#fda full name

[ccrpsorg]

An In-Depth Guide to Form FDA 1572

What is the Form FDA 1572?

The Form FDA 1572 is a form issued by the United States Food and Drug Administration (FDA). It is a document that must be completed and submitted by sponsors and investigators conducting clinical trials in the United States. This form provides the FDA with important information about the clinical trial, such as the protocol, investigator qualifications, and other important information.

CCRPs provides principal investigator certification to ensure accuracy and efficiency for form completion and compliance.

Who is Required to Complete the Form FDA 1572?

The Form FDA 1572 must be completed and submitted by sponsors and investigators involved in clinical trials conducted in the United States. The sponsor is the organization that is responsible for the conduct of the clinical trial, and the investigator is the individual responsible for the conduct of the trial at a specific site.

How to Complete the Form FDA 1572?

Completing the Form FDA 1572 can be a daunting task for investigators and sponsors. However, it is important to understand the information requested on the form, as well as how to accurately and completely fill out the form. A few tips for completing the form include: thoroughly reviewing the instructions before filling out the form, carefully reading each item on the form and providing complete and accurate information, and providing all required information, such as signatures and dates.

Steps to Filling out FDA 1572 Form:

Write the name of the investigator at the top of the form. For example, enter “John Smith” as the Investigator Name.

Enter the address of the investigator in the next line. For example, enter “123 Main Street, Anytown, USA 12345” as the Investigator Address.

Enter a phone number for contact purposes in either a local or international format (e.g., “1-800-555-1234” or “[phone]”).

Enter a valid email address associated with the investigator in the provided field (e.g., [email protected]).

List any previous investigational drug and device studies that have been performed by this investigator under FDA oversight (if applicable). For example, enter “CT-001, DB-002” as Previous Investigational Studies Conducted Under FDA Oversight.

Indicate whether you are requesting approval to conduct clinical trials with drugs or devices by checking one of two boxes: Drugs or Devices/Biologics/Medical Devices/Other Products Regulated by FDA (e.g., select “Drugs” if you are requesting approval for clinical trials with drugs).

Follow up with information about which specific drugs or devices will be used in your studies (e.g., enter “Lipitor, Celebrex” for drugs and/or “Defibrillator XF7500, Pacemaker YZ2300” for medical devices).

Specify how many new indications or dose regimens you will be studying with each drug or device (e.g., enter 2 for Lipitor and 1 for Celebrex).

Provide details about any preclinical studies conducted to evaluate safety and efficacy data related to your proposed clinical trial (if applicable; e.g., provide details about animal models used and results obtained from these tests)

Describe any other research activities related to FDA product regulation that have been conducted by yourself or associates at your organization (if applicable; e.g., enter “Phase II safety study on Lipitor conducted in 2018”)

Sign and date the form after carefully reviewing all information entered into it

FAQs for Form FDA 1572

What is the Statement of Investigator, Form FDA 1572?

The Statement of Investigator, Form FDA 1572, is a document that must be completed and signed by the lead investigator for each clinical investigation conducted under an Investigational New Drug Application (IND). It is used to provide information about the qualifications of investigators conducting studies with investigational drugs.

Why does this form need to be completed by an investigator?

This form needs to be completed by an investigator to ensure that they are qualified and have the necessary experience and expertise to conduct a safe and ethical clinical trial. This form also serves as affirmation from the investigator that he or she has read and understood the protocol of the clinical investigation in question, as well as any other information pertinent to the study provided by the sponsor or sponsor-investigator.

When must this form be completed and signed by an investigator?

The form must be completed and signed by an investigator at or before initiation of a clinical investigation which involves use of an investigational drug. The form must also be updated or a new 1572 must be completed and signed by an investigator if there is new or changed information relevant to the study.

Must the investigator be a physician? What are the minimum qualifications of an investigator?

An investigator does not need to be a physician, but should meet certain criteria set forth by FDA such as having sufficient training, knowledge, and experience pertinent to the type of research being conducted; having access to medical records relevant to studies being conducted; understanding good clinical practice requirements; following protocols; and obtaining informed consent from research participants.

Does the 1572 need to be submitted to FDA?

Yes, this form needs to be submitted to FDA along with supporting documents prior to initiation of a clinical trial involving use of an investigational drug. Even if a foreign clinical study is not conducted under an IND, investigators who conduct such studies still may need to sign a 1572 in certain circumstances.

If a clinical investigation is not conducted under an IND or is for a medical device, must investigators sign a 1572?

A sponsor may conduct a foreign clinical study under an IND only in situations where it does not qualify for exemption from IND regulations due to lack of assurance that subject protection will be maintained without oversight from FDA. If such conditions are met then sponsors must submit an IND application prior initiating the foreign study in order for it to comply with applicable regulations.

Must investigators who conduct studies outside of the United States sign a 1572?

Yes, according to the Food and Drug Administration (FDA), all clinical investigators conducting studies on FDA-regulated products that require an Investigational New Drug (IND) application must sign a Form FDA 1572. This form is used to confirm that the investigator understands their obligations and responsibilities related to conducting IND-related studies.

If a foreign clinical study is being conducted under an IND, what are the investigator's responsibilities with respect to local laws and regulations?

When conducting foreign clinical trials under an IND, investigators must comply with both local laws/regulations as well as those set forth by the FDA in 21 CFR Part 312. This includes ensuring that good clinical practice standards are followed and that any applicable ethical considerations are taken into account when designing and implementing the study protocol. In order to ensure compliance with local laws, investigators may need to obtain permission from national or regional regulatory authorities before beginning the trial. Additionally, depending on the country in which a foreign clinical trial is conducted, additional requirements such as language translations of informed consent forms may be necessary.

For foreign clinical studies conducted under an IND, how can an investigator sign the 1572 when he/she knows he/she cannot commit to all of the requirements on the form, specifically IRB membership (21 CFR 56.107)?

In order for an investigator to sign a Form FDA 1572 for a foreign clinical study under an IND even if they know they cannot commit to all of its requirements (specifically IRB membership), they should discuss this issue with their sponsor prior to signing it in order to find out what alternative arrangements can be made. Furthermore, sponsors should consider both local laws/regulations as well as ICH standards when making these arrangements so that appropriate safety measures can be taken. For instance, sponsors may choose to contract independent consultants or external experts who are familiar with good clinical practice standards in order to review data gathered during trial activities at sites located outside of United States jurisdiction.

If a sponsor chooses to conduct a foreign clinical study (or operate non-US sites in a multinational study) under an IND and the investigators at these non-US sites comply with ICH E6 Good Clinical Practice Consolidated Guidance, would the non-US investigators also be in compliance with FDA's IND requirements under 21 CFR Part 312?

When conducting foreign clinical trials under an IND, compliance with ICH E6 Good Clinical Practice Consolidated Guidance alone may not guarantee full compliance with 21 CFR Part 312 requirements set by the FDA. Although ICH standards provide general guidance on how research should be conducted ethically and safely within different jurisdictions around world, some countries have rules or regulations in place which differs from those established by ICH E6 Good Clinical Practice Consolidated Guidance or which might amend them slightly; therefore potential discrepancies between these two sets of regulations need to be taken into consideration when designing trial protocols for international trials subject to FDA jurisdiction. Furthermore, sponsors should ensure that all parties involved in such trials understand their individual responsibilities related executing Research Ethics Committee approval processes required for each country included in study protocol design prior commencing trial activities at each site outside US jurisdiction

Must foreign clinical study sites in a multinational study that includes domestic sites be conducted under an IND?

Yes, all foreign clinical study sites that are part of a multinational study must be conducted under an IND. The sponsor must submit an application to the FDA for approval to conduct the study and provide detailed information about the site, such as personnel qualifications, resources and facilities available at the site, and protocol for conducting the research. The IND application includes protocols and other information describing how a proposed clinical investigation will be conducted.

How does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND?

The sponsor must submit an Investigational New Drug (IND) Application to the FDA if they wish to conduct a foreign clinical study which has not been previously approved by the FDA. The sponsor should include detailed information regarding the proposed clinical trial, including the proposed protocol, safety measures put in place to protect subjects participating in the trial, qualifications of personnel involved in conducting or supervising the trial, and any other information which will help demonstrate compliance with applicable regulations.

Should a new form be prepared and signed when the OMB expiration date is reached?

No, there is no need for sponsors to prepare or sign any new forms when submitting an Investigational New Drug (IND) Application or when seeking approval from FDA for any particular clinical trial. However, sponsors must follow all applicable laws and regulations related to their research activities and comply with requirements set forth in relevant documents such as Form 1572 (Declaration for Clinical Investigations Involving Human Subjects), Form 3454 (Statement of Investigator), and Form 3753A (Clinical Investigator's Brochure).

Does FDA expect a double-sided 1572, or is a two-page document printed from the FDA website acceptable?

The FDA requires sponsors to submit Form 1572 as part of their IND application as both single-sided copies and double-sided copies. The form should be completed according to applicable regulations outlined by 21 CFR 312.23(a)(7). Sponsors may not use double-sided copies of documents obtained from websites hosted by other organizations, including those belonging to different government agencies or non-profit institutions..

How should the 1572 be completed?

Form 1572 should be filled out completely by each investigator listed on it who is responsible for conducting or supervising certain aspects of research activities at any given site. This includes providing all necessary details such as person’s name, address/location(s), contact information (e-mail address/phone number/fax number etc.), signature(s) etc., along with listing any degrees/licenses held by him/her that show he/she is qualified to conduct/oversee said research activities being funded through this particular project. Furthermore important section detailing ‘Financial Disclosure’ needs special attention especially since this form also serves purpose of informing potential participants about potential conflicts of interest pertaining to investigator’s involvement in these studies alongside his/her salary details etc. So it is crucial that this section is filled out completely without leaving out any significant details so that true picture can be presented in front of future volunteers who might decide whether they want participate in said studies or not based on aforementioned disclosure

Review Questions for FDA Form 1572

What is FDA Form 1572?

A) A form that must be completed and signed by the clinical investigator when a study is initiated, revised, or discontinued

B) A form that must be completed by all patients participating in a study

C) A document used to report adverse drug events to the FDA

D) A document used to collect information about the safety and effectiveness of drugs

Answer: A) A form that must be completed and signed by the clinical investigator when a study is initiated, revised, or discontinued. Explanation: The FDA Form 1572 is an agreement between investigational sites and the FDA. It outlines key elements of studies conducted at those sites such as background qualifications of investigators and staff, source documents, records maintenance, reporting requirements and procedures for handling drugs used in clinical trials.

What type of information must be provided when completing FDA Form 1572?

A) Personal information about each individual participant in a trial

B) Information about drugs being tested in a trial

C) Financial information from sponsors involved in the trial

D) Information about laboratory tests performed during the trial

Answer: B) Information about drugs being tested in a trial. Explanation: The FDA Form 1572 requires that the investigator identify all drugs to be administered during the investigation (e.g., active ingredient names and doses), along with any other products that may affect laboratory results such as vitamins or minerals. This will help ensure accurate record keeping throughout the trial.

