New Delhi: US President Donald Trump’s prescription of hydroxychloroquine (HCQ), the antimalarial drug being explored as a Covid-19 preventive and treatment, and PM Narendra Modi’s decision to sell it to the world countries have made the conversation around the medicine highly polarised, ThePrint Editor-in-Chief Shekhar Gupta has said in episode 484 of #CutTheClutter.
The Indian Council of Medical Research (ICMR) has published the results of an observational study showing that hydroxychloroquine can prevent healthcare workers from contracting Covid-19.
It comes a couple of weeks after The Lancet published a study that showed HCQ did not have any benefit, and was instead harming patients. However, this study has come under question from researchers over certain gaps.
ICMR’s latest study
The Indian study was being awaited ever since the government issued a fresh notification confirming the benefit of HCQ as a preventive against Covid-19 and recommending it for all those who may be at high risk of the disease.
The ICMR study, published in the peer-reviewed Indian Journal of Medical Research, confirms that HCQ has prophylactic benefit. The study found that if the prophylactic dose recommended by the ICMR is taken for more than six weeks, there may be an 80 per cent higher chance of avoiding Covid-19.
The study also showed that if the drug is taken for just a few weeks and then stopped, the chances of getting infected are higher.
The ICMR attributes this to what is known as the “seatbelt effect” or the “condom effect”, Gupta said. This describes a tendency to behave more recklessly when one thinks they are protected.
Over the next few days, this study is likely to undergo scrutiny and we will “see what criticism comes out of it”.
Is promoting HCQ economically beneficial for India?
Many people say India is promoting HCQ because of its commercial interest, that if HCQ becomes successful, India stands to benefit and that is why the ICMR is also plugging it.
However, the value of HCQ is less than that of paracetamol. The total value of the HCQ sold by India to the entire world stands at about Rs 172 crore.
There is also a “conspiracy theory” that HCQ is being undermined because it’s a cheap, off-patent drug. The other promising drug in the race — remdesivir — would “hugely benefit American corporations”.
What created the HCQ controversy?
The drug became a political controversy because US President Trump began to “prescribe it” at his press conferences — and, soon after, PM Narendra Modi started to sell it all over the world.
The very first studies on the drug came out of China and France. A controversial French researcher, Didier Raoult, one of the authors of the second study, said in March that hydroxychloroquine was effective in treating Covid-19 patients.
“These were small sample studies, but at that point, people were looking for straws — so people would clutch at anything,” Gupta said.
A lot of people also clutched at hydroxychloroquine because it was cheap. It was prescribed already for decades for many conditions. It was seen as a drug with “very little side-effects”.
Trump subsequently called the drug a “game changer”, and then the world discovered India was the largest manufacturer of hydroxychloroquine.
“Donald Trump asked India for HCQ, India gave it to him. Then many other countries asked India for it — India sold it to them and then the entire world,” he said.
Initially, there was an immediate pushback from American media and commentators, since Trump was promoting prescription drugs in his press conferences.
However, soon after, studies began to show that HCQ may be dangerous. “And then that became a kind of refrain that this is a deadly, dangerous drug,” Gupta said.
HCQ has been used for decades
In many parts of the world, HCQ is sold over-the-counter. Tourists from western nations visiting tropical countries have been asked to carry it in their travel kits.
The drug is also used for some other diseases such as lupus, rheumatoid arthritis, and, early on, for type-2 diabetes. Essentially, the drug is an immune modulator, working against the inflammatory effect of diseases.
“Indian health authorities — who are also guided by their long old clinical experience — thought it was better to start using hydroxychloroquine as treatment in early stages of the disease, but also as a prophylactic, as a preventive,” Gupta said.
Over two months ago, the ICMR had issued a notification saying healthcare workers and contacts of those who are tested positive for Covid-19 should be given a preventive dose of HCQ.
That again led to controversies in India. There were no studies showing that this was either a prophylactic or a treatment. The ICMR, however, insisted “they had faith in this and carried on”.
The Lancet study
A much-publicised study published on 22 May in The Lancet that led the WHO to pause its HCQ trials has come under criticism for various reasons.
The study claims that not only does HCQ not have any benefit in Covid-19 treatment, it also increases the incidence of death and heart arrhythmia (irregular heartbeats).
“Because of this study WHO, which was holding a very large trial called SOLIDARITY all over the world with HCQ, said that pending safety concerns they were ceasing to enrol more volunteers for the HCQ trial,” Gupta said. “They also issued an advisory, which also advised ICMR to stop using it either as a prophylactic or treatment in India.”
Substantive questions have been raised about the authenticity of The Lancet study by a group of over a hundred scientists, doctors, and researchers from all around the world, who have written a letter to the journal, pointing out some discrepancies in study.
The research is based on data provided by Surgisphere, a medical data firm owned by an Indian-origin medical professional, Sapan Desai, who is also named as one of the co-authors of the study.
First, critics have pointed out that the Lancet study is observational. The authors have not conducted any randomised control trials.
Critics have also noted that the study does not disclose which hospitals the data has been taken from. The authors say that, ethically, they cannot disclose the names of hospitals, but the lack of transparency makes the study liable to be questioned.
It was also found that there were certain discrepancies in the data. The study lists 73 deaths in Australia up to a certain period, from six hospitals that were said to be part of the database. However, at the time, only 67 deaths had taken place in the country.
Critics have also pointed out that the rushed publication of the study, and the WHO’s subsequent advisory, may have led to the drug being stopped for some of the patients who were actually benefiting from it.