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Tallinn Black Nights Fest Chief Tiina Lokk on Her Program, Fighting Conflicts and Cuts: ‘If Someday A-List Stars Would Like to Come, We’ll Find the Money’

Tiina Lokk, the founder and managing director of the Tallinn Black Nights Film Festival (known as PÖFF), one of the largest festivals in Northern Europe, has put together with her team of 15 programmers, another strong and varied harvest for the fest’s 28th edition unspooling Nov. 8-23 in the Estonian capital.  Split into six main competition strands and another 37 sections, […]

MDMA for PTSD: Three studies retracted on heels of FDA rejection

MDMA

Enlarge / MDMA (credit: Getty | PYMCA/Avalon)

A scientific journal has retracted three studies underpinning the clinical development of MDMA—aka ecstasy—as a psychedelic treatment for post-traumatic stress disorder. The move came just a day after news broke that the Food and Drug Administration rejected the treatment, despite positive results reported from two Phase III clinical trials.

On Friday, the company developing the therapy, Lykos Therapeutics, announced that it had received a rejection letter from the FDA. Lykos said the letter echoed the numerous concerns raised previously by the agency and its expert advisory committee, which, in June, voted overwhelmingly against approving the therapy. The FDA and its advisers identified flaws in the design of the clinical trials, missing data, and a variety of biases in people involved with the trials, including an alleged cult-like support of psychedelics. Lykos is a commercial spinoff of the psychedelic advocacy nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS).

FDA advisers also noted the public allegations of a sexual assault of a trial participant during a Phase II trial by an unlicensed therapist providing the MDMA-assisted psychotherapy.

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Syria - Level 4: Do Not Travel

Updated to reflect the risk of wrongful detention

Do not travel to Syria due to the risk of terrorism, civil unrest, kidnapping or hostage taking, and armed conflict. Exercise increased caution due to the risk of wrongful detention.

Country Summary: The U.S. Embassy in Damascus suspended its operations in February 2012. Czechia serves as the protecting power for the United States in Syria. The U.S. government is unable to provide any routine or emergency consular services to U.S. citizens in Syria.

Syria has experienced active armed conflict since 2011. No part of Syria is safe from violence. Hostage taking by armed groups, wrongful detentions, the use of chemical warfare, shelling, and aerial bombardment of civilian centers pose significant risk of death or serious injury. The destruction of infrastructure, housing, medical facilities, schools, and power and water utilities has also increased hardships inside the country.

The U.S. government strongly warns private U.S. citizens against traveling to Syria to engage in armed conflict. The U.S. government does not support this activity. U.S. citizens who undertake such activity face extreme personal risks, including hostage taking by armed groups, wrongful detentions, injury, or death. Our ability to provide consular assistance to individuals who are injured or kidnapped, or to the families of individuals who die in the conflict, is extremely limited.

Protests and demonstrations are quelled by government forces through aggressive tactics and protestors, activists, and political dissenters are routinely detained without access to legal representation or the ability to communicate with friends and family.

Terrorist groups are active in Syria. Parts of Syria have experienced recent increases in incidents of bombings, IEDs, and assassinations. Fighting on behalf of or providing other forms of support to designated terrorist organizations, including ISIS and al-Qaeda affiliates, can constitute the provision of material support for terrorism or a foreign terrorist organization, which is a crime under U.S. law that can result in penalties including prison time and large fines.

There is an ongoing risk of hostage taking of U.S. citizens and other foreign nationals throughout the country. U.S. citizens are also targets of abduction and/or wrongful detention by the Syrian government. Those in detention do not have access to fair judicial process or medical attention. Government detention centers are known to be unsanitary facilities where widespread cruel, inhumane, or degrading treatment of detainees has been documented, as well as torture and extrajudicial killings. Minors, persons with physical, sensory, or mental disabilities, and elderly have frequently been victims of unjust detention. The Syrian government has also been implicated in the enforced or involuntary disappearance of more than 100,000 individuals, including medical and humanitarian workers, journalists, human rights activists, political opposition, and additionally those suspected of affiliation with these groups and their family members. Only the Syrian government can issue a valid entry visa to Syria. Failure to obtain a legitimate entry visa directly from the Syrian government could result in detention.

Due to risks of operating civilian aircraft within or in the vicinity of Syria, the Federal Aviation Administration (FAA) has issued a Notice to Air Missions (NOTAM) and/or a Special Federal Aviation Regulation (SFAR). For more information, U.S. citizens should consult the Federal Aviation Administration’s Prohibitions, Restrictions and Notices.

Read the country information page for additional information on travel to Syria.

If you decide to travel to Syria:

  • Visit our website on Travel to High Risk Areas.
  • Draft a will and designate appropriate insurance beneficiaries and/or power of attorney.
  • Establish a proof of life protocol with your family, so that if you are taken hostage, your family knows specific questions (and answers) to ask the hostage-takers to be sure that you are alive and to rule out a hoax.
  • Leave DNA samples with your medical provider in case it is necessary for your family to access them.
  • Share important documents, login information, and points of contact with family so that they can manage your affairs if you are unable to return as planned to the United States.
  • Develop a communication plan with family and/or your employer or host organization so that they can monitor your safety and location as you travel through high-risk areas. This plan should specify who you would contact first, and how they should share the information.
  • Enroll your trip in the State Department's Smart Traveler Enrollment Program (STEP) to receive Alerts and make it easier to locate you in an emergency.
  • Follow the Department of State on Facebook and Twitter/X.
  • Visit the CDC page for the latest Travel Health Information related to your travel.
  • U.S. citizens who travel abroad should always have a contingency plan for emergency situations. Review the Traveler’s Checklist.
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