New Delhi: The Modi government will look into the suspension of the hydroxychloroquine (HCQ) trials under the WHO’s mega Solidarity initiative, which is aimed at finding an effective treatment for Covid-19, ThePrint has learnt.
The WHO halted the HCQ trials, pending further research, after a controversial study published last month in The Lancet, a reputed medical journal, linked it to increased mortality risk and irregular heart beats in patients. The study was conducted by four researchers from the US and Switzerland.
The Ministry of Health and Family Welfare has asked an expert committee under the Central Drugs Standard Control Organisation (CDSCO), the apex authority overseeing clinical trials in India, to discuss two aspects — the drug dosage administered to patients under the WHO trial and the relevance of the findings published in the study.
“The objective of the expert committee is to assess the validity of The Lancet study. The dosage of HCQ given under the WHO trial was also planned for discussion,” a senior officer of the Union health ministry told ThePrint.
“Under the treatment protocol for using HCQ in India, the drug has shown good efficacy with less amount of dosage in comparison to the high dose given under Solidarity trial,” the officer added.
Health ministry guidelines advise HCQ for critical Covid-19 patients, while clarifying that no specific anti-virals have proven effective. They urge a 400 mg BD (breakfast-dinner) dose for day one, followed by 200 mg BD for four days. Throughout, it has to be administered in combination with 500 mg of azithromycin (OD, once daily) for five days.
However, the officer said, under the Solidarity trial, a 1,600 mg dose of the drug is administered on the first day followed by 800 mg per day for 10 days.
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‘Will be discussed at next meeting’
Hydroxychloroquine, an 80-year-old anti-malarial drug also used to ease other conditions such as rheumatoid arthritis, has been touted as a promising medication as the world battles the biggest pandemic it has seen in decades.
India is the largest producer of HCQ, which has been described as a “game-changer” by US President Donald Trump. However, while it has been used as a preventive, its efficacy in treating Covid-19 remains a matter of research.
The drug is being widely used as a preventive in India, and has also been deployed in treatment in line with health ministry guidelines.
The Solidarity trial is being conducted to test the efficacy of a range of drugs, and HCQ was one of them. The others are remdesivir, ritonavir and lopinavir. The multi-country Solidarity clinical trials are being organised at around 18 locations in India.
The CDSCO expert committee was supposed to take up the suspension of the HCQ trial last week, but the discussions were “deferred”, ThePrint has learnt from a copy of the list of subjects to be discussed by the panel. The list also stated the status of the discussions on the subjects at hand. The WHO Solidarity Trial was listed as the fifth point of discussion.
“The matter is likely to be discussed in the next meeting of the expert committee,” the aforementioned senior officer of the health ministry said. “However, no date has been decided yet.”
The expert committee consists of representatives from top health research institutes, including the Indian Council of Medical Research (ICMR) and the All India Institute of Medical Sciences (AIIMS), along with those of the health ministry and the drug controller general of India, who heads the CDSCO.
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Study that raised alarm is under scrutiny
In light of The Lancet study, the WHO said its ‘Data Safety Monitoring Board’ will review the data collected on HCQ so far, including the harms and benefits, before taking a call on proceeding with its trials.
The large observational study claimed to have analysed data from nearly 96,000 patients. Around 15,000 patients in the study either received HCQ alone or in combination with the antibiotic macrolide and was compared to the data of 81,000 controls who did not receive the drug.
The researchers who carried it out were Professor Mandeep R. Mehra of the Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, US, Sapan S. Desai of the US-based healthcare data analytics firm Surgisphere Corporation, Frank Ruschitzka of the University Heart Center, University Hospital, Switzerland, and Amit N. Patel of the Department of Biomedical Engineering, University of Utah, and HCA Research Institute, US.
However, several questions are being raised about the study, which was published on 22 May.
In an open letter to The Lancet Editor-in-Chief Richard Horton and the paper’s authors, over 100 researchers have demanded details about the origin of data and called for the study to be independently verified by the WHO or another institution.
Experts have alleged discrepancies in the data cited, and criticised the methodology used as well as the authors’ refusal to disclose the names of the hospitals where they acquired the data, and the countries they are located in.
The researchers have issued a correction to settle a data discrepancy regarding the numbers from Australia, which they say doesn’t affect the findings. Desai has also been quoted as saying by The Scientist magazine that he is looking into clearing the confusion surrounding the study findings.
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