Coronavirus (COVID-19): What You Need To Know

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Fri May 29, 2020 11:24 am

A Rapid Systematic Review of Clinical Trials Utilizing Chloroquine and Hydroxychloroquine as a Treatment for COVID‐19 (May 2)
https://onlinelibrary.wiley.com/doi/ful ... acem.14005

"...There are currently seven completed clinical trials and 29 registered clinical trials focusing on HCQ or CQ as a therapeutic avenue for COVID‐19. Of these, five of seven trials have shown favorable outcomes for patients using CQ or HCQ and two of seven have shown no change compared to control. However, all seven trials carried varying degrees of bias and poor study design.
...
There are currently not enough data available to support the routine use of HCQ and CQ as therapies for COVID‐19. Pending further results from more extensive studies with more stringent study parameters, clinicians should defer from routine use of HCQ and CQ. There are several clinical trials currently under way with results expected soon."
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Fri May 29, 2020 11:29 am

thanks zen, for your link to an article from a credible media source, concerning a letter and article of interest.

please also provide a link to the original article discussed, and to the resulting commentary letter.
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Fri May 29, 2020 12:44 pm

Need for Abundant Caution in Prophylactic Application of Chloroquine and Hydroxychloroquine for Viral Infections Including COVID-19: Possibility of Increased Susceptibility (Apr 7)
https://papers.ssrn.com/sol3/papers.cfm ... id=3570607
fft: https://bit.ly/2zBerGO

"...Concern 1: Increased risk of all infections (including COVID-19) from CQ/HCQ mediated immuno-suppression and
immuno-modulation
...
Concern 2: Increased malarial resistance to CQ and HCQ
...
Concern 3: Unavailability of CQ and HCQ for other critical therapies
...
Concern 4: Side-effects of CQ and HCQ
...
Conclusion
Abundant caution needs to be exercised in recommending and using CQ and HCQ as prophylactic agents for COVID-19, especially in the light of their well-recorded immuno-suppressive and immuno-modulatory properties, as well as repeated verification of inefficacy against viral infection and replication in vivo. This is not to persuade against therapeutic application of CQ and HCQ for their anti-inflammatory properties to mitigate SARS-CoV-2 induced pneumonia and inflammatory immuno-hyperactivity."
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Fri May 29, 2020 12:52 pm

Rethinking the role of hydroxychloroquine in the treatment of COVID‐19 (Apr 29)
https://faseb.onlinelibrary.wiley.com/d ... .202000919

"...Given these facts and the growing uncertainty about these agents for the treatment of COVID‐19, it is clear that at the very least thoughtful planning and data collection from randomized clinical trials are needed to understand what if any role these agents may have in this disease. In this article, we review the datasets that support or detract from the use of these agents for the treatment of COVID‐19 and render a data informed opinion that they should only be used with caution and in the context of carefully thought out clinical trials, or on a case‐by‐case basis after rigorous consideration of the risks and benefits of this therapeutic approach."
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Fri May 29, 2020 1:00 pm

preprint: Association of previous medications with the risk of COVID-19: a nationwide claims-based study from South Korea (May 18)
https://www.medrxiv.org/content/10.1101 ... 20089904v2

"... Among the 65,149 eligible subjects (mean age, 48.3 years; 49.4% male), 5,172 (7.9%) were diagnosed with COVID-19. Hydroxychloroquine was not significantly associated with the risk of COVID-19 (adjusted odds ratio [aOR], 1.48; 95% CI, 0.95-2.31). In the overall population, lower risks of COVID-19 were associated with the use of camostat (aOR, 0.45; 95% CI, 0.20-1.02) and amiodarone (aOR, 0.54; 95% CI, 0.33-0.89), although the differences were not significant in the subgroup analyses.
...
Conclusions. No medications were consistently associated with increased or decreased risks of COVID-19. These findings suggest that a more cautious approach is warranted for the clinical use of re-purposed drugs until the results are available from clinical trials."
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Fri May 29, 2020 5:43 pm

preprint: Chloroquine and hydroxychloroquine effectiveness in human subjects during coronavirus: a systematic review (May 11)
https://www.medrxiv.org/content/10.1101 ... 20094326v1

