End of game for controversial Lancet study questioning hydroxychloroquine - France 24

Paris (AFP)

Overwhelmed by criticism from scientists around the world, the Lancet study that led to an ephemeral change in WHO policy on hydroxychloroquine in the treatment of Covid-19 finally sank on Thursday after the withdrawal of three of its four authors.

"We can no longer vouch for the veracity of the sources of the primary data", write the three authors to Lancet, questioning the refusal of the company having collected them, led by the fourth author, to give access to the database of data.

Published on May 22 in the famous medical journal, the study concluded that hydroxychloroquine was not beneficial to hospitalized Covid-19 patients and could even be harmful.

While other works on a smaller scale had come to the same conclusion that it did, its publication had a worldwide impact and spectacular repercussions, pushing in particular the WHO (World Health Organization) to suspend its clinical trials on hydroxychloroquine against Covid-19.

But the critics were quick, en masse, from defenders of the controversial molecule such as the French researcher Didier Raoult qualifying the study as "messy", but also from scientists skeptical about the interest of this drug for contaminated patients by the new coronavirus.

The main criticisms focused on the reliability of the data from this study (96,000 patients from 671 hospitals) collected by Surgisphere, which presents itself as a health data analysis company and which is headed by Sapan Desai, fourth author of the article. .

The authors then responded by announcing an "independent" audit of their results and the origin of the data. But three of them, including the main Mandeep Mehra, finally threw in the towel.

Surgisphere having refused to transfer the database due to confidentiality agreements with its customers, the experts commissioned "could not conduct an independent review and informed us of their withdrawal from the peer review process", write them in the text published Thursday by The Lancet, presenting "their deepest apologies".

In its press release, Le Lancet, assuring that it takes "questions of scientific integrity very seriously", considers it "urgent" to evaluate other collaborations with Surgisphere.

- "Huge scandal" -

"There are still unanswered questions about Surgisphere and the data supposedly included in this study," insists the review, which had already published a warning in the form of an "expression of concern" on Tuesday evening. ).

The New England Journal of Medicine (NEJM), which had published a study by the same team carried out with the data from Surgisphere, on the link between mortality due to Covid-19 and heart disease, also announced Thursday the retraction of this work.

Dr Desai, who defended from the start the "integrity" of his data, for his part declined any comments Thursday, told AFP the agency ensuring its communication.

In an open letter published last week, dozens of researchers around the world had drawn up a long list of problem areas for the study, from inconsistencies in doses administered in some countries to ethical questions about information gathering.

These signatories also believe that rigorous clinical trials are necessary to evaluate the drugs, while the controversial study is only a compilation of pre-existing data.

The study in question also highlighted the need to continue clinical trials to "confirm" its results.

On Wednesday, another study conducted in the United States and Canada published in the NEJM concluded that the molecule is ineffective in the prevention of Covid-19.

These results were eagerly awaited because it was a randomized controlled trial, a protocol considered to be the benchmark for studying clinical results. But it is "too small to be irrefutable," insisted Martin Landray, epidemiologist at the University of Oxford.

After the announced resumption of the trials by the WHO, other results should arrive.

"The results of randomized trials are necessary to draw reliable conclusions. Hopefully the results will be available soon," said Stephen Evans of the London School of Hygiene and Tropical Medicine on Thursday.

Otherwise, with the slowdown of the epidemic which makes it more difficult to recruit new patients, the heated debate between defenders and detractors of the famous molecule is likely to continue.

Anyway, this case around the Lancet study "is a huge scandal very detrimental to the scientific community," said Professor Gilbert Deray of Twitter, Pitié-Salpêtrière in Paris.

© 2020 AFP