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Noteworthy

The NEJM’s peer review from beyond

Following up a recent PubPeer post the journals integrity officer Dawn Peters wrote to me „You may submit a Perspective or letter to the editor“. So I wrote this letter.

NEJM papers forming the empirical backbone of the hygiene hypothesis contain important methodological weaknesses. The journal’s role was active rather than passive: the Bach 2002 review (1) and the accompanying editorial (2) were clear endorsements published alongside the first prominent farm/endotoxin findings. The hypothesis was rarely framed to allow falsification, and was repeatedly reformulated – from “infections” to “endotoxin” to “microbial diversity” to “innate immunity.” Later disclosures of editorial conflicts of interest make a retrospective methodological audit overdue.

Bach (1), cited nearly 3,700 times, built its central argument on figures whose source data cannot be verified. Figure 1A cites a source containing seroprevalence rather than incidence data. Figure 1B assigns incorrect country categories. Figure 3 combines disease and economic data from sources that do not contain the values shown. Figure 4 relies on an unpublished personal communication that has not been replicated. The ecological framing throughout is insufficient to support causal inference.

Braun-Fahrländer (3) pools farming and non-farming children whose endotoxin exposures differ twofold into a single smoothed curve. The smoothing span is changed selectively for the one outcome contrary to the main hypothesis, without justification. Fewer than one third of eligible participants provided complete data, with no analysis of non-completers. After correction for multiple testing, virtually the entire Table 2 collapses to a single marginal result.

Ege (4) excluded wheeze-enriched children from the PARSIFAL sample, reducing wheeze prevalence from 8% to 3%, without disclosure in the main paper. In the resulting sample, the farm-asthma association is non-significant. The SSCP normalization standard contained the same organisms highlighted as the paper’s headline protective finding. In the paper’s own final model, the GABRIELA diversity result is null (OR 1.01, p=0.93) – neither value reported in the abstract.

Stein (5) infers genetic equivalence between Amish and Hutterite children from principal-component analysis of common SNPs, a method not suited to detecting the rare founder variants that distinguish these populations. Shared ancestry is thus not established, and the paper’s central contrast – attributing the four-fold asthma difference to farming environment rather than genetic background – is not warranted.

These concerns – unverifiable source data, undisclosed sample exclusions, selective analytical choices, and abstracts that omit null results from the papers’ own final models – are documented on PubPeer and remain unaddressed. Taken together, they indicate that the hygiene hypothesis was not established on sound empirical foundations.​​​​​​​​​​​​​​​​

I now received this response

Dear Prof. Wjst:

I am writing about your recent letter to the editor. We sent your concerns to authors of the studies you referenced and reviewed the replies we received as well as the studies themselves. I am sorry to say that your letter was not accepted for publication. We believe that limitations you raise were adequately acknowledged by the authors in the published papers and/or were consistent with reporting practices at the time of publication.

Thank you for the opportunity to consider your letter.

Sincerely,

Eric Rubin, MD, PhD
Editor in -Chief

So the New England Journal of Medicine has resolved my concerns about five hygiene hypothesis papers by consulting the authors. One is deceased. The rest are retired. All confirmed their work was fine, a somewhat predictable outcome.

The NEJM calls this research integrity. I call it a new normal: where the bar for correcting the scientific record is the posthumous approval of those who created it. The new normal – figures citing the wrong sources, null results missing from abstracts, undisclosed sample exclusions and a key figure that rests on an unpublished personal communication that has never been replicated. This is an interesting new benchmark for a journal of the NEJM’s standing.

One for the files.

 

CC-BY-NC Science Surf , accessed 24.05.2026
Noteworthy

There is no average patient

I am collecting material for an article questioning EBM (evidence based medicine) while coming across an interesting preprint by Zach Shahn “Trust me, I’m a doctor”.

Suppose that outcomes under usual care, e.g., collected from hospital health records, outperform the outcomes in both arms of a randomized experiment conducted in the same population. A textbook example concerning lung cancer patients comes from Hernan and Robins [2024], see also Sarvet and Stensrud [2025]. Then, Deaton and Cartwright’s argument that one should trust their physician over a trial is validated. In this case, a next step is to find the criteria that physicians are using to make personalized decisions.

He continues to examine study settings in which a randomized trial is nested within an observational cohort, so that outcomes are observed under treatment, control, and usual care while I am following up here his reference to Sarveed & Stensrud  Unfortunately the abstract of this paper is poor – it should have explained the two definitions of “harm” in personalized medicine. So I try it on my own.

Counterfactual harm – a patient is harmed if they received a treatment whose outcome is worse than what would have happened under the alternative – requires knowing unobservable potential outcomes / principal strata. The interventionist harm (the authors’ preference): a patient is harmed if their expected outcome under the assigned treatment is worse than under the alternative, conditional on their measured features which requires only experimentally identifiable quantities. The counterfactual approach is practically problematic because principal strata are metaphysical objects that can never be verified, require non-experimental data and partial identification. The interventionist approach is transparent, observable, and doesn’t coerce commitment to unverifiable metaphysics.

The paper does not explain how to do this in practice – I think this could be just a well-designed RCT with pre-specified effect modification analysis. The workflow would be; pre-register → stratified randomization → interaction-term analysis or causal forest → decision rule by argmax of expected outcome. You never need to ask “what would have happened to this patient under the other treatment” — you only ask “what does the evidence say about patients like this one.”

