Surgisphere

Surgisphere is an American healthcare analytics company established in 2008 by Sapan Desai. Originally a textbook marketing company, it came under scrutiny in May 2020 after it provided large datasets of COVID-19 patients that were subsequently found to be unreliable. The questionable data were used in studies published in The Lancet and The New England Journal of Medicine in May 2020, suggesting that COVID-19 patients on hydroxychloroquine had a "significantly higher risk of death". In light of these studies, the World Health Organization decided to temporarily halt global trials of the drug hydroxychloroquine to treat COVID-19. After the studies were retracted, the WHO trials were resumed and then discontinued shortly after.

Surgisphere
TypePrivate
IndustryHealthcare analytics
Founded2008[1]
Headquarters
Palatine, Illinois
,
US[2]
Key people
Sapan Desai (CEO and founder)
Number of employees
11
Websitesurgisphere.com

History

Surgisphere was established in 2008[1] by Sapan Desai, then a medical resident, to market medical textbooks to medical students. Fake five-star reviews on Amazon from accounts impersonating actual physicians were found.[3] Desai became a vascular surgeon and worked at Northwest Community Hospital.[4][5][6]

Surgisphere had three subsidiaries: Surgical Outcomes Collaborative, Vascular Outcomes and Quartz Clinical.[5] From 2010 to 2013 it published an online medical journal, the Journal of Surgical Radiology.[2][5] It ceased publication despite having claimed to accrue 50,000 subscribers because Desai "ran out of time".[3]

In June 2020 Desai's spokesperson said Surgisphere had 11 employees and had been compiling a global hospital records database since 2008.[7] In its promotional material and press releases, Surgisphere claimed to have a cloud-based healthcare data analytics platform and to be "leveraging... its global research network and advanced machine learning" using decision tree analysis.[8]

After the retractions of two studies in June 2020, company social media accounts were deleted,[9] and on 15 June 2020, the company website was taken offline.[10]

COVID-19 misconduct
Further information: Chloroquine and hydroxychloroquine during the COVID-19 pandemic § WHO trial

Diagnostic tool

Starting in March 2020, Surgisphere promoted a "rapid diagnostic tool" for COVID-19, which it said was in use by over 1000 hospitals.[11][12] The African Federation for Emergency Medicine (AFEM) had promoted the COVID-19 Severity Scoring Tool for use in 26 countries and some institutions had started validation studies. On 5 June 2020, following the scandal about the Lancet and NEJM articles, AFEM recommended that the tool no longer be used.[13]

Ivermectin preprint

In April 2020, Desai et al. published a paper based on purported Surgisphere data which suggested ivermectin reduced COVID-19 mortality.[14] It was described as a "retrospective matched-control study of coronavirus patients using a real-time hospitalization database". It was published as a preprint but was retracted at the end of May.[15][16][17] Several Latin American government health organizations recommended ivermectin as a COVID-19 treatment based, in part, on this preprint; these recommendations were later denounced by the Pan American Health Organization.[17][18]

Lancet and NEJM articles

Surgisphere provided dubious data used for studies of COVID-19 that were published in The Lancet[19] and The New England Journal of Medicine (NEJM) in May 2020.[20][21] The Lancet study claimed that the dataset of hospital records showed that patients taking hydroxychloroquine were more likely to die in hospital, and prompted the World Health Organization to halt global trials of the drug to treat COVID-19.[4][14][22] The NEJM study claimed that hospital data records showed that COVID-19 patients were not harmed by treatment with ACE inhibitors and angiotensin-receptor blockers.[20][23][24]

The dataset from the alleged 1200 hospitals had many errors, including the listing of an Asian hospital as being in Australia, and no indications of how Surgisphere could collect the data, and was widely criticised.[25][26][27][4] As a result, on 28 May over 200 researchers and doctors from various countries published "An open letter to Richard Horton, editor-in-chief of The Lancet, regarding Mehra et al", stating "Both the numbers of cases and deaths, and the detailed data collection, seem unlikely."[28] Science Magazine said critics had "pointed out many red flags in the Lancet paper, including the astonishing number of patients involved and details about their demographics and prescribed dosing that seem implausible."[14][20] One of the signatories, Adrian Hernandez of the Duke Clinical Research Institute, said "the biggest thing that raised a red flag was that there was such a large database across more than 600 hospitals, and no one had really known about its existence".[29]

On 3 June 2020, The Lancet and the NEJM released online "expressions of concern" about the published studies,[30][31] and on 4 June the Lancet paper was retracted by Mehra, Ruschitzka, and Amit Patel, all authors except Desai. In their retraction, the three wrote Surgisphere had not transferred "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", preventing reviewers from conducting an independent and private peer review. The three authors said:

"We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted."[32]

On 4 June, The Lancet retracted the study,[33][34] as did the NEJM.[35][16][36] In the meantime, on 3 June, the WHO resumed its hydroxychloroquine drug trials.[37]

On 6 June 2020, NHS Scotland told the Financial Times that they had "no current or past contractual arrangement" with Surgisphere, nor was the company an approved supplier, nor had it ever had access to data, despite Surgisphere stating it had "collaborated" with the NHS. Surgisphere's website had a picture of Queen Elizabeth University Hospital, an NHS hospital in Glasgow.[38]

On 7 June 2020, fellow author Amit Patel's position with the University of Utah was terminated over the journal retractions. Patel is Desai's brother-in-law.[39]

Richard Horton, editor-in-chief of The Lancet, called the paper "a fabrication" and "a monumental fraud". Eric Rubin, editor-in-chief of NEJM, said "We shouldn’t have published this".[40]

General legitimacy

A July 2020 article in New York Times described an employee extracting data manually to create a spreadsheet for Surgisphere's QuartzClinical. She was "surprised" by claims of a massive data store, stating she knew of only a single hospital that had signed a contract with the company; the May 1 paper in NEJM claimed to use data from 169 hospitals across the globe, and the May 22 paper in The Lancet.[41]

A parallel investigation by the British newspaper The Guardian revealed that several of Surgisphere's employees had little or no scientific background; one employee appeared to be a science fiction author while another, listed as a marketing executive, was an adult model. The Guardian also found that Surgisphere's LinkedIn page has fewer than 100 followers and in late May 2020 listed only six employees. It also found that the company had almost no online presence and that its Twitter account had made no posts from October 2017 to March 2020.[20]

Elisabeth Bik et al. analyzed one of Desai's early first author papers and found apparent evidence of image manipulation.[42][43]

