MisterBlues schreef op 15 oktober 2020 11:07:
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1. Relief en zijn voorganger hebben in het verleden een paar onhandige afslagen genomen die op een mislukking zijn uitgelopen. Ik heb daar eerder over gepost. (Op dit forum ver terug te vinden.)
2. Het is inderdaad een toevallige samenloop van omstandigheden geweest. Toch zijn er blijkbaar meer serieuze onderzoeken geweest:
Someone should interview Dr. Shoemaker who worked with VIP and patients. He gave his finding to FDA in 2016 , found it very safe while using inhaled VIP to treat CIRS, then he unexpectedly observed that some patients started to reverse gray matter nuclear atrophy associated with deteriation of cognitive function - ie nuerological corrections in brain function after VIP crosses blood/brain barrier!. I think there were over 1700 patients who took it inhaled over 18 months (or less when recovered from CIRS) with little to no adverse effects. FDA and committee said it should go through IND process in 2016, even though Dr. Shoemaker argued the drug was already considered safe.
Good try Shoemaker and Hopkinton! They were making inhaled VIP and provided over 8000 refills .. no adverse effects.
www.fda.gov/media/102282/downloadThis is the report that should prove that VIP is safe and helps neurological damage...hmmm reminds me of the same destructive pathway that COvid takes to your brain .... smell, taste, chronic fatigue (also mentioned by Shoemaker as cured by VIP),...
Goede Reactie:Interesting report! Thanks for posting this. There is a lot of information here. Some of which may explain delay in VIP approval. It pertains to its potential adverse immunological response. Even though it may only applied to compound it formulations of VIP it might give the FDA a pause for concern regarding safety.??? I encourage everyone on the board to review this:
?? “To summarize our review of VIP safety, we find that there are insufficient, non-clinical data particularly to determine the safety of VIP for human use in a chronic condition. The majority of adverse events are reported to be mild, however, potential immunologic reactions are an important consideration with the administration of a peptide, and severe reactions of this type have been reported. Therefore, characterization and control of the peptide impurities and degradants is important for the safe use of VIP.
We note that there are no approved treatments in the U.S. for the nominated use of CIRS. Our review considered the evidence of VIP effectiveness to treat a condition called chronic inflammatory response syndrome, CIRS. This condition is not found in standard disease indexes such as ICD-10 or MedDRA. We have identified one publication in which VIP was studied in the treatment of CIRS specifically for a condition in which CIRS is proposed to be attributable to exposure to water-damaged buildings.”