..Outcomes most commonly reported were improved lung function, viral clearance, and hospital discharge. Strong evidence to support the use of chloroquine and hydroxychloroquine in the treatment of COVID-19 is lacking. Fast track trials are riddled with bias and may not conform to rigorous guidelines which may lead to inadequate data being reported. The use of these drugs in combination with other medications may be useful but without knowing which groups they are suited for and when, they may cause more harm than good.
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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Re: Coronavirus (COVID-19): What You Need To Know

Post by vesta » Sat May 30, 2020 1:23 am

Technocracy News & Trends
www.technocracy.news
Accumulating news and articles on Technocracy from around the world with emphasis on ... Scientists, MDs Rip Anti-Chloroquine Study Published In The Lancet.
‎Technocracy And The Rise Of ... · ‎Day 10: Technocracy And · ‎Technocracy Archives


Support for Chloroquine and Hydroxychloroquine has cratered, thanks to a faulty study published by The Lancet. Now, hundreds of MDs and scientists are taking The Lancet and the study’s authors to task for data corruption and false conclusions. ⁃ TN Editor
Open letter to MR Mehra, SS Desai, F Ruschitzka, and AN Patel, authors of
“Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis”. Lancet. 2020 May 22:S0140-6736(20)31180-6. doi: 10.1016/S0140-6736(20)31180-6. PMID: 32450107
and to Richard Horton (editor of The Lancet).
Concerns regarding the statistical analysis and data integrity
The retrospective, observational study of 96,032 hospitalized COVID-19 patients from six continents reported substantially increased mortality (~30% excess deaths) and occurrence of cardiac arrhythmias associated with the use of the 4-aminoquinoline drugs hydroxychloroquine and chloroquine. These results have had a considerable impact on public health practice and research.
The WHO has paused recruitment to the hydroxychloroquine arm in their SOLIDARITY trial. The UK regulatory body, MHRA, requested the temporary pausing of recruitment into all hydroxychloroquine trials in the UK (treatment and prevention), and France has changed its national recommendation for the use of hydroxychloroquine in COVID-19 treatment and also halted trials.
The subsequent media headlines have caused considerable concern to participants and patients enrolled in randomized controlled trials (RCTs) seeking to characterize the potential benefits and risks of these drugs in the treatment and prevention of COVID-19 infections. There is uniform agreement that well conducted RCTs are needed to inform policies and practices.
This impact has led many researchers around the world to scrutinize in detail the publication in question. This scrutiny has raised both methodological and data integrity concerns. The main concerns are listed as follows:
1. There was inadequate adjustment for known and measured confounders (disease severity, temporal effects, site effects, dose used).
2. The authors have not adhered to standard practices in the machine learning and statistics community. They have not released their code or data. There is no data/code sharing and availability statement in the paper. The Lancet was among the many signatories on the Wellcome statement on data sharing for COVID-19 studies.
3. There was no ethics review.
4. There was no mention of the countries or hospitals that contributed to the data source and no acknowledgments to their contributions. A request to the authors for information on the contributing centres was denied.
5. Data from Australia are not compatible with government reports (too many cases for just five hospitals, more in-hospital deaths than had occurred in the entire country during the study period). Surgisphere (the data company) have since stated this was an error of classification of one hospital from Asia. This indicates the need for further error checking throughout the database.
