Doctor Moves SC Against 'Unproven and "Off-label"  Treatment For COVID-19 With Hydroxychloroquine (HCQ) and Azithromycin (AZM)[Read Petition]

A PIL has been filed in the Supreme Court seeking intervention of the Court for making immediate changes in the treatment guidelines for seriously ill covid19 patients.

The petition has been filed by Dr. Kunal Saha and contends that lives of innocent patients in ICU afflicted with COVID19 and who are being treated with an unproven and "off-label" Hydroxychloroquine (HCQ) and Azithromycin (AZM) following guidelines dated March 31, 2020 by the Ministry of Health are at stake.

"As discussed earlier, the "off-label" use of an anti-malarial (HCQ) and broad-spectrum antibiotic (AZM) were recommended for the most serious COVID-19 patients by Respondent no. 1 based primarily on anecdotal evidence and not as a specific therapy against COVID-19 as candidly admitted under the same guidelines"

Stating that mere treatment must not only be given primacy, but as doctors, the ill-effects of the said treatment must be kept in mind, the Government issued guidelines for this off-label treatment lacks "the cryptic precautionary notes .... to prevent the needless loss of life due to the unforeseen adverse reactions to these drugs"

In light of this, the petitioner points out that on April 8, the leading American Cardiology Societies had cautioned that use of HCQ & AZM in COVID19 patients could pose serious dangers due to its inherent adverse effects wherein six specific precautionary therapeutic measures had also been recommended.

Therefore, the petitioner avers that even though he had written to the Ministry elucidating these reservations and had made representations, urging them to take preventive and precautionary measures in the treatment guidelines by immediate implementation of the six specific therapeutic steps as advised by the AHA/ACC/HRS, they Ministry paid no heed.

"Petitioner also wrote to Respondent no. 1 informing them about the serious dangers associated with MCQ and AZM treatment and requesting them for making necessary changes to implement the 6-point precautionary and preventive measures, as recommended by AHA/ACC/HRS, to protect the lives of seriously ill COVID-19 patients through an urgent representation on April 9, 2020... Unfortunately, Respondent no. 1 did not respond to the repeated pleas by Petitioner or took any step to comply with the 6- point preventive recommendations by AHA/ACC/HRS" - the petition states.

Emphasising on the need for adopting "informed consent", the petitioner lays down that patients being treated with HCQ & AZM must be briefed about the possible repurcussions of the "risks of potentially lifethreatening cardiovascular complications due to the inherent side effects of the drugs"

Further to this, the petitioner points out that the treatment of COVID19 based on anecdotal evidence has serious side effects and risks, which the patients have a right to be aware of.

Dr. Kunal Saha is the Founding President of People For Better Treatment which is a humanitarioan society working for promotion of better healthcare.

The petition has been drawn by Advocate-On-Record, Rabin Majumdar.

[Read Petition]