Use of Combination of Hydroxychloroquine and Azithromycin is potentially life threatening against treatment of COVID-19,Dr.Files a Plea in Supreme Court [Read Petition]
(Judicial Quest News Network)
A US based Dr. filed a PIL in Supreme Court seeking an immediate intervention of the Court for making changes in the guide lines issued by Government of India for the treatment of seriously ill COVID-19 patients.
The petitioner Dr. Kunal Saha, President, People for Better Treatment (PBT) has contended that the use of Hydroxychloroquine and Azithromycin to treat COVID-19 is based primarily on “anecdotal evidence and not on direct scientific data”
The petitioner seeks a direction to the Government to make necessary changes in the treatment guidelines for seriously ill COVID-19 patients, which advises the use of a Combination of HCQ and AZM.
It is further submitted that it is no surprise that most of the drugs presently being used to treat COVID-19 patients are based primarily on anecdotal evidence and not on direct scientific data because very little actual research has been published on this new strain of coronaviruses which was isolated for the first time only a few months ago.
COVID-19 patients receive primarily symptomatic therapy because no specific drug against the new SARS-CoV-2 viruses has been invented till now.
In fact, in the “Revised Guidelines on Clinical Management of COVID-19”, Respondent no. 1 has candidly and rightly admitted that no specific antiviral therapy against COVID- 19 exists “as per currently available data”. Needless to say, that when treating the vulnerable patients with a new and unproven drug for its “off-label” use, doctors should be extra vigilant about its potential harmful adverse effects on COVID-19 patients.
The petitioner says that the present treatment guidelines by Respondent no. 1 have recommended to use an old anti-malarial drug, Hydroxychloroquine HCQ a well- known broad-spectrum antibiotic, Azithromycin AZM in the most critically ill COVID-19 patients who are in ICU, p. 18, Section 10 “Specific Therapy”).
The off-label use of HCQ and AZM in COVID-19 patients 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.
In the light of this the petitioner submits that
In fact, the 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. The AHA/ACC/HRS joint bulletin has further advised to follow specific therapeutic measures for preventing fatal outcome in COVID-patients treated with HCQ and AZM.
These precautionary guidelines issued by AHA/ACC/HRS are obviously aimed toward reducing the serious and potentially lethal risks involved with the “off-label” use of HCQ and AZM The AHA/ACC/HRS joint bulletin has issued strong warnings for doctors who plan to treat COVID-19 patients with combination of HCQ and AZM in view of these drugs’ known side effects on the cardiovascular system. The cautionary guidelines by AHA/ACC/HRS also recommended following six specific therapeutic measures that doctors should adopt to prevent.
i) Electrocardiographic (ECG) QT monitoring.
ii) Withhold HCQ and AZM in patients with baseline QT (e.g.
> 500 msec) or with known congenital long QT syndrome.
iii) Monitor QT rhythm and QT interval; withdrawal of HCQ and AZM if QTc exceeds a present threshold of 500 msec.In
iv) 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.
v) Correction of hypokalaemia >4mEq/L and hypomagnesemia>2 mg/dL.
vi) Avoid other QTc prolonging agents whenever feasible.
The petitioner has raised the following questions of law
A) Whether Respondent no. 1 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.
B) 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?
C) 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 Respondent no. 1 violated the fundamental right to life as enshrined under Article 21 of Indian Constitution?
D) Whether Respondent no. 1 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?
E) Whether Respondent no. 1 can remain silent and takes no action to the 6 specific preventive and precautionary therapeutic measures advised by recent American) and Canadian studies?
F) Whether Respondent no. 1 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 COVID- 19 patients as advised by the American and Canadian cardiac medical experts?
G) Whether the Respondents have 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 preventive measures against serious and potentially lethal adverse effects of these drugs?
The Petition has been drawn and filed by Advocate -on -Record
Rabin Majumdar.
[Read Petition]
