Tag Archives: drugs

The Burial of ME

Mary Dimmock has published an extraordinary review of the last thirty years of ME history. With her permission, I’ve reported her announcement with the link to the full document below. I highly recommend reading as much of this document as … Continue reading

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Assessing Outcomes

The IOM, P2P and AHRQ reports all pointed out a serious gap in ME/CFS research: the absence of validated ways of assessing clinical outcomes. I have new information about an initiative to change that, and I’ll be speaking about my … Continue reading

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Guest Post: Slightly Snarky

Joe Landson authors this guest post on the chasm between patient experiences and the people who need to understand them. We suffer through many devastating symptoms, but today I’m only thinking of one. It’s perhaps the most devastating effect of … Continue reading

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They Know What They’re Doing (Not)

This post comes via Mary Dimmock, with assistance from Claudia Goodell, Denise Lopez-Majano, and myself. You are welcome to publish it on your site with attribution to Mary Dimmock.   Last week, Jennie Spotila and Erica Verillo posted summaries of … Continue reading

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Draft Systematic Review is UP

The draft systematic evidence review on the Diagnosis and Treatment of ME/CFS has been published. This review is extraordinarily important because it is being presented to the P2P Panel in a closed door session any day now. This review will … Continue reading

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P2P: Taking Shape

The P2P ME/CFS Workshop has been approved and is scheduled for December 9-10th, 2014. The focus of this post is on analyzing four components of the information released by NIH yesterday: P2P is describing our disease as fatigue, without post-exertional … Continue reading

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Protocol for Disaster?

The study protocol for the systematic review of ME/CFS was posted by the Agency for Healthcare and Research Quality yesterday. It’s a recipe for disaster on its own, and within the broader context of the NIH P2P Workshop it’s even … Continue reading

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Comment on FDA Draft Guidance

I submitted the following comments to FDA on its Draft Guidance to Industry on ME/CFS Drug Development. Please note that there is a 5,000 character limit on electronic comments submitted through regulations.gov, so I sent my comments in by mail. … Continue reading

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FDA Guidance: Doors Open

On Wednesday, April 23rd, the FDA hosted a webinar to explain the Draft Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Development Drug Products for Treatment. FDA briefly reviewed the document and took questions in real time. See my original review … Continue reading

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Guidance from FDA

This Wednesday, FDA will host an informational webinar about the Draft Guidance to Industry on Drug Development for ME/CFS. I hope you can attend and learn more about the Guidance document, because public comments are due May 12, 2014! This … Continue reading

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