India’s Covid-19 battle has been hit by a bigger ‘second wave’ with the number of cases per day crossing two lakh. What has compounded the problem, though, is that several states have reported a shortage of vaccines and medicines. The Narendra Modi government has refuted the claims even as it fast-tracked emergency approval for foreign-produced vaccines. But as the battle for vaccine intensifies, doctors and relatives of patients alike have come to depend on a drug that hasn’t even been proven to be effective in treating Covid-19 — the anti-viral injection remdesivir. And its demand has been such that it too has run into the problem of short supply, so much so that the Modi government has now banned its export and also decided to ramp up the drug’s production to twice the present capacity — around 78 lakh vials per month.
The price of each vial has also been pruned by pharma companies to Rs 3,400 from as high as Rs 5,400. Zydus Cadila’s brand Remdac is the cheapest generic version of Gilead Sciences’ injectable repurposed drug remdesivir, currently being sold at Rs 899.
Due to its short supply, Twitter, Instagram and Facebook are seeing dozens of messages and posts every hour from Indians who need remdisivir.
But India’s clamour for remdesivir sounds like a misfit against the World Health Organization (WHO)’s advice. The WHO had said that there is no evidence to suggest that the antiviral drug can effectively treat Covid-19 patients. With no apparent benefits, the drug suits only a small subset of people, and in the majority of cases, the doctors prescribe the drug either out of pressure from the patient’s relatives or because it is the only drug validated by the US’ Food and Drug Administration (USFDA) for use in the treatment of Covid-19.
And yet, social media is full of posts and WhatsApp messages from patients’ desperate relatives pleading and hunting for vials of remdesivir. Several Twitter users have mentioned receiving requests for the drug besides enquiries about beds, ICUs, and plasma. And that is why, remdesivir is ThePrint’s Newsmaker of the Week.
The drug was in demand last year too. It was being sold in the black market for prices anywhere between Rs 15,000 to Rs 60,000. Even now, police in Pune and elsewhere have been arresting people trying to sell remdesivir at exorbitant rates. Data released by research firm IQVIA showed that remdesivir registered total sales of Rs 593 crore in just six months since its launch — from July to December 2020.
Scientific evidence behind remdesivir
The largest trial organised by the WHO in 2020 — Solidarity Trial — had shown that remdesivir did not produce “any measurable benefit in mortality or disease course.”
However, many smaller studies have shown benefits in limited windows of time, such as during low-flow oxygen state in case of pneumonia or when a patient requires oxygen but has not yet progressed to the ventilator.
For instance, the Adaptive Covid-19 Treatment Trial (ACTT-1) study, sponsored by the US National Institutes of Health, found that “remdesivir was superior to placebo in shortening the time to recovery”.
Amesh Adalja, senior scholar at the US-based Johns Hopkins Center for Health Security, said, “Remdesivir is a beneficial drug. Its primary benefit is in getting patients out of the hospital faster. To be effective, it should be used before a patient progresses to need a mechanical ventilator.”
However, the WHO recommends against using remdesivir while different health agencies have imposed varying conditions on its usage in the treatment of Covid.
Based on data from 7,333 patients in four studies (including the WHO Solidarity trial), remdesivir has no effect on mortality, reducing the need for mechanical ventilation, recovery from symptoms and other patient-important outcomes.
According to Dr Soumya Swaminathan, chief scientist at WHO, and Dr Maria Van Kerkhove, the agency’s technical lead on Covid — quoted in a report by India Today — the results from five clinical trials on the drug had shown that it had not helped in the reduction of mortality or reducing the need for mechanical ventilation among hospitalised patients.
Why are doctors prescribing remdesivir?
The suggested adult dose of remdesivir is 200 mg intravenously on day 1 followed by 100 mg daily for a total of five days.
“Theoretically, it was thought to benefit if administered within nine days of symptoms onset because antivirals are maximally effective in earlier stages of the disease when the viruses are actively multiplying,” said Dr S.P. Kalantri, professor of medicine and medical superintendent at the Mahatma Gandhi Institute of Medical Sciences in Sevagram, Maharashtra.
However, he added that the clinical trials have shown otherwise.
“Given its limited availability, cost, need for five-day hospitalisation and, more importantly, no meaningful benefits, physicians have started questioning if remdesivir is indeed worth the excitement and hope that it created.
“It hardly lived up to the hype that it succeeded in generating. Unfortunately, it has already become part of the toolkit for battling the Covid-19,” he said.
Another doctor treating Covid-19 patients in a government-run hospital in Delhi said they are still hoping that remdesivir will work because they have no other drug for the treatment. “In the absence of an authentic treatment for Covid-19, it is the only authorised drug by the US FDA. So, probably the doctors have no choice and they hope that it works,” he said while requesting anonymity.
Relatives’ only hope
Pressure from patients’ relatives is one of the top reasons the drug is being over-prescribed, which has resulted in its shortage.
“Remdesivir should be used within 14 days of the onset of Covid-19 symptoms. However, the families of the Covid-19 patients believe that it is a magical drug, which might do wonders because of the hype created around the drug,” said Sumit Ray, head of department, Critical Care Medicine, Holy Family Hospital, Delhi.
Ray compared remdesivir with plasma therapy.
“It has been proven that plasma therapy doesn’t work among Covid-19 patients but some hospitals continue to administer it and the families of patients ask us why we are not prescribing (it). The same is the case for remdesivir. The only benefit, if any, is the reduction in the length of hospitalisation in a small subset of selected patients,” he said.
“In this wave, we are witnessing younger patients admitted in ICUs and shifting on ventilators. In this condition, should I wait for moderate patient to turn critical or will I apply all available options? The wave is like a tsunami that the demand of drug — which can be given in moderate cases — is so huge. Secondly, it is being used by doctors to reduce patient’s stay in ICUs or hospital so that new patients can be taken. This is also one reason for more prescriptions,” a senior doctor from a private hospital in Kolkata said.
The majority of the doctors refrained from speaking on the record, because the drug has been suggested by the Ministry of Health and Family Welfare, although with the caution that its use can have adverse effects and the usual disclaimer about the drug having no benefits in terms of reduced mortality.
According to Dr Kamna Kakkar, senior resident, ICUs, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana, “the hype” around the drug has made people believe that remdesivir is a “life-saving drug”.
“Patients and their families won’t understand the specifics of the drug such as when it should be given and how it should be given. It’s not one-size-fits-all solution; instead, it suits a very small subset of patients. We can call dexamethasone and other steroids as life-saving in critical cases, probably not remdesivir.”
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(Edited by Prashant Dixit)