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๐๐ก๐ ๐ก๐ฎ๐ง๐ญ ๐๐จ๐ซ ๐๐ง๐๐ข๐'๐ฌ ๐๐ฎ๐ญ๐ฎ๐ซ๐ ๐๐ฅ๐ฒ๐ฆ๐ฉ๐ข๐๐ง๐ฌ ๐๐๐ ๐ข๐ง๐ฌ. ๐โโก๏ธ ๐ Talent to be identified nationwide ๐ฆ Aged between 5โ15 ๐๏ธ To be trained for excellence ๐ฅEyes firmly on the podium ๐๐ง๐๐ข๐ ๐ข๐ฌ ๐ฉ๐ซ๐๐ฉ๐๐ซ๐ข๐ง๐ ๐ญ๐จ๐๐๐ฒ ๐๐จ๐ซ ๐ญ๐ก๐ ๐๐ก๐๐ฆ๐ฉ๐ข๐จ๐ง๐ฌ ๐จ๐ ๐ญ๐จ๐ฆ๐จ๐ซ๐ซ๐จ๐ฐ. #IndiaIndependenceDay
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![๐๐๐ '๐๐๐๐๐๐๐' ๐๐๐๐๐ ๐๐๐๐๐๐๐๐๐ ๐๐๐๐๐๐๐. A new working paper out of UCLA by political psychologist Samuel Pratt has just measured something American conservatives have been claiming for ten years and pretending was anecdotal. It is not anecdotal. It is now data. Pratt and his team built what they call the ๐๐จ๐ซ๐๐ฌ ๐๐๐ง ๐๐๐ซ๐ฆ ๐๐๐๐ฅ๐ โ a survey instrument asking respondents how strongly they agree with statements like "๐ ๐ค๐ฐ๐ถ๐ญ๐ฅ ๐ฃ๐ฆ ๐ญ๐ฆ๐ง๐ต ๐ฆ๐ฎ๐ฐ๐ต๐ช๐ฐ๐ฏ๐ข๐ญ๐ญ๐บ ๐ด๐ค๐ข๐ณ๐ณ๐ฆ๐ฅ ๐ฃ๐บ ๐ด๐ฐ๐ฎ๐ฆ๐ต๐ฉ๐ช๐ฏ๐จ ๐ ๐ณ๐ฆ๐ข๐ฅ." Three findings. ๐๐ง๐: the belief is stable over time. People who say it this week say it next week. ๐๐ฐ๐จ: the demographic profile of high-scorers is precise. They are ๐ฒ๐จ๐ฎ๐ง๐ , ๐๐๐ฆ๐๐ฅ๐, ๐ง๐จ๐ง-๐ฐ๐ก๐ข๐ญ๐, ๐๐ง๐ ๐ฉ๐จ๐ฅ๐ข๐ญ๐ข๐๐๐ฅ๐ฅ๐ฒ ๐ฅ๐ข๐๐๐ซ๐๐ฅ. They self-rate as higher in intellectual humility, empathy, moral grandstanding, and โ the key variable โ ๐ญ๐ก๐ ๐๐๐ฅ๐ข๐๐ ๐ข๐ง ๐ญ๐ก๐ ๐ข๐ฆ๐ฉ๐จ๐ซ๐ญ๐๐ง๐๐ ๐จ๐ ๐ฌ๐ข๐ฅ๐๐ง๐๐ข๐ง๐ ๐จ๐ญ๐ก๐๐ซ๐ฌ. ๐๐ก๐ซ๐๐: they report lower emotional stability, higher anxiety, higher depression, and a stronger tendency to see themselves as ๐ฏ๐ข๐๐ญ๐ข๐ฆ๐ฌ in everyday conflicts. In one sentence, the psychometric profile of the modern American "empathy advocate" is: ๐๐ง๐ฑ๐ข๐จ๐ฎ๐ฌ, ๐๐๐ฉ๐ซ๐๐ฌ๐ฌ๐๐, ๐ฏ๐ข๐๐ญ๐ข๐ฆ-๐๐จ๐๐๐, ๐๐ง๐ ๐ฉ๐ซ๐จ-๐๐๐ง๐ฌ๐จ๐ซ๐ฌ๐ก๐ข๐ฉ. ๐๐จ๐ฐ ๐ญ๐ก๐ข๐ฌ ๐ฌ๐ก๐จ๐ฐ๐ฌ ๐ฎ๐ฉ ๐ข๐ง ๐ฉ๐จ๐ฅ๐ข๐๐ฒ Watch California Congresswoman Katie Porter at last week's gubernatorial debate, in real time, demonstrating how the empathy mechanism produces atrocious policy. "๐๐ง ๐บ๐ฐ๐ถ ๐ธ๐ฆ๐ณ๐ฆ ๐ช๐ฏ ๐ฎ๐บ ๐ค๐ญ๐ข๐ด๐ด [...] ๐บ๐ฐ๐ถ ๐ธ๐ฐ๐ถ๐ญ๐ฅ ๐ญ๐ฆ๐ข๐ณ๐ฏ ๐ต๐ฉ๐ข๐ต ๐ต๐ฉ๐ฆ ๐ฎ๐ข๐ซ๐ฐ๐ณ๐ช๐ต๐บ ๐ฐ๐ง ๐ฉ๐ฐ๐ฎ๐ฆ๐ญ๐ฆ๐ด๐ด ๐ฑ๐ฆ๐ฐ๐ฑ๐ญ๐ฆ ๐ช๐ฏ ๐๐ข๐ญ๐ช๐ง๐ฐ๐ณ๐ฏ๐ช๐ข ๐ข๐ณ๐ฆ ๐ข๐ค๐ต๐ถ๐ข๐ญ๐ญ๐บ ๐ธ๐ฐ๐ณ๐ฌ๐ช๐ฏ๐จ." Empathetic. Reassuring. Compassionate. Also flatly false. Per CBS News' 2020 Los Angeles survey, only ๐๐% of homeless individuals had done any work in the calendar quarter they became homeless. A 2017 San Francisco survey found ๐๐% working part-time or full-time. The reason is no mystery โ a substantial majority of street-homeless Americans are managing untreated severe mental illness, active substance abuse, or both. The "empathetic" policy that emerges