Ausgerechnet an einer politisch aufgeheizten Berlinale hat eine Parabel über den schleichenden Verlust von Kunst- und Meinungsfreiheit gewonnen. Nun startet der Film im Kino. https://www.nzz.ch/feuilleton/der-gewinner-des-goldenen-baeren-von-berlin-spiegelt-ein-stueck-weit-die-debatten-um-das-festival-selbst-ld.1927274?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030569a6248138899b152280e643
"We must learn from history, and you cannot play Russian roulette with the fate of millions of people." - Spanish PM Pedro Sanchez, who appears to be first EU leader to be openly challenging the rationale behind the Iran war.
R to @anish_koka: 15/ In this context multiple outlets are reporting the FDA is asking for an impossible comparator arm (10 hour sham brain surgery) based on comments from the CEO of UniQure after their Type A FDA meeting. I can't find any evidence that anyone at the FDA actually said this. @HHSGov spokesperson noted the CEO comments to be a "distortion"
R to @anish_koka: 13/ Bottom line: UniQure ran a trial years ago. It failed. Rather than go back to the science to come up with something that works, they found a comparison (an external control group) that looks favorable and want the FDA to approve based on that.
R to @anish_koka: 14/ Huntington's patients deserve better than a therapy that only looks effective when you compare it against people who never had a procedure. The placebo bar exists to protect them — not to obstruct innovation.
R to @anish_koka: 11/ To be clear: FDA isn't being uniquely harsh here. Roche faced the same standard with its therapy that had a failed result in 2023 — see Roche study in NEJM (https://www.nejm.org/doi/full/10.1056/NEJMc2300400). UniQure is being treated like everyone else.
R to @anish_koka: 12/ Per FDA public comments: FDA does not require RCTs for everything : If you treat a severely ill Huntington's patient and they dramatically improve — full approval is possible without an RCT. But that would require a dramatic, unambiguous signal. UniQure doesn't have that.
R to @anish_koka: 9/ UniQure's explanation for failure of the 1 year randomized data: "the drug just takes longer than a year to work." Fine — but if that's true, why does the external controlled data show a benefit within that same year? You can't have it both ways.
R to @anish_koka: 10/ Did FDA ever promise to accept the external control data as sufficient? No documented promise exists. FDA routinely says "we need to see the data." That's not a broken deal — that's standard practice.
R to @anish_koka: 7/ Why doesn't that count? Because external controls don't experience a placebo effect. Patients who believe they received a life-changing brain therapy will report feeling better. Patients who never had any procedure won't. That gap is the placebo effect.
R to @anish_koka: 8/ UniQure's own data is internally inconsistent. Their 1-year randomized data shows no difference between treatment and control. But their historically controlled data shows a big benefit. How is that?
R to @anish_koka: 5/ UniQure has done this before. They ran a sham-controlled study in 2019. Their product failed to show benefit.
R to @anish_koka: 6/ So where does UniQure's claimed 60–75% benefit come from? Not from a randomized trial. From comparing their treated patients against an external cohort — people who never underwent any procedure at all.
R to @anish_koka: 3/ This isn't new policy. For 20+ years, FDA has required placebo-controlled trials for Huntington's treatments — including trials with fake intrathecal injections and even fake brain injections. You haven't heard of those drugs because they all failed.
R to @anish_koka: 4/ What did FDA ask UniQure to do? Compare their brain injection against a sham intervention — a small nick in the scalp under brief anesthesia. Not 10 hours of surgery. A few minutes. ( I can find no official confirmation from FDA they have asked for a 10 hour sham surgery comparator arm)
The UniQure/FDA Huntington's gene therapy controversy explained :
1/ UniQure is battling the FDA in the press over a placebo-controlled trial requirement for their Huntington's gene therapy. Here's a brief summary. 🧵
R to @anish_koka: 2/ Huntington's disease is notoriously heterogeneous — patients decline at very different rates. It's also a condition where the placebo effect is well-documented. This is exactly why FDA requires placebo controls.
