rode in a 100-km Tour de I’lle de Montreal cycling event to raise funds for Simmaron, and his dedication was matched by gifts from many who know them. Every effort to support our work – from individual contributions to hosting fundraisers and helping spread the word – is critical to our ability to do the science that makes a difference. Please contact us (redefiningmecfs@gmail.com ) if you have an idea we can help you with!

 

You Power Simmaron and the Rise of ME/CFS Science

Simmaron is continuing to collaborate on the following studies with a select group of collaborators:

  • Autoimmunity and Non-Hodgkins Lymphoma in ME/CFS: This study evaluates the family history of autoimmunity and the increased prevalence of Non-Hodgkins Lymphoma in patients with ME/CFS. It is led by the University of New York Albany and collaborators include Dr. Paul Levine and Dr. Daniel Peterson.
  • CDC Multi-Site Clinical Assessment of ME/CFS – Year Three: Sierra Internal Medicine is collaborating in the CDC’s 7-site clinical assessment of chronic fatigue syndrome (CFS) to characterize patients with CFS or myalgic encephalomyelitis (ME) in clinical practices of clinicians with expertise in ME/CFS. The data collected will be used by CDC to address the CFS case definition and to improve how to measure illness domains and subsets.
  • Microbiome Study in ME/CFS: The Center for Infection and Immunity at Columbia University is conducting a study of the gut microbiome in a subset of patients from Lipkin and Hornig’s pathogen investigation in ME/CFS, including patients from Sierra Internal Medicine.
  • Arthropod-Borne Disease in Post-Infectious Fatigue: Simmaron was awarded samples from the NIH directed XMRV investigation to study the presence of antibodies to vector-borne pathogens in highly characterized CFS/ME patients and controls. This study recently got underway. It has the potential to aid in subsetting and identifying a role of infection in precipitating CFS/ME. Collaborators include Wisconsin Viral and Sierra Internal Medicine.
  • Genomic and Functional Analysis of Immune Receptors in Chronic Fatigue Syndrome – Part 1. Isabel Barao at University of Reno Nevada will determine whether genetic variations in the genes coding for immune receptors expressed by natural killer (NK) cells, macrophages and B cells, play a role in chronic fatigue syndrome (CFS) risk and pathogenesis. Collaborators include UNR, National Cancer Institute, and Sierra Internal Medicine.
  • Data Analysis of Immune Measures in ME/CFS Patients: Simmaron is extracting and analyzing data from patients at Sierra Internal Medicine to correlate immune measures with treatments and outcome measures.
  • Nested Pathogen Study in Cancer Subset of ME/CFS: This investigation parallels the Columbia University study described above, studying the cerebral spinal fluid of a subset of ME/CFS patients who went on to develop lymphoma or other cancers.

We are powered by your continued support. We thank Drs. Lipkin and Hornig at Columbia for pursuing the science of our disease, and we are honored to collaborate with them. We are equally proud to collaborate with the CDC, NCI, UNR, University of NY Albany, Coppe Healthcare Solutions and Cornell. We are indebted as a community to Dr. Peterson for envisioning ground-breaking spinal fluid studies and pushing for immunological research and treatments. We praise all patients, experts and advocates for tireless work to elevate the federal research program on ME/CFS.

Simmaron is proud to contribute to the rise of ME/CFS science, and we are moved by the knowledge that the more we do now, the sooner the scientific community will fully embrace our disease.

SR_Donate_6.9.14_1Simmaron’s results are made possible by generous donors like you. YOU have the power to change patients’ lives.

 

Dr. Peterson Talks – On Severely Ill Chronic Fatigue Syndrome Patients

November 23, 2015

(This blog was based on Dr. Peterson’s recent talk in Sweden. I added several sections such as the Mike Dessin interlude. They are outlined in parentheses.)

Dr. Daniel Peterson

Dr. Peterson was at the epicenter of Incline Village outbreak three decades ago that helped put chronic fatigue syndrome on the map. He’s been on the cutting edge of immunotherapies and antivirals ever since. He’s been using and gathering data on Ampligen for decades. He was the first to dare to use the powerful antiviral Vistide in ME/CFS and he used it successfully.

Dr. Peterson

Dr. Peterson has been treated people with ME/CFS for over 30 years.

Long before VO2 max exercise equipment showed up in ME/CFS experts offices he was using it. He saved his spinal fluid samples for decades waiting for the right investigator to show up. He was the first to recognize the possibility that non-Hodgkin’s lymphoma is increased in ME/CFS and pushed for studies.

His work with the Simmaron Research Institute has led him to collaborate with research groups around the world. A superb diagnostician, his recent characterization of ME/CFS patients into typical and atypical patients resulted in a successful spinal study – and introduced a subset researchers now need to be aware of. He and the Simmaron Research Institute produced the Immunology Workshop in an attempt to make immune testing a standard part of a physician’s protocol. He may have treated more people with ME/CFS than anyone else in the world.