Who is responsible for ensuring accuracy on FDA Form 1572?

A) The clinical investigator conducting the study

B) The sponsor of the study/trial

C) The patient participating in the study/trial

D) All of the above

Answer: D). All of the Above. Explanation: Accuracy on FDA Form 1572 is essential since it serves as an agreement between investigational sites and the Food & Drug Administration (FDA). Thus, both sponsors and clinical investigators are responsible for ensuring accuracy on this form, as well as patients who participate in studies/trials should they provide any data or information required by this form.

When does an individual need to submit an updated version of FDA Form 1572?

A) When enrolling new patients into a clinical trial

B) When changes are made to protocols related to a given clinical trial

C ) When making changes to personnel associated with a given clinical trial

D ) All of the above

Answer: D). All of the Above Explanation: An updated version of FDA Form 1572 needs to be submitted when enrolling new patients into a given trial; when changes are made to protocols related; or when personnel associated with a given clinical trail have changed since its initiation or last update. This helps ensure accuracy so that all parties involved have access up-to-date information regarding ongoing studies/trials they’re involved with at any given time.

What happens if an individual fails to submit an updated version of FDA Form 1572?

A ) They will not receive funding for their research project

B ) Their research project may not pass inspection from regulatory authorities

C ) They may face legal repercussions from regulatory authorities

D ) All of the Above

Answer: D). All of The Above Explanation: If an individual fails to submit an updated version of FDA Form 1572 then they can face various consequences such as not receiving necessary funding for their research project; having their research project fail inspection upon review by regulatory authorities; or facing legal repercussions from said authorities due its importance in providing complete documentation related to ongoing studies/trials involving human subjects which helps protect participants’ rights while conducting necessary research work safely and ethically within regulatory guidelines set forth by law enforcement bodies responsible for protecting public health around world according these standards set forth through years long process establishing best practices medical community has come accept today across many countries globally depending respective jurisdiction laws apply under question particular case being consider review possible action taken based findings presented within scope parameters policy established maintain highest ethical standard ensure well-being everyone involved

CCRPs provides principal investigator certification to ensure accuracy and efficiency for form completion and compliance.

#fda full name #fda form 1572 #1572 form fda #match the following statements with the appropriate tissue sample. #1572a #fda form 3455 #clinical forms #fda form #conducting investigator-initiated studies according to fda regulations and gcp #fda form 3674 #1572 fda guidance #fda guidance on 1572 #1572 template #form 1572 fda #1572 #fda forms #conducting investigator initiated studies according to fda regulations and gcp #fda 3455 form #form fda 3454 #fda investigator #nursing task #fda 1572 statement of investigator #fda clinical trial #1572 form #1572 fda #fda 1572 guidance #dd quiz #when must the investigator update the irb #fda form 3454 #fda1572

[honkifurhoary]

Emmanuel the Emu: A Story of HPAI Mismanagement

Emmanuel, the TikTok-famous emu owned by Taylor Blake of Knuckle Bump Farms, made national news last month when Highly Pathogenic Avian Influenza (HPAI) hit the farm. According to Blake’s initial Twitter thread, Knuckle Bump Farms lost 99% of their avian flock- over 50 individuals- in only three days. These deaths were attributed both to the disease itself and to a cull carried out by the Florida Department of Agriculture and Consumer Services, who did so with Blake’s permission. Emmanuel and a black swan named Rico were the only two survivors, with Emmanuel left unable to stand, unwilling to eat or drink, and quickly fading. Hundreds of thousands rallied behind Emmanuel on social media as Blake documented Emmanuel’s progress, reaching out to public figures like Dr. Pol of The Incredible Dr. Pol and Bindi Erwin of Crikey! It’s the Irwins for help when she failed to find any other sources for emu rehabilitation. But soon, controversy emerged.

Early on, avian influenza experts expressed concern that Blake was not wearing any PPE when interacting with a presumably HPAI-positive bird. Avian influenza is transmissible from bird to human which, combined with the virus’ ability to mix genes and rapidly change, means that PPE is universally recommended when dealing with a suspected or confirmed HPAI outbreak.

In response to concerns, Blake explained that “Emmanuel freaks out whenever we approach him wearing a mask” and that the farm is on a state-mandated quarantine for 150 days, which is the amount of time HPAI is estimated to survive in the environment under ideal conditions. This quarantine reportedly only allowed Blake, Blake’s girlfriend Kristian Haggerty, Blake’s family, and veterinary professionals to enter the property. “I have taken every precaution recommended by the FDA” Blake stated, referencing the Florida Department of Agriculture and Consumer Services (FDACS) rather than the Food and Drug Administration (FDA).

Many people, including HPAI experts, found this explanation unsatisfactory and instead decided to contact the FDACS and USDA directly. Both the FDACS and USDA work collaboratively to manage avian influenza outbreaks in Florida. Dr. Danielle Stanek of the Florida Department of Health clarified that the DOH can recommend that private individuals comply with CDC guidelines, which includes wearing full PPE when interacting with HPAI-infected birds, but they cannot mandate that they do so. Therefore, Blake’s decision to forgo PPE was hers to make, even if it wasn’t in accordance with the recommendations of the FDACS, CDC, USDA, and Florida DOH.

Just as discourse between experts and Emmanuel fans reached its peak, Blake announced that Emmanuel tested negative for HPAI. Instead, Emmanuel’s sudden decline was attributed to stress. “Emus are incredibly susceptible to stress. He was incredibly overwhelmed by the state coming in and euthanizing our flock . . . He stopped eating the day they depopulated.” His lingering issues- the inability to stand or walk independently, twisted neck (torticollis), continued inappetence and dehydration, and lethargy- were caused by a nighttime collapse that left Emmanuel “thrashing on the ground for hours, trying to get himself up”. “He never once had a single symptom of AI, other than not eating”, Blake stated.

HPAI symptoms in birds varies depending on the species and the individual. In chickens, HPAI often presents as respiratory and digestive distress, followed quickly by death. In other poultry species, symptoms may also include the nervous system, causing “tremors, twisted necks, paralyzed wings, laying down and pedaling”. Ratites- referring to the diverse group of keel-less birds that include emus, ostriches, rheas, kiwis, and cassowaries- also tend to develop neurological symptoms. Notably, emus can present with twisted necks (torticollis), ataxia (discoordination), leg and wing paralysis, inability to stand, decreased food and water consumption, purple discoloration or swelling of the legs and head, and lethargy. This corresponds with many of the symptoms Blake has documented in Emmanuel. And it should, considering that Emmanuel did test positive for HPAI.

Test results completed on October 27th, 2022 at the USDA’s National Veterinary Services Laboratories showed that Emmanuel’s serum sample, collected six days after the start of the outbreak, contained antibody levels that were consistent with recent infection.

When Blake announced Emmanuel’s stress diagnosis, she was likely relying on information provided by a rapid test, which can provide results within 48 hours. These tests detect viral proteins that indicate active infection and virus shedding. Serology tests, on the other hand, look for the presence of antibodies produced in response to infection, not necessarily active infection. For an indeterminate number of days prior to the sample collection (October 17, 2022) Emmanuel had an active HPAI infection that, rather than stress, likely led to his rapid decline.

Why, then, was Emmanuel not included in the state’s cull on Knuckle Bump Farms? An email between Dr. Michael Short, the FDACS’ Animal Industry Director, and Kassandra Curiel of the FDACS’ Office of the Commissioner, answers this question. Dr. Short states that “USDA guidance is that ratites (emus and ostriches), black swans and exotic pet birds do not have to be euthanized due to lower risk”. Blake echoes this on her Twitter, when she says that “the state only focused on the “super spreaders” which are poultry species and ducks. Ratites aren’t included because they typically aren’t as susceptible.”.

This allowed Knuckle Bump Farms’ four emus (Emily, Eliza, Elliot, and Emmanuel) and three black swans (two unnamed females and Rico), to be exempted from the cull. I cannot find any reference, either in USDA literature or anywhere else, that supports Dr. Short’s statement. In fact, all the literature that I reviewed and all the experts I talked to during my research only confirmed the devastating effects that HPAI can have on both ratites and black swans. This, coupled with the fact that three of Knuckle Bump Farms’ four emus and two of their three black swans died when “the virus hit them extremely hard and very quickly”, calls Dr. Short’s statement into question.

The USDA was also unable to substantiate Dr. Short’s statement. When asked how exemptions to culls were determined they explained that, rather than look at individual species, the USDA classifies HPAI-infected domestic birds as either commercial, backyard poultry, or backyard non-poultry. These definitions ascribe risk of potential HPAI spread by determining the level of contact a poultry premise has with other poultry premises. If a private farm or private household, where the poultry does not have any contact with poultry beyond the property, has an outbreak then they are classified as a non-poultry premises, even if they have chickens, turkeys, or other poultry birds. These non-poultry premises can thus be exempted from culling all their birds by being placed on quarantines by state officials, provided that they adhere to the quarantine and continue to not have contact with any poultry facilities. Knuckle Bump Farms does not sell poultry products; therefore, they were classified as backyard non-poultry and eligible for quarantine. The FDACS seems to have added their own interpretation onto this guidance when they specify ratites, black swans, and exotic pet birds as “lower risk”. I reached out to Dr. Short for comment but received no response.

This isn’t the only time Dr. Short and, by extension, the FDACS demonstrated faulty logic. In that same email between him and Curiel, Dr. Short used this comparison to explain why a citizen’s concern about Emmanuel’s exemption from the cull was unfounded.

“I have heard of only one report of a clinically ill human, over the past 1.5 years of a national response to the current avian flu outbreak. The risk of HPAI to the owner is much less than occurred with household pets that tested positive for SARS-CoV-2 (Covid).  I am assuming no one would advocate to euthanize all pets testing positive for Covid (At least I have not heard of anyone asking us to euthanize pets).

The risk of avian influenza is constantly occurring with all the wild birds in South Florida.  My understanding (not being a human health expert) is the risk to people, especially children and those immuno-compromised at public or private lakes, ponds and waterways from the AI being shed by water fowl is much greater than the sick emu at knuckle bump farm.”

Dr. Ben Golas, a VMD and postdoc with the USGS who is currently working on avian influenza research, weighed in. “It’s a bit like comparing apples and oranges to talk about risk of transmission of COVID vs. HPAI. With COVID, our primary concern is human-to-human contact. [. . .] With HPAI, farm animals are euthanized not only because the disease spreads within the farm flock like wildfire, but also to prevent spreading infection locally to other farms, because HPAI virus can be stable in the environment.”