 

 

CC-BY-NC Science Surf , accessed 24.05.2026
Noteworthy

US demands on African countries in exchange for health aid

After dismantling USAID in January 2025, the Trump administration has been negotiating bilateral health agreements with over 30 countries, predominantly in Africa, under its “America First Global Health Strategy.” The deals tie what was previously humanitarian assistance to a bundle of strategic demands:

1. Personal health and genomic data

Ghana walked away from a $109 million deal after Washington demanded access to personal health data (Ärzteblatt, April 2026). In Zambia, the US demanded 10 years of access to national health and genomic data in exchange for only 5 years of funding, with no guarantee that Zambia would benefit from any vaccines or drugs developed from that data (IBTimes UK).

2. Mining concessions for US companies

A leaked State Department memo proposed explicitly using HIV aid for Zambia’s 1.3 million PEPFAR-dependent patients as leverage to extract access to copper, cobalt, lithium, and rare earth minerals (FPRI, March 2026). In the DRC, after demanding 20-year corporate tax exemptions, windfall tax waivers, and duty-free treatment for US imports, Washington secured a deal giving US firms right-of-first-offer on certain mining sites (Capital & Main, April 2026).

3. Recipient country co-financing

Zambia’s proposed deal required the country itself to contribute roughly $340 million in domestic health spending alongside the US offer of $1 billion over five years, sharply reducing the net benefit (Observer Research Foundation, March 2026).

4. Regulatory reforms favoring US investment

Several agreements include clauses requiring recipient governments to create favorable regulatory environments for US direct investment in mining and pharmaceuticals (Al Jazeera, April 2026).

So the strategic goal is to redirect African critical minerals — cobalt, copper, lithium, rare earths — into US supply chains and counter China’s dominance in African mining.

PEPFAR, long regarded as one of America’s most successful humanitarian programs (credited with saving over 26 million lives globally), is now being openly wielded as a negotiating tool. Zimbabwe, Zambia, and Ghana have rejected or walked out of talks; Kenya, Nigeria, Ethiopia, and over a dozen others have signed agreements. Malawi’s Kayelekera uranium mine  restarted and now shipping to the US.

Critics, including former USAID officials, have called the approach “coercion dressed in the language of strategy.”

 

CC-BY-NC Science Surf , accessed 24.05.2026
Philosophy

Was ist das Wahre daran – und was das Falsche?

Antje Schrupp läuft zu neuen Höhen auf. Auszug aus https://steady.page/de/antjeschrupp/posts/99dd25dc-44cc-4d03-b4c2-365a97cc2ab5

Wenn heute über irgendein politisches Thema gestritten wird, ist da weit und breit keine Dialektik in Sicht, also kein differenziertes und komplexes Nachdenken über die Art der Polarität, mit der man es zu tun hat, sondern heute werden Binaritäten schlicht als unvereinbare Gegensätze präsentiert – schwarz oder weiß, richtig oder falsch, Freund oder Feind. Bist du dafür oder dagegen? Wer nicht eindeutig für uns ist, ist gegen uns – und damit als Bündnispartnerin diskreditiert. […] Hegel war anders. Ihm verdanke ich einen echten Lifehack, den ich damals im Seminar gelernt und dann verinnerlicht habe. Die entsprechende Übung im Seminar war simpel: Wenn eine Aussage, ein politisches Phänomen, eine Bewegung zur Beurteilung vorliegt, so lernten wir, lautet die Frage nicht: Ist das richtig oder falsch? Sondern: Was ist das Wahre daran – und was das Falsche?

 

CC-BY-NC Science Surf , accessed 24.05.2026
Noteworthy

The Stockholm declarations never worked

The 1972 Stockholm Declaration is considered a landmark in international environmental law, but it has not achieved its full potential to reverse ecological destruction.

Nice, that  now also this paper finally appeared – it explains why also the Sabel and Larhammar 2025 Declaration will never work.

https://doi.org/10.1098/rsos.252165

 

CC-BY-NC Science Surf , accessed 24.05.2026
Noteworthy

The Padua pipeline – how a sanctioned Iranian university publishes clinical data in an off topic Italian open access journal

I recently came across the European Journal of Translational Myology publishing papers outside the scope of the journal and outside the expertise of the editorial board.

Editor-in-Chief Ugo Carraro (*1943, former University of Padua researcher) supported EJTM’s broadening from muscle physiology into general medicine, proposing a rename to “Myology, Mobility, Medicine”. The journal subsequently started to publish Iranian clinical papers across orthopedics, dentistry, psychiatry, COVID-19, and urology – not related to myology. In 2022, an Iranian author even published in EJTM a bibliometric study of Iranian output in EJTM itself –  a self-referential feedback loop that normalizes the journal as a legitimate Iranian venue inviting further submissions.

The Cegolon bridge

Luca Cegolon (University of Trieste) is the structural intermediary between Baqiyatallah University of Medical Sciences (BMSU) and Italian academia. He holds at least six joint publications with Einollahi and Javanbakht spanning COVID-19, plasma exchange, ozone therapy, and kidney injury — all on Iranian data. Cegolon completed his PhD at Padua University Medical School,  the same institution as Carraro. The Tehran–Trieste–Padua route therefore carries manuscripts from a sanctioned IRGC institution to a Pavia open-access publisher with no regulatory friction.

Javanbakht as serial off-topic submitter

Javanbakht’s EJTM papers cover kidney transplantation pharmacology (Suprotac tacrolimus), male fertility / varicocelectomy, and wrist tendon transfer surgery – none touching myology. The pattern is deliberate: EJTM is Scopus-indexed, open-access and has demonstrated tolerance for off-topic Iranian clinical submissions. The Suprotac APC was almost certainly paid by NanoAlvand Company, the product’s manufacturer, paying a trivially small marketing cost for a PubMed-citable Phase IV label.

