New Delhi: The Indian Council of Medical Research (ICMR) has recommended that healthcare workers and caregivers of confirmed COVID-19 patients, be prescribed hydroxychloroquine (HCQ) 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 HCQ is effective for SARS-CoV-2 prevention [as the novel coronavirus is known], so it cannot replace Personal Protective Equipment (PPE) for health care workers,” said Angela Rasmussen, a virologist at the Mailman School of Public Health in the US-based Columbia University. Currently, there is no preventive drug, cure or vaccine for COVID-19.

The COVID-19 pandemic has claimed more than 28,000 lives globally and affected more than 620,000, according to the Johns Hopkins Coronavirus Resource Center (8.42 p.m. on March 28). In India, the disease has claimed 19 lives and infected at least 918 (as of 5.45 p.m, March 28, 2020), according to Coronavirus Monitor, a HealthCheck database.

At a press conference on March 27, 2020, almost two months since the first Indian COVID-19 case was reported in Kerala, the Indian government said that it has been difficult to make enough PPEs available for medical professionals. Since some of the PPE 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, at this press conference. “There were issues with N95 masks too, because of the imported components. Government is aware of the issue.”

The government’s decision to distribute HCQ 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 PPE, they are distributing a drug such as HCQ to 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, on the condition of anonymity. “They needed to see the government is doing something for them. They needed reassurance. We understand the limitations of the French study. Yes the evidence in favour of HCQ as a prevention, may not yet be 100% clinching. But we had to do something to boost the morale of the health workers.”

HCQ cannot be a replacement for PPE

Although the ICMR’s recommendation cautioned that consuming HCQ 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.

“From this [HCQ] 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 HCQ, it does not mean we can dispense with other precautions. HCQ is not a substitute for the prevention offered by protective gear.”

Lack of evidence

The ICMR’s advisory on HCQ 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, 2020 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 ICMR is basing their 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 ICMR 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 emphasize--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 US 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 HCQ 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. HCQ 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 on HCQ as a cure is scanty, inconclusive

Most of the evidence on HCQ as a cure from COVID-19 is from a small French study. The study has been criticised for its methodology and ethics, experts said.

There are several concerns about the study, said Kuppalli of the John Hopkins Center. It had a very small sample size--20 patients--and did not clarify what existing diseases (or ‘comorbidities’) the patients had, which 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.”

Possibility of drug side-effects, resistance

As Fauci said, HCQ is a well known and widely used drug, 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.

Although in India this drug is supposed to be sold only with a medical prescription, Jain says that in Chhattisgarh for example, 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 Organization (WHO).

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 of HCQ

The WHO announced a global clinical trial called SOLIDARITY on March 18, for a few drugs that could be used to treat COVID-19 including HCQ.

The trial comes at an urgent time: The lack of evidence notwithstanding, France, Italy and Bahrain have started to allow the use of HCQ for COVID-19 treatment. Jordan has, on March 23, 2020, 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 HCQ will work, then it should use it on infected patients as part of the trial. I’m 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 WHO trial. “We are also likely to start our participation soon in [the] SOLIDARITY trial by WHO,” said ICMR’s Raman Gangakhedkar at a press briefing on March 27, 2020. “Earlier we did not do it because our numbers were small. Our contribution would have looked miniscule.”

(Anoo Bhuyan is a special correspondent at IndiaSpend.)

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