The Indian Council of Medical Research (ICMR) on Saturday said that research is underway to study the side effects of hydroxychloroquine (HCQ).
The move follows criticism that HCQ has been endorsed by the ICMR without studying its serious side effects for asymptomatic health-care workers treating patients with suspected or confirmed COVID-19, and for asymptomatic household contacts of confirmed cases.
Dr Raman R Gangakhedkar, senior Scientist of the Epidemiology and Communicable Diseases-I (ECD-I) of the ICMR, said it has conducted cohort study and no trial study yet, as evidence base to conduct the trial is not available.
The ICMR has recommended chemoprophylaxis with HCQ for asymptomatic health-care workers treating patients with suspected or confirmed COVID-19, and for asymptomatic household contacts of confirmed cases.
The ICMR document states “its use in prophylaxis is derived from available evidence of benefit as treatment and supported by preclinical data”.
However, a team of scientists in their review published in the recent issue of The Lancet Infectious Medicine said that although some in-vitro evidence supports the antiviral activity of hydroxychloroquine and its precursor chloroquine, “there is no peer-reviewed publication that evaluates either drug for exposure prophylaxis of SARS-CoV-2 infection.”
Even for treatment of diagnosed cases, only one small study reported faster nasopharyngeal viral clearance, with no data for clinical improvement. This evidence, or the lack thereof, hardly justifies state-endorsed, widespread use of hydroxychloroquine for prophylaxis, said Dr Pranav Ish (Department of Pulmonary Medicine), Vardhaman Mahavir Medical College and Safdarjung Hospital, and Sahaj Rathi (Community Medicine), Ashwani Kalantri and Shriprakash Kalantri both from Department of Community Medicine, Mahatma Gandhi Institute of Medical Sciences, Sevagram.
They said they were deeply concerned that in this environment of global panic, an endorsement by the highest scientific body of India will create an overly optimistic perception of the effectiveness of HCQ among the public.
“The drug is untested, the benefits unknown, and the risks not negligible, especially at this scale of use. Moreover, the safety of these immunomodulators in people at risk of a severe viral illness has never been evaluated,” they said adding that a blanket recommendation for chemoprophylaxis in the absence of credible evidence might be contentious to say the least.
If hydroxychloroquine is to be used, a clear informed choice needs to be offered to every contact, explaining the scarcity of evidence for its efficacy and its potential risks. Additionally, all outcome events should be recorded.