DOCSLIB.ORG

The Timeline of a Scandal

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
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..
Load more

Recommended publications
  • Politicized Science Lancet, NEJM Retract Studies on HCQ
    6/8/2020 Politicized Science: Lancet, NEJM retract studies on HCQ - UncoverDC Medical Scandal of the Decade Erupts as Lancet and NEJM Both Retract Studies Finding Hydroxychloriquine Deadly and Ineffective At 3:15 pm on June 4, I got a text from my friend Josh in Los Angeles that stopped me in my tracks. The text read: “The fake Lancet Hydroxychloroquine study has been retracted.” I called Josh. “Are you serious?” He’d already texted me the retraction, but still I could barely believe it. Turns out NEJM had also retracted. This was huge. Dr. James Todaro, who runs a website, MedicineUncensored, which publishes the results of HCQ studies, tweeted yesterday: “This is exploding into one of the most twisted and unbelievable medical scandals of the decade.” Todaro (and social media “sleuths”) were the first to expose the truth, in late May on his site: James Todaro, MD @JamesTodaroMD · Jun 4, 2020 BOOM. Lancet study on hydroxychloroquine retracted. Published study existed for only 13 days. Did Twitter peer-review result in the quickest retraction ever for a study of this magnitude? #LancetGate twitter.com/thelancet/stat… The Lancet @TheLancet Today, three of the authors have retracted "Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID- 19: a multinational registry analysis" Read the Retraction notice and statement from The Lancet hubs.ly/H0r7gh50 https://uncoverdc.com/2020/06/06/politicized-science-lancet-nejm-retract/ 1/14 6/8/2020 Politicized Science: Lancet, NEJM retract studies on HCQ - UncoverDC James
    [Show full text]
  • Daily Evidence Digest 4 June 2020
    Daily evidence digest 4 June 2020 The daily evidence digest collates recently released reports and evidence – provision of these links does not imply endorsement nor recommendation. Physical distancing, face masks, heart failure, research quality Peer reviewed journals featured: A systematic review on physical distancing, face masks, and eye protection to prevent person- to-person transmission here A rapid review on dysphagia assessment as a potential aerosol generating procedure here Impact of COVID‐19 pandemic on STEMI in a non‐COVID‐19 epicentre here A brief report on eating disorders during the COVID‐19 pandemic in Australia here Data on the impact of COVID‐19 on heart failure hospitalisation and management here A survey on the use of telemedicine for head and neck ambulatory visits here Racial and ethnic disparities in long-term services here Tele-palliative medicine volunteers in New York here A commentary on the physical, mental, and social issues and challenges faced by unpaid home care providers here A BMJ feature article on how NHS mental health services are adapting to provide care here A small case report on three COVID-19 patients with encephalopathy and encephalitis here Two ‘expressions of concern’ about the quality of information and reliability of conclusions of a retrospective study in NEJM on ACE inhibitors and ARBs here and a multinational registry analysis of hydroxychloroquine for treatment of COVID-19 in the Lancet here Letters and correspondence Self-risk assessment for patients with rheumatic disease
    [Show full text]
  • Misinformation in the COVID-19
    Editor’s column J NeuroIntervent Surg: first published as 10.1136/neurintsurg-2020-016683 on 14 August 2020. Downloaded from acute strokes, predominantly affecting Misinformation in the COVID-19 era otherwise healthy people <50 years of age.12 13 Endothelial dysfunction, hyper- Gabor Toth ,1 Alejandro M Spiotta,2 Joshua A Hirsch ,3 coaguability, ACE2 receptor variability, 4 upregulated inflammatory response and David Fiorella resultant thrombotic events have all been hypothesized as possible causes for The COVID-19 pandemic has taken a toll of primary data sources”.7 Medical jour- these unusual cases, but definitive data on humankind that is remarkable for a nals not properly “vetting” and eventually are currently lacking. One of the alter- disease in modern times. As of late June publishing high-impact articles that turn native explanations may be that some 2020, almost 500 000 people have died of out to be based on unverified data can of the “healthy” patients actually have the disease worldwide, including more misguide providers as well as the public. underlying but previously unknown than 120 000 in the USA, with estimates of Information on the disease that was previ- risk factors contributing to the vascular infected individuals approaching ously restricted to medical professionals is events. It is also possible that younger 10 million.1 The numbers of infected and now available to the broad public by the patients are more likely to have asymp- deceased patients will continue to rise. swipe of a screen, just like any other news- tomatic COVID-19 infection, and in In these times of considerable uncer- reel.
