This certainly looks like a significant case of medical fraud. A company called Surgisphere claimed it had a database of information gathered from over 600 hospitals around the world on the success of hydroxychloroquine for the treatment of the coronavirus. The company’s owner authored several papers published in prominent medical journals based on this data. Those papers were then widely reported in the media last month and resulted in drug trials that were already underway being paused:
On its face, it was a major finding: Antimalarial drugs touted by the White House as possible COVID-19 treatments looked to be not just ineffective, but downright deadly. A study published on 22 May in The Lancet used hospital records procured by a little-known data analytics company called Surgisphere to conclude that coronavirus patients taking chloroquine or hydroxychloroquine were more likely to show an irregular heart rhythm—a known side effect thought to be rare—and were more likely to die in the hospital.
Within days, some large randomized trials of the drugs—the type that might prove or disprove the retrospective study’s analysis—screeched to a halt. Solidarity, the World Health Organization’s (WHO’s) megatrial of potential COVID-19 treatments, paused recruitment into its hydroxychloroquine arm, for example.
Just to emphasize how this Lancet study was greeted by the media, here’s the NY Times story about it which is headlined, “Malaria Drug Taken by Trump Is Tied to Increased Risk of Heart Problems and Death in New Study.”
Last week, a group of 100 doctors and scientists wrote an open letter to Lancet asking that the data underlying the study be explained in more detail because it appeared the numbers didn’t add up. At the time, Dr. Sapan S. Desai, the owner of Surgisphere vigorously defended the accuracy of his data but refused to show it to anyone. He later agreed to let Lancet review it. However, today the Guardian reported some additional problems with the credibility of Surgisphere, a company whose total of six employees include a science fiction author and an adult model:
A search of publicly available material suggests several of Surgisphere’s employees have little or no data or scientific background. An employee listed as a science editor appears to be a science fiction author and fantasy artist whose professional profile suggests writing is her fulltime job. Another employee listed as a marketing executive is an adult model and events hostess, who also acts in videos for organisations.
The company’s LinkedIn page has fewer than 100 followers and last week listed just six employees. This was changed to three employees as of Wednesday.
While Surgisphere claims to run one of the largest and fastest hospital databases in the world, it has almost no online presence. Its Twitter handle has fewer than 170 followers, with no posts between October 2017 and March 2020.
Until Monday, the “get in touch” link on Surgisphere’s homepage redirected to a WordPress template for a cryptocurrency website, raising questions about how hospitals could easily contact the company to join its database.
Dr. Desai has previously had three malpractice suits filed against him and back in 2008 he created an Indiegogo page for some kind of wearable device which sounded pretty much like science fiction:
Experience the next generation of human augmentation and wearable electronics. Neurodynamics Flow allows you to learn faster, perform better, and think smarter. Take human evolution into your own hands. Neurodynamics Flow is a next generation human augmentation device that can help you achieve what you never thought was possible. Unlock hidden creativity, improve your memory, and heighten your peak performance using the latest in wearable computer electronics. With its sophisticated programming, optimal neural induction points, and tried and true results, Neurodynamics Flow allows you to rise to the peak of human evolution.
The project was never funded and a video for “Neurodynamics Flow” has been deleted. Shortly after the Guardian approached Lancet with all of this, the journal published a notice of their concern about the reliability of the study.
Today, The Lancet issued an Expression of Concern (EOC) saying “important scientific questions have been raised about data” in the paper and noting that “an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly.”
Hours earlier, The New England Journal of Medicine (NEJM) issued its own EOC about a second study using Surgisphere data, published on 1 May. The paper reported that taking certain blood pressure drugs including angiotensin-converting enzyme (ACE) inhibitors didn’t appear to increase the risk of death among COVID-19 patients, as some researchers had suggested. (Several studies analyzing other groups of COVID-19 patients support the NEJM results.) “Recently, substantive concerns have been raised about the quality of the information in that database,” an NEJM statement noted. “We have asked the authors to provide evidence that the data are reliable.”
We’ll know soon enough if there is any validity to this data but it’s not looking good. Meanwhile, actual research was halted by WHO and others because of this.
Update 6/4: The Lancet study has been retracted after Surgisphere refused to transfer data to independent peer reviewers.
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 https://t.co/pPNCJ3nO8n pic.twitter.com/pB0FBj6EXr
— The Lancet (@TheLancet) June 4, 2020