The Indian Council of Medical Research has recommended that healthcare workers and caregivers of confirmed Covid-19 patients, be prescribed hydroxychloroquine as a preventive against the disease, even as experts told IndiaSpend that the efficacy of this drug for preventing Covid-19 infections is unproven.
At the same time, hospitals are falling short of protective gear, such as masks and bodysuits, which are known to be effective in keeping healthcare workers safe, according to experts. “There is no evidence that hydroxychloroquine is effective for SARS-CoV-2 prevention, so it cannot replace personal protective equipment for health care workers,” said Angela Rasmussen, a virologist at the Mailman School of Public Health in the United States-based Columbia University. Currently, there is no preventive drug, cure or vaccine for Covid-19.
The Covid-19 pandemic has claimed more than 34,686 lives globally and affected more than 732,153, as on March 30, according to Johns Hopkins University. In India, the disease has claimed 29 lives and infected at least 1,071 as on March 30, according to Coronavirus Monitor, a HealthCheck database.
At a press conference on March 27, almost two months since the first Indian case was reported in Kerala, the Indian government said it has been difficult to make enough personal protective equipment available for medical professionals. Since some of the equipment material is imported, there were “some issues, some bottlenecks in terms of its availability”, said Lav Aggarwal, a senior bureaucrat in the Union Health Ministry. “There were issues with N95 masks too, because of the imported components. Government is aware of the issue.”
The government’s decision to distribute hydroxychloroquine is a “politically expedient” one, lacking in evidence, said Yogesh Jain of the Jan Swasthya Sahyog, a non-profit hospital in Chhattisgarh. Since the government has failed to prepare itself with adequate protective equipment, they are distributing the drug to make it appear as if they are protecting health workers, he said.
“Health workers are very scared right now,” said a member of the government-appointed task force for tackling Covid-19. “They needed to see that the government is doing something for them. They needed reassurance. We understand the limitations of the French study. Yes, the evidence in favour of hydroxychloroquine as a preventionmay not yet be 100% clinching. But we had to do something to boost the morale of the health workers.”
Lack of evidence
Although the Indian Council of Medical Research’s recommendation cautioned that consuming hydroxychloroquine should not give a sense of “false security” to health workers that they will be safe from infection, experts said that this is exactly the effect it will have.
“[With] this recommendation, it is clear the government is concerned about losing the medical task force,” said Satyanarayana Mysore, the head of the pulmonology and sleep medicine department at Manipal Hospital. “But just because health workers take the drug, it does not mean we can dispense with other precautions. Hydroxychloroquine is not a substitute for the prevention offered by protective gear.”
The council’s advisory on the drug does not present any evidence on the drug’s efficacy, especially as a preventive. “Hydroxychloroquine is found to be effective against coronavirus,” based on lab studies, in-vivo studies and pre-clinical data, the advisory issued on March 22, said. But it does not mention which are the academic studies that led them to this conclusion. No minutes of the meetings when this decision was taken are available.
“I am curious as to what data the [Indian Council of Medical Research] is basing its recommendations on,” said Krutika Kuppalli, an infectious diseases physician and biosecurity fellow at the US-based Johns Hopkins Center for Health Security. “As far as I am aware there are ongoing clinical trials but nothing that is conclusive at this point.”
The council should immediately publish the minutes of their deliberations so that we can see “how they arrived at their dosages, what were the other drugs individually, or in combination, which they may have considered”, said Soumyadeep Bhaumik, a Delhi-based physician and researcher with the The George Institute for Global Health.
“Please do not take this drug as a preventive measure,” said Delhi-based Shahid Jameel, a virologist and the chief executive officer of the India Alliance, a charity that funds biomedical research. “I emphasise – there is not enough compelling clinical evidence that this is a sure-shot drug in this case.”
India’s recommendation came just two days after United States President Donald Trump endorsed the drug at a press briefing: “It may work. It may not work. I feel good about it. That’s all it is. Just a feeling,” he said. “The evidence [that hydroxychloroquine can be used as a preventive drug against Covid-19] is only anecdotal,” said Anthony Fauci, one of the world’s leading immunologists, who is on the White House’s coronavirus task force, and was on the stage with Trump at that briefing. Hydroxychloroquine is an old drug that has been used to treat malaria, rheumatic issues such as arthritis and diseases such as lupus for decades. “What we don’t know is if you put it in the context of another disease, whether it is safe,” said Fauci at the press briefing.
Research continues
Most of the evidence on the drug as a cure is from a small French study. But the study has been criticised for its methodology and ethics, experts said. There are several concerns about the study, said Kuppalli of the Johns Hopkins Center. It had a very small sample size – 20 patients – and did not clarify what existing diseases the patients had that could have influenced outcomes, she explained. There have been no follow-ups with the patients, so for example, we do not know if the disease recurred, she added.
“Given the limited data that has come out, it would be important to further evaluate the medication in a randomised clinical trial before making recommendations about use,” Kuppali suggested. “We want to make sure that it is safe, there are no adverse effects and that it does in fact help with preventing and/or curing the virus.”
As Fauci said, hydroxychloroquine is a well-known drug used widely for diseases other than Covid-19. However, it should be taken with clinical monitoring and does come with serious side effects such as cardiac arrhythmia and retinal damage.
In India, it is supposed to be sold only with a medical prescription, but Jain says that in Chhattisgarh, his hospital has been finding it hard to get because people have started buying it out of panic. He says this is because there is an “unscientific temper” in India and several drugs which require prescriptions are often sold over the counter anyway.
Hydroxychloroquine and chloroquine are also anti-malarial drugs, and an overuse could lead to resistance, according to this World Health Organisation. The government recommendation says that the drug should be only used by those it is prescribed to – asymptomatic health workers and those who have been in touch with a confirmed Covid-19 case. They have also issued a notification saying that this drug is listed as a Schedule H1 drug, which means chemists need to keep records of who is buying it, for at least three years.
WHO’s clinical trial
The World Health Organisation announced a global clinical trial called SOLIDARITY on March 18, for a few drugs, including hydroxychloroquine, that could be used to treat Covid-19. The trial comes at an urgent time: The lack of evidence notwithstanding, France, Italy and Bahrain have started to allow the use of the drug for Covid-19 treatment. Jordan, on March 23, allowed the use of this drug as well.
“The WHO’s SOLIDARITY trial is a very pragmatically designed one. It is not difficult to be a part of it,” said Gagandeep Kang, executive director at Faridabad-based Translational Health Science and Technology Institute. “If the [Indian] government really believes [hydroxychloroquine] will work, then it should use it on infected patients as part of the trial. I am a researcher and I believe in evidence. Policy recommendations like this shouldn’t be made without evidence.”
As of this week, the Indian government has indicated that it might get involved in the World Health Organisation’s trial. “We are also likely to start our participation soon in [the] SOLIDARITY trial by WHO,” said Indian Council of Medical Research’s Raman Gangakhedkar at a press briefing on March 27. “Earlier we did not do it because our numbers were small. Our contribution would have looked miniscule.”
This article first appeared on Health Check, a publication of the data-driven public-interest journalism non-profit IndiaSpend.