The sanctions geography

From March 2013, OFAC regulations prohibited US-owned journals from handling manuscripts authored by Iranian government employees. Elsevier instructed its US editors to reject such manuscripts outright. OFAC sanctions also generated misunderstanding among editors in other countries, who rejected Iranian manuscripts for political rather than scientific reasons, further narrowing the accessible publishing landscape.

PAGEPress has no US ownership and no OFAC exposure. It accepts APC payments via Italian bank transfer (Banca Popolare di Sondrio), routable through European exchange offices without triggering US sanctions. It fills a structural niche created by the sanctions geography.
Baqiyatallah University of Medical Sciences   (BMSU) was founded in 1994 as the primary medical institution operated by the Islamic Revolutionary Guard Corps IRGC. The US Treasury designated it on under Executive Order 13382 (WMD proliferation) and again in 2017 under Executive Order 13224 (terrorism support). Foreign parties facilitating transactions for the entity are subject to US sanctions. Einollahi, Javanbakht, and their BMSU co-authors are employees of this designated institution.

The primary exchange is probably not financial but metric. For Cegolon, co-authorship with a high-volume Iranian clinical group accelerates publication output at a career stage where Italian Abilitazione Scientifica Nazionale metrics directly determine promotion. For BMSU and NanoAlvand, the European co-author provides editorial access, institutional legitimacy, and a sanctions-circumventing pathway to Scopus. The APC is the transaction cost; mutual bibliometric benefit is the structural incentive — legal, common, and largely misaligned with quality control.

 

CC-BY-NC Science Surf , accessed 24.05.2026
Allergy

Epithelial barrier hypothesis now confirmed

Akdis and colleagues at the Swiss Institute of Allergy and Asthma Research, SIAF have developed what is often called the epithelial barrier hypothesis EBH or epithelial damage theory, most systematically articulated around 2020-2021 in a series of papers. The core idea is that a wide range of modern environmental exposures (detergents, surfactants, emulsifiers, cleaning products, microplastics, particulate matter, tobacco smoke, certain dietary additives) damage the epithelial barriers of the skin, gut, and airway. The theory gives as an explanation for the modern epidemic of allergic disease, autoimmunity, and certain inflammatory conditions – arguing that the hygiene hypothesis and biodiversity hypothesis are partially correct but incomplete, because the primary driver is not simply reduced microbial exposure but active epithelial damage by novel chemicals of the industrial era. Cezmin Akdis published a landmark review 2021 titled something like “Does the epithelial barrier hypothesis explain the increase in allergy, autoimmunity and other chronic conditions?” that laid out the full framework.

An upcoming congress is now dedicated to EBH.

12th Swiss Congress on Environmental Allergology and Epithelial Medicine

“Barriers Under Siege: Modern Threats to Human Interface Biology”

Date: September 14-17, 2026
Location: Congress Center Basel, Switzerland
Host: Swiss Society of Immune Speculation (SSIS)
Co-sponsors: European Academy of Allergic Overreaction (EAAOR)
Global Confederation of Airborne Anxiety (GCAA)

Keynote Speakers: Prof. M. Sidka (FIAS), University of Zurich) – “Epithelial Damage Theory: 5 Years Later”

Prof. Alexandra Steinberg (ETH Zurich) – “The 2.4 GHz Epidemic: Evidence and Implications”
Dr. Rachel Thornfield (St. Bartholomew’s Hospital) – “Microplastic Perforation Syndrome: A New Clinical Entity”

Abstract Submission Deadline:  Feb 15, 2026
Registration: www.swiss-environmental-allergy2026.ch

Three new studies from the online  abstracts to confirm the hypothesis.

Abstract 1: Epithelial Barrier Disruption by Household Detergents Predicts Allergic Sensitization: A Prospective Birth Cohort Analysis

Marta K. Lindström¹, Javier Hernández-Cortés², Elena V. Petrov³, Thomas Müller-Bern¹, Sarah J. Whitfield⁴, Andreas Koller⁵, Fatima Al-Rashid⁶, Dimitri Papadopoulos⁷, Lisa Chen⁸, Marco Antonelli⁹, Ingrid Svensson¹⁰, Robert MacLeod¹¹

¹Swiss Institute of Asthma (FIASC), University of Zurich, Switzerland ²Department of Pediatric Allergology, Hospital Infantil La Paz, Madrid, Spain ³Institute for Environmental Health, Karolinska Institute, Stockholm, Sweden ⁴Centre for Barrier Biology, University of Edinburgh, UK ⁵Department of Dermatology, Medical University of Vienna, Austria ⁶Environmental Toxicology Unit, King Saud University, Riyadh, Saudi Arabia ⁷European Centre for Allergy Research Foundation, Athens, Greece ⁸Division of Immunology, Boston Children’s Hospital, Harvard Medical School, USA ⁹Department of Molecular Medicine, University of Padova, Italy ¹⁰Scandinavian Epithelial Research Consortium, University of Bergen, Norway ¹¹Department of Public Health, University of Glasgow, UK

