NEW DELHI: The Centre has refused to fund a randomised control trial of the anti-malaria drug, hydroxychloroquine, among healthcare workers. Instead, it has only cleared an observational study of the drug’s efficacy.
Randomised controlled trials are meant to evaluate a drug’s performance between two groups of people under ideal conditions whereas observational studies examine its effects in only one group over a period of time under real-world settings.
Observational studies are considered to be of poor quality in scientific research.
The proposal for a randomised control trial among 10,000 healthcare workers was made by Delhi-based George Institute of Public Health (GIPH), in collaboration with doctors from Apollo hospitals, Tamil Nadu, and the St John Medical College, Karnataka.
The aim was to evaluate whether a strategy of prophylaxis with HCQ taken weekly for three months reduces the risk of acquiring symptomatic Covid-19 infection.
But the proposal did not find favour with two government agencies, the Indian Council of Medical Research and the Department of Biotechnology, under the Union Ministry of Science and Technology.
On March 23, the ICMR had issued an advisory asking all high-risk individuals to take HCQs as a prophylactic. But since then there is growing evidence that the medicine may not be useful for the treatment of the disease and may even be harmful.
The HCQ is known to have cardio-toxicity effect for many and can be even fatal for those with heart diseases such as the history of the prolonged QT interval. A study published in The Lancet on Friday has found links between the use of HCQ and increased rates of mortality and heart arrhythmias among Covid-19 patients.
With the HCQ coming under a cloud, healthcare professionals were keen on a randomised control trial to scientifically establish the drug’s performance, which in turn would enable doctors to take a considered view before prescribing the medicine.
“While the DBT turned down the proposal saying the ICMR has already started an observational study to evaluate the risk, the ICMR called a meeting to discuss it and then cancelled it without offering any explanation,” said Vivekanand Jha, executive director of the GIPH.
The office of the DBT Secretary, Renu Swarup, when reached for comment, said a high-level committee did not recommend the project as it fell under the ICMR’s domain.
While ICMR director general Balram Bhargava could not be reached for comment, R R Gangakhedkar, chief epidemiologist at the council, told the media earlier this week that it was “reviewing” the earlier guidelines.