#Peter Doshi

[informationglob]

Jaipur Music Stage welcomes its visitors at Hotel Clarks Amer

Jaipur Music Stage welcomes its visitors at Hotel Clarks Amer

The Jaipur Literature Festival 2023 is all set to bring a range of exhilarating performers to the Jaipur Music Stage, which will run parallel to the festival. Infusing the audience with a melodic exuberance at the literary extravaganza, the Jaipur Music Stage will be a 3-day long program, set to run from 19th- 21st January 2023, featuring a range of celebrated artistes from all around the…

[100hands]

Thanks to SwissNex and the Swiss Consulate, it was our good fortune to have had some time with Mr. Peter Zumthor, the great Swiss architect here in Bangalore. As part of his visit he saw BV Doshi’s masterwork, the Indian Institute of Management Bangalore, the Bhoga Nandeeshwara Temple, Bangalore International Centre and MAP.

I also had the opportunity to engage Mr. Zumthor in an hour long conversation about his work and realizations. This event felt like the opening night of a big Bollywood blockbuster. Mr. Zumthor’s work and writings find a particular resonance in India. His ideas of work predicated on place, memory, materiality and presence, a word he uses often, make direct connections to our own traditional buildings and the work of masters like Le Corbusier, Louis Kahn, Charles Correa and BV Doshi.

I haven’t visited any of Mr. Zumthor’s buildings, but from his drawings and ethereal photographs often by Hélène Binet, they seem archaic, primordial – evoking the sense of refuge within geological formations. His work and methods seem anachronistic – reminding us of the rigour and care architecture demands and the single minded pursuit of emotionally charged space. Mr. Zumthor’s work attempts to discover ‘deep structure’, drawing out a shared recapitulation of ancient memory.

[palmiz]

"PETER DOSHI ALL'FDA: "INSERITE LA MORTE IMPROVVISA NEI BUGIARDINI" - Corto tg 14/06/2023"

[darkmaga-returns]

Fierce Pharma with important news

Stephen Hahn, Former FDA Commissioner was the subject of an article in Fierce Pharma, dated June 14, 2021:

He authorized Moderna's vaccine 6 months ago. Now, ex-FDA chief Hahn joins biotech's backer

“Under Hahn's watch, the FDA granted emergency use authorization to the company's COVID-19 vaccine just behind a similar OK for Pfizer and BioNTech's jab. Tens of millions of Americans have now received a Moderna shot…

…Hahn also follows the precedent of Scott Gottlieb, M.D., who ran the FDA from May 2017 to April 2019. Less than three months after leaving, he joined the board of Pfizer after partnering with VC firm New Enterprise Associates and think tank American Enterprise Institute, all of which went against Trump's pledge to “drain the swamp."

This is NOT OK

If anyone is in doubt—THIS IS NOT OK.

While this continues, consumer safety in the US will always be a game of chance. So long as FDA has divided loyalties between the companies selling drugs, and the patients that use them, lives are at risk.

Also, if you believe that revolving doors are limited to the most senior positions at FDA, think on. We learn again from Fierce Pharma, in an article dated July 1, 2024:

Departing FDA staffers told they can still influence the agency in Big Pharma jobs: BMJ report

“Under federal law, former FDA employees are prohibited from engaging in certain lobbying activities—but an investigation published in the BMJ medical journal on Monday (Published 01 July 2024) claims that the agency’s staffers are often advised of loopholes in those regulations on their way out the door.”

This is how the BMJ article begins:

Revolving door: You are free to influence us “behind the scenes,” FDA tells staff leaving for industry jobs

“Internal emails show that the US Food and Drug Administration informs employees leaving for industry jobs that, despite restrictions on post-employment lobbying, they are still permitted to influence the agency. Peter Doshi reports

During his final three years at the US Food and Drug Administration the physician scientist Doran Fink’s work focused on reviewing covid-19 vaccines. But a decade after joining the agency Fink had accepted a job with Moderna, the covid vaccine manufacturer, and was undergoing mandatory FDA exit requirements. As he left for the private sector, the FDA’s ethics programme staff emailed him guidelines on post-employment restrictions, “tailored to your situation.”

The email, obtained by The BMJ under a freedom of information request, explained that, although US law prohibits a variety of types of lobbying contact,1 “they do not prohibit the former employee from other activities, including working ‘behind the scenes.’”

