Good news: Early Outpatient Treatment of Symptomatic, High-Risk Covid-19 Patients that Should be Ramped-Up Immediately as Key to the Pandemic Crisis, Harvey A Risch, May 27, 2020, American Journal of Epidemiology
Five studies, including two controlled clinical trials, have demonstrated significant major outpatient treatment efficacy. Hydroxychloroquine+azithromycin has been used as standard-of-care in more than 300,000 older adults with multicomorbidities, with estimated proportion diagnosed with cardiac arrhythmias attributable to the medications 47/100,000 users … These medications need to be widely available and promoted immediately for physicians to prescribe.
The rest of the post discusses a fraudulent paper (Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis, Mehra et al., May 22, 2020, The Lancet), based on Surgisphere’s fake data, RETRACTED on June 4, 2020.
Surgisphere Corporation is fraud. Some of its services are being used for COVID-19 diagnostics and/or clinical decisions: QuartzClinical, COVID-19 Decision Support Tools (Rapid Triage, Severity Scoring, Diagnosis, Mortality Risk), Surgical Outcomes Collaborative analytics platform.
This anti-HCQ Lancet paper claims: “We included all patients hospitalised between Dec 20, 2019, and April 14, 2020, at hospitals participating in the registry” with COVID-19 and records of death or discharge. 671 hospitals from six continents allegedly provided their data for this database. The US hospitals were allegedly “selected to match the epidemiological characteristics of the US population”. In this great database, the authors have found 96,032 hospitalized patients with COVID-19, including 14,888 treated with HCQ or CQ with either Azithromycin (AZM) or Clarithromycin.
At this point, one would ask: Who has a database with detailed information on 96,000 patients? What about privacy laws? What about network security and data compatibility? Is Surgisphere a three-letter agency with such unrestricted global access? No, this is a one-man fraud. Paper’s second author is the man. There is no patients’ database and any raw data was fabricated or did not exist at all.
Some of the many mysteries in the alleged data:
- The population data is very homogeneous, almost the same across the six continents – this is highly unlikely. For example, the patients with qSOFA < 1 are 82.6% in Europe and North America (what a coincidence!), and 82.7% in South America (Table S3).
- The study data shows only 42% of patients (6,221 out of 14,888) in the treatment groups received HCQ+”macrolide”. However, it is widely known that almost all people treated with HCQ or CQ received HCQ+AZM.
- In the study data for North America, 35% of patients (3,415) received CQ and 65% of patients (6,462) received HCQ. However, it is widely known that, outside of China, CQ was used significantly less than HCQ. The actual ratio is closer to 1:99 than to 35:65.
- All patients treated with CQ/HCQ received antibiotics, almost always AZM. In the study, 32% of the North American patients received no “microlide” (Appendix, Table S3). Do peer reviewers really believe that almost a third of patients hospitalized with respiratory infection received immunosuppressives without antibiotics?
Tweets from an Australian MD & PhD helped explain some of the mystery. Not only is the data fake, but the database itself, Surgical Outcomes Collaborative, is fake as well. Here are some of the many red flags:
… the study says that they received data from 600 hospitals up to mid-April, and it was published end-May. This is impossible. If you have ever collected clinical research data you will know how impossible it is.
… you need ethical approval, suitable web servers set up, access set up for each hospital (and ideally each worker). This is what the authors say happened – they say they questioned existing repositories
I’m sorry but these don’t exist. Repositories do exist that maintain some of this data but it is mostly unlinked, relies on it being filled in correctly and exists on different systems that don’t talk to each other. …
… for each hospital system providing access you have to go through a complex ethics approval system (otherwise your hospital has just given your personal data to some strangers). …
An ethics approval of this magnitude would take months but it would take even longer to get the system up and running to allow secure access to hospital data systems externally. IT JUST DOES NOT HAPPEN.
The thread continues. The doctor takes note that the patients’ data matches, almost perfectly, on 23 factors.
This is pretty much statistically impossible, and they are claiming that they got this matching in 7000 patients out of a pool of 96000 patients for which they received high quality information from 671 hospitals. Nope. Sorry, the data is too “clean”.