The CDC agrees. “There is no evidence that animals play a significant role in spreading SARS-CoV-2, the virus that causes COVID-19, to people. […] It’s important to remember that people are much more likely to get COVID-19 from other people than from animals. There is no need to euthanize or otherwise harm animals infected with SARS-CoV-2.” When it comes to HPAI, however, they emphasize that human-to-human spread is rare and often limited to only a few individuals. Bird-to-human transmission is the primary method of human infection, with each new infection increasing the risk that a new, more virulent strain will emerge. This, along with the potential for massive bird-to-bird outbreaks that could devastate both wildlife and industry, is why complete depopulation (euthanasia) is standard for HPAI and not COVID-19.

The FDACS seems to be operating on contradicting and unsubstantiated information when it comes to managing HPAI outbreaks. Unsurprisingly, the employees seem equally conflicted in their internal emails regarding Knuckle Bump Farms. One Florida USDA representative noted, while forwarding a citizen concern about Blake’s lack of PPE, that “her face is real close to a bird that has HPAI”. Another USDA employee responded “actually, in one of the pictures she appears to be kissing it on the head.”. Dr. Kendra Stauffer of the USDA wrote, “. . . part of the allowing the pet bird to live was that there were rules the owner was to follow from DOH, which clearly she is not”.

Other employees, however, were eager to show their support. Commissioner Nikki Fried of the FDACS posted a photo of her, Blake, and Haggerty, and later posted a photo of herself drinking Knuckle Bump Farms’ branded beer while wearing an Emmanuel t-shirt.

Fried’s support generated a lot of concern, particularly amongst local farmers. One Florida emu farmer stated, “my disappointment and concern is 100% with the actions of Nikki Fried as Agricultural Commissioner to allow some birds to be exempt from depopulation, including emus, for no quantifiable reason. Emus are susceptible to HPAI. Emus in other states have contracted HPAI in this current outbreak and they either died on their own or were put down. Research shows they are susceptible to HPAI, and can spread it to other birds and humans. The decision by Fried and FDACS makes no sense and it sets a dangerous precedent.”

Considering that Blake has over 847.4K followers on Twitter, 938K on Instagram, and 2.4 million on TikTok, the precedent the FDACS and USDA have set here is, indeed, dangerous. Many of Blake’s followers learned about avian influenza for the first time through her documentation of Emmanuel’s illness and the state’s response to the outbreak. “I watch for Emmanuel updates every day! This has also been a great lesson for many people in farming education.”, one follower said. Another echoed this sentiment, saying “Thank you for taking the time to let us know what’s going on, and answering questions. You truly are an educator”.

Herein lies the problem. Knuckle Bump Farms is a small, backyard operation. Through social media, however, they reach millions. This specific outbreak of HPAI and its subsequent (mis-)management by the FDACS and USDA has now set the standard for many, rather than the exception. Blake’s public failure to comply with PPE recommendations, the lack of transparency regarding Emmanuel’s true diagnosis, a similar lack of transparency within the FDACS and USDA regarding this outbreak, exemptions to cull protocols made with seemingly no supporting data, and a publicly-elected official openly (and financially) supporting Blake through this process, all pose a serious threat to public confidence in HPAI management and future public health. The concerns of farmers, virologists, public health workers and organizations, wildlife rehabilitators, and animal sanctuaries have been ignored, particularly when they asked whether Emmanuel’s fame and the risk of public backlash led to the FDACS’ decision to leave him and several other symptomatic birds alive. It seems, through this research, that there is more support for this theory than the narrative we’ve been provided until now. It is my hope that, with the publishing of this information, the very real concerns raised by people directly effected by HPAI will be given the weight they deserve.

Please take this opportunity to learn about avian influenza from reputable sources:

Protecting Birds from Avian Influenza

Avian influenza and PPE

CDC Avian Influenza

USDA HPAI Response Plan

Florida Avian Influenza Update (Oct 2022)

A huge thank you to the following experts who generously answered my questions: Dr. Ben Golas, Dr. Jim Wellehan, and Dr. Jennifer Riley.

#emmanuel the emu #hpai #avian influenza #florida #avian flu

[lil-shiro]

Lance Lore: Florida Winter Series 2014

This post will cover Lance’s participation in the 2014 Florida Winter Series, or as I like to call it: Baby Racing Summer Winter Camp.

Which is where this picture originated from:

First things foremost, what was the Florida Winter Series? 

It was a “non-championship racing series organized by the Ferrari Driver Academy in Florida”. The series used the Tatuus FA010B chassis. This car is also used in Formula Abarth and other regional championships. The car was built to Formula 3 safety regulations.

It was an educational experience for young drivers to gain familiarity and development with single seater racing. For some drivers such as Lance and Max, it was their first ever time racing single seaters as they were literally in karting before this. 

Who participated? 

The series had 11 fixed participants, and Lance was the youngest.

From the FDA there was Lance, Antonio Fuoco (current WEC driver for Ferrari AF Corse), and Raffaele Marciello (current WEC driver for BMW M Team WRT). 

[Lance and fellow FDA participants]

Other notable names include, Max Verstappen, Nicholas Latifi, Ed Jones (WEC, IndyCar), and Tatiana Calderón (WEC, IndyCar).

[The Palm Beach Drivers’ Photo]

Will Buxton’s Reporting

Will Buxton, who if you don’t know is a British motorsport journalist and presenter for F1, was invited to participate for a weekend of the series. He documented his experience on his blog and there was also an NBC mini series. You can read/watch the whole thing online, I’ll just be focusing on Lance for this post.

[Pre Race Warm Up]

From his blog, it’s easy to tell that he quickly became friends with Lance, his garage mate, over the weekend. He documents his first impression of Lance as followed.

Lance Stroll. My garage mate. And on first impressions of him being late for every meeting, playing with his phone, goofing around, I presumed was going to be a cocky karting graduate nightmare. How wrong first impressions can be. A genuinely lovely guy, still so young at 15 and blisteringly quick. Supportive of his boys in the garage, a smart brain… and ever so confident. Confident to the point that if you don’t know him, you’d think he was being arrogant. Just as I had, before I really knew him.

Will realized how behind he was compared to the others, after FP1 he was 8.485s off the leading session time. He writes,

After each session, Lance would sit with me briefly and ask how my session had gone and advise on where I could find some time. After FP1 he handed me a tip that served me impeccably.

“Have you got a tinted visor?”

“Absolutely,” I said.

“Use it, man. The glare out there is so bad, you’ll tidy right up with it.”

And so I did.

I sat with Mario as he overlayed Lance’s lap with mine to give me an idea of how much later I could be braking, and even how I could change my style of braking. I was hitting the brakes early and with about three quarters of the pressure of Lance, pressing on them and then coming off almost completely in a square shape.

[Will and Lance discussing]

During Will’s second run of the first quali session for the race weekend, there was a red flag because Lance had crashed into the barrier. He wrote the following:

Lance was going over his crash, and we all sat down and watched the GoPro footage. He’d turned in just a touch early for Turn 8, a slight lift and then full throttle. The early apex had drawn him out to the edge of the track too soon and his front left had touched the grass moments before the kerbing started. On the slippery green stuff, and at that speed, he was a passenger for the five metres or so before the tyre barrier. The hit was recorded at 5.2G.

“You OK?” I asked.

“Yeah. My knee hurts a bit but I’m OK. I’m just pissed off because if I’d got the turn in right I reckon I could take it flat.”

This was another moment where I realized how much I liked Lance. A big shunt, and he was already thinking about taking the corner faster next time out.

Although during the break between quali’s, they managed to fix Lance’s car. After Will completed his first ever race (he came last and got lapped twice), Nuno Pinto (prema driving coach/manager and Lance’s coach to this day) told Will he did a good job, but was “almost too courteous to the other drivers.”

Which Lance replied: “Yeah man,” laughs Lance. “You’re way too nice. You could have held the other guys up so I could have had a run at them!”

Other Facts/Media

Over the course of the month, Lance podiumed twice (both times with Nicky)!

[Palm Beach R2 Podium]

[Homestead R3 Podium]

He also achieved 1 pole position. Bonus fun fact: Will beat Nicky in one race (due to a DNF). Now for some more pictures!

[Car check and rebuild, Lance removing the air filter to clean it]

[Other pictures of Lance]

[Lance and Antonio Fuoco]

[FWS Class of 2014]

[Bonus: Will congratulating + Interviewing Lance after his first F1 Podium]

Links/further media Will's blog NBC Mini series (spot the boys!) Homestead Race recap FWS 2014 - Highlight Video Florida Winter Series - Funniest moments Will Interviews Lance after Baku 2017

Note I know this was long, but thank you for reading! I've been meaning to write this up for a while now <3

#I finally did it #lance when he was a silly goober #feel free to ask questions etc I'll try my best to answer #lance stroll #f1 lore #2014 #him being more occupied with how he could've driven over his knee hurting makes me sob #how could you possibly think he never wanted this...

[mostlysignssomeportents]

Monopolizing turds

Update 31 May 2023: an earlier edition of this article identified the price of Rebyota as $20,000; this was the rumored price prior to Rebyota’s release in December  2022, when Stephen Skolnick wrote the article I referenced. When Rebyota was actually released in 2023, the average wholesale price (AWP) was $10,800. Thanks to Benjamin Jolley for catching this error, and to Stephen Skolnick for getting to the bottom of it.

It’s been ten years — to the day! — since I first started writing about the bizarre, amazing world of turd transplants, in which a sick person receives a microbiotic infusion in the form of some processed poop from a healthy person:

https://web.archive.org/web/20130608030455/http://blogs.plos.org/publichealth/2013/05/29/why-diy-fecal-transplants-are-a-thing-and-the-fda-is-only-part-of-the-reason/

Gut biomes are one of those understudied, poorly understood medical areas that are both very promising and also full of sketchy medical claims from “supplement” companies, influencers, quacks and grifters. But in the decade since I first started tracking turd transplants (formally called “Fecal Microbiota Transplants” or FMTs), a growing body of sound science has emerged on the subject.

One thing that’s increasingly undeniable is that the composition of your microbial nation is related in significant ways to both your physical and mental health. What’s more, as antibiotic resistant “super bugs” proliferate, FMTs are becoming increasingly central to treating dangerous gut infections that otherwise stand a high chance of killing you.

“Eat Shit and Prosper” is Stephen Skolnick’s delightfully named newsletter about poop and health science. Skolnick is a physicist by training, but has a long history of collaboration with Openbiome, a nonprofit that coordinates between doctors, patients and donors to provide safe FMTs:

https://stephenskolnick.substack.com/

In an edition of Eat Shit from last December, Skolnick recounts the amazing history and dismaying future of FMTs. In 2013, the FDA announced it would regulate FMTs as “Investigational New Drugs,” which could only be administered as part of a registered clinical trial:

https://stephenskolnick.substack.com/p/a-monopoly-on-poop

At that point, FMTs were already in widespread use by docs to treat otherwise untreatable cases of Clostridioides difficile (C. diff), an antibiotic resistant bacterial infection that literally makes you shit yourself to death. These doctors were in no position to run registered clinical trials, which meant that they would have to stop using the most effective therapy they had for a potentially lethal infection.

