#off label

[religion-is-a-mental-illness]

By: Bernard Lane

Published: Sep 6, 2023

America’s drug regulator, the FDA, has been asked to take urgent action on the unapproved use of hormone suppression drugs to block the natural but unwanted puberty of transgender-identifying children.

“Although this use has not been approved by the [Food and Drug Administration], the FDA must not turn its back on the potential harm to children,” says a citizen petition filed with the agency.

“Despite the widespread—and rapidly growing—use of these drugs in this population [of children with the distress of gender dysphoria], and despite serious known and potential risks from these drugs, this use has never been evaluated for safety and effectiveness by the FDA.”

The petitioners include child and adolescent psychiatrist Dr Miriam Grossman, paediatric endorcinologist Dr Quentin van Meter and the groups Genspect, Detrans Help, FAIR in Medicine and the Gender Dysphoria Alliance.

The webpage hosting the petition is open to public comment. The FDA acknowledged receipt of the petition on September 5.

“Puberty blockers, or gonadotropin-releasing hormone (GnRH) agonists, are a class of drugs that are FDA-approved for treating certain cancers, endometriosis, and, in pediatric populations, central precocious puberty. Brand name puberty blockers include Lupron Depot-PED, Supprelin LA, Fensolvi, Synarel, and Triptodur. These drugs suppress the release of sex-specific hormones—testosterone in males and estrogen in females. When given to children in the early stages of puberty, they delay sex-related changes normal to adolescent development, such as deepening voice in males and breast development in females.”—citizen’s petition to the FDA, September 2023

The petitioners urge the FDA to—

• commission the National Academies of Sciences, Engineering, and Medicine (NASEM) to undertake a transparent and unbiased systematic review of the evidence for trans puberty blocker drugs • issue requests for long-term registry studies of the children given trans puberty blockers, given that long-term data “is critically important and sorely missing” • create a webpage disclosing the known and potential risks of off-label puberty blockade to “help to counter widespread confusion and misinformation about this use”

“Many in the medical profession and the media continue to represent the off-label use of puberty blockers as ‘well established’ and ‘lifesaving’,” the petition says.

“While the FDA has taken an aggressive stance against medical misinformation in other contexts, it has done nothing to counter these misrepresentations.

“What is most concerning is that, because puberty blockers are not FDA-approved in children with gender dysphoria, there is no demonstrated benefit of the drugs to justify these risks.

“This is why Sweden, Finland, the UK, Norway and other countries have all turned against the use of puberty blockers and other medical interventions as a front-line treatment of gender dysphoria, recognizing this use as experimental.

“The [American] public deserves the truth from its government about the potential harms of these drugs and the lack of established benefit.”

Puberty blockers are used off-label for gender dysphoria internationally, although brand names may vary from country to country.

Misinformation

“The FDA can address the misinformation surrounding the off-label use of puberty blockers in children by commissioning a systematic review of existing peer-reviewed studies by NASEM with the goal of developing an authoritative assessment of the evidence,” the petition says.

The citizen’s petition says the gender-affirmative treatment model used in the United States lacks the safeguards imposed by the Amsterdam gender clinic which in the late 1990s pioneered the use of puberty blockers followed by cross-sex hormones and surgery.

“Because of the prevalence of the affirmative model in the US, the number of children with gender dysphoria receiving puberty blockers has also risen sharply, more than doubling between 2017 and 2021,” the petition says.

“These drugs are known to interfere with bone development and fertility (when followed by cross-sex hormones) and serious concerns exist about their effect on long-term bone health and neurocognitive development.

“What is most concerning is that this [poorly understood] safety profile is currently tolerated in drugs prescribed to children for which the benefit is highly uncertain.”

The petition notes the vulnerability of dysphoric children, who have “higher rates of other psychological and developmental conditions, including autism, eating disorders and depression.”

“US District Court judges have been asked to compel the FDA to reveal what it knows about the off-label use of puberty blocker drugs by gender clinicians.”—news report, Gender Clinic News, 16 March 2023

This week’s citizen petition also calls upon the FDA to warn drug companies and health providers of the consequences of unlawful promotion of puberty blockers for children with dysphoria.