Background: The epithelial damage theory proposes that modern chemical exposures compromise barrier integrity, promoting type 2 immunity. We tested whether early-life detergent exposure predicts subsequent allergic sensitization.
Methods: We recruited 847 newborns from three European cities (2019-2021) and measured transepidermal water loss (TEWL) at 6 weeks using standardized methodology. Parents completed detailed questionnaires on household cleaning product use, including specific brand names and frequencies. Serum samples at 24 months were analyzed for specific IgE to 15 common allergens using ImmunoCAP. Primary outcome was ≥1 positive sensitization (≥0.35 kU/L). Secondary analyses examined TSLP, IL-33, and tight junction protein expression in nasal epithelial brushings.
Results: Complete data were available for 739 children. Median TEWL was 12.4 g/m²/h (IQR 9.1-16.8). Children with high TEWL (>90th percentile, n=74) had significantly elevated sensitization rates compared to low TEWL (<10th percentile, n=73): 48.6% vs 12.3% (adjusted OR 4.7, 95% CI 2.1-10.4, p<0.001). Unexpectedly, this association was entirely driven by households using premium fabric softeners containing quaternary ammonium compounds ≥3 times weekly (interaction p=0.003). Among high-detergent-use families, TEWL >15 g/m²/h predicted sensitization with 94% specificity and 61% sensitivity. Nasal epithelial TSLP expression correlated strongly with TEWL (r=0.72, p<0.001) and was 3.8-fold higher in the high-TEWL group.
Conclusions: Infant epithelial barrier dysfunction, as measured by TEWL, powerfully predicts allergic sensitization at 24 months. The unexpected concentration of risk among users of premium fabric softeners suggests specific quaternary ammonium formulations may be particularly damaging to developing epithelial barriers.

Abstract 2: Microplastic-Induced Epithelial Perforation Syndrome: Evidence from Emergency Department Skin Biopsies

Dr. Rachel M. Thornfield¹, Prof. Klaus Weber-Hoffmann², Yuki Tanaka³, Maria Fernanda Santos⁴, Erik J. Lindqvist⁵, Priya Sharma⁶, Jean-Claude Dubois⁷, Dr. Anastasia Volkov⁸, Prof. Giovanni Benedetti⁹, Dr. Amira Hassan¹⁰, Dr. James O’Sullivan¹¹, Dr. Nina Petersen¹², Prof. Rajesh Mehta¹³, Dr. Sophie Laurent¹⁴

¹Emergency Medicine Research Unit, St. Bartholomew’s Hospital, London, UK ²Institute for Microplastic Pathology, Technical University of Munich, Germany ³Department of Environmental Dermatology, Tokyo Medical University, Japan ⁴Brazilian Centre for Plastic Pollution Health Effects, University of São Paulo, Brazil ⁵Nordic Institute for Particle Toxicology, University of Copenhagen, Denmark ⁶Centre for Urban Environmental Health, All India Institute of Medical Sciences, New Delhi, India ⁷Laboratory of Environmental Pathophysiology, INSERM, Lyon, France ⁸Department of Cellular Ultrastructure, Moscow State University, Russia ⁹Institute of Advanced Microscopy, University of Florence, Italy ¹⁰Environmental Health Department, Cairo University, Egypt ¹¹Trinity Centre for Environmental Health, Trinity College Dublin, Ireland ¹²Scandinavian Environmental Medicine Institute, University of Oslo, Norway ¹³Department of Occupational Health, Tata Institute, Mumbai, India ¹⁴Centre de Recherche Environnementale, University of Geneva, Switzerland

Background: Microplastics are ubiquitous environmental contaminants, but their direct pathological effects remain unclear. We investigated an unexpected clustering of acute dermatitis cases presenting to our emergency department.
Methods: Between March-August 2025, we observed 23 patients (ages 4-67) presenting with sudden-onset vesicular eruptions and intense pruritus, all within 15km of a municipal recycling facility. Standard patch testing was negative. We performed 4mm punch biopsies and analyzed tissue samples using scanning electron microscopy (SEM) and energy-dispersive X-ray spectroscopy. Household dust samples were collected from all patients’ homes and analyzed for microplastic content via pyrolysis-GC/MS.
Results: SEM revealed remarkable ultrastructural findings: polyethylene terephthalate (PET) fragments 2-8 μm in diameter were physically embedded within stratum corneum, with sharp edges penetrating into the stratum granulosum. These “microplastic daggers” created microscopic perforations associated with intense inflammatory infiltrates. Affected keratinocytes showed 847-fold elevation in TSLP expression compared to normal skin (p<0.001). Household dust analysis revealed PET concentrations 23-156× higher than control homes (geometric mean 89,400 vs 1,240 particles/g, p<0.001). All patients lived <500m from major roadways with heavy recycling truck traffic. Symptoms resolved within 72 hours of temporary relocation, but recurred upon return home. Electron microscopy of automotive tire dust from the recycling route showed identical PET morphology to the embedded skin fragments.
Conclusions: This represents the first documented case series of direct mechanical epithelial barrier breach by airborne microplastics. The “dagger hypothesis”—sharp-edged plastic fragments acting as microscopic penetrating trauma—may explain certain idiopathic dermatoses in industrialized areas.

