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It's #ElectionDayinGhana! Disinformers will be busy spreading false info. Remember: #VerifyBeforeSharing #ChecktheFactsDontgetTwisted #FactsMatter #DontbeDeceived GhanaFact Media Foundation for West Africa @moigovgh #NCCEGHANA Electoral Commission Of Ghana European External Action Service - EEAS 🇪🇺 Ras Nene Official EUvsDisinfo Sister Deborah
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![Intelligence Agency Alleges “Pro-Russia” TikTok Accounts Are Interfering In Czech Elections Despite speculation, there is no evidence tying social media accounts to Russia by Cecílie Jílková alex gutentag and Michael Shellenberger Almost 1,000 accounts on TikTok are promoting pro-Russian narratives in support of “extremist” parties ahead of this week’s elections in the Czech Republic, according to a Czech intelligence agency and a group of analysts who identify as the “Center for Online Risk Research.” And some in the Czech news media are suggesting that Russia may be behind the accounts. “Secret services have discovered hundreds more pro-Russian accounts that want to influence the election,” reported Denik N, a Czech news publication, this morning. “They have millions of views.” But neither BIS nor the Center for Online Risk Research says they can link the Russian government to any of the accounts. “We don’t know,” said researcher Vendula Prokůpková to Public. “We don’t have the tools to find out.” The BIS declined to comment. A TikTok spokesperson told Public, “We have proactively implemented additional safety and security measures ahead of the elections in Czechia, including an in-app Election Center to provide access to authoritative information about the vote. We continue to aggressively counter deceptive behaviour, and we have already prevented and removed millions of fake likes and follow requests in Czechia since the start of August.” Notably, the Czech media and the Center are making similar arguments to those used by a Romanian court last year to nullify the presidential election, which legal scholars viewed as unconstitutional. The case may seem unimportant to Americans, given the relatively small size of the Czech Republic, which has 11 million people, and since the Romanian intelligence agencies made stronger claims about Russian interference than the Czech BIS or the Center for Online Risk Research have made. And the possibility remains that Russia, or Russia-linked bot networks, are indeed engaged in algorithm manipulation to help the Czech parties opposed to continuing arming of Ukraine. In Romania, intelligence officials accused the Russians of creating fake accounts and manipulating algorithms. But the information comes at a moment when Internet censorship is a sticking point between the Trump administration and the EU over a trade deal, and just days after the European Commission leaked plans that it could fine Meta’s Instagram and Facebook up to six percent of its global revenue if it doesn’t make it easier for users to flag posts for censorship. The Commission is currently investigating Facebook and Instagram for supposed failure to stop “disinformation” and “deceptive advertising” in advance of last year’s European Parliament elections. The EU has made no secret of its desire to censor social media worldwide, not just in Europe. Meanwhile, Americans are obligated under NATO to defend both Romania and the Czech Republic, and the NATO treaty requires its members to hold free and fair elections, which Romania did not do. Romania’s intelligence officials presented no evidence to support their claims, and subsequent analyses revealed that the Romanian ruling party had funded at least some of the allegedly pro-Russian TikTok accounts. Where the Romanian TikTok accounts supposedly promoted a right-wing populist, the Czech Center claims that the Czech language TikTok posts, back the “far-right SPD party, which ranks third in most polls with around 13% support, and the far-left Stacilo!,” according to Reuters, “which is gaining just over the 5% threshold needed to secure parliamentary seats.” Notes Reuters, “Both parties advocate for Czechia to leave NATO and the European Union.” Prokůpková said, despite its name, that “Center for Online Risk Research” is “not an organization. We are an initiative.” However, she also said, “My partner is the CTU,” referring to the Czech government’s Telecommunications Office. This office organized a meeting on August 29th due to the upcoming Czech elections, which was attended by the European Commission, Google, Meta, Microsoft, TikTok, and