Indian studies yet to be completed; Indian Council of Medical Research says drug is safe
Therefore, India would not go back on its advisory regarding the drug’s prophylactic (preventive) role in healthcare workers (HCWs), frontline novel coronavirus disease (COVID-19) workers and contacts of confirmed cases, he added.
The World Health Organization (WHO) on May 25, halted the use of HCQ even for trials, taking into account its serious adverse events published in a Lancet paper.
“We have six-week data of observational and case control studies. They found no significant side effects except nausea and vomiting,” Bhargava said.
“We have advised that it should be taken only along with a meal and an electrocardiogram (ECG) should be done when someone is on the course of this drug,” he added. Bharagava evaded a query on India’s reaction to WHO's stance.
The Lancet, in one of the biggest observational studies conducted on 26,000 hospitalised SARS-CoV-2 positive patients across six continents, found HCQ increased the chances of arrhythmia (irregular heartbeat). This can potentially lead to cardiac arrest. The study was done to understand the therapeutic (treatment) role of HCQ in COVID-19, which, it ruled out.
It was after the publication of this paper on May 22 that the WHO announced it would pause trials till all the safety data of the drug was being reviewed. It was after this announcement by the WHO on May 25 that the ICMR was expected to make a statement on its advisory issued on May 22.
The ICMR advisory on HCQ talked about three studies in India that apparently showed a positive prophylactic effect. None of them have been published in any journal yet.
“This would be published soon,” Rajnikant Srivastva, head, research, management, policy, planning and coordination at ICMR, told Down To Earth (DTE) without qualifying any further.
For further information, he directed DTE to Suman Kanungo, a senior scientist in the National Institute for Cholera and Enteric Diseases as he is co-ordinating one of the studies.
“Ours is a large observational study. It will still take 12 more weeks to complete and after that, some more time to get published,” he said. ICMR’s own study is also undergoing.
“I am surprised. How can ICMR prescribe a drug for prevention on the basis of ongoing studies when we have good randomised control trials (RCTs) to say whether the drug is potentially harmful,” SP Kalantri, Director, Mahatma Gandhi Institute of Medical Sciences, Sevagram, told DTE.
Kalantri said the step might add fuel to fire. “We do know that SARS-CoV-2 may attack your heart, if infected. We do know, thanks to this Lancet study, that HCQ can cause cardiac arrest. So, if an asymptomatic but infected HCW or frontline healthcare worker takes this drug, you would end up increasing the risk for him / her,” he said.
Bhargava tried to allay this fear by saying an ECG would be done to monitor heart rhythm. However, it may not be practical for all of workers to undergo this type of monitoring, Kalantri said.
What is also significant in Bhargava’s reply is that the studies conducted in India are either observational or case-control. They are not RCTs.
The RCTs are considered the gold standard because they study both groups of the trials — the one who are given the drug and the one who are not (called control group) — to have unbiased results. They are randomised so that the neither the researcher nor the participating volunteers know what they are being administered. This is done to avoid the bias in research and participant.
On the other hand, in an ‘observational study’, the control group is absent and the ‘case control’ studies are retrospective in nature and are not randomised.
ICMR’s Srivastava defended India's HCQ advisory, saying all earlier studies done in various countries, had been to find out the drug’s treatment measure. Whereas, ICMR was talking about prohylaxis, not treatment.
“I agree. But where is the RCT or study to say that the drug is good for prevention,” Kalantri asked.
It was not that the WHO was wary only about the drug’s treatment role. WHO Emergencies Programme Director Michael Ryan had gone on record in an earlier press conference on May 20 to say that there was no evidence to suggest even a ‘prophyalctic’ measure. He added there were potential side-effects of the drug.
Bhargava, however, also said that considering the risk-benefit analysis, ICMR “thought” it should “possibly” not deny the advantages of the drug which is “very old”, “popular” and even found its place in “inland letters” a couple of decades ago.
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