- 06 Jun 2020 04:59
#15097956
Covid-19: Lancet retracts paper that halted hydroxychloroquine trials
4 Jun 2020
The Lancet paper that halted global trials of hydroxychloroquine for Covid-19 because of fears of increased deaths has been retracted after a Guardian investigation found inconsistencies in the data.
The lead author, Prof Mandeep Mehra, from the Brigham and Women’s hospital in Boston, Massachusetts decided to ask the Lancet for the retraction because he could no longer vouch for the data’s accuracy.
The journal’s editor, Richard Horton, said he was appalled by developments. “This is a shocking example of research misconduct in the middle of a global health emergency,” he told the Guardian.
A Guardian investigation had revealed errors in the data that was provided for the research by US company Surgisphere. These were later explained by the company as some patients being wrongly allocated to Australia instead of Asia. But more anomalies were then picked up. A further Guardian investigation found that there were serious questions to be asked about the company itself.
In a statement on Thursday, Mehra said: “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.”
The Lancet study had a dramatic impact on attempts to find out whether the antimalarial drug hydroxychloroquine, and its older version, chloroquine, could help treat patients with Covid-19. The US president, Donald Trump was among those who backed the drug before any high-quality trial evidence had been published.
The World Health Organization and several countries suspended randomised controlled trials that were set up to find an answer. Those trials have now been restarted. Many scientists were angry that they had been stopped on the basis of a trial that was observational and not a “gold standard” RCT.
Mehra had commissioned an independent audit of the data after scientists questioned it.
Shortly after the Lancet retracted its study, the New England Journal of Medicine retracted a paper based on the Surgisphere database, also co-authored by Mehra and Desai. The study purported to include data from Covid-19 patients from 169 hospitals in 11 countries in Asia, Europe and North America.
In a statement, published by the journal, the authors said: “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’. We therefore request that the article be retracted.
“We apologise to the editors and to readers of the Journal for the difficulties that this has caused.”
https://www.theguardian.com/world/2020/ ... ine-trials
The Lancet pulls study flagging hydroxychloroquine risks
05/06/2020
The Lancet on Thursday retracted a study that raised safety fears over the use of a drug favored by President Donald Trump to treat COVID-19, after the paper's authors said they could no longer vouch for its underlying data.
It was soon followed by the withdrawal of another coronavirus paper in the New England Journal of Medicine (NEJM) that was not linked to hydroxychloroquine but relied upon the same healthcare company's patient database.
The unfolding research scandal threatens to undermine confidence in two of the world's top medical journals in the midst of a pandemic.
But it is the retraction of The Lancet study that may supercharge what has become a highly politicized debate about hydroxychloroquine, an old malaria and rheumatoid arthritis drug now backed by many US conservatives against the SARS-CoV-2 virus.
This finding led the World Health Organization to temporarily suspend clinical trials into the medicines, though the paper soon triggered widespread concern among scientists over a lack of information about the countries and hospitals that contributed data.
But Surgisphere, a little-known healthcare analytics firm based in Chicago that provided the data, refused to cooperate.
"Due to this unfortunate development, the authors request that the paper be retracted," the three said.
"We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused."
The Lancet, a British journal, offered its own statement, saying, "There are many outstanding questions about Surgisphere and the data that were allegedly included in this study."
Researchers began to closely scrutinize The Lancet paper shortly after its publication, highlighting numerous red flags ranging from the huge number of patients to the unusually complete information on their demographics.
Internet sleuthing by the Guardian revealed that Surgisphere had a scant online presence, with only a handful of staff listed on LinkedIn including a science fiction author and an adult model.
The firm was involved in yet another attention-grabbing study that found the anti-parasite drug ivermectin could be useful against COVID-19.
Though this paper had not been peer-reviewed or appeared in a journal, it caused a run on the drug in Latin America where it is widely available.
Chris Chambers, a professor of psychology at Cardiff University, added the affair "raises serious questions about the standard of editing at the Lancet and NEJM -- ostensibly two of the world's most prestigious medical journals."
https://www.france24.com/en/20200605-th ... uine-risks
4 Jun 2020
The Lancet paper that halted global trials of hydroxychloroquine for Covid-19 because of fears of increased deaths has been retracted after a Guardian investigation found inconsistencies in the data.
