Tag Archives: government

Simple Action

Posted on September 4, 2013 by Jennie Spotila

I am not the only ME/CFS patient worried about what kind of case definition the Institute of Medicine might create for my disease. I don’t have anything against the IOM. To the contrary, I recognize that it is an institution … Continue reading →

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If You Want Our Support

Posted on September 3, 2013 by Jennie Spotila

A week ago, ME/CFS patients found out about HHS’s plan to sole source a contract to the Institute of Medicine to create a consensus case definition for our disease when the sole source notice was published. Today, the CFS Advisory … Continue reading →

Posted in Advocacy, Commentary | Tagged , , , | 5 Comments

Foreshadowing

Posted on September 3, 2013 by Jennie Spotila

The prospect of the Institute of Medicine creating a consensus case definition for ME/CFS scares me. It’s not free-floating anxiety or IOM-hatred. We have a current example of what this IOM contract might mean for ME/CFS and it’s not pretty. … Continue reading →

Posted in Advocacy, Commentary | Tagged , , , | 10 Comments

IOM On The Case

Posted on August 29, 2013 by Jennie Spotila

No announcement and no fanfare, but it became public this week that the Office of the Assistant Secretary intends to award a sole source contract to the Institute of Medicine to create a consensus clinical definition for ME/CFS. Here’s the … Continue reading →

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Drug and FDA News, August 2013

Posted on August 23, 2013 by Jennie Spotila

Next week, I will be attending the FDA’s Patient Representative Workshop for new patient reps. The meeting is 1.5 days of orientation and discussion, and I am eager to meet my fellow patient representatives. I will report back on the … Continue reading →

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The Full Ninety

Posted on August 22, 2013 by Jennie Spotila

Ninety-one days have passed since the last CFS Advisory Committee meeting. As of the date and time of this post, none of the materials related to the meeting have been posted on the CFSAC website. Federal law requires that the … Continue reading →

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CFSAC Interviews

Posted on August 20, 2013 by Jennie Spotila

Gabby Klein has written an article for Phoenix Rising that features interviews with CFS Advisory Committee members Dr. Gailen Marshall and Dr. Susan Levine, and non-voting members Dr. Kenneth Friedman, Leigh Reynolds and Dr. Fred Friedberg. It’s an interesting read, … Continue reading →

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Hypersensitive

Posted on August 13, 2013 by Jennie Spotila

FDA recently issued a warning about the risk of rare but serious skin reactions to acetaminophen. Widely known by the brand name Tylenol, acetaminophen is an active ingredient in many prescription and over-the-counter medicines for pain, headaches, migraine, cold and … Continue reading →

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Drug and FDA News, July 2013

Posted on July 25, 2013 by Jennie Spotila

The big BIG reminder for the ME/CFS community is that the public comment docket on drug development for ME/CFS will close on August 2, 2013. As of this morning, there are only 201 comments! That’s disappointing, given that FDA said … Continue reading →

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Drug and FDA News, June 2013

Posted on June 28, 2013 by Jennie Spotila

We’ve had a good discussion in the comments on the advocacy action to request another meeting with FDA. I asked FDA if they would be pursuing Guidance to Industry on ME/CFS drug development, and was told it is already underway. … Continue reading →

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