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Emotional Interview w/ Robert Downey Jr 🤔🥰🥺🥳 #FallonFlashback Original Air Date: April 28th, 2015
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![JAMES COMEY LEAKED CLASSIFIED INTELLIGENCE TO THE NEW YORK TIMES in order to push the Russia Collusion narrative onto the American people to take down Trump. Adam Schiff wasn't the only leaker of classified intel. James Comey specifically leaked classified intel to the NYT in order to enable a special prosecutor to take down Trump and conspire with other mainstream media organizations to fool and lie to the American people to push them to go against Trump with a false narrative. This is basically "Project Mockingbird." The main media channels were colluding with government in order to take down a sitting president and undermine the U.S. This has been going on since 2016 against Trump and still is to this day. The FBI concluded numerous legacy news media stories that crafted the false Russia collusion narrative contained illegally leaked classified intelligence but failed to definitively identify the leakers. But agents did force a stunning admission that ex-FBI Director James Comey used a special conduit to the Pulitzer Prize-winning New York Times in his bid to polish his image and push for a special prosecutor to take down President Donald Trump. Columbia University law professor Daniel Richman admitted to agents in interviews he routinely communicated on behalf of Comey, his longtime friend, with Times reporter Michael Schmidt, whose work was among the newspaper's 2018 Pulitzer-winning stories on Russian election interference. The goal, Richman told the FBI, was "to correct stories critical of Comey, the FBI and to shape future press coverage" outside of the bureau's official press office, according to internal FBI memos that current Director Kash Patel delivered to Congress this week. While Richman was known to have been publicly quoted in news stories as an advocate for Comey, he admitted to agents — who were part of the FBI’s Arctic Haze classified leaks inquiry — that he was given access by Comey to what turned out to be highly classified information up to the SCI level and sometimes provided information to reporters on an anonymous basis. Richman insisted he did not believe he had confirmed or provided classified intelligence to reporters but said he could not be 100 percent, the memos state, noting he could only make his leak denial “with a discount.” "Richman was pretty sure he did not confirm the Classified Information. However, Richman told the interviewing agents he was sure 'with a discount' that he did not tell Schmidt about the Classified Information," one FBI memo recounted. In the end, the Justice Department decided not to pursue any criminal charges against Comey or any of his lieutenants or now-Sen. Adam Schiff despite potential evidence of leaks, saying it could not be certain of who leaked what and when. But its interrogation of Richman and his admissions of significant contact with the Times' Schmidt provide the most detailed account to date of how Trump critics like Comey — who was fired by the president — used the media to craft narratives that ultimately turned out to be untrue or misleadingly overstated, the memos show. Just the News also revealed this week that a career intelligence officer who worked for Democrats on the House Intelligence Committee for more than a decade repeatedly warned the FBI beginning in 2017 that then-Rep. Adam Schiff had approved leaking classified information to smear then-President Donald Trump over the now-debunked Russiagate scandal. Schiff has denied the allegation. Newly-declassified FBI memos also include details on classified leaks investigations dubbed Tropic Vortex, Foggy Falls, Riding Hood, Sirens Lure, Echos Fate, and Genetic Christmas. Comey, Richman, and “Arctic Haze” The FBI leak investigation code-named “Arctic Haze” revealed key details about Richman — Comey’s longtime friend, confidante, and media conduit — including what was at that time his nearly decade-long source relationship with Michael Schmidt of The New York Times. The leak investigation zeroed in on four news articles which contained leaked classified information. The first was a New York Times article by four reporters — Schmidt, Matt Apuzzo, Adam Goldman, and Eric Lichtblau — from late April 2017 titled “Comey Tried to Shield the F.B.I. from Politics. Then He Shaped an Election.” The second was a Washington Post story by Ellen Nakashima from early April 2017 titled “New details emerge about 2014 Russian