iiinova — where your digital self keeps evolving

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amy brown 👻 @amybrown.xyz · 20/08/2026

affirmations: - tomorrow I will be normal - I am doing a good job - nobody whose opinion I respect is mad at me - I am not “muppet-coded”

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Shepherd @neolithicsheep.bsky.social · 26/07/2026

Never let someone tell you that you must excuse owning enslaved people or participating in killing Native people because someone was "of their time". Silas Soule was of the same time.

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Gabe Ortíz @tusk81.bsky.social · 18/07/2026

“The Montclair Township Council voted unanimously Tuesday to pull all of the town’s money — about $91.1 million — out of Citizens Bank, protesting the bank’s financing of the private companies that run federal immigration detention centers.” www.nj.com/essex/2026/0...

nj.com

This N.J. town just pulled $91M from Citizens Bank over ICE

Two N.J. municipalities have now pulled more than $330 million combined, according to the De-ICE Citizens Bank coalition.

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Mr. Joshua @pantspants.bsky.social · 05/06/2026

The New PJs (1/4)

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Matt Herdman @mattherdman.bsky.social · 01/06/2026

Happy Pride month to the whole LGBTQNJ+ rainbow!

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Alice Roberts @profaliceroberts.bsky.social · 01/06/2026

Yesterday I witnessed something extraordinary: the author Sarah Wynn-Williams sitting silent on a stage at @hayfestival.bsky.social. And she got a standing ovation. I hope the attempt to censor her backfires magnificently. I have just ordered her book. www.theguardian.com/technology/2...

theguardian.com

Meta legal action forces Facebook whistleblower to sit in silence at Hay festival

Sarah Wynn-Williams did not speak during event after lawyers warned of possible sanctions from tech firm

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itsonlyzach @itsonlyzach.bsky.social · 22/04/2026

Now why did just realizing tonight is Gritty's first playoff game make me emotional?

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Claire Willett @clairewillett.bsky.social · 27/02/2026

I fell several seasons behind on "Slow Horses" and am finally catching up and I don't think I've ever shrieked at a deadpan line delivery like Jackson's "... can you walk me through your thinking here?" after Roddy drives a party bus into a house only thing funnier than "500 Miles" in the s1 finale

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Joshua J. Friedman @joshuajfriedman.com · 04/12/2025

"The net effect would be to disadvantage the people the FDA exists to protect. ... The proposed new directives are not small adjustments or coherent policy updates. ... These arguments misrepresent both the science and the regulatory record." —former FDA commissioners writing in NEJM

The NEW ENGLAND JOURNAL of MEDICINE
Perspective
A Threat to Evidence-Based Vaccine Policy and Public Health
Security at the FDA

As former commissioners of the U.S. Food and Drug Administration (FDA) — who collectively guided the agency’s oversight for more than 35 years, through myriad public health crises — we are committed to medical product safety and identifying new medical evidence with the speed, rigor, and openness that the public should expect. We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most.
The existing regulatory model builds public trust by encouraging open information exchange and rigorous, transparent scientific debate. Yet a memo sent last week to FDA staff will upend core policies governing vaccine development and updates.1 These measures, and the unilateral way they are being imposed, undermine the public interest. They are the latest in a series of troubling changes at the FDA, including substantial departures of FDA staff, that could diminish both the FDA’s strength and Americans’ health and safety.
The memo (available at https://www-biocentury-com.ezproxy.cul.columbia.edu/article/657740) was written by Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), who also serves as the agency’s chief scientific officer, chief medical officer, and acting head of CBER’s office of biostatistics, as well as overseeing the division responsible for vaccine review and approval. His memo characterizes the actions of FDA scientists who express concerns about agency processes or decisions to outside parties as “unethical” and “illegal.” It calls for scientific debates to be kept within the agency “until they are ready to be made public,” and instructs staff members who disagree with the new framework to “submit your resignation letters.”

The proposed guidelines would dramatically change vaccine regulation on the basis of a reinterpretation of selective evidence and by a process that breaks sharply with the norms that have anchored the FDA’s globally respected scientific integrity. If enacted, the framework would impede the ability to update vaccines to keep up with the natural evolution of respiratory viruses or changes in the prevalence of bacterial serotypes; it would also suppress innovation and competition. The net effect would be to disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.
The new framework rejects the agency’s long-standing reliance on “immunobridging” studies for well-understood vaccines with extensive safety data. Using this approach, once a reliable correlation with effectiveness has been established, a vaccine’s ability to stimulate the immune system to produce protective antibodies can serve as a surrogate for its efficacy in helping patients avoid infections and complications from rapidly evolving viruses such as SARS-CoV-2 and influenza. Because these viruses change frequently, repeating large-scale efficacy trials for every new seasonal strain is not feasible within the time needed to update the vaccines. Bridging studies have also been used to broaden vaccine protection to additional serotypes of bacteria.2 The FDA continually updates the correlate strains used for immunobridging studies to ensure that vaccines remain safe and effective as threats evolve. Immunobridging studies have also been used for some new products, including the human papillomavirus vaccine that could largely eliminate cervical cancer.