Doctors and patients kicked up a fuss, and the FDA walked back its guidance, announcing that it would exercise “discretion” in enforcing its Investigational New Drug rule, giving a pass to docs who were treating C. diff with FMTs:

https://www.federalregister.gov/documents/2013/07/18/2013-17223/guidance-for-industry-enforcement-policy-regarding-investigational-new-drug-requirements-for-use-of

That’s where things have stood for the past decade or so. The “discretion” rule means that patients could still get FMTs, but their insurance wouldn’t cover it. But even if you had cash to pay for an FMT, your doc probably wouldn’t administer it for anything except a C. diff infection, despite the promising signs that FMT can help treat other conditions, and despite the generally safe nature of FMTs.

If your doc did give you an FMT, chances are good that they sourced their poop from Openbiome. Openbiome recruits very healthy people, gets them to poop in a bag, then processes the poop — removing nonbacterial solids, testing it for pathogens, freezing it, portioning it, and sending it to docs. All this is done at cost, and it’s not cheap: $1–2k/treatment, mostly due to cold-chain logistics (the poop is shipped at -80C).

Despite the cost, and despite the limitations on treatment, the Openbiome method has proved very reliable. Indeed, FMTs as a whole are pretty darned safe, with the most common side-effects being transient gas and bloating. In the past decade, there’ve been a total of six “adverse effects” associated with Openbiome’s 5,000+ procedures, all in severely immunocompromised people, and none conclusively linked to the treatment:

https://www.sciencedirect.com/science/article/pii/S0016508522003511/pdf

A decade into this system, the FDA has taken the next step forward — only it’s actually a step backwards.

During this intervening decade, a pharma company called Ferring has conducted clinical trials on FMTs and received approval for an FMT product called Rebyota. The process for making Rebyota is effectively identical to the process used by Openbiome: collect poop, remove solids, test for pathogens, add glycerol, freeze and ship.

The main difference between Rebyota and Openbiome’s poop is price. While Openbiome charges $1–2k per treatment, Rebyota charges $10,800

That’s some expensive shit!

Fine. Getting Rebyota through clinical trials means that insurers might start covering it, and perhaps some patients will prefer brand-name poop to open-source poop. But as part of the FDA’s approval of Rebyota, the agency also rescinded its “discretionary enforcement” guidance, making it illegal for docs to source their poop from Openbiome:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-regarding-investigational-new-drug-requirements-use-fecal-microbiota

For Ferring, this is a monopoly on shit, one that lets them charge patients $10.8k for poop that costs $1–2k to process. The FDA does not claim that this is being done in the name of safety. Instead, an FDA official told Skonick that the goal was to “incentivize innovation without creating an access crisis.”

That is, the FDA changed its guidance and put nonprofit stool banks out of business because it wants to incentivize pharma companies to perform expensive clinical trials, and it believes that these companies won’t pay for trials if they have to compete with the likes of Openbiome, which would make it impossible to charge 900% markups on poop.

Trials are important! Evidence-based medicine is important! But Ferring’s clinical trials didn’t tell us anything we didn’t already know. FMTs were already the best therapy we had for C. diff. Testing Rebyota against a placebo didn’t tell us anything new — unlike testing Rebyota against the existing therapies, e.g. product from open stool banks.

Such a trial might have given rise to a very different regulatory outcome, because the cure rate reported by Rebyota is much lower than the cure rate from Openbiome’s own interventions:

https://link.springer.com/article/10.1007/s40265-022-01797-x

That is, using the $1k poop from Openbiome seems to be much more effective than using the $10.8k poop from Ferring. But Openbiome, a nonprofit, hasn’t been able to perform the kind of rigorous — and expensive — clinical trial that Ferring funded.

This points to a significant problem with the FDA’s model. The agency wants good clinical data for the medicines it regulates, as it should, It presumes that the only way to get that data is through granting commercial exclusivity to a for-profit, which ends up costing patients vast sums, and locking many patients out altogether.

This creates all kinds of new dangers. 150,000 people/year in the US contract Recurrent Clostridium difficile Infection (RCdI). FMT increases the cure rate by 20% relative to antibiotics alone. That means that if everyone with RCdI gets a poop transplant, 30,000 extra people will get better. That’s a big number!

For well insured people, Rebyota probably represents a cash-savings — if your insurance covers the $10,800 procedure, you might pay $500 out of pocket, which is far less than the $1–2K you’d pay to get an Openbiome poop transplant. But if you’re uninsured or underinsured, the FDA’s new enforcement rules mean that you’re now on the hook for $10,800.

The FDA did carve out a loophole: if your doc or their hospital are willing to prepare the poop transplant themselves, they can administer that. On the one hand, preparing a poop transplant isn’t that hard — some people do them at home, on their own:

https://web.archive.org/web/20211015060558/https://thepowerofpoop.com/epatients/fecal-transplant-instructions/

But on the other hand, there’s been exactly one death conclusively linked to FMT, and it was from one of these hospital-prepared transplants (the patient had just had a marrow transplant for cancer that wiped out their immune system, and the donor had a novel pathogen that the hospital failed to test for).

So the FDA has created a situation where, if you can’t afford a $10,800 proprietary formulation, your only option is to convince your doc or hospital to prepare their own poop transplant, which will cost less than the $10.8k for Rebyota, but more than the $1–2k from Openbiome, which has all kinds of economies of scale. And if you do manage it, you’ll be getting a procedure that has a much worse safety track-record than the Openbiome process that the FDA just killed.

The FDA has an important role to play here, but as with so many policy questions, how the FDA plays that role depends on things that are far upstream from the agency and its decisions. The choice to fund medical trials through the promise of exclusivity — and with it, extremely high margins — puts the FDA in the position of choosing winners in the marketplace: Ferring wins, Openbiome loses.

Ironically, this is the thing that exclusivity is supposed to prevent. By using profit to incentivize medical research, the FDA is supposed to be recruiting the Invisible Hand as its partner in regulation. But exclusivity is incompatible with the idea of medicine as a public good. The tens (hundreds) of millions that Americans will pay for $10.8k poop transplants from Ferring will add up to far more than it would cost to underwrite clinical trials for an open process like Openbiome’s.

The result: both Americans’ wallets and Americans’ guts suffer.

Catch me on tour with Red Team Blues in Hay-on-Wye, Oxford, Manchester, Nottingham, London, and Berlin!

If you’d like an essay-formatted version of this post to read or share, here’s a link to it on pluralistic.net, my surveillance-free, ad-free, tracker-free blog:

https://pluralistic.net/2023/05/29/oh-shit/#rebyota

[Image ID: A poop emoji wearing a top hat and a monocle, posed against a backdrop of e coli bacteria seen through a high-resolution microscope.]

#pluralistic #stool bank #eat shit and live #pharma #fda #regulatory capture #fecal transplants #microbiomes #rebyota #openbiome #c diff #fmt #fecal microbiota transplant

[yunisverse]

Oi! You! What is a rant about a cartoon/animation/passion that you’ve wanted to spill for a while but haven’t gotten the opportunity to? Lay it on me!

you want it? you got it.

let's talk about Cloverfield's viral marketing campaign.

July 2007, the first Transformers movie hits theaters preceded by a strange trailer. There's no name for the film, just the date of release: 1-18-08.

1-18-08.com is found (don't go there now, some jerk snatched the domain and runs malware ads now), a site which has some scattered photos of the party from the trailer. You can move around the photos, and flip some over to get notes.

Slusho!, a Japanese drink company, is found thanks to its logo on a shirt in the trailer. The company's site loaded with Engrish about how Slusho makes you Zoom! You can't drink just six! It boasts of its secret ingredient, known only as Seabed Nectar.

Then comes the discovery of Tagruato, Slusho's parent organization. Tagruato is vague as hell about what their company is actually about, but what's most clearly documented are their deep sea drilling sites, and news of them sending a satellite into orbit.

The Myspace pages for various characters in the upcoming movie are found, mostly just the characters chatting like normal pals. One character's page, Jamie, hides a link to the secret site shared with her long-distance boyfriend Teddy where she records video messages to him. She knows he's off saving the world or whatever, but she's lonely!

Tagruato's website uploads an assurance to investors that the claims in the article from Ravaille Research Center are baseless, and its author is known for suspicious work. Googling RRC results in worried posts from families asking about the article, which says that cursory experiments with samples of Seabed Nectar show rapid cell growth, muscle growth, sharper eyesight, increased strength, and a sensation of full-body tingling described as a "wave of happiness."

People can buy merch of shirts from the Slusho! website. At first the packages are lined with Japanese newspapers, but over time some people find crumpled Tagruato documents with a hastily scrawled message to the recipient, from "The Whistleblower," trying to warn that employees have gone missing.

Tagruato's site is hacked, images of its CEO defaced. Hints in the images eventually lead to the site of the ecoterrorist organization TIDO-Wave, who are determined to bring to light the shady underbelly of Tagruato and Slusho. Most notable is this Seabed Nectar stuff is a closely-guarded secret, and definitely not FDA-approved.

Jamie's videos to Teddie are getting less sweet and more irritable. He used to be so good about calling, now he's gone radio silent. After weeks of nothing, Jamie opens a package from Teddie containing "evidence" and some kind of warning about Tagrutto or whatever, and frankly she's insulted he had to make up a whole song and dance instead of breaking up with her like a normal person.

At one point, calling Tagruato's contact line mentions a memorial service. TIDO-Wave's site uploads an article with more information: a famed marine biologist who'd been working for Tagruato's medical branch tragically died while camping with his family shortly after his retirement. It's rumored he made an incredible discovery right before retiring, but his computer, papers, and all research files are mysteriously missing.

1-18-08.com is slowly being uploaded with more and more photos, of soldiers and debris-filled streets and an explosion on some sort of ocean tanker. The photos show timestamps all throughout the night the movie takes place, and a timeline is starting to form. If you stay on the site for six minutes, a monster's roar can be heard.

The Whistleblower leaks a report of the various deep sea oil drills owned by Tagruato, noting that their most recently constructed drill not far offshore from New York has no report of oil whatsoever. So what are they doing there?

Tagruato's space division happily reports the success of their satellite in orbit. It even got a really good picture of a piece of a satellite falling. Some other satellite, not theirs. It's probably fine.

TIDO-Wave has been making plans to infiltrate the suspicious drill site off the coast of New York called Chuai Station, but when they arrive at the coordinates there's nothing there.