hack of the State Department: It was ‘hand to hand combat’.” The third was another Washington Post piece by Karoun Demirjian and Devlin Barrett from late May 2017 titled, “How a Dubious Russian Document Influenced the FBI’s Handling of the Clinton Probe.” The fourth was a Wall Street Journal article by Holman Jenkins Jr. from late May 2017 titled, “The Trump-Russia Story Starts Making Sense.” The April 2017 Times article by Schmidt quoted Richman defending Comey: “Jim sees his role as apolitical and independent. The F.B.I. director, even as he reports to the attorney general, often has to stand apart from his boss.” Schmidt wrote that “confidants like Mr. Richman say he was constrained by circumstance” while “navigating waters in which every move has political consequences.” Richman also reportedly said that Comey displayed “a consistent pattern of someone trying to act with independence and integrity, but within established channels” and that “his approach to the Russia investigation fits this pattern.” The Times article wrongly argued that, in the case of the Trump-Russia investigation, Comey “conducted the investigation by the book.” The FBI memos show that Arctic Haze was opened by the FBI’s Washington Field Office as a media leak investigation in mid-August 2017, after a redacted source in late June 2017 “reported the unauthorized disclosure of classified information in eight articles published between April and June 2017” and after a DOJ request at the start of August 2017. Arctic Haze was predicated on the four aforementioned stories. The FBI closed the investigation in early September 2021 — with the DOJ charging no one with leaking classified material — with the bureau’s closure document providing details about the FBI’s failed attempt to catch the leakers. The bureau document indicated that it had been treated as an “Espionage Investigation.” The FBI said the “factual predication” for the leak inquiry was largely based on the classified information which first appeared in the April 2017 Times piece. The FBI noted that Comey had “publicly indicated on several occasions that classified information contributed to his decision” to unilaterally and preemptively announce in early July 2016 that he did not believe any reasonable prosecutor would charge Hillary Clinton over her mishandling of classified information on a private email server and his further announcement in October 2016 that the Clinton emails investigation was (briefly) being reopened. The bureau said Comey had four reasons for making the announcements the way he did, including that “Comey had concerns the Classified Information, which directly related to whether or not the Attorney General [Loretta Lynch] should have been recused from the Midyear Exam investigation, would be leaked to the media or would otherwise be disclosed.” Comey had told the Senate Intelligence Committee in July 2017 that “one significant item I can’t, I know the committee’s been briefed on. There’s been some public accounts of it, which are nonsense, but I understand the committee’s been briefed on the classified facts.” The bureau said that, in classified testimony to a bureau watchdog, “Comey confirmed the specific Classified Information, which was discussed in the New York Times article, and indicated it did impact his decision to make unilateral, public statements about the Midyear Exam [Clinton] investigation.” Recent declassifications provide more details on the classified intelligence which swayed Comey to let Clinton off the hook, as well as revealed more information on so-called Clinton Plan intelligence which the Comey FBI seemed to ignore as it launched the Crossfire Hurricane investigation into Trump. Comey hires Richman to afford him Top Secret Clearance. The FBI said that “Comey instructed the FBI to hire Richman as a Special Government Employee (SGE)” in 2015 and “to grant him a Top Secret clearance with access to Sensitive Compartmented Information” and that “FBI records indicated Richman was hired to work on ‘Going Dark’ matters.” The bureau said its investigation “revealed Comey also hired Richman so Comey could discuss sensitive matters, including classified information, with someone outside of the FBI’s regular leadership. Comey also used Richman as a liaison to the media.” “The investigation revealed Richman had been a source for Michael Schmidt, one of the reporters credited with writing the article at issue, and The New York Times since at least 2008,” the bureau wrote. “Richman first spoke with Schmidt regarding an investigation into illegal activity in sports. Prior to Richman