Two respected medical journals have raised questions about the reliability of data provided by a controversial data analytics company in two different trials done for two COVID-19 treatments.
The New England Journal of Medicine (NEJM) has raised concerns about a study that evaluated the link between two types of blood pressure drugs and the risk of death from COVID-19.
The trial reported in NEJM looked at data on 8,910 hospitalized COVID-19 patients in 169 hospitals in Asia, Europe and North America. Results reported in NEJM found no association between fatalities from coronavirus infections and the use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBS) (DID, May 5).
NEJM said that “substantive concerns” have been raised about the quality of the information in the database for the trial, which was provided by data analytics company Surgisphere. NEJM’s editorial boardasked the study’s authors to provide evidence that the data are reliable.
The Lancet has also alerted its readers to “serious scientific questions” raised about a study that Surgisphere which was involved in and that linked hydroxychloroquine to increased risk of death.
The large international study evaluated 96,032 hospitalized COVID-19 patients from six continents in the past few months, of which 14,888 took the antimalarials. Results were reported in The Lancet and found that the drugs offered no benefit and caused deaths and cardiac arrhythmias (DID, May 26).
A coalition of over 180 doctors and clinicians wrote an open letter to The Lancet questioning its findings. It called on Surgisphere, which holds the data for the trial, to provide aggregated patient data at the hospital level (DID, June 1).
The Lancet said in a statement that an independent audit of the data has been commissioned, and that results are expected “shortly.”
Surgisphere said it stood behind the integrity of its databases and is commissioning an independent audit of the data from both studies.
Meanwhile, the World Health Organization, which suspended the hydroxychloroquine arm of its Solidarity trial of potential COVID-19 treatments, announced yesterday that it is resuming the trial after a review of the data. — Jordan Williams