References
  1. "Surgisphere Corp". Bloomberg. Retrieved 11 June 2020.
  2. Offord, Catherine (30 May 2020). "Disputed Hydroxychloroquine Study Brings Scrutiny to Surgisphere". The Scientist. Archived from the original on 3 June 2020. Retrieved 3 June 2020.
  3. Catherine Offord (2020-05-30). "Disputed Hydroxychloroquine Study Brings Scrutiny to Surgisphere". The Scientist Magazine®. Retrieved 2020-06-08.
  4. Davey, Melissa (28 May 2020). "Questions raised over hydroxychloroquine study which caused WHO to halt trials for Covid-19". Guardian. Retrieved 3 June 2020.
  5. Todaro, James (29 May 2020). "A Study Out of Thin Air". MedicineUncensored. Retrieved 3 June 2020. Dr. Desai appears to be the founder of Surgisphere, which was formed in 2007. A PubMed search for "Sapan Desai" shows 39 medical publications in the last five years. With the exception of the two very recent COVID-19 papers, the Surgisphere database does not appear to have been used in any of the other 37 publications. Why would the founder of Surgisphere have access to one of the largest repositories of real-time patient data, but not use it until publishing on COVID-19? If we ignore the image of multiple shell corporations enshrouding a hastily organized Surgisphere Corporation and stick to analyzing the COVID-19 data from the Lancet study, the findings are even less reassuring.
  6. "Dr Sapan Desai, United States of America". World Hospital Congress. Iceberg events. Retrieved 3 June 2020. Sapan Desai, MD, PhD, MBA is President and Chief Executive Officer of the Surgisphere Corporation, a medical education and healthcare data analytics company with hundreds of clients around the world. He has held multiple physician leadership roles in clinical practice, including serving as the Vice Chairman for Research at Southern Illinois University, Director of Quality at Memorial Medical Center, and Director of Performance Improvement at Northwest Community Hospital. Dr. Desai is a certified lean six sigma master black belt, and a certified professional in healthcare quality. He is the recipient of the international grand prize in healthcare quality by the International Hospital Federation in 2015.
  7. Servick, Kelly; Enserink, Martin (2020-06-05). "The pandemic's first major research scandal erupts". Science. Vol. 368, no. 6495. pp. 1041–1042. doi:10.1126/science.368.6495.1041. ISSN 0036-8075. PMID 32499418. Retrieved 2020-07-07.
  8. Zaidisays, Al (2020-05-27). "Surgisphere's COVID-19 Tools are Deadly Fraud". Retrieved 2020-07-07.
  9. Hopkins, Jared S.; Gold, Russell (11 June 2020). "The Big-Data Mystery Behind Retracted Covid-19 Studies of Hydroxychloroquine, Other Drugs". Wall Street Journal. Retrieved 17 June 2020.
  10. Owermohle, Sarah (16 June 2020). "Hydroxychloroquine is out". Politico. Retrieved 17 June 2020.
  11. Offord, Catherine (30 May 2020). "Disputed Hydroxychloroquine Study Brings Scrutiny to Surgisphere". The Scientist Magazine®. Retrieved 3 June 2020. James Watson, a senior scientist at the Mahidol Oxford Tropical Medicine Research Unit in Thailand, says he has doubts that any research organization would have been able to obtain such detailed records for so many people in Africa so quickly. He outlined this and concerns about multiple other aspects of the study in the open letter, which includes 17 signatories based at institutions in Africa.
  12. James Watson [@jwato_watson] (27 May 2020). "As you might expect, it's a different story... conclusion: a prediction tool that is basically just linear regression and estimates age-dependent mortality that conflicts with a very large and reliable (we know where the data came from!) study. Wonderful AI/ML companies..!(6/n)" (Tweet) – via Twitter.
  13. Offord, Catherine (7 June 2020). "Surgisphere Fallout Hits African Nonprofit's COVID-19 Efforts". The Scientist Magazine. Retrieved 19 June 2020.
  14. Servick, Kelly; Enserink, Martin (2 June 2020). "A mysterious company's coronavirus papers in top medical journals may be unraveling". Science. AAAS. Retrieved June 3, 2020.
  15. Lowe, Derek (11 May 2020). "What's Up With Ivermectin?". science.com. Retrieved 4 June 2020.
  16. Piller, Charles; Servick, Kelly (4 June 2020). "Two elite medical journals retract coronavirus papers over data integrity questions". Science. Retrieved 5 June 2020.
  17. "Surgisphere Sows Confusion About Another Unproven COVID-19 Drug". The Scientist Magazine®. 2020-06-16. Retrieved 2020-07-09.
  18. "Lancet, NEJM Retract Surgisphere Studies on COVID-19 Patients". The Scientist Magazine®. Retrieved 2021-07-23.
  19. Mehra, MR; Desai, SS; Ruschitzka, F; Patel, AN (May 2020). "Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis". Lancet. doi:10.1016/S0140-6736(20)31180-6. PMC 7255293. PMID 32450107. Lay source (Retracted, see  )
  20. Davey, Melissa; Kirchgaessner, Stephanie; Boseley, Sarah (3 June 2020). "Governments and WHO changed Covid-19 policy based on suspect data from tiny US company". Guardian. Retrieved 3 June 2020.
