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![The following is a message from Diana Bloom, an anonymous Iranian activist living in Germany who is being threatened with potentially extremely dangerous "exposure" by what appears to be a lunatic. I am passing this message on since Diana has deleted her account for her own protection and safety. To note, I don't think I should be involved with this crazy Evil Evi woman or her OSINT dramas whatsoever since she went bonkers the other day, but she is acting in defamatory ways and with malicious recklessness in a way that endanger an anonymous Iranian dissident I believe to be good, so I must pass this along. A MESSAGE FROM DIANA BLOOM This is a post in two parts. Part one is a brief summary of what has happened so far. Part two addresses the defamatory claims being made about me. PART 1 - [JL: Diana's explanation and responses] For everyone who doesn’t understand what led to this point, here’s the shortest summary possible: Evi [Kokalari] and I had been friendly in DMs since the end of June. She messaged me first. After [DataRepublican] published her piece on the State Department, I asked Evi not to go too hard against DR. Evi did anyway, and James Lindsay defended DR. I didn’t like the way Evi went after James, including citing Milo. So I unfollowed and removed Evi. She confronted me in DMs, and I explained why. Evi then made a post attacking James that started and ended with me and used my profile picture. I responded once, as politely as I could. Evi then repeatedly threatened to dox me, so I deactivated my account. Now, regarding the substance of the accusations she has made so far: 1. I am not a man. My name is not Derek. 2. I am Iranian. 3. I do know stuff about American politics because (and that is the boring truth) German television is really bad. So I’ve only watched English/American stuff for the past, I don’t know, 15 years, podcasts, late night shows, etc. I didn’t think about it, I just did. Little did I know that that would give me an understanding of the inner dynamics of what’s going on within the Republican Party that would tie back to the Iranian people’s cause in 2026. Believe me, I’m still baffled by it whenever I pause to think about it. But that’s the truth, and here we are. 4. I am not in the United States. I shared a blog, and the provider of that blog (a big, common one) is in the United States. My VPN location is sometimes in the United States. Not me. 5. I am not responsible for the content of people defending me. I have no control over it. It’s not my content, and I keep my distance whenever I see problematic stuff. Many accounts defended me, but going to look for one that has done/said problematic stuff to tie it back to me is not right or fair. I am not responsible. I have nothing to do with it. 6. I wanted to help DR because Evi was threatening to go after her hard, and I didn’t think DR deserved that. I meant no harm, I wanted to help. I made a mistake, and I regret it now, but my intention wasn’t bad at that moment in time. 7. Evi herself was the first to come into my DMs and tell me not to fight with an account named Stephanie. So I did Evi that favor. Meaning: Evi came into my DMs first and tried to calm down a public disagreement between me and someone else. When I did this in defense of DR, I did the same thing Evi had done before. I would never think to accuse Evi of restricting my right to free speech because of it. 8. Publishing private DMs from someone without their permission is wrong. It is something both Evi and Stephanie have now done. Both have shared private messages from me without my permission. 9. Part of Evi’s “sources” seem to be Azi Yazdi (granddaughter of Khomeini’s first foreign minister), Benji, and Nima Yamini, as well as his ghost accounts (I have blocked multiple of them by now). If you know any of them, you know this is insane. None of them are reliable. It’s like using Milo as a source against James Lindsay. This is not about truth but about a (malicious) takedown to silence me and get me out of the way. 10. Evi has threatened to dox me (there is no doubt) multiple times, and she keeps going after me. This puts my life and my family’s lives in Iran in real danger, but she doesn’t care. She keeps going, and I can’t stop her. She keeps putting out one lie after another, and it traps me in a forever loop of defending myself. If I don’t respond to more and more accusations from her against me, rest assured, my silence should never be taken as agreement with the lies she puts out there. Be sure there is always context, a counterargument, counterevidence, etc., that would show that none of what she shares is fair or true. But it’s a forever war that is meant to drain me. So me not commenting on her stuff moving forward is never, ever, ever an admission that she is right about something. It’s just a rejection of playing a game I cannot win. To ALL the people who wrote/shared one or multiple posts and comments in my defense: Thank you very, very, very much. I’ve seen it, and I am grateful. But I think it’s best for my own and my family’s safety, as well as for the whole situation, that I step away and stay away from X. I hope that’s understandable. And Evi, for the last time: if you are not malicious, please just stop. Let me out of this. I am not your target. Just leave me and, through doxxing/"exposing", my family out of it moving forward. I beg of you, please. PART 2 - proof - [JL: The following are direct quotes from Evi indicating her intention to "expose" Diana, which she tries to claim is different than "doxxing," though for all practical purposes the effect will be the same and this is a distinction without a difference. The video below shows all of these quotes from her own posts.] 1. “I’m getting enough information on her from her own community. I may share it…” 2. “Either log back in with your real name, or I will start exposing you. And trust me, you will not like that.” 3. “So stop provoking me. If you continue, I will look much deeper into who you are and what your actual role is behind this anonymous account.” 4. “You know what...WAR IT IS. I will start with Diana!! STAY TUNED” 5. “So I will take those words seriously and dig as deep as I can” 6. “The identities of the "Iranian activists" would never have been called into question had they not attacked my right to freedom of speech in my own country.” 