An open plea for dignity and respect in science

August 1, 2021

Addendum to July 31 blog below:

1.) It is not “disingenuous” to cite pre-pandemic flu data as the point I was making is that despite a small number of annual flu deaths among children (using around 100-300’ish) we almost never close schools;

2.) Saying (as some do) that children have 300-fold greater risk of dying of covid than flu is the sort of relative risk assessment that most of us know better than to use in isolation from absolute risk. Drug companies use that tact to frighten people into taking a drug they want to sell by saying you have a risk factor that puts you at “double the risk of dying of Disease X”. Sounds scary. However, if the occurrence of Disease X is 1 in 1,000,000, then an increase from 1 in a million to 2 in a million is indeed “double the risk” but it’s still extremely low risk. The point being that there are more than 74,000,000 children ages 0 through 17 years old in the US, and one can argue whether the number who die of flu is between 150 or 477 as CDC reported for the 2018-1019 flu season; CDC also reports that 406 children have died of covid since the beginning of the pandemic (roughly 18 months). Assuming those stats are right (and there’s reason to think the covid deaths may actually be lower than 406), but assuming that’s correct, even if one assumes a higher rate of covid deaths in the 400 range and a low rate of flu deaths in the 200 range (double the relative risk) the absolute risk difference would be 0.0002. In other words, whatever exact number one wants to argue (is it 100? 200? or at 400’ish each for flu and covid) deaths from either spread across the more than 74 million children in the US means death from flu and from covid among children is rare, and one has to weigh the harms of closing schools and the devastating downstream effects that are hurting so many kids.

July 31, 2021:

I cited some statistics exactly as they exist on the CDC website. The ad hominem attacks that followed were disturbing: for this I was called “intellectually dishonest”, “shameful” and that I was using my “power” to “convince people to die.”

So, what upset people so deeply? Using statistics directly from the CDC, I cited the number of deaths of young people ages 0-17 years from one season of the flu prior to the pandemic with deaths from covid among young people ages 0-18 years over the entire covid pandemic (jan 2020 through July 2021). The results: 477 deaths from flu during the 2018-2019 flu season vs 406 deaths from covid. I asked (in irony) whether people would suggest closing schools every year due to flu deaths.

I understand in retrospect that people – good people, science-loving people, may have been upset that I used the flu comparison because so many science-denying pro-Trumpers have used the flu comparison to essentially deny the existence of covid.

However, we can’t let them own the facts and make us blind to actual data. While some individuals attacked me and said flu deaths weren’t really quite so high (maybe just 157); my point remains the same: covid deaths stretched over more than 74 million children in the US are very low, and closing schools has very definite and even devastating downstream harms that need to be considered.

An interesting poll found that when asked about just how dangerous covid is, Republicans tended to underestimate its harms, while Democrats tended to overestimate its harms.

Mostly, I just want to convey a more realistic understanding of the risks to children and for everyone to consider the downstream harms of school closures (which some propose).

In the end, should I have avoided the flu comparison for children because it has indeed been misused by science-deniers to say covid doesn’t exist? I don’t know. Maybe I could have used a different approach. But my point is that deaths from flu are not nil, yet we accept this, whether it is 150’ish or 400’ish - we don’t close schools.

The ad hominem attacks on me for using CDC statistics are a sign of the (unfortunate) times in which people attack, imply moral turpitude, and make all sorts of assumptions rather than addressing the data. And that doesn’t advance science at all.

Jeanne Lenzer July 31, 2021

See this blog (linked above) about scholarly debate in a time of pandemic. Written by Jerome R Hoffman, Professor of Medicine Emeritus, UCLA School of Medicine'; Iona Heath, Past President, UK Royal College of General Practitioners; and Luca De Fiore publisher, Il Pensiero Scientifico, and Past President, Associazione Liberati, an affiliate of Cochrane Italy

See also: The Covid Science Wars by Jeanne Lenzer and Shannon Brownlee

And see: The Scientific American Scandal by Lenzer and Brownlee

 

Danish article on RCT of mask wearing and covid-19

Videnskab.dk

Google translate

Professor: Large Danish mask study rejected by three top journals

The researchers behind a large and unique Danish study on the effect of wearing a mask even have great difficulty in getting their research results published. One of the participating professors in the study admits that the still secret research result can be perceived as 'controversial'.

For weeks, media and researchers around the world have been waiting with increasing impatience for the publication of a large Danish study on the effect - or lack thereof - of wearing a bandage in public space here during the corona pandemic.

