TWO DAYS after receiving the application, FDA greenlit the new pancreatic cancer drug daraxonrasib for expanded access.
This drug has also been granted a national priority voucher, which means a full application could be reviewed in a matter of weeks instead of 10-12 months.
Couldn't agree more...RRM bs IVF and improving health outcomes for Mom and baby.
https://www.realclearscience.com/articles/2024/04/26/restorative_reproductive_medicine_is_a_better_way_to_tackle_infertility_1027608.html
Wow. Very touching and honest. I'd love to know what this clip is from. He's completely right.
She did it AGAIN!! @Jennifersey just put together another video that has me in tears.
Wait for it.
Sound on.
They block these videos on other platforms bc they don’t want you seeing them. But you can see them here!!
R to @KrugAlli: What we cover:
Creators, Combiners and Disruptors
Conflict and Passion
School vs Learning
Outnumbered
Personality and Identity
College and Career
Parents of complex kids - our fifth cohort of incredible parents starts next week (Tues April 14 at noon EDT). We'd love to see you there! Signups are coming in now, and space is limited to 14. Your spouse or partner is welcome to attend at no extra charge - we love seeing Dads!! Please join!
https://trainmyaim.com/home/seng-group-gifted-2e-families
Our church, too! Shoulder to shoulder! This is so beautiful. Meaning and purpose found in sharing Christ's love with others and offering His peace in this painful time. Happy Easter, everyone!
I’m not asking you, I’m telling you.
Take a moment and listen to this 81 second response from Victor Glover after being asked if he had any thoughts leading up to Easter.
I don’t quite think it can be overstated how perfect this crew is for the job.
Growing up, the hospital near my town had a McDonald’s in it, and even as a kid I thought that was weird.
I heard him mention military food in addition to schools and hospitals. Several years ago I had a great DM thread going with a military medicine clinician who was actually quite open to talking about the link between the gut microbiome and mental health for servicemembers, who live and work under a great deal of stress, and for whom high performance nutrition really matters. I will have to find that amazing person and reconnect!
Today, CMS issued a memo to every hospital telling them to stop serving sugary drinks + inflammatory processed food to patients or risk federal reimbursement.
Bold, common sense action that will save lives.
We are anxiously awaiting how the media spins this negatively.
Check out @theirish_yank on Instagram. He goes to the Sunday evening Mass there and regularly posts about the "banger of a Mass." Last night: "If you're wondering why there's so many people walking up 6th Avenue, it's because we're all going to Mass!"
https://www.instagram.com/reels/DWfU3aegdfg/
Totally amazed by the mass I attended this morning at St. Joseph’s in Greenwich Village
A queue out the door. Standing room only + full of young people
I’ve never seen a mass with this many young people. Average age was probably mid-to-late 20s
Fr Jonah + the team are crushing it. The revival of Catholicism is very real
This could not have been stated better.
"That’s why this has stuck with me. Because once in a lifetime hires don’t come along often. And when the system spits them out this quickly, it tells you less about the person than about the institution and media environment that couldn’t handle him."
If you’ve been wondering why I can’t let go of the ousting of Vinay Prasad from the FDA, here it is, plain and unvarnished.
He was a once in a lifetime hire.
Prasad was one of the strongest appointments the agency has ever made, and the FDA should have fought like hell to keep him. That doesn’t mean I agreed with every call. For example, I support advisory committees. But it’s worth noting that advisory committees were already in decline prior to his appointment. Besides, disagreement with one aspect does not negate the whole.
The failure to retain Prasad was a consequential mistake; it signals exactly how the agency, the media, and the investor class handle serious challenges to the status quo. And the backdrop makes it worse. Prasad walked into the CBER director’s office after a truly rough stretch in FDA history: overly broad use of COVID vaccines, with related resignations of two top vaccine officials, Paxlovid cheerleading, Elevidys and Aduhelm debacles, and misguided misinformation-policing, among others. This stretch had eroded public trust. He inherited a scarred institution, and the expectation was that he would challenge the status quo and repair the perception of the FDA as acting merely as a rubber stamp.
What’s been maddening to watch is the yawning gap between what everyone claims to want, like higher evidence standards, fewer weak approvals, more appropriate use of accelerated approval, and how violently the system recoils the moment someone tries to deliver it. Modest, data driven moves were treated like heresy. The loudest critics rarely engaged the substance; they only amplified an outrage coming squarely from the perspective of pharma and investor interests.
A clearer accounting of what actually changed and what didn’t during the time Vinay Prasad was at the FDA is still worth laying out.
Accomplishments included the COVID vaccine framework, the Elevidys label narrowing, and proposing to strengthen CBER research and vaccine standards more generally. The Moderna flu vaccine refuse to file decision was an example of using an unconventional approach. It was resolved quickly in a manner that will result in better evidence generation, but with much media fanfare. And worth noting: not all of his accomplishments were around tightening standards. He co-authored significant approaches to introduce regulatory flexibility and support true innovation: formal guidance documents for the new plausible mechanism pathway and Bayesian methodology. Both of these are being praised, but no one is bothered that a key architect on these projects is leaving the FDA? Not to mention the single trial paper.
