The PIL filed by People for Better Treatment (PBT) through its President Dr Kunal Saha, said the use of HCQ and AZM was recommended for very serious COVID-19 patients by Ministry of Health based primarily on anecdotal evidence and not on direct scientific data. It states – Mere treatment must not only be given priority but as doctors, the side-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”.
Studies Conducted For The Use of HCQ & AZM
American Heart Association (AHA), Heart Rhythm Society (HRS), American College of Cardiology (ACC) did a study. The study asserted that the direct analysis of more than 300,000 patients’ data published online. It emphasizes on the potential but serious dangers and the pressing need to take preventive measures for any “off-label” use of HCQ and AZM in COVID-19 patients.
In light of this, the petitioner asserts that on April 8, these above-mentioned societies recommended some measures. The six specific therapeutic measures that doctors should undertake while treating COVID-19 patients are:
- Electrocardiographic (ECG) QT monitoring.
- Withhold HCQ and AZM in patients with baseline QT (e.g. > 500 msec) or with known congenital long QT syndrome.
- Monitor QT rhythm and QT interval; withdrawal of HCQ and AZM if QTc exceeds a present threshold of 500 msec.
- Critically ill patients, frequent caregiver contact may need to be minimized. Therefore optimal electrocardiographic interval and rhythm monitoring may not be possible.
- Correction of hypokalemia >4mEq/L and hypomagnesemia >2 mg/dL.
- Avoid other QTc prolonging agents whenever feasible.
Response Sought From Ministry of Health
The petitioner also states that before filing the instant PIL, they communicated to the Ministry of Health via representations. However, they did not get a response.
“Petitioner-organization also wrote to Respondent no. 1. A joint bulletin released by the AHA/ACC/HRS on 8th April 2020 suggested the Ministry of Health about the severe and potentially life-threatening dangers for using HCQ and AZM of COVID-19 and prodding Respondent no. 1 to immediately adopt the precautionary measures as advised. However, this was never responded to,” reads the PIL. Pressing on the need for ‘informed consent’; the petitioner says such patients receiving HCQ and AZM treatment must be briefed about the possible side effects.