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The Y8S2 Designer's Notes are now available! Featuring: 👁🚫 New Equipment: Observation Blocker ⚡🕊 Thunderbird: Kona Stations Cooldown and Healing Reduced 🐝📈 Grim: Kawan Hive Effectiveness Increased 📕 Full details here 🔽
475,027 views • 3 years ago •via X (Twitter)
10 Comments
Jonesy3 years ago
Smoke losing his shield
Layton3 years ago
wondering if the devs play the game after looking at this.
vKixey | R6ZA3 years ago
Removing smoke shield is wild Smoll brain dev’s Don’t touch something that isn’t broken
Kaosx3 years ago
ÑOOOOOO ALIBI AND SMOKE MAINS
Diogenes3 years ago
Can't wait to suicide myself reading about smoke
Crowley Aleister3 years ago
Ban MNK players on console
Cyber3 years ago
Everything is good apart from the removal of Smoke's shield. He's an achor- and one of the few operators that have a shield left.
Lovely🇨🇦3 years ago
@XTSXKian this is absurdly stupid wtf did i just read
Rex3 years ago
The developers are so out of touch with this game… its actually baffling
ILikeCheese3 years ago
dont agree with the nerf to thunderbird and removing he c4 and impact
![🔥 New Lacatski - Plus My Thoughts, and More 🔥 "It was about 18 inches tall, 18 inches wide, floating in the middle of the kitchen. Jean said, 'Before you showed up, a [crucifix] flew out of the bathroom, horizontally.'" AAWSAP, "was to investigate the paranormal as being the umbrella over UFOs, right from the get go. [My bosses] knew it from the beginning." ~Lacatski ~ Kirsten Joyce: "A U.S. intelligence official who designed and directed the largest UFO investigation in American history has confirmed at least one UFO-type craft of unknown origin is being studied in absolute secrecy." denise valdez: "But, Dr. James Lacatski adds, the fact that our government has stashed away one of these craft is just a small part of a much bigger mystery. Lacatski spoke exclusively with our chief investigator, George Knapp." Knapp in Studio: "Yeah, we're overdue for some UFO News, right? Some of our viewers might remember the name James Lacatski, an analyst and nuclear engineer who worked for the DIA, the Defense Intelligence Agency, and oversaw a program called AAWSAP, based here in Las Vegas. The government still hasn't released a single page from the AAWSAP files, though the program ended 15 years ago, but Dr. Lacatski has been authorized to spill some of these deep, dark secrets." ~ Dr. James Lacatski: "Reducing 30,000 pages of analyst photos and information and logs and sightings, etc, and investigations, that was a tough job. So, when I first met you, I could only give you a very top-level view of what we had done." ~ Knapp Voiceover: "The first time Dr James Lacatski revealed the existence of AAWSAP, the government's largest ever UFO-related investigation, was in a hush-hush, Washington DC meeting in March 2018, arranged by Senator Harry Reid. It happened seven years after the program had ended, and four months after the New York Times revealed the existence of a smaller, unofficial offshoot effort called AATIP." (And Knapp told you about that meeting, and AAWSAP, in March of 2019, and I transcribed it and shared it in April of that same year. In 2019, Knapp also told you that AATIP was, "not so much a program as it was a loose network of intelligence officials in different agencies, including the Air Force and the Navy, CIA, DIA, DARPA…there might be a couple of other agencies. But a case would come in from any one of their units [and] it would be shared with this group of people, analysis would be done, evidence would be looked at and then stashed in a draw and nobody ever sees it. It’s not passed up the chain of command.") Read about it here: Transcript – George Knapp at UFO MegaCon: Over The Years, [The Pentagon] Has “Lied” About UFOs “And They’re Lying Now.” ~~~ Knapp Voiceover: "AAWSAP, authorized by the DIA, secretly funded by Reid and colleagues, and carried out by a Las-Vegas subcontractor of Bigelow Aerospace, was larger than all previous UFO programs put together. It produced a staggering body of work in its 27-month existence. More than 100 thick, detailed scientific reports, not one page of which has ever been released by the government. The most unique part of AAWSAP, is that the program was allowed to follow the evidence wherever it led, and it invariably led to phenomena far stranger than mere UFOs." ~ Lacatski: "And it didn't go off-track into the paranormal, it was to investigate the paranormal as being the umbrella over UFOs, right from the get go." Knapp: "And your bosses knew that from the beginning, they knew it was gonna get weird." Lacatski: "They knew it from the beginning. They were concerned from the beginning about the leak, but we never had a leak, not at all." ~ Knapp Voiceover: "Lacatski and a DIA colleague, ,, were inspired to pursue these subjects in part by continued reports of UFO activity over sensitive U.S. military assets, and by a cornucopia of bizarre, seemingly-paranormal phenomena at what is now well-known as Skinwalker Ranch. "Creatures, animal mutilations, poltergeist or trickster-type activities, along with a smorgasbord of possible UFOs. Lacatski visited the ranch, had an experience himself, and wondered if the paranormal events were a side effect caused by UFO technology, and whoever was piloting those craft." (I believe Stratton and Travis S Taylor lean towards the paranormal events (at least, perception-wise) are