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phillystrega · 2 months ago

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To Be Gorgeous, To Be Seen 3/5

Yeah I don’t know, for some reason I double dipped this week. I’m caught up now so next chapter won’t come until next week. Like it’s SUPPOSED to.

Anyway, in this chapter: casual homophobia from the FDA, krispie treat abuse, and Buck’s betrayed by his own tendency to deep dive into documentaries.

Part One | Part Two | Part Three on AO3 or below

When the federal rules changed around blood donation, Buck remembered making a note of it briefly and then moving on with his day. It wasn’t that he didn’t care, it was just that blood drives at the 118 were Hen and Chim’s thing and Buck didn’t usually have to worry much about the rules surrounding them. His role on blood drive days was limited to helping set up tables for sign in sheets or picking up post blood draw snacks at Costco.

But now, he was an out bisexual firefighter, and suddenly he needed to review the rules around blood donation. So he looked them up, read them, read them again–and then he got angry–a kind of angry that lingered, simmering in the background for days until suddenly it was blood drive day and Buck was setting up the snack station with maybe more force than individually wrapped rice krispie treats deserved.

“Are you off refined sugar again?” Chim asked.

“What? No.”

“Well then unless Snap, Crackle, and Pop insulted your sister, I don’t think they deserve such rough treatment.”

Buck stared down at his hand and realized he’d unconsciously closed his fist around one of the krispie treats. The package stayed shut but what was in there was now definitely squished into a ball.

Eddie walked up to them then, as Buck was hiding the mangled krispie treat at the bottom of the pile, and said, “You two signed up yet?”

“Yup,” Chimney said at the same time Buck growled out, “absolutely not.”

And then Chim and Eddie were both looking at him, their heads cocked in confusion.

“They changed the rules, Buck, you can donate,” Bobby called over from where he’d been silently organizing sign in sheets and Buck had fully forgotten he was over there, one day he was going to put a bell on Cap and it’d be worth the latrine duty he got afterwards.

“Oh I know,” Buck said pointedly because he was now annoyed and mildly embarrassed that he had a small audience. “I know all about the rule change, particularly the part where only monogamous bisexual and gay men can donate.”

“Uh,” Chim exchanged a look with Eddie who seemed as lost as he was. “Are you and Tommy open? Because if so, you know, you do you, but that is way more than I need to know about my brother in law.”

“What? No.” Buck scoffed. “One boyfriend is all I can handle right now, thanks. Our schedules are complicated enough as it is.” They only got time together through sheer force of will and a shared google sheets doc that Buck put together at the start of every week to identify overlapping free time.

“Okay then, I admit,” Bobby said slowly. “Not sure what the problem here is.”

“The problem is that they only ask gay and bisexual men to be monogamous,” Buck said, waving his arms around as his voice increased in volume. “They don’t ask STRAIGHT guys if they’ve been loyal to their partner or confirm they’re not poly first.”

Eddie was looking down at one of the guidance sheets like he was seeing it for the first time and said, “huh.”

“And, I mean, maybe I’m monogamous but I sleep with other people, right?” He had soared past waving his arms and was now actively flailing a bit–for emphasis, it was necessary. “As long as it’s been negotiated with my partner and everyone is safe then it’s fine but I guess NOT for the FDA, who tests blood ANYWAY–”

“Okay,” Hen said as she darted into the scene from the side and gently began to herd Buck further into the fire station and, most importantly, away from the public. “Why don’t we go inside–”

“I guess only gay and bi men can be giant sluts,” Buck said, “I thought I was straight for YEARS and I had so much sex so I can attest that is NOT true–”

“Yup, I hear you, let’s go,” Hen said, practically leaning her shoulder into Buck’s sternum to shove him the extra few feet towards the locker room.

“Okay that got a little loud,” Buck admitted once they were inside.

“It did,” Hen said.

“But I was NOT wrong.”

“You were not.”

Buck stared at Hen for a minute before he sighed and crumpled into a seat on the empty bench. “Thank you,” Buck said.

Hen shrugged and leaned against the closed lockers. “I’m not a gay or bi man, I can’t tell you how to feel about this, you should feel any way you need to feel about it.” She smirked. “Just maybe, you know, feel those things AWAY from the poor blood drive volunteers.”

Buck groaned in frustration and dragged his hands through his hair. “Sometimes I just…I learn these things and I get angry.” He let out a dark laugh. “And then I feel stupid for not, you know, knowing about them before. So then I get more angry.”

Hen sat down next to him, her knee bumping against his. “You know now, Buck. Save your anger for the feds where it belongs.”

Buck huffed out a laugh. “Yeah.”

They say in silence for a minute before Hen rocked sideways, bumping her shoulder against his. “So…can’t help but notice the specific example you brought up out there.”

“Yeah, uh,” he cleared his throat a little awkwardly. “Tommy and I talked recently about how if I wanted to have sex with someone else, it’d be fine because our relationship is our relationship and whatever works for us is what’s most important.” And it had only been a week since their talk, Buck hadn’t had the chance to follow through on anything. Truthfully he wasn’t even sure he wanted to, he mostly just liked fantasizing about it with Tommy, but the blood drive rules felt like a hard smack from reality that flattened him for a bit.

“Historically our identities and relationships haven’t fit neatly or nicely into the boxes the government or polite society give us,” Hen said, shrugging. “Doesn’t make us wrong.”

“Even when it means I can’t donate blood?” Buck gestured behind them to the set up that continued without them.

“Buck,” Hen said dryly. “You’re O negative.”

“Okay, and?”

“We’re hardly running low on universal donor blood.” She gave him a ‘there, there’ pat on the head and he tipped himself sideways to accept the mildly mocking affection.

“But there’s a shortage,” he whined.

“Then donate today and if you ever decide to have some, uh, extra fun with Tommy,” Hen said, clearly amused by Buck’s pink cheeks. “You’ll skip donation day and the world will not fall apart around us, I promise.”