Now, one of the researchers who has been involved in the study can state that the finished research result has been rejected by at least three of the world's absolutely leading medical journals.

These include The Lancet, The New England Journal of Medicine and the American Medical Association's journal JAMA.

"They all said no," says the professor, dr. with. and chief physician at the research department at North Zealand Hospital, Christian Torp-Pedersen.

However, the professor does not want to give the reasons for the journals.

"We can not start discussing what they are dissatisfied with, because in that case we must also explain what the study showed, and we do not want to discuss that until it is published," explains Christian Torp-Pedersen.

Outstanding study

The study was initiated at the end of April after a grant of five million kroner from the Salling Foundations. It involved as many as 6,000 Danes, half of whom had to wear bandages in the public space over a long period of time. The other half was selected as the control group.

A large part of the test participants were employees of Salling Group's supermarkets: Bilka, Føtex and Netto.

The studio and its size are unique in the world, and the purpose was once and for all to try to clarify the extent to which the use of sanitary napkins in public space provides protection against corona infection.

 

For the same reason, the researchers behind the study have regularly received inquiries from both Danish and international media with inquiries about when the results will be available. In the world of research, it is good practice not to comment on a research result until it has been published in a recognized so-called peer review journal.

However, the question of publication was approached by another of the study's participating researchers, professor at Hvidovre Hospital's infectious diseases department, Thomas Lars Benfield, on Sunday. It happened in an email that was shared on Twitter by former New York Times journalist Alex Berenson. Professor's answer:

"As soon as a journal is brave enough to accept the study."

 Thomas Lars Benfield does not want to elaborate on what he means by a magazine having to be "brave" to publish the study. However, he writes in an e-mail to Berlingske:

‘The quote a bit out of context. The article is being reviewed by a respected journal. We have decided not to publish data until the article has been accepted. "

However, Thomas Lars Benfield's co-researcher at the studio, Christian Torp-Pedersen, says that he "might also have dared to go as far as Benfield" in an answer to the question from his side.

Does this mean that in the eyes of some, your research results may be perceived as controversial?

"That's how I want to interpret it, too."

Can one interpret a controversial research result in the sense that no significant effect of mask use is demonstrated in your study?

"I think that's a very relevant question you are asking."

The expedient

It must be up to the readers themselves to assess what one should put in these answers.

But if the Danish research result is truly "controversial", and if it is meant that no evidence has been found of any major infection-protecting effect of mask use in public space, it will be highly startling.

For in that case, one must question the expediency of the fact that the vast majority of the world's population currently walks around with a mask in their pocket or on their face.

But of course it can not be ruled out that the three medical journals are of the opinion that the data base in the Danish study is deficient - that for example there are too few corona infected in the study to be able to draw unambiguous conclusions about the protective effect of masks against infection with the new virus.

In this connection, it is worth noting that the study was conducted at a time (predominantly in May), when the infection pressure in Denmark was falling sharply.

 

HENNING BUNDGAARD, PROFESSOR AND SUPERVISOR, RIGSHOSPITALET

"This is the world's largest study of its kind and is expected to be an important factor in the basis for regulatory decisions regarding the use of masks."

____________________________________________

 

The study's spokesman and main author is professor of cardiology and chief physician at Rigshospitalet, Henning Bundgaard. He strongly emphasizes that he wants to be in charge of 'high-quality' research.

But the professor cannot enter into a discussion about what the study may show or relate to the information that Berlingske has received from another of the study's authors.

However, he explains that he is 'sorry' that the study has not yet been published in a peer review journal. That is, in a journal where research results are evaluated by independent peers in the field.

»This is the world's largest study of its kind and is expected to be included as an important factor in the basis for government decisions regarding the use of masks - not only in Denmark - but everywhere. That is why the publication is urgent - and we are doing what we can on our part, "he says and continues:

‘If I wanted to publish things outside of a magazine, I would have done it a long time ago. But there are a variety of scientific reasons why I do not. The research I want to be responsible for must be of high quality, and this means, among other things, that other researchers must be able to see my data and look at calculations and statistics before publication, so that they can assess whether they arrive at the same conclusion like us. This is an absolutely crucial quality criterion for good research. "

The Danish study sheds light on "only" how much masks may protect a mask wearer from becoming infected. In other words, it does not shed light on whether an infected mask wearer also protects others (who do not wear a mask) from becoming infected.