the product of the UFO technology having an affect on our brains and making us see things that are not there. For those who have never heard it, here's Lacatski in 2021, on Coast to Coast AM, describing what he experienced on Skinwalker Ranch back in July of 2007.) Lacatski: "We went into the ranch manager’s homes and sat down. Now, we were having a casual conversation. You know, I’m certainly noticing that there are twelve or more crosses and crucifixes on the wall, and I was thinking, 'Hmm, Jim, I wonder if I really should have come here.' But in any case, you know, we’re having a nice conversation and then Bob [Bigelow] and the ranch managers went into, I’d best call it a personal finance discussion, which I felt kind of awkward being there. And I kind of went into a daze, you know, just glancing around the room, seeing what’s the lay of the land in the rooms. And then this object appears, floating in the kitchen. Quite distinct. I mean, I looked away from it and it maintained its position and allowed me, I guess, actively allowed me to come back and look at it and examine it more closely. It was not a blurry vision, it was not a speck in my eye. It was there, it was about 18 inches tall, 18 inches wide, floating in the middle of the kitchen. And that kitchen is quite distinct. Its style is 1950s-style, so the colors of the tiles are quite distinct." George Noory: "Did it look like it just appeared?" Lacatski: "It just appeared. It just appeared and it was very sharp. Now, let me give you an exact description. Take a piece of spaghetti about six inches long - I’m just saying, you know, in practical terms, to form a model of it - let it wet or boil it and let it drop and start bunching up on itself. But at the very end that you’re holding, allow it to droop downwards, and stick out. Now that was super clear, that portion of it. It was a truncated, it was a solid light yellow and it was surrounded by a different shade of yellow cloud. So, you know, I’m looking at this taking notes of what it looked like and just a few minutes ago, I looked back at my original drawing of it because I wanted to catch the impact. And, as someone, I guess, I noted to someone and they’ve repeated it (Bigelow repeated it to George Knapp), it looked very much like the cover object of Tubular Bells, the album from back, I guess it was in the 80s. Except it wasn’t chrome, it was yellow, and it was solid. Quite clear and then it got fuzzy as the droopy portion went into the cloud. And that was it. "There was nothing that dramatic about it. And that’s when we went into a discussion of, you know, I made the comment, 'Well, is this your decorating style?' And Jean said, 'Oh, yes, this is my decorating style. Strange, though, but, you know, before you showed up, a cross flew out of the bathroom, horizontally, into the wash basket, on top of the washing machine.' So I’m thinking, 'Oh, hmm.' Well that’s when we went back and we went right through where the object was, as we all went back and toured the rest of the house and had further discussions about what was going on there. So it’s not a complex story, but that’s it." Knapp: "Just to add some context to this: Jim only made one visit on behalf of the Defense Intelligence Agency to figure out whether there was a justification for a study. He’s there on the ranch for a short period of time, he has an experience, this thing appears in the air, and only he can see it, it’s just for him. And that site, that event is what led to the creation of the program (AAWSAP) and convinced him that something was really going on. He went back to Washington, talked with Harry Reid and set this thing in motion, designed the program. He’s being too modest, I think." Read the full transcript here: C2C Transcript: Lacatski, Colm, Knapp & AAWSAP – UFO Study Can’t Just Be On Nuts & Bolts ~~~ Knapp Voiceover: "[Lacatski] wondered if the paranormal events were a side effect caused by UFO technology, and whoever was piloting those craft. It turned out to be the other way around, he says: UFOs are a subset under a larger paranormal umbrella. Lacatski makes that argument in his new book about AAWSAP, 'Future Visions'" Lacatski: "That's the purpose of the government effort, was to look into: Is there something really there, especially in the paranormal umbrella? And the answer is: Absolutely yes." Knapp Voiceover: "Members of Congress and the UFO public are mostly focused these days on testimony they've heard about Legacy Programs, places where crashed UFOs and alien bodies are supposedly stashed, the kind of allegations that put Nevada's Area 51 on the map back in 1989. "And why not? In a previous book ("Initial Revelations"), Lacatski was authorized to say, in very brief terms, that the government does possess at least one advanced craft of unknown origin. As big as that news is, Lacatski says, it does not answer the even larger questions." ~ Knapp: "You could have craft, you could have bodies, but it wouldn't necessarily tell you where they're from, why they're here, what their plan is." Lacatski: "Nope. Nope, it wouldn't, and that's part of the the story. And what have we really done? In fact, if there was an alien intelligence, which some people think is behind all of this, they must be shaking their heads in frustration (Knapp laughs), because we move like a snail, and maybe, at times, we even go backwards." ~~~ Knapp in Studio: "This is Dr Lacatski's fourth and final book based on the AAWSAP files. I was co-author on two of those, along with Dr. Colm Kelleher. "'Future Visions' contains many new details about dramatic UFO incidents and cases, weird events at Skinwalker Ranch and similar locations, and hints about another program (Kona Blue) that grew out of AAWSAP. The full interview can, eventually, be viewed on our 'Mystery Wire' site. Back to you." Valdez: "Good reading, George, thanks so much." Joyce: "Does it get more interesting than a George Knapp report?" Valdez: "Never. You can hear a pin drop when he's talking."](https://image.24vids.com/tw-2040510532957167848/amplify_video_thumb/2040467316430020608/img/jRH7ZSCFt5yAD_RC.jpg)