[poligrafoserio]

Ciência da vacina contra a Covid a alcançar os "teóricos da conspiração"

Dois novos artigos de periódicos médicos revisados ​​por pares indicam que a ciência está começando a alcançar os "teóricos da conspiração" e os "antivacinas" como eu, também conhecidos como pessoas que racionalmente fizeram perguntas sobre novos produtos que foram lançados às pressas para ajudar a conter um vírus pandêmico que era  muito menos mortal do que todas as outras causas , incluindo  doenças cardiovasculares ,  câncer e até mesmo  o uso de tabaco  (e observe que as mortes por COVID-19 tendem a ser  infladas ).

Publicando no  Polish Annals of Medicine , Michael Thoene conduz uma revisão limitada da literatura sobre o relato de eventos adversos graves da vacina contra a COVID-19 em periódicos científicos, descobrindo:

De 2020 a 2024, a literatura passou de alegar que não há absolutamente nenhum SAE [eventos adversos sérios] de vacinas baseadas em mRNA (2020-2021) para um reconhecimento de um número significativo de vários SAE (2023-2024); incluindo, mas não se limitando a complicações neurológicas, miocardite, pericardite e trombose. … A literatura científica inicial era tendenciosa para não relatar SAE devido a preocupações sociais e políticas e ganância corporativa avassaladora. Somente no ano passado os cientistas conseguiram publicar artigos que reconhecem um alto número de SAE vinculados a vacinas baseadas em mRNA. Isso deve servir como um aviso de que a ciência deve ser completamente objetiva ao avaliar os riscos à saúde, mas muitas vezes pode ser influenciada por considerações sociais e econômicas.

Provando mais uma vez que os europeus orientais são baseados (os húngaros enfrentam a UE sobre imigração , e os búlgaros publicaram meu pequeno estudo sobre a  correlação entre a vacinação contra a COVID-19 e o excesso de mortalidade europeia ), o periódico polonês gentilmente aceitou minha breve resposta, intitulada ' Visões científicas sobre vacinas contra a COVID baseadas em mRNA estão mudando, mas com que finalidade? ' Nele, elogio o periódico e o autor por este importante artigo, e observo que esta é apenas a ponta do iceberg. Há muito mais na ciência publicada que a maioria das pessoas desconhece, como:

Thacker , sobre “questões como falsificação de dados e desmascaramento de pacientes em relação ao teste da vacina da Pfizer”.

Fraiman et al. , sobre o “risco excessivo de eventos adversos graves de interesse especial com as vacinas de mRNA”.

Benn et al. , sobre não haver “nenhuma redução estatisticamente significativa nas mortes por COVID-19 nos ensaios clínicos da vacina de mRNA, enquanto houve um aumento (também não estatisticamente significativo) no total de mortes”.

Os   artigos do JECP4  da equipe de Peter Doshi e eu sobre "problemas de janela de contagem (como atrasos de janela de contagem, vieses de janela de contagem e classificações errôneas de janela de contagem), provavelmente levando a estimativas exageradas de eficácia e segurança" nos ensaios clínicos e principais estudos observacionais, com um dos principais problemas sendo "quando as infecções por COVID-19 estão sendo negligenciadas nos 'parcialmente vacinados' e, em alguns casos, foram até mesmo atribuídas a grupos não vacinados". Observe que Mead et al. discutiram algumas questões semelhantes e, ainda assim, foram surpreendentemente retratados.

Faksova et al. , que Thoene mal mencionou e que demonstrou que as vacinas estão associadas a vários efeitos adversos preocupantes, apesar de empregar um ponto final de janela de contagem de apenas 42 dias após a vacinação.

Raethke et al. , “que observaram uma taxa de reações adversas graves a medicamentos de aproximadamente uma por 400 pessoas”, o que, segundo observo, se compara “muito desfavoravelmente com as estimativas do governo do Reino Unido sobre os  números necessários para vacinar  pessoas jovens e saudáveis ​​para evitar uma hospitalização grave por COVID-19, que está na casa das centenas de milhares”.

Mostert et al. , sobre o “misterioso problema do excesso de mortalidade pós-pandemia, que eles sugerem que pode estar relacionado às vacinas contra a COVID-19”, e meu   artigo mencionado anteriormente na Bulgarian Medicine  demonstrando que há de fato correlações entre a vacinação contra a COVID-19 e o excesso de mortes na Europa.

