Gabby (Nielk) and Russell (Firestormm) continue our summary of the FDA Workshop with a look at the first part of Day Two – a discussion entitled “Innovation, Expedited Pathways, and Regulatory Considerations” The 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
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Advocacy issues in chronic fatigue syndrome (ME/CFS)
Call for Investigation into CFSAC Intimidation Allegations
by Mark On June 12, twelve ME/CFS organizations (including Phoenix Rising) and twenty-three advocates wrote to William B. Schultz, General Counsel of Department of Health and Human Services (DHHS), calling for an immediate investigation into the alleged intimidation of three voting members of the CFS Advisory Committee (CFSAC). Enclosed with the letter to Schultz was a transcript by Joe Landson
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“Intimidated, Frightened, Threatened with Eviction” – CFSAC Spring 2013, Day Two
Mark Berry looks back on the second day of a controversial CFS Advisory Committee Meeting The CFS Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services (HHS), through the Assistant Secretary for Health, on issues related to myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). The committee meets twice a year, and the Spring 2013
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“Fatigue is not a disease” – Unger Responds, Advocates Launch Petition
On May 12th, 9 ME patient organizations (including Phoenix Rising) and 26 advocates sent a letter to Secretary Sibelius, Dr. Howard Koh, Dr. Thomas Frieden and Dr. Francis Collins at the Department of Health and Human Services (DHHS). In that letter, we expressed our strong concerns about the department’s current definition activities related to “CFS” and called on them to
Continue “The Bar Has Been Raised” – CFSAC Spring 2013, Day One
Mark Berry looks back on the first day of a controversial CFS Advisory Committee Meeting The CFS Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services (HHS), through the Assistant Secretary for Health, on issues related to myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). The committee meets twice a year, and the Spring 2013
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Experts Reflect on the FDA Stakeholder Meeting
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
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Patients to DHHS: Fix the Broken ME/CFS Case Definitions NOW!
On 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
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FDA Drug Development Workshop: Part Two
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” The 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,
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International Awareness Day, May 12th 2013: Worldwide Protests and Events
Mark takes a look at what’s going on around the world this weekend to mark International Awareness Day May 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
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CFSAC Spring 2013 (May 22-23): How to Participate
Jennie Spotila looks forward to the next meeting of the CFS Advisory Committee – and explains how you can participate. 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
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FDA Drug Development Workshop: Part One
by Joel (snowathlete) and Gabby (Nielk) The 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
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Historic FDA Stakeholder Meeting on ME/CFS, April 25-26: How To Have Your Say
As the FDA Stakeholder Meeting approaches, we explore the various ways that patients can get involved – and offer some suggestions on how to make the most of this unprecedented opportunity. On April 25-26, 2013, the United States Food and Drug Administration (FDA) is holding a workshop in Bethesda, MD to discuss how best to facilitate and expedite the development
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