from Porter's framing is to leave them on the street. The actually humane policy involves involuntary commitment, mandated treatment, and structured housing โ every one of which the empathy-coded liberal reflexively rejects as cruel. Pratt's data and the on-the-ground reality converge on the same uncomfortable conclusion: ๐ญ๐ก๐ ๐ฆ๐จ๐ฌ๐ญ ๐๐ฆ๐ฉ๐๐ญ๐ก๐๐ญ๐ข๐ ๐๐ฆ๐๐ซ๐ข๐๐๐ง๐ฌ ๐ฌ๐ฎ๐ฉ๐ฉ๐จ๐ซ๐ญ ๐ญ๐ก๐ ๐ฅ๐๐๐ฌ๐ญ ๐ญ๐จ๐ฅ๐๐ซ๐๐ง๐ญ, ๐ฆ๐จ๐ฌ๐ญ ๐๐๐ฌ๐ญ๐ซ๐ฎ๐๐ญ๐ข๐ฏ๐ ๐ฉ๐จ๐ฅ๐ข๐๐ข๐๐ฌ, because empathy at scale stops asking ๐ธ๐ฉ๐ข๐ต ๐ธ๐ฐ๐ณ๐ฌ๐ด and starts asking ๐ธ๐ฉ๐ฐ ๐ค๐ข๐ฏ ๐ฃ๐ฆ ๐ฃ๐ญ๐ข๐ฎ๐ฆ๐ฅ. ๐๐ก๐ ๐๐๐ง๐จ๐ซ๐ฆ๐๐ฅ๐ข๐ณ๐๐ญ๐ข๐จ๐ง ๐๐๐๐ก๐๐ง๐ข๐ฌ๐ฆ How does a fringe view โ communist Twitch streamers, candidates openly excusing full-scale mโrder, congressmen calling themselves democratic socialists โ capture an entire major American political party? Nassim Taleb has the cleanest explanation. He calls it ๐ซ๐๐ง๐จ๐ซ๐ฆ๐๐ฅ๐ข๐ณ๐๐ญ๐ข๐จ๐ง. A family of four. One daughter โ ๐๐% of the household โ only eats organic. Mom faces a nightly choice: cook two meals or cook one all-organic meal. The all-organic meal is easier. The household renormalizes to the daughter's preference. The family then attends a barbecue with three other families. The host has the same choice: two menus, or one all-organic. The all-organic menu is easier. ๐๐% renormalizes ๐๐๐% of dinner. Now imagine the daughter's "preference" is not organic food. It is the belief that bank robbery is righteous, that Israel is a colonial regime which must be dismantled, that your health insurance executive should be eliminated by force, and that anyone who objects is a fascist. The mechanism is identical. The intransigent minority creates an asymmetric cost on resistance. The majority renormalizes for convenience. French physicist ๐๐๐ซ๐ ๐ ๐๐๐ฅ๐๐ฆ has modeled the threshold formally. In his work on opinion dynamics, an extreme view captures a population at roughly ๐๐% activated support โ provided the activists do three things consistently. They activate latent prejudices already present in the population. They impose a binary choice: "๐บ๐ฐ๐ถ ๐ข๐ณ๐ฆ ๐ธ๐ช๐ต๐ฉ ๐ต๐ฉ๐ฆ ๐ฐ๐ฑ๐ฑ๐ณ๐ฆ๐ด๐ด๐ฆ๐ฅ ๐ฐ๐ณ ๐บ๐ฐ๐ถ ๐ข๐ณ๐ฆ ๐ธ๐ช๐ต๐ฉ ๐ต๐ฉ๐ฆ ๐ด๐บ๐ด๐ต๐ฆ๐ฎ ๐ต๐ฉ๐ข๐ต ๐ฐ๐ฑ๐ฑ๐ณ๐ฆ๐ด๐ด๐ฆ๐ด ๐ต๐ฉ๐ฆ๐ฎ." And they refuse, ever, to compromise on their core position. Pseudo-moderates then join โ not because they have been persuaded by the full activist position, but because the binary has been imposed and the alternative ("siding with the oppressor") has been made socially intolerable. ๐๐๐ฌ๐๐ง ๐๐ข๐ค๐๐ซ ๐ข๐ฌ ๐ง๐จ๐ญ ๐ญ๐ก๐ ๐ญ๐ก๐ซ๐๐๐ญ This is the most important paragraph in this