The Timeline of a Scandal

The Timeline of a Scandal

THE TIMELINE OF A SCANDAL Actions taken by Surgisphere and its founder, Sapan Desai Surgisphere Corporation had a busy few months in 2020, overseeing the launch of a new website, the publication of high-impact papers on treatments and outcomes in COVID-19 patients, and eventually a collapse of its reputation. Collaborations and publications Fallout from the company’s actions MAY 30 The Lancet posts a correction notice on the hydroxychloroquine paper noting MAY 28 that the study authors have updated The Guardian reports that the number of COVID- the paper to resolve the discrepancies *Timeline scale adjusted in some places for fit. 19 hospital admissions and deaths reported in the in the Australian data and to present Lancet study as coming from Australia do not match raw rather than adjusted data. The jour- official records. nal states that the study’s conclusions remain unchanged. More than 100 researchers sign an open letter to the Lancet study authors and to the journal, listing 10 serious JUNE 3 MAY 1 concerns about the paper’s data sources and analysis. Surgisphere’s website is edited to remove Desai and four coauthors publish a mentions of collaborations with the University paper in The New England Journal of of Minnesota and other institutions after Medicine (NEJM) about the association the university contacts the company in between cardiovascular disease, response to inquiries by The Scientist. treatment with heart drugs, and The WHO resumes the hydroxychloroquine MARCH 26 COVID-19 mortality. All authors arm of the Solidarity Trial. Surgisphere announces the devel- approve a statement that they can opment of a set of COVID-19 “vouch for the accuracy and complete- diagnostic tools in collaboration ness of the data provided.” with the nonprofit African Federation MAY 31 JUNE 5 JUNE 26 for Emergency Medicine (AFEM) to The preprint on ivermectin The AFEM issues a statement withdrawing its MHRA allows COPCOV to help clinicians in low-resource areas. MAY 8 MAY 27 disappears from SSRN. recommendation of the COVID-19 diagnostic resume recruitment to its trial of Peru becomes one of the first countries The French government Mehra will later tell tools developed in collaboration with Surgisphere, hydroxychloroquine as prophy- to include ivermectin in official guidelines reverses a decree that had The Scientist that he and halts plans for a clinical trial to test them. lactic in healthcare workers. MID-FEB for COVID-19 treatment. Researchers across allowed hospitals to prescribe requested the removal AFEM founder Lee Wallis tells The Scientist the Surgisphere Corporation, Latin America cite Surgisphere’s paper along- hydroxychloroquine to because he “felt further nonprofit will work through the end of the year the company Desai APRIL 19 side an in vitro study and doctors’ anecdotes COVID-19 patients. analysis was needed to to develop, test, and roll out a replacement. founded in 2008, launches The original ivermectin preprint as evidence of the drug’s efficacy. consider additional con- a new website. The con- is replaced on SSRN with a second founding factors.” tent, including articles version that contains different describing collaborations patient numbers but draws the same MAY 23-24 JUNE 8 that didn’t take place, will conclusion about ivermectin’s link Over the weekend, epidemiologists MHRA formally suspends the COPCOV trial despite the be uploaded starting in to patient survival. and statisticians question the Lancet retraction of the Lancet paper and a response from organizers March, some with 2019 study’s data and its conclusions on social with reasons the study should continue. publication dates. media and in blog posts. Researchers start sending letters to the journal’s editor, Surgisphere’s COVID-19 diagnostic tools are removed from Richard Horton, expressing concerns about the company’s website hours after The Scientist publishes a the study’s data sources and analyses. story about researchers’ criticism of them. JUNE 4 JUNE 19 MAY 7 The Lancet and NEJM retract the FEB 10 MAY 25 The Pan American Health Organization, Researchers at ISGlobal in Barcelona write to all papers based on Surgisphere’s Facing at least three medical The World Health Organization JUNE 12 a regional office of the WHO, circulates a four coauthors on the ivermectin study with database after independent malpractice lawsuits, Sapan (WHO) announces the suspension Surgisphere’s document warning that there is a lack of concerns about potential discrepancies between auditors tasked with checking Desai leaves Northwest of recruitment to the hydroxychloro- website is suspended. clinical evidence of ivermectin’s efficacy the numbers in Surgisphere’s database and gov- its validity are refused access. Community Hospital. He quine-testing arm of the interna- in COVID-19 patients and that the drug ernment-reported COVID-19 statistics. Desai and the hospital later say he tional Solidarity Trial, which aims JUNE 2 should not be used to treat the disease. and coauthor Mandeep Mehra respond, but do left for personal reasons. to find treatments for hospitalized A second open letter, this time addressed to Still, many Latin American countries now not take action to address the issues raised. COVID-19 patients. NEJM and the authors on that study, details fur- recommend ivermectin as treatment and ther discrepancies in Surgisphere’s database as prophylaxis. evident from this paper. JUNE 7 MAY 22 Mehra distances himself from APRIL 6 Desai and three coauthors (including Mehra) publish a paper in The Lancet that reports increased After making inquiries in the US states hit hard- Desai and Surgisphere in Desai and three coauthors post a preprint on SSRN mortality among COVID-19 patients taking hydroxychloroquine or the related molecule chloroquine est by COVID-19, The Scientist reports that it’s statements to multiple news reporting a positive association between treatment compared with controls. The paper claims to include data from more than 96,000 patients from unable to find any health systems that contrib- organizations. He later tells with the antiparasitic drug ivermectin and survival 671 hospitals on six continents. uted data to Surgisphere’s registry. The Scientist that he didn’t JUNE 17 of hospitalized COVID-19 patients. The paper uses become aware of potential dis- The WHO drops hydroxychloroquine Surgisphere’s proprietary patient registry, which The UK Medicines and Healthcare products Regulatory Agency (MHRA) writes to organizers Within hours of each other, NEJM and The Lan- crepancies in the company’s from the Solidarity Trial, this time because Desai claims gathered real-time electronic medical of COPCOV, an international trial of hydroxychloroquine as prophylaxis led by scientists at the cet issue expressions of concern on the papers database until after the publi- interim data indicate a lack of efficacy in records from hospitals around the world. University of Oxford, saying they’re expected to “immediately cease recruitment.” EDEVARDE_ © ISTOCK.COM, BORISLAV; © ISTOCK.COM, ORGANIZATION HEALTH MOREIRA; WIKIMEDIA, THE WORLD based on Surgisphere’s database. cation of the Lancet study. hospitalized COVID-19 patients..

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