Lancet study expresses concern about article against use of Hydroxychloroquine

WHO chief Tedros Adhanom Ghebreyesus speaks during a coronavirus briefing in February 2020

A major study of hydroxychloroquine for Covid-19 is drawing criticism—and a formal correction

In the University of Minnesota trial, 40% of the those who took hydroxychloroquine reported less serious side effects like nausea and abdominal discomfort versus 17% in the placebo group.

Approximately 12% of those given hydroxychloroquine developed Covid-19, compared to 14% who were given the vitamin folate as a placebo. That difference was not statistically significant, and "it's also not clinically meaningful", Rajasingham says.

Speaking at a virtual press conference, WHO Director-General Tedros Adhanom Ghebreyesus said that experts have been reviewing the data and recommended that "there are no reasons to modify the trial protocol".

Also Wednesday, the World Health Organization said it is resuming a clinical trial testing hydroxychloroquine as a treatment after pausing it over safety concerns.

An worldwide trial using hydroxychloroquine to treat Covid-19 patients will be restarted after questions arose about a study linking the antimalarial drug to increased death and heart risks.

The NEJM correspondence took aim at a May 1 study in the NEJM by Mandeep Mehra, et al, entitled "Cardiovascular Disease, Drug Therapy, and Mortality in COVID-19". Lately, its role is being investigated in the treatment and prevention of Covid-19.

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The new trial found no serious side effects or heart problems from use of hydroxychloroquine.

"I think both sides - one side who is saying "this is a unsafe drug" and the other side that says "this works" - neither is correct", said Boulware.

The Lancet, the British medical journal that published the paper, has attached an "expression of concern" to the study, which may be a precursor to its retraction.

Last month, The Lancet published a study that showed the anti-malaria treatment hydroxychloroquine, which has been widely touted by President Trump as a potential treatment for Covid-19, was linked with an increased risk of death among Covid-19 patients. The goal of the randomized trial was to see if hydroxychloroquine could prevent symptoms of infection, known as postexposure prophylaxis, compared with taking a sugar pill. The results of the trial were published Wednesday in the New England Journal of Medicine.

"Our objective was to answer the question of whether hydroxychloroquine worked to prevent disease or did not work", said lead researcher Dr. David Boulware, an infectious disease doctor at the University of Minnesota. "Universal face mask use might enable safe lifting of restrictions in communities seeking to resume normal activities and could protect people in crowded public settings and within households", Raina MacIntyre, professor of global biosecurity at the University of New South Wales in Sydney, said in a linked comment on the study.

In March, Trump said hydroxychloroquine used in combination with the antibiotic azithromycin had "a real chance to be one of the biggest game changers in the history of medicine" with little evidence to back up that claim. Participants enrolled nationwide in the USA and in Quebec, Manitoba and Alberta in Canada. The researchers said the data discrepancy did not affect the study's findings.

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