Studies That Most Likely Led WHO to Halt Hydroxychloroquine Covid-19 Trials Are Under Fire Amid Questionable Data From Surgisphere

Two world-renowned medical journals are currently on the hit list after inconsistencies were seen in their published studies regarding hydroxychloroquine. Moreover, the data provided in the papers are owned by an Illinois-based company called the Surgisphere Corporation.

The antimalarial drug has previously been widely used in various clinical trials in treating COVID-19 patients, especially after receiving a special mention from US President, Donald Trump.

However, recently, the World Health Organization has requested to halt clinical studies involving hydroxychloroquine's use due to claims and reviews claiming the drug was harmful. The study that most likely led the WHO to halt the trials was published in the journal The Lancet on May 22, 2020.

On June 2, 2020, the journal released an Expression of Concern (EOC) addressing inquiries about their study. It noted that an independent analysis of the source and validity of the data had been delegated by the authors not affiliated with Surgisphere. Furthermore, it assured that the audit is ongoing and that results will come soon.

Hours ahead, The New England Journal of Medicine (NEJM) also issued its own EOC regarding a study published on May 1, 2020. The study also used data coming from Surgisphere Corporation. In the paper, authors claimed that some hypertensive drugs such as angiotensin-converting enzyme (ACE) inhibitors did not appear to increase the risk of death among COVID-19 patients, just like how other researchers had suggested.

In the EOC, the statement said that as theoretical concerns have been raised about the information's credibility in the database, the authors of the study were asked to supply evidence that the data are reliable.

Surgisphere has yet to release the data underlying the studies publicly. However, Sapan Desai, the CEO and founder of the company, told Science through a spokesperson that he was arranging a nondisclosure agreement that will grant the authors of the NEJM paper with the data access requested by the journal.

Also Read: Yale Epidemiologist: Hydroxychloroquine Should be Used as Standard COVID-19 Treatment Despite Being Potentially Harmful

To Continue Trials or Not

With the credibility of the study responsible for halting trials using hydroxychloroquine hanging in the air, many researchers are now weighing whether to restart their trials. According to Nicholas White, a malarial researcher and co-investigator on a hydroxychloroquine trial, the problem with trying to resume is that damage has been done.

With headlines all over the world broadcasting that the antimalarial drug is harmful, he says that the world now thinks that the drugs are "poisonous." Since the WHO announced the temporary pause of hydroxychloroquine trials on May 25, many have complied and stopped their trials.

Sanofi, which manufactures the drug under the brand, Plaquenil, also said it would temporarily stop their recruitment of patients to its two clinical trials.

Since then, the authors of the study from The Lancet acknowledged that their results warranted validation from more accurate randomized trials. However, in an interview with TRT World, Desai confidently asserted how a randomized controlled trial was even needed with data like what they provided.

Oddities and Inconsistencies

A third COVID-19 study utilizing Surgisphere data has also recently received some attention from spectators. In a preprint posted early in April, Desai and his co-authors have concluded that ivermectin, an antiparasitic drug, drastically reduced mortality in coronavirus patients.

A preprint of a study used Surgisphere data collected from 169 hospitals around the world between January 1 and March 1. The paper reportedly included three patients in Africa who received ivermectin, even though only two COVID-19 cases had been reported in all of Africa by March 1.

Carlos Chaccour from the Institute for Global Health in Barcelona and two colleagues have noted this in a recent blog post. Miguel Hernán, a Harvard epidemiologist and co-investigator on an ongoing hydroxychloroquine trial in Spain and Latin America, says that the dispute has been a regrettable distraction. In a time where everyone should be united in finding measures to battle a common enemy, and with millions dying, two of the most prestigious clinical journals in the world have disappointed many, Chaccour deplored.