  21. Piller, Charles (2020-06-08). "Who's to blame? These three scientists are at the heart of the Surgisphere COVID-19 scandal". Science | AAAS. Retrieved 2021-07-23.
  22. "Was the Surgisphere case a one-off, or does it highlight the bigger systemic problem of research fraud?". Transparency International UK. Retrieved 2021-07-23.
  23. "Could the Surgisphere Retractions Debacle Happen Again?". Medscape. Retrieved 2021-07-23.
  24. "Surgisphere Data Used in Two COVID Studies Called Into Question". www.medpagetoday.com. 2020-06-03. Retrieved 2021-07-23.
  25. Mehra, M. R.; Desai, S. S.; Ruschitzka, F.; Patel, A. N. (2020). "PubPeer - Hydroxychloroquine or chloroquine with or without a macrolid..." Lancet. doi:10.1016/s0140-6736(20)31180-6. ISSN 0140-6736. PMC 7255293. PMID 32450107. Retrieved 3 June 2020.
  26. Gelman, Andrew (24 May 2020). "Doubts about that article claiming that hydroxychloroquine/chloroquine is killing people « Statistical Modeling, Causal Inference, and Social Science". statmodeling.stat.columbia.edu. Retrieved 3 June 2020.
  27. Gelman, Andrew (25 May 2020). "Hydroxychloroquine update: Statistical Modeling, Causal Inference, and Social Science". statmodeling.stat.columbia.edu. Retrieved 3 June 2020.
  28. James Watson On The Behalf Of 201 Signatories (2020). "An open letter to Mehra et al and The Lancet". Zenodo. doi:10.5281/zenodo.3871094. Retrieved 5 June 2020.
  29. Roni Caryn Rabin (29 May 2020). "Scientists Question Validity of Major Hydroxychloroquine Study". The New York Times. Retrieved 3 June 2020. The experts who wrote The Lancet also criticized the study's methodology and the authors' refusal to identify any of the hospitals that contributed patient data, or to name the countries where they were located. The company that owns the database is Surgisphere, based in Chicago.
  30. The Lancet Editors (3 June 2020). "Expression of concern: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis". The Lancet. 395 (10240): e102. doi:10.1016/S0140-6736(20)31290-3. PMC 7269709. PMID 32504543. {{cite journal}}: |last1= has generic name (help)
  31. Rubin M.D, Ph.D, Eric J. (2 June 2020). "Expression of Concern: Mehra MR et al. Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19". New England Journal of Medicine. 382 (25): 2464. doi:10.1056/NEJMe2020822. PMC 7269012. PMID 32484612. S2CID 219174075.
  32. Mehra MR, Ruschitzka F, Patel AN (June 2020). "Retraction: "Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis"". Lancet. 395 (10240): 1820. doi:10.1016/S0140-6736(20)31324-6. PMC 7274621. PMID 32511943.
  33. Mehra, Mandeep R.; Ruschitzka, Frank; Patel, Amit N. (4 June 2020). "Retraction: "Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis"". The Lancet. 395 (10240): 1820. doi:10.1016/S0140-6736(20)31324-6. PMC 7274621. PMID 32511943.
  34. Boseley, Sarah; Davey, Melissa (4 June 2020). "Covid-19: Lancet retracts paper that halted hydroxychloroquine trials". The Guardian. Retrieved 4 June 2020.
  35. Mehra, Mandeep R.; Desai, Sapan S.; Kuy, Sreyram; Henry, Timothy D.; Patel, Amit N. (4 June 2020). "Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19. N Engl J Med. DOI: 10.1056/NEJMoa2007621". The New England Journal of Medicine. 382 (26): 2582. doi:10.1056/NEJMc2021225. PMC 7274164. PMID 32501665.
  36. Hopkins, Jared S.; Gold, Russell (4 June 2020). "Hydroxychloroquine Studies Tied to Data Firm Surgisphere Retracted". The Wall Street Journal. Retrieved 5 June 2020.
  37. Mancini, Donato Paolo; Kuchler, Hannah (3 June 2020). "WHO restarts drug trial as doubts grow over clinical data". Financial Times. Retrieved 5 June 2020.
  38. Mure Dickie; Donato Paolo Mancini; Hannah Kuchler (6 June 2020). "Edinburgh disavows Surgisphere claims of co-operation with NHS Scotland". Financial Times. Retrieved 8 June 2020.
  39. Matthew Herper; Kate Sheridan (7 June 2020). "Researcher has faculty appointment terminated after Lancet retraction". STAT. Retrieved 8 June 2020. The University of Utah has "mutually agreed" to terminate the faculty appointment of Amit Patel, who was among the authors of two retracted papers on Covid-19 and who appears to have played a key role in involving a little-known company that has ignited a firestorm of controversy.
  40. Roni Caryn Rabin (14 June 2020). "The Pandemic Claims New Victims: Prestigious Medical Journals". The New York Times. Retrieved 18 June 2020.
  41. Ellen Gabler; Roni Caryn Rabin (27 July 2020). "The Doctor Behind the Disputed Covid Data". The New York Times. Retrieved 27 July 2020.
  42. The Surgisphere Founder and the Melba Toast figure, Science Integrity Digest, June 6, 2020.
  43. Davey, Melissa; Kirchgaessner, Stephanie (2020-06-10). "Surgisphere: mass audit of papers linked to firm behind hydroxychloroquine Lancet study scandal". the Guardian. Retrieved 2020-06-10.
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