Abstract 3: Bluetooth-Induced Epidermal Permeability: The 2.4 GHz Tight Junction Phenomenon

Prof. Alexandra Steinberg¹, Dr. Mohammad Al-Zahra², Dr. Jennifer Liu-Kim³, Prof. Hans-Peter Krämer⁴, Dr. Olga Mikhaylova⁵, Dr. Benjamin Kowalski⁶, Prof. Maria Isabel Rodríguez⁷, Dr. Kenji Yoshimura⁸, Dr. Fatou Ndiaye⁹, Prof. Sebastian Larsson¹⁰, Dr. Pradeep Gupta¹¹, Dr. Catherine Brennan¹², Prof. Ahmed El-Mansouri¹³, Dr. Valentina Romano¹⁴, Dr. Michael O’Brien¹⁵, Prof. Yusuf Hassan¹⁶, Dr. Anna Korhonen¹⁷, Dr. Philippe Moreau¹⁸

¹Department of Electromagnetic Biology, ETH Zurich, Switzerland ²Institute for Wireless Health Effects, American University of Beirut, Lebanon ³Center for Digital Health Research, University of California San Francisco, USA ⁴Fraunhofer Institute for Biomedical Engineering, Heidelberg, Germany ⁵Laboratory of Electromagnetic Pathophysiology, Lomonosov Moscow State University, Russia ⁶Institute of Bioelectromagnetics, Technical University of Warsaw, Poland ⁷Centro de Investigación en Campos Electromagnéticos, Universidad Complutense Madrid, Spain ⁸Department of Radiation Biology, Kyoto University, Japan ⁹African Centre for Electromagnetic Research, University of Dakar, Senegal ¹⁰Swedish Institute for Wireless Safety, Karolinska Institute, Stockholm, Sweden ¹¹Centre for Electromagnetic Medicine, All India Institute of Medical Sciences, India ¹²School of Electronic Engineering, University College Dublin, Ireland ¹³Institute of Applied Physics in Medicine, University of Alexandria, Egypt ¹⁴Department of Bioengineering, Politecnico di Milano, Italy ¹⁵Centre for Occupational Electromagnetics, University of Melbourne, Australia ¹⁶Department of Physics in Medicine, University of Cape Town, South Africa ¹⁷Finnish Centre for Electromagnetic Health, University of Helsinki, Finland ¹⁸Laboratory of Environmental Biophysics, CNRS Toulouse, France

Background: Wireless device proliferation has increased ambient electromagnetic radiation exposure, but biological effects remain controversial. We investigated an unexpected correlation between infant eczema severity and household Bluetooth device density discovered during routine allergy clinic visits.
Methods: During a power outage at our pediatric allergy unit (June 2024), we serendipitously observed that 4 infants with severe atopic dermatitis showed dramatic symptom improvement within 90 minutes of complete electromagnetic silence. We subsequently recruited 156 families and conducted a novel “digital detox intervention”: 72-hour complete removal of all Bluetooth devices (phones, tablets, smart watches, wireless headphones, baby monitors, smart thermostats). Transepidermal water loss (TEWL) was measured using AquaFlux before, during, and after the intervention. We simultaneously measured 2.4 GHz electromagnetic field strength using calibrated spectrum analyzers.
Results: Baseline TEWL correlated strongly with household Bluetooth device count (r=0.83, p<0.001) and 2.4 GHz field strength (r=0.79, p<0.001). During digital detox, TEWL decreased by mean 47% (95% CI 39-55%, p<0.001). Most remarkably, infants living in homes with >15 active Bluetooth connections showed a biphasic response: initial TEWL reduction at 6 hours, followed by paradoxical elevation at 24 hours, then dramatic normalization by 72 hours—suggesting a “wireless withdrawal syndrome.” Upon device reintroduction, TEWL returned to baseline within 8 hours. In vitro keratinocyte cultures exposed to 2.4 GHz pulsed radiation showed 340% increase in claudin-1 degradation compared to controls (p<0.001).
Conclusions: These preliminary findings suggest that ubiquitous 2.4 GHz Bluetooth radiation may directly compromise epithelial barrier function through tight junction protein destabilization. The “digital detox response” warrants urgent replication given the public health implications for 3.2 billion wireless device users globally.

 

CC-BY-NC Science Surf , accessed 24.05.2026
Pages: 1 2
Joke, Video

Tarzahn aus Timbuktu

Privates wird sich hier auf dem Blog hier kaum etwas finden, aber als ich ein Video meines langjährigen Zahnarztes zufällig gefunden habe,  muss ich es natürlich teilen.

 

CC-BY-NC Science Surf , accessed 24.05.2026
Noteworthy

Why Maxwell’s statement proved too much

Having been working on the infamous Giuffre/Mountbatten/Maxwell photo, I came across now an email draft of a defense attributed to Maxwell that seems to confirm the authenticity of the photo  “In 2001 I was in London when met a number of friends of mine including Prince Andrew. A photograph was taken as I imagine she wanted to show it to friends and family.“

The media coverage was extensive and remarkably uniform. Continue reading Why Maxwell’s statement proved too much →

 

CC-BY-NC Science Surf , accessed 24.05.2026
Allergy, Vitamins

Why you can’t change the rules after the game has started

It was a long wait – 10 years –  for the Vitality vitamin D study in newborns to come to an end. It is super disappointing to see now their first study abstract at the 2026 AAAAI Annual Meeting with a null result. Besides the fact that they got it wrong – Vitamin D3 supplementation was never protective but allergy risk  in newborn –  the following  three screenshots show something that should make any methodologist uncomfortable.

The VITALITY trial filed its first ClinicalTrials.gov record in April 2014. By November 2022 with the data at hand, version 12 shows sweeping rewrites to both the primary outcome and the inclusion criteria. Pink = deleted, green = added.

What changed, concretely:

– The original primary outcome was “prevalence and severity of challenge-proven food allergy in participants with positive skin prick tests at age 12 months.” Version 12 splits this into two primaries, adds a second time point (6 years of age), and quietly drops “severity” and the SPT-positive filter. That filter was doing real work: restricting the analysis to sensitised children would have given a much smaller, higher-risk denominator.
– The inclusion criteria went from “healthy, term, breastfeeding infants” to a detailed specification with an age window (6–12 weeks), formula tolerance up to 120 mL/day, and a new informed-consent bullet. Each addition narrows or shifts the enrolled population.

