Lancet study is not randomised clinical trial, only analysis of hospital registers worldwide: CSIR on WHO suspending HCQ drug testing

Dismissing the reports of health risks from Hydroxychloroquine (HCQ) as per simmering reports cited by the World Health Organisation (WHO), Shekher Mande, Director General of the Council of Scientific and Industrial Research (CSIR), India, said on Wednesday that the study related to the anti-malarial drug, which suspended the drug usage, is not a randomised clinical trial and rather only an analysis of hospital registers around the world.

Dismissing the reports of health risks from Hydroxychloroquine (HCQ) as per simmering reports cited by the World Health Orgsation (WHO), Shekher Mande, Director General of the Council of Scientific and Industrial Research (CSIR), India, said on Wednesday that the study related to the anti-malarial drug, which suspended the drug usage, is not a randomised clinical trial and rather only an analysis of hospital registers around the world.

The WHO, on Sunday, announced for a temporary suspension of clinical trials of hydroxychloroquine, which has been used for the treatment of COVID-19 patients, after a study published in the online medical journal The Lancet found that the use of the drug increased the risk of death by 34 per cent and a 137 per cent increased risk of serious heart arrhythmias.

Based on 96,000 hospital registries, the researchers came to the conclusion that critical patients, when given hydroxychloroquine, do not show any improvement rather in some, the conditions worsen.

"The Lancet study is based on hospital registry data. That is not a randomised clinical trial. It is only an analysis of hospital registers around the world. But still, in some people, the conditions have worsened, and the WHO temporarily halted the use of the drug. I am sure the WHO will take considered call in the coming time," Mande told .

Indian researchers have not found any major side-effects of HCQ and its use should be continued in preventive treatment for COVID-19, the Indian Council of Medical Research (ICMR) said on Tuesday.

"So, we should trust the judgement of ICMR. ICMR people are exceptionally well qualified in this. If they say it should be continued we should trust their judgement and will continue this drug," the official said.

He further noted that the CSIR does not have any particular suggestion about hydroxychloroquine. "All it can do is to undertake a clinical trial. At this moment, the hydroxychloroquine is not on our radar to conduct any clinical trial. So CSIR ever has to advise any particular trial of drug formulation, we will do that based on scientific evidence. But we have not generated any scientific on hydroxychloroquine on our own," Mande added.

Based on profile access, including conditions such as people who are at higher risk of contact with covid patient because of their family relation and profession, Mande said, people should take hydroxychloroquine. "I don't think ICMR ever advice that critically ill patient and ventilator all should give hydroxychloroquine. But we should actually trust what the ICMR has advised," he told further.

During an extraordinary meeting of the WHO's executive group of the Solidarity Trial on Sunday, the global health body suspended allocation of patients in the hydroxychloroquine arm of the Solidarity Trial. A call will be taken once the existing evidence has been reviewed. Patients who were randomised to the HCQ arm earlier will complete their treatment, it said.

India, however, continues to use the drug, along with azithromycin, for prophylaxis among health and other frontline workers and family members of Covid positive patients.

The Health Ministry of India also wrote to the WHO after the decision was taken, saying, "It appears all reports about the safety and efficacy of HCQ has not been considered before giving the decision to put HCQ clinical trial on hold."

( With inputs from ANI )