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Negative Report on Hydroxychloroquine RETRACTED, Used False Information

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The Lancet, New England Journal of Medicine is now a laughing stock as widely-touted hydroxychlorine study is  found to be based on fabricated data.

Three scientists RETRACT study that claimed Trump-backed malaria drug raised the risk of death for coronavirus patients over ‘concerning data’

  • Three authors of a study published in The Lancet suggesting the drug raised coronavirus patients’ risk of death retracted it Thursday
  • The Lancet published an ‘expression of concern’ over the study’s data Tuesday
  • An outside review of the study was launched, but could not be completed because the data supplier refused to turn over its information
  • The study relied on data from health care data analytics company Surgisphere
  • It came after more than 120 leading scientists raised concerns about the data
  • They highlighted 10 major flaws, including that patient data was wrong
  • The Lancet published the research on May 22, which found the drug may be dangerous, causing heart problems of death. Major trials were halted as a result

By Vanessa Chalmers Health Reporter For Mailonline and Natalie Rahhal Acting Us Health Editor, Daily Mail, 5 June 2020

The authors of a momentous study that claimed that hydroxychloroquine raised the risks of death for coronavirus patients treated with the controversial malaria drug have retracted their research.

The retraction was published in the Lancet on Thursday, and comes just two days after the medical journal posted an ‘expression of concern.’

Along with the publication, more than 120 prominent scientists raised questions about the data used in the study, which was sourced from a database run by a private company, Surgisphere.

On the heels of that research’s May publication, international trials of the drug were halted – but the World Health Organization (WHO) announced Wednesday it would restart the hydroxychloroquine arm of its international SOLIDARITY trial.

And President Donald Trump himself continued to take the drug he dubbed a ‘game-changer’ in the hopes it would prevent infection.

The research, led by Dr Mandeep Mehra of Harvard Medical School, Dr Amit Patel of the University of Utah and Dr Frank Ruschitzka of the University Hospital Zurich, has been under outside review.

But Surgisphere refused to transfer its data to the auditors, citing patient privacy. As a result, the review was cut short and the study was retracted.

‘We can no longer vouch for the veracity of the primary data sources,’ the authors wrote to The Lancet in their retraction.

A momentous study on hydroxychloroquine that suggested the controversial malaria drug hydroxychloroquine raised death risks in coronavirus patients has been retracted from The Lancet by three of its authors, the leading British medical journal said Thursday (

The study was retracted by three of its four authors: Dr Mandeep Mehra, of Harvard Medical School, Dr Frank Ruschitzka from University Hospital Zurich and Dr Amit Patel of the University of Utah (pictured from left to right) all co-signed the retraction

‘We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.’

The fourth author listed on the study, Dr Sapan Desai, who runs Surgisphere, did not sign the retraction.

Even before the study was retracted from The Lancet, hydroxychloroquine was a controversial subject, politicized by President Donald Trump’s references to the drug as a ‘game-changer’ and a ‘gift from God.’

The study’s lead author, Dr Mehra, is a cardiovascular surgeon and registered Republican.

According to the app, Vote With Me, Dr Mehra voted Republican in the 2016 Presidential Primary. He also voted in the 2016 Presidential election, although data from LexisNexis lists only his registration in Louisiana, and does not give a party affiliation.

Dr Mehra said in a personal statement shared with DailyMail.com that he found Surgisphere through a co-author and personally reviewed the company’s data, but admitted that in hindsight, his review was perhaps not thorough enough.
The study authors published a retraction of their research on June 4, less than a month after the original article was published. They revealed that their data could not be reviewed and apologized for any ’embarrassment or inconvenience that this may have caused’

‘I did not do enough to ensure that the data source was appropriate for this use. For that, and for all the disruptions—both directly and indirectly—I am truly sorry,’ he said in the statement.

Results from Vote With Me suggest that Dr Patel, an adjunct professor of biomedical engineering at the University of Utah may be a registered Democrat.