Henning Bundgaard also explains that the study alone sheds light on the extent to which masks protect mask wearers from infection. In other words, it does not shed light on another side of the infection cube - whether people who go without a mask near an infected mask wearer are at reduced risk of becoming infected with coronavirus.

"But in my opinion, that study cannot be carried out," says the professor and elaborates:

"In that case, you had to take someone who was documented to be infected and carried the virus, and then you had to let one half go with a mask and the other without a mask. Next, in their environment, one had to measure how many became ill and how many did not become ill. It would be, for example, colleagues and families and those on the bus and in shops. It would be terribly unethical and would - as far as I can see - never be implemented. "

Already early in the corona pandemic, it was demonstrated that infection in some cases can occur from individuals before clear symptoms have emerged. Even infected people who never get symptoms can in some cases infect others with the new coronavirus.

The mask journey

In Denmark, the National Board of Health was for a very long time opposed to the use of face masks in public spaces - even though a large number of countries south of the border already in the spring made masks mandatory in shops and public transport.

For example, the director of the National Board of Health, Søren Brostrøm, said as recently as July 29, according to DR:

"Mouthpieces make no sense in the current situation, where we still have a very low infection in Denmark."

But on 15 August, when Prime Minister Mette Frederiksen (S) launched a nationwide order to use bandages in public transport in Denmark, the tone was different with the director.

"We ourselves have become wiser about this," he said, adding that bandages "have an effect on the vulnerable."

WHO hesitation

The World Health Organization (WHO) also expressed some doubts at the beginning of the pandemic and stated, among other things, that there is insufficient evidence that it makes sense for healthy people to wear a mask.

But on June 6, the WHO changed its position, including the following statement by Tedros' Director General Adhanom Ghebreyesus:

"In the light of new research, the WHO recommends that governments encourage the public to wear bandages in places where there is mass dispersal and where social distance is difficult to maintain."

The research he referred to was in particular a WHO-funded so-called meta-study in The Lancet, in which researchers concluded that masks appeared to have a protective effect on 'people in the public space who were exposed to infection'.

Berlingske has previously interviewed one of the world's leading experts in the effects of wearing a sanitary napkin, professor and head of Hong Kong University's Department of Epidemiology and Biostatistics, Benjamin Cowling. His overall assessment is as follows:

"Based on all available evidence, it is my opinion that the widespread and correct use of bandages in society reduces covid infection by between 10 and 20 percent."

In other words, the completely nail-biting and unequivocal documentation of a protective effect of bandages in public space is still lacking. The big question now is whether Danish researchers are able to deliver it.

There is still no indication of when a journal will accept the Danish research result and publish it - after which the public can gain more knowledge.

////

Professor: Stort dansk maskestudie afvist af tre top-tidsskrifter

Forskerne bag et stort og enestående dansk studie om effekten af at bære maske har endog meget store vanskeligheder ved at få deres forskningsresultat offentliggjort. En af de deltagende professorer i studiet medgiver, at det fortsat hemmeligholdte forskningsresultat kan opfattes som »kontroversielt«.

I ugevis har medier og forskere over hele verden med stigende utålmodighed afventet offentliggørelsen af et stort dansk studie om effekten – eller manglen på samme – af at gå med mundbind i det offentlige rum her under coronapandemien.

Nu kan en af de forskere, der har været involveret i studiet, oplyse, at det færdige forskningsresultat er blevet afvist af mindst tre af verdens absolut førende medicinske tidsskrifter.

Det drejer sig om The Lancet, The New England Journal of Medicine samt den amerikanske lægeforenings tidsskrift JAMA.

»De sagde alle nej,« fortæller professor, dr. med. og overlæge ved forskningsafdelingen på Nordsjællands Hospital, Christian Torp-Pedersen.

Professoren ønsker imidlertid ikke at oplyse tidsskrifternes begrundelse.

»Vi kan ikke begynde at diskutere, hvad de er utilfredse med, for i givet fald skal vi også forklare, hvad studiet viste, og det ønsker vi ikke at diskutere, før det er offentliggjort,« forklarer Christian Torp-Pedersen.

Enestående studie

Studiet blev igangsat i slutningen af april efter en bevilling på fem millioner kroner fra Salling Fondene. Det involverede hele 6.000 danskere, hvoraf halvdelen over en længere periode skulle gå med mundbind i det offentlige rum. Den anden halvdel var udvalgt som kontrolgruppe.

