Tempering hope with caution
Between April-March this year, the pandemic became 'real' for many people. Experts were putting up ever more conservative estimates of post-pandemic recovery and those willing to laugh off the pandemic as a 'little flu' were looking particularly foolish. At such a time, the world rested its hopes on science. Even at this early stage, dozens of potential vaccines had been announced. Amongst them, Gilead Sciences' Remdesivir stood out. Dr Anthony Fauci, America's leading disease expert, had called the drug 'promising'. Coming from the man who has become one of the recognisable faces of the scientific response against the contagion, this is high praise indeed. Fast forward to June-July and Remdesivir is now being used as part of one of the few available drug therapies for COVID-19. It may be noted that the drug is the only one of its kind to gain a USFDA approval for emergency use in severe cases of COVID-19. While Remdesivir is far from the 'cure' that society expected it to be, many studies have shown that the drug does have some use in decreasing the time needed for clinical improvement in the condition of patients undergoing moderate to severe symptoms of the infection. Before going further, it is important to note that Remdesivir was not purpose-built to fight COVID-19, it was repurposed. It was originally developed as a treatment for hepatitis C. When it did not perform as per required standards, it was repurposed to fight against Ebola, a viral disease against which the drug showed some promise of working. Successful animal trials did not, however, result in successful human use. Congolese officials, for instance, announced that the drug was much less effective than existing antibody treatments but was 'safe' for use. Moving forward from the West African Ebola epidemic of 2013-16 to the COVID-19 pandemic, and Gilead once again come forward with Remdesivir as a potentially effective drug treatment. The company was basing its assertion on experiments done on animals which showed that the drug was effective in tackling both SARS and MERS, diseases caused by similar kinds of coronaviruses. The Chinese became the first to apply for a use-patent and began trial runs for patient treatment. These trials ultimately were shutdown as not only did Remdesivir not help in reducing the time for clinical improvements in patients, it also had several adverse effects which could not be overlooked. While the Chinese trials were terminated in March itself, both the USFDA and WHO were calling it the most promising candidate of the treatments that were being developed. Simultaneously, the EU was holding its own 'reviews' of the drug for use. In July, the EU approved the emergency use of the drug. In India, the Drug Controller General of India (DCGI) also approved the drug during the same time period. The drug was licensed for production in India to Cipla and Hetero Labs. Cipla rolled out the drug under the label 'Cipremi'. The Indian pharma giant has claimed that the pricing of the drug, at Rs 4,000 per 100 mg vial was the cheapest anywhere in the world and that they were aiming to supply 80,000 vials within the first month itself.
While there is optimism regarding the drug treatment and its effects, there is justified caution as well. Just this week, both the Indian Council of Medical Research (ICMR) and the All India Institute of Medical Sciences (AIIMS) warned the Indian states eager to make large orders of the drug about the dangers of indiscriminate use. They cautioned that the drug may not have significant enough positive effects to justify the negative effects it can have on kidney and liver health. Pending proper DGCI approval for widespread use, the states have been cautioned to not only use the drug as a truly emergency measure but to also acquire written consent for its use as the drug was an 'experimental' treatment.
At a time when our desperation to return to normal is taxing our rationality, it is important to resist the urge to jump at every 'promising' treatment. Governments must also resist the tendency to pre-emptively call for extensive use of such drugs without proper medical investigation. The case of hydroxychloroquine is a rather clear indicator of this unfortunate haste where several nations such as Brazil and the US rushed to extoll the anti-malarial drug as a gamechanger, only to pull back from such assertions when clinical trials showed that the drug had too many side effects to justify its marginal (or absent) gains. Precisely because so much is riding on a vaccine, an abundance of caution is justified.