Category Archives: Advocacy

A Different CFSAC

Posted on June 5, 2014 by Jennie Spotila

It’s that time again: meaning it is time for another CFS Advisory Committee meeting. Due to the make up day in March, the meetings have fallen very close together. Presumably this spring meeting puts the calendar back on track (but … Continue reading →

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Tell Dr. Collins to Stop P2P

Posted on June 2, 2014 by Jennie Spotila

As I explain in this previous post, Mary Dimmock and I have sent a letter to Dr. Francis Collins requesting that he cancel the P2P Workshop and reexamine the best way to collaborate with the ME/CFS research and clinical community. … Continue reading →

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Collins: Please Cancel P2P

Posted on June 2, 2014 by Jennie Spotila

Last week, Mary Dimmock and I sent a letter to Dr. Francis Collins, Director of NIH, requesting that he cancel the P2P Workshop on ME/CFS and reexamine how to best collaborate with the ME/CFS research and clinical community. We offered … Continue reading →

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P2P Agenda Fatigue

Posted on May 22, 2014 by Jennie Spotila

HHS officials have made confusing statements about the goals of the P2P Workshop, but I have obtained documents through FOIA that give us insight into the structure of the meeting. Two versions of the Workshop draft agenda strongly suggest that … Continue reading →

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Will the Real P2P Please Stand Up?

Posted on May 19, 2014 by Jennie Spotila

What is the purpose of the ME/CFS P2P meeting at NIH? You would think that we would know by now, since Assistant Secretary Dr. Howard Koh first announced the effort in October 2012. But to say the rhetoric has evolved … Continue reading →

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IOM: Sum of the Whole Matter

Posted on May 10, 2014 by Jennie Spotila

The IOM panel on ME/CFS held its second (and likely final) public meeting on May 5, 2014. On display near the meeting room was this painting by Robert Van Vranken: Untitled (Everything at once, or one thing at a time?). … Continue reading →

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Protocol for Disaster?

Posted on May 2, 2014 by Jennie Spotila

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

Posted on April 29, 2014 by Jennie Spotila

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

Posted on April 25, 2014 by Jennie Spotila

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

Posted on April 21, 2014 by Jennie Spotila

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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