Video wird geladen...
Video konnte nicht geladen werden
🚨 LATEST #8 - ANOTHER MAJOR ENERGY INFRASTRUCTURE ATTACK 🔥 Drones attacked the "Gorky" oil pumping station in Russia’s Nizhny Novgorod region. 3 oil storage tanks damaged, massive fire covering 20,000 m². *8 energy incidents in just 8 days!* 15 Apr → Australia's Geelong Refinery 16 Apr → Pakistan... show more
25,194 Aufrufe • vor 5 Monaten •via X (Twitter)
0 Kommentare
Keine Kommentare verfügbar
Kommentare vom Original-Post werden hier angezeigt
![🎥 #Trumps_Art_of_the_Deal: #Swallowing_Venezuela, #Greenland and #Iran by #America; #Swallowing_the_Middle_East by #Israel👇👇 👈 #Akbar_Ganji, 22 September 2026 ✅ Iranians should keep a very close eye on Trump—the oil thief and land thief—so that he does not, with the bribe of power and wealth, buy the sellouts who are Iranian in name only and take Iran’s oil, or part of Iran’s territory (as with Venezuela and Greenland), for himself. ✅ He gave an $800,000 house to the husband of Greenland’s foreign minister and seized the place. ✅ Trump has said, again and again and in so many words, that he has taken Venezuela’s oil for America and that he wants to do the same to Iran. On 16 December 2025 he wrote on Truth Social that the pressure would continue “Until such time as they return to the United States of America all of the Oil, Land, and other Assets that they previously stole from us.” On 17 December 2025 he told reporters they had taken America’s energy rights and oil “not so long ago,” that Washington wanted it back, and that it had been taken illegally. On 3 January 2026, after the military operation and the arrest of Maduro, he said the United States would “run” Venezuela and “we’re going to be taking out a lot of wealth out of the ground.” On 24 January 2026 he told the New York Post: “Let me put it this way, they don’t have any oil. We’re taking the oil.” The oil was being sent to Houston refineries. In June 2026 he wrote on Truth Social that he would soon take Kharg Island and other Iranian oil sites and take complete control of their oil and gas market “just like Venezuela.” On 13 September 2026 in Ireland he said America would eventually get out of Iran, “unless we decide to stay and keep the oil, like Venezuela.” On 9 January 2026, on Greenland, he said: “I’m going to do something in Greenland, whether they like it or not… I’d like to make a deal the easy way, but if we don’t do it the easy way, we’re going to do it the hard way.” ✅ In Iran, Trump is after a repeat of the Iraq and Venezuela model: control of foreign-exchange revenues and a client state. He has said repeatedly that he wants to apply the Venezuela model to Iran. Since 2003, Iraq’s oil revenues have sat in an account of the Central Bank of Iraq at the Federal Reserve Bank of New York, and every U.S. president has renewed Executive Order 13303; Trump renewed it on 4 May 2026. Reuters reported on 23 January 2026 that Washington threatened even to target Iraq’s oil income if forces close to Iran entered the new government. The New York Times wrote that the Trump administration temporarily blocked the transfer of Iraq’s own dollars from U.S. banks to Baghdad. After Iraq’s November 2025 election, the Shiite majority nominated Nouri al-Maliki for prime minister. On 27 January 2026 Trump wrote on Truth Social that if Maliki were chosen, “the United States of America will no longer help Iraq,” and that without U.S. help Iraq would have “ZERO chance.” Maliki rejected the interference, but his candidacy was withdrawn and, under Washington’s pressure, Ali al-Zaidi became prime minister. In May 2026 Trump said “we support [him] very strongly” and received him at the White House in July. In Venezuela, oil income is likewise under American arrangements. On 18 September 2026 Reuters and the Financial Times reported that the interim government and a faction of the opposition were close to moving some 31 tons of Venezuelan gold—nearly $4 billion—from the Bank of England to the Federal Reserve Bank of New York, with the United States controlling access. The twin earthquakes of 24 June 2026 left more than 1,700 officially dead; some reports put the toll higher. They want the gold released in the name of post-earthquake reconstruction, but spending it is subject to U.S. oversight and a Treasury account. Without Washington’s permission—and in practice without Marco Rubio—Caracas cannot touch its own reserves. ✅ Many Republican leaders have repeated Trump’s words on Venezuela, Greenland, and Iran almost verbatim. ✅ Most recently, Carla Sands, former U.S. ambassador to Denmark, told Fox News: “We have Venezuela, we’ll have Iran, and now if we have Greenland, we can supply the world with energy for hundreds of years to come—and I mean hundreds of years—with the energy that’s been discovered.” ✅ Watch Rachel Maddow’s (Rachel Maddow) five-minute exposé. She is a leading American liberal political analyst. It calls to mind the worst age of colonialism and imperialism—with this