Update on the European withdrawal on high dose biotin application
As promised it was the first question I asked my neurologist. She explains that the study had 93 people in it. According to the study, over the course of a year, of the 93 people enrolled something like 20 of them had relapses that I never had a relapses before. That’s why they deemed that the high does biotin was not effective. This is the information on the application for the withdrawal. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004153/wapp/Initial_authorisation/human_wapp_000247.jsp&mid=WC0b01ac058001d128.
Well my doctor explained that she, as well about her colleagues, looked at the information and felt something just didn’t seem right. First of all it didn’t coincide with the results that they’ve seen in clinical trials here and evidence they’ve seen in clinical trials elsewhere. The other thing that made really no sense is this was being studied for people that have had secondary progressive MS as well as primary progressive MS. These people didn’t necessarily have relapses, if they were secondary or progressive MS, they would just progressively get worse, not necessarily marked by a relapse. So to have had 20 people have a relapse doesn’t really make much sense. Especially the fact that they’ve never had relapses???? If they’ve never had relapses how are they considered secondary or primary progressive MS? That is usually the first stage of MS. It was also very small study. There was only 93 patients in the second clinical trial. It was also one company, one medical institution. Both my doctor hercolleagues and most people in her field all had the same reaction to this this study, they felt that it just didn’t add up to the data and the results that they have seen everywhere else. Therefore they paid it no mind that this company pulled out. I hope that gives a clear picture and helps everybody in the decision of whether they want to or not want to take high dose biotin. If you’re looking to get the clinical trial dosage, you can kick click on the pill bottle on my page or you can click on the link provided below. https://highdosebiotin.net/