Experts Reflect on the FDA Stakeholder Meeting

May 19, 2013

Joel asks a variety of leading doctors, researchers and patient advocates for their reflections on the FDA Drug Development Workshop.

A short while ago, the US Food and Drug Administration (FDA) held a workshop for patients, doctors, and other stakeholders, to talk about drug development for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). You can read a summary of the first and second parts of day one of the two-day workshop, here and here. (Day two summaries will be published shortly).

Following the event, we caught up with some of the doctors and the advocates who attended and asked them each how they thought the workshop went.… Read More

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Vertigo: Unwelcome Gift on My 25th Wedding Anniversary

May 17, 2013

by Jody Smith

pixabay-winter-storm

I’ll always remember my 25th wedding anniversary as being something special. I wish I could say that this was because my husband and I celebrated in some marvelous fashion, but that wasn’t it. At the age of 49, I thought I was having a stroke.

I got up that morning feeling fine — or no worse than usual at any rate — but when I went to my bedroom to get dressed all that changed. Waves of sensory chaos began to crash over me, and I sat on the bed waiting for it to pass. It didn’t. I’d had a wide variety of sensory chaos and problems with my brain for many years by that time, but this was different.… Read More

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Patients to DHHS: Fix the Broken ME/CFS Case Definitions NOW!

May 14, 2013

change-request-form-hiOn May 12 – International Awareness Day for ME/CFS/FM/MCS/etc – Phoenix Rising joined with 8 other US ME/CFS patient organizations and 26 independent patient advocates to call on the Department of Health and Human Services (DHHS) to finally fix the problem of the many and diverse case definitions associated with our disease. In a letter to Secretary Sebelius, Dr Howard Koh, Dr Thomas Frieden and Dr Francis Collins, we explained our concerns about the current definition activities of the DHHS in relation to “Chronic Fatigue Syndrome”, and listed the steps we believe must be taken to rectify the situation.

You can read our letter to the DHHS here.… Read More

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FDA Drug Development Workshop: Part Two

May 13, 2013

Gabby (Nielk) continues our summary of the FDA Workshop with a look at the second half of Day One – a discussion entitled “Patients’ Perspective on Treatment Approaches”

FDA Workshop 3The FDA Drug Development Workshop for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) took place on the 25th and 26th of April 2013. It was well attended by patients, advocates, doctors, representatives of the CDC and even a few pharmaceutical reps.

The workshop was also broadcast live over the internet, enabling many more people to follow what happened without being there in person. This meeting was an opportunity for us to be heard, and continues to be an opportunity as comments can still be added to the docket until August 2nd 2013.… Read More

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International Awareness Day, May 12th 2013: Worldwide Protests and Events

May 10, 2013

Mark takes a look at what’s going on around the world this weekend to mark International Awareness Day

Awareness Day RibbonsMay 12th is International Awareness Day for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Awareness Day events also recognize Fibromyalgia (FM), Multiple Chemical Sensitivities (MCS), Gulf War Syndrome (GWS), Lyme Disease, and other chronic neuro-endocrine-immune diseases (NEIDs). Awareness Week runs from May 12th-18th, and the whole of May is Awareness Month. As with many awareness campaigns, ribbons are worn to show support for the campaign – blue for ME/CFS, purple for FM, and green for MCS.

A multitude of Awareness and Fundraising events are taking place this weekend, all across the real and virtual worlds, so I’ve been trawling the web to find out what’s going on.… Read More

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CFSAC Spring 2013 (May 22-23): How to Participate

May 8, 2013

Jennie Spotila looks forward to the next meeting of the CFS Advisory Committee – and explains how you can participate.

Current Members of the CFS Advisory Committee

Current Members of the CFS Advisory Committee

The spring meeting of the CFS Advisory Committee is May 22-23, and we only have a few weeks to prepare. The agenda is not available yet, but we do know about a few new things happening at the meeting.

New Members

There will be some new faces at the table. Rebecca Collier, RN has been appointed to replace Dr. Jacqueline Rose, who resigned last June. Dr. Ann Vincent recently resigned from the Committee, so the number of voting members will remain at 10 (the Charter provides for 11 members).… Read More

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MEandYou and Rituximab: Dr Maria Gjerpe’s Fundraising Marathon Update

May 6, 2013

by Sasha

Kavli Foundation donation at bank 300 pixels

Maria gets 300,000 krone from the Kavli Foundation
(Photo: Skjalg Ekeland/BA)

I call Dr Maria Gjerpe’s 90-day campaign to raise money for a crucial confirmatory Rituximab trial a ‘fundraising marathon’ but that hardly covers it. It’s more like a triathlon a day for three months. Maria, previously bedridden for years with ME/CFS, has been working 12-hour days non-stop to fund the Phase III trial on the drug that has, for now, restored her to health.

As she explained in her article in March, Maria doesn’t expect to stay well. She was a patient in Drs Fluge and Mella’s ME/CFS pilot study on Rituximab and received her last infusion of the drug earlier that month.… Read More

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FDA Drug Development Workshop: Part One

May 3, 2013

by Joel (snowathlete) and Gabby (Nielk)

Title Slide from FDA Workshop: Drug Development for CFS and METhe FDA Drug Development Workshop for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) took place last week on the 25th and 26th of April. It was well attended by patients, advocates, doctors, representatives of the CDC and even a few pharmaceutical reps.

The workshop was also broadcast live over the internet, enabling many more people to follow what happened without being there in person. This meeting was an opportunity for us to be heard, and continues to be an opportunity as comments can still be added to the docket until August 2nd 2013.… Read More

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Launch of inclusive UK CFS/ME Research Collaborative

April 30, 2013

by Simon McGrath

stephen holgate

Prof Stephen Holgate

Last Monday, 22 April, saw the launch of the new UK Chronic Fatigue Syndrome/Myalgic Encephalitis Research Collaborative (CMRC). Set up by Stephen Holgate, MRC professor of immunology, and backed by the UK’s main research funders (MRC, Wellcome Trust and NIHR) it aims “to create a step change in the amount and quality of research into chronic fatigue and ME”. The launch featured some eye-catching provisional results that got good media coverage, particularly the study from Newcastle showing differences in lab-cultured muscle from CFS patients versus healthy controls. And an fMRI study found that patients had to use more brain regions to accomplish the same mental tasks as controls, confirming earlier work in this field.… Read More

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