FDA conferentie, Bob Miller vraagt jouw input!
Geplaatst: 02 apr 2013, 15:26
Oké mensen, tijd voor weer wat actie!
Op 25 en 26 april praat de FDA (Amerikaanse voedsel en medicijn-autoriteit) over de ontwikkeling van medicatie voor ME/CVS. Dit is dé gelegenheid om onze input te geven. Helaas hebben nog weinig mensen gehoor gegeven aan de oproep om onderstaande tekst in te vullen op de volgende website:
http://www.regulations.gov/#%21submitCo ... -0962-0004
De vraag om dit te doen komt van Bob Miller, de man die in hongerstaking ging om betrokkenheid van de FDA te bereiken en de man van de Obama brief. Dus we gaan hem helpen!
Gewoon even onderstaande tekst kopiëren in een Word document plakken en uploaden op die site. Of zeer verkort in het 'comment' venster plakken.
Oja, vul even je eigen symptomen en testresultaten aan. Weet je iets niet, sla het gewoon over. Dit moet voor 8 april binnen zijn.
Zie ook: http://www.cortjohnson.org/blog/2013/04 ... o-fda-now/
Dear FDA Commissioner Hamburg,
I have been ill with ME/CFS for ____years now. There still are no FDA-approved treatments for me and the other One Million Americans suffering daily from ME/CFS. We need a stated path to drug approval for ME/CFS, with special evaluation criteria to fill the profound unmet need and the empty pipeline, just like you announced for treating Alzheimer’s, “FDA to Ease Alzheimer’s Drug approval”.
The FDA Workshop should lead to a proposal including these points:
1. ME/CFS clinicians with the most experience conducting clinical trials in ME/CFS will be consulted to produce a compendium of biological outcome measurements that correlate with patient improvement.
2. Enrichment studies will be acceptable to demonstrate efficacy for approval for ME/CFS, conditioned on selection criteria for use and continued Phase IV studies.
3. FDA request CDC and NIH study the responders to Ampligen, Valcyte, Vistide, Valtrex and other medicinal treatments to learn what works and how to design studies around appropriate subsets (NIH did that with MS drug – daclizumab, and implicated a unique cell in that disease)
4. FDA request NIH to spearhead clinical trials for ME/CFS where the outcome measures are set through collaboration with the most experienced treating clinicians, just like AZT
My ME/CFS symptoms are
(example – put yours here: Susceptible to opportunistic infections(EBV, HSV, HHV-6, CMV, Coxsackie, H. Pylori) cognitive decline(unable to read a newspaper article), inability to concentrate( only one person can speak at a time), bedridden ( I require 20 hrs. of sleep and rest daily) , muscle pain (unable to use legs, arms and back due to increased pain) headaches (severe migraine like), fevers ( low grade), night-sweats)
My abnormal test results include (put yours in place of mine below):
a. low natural killer cell function, which improves when I am treated with Ampligen
b. Low T-cell count
c. High Epstein-Barr virus titers and HHV6 or Active infection
d. Low VO2max
e. Elevated Cytokines
Thirty years is too long for any illness to go without a single FDA-approved treatment. As long as safety is demonstrated, patients must have access to medicines in order to alleviate our tremendous suffering and to advance our scientific understanding of ME/CFS. Who a treatment works for is more important that whether it works for everyone. We need FDA to start somewhere.
Op 25 en 26 april praat de FDA (Amerikaanse voedsel en medicijn-autoriteit) over de ontwikkeling van medicatie voor ME/CVS. Dit is dé gelegenheid om onze input te geven. Helaas hebben nog weinig mensen gehoor gegeven aan de oproep om onderstaande tekst in te vullen op de volgende website:
http://www.regulations.gov/#%21submitCo ... -0962-0004
De vraag om dit te doen komt van Bob Miller, de man die in hongerstaking ging om betrokkenheid van de FDA te bereiken en de man van de Obama brief. Dus we gaan hem helpen!
Gewoon even onderstaande tekst kopiëren in een Word document plakken en uploaden op die site. Of zeer verkort in het 'comment' venster plakken.
Oja, vul even je eigen symptomen en testresultaten aan. Weet je iets niet, sla het gewoon over. Dit moet voor 8 april binnen zijn.
Zie ook: http://www.cortjohnson.org/blog/2013/04 ... o-fda-now/
Dear FDA Commissioner Hamburg,
I have been ill with ME/CFS for ____years now. There still are no FDA-approved treatments for me and the other One Million Americans suffering daily from ME/CFS. We need a stated path to drug approval for ME/CFS, with special evaluation criteria to fill the profound unmet need and the empty pipeline, just like you announced for treating Alzheimer’s, “FDA to Ease Alzheimer’s Drug approval”.
The FDA Workshop should lead to a proposal including these points:
1. ME/CFS clinicians with the most experience conducting clinical trials in ME/CFS will be consulted to produce a compendium of biological outcome measurements that correlate with patient improvement.
2. Enrichment studies will be acceptable to demonstrate efficacy for approval for ME/CFS, conditioned on selection criteria for use and continued Phase IV studies.
3. FDA request CDC and NIH study the responders to Ampligen, Valcyte, Vistide, Valtrex and other medicinal treatments to learn what works and how to design studies around appropriate subsets (NIH did that with MS drug – daclizumab, and implicated a unique cell in that disease)
4. FDA request NIH to spearhead clinical trials for ME/CFS where the outcome measures are set through collaboration with the most experienced treating clinicians, just like AZT
My ME/CFS symptoms are
(example – put yours here: Susceptible to opportunistic infections(EBV, HSV, HHV-6, CMV, Coxsackie, H. Pylori) cognitive decline(unable to read a newspaper article), inability to concentrate( only one person can speak at a time), bedridden ( I require 20 hrs. of sleep and rest daily) , muscle pain (unable to use legs, arms and back due to increased pain) headaches (severe migraine like), fevers ( low grade), night-sweats)
My abnormal test results include (put yours in place of mine below):
a. low natural killer cell function, which improves when I am treated with Ampligen
b. Low T-cell count
c. High Epstein-Barr virus titers and HHV6 or Active infection
d. Low VO2max
e. Elevated Cytokines
Thirty years is too long for any illness to go without a single FDA-approved treatment. As long as safety is demonstrated, patients must have access to medicines in order to alleviate our tremendous suffering and to advance our scientific understanding of ME/CFS. Who a treatment works for is more important that whether it works for everyone. We need FDA to start somewhere.