The authors of a sensational paper that last month reported dismal findings about the use of chloroquine and hydroxychloroquine to treat Covid-19 patients have retracted their report after the data that it was based on was called into question.
The paper, published in The Lancet in May, led to the suspension of some clinical trials of the medications, including by the World Health Organization.
The drug has been repeatedly promoted by President Trump, despite the lack of evidence that it is effective against the virus. He has said that he had taken it himself to try to ward off infection, even though the Food and Drug Administration had issued a safety warning that it could cause dangerous abnormalities in heart rhythm in coronavirus patients. His endorsement had the effect of politicizing scientific questions that normally would have been left to dispassionate researchers.
The retracted Lancet paper was not the only study that called the drug’s effectiveness into question. A more rigorous study — the first large controlled clinical trial of hydroxychloroquine — found that hydroxychloroquine did not prevent Covid-19 in a randomized test of 821 people who had been exposed to patients infected with the virus.
After Mr. Trump promoted the use of hydroxychloroquine and another malaria drug, chloroquine, at a White House briefing on March 19, many people flocked to try them; the rate of first-time prescriptions surged to more than 46 times the weekday average by that evening. His announcement in May that he had started taking hydroxychloroquine himself did not inspire many Americans to follow his lead: By the next day, the rate was only about 2.8 times the average, the equivalent of an increase of about 400 prescriptions.
The Lancet paper, which was purportedly based on data from a huge, privately held registry of patient records from hundreds of hospitals around the world, had concluded that the anti-malaria drugs were associated with dramatically higher rates of heart arrhythmias and deaths in Covid-19 patients.
The database belonged to a company called Surgisphere, which is owned by Dr. Sapan Desai, one of the four co-authors.
The other three co-authors, including Dr. Mandeep R. Mehra, a professor at Harvard Medical School, retracted the article on Thursday after their attempts to verify the database’s veracity and authenticity were stymied by Dr. Desai.
“We launched an independent third-party peer review of Surgisphere with the consent of Sapan Desai to evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper,” their statement said.
“Our independent peer reviewers informed us that Surgisphere would not transfer the full data set, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements.”
Controversy over the provenance of the database and inconsistencies in the patient records has been rising in scientific circles since publication of the study.
Later on Thursday, The New England Journal of Medicine retracted a heart study that was published by the same authors with data from the same registry. That study, published in May, was said to analyze 8,910 Covid-19 patients hospitalized through mid-March at 169 medical centers in Asia, Europe and North America. The authors concluded that cardiovascular disease increased their risk of dying.
“Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article,” the authors wrote in the retraction of the study.
Source : The New York Times