“Yeah, okay,” Buck grumbled halfheartedly. After a few more moments of silence he added, “don’t feel like you have to stay in here with me.”

“Oh I don’t, I’m just killing time,” Hen said cheerfully.

Buck frowned. “Til what?”

There was a knock on the doorway to the locker room and Buck looked up to see Tommy there, leaning into the room carefully, like he was worried about interrupting.

“Til that,” Hen said, popping up to her feet. “I have a blood drive to help run, I’m tagging in the specialist.”

“Specialist?” Buck said, confused. He watched Hen pat Tommy on the shoulder and slide past him out the door.

“Evan specialist,” Tommy said. “I guess I qualify now.” He sat down carefully next to Buck on the bench and he must’ve rushed through his routine leaving Harbor because he was wearing jeans and non-work shoes but had on one of the t-shirts Buck knew he saved for wearing under flight suits and his hair was still damp from the shower.

“Hey, that is a highly sought after speciality,” Buck said. “It takes hours to get certified.”

“I am happy to put in the time,” Tommy said, leaning over to press a quick kiss to Buck’s temple.

Buck sighed. “You didn’t have to come here.”

“Well, Eddie texted me,” Tommy said. “And then Bobby texted me. And then Howie–”

“Jesus,” Buck groaned.

“He, as far as I know, has not texted me,” Tommy said.

“No, just everyone else on my team,” Buck said, rolling his eyes. He looked in the general area of the rest of the crew and watched as Chimney and Eddie, who had clearly been watching them but trying to look like they weren't, moved at the same time to appear busy with other things and knocked over a box of pamphlets on organ donation.

Tommy huffed out a small laugh. “Howie’s text said pretty firmly that he thought this was a ‘guy loving thing’ and my presence was needed.”

“I don’t even know how to respond to that,” Buck muttered.

“Yeah I’m trying not to think about it too much,” Tommy admitted. He wrapped his arm around Buck’s back, his thumb rubbing at the curve of Buck’s shoulder. “What’s going on?”

“I may have…gotten a little shouty,” Buck admits, waving at the blood drive going on outside. “Medical history of homophobia, the FDA…etc.”

Tommy hummed. “Evan.”

“Yeah?”

“Were you, by any chance…spending your down time during shift watching documentaries?”

Buck suddenly was looking everywhere but at Tommy. “I watch a lot of documentaries.”

“Right, but were these documentaries by any chance about the gay community in the 80s?”

Buck winced. “Maybe?”

“Evan–”

“I know, I know, I promised no more mainlining movies about the AIDS epidemic, but I thought Paris Was Burning was more about dance moves!”

“That’s some seriously heavy subject matter to get lost in for…hours on end.”

“Right but don’t you think I should know this?”

“Sure, but as a firefighter you should also know it’s better to drink from the water fountain than the firehose,” Tommy said knowingly. “I’m just saying, I can see why you weren’t in the best mood for the casual homophobia of the blood drive today.”

Buck groaned and pitched forward to bury his head in his hands. The blood drive rules, the FDA, the conversation he’d had with Tommy, the documentaries, even the savior sibling thing, he had to admit–it all sort of pulled together to create a chum of anger and fear and joy and frustration. He heaved out a heavy sigh, just so tired of himself and the weight of his feelings. “This is embarrassing, isn’t it.”

“No, no,” Tommy said immediately, his big hand coming up to rub comfortingly across Buck’s back. “It’s a lot to learn about the community and yourself, and I mean, you just got a little shouty at a blood drive, I alienated my only nice coworkers and punched at least one bartender.”

Buck squinted at him for a moment before he said, “so when you said you met your ex Alex in a bar fight…”

“Yeah, not my greatest moment,” Tommy said flatly. “This…realigning your concept of yourself and your place in the world shit is a lot. In so many ways you’ve been amazing at it. You’re allowed to struggle with it from time to time too.”

“Yeah?” Buck sat up and leaned into Tommy, wrapping his arm around Tommy’s middle and encouraging Tommy to settle his arm around Buck’s shoulders.

“Yeah,” Tommy said and he pressed another kiss to Buck’s temple. “In fact, being a bit of a mess is practically a cultural must-have, so…”

“Oh great,” Buck said, laughing. At least that was one way he could align with the community–through being a disaster. It was strangely comforting.

“Listen,” Tommy said softly. “You’re already clocked out for the day, the blood drive was volunteer stuff. Why don’t we skip it. Go home. Order some food.” When Buck frowned Tommy quickly added, “You can put on that movie about Mars–”

Buck’s eyes widened. “The Martian?”

“Sure.”

“Andy Weir really studied orbital mechanics to write the book, Tommy, the scientific detail is amazing,” Buck said in a rush. “NASA was so inspired by it they published a whole study on human health hazards related to a prolonged mission to Mars’ surface.”

“I’m going to assume you mean health hazards other than trying to exist on a planet with no oxygen.”

“Not no oxygen, just extremely low oxygen, like, 0.13%,” Buck said, fully aware that he was flailing again, but it was a more enthusiastic, excited flail than a sad and confused sort of flail, so that was a win.

“If you say so,” Tommy said. He smiled, shook his head, and stood up so he could open Buck’s locker and begin to pull his things out of it, handing them one by one to Buck with a sappy indulgent grin.

“Wait,” Buck gasped suddenly, and Tommy froze mid-reach towards Buck’s overnight bag. “Have I ever told you about carbon dioxide snow?”

#bucktommy #911whatisyourpride

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gwydionmisha · 6 months ago

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As flu cases spike in Florida ERs, the CDC issues new guidance to identify bird flu

Left over from Biden. 47 has barred all communication about infectious disease because the numbers might make him look bad. Republicans broadly believe it is better to let large numbers of people die than to warn them about risk so they can take precautions.

