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What people think: The treatment had garnered considerable support from patients, leaders in the field of mental health and psychedelics and politicians from both parties. In recent weeks, advocates mounted a major public pressure campaign, arguing there is a dire need for new and effective treatments for veterans and the millions of people affected by PTSD. Go deeper Instead, the agency asked the drugmaker to further study the safety and efficacy of the treatment. It represents a significant setback for the company and the broader movement to bring psychedelics into the mainstream of mental health care. Boris Heifets , an anesthesiologist at Stanford University whose lab studies psychedelics. Lykos said it plans to request a meeting with the FDA to ask for reconsideration of the decision. The treatment had garnered considerable support from patients, leaders in the field of mental health and psychedelics and politicians from both parties. In recent weeks, advocates mounted a major public pressure campaign, emphasizing the dire need for new and effective treatments for veterans and the millions of people affected by PTSD. Many in the psychedelics industry had viewed this as a pivotal moment. But Dr. The wave of enthusiasm around MDMA's therapeutic potential has come from research scientists at top academic centers and even the Department of Veterans Affairs. The committee's downvote put the FDA in a tricky spot, given that it historically sides with the advisors. He worries the decision to deny approval will stifle innovation and funding into other novel treatments, including MDMA-like drugs that are being developed. Researchers affiliated with the nonprofit Multidisciplinary Association for Psychedelic Studies, or MAPS, pioneered the early studies and developed the therapy protocol embedded in the treatment. That work ultimately set the stage for the drugmaker, which was incubated by MAPS, to press forward with larger human trials and seek approval from federal regulators. Follow-up research from the company showed participants were still benefiting from the treatment at least half a year after their last dosing session. The drugmaker and many of the therapists involved in the research have steadfastly denied those claims. Support for LAist comes from. Become a sponsor. LAist logo. The Brief. How To LA. Imperfect Paradise. All Programs. Support Us. About Us. Stay Connected. News Listen. The Brief The most important stories for you to know today. Jump to a story. MDMA approval rejected. Published August 11, AM. Share This Facebook Twitter. Read the full story. Supporters of the drug were dismayed by Friday's decision. In its press release, Lykos said the FDA echoed the issues raised by the committee.

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The collision resulted in the deaths of the two officers on board and calls for the resignation of Interior Minister Fernando Grande-Marlaska. Since , more than 20 deaths have been recorded as a result of drug trafficking in the Strait of Gibraltar. The rise in drug trafficking-related violence in southern Spain is partly linked to the increase in the illegal possession of weapons by criminal groups and inadequate police resources to curb the drug and arms trades. Insecurity and violence have intensified in recent months, amid a perception that drug criminals enjoy impunity and freedom of movement. Spain ranks fifth out of 44 European countries in terms of criminality, according to the Global Organized Crime Index. With a criminality score of 5. Spain scores particularly high in the drug markets measured by the Index, especially in the cannabis and cocaine trades 7. Although the synthetic drug trade has a lower score 5. Heroin trafficking has remained stable, with a score of 6. Spain continues to be a strategic point of entry for drugs into Europe. Pending the latest data on total cocaine seizures in Spain in , police sources believe that the country has doubled its cocaine seizures compared with The drug, hidden among a shipment of frozen tuna and false bottoms of shipping containers, came from South America and was destined for consumer markets in Europe. Twenty people suspected of belonging to an organized crime group from the Western Balkans were arrested in connection with the seizures. With direct maritime links to South America and Africa, Spain is a transit point for drugs heading to other countries in Europe via Valencia, Andalusia, Galicia and Catalonia. It is also a consumer destination market. Most drugs that arrive in Spain are hidden in shipping containers used to transport legal goods, making it difficult to detect illicit cargoes that evade security and surveillance controls, or they are smuggled in specially designed narco-boats. To stem the flow of drugs into Europe, in January , the European Commission launched a public — private partnership between ports, national authorities, European agencies, customs and police authorities to control and process the millions of containers entering the continent each year. However, more needs to be done to ensure a holistic response. A very broad strategy is needed. Drug trafficking is not going away; it is a continually developing economy, and public institutions often do not have adequate instruments to combat it. Dismantling the criminal networks involved can therefore be a Herculean task. International cooperation should be a key component in the response, including the exchange of police information between agencies from different continents, a package of public policies adapted to each country and better anti-corruption policies. The deaths of the two Spanish police officers in February are just the tip of the iceberg. Hay que hacer una estrategia muy amplia». Cocaine trafficking routes and methods in Europe. Source: The cocaine pipeline to Europe, GI-TOC and InSight Crime, February To stem the flow of drugs into Europe, in January , the European Commission launched a public — private partnership between ports, national authorities, European agencies, customs and police authorities to control and process the millions of containers entering the continent each year. Related analysis.

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