The lead author, Prof Mandeep Mehra, from the Brigham and Women’s hospital in Boston, Massachusetts decided to ask the Lancet for the retraction because he could no longer vouch for the data’s accuracy.
The journal’s editor, Richard Horton, said he was appalled by developments. “This is a shocking example of research misconduct in the middle of a global health emergency,” he told the Guardian.
A Guardian investigation had revealed errors in the data that was provided for the research by US company Surgisphere. These were later explained by the company as some patients being wrongly allocated to Australia instead of Asia. But more anomalies were then picked up. A further Guardian investigation found that there were serious questions to be asked about the company itself.
In a statement on Thursday, Mehra said: “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.”
The Lancet study had a dramatic impact on attempts to find out whether the antimalarial drug hydroxychloroquine, and its older version, chloroquine, could help treat patients with Covid-19. The US president, Donald Trump was among those who backed the drug before any high-quality trial evidence had been published.
The World Health Organization and several countries suspended randomised controlled trials that were set up to find an answer. Those trials have now been restarted. Many scientists were angry that they had been stopped on the basis of a trial that was observational and not a “gold standard” RCT.
Mehra had commissioned an independent audit of the data after scientists questioned it.
Shortly after the Lancet retracted its study, the New England Journal of Medicine retracted a paper based on the Surgisphere database, also co-authored by Mehra and Desai. The study purported to include data from Covid-19 patients from 169 hospitals in 11 countries in Asia, Europe and North America.
In a statement, published by the journal, the authors said: “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’. We therefore request that the article be retracted.
“We apologise to the editors and to readers of the Journal for the difficulties that this has caused.”
https://www.theguardian.com/world/2020/ ... ine-trials
The Lancet pulls study flagging hydroxychloroquine risks
05/06/2020
The Lancet on Thursday retracted a study that raised safety fears over the use of a drug favored by President Donald Trump to treat COVID-19, after the paper's authors said they could no longer vouch for its underlying data.
It was soon followed by the withdrawal of another coronavirus paper in the New England Journal of Medicine (NEJM) that was not linked to hydroxychloroquine but relied upon the same healthcare company's patient database.
The unfolding research scandal threatens to undermine confidence in two of the world's top medical journals in the midst of a pandemic.
But it is the retraction of The Lancet study that may supercharge what has become a highly politicized debate about hydroxychloroquine, an old malaria and rheumatoid arthritis drug now backed by many US conservatives against the SARS-CoV-2 virus.
This finding led the World Health Organization to temporarily suspend clinical trials into the medicines, though the paper soon triggered widespread concern among scientists over a lack of information about the countries and hospitals that contributed data.
But Surgisphere, a little-known healthcare analytics firm based in Chicago that provided the data, refused to cooperate.
"Due to this unfortunate development, the authors request that the paper be retracted," the three said.
"We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused."
The Lancet, a British journal, offered its own statement, saying, "There are many outstanding questions about Surgisphere and the data that were allegedly included in this study."
Researchers began to closely scrutinize The Lancet paper shortly after its publication, highlighting numerous red flags ranging from the huge number of patients to the unusually complete information on their demographics.
Internet sleuthing by the Guardian revealed that Surgisphere had a scant online presence, with only a handful of staff listed on LinkedIn including a science fiction author and an adult model.
The firm was involved in yet another attention-grabbing study that found the anti-parasite drug ivermectin could be useful against COVID-19.
Though this paper had not been peer-reviewed or appeared in a journal, it caused a run on the drug in Latin America where it is widely available.
Chris Chambers, a professor of psychology at Cardiff University, added the affair "raises serious questions about the standard of editing at the Lancet and NEJM -- ostensibly two of the world's most prestigious medical journals."
https://www.france24.com/en/20200605-th ... uine-risks
The more I study science, the more I believe in God.
- Albert Einstein
- Albert Einstein