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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Virus Pushes Science And Its Controversies Centre Stage – Barrons (Stéphane ORJOLLET | May 2020)0

Posted by Admin in on May 27, 2020
 

Hydroxychloroquine, double-blind studies, convalescent plasma, herd immunity — the coronavirus pandemic has thrust the language of science into public view as never before.

Those of us blessed with an understanding of research must embrace our responsibility to explain the publication process, peer review, questionable publishers, junk science and the clinical trial process to family, friends and neighbours.  Observing social distancing of course.

Having escaped the confines of the laboratory, these and other once-obscure terms are fast becoming part of household parlance.
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But familiarity with the terminology does not necessarily lead to a better understanding, especially when there is an avalanche of new findings, experts caution.
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When researchers disagree or change their mind on the efficacy of a treatment or policy, the normal back-and-forth of the scientific process can breed confusion, they say.
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This is only amplified by a 24-hour news cycle and social networks, they add.

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Waste in covid-19 research (Editorial – Paul P Glasziou, et al | May 2020)0

Posted by Admin in on May 26, 2020
 

A deluge of poor quality research is sabotaging an effective evidence based response

The medical research world is responding to the covid-19 pandemic at breathtaking speed. There has been a maelstrom of global research, with mixed consequences. Positives include the greater provision of open access to covid-19 studies, some increased collaboration, expedited governance and ethics approvals of new clinical studies, and wider use of preprints. But many problems have become evident. Before the pandemic, it was estimated that up to 85% of research was wasted because of poor questions, poor study design, inefficiency of regulation and conduct, and non or poor reporting of results.1 Many of these problems are amplified in covid-19 research, with time pressures and inadequate research infrastructure contributing.

A fabulous editorial piece by Paul P Glasziou, et al about all the …noise/junk… being rushed to publication about COVID-19.  An important read.   We have included links to 21 related reads.  Who is hurt by this questionable behaviour?  Us as we wait tensely for a cure.

Trials
An extraordinary number of covid-19 trials have been registered since the pandemic started. The National Library of Medicine registry ClinicalTrials.gov lists 1087 covid-19 studies, and though some will provide useful information, many are too small and poorly designed to be helpful, merely adding to the covid-19 noise. Of the 145 registered trials of hydroxychloroquine, for example, 32 have a planned sample size of ≤100, 10 have no control group, and 12 are comparative but non-randomised. Outcome measures vary widely, and only 50 seem to be multicentre. Strikingly, only one provides a protocol, and even limited registry details reveal unjustified outcome switching.2
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The imbalance in trial topics is worrying, in particular the paucity of trials on non-drug interventions. Despite non-drug interventions being the mainstay of current mitigation,3 we could find just two trials of masks on ClinicalTrials.gov and none examining social distancing, quarantine effect or adherence, hand hygiene, or other non-drug interventions. Covid-19 research funding mirrors this woeful imbalance. A search of Covid-19 Research Project Tracker, a live database of funded covid-19 projects, found almost no primary research of the effects of non-drug interventions on transmissibility, compared with hundreds of drug intervention projects worth at least $74m (£60m; €67m).

Glasziou, P. P., Sanders, S. & Hoffmann, T. (2020) Waste in covid-19 research. BMJ 2020; 369 :m1847
Publisher: https://www.bmj.com/content/369/bmj.m1847

(France) French hydroxychloroquine-COVID-19 study withdrawn – Retraction Watch (Ivan Oransky | May 2020)0

Posted by Admin in on May 25, 2020
 

The authors of a preprint on use of hydroxychloroquine — the controversial drug heavily promoted by, and now apparently taken by, President Trump, at least for a few more days — along with azithromycin for COVID-19 have withdrawn the paper.

Whatever you might think of peer review, sometimes it plays an important role.  We have listed 8 related items.

The preprint, “Hydroxychloroquine plus azithromycin: a potential interest in reducing in-hospital morbidity due to COVID-19 pneumonia (HI-ZY-COVID)?” was posted to medRxiv on May 11 by authors at Hopital Raymond Poincare, and sometime yesterday replaced with this statement:
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The authors have withdrawn this manuscript and do not wish it to be cited. Because of controversy about hydroxychloroquine and the retrospective nature of their study, they intend to revise the manuscript after peer review.

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(France) He Was a Science Star. Then He Promoted a Questionable Cure for Covid-19 – New York Times Magazine (Scott Sayare | May 2020)0

Posted by Admin in on May 23, 2020
 

The man behind Trump’s favorite unproven treatment has made a great career assailing orthodoxy. His claim of a 100 percent cure rate shocked scientists around the world.

When diagnosing the ills afflicting modern science, an entertainment that, along with the disparagement of his critics and fellow researchers, he counts among his great delights, the eminent French microbiologist Didier Raoult will lightly stroke his beard, lean back in his seat and, with a thin but unmistakable smile, declare the poor patient to be stricken with pride. Raoult, who has achieved international fame since his proposed treatment for Covid-19 was touted as a miracle cure by President Trump, believes that his colleagues fail to see that their ideas are the products of mere intellectual fashions — that they are hypnotized by methodology into believing that they understand what they do not and that they lack the discipline of mind that would permit them to comprehend their error. “Hubris,” Raoult told me recently, at his institute in Marseille, “is the most common thing in the world.” It is a particularly dangerous malady in doctors like him, whose opinions are freighted with the responsibility of life and death. “Someone who doesn’t know is less stupid than someone who wrongly thinks he does,” he said. “Because it is a terrible thing to be wrong.”

Gary’s view of the Commander in Tweet dropped further this week.  Is it possible to have an approval rating below zero?  After the US President announced he was taking hydroxychloroquine to ward off COVID-19, FOX News warned its viewers that copying the President could be lethal.  The response?   The President tweeted Fox’s standards were dropping and he was looking for another news outlet … 😐 …

Raoult, who founded and directs the research hospital known as the Institut Hospitalo-Universitaire Méditerranée Infection, or IHU, has made a great career assailing orthodoxy, in both word and practice. “There’s nothing I like more than blowing up a theory that’s been so nicely established,” he once said. He has a reputation for bluster but also for a certain creativity. He looks where no one else cares to, with methods no one else is using, and finds things. In just the past 10 years, he has helped identify nearly 500 novel species of human-borne bacteria, about one-fifth of all those named and described. Until recently, he was perhaps best known as the discoverer of the first giant virus, a microbe that, in his opinion, suggests that viruses ought to be considered a fourth and separate domain of living things. The discovery helped win him the Grand Prix Inserm, one of France’s top scientific prizes. It also led him to believe that the tree of life suggested by Darwinian evolution is “entirely false,” he told me, and that Darwin himself “wrote nothing but inanities.” He detests consensus and comity; he believes that science, and life, ought to be a fight.
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It is in this spirit that, over the objections of his peers, and no doubt because of them, too, he has promoted a combination of hydroxychloroquine, an antimalarial drug, and azithromycin, a common antibiotic, as a remedy for Covid-19. He has taken to declaring, “We know how to cure the disease.” Trump was not the only one eager to embrace this possibility. By the time I arrived in Marseille, some version of Raoult’s treatment regimen had been authorized for testing or use in France, Italy, China, India and numerous other countries. One in every five registered drug trials in the world was testing hydroxychloroquine.
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