6. Data from Africa indicate that nearly 25% of all COVID-19 cases and 40% of all deaths in the continent occurred in Surgisphere-associated hospitals which had sophisticated electronic patient data recording, and patient monitoring able to detect and record “nonsustained [at least 6 secs] or sustained ventricular tachycardia or ventricular fibrillation”. Both the numbers of cases and deaths, and the detailed data collection, seem unlikely.
7. Unusually small reported variances in baseline variables, interventions and outcomes between continents (Table S3).
8. Mean daily doses of hydroxychloroquine that are 100 mg higher than FDA recommendations, whereas 66% of the data are from North American hospitals.
9. Implausible ratios of chloroquine to hydroxychloroquine use in some continents
10. The tight 95% confidence intervals reported for the hazard ratios are unlikely. For instance, for the Australian data this would need about double the numbers of recorded deaths as were reported in the paper.
The patient data have been obtained through electronic patient records and are held by the US company Surgisphere. In response to a request for the data Professor Mehra has replied; “Our data sharing agreements with the various governments, countries and hospitals do not allow us to share data unfortunately.”
Given the enormous importance and influence of these results, we believe it is imperative that:
1. The company Surgisphere provides details on data provenance. At the very minimum, this means sharing the aggregated patient data at the hospital level (for all covariates and outcomes)
2. Independent validation of the analysis is performed by a group convened by the World Health Organization, or at least one other independent and respected institution. This would entail additional analyses (e.g. determining if there is a dose-effect) to assess the validity of the conclusions
3. There is open access to all the data sharing agreements cited above to ensure that, in each jurisdiction, any mined data was legally and ethically collected and patient privacy aspects respected
In the interests of transparency, we also ask The Lancet to make openly available the peer review comments that led to this manuscript to be accepted for publication.
This open letter is signed by clinicians, medical researchers, statisticians, and ethicists from across the world. The full list of signatories and affiliations can be found below.
List of Signatories
Dr James Watson (Statistician, Mahidol Oxford Tropical Medicine Research Unit, Thailand)1
1 For correspondence: james@tropmedres.ac
Professor Amanda Adler (Trialist & Clinician, Director of the Diabetes Trials Unit, UK)
Dr Ravi Amaravadi (Researcher, University of Pennsylvania, USA)
Dr Ambrose Agweyu (Medical researcher, KEMRI-Wellcome Trust Research Programme, Kenya)
Professor Michael Avidan (Clinician, Washington University in St Louis, USA)
Professor Nicholas Anstey (Clinician, Menzies School of Health Research, Australia)
Dr Yaseen Arabi (Clinician, King Saud Bin Abdulaziz University for Health Sciences, Saudi Arabia)
Dr Elizabeth Ashley (Clinician, Director of the Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Laos)
Professor Kevin Baird (Researcher, Head of the Eijkman-Oxford Clinical Research Unit, Indonesia)
Professor Francois Balloux (Researcher, Director of the UCL Genetics Institute, UK)
Dr Clifford George Banda (Clinician, University of Cape Town, South Africa)
Dr Edwine Barasa (Health economist, KEMRI-Wellcome Trust Research Programme, Kenya)
Professor Karen Barnes (Clinical Pharmacology, University of Cape Town, South Africa)
Professor David Boulware (Researcher & Triallist, University of Minnesota, USA)
Professor Buddha Basnyat (Clinician, Head of the Oxford University Clinical Research Unit – Nepal, Nepal)
Professor Philip Bejon (Medical researcher, Director of the KEMRI-Wellcome Trust Research Programme, Kenya)
Professor Mohammad Asim Beg (Clinician/Researcher, Aga Khan University, Pakistan)
Professor Emmanuel Bottieau (Clinician, Institute of Tropical Medicine, Antwerp, Belgium)
Dr Sabine Braat (Statistician, University of Melbourne, Australia)
Professor Frank Brunkhorst (Clinician, Jena University Hospital, Germany)
