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Questions raised over hydroxychloroquine study which caused WHO to halt trials (now resumed) {off again} for Covid-19 - Lancet retracts
Wed 27 May 2020 22.27 EDT Last modified on Thu 28 May 2020 02.05 EDT
Questions have been raised by Australian infectious disease researchers about a study published in the Lancet which prompted the World Health Organization to halt global trials of the drug hydroxychloroquine to treat Covid-19...
"...there’s an obvious contest that’s happening between different sectors of the colonial ruling class in this country. And they would, if they could, lump us into their beef, their struggle." ---- Omali Yeshitela, African People’s Socialist Party
(My posts are not intended as advice or professional assessments of any kind.) Never forget Excalibur.
That's a good one even machine translated, Bertrand. I don't know why, but the first step to introducing a new drug in the US is to demonize the one one it's replacing.
A lot of questions indeed,no answers yet. Surgisphere seems to be the company that delivered the data. How did they get that? Some hospitals did not know they were in the study, claimed they never gave data? Who and what is Surgisphere?
And: you can't make a lot of money with HCQ?
?Addressing chronic disease is an issue of human rights ? that must be our call to arms"
Richard Horton, Editor-in-Chief The Lancet
Important scientific questions have been raised about data reported in the paper by Mandeep Mehra et al—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis 1
—published in The Lancet on May 22, 2020.
Although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly, we are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention. We will update this notice as soon as we have further information.
On June 3, the World Health Organization (WHO) resumed a study looking into whether the malaria drug hydroxychloroquine could be effective in treating COVID-19.
On its face, it was a major finding: Antimalarial drugs touted by the White House as possible COVID-19 treatments looked to be not just ineffective, but downright deadly. A study published on 22 May in The Lancet used hospital records procured by a little-known data analytics company called Surgisphere to conclude that coronavirus patients taking chloroquine or hydroxychloroquine were more likely to show an irregular heart rhythm—a known side effect thought to be rare—and were more likely to die in the hospital.
Within days, some large randomized trials of the drugs—the type that might prove or disprove the retrospective study’s analysis—screeched to a halt. Solidarity, the World Health Organization’s (WHO’s) megatrial of potential COVID-19 treatments, paused recruitment into its hydroxychloroquine arm, for example. (Update: At a briefing on 3 June WHO announced it would resume that arm of the study.)
But just as quickly, the Lancet results have begun to unravel—and Surgisphere, which provided patient data for two other high-profile COVID-19 papers, has come under withering online scrutiny from researchers and amateur sleuths. They have pointed out many red flags in the Lancet paper, including the astonishing number of patients involved and details about their demographics and prescribed dosing that seem implausible. “It began to stretch and stretch and stretch credulity,” says Nicholas White, a malaria researcher at Mahidol University in Bangkok.
"Safety and security don't just happen, they are the result of collective consensus and public investment. We owe our children, the most vulnerable citizens in our society, a life free of violence and fear." -Nelson Mandela
Surgisphere, whose employees appear to include a sci-fi writer and adult content model, provided database behind Lancet and New England Journal of Medicine hydroxychloroquine studies
Melissa Davey in Melbourne and Stephanie Kirchgaessner in Washington and Sarah Boseley in London
Wed 3 Jun 2020 14.47 EDT First published on Wed 3 Jun 2020 06.54 EDT
The Guardian’s investigation has found:
A search of publicly available material suggests several of Surgisphere’s employees have little or no data or scientific background. An employee listed as a science editor appears to be a science fiction author and fantasy artist. Another employee listed as a marketing executive is an adult model and events hostess.
The company’s LinkedIn page has fewer than 100 followers and last week listed just six employees. This was changed to three employees as of Wednesday....
...
“The very serious concerns being raised about the validity of the papers by Mehra et al need to be recognised and actioned urgently, and ought to bring about serious reflection on whether the quality of editorial and peer review during the pandemic has been adequate. Scientific publication must above all be rigorous and honest. In an emergency, these values are needed more than ever.”