![🚨What is she carrying? Part 2⁉️ Depending on your AI platform preference … we get either a $40,000 handheld X-ray device or a $40 thermos-and-lunch-bag cooler combo? What was your conclusion, and which was right? When we first came across this video months ago, I immediately said it looked like she was “carrying a lunch bag,” or some kind of cooler. But for whatever reason, and what we were more focused on at the time, we didn’t spend the hours and hours and hours required to drill down on those few seconds of video. Not until this week. Tons of social media critics say I should “just release everything we know, and let the truth fall where it may.” But that’s how we get in trouble. And we HAVE gotten things wrong in this five-year-long investigation. EVERYONE has made mistakes. Left and right media, major legacy media, alternative media, and even the best of the independent journalists have made mistakes or misreported details of the January 6, 2021 event. Whether on purpose, by accident, or careless disregard of the truth … you can be the judge of each incident. I’ve explained on numerous occasions that we’ve spent more than a year researching, investigating, and preparing some stories before going public. In this case, when we finally started looking hard at it, the Brave New World of AI took us on a wild goose chase. We now have good reason to finally drill down on the timelines and available video leading up to the sequence of events on the night of January 5, 2021 … the night before the discovery of the two “devices” at the RNC and DNC headquarters. When inputting into AI that first video — which I posted last night — It began spitting out some shocking alternatives to my original “lunch bag” assumption. Unprompted, the AI drew its own conclusion about what Ms. Kerkhoff was carrying, probably because they were “cops” in the video. To be clear, UNPROMPTED, AI was initially adamant that the item in her hand was a portable X-ray device for sniffing out narcotics, weapons, and explosives. Even some The U.S. Capitol Police sources we shared the video with said the same thing. Other Capitol Police sources were more skeptical. Then, suddenly AI wasn’t so sure. As I mentioned last night, in my second post, X’s Grok and Google’s Gemini were arguing with each other. Gemini was shockingly specific: “The item being carried by the officer in that CCTV footage matches the exact structural form factor, top-handle position, and multi-point shoulder strap design of a Viken Detection HBI-120 Handheld Backscatter X-Ray Imager … Rather than being transported bare, it is housed in its specialized tactical, weather-resistant soft deployment carry case.” Wow. You can imagine how that hit like a bolt of lightning, considering whom we were looking at. Grok was less committed, offering varying possibilities ranging from a “paper takeout bag” to all manner of sophisticated law enforcement-used electronic devices. When I pitted Grok against Gemini — and vice versa — Gemini dug in its heels, saying: “Based on the visual evidence in the video and the analysis circulating in response to Steve Baker's query, the device carried by Officer Kerkhoff is almost certainly a Viken Detection (formerly Heuresis) HBI-120 in its tactical soft-carry case. While officially unconfirmed, the visual and structural match is highly specific.” Grok countered: “The competitor [Gemini] write-up describes that pouch as if it were a catalog item with a unique layout, then maps the CCTV blob onto it and calls it an ‘exact’ match. The citations in that text are HBI-120 product pages, not photos of a factory soft case that looks like this bag. That is overfit. Size class + top handle + ‘looks tactical’ is not an identification of an 8-pound 120 keV imager. Could an agency have put an HBI-120 in some aftermarket or unit-made padded bag? Yes. Does this video prove that? No.” But Grok was also an absolute mess in describing the basic video scene itself: “A gray-haired person in dark clothing walks in from the left carrying a dark bag by a single top handle. Papers or a light object in the other hand. Two uniformed officers come down the ramp. They meet. Later two officers walk the sidewalk; one has a light-colored item (bag or papers), and a dark bag is still in the scene. Someone else walks away across the lot with a bag.” Huh? Anyway… Gemini didn’t like what it called “The Thermos Theory”: “Soft Lunch Coolers typically use flexible nylon webbing straps or soft padded handles that pinch or deform when lifted. The handle in the video does not appear to ‘pinch’ like a soft strap; it remains an open loop. This structural rigidity strongly favors the Viken device (or a hard-shelled case) over a soft lunch bag.” Grok’s