Dr Todd Campbell Lee (Researcher, McGill University, Canada)
Professor Caroline Buckee (Epidemiologist, Harvard TH Chan School of Public Health, USA)
Dr James Callery (Clinician, Mahidol Oxford Tropical Medicine Research Unit, Thailand)
Professor John Carlin (Statistician, University of Melbourne & Murdoch Children’s Research Institute, Australia)
Dr Nomathemba Chandiwana (Research Clinician, University of the Witwatersrand, South Africa)
Dr Arjun Chandna (Clinician, Cambodia Oxford Medical Research Unit, Cambodia)
Professor Phaik Yeong Cheah (Ethicist/Pharmacist, Mahidol Oxford Tropical Medicine Research Unit, Thailand)
Professor Allen Cheng (Clinician, Monash University, Australia)
Professor Leonid Churilov (Statistician, University of Melbourne, Australia)
Professor Ben Cooper (Epidemiologist, University of Oxford, UK)
Dr Cintia Cruz (Paediatrician Mahidol Oxford Tropical Medicine Research Unit, Thailand)
Professor Bart Currie (Director, HOT NORTH, Menzies School of Health Research, Australia)
Professor Joshua Davis (Clinician, President of the Australasian Society for Infectious Diseases, Australia)
Dr Jeremy Day (Clinician, Oxford University Clinical Research Unit, Vietnam)
Professor Nicholas Day (Clinician, Director of the Mahidol Oxford Tropical Medicine Research Unit, Thailand)
Dr Hakim-Moulay Dehbi (Statistician, University College London, UK)
Dr Justin Denholm (Clinician, Researcher, Ethicist, Doherty Institute, Australia)
Dr Lennie Derde (Intensivist/Researcher, University Medical Center Utrecht, The Netherlands)
Professor Keertan Dheda (Clinician/Researcher, University of Cape Town, & Groote Schuur Hospital, South Africa)
Dr Mehul Dhorda (Clinical Researcher, Mahidol Oxford Tropical Medicine Research Unit, Thailand)
Professor Annane Djillali (Dean of the School of Medicine, Simone Veil Université, France)
Professor Arjen Dondorp (Clinician, Mahidol Oxford Tropical Medicine Research Unit, Thailand)
Dr Joseph Doyle (Clinician, Monash University and Burnet Institute, Australia)
Dr Anthony Etyang (Medical Researcher, KEMRI-Wellcome Trust Research Programme, Kenya)
Dr Caterina Fanello (Epidemiologist, University of Oxford, UK)
Professor Neil Ferguson (Epidemiologist, Imperial College London, UK)
Professor Andrew Forbes (Statistician, Monash University, Melbourne, Australia)
Professor Oumar Gaye (Clinical Researcher, University Cheikh Anta Diop, Senegal)
Dr Ronald Geskus (Head of Statistics at the Oxford University Clinical Research Unit, Vietnam)
Professor Dave Glidden (Biostatistics, University of California, USA)
Professor Azra Ghani (Epidemiologist, Imperial College London, UK)
Prof Philippe Guerin (Medical researcher, University of Oxford, UK)
Dr. Raph Hamers (Clinician/Trialist, Eijkman-Oxford Clinical Research Unit, Indonesia)
Professor Peter Horby (Clinical Researcher, Centre for Tropical Medicine and Global Health, University of Oxford)
Dr Jens-Ulrik Jensen (Clinician/Trialist, University of Copenhagen, Denmark)
Dr Hilary Johnstone (Clinical Research Physician, Independent)
Professor Kevin Kain (Clinical Researcher, University of Toronto, Canada)
Dr Sharon Kaur (Ethicist, University of Malaya, Malaysia)
Dr Evelyne Kestelyn (Head of Clinical Trials, Oxford University Clinical Research Unit, Vietnam)
Dr Tan Le Van (Medical Researcher, Oxford University Clinical Research Unit, Vietnam)
Professor Katherine Lee (Statistician, University of Melbourne, Australia)
Professor Laurence Lovat (Clinical Director of Wellcome EPSRC Centre for Interventional & Surgical Sciences, UCL, UK)
Professor Kathryn Maitland (Clinician, Imperial College London/KEMRI Wellcome Trust Programme, Kenya)
Dr Julie Marsh (Statistician, Telethon Kids Institute, Australia)
Professor John Marshall (Clinician/Researcher, University of Toronto, Canada)
Dr Gary Maartens (Clinician, University of Cape Town, South Africa)
Professor Mayfong Mayxay (Clinician/Researcher, Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Laos)
Dr John McKinnon (Clinician/Researcher, Wayne State University, USA)
Dr Laura Merson (Clinical researcher, University of Oxford, UK)