So, this group are telling us that, not only have they got access to 671 hospital clinical record systems but (and this is a problem) … They have access to all the pathology providers linked to those 671 hospitals and THEY CAN DATA LINK THE PATIENT RECORDS. Not a chance.
This didn’t happen, and if it did it would be a massive privacy scandal. There would be serious financial and potentially criminal repercussions
So, either this data is completely fabricated -or- The authors have been able to overcome impossible hurdles of data sharing and probably broken a number of laws in the process.
Surgisphere has only a few employees, hired since February 2020. They did not overcome any hurdles.
This Lancet paper also heavily promotes Surgical Outcomes Collaborative, the fake database from which the data has been obtained. The “Collaborative” is owned by the Surgisphere Corporation. Sapan S. Desai, one of the paper’s authors, is a Surgisphere founder (disclosed) and CEO (not disclosed). The “Collaborative”, which was unknown before May 2020, is mentioned by name seven times in the paper. Two paragraphs (~500 words) are used as Collaborative advertisement: “a cloud-based health-care data analytics platform that includes specific modules for data acquisition, data warehousing, data analytics … A manual data entry process is used for quality assurance and validation to ensure that key missing values are kept to a minimum … ensures compliance with the US Food and Drug Administration (FDA) guidance on real-world evidence … data are collected through automated data transfers that capture 100% of the data from each health-care entity at regular, predetermined intervals … the standard operating procedures in place for each of the four ISO 9001:2015 and ISO 27001:2013 certified features of the registry … Collection of a 100% sample from each health-care entity is validated against financial records … capturing all-comer data and consecutive patient enrolment by capturing 100% of the data within electronic systems … compliant with the US Agency for Healthcare Research and Quality guidelines for registries …”.
None of this is true.
- Surgisphere’s website does not display its directors or executives, other than its founder-CEO Sapan S Desai (SSD) (About)
- The website surgisphere.com is excluded from Archive.org – a sure sign that the company does not want people to know what it looked like in the past.
- SSD worked in Surgisphere only part-time until February 2020, according to his profile in LinkedIn. His last full-time position was “Full-time clinical vascular surgeon, Medical Director of Surgical Quality, and Director of CME at Northwest Community Hospital” in Arlington Heights, IL
- LinkedIn also shows profiles of four other employees. The three employees visible to me were hired in February 2020 or later. All of them live in different areas of the USA.
- The address of Surgisphere is a private house in Palatine, IL, probably SSD’s home. (Buzzfile)
- Surgisphere is not listed as a tenant at the address listed on its websites (875 N Michigan Ave, 31st Floor, Chicago, IL 60611)
In other words, Surgisphere Corporation existed mostly on paper, until February 2020, when its founder decided to cash out on the COVID-19 epidemic. Its software and services are vaporware.
The Surgical Outcomes Collaborative (database)
The Surgical Outcomes Collaborative has its own website surgicaloutcomes.com. Surgisphere markets it as an analytics platform, not a database. Nowhere does it claim possession of or access to patients’ information from multiple hospitals. Further, its website is a re-branding of another company’s website vascularoutcomes.com. Another Surgisphere’s website is quartzclinical.com.
This Lancet paper does not break down results between AZM and Clarithromycin, nor do they explain why they selected Clarithromycin, so I will. Clarithromycin has harmful interactions with CQ and HCQ (unlike AZM), and Clarithromycin is a strong QT prolonger, (unlike AZM, which is a mild one). This is why physicians did not use Clarithromycin with HCQ as a COVID-19 treatment. I could only find a couple of single patient reports of combining Clarithromycin with CQ. The authors included Clarithromycin in the paper to smear Azythromycin “by association.”
This paper was published on Friday, May 22, on the eve of a long weekend. The paper immediately received wall to wall coverage in the media. On the same day The Lancet published a fawning comment Chloroquine or hydroxychloroquine for COVID-19: why might they be hazardous? These factors suggest careful coordination between the authors, the editors, and news media to catch the public and media community off-guard,causing maximum shock to reverberate over Memorial Dayweekend.
Another Conflict of Interest?
The first author Mandeep R Mehra works in Brigham and Women’s Hospital, which conducts Gilead-initiated clinical trials of Gilead’s Remdesivir for COVID-19.
Published on May 23. Updated on May 24-27, June 4.