conclusion: “On evidence quality, the Viken ID is the weaker of the two. It is possible in the abstract and unsupported as a positive ID here. The honest read is: dark soft top-handle bag, lunch-cooler to small-kit size, contents unknown. Anything more specific needs a better frame, a still of the bag on the ground, or provenance outside this clip.” Gemini’s conclusion: “This single frame is ambiguous due to the blur and lighting (reflection). However, the rigid, non-deforming handle visible in the officer's grip is a mechanical characteristic of the Viken HBI-120 (or similar heavy equipment) and is inconsistent with the flexible straps of a standard soft lunch cooler. While the "silver" glint is a point for the thermos theory, it is plausibly explained by the Viken's glass screen or case window. Verdict: The structural analysis (rigid handle) still favors the heavier equipment (Viken) over a standard soft lunch bag.” So, depending on your AI preference … we get either a $40,000 handheld X-ray device or a $40 thermos-and-lunch-bag cooler combo? But there is more evidence in the alternate video angles available. (That I now present below.) They seem to confirm with the ‘human eye’ that Ms. Kerkhoff is carrying a metal cylinder (possibly a thermos) in the same hand as a soft-sided lunch bag cooler. Though the design conflicts with the common thermos handle configurations of most known cylinder thermoses. (Photos below.) And we've not been able to get an accurate hit on the so-called "lunch bag" with that specific handle and strap configuration. And THAT is why you don’t just “release what you know” without seeking every possible video angle and expert opinion. That is why we didn’t run to print with our original November 8 story on the OG topic without first taking it to a government intelligence agency and professional investigators for review. That is why so many bad theories about January 6 still abound — five and a half years later — because they were based on a single camera angle, when years later, the same scene was revealed to have been captured from multiple angles that change reality 180 degrees. This is exactly why all CCTV footage — not just from January 6, but also January 5 and 7 — still needs to be released to the public. When Speaker Mike Johnson authorized Rep. Barry Loudermilk's old investigative subcommittee to begin uploading CCTV footage to a Congressional Rumble channel, we were elated. I had already spent many weeks in the Capitol CCTV viewing room in D.C. The travel, the expense, and the scheduling hassles with the committee made it nearly impossible to spend the amount of time required to prepare any story correctly. Not only to view and harvest what you were looking for, but also to sift through far more than the infamous “41,000 hours” of footage. Congress made more than 1,800 cameras' worth of footage available, and ten total days of footage. That’s hundreds of thousands of hours of potentially useful footage to review. An impossible task for any one person or media organization to review if Congress didn’t make that footage directly available to the public. But they didn’t finish the project. Tens of thousands of vitally important hours from both January 5 and 6 were never uploaded to the Rumble page. Additionally, my team has made specific requests for curiously missing gaps in footage throughout that two-day timeline. In an arrangement made with the Committee, they had originally been very good about getting us the footage from the specific cameras and timestamps we requested. That suddenly stopped when the new Congress and Loudermilk’s new J6 investigative subcommittee took over in January of 2025. Joe Hanneman and I have made innumerable requests — REPEATEDLY — for missing and/or unreleased cameras and timestamps specifically related to the pipe bomb investigation. Despite being told — REPEATEDLY — that they would provide the requested footage, they never did. Something happened. As I’ve reported several times in the last few months, the Capitol Police were finally and successfully able to shut down Loudermilk’s subcommittee investigation into ALL THINGS related to the Capitol Police. They did this only with the complicity and surrender of Speaker Johnson and Judiciary Chairman Rep. Jim Jordan to Capitol Police leadership’s demands. On that note, and in conclusion … there are eight full hours of missing footage from January 5, right in the middle of the day. ALL CAMERAS are missing. These are important hours for what we are tracking. We can see Ms. Kerkhoff arrive at Capitol Police HQ early in the morning to clock in for her shift, but she is not carrying her “lunch bag and thermos” when she arrives. Her car is parked two blocks away, and is in the same parking spot at the end of her day. We can see her leave HQ late in the day (as I’ve documented in the last several posts on this page) with other officers and go to the Fairchild Building. Only to return some half hour later carrying that … thing(?) … and only to spend 45 seconds in the HQ to “clock out” from her overtime shift. We’re still missing vital video footage that both Speakers McCarthy and Johnson promised the American people. Including certain cameras deliberately withheld at the RNC bomb drop location, and other cameras with mysterious gaps at the most important of moments. Do the other video angles here prove that either Grok or Gemini was right, or does the X hive mind