A real-world study spanning six continents and nearly 100,000 patients — the largest of its kind — finds no evidence of a reduction in death rate among COVID-19 patients who were treated with hydroxychloroquine or chloroquine analogues. However, it did observe that patients treated with hydroxychloroquine or chloroquine were far more likely to experience abnormal and rapid heart rhythms, known as ventricular arrhythmias, than those who had not received the drugs.
“With the release of our data, I cannot imagine that the FDA will not reconsider their decision,” said Dr. Mandeep Mehra, MD, corresponding author on the research and the executive director of the Brigham’s Center for Advanced Heart Disease. The study found that the rate of significant heart arrhythmias in COVID-19 patients quadrupled for those who were treated with hydroxychloroquine or chloroquine regimens. The risk of harm and the magnitude of risk with the use of these drugs was persistent irrespective of continents and was similarly present across all ethnic populations, added Dr. Mehra.
The anti-malarial medicine has been touted as a “game-changer” by the US President Donald Trump. The US Food and Drug Administration (FDA) while warning of the use of hydroxychloroquine in ambulatory patients, has also provided an emergency use authorisation (EUA) for the off-label use of these drugs on hospitalised patients with COVID-19.
Last Friday, a revised Indian government advisory recommended use of hydroxychloroquine as a preventive medication for asymptomatic healthcare workers working in non-COVID-19 hospitals, frontline staff on surveillance duty in containment zones and paramilitary/police personnel involved in coronavirus infection related activities.
It was the buzz around hydroxychloroquine and chloroquine that pushed Dr. Mehra to focus his energy on COVID-19 research when the pandemic struck. His earlier study in the New England Journal of Medicine established that patients with underlying cardiovascular disease were associated with an increased risk of in-hospital death among those hospitalised with Covid-19.
The Delhi-born doctor is the founding medical director for the Brigham Heart and Vascular Center and the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine and a professor of medicine at Harvard Medical School. He is a globally renowned cardiologist for his work on advanced heart failure and heart transplantation and his research on Left Ventricular Assist Device (LVAD) systems.
“I did my medical school training under Gandhian principles which I found to be extraordinarily rewarding and those have carried me through my current life in a fairly principled way,” he said about his education and research. Dr. Mehra did his MBBS at Mahatma Gandhi Institute of Medical Sciences and cites his time in Wardha at the Sevagram ashram as one of his formative influences.
A lifelong avid learner and educator, Dr. Mehra recently pursued a Master’s in Health Economics from the London School Economics to look towards a global viewpoint in science and has been pursuing further research and observational studies that examine healthcare economics and values of different care.
When asked about expansion in the use of hydroxychloroquine (HCQ) in India as a prophylactic medicine to prevent the contraction of COVID-19, Dr Mehra said: “If they are rolling it out under controlled well-monitored conditions to assess scientific value of this, then I would support it. If they are simply pursuing this in an effort to hopefully prevent the virus from taking root, I think that may be a bit misguided at this time and this would be basically unscientific evangelism to say the least.”
The study by Dr. Mehra and his colleagues is in conjunction with similar safety concerns raised about treating COVID-19 patients with high doses of chloroquine. Last month, a preliminary analysis of a trial in Brazil of patients treated with chloroquine and an antibiotic suggested that high doses of chloroquine could be a safety hazard. The study was halted by a safety monitoring board before even one-fourth of the planned 440 patients were enrolled after high doses of the drugs proved lethal to some patients.
The Lancet, one of the world’s oldest and well-renowned medical journals, also published an unsigned editorial last week lambasting the US administration for its “inconsistent and incoherent national response” to the COVID-19 crisis and called for Americans to vote for a president “who will understand that public health should not be guided by partisan politics” in the upcoming elections.
The authors do caution about the observational nature of the COVID-19 study.
“These findings suggest that these drug regimens should not be used outside of the realm of clinical trials and urgent confirmation from randomised clinical trials is needed,” the authors conclude in the study.