“Puberty blockers have been marketed directly to teenagers with promotions that characterize the drugs as a safe way to ‘put puberty on hold,’ without disclosing any of the required risk information,” the petition says.

“For example, a Planned Parenthood ad that first aired in 2022 depicts two cartoon teenagers speaking directly to potential users, stating—

‘[p]uberty blockers are safe and can give you more time to figure out what feels right for you, your body, and your gender identity,’ and ‘[y]our gender identity is real. You should be the one to decide what changes you want to make to your body’

The petition says, “Pharmaceutical companies that promote their drugs for off-label uses have paid multi-million-dollar settlements to avoid civil and criminal judgments.

“But the potential for harm to users doesn’t depend on who runs the ad: off-label promotions by practitioners that oversell the benefits of an off-label use and fail to disclose the risks have the same potential to deceive consumers.”

GCN has contacted the FDA for comment

==

Hopefully sanity will prevail.

[currentlyonstandbi]

i dont care what kind of lore they're coming up with for that zepotha film or whatever the fuck over on tiktok, nothing will ever come close to the fact goncharov was spawned entirely from a label on a boot

[a-scary-lack-of-common-sense]

I cannot wait for this Stan to reconnect with his Ford.

I still haven't figured out HOW exactly they'll meet yet, but I do think that Ford would ATTACH himself to Stanley and talk his ears off forever when they eventually get comfortable :] and Stanley would listen because HOLY SHIT, THAT'S HIS BRO HE HASN'T SEEN FOR 40-ISH YEARS, HE MISSED HIS VOICE. Nonstop certified Yapper & Listener relationship <3

Stanley looks dead faced because of his ingrained poker face, but he's thouroughly enjoying it, even if sometimes he has no idea what the fuck Ford is saying. He never interrupts him though, since he knows people usually ignore or interrupt him mid-talk already. So sometimes Stan gets stuck in awkward situations where he has to leave or do stuff, but also doesn't have it in his heart to stop Ford and extract himself out of a (one-sided) conversation.

[dicipher]

I think an interesting idea- considering some people argue that there isn't much romance in homicipher, is that this game IS full of love, just not traditional kinds. Variety! Woo!

"Unconditional love, simply put, is love without strings attached. It's love you offer freely. You don't base it on what someone does for you in return. You simply love them and want nothing more than their happiness."

"Someone is said to be suffering from delusional love disorder when they feel that that their feelings of love are reciprocated, despite glaring evidence of this being not true. People with delusional love disorder often feel that other people are in love with them."

"A love-hate relationship means that you hold both positive and negative feelings toward something. In the case of relationships, a person with a love-hate relationship with their partner both loves and hates something(s) about said relationship. These feelings can be both simultaneous or alternating — someone might go from loving to hating their partner very quickly, or experience a complicated mix of both at all times."

"One-sided love, also known as unrequited love, occurs when one person has romantic feelings for another who does not reciprocate those feelings. This situation can arise in various contexts, including friendships, crushes, or even long-term relationships where one partner may not feel the same way." (Note: this refers to the player's love, not his)

"Caring, on the other hand, can be seen as a broader concept that encompasses concern, empathy, and a willingness to support and help someone. While love is often seen as a more intense and emotional state, caring can be a more practical and action-oriented expression of concern for someone's welfare." (Note: custodial as in, in charge of someone. Like a caretaker, parent, etc)

"Ludus is playful, noncommittal love. Ludus covers things like flirting, seduction, and casual sex. Ludus means “play” or “game” in Latin, and that pretty much explains what ludus is: love as a game. When it comes to ludus, a person is not looking for a committed relationship."

"Conditional love is often characterized by the idea that affection and support are given based on specific conditions being met (eg, behavior, achievements, or circumstances)." (Note: Gap's love is ironically, transactional)

"Platonic love is a type of love in which sexual desire or romantic features are nonexistent or have been suppressed, sublimated, or purgated, but it means more than simple friendship" (extra: "Self-love is a state of appreciation for oneself that grows from actions that support our physical, psychological and spiritual growth. Self-love means having a high regard for your own well-being and happiness. Self-love means taking care of your own needs and not sacrificing your well-being to please others."