I'm including animal stuff in here because it crosses species.

I noticed the forage boxes contained no eggs this week. I know the price is skyrocketing because of the bird flu. I am worried we won;t be able to get Livia's special food. Meanwhile Trump and RFK Jr. want to let people sell infected raw milk and don't care who is harmed or killed.

CW: Dead Animals

CW: Dead Pets

I beg of you do not drink raw milk.

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justinspoliticalcorner · 7 days ago

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Kiera Butler and Anna Merlan at Mother Jones:

In 2003, the Hazlehurst family filed a claim with the Office of Special Masters of the US Court of Federal Claims. The office is part of the National Vaccine Injury Compensation Program (VICP), which was established in the 1980s by Congress to compensate people who are able to prove a likely vaccine injury. The money comes from a fund of billions of dollars accumulated from a small excise tax applied to most childhood vaccines.

From 2006 to 2023, about 70 percent of those who brought cases were awarded money without going to trial. Given the safety of vaccines, in the majority of those cases, the government did not conclude that a vaccine was responsible for the alleged injury. Instead, as the federal Health Resources and Services Administration, which keeps data about vaccine injury claims, explains, the government might settle based on precedent or “to minimize the time and expense of litigating a case.”

More challenging cases are evaluated not by a jury or a trial judge, but in a separate courtroom presided over by special masters, judicial appointees who have extensive knowledge in vaccine injury cases. In Yates’ case, one of his attorneys was his father. Rolf Hazlehurst, currently an assistant district attorney in Tennessee, became focused on vaccine injuries after his son’s diagnosis. Beginning in 2019, he worked for six years as a senior staff attorney at Children’s Health Defense, the anti-vaccine organization Robert F. Kennedy Jr. chaired before going on leave to launch his presidential bid in 2023. Like many other parents of autistic children, Rolf and his wife, Angela, had become convinced that the MMR vaccine had caused Yates’ condition, a theory that, despite having been repeatedly and conclusively disproved, remains a perennial claim in the anti-vaccine world.

Eventually, the Hazlehursts’ case would become part of the Omnibus Autism Proceedings, where a slate of vaccine court special masters carefully considered three theories about how vaccines might cause autism, using six test cases, including the Hazlehursts’. In 2009 and 2010, the special masters handed down several decisions, concluding the vaccines could not be credibly linked to any of the children’s autism diagnoses.

[...] Almost 50 years ago, a similar courthouse crush had prompted Congress to set up the specialized vaccine court to ensure lifesaving shots taken by millions would always be available despite any legal liabilities. Its success is why HHS Secretary Robert F. Kennedy Jr. and the broader anti-vaccine movement have moved to kill it off.

[...] As secretary of the nation’s most powerful health agency, with oversight of everything from the FDA to the CDC and the NIH, Kennedy has been able to turn his long history of attacks on vaccinations into government policy. He has stacked HHS leadership with critics of both vaccine and basic public health policy, including contrarian physician friends who first gained notoriety opposing Covid vaccines. There’s Dr. Vinay Prasad, a former University of California, San Francisco, hematologist-oncologist who has regularly opposed the FDA’s recommendations to get Covid boosters, who in May was named the agency’s top vaccine regulator. Dr. Marty Makary, a pancreatic surgeon at Johns Hopkins University who now leads the FDA, has made a career opposing mainstream medical knowledge, especially on vaccine guidance, including questioning the efficacy of Covid booster shots and what he called “booster mandates,” meaning requirements by some institutions and workplaces to get vaccinated during the height of the pandemic. Former Stanford University health economist Dr. Jay Bhattacharya, who has downplayed the success of the Covid vaccines and argued that the virus should have been left to run rampant, now heads the NIH. Kennedy also tapped David Geier, a vaccine critic who was disciplined by the Maryland medical board for practicing without a license, to rehash the settled science of a purported link between vaccines and autism.

In late April, the Washington Post reported that Kennedy planned for all new vaccines, including updated Covid shots, to be tested against a placebo—an ethically and scientifically questionable mandate that could hamstring approvals. In May, the FDA suggested it would now recommend regular Covid vaccines only to people 65 and older and those 6 months or older who have at least one risk factor for serious illness. In June, the Wall Street Journal reported that Geier was “hunting for proof” in the federal Vaccine Safety Datalink database to find a basis for his claims that the CDC hid evidence that vaccines cause autism. Both Geier and his father, Mark, were banned from accessing the VSD in 2004 “after CDC officials determined they had misrepresented what they were going to do with the data.” They were banned again in 2006, but today, David Geier works for HHS as a “senior data analyst,” according to an agency directory.

One of Kennedy’s most shocking moves came on June 9, when he executed what critics saw as an administrative coup by removing all 17 members of the Advisory Committee on Immunization Practices, an expert body that issues recommendations on vaccines to the CDC. While all of the ousted ACIP members warned in an editorial that the US vaccine infrastructure had been left “critically weakened,” an HHS press release called the removals “a bold step in restoring public trust” and quoted Kennedy hailing them as a way to promote “unbiased science—evaluated through a transparent process and insulated from conflicts of interest,” irrespective of a “specific pro- or anti-vaccine agenda.”

But Kennedy went on to stack the committee with his friends from the anti-vaccine world, including Dr. Robert Malone, who claims to have invented mRNA vaccines—an oversimplification, according to other researchers who helped develop the technology—and has gone on to question their safety, as well as Vicky Pebsworth, a nurse who’s served on the board of the anti-vaccine National Vaccine Information Center. Also appointed was Martin Kulldorff, a dismissed Harvard University researcher and Covid lockdown opponent who Reuters reported has earned substantial sums as an expert witness in lawsuits against Merck’s HPV Gardasil vaccine. The CDC—for now—recommends Gardasil, which protects against the virus that causes cervical cancer, to people under 26, citing numerous safety studies and noting that the most common side effect is pain, swelling, and redness at the injection site. But Kennedy has a close relationship with Wisner Baum, a Los Angeles law firm that is representing a large number of Gardasil plaintiffs who allege a laundry list of injuries from getting the shot, ranging from seizures and fibromyalgia to diabetes and arthritis. Kennedy served as co-counsel on the firm’s Gardasil cases before stepping aside to serve as HHS secretary.

