Please tell your friends about federated social media site that speaks several fediverse protocols thus serving as a hub uniting them, hubzilla.eskimo.com, also check out friendica.eskimo.com, federated
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Recent investigative findings have brought to light significant concerns regarding the approval and trial processes of mental health medications. Between 2013 and 2024, the U.S. Food and Drug Administration (FDA) approved 16 novel psychiatric drugs. However, the underlying clinical trials that supported these approvals show a mixed record of success and rigor. Out of 73 clinical trials for these drugs, approximately 62% were judged positive by the FDA, but some drugs were approved despite more failed or negative trials than successful ones. For instance, brexipiprazole, pimavanserin, and gepirone had fewer than half of their submitted efficacy trials deemed positive, with one even overturned by higher FDA leadership after initial rejection by medical reviewers. Notably, three drugs were approved based on a single pivotal trial, raising questions about the robustness of evidence required for market entry.
[1]Moreover, despite the ongoing intake of these medications by millions, the scientific understanding of how many psychiatric medications exert their effects remains limited. Most of the approved drugs operate through variations of mechanisms involving serotonin, dopamine, and norepinephrine systems, pathways known since psychiatric drug development began over half a century ago. There has been little advancement in fundamentally new mechanisms of action, although improvements in safety and tolerability have been made. This stagnation raises concerns about the innovation in psychiatric drug development when the efficacy and safety evidence supporting approval vary greatly and sometimes rely on unclear biological assumptions.[3]
[1]This situation prompts pressing questions: Why have so many mental health medications not gone through more rigorous and conclusive trials before approval? If the basic science behind these medications is not fully understood, how can we be certain that these drugs help patients in meaningful, long-term ways? Psychiatric disorders are complex illnesses with no validated biological biomarkers, making it difficult to measure treatment effects objectively. This scientific uncertainty may partially explain the reliance on clinical scales and the variability in trial outcomes.[1]
[3]Additionally, some critics argue that some clinical trials lack a true placebo group, as "placebo" groups often consist of patients withdrawn from other psychiatric medications, thus complicating interpretation of drug efficacy. Research on first-episode psychosis patients, for example, lacks placebo-controlled trials altogether, making it difficult to confirm short-term benefits conclusively.
[2]In summary, the recent disclosures about the variability and limitations in trials preceding FDA approval for mental health medications underscore an urgent need for greater transparency, rigorous scientific inquiry, and innovative approaches in psychiatric drug development. Until we clearly understand how these medications work and verify their benefits with solid evidence, patients and practitioners must ask: If these drugs were created with unknown science and incomplete trials, how exactly do they help? Why wasn't more stringent testing required before approval to ensure patient safety and effectiveness?
***
This essay aims to highlight the current concerns and calls for deeper investigation and clarity in the mental health medication approval process based on recent research and regulatory reviews. If you want, I can provide a detailed list of the specific drugs and trials mentioned in the latest studies. Would you like me to include that information?[2][3]
tranny gender fluid doesn't look too bad. it has a slight shimmer of metal particles which seems pretty normal after a decade or more since the last fluid change
@Desiree4freedom🇺🇸 If we go back far enough in history we can always find a reason to hate each other. The question we have to ask ourselves is do we keep wanting to relive a history of death and dismemberment or do we want to create for ourselves a better future?
🤣 😭 🤣 😭 🤣 😭 Harsh, but pretty accurate... For me, the reaper ever lurks in a sun-bathed field I am mowing, or wherever my mind may wander... Relative contentment, if not happiness, always coupled with existential dread... Is death relief, or...? The clock keeps ticking...
>Is death relief, or...? The clock keeps ticking... Nobody knows for sure. People have their beliefs, but that's all they are, beliefs. All we know for sure, is we're no longer in this dimension when we are dead.
Halloween: The Game Announced, Will Feature Multiplayer And Solo Story Mode
This new Halloween game is set to arrive on consoles and PC sometime in 2026 The post Halloween: The Game Announced, Will Feature Multiplayer And Solo Story Mode appeared first on Kotaku.
A Yosemite National Park ranger was fired after hanging a pride flag from El Capitan while some park visitors could face prosecution under protest restrictions that have been tightened under President Donald Trump.
President Emmanuel Macron earlier said that France will officially recognize a Palestinian state at a session of the UN General Assembly in New York in September
What the actual #EpsteinFiles Contain - Not the "Files" or Grand Jury Testimony - 30 gigabytes of data/information - 100,000+ pages of evidence seized from Epstein’s homes, computers, safes. - #Flight logs. visitor lists implicating elites. - #FBI interviews w #victims & associates. - #Banking #financial records tracing Epstein’s funding networks. -Civil lawsuits, sealed depositions that name names. & yes, Trump’s name is all over them. #Jeffreyepstein #GhislaineMaxwell #sextrafficking #coverup
Airplane! movie clips: http://j.mp/1JagwTJBUY THE MOVIE: http://amzn.to/tk9JjsDon't miss the HOTTEST NEW TRAILERS: http://bit.ly/1u2y6prCLIP DESCRIPTION:As t...
Note from Teemu, Tim, and Torin to the Open Policy Agent community
Today we’re excited to announce that the creators of Open Policy Agent (along with many team members from Styra) have joined Apple …
Worried by a "#reading crisis," #Denmark government will eliminate its #salestax on #books, looking to get more citizens buying them, The country's 25% tax on books is currently highest in Europe, stands in stark contrast w countries such as Britain that charge no sales tax on book purchases. "We need to do all we can to fix this reading crisis that has unfortunately spread in recent years," eliminating sales tax on books would cost the state estimated 330 million kroner ($51 million) a year.
