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Monthly Archives: December 2013
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
Dr. Woodcock: Please Approve Ampligen Now!
My letter to Dr. Woodcock from earlier this week: Jeannette K. Burmeister [email] [phone] [street] [street] [city, state, zip code] … Continue reading
Posted in Uncategorized
Tagged 21 CFR §312.80, 21 CFR §314.105(c), 21 CFR §314.126(c), accelrated approval, Ampligen, April FDA Drug Development Meeting, Bexsero, CFS, Chronic Fatigue Syndrome, Commissioner of the Food and Drug Administration, Dr. Margaret Hamburg, Dr. Theresa Michele, fast track, Improvements in exercise capacity, Improvements in immune-system markers, Jeannette Burmeister, Joseph Pitts, Letter to Dr. Woodcock, life threatening or severely debilitating disease, ME, ME/CFS, meningitis, meningococcus B, Myalgic Encephalomyelitis, Princeton University, priority review, Serious or life-threatening disease, surrogate end points, U.S. House of Representatives, UCSB, Unmet need, Vaccine, Waive criteria for adequate and well-controlled studies
12 Comments
Today’s Tweets: #NotAPersonalAttack
@Sebelius Irony: Disrespect by #HHS unifies #MECFS community more than ever. Many call for Dr. Lee’s resignation. #NotAPersonalAttack @HHS_DrKoh Irony: Disrespect by #HHS unifies #MECFS community more than ever. Many call for Dr. Lee’s resignation. #NotAPersonalAttack I am very sick … Continue reading
Posted in Uncategorized
Tagged #NotAPersonalAttack, CFS, CFSAC, Chronic Fatigue Syndrome, December 2013 Meeting, Dr. Nancy Lee, HHS, ME, ME/CFS, Myalgic Encephalomyelitis
8 Comments
My December 2013 Written Testimony
This includes parts I had to cut for the video testimony to stay within the 5 minutes. CFSAC Comments December 10-11, 2013 Jeannette Burmeister Attorney at Law My name is Jeannette Burmeister and I’d like to address the IOM contract. … Continue reading
Email to Dr. Lee: Request to Cancel Today’s CFSAC Meeting
Dear Dr. Lee, Thank you for sending the updated agenda for today’s CFSAC meeting 1.5 hours before the start of the meeting. I take that to mean that the meeting will take place although the email did not expressly say … Continue reading
Posted in Uncategorized
Tagged CFS, CFSAC, Chronic Fatigue Syndrome, Dr. Lee, ME, ME/CFS, Myalgic Encephalomyelitis
3 Comments
Twilight Zone: IOM Committee Nominations Not Even in the Realm of Reasonableness
Today, the IOM published the provisional IOM committee appointments for the institution’s ME/CFS “study.” I have only taken a brief look at the list of nominees. Others are in the process of “vetting” the nominees and researching their background. I … Continue reading
CFSAC Meeting Needs to be Rescheduled as a Two Full Day In-Person Meeting
[Update: Please email Dr. Lee with copies to Sebelius, Koh and Jones requesting that the meeting be rescheduled as a two full-day, in-person meeting: Nancy.Lee@hhs.gov Kathleen.Sebelius@hhs.gov howard.koh@hhs.gov Wanda.Jones@hhs.gov] Even the weather gods don’t agree with HHS’s cowardly decision to hold … Continue reading →