All the authorities and journals who crammed into that clown car should hire the Guardian to vet data sources like this in the future. Their credibility has been undermined and they did a lot of damage to needed research studies and wasted a lot of time and money that could have been put to better use.
"...there’s an obvious contest that’s happening between different sectors of the colonial ruling class in this country. And they would, if they could, lump us into their beef, their struggle." ---- Omali Yeshitela, African People’s Socialist Party
(My posts are not intended as advice or professional assessments of any kind.) Never forget Excalibur.
Despite what the article says, the paper is still online at this minute....
The Lancet, one of the world’s top medical journals, on Thursday retracted an influential study that raised alarms about the safety of the experimental Covid-19 treatments chloroquine and hydroxychloroquine amid scrutiny of the data underlying the paper.
The retraction came at the request of the authors of the study, published last month, who were not directly involved with the data collection and sources, the journal said.
“We can no longer vouch for the veracity of the primary data sources,” Mandeep Mehra of Brigham and Women’s Hospital, Frank Ruschitzka of University Hospital Zurich, and Amit Patel of University of Utah said in a statement. “Due to this unfortunate development, the authors request that the paper be retracted.”
expert reaction to the retraction of a Lancet paper on hydroxychloroquine and chloroquine treatment for COVID-19 and the retraction of a NEJM paper on Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19
The authors of two studies into COVID-19 treatment, published in The Lancet and New England Journal of Medicine (NEJM), have retracted both papers following expressions of concern regarding the data.
Prof Chris Chambers, School of Psychology, Cardiff University Brain Research Imaging Centre, (Chair of the Registered Reports Committee, Center for Open Science and Member of the UK Reproducibility Network Steering Group) said:
“It is right that these articles were retracted. However, the failure to resolve such basic concerns about the data during the course of normal peer review raises serious questions about the standard of editing at the Lancet and NEJM — ostensibly two of the world’s most prestigious medical journals. If these journals take issues of reproducibility and scientific integrity as seriously as they claim, then they should forthwith submit themselves and their internal review processes to an independent inquiry.”
"Safety and security don't just happen, they are the result of collective consensus and public investment. We owe our children, the most vulnerable citizens in our society, a life free of violence and fear." -Nelson Mandela
High-profile coronavirus retractions raise concerns about data quality in pandemic studies
...
Scientists say the affair raises serious questions about the way researchers and journals evaluate the data underlying papers that they publish, and may complicate the effort to trial drugs during the coronavirus pandemic.
“This whole event is catastrophic — it is problematic for the journals involved, it is problematic for the integrity of science, it is problematic for medicine, and it is problematic for the notion of clinical trials and evidence generation,” says Ian Kerridge, a bioethicist at the University of Sydney, Australia.
...
Bioethicists say the retractions, and the pulled preprint, raise questions not only about the quality and nature of Surgisphere's data, but also about why the paper’s other authors agreed to work with a large data set they couldn’t validate, and how the work passed peer review at prestigious medical journals.
...
Researchers testing hydroxychloroquine in large clinical trials say they’re worried that the publicity around the Lancet findings may make it harder to complete their research, even though the paper has now been retracted. “We’re hearing that people just aren’t interested in hydroxychloroquine,” says David Smith, an infectious disease specialist at the University of California, San Diego, who is helping to run a trial funded by the US National Institute of Allergy and Infectious Diseases to test the drug in people with COVID-19 who have not been hospitalized. “The retraction won’t get anywhere near as much news as the original study,” he says. “We may never get an answer about treatment with hydroxychloroquine.”
...
"Safety and security don't just happen, they are the result of collective consensus and public investment. We owe our children, the most vulnerable citizens in our society, a life free of violence and fear." -Nelson Mandela
Covid-19 studies based on flawed Surgisphere data force medical journals to review processes
New England Journal of Medicine and Lancet peer reviewers did not see raw data behind findings before publication
Melissa Davey
@MelissaLDavey
Fri 12 Jun 2020 01.50 EDTLast modified on Fri 12 Jun 2020 02.04 EDT
...