becoming an SGE, Schmidt visited Richman’s house numerous times. The New York Times quoted Richman several times, both on the record and on background, in stories regarding Jim Comey. After he was terminated by President Trump, Comey used Richman as a conduit to convey to the media memoranda of his meetings with President Trump.” “According to Richman, Comey and Richman talked about the ‘hammering’ Comey was taking from the media concerning his handling of the Midyear Exam investigation. Richman opined Comey took comfort in the fact Richman had talked to the press about his feelings regarding Comey’s handling and decision-making on the Midyear Exam investigation. Richman claimed Comey never asked him to talk to the media,” the FBI notes say. The FBI wrote that “Richman recalled Comey told him there was some weird classified material related to Lynch which came to the FBI’s attention” and that “Comey told Richman about the Classified Information, including the source of the information.” The FBI said that “investigators learned that FBI Office of Public Affairs was told to assist The New York Times with the April 2017 article” and that “Comey either directed or otherwise authorized FBI’s official assistance to The New York Times.” Disgraced and fired FBI special agent Peter Strzok and former FBI lawyer Lisa Page, with whom Strzok was having an affair, appear to have been involved in briefing the Times, according to the bureau memos. “Strzok stated he believed FBI Executive Management told them to meet with the New York Times. Strzok said he recalled being told to provide an investigator-level briefing on the Midyear Exam investigation,” the FBI said. “During the March 30, 2017, meeting, the Times told Strzok and Page they had the Classified Information.” The “summary of investigative steps” by the FBI included interviews with bureau and intelligence community officials, document reviews, phone and email records researches, the review of a 2017 “Tropic Vortex” investigation conducted by then U.S. Attorney John Durham and the U.S. Postal Inspection Service, and more. “Based upon discussions with DOJ, these investigative steps did not generate sufficient proof to charge any individual with willfully transmitting the Classified Information, conspiring to transmit the Classified Information, or aiding and abetting another person’s Transmission,” the FBI concluded in 2021. The FBI claimed that “the investigation has not yielded sufficient evidence to criminally charge any person, including Comey or Richman, with making false statements or with the substantive offenses under investigation.” Inspector General calls Comey's leaks "unauthorized" DOJ inspector general Michael Horowitz wrote a report released in August 2019 criticizing Comey’s decision to leak his so-called “Comey Memos” — including details about Trump’s alleged comments about Lt. Gen. Mike Flynn — to the media in 2017 in an effort by the then-fired FBI director to spur the appointment of a special counsel. Horowitz wrote that his investigation “interviewed 17 witnesses, including former Director Comey and Daniel Richman, the individual who, at Comey's request, shared the contents of one of the Memos with a reporter [Schmidt] for The New York Times.” Comey told Horowitz that the day after being fired by Trump, he retained Richman as an attorney. “We have previously faulted Comey for acting unilaterally and inconsistent with Department policy,” the DOJ watchdog wrote. “Comey’s unauthorized disclosure of sensitive law enforcement information about the Flynn investigation merits similar criticism.” Comey admitted in 2017 that he had hoped leaking this information “might prompt the appointment of a special counsel.” Horowitz concluded Comey’s leaks were “an attempt to force the Department to take official investigative actions.” “Comey had several other lawful options available to him to advocate for the appointment of a special counsel, which he told us was his goal in making the disclosure,” Horowitz wrote. “What was not permitted was the unauthorized disclosure of sensitive investigative information, obtained during the course of FBI employment, in order to achieve a personally desired outcome.” Horowitz sent a criminal referral to the DOJ over Comey’s memos at the time, but the DOJ declined to prosecute. Comey’s leak efforts were successful, however, as Robert Mueller was appointed special counsel within days of the Comey Memo leaks making their way to the New York Times. An article in the Times penned by Schmidt was titled “Comey Memo Says Trump Asked Him to End Flynn Investigation” and