We are not experts, says SC on use of HCQ, AZM on COVID-19 patients

The Supreme Court, on Thursday, refused to consider a plea against use of anti-malarial drug, Hydroxychloroquine and broad-spectrum antibiotic Azithromycin, in the treatment of critically ill COVID-19 patients in view of lethal side effects on cardiovascular system.

"Can the courts say which type of treatment should be used? We are not experts for these things," a bench presided over by Justice N V Ramana told Kunal Saha, president of petitioner NGO 'People for Better Treatment'.

Saha, for his part, contended that patients did have a right to know if there was a risk in the treatment. He said there should be informed consent due to serious side effects.

The bench, however, said it was not going to issue any direction. The Indian Council for Medical Research may consider the petition as a representation, it added.

Saha, a medical practitioner, contended that the updated treatment guidelines issued on March 31, 2020, for doctors and hospitals across India has made categorical recommendations to use a combination of the two drugs without any direct scientific evidence.

"The off-label use of HCQ and AZM in COVID-19 patients on anecdotal evidence has already created a great deal of controversy among healthcare professionals because of their previously known potentially life-threatening side effects, particularly on the cardiovascular system," it said.

It sought a direction to the Centre and the ICMR for reconsideration of any use of both the drugs. The plea sought immediate implementation of a six-point specific recommendations made jointly by the American Heart Association (AHA), American College of Cardiology (ACC) and Heart Rhythm Society (HRS) in the USA on April 8 against such a use without an informed consent in order to save potential loss of innocent patients due to cardiac complications and heart failure.

Soon after a joint bulletin by the USA bodies was released on April 8, 2020, the petitioner claimed it intimated the Health Ministry about "serious and potentially life-threatening dangers for using HCQ and AZM" in COVID-19 patients and asked it to immediately adopt precautionary measures.

"Unfortunately", even after several reminders on extremely urgent situation, the Centre has remained absolutely silent and did not respond or show any interest to adopt any precautionary measures to mitigate the obvious risks, including heart failure and death, involved with the acutely sick ICU patients, it said.

"It is truly alarming that while off-label treatment with HCQ and AZM mostly on anecdotal evidence for serious COVID-19 patients has been advised. They have failed to provide the important and specific precautionary measures that doctors should take before and during the use of these drugs apart from vaguely stating that ‘these drugs should be administered under close medical supervision’," it added.

An extraordinary joint bulletin by the American associations asked the doctors to give stark warnings to patients for before and during the use of HCQ and AZM in COVID-19, especially for patients with existing cardiac conditions since these drugs have potential to trigger arrythmia (abnormal heartbeat), heart failure and even death.

The petition contended that doctors and healthcare workers across India always looked toward the central health ministry for proper guidance and management of COVID-19 patients as there is very little medical research on a novel virus first isolated in China only four to five months ago.