A Study Out of Thin Air

A Study Out of Thin Air

by James M Todaro, MD (Columbia MD, @JamesTodaroMD)

Misinformation is bad. Misinformation in medicine is worse. Misinformation from a prestigious medical journal is the worst.  Herein is a detailed look at the controversial Lancet study that resulted in the World Health Organization ending worldwide clinical trials on hydroxychloroquine in order to focus on patented therapeutics.

Study Overview

In brief, the Lancet study is a multinational registry analysis assessing the effectiveness of hydroxychloroquine or chloroquine with or without macrolide therapy (e.g. azithromycin) in treatment of COVID-19 in hospitalized patients. The study was very large (perhaps impossibly so, but we will address that later) and included 96,032 patients, of which 14,888 were in treatment groups. The study found that hydroxychloroquine and chloroquine with or without macrolide therapy resulted in significantly increased risk of both in-hospital mortality and de-novo ventricular arrhythmia during hospitalization. In summary, the authors concluded that hydroxychloroquine and chloroquine are actually harmful and increase risk of death when used for in-hospital treatment of COVID-19.

The Lancet study was released on Friday, May 22. After deliberating over a weekend, on Monday, May 25, the World Health Organization hastily announced the cessation of all COVID-19 clinical trials on hydroxychloroquine in 17 different countries. Instead of performing its own due diligence, the WHO immediately relied on an observational study cloaked in the reputation of the nearly 200-year old medical journal The Lancet.

After its publication, a grass-roots investigation by hundreds of physicians and researchers worldwide revealed irreconcilable inconsistencies in the data that The Lancet’s peer-review process overlooked. The study is now found to have inconsistencies with data from national registries of hospitalized COVID-19 patients. The authors continue to hide data sources in a black box controlled by an unknown corporation called Surgisphere.

Only one peer-reviewed publication prior to the Lancet study.

Surgisphere appears to be the sole provider of the data for the Lancet study, and boasts itself to be a real-time global research network that “performs cloud-based healthcare data analytics” using machine learning and artificial intelligence.

Based on the Lancet study, it must be a very large, sophisticated network indeed to have partnered with hundreds of hospitals worldwide with the capability of retrieving detailed patient data in real-time.

One would expect a multinational database such as this to be a treasure trove coveted by researchers. Strangely, this is not so. Surgisphere has a razor thin folder of contributions to past publications. Besides the Lancet publication, Surgisphere’s only other peer-reviewed publication is one entitled Cardiovascular, Drug Therapy, and Mortality in Covid-19 that was published on May 1, 2020 in The New England Journal of Medicine.

The Research section of Surgisphere’s website features twenty-three “Case Studies from Around the World” as evidence of their prior work and product features.  The vast majority of these “case studies” lack scientific substance and actually consist of short letters, press releases or potential use-cases for its database.

In place of actual research, the website appears primarily promotional and gives the impression of an immature tech company with lofty goals as opposed to a global database with real-time data on millions of patients.

A company with only five employees, most of which joined only two months ago.

According to LinkedIn, Surgisphere has five employees, only one of which has a medical degree—the founder Dr. Sapan Desai. The remaining four employees appear to have little to no science or medical background, but with a plethora of experience in business development and sales & marketing. The team’s personnel consist of a VP of Business Development and Strategy, VP of Sales and Marketing and two freelance writers creating content for Surgisphere.

With the exception of the founder, the entire Surgisphere team joined the corporation only 2-3 months ago. Actually, according to LinkedIn, the VP of Sales & Marketing is still employed by another tech company, W.L. Gore & Associates. Prior to February 2020, Surgisphere appears to have had a single employee, the founder.

A shrouded internet history.

The internet trail behind Surgisphere is peculiar to say the least. Mostly because it isn’t there. The Internet Archive (Wayback Machine) has records on more than 439 billion web pages and has long served as a tool to view webpages as they existed in the past. I’ve used the tool hundreds of times and am frequently surprised by the breadth of its database. Even some of the most obscure webpages have historical snapshots available. In the rare circumstances where a historical snapshot is not available, the Wayback Machine’s response is “Wayback Machine doesn’t have that page archived.” A far less common response—one I’ve never seen before—is “Sorry. This URL has been excluded from the Wayback Machine.”

It’s this last response that is delivered when searching https://surgisphere.com/ in the Wayback Machine.

There are primarily two ways for companies to hide internet histories. First, they can insert special codes into their websites to hide from the Wayback Machine’s automated crawlers. Secondly, companies can request the removal of their historical snapshots, but there’s no guarantee the Internet Archive will honor these requests. Both of these practices are highly unusual and almost exclusively used for obscuring nefarious activities.

A list of subsidiary companies without substance.

A deeper dive into Surgisphere reveals three subsidiary companies: Surgical Outcomes CollaborativeVascular Outcomes and Quartz Clinical. On each of the homepages of these three websites, the Surgisphere copyright is publicly visible near the bottom of the page.

