ICMR unfazed by WHO’s pause on hydroxychloroquine trial

Maitri Porecha New Delhi | Updated on May 27, 2020 Published on May 26, 2020

Up to 800 samples from every district will be picked up, the ICMR protocol states   -  Getty Images/iStockphoto

Says anti-viral drug will be given based on case-control studies as RCTs are difficult

Controversial anti-malarial drug hydroxychloroquine (HCQ) will continue to be used as preventive treatment in health-care workers despite the World Health Organization (WHO) temporarily suspending its use in solidarity clinical trials, worldwide.

Balram Bhargava, Director General, Indian Council of Medical Research (ICMR), pointed out that HCQ will be continued in consonance with the Centre’s May 18 advisory which propagated its use.

While WHO is halting all HCQ trials globally, Bhargava said the ICMR has conducted observational and case-control studies on HCQ at the All India Institute of Medical Sciences and three other public hospitals in Delhi, based on which these recommendations were issued. However, none of these studies is published or available in public domain.

Experts say randomised controlled trial (RCT) is the best way to ascertain if HCQ is effective or harmful. This will involve recruiting a large sample size of healthcare workers who take the drug, along with a control arm who are given a placebo, for instance. However, Bhargava said the ICMR is not planning any RCTs.

Case studies

“We conducted in-vitro studies (in test tubes on cell cultures), examined the biological plausibility of it being an antiviral drug. It is difficult to do an RCT, so we looked at data from observational and case control studies and we found it may be working. There is nausea, vomiting and occasional palpitations in persons who take it,” pointed out Bhargava.

R Gangakhedkar, head, infectious diseases, ICMR, had earlier said certain healthcare workers had also suffered from irregular heartbeat while taking the drug, and some had self-medicated themselves, going against the protocol of getting a drug prescription or consuming the drug in study settings.

Safety concerns

WHO’s decision to pause and review evidence of safety in HCQ on May 25, came after a recent Lancet study of over 96,000 persons. The observation was that HCQ may be doing more harm than good in those who consume the drug, including the risk of dying.

While India is not conducting any RCT studies on HCQ to conclude if it is useful or not in preventive or treatment settings, Soumya Swaminathan, former ICMR DG and currently Chief Scientist with WHO, said: “We firmly believe that RCTs are the best way to ascertain whether a drug or intervention is safe and efficacious for treatment or prevention of Covid. The executive group of the steering committee of WHO solidarity trial took the decision to temporarily suspend enrolment into the HCQ arm, awaiting further analyses from the trial as well as other ongoing RCTs.”

Published on May 26, 2020
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