ElmonocitoPepe

Physician,book worm, classical music lover. My latest interest: MSK US/Science without politics has no impact, politics without science can be dangerous

[ElmonocitoPepe @esculapio2001]

"Life is a war of attrition. You have to stay active on all fronts. It's one thing after another... And it's a losing battle"Harvey Pekar

[ElmonocitoPepe @esculapio2001]

@chungopailot Hay mucho residente flipado de m***** que se cree adjunto y no quiere ver las interconsultas

[UN Human Rights @UNHumanRights]

The racist, dehumanising remarks against @KMbappe by Paraguayan Sen. Celeste Amarilla are despicable, regrettably not isolated.

States & sports organisations must prevent acts of racism & discrimination, and ensure independent and effective accountability. Social media must also prevent and address racial discrimination on their platforms.

https://t.co/TVawwmw3Qo

[Sai Ishaya @Sai_Ishaya_]

To summarise this thread: Europeans passively accept unfairness, while the American spirit refuses to let an injustice go uncorrected.😅

Watching Americans frame the LITERAL geopolitical blackmail of FIFA as a proud, patriotic stand for justice is incredible.

They are weaponising state power to cheat, & then writing poetic essays about their moral superiority.🫠

It's the exact same geopolitical narcissism that allows them to obliterate a country for natural resources, & then demand global sympathy via a 3-hour Oscar-winning film about the psychological toll it took on their patriotic invading army.

[ElmonocitoPepe @esculapio2001]

@coronel_gagarin No conoces a los argentinos, son los mas racistas de Sudamérica

[Medscape @Medscape]

For nearly 30 years, the media and many physicians promoted the belief — fueled by the French paradox and bias-ridden observational studies — that a drink or two a day could be good for many adults.

Now, better-designed research has uncorked a new truth: Even one drink a day can raise the risk for cancer, cardiovascular problems, liver disease, and early death. The government-commissioned Alcohol Intake and Health Study, published in June, found a level of drinking once considered potentially protective — a glass of red wine with friends, a beer on a summer night, a brunch-time cocktail — have no meaningful health benefits.

The study joins a growing body of research presenting physicians with a challenge: How to explain to patients, even light drinkers, that older studies were flawed, and the healthiest drink is none at all. Tap the link to read the full story. https://t.co/g6jJ7F2bXU

[Anish Koka, MD @anish_koka]

And this isn’t a one off. It’s a pattern that follows biotechs with one drug they’re developing for a rare disease.

You can’t do large RCTs by definition in this group. The FDA understands that and accepts surrogates (as they should).. but this has become arbitrage for bad actors to get bad drugs on the market with bogus surrogates and the drugs have serious toxicities!

This is the playbook Sarepta has been running for a while with Duchennes, what Uniqure is trying to actively do with AMT-130, and what Capricor is doing with Deramiocel.

Resistance to obvious gaming by regulators .. leads to daily media stories about fda chaos and ultimately regulators being axed.

This is why @MartyMakary @VPrasadMDMPH @TracyBethHoeg aren’t at the FDA anymore.

Suddenly the media that didn’t cover the Chemocentryx NOOH letter or the avocapan retraction are very happy with the FDA.

“Stability returns”

Total Bullshit.

[Diario Médico @diariomedico]

📢Las agencias EMA y FDA ponen en su punto de mira el 💊fármaco para vasculitis 'Tavneos' (avacopan).

👉Se endurecen las medidas de ⚠️seguridad para prevenir la hepatotoxicidad y 🔎examinan la integridad de los datos del ensayo 'Advocate'. https://t.co/sROZ78RNJw

[Kei @_o0bpxqd0o_]

このRetraction本当に酷いな！！　これで患者に害を与えてもいるのだからAmgenは恥を知れという感じだ

Retraction: Jayne DRW et al. Avacopan for the Treatment of ANCA-Associated Vasculitis, N Engl J Med 2021;384:599-609. | New England Journal of Medicine https://t.co/Gb9jyPc9GU

[ElmonocitoPepe @esculapio2001]

@caminalm Se está hablando muy poco de este tema

[Kenar Jhaveri @kdjhaveri]

A fatal case of vanishing bile duct syndrome progressing to acute liver failure during avacopan therapy for microscopic polyangiitis https://t.co/peNJVGTMiv

[RheumatologyLive @RheumLive]

Avacopan's ADVOCATE trial has been retracted due to suspected data manipulation. The EMA calls to revoke the drug's marketing authorization and in the US, an FDA hearing is scheduled for July.
Read more of the latest on avacopan below:
https://t.co/swnI5f5vGE

[Mike Putman @EBRheum]

@AnilMakam @NEJM Great question

1. I do think Avacopan “works” for AAV, just well enough to show superiority at week 52. There are plenty of signals for efficacy in the endpoints that weren’t manipulated

I discuss in some detail here: https://t.co/GNh4W7DYkF

[ElmonocitoPepe @esculapio2001]

@deltabloqueante Después de una consulta chunga,es lo que mas te apetece

[MedPage Today @medpagetoday]

A European Medicines Agency committee recommended pulling the marketing authorization for avacopan (Tavneos) following a review over data integrity concerns in the vasculitis drug's key supporting trial.
https://t.co/h1l9ulEAyh

[21Noticias @21NoticiasCom]

La AEMPS informa de las nuevas medidas para prevenir el daño hepático con avacopan (Tavneos) https://t.co/ppVeXhybFK

[La Opinión de Murcia @diariolaopinion]

La Agencia Europea de Medicamentos recomienda la retirada de avacopan, un fármaco para dos enfermedades raras que causa daño hepático https://t.co/izJ7j4TlDD

[日本医科大学リウマチ膠原病内科 Nippon Medical School Rheumatology @NMSrheumatology]

AvacopanのADVOCATE trialの2021年論文が、昨日撤回（retraction）されたそうです。FDAの調査で、有効性評価に関わるデータの修正と一部の研究者の盲検解除に関して指摘があったようです。

一方、国内では、市販後に薬剤性肝障害が出現した件の方がニュースになりました。
https://t.co/zsuJ9AgqKf

[Anish Koka, MD @anish_koka]

On June 30, 2026, the NEJM retracted the clinical trial that got a drug approved by the FDA, triggering a $3.7B acquisition by Amgen.

The reason: the primary endpoint data was manipulated.

Here's how it happened, how it came to light, and who paid the price. 🧵

[Anish Koka, MD @anish_koka]

“ChemoCentryx’s stock price was flying high from late 2019 to early 2021 thanks to positive readouts from the phase 3 Advocate trial for Tavneos (avacopan) in a rare autoimmune disease called antineutrophil cytoplasmic antibody-associated vasculitis. During the period, Schall sold about $40 million worth of ChemoCentryx shares.”

They clearly suppressed the hepatotoxicity signal. And they then reanalyzed the data to get a statistically significant result.

Other than that everything was ok.

[Silo @SiloSeries]

We will soon.