• The authors of two studies that warned about the harmful effects of hydroxychloroquine retracted

 

  • “We can no longer guarantee the veracity of the primary data sources,” – The Lancet

 

  • The article unleashed a flurry of criticism, not only from defenders of the controversial drug.

Published in The Lancet and The New England Journal of Medicine, they had led the WHO to suspend testing to treat patients with Covid-19. The author who provided the database was questioned by the other three.

The study, published May 22 in the prestigious medical journal The Lancet, had made a profound impact on the health world. In fact, it caused an ephemeral change in the World Health Organization’s policy on hydroxychloroquine by considering it ineffective in the treatment of Covid-19 . But it fell apart this Thursday after three of its four authors retracted.

“We can no longer guarantee the veracity of the primary data sources,” the three wrote in The Lancet , thus accusing the fourth author, the head of the company that collected those indicators and refuses to give access to the database. The investigation concluded from this information that hydroxychloroquine is not beneficial for hospitalized Covid-19 patients and could even be harmful for them.

The article unleashed a flurry of criticism, not only from defenders of the controversial drug, such as the French researcher Didier Raoult, who called it “lousy”, but also from skeptical scientists about the interest of this drug for patients infected with the new coronavirus . So on Wednesday the WHO announced the resumption of clinical trials with hydroxychloroquine and the European study Discovery plans to do the same.

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Critics questioned the reliability of the data on which the study was based (96,000 patients from 671 hospitals) collected by the American company Surgisphere, which is presented as a health data analysis company and is led by the fourth author of the article, Sapan Desai. The other authors responded by announcing an “independent” audit of their results and the origin of the data. But finally three of them, including director Mandeep Mehra, threw in the towel.

As Surgisphere refused to transfer the database due to confidentiality agreements with its clients (the hospitals where they were obtained). “(The auditors) were unable to conduct an independent review and informed us of their withdrawal from the assessment process,” the three researchers wrote in the text released Thursday, in which they present “their deepest apologies.”

In a statement, The Lancet said it takes “scientific integrity issues very seriously” and deemed it “urgent” to evaluate other collaborations with Surgisphere. “There are still pending questions about Surgisphere and the data supposedly integrated into this study,” the magazine insisted.

For its part, The New England Journal of Medicine (NEJM), which published a study by the same team using Surgisphere data on the link between Covid-19 mortality and heart disease , also announced the retraction Thursday night. of the document. Dr. Desai, who has defended “the integrity” of his data from the beginning, declined to comment on Thursday, the agency in charge of his communication told AFP .

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In an open letter published last week, dozens of researchers from around the world drew up a long list of the study’s trouble spots , from inconsistencies in the doses administered in some countries to ethical questions about gathering information. Furthermore, the signatories felt that rigorous clinical trials are needed to evaluate the drugs, while the controversial study is nothing more than a compilation of pre-existing data.

The controversial study itself stressed the need to continue clinical trials to “confirm” its results. On Wednesday, another study carried out in the United States and Canada and published in the NEJM concluded that hydroxychloroquine is ineffective in preventing Covid-19 .

These results were highly expected because a protocol considered to be the reference for the study of clinical results was followed . But the trial is “too small to be irrefutable,” said Martin Landray, an epidemiologist at Oxford University.

Following the resumption of WHO trials, further conclusions are expected. “The results of randomized trials are necessary to draw reliable conclusions. Hopefully they will be available soon, ” said Stephen Evans of the London School of Hygiene and Tropical Medicine on Thursday.

With information from AFP