Covid-19: Supreme Court refuses to pass direction on changing treatment guidelines

New Delhi: The Supreme Court Thursday refused to pass any direction on changing treatment guidelines for seriously ill Covid-19 patients who are receiving a combination of anti-malarial drug hydroxychloroquine (HCQ) and antibiotic azithromycin (AZM) saying that it is not an expert on the matter.

A bench of Justices N V Ramana, Sanjay Kishan Kaul and B R Gavai asked the plea filed by an NGO, 'People for Better Treatment' (PBT), to be considered as representation to the Indian Council of Medical Research (ICMR).

During the hearing, Ohio-based Indian origin doctor and PBT President Kunal Saha said he has not challenged the treatment line for Covid-19 per se but the use of HCQ and AZM combination has side effects and people are dying due to it.

Saha, appearing through video conferencing, said that a serious warning about the side effects has been issued by an American heart institute, which should be considered.

The bench said that as of now there are no medicines for the treatment of Covid-19 and doctors are trying different ways. It said the type of treatment guidelines to be followed is up to the doctors to decide as courts are not experts and it cannot decide what type of treatment can be prescribed. The bench asked Saha to take his petition as representation to the ICMR, which can examine its suggestions.

Saha said he was not saying whether a particular line of treatment is correct or not, but was asking for precautions as people are dying of side effects. He said there should be an informed consent as a patient has a right to know that there is a risk involved in a particular line of treatment.

Saha contended that the doctors should explain to the patient about the risk involved in the particular line of treatment and take his or her consent.
The bench said that court cannot ask for providing particular line of treatment and asked Solicitor General Tushar Mehta, appearing for Centre, to provide the petition to ICMR which shall look into the suggestions.

The PIL said the use of HCQ and AZM was recommended for the most serious Covid-19 patients by the Health Ministry based primarily on anecdotal evidence and not as a specific therapy.

The petition has also sought directions for taking necessary steps for immediate implementation of all the specific preventive measures recommended in hospitals across India to protect the lives of Covid-19 patients who are being treated with HCQ and AZM.

It said the Ministry of Health & Family Welfare published comprehensive 'Revised Guidelines on Clinical Management of Covid-19' on the website on March 31 that included detailed description of how to test, diagnose and treat Covid-19 patients.

"Ministry of Health has specifically advised that although no specific anti-viral medicines are available against Covid-19, a combination of HCQ and AZM may be administered as an 'off-label' use to the most seriously ill COVID-19 patients who are in ICU," it said.

Many doctors have started using the combination to treat their most critically ill Covid-19 ICU patients across India following the ministry's guidelines, it said.

"Off-label use of HCQ and AZM in acutely ill Covid-19 patients has been highly controversial from the very beginning. However, both HCQ and AZM were studied extensively prior to FDA approval for their use in indicated medical conditions and both drugs are known for occasional and serious adverse reactions, particularly on the cardiovascular system in humans," the plea said.

It said an extraordinary joint bulletin issued on April 8 by leading American cardiology societies have cautioned that use of HCQ and AZM in Covid-19 patients can pose serious dangers due to its inherent adverse effects.

Canadian Medical Association Journal published a very similar warning for using HCQ and AZM to patients with COVID-19, the plea said, adding that they also increased the risks of heart failure and cardiac mortality.

"The petitioner-organization submitted an urgent written representation to Ministry of Health intimating it about the serious and potentially life-threatening dangers for using HCQ and AZM in Covid-19 patients and urging it to immediately adopt the precautionary measures.

It has also sought directions to the health ministry to obtain "informed consent" from all Covid-19 patients for treatment with HCQ and AZM by bringing necessary changes in the treatment guidelines.