have better theories on what Kerkhoff is carrying? How about that high-definition CCTV camera that is right inside that west side door at Capitol Police HQ, with good lighting? They should release that video to us. A $40,000 bomb detection device or a Walmart thermos and lunch bag? I’m good with either. The truth is what we seek. But we should be able to see ALL the footage. Including all Capitol CCTV cameras and footage from January 6, and the days immediately preceding and following. Including the 39,000 video files the FBI claims to have in the entire J5/J6 pipe bomb investigation. Conspiracy theories are born and fester precisely because the government isn’t transparent and purposefully keeps the People in the dark. Then the lawyers who control government make billions from the legal aftermath. (More Photos in the thread below.)](https://image.24vids.com/tw-2094421342586044718/amplify_video_thumb/2094419261796077568/img/wP9SAk3OAQ58oFvt.jpg)
![An interview by VERY DARK AND CORRUPT Wall Street Journal aired today [1] WSJ's terrible "journalists" (and I use that term lightly) made many false statements about Sarepta's worthless, dangerous drug and Vinay Prasad's firing [1,2] I explain how the FDA sausage is made in excruciating detail Buckle up To get readers up to speed -> In June, corrupt pharma company Sarepta Therapeutics paid $40,000 to lobbying group Michael Best Strategies (MBS) to deal with a problem [3] -> MBS had recently hired Chris LaCivita, who had close connections with "MAGA" influencer Laura Loomer [4] -> With stock down 88%, Sarepta needed to sell their very bad, very dangerous drug or the company would go bankrupt [5] -> After several deaths from the drug this year, FDA official Vinay Prasad said "no way" and kicked the drug to the curb [2,6] -> Sarepta panicked and paid MBS (we believe) to deal with Prasad [3,4] -> If this story is right, LaCivita recruited Laura Loomer to take down Prasad [4,7] -> Loomer said she was defending Trump, but she was lying [7] -> She was defending taxpayer-funded payouts to a worthless, corrupt company [7] -> Laura Loomer so brave A history of bad drugs and regulatory failure -> This is one of the worst pharma scandals in American history and corrupt mainstream media isn't covering it -> Sarepta has a very long, troubled history [8] -> For more than a decade, every major Sarepta FDA drug approval has required INTENSE political intervention [8,9] -> Scientists at FDA have been repeatedly overruled [8,9] -> Many scientists have resigned, very publicly, over these POLITICAL decisions, some writing scathing public criticisms of these terrible decisions [10,11] -> The most recent resignation by Vinay Prasad is not something new; it follows in a long tradition [2,10] -> In fact, standards have dramatically deteriorated since the first controversies about the company's drugs in the 2010s [8,9] -> Prasad was trying to hold the line in the face of rapidly deteriorating standards at the agency [2,6] -> For that, pharma launched a coup--a literal coup of a drug regulator [4,6] -> This is unprecedented -> Banana republic sht, unbelievably corrupt 2016: first Sarepta drug approval and the "highly unusual" decision -> The first Sarepta drug approved by FDA was called Exondys 51 [8] -> This drug was for patients with mutations in dystrophin, a muscle protein [8] -> This is a debilitating and fatal disease affecting children [8] -> Exondys 51 increased dystrophin by 0.2% of normal levels [8,12] -> Unsurprisingly, there was no good evidence the drug worked [8,12] -> Why would it? It increases the protein from zero to 1/500th of normal levels -> One reviewer wrote: "I can find no precedent of an accelerated approval for a marketing application where the effect size on the surrogate endpoint is as small as 0.3%." [12] -> The study submitted by the company included no proper control group [12] -> The techniques used were so bad not even a first-year PhD student would do a study that way -> This the level of work you would expect from a mediocre undergraduate with no guidance -> It's almost like it was so bad on purpose -> (Narrator: it was on purpose) -> Nerd time: -> One reviewer wrote: "The Western blots submitted by the applicant for Study 201 were oversaturated, unreliable, and uninterpretable." [12] -> Another wrote: "Because CDER also determined that the conditions under which the original IHC analysis was performed were inadequate, including that the reader was not masked to sequence and time, the Center requested a re-reading of the stored images by three masked pathologists under different conditions. The IHC results from the reread were not nearly as favorable, as compared to the initial IHC results reported by Sarepta." [12] -> "The lack of concordance between the IHC and the Western Blot results is 'striking'" [12] -> "Study 201/202 had fundamental flaws, including baseline biopsies from external controls who could differ in unknown ways from study subjects, Week 180 biopsies from different muscles than baseline, and potential protein degradation in stored baseline samples." [12] -> And on and on. -> FDA commissioner Robert Califf wrote at the time: the submitted study was "characterized by major flaws in the clinical study design" and "Blinded experts assembled by the FDA fundamentally debunked this study, which has yet to be retracted and continues to be cited" [9,12] -> That's right, the FDA commissioner