Soon after, reports flood in about a horrible altercation at the site; there are news reports in at least six different languages about the event showing footage of Chuai collapsing and sinking under the waves in a matter of minutes. Footage from workers trying to escape from inside the station shows armed Tagruato personnel on the site, and a recording from an escaping lifeboat shows massive chunks of metal debris launched out of the ocean after them as they escape. With knowledge that TIDO was in the area at that time, it's believed to be a terrorist attack. One news report mentions concern about dark shapes under the water shortly before Chuai sunk: if it's an oil leak, that could spell huge consequences for the surrounding area.

Jamie's still uploading videos to let Teddy know how Over Him she is. Him and his stupid games and his fake evidence. "Do Not Eat," huh, well, here's what she thinks about your stupid spy games, what are you gonna do, asshole? oh wow it tastes really good though. Damn she is FULL of energy. Fuck you Teddy she's gonna go PARTY and NOT think about YOU.

On MySpace, friends are congratulating their buddy Rob on getting an incredible job opportunity what will require him to relocate to Japan--he's supposed to help figure out how to market this super popular drink over there to Western buyers. His friends are planning a goodbye party on the night of the 18th.

So like. Know that 99% of this never appears in the movie. One character wears a Slusho! shirt, Jamie can be seen for a split second passed out on a couch. At the end of the movie, you can catch a distant splash as a piece of a satellite falls into the Atlantic. Most audiences don't notice or care and lose nothing having missed all of it. In fact, I didn't find most of this until AFTER seeing the movie.

but GOD did I think it was rad. For most people Cloverfield was just a generic monster movie that gave them motion sickness, but the marketing campaign gave me brainrot for YEARS after it faded from the public consciousness.

I have not and don't intend to ever care about anything else JJ Abrams has ever done but god DAMN if he didn't get me with this one.

so yeah there's your ramble thank u come again

#long post #queries and comments #cloverfield #anunusualvisitor #i didn't even get into the part where people thought it was a Voltron movie #bc they misheard someone screaming 'IT'S ALIVE IT'S HUGE' as 'IT'S A LION IT'S HUGE' #which lead to some hilarious jokes behind the scenes

[weirdmarioenemies]

Name: Chemitory

Debut: Kirby: Planet Robobot

Hello everyone! I hope you’ve remembered to take your medicine lately! And I hope you take it from a secure and clean container received from your pharmacy, and not from a funny robot who throws ambiguous pills at you! Because that would not be healthy. That’s a Science Fact!

Of all the robobots they put in Planet Robobot, Chemitory is my favorite! This design is so so pleasant, and as it idles, it waves its hands gently and happily. Perfectly pill-shaped, since it is all about pills, with floaty hands and an eyes-in-a-void face! That is such a common kind of face for Kirby characters, but it works so especially wonderfully here! Perhaps this is a Haltmann Works Company healthcare robot, here to allegedly help. Instead, it throws pills at what it considers a problem in hopes that it will go away. A scathing satire of modern psychiatry!

Of course, Chemitory has a big clear dome full of pills, and it is here to throw them at you! This dome, delightfully, swings back on the two hinges on either side of its head, allowing it to reach in! What is Chemitory’s prescription?

Chemitory has been officially diagnosed as Mad Scientist! If it doesn’t have its pills, it probably turns into a boring ol’ Regular Scientist. Doing dilutions in a lab. Wearing proper protective equipment. That’s not Chemitory’s style! Chemitory would rather endanger lives and not be approved by the FDA, like a GOOD mad scientist!

Kirby can swallow Chemitory, OR its pills, to obtain the Doctor ability! I am a little surprised the ESRB was fine with letting Kirby consume strange pills, and receive a benefit from doing so. Again, please don’t consume strange pills. But I’m glad Kirby does it, because Doctor is perhaps my favorite ability! It is so fun! Kirby can throw pills like Chemitory, as well as lots of other medical-themed stuff! It is also probably the silliest looking Copy Ability. That is so many accessories! Wonderful.

Something I think is so delightfully wacky about Chemitory, and Doctor as a whole, is that they may very well owe their entire existence to the Dr. Mario amiibo! Planet Robobot allows for amiibo to be scanned to give Kirby certain abilities, and it seems that its new abilities were designed with this in mind! ESP is obviously a Ness reference, almost obnoxiously so. Poison, while the most original of the three, can be reasonably linked to Splatoon, since it features goop that splatters onto surfaces, and damages enemies that touch it. Doctor, of course, is heavily based on Dr. Mario!

Do you think, if amiibo did not exist, or if Dr. Mario was not added to Smash 4, the Doctor ability, and by extension Chemitory, would have never even been conceptualized? It feels rather possible to me, so I am glad both of those things happened!

Chemitory is a sort of one-hit wonder, appearing only in one game. At the end of Planet Robobot, when the mechanization is reverted, maybe every Chemitory even ceased to exist! I have faith, however, that we will see Chemitory again, since Copy Abilities always make their return eventually! And hopefully, Doctor will make its comeback in Kirby Star Allies 2: Chemitory Is In This One And Is Playable!

#chemitory #kirby #kirby planet robobot #kirby enemies #not mario #funky friday #mod chikako #a very funny thing about Chemitory is #before its name was confirmed #the Fandom Kirby Wikia just sort of assigned it the name Pillah with no actual basis #and we all just went with it #because a wiki is supposed to be trustworthy #always check sources for claims folks

[onlyonetifosi]

I'm not him

-> Word Count: 572

-> Warnings: a lot of fluff, angst at the beggining, some steam at the end but nothing explicit

->Author note: Short fic about a mix of emotions for mick. I would appreciate if you send some ideas or requests for me to write. English is not my first language so sorry for mistakes

It's been almost five years since Michael Schumacher's devastating skiing accident. The world mourned the loss of one of the greatest Formula One drivers of all time. But for Mick Schumacher, it was a personal tragedy. He's the 23-year-old son of the seven-time world champion, he's not Mick, he's Michael's Schumacher son, and he's determined to make his own way in the sport. But the shadow of his father's accomplishments looms large. Mick knows that he will always be compared to his father. It's an impossible standard to live up to. And the pressure can be overwhelming at times. But Mick is determined to prove that he is his own man. He is a talented driver in his own right and he is determined to make a name for himself in the world of motorsport.

-Liebling this is mentally exhausting i can't keep being compared to my dad , it feels like i can't do anything without him being brought up. -Mick, you have to understand that your father is one of the most successful drivers in history. It's only natural that people are going to compare you to him.

-I know, but it's still hard. I just want to be my own person. -You are your own person, Mick. You're a talented driver with a bright future ahead of you. Just keep doing what you're doing and you'll make a name for yourself in this sport.

-No I'm not there isn't a gp where i see coments about my driving compared to my dad's- He says angry, getting up of the couch where we were cuddling.

-Micky, come back baby, I know you are having a hard time at Haas and being compared not only with your dad but Kevin- I say following him to our beedroom.

-I know he was a better driver than me, but who cares? I'm not him, I'm Mick not Michael- He says crying and i hug him.

-And you are the best driver in my eyes- I say kissing his tears as they fall from his face.

-I love you prinzessin- He says with a small smile and i kiss him passionately.

-What a nice view- he says pointing to the countryside from the balcony of our hotel in Monza.

We are here for the italian gp, we don't have many holidays but they are always special.

-I'm glad we could come here, honey- I say happy.

-You lived here, didn't you?- i say remembering some thing he told me about his junior categories years and living in Italy because of being a driver of the FDA.

-Yeah for 3-4 years actually- He says- I love my years here but i prefer home in Switzerland, with mum, Gina, Angie and going to Seb's to see him, Hanna and their kids.

-I hope we can go home soon- he sighs.

Only two weeks more, baby- I say hugging him and sitting on his lap.

Our kiss gets heated and more intense but not messy, deep and full of love, just like we do it.

We make sweet and pasionate love with the first rays of sun going through the window.

After that we go into the streets, enjoying the golden hour light that makes everything look even more beautiful. Now we're sleeping in my bed and i'll have to wake up early to go to work but i feel happier than ever with him.

I hope you like this! send me whatever you want to my asks.

I would love to know something about you!!

And would you like a mention list? like for me to mention you in my fics <3 <3

#mick shumacher imagine #mick schumacher x reader #mick schumacher smut #mick schumacher #mick schumacher fluff #f1 blurb #f1 drivers x reader #f1 imagine #f1 fic

[mittenwonders]

That School of Rock post got me crying right now!

I hate people and this world sometimes. You can be brilliant, funny, compassionate and have the biggest heart but if you’re fat - well that’s all anyone notices. And the jokes start or a keyboard warrior starts typing a million times that “we shouldn’t be promoting obesity!!”

Even this article by Forbes….fricken Forbes is counterproductive talking about acceptance and then how that acceptance is causing obesity!!

No, what’s causing obesity is our food sources because the FDA doesn’t regulate what goes into our food. And who’s responsible for that? Lobbyist and politicians who take corporate bribes that create profits for companies. Clean food is also not accessible to all - especially low income families and neighborhoods. All the added preservatives that increase shelf life in the US has fucked up our DNA after decades of consuming it all. Obesity is genetic at this point and you can find this in many published medical journals. Why do you think many families usually are all on the heavier side? It’s rare to find only one person in a family who is bigger. Even when I was little and skinny as hell, my arms still were on the bigger side because of my lovely mother’s side genetics. All the women on that side have the same exact arms.

Medical conditions also increase the likelihood of being fat. Women for instance usually struggle with weight more because we have uterus’ and constantly have hormones trying to balance itself out every month. You will never find a woman with a completely flat stomach as the uterus changes throughout the month and causes bloating. As one breast doctor told me during a breast cancer scare, “your body is mad at you because it wants to have a baby!” I wish that wasn’t real. Things such as endometriosis, PCOS and other uterine/ovarian disorders contribute highly to weight gain. Thyroid disorders can cause extreme weight gain for both men and women. And medications for various illnesses, including birth control can contribute to it as well even though they’ll say it doesn’t. Steroids are another culprit but usually when you’re put on steroids, it’s a pretty bad disease fighting inflammation.

As someone with autoimmune diseases that also contains the thyroid (Hashimoto’s), I can say that when my joints act up due to arthritis, I can’t move some days. Literally I wake up with morning stiffness & can’t move. Of course I’m not going to work out in agonizing pain to the point I have to rely on opioids later. Weight gain also comes on, no matter how clean you eat, from lack of movement caused by underlying illnesses. In fact Hashimoto’s is often treated differently than regular hypothyroidism. Every year my thyroid medicine increased until I finally got sent to an endocrinologist at University of Michigan who was like “yo you know you have this right?” NEWS TO ME!! I actually have to take two diff thyroid meds to treat it and I have to be on name brand synthroid. I learned that generics only have to contain so much of the actual medicine. The rest is random fillers and it can change company to company. It’s up to the pharmacy to choose their suppliers and often it changes due to bids by companies and whoever is cheaper. So even though you think you’re taking the same medicine every month, you’re really not and your dosing is getting thrown off. Only the name brand has the patent to have the full formula. Generics are “may god be with you” energy. (Fuck capitalism and again, our FDA who is loyal to lobbyists) Since I have changed to name brand and been on the new treatment, I did lose 40lb. And my insurance still tries to fight me for using the name brand because it costs them more. So now we have to fight for clean food and the correct medicine.