    [Show full text]
  • COVID-19: Make It the Last Pandemic
    COVID-19: Make it the Last Pandemic Disclaimer: The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Independent Panel for Pandemic Preparedness and Response concerning the legal status of any country, territory, city of area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Report Design: Michelle Hopgood, Toronto, Canada Icon Illustrator: Janet McLeod Wortel Maps: Taylor Blake COVID-19: Make it the Last Pandemic by The Independent Panel for Pandemic Preparedness & Response 2 of 86 Contents Preface 4 Abbreviations 6 1. Introduction 8 2. The devastating reality of the COVID-19 pandemic 10 3. The Panel’s call for immediate actions to stop the COVID-19 pandemic 12 4. What happened, what we’ve learned and what needs to change 15 4.1 Before the pandemic — the failure to take preparation seriously 15 4.2 A virus moving faster than the surveillance and alert system 21 4.2.1 The first reported cases 22 4.2.2 The declaration of a public health emergency of international concern 24 4.2.3 Two worlds at different speeds 26 4.3 Early responses lacked urgency and effectiveness 28 4.3.1 Successful countries were proactive, unsuccessful ones denied and delayed 31 4.3.2 The crisis in supplies 33 4.3.3 Lessons to be learnt from the early response 36 4.4 The failure to sustain the response in the face of the crisis 38 4.4.1 National health systems under enormous stress 38 4.4.2 Jobs at risk 38 4.4.3 Vaccine nationalism 41 5.
    [Show full text]
  • New Infections High Among Blacks
    01-15 December 2013 World Aids Day 2013: No time for complacency Independent Blogs, UK – 1 December 2013 Sitting in conversation with Professor Sharon Lewin in Bangkok, it is difficult not to be stunned into silence by her encyclopaedic knowledge of HIV. ...the ‘Towards an HIV Cure project’, an initiative of the International AIDS Society (IAS) which advocates a greater investment in HIV cure research. Incarceration is associated with used syringe lending among active injection drug users with detectable plasma HIV-1 RNA: a longitudinal analysis Bio Med Central, UK – 1 December 2013 Dr. Montaner has also received financial support from the International AIDS Society, United Nations AIDS Program, World Health Organization, Myth of an AIDS-free world Trinidad and Tobago's Newsday, Trinidad & Tobago – 1 December 2013 In 1988, the World Health Organisation (WHO) declared December 1 to be the first World AIDS Day, and it is appropriate today, 25 years later, to reflect on where we are with respect to the HIV/AIDS pandemic. ...control. This is also my firm opinion and forecast. At last year’s International AIDS Society Meeting in Washington, DC, Dr. Richard Horton, present... Made-in-Canada HIV strategy embraced internationally — but not here Thestar.com, Canada – 1 December 2013 The Treatment as Prevention strategy, pioneered in B.C., calls for the immediate provision of highly effective antiretroviral therapy to those living with HIV. HIV response ‘at turning point’ Rocket News, USA – 1 December 2013 Nobody Left Behind campaign Access to HIV drugs has improved significantly December 1 is, as it has been every year since 1988, World Aids Day.
    [Show full text]
  • Frauds in Scientific Research and How to Possibly Overcome Them Erik Boetto,1 Davide Golinelli ‍ ,1 Gherardo Carullo,2 Maria Pia Fantini1
    Current controversy J Med Ethics: first published as 10.1136/medethics-2020-106639 on 6 October 2020. Downloaded from Frauds in scientific research and how to possibly overcome them Erik Boetto,1 Davide Golinelli ,1 Gherardo Carullo,2 Maria Pia Fantini1 1Department of Biomedical and ABSTRACT their activities, while also evaluating the quality of Neuromotor Sciences, University Frauds and misconduct have been common in the history the scientific evidence provided. of Bologna, Bologna, Italy 2Department of Italian and of science. Recent events connected to the COVID-19 COVID-19 pandemic is giving us a glimpse of Supranational Public Law, pandemic have highlighted how the risks and consequences how scientific research might evolve in the future: University of Milan, Milano, of this are no longer acceptable. Two papers, addressing researchers want to share their work in a quick, Lombardia, Italy the treatment of COVID-19, have been published in two of open- access fashion, in order to receive immediate the most prestigious medical journals; the authors declared feedback and recognition by their peers. Preprint Correspondence to to have analysed electronic health records from a private servers allow them to do so, as shown by their Dr Davide Golinelli, Department of Biomedical and Neuromotor corporation, which apparently collected data of tens of increased popularity: almost 4000 COVID-19 Sciences, University of Bologna, thousands of patients, coming from hundreds of hospitals. papers have been submitted to medRxiv alone as Bologna 40126, Italy; Both papers have been retracted a few weeks later. When of June 2020.1 davide. golinelli@ unibo. it such events happen, the confidence of the population While this ‘torrent of preprints’ surely contrib- in scientific research is likely to be weakened.