I am late to the party, by around 40 years. But I have recently delved into Terry Pratchett's Discworld and although I'm only 2 books into this 41 book epic, I feel this is becoming a new obsession. The world building in these books is wonderful. And I've never sat and giggled to myself as much when reading. These books are weird and wonderful and very silly in the best way. Can we please appreciate Josh Kirby's original artwork for the series and how sick his designs are. The attention to detail is 🔥
welcome! This is almost certainly a controversial opinion, but the books keep getting better. If you like the early ones you will *love* the last ones.
Actually this is one I dislike. In the book Pratchett specifically states, with reference to typical fantasy cover art of the Boris Valejo sort, that Herenna the Henna-haired Harridan wears sensible warm clothing with functional armour on top, not something out of a fetish shop. But Kirby doesn't seem to have read that bit.
I too came a few decades late to Terry Pratchett and now I love Discworld! I'm only about 10 novels in so far but Death is definitely my favourite character. 💀
What Does Xbox's Future Look Like As This Generation Draws To A Close?
Xbox's Design Head posted on LinkedIn about the current generation of Xbox wrapping up. That could mean a lot of things, so we can't read much into it. Given the timing though, it makes sense that Microsoft is thinking about what's next. Here's what was said, and what's happening with Microsoft's gaming division these days, to help us make sense of the ...
I suppose it is finally time I posted, given that I have been floating around in the background of Mastodon like some sort of strange aetherial ghost.
I'm Holly. I work in Mental health. Moving over to Mastodon feels like a form of self care. I will explain this more in another post.
I adore heavy music. Not always heavy in the traditional sense of the word, but anything that gives me goosebumps, whether instrumentally or lyrically profound.
I love black metal, death-metal, post-rock, post-metal, ambient, blackgaze.
In terms of gaming, I play on PS5. I am a lover of open world games, RPG's. Currently playing Clair Obscure 🩶 (which is beautiful btw)
Your regular reminder that you don't need to be trans, nonbinary, or otherwise not cis to choose a new name or set of pronouns for yourself. You have the right to identify however you feel most valid. Be supportive of those around you and their choices, be gentle with yourself, and above all, be kind to everyone including you. Have a great day out there.
What Religion Never Told You About Its True History | Jordan MaxwellDive deep into the hidden history of religion with Jordan Maxwell, as he uncovers the sup...
India-based developer Ayelet Studio has announced Son of Thanjai, an action adventure game set in 11th century South India. It will launch for PlayStation 5…
out of it all, I always sorta found it unbelievable that ol sheev could stand there in front of the Senate and just tell everyone he was calling it the galactic empire as he consolidated power and everyone would just cheer with the padme line being super like cringe in a way for being so ham-fisted about the whole thing.
until now. turns out that's almost exactly how it happens.
#Trump has purchased @ least $103M in corporate & municipal #bonds since taking office in Jan, per ethics filings, unprecedented move 4 sitting president allows him 2 profit directly from companies, banks, local govts affected by his policies; spree included nearly 700 bond purchases #MorganStanley, #WellsFargo, #Qualcomm, #TMobile, #UnitedHealth, + municipal bonds tied to #hospitals, #airports, #schools, raising conflict-of-interest concerns = Trump’s sway over federal funding, monetary policy
🎸 #NaData de hoje, mas em 1994, a banda punk Fugazi, de Washington, tocou no Aeroanta, em SP. Independentes a sério, rejeitavam as grandes gravadoras, e não faziam clips.
O cover anexo, dos alunos de uma escola de rock, foi aplaudido pela banda, e é do sucesso Waiting Room, que também tocou nesse show em SP (foi a 9ª do set list):
This is actually a story from 2016 that I wanted to make sure people knew about. I can't even count the number of Christians that I have had using NASA as proof of space and the globe when presented with contradictory evidence from the Bible.
BRICS is an informal group of states comprising the Federative Republic of Brazil, the Russian Federation, the Republic of India, the People's Republic of China and the Republic of South Africa.
First post on a new instance! I blame @joel for perking my interest in the modern Solaris variants. I also have a tendency to self flagellate with SPARC based hardware and I wonder if these to great tastes taste great together.. Anyway, excited to be here despite my utter lack of practical experience with these variants!
I hope the word “slop” doesn’t get too diluted because I think it’s extremely helpful to have such a short word that means “soulless mass-produced content that exists only to make money with the least effort or creativity possible”
Sometimes I spontaneously think in German now which is not unexpected, but what is unexpected is the level of effort required to translate said thoughts to English
Spider-Verse Filmmakers Lord and Miller Are Making an Archie Comics Movie
Phil Lord and Christopher Miller, the famous filmmaking pair known for Cloudy With a Chance of Meatballs, The Lego Movie, 21 Jump Street, The Mitchells vs. the Machines, and the Spider-Verse films, are about to tackle a new, unexpected project. They're making a film based on Archie comics.
Browse millions of anime, manga, videos, hentai, and video game themed images on Gelbooru. Discover art with detailed tags. Contains explicit hentai content.
Club fit! You’ll recognize a lot of it from my profile pic 😘 this outfit makes me feel so adorable! And yes, going out with a fresh thick megamax so there is no hiding my padded booty from the other ageplayers. If you see me there feel free to say hi! #abdl #diaper #diapers #diapergirl #adultbaby #diapered247 #FitCheck
They just need more blacks in Atlanta city limits for it to work. Quick send all black people there then we can build a wall around it to make sure they are all inside and boom the power of Atlantis will manifest.
JEREMY WAS seven when he first went to boarding school, his expensive new grey shorts enveloping his skinny knees, a roll of comis for the journey smudging in his tight-clasped, birdboned little hand.
Nanook
in reply to Desiree4freedom🇺🇸 • •