X. “The participants discussed their readiness to address potential systemic risks in connection with the parliamentary elections and respond to possible incidents,” a European Commission spokesperson told Public today. Prokůpková also said, “I proceed in accordance with the DSA,” the EU’s Digital Services Act, which entitles anyone to report false accounts or misinformation on social media to the Czech Telecommunications Office.”We are ordinary citizens and we use the R programming language,” she explained. One of the Center’s members is Josef Šlerka, who collaborated with “The Organized Crime and Corruption Reporting Project,” which the US State Department created in 2008, and which the USAID funded. After President Trump cut off USAID funding, the European Commission began to financially support OCCRP. In January, Šlerka and the director of the Czech government’s Security Information Service (BIS), the equivalent of the FBI and DHS in the US, briefed Czech members of Parliament about the Romanian TikTok case as a potential model for the Czech Republic. Now, the BIS has sent a report on Czech-speaking pro-Russian TikTok accounts to the president, prime minister, and Czech Telecommunications Office. Earlier this year, a Czech Army group admitted to monitoring opposition figures. Leaked documents show the group monitored “the opinions and attitudes of these [opposition] individuals towards the activities of the Ministry of Defense, its leaders, senior representatives of the Czech army, and the war in Ukraine.” General Karel Řehka later defended the Army’s actions by alleging that it was just a military exercise in case of possible future interference in the elections. A few weeks ago, Romania’s Interior (security) Minister said the intelligence agencies of the Czech Republic and those in other nations admire what Romania did. “I believe that what happened in Romania last year is currently being studied by all intelligence agencies in the Western world,” said Cătălin Predoiu. “Conclusions are being drawn and countries are taking defensive measures, inspired by how Romania defended itself.” He went on to say that “my Czech colleague, who is a good friend of mine, approached me and said, ‘We also have elections in the fall, and we are watching very closely what has happened in your country.’” From left: Vít Rakušan, Czech Minister of the Interior and Deputy Prime Minister, and Marian-Cătălin Predoiu, Romanian Minister of the Interior and Deputy Prime Minister, at the Round Table (Justice and Home Affairs Council) on December 12, 2024. Source: Other groups are involved in the possible influence operation. A liberal website called Voxpot recently published a list of websites that repost content from Russian state platforms, but provided no information about any links to or financing from Russia. The Independent Journalism Foundation financed the Voxpot report. And Seznam, a news website that has advocated for EU government censorship of “misinformation,” finances the Foundation. Finally, GLOBSEC, the Institute for Strategic Dialogue (ISD), and CEDMO (Central European Digital Media Observatory), all of which appear to have links to the intelligence community, published a report warning of the alleged risks of Russian interference; however, it contained no evidence to support these claims. Major military contractors, including Lockheed Martin, KNDS, and Saab finance GLOBSEC, while the US, UK, EU, and other Western governments finance ISD and CEDMO. While the allegations focus on alleged pro-Russian support for the nationalist-populist SPD party and the radical Left-Wing coalition Stacilo!, party, the latest polls show that the ANO party, led by former Prime Minister and billionaire Andrej Babiš has over 33% support, which is 12 points more than the centre-right SPOLU (Together) coalition, which the current Prime Minister leads. Like the SPD and Stacilo!, Babiš is running directly against the EU’s agenda, including on migration, climate change, the Ukraine war, and censorship. His party rejected NATO’s new defence spending target and called for halting ammunition supplies to Ukraine. With the SPD and Stacilo! expected to win roughly 18% of the vote, and given their shared opposition to arming Ukraine, they could join in a coalition government with ANO to end further military support. “If the electoral contest were close, then even several tens of thousands of votes that voters cast for someone (or conversely decided not to cast) could determine whether, for example, the Czech ammunition initiative, crucial aid for defending