The proposed new directives are not small adjustments or coherent policy updates. They represent a major shift in the FDA’s understanding of its job. The memo states that “no amount of cell or humoral mediated immune surrogates” can justify approval of new or updated vaccines — logic that Prasad claims is implied by the lack of a full biosimilar pathway for vaccines. These arguments misrepresent both the science and the regulatory record, especially in the case of vaccines that target well-understood pathogens through an established mechanism of action.
Abandoning the existing methods won’t “elevate vaccine science,” as the memo asserts. It will subject vaccines to a substantially higher and more subjective approval bar. The proposed measures will slow the replacement of older products with better ones and will create potentially prohibitive expenses for new market entrants, especially small biotechnology companies. It’s true that vaccines can generate substantial profits and that their complexity thwarts true generic competition, as the memo observes. But the proposed policy response would reduce competition and raise prices by demanding premarketing randomized clinical trials “for most new products.”1,3 Moreover, insisting on long, expensive outcomes studies for every updated formulation would delay the arrival of better-matched vaccines when new outbreaks emerge or when additional groups of patients could benefit. It is important to create a clear, science-driven, and well-reasoned pathway to approval; otherwise, innovators will have no reliable way to design their development programs. The people most affected by the FDA’s proposed framework will include older Americans and those with weakened immune systems who rely most on the protection that timely and updated vaccines can offer.
The new approach would also evade public transparency, including long-standing statutory and regulatory mechanisms that enable disagreements about benefit–risk balance, clinical tria…

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Yaroslava @strategywoman.bsky.social · 25/10/2025

It is not about that. It is about living life. It is about doing your best, trying to leave something positive behind yourself. It is about stopping to complain. It is about seeing light and being that light for others.

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Parkrose Permaculture @parkroseperma.bsky.social · 22/10/2025

My kid: I always thought CS Lewis ruined Narnia by having Susan abandon it for "lipstick and boys". As if girls are only interesting when they're prepubescent. Me: Well...it was the 40s Kid: you know what else was written in the 40s? Moomin. And that shit is woke AF.

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Fooge @fooge.bsky.social · 25/09/2025

Hey, that was me! Reading it now and really enjoying it. Thanks for writing it! Btw the person who rang me up had read just about everything but Starter Villain. Managed not to spoil the dolphins. But it was close.

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Flock-o'-Lantern @buckrawheat.bsky.social · 24/05/2025

You know what, there *should* be a Pulitzer for best callouts of shit journalism.

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Fooge @fooge.bsky.social · 11/04/2025

You are on the wrong side of history.

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Fooge @fooge.bsky.social · 01/04/2025

Not even for a moment.

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Fooge @fooge.bsky.social · 18/03/2025

Even better, the article contains tips about what types of milkweed to plant by region, where to get them, and where in your garden to plant them to best support the monarchs. Thank you!

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Fooge @fooge.bsky.social · 13/03/2025

Good for you guys. There really was a moment that felt like that. Even if it’s hard to imagine now. Thank you.

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Crows Labyrinth @crowslabyrinth.com · 15/02/2025

Me the first week after buying a bass: cool, cool. I can do this. Me after following lessons for a year, trying to learn jazz and metal songs: fuck, this is hard.

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Fooge @fooge.bsky.social · 12/02/2025

I always figured that Sauron would have noticed the eagles and would have further noticed they were carrying cargo. Too risky.

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Fooge @fooge.bsky.social · 10/02/2025

On first light it still appears to be true.

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Ghostly Anarchic Squid @leahanelson.bsky.social · 02/02/2025

I am a master at compartmentalizing but I have unexpectedly run out of compartments so I am going to need nothing dire or even just upsetting to happen for the next little bit while I restack my hard drive

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Fooge @fooge.bsky.social · 26/01/2025

A very go birds to you and yours

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Fooge @fooge.bsky.social · 19/01/2025

A very go birds to you.

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