Backlash against The Lancet’s Chloroquine Study

02.06.2020 -

The World Health Organization’s decision to halt trials with hydroxychloroquine as a therapeutic for Covid-19 is facing a backlash from clinicians wanting to continue the studies. At the same time, US president Donald Trump is continuing his promotion campaign for the drug – in Brazil.

In late May, following a critical report published in the British medical journal The Lancet, WHO halted its own trials, pending additional safety conclusions, and two other major clinical trials of hydroxychloroquine for Covid-19 treatment were put on hold as a result of the study funded by Brigham and Women’s Hospital in Boston.

 On the heels of The Lancet’s report, one of several that linked hydroxychloroquine to cardiac issues but the first to link it with a higher rate of deaths, the governments of France, Belgium and Italy banned doctors from using it as a coronavirus treatment

Now an open letter reportedly signed by more than 180 scientists around the world has raised concerns questions about the findings, due to what they regard as inconsistent data used by the Lancet.

“This scrutiny has raised both methodological and data integrity concerns,” the authors wrote, and asked the Lancet to make available the peer review process that led to the manuscript being accepted for publication.

Ironically, the international studies reviewing the drug’s efficacy were conducted to achieve clarity in the wake of a French doctor’s report praising its benefit – which was not peer reviewed.

One red flag, critics of The Lancet’s report said, is that the average daily doses of hydroxychloroquine detailed in the journal were higher than those recommended by the US Food and Drug Administration (FDA).

The letter writers noted also that data the magazine reported from Australian patients did not seem to match data from that country’s government. Another major concern, they said, was that the study’s authors did not release their code or data despite signing a pledge to share information on the coronavirus.

Researchers behind the Lancet report meanwhile have reportedly corrected some of its figures but stressed that their conclusions had not changed.

US to ship chloroquine to Brazil

Meanwhile, Trump continues to promote hydroxychloroquine as a prophylactic. The White House announced on May 31 that the US plans tol send 2 million doses – along with 1,000 ventilators – to Brazil. The Latin American country is grappling with steeply rising numbers of people infected with Covid-19.

It wasn’t clear which drugmakers’ donations were to be sent to Brazil. In reaction to Trump’s promotion in April, Bayer offered three million doses. Switzerland’s Novartis  Israeli generics producers Teva and Netherlands-headquartered, US-managed Mylan between them offered to deliver tens of millions of tablets.

In a joint statement with the Brazilian government, the Trump administration said the hydroxychloroquine doses will be used as a preventative treatment for nurses, doctors and health care professionals. Brazilian civilians who contract the virus will also be permitted to use the drug. 

Additionally, the statement said, the US and Brazil plan to launch a joint research effort, including randomized controlled clinical trials, to test the old malaria drug’s use as a preventative measure and early treatment of Covid-19.

The Lancet’s criticism targeted the therapeutic use. The study did not examine whether the drug is effective in preventing infection. Some pointed out, however, that in both applications the cardiovascular risks should be similar for those with pre-existing conditions.

At the end of May, Brazil counted almost 500,000 confirmed cases of the coronavirus, the second-highest number behind the US with more than 1.7 million. At least 27,878 people have died from Covid-19 in Brazil, according to Johns Hopkins University.