The FDA don't dispute efficacy. Ryoncil has been used in an EAP for well over a decade. With severe gut inflammation, you have to be THICK not to know if something works or not. I only had 3 correlations with EEN for my younger daughter, which became negative (for all 3) when we stopped it (just as lesser efficacy in GvHD and ARDS confirms a therapy works when you know WHY).
I doubt the hospital ran a "proper" RCT to determine if EEN "worked". It's very difficult to do, if not impossible. A couple of years later, I heard from a friend whose very young child had been diagnosed with Crohn's Disease that the parents were offered the chance of doing this first-line. This showed a major shift in thinking. At the time my daughter was diagnosed (15 years ago), there was much resistance to dietary therapy - the wonderful dietitian who checked my product was referred to by daughter's doctor as "whatshername".
Don't forget many of us SHs have a personal interest in this medicine because of the potential for label extension. My eldest daughter could still lose her colon even tho there's just mild inflammation at the end. She also needs a joint replacement. The only time her IBD was ever fully in remission was when she followed the same diet my younger daughter did but wasn't able to stick to it. Seattle Children's use the same diet and now Stanford is also studying it.
Paediatric IBD is a total disaster. Fifteen years ago Humira was being used on compassionate grounds even tho it hadn't been tested in children.
Regardless of what you claim to think of Ryconcil, surely the giving of Ruxolitinib to adults and children, including those below the age of twelve, who have severe acute GvHD of the gut and skin (looks like severe burns from photos I've seen in journals) can be considered a crime against humanity? It's now acknowledged Ruxolitinib doesn't work for this degree of severity. It's likely the drug is killing more patients than if it had never been approved for acute GvHD - the lack of transparency in what happened to patients who withdrew from Reach1 is very telling.
Over 17000 doctors and scientists signed a declaration of crimes against humanity. You may not agree with them but they have. The FDA should go down for Remdesivir alone.
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