Claro, meu tópico 'favorito', eficácia negativa da vacina contra COVID-19, onde "as vacinas aumentam a chance de infecção por COVID-19, e até mesmo morte por COVID-19, um 'benefício' que é, claro, uma troca ruim pelo risco de (outros) efeitos adversos". Isso "levou a alguma discussão em grandes periódicos médicos como  o  BMJ  [e  também  o AJGP ], com a desculpa mais comum para esse fenômeno sendo que deve haver alguma variável de confusão em jogo", uma "desculpa que de alguma forma não se aplica antes que a eficácia da vacina cruze o eixo x [fique negativa], indicando um claro padrão duplo (um de muitos) em como as vacinas são avaliadas".

Fürst et al. (aqueles europeus orientais de novo!), com base em evidências “de que um viés de vacina saudável está em jogo”, o que “implicaria ainda mais que a eficácia das vacinas contra a COVID-19 está sendo exagerada, além dos efeitos de problemas de janela de contagem e outras manipulações de dados, mesmo quando declinando para zero e além”.

As “críticas substantivas que aparecem em revistas médicas influentes de grandes estudos observacionais que pretendem os benefícios das vacinas (com mais a caminho)”. Isso inclui minha  resposta rápida do BMJ  sobre o estudo da vacina da OMS  e o pequeno debate acadêmico entre mim e  uma equipe da Johns Hopkins . Muito mais em breve…

Ainda me perguntando como consegui publicar isso, termino com um aviso severo para aqueles que participaram do golpe mortal:

Há claramente muita pesquisa sobre as vacinas contra a COVID-19, publicadas nas maiores revistas médicas, o que contradiz amplamente as alegações tradicionais e iniciais (bem como as atuais) sobre sua segurança e eficácia, e até mesmo necessidade, para todos. Há muito mais não mencionado neste breve artigo, e sem dúvida há mais por vir. Parece óbvio para mim que, pelo menos para os jovens e saudáveis, as vacinas contra a COVID-19 certamente não valem o risco, mesmo quando se considera apenas um único efeito adverso (miocardite), não importa o quão raro ele seja alegado - a COVID-19 grave em jovens e saudáveis ​​é ainda mais rara, e o mesmo é ainda mais verdadeiro quando se considera os poucos ou nenhum benefício oferecido pelo que cada vez mais parece ser uma vacina irresponsável. Já houve muitas ações judiciais, incluindo vitórias ( como comigo ), iniciadas em nome dos ( de alguma forma ainda vivos ) não vacinados que foram perseguidos por um produto farmacêutico do qual claramente não precisavam, e dos vacinados que morreram e foram feridos de outra forma como resultado da vacinação. Prevejo que muitos outros processos judiciais estão no horizonte, envolvendo – entre outros – os fabricantes de vacinas; os funcionários do governo que aprovaram, encorajaram e até mesmo tornaram obrigatórias as vacinas; e os muitos médicos e cientistas que efetivamente traíram suas profissões e a confiança pública ao encorajar o uso desses produtos falhos com base em evidências científicas muito limitadas e até mesmo manipuladas.

É claro que, embora a ciência esteja começando a se atualizar e os processos judiciais continuem a todo vapor , nossos governos e a grande mídia ainda nos dizem para arregaçar as mangas , mesmo aqueles que têm apenas seis meses de idade.

Artigo original:

[sutrala]

(NaturalNews) The U.S. Food and Drug Administration (FDA) encourages staffers departing for pharmaceutical industry jobs that they can work behind the scenes to...

[mightyflamethrower]

I have been highly critical of the British Medical Journal, with good reason. It publishes some good research, and way too much political tripe. 

This story falls more into the former category than the latter. 

Anybody who has taken a serious interest in the relationship between the Food and Drug Administration and the pharmaceutical and medical device industries is struck by an obvious fact: the revolving door between the regulators and the regulated is utterly corrupt. 

The phenomenon is called regulatory capture. When this happens, as it often does, the regulators see their own interests as more aligned with the industry than with the general public. It happens much more often than you would think or hope. I once heard a story from a friend who worked on Capitol Hill about a Senate researcher who helped write tax laws. 

He put in a provision that was so complicated that nobody could make heads or tails of it, then went into business as a consultant who explained what it meant to people. 

He made bank. 

Regulatory capture is similar to this. The regulators become "experts" on how the system works, making themselves extremely valuable to the regulated. No industry would ignore the value of having especially good relations with the people on the other side of a negotiating table. 

