120 researchers and healthcare professionals question Covid-19 study on use of hydroxychloroquine world news

More than 120 researchers and health professionals from around the world have sent open letters to Lancet’s editors, expressing serious concern about the large and widely published global studies that have backed the world. health An organization that discontinues some Covid-19 clinical trials.

On thursday Parents Australia revealed Australian data Research published last week It is not consistent with the Ministry of Health records and databases.

The study found that Covid-19 patients who received the malaria drug hydroxychloroquine had a higher mortality rate than other viral patients and experienced heart-related complications. A large observational study analyzed data from nearly 15,000 patients with Covid-19 who received the drug alone or in combination with antibiotics and compared this data to 81,000 controls who did not receive the drug. did.

Questions about Statistical modeling of papers Also, to Surgisphere, a company that manages a database of patients raised by Columbia University in the United States and used to inform research. Make a public statement Protect research integrity.

But now more questions are being asked about the Surgisphere database and how to investigate. Signers of the open letter to Lancet and the study authors include prominent skeptics about the value of treating Covid-19 with hydroxychloroquine. The letter sets out ten key concerns about the statistical analysis and data integrity of the survey.

“The author does not adhere to standard practices in the machine learning and statistics community.” The letter says. “They don’t release any code or data.”

Lancet is one of many signers Covid-19 Research Data Sharing Statement.

“There was no ethical review,” the letter continues. “There was no mention of the countries or hospitals that contributed to the data source, and no acknowledgment of their contribution. Requests to the author for information about the contributor center were denied. Australian data are incompatible with government reports. No Surgisphere Since then, this has been described as a misclassification of a hospital in Asia. This indicates that further error checking needs to be done on the entire database. “

The letter also found that data from Africa in the study show that nearly 25% of all Covid-19 cases and 40% of all deaths on the continent had sophisticated electronic patient data records and patient monitoring at Surgisphere-related hospitals. It also states that it has occurred in. “Neither are cases and deaths, nor is detailed data collection likely,” the letter said.

The letter also expressed concern about unusually small reported differences in baseline variables, interventions, and intercontinental results, despite significant demographic differences.

Currently, there is no strong duplicated evidence that there are effective drugs for the treatment or prevention of Covid-19. It includes hydroxychloroquine, which has long been used for malaria and autoimmune diseases, but the safety and harm profiles for treating these diseases are understood. Not well understood at Covid-19.

Governments around the world have warned against using hydroxychloroquine to treat or prevent the virus, emphasizing potentially toxic side effects of the drug and possible heart abnormalities. There are serious reports of harm by people self-medicated with hydroxychloroquine and related drugs during a pandemic.

Researchers have not demanded that clinical trials be discontinued in light of the Lancet study. There is consensus that more intense research is needed to explore treatments such as antibiotics, antivirals, and antimalarials.

“A properly implemented RCT [randomised control trials] The signer of the Lancet letter said.

Guardian Australia has contacted the authors of the Lancet, the Saga Sphere, and the study to address their concerns in the letter.

Before the letter, Dr. Sapan Desai, founder of Surgisphere, who is also the author of the Lancet, praised “the enthusiasm and lively debate on significant multinational observational registration studies published in the Lancet Medical Journal”. did.

“We appreciate the very complementary responses we received and the demands and clarifications of data-driven partnerships,” he said.

“The analysis was done carefully and the interpretations provided were intentionally measured. We studied a very specific group of inpatients with Covid-19, and the results of the analysis show that such diseases still It clearly states that it should not be over-interpreted in unaffected or non-hospitalized patients, and clearly outlines the limitations of observational studies that do not allow complete control of unobservable confounding measurements, and We conclude that off-label use of non-trial drug therapy should not be recommended. ”

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