Dr Alistair McLean (Medical researcher, University of Oxford, UK)
Professor Ramani Moonesinghe (Clinician researcher, University College London, UK)
Professor Bryan McVerry (Medical researcher, University of Pittsburgh, USA)
Professor William Meurer (Clinician/Medical researcher, University of Michigan, USA)
Dr Kerryn Moore (Epidemiologist, London School of Hygiene and Tropical Medicine, UK)
Dr Rephaim Mpofu (Clinician, University of Cape Town, South Africa)
Dr Mavuto Mukaka (Statistician, Mahidol Oxford Tropical Medicine Research Unit, Thailand)
Dr Srinivas Murthy (Clinical Researcher, University of British Columbia, Canada)
Professor Kim Mulholland (Clinician, London School of Hygiene & Tropical Medicine, UK)
Professor Alistair Nichol (Clinician Researcher, Monash University, Australia)
Professor Francois Nosten (Clinician, Director of the Shoklo Malaria Research Unit, Thailand)
Dr Matthew O’Sullivan (Clinician, Westmead Hospital & University of Sydney, Australia)
Professor Piero Olliaro (Clinical Researcher, University of Oxford, UK)
Professor Marie Onyamboko (Clinical researcher, Kinshasa School of Public Health, DRC)
Dr Marcin Osuchowski (Medical researcher, Ludwig Boltzmann Institute, Austria)
Professor Catherine Orrell (Clinical Pharmacologist, University of Cape Town, South Africa)
Professor Jean Bosco Ouedraogo (Medical Researcher, WWARN, Burkina Faso)
Dr Elaine Pascoe (Statistician, University of Queensland, Australia)
Professor David Paterson (Clinician, Director, UQ Centre for Clinical Research, Australia)
Dr Kajaal Patel (Paediatrician, Cambodia Oxford Medical Research Unit, Cambodia)
Dr Tom Parke (Statistician, Berry Consultants, UK)
Professor Philippe Parola (Researcher, Aix-Marseille University, France)
Professor Paul Newton (Clinician, University Oxford, UK)
Professor David Price (Statistician, Doherty Institute & University of Melbourne, Australia)
Professor Richard Price (Clinician, Menzies School of Health Research, Australia)
Professor Sasithon Pukrittayakamee (Clinician, Mahidol University, Thailand)
Dr Ben Saville (Statistician, Berry Consultants & Vanderbilt University)
Professor Jason Roberts (Pharmacist/Clinician, The University of Queensland, Australia)
Professor Stephen Rogerson (Clinician, University of Melbourne, Australia)
Professor Kathy Rowan (Researcher, Director of the ICNARC Clinical Trials Unit, UK)
Dr William Schilling (Clinician, Mahidol Oxford Tropical Medicine Research Unit, Thailand)
Dr Anuraj Shankar (Clinician/Trialist, Eijkman-Oxford Clinical Research Unit, Indonesia)
Professor Sanjib Kumar Sharma (Clinician, Koirala Institute of Health Sciences, Nepal)
Professor Julie Simpson (Statistician, University of Melbourne, Australia)
Professor Frank Smithuis (Clinical researcher, Director of the Myanmar Oxford Tropical Research Unit, Myanmar)
Dr Tim Spelman (Statistician, Burnet Institute, Australia)
Dr Kasia Stepniewska (Statistician, University of Oxford, UK)
Dr Nathalie Strub Wourgaft (Clinician, Drugs for Neglected Diseases initiative, Switzerland)
Dr Aimee Taylor (Statistician, Harvard T.H. Chan School of Public Health, USA)
Dr Walter Taylor (Clinician, Mahidol Oxford Tropical Medicine Research Unit, Thailand)
Professor Guy Thwaites (Clinician, Director of the Oxford University Clinical Research Unit, Vietnam)
Professor Tran Tinh Hien (Clinician, Oxford Clinical Research Unit, Vietnam)
Professor Steven Tong (Clinician, University of Melbourne, Australia)
Professor Paul Turner (Clinician/Researcher, Director of Cambodia Oxford Medical Research Unit, Cambodia)
Professor Ross Upshur (Head of Division of Clinical Public Health, University of Toronto, Canada)
Professor Rogier van Doorn (Clinical Microbiologist, University of Oxford, UK)
Professor Sir Nicholas White (Clinician, Mahidol Oxford Tropical Medicine Research Unit, Thailand)
Professor Thomas Williams (Clinician, KEMRI-Wellcome Trust Research Programme, Kenya)
Professor Chris Woods (Researcher, Duke University, USA)
Dr Sophie Yacoub (Clinician, Oxford University Clinical Research Unit, Vietnam) Professor Marcus Zervos (Researcher, Wayne State University School of Medicine, USA)