It's a match made in heaven, except for you and me. We are the rats experimented upon. 

There are, of course, ethics rules that are supposed to prevent conflicts of interest, and when regulators are working in government they are not allowed to invest in companies they regulate. 

The US Food and Drug Administration says that it takes conflicts of interest seriously. But financial entanglements with the drug industry are common among its leaders. Peter Doshi reports At his public confirmation hearing in late 2021, Robert Califf, President Biden’s nominee to lead the US Food and Drug Administration (FDA), faced pointed questions about his financial relationships with industry. Bernie Sanders, the senator from Vermont, asked, “At a time when the American people are outraged by the high cost of prescription drugs, deeply disturbed about what happened with Purdue and Oxycontin, what kind of comfort can you give to the American people when you have been so closely tied to the pharmaceutical industry yourself?” He added, “How can the American people feel comfortable you’re going to stand up to this powerful special interest?” Califf responded: “Senator Sanders, I have a history of doing that. But I’d also point out that this administration has the most stringent ethics pledge in the history of administrations.” Califf did not earn Sanders’s vote, but he got the job. With it, the incoming FDA commissioner committed to sell his pharmaceutical stocks and sever his financial relationships with biotech companies such as Alphabet owned Verily Life Sciences, which paid Califf $2.7m as a senior adviser, according to his federal disclosure (see supplementary files on bmj.com).

Of course, when there is a revolving door, this is something of a scam. While it is true that having people with experience in the medical industries can be valuable for government regulators--they know the business, after all--the opposite is true as well.

And, of course, the friendlier the regulator is to an industry, the more valuable they become to those within it. 

The year 2022 marked Califf’s second time leading the FDA, having previously served during the Obama administration’s final year. It was therefore his second time terminating a host of ties with the companies that the agency is meant to regulate, and his second time signing an ethics pledge. The Trump administration, too, required that appointees sign an ethics pledge, committing not to lobby the agencies for five years after public service. But the requirement was rescinded on 19 January 2020, Trump’s last full day in office. In addition, the ban only applied to lobbying activities, not employment in general, and within three months of vacating the FDA’s top job, Scott Gottlieb, Trump’s first nominee who led the agency from 2017 to 2019, was nominated to Pfizer’s board of directors, subsequently gaining enormous public visibility through regular media appearances as a covid expert commentator. (While a medical student, Gottlieb interned at The BMJ as a Clegg scholar; he subsequently penned a number of BMJ news articles.) The revolving door between the FDA and industry surprises few anymore, despite the widely acknowledged potential it has for undermining public trust in government. And stories about FDA commissioners’ heavy ties to industry have become commonplace: nine of the FDA’s past 10 commissioners went on to work for the drug industry or serve on the board of directors of a drug company.

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This happens all the time, and bureaucrats like it that way. And, frankly, so do many lawmakers who can do the same sort of thing--build up good relationships with companies and retire later with a windfall. 

In political science we call this the iron triangle, where the regulators, the industries, and the politicians all share a common interest that diverges from the public's.

This is how you get unsafe and/or ineffective drugs through the system and how, I suspect, the jabs got out into the wild. Tens of billions of dollars are made based on these sorts of decisions. 

Paxlovid is a great example. It has never been shown to be effective in the least, but the government spent zillions of dollars buying it and promotes the heck out of it as the money rolls into the coffers of Pfizer. It also has a pretty nasty side-effect profile. 

This is how it works, folks. Follow the money.

[alexishectorr]

Tamiflu and Relenza review questions effectiveness against flu

Tamiflu (oseltamivir) and Relenza (zanamivir) are classes of drugs known as neuraminidase inhibitors. Both drugs are thought to prevent and reduce symptoms of flu by stopping the influenza virus from spreading inside the body.

At present, Tamiflu is used to combat flu in patients 2 weeks of age and older whose symptoms have not lasted longer than 2 days. It can be used to prevent flu in patients aged 1 year and older. Relenza is used to tackle flu in patients aged 7 years and older and can be used for flu prevention in those aged 5 years and older.

According to the researchers involved in this latest review, including Dr. Carl Heneghan of the University of Oxford in the UK and Dr. Peter Doshi of the University of Maryland School of Pharmacy in the US, both drugs are stockpiled for use against seasonal and pandemic influenza. For example, the US has spent over $1.3 billion on reserves of influenza antivirals.