Reporting two significant p-values from what are effectively subgroup analyses in an abstract whose primary result failed (p=0.537) is textbook outcome fishing. With 10 allergens tested, finding two below 0.05 by chance alone is entirely expected. In short: a failed trial has been dressed as a promising one through a combination of dual estimands, allergen subgroup mining, heavy imputation, and conclusion spin. Each element is individually defensible in isolation; together they constitute a coordinated rhetorical strategy to salvage a null result.

Why this is a fundamental problem?

Clinical trials are hypothesis tests, not explorations. The logic is identical to a one-sample t-test: you fix the null hypothesis, the test statistic, and the decision threshold before you look at the data, because the Type I error rate (your false-positive probability) is only valid under those pre-specified conditions. The moment you select or redefine your outcome after seeing interim results — even partially, even innocently — you are performing an implicit multiple comparison. You have, in effect, tested several hypotheses and reported only the one that worked.

Changing inclusion criteria mid-study is equally damaging. It redefines the population to which your result generalises. If the original enrolment targeted a broader group and the amended criteria select a more compliant or biologically distinct subgroup, the treatment effect you ultimately report belongs to a population that was never pre-specified. Reviewers and readers have no way to know whether the amendment was scientifically motivated or outcome-motivated.

The specific mischief of outcome switching

Dropping “severity” from the primary outcome is not cosmetic. A trial that fails on prevalence-plus-severity can be reframed as a success on prevalence alone. Dropping the SPT-positive filter expands the denominator, which typically dilutes an effect — unless the intervention actually works better in unselected infants, a hypothesis that was apparently not the original one. Adding a six-year follow-up endpoint transforms a 12-month study into something else entirely, with a different sample-size justification and a different regulatory profile.

What preregistration is supposed to prevent

The entire point of a trial registry is to create a timestamped public contract. Investigators declare in advance: this is our question, this is our population, this is how we will measure success. Journals and regulators can then verify that the published analysis matches the contract. When version 12 diverges this substantially from version 2, the contract has been renegotiated — and the renegotiation happened after years of data collection, when results were at least partially visible to the investigators.

This does not automatically mean misconduct. Trials genuinely need protocol amendments — safety signals emerge, recruitment proves impossible under original criteria, regulatory agencies request changes. But every such amendment requires a documented, dated rationale filed before the analysis is run, and the published paper must report both the original and amended specifications with transparent explanation. Silently absorbing eight versions of changes into a final paper, with no mention of what the original primary endpoint was, converts a confirmatory trial into a disguised exploratory one — while retaining the inferential authority of a pre-registered RCT.

The VITALITY screenshots are a clean teaching example of exactly this problem.​​​​​​​​​​​​​​​​

 

CC-BY-NC Science Surf , accessed 24.05.2026
Genetics, Noteworthy

Genetic discrimination

Unfortunately with the decline of genomic research, there are some “hobbyist” researchers coming up with their own agenda. Three recent investigations lay out just how bad things have gotten – and how difficult it is to stop the damage once it starts.

The New York Times revealed that fringe researchers systematically deceived the NIH to gain access to genetic and brain-scan data from over 20,000 American children enrolled in the Adolescent Brain Cognitive Development Study. Using deliberately misleading applications, they extracted the data, shared it with unauthorized collaborators, and produced at least 16 papers purporting to rank racial groups by IQ. The papers have since been amplified millions of times on social media, cited by AI chatbots, and used as ammunition by white nationalists. The NIH eventually suspended the lead researcher and he was fired – yet his collaborators apparently retained copies of the data and kept publishing.

The Guardian then showed the problem is not limited to bad-faith actors inside the system. UK Biobank, which holds health records on 500,000 British volunteers, found that well-meaning researchers had accidentally posted sensitive datasets to GitHub dozens of times. One exposed file contained hospital diagnoses and birth details for 413,000 participants – enough to re-identify individuals with just a date of birth and one known medical procedure.

Harvard geneticist Sasha Gusev ties both stories together in a sharp Substack essay. His core point is simple: these systems were designed assuming everyone plays by the rules. They were not built for people who lie on their access applications, quietly pass data to friends, or treat a children’s health study as raw material for race propaganda. When something goes wrong, the response tends to be more paperwork, more committees, more strongly worded statements — none of which does much against someone who was never going to read them anyway. Gusev’s actual prescription: stick to what participants consented to, ban anyone who leaks data permanently, and when bad science appears, criticize it loudly in plain language where people can actually read it – not in a journal response that ten specialists will see.

The people who donated their data, often hoping to help find cures for cancer or diabetes, deserve at least that much.

 

 

CC-BY-NC Science Surf , accessed 24.05.2026
Vitamins

Das Deutsche Ärzteblatt und die Münchner Medizinische Wochenschrift: Vitamin D Märchenstunde

Sowohl das Deutsche Ärzteblatt als auch die Münchner Medizinische Wochenschrift veröffentlichten nun in kurzer Folge methodisch fragwürdige Beiträge zur Vitamin-D-Forschung. Und da sie eine enorme Reichweite in der ärztlichen Fortbildung haben, landet der Vitamin-D-Hype direkt in der Praxis mit den bekannten Folgen: Überdiagnostik, unnötige Supplementierung, wir kennen die Probleme viele Jahre zB hier.  Von einer Erwiderung habe ich dennoch abgesehen, da dem Erstautor der Schlusskommentar vorbehalten bleiben sollte.