"Childish/child-like love is blind. It buys love and doesn't hesitate to manipulate in order to do so. Childish love tends to control and hang onto and therefore doesn't set us or the people we love free." "Selfish love in a relationship is when one prioritizes their own desires and needs over their partner's. It often involves manipulating or expecting the relationship to cater primarily to one's own comfort and goals."

[fortjester]

screenshot of a poll by @kobolde from may of 2023 that i took for tlt meme purposes and left to rot in the depths of my files for over a year lol

[poorly-drawn-mdzs]

Daddy, don't go.

[First] Prev <–-> Next

[messylustt]

just a reminder to those who report works for being too sexual. if you feel uncomfy or dislike the work don’t put a community label on it, instead don’t read it. most writers put content warnings on their posts. read them before venturing further, please. and if you dislike something on there, again don’t read any further. smut etc. isn’t for everyone, that’s perfectly fine. but don’t do that to a writers hard work. please and thank you.

[wonryllis]

ENHYPEN REVEALING THEIR NON!IDOL S/O.

────────𝖺𝗅𝗍𝖾𝗋𝗇𝖺𝗍𝗂𝗏𝖾𝗅𝗒, 𝗐𝗁𝖾𝗋𝖾 𝗍𝗁𝖾𝗒 𝖽𝖾𝖼𝗅𝖺𝗋𝖾 𝗂𝗍 𝗍𝗈 𝗍𝗁𝖾 𝗐𝗈𝗋𝗅𝖽.

CONTAINS. idol!enhypen showing you GENRE. fluff, fem!reader, requested WORDCOUNT. 727 LIB?

𝗵𝗲𝗲𝘀𝗲𝘂𝗻𝗴 everyone knows okay everyone just does. it's in his eyes, it's in the way he speaks, it's in his body language, it's in the way he dresses, it's in the little advice and messages he leaves on weverse, it's in the pictures he posts. just everything exudes that he's a taken man desperately in love. his reveal is normal, an official announcement from the company the day after their contractual dating ban is over. appearing on a talk show after all excited to tell everyone about you to be hit by the realization that people actually did have idea just not that you are non celeb.

𝗷𝗼𝗻𝗴𝘀𝗲𝗼𝗻𝗴 he does not give a fuck about anyone but you. would reveal it so nonchalantly like he's on a live and fans accidentally spot you moving around in the background and he's like,"oh yeah that's my girl, would y'all like to say hi?" he'd call you over and have you sit on his lap the entire time, though not showing your face he doesn't want your privacy getting taken away. you both would laugh and interact with the comments and answer fan questions like you've been public for years. talking about first impressions, who's more clingy, why you chose him yk.

𝗷𝗮𝗲𝘆𝘂𝗻 he's scared, not for himself but for you. baby doesn't want his baby getting those hates and threats. he takes a little safer side, writing a personal note addressing the love of his life and asking to be respected and given privacy. monitors the response and as soon as everyone seems accepting he's showing you off everywhere he can, from talking about you on lives and interviews and shows to posting little tmis on social media. fans even grow to tease him with your name challenging him to things he wouldn't otherwise do. cutesy and hot alike.

𝘀𝘂𝗻𝗴𝗵𝗼𝗼𝗻 he has no intentions of revealing it like until he has a baby with you or something. but poor guy is so bad at concealing his feelings like he's on a show to give advice on fans queries and there's this specific question about how do you know you love someone and hoon is just K.O. ed rambles on about how there's this internal feeling and you just know it when you look at them, they're the best in the entire world and everything. then later on panics when articles surface about it, "oh my god baby they know! they know!" and he ends up confirming the rumours.

𝘀𝘂𝗻𝘄𝗼𝗼 this guy can't wait to let the world know about you, his special person, his home. takes every chance he gets to reveal y'all but the manager jumps in every single time telling him it's not the 'right time' yet. he's so annoyed now, he's taking it the dispatch way. sneakily going places without cover, not necessarily to you and then when the articles are out jumping at the first opportunity to introduce his lovely partner through a message to his fans. talking about how long he's been waiting to let them know this important person and how much he loves you.

