Hopefully, the Fluge/Mella cyclophosphamide trial results will be published shortly. https://clinicaltrials.gov/ct2/show/NCT02444091 (CYCLOME). This was a phase 2 unblinded study.
Jumping the gun a bit, what if the trial is positive, that is there was a response in the patients (let's say that maybe more than 20% of the patients responded significantly)?
Haukeland will invariably state that no one should try this until they complete a phase 3 (blinded) study. They will say look what happened with rituximab.
It will likely take another 5 years or so to complete a phase 3 study. Most people, myself included, do not want to wait 5 years.
Cyclophosphamide is widely available (unlike Ampligen) and relatively inexpensive (unlike Copaxone). In many countries, physicians can prescribe medications for off-label use so long as the medicine is approved for use in that country.
So, if the trial is positive, will the various NGO's and patient groups try to encourage clinicians to administer IV cyclophosphamide to treat ME/CFS? Being too cautious here is problematic as many ME/CFS patients note increasing disability with time.
If patients/physicians agree to informed consent https://www.ama-assn.org/delivering-care/ethics/informed-consent, and the patient is aware that there are serious risks associated with receiving cyclophosphamide, then then shouldn't the patient have the ability to receive it?
Sorry for jumping the gun here, but if it looks likes cyclo treats ME, I want to be first in line......
Jumping the gun a bit, what if the trial is positive, that is there was a response in the patients (let's say that maybe more than 20% of the patients responded significantly)?
Haukeland will invariably state that no one should try this until they complete a phase 3 (blinded) study. They will say look what happened with rituximab.
It will likely take another 5 years or so to complete a phase 3 study. Most people, myself included, do not want to wait 5 years.
Cyclophosphamide is widely available (unlike Ampligen) and relatively inexpensive (unlike Copaxone). In many countries, physicians can prescribe medications for off-label use so long as the medicine is approved for use in that country.
So, if the trial is positive, will the various NGO's and patient groups try to encourage clinicians to administer IV cyclophosphamide to treat ME/CFS? Being too cautious here is problematic as many ME/CFS patients note increasing disability with time.
If patients/physicians agree to informed consent https://www.ama-assn.org/delivering-care/ethics/informed-consent, and the patient is aware that there are serious risks associated with receiving cyclophosphamide, then then shouldn't the patient have the ability to receive it?
Sorry for jumping the gun here, but if it looks likes cyclo treats ME, I want to be first in line......