Medical journal The Lancet has admitted that questions have been raised about the data published in its earlier paper on hydroxychloroquine drug. The study had linked HCQ to higher risk of death in Covid-19 patients, following which the WHO suspended allocating patients to HCQ arm for solidarity trial. An ICMR study had said that HCQ doses could reduce the chances of getting infected by Covid-19.
ThePrint asks: Lancet HCQ study row: Did WHO, experts rush to damn the drug due to Trump, Modi politics?
India depending on studies and drug approval from West shows it suffers colonial hangover
Chairperson and MD, Biocon
From HCQ to remdesivir, I am skeptical about a number of repurposed drugs being either pushed or poo-pooed. Studies, like those carried by The Lancet, and clinical trials in general are extremely expensive and governments need to support them, given it is an emergency. All over the world, the Covid-19 conversation is slowly moving from concerns around the economy to strengthening homegrown scientific innovation.
I feel India is suffering from a colonial hangover. Take remdesivir, for instance. India’s drug controller approved its emergency use based on the green light given by the US’ Food and Drug Administration (FDA). Other such drugs are also being pushed by Big Pharma. India has failed to pursue credible clinical research on whether a certain drug is efficacious for curing Covid-19 or not. Meanwhile, we still are relying on information from the West and elsewhere.
Moreover, we are hesitant about our own research and need to foster a stronger scientific temper. Serum Institute of India is working on a BCG vaccine that seems promising, as it works to boost immune systems. Why not use BCG vaccines until we get a Covid-19 vaccine? Nobody seems to be asking this question, forget investing in it.
Biocon’s repurposed drug Alzumab has shown very good data in clinical trials but there is no sight of emergency use approval. Is this because the US FDA has not blessed it? Are we going to start doing autopsies of deceased Covid-19 patients or continue relying on data from Italy or the US? Given the number of Covid-19 patients, we ought to be doing more research.
HCQ is backed by lab data and decades of safety evaluation, other Covid studies are small and reported in a hurry
Head, Division of Clinical Research, St. John’s Medical College
The reason hydroxychloroquine, or HCQ, became important in the fight against Covid-19 is because of the laboratory data on Covid-19 and safety evaluated over decades. Studies being done on Covid-19 now are small and reported in a hurry.
The recently published Lancet paper was an observational study. Despite the sophisticated statistical analysis, it is not enough to make a clean judgement for treatment of Covid-19. The results of the study clearly state that HCQ can lead to increased mortality and rise in dangerous adverse effects such as cardiac arrhythmia. The study is being questioned now.
This begs the question: did WHO act too quickly to stop the HCQ arm of the ongoing solidarity trial?
No. The WHO has temporarily stopped the HCQ arm in the trial, which is just one out of five arms. The data and safety monitoring committee at the WHO is carefully verifying the data available in the study so far. Meanwhile, The Lancet and others are further investigating the study, and The Lancet has already published an expression of concern.
I think the WHO will soon take the bold step of resuming the HCQ trial arm because it’s a cheap and widely used drug all over the world, particularly in low-income countries.
We should also not lose sight of the emerging data from India on HCQ for prophylaxis, which is encouraging.
Desperation for evidence-backed medicines to cure Covid leaves room for malpractice
Oommen C. Kurian
Senior Fellow & Head of Health Initiative, ORF
Many experts raised concern in the past about ICMR recommending HCQ as prophylaxis for asymptomatic Covid-19 health workers and household contacts of confirmed patients, due to lack of compelling evidence. Despite this, several states have been using HCQ as a prophylaxis as well as for treatment, partially because of a lack of affordable and effective alternatives. There was also a need to prevent panic on the frontline.
However, when the Lancet study suggested there was no evidence of benefits from HCQ, and that the drug instead increased the risk of abnormal heartbeats and a greater hazard for in-hospital deaths in Covid-19 patients, there was fresh public outcry against the ICMR’s decision. Another study in the prestigious New England Journal of Medicine (NEJM) in May by some of the same authors as the Lancet study, had ruled out high mortality risks from blood pressure medications for Covid-19 patients.
Interestingly, The Lancet and New England Journal of Medicine have raised red flags about the possibility of data manipulation in these studies. Meanwhile, the ICMR published a study, which found no major side-effects of HCQ, and recommended that it should be continued as prophylaxis.
The fog of war surrounding Covid-19 and the desperation of the scientific community for evidence-backed medicines and vaccines may leave room for large-scale malpractice. As Covid-19 is a self-limiting disease for a majority of patients, true effectiveness of any drug should be identified only through rigorous scientific studies. Any commercial interest meddling with that process must be resisted and punished, because the scope for profiteering by unethical corporate interests is high.
Geo-politics surrounding HCQ has overshadowed clinical studies on the drug’s efficacy
Amir Ullah Khan
Professor of Health Economics at Indian School of Public Policy
The hunt to find a cure for Covid-19 remains elusive. All hypotheses, including the famous one that heat will kill the virus, have been nullified. The most discussed one, thanks to its endorsement by Donald Trump himself, was Hydroxychloroquine. Now the Mehra, Desai, et al paper published in The Lancet has clearly concluded that these drug regimens, with or without a macrolide, showed a decrease in in-hospital survivals. Hydroxychloroquine and chloroquine have always been controversial because of their severe side effects. After the paper was published, WHO suspended clinical trials. In a fraught international situation, the HCQ issue again puts India, China and the US on the hot seat, with an already troubled WHO unable to handle the heat.
In India, ICMR had recommended Hydroxychloroquine as a prophylactic, which led to mass buying and shortages. On the same day, India banned the export of the drug. But Trump threatened retaliation and PM Modi agreed to partially lift the ban. The geo-politics that dominated these discussions overshadowed the clinical studies on the very efficacy of the drug. Before being pushed as a wonder drug, both leaders would have done well to take expert advice on this medical issue. A needless controversy over an 80-year-old drug and the impact it had on increased morbidity could have been avoided if the two leaders stepped aside and allowed their health specialists to take decisions.
By Pia Krishnankutty, journalist at ThePrint