This stockpiling has been based on international and national recommendations from bodies such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). But what are their recommendations based on?

[clemsbiggestfan]

Literally just a list of every book I've read this year, ranked.

A Heart That Works - Rob Delaney

Written in Bone - Sue Black

Our Wives Under the Sea - Julia Armfield

The Memory of Animals - Claire Fuller

A Marvellous Light - Freya Marske

The Cockroach - Ian McEwan

Why I'm No Longer Talking To White People About Race - Reni Eddo-Lodge

Notes on an Execution - Danya Kukafa

War Doctor: Surgery on the Front Line - David Nott

It's OK to Be Angry About Capitalism - Bernie Sanders

Taste - Stanley Tucci

Glutton: The Multi-Course Life of a Very Greedy Boy - Ed Gamble

Strong Female Character - Fern Brady

Uncomfortable Conversations With a Black Man - Emmanuel Acho

The Nickel Boys - Colson Whitehead

Sidesplitter - Phil Wang

LOTE - Shola von Reinhold

Vladimir - Julia May Jonas

Lessons in Chemistry - Bonnie Garmus

Patricia Wants to Cuddle - Samantha Allen

Climate Change is Racist - Jeremy Williams

Chlorine - Jade Song

The Transgender Issue - Shon Faye

Le Consentement - Vanessa Springora

Black Klansman - Ron Stallworth

Pageboy - Elliot Page

The Herd - Andrea Bartz

All That Remains - Sue Black

James Acaster's Guide to Quitting Social Media - James Acaster

What Would the Spice Girls Do? - Lauren Bravo

Educated - Tara Westover

The Frighteners - Peter Laws

Gay Bar: Why We Went Out - Jeremy Atherton-Lin

Fix the Systen, Not the Women - Laura Bates

The History Boys - Alan Bennett

Letters of Note: Love - Shaun Usher

The Metamorphosis - Franz Kafka

What a Shame - Abigail Bergstrom

Burnt Sugar - Avni Doshi

Just by Looking at Him - Ryan O'Connell

Devil House - John Darnielle

Poor - Caleb Femi

The Decagon House Murders - Yukito Ayasuji

I'm Afraid of Men - Vivek Shraya

I'm a Fan - Sheena Patel

The Mad Women's Ball - Victoria Mas

Daisy Chains - Lynne Vande Stouwe

Lemons Lemons Lemons Lemons Lemons - Sam Steiner

Confessions of a Funeral Director - Caleb Wilde

Misfits: A Personal Manifesto - Michaela Coel

Insomnia - Marina Benjamin

My Darling from the Lions - Rachel Long

Bluets - Maggie Nelson

Heatwave - Victor Jestin

[iamnaturalnana]

The FDA and Moderna’s Cozy Relationship: How Lax Rules Enable a Revolving Door Culture

Cited as: BMJ 2023;383:p248 Peter Doshi, senior editor pdoshi@bmj.com After holding oversight roles for covid vaccines, two regulators from the US Food and Drug Administration went to work for Moderna. Peter Doshi reports The physician-scientist Doran Fink worked his way up at the Food and Drug Administration, with a focus on the regulation of vaccines. Starting as a clinical reviewer in…

[stuartbramhall]

Experts ‘Astounded’ After FDA Rejects Request to Add Health Risks to COVID Vaccine Labels

By Michael Nevradakis, Ph.D. The U.S. Food and Drug Administration (FDA) had the opportunity to improve COVID-19 vaccine labeling — but according to a team of medical and public health experts, the agency refused to make the changes. In an op-ed published last week in The Hill, Peter Doshi, Ph.D., Linda Wastila, Ph.D., and Kim Witczak wrote that the FDA rejected their petition to make changes to…

[didanawisgi]

Does the FDA think these data justify the first full approval of a covid-19 vaccine?

August 23, 2021

The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines, says Peter Doshi

On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.”

But you won’t find 10 month follow-up data here. While the preprint is new, the results it contains aren’t particularly up to date. In fact, the paper is based on the same data cut-off date (13 March 2021) as the 1 April press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic covid-19 through “up to six months of follow-up.”

The 20 page preprint matters because it represents the most detailed public account of the pivotal trial data Pfizer submitted in pursuit of the world’s first “full approval” of a coronavirus vaccine from the Food and Drug Administration. It deserves careful scrutiny.

