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#1
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SwissMedic Approves MAPS Sponsored MDMA Study
Switzerland's FDA equivalent, SwissMedic, has now fully approved Dr. Peter Oehen's MAPS-sponsored MDMA/PTSD study. The protocol design had already been approved, and earlier this week we received approval for the source of the MDMA itself, which MAPS is purchasing from a Swiss manufacturer. Now that Dr. Oehen has received permission from SwissMedic and an Ethics Committee (the Swiss IRB equivalent), the only regulatory hurdle remaining is licensing from BAG, the Swiss DEA equivalent, which is expected within a month. Initiation of Dr. Oehen's study will take place shortly thereafter.
You can read the entire study layout here: http://www.maps.org/mdma/swissptsd/protocol011806.pdf It's nice to see that some countries are willing to approve these methods of medical research in hopes of finding cures. One of my biggest peaves is that there are so many scheduled substances listed as having "no medical value", when so many of them do. Anybody else find it odd that the government decides which chemicals are harmful for you instead of medical professionals? |
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#2
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This is excellent news. Hopefully the research will continue as scheduled so there is a chance MDMA will be fully FDA approved as a prescription medicine for PTSD.
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