difference: this naked imperialism can no longer be dismissed as “conspiracy theory.” Many American politicians have said the same, among them Michael McFaul (Michael McFaul), U.S. ambassador to Russia under Obama. On 29 August 2026 he wrote that Trump had taken America back to the nineteenth century and was behaving like a typical imperial empire of that century, and that the Venezuela oil deal was naked imperialism: taking another country’s assets in the south by military force. On 3 September 2026, answering the White House, he wrote: “That’s called imperialism. We are profiting from the use of force in another country.” (McFaul has also written, of the same policy: “Straight up colonialism. We invaded not to restore democracy, but to take their oil.” And: “That this outrageous statement celebrating imperialism was not page one news today underscores how numb we have become to Trump.”) ✅ Most important is Bill Kristol’s (Bill Kristol) conversation three days ago with Robert Kagan. Kagan is a leading neoconservative theorist of the Middle East wars, a co-author of the Project for the New American Century statements, and an advocate of military intervention after the Cold War. His wife, Victoria Jane Nuland, is among the “Israel-first” Zionists and is fiercely hawkish. The four-person debate of 20 May 2026 (30 Ordibehesht 1405) at Meridian Hall in Toronto—John Mearsheimer and Stephen Walt versus Victoria Jane Nuland and Mike Pompeo, the Munk Debate titled “Be it resolved, don’t go hunting monsters”—is historic and unforgettable: In his interview with Bill Kristol, Kagan treats the Trump administration as predatory and imperialist, having taken Venezuela’s oil and Greenland for America by open, naked force. He says this colonial appetite is insatiable: whatever it takes, it is never full, and it has an extraordinary hunger for other people’s property. (I have posted the Kagan–Kristol interview separately.) Kristol himself is a neoconservative and a serious opponent of Trump. He has not become an anti-interventionist, but he treats Trump’s intervention as the seizure of oil and land, not as leadership of a world order, and he calls the Greenland threat and the Venezuela oil deal imperial bullying. ✅ I could go on, with film, tweets, and debates, to show that what has happened—and is happening—to Iran follows the same imperial program. 🔺 Mike Pompeo (Mike Pompeo), an “Israel-first” neocon, wrote on X on 2 January 2026: “Happy New Year to every Iranian in the streets. Also to every Mossad agent walking beside them.” The Jerusalem Post and The Times of Israel carried it the same day. A few days earlier, a Persian-language channel attributed to Mossad had written: “Let us go out into the streets together… not only from afar; we are with you in the field as well.” 🔺 John Bolton and Mike Pence have held the same line. All three have sat with the Mujahedin-e Khalq. In July 2018, at an MEK rally in Paris, Bolton said they would celebrate in Tehran before 2019. 🔺 Netanyahu and other Israeli leaders have said repeatedly that without regime change in Iran their work is incomplete. In Israeli elections there is no real contest among rivals over “regime change in Iran.” Israel has also had a close relationship with the MEK, but publicly it defends Reza Pahlavi and the restoration of the Pahlavi monarchy. Shahriar Ahy—then Reza Pahlavi’s most serious adviser—said in New York in 2006 that Israel first offered the leak of Iran’s secret nuclear documents to them; when they refused, Israel gave the documents to the MEK to publish. 🔺 On 5 April 2026 Trump told Fox News that America had sent “guns, a lot of guns” for Iranian protesters, through the Kurds, and that he thought the Kurds had kept the weapons. On 4 March the New York Times wrote that the CIA had given light arms to Iranian Kurdish forces before the war. Iranian Kurdish parties denied receiving the weapons. 🔺 On 12 February 2026 the Wall Street Journal, citing U.S. officials, wrote that after the January crackdown the Trump administration had smuggled some 6,000 Starlink terminals into Iran; the State Department had bought nearly 7,000, and Trump knew of the deliveries. 🔺 On 24–25 February 2026 the CIA posted in Persian on X, Instagram, and YouTube: “The Central Intelligence Agency hears you and wants to help,” and gave instructions for a secure call by informants. AP and Reuters reported it the same day. Yasmine, Noor, and Iman Pahlavi—according to their Instagram records—storyed the CIA notice at the same time. ✅ The defining fact of this moment is that the governments of the United States and Israel no longer hide their aims; they state them in public every day, so that no one can be silenced with the label “conspiracy theory.” The imperial neoliberal government of Trump and Netanyahu has forced even leading neoconservative theorists to distance themselves. Democratic leaders—Obama, Biden, Kamala Harris, Hillary Clinton, Susan Rice, John Kerry, Biden’s secretary of state, the