The elephant named “waning immunity”

Since late last year, we’ve heard that Pfizer and Moderna’s vaccines are “95% effective” with even greater efficacy against severe disease (“100% effective,” Moderna said).

Whatever one thinks about the “95% effective” claims (my thoughts are here), even the most enthusiastic commentators have acknowledged that measuring vaccine efficacy two months after dosing says little about just how long vaccine-induced immunity will last. “We’re going to be looking very intently at the durability of protection,” Pfizer senior vice president William Gruber, an author on the recent preprint, told the FDA’s advisory committee last December.

The concern, of course, was decreased efficacy over time. “Waning immunity” is a known problem for influenza vaccines, with some studies showing near zero effectiveness after just three months, meaning a vaccine taken early may ultimately provide no protection by the time “flu season” arrives some months later. If vaccine efficacy wanes over time, the crucial question becomes what level of effectiveness will the vaccine provide when a person is actually exposed to the virus? Unlike covid vaccines, influenza vaccine performance has always been judged over a full season, not a couple months.

And so the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.

Now Israel, which almost exclusively used Pfizer vaccine, has begun administering a third “booster” dose to all adults over 40. And starting 20 September 2021, the US plans to follow suit for all “fully vaccinated” adults eight months past their second dose.

Delta may not be responsible

Enter Pfizer’s preprint. As an RCT reporting “up to six months of follow-up,” it is notable that evidence of waning immunity was already visible in the data by the 13 March 2021 data cut-off.  

“From its peak post-dose 2,” the study authors write, “observed VE [vaccine efficacy] declined.” From 96% to 90% (from two months to <4 months), then to 84% (95% CI 75 to 90) “from four months to the data cut-off,” which, by my calculation (see footnote at the end of the piece), was about one month later.

But although this additional information was available to Pfizer in April, it was not published until the end of July.

And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were from the United States, where Delta was not established until months after data cut-off.

Waning efficacy has the potential to be far more than a minor inconvenience; it can dramatically change the risk-benefit calculus. And whatever its cause—intrinsic properties of the vaccine, the circulation of new variants, some combination of the two, or something else—the bottom line is that vaccines need to be effective.

Until new clinical trials demonstrate that boosters increase efficacy above 50%, without increasing serious adverse events, it is unclear whether the 2-dose series would even meet the FDA’s approval standard at six or nine months.  

The “six month” preprint based on the 7% of trial participants who remained blinded at six months

The final efficacy timepoint reported in Pfizer’s preprint is “from four months to the data cut-off.” The confidence interval here is wider than earlier time points because only half of trial participants (53%) made it to the four month mark, and mean follow-up is around 4.4 months (see footnote).

This all happened because starting last December, Pfizer allowed all trial participants to be formally unblinded, and placebo recipients to get vaccinated. By 13 March 2021 (data cut-off), 93% of trial participants (41,128 of 44,060; Fig 1) were unblinded, officially entering “open-label followup.” (Ditto for Moderna: by mid April, 98% of placebo recipients had been vaccinated.)

Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.

It is hard to imagine that the <10% of trial participants who remained blinded at six months (which presumably further dwindled after 13 March 2021) could constitute a reliable or valid sample to produce further findings. And the preprint does not report any demographic comparisons to justify future analyses.

Severe disease

With the US awash in news about rising cases of the Delta variant, including among the “fully vaccinated,” the vaccine’s efficacy profile is in question. But some medical commentators are delivering an upbeat message. Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: “Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”

Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe covid-19” endpoint results as “preliminary evidence.” Hospital admission numbers were not reported, and zero covid-19 deaths occurred.

In the preprint, high efficacy against “severe covid-19” is reported based on all follow-up time (one event in the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data last year showed that 21 of 30 “severe covid-19” cases were not admitted to hospital; Table S14).

And on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).

The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease. Unfortunately, Pfizer’s new preprint does not report the results in a way that allows for evaluating this question.

Approval imminent without data transparency, or even an advisory committee meeting?

Last December, with limited data, the FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans who wanted one. It sent a clear message that the FDA could both address the enormous demand for vaccines without compromising on the science. A “full approval” could remain a high bar.

But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data. (The preprint reports “decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis were new adverse events attributable to BNT162b2 not previously identified in earlier reports,” but provides no data tables showing the frequency of these, or other, adverse events.)

It’s not helping matters that FDA now says it won’t convene its advisory committee to discuss the data ahead of approving Pfizer’s vaccine. (Last August, to address vaccine hesitancy, the agency had “committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.”)

Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.

I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”

FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.

Peter Doshi, senior editor, The BMJ.

Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.

Provenance: commissioned; externally peer-reviewed.

Footnote: Calculations in this article are as follows. “About 1 month” past month 4 is based on the final row of Fig 2 in the preprint: 1030/12670*12 = 0.98 months (vaccine group) and 895/11802*12 = 0.91 months (placebo group). “53%” is based on Fig 2: (12670+11802)/(23040+23037). “4.4 months” is based on the average of 8412/22505*12 = 4.5 (vaccine) and 8124/22434*12 = 4.3 (placebo) in Fig 2.

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Vitra Design Museum: Diskurs

Vitra Design Museum: Diskurs

Wir alle hängen in der C-Themen-Schleife und es kostet wirklich Energie aus diesem Kreisen um Konsequenzen, Beunruhigung und Furcht heraus zu kommen. Uns allen fehlt das direkte Gespräch mit interessanten Menschen über Gestaltung, Leben und Zukunft, Inspirationen für neues Sehen, Denken und Handeln. Also empfehle  ich heute einen online-Ausflug “ins” Vitra Museum. Dort warten viele Videos,…

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“There’s something to be curious about”

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Os estudos observacionais sobre a eficácia da vacina contra a COVID estão repletos de preconceitos/Não contar os casos 14 dias após a dose 2 é um problema

Finalmente tive a oportunidade de ler este artigo de Peter Doshi , professor e pesquisador da Universidade de Maryland. É bastante inteligente e ensina princípios de epidemiologia. Vou resumir uma parte do artigo e, em capítulos futuros, aprofundarei seus outros pontos.

Ponto nº 1: muitos estudos observacionais sobre a eficácia da vacina excluem casos que ocorreram dentro de 14 dias após a dose 2. Em outras palavras, qualquer pessoa que contraia COVID 36 dias após a primeira dose (as doses têm 21 dias de intervalo para a Pfizer) não conta contra o vacina. Isso ocorre porque - continua o argumento - leva tempo para a vacina fazer efeito, então você não pode usar os primeiros dias contra ela.

Claro que é um argumento bobo. Um produto médico é dono de tudo o que acontece depois que você começa a tomá-lo. É claro que se as vacinas demorassem um milhão de anos a fazer efeito, seriam inúteis. Se demorarem um ano inteiro e todos ficarem cobiçosos nesse ano, seriam inúteis. Omitir estes casos é irresponsável, mas continua.

Mas o que Doshi quer dizer é que isso pode fazer com que um produto inativo — algo totalmente inútil — pareça funcionar. Ele fornece esse experimento mental.

No experimento, diz ele, e se compararmos o braço de controle do estudo da Pfizer com um braço imaginário da vacina. E para o experimento mental, presuma que a vacina é inútil. Como mostra a tabela acima, ambos os grupos têm números idênticos de casos de covid – exatamente o que seria de esperar de uma vacina inútil. Uma análise direta não mostra nenhum benefício (penúltima linha)

Mas no “estudo observacional de vacina fictícia” os casos são excluídos durante 36 dias. Quando isso é feito, a vacina inútil parece reduzir as infecções em 48%!!

Doshi destaca em seu artigo que a solução é subtrair a taxa de infecção de 36 dias do braço de controle observacional. Infelizmente, a maioria das investigações não faz isso.

Este é um dos vários preconceitos discutidos por Doshi e que prejudica a literatura sobre vacinas. Mais na próxima vez. Se inscrever.

Artigo original:

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Le professeur de pharmacie a conclu sa brève intervention en contestant l’utilisation du terme vaccin pour les produits ARNm. "Je trouve d’ailleurs fascinant que le dictionnaire Merriam-Webster ait changé sa définition du mot vaccin au début de l’année afin d’y inclure les produits ARNm." Par conséquent : "Que penseriez-vous de l’obligation des vaccins Covid si on ne les appelait pas ‘vaccins’. Qu’en serait-il si ces injections étaient appelées ‘médicaments’." Et de conclure : "Ce n’est pas parce qu’on les appelle ‘vaccins’ que ces nouveaux produits sont semblables aux autres vaccins obligatoires pour les enfants. […] Je crois qu’il est temps d’injecter un peu d’esprit critique dans ce débat." L'intégralité de l'intervention du professeur Peter Doshi sous-titrée en français