US-based Indian doctor challenges Trump’s COVID-19 ‘gamechanger’ drug in Supreme Court

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Dr. Kunal Saha, President, People for Better Treatment 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.”

A US-based Indian doctor has challenged the safety of ant-malaria drug Hydroxychloroquine touted by US President Donald Trump as a ‘gamechanger’ in the fight against COVID-19 in the Supreme Court.

Dr. Kunal Saha, President, People for Better Treatment has contended that the use of the drug along with Azithromycin to treat COVID-19 is based primarily on “anecdotal evidence” and not on “direct scientific data.”

The plea sought 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 petition has cited a few studies indicating serious adverse effects leading to heart failure.

It pointed out that American Heart Association (AHA), American College of Cardiology (ACC) and Heart Rhythm Society (HRS) in USA had issued an “extraordinary joint bulletin on April 8, 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” 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 petitioner maintains that before filing the instant PIL, a communication was made to the Ministry of Health, but failed to elicit any response (with inputs from Bar & Bench)

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