Fall 1

Die MMW druckt eine “Fortbildung”, genauer einen CME-Beitrag „Wer braucht wann wie viel Vitamin D?“ eines lange pensionierten fachfremden Arztes (MMW Fortschr Med. 2025; 167 (S3): 76–82).  Leider übernimmt die KI den Unsinn nun als Expertenmeinung…

Screenshot  Google 26.3.2026

Mein Kommentar zu dem Artikel war

1. Interessenkonflikt
Der Autor gibt „keine Interessenkonflikte“ an, betreibt jedoch die Akademie für menschliche Medizin GmbH, die kommerziell Vitamin-D-bezogene Präventionsangebote vertreibt. Diese Verbindung ist gemäß DFG- und ICMJE-Regeln deklarationspflichtig. Medwatch schreibt von 225.000€ Umsatz im Jahr 2019.
2. Epidemiologische Angaben
Die Behauptung, „90 % der Bevölkerung“ hätten < 30 ng/ml Vitamin D, stützt sich auf veraltete RKI-Daten (2007–2011). Neuere Erhebungen (DEGS II, 2019) zeigen nur 30–40 % unter 50 nmol/l. → Übertriebene Darstellung eines Mangels.
3. Dosierungsempfehlung
Empfohlene 4 000–6 000 IE/Tag überschreiten den international anerkannten Upper Level von 4 000 IE/Tag (EFSA 2023). Für gesunde Erwachsene fehlt jede Evidenz.
4. Toxizität und „Coimbra-Protokoll“
Die Aussage, Werte bis 150 ng/ml seien unbedenklich, widerspricht Daten zu Hyperkalzämie und Nephrokalzinose. Das „Coimbra-Protokoll“ (≥ 100 000 IE/Tag) ist nicht evidenzbasiert und medizinisch riskant.
5. Extra-skelettale Effekte
Im Artikel werden präventive Wirkungen (Demenz, KHK, Krebs, Blutdruck, Diabetes u. a.) behauptet, obwohl große RCTs (VITAL, D2d, ViDA) keinen Nutzen zeigten. Die Darstellung ist selektiv und irreführend.
6. Schwangerschaft
Die genannte 60 %ige Reduktion von Frühgeburten entstammt keiner belastbaren Quelle; die zitierte Pilotstudie (Wagner et al. 2006) weist diese Endpunkte nicht auf.
7. COVID-19-Bezug
Die angeblich 16-fache Mortalitätssteigerung bei Vitamin-D-Mangel beruht auf einem Meinungsartikel, nicht auf einer Originalstudie. Die Darstellung ist faktisch falsch.
8. Fehlende Neutralität im CME-Kontext
Der Beitrag enthält werblich anmutende Aussagen, selektive Quellenwahl (u. a. Masterarbeit Göthel 2020) und unkritische Übernahme von Hypothesen. Damit ist die formale Neutralitätsanforderung der CME-Zertifizierung (§ 4 CME-Richtlinie BÄK) nicht erfüllt.

Der Chefredakteur Cornelius Heyer nimmt auf meine Reklamation zwar die CME Akkreditierung heraus, aber statt einer Korrektur oder Löschung des Beitrages, druckt die MMW einen Leserbrief nach dem Spitz das letzte Wort in der Diskussion hat und tatsächlich in Bhakdi Manier schreibt “Die von mir dargestellten Fakten entsprechen der aktuellen internationalen Forschung – wenn die Leitlinien das nicht tun bitte ich, dies mir nicht anzulasten”.

Screenshot 26.3.2026 Nota bene – Spitz hat nie wissenschaftlich zu dem Thema gearbeitet
Passiva  der Akademie für menschliche Medizin 2021

Ein beliebiger Leser der Tageszeitung ist damit nun also besser informiert als ein/e Arzt/Ärztin der die MMW abonniert hat.

 

Fall 2

Das Deutsche Ärzteblatt druckt ein Review eines Kongressabstracts “Personalisierte Vitamin D Supplementierung kann das Re-Infarktrisiko halbieren”.  Wer nec ist weiss  ich nicht, allerdings weiss ich genau, dass es wieder Märchen sind die nec hier erzählt. Der Leiter der Medizinisch-Wissenschaftlichen Redaktion des DÄ Christopher Baethge verweist mich an die journalistische Redaktion in Berlin Michael Schmedt, der allerdings auch nach Wochen immer noch nicht geantwortet hat.

New Orleans – Eine Supplementierung mit Vitamin D in individuell titrierter Dosierung kann das Risiko für einen erneuten Herzinfarkt bei vorerkrankten Personen um mehr als die Hälfte reduzieren. Das berichteten Forschende bei den Scientific Sessions 2025 der American Heart Association in New Orleans (Abstract Nr. 4382525).
[…]

Warum ist das so?

Die TARGET-D-Studie wird als Korrektur früherer negativer Vitamin-D-Studien präsentiert, mit der Behauptung, diese seien gescheitert, weil sie Vitamin D nicht „zielgerichtet“ titriert hätten. Bei genauer Betrachtung reproduziert TARGET-D jedoch genau jene strukturellen Schwächen, die die Vitamin-D-Outcome-Literatur seit Jahren geplagt haben.