𝗷𝘂𝗻𝗴𝘄𝗼𝗻 my boy is soft launching it. he's posting these random ass pictures of succulents and cardigans and hairpins and lipgloss and everyone is so confused until he starts with pictures of hands that are too pretty to be his, skirts with thighs that couldn't be him and lastly a picture of him twirling around someone with the caption,"everyone meet my baby! :))" and after that he's making everyone sick with lovey dovey pictures of you everyday everywhere, twitter, instagram, weverse you name it, everywhere! fans be getting every little update of your love life.

𝗿𝗶𝗸𝗶 leaves little hints and tricks here and there to get the fans crazy with suspicions but at the same time not enough to expose y'all. plays at it for about a year before he gets impatient and unsatisfied with just little bits and pieces wants to upload full on vlogs about his days with you. wanting to post things like 'dance challenge with my beloved' literally has it on the tip of his mouth "i love my girlfriend," begs the company to let him reveal it and they're like we never stopped you?? so he does talking about it with fans- my girlfriend does that too! my girlfriend would love that!

taglist ( open. ) @kangseulgithegreat @s00buwu @luvyev @pockyyasii @nctislifue @ashtxrie @miniature-tragedy @jayujus @nanabbg @thoughtsmeander2tumblingblindly

[trans-axolotl]

oh having thoughts today about the way that some psych survivors and tbh the disabled community in general distance themselves from the label of “drug seeking patient.” cause it’s like—I think it’s totally okay to be drug seeking, actually, and I wish it was easier to just go up to doctors and ask for the drugs you need and then just get them. I wish that there was easy access to a safe supply of a whole lot of drugs and there’s nothing morally wrong with trying to seek that through the medical system.

and i very much do understand how having that label plastered on your medical record can be incredibly harmful in terms of preventing access to care, I know very deeply how destructive medical records can be on our lives, especially when we’re already marginalized. I know that sometimes we need to fight to have our medical records represent a certain narrative so that we are able to keep accessing the care we need. And I support doing whatever you need to do in the medical system to get the care you need, including lying to doctors, trying to get stuff taken off your medical record, saying things about your drug use to your doctor that isn’t the way you talk about it the rest of the time, cause this shit is impossible to navigate. I’m never going to attack someone for being upset that this shit gets put into their record—I know how destructive and violating it can feel to have the things that professionals say about you dictate all your access to lifesaving care after that.

I guess I’m just saying that regardless of whatever pragmatic steps we need to take when it comes to navigating our own medical records and care, I don’t want us to lose sight of the bigger picture of solidarity with people who use drugs and that we focus our anger on the root of the problem, which is that no one should be denied access to treatment and medication, including controlled substances and Adderall and opiates, regardless of what labels are applied to us, regardless if we’re using drugs for “recreational” or “medical” use (like the two can even be neatly separated in the first place lmfao). And that we keep an eye out for propaganda that encourages us to throw people who use drugs under the bus, that blames us for (artificially created) medication shortages or bullshit DEA policies that create all these restrictions in the first place. the disabled community cannot discard the many people who use drugs, criminalized or otherwise, from our community.

[satans-knitwear]

At the pub, I got asked twice where I bought my lingerie, bc the bodysuit I wore over it was the perfect tease.

Treat me ~ Tip Me ~ More of me

[sticcmann]

HAPPY BIRTHDAY @clovreat3r YEAHHHHHHHHHHHH ur so coolll

[sleepnoises]

bits from the secondhand fabric store. mostly fat quarters. the solids to the left are miscellaneously sized scraps that were bundled in ziploc baggies

[laora-ryn]

Just in case anyone was wondering, I am in fact a federal employee and I am in fact having A Fucking Time Of It

In roughly chronological order, here's all the things that have fucked us over the last two weeks:

Hiring freeze effective immediately, which involved rescinding final offers to people who were about to start their job. A final offer is something you can get a mortgage with btw. It's what you get after months of paperwork. It's something you move cross country for. Eighteen people just at our hospital had a final offer rescinded

A demand for a return to in person work, with no explanation given for why they want this so badly. No explanation on people who have teleworking written into their contracts, or people who have teleworking as a reasonable accommodation

Related to the hiring freeze: no creation of any new jobs in even a preliminary way, even to prep to fill existing vacancies after the 90 days are over

Closing of all DEIA teams groups, webinar series, webpages, department gatherings... Anything you can think of. This included the queer teams based communities that were just a place for people to chat

