Wednesday, June 3, 2020

A mysterious company's coronavirus papers in top medical journals may be unraveling

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.

Hours earlier, The New England Journal of Medicine 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 inhibitors didn't appear to increase the risk of death among COVID-19 patients, as some researchers had suggested.

Chicago-based Surgisphere has not publicly released the data underlying the studies, but today Desai told Science through a spokesperson that he was "Arranging a nondisclosure agreement that will provide the authors of the NEJM paper with the data access requested by NEJM.".

Mehra and Patel declined to speak to reporters about the various papers, referring inquiries to BWH, which released a statement on Mehra's behalf this evening saying "Independent of Surgisphere, the remaining co-authors of the recent studies published in The Lancet and The New England Journal of Medicine have initiated independent reviews of the data used in both papers after learning of the concerns that have been raised about the reliability of the database."

Physician and entrepreneur James Todaro of the investment fund Blocktown Capital wondered in a blog post why Surgisphere's enormous database doesn't appear to have been used in peer-reviewed research studies until May. Another post, from data scientist Peter Ellis of the management consulting firm Nous Group, questioned how LinkedIn could list only five Surgisphere employees-all but Desai apparently lacking a scientific or medical background-if the company really provides software to hundreds of hospitals to coordinate the collection of sensitive data from electronic health records.

Chaccour wonders how such a tiny company was able to reach data-sharing agreements with hundreds of hospitals around the world that use many different languages and data recording systems, while adhering to the rules of 46 different countries on research ethics and data protection.

A hydroxychloroquine trial known as ORCHID, funded by the U.S. National Heart, Lung, and Blood Institute, opted to keep running after its data and safety monitoring board reviewed safety data from already enrolled participants, says Semler, a co-investigator on the study.

No comments: