With no definitive research data, Karnataka relies heavily on 'investigative' Covid-19 drugs

If you are taking a severely ill patient to a Covid-19 hospital in Karnataka, there's a possibility that they may be administrated with 'investigative' drugs.

Two of these drugs, Remdesivir and Itolizumab, are for emergency use, two others - Tocilizumab and convalescent plasma - are for 'off-label' use.

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The results of using the drug are unknown. Even treating doctors cannot predict the clinical outcome of administering the drug.

But this hasn't stopped the state from procuring more vials of the drugs.

It is also to be noted that recently, Biocon's Itolizumab was rejected by the national Covid-19 task force for inclusion in the clinical management protocol of the infection.

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For example, the state has so far procured 15,000 vials of Remdesivir, branded as 'under emergency use authorisation' and another 50,000 are in the process of being procured.

Tens of patients in the state, in both public and private sector, have been administered the drug. The Karnataka Drug Logistics and Warehousing Society has also invited bids for 1,500 vials of Itolizumab and Tocilizumab.

Dr. Anant Bhan, Researcher, Global Health, Bioethics and Health Policy, told DH, "For Remdesivir, the evidence so far indicates its utility might be primarily in reducing time taken for clinical improvement. Its impact on critical outcomes is much less uncertain, and in that light, it might be best used in randomised controlled trials for gathering more data, especially in the local context."

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Dr S Sacchidanand, Vice-Chancellor, Rajiv Gandhi University of Health Sciences, who heads the state therapeutic committee that approves the treatment protocol for Covid-19 from time to time is however optimistic about the investigational therapies despite latest revelations about the efficacy of these drugs.

About Itolizumab (a drug that is branded as 'restricted emergency use'), he said, "We are discussing it in our next meet of the state therapeutic committee. The rejection has only come recently. It has to be officially communicated. Till then we will have to withdraw."

Seema Ahuja, Global Head of Communications at Biocon was not available for comment on the same to DH.

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About drug manufacturer Roche saying that its drug Tocilizumab shows no benefits in clinical status or mortality in Covid-19 patients, Dr. Sacchidanand told DH, "It might not have met certain defined endpoints of its phase 3 clinical trial but has reduced time for discharge. It does act on IL6 cytokines, an inflammatory mediator released during Covid-19 infection."

First patient to be administered Itolizumab in Victoria Hospital dies

Blissfully unaware of such developments, in the power corridors of the country, people like Zaffer, still go ahead and procure these drugs in a hope to save their loved ones. He recently spent Rs. 32,000 to procure four vials of Itolizumab for his 42-year-old brother-in-law who was a Covid-19 patient being treated at Victoria Hospital. The patient, unfortunately, died on August 3.

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He told DH, "We procured four 25 mg vials of Itolizumab from a wholesaler called Sri Vignesh Pharma Distributors in Rajajinagar. The doctors told us this is the last option and my brother-in-law can be saved if we get the drug, so we did. But we had to pay the MRP of Rs. 31,800 costing us around Rs. 8,000 per vial."

"The doctors told us my brother-in-law will recover on the fifth day after administering the injection but he passed away on the fourth," Zaffer said.