Dr. Peterson recently spoke on severely ill ME/CFS in Sweden – a place he’s returned to again and again. Thankfully the Swedes have been videotaping their conferences for years. Let’s see what he had to say.

The Severely Ill

Peterson has a reputation for saying it like it is. He started off his talk stating that the really severely ill are like the elephant in the room everyone has danced around for years. Not because they’re not important but because so little is known about them. That, however, is changing.

Peterson pointed that prevalence estimates of the severely ill (25%) are simply guesses at this point. The really severely ill are so debilitated that they rare show up in doctor’s offices, and almost never participate in studies. They are often self-diagnosed and most lack insurance. Visits to the emergency room are rare simply because the emergency room has nothing to offer them and often makes them worse.

Interlude – Mike Dessin’s Story

Mike Dessin is one of the few severely ill ME/CFS patients to have fully recovered. He has an interesting tie-in with Dr. Peterson. When Mike was still relatively healthy he meet Dr. Peterson and afterwards sent his test results to him. Peterson never treated Mike but Mike’s test results were all wrong end and Peterson predicted Mike was in for rough times.

He couldn’t have been more correct. Mike’s health continued to worsen until he was forced to retreat first to his Dad’s house and finally, too sensitive to endure human company, into an apartment. For over a year Mike lived in a blacked out apartment room wearing eye shades even in the dark. He became unable to tolerate foods and became emaciated.

He’s provided a stunning account of what the very severely ill experience.

Dessin,-Mike---emaciatedI was completely bedridden and unable to lean up more than a few inches. I was unable to read, write, understand words when spoken too, or complete a thought process. I would not be able to tolerate touch, whispers or even be able to sustain a mere thought process without getting over stimulated!!! If I was pushed too far mentally I would have a seizure from the over-stimulation.

He believes the overstimulation problems are the most problematic severe ME/CFS patients face.

I believe by far this is the most debilitating and confining element of severe M.E. This is what drives people with M.E. into complete isolation.

Simply getting to a doctor’s office was challenging. Wearing eye shades and ear muffs he said:

“I crawled into my dad’s car. We arrived at the doctor’s office where I crawled my way into the lobby. I laid in the lobby until my name was called. Dad lifted me up onto the table and the doctor walked in. At this point I could only stay conscious when I was stimulated so he put his hands on my shoulders to awaken me.”

The first sign that Mike was beginning to recover was finding a blob of fat on his tush. He began to recognize the items around him, to tolerate light, eat and read short sentences.

Mike Dessin is living proof that it’s possible to go right up to the edge and almost fully recover. He’s also a living example of how difficult it is treat the severely ill.  Other patients visited his doctor yet none responded as Mike did.

Dr. Peterson’s characterization of the severe or very severe ill patients as being “bed bound” at some point in their illness brings up the question whether people who are bed bound at some point in their illness end up being the most difficult to treat. That idea would seem to fit the Dubbo findings which indicated that people with the most severe symptoms after an infection were most likely to come down with ME/CFS.

How sick did you get in the first couple of years – and how are you now? Take

Peterson noted, however, that ME/CFS is not unidirectional – that relapses and remissions can occur unpredictably.

(One of Dr. Peterson’s patients, Corinne Blandino, provides a poignant example of this unpredictability. When she first saw Dr. Peterson she had been wheelchair bound for many years. She improved to the point where she was able to get out and drive and travel but then suddenly and unexpectedly she relapsed. Later she was found to have a spinal fluid lesion.

A Health Rising survey indicated that a subset of patients experience dramatic remissions that are often at some point followed by relapses. Some have undergone several cycles of remissions and relapses.)

exhaustion

If you become bed bound at some point are you less likely to get better?

Peterson also noted that a CDC study found that unless significant recovery began in the first five years of the illness complete recovery is unlikely. When asked later about the importance of treating patients early he said it took him years to learn that the best approach with acute post-infection patients – people who have recently become ill – was to immediately aggressively treat them with immunoglobulin and antivirals.

What about longer term patients – the ones that are probably most prone to be severely ill. Dr. Horning cautioned that the CFI’s immune study showing drops in immune activity after three years needs to be replicated but suggested that immunomodulating drugs like Ampligen and Anakinra could be helpful in longer duration patients.

Dr. Peterson noted that the severely ill are the most difficult patients to treat and have the most guarded outcomes.

(Whitney Dafoe is a good example of how difficult to treat these patients can be. Whitney is located in the San Francisco Bay area – as ME/CFS knowledgeable a place as any. Whitney has had the resources to try many different options but all have failed and some have made him worse. The same was true for Mike Dessin. Glutathione IV’s, alpha lipoic acid and other detoxification treatments that have been helpful for some patients left him worse off and may have set the stage for his almost complete relapse.