was published on May 16, 2017. Then-Deputy Attorney General Rod Rosenstein appointed Mueller as special counsel the next day. After two years, Mueller “did not establish” any criminal Trump-Russia collusion. Other classified leaks inquiries also come up short, here is a list: The newly-declassified FBI memos also detail a host of other failed or botched classified leaks investigations that made their way into legacy media. They were given operational code names such as Tropic Vortex, Foggy Falls, Riding Hood, Echos Fate, and Genetic Christmas. Tropic Vortex: he Justice Department’s Tropic Vortex classified leaks investigation focused on an unspecified October 2016 article by The New York Times as well as an early March 2017 article written by Times reporters Schmidt and Michael Shear and titled, “Comey Asks Justice Dept. to Reject Trump’s Wiretapping Claims.” Foggy Falls: The FBI’s Foggy Falls classified inquiry focused on a Washington Post article by three reporters — Ellen Nakashima, Devlin Barrett, and Adam Entous — from mid-April 2017 titled, "FBI obtained FISA warrant to monitor former Trump adviser Carter Page.” The bureau’s Riding Hood investigation included a main focus on a Buzzfeed News article from early April 2017 written by Ali Watkins and titled, “A Former Trump Adviser Met With A Russian Spy.” The FBI speculated that the classified information in that article may have informed a mid-April 2017 story by the Washington Post written by three reporters — Ellen Nakashima, Devlin Barrett, and Adam Entous — and titled, "FBI obtained FISA warrant to monitor former Trump adviser Carter Page.” Siren's Lure: The FBI’s unsuccessful Sirens Lure classified inquiry focused on three Washington Post stories. The first was one by four reporters — Matt Zapotosky, Sari Horwitz, Devlin Barrett, and Adam Entous — from late May 2017 titled, "Jared Kushner Now a Focus in Russia Investigation.” The second was an article by three reporters — Ellen Nakashima, Adam Entous, and Greg Miller — from late May 2017 titled, "Russian Ambassador Told Moscow that Kushner Wanted Secret Communications Channel with Kremlin.” The third was a piece by four reporters — David Filipov, Amy Brittain, Rosalind Helderman, and Tom Hamburger — from early June 2017 titled, "Explanations for Kushner's Meeting with Head of Kremlin-linked Bank Don't Match Up.” Echos Fate: The bureau’s Echos Fate classified leaks inquiry focused on two Washington Post stories. The first one mentioned by the FBI was a mid-January 2017 story by David Ignatius originally titled “Four burning questions on Russia” which was renamed “Why did Obama dawdle on Russia’s hacking?” The second was by three reporters — Greg Miller, Adam Entous, and Ellen Nakashima — published in early February 2017 and titled, “Officials Say Flynn Discussed Sanctions.” Genetic Christmas: The FBI’s failed Genetic Christmas classified leaks investigation focused on an NBC News article written by three reporters — William Arkin, Ken Dilanian, and Cynthia McFadden — which was published in mid-December 2016 and was titled, “U.S. Officials: Putin Personally Involved in U.S. Election Hack.” Series of leaks fed "blatantly false" information to media: Director of National Intelligence Tulsi Gabbard recently harshly criticized this specific leak to NBC News, as well as one to The Washington Post, arguing that they fed a false narrative that the intelligence community had already reached a conclusion on Russian leader Vladimir Putin’s intentions during the 2016 election when the Obama-ordered Intelligence Community Assessment had not yet been completed. “Deep State officials in the IC begin leaking blatantly false intelligence to the Washington Post, as proven by the unpublished PDB and previous IC products, claiming that Russia used ‘cyber means’ to influence ‘the outcome of the election.’ … Another leak to the Washington Post falsely alleges that the CIA ‘concluded in a secret assessment that Russia intervened’ in the election to help President Trump,” the Gabbard-led Office of the Director of National Intelligence assessed last month. ODNI added: “At this point, there is no official IC assessment that contains that conclusion [...] IC officials again leak to the media, this time claiming [to NBC News] that IC officials believe ‘with a high level of confidence’ that Russian President Vladimir Putin was personally involved in the ‘U.S. Election Hack’.” Source: Just The News](https://image.24vids.com/tw-1955649487805837436/amplify_video_thumb/1955643816204996608/img/tboj1ANSkZ47kssp.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)