India, which is major HCQ exporter, needs to insist that any move to discontinue HCQ trials be based on rigorous, review-able research.
Now is the time that India should urge continuation of hydrochloroquine (HCQ) trials across the globe. The observational study published in The Lancet on May 22, which claimed a much higher proportion of adverse consequences (including in-hospital death) among Covid-19 patients administered chloroquine/hydrochloroquine than those that received standard care, has come under serious criticism from medical researchers across the globe.
The study’s claim of a formidable dataset of 96,032 patients from 671 hospitals in six continents gave it an air of incontrovertibility, but nearly 180 scientists and researchers have written to Lancet, raising serious concerns about it. Apart from the study’s authors refusing to disclose the sources for their dataset (pleading ironclad privacy agreements with hospitals), the fact that several experts have questioned the extraordinary homogeneity of patient data across continents, the marked differences in demographics and population-level health condition notwithstanding, is only one of the red flags.
The letter talks of how there hasn’t been enough adjustment for known confounders (severity of disease, dose used, etc), how the mean daily dose of HCQ was 100 mg higher than the US FDA recommendations though 66% of the cases considered in the study are from North American hospitals, etc.
While WHO suspended the HCQ arm of its multi-country SOLIDARITY trial citing the results, the UK advised a pause in the recruitment for HCQ trials while France put all such trials in abeyance. This has also driven fear among participants, with implications for ongoing studies. Given how it isn’t yet certain that HCQ doesn’t work, unless the study in Lancet withstands methodological rigour, the halting of HCQ trials must be reconsidered.
Indeed, India, which is major HCQ exporter, needs to insist that any move to discontinue HCQ trials be based on rigorous, review-able research. To that end, the heads of the Council for Scientific and Industrial Research and the Institute of Genomic and Integrative Biology urging the WHO to resume HCQ trial is a good start. The Indian Council of Medical Research, which recently expanded the cohort for which it advises prophylactic use of HCQ, must provide the impetus from its findings so far; it reported a correlation between prophylactic use of HCQ as per the earlier protocol and lower Covid-19 contraction among those who received HCQ.
It now needs to bring out the findings in a more detailed manner. It will also have to collate and report the findings of HCQ use in treatment of Covid-19 patients—as per its existing protocol, severe coronavirus patients requiring ICU management are given 400mg of HCQ in the morning and evening on the first day of this treatment course, followed by 200 mg HCQ twice daily for the next four days. This is a battle where India must lead, not just because it is a major HCQ producer, but HCQ working against Covid-19, could mean a turnaround for the outlook on the outbreak in the country.