Lancet Issues 'Expression of Concern' After Scientists Question Validity of HCQ study


The Lancet study was a "retrospective observational" study, using a data set from an analytics firm, to see what effects the drug had had on some COVID-19 patients, compared to those who did not get it.

However, a day after its publication over 50 clinicians from across the world raised questions about the trial method and authenticity of the data that the researchers used to conclude about the dangers of the drug.

"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. In their statement Thursday, they said that Surgisphere was not cooperating with the independent reviewers and would not provide the data. Initial studies, particularly in France and China, suggested that the use of hydroxychloroquine in combination with antibiotics could speed up recovery.

A report on on Tuesday said that the Lancet results have begun to unravel, and Surgisphere, which provided patient data for two other high-profile COVID-19 papers, has come under withering online scrutiny from researchers and amateur investigators.

The renewed research push follows widespread criticism of the quality of data in a study published by The Lancet, an influential medical journal, which found high risks associated with the treatment. It was the first country to reverse its support over the drug use, although the health ministry said its stance may change if new evidence emerges and proves otherwise. He asked: Should other trials continue unchanged?

Tedros said that to date, more than 3,500 people have been recruited into the trial in 35 countries. Side effects were more familiar with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no severe adverse reactions were reported.

The findings led to the pause of some global clinical trials studying hydroxychloroquine so researchers could check for any safety concerns.

USA astronatus board space station on landmark SpaceX mission
The blastoff assumes significance as it marks the launch of humans into orbit from U.S. soil for the first time in almost one decade.

Results were no different among a subgroup of participants who were taking zinc or vitamin C, which some people believe might help make hydroxychloroquine more effective. The database, compiled by Chicago company Surgisphere Corp., was also used in an observational study of almost 100,000 patients published in Lancet that linked the malaria drugs hydroxychloroquine and chloroquine to a higher risk of death in hospitalized patients with COVID-19.

Meanwhile, the White House said that President Trump remains healthy and free of any side-effects of hydroxychloroquine.

The participants were divided into two groups and received either hydroxychloroquine or a placebo 4 days after exposure.

'We were disappointed. We would have liked for this to work, ' study leader, Dr David Boulware, an infectious disease specialist at the University of Minnesota, told the Associated Press.

The World Health Organization and several world governments have changed their coronavirus policies and resumed trials of hydroxychloroquine because they got questionable data from a small USA healthcare company - with a science fiction writer and an adult content model on staff.

The drugs are safe for people to take for malaria, rheumatoid arthritis, and lupus, for whom they are shown to have benefits, experts stress. Analyzed statistically, the difference between those rates was not significant.