How Indiscriminate Use Of HCQ In Mumbai is A Cause Of Concern ? Jan Swasthya Abhiyan

How Indiscriminate Use Of HCQ In Mumbai is A Cause Of Concern ? Jan Swasthya Abhiyan

New Delhi, 12 May 2020:


Health authorities in Mumbai are indiscriminately giving hydroxychloroquine (HCQ) to adults and children in a bid to curb the spread of Covid-19, a health advocacy group has alleged, raising ethical questions over a therapy that lacks clinical evidence of efficacy in treating the disease.


The disclosure was made by the Directorate of Medical Education and Research (DMER) of Mumbai, which outlined its Covid-19 management protocol in an affidavit filed before the Bombay High Court.


The affidavit was submitted following a public interest litigation by Jan Swasthya Abhiyan, which alleged that the authorities were conducting human tests to determine the viability of HCQ.


According to the DMER protocol, HCQ is given to both asymptomatic and symptomatic people with and without comorbidities, or other health conditions. In some cases, HCQ is given with oseltamivir or HIV combination drugs liponavir and ritonavir, and azithromycin.


The dosage for children depends on their weight. Drug Controller General of India VG Somani agreed that some states have set their own protocol.


“These drugs should be administered under close medical supervision, with monitoring for side-effects, but then some states have started setting their own protocol during the time of a health emergency,” he said.


The use of HCQ prescribed in the Mumbai protocol is questionable, public health experts said. “Our concern is that the drug has an inconclusive preventive and therapeutic value,” said Brinelle D’Souza, one of the petitioners in the Mumbai case. “We have seen that HCQ is being given even in quarantine centres as part of the treatment regime. If it’s used on compassionate grounds, people have a right to refuse. There are a lot of issues which need to be ironed out.” Health lawyer Murali Neelakantan said even the recommendations of the ICMR are random and not backed by evidence.


“Even for paracetamol, we had a trial to see what it can do in a human body. We know what HCQ will do in lupus — we had a trial for it. But we don’t know what it will do to a Covid patient,” Neelakantan said.


“The government did not realise the seriousness of the issue. There is no basis for using the drug on Covid patients. Forget animals, the drug has not even been tested in lab conditions.”


The ICMR and health ministry guidelines do not clearly mention the precautions to be taken with off-label use such as the need for informed consent, screening for eligibility, close monitoring of side-effects and the need to get approvals from ethics committees, a public health expert said on condition of anonymity.


“There is a lack of coordination between the ICMR, ministry of health and the states. There is no information on what basis the national level guidance was framed,” the expert alleged.


Experts said the government itself has not followed guidelines for Monitored Emergency Use of Unregistered and Investigational Interventions, an ethical protocol developed to evaluate the potential use of experimental drugs in the event of public health emergencies. Economic Times