Author Archives: Jennie Spotila

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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On It or In It?

Posted on May 12, 2014 by Jennie Spotila

I’ve been spending a lot of time in bed, recently. This is unusual for me. Usually, I’m ON the bed but not IN the bed. I see a really big distinction. On a normal day, I’m out of bed in … 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Comment on FDA Draft Guidance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I submitted the following comments to FDA on its Draft Guidance to Industry on ME/CFS Drug Development.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On Wednesday, April 23rd, the FDA hosted a webinar to explain the Draft Guidance for Industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Development Drug Products for Treatment.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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Research Roadmap

Posted on April 14, 2014 by Jennie Spotila

The Research Recruitment Working Group of the CFS Advisory Committee has been formulating recommendations that could potentially change the direction of ME/CFS research at NIH. Not much time has been spent on it at the last two meetings, but I … Continue reading →

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Don’t Silence Yourself

Posted on April 8, 2014 by Jennie Spotila

On May 5th, the IOM panel creating new diagnostic criteria for ME/CFS will hold its second public meeting. The only way you can provide input is by submitting written comments, unless you are an invited speaker. I’m here to plead … Continue reading →

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