[...] The National Childhood Vaccine Injury Act of 1986 was meant as a compromise among families, drug manufacturers, public health officials, and the federal government to ensure that vaccine-injured people could be compensated without endangering the vaccine supply. When the VICP launched two years later, a key aspect of the program was the use of special masters, who are appointed by the US Court of Federal Claims to four-year terms to hear only vaccine injury cases. [...]

Today, most vaccines are covered by the program, with some exceptions, including ones for Covid. Vaccine manufacturers can be sued in civil court only after a claim has gone through the vaccine court system. That system is designed to serve the petitioners claiming injury, Vowell says; vaccine court has more lenient rules of evidence and allows them to make arguments and produce experts who wouldn’t necessarily be allowed in civil court. “If you can’t win in the vaccine court, you probably can’t win anywhere,” she says. [...]

Vaccines are widely considered the greatest breakthrough in public health history: They prevent millions of deaths each year, save billions in health care costs, and have played a major role in extending lifespans by decades. So why would Kennedy want to undermine them? The answer lies in knowing that Kennedy’s skepticism extends beyond immunizations. Despite more than a century of research and indisputable health outcomes, he simply rejects most of what is understood about germ theory. [...]

Against the backdrop of this belief, Kennedy’s malign plan to undermine the country’s vaccine infrastructure comes into sharper focus. As his tenure as HHS secretary continues, the experts we spoke with believe that abolishing or weakening the federal vaccine injury program is likely one of his ultimate goals—and would be a huge mistake. If the vaccine injury compensation program is opened to include children with autism or asthma, it could overload the system meant to compensate people with legitimate, scientifically supported vaccine injuries. If litigants could sue drug companies in civil court without going through the VICP’s special masters first, it could create a mass of lawsuits, frightening drug manufacturers out of making vaccines at all, as nearly happened in the 1980s.

Offit points out that there’s even more precedent for this than just the DPT lawsuits; LYMErix, a vaccine for Lyme disease, was pulled off the market in 2002 after just three years. That happened in part because, following only a weak endorsement from the Advisory Committee on Immunization Practices, it wasn’t covered by the VICP. Some patients began reporting alleged autoimmune side effects from the vaccine and sued its manufacturer in civil court, and the producer discontinued the drug. The manufacturer spent $1 million in legal fees, but the alleged autoimmune effects were never conclusively proved, and an FDA analysis did not find any evidence of a causal link between the vaccines and the symptoms. “Litigation drove it off the market,” Offit says. Kennedy’s crusade will create even more doubt over vaccines’ effectiveness, as he uses his position to broadcast and legitimize debunked ideas about their risks. In the end, experts warn, it will be patients who suffer.

“When you start a fire, there are unintended consequences,” cautions Vowell, who retired as the court’s chief special master after nearly a decade of cases. “We’d be reaping those unintended consequences. I’m not accusing Secretary Kennedy of being indifferent to the suffering of children with vaccine-preventable illnesses, but if he gets what he asks for, I hope he lives to regret it.”

This Mother Jones piece on the war on vaccines by RFK Jr. and his allies is a must-read.

#Vaccines #Anti Vaxxer Extremism #Robert F. Kennedy Jr.#National Vaccine Injury Compensation Program #Trump Regime #Children’s Health Defense #Autism Vaccine Conspiracies #Dr. Jay Bhattacharya #Dr. Marty Makary #David Geier #Marty Makary #Jay Bhattacharya #Vicky Pebsworth #Dr. Robert Malone

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autisticadvocacy · 1 year ago

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The Autistic Self Advocacy Network (ASAN) condemns the United States Supreme Court ruling on two combined cases, Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce. The decision overturns a decades-old legal principle known as the Chevron Doctrine, which gives federal agencies the authority to reasonably interpret ambiguous laws when they create federal regulations. These regulations are made legally binding through a rulemaking process that is shaped by the public servants within federal agencies, the input of subject area experts across fields, and anyone who chooses to share their opinion. Instead, federal courts will now have the final say in circumstances where knowledge of highly specialized, complex, and technical issues is required. This ruling will weaken the regulatory authority of all federal agencies, including the Departments of Labor (DOL), Education (ED), Health and Human Services (HHS), the Social Security Administration (SSA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA).

Federal agencies create regulations or rules that fill in the gaps of laws intended to protect disability rights, civil rights laws, housing, healthcare, and more. The overturning of Chevron and the deference it gives to the courts will have devastating impacts on all marginalized people, including disabled people and particularly disabled people of color. Often, these rules concern subjects well outside of the scope of legal training, including, as Marissa Ditkowsky noted, drug safety evidentiary standards, eligibility criteria for public benefits, the threshold for disability discrimination, or guidance around worker protections. This change will lead to inconsistent and conflicting adjudication across the country, driving avoidable litigation, confusion, and decisions that do not work well for the people they affect. These harms will fall disproportionately on marginalized people, including the disability community. As the American Cancer Society explained in its amicus brief, “The resulting uncertainty would be extraordinarily destabilizing, not just to the Medicare and Medicaid programs but also – given the size of these programs – to the operational and financial stability of the country’s health care system as a whole.” The same can be said for programs within DOL, ED, SSA, and many other federal agencies. This decision is also undemocratic, moving crucial decisions out of a process where the public has an opportunity to weigh in and into the purview of the courts.