Neither were rapid onset either. While both probably had infectious onset their slide to debilitating health was a gradual one. They just kept slipping backwards.

Many doctors probably don’t know where to start and are probably justifiably worried if they treat the severely ill aggressively they’re going to do something to kill them. These patients are delicate in the extreme.)

Basic Support

Dr. Peterson stated, however, there are basic things any doctor can do. Hydration, nutrition, appropriate physical therapy and “intervention based on present pathophysiology” are standard approaches to ME/CFS that can be employed. He recommended the Primer for Clinical Practitioners produced by the IACFS/ME for a good symptom by symptom approach to ME/CFS.

Peterson cautioned that rigorous pacing and energy conservation should not be considered the only treatments but strongly recommended them. He’s found the use of heart rate and blood pressure monitoring devices such as the Fitbit and Apple Watch to be helpful in keeping patients “in the zone”.

saline-chronic-fatigue-syndrome

Regular use of saline can be helpful. A study underway will tell us more about salines effect on ME/CFS.

The effects of immobilization can be high. He recommend simple stretching to reduce muscle atrophy and joint problems; saline, midodrine and florinef to combat orthostatic intolerance; and IV nutrition to combat malnutrition. Peterson stated that he starts IV nutrition early.

Turning off the TV, reducing exposure to computer screens, wearing sunglasses, etc. can help with over stimulation.

In the discussion period Dr. Peterson said the question he always asks all patients is what is the one symptom you want most dealt with – just don’t choose fatigue. If brain-fog is a big problem he uses brain scans (SPECT, MRI) to inform his treatment options.  Increased intracranial pressure might lead to the use of Diamox, inflammation could trigger the use of anti-inflammatories, brainstem problems could result in Nuvigil or even amphetamine-based drugs. If orthostatic problems show up that interfere with blood flows to the brain Dr. Peterson said he goes after those aggressively.

When asked about long term anti-inflammatory therapy Dr. Peterson said he’s seen good short-term responses (increased energy and mental clarity) with steroids but worried about their long term effects.  He hasn’t had much experience with fecal transplants to assess them but feels he’s seen enough people trying stem cell transplants to suggest they’re not a viable option.

Drugs

Ampligen

The good news on the drug front is that Ampligen has been approved for use in Europe and Turkey. Ampligen is an immune stimulator and antiviral that’s been approved for limited use in the U.S. since 1988. It’s not easy to get, though, and is quite expensive. It’s one of the few drugs shown to increase NK cell activity. Dr. Peterson gave Ampligen a strong endorsement stating that it’s the only therapy he’s seen in his three decades of work that’s been able to return ME/CFS patients to full health. He gets about a 70% response rate (not all of which get such strong results.)

Anakinra

IL01B

Dr. Peterson believes cytokine blockers could be helpful.

Anakinra – a soon to begin placebo-controlled, double-blinded trial in the Netherlands, Anakinra presents an intriguing possibility. Anakinra blocks the production of two cytokines, IL-1b and TNF-a, that are greatly increased in some ME/CFS patients. A safe drug, Dr. Peterson saw no reason not to test it and other cytokine blockers on the market right now.

(The Anakinra sudy authors noted that concentrations of cytokines in the blood rarely reflect what is happening in the brain. They proposed, therefore that the only way to accurately assess a cytokine’s contributions to a disease is to block them using drugs and see what happens.

Rituximab and Cytoxan

He also pointed to the Rituximab and Cytoxan trials now underway in Norway as possible treatments.

Caregivers are an incredibly important factor for the severely ill. Dr. Peterson encouraged caregivers to get more support for themselves, to take time for themselves and get counseling if necessary.

Hope for the Future

Open Medicine Foundation Study - Dr. Peterson highlighted the Ron Davis/Open Medicine Foundation severely ill big data study and proposed that ME/CFS’s signature does indeed burn more brightly in them. While welcoming it, he added some cautions regarding the small sample size and the enormous data set that will be generated.

He added that newer technologies such as Next Generation Sequencing (NGS) will enable more and more patients to be assessed more cheaply. (Ron Davis has reported that most of the methodological issues the study posed have been taken care and the study will begin soon.)

CDC Study – The huge, (huge) CDC multisite study will search the serum and saliva of 800 people (!) for biomarkers using RNA/DNA analysis and other techniques. This phase will also include 40 severely ill patients. That’s just five people per site but these patients are hard to find, and Peterson said that even his office was having trouble finding them.

Australian Work – The Australians are also beginning to differentiate immunological markers in the severely ill from moderately ill and healthy controls.

The Lipkin/Hornig CFI immune study Dr. Peterson and the Simmaron Research Foundation participated in suggested that longer duration patients – who are probably more likely to be severely ill – may suffer from immune exhaustion. That finding needs to be replicated but if its true immune enhancers may be more likely to help the more severely ill.

Simmaron Research | Give | Donate | Scientifically Redefining ME/CFS