Dr Ruschitzka does not practice in and is not a citizen of the US.

The missing author, Dr Desai, and his company have drawn the most pointed scrutiny in the aftermath of the hydroxychloroquine study.
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Dr Desai is trained as a vascular surgeon but in practice is also an entrepreneur, founding Surgisphere in 2007. He is also a science fiction writer.

Two criminal flings were made against Dr Desai in 2011 in North Carolina, but it is unclear what the nature of these filings were.

Dr Desai was also named in two medical malpractice suits, but called the allegations ‘unfounded’ in an interview with The Scientist.

His company, Surgisphere, claims to use AI to harvest and organize clinical data from around the world.

Its website boasts a database that includes more than 231 billion data points.

Yet the company employs only between 11 and 50 people, just five of whom are on LinkedIn, according to its page on the professional networking site. Just over 200 LinkedIn users follow the company.

More than 120 top scientists and doctors had criticized the study in an open letter to the journal, flagging 10 major flaws.
Dr Sapan Desai founded Surgisphere in 2007 and was a co-author on the paper in The Lancet. His name was not included in the retraction, but he did co-sign the retraction of a second study from the NEJM

Dr Sapan Desai founded Surgisphere in 2007 and was a co-author on the paper in The Lancet. His name was not included in the retraction, but he did co-sign the retraction of a second study from the NEJM

The Lancet then admitted there are ‘serious questions’ that need to be answered about the data – but did not reveal what those question were – in a public statement.

But scientists say the move was too late and that the ‘harm was already done’, as the race for a cure to halt the virus that has ravaged the world continues.

However, the World Health Organization announced Wednesday that the hydroxychloroquine arms of its international SOLIDARITY trial of potential coronavirus treatments would resume.

The study in the Lancet, published on May 22, claimed hydroxychloroquine raised the risk of death from the coronavirus by up to 45 percent.

And Covid-19 patients taking the drug were up to five times more likely to develop a life-threatening arrhythmia – a known complication.

The paper came as a massive blow to hopes of finding a cure after hype was built around the medicine built early on in the pandemic by a French study (which has also since been retracted) that suggested the drug’s promise.

US President Donald Trump has been criticized for promoting the drugs – which are used to treat malaria, arthritis and lupus – as a cure for the new virus.

The authors from Brigham and Women’s Hospital in Boston, Massachusetts, led by Professor Mandeep Mehra, said they were ‘unable to confirm a benefit’ of hydroxychloroquine.

Their finding prompted the UK’s drugs watchdog to temporarily suspend two major Oxford University clinical trials of the antimalarial.
WHAT DID THE LANCET SAY?

The Lancet: Expression of concern: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis

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 analysis1 —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.

The World Health Organization also pulled the plug on its SOLIDARITY study, on the back of the worrying results.

But on Tuesday evening, the Lancet’s editors published an ‘expression of concern’ and said ‘important scientific questions’ had been raised about the data used in the study.

The data set was supplied by US-based healthcare data analytics company Surgisphere Corporation and its founder, Dr Sapan Desai, was one of the paper’s four co-authors.

Among the criticisms were the seemingly high mortality rates linked to drugs that have been routinely prescribed since the 1950s.

The Lancet’s editors said: ‘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.’

Surgisphere said: ‘In our hydroxychloroquine analysis, we studied a very specific group of hospitalised patients with Covid-19 and have clearly stated that the results of our analyses should not be over-interpreted to those that have yet to develop such disease or those that have not been hospitalised.

‘We also clearly outlined the limitations of an observational study that cannot fully control for unobservable confounding measures, and we concluded that off-label use of the drug regimens outside of the context of a clinical trial should not be recommended.

‘Our Covid-19 research was not funded by any drug company, private or public donor, or political organisation.

‘Our research collaborators on the piece for The Lancet devoted their time through personal funds and resources because they saw the urgent humanitarian need and opportunity to inform rapidly evolving pandemic responses.’

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