I can’t be sad I’m fat…I have the trifecta of everything described above: genetics, woman, grew up very poor, ovarian cyst for 8 years, autoimmune diseases and medications. It’s kind of like no wonder!! But if I express this to anyone, its always “well do something about it then! Diet!”

I do work out regularly as much as I can. I do try to watch what I eat. I also deal with chronic major depressive disorder so sometimes food is a comfort like it is for many because it’s something I feel I have control over (I don’t). It’s better than cutting I guess. However it just went from one out of control coping mechanism to another. I’ve been in counseling for 3 years (well she’s fired now as of yesterday) but I have had to learn to have a better relationship with food. I don’t view working out or eating better as a means to lose weight but as a way to just make sure I’m as healthy as possible. I also eat cake. I allow myself to indulge still in small doses because when you try to take everything away, you’re asking for relapse or binge eating. It’s been great and it did have a positive shift for my mental health too.

I also see my 9 yo niece struggling in school with this. She’s bigger and maybe its genetics but mostly she has an extremely rare metabolic disorder. Literally only 20 kids in the US have it and 4 have died in her age bracket since she was born. Her body does not break down long chain fatty acids so since she was a baby, she has been on special formulas and has had to watch every spec of food she consumes. She’s been in and out of children’s hospital more times than I can count on my hands. It’s been noted so far from what they know of the disease that kids usually have bellies. She did as a baby and as she was still growing. Kids do learn from their parents though and she did deal with unfortunate bullying last year due to being “fat.” They’re 3rd grade!!! I never want her to go through what I went through as middle school is what really fucked me up, so I do check myself before I talk out loud about myself around her. I do work out with her sometimes but I don’t use the term and I do random things like dance parties in the kitchen with her instead so she doesn’t think it’s about losing weight or a “work out” but we’re just vibing while blasting Harry Styles. We always use the terms “healthy choices” in place of anything and it’s been effective overall in her relationship with food and dealing with some asstwat kids at school. I want her to have all the resources and tools that I didn’t have when I was younger. Her confidence has soared this year & she’s really come into her own and I’m so damn proud of her!!

However, all it takes is one doctors visit of weighing you or a run in with someone cruel in public or going online to watch a fun video just to see an unnecessary comment about promoting fat people that is so out of context. Look - if I was given Ozempic as an option tomorrow, I will be honest and say I would definitely take it. I am nervously talking to my doctor this Thursday about a possible action plan. There comes a point when you’re just tired and you want to be fully accepted and something has to give. I shouldn’t have to change anything about myself but when I just want to feel seen as myself instead of the funny fat girl, it seems I don’t have any other choice. I know my worth and I do truly love myself as a person but I do hate the shell I have been given in life. It is hard when no one will listen and your day to day is a never ending fight in a world that is overall bitter and cruel.

It’s like my coworker: I love her dearly I do, but she was just diagnosed with a kidney disorder. She vented to me how she does everything right, she’s fit and not overweight, she watches what she eats etc and doesn’t understand why she’s sick. Meanwhile I’m just chilling there listening. Then she quickly realized her comments about weight and apologized. Yes I have autoimmune issues but overall I have perfect blood pressure, I’m not even pre-diabetic which every doctor almost hopes for, I don’t have sleep apnea (which they try to shove on me) - I���m pretty healthy! Doctors have been biased for decades but have learned health is not actually always dependent on size. It’s why most have had to go through training again to learn bias against patients and they can’t automatically jump to weight as the problem anymore. So many lives have been lost because they weren’t diagnosed correctly and the cancer that spread was blamed on their weight. 🙄

Which all leads me to this fun fact about the body positive movement which is that it was created in the 1960’s as part of a fat-acceptance movement. It was literally created for fat people!! We have been wanting to be heard and seen for so long!! But the body positivity movement got hijacked as a way to say “all body shapes are loved!!” I swear, this is the same concept equivalence as when black people said “black lives matter!!” and others said “but all lives matter.” You defeat the message of that group wanting to be fucking seen and heard!!!

We are not saying thin people should not love themselves or what the correct body type should be. I understand some people want to gain weight and struggle. But fat people are the ones actively targeted and our lives made hell for almost every single day of our lives. We are not allowed anywhere near the performing arts unless you do opera because hahaha the fat lady sings and the media and Hollywood actively shames us. I originally wanted to go into music professionally; much of my childhood was performing arts camps and most of high school was not only school classes but actively participating in state competitions and placing! But I was told from nearly every adult, including teachers that I was too fat and would be living in a box struggling. Childhood dreams/ambitions crushed in a single minute. From bullying at school, to bullying online to not being able to go shopping with your friends because you have to shop in a different section or store altogether, constantly having diets shoved in your face or backhanded comments of “do you really need that?” The usual “why don’t you try to lose weight” all the time is not productive. You don’t think the person has tried? Also never ask someone if they lost weight…or how good you think they look once you notice they have. It mentally fucks a person up way more long term. Tell them they look great and you think they’re pretty now while they’re fat. The diet industry makes billions every year for promises that don’t do anything. I’m sad they even got some of my money at points in my life.

Even airline travel as airlines make the seats smaller and smaller. I think it’s a fricken shame a person is forced to buy two seats for something that could be totally prevented if airlines weren’t so greedy to fit as many people possible on a plane. On top of it, they must ask out loud for seatbelt extenders. I have seen videos of people trying to show what it’s like to travel as a fat person and the comments are awful. Saying they shouldn’t fly and shouldn’t do this or that. Ok - say she is trying to actively lose weight right now….you know you don’t lose weight overnight right?? Even when you have weight loss surgery, it takes time. So in the meantime, she’s just not supposed to do things like travel? You want us all locked up in basements so you feel better not having to see us? That’s what we should do?!? And then people wonder why fat people have some of the highest suicide statistics. I know that was the personal reason I tried in high school. If you see the semicolon tattoo on someone, that means they once tried to take their life but kept going. I will say 90% of people I have seen this tattoo on are plus sized. I’ve often thought of getting this tattoo myself as a means to spread awareness or let someone else who is silently struggling know “I got you” but that’s for another topic.

What I am trying to get at (while obviously venting at the same time) is that the body positivity movement is great I guess but it has taken away from fat acceptance which was the hallmark of the movement and started by fat people. Because of this, people have found a way to just put the blame back on fat people being lazy, unworthy, and undeserving again and the cycle continues. The movement goes on to celebrate bodies that are already highly celebrated and looked up to for inspiration today with or without the movement!! The movement has entirely forgotten its roots.

You don’t have to look hard to find some of the top google searches for body positivity show articles like that Forbes article above and other random little articles like these:

Ah but it is fat shaming, Jess!! Hypocritical articles everywhere!!! They really think they’re helping and doing something here but instead are creating more mental health issues and more fat people. Shaming just doesn’t work the way people think it should work.

Fat people matter. Our lives matter and we are valuable. THE END! We shouldn’t have to hide because society has been conditioned to believe we should not be seen or that we are gross. Or that we have some sick agenda to spread and make sure others are fat too. We have feelings, we have emotions, we have brains, we have talents - we are people and bleed just the same. I’m tired of seeing the mental health statistics that our community goes through and if I hear one more skinny person say they matter too, Imma lose it because you’re not actively listening to understand! You do not know the daily struggle!! Be an ally, learn, and put yourself in our shoes!! Empathy goes a long ass way in spreading acceptance.

#fat acceptance #body posititivity #i’m tired #hypocrites everywhere #be an ally #mental heath support #mental health awareness #depression

[princemick]

Micklore for dummies his racing history

here's part 2, random important micklore

so, Mick, well like his last name is important ig but also he is esteban ocons best friend so priorities anyway, when he was karting he drove under his second name 'junior' and his moms name 'Betsch' he mostly raced with Tony Kart. during the start of his single seater career and a bit during karting Mercedes sponsored him, did a few sponsor things with them too.

when he got to F4 he started using the Schumacher name and in 2015 he signed with van Amersfoort racing he didnt accomplish much with them but in 2016 he signed with Prema racing, an italian racing team closely connected to Ferrari and later in 2019 he signed with the Ferrari Drivers Academy.

with Prema he finished second twice in Italian F4 and ADAC F4. then in 2017 he got to F3, where he finished 12th in his first season and 1st in his second. so in 2019 he moved to F2 where he again finished 12th in his first season and 1st in his second.

in his second F2 season he was a test driver for both Haas and Alfa Romeo. later in 2021 after his F2 win he ended up signing with Haas in F1. in his first season he ended 19th in the championship not getting any points. in his second season he ended 16th with 12 points. during this period he was still an FDA driver and reserve driver for Ferrari.

in 2023 he is going to be the full time Mercedes reserve driver.

under the read more there are important names and races in Micks single seater career.

important names that go along with Micks racing career.

Callum Ilott, his F3 teammate and 2020 Championship rival. he was also part of the FDA.

Robert Shwartzman, his 2020 F2 teammate and also part of the FDA.

Sean Gelael, his 2019 F2 teammate.

Nikita Mazepin, his 2021 Haas teammate.

Kevin Magnussen, his 2022 Haas teammate.

Gary Gannon, his F1 race engineer.

do I have to mention Seb? anyway yeah Sebastian Vettel, one of his closest friends and mentor.

Antoine Okla, his F2 race engineer.

Paul Beauvie, part of Micks F2 team.

Rene Rosin, Prema racing's TP.

Important races and moments in Micks racing career:

Monza, 2020. his first race win in Formula 2.

Silverstone 2021, his first F1 points.

Austria 2021 sprint. mick defending his lil ass off.

in F3 he won 5 races in a row. race 22 til 26 of the 2018 season.

during the 2020 Monza feature race, he qualified P7 and got to P2 in the first corner.

there's probably more stuff and obviously more you can learn about Mick at all times but IMO these are the most important basic mick facts to know.

#f1 #mick schumacher #kyle.txt #micklore

[lifewithchronicpain]

Shortages of opioid pain medication in the U.S. appear to be worsening, with no apparent action from the FDA or DEA to ease the suffering of patients left in uncontrolled pain or going into withdrawal.

Last week the American Society of Health-System Pharmacists (ASHP) added another widely used painkiller to its drug shortage list: oxycodone/acetaminophen tablets, which are more widely known under the brand names Percocet and Endocet. The medication is typically prescribed for moderate to severe pain.

The ASHP reports that five drug makers are either running low or have exhausted their supply of oxycodone/acetaminophen in 2.5, 5, 7.5 and 10mg tablets. Amneal, Major and Rhodes did not provide ASHP with a reason for the shortage, while Camber and KVK-Tech said they were “awaiting DEA quota approval for active ingredient.” Amneal, Camber and KVK-Tech said the tablets were on back order with no estimated resupply date. Major and Rhodes said additional supplies were expected in mid-September or early August, respectively. Limited supplies and doses of oxycodone/acetaminophen tablets are still available from other drug manufacturers...

