At the initial stage of COVID-19 pandemic more than one year ago, Indian doctors started widespread use of unproven anti-malarial drug, Hydroxychloroquine (HCQ), to treat COVID-19 following recommendation from the Indian Council of Medical Research (ICMR), top governmental authority responsible for control of COVID-19 pandemic. Most medical experts around the globe rejected any role of HCQ against COVID-19 and premier cardiac groups issued strong warning that adverse effects for HCQ use may trigger heart failure and death in COVID-19 patients with pre-existing heart condition. PBT brought a PIL against ICMR for reckless recommendation to use HCQ in COVID-19 patients with scientific evidence and at the direction of the Apex Court, ICMR was compelled to issue instructions that doctors must obtain valid “informed consent” from COVID-19 patients before starting HCQ therapy. One year later, large multi-national clinical trials have established that not only HCQ has no beneficial role, it can increase mortality rate when used along with Azithromycin in COVID-19 patients. While the public hype with HCQ for treatment of COVID-19 patients is no longer visible, ICMR has still continued to keep HCQ in their published COVID-19 treatment guidelines despite almost universal rejection by the world medical community.
While the hype with HCQ may have died down, a new hype has started with another “off-label” and untested drug, Ivermectin, for treatment of hapless COVID-19 patients in India. The Food and Drug Administration (FDA),world’s “gold-standard” for approval of new drug and World Health Organization (WHO), premier international health organization, have issued warnings that Ivermectin should not be used in any COVID-19 patients except in a formalized clinical trial. While use of a known drug is sometime used for an unapproved medical condition (known as “off-label” use) but such “off-label” use must be done with extreme caution and must be backed by supporting scientific evidence. Reckless use of an approved medicine for an untested disease can also cause unforeseen but serious adverse effects. Patients have every right to know all drugs used by their doctors and whether there is scientific reason for using “off-label” medicine and about all potential side effects of the medicine. Doctors must explain any “off-label” use of Ivermectin in COVID-19 patients and should obtain a valid “informed consent” before starting this untested medicine. PBT submitted an urgent memorandum to ICMR this week asking them to direct Indian doctors that they must obtain “informed consent” from the patient if they intend to start unproven Ivermectin on a COVID-19 patient. Reckless promotion of Ivermectin therapy and baseless claim that this drug can prevent or cure COVID-19 must be strongly reprimanded and violators should be punished in accordance to law.