This decision invites challenges to the forty years of legal precedents relying on Chevron. While these cases and the existing Code of Federal Regulations are not automatically overturned by Loper and Relentless, many will be challenged in the months and years to come. Future regulations are also under threat. Agencies may be less ambitious in fulfilling their mandates, protecting the public, and using taxpayers’ resources well in the face of increased risk that courts will undo their work. The endangered regulations include the Home and Community Based Services (HCBS) Settings Rule, the final rule implementing Section 504 of the Rehabilitation Act, the final rule implementing Title IX of the Education Amendments, and the final rule regarding section 1557 of the Affordable Care Act (ACA).

ASAN echoes the demands of the American Federation of Teachers (AFT): “Congress should urgently enact Chevron deference into law by passing the Stop Corporate Capture Act (H.R. 1507), a comprehensive blueprint for modernizing, improving and strengthening the regulatory system. That would ensure public input into regulatory decisions, promote scientific integrity and restore our government’s ability to help the workers and consumers it is meant to serve.”

ASAN will fight to safeguard federal agencies’ ability to protect the people we serve. We will continue to do what we always have: defend the rights, health, services, safety, and well-being of all people with disabilities.

Here are statements on this issue from our allies:

Democracy Forward

National Health Law Program (NHeLP)

National Education Association (NEA)

American Federation of Teachers (AFT)

The Autistic Self Advocacy Network (ASAN) is a national grassroots disability rights organization run by and for autistic people. We believe that the goal of autism advocacy should be a world in which autistic people enjoy equal access, rights, and opportunities. ASAN works to make sure autistic people are included in policy-making, so that laws and policies meet our community’s needs. Our members and supporters include autistic adults and youth, cross-disability advocates, and non-autistic family members, professionals, educators, and friends.

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darkmaga-returns · 6 months ago

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READ MORE: Trump enemies hope he is one Big Mac away from a heart attack

LISTEN: Welcome to MAGAland, our podcast on the latest inside the White House

By LUKE ANDREWS SENIOR HEALTH REPORTER FOR DAILYMAIL.COM

Published: 09:32 EST, 22 January 2025 | Updated: 10:46 EST, 22 January 2025 Donald Trump has ordered a communications blackout at America's federal health agencies, according to reports. The CDC, FDA, HHS and NIH have all been told to pause external communications, including publishing scientific reports, updating websites or issuing health advisories. The directive came without warning, sources told the Washington Post, and with little guidance as to how long it may last. The health agencies play a vital role in gathering and sharing critical information with the public, including on outbreaks of infectious diseases, raising the alarm over foodborne disease outbreaks and food recalls. However, DailyMail.com received its automated weekly FDA recall email at 8am ET this morning. It is not entirely unusual for incoming administrations to pause external communications temporarily, which may be done to help newly appointed officials understand the scope of information that is being released. But some said that if the pause lasts longer than a week or two then it could be seen as concerning. The new president, 78, singled out public health agencies in his inaugural address — saying that they 'do not deliver in times of disaster', referring to what many have seen as a mishandling of Covid messaging.

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vitaminseetarot · 1 year ago

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July Elements Game - CLOSED 🔥💧🌫🌸

Messages From Nature

Saturday 7/13 @ 3pm EST

til

Monday 7/15 @ 3pm EST

So I have this huge oracle deck called Alchemy Elementals that I've been slowly learning. I'm reading its ridiculously massive (size wise) book, and writing down long notes about each card. And I decided, for this deck, I wanted to do something different and use it for this game. Each card, save for 8 special cards, belong to one of four classical elements (Fire, Sky, Water, and Land). I can separate them into 4 piles and draw them along with 1 of the special cards to get a reading, coupled with Tarot cards.

I've also got a die, a D4, that will help us determine what element each person will get. When you request a reading, I will roll the die then draw from one of the piles, along with a special card and a tarot card, to get your message. This game is similar to the Aura reading, except that your element will represent your most current energy, as well as its gifts and challenges. This isn't a natal reading, so the element you get may not necessarily be one that you prefer the most; it will be whatever is most relevant to your current life path.

:Key: 1 = Fire 🔥2 = Water 💧3 = Sky 🌫4 = Land 🌸

RULES to Play:

❣ 1 Follow this blog if you're not already a follower: VitaminSeeTarot

❣ 2 Reblog this post with the tag #vitaminseetarotgame

❣ 3 Send me an Ask (not DM) along w/ any two random signature emojis of your choice (some examples 💎🌙 🌈🧙‍♂️ 👽💌)

❣ 4 Asks will be accepted starting 7/13, deadline is 7/15 @ 3pm EST (NYC time). Be sure to check the open/closed status of this post and the masterlist before submitting. Asks submitted before 7/15 will receive their reading after the 7/15 deadline has passed, however Asks submitted after the deadline will not. Make sure to submit your Ask before the deadline if you want to participate.

❣ 5 Please be kind & patient while I finish your reading, as I don't know how many will play.

❣ 6 This game is for your specific energy/aura/life only. This free reading game is not meant for your friends, family, or other people in your life (unless the reading calls me to mention somebody important). I will not do readings for celebrities, events, or situations here.

❣ 7 Remember that this is mainly for entertainment, insight, and guidance only. Energy is always in flux, so please take what resonates and leave behind the rest. The element picked for you represents your current state and not a fixed placement for life.

❣ 8 I reserve the right to refuse a reading for any reason. (Admittedly, alliteration is always appealing and accurately applicable.)

❣ 9 You must fully read and agree to the above rules before playing.

❣ 10 If you would like to leave a tip, you can do so on my Kofi page. Check back after the game because I will be opening paid readings right after. My menu will be posted up along with instructions for booking. Thank you so so so much for your patience and patronage!

This reading has not been evaluated by the FDA to diagnose, prevent, treat, or cure any disease or infection. Please ask your physician before going online.