Ukraine, will continue,“ confirms in today’s article the Czech liberal newspaper Deník N. Czech President Petr Pavel is a former NATO general and a strong supporter of supplying Ukraine in its war with Russia. Nothing happened after the Romanian court nullified its election. Romania remains a member of NATO and the EU. Indeed, the EU supported the judicial coup. The same could happen in the Czech Republic. Others think that’s unlikely. “I don’t think we are approaching what is known as the ‘Romanian scenario,’” wrote Lukáš Prchal, a journalist who has written on the TikTok scandal for Deník N, in an email to Public. Whatever the case, the fact remains that there is no evidence of Russian government interference in the Czech elections, and any effort to nullify it based on allegations about anonymous TikTok accounts would violate the Czech Republic’s constitution, the European Union’s constitution, and the NATO treaty. “There is an attempt here,” a source told Denik N, “but the potential and significance are not essential. It is an unsuccessful attempt.”](https://image.24vids.com/tw-1973452631139033346/amplify_video_thumb/1973450924258697216/img/R-E35fTqfWML2Zih.jpg)
![WTF happened to Europe? [My speech at DiEM25's event at the National Theatre, Brussels, on 7th March 2025] We once had a dream. It was a dream of what Europe could have been. A Europe of shared prosperity, dignity, freedom – a Europe of Peace and Hope. That dream is now dead, lost, gone, kaput. Why? What the hell happened to Europe? We know what happened to Europe! We know why politicians from all over are descending on Brussels today like manic drones intent on bombarding to smithereens what is left of Europe as a Peace Project – determined to turn the flailing European Union into a War Union. We know what happened to Europe because we foretold it. When DiEM25 was inaugurated nine years ago at the Volksbühne Theatre in Berlin, we had said it loud and clear: “Europe will be democratised. Or it will disintegrate!” Well, Europe did not democratise and so it is disintegrating – it is degenerating into a Totalitarian War Union. Austerity for the many and money printing for the few begat stagnation mixed with mind-numbing inequality. Every time capitalism stagnates and inequality surges, while the official Left joins the centre in a futile attempt to prop up a Bankrupt Liberal establishment, fascism and war are never too far. Just like in the 1930s, two varieties of totalitarianism began to tussle for power. · On the one side, the Radicalised Neofascist Right promises to make us great again not through ending austerity or exploitation but through a moral reckoning – a cultural cleansing that targets the impure foreign bodies within the pure body of the Nation or of an Ethno-White-Christian-Patriarchal Europe: foreigners, trans, lesbians, Muslims and Jews, especially those who oppose the cleansing benefits of genocide are the enemy within. · On the other side, the Radicalised Totalitarian Centrists succeeded in retaining their relevance as the only bulwark against the fascists, deepening the crisis that fuels fascism and thus their claim to be our last defence against the fascism that they reinforce – a Perfect Vicious Cycle turbocharging totalitarianism. Like Tweedledum and Tweedledee, the Radicalised Totalitarian Centrists clash with the Radicalised NeoFascist Right, sucking the air out of democratic politics, making totalitarianism great again. Lest we forget: · We did not have to wait for the fascists to win government before our magnificent July 2015 referendum in Greece was overturned. · We did not have to wait for the fascists to win government before they fired Melanie Schweizer from her civil service job in Germany for not supporting genocide. · We did not have to wait for the fascists to win government before they banned me from entering Germany even via Zoom! · We did not have to wait for the fascists to win government before the Romanian presidential elections were banned because the Radicalised Totalitarian Centrists did not like the result. The only substantive difference of our times and the 1930s is that Tweedledum (the Radicalised Totalitarian Centrists) and Tweedledee (the Radicalised NeoFascist Right) have traded places when it comes to war: Today, somewhat confusingly, it is Tweedledum (the Radicalised Totalitarian Centrists) who are weaponising Military Keynesianism and demand more war and it is Tweedledee (the Radicalised NeoFascist Right) who proclaim Peace – a chilling, totalitarian Peace. Yes, we had foretold all this back in 2015. But that did