...At PNN, we hear from readers almost daily about opioid shortages. “I am now past my usual fill date,” said Rick Martin, a retired pharmacist in Las Vegas who lives with chronic back pain. “My CVS pharmacist manager told me that she was told by their wholesaler that hydrocodone won't be available until the middle of August.” Martin said pharmacists at Walgreens, Smith’s and Sav-on have also told him they were out of oxycodone and hydrocodone tablets. “It's been spotty for 6 months but now seems entrenched. I got switched to tramadol. Not as effective, but I can just barely get by. I've heard that's what doctors are doing. Tramadol or Tylenol with codeine,” he told PNN.

Steve Keating, another Las Vegas resident, has been taking oxycodone for chronic neck pain after his vehicle was rear-ended by another driver. He had no problems getting his prescription refilled at either Walgreens or CVS, until last month. Now he is out of pain medication. “I began having withdrawal symptoms. No one seems to care,” said Keating, who turns 73 this month. “The pharmacy recommendations were to obtain tramadol, which I've tried in the past and found ineffective. I cannot take opiates with acetaminophen as it upsets my stomach.

“It seems that there is a huge gap between prescribers, pharmacies and whatever governmental agencies are involved. Do these governmental idiots not realize how important the medication we've been prescribed for months or years is to give us some degree of a better quality of life?” (Read full article at link)

None of this, absolutely none of this, stops people from dying from illicit fentanyl. It just punishes people in pain.

#disability #chronic pain #ableism #opioids #chronic illness #medical bias #opioid shortages #pain patients #article

[izukunii]

JAM TOMORROW AND JAM YESTERDAY

featuring: sakusa kiyoomi x filipina!reader

contains: hamster wheel thoughts about children, there's two children (not yours) wandering a pharmacy so-- "bad parenting?", mentions of pregnancy, self insert!reader (tagalog pet names), fluff to “angst” if you squint

summary: sakusa never wanted kids until he wanted you

warnings: references a quote from alice and wonderland in this work: “the rule is jam tomorrow and jam yesterday, but never jam today.”

sakusa kiyoomi doesn't like things he can't control. he can't control other people, can't control what they do or what they touch. and even as loud as he could howl, he can't make someone leave or stay whichever way he wanted, at home or on the court.

and besides the obvious bacterial infestations, knowing he could never really control them was one of the reasons why he didn't want to have kids.

didn't.

until he found you, the mere idea of a child prancing around with jammy hands, sticky and dirty little fingers touching anything and everything, made him sick to his stomach.

but sakusa can only control what he can control.

he was on his way home from practice when he'd gotten your text.

i'm late.

sakusa sees a future flash before his eyes, a future full of jam hands. jam hands today, tomorrow, jam hands in his space. in his house. one little one running a-mock around the house with their jam hands and-

a car horn is the dramatic hook that yanks him off the stage of paranoia. before he goes at the green light, he presses his forehead against the steering wheel and jerks back into the headrest. he takes the necessary minute to ground himself, watching the car skirt around his. when he's centered, he pulls over. he takes his phone off the holder and reroutes his gps to the nearest pharmacy.

it just so happens to be a mom-and-pop shop, full of far too many candy displays to pass fda approval, and complete with who could only be the disinterested daughter of said mom-and-pop working the register, jam hands knuckle deep in a full case of candy popped open right on her checkout counter.

rather than entertain a conversation her, he lets his eyes scan the signage until he locks his gaze on ‘family planning.’

his head is still spinning. jam hands. jam hands. jam hands.

a warm laughter is the dramatic hook that yanks him off the stage of paranoia, and sakusa looks up from the box he’d been studying on his way to the registers, that was before he got lost in the jam, and there’s a kid a mere five inches away from his face, and hers is covered in jam.

sticky strawberry jam, smeared across tubby, rosy cheeks as she reaches sweet, pudgy hands up to reach for a candy tucked into a tree-like display beside them.

and sakusa can’t breathe, but not because of the jam hands.

the girl has thick, dark, curly hair. just like him. and her eyes are the same as yours, bright and warm like shining suns glowing over the oceans of all your emotions tucked away in a clever gleam.

she can't be more than eight years old but she's almost up to his hip. he remembers that stage, tall enough to brag about it but not tall enough to count for anything. still she's lithe, floating across the tiles to try and reach her favor-- a blue sucker that's all the way at the top of the display.

why is blue your favorite? he'd once asked you after you'd plucked yourself a similar prize from a similar place.

blue raspberry is the best flavor of anything, omi-ko. it just is. was your perfect response.

around the corner comes another little one, a boy, with hair a mess across his face that reminds him of your tornado of tresses every morning. his laugh is boisterous and contagious, not unlike yours.

he's taller than who sakusa assumes to be his sister. plucking a red sucker from the display comes with ease, and there's that joyful melody once more.

cherry's always my go to. that had been his follow up. it's the same every time.

after all, cherry was and always would be cherry. that was something he could control. he could control his choice, bet safe. and there was never a cherry flavor sakusa disagreed with.

he attempts to soften the sigh he lets out, but the children hear him as if the breath was a hailstorm. four eyes blink up at him. even as he grabs the blue sucker from the tree, he watches the smudge of jam contort as the little girl phases through expressions from fear to surprise. the change is more beautiful than he thought. he passes it down to her wordlessly and sets the pregnancy test on the counter.

he readjusts his mask as he hands the cashier his card and soon his attention settles back on the girl. sakusa doesn't hesitate to open the wrapper when she lifts it his way, and he crouches to give it back to her.

now eye level with the dreaded jam schmear, he does a much better job concealing his sigh when he asks her, "if there were such a thing as. . . blue raspberry jam, would you pick it?"

"do you. . have bwlue jam?" that is her follow up.

he tells her he's sorry that he doesn't. that he hopes not one, not two, but four free blue raspberry suckers plucked from the tree will make up for it. and he rightfully earn's jam's forgiveness.

sakusa kiyoomi can only control what he can control, and because he couldn't control himself, here he drives the semi-familiar route home to your shared apartment from the mom-and-pop pharmacy.

so sakusa sets out to control what he can control. he carries the test box hand over hand with you. you sit up on the bathroom counter, a good six feet away from the test, with your eyes squeezed tightly shut. he sits on the ledge of the tub and softly traces his fingers down your legs to soothe their restlessness.

sakusa sees a future flash before his eyes, a future full of jam hands. jam hands today, tomorrow. and the hands, and the jam, they're not just on a girl or a boy in a pharmacy. they're hands from your hands, and from his. hands the two of you made.

and maybe he can't control jam hands but he could certainly teach them--

“you were worried about jam hands, weren’t you, kiyoomi?” you ask when you hop off the counter to retrieve the results you left on the toilet seat.

hearing his name is the dramatic hook that yanks him off the stage of paranoia. paranoia however, had now become a hopeful daydream: that maybe jam hands were okay, would be okay, if they were yours and his.

"jam yesterday, and jam tomorrow—” you start, reciting the quote almost perfectly in a shrill voice, using the comedy to try and hide the disappointment on your face, disappointment you didn’t anticipate feeling.

because the test is negative.

“today isn't a jam day, omi-ko."

sakusa kiyoomi can only control what he can control. he’s always hated that about himself.

he rises from the tub and bounds over to you in two steps. the test falls right into the bin as he reaches for your hands.

he kisses you. you taste like blue raspberry.

“jam tomorrow, then?”

#my work #my writing #self insert #sakusa x reader #sakusa kiyoomi #haikyuu #filipina!reader

[ivygorgon]

Sharing Women's March open letters and petitions. Please sign and share!

14 states have already banned abortion, and more restrictions are on the way. Here are a few of the latest GOP proposals:

⚫ A 12-week abortion ban in Nebraska

⚫ A 6-week ban (because GOP attempts at a full ban failed three times) in South Carolina

⚫ A bill that charges abortion patients with MURDER in Alabama

We HAVE to fight back.

Our state-level mobilizations *are working.* We helped elect a pro-choice state Supreme Court justice in WI and brought national attention to the abortion pill case that started in TX. But we CANNOT stop now.

TY! -Women's March

SIGN ON: TELL THE COURTS TO STAY OUT OF FDA APPROVAL OF ABORTION MEDICATION Medication abortion is safe and effective, and it should be readily available everywhere. Add your name right now to DEMAND the courts stay out of FDA approvals >>>

SIGN ON: TELL THE JUDICIAL SYSTEM TO STAY OUT OF FOOD & DRUG ADMINISTRATION APPROVALS! A Trump-appointed judge may strike down the FDA’s approval of a critical abortion medication later this month. The ruling would set a dangerous precedent that radical right-wingers can challenge the approval of ANY medication they don’t approve of — like the birth control pill or emergency contraception (aka Plan B). We need you to take action to tell the courts to stay OUT of FDA approvals!

ATTN: SOUTH CAROLINA LEGISLATIVE REPUBLICANS Check out our letter to the South Carolina GOP below, then sign it as is or add your own spin:

Make your voice heard

As you well know, abortion bans will not end abortion. Instead, you propose penalties so extreme – so draconian – that they will terrify women into compliance. Your goal was never to “protect life.” It is to control our bodies. You should know: We won’t go back. We’ll fight back. I’m signing this letter to voice my ongoing commitment to opposing any rollback of our human right to reproductive freedom.

ATTN: RON DESANTIS, FLORIDA REPUBLICANS, & THE STATE BOARD OF EDUCATION Sign our open letter condemning the Don’t Say Gay law in Florida! Make your voice heard The cruel “Don’t Say Gay” law is harming Florida students, teachers, and families. Instead of expanding it, you should be repealing this attack on LGBTQ+ Floridians! Despite your fear and hate-mongering, LGBTQ+ people — including kids — always have existed and always will. We will keep fighting for them to be treated with the respect and dignity they deserve. We know that more of us are in solidarity with the LGBTQ+ community than agree with your regressive and cruel legislation. Women’s Marchers and our allies WON’T stop fighting for a world where all of us can be safe as our authentic selves. We WON’T let your hateful legislation stop us from supporting LGBTQ+ Floridians, and we condemn the “Don’t Say Gay” law.

ADD YOUR NAME TO OUR DEMANDS TO PROTECT REPRODUCTIVE HEALTH CARE ACCESS! We demand reform of our broken judicial system. We demand that state and local leaders defend access to mifepristone despite this illegitimate ruling. We demand the FDA issue guidance to disregard the decision. We demand the Biden administration implement a whole-of-government response to this public health crisis. We demand pharmacies execute their mandate faithfully and with the health of their patients rather than the personal ideologies of a few politicians in mind. Sign on to sponsor our demands >>>

REMOVE CLARENCE THOMAS FROM THE SUPREME COURT Congress must impeach Supreme Court Justice Clarence Thomas now! Justice Clarence Thomas has violated his oath and broken the law by failing to disclose decades of luxury vacations and private jet travel from billionaire and GOP megadonor Harlan Crow. Crow also paid the private school tuition for a Thomas family member. Sign our petition, stating loud and clear: No one is above the law, and Justice Thomas must be held accountable and removed from his position of power.