    [Show full text]
  • Covid-19 Retractions Raise Concerns About Data
    News in focus in South America, says Carlos Chaccour of the Barcelona Institute for Global Health in Spain, COVID-19 RETRACTIONS who is running a clinical trial of ivermectin and had raised questions about the preprint’s data. RAISE CONCERNS ABOUT Researchers testing hydroxychloroquine in clinical trials are worried that the Lancet find- DATA OVERSIGHT ings might make it harder for them to complete their research, despite the fact that the paper Studies relied on health-record analyses from firm has been retracted. “We’re hearing that people just aren’t interested in hydroxychloroquine,” that declined to share its raw data for an audit. says David Smith, an infectious-disease special- ist at the University of California, San Diego, By Heidi Ledford and who is helping to run a trial of the drug in people Richard Van Noorden with COVID-19 who have not been hospitalized. Most data on hydroxychloroquine in wo weeks after a high-profile paper COVID-19 have come from in vitro studies in The Lancet1 reported that the anti- or small clinical trials. On 5 June, however, malarial drug hydroxychloroquine researchers working on a large randomized might be dangerous to people with UK trial called RECOVERY announced that their COVID-19, three of its four authors data on more than 4,600 hospitalized people Tretracted the work because they were unable indicated that hydroxychloroquine didn’t to independently verify their data set, a reduce the risk of death, and that they were large proprietary collection of electronic stopping that arm of the trial. health records analysed by the US company It is not uncommon for studies that use Surgisphere.
    [Show full text]
  • Church Closures, Lancet, Rioters, Planned Parenthood …And Thomas More
    Church Closures, Lancet, Rioters, Planned Parenthood …and Thomas More Click here to watch the video. A couple of weeks ago, I uploaded a video about the coronavirus lockdowns in California, especially with regard to the closure of churches. Since that time, many governors across the nation have issued new rules dictating exactly how many people are allowed to attend church at any given time. In all of California, for example, churches can only open their doors to 25% of their total capacity or 100 people, whichever is less. New Jersey churches can only open to 25 people. Period. In Minnesota, all religious books must be removed from churches, even though the CDC recently came out with new guidance saying the threat of spreading the virus through surface contact is remote. And until a few days ago, religious services in New York were limited to 10 people. A church in Southern California sued the governor in federal court to lift California’s restrictive order. When they lost at the Ninth Circuit Court of Appeals, they petitioned the Supreme Court to review their case. And, thanks to Chief Justice John Roberts, the church lost. It should be noted that the church is located in San Diego county—a county of 3.3 million people that has seen a total of 296 COVID deaths to date. Nevertheless, Justice Roberts gave short shrift to the First Amendment, finding that “Our Constitution entrusts the safety and the health of the people to the politically accountable officials of the States to guard and protect.” In other words, the highly questionable power of governors to lock healthy people in their homes for months on end trumps the express religious rights found in the Constitution.
    [Show full text]
  • Stocks Cap Best Week Since July
    P2JW284000-8-A00100-17FFFF5178F What the Are Yo u Ready for Pandemic Has Fashion Again? Taught Us OFF DUTY About Science REVIEW WSJ THE WALL STREETJOURNAL WEEKEND ******** SATURDAY/SUNDAY,OCTOBER 10 -11, 2020 ~VOL. CCLXXVI NO.86 WSJ.com HHHH $5.00 Hurricane Delta Lashes Storm-Scarred Louisiana Coast Boosted What’s News Offer World-Wide Kindles he White House sub- Hope for Tstantially increased its offer to Democrats on a coronavirus-relief pack- Stimulus age, further closing the gap between the parties in the on-again, off-again ef- White House narrows fort to pass new aid for households and businesses gap with Democrats, before the election. A1 but a deal before Painful social lockdowns election faces hurdles in Europe and some Ameri- canstateshelped blunt the The White House substan- coronavirus.Now,amid afit- tially increased itsoffer to fulreopening,the pandemic S Democrats on a coronavirus- is onceagain surging. A1 PRES relief package, further closing TheCommission on Pres- the gapbetween the parties in TED idential Debates scrapped CIA the on-again, off-again effort the planned matchup next SO to passnew aid forhouseholds AS week between Trump and T/ and businesses beforethe Biden afterthe president election. said he wouldn’t partici- HERBER pateinavirtual debate. A7 ALD By Kristina Peterson, Barr has told top Re- GER Kate Davidson SECOND BLOW: Danielle Fontenot raN with her son, Hunter, to a relative’s house in Lake Charles on Friday as Delta buf- publicans that the results and Andrew Duehren feted southwest Louisiana, which is still recovering from the ravages of Category 4 Hurricane Laura six weeks ago.
