Research Keyword: FDA approval

From Efficacy to Effectiveness: Evaluating Psychedelic Randomized Controlled Trials for Trustworthy Evidence-Based Policy and Practice

This paper discusses why testing psychedelic therapies in clinical trials is more complicated than testing regular drugs. When people take psychedelics like MDMA or psilocybin, they clearly notice the effects, which makes it hard to keep the study ‘blinded’ (where neither patients nor researchers know who got the real drug). The author argues that for therapies combining drugs with counseling, this actually makes sense because the therapy itself is part of how the treatment works, not just a confounding factor. However, for stand-alone drug use, this unblinding is a real problem that makes it unclear whether the drug or people’s expectations caused the improvement.

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Ethical Considerations Regarding Psychedelics for Clinical Pain Research

This paper examines the ethical considerations necessary when conducting research on psychedelics like psilocybin for treating chronic pain. With chronic pain affecting millions of Americans and traditional treatments like opioids causing significant problems, researchers are exploring psychedelics as alternatives. The authors provide guidance on obtaining proper informed consent, protecting vulnerable patients, managing regulatory requirements, and ensuring research benefits participants while following four key ethical principles: autonomy, beneficence, justice, and avoiding harm.

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Hype or hope? Ketamine for the treatment of depression: results from the application of deep learning to Twitter posts from 2010 to 2023

Researchers analyzed over 18,000 Twitter posts from 2010 to 2023 to understand what the public thinks about using ketamine to treat depression. They found that public opinion became much more positive after the FDA approved ketamine as a depression treatment in 2019. Most discussions consisted of personal stories from people who found ketamine helpful, especially those whose depression didn’t respond to other medications. While some people expressed caution and concerns, overall the public seems hopeful about ketamine’s potential.

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New and emerging pharmacologic treatments for MDD

Major depressive disorder affects millions worldwide and current antidepressants often don’t work well or take weeks to be effective. Researchers have developed exciting new treatments that work through different brain mechanisms and show promise for rapid symptom relief. These include nasal spray ketamine (approved 2019), oral medications like zuranolone (approved 2023), and investigational treatments including psilocybin, which show benefits especially for treatment-resistant cases. While many show great promise, more research is needed on long-term safety and how to make them widely available.

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A Review of the Food and Drug Administration Pipeline and Proposed California Legislation on Medicinal Psychedelics

Psychedelic compounds like psilocybin and ketamine show promise in treating serious mental health conditions including PTSD and depression. The FDA carefully evaluates these drugs through multi-phase clinical trials to ensure they are safe and effective. While California has proposed making psychedelics more widely available through legislation, the FDA’s thorough approval process provides important protections by identifying potential risks and ensuring proper medical oversight.

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Renaming Candida glabrata—A case of taxonomic purity over clinical and public health pragmatism

Candida glabrata is a common yeast infection that causes serious illnesses in humans, affecting millions of people worldwide. Scientists have recently proposed renaming it to Nakaseomyces glabrata for technical taxonomic reasons. However, this article argues against the change because it would create confusion for doctors, complicate treatment instructions on medications, disrupt disease tracking systems, and make it harder for patients to understand their conditions. Keeping the familiar name Candida glabrata is more practical and helpful for patient care and public health than strict adherence to taxonomic classification rules.

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