Surgical Outcomes Collaborative has almost no internet history and the page does not appear in the Internet Archive until 2019, in which it just redirects to the webpage for Vascular Outcomes.

search of https://vascularoutcomes.com in the Internet Archive returns one snapshot from December 2019. The snapshot shows a webpage that is largely similar to that of Surgical Outcomes Collaborative and does not include any details about a team or published research.

Similarly, Quartz Clinical, another healthcare data analytics branch of Surgisphere, also appears to be devoid of published research and without a publicly visible team.

Each of the company webpages above provide a LinkedIn link. Instead of showing company profiles with track records, however, the links all direct to the profile of just one person, Dr. Sapan Desai.

Forming partnerships with hundreds of hospitals, formatting electronic medical records in dozens of different languages and pushing the forefront of technology in machine learning and AI is an insurmountable task for a large multi-talented team over many months, let alone one person in a few weeks.

“Get in touch with us”

Just yesterday, the Get in touch with us link on Surgisphere’s homepage redirected to a strange WordPress template for cryptocurrency. The Surgisphere website has since been changed and the link deleted; however, this serves as just another example of incompleteness and unprofessionalism from a company supposedly holding highly sensitive records on millions of patients.

Dr. Sapan Desai

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.

The Data

Surgisphere provides scant detail on their data sources. Not only does Surgisphere omit which hospitals supposedly contributed, but they will not even specify the contributing countries. Instead, they categorize hospitals and patient numbers by continent. Notably, the larger the pool of data, the easier it is to obfuscate false data.

Data inconsistencies were found nonetheless.

Strike #1. Australia is unique because it is both a country and continent, which makes data obfuscation more challenging. Thus, it is no surprise that false data was first discovered in Australia. The Guardian reported yesterday that the number of COVID-19 deaths included in the Lancet study for Australia exceeded the total nationally recorded number of COVID-19 deaths. The Lancet study reported 73 deaths from the continent of Australia, but records show that Australia had only a total of 67 COVID-19 deaths by April 21. When confronted with this inconsistency, the lead author of the study, Dr. Mandeep Mehra, admitted the error but dismissed it as simply a single hospital that was accidentally designated to the wrong continent.

Strike #2. North American data from the study is highly suspicious. The study reports that 63,315 hospitalized patients with COVID-19 met inclusion criteria prior to April 14, 2020. A review of the well-curated data from the COVID Tracking Project by The Atlantic shows that there were only 63,276 patients hospitalized with COVID-19 by April 14. It is theoretically possible that Surgisphere also collected patient data from Canada and Mexico. However, both of these countries had a tiny number of COVID-19 hospitalizations in comparison to the USA. On April 16, Canada reported 2,019 COVID-19 hospitalizations. Although data is not readily available on COVID-19 hospitalizations in Mexico, the country had only 5,014 positive cases and 332 deaths by April 14. Based on common rates of case-to-hospitalization ratios, it is likely that Mexico had fewer than 1,000 COVID-19 hospitalizations. Thus, the total number of COVID-19 hospitalizations in North America (USA, Canada and Mexico) by April 14 is about 66,000.

Are we to believe that Surgisphere truly had relationships and data exchange agreements with 559 hospitals in the USA, Canada and Mexico that captured detailed patient records for 63,315 COVID-19 patients out of a total of 66,000 patients? These figures do not even include the 2,230 patients with COVID-19 who did not meet the inclusion criteria, meaning that Surgisphere is claiming they have patient data on even a greater number than 63,315 patients.

Strike #3. The study reports patient data from Africa that requires sophisticated patient monitoring technology and electronic medical record systems. An open letter to The Lancet signed by 146 physicians and medical researchers believes this to be unlikely. For the data to be valid, nearly 25% of all COVID-19 cases and 40% of all deaths in the continent would have occurred in Surgisphere-affiliated hospitals with sophisticated electronic patient data recording and monitoring capable of detecting and recording “nonsustained [at least 6 sec] or sustained ventricular tachycardia or ventricular fibrillation.” In the setting of a highly contagious virus, continuous cardiac monitoring is not always utilized as it increases high-risk patient contact for healthcare workers. A combination of cardiac monitoring practices during COVID-19 and the sophisticated equipment necessary to do so make it highly unlikely that cardiac arrhythmia data is available for such a large percentage of patients in Africa.

There are additional data oddities not mentioned above which include unusually small variances in patient baseline characteristics, interventions and outcomes among continents.

Any one of the above findings warrants closer inspection of data for a study of this importance and with such global implications on patient care.

Surgisphere Responds

Surgisphere responded to inquiries by refusing to provide any additional details on the data sources and instead asking physicians and researchers to trust them.

Does a corporation that appeared out of thin air two months ago deserve this trust?

UPDATE May 30, 2020: The section “Dr. Sapan Desai” was added to reflect Dr. Desai’s prior research work.

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