Off-label use of the anti-malarial drug hydroxychloroquine (HCQ) amongst hospitalized patients during the first wave of covid-19 contributed to thousands of deaths worldwide, according to a new study by a team of French scientists.
Researchers estimate that approximately 17,000 patients died in hospitals between March 2020 to January 2021 due to HCQ use across six countries analyzed: Belgium, France, Italy, Spain, Turkey, and the United States.
This figure represents a median estimate, with the potential range between 6,267 and 19,256 deaths.
Published by Elsevier in the February issue of the journal Biomedicine & Pharmacotherapy, the study points out the dangers of relying on off-label prescribing, or using a drug for a purpose not originally approved, in the absence of reliable data.
Early research on HCQ for covid, for example, showed limited or no effect on mortality reduction, highlighting the risk of basing decisions on shaky evidence.
Analyzing 14 clinical trials involving hospitalized covid patients, the study found that HCQ treatment was associated with an 11% increase in all-cause mortality compared to those who didn’t receive the drug.
This translates to a potential additional 11 deaths for every 100 patients treated with HCQ.
Notably, the study focused on the period before reliable randomized controlled trials (RCTs) were conducted, when HCQ was often administered under “compassionate use” guidelines in the absence of definitive evidence.
The highest number of deaths out of all the countries analyzed—12,739—were observed in the US where Donald Trump, then president, claimed that the drug was a “miracle drug” while claiming that he too had been taking the medication.
“Given that reliable data on hospitalizations, HCQ use, and in-hospital mortality for most countries, these numbers likely represent the tip of the iceberg only thus largely underestimating the number of HCQ-related deaths worldwide,” said the researchers.
HCQ emerged as a potential treatment for covid-19 due to a confluence of factors in the early days of the pandemic, owing to its anti-viral and anti-inflammatory properties.
In the absence of established treatments, HCQ found its way into the World Health Organization’s (WHO) solidarity trial, a collaborative effort to test potential covid-19 treatments. It even gained traction in many countries, including India and the US, where it was prescribed to hospitalized patients and healthcare workers for both prevention and treatment.
By May 2020, however, the WHO paused its HCQ arm due to growing evidence of ineffectiveness and potential harm.
Despite the WHO’s pause, some countries, including India, continued HCQ use, driven by local factors and the lack of clear alternatives.
In the US, the FDA initially granted emergency use authorization for HCQ, but revoked it later as evidence against its efficacy strengthened.
More than just highlighting the ineffectiveness of the drug, the research exposes a critical gap in our ability to respond to new diseases – the fragility of extrapolating treatment effects from chronic conditions to severe, acute ones without accurate data.
The study also underscores the importance of robust evidence-based practices during healthcare emergencies. The reliance on unproven treatments like HCQ in the early stages of the pandemic demonstrates the potential for unintended consequences.
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