2024, @VitaminseeTarot ™

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macmanx · 6 months ago

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"It's hard for me to understand why anyone would be opposed to clinical trials including the variety of people for whom the drug or device is intended," Dr. Robert Califf, the most recent FDA commissioner in the Biden administration, told NPR. "That's the essence of the FDA guidances."

#health #science #cancer #fda #usa

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stevishabitat · 5 months ago

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Judge orders HHS, CDC and FDA to restore webpages and data : Shots - Health News : NPR

A federal judge has ordered federal health agencies to restore websites and datasets that were abruptly pulled down beginning in late January, prompting an outcry from medical and public health communities.

The temporary restraining order was granted in response to a lawsuit filed against the federal government by Doctors for America (DFA), a progressive advocacy group representing physicians, and the nonprofit Public Citizen, a consumer advocacy group.

Last week, a spokesperson for the Centers for Disease Control and Prevention told NPR "changes to the HHS website and HHS division websites are in accordance with President Trump's January 20 Executive Orders, Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government and Ending Radical And Wasteful Government DEI Programs And Preferencing."

The pages that are now set to be revived include information for patients about HIV testing and HIV prevention medication, guidance on contraceptives, datasets that show vulnerability to natural disasters and emergencies, and an action plan for improving enrollment of underrepresented populations in clinical trials.

Judge John Bates with the U.S. District Court for the District of Columbia, who was appointed by President George W. Bush in 2001, said the sudden loss of these resources had jeopardized the work of clinicians and public health. "It bears emphasizing who ultimately bears the harm of defendants' actions: everyday Americans, and most acutely, underprivileged Americans, seeking healthcare," he wrote in his opinion.

The Department of Health and Human Services, the Food and Drug Administration and the Centers for Disease Control and Prevention have until midnight Tuesday to bring back the specific webpages cited in the lawsuit.

By the end of the week, the order directs the federal government to identify any other resources that physicians rely on to provide medical care and restore those as well.

Questions remain about how much information was changed

"This is a very strong decision," said Dorit Reiss, a law professor at the University of California College of the Law San Francisco. The order explains how the takedown of websites and data was "likely legally flawed" because it "lacked notice" and there was "no explanation for the broad action," she said. "It suggests the government is in a weak place for this case."

HHS didn't reply to NPR's request for comment on the order.

Many webpages that were initially removed have since reappeared on CDC, FDA and HHS websites, although it's still unclear how much remains missing and what information has been modified.

"There's a lot of shifting ground here where they tore down a lot of stuff. They put some of it back up, but not nearly all of it," said Zach Shelley, an attorney with Public Citizen Litigation Group. "Hopefully with this order, we get everything that's important back up."

The sudden loss of websites prompted a mad rush in the scientific community to download and archive data. Dr. Joshua Sharfstein was among those on a CDC advisory committee who wrote the CDC's acting director protesting the purge of data.

He said the advisers have now sent a second letter pointing out that they remain concerned about "how communities will be able to monitor diseases and receive guidance on current disease investigations," the possibility of "broad workforce reductions," and "disruptions in grant funding."

The judge's order underscores any changes to resources and data should be based on "reasoned decision-making," said Sharfstein, a professor of public health practice at the Johns Hopkins Bloomberg School of Public Health.

"Some of these websites provided actual recommendations on how to take care of patients," he said. "These are not just like books on the shelf. These are like heavily thumbed through manuals that people really need."

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mariacallous · 7 days ago

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For decades, countries around the world have held up the United States’s rigorous approach to vaccine policy as a global ideal. But in Robert F. Kennedy Jr.’s Department of Health and Human Services, many of the officials responsible for vaccine policy disagree. For the best immunization policy, they argue, the U.S. should look to Europe.

Marty Makary, the new FDA commissioner, and Vinay Prasad, the new head of the agency’s center for regulating vaccines, have criticized the nation’s COVID-19-vaccine policy for recommending the shots more broadly than many European countries do. Tracy Beth Høeg, a new adviser at the FDA, has frequently compared the U.S.’s childhood vaccination schedule unfavorably with the more pared-down one in Denmark, and advocated for “stopping unnecessary vaccines.” (Prasad, citing Høeg, has made the same points.) And the new chair of the CDC’s Advisory Committee on Immunization Practices, Martin Kulldorff—whom Kennedy handpicked to serve on the panel, after dismissing its entire previous roster—announced in June that ACIP would be scrutinizing the current U.S. immunization schedule because it exceeds “what children in most other developed nations receive.”

This group has argued that the trimness of many European schedules—especially Denmark’s—implies that the benefits of the U.S.’s roster of shots may not outweigh the risks, even though experts discussed and debated exactly that question when devising the guidance. But broadly speaking, the reasons behind the discrepancies they’re referencing “have nothing to do with safety,” David Salisbury, the former director of immunization of the U.K.’s Department of Health, told me. Rather, they’re driven by the factors that shape any national policy: demographics, budget, the nature of local threats. Every country has a slightly different approach to vaccination because every country is different, Rebecca Grais, the executive director of the Pasteur Network and a member of the World Health Organization’s immunization-advisory group, told me.

One of the most important considerations for a country’s approach to vaccines is also one of the most obvious: which diseases its people need to be protected from. The U.S., for instance, recommends the hepatitis A vaccine for babies because cases of the contagious liver disease continue to be more common here than in many other high-income countries. And conversely, this country doesn’t recommend some vaccine doses that other nations do. The U.K., for example, routinely vaccinates against meningococcal disease far earlier, and with more overall shots, than the U.S. does—starting in infancy, rather than in adolescence—because meningitis rates have been higher there for years. Using that same logic, countries have also modified prior recommendations based on emerging evidence—including, for instance, swapping the oral polio vaccine for the safer inactivated polio vaccine in the year 2000.