national-security advisers of Obama and Biden, and Democratic candidates in the 3 November midterms—mainly say the JCPOA worked and that under it Iran would never have obtained a nuclear weapon (and on that claim they are entirely right), and that the causeless, illegal, economically costly, and failed military attack on Iran at Netanyahu’s request was unnecessary. But if Trump also swallows Iran as he has Venezuela and Greenland, and if the next president is a Democrat, they will welcome it—just as the Obama and Biden administrations never restored Iraq’s economic independence. The executive order keeping Iraq’s oil account at the New York Fed was renewed under both. ✅ In Part I of The Communist Manifesto, Karl Marx offered a brilliant, deep analysis of modernity’s victories in the modern age. But Marx saw that age as the age of revolution against capitalism and of human emancipation, to which both the inner contradictions of capitalism would lead of necessity and which the working class would will into being. That did not happen. Even serious defenders of liberal democracy—including John Rawls, the most important political philosopher of the theory of justice, and Paul Starr in Freedom’s Power: The True Force of Liberalism—were compelled to criticize, in earnest, the coups and foreign aggressions of “liberal imperialism.” Rawls, who in The Law of Peoples was a theorist of humanitarian intervention and just war, criticized and rejected CIA coups in other countries in that same book, including the CIA coup against Dr. Mohammad Mossadegh in 1953. In §5.4 Rawls wrote that the United States overthrew the democracies of Allende in Chile, Árbenz in Guatemala, Mossadegh in Iran, and, on some accounts, the Sandinistas in Nicaragua. Whatever the merits of those regimes, the covert operations against them were carried out by a government motivated by monopolistic and oligarchic interests without the knowledge or criticism of the public. This was made easier by a skillful appeal to national security in the context of superpower rivalry, which allowed such weak democracies to be seen, however implausibly, as a threat. Although democratic peoples are not expansionist, they do defend their security interest, and a democratic government can easily appeal to that interest to support covert interventions even when the actual motive is hidden economic interests. Rawls also wrote, in §14.1, that the atomic bombings of Hiroshima and Nagasaki, aimed primarily at civilian populations, were very great wrongs. He went on (§4.4 and the footnotes to that section) to say that Japan was already close to surrender and that there was no need for the atomic bombings. But Truman was a racist and called the Japanese savages and barbarians and said they should be treated as such; yet how foolish it now seems to regard the Germans and the Japanese as wholly barbarian and savage. Look at the names Donald Trump has given Iranians in his second term. On 1 April 2026, in a televised address, he said: “We’re going to hit them extremely hard over the next two to three weeks. We’re going to bring them back to the Stone Ages where they belong.” That same night: “If there is no deal, we are going to hit each and every one of their electric generating plants very hard and probably simultaneously. We have not hit their oil, even though that’s the easiest target of all, because it would not give them even a small chance of survival or rebuilding.” In early April: “No bridges, no power plants… Stone Ages.” April reports of Trump on Iranians: “animals,” and once “horrible genes, not like our own.” In July 2026 he called Iran’s leaders “scum” and “sick people.” In September 2026 he told Axios: “Do I want to go in and annihilate them or do I not? It’s a big decision.” In another interview he set out the options as obliterating Iran, letting it rot economically, or making a deal. You see exactly the racist gaze that Edward Said mapped so well in Orientalism. (One of the charges Republicans leveled at Barack Obama was that he had met Edward Said.) That racist attitude cannot and must not be ignored in the bombing of Iran’s infrastructure—including the 28 February 2026 attack on Shajarah Tayyebeh Elementary School in Minab, which the UN fact-finding mission on 17 September 2026 found, on “reasonable grounds,” to have been the work of the United States and a war crime: about 157 dead, including more than 120 children. Major American media carried the same report. Trump said it was a wartime mistake. The military attack on Iran had, and has, nothing to do with freedom, human rights, or democracy (whenever Trump feels Iran’s leaders are coming around to him, he lavishes astonishing praise on them). This attack is for oil, domination, colonialism, imperialism, racism, and the interests of Israel, and nothing else. Only that.](https://image.24vids.com/tw-2102403679840084316/amplify_video_thumb/2102401955947544576/img/PXrApHdtZ2iZqhoU.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)
