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Tag Archives: FDA
CFSAC Comments August 2015: Ampligen Price Increase on Shaky Ground
I looked into the Ampligen issue–the exorbitant 267% price increase by Hemispherx–some more. Here is one thing that patients who are currently enrolled in the trial can do. They can contact Schulman Associates, the Institutional Review Board (IRB) for this … Continue reading
267% Price Increase for Ampligen
[Please see here for my follow-up letter to Dr. Woodcock.] I just sent the following message regarding Hemispherx’s extraordinary 267% price increase for Ampligen to Dr. Janet Woodcock, the FDA’s Director of the Center for Drug Evaluation and Research: Dear Dr. … Continue reading
Posted in Uncategorized
Tagged Ampligen, CFS, Chronic Fatigue Syndrome, Dr. Woodcock, FDA, HEB, Hemispherx, ME, ME/CFS, Myalgic Encephalomyelitis, Price Increase
31 Comments
Ampligen: The FDA’s Unequal Treatment of a Second-Class-Citizen Drug
On December 11, 2013, I wrote a letter to the FDA’s Director of the Center for Drug Evaluation and Research, Dr. Janet Woodcock. I pleaded with her to use her considerable discretion and potentially accelerated procedures regarding the approval of … Continue reading
Posted in Uncategorized
Tagged Aricept, Belviq, Bexsero, Bob Miller, Canagliflozin, CFS, Chronic Fatigue Syndrome, Dr. Janet Woodcock, FDA, Invokana, ME, ME/CFS, Mindy Kitei, Myalgic Encephalomyelitis, Qsymia, Sirturo, Unequal Treatment
8 Comments
Thoughts on the May 2013 CFSAC Meeting
I’ll have a lot more thoughts about this week’s CFSAC meeting in Washington, D.C. once I get a chance to watch the videos because I wasn’t well enough to take notes or attend (or closely follow) the entire meeting. But … Continue reading
Posted in Uncategorized
Tagged Alaine Perry, Ampligen, Bob Miller, Case Definition, CFS, Chronic Fatigue Syndrome, Dr. Elizabeth Unger, Dr. Gailen Marshall, Dr. Howard Koh, Dr. Mary Ann Fletcher, Dr. Nancy Lee, Dr. Susan Maier, Eileen Holderman, FDA, Hemispherx, May 2013 CFSAC, ME, ME/CFS, Myalgic Encephalomyelitis, NIH, out of order, Seamon Corporation, Steven Krafchick
38 Comments
Mary Dimmock’s May 2013 CFSAC Testimony
Patients have been asking where they can find Mary Dimmock’s CFSAC testimony from today and she has graciously agreed for me to publish it here. I have a few things to say about this CFSAC meeting, but I need to … Continue reading
Posted in Uncategorized
Tagged Canadian Consensus Criteraia, CFS, CFSAC May 2013, definition, FDA, Mary Dimmock, ME, ME/CFS, NIH, Oxford, PEM
5 Comments
My Written May 2013 CFSAC Testimony
CFSAC Meeting May 2013 Public Comment by Jeannette B., Attorney at Law My name is Jeannette B. I have been sick with ME for more than seven years. I appreciate the opportunity to address the committee today. I attended the … Continue reading
Posted in Uncategorized
Tagged Ampligen, CFS, CFSAC, CFSAC May 2013, Chronic Fatigue Syndrome, Dr. Dan Peterson, Dr. Enlander, Dr. Klimas, Dr. Kogelnik, Dr. Lapp, FDA, Kweder, ME, ME/CFS, Myalgic Encephalomyelitis, Theresa Michele
7 Comments
SF Chronicle Article on the FDA’s Denial of Ampligen
We got an article about the FDA’s denial about Ampligen on the front page of the San Francisco Chronicle’s weekend edition. I wish Dr. Montaya had framed his thoughts only positively (works in a sub-group of patients) instead of also … Continue reading
Sign the Ampligen Petition!
Please sign this urgent Ampligen petition. As many of you know, the FDA is about to make a decision on whether or not to approve Ampligen, the drug that has improved my quality of life dramatically with very little side effects. … Continue reading
Posted in Uncategorized
Tagged Ampligen, Bias, CFS, Chronic Fatigue Syndrome, Dr. Nancy Klimas, Effective Treament, FDA, ME, ME/CFS, Myalgic Encephalomyelitis
12 Comments
“I have a plane to catch”
I am still working through all the emotions triggered by the highly anticipated December 20, 2012 FDA Arthritis Advisory Committee meeting about the approval of Ampligen, an immune-modulatory drug that has been very successful in treating a sub-group of myalgic … Continue reading
My Oral Testimony at the AAC Meeting Regarding Ampligen on December 20, 2012
My name is Jeannette. I am very pleased to have this opportunity to address you and want to express my sincere thanks for your consideration of this critically important decision. I have suffered with CFS for almost 7 years and … Continue reading
Posted in Uncategorized
Tagged 2012, AAC, Ampligen, Arthritis Advisory Committee of the FDA, CFS, Chronic Fatigue Syndrome, December 20, FDA, ME, ME/CFS, Myalgic Encephalomyelitis
4 Comments
Thoughts About M.E. 