Three of the four authors of the large Lancet study who concluded that hydroxychloroquine in Covid-19 patients had serious adverse effects withdrew their study. This was due to the refusal of the company Surgisphere, from which the data came, to clarify the source of the data in favor of expert analysis.
Disappointed by criticism from scientists around the world, the Lancet study, which led to a short-term change in WHO policy on hydroxychloroquine in the treatment of Covid-19, finally collapsed on Thursday 4 June 2020 after three of its four authors withdrew their statements. The issue was the refusal of the company Surgisphere, on whose data this work was based, to open its database to experts responsible for validating the quality of the results.
The study was criticized by both the skeptics and the pro-hydroxychloroquine camp
“We can no longer attest to the veracity of the primary data sources,” the three authors wrote to the Lancet, citing the refusal of the Surgisphere to grant access to the database. The study, published in the famous medical journal of 22 May, concluded that hydroxychloroquine is not beneficial and may even be harmful to patients hospitalized with Covid-19. Although other smaller-scale studies came to the same conclusion, the publication of the study had global implications and dramatic consequences, including the suspension by the World Health Organization (WHO) of clinical trials of hydroxychloroquine against Covid-19.
However, mass criticism soon came from defenders of the controversial molecule, such as the French researcher Didier Raoult, who described the study as “imperfect”, but also from scientists skeptical about the interest of this drug for patients infected with the new coronavirus. Finally, on Wednesday 3 June the WHO announced the resumption of clinical trials on hydroxychloroquine, and the European Discovery study is considering doing the same.
In an open letter published on 28 May 2020, dozens of researchers from all over the world had drawn up a long list of problem points in the study, from inconsistencies in the doses administered in some countries to ethical issues in the collection of information. They also considered that rigorous clinical trials are needed to assess medicines, while the controversial study is merely a compilation of existing data. Further clinical trials are also required for the study in question to ‘confirm’ its results.
A non-verifiable database
The main points of criticism concern the reliability of the data from this study (96,000 patients from 671 hospitals) collected by the Surgisphere, which presents itself as a company for the analysis of health data. Surgisphere founder Dr. Sapan Desai is also the fourth author of the article. The authors responded by announcing an “independent” review of their results and the origin of the data. But three of them, including Dean Mandeep Mehra, finally threw in the towel. Since Surgisphere refused to transfer the database because of confidentiality agreements with its clients, “the experts were unable to conduct an independent review and informed us of their withdrawal from the peer review process,” they wrote in the Lancet on Thursday, June 4, offering “their deepest apologies.”
Surgisphere in question
In its communiqué, the Lancet assures that it takes issues of scientific integrity “very seriously” and considers the evaluation of other collaborations with Surgisphere “urgent”: “There are still open questions about Surgisphere and the data allegedly contained in this study,” stresses the magazine, which had already published a warning in the form of an “expression of concern” on Tuesday evening, June 2. The New England Journal of Medicine (NEJM), which had published a study by the same team using Surgisphere data on the link between Covid-19 mortality and heart disease, also announced on the evening of June 4 that it had withdrawn the study. Dr. Desai, who has defended the “integrity” of the data from the beginning, refused to comment on Thursday, June 4, the AFP told the authority responsible for her report.
On Wednesday, June 3, another study conducted in the United States and Canada and published in the NEJM concluded that the molecule is ineffective in preventing Covid-19. But it is “too small to be irrefutable,” stressed Martin Landray, an epidemiologist at Oxford University. Further results are expected after the WHO has announced the resumption of the studies. “In order to be able to draw reliable conclusions, randomized study results are necessary. I hope the results will be available soon,” said Stephen Evans of the London School of Hygiene and Tropical Medicine on Thursday. Otherwise, if the epidemic slows down and it becomes more difficult to find new patients, the heated debate between defenders and supporters of the famous molecule is likely to continue.