Wegen der hohen Spritpreise fordern Politiker Erleichterungen für Konsumenten und Unternehmen. Geld dafür dürfte kaum vorhanden sein. Die Kritik richtet sich auch gegen die Mineralölkonzerne. Sie stammt nicht nur aus der Politik. https://www.nzz.ch/international/abzocke-regierungsversagen-jetzt-entbrennt-der-politische-streit-um-den-preissprung-an-den-tankstellen-ld.1927630?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030569a6248138899b152280e642
San Francisco: Muslim Sadat Mousa arrested Saturday after officers discovered swastikas and antisemitic & anti-gay words painted on a Pacific Heights church. https://www.sfchronicle.com/crime/article/sf-church-hate-graffiti-arrest-21948575.php
Do notice that the idi0t vaxx pushers always try to avoid discussing or debating ANY data point which exposes third rate pharmacovigilance.
@Jikkyleaks
@carl_jurassic
@canceledmouse
As an example, that's why you NEVER see them mention CDC hiding foreign VAERS reports.
It is completely ridiculous when you think about it.
The Biden era CDC, all the while pretending like it was some kind of "gold standard" for vaccine data analysis, had literally stopped publishing VAERS report clinical narratives!
That's how you get a situation like this, where someone like Jake Scott MD can just blatantly lie and pretend that all data has been shared
https://x.com/aravindmc/status/2029207886665285872
BREAKING: President Trump has brokered a "multimillion-dollar" gold deal between the US and Venezuela, per Axios.
Details include:
1. Venezuela's state-owned mining company, Minerven, agrees to sell up to 1,000 kilograms of gold destined for US markets
2. Trafigura will "shepherd" the gold to US refineries under a separate arrangement with the US government
3. The contract calls for 98% final gold content, sources say
4. The deal could be worth more than $150 million
The US is eying Venezuela's gold.
Zum zweiten Mal ersucht der Stadtrat um eine Fristerstreckung. Das führt im Gemeinderat zu «aufgesetzter» Aufregung und einem «haarsträubenden» Vergleich. https://www.nzz.ch/zuerich/35-stunden-woche-in-zuerich-stadtrat-erhaelt-mehr-zeit-fuer-pilotversuch-ld.1927421?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030569a6248138899b152280e641
Good thing the Supreme Court stepped in on Monday night to stop California from violating parental rights.
If not for the work of conservative activists and Republicans in the Tennessee General Assembly, this would have been Nashville.
In 2021, all nine Metro Nashville Publics Schools board members wore rainbow face masks as they voted to implement a "Gender Support Plan" that would facilitate a child's so-called "gender transition" at school. The school could determine, based on the child's answers to several questions, whether the parents would have any knowledge of the "Gender Support Plan."
It matters who governs. It matters who you vote for. It has never mattered more.
[Screenshot from The Tennessee Star]
Hospitals employ teams of coders to make patients seem sicker at baseline to adjust their expected mortality because it helps their bottom line/ improve margins.
Not fraud. But abuse?
Risk adjusting used frequently by the metric industrial complex is gameable - doesn't work and ultimately harms patients.
Das Parlament ist uneins, wie «modern» das Namensrecht sein soll. Die Idee, dass Geschiedene den Namen des Ex-Gatten weitergeben dürfen, ist abzulehnen. https://www.nzz.ch/meinung/neues-namensrecht-es-braucht-keinen-tourismus-mit-dem-familiennamen-ld.1927670?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030569a6248138899b152280e640
Performance metrics and the cost of reporting that's borne by independent physicians.. how it contributes to physicians dropping out of the Medicare program.
Am Mittwoch war @nymoen_ole zu Gast bei Markus Lanz. Entweder ist Lanz ein Lügner oder so unglaublich unklug, und zusätzlich auch noch fies, dass er mittlerweile völlig ungeeignet ist, eine solche Sendung zu moderieren.