Vaccines are expensive, and countries with publicly funded insurance consider those costs differently than the U.S. does. Under U.K. law, for instance, the National Health Service must cover any vaccine that has been officially recommended for use by its Joint Committee on Vaccination and Immunisation, or JCVI—essentially, its ACIP. So that committee weights the cost effectiveness of a vaccine more heavily and more explicitly than ACIP does, and will recommend only a product that meets a certain threshold, Mark Jit, an epidemiologist at NYU, who previously worked at the London School of Hygiene & Tropical Medicine, told me. Price also influences what vaccines are ultimately available. In 2023, JCVI recommended (as ACIP has) two options for protecting babies against RSV; unlike in the U.S., though, the NHS bought only one of them from manufacturers, presumably “because the price they gave the government was cheaper,” Andrew Pollard, the director of the Oxford Vaccine Group, the current JCVI chair, and a former member of the World Health Organization’s advisory group on immunizations, told me. (The prices that the U.K. government pays for vaccines are generally confidential.)

The nature of a country’s health-care system can influence vaccine policy in other ways too. In the U.S. system of private health care, health-equity gaps are massive, and access to care is uneven, even for one person across their lifetime. Many Americans bounce from health-care provider to provider—if they are engaged with the medical system at all—and must navigate the coverage quirks of their insurer. In this environment, a more comprehensive vaccination strategy is, essentially, plugging up a very porous safety net. Broad, simple recommendations for vaccines help ensure that a minimal number of high-risk people slip through. “We’re trying to close gaps we couldn’t close in any other way,” Grace Lee, a pediatrician and a former chair of ACIP, told me.

The U.S. strategy has worked reasonably well for the U.S. Universal flu-vaccine recommendations (not common in Europe) lower the burden of respiratory disease in the winter, including for health-care workers. Hepatitis B vaccines for every newborn (rather than, like in many European countries, for only high-risk ones) help ensure that infants are protected even if their mother misses an opportunity to test for the virus. More generally, broad recommendations for vaccination can also mitigate the impacts of outbreaks in a country where obesity, heart disease, and diabetes—all chronic conditions that can exacerbate a course of infectious illness—affect large swaths of the population. American vaccine experts also emphasize the importance of the community-wide benefits of shots, which can reduce transmission from children to elderly grandparents or decrease the amount of time that parents have to take off of work. Those considerations carry far more weight for many public-health experts and policy makers in a country with patchy insurance coverage and inconsistent paid sick leave.

The current leadership of HHS thinks differently: Kennedy, in particular, has emphasized individual choice about vaccines over community benefit. And some officials believe that a better childhood immunization schedule would have fewer shots on it, and more closely resemble Denmark’s, notably one of the most minimalist among high-income countries. Whereas the U.S. vaccination schedule guards against 18 diseases, Denmark’s targets just 10—the ones that the nation’s health authorities have deemed the most severe and life-threatening, Anders Hviid, an epidemiologist at Statens Serum Institut, in Copenhagen, told me. All vaccines in Denmark are also voluntary.

But “I don’t think it’s fair to look at Denmark and say, ‘Look how they’re doing it, that should be a model for our country,’” Hviid told me. “You cannot compare the Danish situation and health-care system to the situation in the U.S.”

Denmark, like the U.K., relies on publicly funded health care. The small, wealthy country also has relatively narrow gaps in socioeconomic status, and maintains extremely equitable access to care. The national attitude toward federal authorities also includes a high degree of confidence, Hviid told me. Even with fully voluntary vaccination, the country has consistently maintained high rates of vaccine uptake, comparable with rates in the U.S., where public schools require shots. And even those factors don’t necessarily add up to a minimalist schedule: Other Nordic countries with similar characteristics vaccinate their children more often, against more diseases.

At least some of Kennedy’s allies seem to have been influenced not just by Denmark’s more limited vaccine schedule but specifically by the work of Christine Stabell Benn, a researcher at the University of Southern Denmark, who has dedicated much of her career to studying vaccine side effects. Like Kennedy and many of his allies, Benn is skeptical of the benefits of vaccination: “It’s not very clear that the more vaccines you get, the healthier you are,” she told me. Along with Kulldorff, Høeg, and National Institutes of Health Director Jay Bhattacharya, Benn served on a committee convened in 2022 by Florida Governor Ron DeSantis that cast COVID-19 vaccines as poorly vetted and risky. She and Høeg have appeared together on podcasts and co-written blogs about vaccine safety; Kulldroff also recently cited her work in an op-ed that praised one Danish approach to multidose vaccines, noting that evaluating that evidence “may or may not lead to a change in the CDC-recommended vaccine schedule.” When justifying his cuts to Gavi—the world’s largest immunization program—Kennedy referenced a controversial and widely criticized 2017 study co-authored by Benn and her husband, Peter Aaby, an anthropologist, that claimed that a diphtheria, tetanus, and pertussis vaccine was increasing mortality among children in Guinea-Bissau. (Benn wrote on LinkedIn that cutting Gavi funding “may have major negative impact on overall child survival,” but also noted that “it is reasonable to request that WHO and GAVI consider the best science available.”)

Several of the researchers I spoke with described Benn, with varying degrees of politeness, as a contrarian who has cherry-picked evidence, relied on shaky data, and conducted biased studies. Her research scrutinizing vaccine side effects—arguing, for instance, that vaccines not made from live microbes can come with substantial detriments—has been contradicted by other studies, spanning years of research and scientific consensus. (In a 2019 TEDx talk, she acknowledged that other vaccine researchers have disagreed with her findings, and expressed frustration over her difficulties publicizing them.) When we spoke, Benn argued that the U.S. would be the ideal venue for an experiment in which different regions of the country were randomly assigned to different immunization schedules to test their relative merits—a proposal that Prasad has floated as well, and that several researchers have criticized as unethical. Benn said she would prefer to see it done in a country that would withdraw vaccines that had previously been recommended, rather than add new ones. In a later email, she defended her work and described herself as “a strong advocate for evidence-based vaccination policies,” adding that “it is strange if that is perceived as controversial.”