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Re: Coronavirus (COVID-19): What You Need To Know

Post by vesta » Sat May 30, 2020 1:41 am

Here can be found Dr Raoult's Marseille study of hydroxychloroquine.


Updated proofs of our paper published in Travel Medicine and Infectious Disease : "Early treatment of COVID-19 patients with hydroxychloroquine and azithromycin: A retrospective analysis of 1061 cases in Marseille, France." https://sciencedirect.com/science/artic ... 3920302179… Abstract
Background
In France, the combination hydroxychloroquine (HCQ) and azithromycin (AZ) is used in the treatment of COVID-19.
Methods
We retrospectively report on 1061 SARS-CoV-2 positive tested patients treated for at least three days with the following regimen: HCQ (200 mg three times daily for ten days) + AZ (500 mg on day 1 followed by 250 mg daily for the next four days). Outcomes were death, clinical worsening (transfer to ICU, and >10 day hospitalization) and viral shedding persistence (>10 days).
Results
A total of 1061 patients were included in this analysis (46.4% male, mean age 43.6 years – range 14–95 years). Good clinical outcome and virological cure were obtained in 973 patients within 10 days (91.7%). Prolonged viral carriage was observed in 47 patients (4.4%) and was associated to a higher viral load at diagnosis (p < .001) but viral culture was negative at day 10. All but one, were PCR-cleared at day 15. A poor clinical outcome (PClinO) was observed for 46 patients (4.3%) and 8 died (0.75%) (74–95 years old). All deaths resulted from respiratory failure and not from cardiac toxicity. Five patients are still hospitalized (98.7% of patients cured so far). PClinO was associated with older age (OR 1.11), severity of illness at admission (OR 10.05) and low HCQ serum concentration. PClinO was independently associated with the use of selective beta-blocking agents and angiotensin II receptor blockers (p < .05). A total of 2.3% of patients reported mild adverse events (gastrointestinal or skin symptoms, headache, insomnia and transient blurred vision).
Conclusion
Administration of the HCQ+AZ combination before COVID-19 complications occur is safe and associated with a very low fatality rate in patients.
Keywords
SARS-CoV-2
COVID-19
Hydroxychloroquine
Azithromycin

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Sat May 30, 2020 7:05 am

repeating my previous request for one direct link to the original lancet article discussed, and one more direct link to the original response letter.
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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Re: Coronavirus (COVID-19): What You Need To Know

Post by zen2010 » Sat May 30, 2020 7:36 am

jimmylegs wrote:
Sat May 30, 2020 7:05 am
repeating my previous request for one direct link to the original lancet article discussed, and one more direct link to the original response letter.
Hi JL,
That will be my last post on this topic

original lancet article discussed
https://www.thelancet.com/journals/lanc ... 6/fulltext


direct link to the original response letter
https://zenodo.org/record/3862789#.XtDIRDozaUn


Stay safe

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Sat May 30, 2020 8:08 am

better; thank you zen. i suppose i ought to have specified titles with links. mea culpa.
i managed to find the letter after searching the unfamiliar zenodo database for results including the name of the lancet article's lead author.
commentary:
  • Safety fears over hyped drug hydroxychloroquine spark global confusion (May 29)
    A study that suggested treatment with the malaria drug could be dangerous to people with coronavirus has slowed clinical trials — but the study itself has also been questioned.
    https://www.nature.com/articles/d41586-020-01599-9

    In light of the study, this week, the World Health Organization (WHO) has paused enrolment in its trial of the drug as a treatment for COVID-19, as have regulators in the United Kingdom, France and Australia, where similar trials are under way. But the picture isn’t clear-cut: on 28 May, 120 researchers signed a letter to The Lancet, which published the study1, highlighting concerns about the quality of the data and its analysis.
    ...
    observational studies can also be prone to real-world bias: one concern, for example, is that physicians might be more likely to give a drug to patients who are sicker and more likely to die.
    ...
    Nevertheless, the results have led regulators and clinical-trial sponsors to take action...
    ...
    The Lancet study’s lead author, Mandeep Mehra, a cardiologist at Brigham and Women’s Hospital in Boston, Massachusetts, says that he agrees with the WHO’s decision to take a hard look at the safety data from the Solidarity trial. But he does not support ending clinical trials of hydroxychloroquine altogether. “We never called for halting clinical trials,” he says. “In fact, we called for the opposite.”
    ...
    In the midst of it all, the Lancet analysis itself has come under fire. Some researchers have pointed to oddities in the data...
    ...
    Following these criticisms, Mehra’s team tracked down some errors ... The Lancet will soon issue a correction, Mehra says, but the errors did not affect the paper’s conclusions. And the company that gathered the proprietary data, Surgisphere Corporation of Chicago, Illinois, says that it will accept proposals from other researchers to analyse its data...
    ...
    but some remain sceptical ... patients who received hydroxychloroquine in the study were often sicker in the first place than those who did not...
    ...
    [Mehra] says, his study merely highlights an association between the treatment and increased death, but because it is an observational study and not a clinical trial, it cannot exclude the possibility that other factors may have contributed to that difference in mortality'.
update: end update