En større del af testdeltagerne var ansatte i Salling Groups supermarkeder: Bilka, Føtex og Netto.

Studiet og dets størrelse er enestående i verden, og formålet var én gang for alle at forsøge at klarlægge i hvor stort omfang, at brug af mundbind i det offentlige rum yder beskyttelse mod coronasmitte.

 

Af samme årsag har forskerne bag studiet med jævne mellemrum fået henvendelser fra både danske og internationale medier med forespørgsler om, hvornår resultatet foreligger. I forskningsverdenen er det god skik ikke at udtale sig om et forskningsresultat, før det har været offentliggjort i et anerkendt såkaldt peer review-tidsskrift.

Spørgsmålet om offentliggørelse nærmede en anden af studiets deltagende forskere, professor på Hvidovre Hospitals infektionsmedicinske afdeling, Thomas Lars Benfield, sig imidlertid et svar på i søndags. Det skete i en e-mail, der på Twitter blev delt af den tidligere New York Times-journalist Alex Berenson. Professorens svar:

»Så snart et tidsskrift er modig nok til at acceptere studiet.«

 Thomas Lars Benfield ønsker ikke i detaljer at uddybe, hvad han mener med, at et tidsskrift skal være »modig« for at offentliggøre studiet. Dog skriver han i en e-mail til Berlingske:

»Citatet en smule uden for kontekst. Artiklen er ved at blive bedømt af et respekteret tidsskrift. Vi har besluttet ikke at offentliggøre data, før at artiklen er accepteret.«

Thomas Lars Benfields medforsker på studiet, Christian Torp-Pedersen, siger imidlertid, at han »måske også ville have vovet sig lige så langt som Benfield« i et svar på spørgsmålet fra sin side.

Indebærer det, at jeres forskningsresultat i nogles øjne kan opfattes som kontroversielt?

»Sådan vil jeg også tolke det.«

Kan man tolke et kontroversielt forskningsresultat i retning af, at der ikke påvises nogen nævneværdig effekt af maskebrug i jeres studie?

»Jeg synes, at det er et meget relevant spørgsmål, du stiller.«

Det formålstjenlige

Det må være op til læserne selv at vurdere, hvad man bør lægge i disse svar.

Men hvis det danske forskningsresultat vitterligt er »kontroversielt«, og hvis der dermed menes, at man ikke har fundet evidens for nogen større smittebeskyttende effekt af maskebrug i det offentlige rum, vil det være stærkt opsigtsvækkende.

For i givet fald må man sætte spørgsmålstegn ved det formålstjenlige i, at langt størsteparten af verdens befolkning aktuelt går rundt med en maske i lommen eller på ansigtet.

Men naturligvis kan man ikke udelukke, at de tre medicinske tidsskrifter har den opfattelse, at datagrundlaget i det danske studie er mangelfuldt – at man eksempelvis har for få coronasmittede i studiet til at kunne drage entydige konklusioner om maskers beskyttende effekt over for smitte med den nye virus.

I den forbindelse er det værd at bemærke, at studiet blev gennemført på et tidspunkt (overvejende i maj), da smittetrykket herhjemme var stærkt dalende.

 

HENNING BUNDGAARD, PROFESSOR OG OVERLÆGE, RIGSHOSPITALET

»Dette er verdens største studie af sin art og forventes at kunne indgå som en vigtig faktor i grundlaget for myndighedsbeslutninger vedrørende maskebrug.«

 

Studiets talsmand og hovedforfatter er professor i kardiologi og overlæge ved Rigshospitalet, Henning Bundgaard. Han understreger kraftigt, at han ønsker at stå for forskning »af høj kvalitet«.

Men professoren kan ikke gå ind i en diskussion om, hvad studiet måtte vise eller forholde sig til de oplysninger, Berlingske har fået fra en anden af studiets forfattere.

Han forklarer imidlertid, at han er »ærgerlig over«, at studiet endnu ikke er blevet offentliggjort i et peer review-tidsskrift. Det vil sige i et tidsskrift, hvor forskningsresultater bliver vurderet af uafhængige fagfæller på området.