7. Someone: “She deleted her account because she’s concerned for her safety and the safety of her relatives in Iran your threats to dox her” Evi: “She should be...but if she turns out to be clean, I shall protect her identity. But trust me, she is not who she claims to be” 8. “Last I checked, Support on X is against fake accounts. Why are we being threatened for wanting to know the true identity of certain accounts…” 9. “Do you think I know who Diana bloom is? No but I need to find out at this point” 10. “... because I asked one of their group operatives from Germany to debate me using her/his true identity, or I would expose who’s behind the account.” 11. “So I don’t know what you’re all thinking, but this isn’t simply about Diana being scared of the IRGC in Iran. The IRGC has been significantly weakened and has plenty of other things to worry about. There are thousands of Iranian accounts fighting for Iran’s freedom under their own names while still having family members back in Iran. At this point, I think people have every right to ask who is actually behind these anonymous accounts… After a few more new posts on her feed, I was forced to tell her to either come back on X and do this under her real name, or I would expose who she was, so at least we would be having this discussion on equal grounds.” 12. “Don’t freaking interfere with other people’s business like that retard did and no one comes after you. So go ahead down and sue me and I will push harder to expose her and you and anyone else…” MY OWN [JL's] COMMENTS, which Diana has nothing to do with and doesn't know I'm appending here. I now believe Evi is likely to be a malignant narcissist who is incapable of admitting that she is wrong. She will not stop in her behavior, and she will aim to harm anyone who attempts to intervene. I do not recommend you do this. I recommend you mark, avoid, and block. Fighting with her will only fuel her because she simply cannot admit that she's wrong about all of this and can only double down in increasingly insane, dangerous, and reckless ways, including toward Diana and her safety. She believes everything she sees that's trying to talk sense into her about any of this is part of an elaborate "op" that "disrespects her free speech" (which isn't a thing, by the way). No one is silencing her. People are just trying to talk sense into her to stop spreading defamation and reckless "exposure" of people who she will put at risk with it and who do not in any way deserve it, people she considered friends and allies until literally four days ago when she suddenly blew up. Therefore, not only is her reckless belief hermetically sealed against any disagreement, she turns any disagreement into proof of allegedly coordinated attacks against her from a network that simply doesn't exist. As a response, in her malignancy, she is threatening to damage, "expose," or otherwise reputationally harm anyone who even tries politely to talk sense into her, much less to disagree with her or oppose her. I strongly recommend everyone realize what they're getting into if they work with or ally themselves with this crazy woman going forward. You do so at your own risk. I can attest from watching her over the last few days that her research abilities, at least when agitated, are so sloppy as to be beyond worthless, even dangerous. The post I'm quoting below is proof of that. She's trying to prove Diana is secretly an American because she's too sloppy and stupid to realize that a Wordpress domain has an American location. She isn't doing research in good faith or with fidelity on this issue, or about me. She is looking for any information she can to hurt people who have upset her. In fact, she is presently being sued for defamation by an Albanian singer (Evi is an Albanian immigrant to the United States and a U.S. citizen for at least a couple decades), so we might recognize this bad behavior and poor praxis as a pattern with her. I can provide just from the last few days, as can others, much evidence that she's simply grasping at the nastiest straws she can find to try to harm people she has suddenly decided are her opponents because of her jealous outburst at DataRepublican and her narcissistic injury at being called on it. The sloppiness and outright retardation of her "fact" finding and "analysis" are so shocking that it's hard not to laugh even given how horrifically dangerous it is. We can therefore infer this sloppiness, recklessness, and malice-when-opposed to be at least partially true of her other "research" against her other targets, by extension. That's a shame because many of those targets are worthy of real scrutiny, which she is undermining with her loose cannon. Therefore, I insist her OSINT "research" is at best worthless and at worst maliciously harmful. In either case, it cannot be engaged by people who want to make a positive difference in the world, so mark and avoid. Evi seems good at making connections. She was quite positively in my own DMs for a while, trying to find ways to work productively together, even suggesting we start an alternative to CPAC (lol). She appears to be friends with both Eric Trump and Don Jr., though the relationship with the former appears to be more solid. She seems to have worked behind the scenes with a lot of relatively prominent Republican groups. I find all of this incredibly concerning after the events of this week, even though I wouldn't have beforehand. My own assessment from this stupid and nasty drama is that Evi's primary motivation is that she is pathologically envious of DataRepublican and her influence, likely believing it should be her in DataRepublican's place. As we can see, she isn't nearly careful or accurate enough for that. Mark and avoid. Further, though, while DataRepublican has no driving interest to be who or what she is and is doing it in service to the best of her abilities (which are considerable but still limited and imperfect as are anyone's), Evi appears to covet the role, which she has demonstrated she cannot possibly handle responsibly. Again, mark and avoid. Block if you will. I will not unblock her for this post or in the future. You can think of that whatever you want. I will rarely, almost never, say anything about her except in the defense of others she is wantonly and recklessly attacking. I will NEVER interact with her directly again, no arguments, no back and forth, no dunks, nothing. My involvement here is pure exposure and nothing else. Thank you for your attention to this matter.](https://image.24vids.com/tw-2093725313872085205/amplify_video_thumb/2093718725035712512/img/t5AqANtbD3mDn808.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)