Der entscheidende Befund ist eindeutig: Der vordefinierte primäre Endpunkt, schwere kardiovaskuläre Ereignisse (MACE), wurde in der Intention-to-treat-Analyse nicht signifikant reduziert. Nach elementaren CONSORT-Prinzipien müsste dieses Ergebnis die Interpretation bestimmen. Stattdessen verlagert die Studie den Fokus sofort auf ein einzelnes positives Signal in einer Unterkomponente des kombinierten Endpunkts, den Folge-Myokardinfarkt. Diese Verschiebung rettet die Studie nicht, sondern verschleiert ihr negatives Hauptergebnis. Wenn ein kombinierter Endpunkt scheitert, stellt die selektive Hervorhebung einer einzelnen Komponente keine Evidenz dar, sondern narrative Verzerrung.

Die anschließende Betonung von Per-Protocol-Analysen untergräbt die Aussagekraft weiter. Diese Analysen vergleichen nicht mehr randomisierte Gruppen, sondern Untergruppen, die nachträglich anhand des Erreichens eines willkürlich gewählten Vitamin-D-Schwellenwertes definiert werden. Damit wird nicht mehr die Wirkung einer Intervention geprüft, sondern der Gesundheitszustand einer selektierten, therapietreuen, Responder Population dem einer Restgruppe gegenübergestellt, die überproportional Nicht-Responder, Gebrechliche und Patienten mit höherer Krankheitslast enthält. Der Vitamin-D-Spiegel fungiert hier als Marker guter Gesundheit und Compliance, nicht als kausaler Faktor. Genau dieser Denkfehler hat frühere Beobachtungsstudien diskreditiert, was auch in allen Umbrella Reviews klar herauskam, aber hier innerhalb eines randomisierten Designs erneut eingeführt wird.

Das Ausmaß der postrandomisierenden Selektion macht dieses Problem unübersehbar. Ein erheblicher Teil der dem Vitamin-D-Arm zugewiesenen Patienten wird aus der Per-Protocol-Analyse ausgeschlossen, weil der Zielwert nie erreicht wurde oder nur unvollständige Nachbeobachtung vorlag. Die Konditionierung auf einen postrandomisierten Biomarker zerstört die durch Randomisierung erreichte Vergleichbarkeit der Gruppen. Die daraus resultierenden Effekte sind selektionsgetrieben und nicht kausal interpretierbar.

Auch die biologische Grundannahme der Studie ist schwach fundiert. Der gewählte Zielwert von über 40 ng/ml für 25-Hydroxyvitamin D ist nicht leitlinienbasiert, entspricht nicht der neuesten Literaturund impliziert einen Schwellen- oder Dosis-Wirkungs-Effekt, der in großen randomisierten Studien und genetischen Analysen nicht bestätigt wurde. Indem der Studienerfolg über das Erreichen dieses Zielwerts definiert wird, wird der behauptete Nutzen nicht getestet, sondern implizit vorausgesetzt.

Die Darstellung der Ergebnisse verstärkt diesen Eindruck. Formulierungen wie „klinisch relevante Risikoreduktionen“ oder „Reduktion des Myokardinfarktrisikos um mehr als die Hälfte“ suggerieren einen kausalen Effekt, den das Studiendesign und die Resultate nicht tragen. Andere Komponenten des kombinierten Endpunkts zeigen keine konsistente Verbesserung, werden jedoch deutlich weniger betont. Der Gesamteindruck ist nicht der einer neutralen Prüfung einer Hypothese, sondern der Versuch, aus einer im Kern negativen Studie ein positives Narrativ zu extrahieren.

Insgesamt liefert TARGET-D keinen belastbaren Beleg dafür, dass eine Vitamin-D-Normalisierung das kardiovaskuläre Risiko nach akutem Koronarsyndrom senkt. Der primäre Endpunkt ist negativ, die sekundären Aussagen beruhen auf selektiver Gewichtung, und die Per-Protocol-Analysen ersetzen Randomisierung durch Adhärenz- und Selektionsmechanismen. Die Studie bestätigt letztlich nur, was die Literatur seit Langem zeigt: Niedrige Vitamin-D-Spiegel korrelieren mit schlechter Gesundheit, ihre Korrektur verändert jedoch harte kardiovaskuläre Endpunkte nicht zuverlässig. Neu an TARGET-D ist nicht die Überwindung dieser Limitationen, sondern ihre methodisch aufwendigere und potenziell irreführende Verpackung.

Die Assistentin der Chefredaktion Monia Jacobs entgegnet sinngemäß am 15.4. per Email, die Studie sei auf dem renommierten AHA-Kongress vorgestellt und von der AHA selbst per Pressemitteilung kommuniziert worden – ergo nicht das Problem des Ärzteblattes. Der eigene Beitrag würde die Ergebnisse transparent darstellen, einschließlich des verfehlten primären Endpunkts.  Die Umdeutung ist aber m.E. narrative Verzerrung. Journalistische Sorgfaltspflicht verlangt, genau das zu benennen – sofern man denn überhaupt verstanden hat worum es hier geht.

 

CC-BY-NC Science Surf , accessed 24.05.2026
Software

My last visit to Stack Overflow

Coding with AI has a nice chart, that I am redrawing here

 

data source https://data.stackexchange.com/stackoverflow/query/1882532/questions-per-month

 

so it is time to say Good-Bye now after 14 years

Screenshot 23/3/26 Last Visit to SO

and sticking to the new 10 commandments by Russell Poldrack

Gather Domain Knowledge Before Implementation
Distinguish Problem Framing from Coding
Choose Appropriate AI Interaction Models
Start by Thinking Through a Potential Solution
Manage Context Strategically
Implement Test-Driven Development with AI
Leverage AI for Test Planning and Refinement
Monitor Progress and Know When to Restart
Critically Review Generated Code
Refine Code Incrementally with Focused Objectives

 

CC-BY-NC Science Surf , accessed 24.05.2026