An interesting problem in the scientific literature surrounding COVID-19 cropped up today. Two journals, the Lancet and the New England Journal of Medicine (NEJM) published what they describe as “expressions of concern” (EOC) about a study in each journal focusing on coronavirus infection and drug therapy. The first study, in the Lancet, suggested that cardiovascular side effects from hydroxychloroquine were significant and would prevent its use in treating patients with COVID-19. The other study, published in the NEJM on May 1, reported that drugs that alter angiotensin-converting enzyme (ACE2) inhibitors did not appear to increase death risk in patients with COVID-19.
The common factor involved in both of these studies was that the data came from a corporation called Surgisphere. Apparently, it is not at all clear whether the data from this organization is of high quality and reliable.
Surgisphere appears to be a data warehouse that does analysis of reports from different health care sources including hospitals and healthcare chains. Its website gives very little information about the organization, its data sources, or any of its scientific review or evaluation. Its Wiki entry says “Surgisphere is a United States healthcare analytics company that provided data used for studies of COVID-19.” This company is founded by a surgeon, Dr. Sapan Desai.
Surgisphere’s website states that, “When Dr. Sapan Desai (the CEO) founded Surgisphere Corporation, the mission was simple: “to harness the power of data analytics and improve the lives of as many people as possible. Over the last decade, that unifying mission has led both Dr. Desai and the entire Surgisphere team to relentlessly pursue advancements in machine learning, artificial intelligence, and big data with the intention of developing industry-leading tools that empower healthcare providers to make better, faster, and more accurate decisions.”
One thing that is remarkable is the number of patient records the company claims to have. In the Lancet article alone, they claim to have reviewed 96,032 patients hospitalized with COVID-19; and this was from late March! The patients come from all over the world and many countries, and the quality of the data reported from these multiple sources is not clear. They also claim data from 671 different hospitals; however, no specific source is identified.
The NEJM study was also large, having patients from an observational database of 169 hospitals in Asia, Europe, and North America with 8,910 patients qualifying for the study.
In an excellent review on this issue in the Science Magazine website, Kelly Servick and Martin Enserink point out that there are concerns with the data including the large numbers of patients that were quickly assembled as well as the interpretation of the data.
While there have been other studies that raised concerns with hydroxychloroquine, this Lancet study was influential and caused a number of clinical trials to be put on hold, so that a full evaluation the drug was not performed. In addition, the second study suggested that using drugs that alter angiotensin-converting enzyme, the molecular target of the coronavirus, had no deleterious effect, and encouraged physicians to continue the therapy even in light of coronavirus infection. If the conclusions of this study were incorrect, it could cause increased risk for patients on this drug.
There is a third study using data from Surgisphere. This report, still awaiting peer review, suggests that using an antiparasitic drug, ivermectin, could dramatically reduce mortality in COVID-19 patients. This study has led to many governments in Latin America recommending the drug for patients infected with COVID-19. The value of this drug, which has some toxicity, is unclear. Other reviewers had suggested the data from this and the other studies are likely fraudulent.
If there is a take home message for people who are not actively involved in research in this area it is that even the results of a single published study even. in a highly reputable journal, such as the NEJM, may not be definitive and should not be taken as absolute proof that a drug works with COVID-19.
Until the studies have been repeated with consistent results several times, don’t assume any apparent benefit from a drug. This has been demonstrated with remdesivir, where some of the studies did not show value even though the majority are now showing benefit in COVID-19 patients.
Therefore, do not change your drug therapy if you get COVID and do not start any new medications without first contacting your physician.