personally, recognizing that i am generally distanced from others in ways not available to all, i will continue as previously throughout lockdown and any gradual reopening. more careful with social distancing and hygiene than most of my acquaintance (even within my household, which includes a much less careful 70-something) or wider community in general, with as well nourished an immune system as I can manage - including as much evidence of optimal status as possible given my somewhat limited access to testing.

other than that, i will await the results of forthcoming properly designed and implemented RCTs with interest.
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Wed Jun 03, 2020 6:13 am

five part COVID webinar series available at:
Multiple Sclerosis Information (MSi) Video Library
On-Demand Videos, Webinars, and Webcasts

https://mymsaa.org/ms-information/videos/
(scroll down to the last five links in the Multiple Sclerosis/Symptoms/Research section)
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Wed Jun 03, 2020 6:36 pm

A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19 (June 3)
https://www.nejm.org/doi/full/10.1056/N ... tured_home
...
CONCLUSIONS
After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure.
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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NHE
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Re: Coronavirus (COVID-19) News

Post by NHE » Wed Jun 10, 2020 1:47 am

The Lancet retracts large study on hydroxychloroquine

https://www.nbcnews.com/health/health-n ... e-n1225091

The medical journal The Lancet on Thursday retracted a large study on the use of hydroxychloroquine to treat COVID-19 because of potential flaws in the research data. The study, published two weeks ago, found no benefit to the drug — and suggested its use may even increase the risk of death.

Thursday's retraction doesn't mean that the drug is helpful — or harmful — with respect to the coronavirus. Rather, the study authors were unable to confirm that the data set was accurate.

Researchers from Brigham and Women's Hospital in Boston had worked with a health care analytics company, Surgisphere Corp., on the study.

"After publication of our Lancet article, several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation," the study authors wrote in their retraction.

The study authors said they launched an independent review to confirm the findings, but said the company would not provide access to all of the data.

"Based on this development, we can no longer vouch for the veracity of the primary data sources," the authors wrote.

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Re: Coronavirus (COVID-19): What You Need To Know

Post by jimmylegs » Wed Jun 10, 2020 2:38 am

Retraction—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis (Jun 4)
https://www.thelancet.com/journals/lanc ... 6/fulltext

"...Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements. As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process..."

Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19 (Jun 4)
https://www.nejm.org/doi/full/10.1056/NEJMc2021225

"Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article, “Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19.”1 We therefore request that the article be retracted. We apologize to the editors and to readers of the Journal for the difficulties that this has caused."

Lancet, NEJM Retract Surgisphere Studies on COVID-19 Patients (Jun 4)
https://www.the-scientist.com/news-opin ... uine-67613

'... Today, three authors—all the coauthors on the study except Surgisphere founder and CEO Sapan Desai—contacted The Lancet to retract their report. “They were unable to complete an independent audit of the data underpinning their analysis,” the retraction notice in The Lancet reads. “As a result, they have concluded that they ‘can no longer vouch for the veracity of the primary data sources.’” ...'

Lancet, New England Journal retract Covid-19 studies ... (Jun 4)
https://www.statnews.com/2020/06/04/lan ... ria-drugs/

"... Meanwhile, on Wednesday, researchers reported the results of the first gold-standard clinical trial of hydroxycholoroquine in Covid-19, concluding that it did not prevent infections any better than placebo. Other clinical trials, including some looking at the drugs as treatments, are ongoing..."
https://www.who.int/news-room/q-a-detail/q-a-coronaviruses

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