Related to this: our acting secretary sending out an email that sounds straight out of the fucking Gestapo, where "we are aware of efforts by some in government to deliberately redefine DEIA positions in an attempt to keep their jobs. If you know of this happening, here's an email line we've set up for tips. There won't be adverse consequences for reporting, however, failure to report may have adverse consequences"

What appears to have been trying to be a total freeze on federal spending, which threw literally everything into chaos, I was not able to follow it at all, but the hospital is still running so I'm assuming money is happening somewhere

Two strange emails from OPM.gov, marked EXTERNAL, saying they're testing a new distribution list and to please reply yes. These were considered so universally sus by employees that they had to come down from central office and confirm that yes, these are legit, please reply

A day later, an email from that same external address offering voluntary resignation, which I'm pretty sure is the bit that's been all over the news for (checks notes) being word for word the same email musk sent to Twitter before proceeding to Not Pay Them

A restriction on communication and travel. "No speaking engagements or attendance at public facing events, seminars, or conferences (unless approved by chief of staff) for 6 months. VA only events are excluded." Which was later clarified to mean "well if you're going for continuing Ed, as long as you aren't presenting, it's ok" but then backtracked to "it's probably ok but you still need approval which can take upwards of a month." Why are they restricting speaking at conferences? It's not a money thing because traveling for VA events still costs money. It's like they're looking to prevent staff from interacting with anyone external, for some reason

And today, an email this morning that "leadership has received guidance from the office of personnel management [regarding the EO about "gender ideology extremism and restoring biological truth"] and is working to execute the EO fully, faithfully, and thoughtfully."

This afternoon at 4:30, this began with an all employee email saying that all personal pronouns are being removed from Outlook display names by IT, which was a system implemented several years ago and broadly popular! But nope, we'll need to go back to guessing what genders new coworkers named Quinn, Alex, Morgan, and Taylor are.

(oh I forgot! I can't use the word gender at work anymore. Using Proper Terminology (as interpreted by our ~~~Illustrious President~~~) in all communications at work is now required)

It's been a fucking week and a half and I am so goddamn tired guys. Sorry I haven't been on again but I'm spending most of my energy on Not McFucking Losing It rn

[dismas-n-dismay]

I'm not fucking joking when I tell you I saw this panel and literally started sobbing and crying over seeing my babygirl buying chocolate with just fucking quarters. This is the people's jason todd for real, thank you Juni Ba

[tubbytarchia]

Thinking about them still and always

So I was trying to do a meme redraw and halfway through realised that I mixed two memes up into one so now this is the result lmao. But either way I was thinking of these:

[itbeaheadcannon]

hc that merlin and Gwen (who are besties btw) are absolutely running shit. Got a problem? Go to them - always to them. They're the ones who know the most about the castle and have full control of the royal schedules.

Uther does not know about this and neither does Arthur - however whenever either one of them pisses Merlin or Gwen off or they just do something like seriously fucked up (looking at you Uther you absolute ass) they bury them in work.

and I mean like bury them: making them wake up at like first light for an 'emergency' (apparently someone thought they saw a sorcerer) straight to training the Knights, to a meeting with the council to deal with the non-existant sorcerer, to confirmations of a celebration

they don't know what the celebration is for. (in truth it's not for anything, the castle just wanted an excuse for a party, and it's funny gaslighting the royals into thinking they approved some random ass celebration a few weeks ago)

The servants know and 100% annoy them with inane shit because their "input" is needed (no the fuck it's not, but getting to fuck over royalty is fun for them)

random servant #1 to Uther: Apologies for interrupting Sir, but the seamstress wanted to confirm time for your fitting for your outfit for the celebration tonight?

Uther, baffled asf running on 5hrs sleep: celebration? there is no celebration??? and what colour scheme

Servant #1 trying not to cackle: yes sir there is? you advised of it just last month - the seamstress just wanted to take last measurements

Servant #2 elbowing #1 to get their shit together: and the blue and purple scheme? You approved it over a month ago, and Prince Arthur confirmed last week before preparations were made.

(all the food is stuff Arthur and Uther barely tolerate and mildly hate and their alcohol is weak asf - meanwhile the knights and everyone else are eating amazingly, drunk off their asses)

more in the tags lol