On Thursday, the Supreme Court of India refused to give any direction to change the guidelines for the treatment of Covid-19 patients. Supreme Court denied intervening on a writ petition filed by NGO People for Better Treatment, saying the court is not an expert.
A combination of antimalarial drug Hydroxychloroquine (HCQ) and antibiotic Azithromycin (AZM) are given to the Covid-19 patients.
‘People for better treatment’ is an NGO which drew the apex court’s attention to a bulletin on giving Hydroxychloroquine, Azithromycin to patients with cardiac conditions.
The bulletin said the use of these drugs on patients with cardiac conditions would possibly trigger arrhythmia (abnormal heartbeat), heart failure and even death. It advised specific therapeutic measures in such cases.
The NGO filed a petition which was considered by a bench of Justices NV Ramana, Sanjay Kishan Kaul and BR Gavai in which an Ohio based Indian-origin doctor and PBT president Kunal Saha challenged the side effects of using hydroxychloroquine and azithromycin, not the treatment of Covid-19.
Via video conferencing, Saha addressed a serious warning about the side effects issued by an American heart institution which should be considered. The bench said there’s no medicine to treat Covid-19 and doctors are trying different methods for treating Covid-19 patients.
The court said there’s no expert on treatment. The methods of treatment are in the hands of doctors and the court can’t decide what kind of treatment should be given. The bench also asked Saha to take up its petition as a representation of the ICMR (Indian Council of Medical Research) which could examine his suggestions.
Saha further said that he is not claiming any particular method of treatment as right or wrong but he is asking to take precautions because people are dying because of the side effects. He mentioned that there should be informed consent as the patient has a right to know that this method of treatment involves risk.
The bench reverted that the court cannot give directions on any specific method adopted for treatment. The court asked Solicitor General Tushar Mehta, to make the petition available yo the ICMR, which would consider these suggestions.
The PIL addressed the following issues:
- 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 a 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 before 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 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.
The petitioner-organization submitted an urgently written representation to the Ministry of Health intimating it about the serious and potentially life-threatening dangers for using HCQ and AZM in Covid-19 patients
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.
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