Plea in Supreme Court against treatment of COVID-19 with "potentially-life threatening" use of Hydroxychloroquine and Azithromycin

An Ohio-based Indian origin doctor has moved the Supreme Court against the Ministry of Health for subjecting seriously ill COVID-19 patients to the controversial, unproven, non-specific and potentially toxic “off-label” use of drugs, Hydroxychloroquine (HCQ) and Azithromycin (AZM)..The plea seeks a direction to the government to make necessary changes in the present treatment guidelines for seriously ill COVID-19 patients, which advises the use of a combination of HCQ and AZM..The petitioner, Dr. Kunal Saha, President of the People for Better Treatment (PBT) has contended that the use of HCQ and AZM for COVID19 treatment is based primarily on “anecdotal evidence” and not on “direct scientific data.”.The plea further states that American Heart Association (AHA), American College of Cardiology (ACC) and Heart Rhythm Society (HRS) in USA issued an “extraordinary joint bulletin on 8th April, 2020” with stark warnings for doctors 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..Further, another massive multi-national (USA, UK, Germany, Spain, Japan, Netherlands) study entitled “Safety of hydroxychloroquine, alone and in combination with azithromycin, in light of rapid widespread use for COVID-19: a multinational, network cohort and self- 12 controlled case series study” has been placed in the plea..The study, with direct analysis of more than 300,000 patients’ data published online, underscores the potential but serious dangers and the urgent need to take precautionary measures for any “off-label” use of HCQ and AZM in COVID-19 patients..The plea states that this major international study found that although no excessive risk for severe adverse events (SAE) was associated with short-term use of Hydroxychloroquine (HCQ) alone, increased risks of 30-day cardiovascular mortality, chest pain/angina and heart failure were observed when both HCQ and AZM were used together, the petition states..The petitioner maintains that before filing the instant PIL, a communication was made to the Ministry of Health, which remained unresponded to..“Petitioner-organization submitted an urgent written representation to Respondent no. 1 soon after the joint bulletin was released by the AHA/ACC/HRS on 8th April, 2020 intimating the Health Ministry about the serious and potentially life-threatening dangers for using HCQ and AZM in COVID-19 patients and urging Respondent no. 1 to immediately adopt the precautionary measures as advised by AHA/ACC/HRS and other international medical organizations. However this was never responded to,” reads the plea..The petition drawn by Advocate on Record, Rabin Majumder states that cautionary guidelines by AHA/ACC/HRS also recommended following six specific therapeutic measures that doctors should adopt to prevent 9 catastrophic medical outcome when treating acutely ill COVID-19 patients with HCQ and AZM:.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.In patients critically ill with COVID-19 infection, frequent caregiver contact may need to be minimized, so 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..The plea prays for directions to the Ministry of Health so that necessary changes can be made at once in the treatment guidelines for seriously ill COVID-19 patients in ICU who are receiving a combination of HCQ and AZM as per the recommendations made by the American and Canadian reports. .Further, the Supreme Court has been urged to direct that the government implement that above outlined preventive steps in hospitals across India to protect the lives of COVID-19 patients who are being treated with HCQ and AZM..The petition also seeks that informed consent be taken from patients who are given the HCQ and AZM treatment..The plea has noted down the following questions of laws:Whether Ministry of Health can recommend unproven anti-malarial (HCQ) and antibiotic (AZM) medicines primarily based on anecdotal evidence that are known to have potential life-threatening side-effects, for treatment of acutely ill COVID-19 patients in ICU without necessary warnings and precautions ?Whether “informed consent” must be obtained from COVID-19 patients before starting an “off-label” use of unproven and non-specific treatment with HCQ and AZM by full disclosure of the potential and serious risks of heart failure and death?Whether treatment of ICU patients with COVID-19 in hospitals across India with an experimental and unproven combination of drugs, HCQ and AZM, with known and potentially lethal side effects, as advised by Ministry of Health violated the fundamental right to life as enshrined under Article 21 of Indian Constitution?Whether government can overlook the findings by multi-national medical groups that treatment with HCQ and AZM can significantly increase 30-day cardiovascular mortality rate and takes no precautionary steps to change their guidelines for treatment of COVID-19 patients with a combination of HCQ and AZM?Whether government can remain silent and takes no action to the 6 specific preventive and precautionary 52 therapeutic measures advised by recent American and Canadian studies?Whether government is justified to completely ignore the urgent appeal/representation made by the Petitioner requesting them to take necessary and immediate preventive and precautionary measures to mitigate the serious risks involved with the “off-label” use of HCQ and AZM in the management of COVID19 patients as advised by the American and Canadian cardiac medical experts?Whether the government has not been wrong in deciding and dealing with such pandemic medical issues so light-heartedly by adopting ad-hoc measures to treat COVID-19 patients in ICU with an unproven drug combination of HCQ and AZM without adequate 53 preventive measures against serious and potentially lethal adverse effects of these drugs?