Instead, the public narrative chose to fixate on three leadership overrides, endlessly framed as “chaos” or a break from sacred norms. Conveniently omitted: every single override aligned decisions with the new COVID vaccine framework that Prasad had developed to navigate uncertainty without rubber stamping. Approval volume stayed roughly in line with historical norms. Rare disease decisions weren’t some override spree; they were part of long running debates over accelerated approval pathways that predate Prasad by years. Reasonable people can quarrel over individual calls. What’s indefensible is pretending the record was defined by recklessness rather than a short, intense effort to tighten standards in an agency long accused of being too cozy with industry.
...
R to @KrugAlli: Update - not that anyone is waiting, lol! I got through the customer service line and filed the rebate that way. Hang in there if you're playing the same game!
Stupid ALCON rebate system is down - trying to get a rebate for contacts. I go through the 14-step process only to have it rejected. I try again from computer vs phone. Same thing. I call the customer support number and they have a message on hold saying they're having a problem processing claims, but that they've fixed it and I should try again. But it's not fixed! Then they say that I should try again. I have 60 days to submit. Do I really want to keep trying every day to see if it is magically fixed?
This is just another gimmick to hold onto people's money :(
The Anxious Generation was published two years ago today, in a very different world. Back then, the most common objection I got was resignation: "The train has left the station." "You can't put toothpaste back in the tube." "It's how the kids connect today."
Today, the world looks very different. It turns out that if our kids were all on a train and we learned it was heading toward a collapsed bridge, we'd find a way to stop it and bring them safely back to the station. That’s what’s happening now.
After the historic verdicts in Los Angeles and New Mexico, today is a great day to reflect on the capacity of people in democratic societies to take action, even when opposing some of the most powerful corporations in history. We're getting access to the courts. We're getting phone-free schools. We're seeing whole neighborhoods letting kids out to play, unsupervised, which is what we older folk all remember as the best part of childhood.
So I want to recognize:
--The mothers (and, right behind them, fathers) who rose up by the millions and powered the movement.
--The farsighted governors and legislators in red states and blue states who have been innovating on policy solutions.
--The leaders of a dozen of nations, who are raising the age to 16 for opening social media accounts (with a special shoutout to Australia, for going first).
--The teachers and school administrators who had their classrooms disrupted for 15 years, and who are now eager to think through new solutions as screens have taken over and obstructed learning.
--The grassroots organizations who have been dedicating their efforts to advocate for all of the above in their local communities.
--The millions of members of Gen Z who have been rising up, demanding agency over how they spend their lives in the digital era, and finding better ways to connect in real life.
And one final group: the survivor parents--the ones you saw in those pictures of people embracing on the front steps of the LA courthouse. I have met many over the years. I am in awe of their courage and tenacity, their willingness to tell their stories of loss, over and over again, to different audiences, in the hope that no other parent would have to endure what they have endured. At long last, juries and legislatures are hearing you, and are acting.
Together, we are calling the train back to the station. Together, we are rolling back the phone based childhood and reclaiming life in the real world.
The work continues. If you’re not already involved, join us: http://anxiousgeneration.com/join
At HHS, we reject the idea that our health system is too broken to fix.
Today, @DrOzCMS and I are announcing a new Healthcare Advisory Committee—top experts from across the country coming together to provide insight on how to cut costs, reduce red tape, and put patients first.
Real reform starts now.
This is so powerful!! The frameworks presented illuminate conflict between parents and adolescents - regardless of the specific issue. Very helpful.
"COVID-19 is God's gift to the Left." - Jane Fonda
@HollywoodInToto just gave #15Days a rave. Watch and see for yourself.
https://www.hollywoodintoto.com/15-days-review/
Skills before Pills - Danielle Gansky's story (started ADHD meds at age 7, leading to polypharmacy for OCD and anxiety). Please listen - parents are not given truly informed consent, and children are certainly not informed.
https://open.spotify.com/episode/6o0k7yTOBNjdMGCR5W9qDT?si=O4q0u7WmRLSZb48At67yLg
cc @physiologyfirst
R to @KrugAlli: As a high-performance coach, I enjoy helping people address the mind, body, and spirit. Sleep is a body-focused intervention that has impacts on the mind and spirit. It's amazing, really. I am so grateful to wake up each morning and be given a new chance to live out my God-given mission on earth. Most days, it's to discern what that mission is - respond to the prompt!
R to @KrugAlli: If you got all the way down here and are curious to learn more, please visit http://www.trainmyaim.com. I offer individual and group coaching to enhance self leadership - my current focus is communication in relationships (marriage, parenting younger kids, adult children with their parents, and workplace influence).
R to @KrugAlli: If anyone has full text access, please feel free to elaborate, but from what I can gather, they offered standard sleep intervention guidance, including wind-down routines (30-min to 60-min before bed), bed is only for sleep, don't hyper-focus on sleep being the outcome but just focus on preparing the body to accept sleep (my paraphrasing). Also be mindful of timing of stimulants, food, etc.
