NEW DELHI: The Centre has refused to fund a crucial randomised control trial to assess the effectiveness of anti-malaria drug hydroxychloroquine for preventing COVID-19 among healthcare workers while choosing instead to go ahead with an observational study, considered "poor quality" in scientific research.
The proposal designed by the New Delhi-based George Institute of Public Health, in collaboration with doctors from Apollo Hospitals, Tamil Nadu and St John Medical College, Karnataka aimed to evaluate whether a strategy of prophylaxis with HCQ taken weekly for 3 months reduces the risk of acquiring symptomatic COVID-19 infections in over 10,000 healthcare workers.
However, the pitch did not find favour with two government agencies--India’s top health research body, Indian Council of Medical Research and the department of biotechnology under the Union Ministry of Science and Technology.
The decision has raised eyebrows as the chorus is growing against an ICMR advisory, issued nearly two months back asking all high risk individuals to take HCQ, as the evidence is now growing that the medicine may not be useful at all for the treatment or prevention of the disease and may be harmful in several cases.
Those who have recommended HCQ in the March 23 advisory include healthcare workers treating COVID-19 patients and close contacts of those for infected. HCQ is known to have cardio-toxicity effect for many and can be even fatal for those with heart diseases such as history of prolonged QT interval.
"While DBT turned down the proposal saying ICMR has already started an observational study to evaluate the risk, ICMR itself called a meeting to discuss it and then cancelled it later without offering any explaination," Dr Vivekanand Jha, Executive Director of GIPH told The New Indian Express.
"It is both disappointing and perplexing as poor quality science should not be given precendence at any cost," he added pointing at the observational study started by ICMR that will simply monitor health of 2000 healthcare workers taking HCQ at six medical centres.
The office of DBT secretary Renu Swarup, when reached for a comment, said that a high level committee did not recommend the project as it fell under ICMR's domain. Message and email sent to ICMR director general Dr Balram Bhargava have remained unanswered.
Dr RR Gangakhedkar, chief epidemiologist at the ICMR, on Wednesday said in a press briefing that it is "reviewing" the earlier guidelines.
Meanwhile, bioethicists pointed out that while ideally, the ICMR advisory should not have been issued in March without proper evidence—an effort to look for good quality evidence being shunted was even worse.
"A properly done RCT is the only way to scientifically evaluate the efficacy of a drug and it should not be comprised for a lesser quality study, especially by country’s top health research agency," said Dr Anant Bhan, a researcher in bioethics, public health and policy.
He wondered if the ICMR may have down the proposal thinking that a negative outcome will show it in bad light later.
Sources in the Union Health Mministry and ICMR conceded that the government is rethinking its earlier recommendation to include HCQ for both treatment and prohylaxis of COVID-19. Meanwhile, Jha said that he is still looking for funding to take forward his project which has received ethical clearance.