    [Show full text]
  • WHO Should Declare Climate Change a Public Health Emergency
    BMJ 2020;368:m797 doi: 10.1136/bmj.m797 (Published 31 March 2020) Page 1 of 3 Analysis BMJ: first published as 10.1136/bmj.m797 on 30 March 2020. Downloaded from ANALYSIS HEALTH IN THE ANTHROPOCENE WHO should declare climate change a public health emergency OPEN ACCESS Rapid and potentially irreversible climate change poses a direct threat to global public health. Andrew Harmer and colleagues argue that WHO should recognise this in the same way as global threats from specific diseases Andrew Harmer senior lecturer in global health 1, Ben Eder medical doctor 2, Sophie Gepp medical student 3, Anja Leetz consultant 4, Remco van de Pas senior research fellow in global health policy 5 1Queen Mary University of London, London, UK; 2People’s Health Movement, London, UK; 3Berlin, Germany; 4German Alliance for Climate Change, Berlin, Germany; 5Institute of Tropical Medicine, Antwerp, Belgium http://www.bmj.com/ Anthony McMichael first established the link between climate environment,” and the planet is now experiencing total change and human health in the 1990s.1 In a distinguished career environmental change.5 Furthermore, the constitution allows that established him as a leading authority on the health impacts WHO’s executive board “to take emergency measures within of climate change, he repeatedly asked whether we understood the functions and financial resources of the Organisation to deal the profound significance of climate change for global health.2 with events requiring immediate action... and undertake studies Were we to ask that question today, as we should, the answer and research the urgency [of those events]” (article 28, i).6 The on 29 September 2021 by guest.
    [Show full text]
  • WHERE University College London Kennedy Lecture Theatre, 30 Guilford St
    You Are Cordially Invited to the Symposium Launch of Our future: A Lancet Commission on adolescent health and wellbeing HOSTED BY University College London London School of Hygiene & Tropical Medicine WHEN Tuesday, 10 May 2016 09:00-17:30 BST, Reception to follow WHERE University College London Kennedy Lecture Theatre, 30 Guilford St. London WC1N 1 EH Please register your attendance here. http://bit.ly/lancetadolescent Presenters and speakers include: Carmen Barroso Richard Horton International Planned Parenthood Federation The Lancet Anthony Costello George Patton World Health Organization University of Melbourne Lola Dare Kikelomo Taiwo CHESTRAD Girls Educational & Mentoring Services Robin Gorna Russell Viner PMNCH University College London Adolescence is a critical time of formative growth to achieve human potential—a fascinating period of profound physical, psychological, and emotional change. It is a life stage marked by both vulnerability and opportunity. As adolescents develop, they reach for engagement beyond their families, and a greater sense of place in the world. The decisions they make, and habits they form, can determine their health and wellbeing for a lifetime. Investments in adolescent health and wellbeing are therefore critical. They are also key to sustainable development. Our Future: A Lancet Commission on Adolescent Health and Wellbeing report brings together perspectives from public health, economics, political and social science, behavioural science and neuroscience and provides recommendations for action to protect and promote the health, wellbeing and potential of the largest generation in human history. Copies of the Commission report will be available at the symposium. Please email [email protected] with any questions. .
    [Show full text]
  • The Pandemic's First Major Research Scandal Erupts Kelly Servick and Martin Enserink
    Corrected 4 June 2020. See full text. A hydroxychloroquine study is being audited. statement, Surgisphere defended the integ- rity of its research and said it was pursu- ing “an independent academic audit” of its results in The Lancet. The journal and non- Surgisphere authors also said data reviews were underway. The episode has left leaders of halted hy- droxycholoroquine trials weighing whether to restart. “The problem is, we are left with all the damage that has been done,” says White, a co-investigator on a halted trial for COVID-19 prevention. It will now be hard to recruit people to key studies, he says. “The whole world thinks now that these drugs are poisonous.” Desai co-authored the Lancet paper with cardiologist Mandeep Mehra of Harvard University’s Brigham and Women’s Hospi- tal (BWH), cardiologist Frank Ruschitzka of Downloaded from University Hospital Zürich, and cardiac sur- geon Amit Patel, who listed affiliations with COVID 19 the University of Utah and HCA Research Institute in Nashville, Tennessee. (Mehra and Patel referred inquiries to BWH. Ruschitzka The pandemic’s first major did not respond to requests for comments.) http://science.sciencemag.org/ The authors describe an analysis of electronic health record data from patients already research scandal erupts treated for COVID-19 at 671 hospitals on six continents—nearly 15,000 people prescribed Critics question patient data used to challenge malaria drugs chloroquine or hydroxychloroquine, alone or in combination with an antibiotic, and a By Kelly Servick and Martin Enserink White, a malaria researcher at Mahidol Uni- control group of 81,000 other patients.
    [Show full text]