R to @KrugAlli: What I think is very important for folks to remember here is physiology matters - not just for kids with ADHD but for ADULTS with sleep challenges, and all humans in this wired-and-tired world.
Lack of quality sleep impairs athletic performance, cognitive flexibility, emotional regulation, and all the things that go into good self-leadership.
R to @KrugAlli: An RCT sleep intervention - SIESTA sleep protocol offered + treatment as usual (TAU) in one group vs TAU in the other. Pre/post surveys plus 4-month followup.
Note that depression improved. With sleep.
R to @KrugAlli: Keuppens L, Marten F, Baeyens D, Boyer B, Roose A, Becker S, Danckaerts M, Van der Oord S. Effectiveness of a cognitive-behavioral sleep hygiene intervention for adolescents with ADHD: a randomized controlled trial. Eur Child Adolesc Psychiatry. 2025 Nov;34(11):3415-3426. doi: 10.1007/s00787-025-02755-0.
https://link.springer.com/article/10.1007/s00787-025-02755-0
Sleep intervention for ADHD improves depression in adolescents:
"Results: Results indicated significant improvement in SIESTA+TAU compared to TAU from pre- to post-test on sleep hygiene ([Formula: see text] =.21), chronic sleep reduction ([Formula: see text] =.15), and sleep-wake problem behaviors ([Formula: see text] =.05). Actigraphy and sleep diaries showed no significant differences, with both groups improving on sleep diaries. The improvements in sleep hygiene were maintained at follow-up ([Formula: see text] =.09). Of secondary outcomes, depressive symptoms reduced significantly more from pre- to post-test in SIESTA+TAU than in TAU only ([Formula: see text] =.09)."
cc @physiologyfirst
I think the High Point band has identified the proper amount of cowbell.
The FDA did a very unusual thing this week: It included photos from a recent unannounced inspection of an Indian drug manufacturer in its Warning Letter to the company - the first time I believe it's ever done so.
Would you believe this is from a drug manufacturer?
23% of schizophrenia patients test positive for anti-gluten antibodies.
In people without schizophrenia, that number is 3%.
A gluten-free diet improved negative symptoms with an effect size more than double what antipsychotics achieve.
Up to 30% of schizophrenia patients may not need to be on medication at all.
I met an 84-year-old woman who was offered euthanasia at a Canadian hospital practically upon arrival.
Miriam didn’t want to die. She recovered well and travelled to Cuba, Mexico, and Guatemala.
Stop offering death to people who have adventures to lead!
A Childhood on Psych Drugs: 14 Prescriptions by Age 20. @ChildrensHD @CHDTVLive #thirdCause @RxISKS #MAHA
At deaths at 1/118 for anyone who got the second dose of the Pfizer-BioNTech shot, the risk of death alone outweighed any potential benefits for which there were essentially none. The deaths that my have been averted early due to induction of trained immunity following the first dose were cancelled out by the high number of deaths following the second dose.
While @NYCMayor outrageously sugarcoats Saturday’s horrific act of terrorism, I am beyond grateful to know NYPD heroes like Chief Aaron Edwards are working every day to keep us safe. This incredible image should remind New Yorkers to honor our brave @NYPDnews and thank them 🙌
Hospitals kill between 250,000 and 400,000 Americans per year through preventable medical errors. That makes “your doctor’s mistake” the third leading cause of death in the United States, behind only cancer and heart disease.
Everyone reads advice like “stay with your loved one in the hospital” as a family values tip. The actual reason is darker. A board-certified physician is publicly admitting the system he operates in has enough failure points that an untrained person sitting in a chair provides a meaningful safety layer.
The math explains why. A landmark Penn study tracked 170,000+ surgeries across 168 hospitals. Each additional patient added to a nurse’s workload raised the odds of dying within 30 days by 7%. Staffing ratios across US hospitals range from 4.3 to 10.5 patients per nurse. That means one hospital gives your family member 2.4x less nursing attention than the hospital down the street, and you have zero way of knowing which one you walked into.
So what does a family member in the room actually do? They catch the wrong medication bag. They notice breathing changes at 2am when the nurse is covering nine other beds. They flag a deteriorating condition 6 hours before anyone on staff would have checked. They function as an unpaid, around-the-clock monitor compensating for a staffing model designed around reimbursement rates, not patient survival.
When a physician says “be cordial with staff but watch everything like a hawk,” he’s describing a system where the margin between good outcome and catastrophe is one missed check during a shift change. Hospitals don’t optimize for your family member’s recovery. They optimize for throughput.
700 people die from preventable hospital errors every single day. Your presence in that room isn’t emotional support. It’s a rounding error in a broken staffing equation that nobody has the budget to fix.
Not only does the U.S. have the highest per capita healthcare spending (to go along with its poorer outcomes), it’s the most liberal when it comes to drug approval. Too bad media doesn’t care to look into that very much, instead piling onto the Prasad takedown.
I am very sad that he has been pushed out. It is a sign of very deep corruption. However, I look forward to him being back on @Sensible__Med at some point in the future.