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Animal Ethics Biosafety Human Research Ethics Research Integrity

The Surgisphere Scandal: What Went Wrong? – The Scientist (Catherine Offord | October 2020)

Posted by Dr Gary Allen in Human Research Ethics, Research Integrity on October 11, 2020
Keywords: Biomedical, Breaches, Clinical trial, Data management, Human research ethics, Institutional responsibilities, Journal, Medical research, Merit and integrity, Publication ethics, Research integrity, Research Misconduct, Research results, Researcher responsibilities
The words "FAKE NEWS" coming out of a COVID-19 cell

The high-profile retractions of two COVID-19 studies stunned the scientific community earlier this year and prompted calls for reviews of how science is conducted, published, and acted upon. The warning signs had been there all along.

It sounds absurd that an obscure US company with a hastily constructed website could have driven international health policy and brought major clinical trials to a halt within the span of a few weeks. Yet that’s what happened earlier this year, when Illinois-based Surgisphere Corporation began a publishing spree that would trigger one of the largest scientific scandals of the COVID-19 pandemic to date.

At the heart of the deception was a paper published in The Lancet on May 22 that suggested hydroxychloroquine, an antimalarial drug promoted by US President Donald Trump and others as a therapy for COVID-19, was associated with an increased risk of death in patients hospitalized with the disease. The study wasn’t a randomized controlled trial—the gold standard for determining a drug’s safety and efficacy—but it did purportedly draw from an enormous registry of observational data that Surgisphere claimed to have collected from the electronic medical records of nearly 100,000 COVID-19 patients across 671 hospitals on six continents.

The study was a medical and political bombshell. News outlets analyzed the implications for what they referred to as the “drug touted by Trump.” Within days, public health bodies including the World Health Organization (WHO) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) instructed organizers of clinical trials of hydroxychloroquine as a COVID-19 treatment or prophylaxis to suspend recruitment, while the French government reversed an earlier decree allowing the drug to be prescribed to patients hospitalized with the virus.

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