When I asked her whether anyone currently at HHS, or affiliated with it, had consulted her or her work to make vaccine decisions, she declined to answer. Kulldorff wrote in an email that “Christine Stabell Benn is one of the world’s leading vaccine scientists” but did not answer my questions about Benn’s involvement in shaping his recommendations. HHS did not respond to a request for comment.

What unites Benn with Robert F. Kennedy Jr. and his top officials is that, across their statements, they suggest that the U.S. is pushing too many vaccines on its children. But the question of whether or not the U.S. may be “overvaccinating” is the wrong one to ask, Jake Scott, an infectious-disease physician at Stanford, told me. Rather, Scott said, the more important question is: “Given our specific disease burden and public-health goals, are we effectively protecting the most vulnerable people? Based on overwhelming evidence? The answer is yes.”

That’s not to say that the U.S. schedule should never change, or that what one country learns about a vaccine should not inform another’s choices. Data have accumulated—including from a large clinical trial in Costa Rica—to suggest that the HPV vaccine, for instance, may be powerful enough that only a single dose, rather than two, is necessary to confer decades of protection. (Based on that growing evidence, the prior roster of ACIP was considering recommending fewer HPV doses.) But largely, “I’m not sure if there’s a lot in the U.S. schedule to complain about,” Pollard, the JCVI chair, told me. On the contrary, other nations have taken plenty of their cues from America: The U.K., for instance, is expected to add the chickenpox shot to its list of recommended vaccines by early next year, Pollard told me, based in part on reassuring data from the U.S. that the benefits outweigh the risks. The U.S. does recommend more shots than many other countries do. But the U.S. regimen also, by definition, guards against more diseases than those of many other countries do—making it a standout course of protection, unparalleled elsewhere.

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justinspoliticalcorner · 2 months ago

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Berkeley Lovelace Jr. at NBC News:

The Food and Drug Administration is planning major changes for how Covid vaccines are rolled out and who will be able to get the updated shots this fall. In a paper published Tuesday in the New England Journal of Medicine, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the FDA’s new vaccine chief, wrote that any new Covid vaccine now must undergo placebo-controlled clinical trials — meaning, some people would get the actual vaccine while others get an inactive substance like a saline shot, to compare results. At a planned FDA vaccine panel meeting on Thursday, agency advisor are expected to advise the vaccine makers which strains to target for new shots. The new clinical trial requirement isn't expected to affect the fall rollout for older adults and other people at high risk for severe illness because drugmakers are exempt from additional testing for those groups. Makary and Prasad said in a question and answer session later Tuesday that annual shots for healthy children and adults would no longer be routinely approved. They also suggested that the vaccines may not be updated each year. ”Instead of having a Covid strategy that’s year to year, why don’t we let the science tell us when we should change?” Prasad said. “The virus doesn’t have a calendar.” Previously, updated Covid vaccines had been cleared by the FDA similar to flu vaccines.

The original Covid shots, from Pfizer and Moderna, approved in late 2020, went through placebo-controlled trials. Then, the drugmakers transitioned to smaller studies to test how well the updated shots triggered an immune response against the current variants circulating in the U.S. In the journal article, Makary and Prasad cast doubt on the flu vaccine model, noting that only a quarter of people in the U.S. get the updated shots each year, including less than a third of health care workers. In comparison, about 75% of health care workers get seasonal flu shots, according to data from the Centers for Disease Control and Prevention. The Covid shot policy, the officials wrote, “has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations.” “We reject this view,” they added. Dr. Jesse Goodman, a professor of medicine and infectious disease at Georgetown University and a former chief scientist at the FDA, agreed that people can understand their own health risks, but was skeptical of the agency’s new approach, saying it limits people’s “freedom to choose.” “What about people with elderly or high risk relatives/housemates?,” he wrote in an email. “What about people who are not at increased risk of severe disease who want to reduce their risk of infection or time off from work?,” Goodman asked.

[...]

Who will be able to get the Covid shots?

Under the FDA’s new guidance, the drugmakers will need to run new trials that track participants for at least six months. The main goal of the trials should be showing that the shots help prevent symptomatic Covid, the officials wrote, with data showing at least 30% effectiveness. People who’ve had Covid in the past should still be included in the trial to better reflect the general population, they said. Drugmakers can still use smaller studies, known as immunogenicity studies, to get approval for adults 65 and up, as well as children and adults with at least one medical condition that puts them at higher risk for Covid. The FDA said many people are considered at high risk, including pregnant women and those with obesity or who have mental health conditions such as depression. Other conditions linked to severe Covid illness include diabetes, heart disease and asthma. “Ultimately, these studies alone can provide reassurance that the American repeat-boosters-in-perpetuity strategy is evidence-based,” the officials wrote. Estimates, they said, suggest that 100 million to 200 million Americans will have access to the updated vaccines.

[...]

Kennedy's influence on vaccine rules

A change to the way Covid vaccines are updated was expected. Earlier this month, Health and Human Services Secretary Robert F. Kennedy Jr. mandated that all new vaccines must undergo placebo-controlled clinical trials. Until Tuesday, it wasn’t clear whether HHS considered Pfizer’s and Moderna’s updated shots “new vaccines,” requiring new clinical trials. Former government health officials feared that the FDA, under Kennedy, was moving to slow-walk vaccine approvals. Over the weekend, the FDA approved Novovax’s vaccine after weeks of delay. In an unexpected turn, however, the agency limited the use of the shot to people 65 and up and teens and adults with at least one medical condition that puts them at risk of severe illness. Typically, it’s the CDC that makes recommendations about who should get the vaccines.

Coming this fall, thanks to the FDA and the Trump Regime’s pandering to the anti-vaxxer crazies: the COVID vaccine eligibility criteria has been significantly tightened to adults 65 and older as well as children and younger adults with at least one high-risk health problem.