#womens healthcare #womens rights #womens march #feminists; asemble! #reproductive rights #reproductive health #fertility #abortion #FDA #medical abortion #abortion medication #south carolina #republicans #republican #gop #petitions #open letter #reproductive freedom #florida #ron desantis #dont say gay #LGBTQ+ #clarence clemons #impeach #impeach clarence thomas #politics #us politics #intersectional feminism #intersectional social justice #intersectional activism

[nwbeerguide]

Stone Brewing Company adds Stone Delicious Hazy IPA to their already popular lineup.

Press Release

ESCONDIDO, CA (January 31, 2024) – Stone Brewing, among the world’s most renowned IPA breweries, introduces a new addition to its popular lineup of Delicious IPAs. Stone Delicious Hazy IPA is now available on draft and in cans year-round and nationwide. Thanks to this fourth Stone Delicious variation, the brewery also announces the anticipated release of a Stone Delicious IPA Variety 12-Pack in addition to its innovative variety six-pack. 

The newly expanded Stone Delicious lineup includes: 

Stone Delicious Hazy IPA (7.2% ABV) Brewed with Sabro, El Dorado and Azacca hops, giving the beer intense creamsicle, peach and pineapple flavors with a beautiful slightly opaque appearance.

Stone Delicious IPA (7.7% ABV) The original Stone Delicious IPA packs a refreshing and hoppy lemon candy flavor making it especially complementary to an array of foods and a superior standalone IPA. 

Stone Delicious Double IPA (9.4% ABV!) A beer that stands out with a serious depth of flavor and explosive aroma of lemon and tropical fruit from Centennial and Amarillo hops. With less bitterness than a typical double IPA, this one is extra fruity, extra gratifying and extra Delicious. 

Stone Delicious Citrus IPA (7.7% ABV) Brewed with Talus hops that impart vibrant citrus notes complemented by the addition of sweet orange peel. The result is especially bright and satisfyingly juicy.   

Stone Delicious Hazy IPA – like all the beers in the Delicious series – also happens to be gluten reduced. In fact, each beer clocks in below the FDA requirement for “gluten free” labeling (less than 20 parts per million). A gluten-reduced Hazy IPA is hard to come by. Not only does this one exist, but it also packs an unparalleled flavor rendering that gluten conversation nearly irrelevant. The beer is juicy, creamy and full-bodied with notes of peach candy, orange, vanilla and sweet pineapple.

“The Brewing Team takes the challenge of calling a beer ‘Delicious,’ very seriously and all four of the beers need to live up to that name,” explained Jeremy Moynier, Senior Manager of Brewing & Innovation. “Stone Delicious Hazy IPA definitely lives up to the Delicious standard and is a great addition to the Delicious family of beers.”

Fans of Delicious things can find Stone Delicious Hazy IPA nationwide in stand-alone six-pack as well as in Stone Delicious Variety Six-Packs and Stone Delicious Variety 12-Packs. Find them nearby at Find.StoneBrewing.com or order online in select states at Shop.StoneBrewing.com. 

...

ABOUT STONE BREWING

Founded in 1996, Stone pioneered the West Coast Style IPA, helping to fuel the modern craft beer revolution and inspire generations of hop fanatics. Today Stone operates breweries in Escondido, CA and Richmond, VA plus seven tap room and bistro locations. Stone offers a wide range of craft beers including its most popular Stone IPA, Stone Delicious IPA and Stone Buenaveza Salt & Lime Lager. The company’s long list of environmental efforts includes a LEED Silver Certification, world-class water reclamation and creative uses of spent grain. Stone has been called the “All-time Top Brewery on Planet Earth” by BeerAdvocate magazine twice. To find Stone beers, visit find.stonebrewing.com. For more information on Stone Brewing visit stonebrewing.com, Facebook, Instagram or Twitter. 

#Stone Brewing Company #California #Escondido #San Diego #Beer #Press Release

[holyhappyhour]

Glossary of Characters & Terms

(some of these terms may be different than what was established in the early days of this blog/TL. I'm pretty much making this up as I go and sometimes I change my mind about thing I've come up with on the fly. list will update as I think of/establish more)

Important Characters:

Conrad Walsh: Le's hunting/work partner, and romantic partner as well. Connie's a sweetheart with a lot of energy and a sweet tooth. What he lacks in fighting ability, he more than makes up for in loyalty. more

Alice Walsh: Conrad's older sister, Alice is much more fearsome than her kind smile and effeminate appearance suggest. She's a powerful witch, specializing in both holy and necromantic spells that make her a nightmare for vampires and have earned her the nickname of Archangel. But it's been years since she's seen fieldwork after being promoted to an executive administrative position, issuing assignments, overseeing investigations, and acting as the face of the Missionaries' public relations.

Nico Martin: Le's best friend and mentor, Nico is a terrifying, sadistic force of nature hiding behind a polite smile and pastel sweater. They've chased the vampire who turned them across two continents, dedicating their life to revenge. However, after finding himself growing more cold and unforgiving towards his own kind, Nico agreed to step aside from fieldwork for a while. more

Marcel La Rouge: Perhaps one of the most wanted vampire lords of the modern era, Marcel is personally responsible for a population boom of freshly turned vampires in the 1960's, the effects of which the world continues to see as those vampires have gone on to turn their own exponentially. Though he no longer leads a religious cult, his following is as strong as ever as he continues preaching and and pushing for supernatural superiority over humankind.

Matthew [redacted]: Le's beloved older brother, Matt was a big dreamer with great humor, passion for movies and exploring. Unfortunately, after being lured and bitten by Marcel, Matty tried to hide his transformation from his family, driving him to Frenzy. more

Important Terms:

Missionaries: the official title given to those who work for the branch of the Catholic Church that handles all matters dealing with the Supernatural. all missionaries are designated by the simple, blocky cross necklace they're to wear both on and off duty, engraved with coded identification and acting as a badge.

Reapers: an unofficial title given to active, high-ranking Hunters within the Missionaries, designated by the black sash they're meant to wear at all times. Reapers hold a license to kill and may be given special assignment including bounty hunting and high profile investigations.

Full Moon Patrol: the three night period around each month's full moon, when all active field Missionaries, including Reapers, are required to patrol the city watching for and responding to werewolf and other supernatural activity that may endanger humans.

LifeBlood (LB): the only FDA-approved supplement for vampire nutrition and a surprisingly effective alternative to the real thing, available for free, only through approved distributors.

(Unholy) Communion: the Catholic Church's own little name for LifeBlood, its werewolf equivalent, and the ritual consumption of such.

Frenzy: an uncontrollable state of hunger, usually triggered by the smell or taste of blood during a state of starvation. Frenzied vampires may attack indiscriminately, feeding and feasting until completely and utterly satiated. during this state, latent magic abilities may be unlocked, allowing vampires to use special powers despite prior magic ability or training, even after returning to normal. entering and surviving one's first Frenzy is sometimes seen as a rite of passage for some. vampires who survive Frenzy often come out with permanent physical changes as well, the most common of which is one's eye color turning red, gold, or black.

Monstrosity: an advanced stage of Frenzy, usually caused by a Frenzied vampire continuing to feed well past satiation. after entering an unstoppable, animalistic rage, vampires in Monstrosity undergo rapid physical mutation, beyond anything recognizable as human, and develop powerful magic abilities, often beyond their own control. unlike the common Frenzy, Monstrosity is irreversible.

#ooc #headcanons #h. #I'm still working on asks I got when I was low and begging for them earlier #but I was not in a creative mindset yesterday sbqhzhshzh #I wanted to do this for a while but kept forgetting #so #wow this was supposed to be quick and easy but I've been working on it all day at work lol #lmk if I missed anything you might have questions about #also I haven't thought of a last name for Le and her family #since Nielson is an alias she took on entering the Church

[on-this-day-btvs]

November 30, 1999

Hero aired for ATS season 1, episode 9. This was the last appearance of Doyle, whose full name is Allen Francis Doyle. Doyle is an Irishman who receives prophetic visions. Doyle is played by Glenn Quinn. Doyle is in nine episodes of ATS, all in season 1. (Later appearances used archived footage.)

Glenn Quinn's full name is Glenn Martin Christopher Francis Quinn. Quinn was allowed to use his native Irish accent for Doyle and said: "I've been hiding it for so long that it's amazing to have some freedom. It was like putting on an old pair of shoes. It's bringing my soul back to life." Doyle advised Angel and after Cordelia joined them, the three formed Angel Investigations.

-----

PSA: Glenn Quinn died of an accidental heroin overdose in 2002. Opioids include heroin, fentanyl, OxyContin, and others. Narcan - generic name Naloxone - can be given to people in opioid overdose through injection or nasal spray. Narcan / Naloxone is FDA approved and available over-the-counter.

(image credit to buffyversefans) (Glenn Quinn quote via wikipedia) (narcan / naloxone - more information)

#ats #ep: 1x09 hero #doyle #allen francis doyle #glenn quinn #quote #month: november #date: 30 #year: 1999 #narcan #naloxone #i don't usually do a PSA like this but knowledge is power #if Narcan existed back in 2002 Glenn Quinn might still be alive #in my state they are selling it OTC in gas stations and grocery stores in addition to OTC at pharmacies #a nice quote is carrying narcan is like knowing how to do CPR #you can do trainings to learn how to administer both versions #come for the buffy trivia and stay for the drug PSA apparently #i promise this won't be a typical thing

[franki-lew-yo]

Pink sussss

As much as I want to enjoy the people like moistcr1tikal calling out Pink Sauce lady, I can't help but fear this sitch is gonna get commandeered by White supremacists chuds???

I don't know maaan. Something about the more popular youtube results isn't passing my smell test, is all...

Maybe I'm just paranoid, but, as much everyone should be calling out Pink Sauce (and supporting AlluredBeauty, who IS in the right), I just can't shake the feeling that this is gonna result in hating support of black creators, rather this lady who's EXPLOITING that notion to promote trash and gaslight people- is what I mean. I hope that makes sense?

One of the best take aways, and few I could find addressing this concerns, comes from a lawyer named Wine n' Chill. If you want to full run down of the situation and why it's bad and Pink Sauce lady should be sued and not cheered on a talkshow, trust her insight.

#discrimination #pink sauce #franki's features #yes I know RuinedLemon is a black creator himself #I'm talking about chuds using Pink Sauce lady's logic to justify their racism #tw: racism #discussion wanted