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By August 11, the Food and Drug Administration is expected to decide whether MDMA — the chemical found in ecstasy or molly — can be prescribed as a treatment for post-traumatic stress disorder. And supporters have launched an all-out push to convince the agency to greenlight the therapy, despite the fact that advisors to the agency overwhelmingly rejected the evidence supporting MDMA in combination with psychotherapy in June. The push includes bipartisan support from Congress. As of Friday, more than 60 House Democrats and Republicans had signed onto their own letter addressed to President Biden, voicing support for the treatment and pushing back on some of the recent criticism. Military veteran groups helped rally this Congressional support. Veterans have emerged as some of the most visible advocates, arguing it fills a much-needed gap in effective treatments for PTSD. C in the coming days to meet with lawmakers and lobby with other veterans. Recently, some prominent figures in mental health and psychedelics, plus a few billionaires on social media, have joined the fight, too. The drugmaker, Lykos Therapeutics, is also putting resources into the effort to build public support. The downvote in June — not to mention controversy about the trials that spilled into full view during a public hearing — has put the FDA in a tough spot. Or greenlight the long-awaited decision on psychedelics? Research shows FDA sides with its advisory committee in most circumstances. There are times when the agency has moved ahead in spite of its advisors, particularly when patients have mounted an aggressive advocacy campaign. The agency has a range of options: Lykos could be required to submit additional data, or even run a new clinical trial, which could push back the timeline considerably. Alternatively, approval could come with the requirements to do post-market research, plus tight restrictions on how the drug is administered. We've put decades of time and resources into doing this research. Still, most in the field believe that approval for MDMA is not so much a matter of if , but when. The treatment was granted breakthrough status , and FDA staff signed off on the trial design, although it became clear during the advisory meeting that certain recommendations were not followed. George Greer , who signed a letter with de Wit and a handful of other researchers, was surprised by the unfavorable reception in June. Still, he remains confident the drug will have its day. The argument many U. Earlier this year, a top doctor at the Department of Veterans Affairs signaled his support for the treatment, which his agency plans to study for mental health along with other psychedelic compounds. There were also concerns about missing data related to safety and a lack of evidence supporting the therapy protocol, to name a few. Jeffrey Lieberman , a professor of psychiatry at Columbia University Medical Center who has written critically about the hype surrounding psychedelics. There is a well-documented instance of therapists having inappropriate physical contact with a patient, Meaghan Buisson, while she was under the influence of MDMA during the phase 2 trials. These issues and others were raised in a report from an institute that evaluates clinical research and in a petition to the FDA, calling for a public hearing because of allegations that bias influenced the results and some patients experienced adverse events that were not reported. During the June advisory meeting, FDA staff alluded to an ongoing investigation, but a spokesperson told NPR the agency cannot comment on the details. Since the hearing, online disputes have played out between the factions in favor of and against approval, with both questioning their underlying motives. The form of therapy used in MDMA sessions, which was developed by MAPS, has faced criticism that it can lead to abuses of power when patients are under the influence and vulnerable to suggestion. McGuire, the Baylor College bioethicist, notes people are already seeking out the drug in the context of underground psychedelic retreats. Her research has tallied nearly of them, many of which are advertising in the U. Search Query Show Search. Support KPBS. Watch Live. Public Matters. Show Search Search Query. Give Now. Play Live Radio. Next Up:. Available On Air Stations. Full Schedule. All Streams. By Will Stone. Facebook WhatsApp Email. Healing Breakthrough. Become a KPBS sponsor. Rogers Masson. Travis Dove for The Washington Post. Will Stone. More News. From school funding to climate warnings, what Project could mean for San Diego. Monday is the final day for San Diegans to register to vote to receive a mail-in ballot. Calmer weather helps contain Oakland, California, fire that forced evacuations.

Drugs in Denmark

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Christiania is one of the tourist attractions of Copenhagen. This old military base, which was taken over by hippies during the s, is a unique place, with dirt roads and ramshackle wooden buildings put together with odds and ends and some gorgeous wild nature which is surprising to find in the middle of a European capital city. Pusher Street was a row of wooden booths where until recently buyers could choose from a selection of hashish being sold openly, although the dealers would smash your camera if you tried to take a picture of it. The truth is many Copenhageners like the fact that hashish dealing is centralized in one place. Via text messages, or on apps that are popular with young people, like Snapchat. Legal prescription drugs are a different category entirely. However, many internationals have noticed that Danish doctors are not as free with prescriptions as doctors might be in their home countries. For example, it is a perennial complaint of internationals that Danish doctors are reluctant prescribe antibiotics. This is because they are concerned about the development of antibiotic resistance. Danish doctors will provide antibiotics for bacterial infections, but not for flu or other viral illnesses or just random things people want them for. I have seen some internationals take this the wrong way and get very angry. Sleep medication is another drug that can be difficult to get in Denmark, where even melatonin requires a prescription. If you can get prescription sleeping pills at all, they will be prescribed to you in very limited amounts, like two weeks, and the doctor will monitor your use of them. Repeat prescriptions can be very difficult to get. The Danes feel that you should address the underlying cause of your sleep problems instead of taking a pill. Now, you might think you could simply this order this stuff from abroad, or have a friend send it to you. That would be a mistake. The Danish customs team is quite effective at finding medicine shipped in packages and envelopes, even from the EU. You will get a fine, a fine big enough to disrupt your application for permanent residency and citizenship if you get that far. Maybe your mom always used to give you some non-prescription concoction when you had a bad cold or a flu. You can probably bring a limited amount with you in your suitcase without running into problems. It all depends on your luck, your doctor, and what the Danish health authorities have approved. But in general, the Danish point of view is, the fewer drugs, the better. Except, of course, for caffeine — the country runs on coffee and energy drinks. And alcohol, the most widely used, and abused, drug in Denmark, which has the highest binge drinking rates in Europe. Kay Xander Mellish is a writer and a keynote speaker on Scandinavian culture. She is an American living in Copenhagen, Denmark. Podcasts , Stories about life in Denmark Drugs in Denmark. September 29, by Kay Xander Mellish. Previous Post Next Post. The Bridges of Denmark August 30, Practical tips for moving to Denmark November 5,

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