not stop us from failing to stop it, a cruel reminder that being right is not enough. Why did we fail? Why did we miss the popular wave that favoured our side in 2015, allowing the fascists to exploit the revived thirst for radicalism? Yes, yes, it is true, we were ruthlessly squeezed between Tweedledum (the Radicalised Totalitarian Centrists) and Tweedledee (the Radicalised NeoFascist Right). BUT, we also made some unforced errors: · We invested too much in Green Keynesianism, forgetting the timeless lesson that, even when it adopts Keynesianism as a last resort, the ruling class will always ditch it once theirbottom line recovers – well before the many taste its fruits. Our Green New Deal was never even adopted, except partially in name. Is it any wonder that, In the mind of the struggling many, ‘green’ became synonymous with even lower living standards? · We also proved unable to liberate people from exploitation, giving them only the freedom to choose their pronouns on our web site – which of course would be fine had it not been so pathetically inadequate in the larger scheme of things. Instead of organising the precariat and auto-workers we ended up organising signifiers, appearing as a self-styled intellectual vanguard enjoying the subversive thrill of an imagined revolution with all the comforts and trappings of a ruling class soiree. · And last but not least: We thought we could mobilise existing Left and Green parties across Europe, only to discover they were not interested. And now? What must we now do? Let’s begin by acknowledging that we are at the endof a forty-year long vicious austerity-driven class war and at the beginningof a new cycle of military Keynesianism, weaponised xenophobia, totalitarianism within and technofeudalism all around. So: It's time to be bold. Time to be clear on seven crucial issues: On Peace with Security, and how to end the carnage on the killing fields of Ukraine were lives are devoured with a ruthless, mechanical precision, let us: · Reject outright Trump’s predatory seizure of Ukraine’s natural resources. · Campaign to get the whole of Europe out of NATO, immediately! · Plot a course to a non-aligned, but never neutral, Europe. · Offering to relax sanctions and return Russia’s $300 billion in frozen assets, commence negotiations with the Kremlin and Beijing on a comprehensive strategic arrangement within which Ukraine becomes what Austria was during the Cold War: sovereign, neutral, and as integrated with Europe as its citizens desire. On Green Prosperity: Oppose fiercely Military Keynesianism, replacing it with a vast Green Investment Program that combines Development with Degrowth. On Dignity, campaign for a new Monetary Commons that sidelines private banks, offers a trust fund to all, and guarantees a personal dividend - a basic income - to each. On Migration, turn the accusation of us being soft on foreigners into a virtue. Shout it from the rooftops that Europe without mass migration will die – that we wantmigrants not out of solidarity but out of self-interest. On Combating Technofeudalism, sanction immediately the Cloudalist Tech Lords, restrict Amazon, Uber, Google, Meta, Airbnb, tax them to extinction, impose interoperability, end the ban on European tech companies, like ASML, to export to China, and, above all, develop our own, socialised cloud capital - the stirrings of a magnificent Technosocialism. On Freedom: Dismantle totalitarianism now. Fight for everyone’s freedom to vote, for the freedom of expression of our enemies too – unlike the hypocritical JD Vance who rightly spoke out against Europe’s descent into censoriousness but never defended Julian Assange’s right to journalism or the free speech of opponents to the Palestinians’ genocide. Speaking of Palestine and free speech, it is clear now (is it not?) that what started in Gaza does notstay in Gaza! Such brutality couldn’t be contained. To keep it from our media, from our cultural institutions, from the streets, they had to dissolve basic liberties in the US, in Germany, in France, across the West. That’s why our final, our seventh, campaign must be: Stop the genocide. Get the whole of Europe to Boycott, Divest and Sanction the last Apartheid state – just as we did against South Africa. Friends, fellow-travellers, comrades, we have much to do. The European dream is dead. Long live the new dream we are beginning to dream tonight. Together! Carpe DiEM25](https://image.24vids.com/tw-1898856519191699692/amplify_video_thumb/1898846630494744576/img/CcuX41foDRrGgCb4.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)