Quelle WELT:
https://www.welt.de/politik/ausland/video69352bd6074aff6076811fd6/mangel-an-soldaten-gewaltsame-rekrutierungen-in-der-ukraine-immer-noch-haeufig.html
Now discussing Doctors and Performance Stats ..
https://x.com/DrDiGiorgio/status/2028573232903893058
Great discussion about the difficult decision surgeons have to make to take a patient back to the operating room because of a complication.
Mexikanischen Sicherheitskräften ist mit der Tötung von El Mencho ein wichtiger Schlag gegen die Drogenkartelle gelungen. Doch der Triumph könnte von kurzer Dauer sein, denn die Gewaltspirale droht nun erst recht angefacht zu werden. Und das vor der... https://www.nzz.ch/podcast/kartell-krieg-in-mexiko-die-folgen-nach-dem-tod-von-el-mencho-nzz-akzent-ld.1926964?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030569a6248138899b152280e63f
Discussing the great article by @lee_c_zhao on the death of the former Shah of Iran, potentially at the hands of famed surgeon Michael Debakey.
https://www.leezhaomd.org/post/the-second-cut-debakey-the-shah-and-the-hubris-of-the-comforting-explanation
Fun project. Let’s trace the propaganda to its origins and figure out how it got injected into American media.
Claim # 1: Israel did 9/11 because 4,000 Jews didn’t go to work that day
Four days after 9/11, the first piece of evidence linking Israel to the attacks was reported in Syrian government newspaper Al-Thawra.
The paper stated that “4,000 Jews were absent from their work on the day of the explosions.”
The original source of that precise 4,000 number was actually the Jerusalem Post, which reported on the day of the attacks that the Foreign Ministry in Jerusalem had received the names of 4,000 Israelis believed to have been in the areas of the World Trade Center and the Pentagon at the time of the attacks.
So the Syrians took a real news report about Israelis who might have been in the area and deliberately inverted it into a claim that 4,000 Jews had been warned to stay away.
That is the precise moment of fabrication. It then moved to Hezbollah’s Al-Manar television and spread through the Arab world.
From Al-Thawra, it was picked up by the Hezbollah-owned TV station Al-Manar on September 19, 2001. Al-Manar had received its Lebanese media license in 1997 at the request of then-Syrian president Hafez Al-Assad. The Al-Manar report was cited as the story spread around the world, including where it appeared in Russia’s Pravda before it was pulled.
The claim made its way into American media through Carto who founded the Institute for Historical Review, a Holocaust denial organization, and was one of the first American writers to deny the Holocaust in print. The IHR once offered a $50,000 reward to the first person who could prove Jews were gassed at Auschwitz, then refused to pay the Holocaust survivor who provided documentary evidence.
A total of 2,071 occupants of the World Trade Center died on September 11. According to the Wall Street Journal, roughly 10% of those identified by religion were Jewish. A later article stated there were at least 400 victims confirmed or strongly believed to be Jewish approximately 15% of total WTC victims (at the time NYC was 9% Jewish).
This is just one of many. Pay attention to who pushes this. It’s enlightening.
Welcome to our live show! https://x.com/i/broadcasts/1YxNrZbVzlXxw
Welcome to our live show! https://x.com/i/broadcasts/1AxRnaZrzQyxl
Rape, he raped a little boy
Call it what it is
O.M.G. Aaron Siri's "Vaccines Amen" is amazing. So powerful.
Auf der Suche nach neuen Einnahmen waren die Finanzpolitiker des Nationalrats phantasievoll. Doch ihre Vorschläge sind am Mittwoch nicht durchgekommen. Auch der Nationalrat will weniger «sparen» als der Bundesrat. https://www.nzz.ch/schweiz/keine-neuen-agrarzoelle-keine-express-millionen-von-den-banken-der-nationalrat-versenkt-die-sonderbarsten-vorschlaege-zum-sparpaket-ld.1927676?utm_campaign=mrf-twitter-NZZ&mrfcid=2026030569a6248138899b152280e63e