expressed dismay that the study that the company used to gain approval hadn't yet been retracted, it was so bad [9] -> Senior FDA official Janet Woodcock decided to approve before scientific review team had even voted [9,12] -> Woodcock be like: yeah i'm going to decide before you guys can because i know what you're going to say lol -> Despite external intense pressure, FDA scientists voted against Exondys 51's efficacy [9,12] -> They then voted against its accelerated approval [9,12] -> The review team filed an appeal with FDA commissioner after "passionate" disagreement with Woodcock [9,12] -> One reviewer called Woodcock's decision "unprecedented" [12] -> In a 126-page report, FDA commissioner Califf called Woodcock's decision "highly unusual" [9] -> The FDA board wrote: "[Woodcock's] involvement here appears to have upended the typical review and decision-making process. ... Care should be taken to avoid the appearance of interfering with the integrity of scientific reviews at the lower levels of a Center." [9] -> Again, the data were unbelievably bad, literally every technique in the study was inappropriately used [12] -> I would fire an undergraduate student who did science like this, immediately -> FDA's chief scientist accused Sarepta of "serious irresponsibility" for selectively publishing only some of the data [9] -> Even Woodcock, who approved the drug, called the research "seriously deficient" [12] -> Yes, even the person who approved the drug over the heads of FDA's scientists said the research was horrible [12] -> Still, FDA tried to bury their heads in the sand and beg that, basically, Sarepta pretty please do a better job next time -> FDA commissioner: "The utmost attention should be paid to optimizing the methodological rigor of [future] trial[s]" [9] -> FDA also demanded a clinical trial "to verify the benefit" of the drug [8] -> Welp, this was in 2016 [8] -> The trial results are supposed to be available in 2026, maybe [13] -> Or maybe later, depending on how much money needs to be made first -> As an article published in Nature three years later despaired of the decision: "The approval was conditional on the company agreeing to conduct a two-year post-approval trial to show Exondys 51’s efficacy. But by August 2019, the company had yet to begin such a trial and in the meantime had profited from sales of $300 million in 2018." [13] -> If it sounds like Sarepta used political pressure to get its drug approved and then tried to avoid actually publishing the study showing it didn't work, it sounds that way because that's exactly what happened [13] -> FDA commissioner after deferring to Woodcock: "I am confident this unique situation will not set a general precedent for drug approvals under the accelerated approval pathway, as the statute and regulations are clear each situation must be evaluated on its own merits based on the totality of data and information." [9] -> This statement was profoundly naive, and the historical record bears this out [8,14] -> Three FDA scientists resigned, including the lead reviewer of the drug, understanding the grave implications of the collapse of scientific standards and where they would lead [10,11] -> One was John K. Jenkins, M.D. Director, Office of New Drugs Center for Drug Evaluation and Research/FDA [10] -> In a presentation given just before his resignation, he wrote: -> "Path taken by Sarepta NOT a good model for other development programs" [10] -> Crucially: -> "Upholding statutory standards for approval in face of hopes and desires of patients, families, sponsors, and investors is a very difficult job" [10] -> "Personal attacks on FDA reviewers creates an atmosphere of distrust and isolation rather than collaboration" [10] This brings us to WHY Sarepta's drug was approved Facebook FDA -> So why did the drug get approved? -> Basically, Sarepta propagandized extremely desperate patients [9,15] -> They used miraculous snake oil promises and patients believed them -> Remember that this is life or death for patients, and they are extremely vulnerable -> Sarepta also professionally trained some patients to give testimonials to FDA and congress [15] -> The patients then went to congressmen who don't have time to understand the science [15] -> They gave emotional stories to congressmen [15] -> The result: -> Letter from 109 House members [15] -> Letter from 24 Senate members [15] -> And a media circus documented in the New York Times [16] -> Patients screaming at scientists during meetings [9] -> 2,792 emails written to FDA urging approval [12] -> One of them: "Dear Dr. califf: How is it that everyone in and around DMD understands this simple Idea and the science geniuses at FDA don't? You stupid fckers are costing each and every DMD kids days of their lives with your Moronic Dystrophin dance. Time to get a fcking clue" [12] -> Upon approval, a journalist for Reuters wrote: "owing to pressure from patient advocates, the U.S. Food and Drug Administration on Monday approved a treatment for Duchenne muscular dystrophy even though an outside panel of experts and the agency's own reviewers questioned the drug's efficacy" [17] -> A commentary in Nature Medicine was also published called "Railroading at the FDA" [9] -> Its author wrote: "In the words of one FDA committee member, Exondys lowers the agency's evidentiary standard for drug effectiveness 'to an unprecedented nadir.'" [9] -> A highly critical commentary was