»Dette er verdens største studie af sin art og forventes at kunne indgå som en vigtig faktor i grundlaget for myndighedsbeslutninger vedrørende maskebrug – ikke kun i Danmark – men overalt. Derfor haster offentliggørelsen – og vi gør, hvad vi kan fra vores side,« siger han og fortsætter:

»Hvis jeg ville offentliggøre tingene uden om et tidsskrift, havde jeg gjort det for længe siden. Men der er en lang række videnskabelige grunde til, at jeg ikke gør det. Den forskning, jeg ønsker at stå for, skal være af høj kvalitet, og det indebærer blandt andet, at andre forskere før offentliggørelsen skal kunne se mine data og kigge beregninger og statistik igennem, for at de kan vurdere, om de kommer frem til samme konklusion som os. Dette er et helt afgørende kvalitetskriterie for god forskning.«

 

 

Det danske studie belyser »kun«, hvor meget masker måtte beskytte en maskebærer mod selv at blive smittet. Det belyser med andre ord ikke, om en smittet maskebærer også beskytter andre (som ikke bærer maske) mod at blive smittet.

 

Foto: Liselotte Sabroe/Ritzau Scanpix.

 

Henning Bundgaard forklarer også, at studiet alene belyser, i hvor høj grad masker beskytter maskebærere mod smitte. Det belyser med andre ord ikke en anden side af smitteterningen – om mennesker, der går uden maske i nærheden af en smittet maskebærer, er i reduceret risiko for at blive smittet med coronavirus.

»Men det studie kan i mine øjne ikke gennemføres,« siger professoren og uddyber:

»I givet fald skulle man tage nogle, der dokumenteret var smittet og bar virus, og så skulle man lade den ene halvdel gå med maske og den anden uden maske. Dernæst skulle man i deres omgivelser måle på, hvor mange der blev syge, og hvor mange der ikke blev syge. Det ville for eksempel være kolleger og familier og dem i bussen og i forretninger. Det ville være frygtelig uetisk og ville – så vidt jeg kan se det – aldrig kunne gennemføres.«

Allerede tidligt under coronapandemien blev det påvist, at smitte i nogle tilfælde kan ske fra personer, før end tydelige symptomer er opstået. Også smittede, der aldrig får symptomer, kan i visse tilfælde smitte andre med den nye coronavirus.

Maskerejsen

Herhjemme var Sundhedsstyrelsen meget længe afvisende over for brug af ansigtsmasker i det offentlige rum – også selv om en lang række lande syd for grænsen allerede hen på foråret gjorde masker obligatoriske i butikker og offentlige transportmidler.

For eksempel sagde Sundhedsstyrelsens direktør, Søren Brostrøm, så sent som 29. juli ifølge DR:

»Mundbind giver ingen mening i den nuværende situation, hvor vi stadig har en meget lav smitte i Danmark.«

Men 15. august, da statsminister Mette Frederiksen (S) lancerede et landsdækkende påbud om at anvende mundbind i offentlige transportmidler herhjemme, var tonen anderledes hos direktøren.

»Vi er jo selv blevet klogere på det her,« sagde han og tilføjede, at mundbind »har en effekt over for de sårbare«.

WHO-nølen

Også Verdenssundhedsorganisationen (WHO) udtrykte i pandemiens begyndelse en vis tvivl og udtalte blandt andet, at der ikke er tilstrækkelig dokumentation for, at det giver mening for raske mennesker at gå med maske.

Men 6. juni skiftede WHO holdning, blandt andet med følgende udtalelse fra generaldirektør Tedros Adhanom Ghebreyesus:

»Set i lyset af ny forskning anbefaler WHO, at regeringer bør opmuntre offentligheden til at bære mundbind på steder, hvor der er massespredning, og hvor social afstand er svær at overholde.«

Forskningen, han refererede til, var især et WHO-finansieret såkaldt metastudie i The Lancet, hvori forskere konkluderede, at masker har set ud til at virke beskyttende for »folk i det offentlige rum, der blev eksponeret for smitte«.

Berlingske har tidligere interviewet en af verdens førende eksperter i effekten af at bære mundbind, professor og leder af Hong Kong Universitys afdeling for epidemiologi og biostatistik, Benjamin Cowling. Hans samlede vurdering lyder således:

»Baseret på al tilgængelig evidens er det min opfattelse, at bred og korrekt anvendelse af mundbind i samfundet reducerer smitten med covid med mellem 10 og 20 procent.«

Den fuldstændig nagelfaste og utvetydige dokumentation på en beskyttende effekt af mundbind i det offentlige rum mangler med andre ord stadig. Det store spørgsmål er nu, om danske forskere er i stand til at levere den.

Der er endnu intet bud på, hvornår et tidsskrift accepterer det danske forskningsresultat og offentliggør det – hvorefter offentligheden kan få mere viden.