A person carries a box of hydroxychloroquine tablets in Seattle, Washington, March 31, 2020. Photo: Reuters/Lindsey Wasson.
The Indian Council of Medical Research (ICMR) recently issued a clarification on a study to evaluate the prophylactic efficacy of hydroxychloroquine against COVID-19 – but the clarification has only raised more questions about whether ICMR is really groping in the dark with this unproven drug.
After Raman Gangakhedkar, ICMR’s chief of epidemiology, spoke repeatedly of a study to evaluate hydroxychloroquine, The Wire Science asked for more details. In a press conference held on Saturday, Gangakhedkar responded that he had been talking of an observational study with 480 patients, expected to go on for about eight weeks. He added that it was not a clinical trial because there wasn’t enough evidence to conduct such a trial.
These statements are illogical – and they also contradict what Gangakhedkar himself has previously said. In an April 1 press conference, he had said hydroxychloroquine was already being given to healthcare workers as part of a “demonstration study”. However, on Saturday, he spoke about the study in the future tense, suggesting that it hadn’t yet commenced.
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So, has the study begun or not? If it hasn’t, why the delay, given that thousands of healthcare workers across India are already popping the drug?
The second question is why ICMR chose to conduct an observational study instead of a randomised controlled trial (RCT). India is likely the only country in the world where a government scientific agency has recommended the use of hydroxychloroquine as prophylaxis. And Gangakhedkar claimed on April 1 that the results of the demonstration study would be used to decide if the drug could be given to people in the community at large.
If this was the purpose of the demonstration study, an observational design is ill-suited to meet it. Researchers choose to perform an observational study when it is difficult to perform an RCT, for reasons ranging from the higher cost of RCTs to ethical issues in denying potentially effective drugs to the people in the study’s control group.
Observational studies provide no information on causation: they can’t show whether hydroxychloroquine is responsible for preventing the disease (or not). “If you want to prove a point, you should do a well-designed randomised control study. Any other design will not give you convincing proof, and you are back to square one,” said Urmila Thatte, a clinical pharmacologist and bioethicist at the Seth GS Medical College and KEM Hospital, Mumbai, said. “Why do you want to waste your time and money doing a poor quality study?”
Gangakhedkar’s statement that there was not enough evidence in favour of hydroxychloroquine to conduct a randomised trial is more bizarre. A lack of evidence is the perfect scenario in which to conduct an RCT – as well as the worst scenario in which to recommend the drug to healthy individuals, like ICMR has done. The agency’s decision to jump the gun on evidence has since encouraged the Brihanmumbai Municipal Corporation to consider giving the drug to 50,000 people in the city’s Dharavi and Koliwada areas. A COVID-19 outbreak is currently on in these places, whose population belongs mostly to the middle and lower economic classes.
Source: The Wire Science