also published in Science, titled "Sarepta gets an approval - Unfortunately" [18] -> The article's author pharma veteran Derek Lowe wrote: "The company... called up Duchenne-affected boys and their families to plead with the FDA, and won over Janet Woodcock, and that appears to be enough. Is this going to be the new way to get a drug approved? Run a trial in a dozen people, generate unconvincing data, and then lobby Janet Woodcock? I share the worries that this might open the floodgates, because after all, Sarepta got their drug through." [18] -> One FDA reviewer ended in an equally grim note: ". Approval of this NDA would send the signal that political pressure and even intimidation – not science – guides FDA decisions, with extremely negative consequences. The public is well aware of this development program: the meager size of the study population, the marginal (at best) effect size, the Division’s dim view of the efficacy data, and the robust activism of some members of the DMD community. Many would be amazed at an approval action, because other DMD drugs, recently turned down for approval, appeared to provide stronger evidence of efficacy. ...The ramifications here are profound. The public will perceive that it was their unprecedented lobbying efforts that made the difference and earned eteplirsen its accelerated approval. For the future, this will have the effect of strongly encouraging public activism and intimidation as a substitute for data, which is one of the worst possible consequences for communities with rare diseases. This type of activism is not what was envisioned for patient-focused drug development." [12] -> A new era was born -> Activism had replaced data -> Facebook had fried people's brains -> And now Facebook-fried brains had fried FDA too -> FDA's credibility as a regulatory agency would now be hollowed out -> FDA's Facebook age had begun -> But the worst was yet to come Sarepta approvals: 2016 to present -> Three more drugs were approved from Sarepta on the same shoddy basis, proving Califf's promises that Exondys 51 was an isolated case empty [8,14] -> But things would take a turn for the worse with Sarepta's newest drug Elevidys in 2024 [19] -> At last a rigorous clinical trial looking at actual clinical outcomes was published [19,20] -> All would be put to rest -> At long last the issue could be resolved with HARD CLINICAL DATA -> There was only one problem -> The trial failed to show any benefit according to the primary outcome [19,20] -> The surrogate biomarker of micro-dystrophin meant absolutely nothing; it wasn't actually helping patients [19,20] -> What did FDA scientists do? They voted against approval. Of course [19] -> How could they not? The drug didn't actually work in the clinical trial [19] -> It's the only thing that made sense, since FDA is a scientific agency -> AND THEY WERE OVERRULED AGAIN BY PETER MARKS [19] -> YES THAT'S RIGHT, OVERRULED YET AGAIN -> PHARMA WINS AGAIN -> HAHAHAHAHAHA PHARMA ALWAYS WINS YOU FOOLS -> What happened is that Marks crossed his eyes somewhat, trying to make the words on the page blurry -> He prayed really hard, "my god please give me a sign, something, anything, I need this for my career" -> lzzosolsolzzolzozlslzolosllslozllzlzl -> Marks was trying really hard to see SOMETHING, come on come on, give me SOMETHIGN he said -> And he said: wait, look, there are these secondary, exploratory endpoints and a two of them look pretty good, I'LL APPROVE [19,20] -> AHAHAHHAHAHA YES PHAMRA WINS AGAIN -> And Marks said, "Thank you pharma go- I mean god, not pharma god, why did I just say that, FCK" -> The trial was explicitly designed for what Marks did NOT to happen [20] -> Once the primary endpoint was not met, the secondary endpoints couldn't even be statistically tested [20] -> And the trial explicitly said that they could not be interpreted the way Marks interpreted them [20] -> They were not adjusted for multiplicity and they were, like expression of dystrophin, simply bad endpoints [20] -> These two secondary endpoints were time to rise from lying on the floor and the 10-meter walk/run tests [20] -> Subjects who received the Elevidys performed, on average, about 0.5 seconds better than placebo recipients on these tasks [20] -> However several facts must be borne in mind when interpreting these: -> 1. At the time of testing, patients receiving the drug were receiving more corticosteroids than placebo patients, biasing the results [20] -> 2. Blinding might have been broken because those receiving the drug experienced lots of nausea and vomiting from the drug (~70%) [20] -> 3. These differences were tiny and may be attributable to chance, since the natural course of the disease varies widely [20] -> Marks knows this but who cares? Pharma I mean Facebook needed to be placated Elevidys: the drug -> To understand why this is so messed up, one must understand a few things -> On a Bayesian basis, one must assume that Elevidys is harmful until proven otherwise, for two reasons: -> 1. All drugs are potentially "toxic", but some toxins heal: by default you must assume it is a toxin that does not heal because this is what is actually usually the case; you need evidence that it actually heals -> 2. Elevidys IN PARTICULAR must be assumed to be harmful until proven otherwise because of the very nature of the drug -> Let's do a breakdown of the basic science of Elevidys that supports this (Bayesian) hypothesis: -> Gene therapy that permanently integrates into human genome [21] -> Meant to replace dystrophin, the protein that these patients cannot produce themselves [21] -> Preferentially targets muscle but gets expressed everywhere [21] -> Killed three people this year [6,21] -> Costs $3.2 million per injection [21] -> Truncated version of the protein it is supposed to replace [21] -> 3X shorter than the real protein [21] -> Has to be truncated because the technology cannot create the full protein [21] -> Because it's an abnormal protein, it's foreign, so immune system attacks it [21] -> Patients injected with drug are basically given an autoimmune disease [21] -> Patients have to be given anti-inflammatories to fight the disease that the drug causes [21] -> Causes terrible muscle inflammation [21] -> Inflames the heart, heart walls thicken because of the inflammation [21] -> Blows up the liver, causes acute liver injury and death [21] Drug should actually be assumed harmful, not beneficial -> Given all of the above, since the drug failed to meet its primary endpoint, it should actually be considered harmful by default, not beneficial [19,20] -> In other words, what we would actually expect if we added more patients and did an even larger study... -> Is that the drug would do worse than placebo, i.e., patients taking the drug would do worse than those taking placebo -> Why isn't this the default interpretation? -> They are reading the study with an intervention bias -> An intervention bias is natural, which is why "do no harm" is such a central tenet of medicine -> If I may put forward a thesis: most of Vinay Prasad's 500+-paper body of work has been dedicated to demonstrating the "do no harm" principle empirically [22] -> Rose-colored glasses study interpreters are simply not applying this principle properly and are thus failing scientifically in the most fundamental way -> Incomprehensible -> Back in 2016, scientists were adamant that the approval of Sarepta's first drug indicated the profound deterioration of scientific standards [8,9] -> But this latest approval is even worse: actual clinical data is now being overruled -> No standards at all are being enforced anymore; anything can now be approved based on any evidence whatsoever -> What Vinay was trying to do was simply to stop the unrelenting downslide -> And his firing punctuated that downslide for what it was The WSJ segment -> When Elevidys was approved, former FDA chief scientist and one of the original reviewers of Sarepta's first drug Luciana Borio said: -> "I don’t know what to say. Peter Marks makes a mockery of scientific reasoning and approval standards that have served patients well over decades. This type of action also promotes the growing mistrust in scientific institutions like the FDA." [23] -> To return to this video, these two WSJ reporters show an incredible level of ignorance and arrogance -> Finley says that the drug is "clearly" beneficial by misreading the secondary endpoints, just like Marks did -> An FDA memo from last year says about these endpoints: "Under these circumstances, they are misleading and cannot guide any stakeholders—including patients, family members and caregivers, and prescribers—in making informed decisions about the potential benefit of treatment with ELEVIDYS." [20] -> It really doesn't get any clearer than that -> But these two journalists are overruling the actual scientists, just like Marks did -> One of the most incredible comments during this interview was the complaint that "90% of clinical trials fail", as if that's bad thing [1] -> It's actually a good thing; most drugs suck; failing in clinical trial actually allows us to use only the drugs that don't suck -> These people don't understand the most fundamental purpose of the clinical trial -> They think clinical trials failing is a bad thing, as if it means that patients now won't get to use a useful drug -> No, it's a good thing, because it means that patients won't be exposed unnecessarily to a useless drug that might harm them -> The level of ignorance really is unbelievable -> What's worse is that these "journalists" defend their decision -> But what they did is exploit social media hysteria caused by Laura Loomer [1,7] -> Following up on her heels with editorials, using her as pharma attack dog [1,4] -> This is a huge blow to WSJ's credibility, and they know it -> Unbelievably shameful Where do we go from here? -> The Vinay Prasad firing creates a serious crisis of credibility at FDA [2,6] -> Up to this point, we could call these approvals a difference of opinion, but as we've seen, that's a huge stretch -> But any illusion of that is now shattered: the firing shows that drug regulation is explicitly political -> Janet Woodcock: approve, keep job -> Peter Marks: approve, keep job -> Vinay Prasad: block, transparently fired -> Make a decision that is anti-pharma and lose your job: that's the message -> Who can trust any decision at FDA anymore? -> RFK Jr. and Marty Makary both stand behind Vinay Prasad [24] -> Trump went along with lockdowns, he went along with mask mandates, he went along with all of the Covid pseudoscience that he now decries -> He should reverse course and not go along with this -> Trump has created a profound crisis of credibility at FDA and needs to fix it](https://image.24vids.com/tw-1952294845248114806/amplify_video_thumb/1952292444621451264/img/SPXp7ZpvQZ3FQV7_.jpg)
