Health authorities around the world, including the US Food and Drug Administration and the Indian Council of Medical Research, are calling for restricting the use of 'promising' COVID treatments including monoclonal antibodies, that have taken the market by storm in recent months.
The US FDA, in a statement put out on 24 January, said they were revising the authorisations for two monoclonal antibody treatments —bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) —"to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments."
The phenomenons is reminiscent of the second wave when desperation was the driving force behind sky-high demand for 'miracle' drugs like Remdesivir, Ivermectin and HCQ—all of which lacked scientific evidence and were proven to be ineffective in treating COVID-19
Here's a quick run down of what we know about monoclonal antibody treatments.
They involve lab-grown antibodies that act like your body's natural antibodies.
They work by attaching to the coronavirus and prevent it from attaching to the human cells and hence preventing symptoms and progression of disease.
They are meant for mild to moderate COVID in high-risk patients
They were found to be effective against many COVID variants including the highly contagious Delta variant.
Recent studies, however, have found that monoclonal antibody treatments are ineffective against the Omicron variant.
In India, the treatment developed by Roche in partnership with Regeneron, that contains two neutralizing antibody drugs, casirivimab and imdevimab is available.
The antibody cocktail is being marketed and distributed by pharmaceutical giant Cipla Limited.
Monoclonal antibodies have both been notably left out of the national COVID-19 task force's list of treatments citing a lack of scientific evidence to support their effectiveness against Omicron.
And yet, their demand has not slowed down.
Renowned virologist, Dr Gagandeep Kang, took to Twitter to address this, saying, "We know that 90% or greater infections are currently omicron in Indian cities. We know that the licensed monoclonal antibody products in India do not neutralise omicron. Yet doctors in private hospitals are prescribing monoclonal antibody therapy (and admission)."
In the Twitter thread, she goes on to call the practice "unethical, immoral and unscientific."
Dr Kang ends by urging patients to ask details about each medicine that they are prescribed, what they are meant to do and the evidence to back it up.
Researchers have also raised the issue of the long term impact of these drugs.
The ICMR, earlier this month, warned of 'major safety concerns,' associated with the antiviral pill, Molnupiravir, another 'promising' antiviral treatment that lacks scientific evidence to support effectiveness against Omicron.
"I am a bit concerned about this drug because although the results look positive, we don't know what would happen in the long run," Dr Kalantri Director professor of Medicine at MGIMS and Medical Superintendent of Kasturba Hospital told FIT previously.
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