post. Read it twice. Hasan Piker โ the Twitch streamer who endorses bank robberies, defends H-m-s, and lives in a $3 million Brentwood mansion โ is ๐ง๐จ๐ญ ๐ญ๐ก๐ ๐ญ๐ก๐ซ๐๐๐ญ ๐ญ๐จ ๐๐ฆ๐๐ซ๐ข๐๐. He represents maybe 5-7% of the country. He does not move the needle by himself. The threat is the ๐ฉ๐ฌ๐๐ฎ๐๐จ-๐ฆ๐จ๐๐๐ซ๐๐ญ๐ ๐ฅ๐ข๐๐๐ซ๐๐ฅ โ the ๐๐ฆ๐ธ ๐ ๐ฐ๐ณ๐ฌ ๐๐ช๐ฎ๐ฆ๐ด reporter who profiles him sympathetically, the Democratic congressman who appears on his stream, the Hollywood actor who shares his clips, the Brooklyn schoolteacher who attends his rallies, the empathetic college freshman who decides he is "๐ข ๐ญ๐ช๐ต๐ต๐ญ๐ฆ ๐ฆ๐น๐ต๐ณ๐ฆ๐ฎ๐ฆ, ๐ฃ๐ถ๐ต ๐ต๐ฉ๐ฆ ๐ด๐บ๐ด๐ต๐ฆ๐ฎ ๐ณ๐ฆ๐ข๐ญ๐ญ๐บ ๐ช๐ด ๐ถ๐ฏ๐ซ๐ถ๐ด๐ต." That coalition โ Galam's ๐๐% โ is what flips the country. Hasan is just the visible 5%. This is also why Pratt's UCLA paper matters. The trait that creates the pseudo-moderate flank is the same trait the activists exploit: ๐ก๐ข๐ ๐ก ๐๐ฆ๐ฉ๐๐ญ๐ก๐ฒ, ๐ฅ๐จ๐ฐ ๐๐ฆ๐จ๐ญ๐ข๐จ๐ง๐๐ฅ ๐ฌ๐ญ๐๐๐ข๐ฅ๐ข๐ญ๐ฒ, ๐ก๐ข๐ ๐ก ๐ฏ๐ข๐๐ญ๐ข๐ฆ ๐ข๐๐๐ง๐ญ๐ข๐ญ๐ฒ, ๐ก๐ข๐ ๐ก ๐ฌ๐ฎ๐ฉ๐ฉ๐จ๐ซ๐ญ ๐๐จ๐ซ ๐ฌ๐ข๐ฅ๐๐ง๐๐ข๐ง๐ ๐จ๐ญ๐ก๐๐ซ๐ฌ. That is the recruitable population. That is the lever Hasan and his industry operate. ๐๐ก๐ ๐๐จ๐ซ๐ซ๐๐๐ญ ๐
๐ซ๐๐ฆ๐ Empathy is not a virtue. It is a ๐ฆ๐จ๐ซ๐๐ฅ ๐ฌ๐๐ง๐ฌ๐ข๐ญ๐ข๐ฏ๐ข๐ญ๐ฒ. Like physical sensitivity to heat, it can produce wisdom or it can produce hysteria, depending entirely on what is paired with it. What converts empathy into wisdom is ๐ฃ๐ฎ๐๐ ๐ฆ๐๐ง๐ญ โ the willingness to evaluate consequences, to insist on results, to ask whether the policy that "feels compassionate" actually produces outcomes you would call humane in a year, a decade, or a lifetime. What converts empathy into tyranny is the ๐๐๐ฌ๐๐ง๐๐ of judgment โ pure feeling, with no constraint, in service of a binary moral choice imposed by an activated 20%. That is the Democratic Party of 2026. The Pratt scale measures it. The Galam threshold predicts it. Katie Porter demonstrates it. Hasan Piker exploits it. ๐
๐ข๐ฑ ๐ญ๐ก๐ ๐ฉ๐จ๐ฅ๐ข๐๐ฒ. ๐๐ก๐ ๐๐ฆ๐ฉ๐๐ญ๐ก๐ฒ ๐ฐ๐ข๐ฅ๐ฅ ๐๐จ๐ฅ๐ฅ๐จ๐ฐ.](https://image.24vids.com/tw-2050939575993069948/amplify_video_thumb/2050938608597737472/img/59L68TDVsmWi6NJz.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 51โs 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 โ not science โ 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 Divisionโs 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 donโt 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 stakeholdersโincluding patients, family members and caregivers, and prescribersโin 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)