None of the peer reviewers who examined a questionable study on the impact of blood pressure medications on Covid-19 saw the raw data behind the findings before it was approved for publication in world-renowned medical journal, the New England Journal of Medicine.
The study was based on a massive dataset supposedly gathered from hospitals worldwide by a US company called Surgisphere...The Lancet, another leading medical journal, also published a study based on the Surgisphere database.
...
A spokeswoman for the New England Journal of Medicine told the Guardian that the Surgisphere paper was reviewed by four external experts and a statistical reviewer. But none of these experts saw the raw data from Surgisphere, she said.
...
The journal is now in the process of assessing existing guidelines for the conduct and reporting of research on big data, and is also developing internal policies for reviewing and reporting these articles.
The Lancet did not provide as much detail when asked the same questions by the Guardian about how the Surgisphere hydroxychloroquine study passed peer review, and whether the incident would trigger a review of the process. It was the Lancet that under the same editor, Richard Horton, published a fraudulent study linking the measles, mumps and rubella vaccine with autism. In 2010, 12 years after the paper was first published, the Lancet retracted the paper. The author of the paper, Dr Andrew Wakefield, was also banned from practising medicine in the UK due to his fraudulent work.
...
The Surgisphere website and Twitter account have both been deleted since the retractions on 5 June.
Authors, elite journals under fire after major retractions
Charles Piller, John Travis
See all authors and affiliations
Science 12 Jun 2020:
Vol. 368, Issue 6496, pp. 1167-1168
DOI: 10.1126/science.368.6496.1167
...
Desai, Mehra, and Patel had never before published together, and that should have been a red flag to any journal, says Jerome Kassirer, editor-in-chief of NEJM during the 1990s. Co-authors of high-profile papers normally share subject area expertise or have clear professional ties, he says, calling the collaboration of the apparently disparate individuals “completely bizarre.”
...
Patel recently tweeted that he is “related to Dr. Desai by marriage,” but added that he remains in the dark about the Surgisphere data.
...
Mehra says he met Patel in “academic and medical circles” and that Patel connected him to Desai. In journal papers, including the retracted ones, Mehra also acknowledged receiving consulting fees from Triple-Gene, a gene therapy company Patel co-founded. “I think [Mehra] just fell into this—perhaps a little na?vely,” says another collaborator, surgeon Daniel Goldstein of the Albert Einstein College of Medicine.
But Kassirer faults Mehra for apparently letting ambition get the best of him. “If you're a scientist and you're going to sign on to a project, by God you should know what the data are,” Kassirer says.
...
"Safety and security don't just happen, they are the result of collective consensus and public investment. We owe our children, the most vulnerable citizens in our society, a life free of violence and fear." -Nelson Mandela
From:WHO Media <Media@campaign.who.int> To: "flutrackers@earthlink.net" <flutrackers@earthlink.net> Subject: Update on hydroxychloroquine and Solidarity Trial Date: Jun 17, 2020 4:42 PM
Wednesday, 17 June 2020
MEDIA ADVISORY
Update on hydroxychloroquine and the Solidarity Trial
On 17 June 2020, WHO announced that the hydroxychloroquine (HCQ) arm of the Solidarity Trial to find an effective COVID-19 treatment was being stopped.
The trial's Executive Group and principal investigators made the decision based on evidence from the Solidarity Trial, UK's Recovery trial and a Cochrane review of other evidence on hydroxychloroquine.
Data from Solidarity (including the French Discovery trial data) and the recently announced results from the UKs Recovery trial both showed that hydroxychloroquine does not result in the reduction of mortality of hospitalised COVID-19 patients, when compared with standard of care.
Investigators will not randomize further patients to hydroxychloroquine in the Solidarity trial. Patients who have already started hydroxychloroquine but who have not yet finished their course in the trial may complete their course or stop at the discretion of the supervising physician.
This decision applies only to the conduct of the Solidarity trial and does not apply to the use or evaluation of hydroxychloroquine in pre- or post-exposure prophylaxis in patients exposed to COVID-19.
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