Bhargava ignores question on why plasma therapy still used despite a negative ICMR study
CORRECTION: An earlier version of this article read that “A trial done by a few agencies in Brazilian laboratories has showed that equine serum, generated after horses were inoculated with SARS-CoV-2, contained 50 times more antibodies than convalescent plasma”. The experiments were conducted in Argentina and not Brazil. We regret the error. This article was published on Down To Earth October 6, 2020
Equine serum may get approval for novel coronavirus disease (COVID-19) treatment in India, Indian Council of Medical Research (ICMR) Director-General Balram Bhargava said at a press conference October 6, 2020.
Convalescent plasma did not really help in beating COVID-19, an ICMR-sponsored study, the results of which were published last month, had said. However, it still continues to be a part of our clinical management of COVID-19 protocol.
Union Minister for Health and Family Welfare Harsh Vardhan, under whose ministry ICMR comes, had also said in his ‘Sunday Samvaad’ programme October 4 that people, who had recovered from COVID-19, should not hesitate from donating plasma.
Bharagava repeated the results of the study emphatically in reply to a question about this dichotomy. He said it “clearly demonstrated” that plasma therapy neither reduced mortality in COVID-19 patients nor helped in preventing the progression of disease from being moderate to severe. But he failed to clarify as to why plasma therapy continued to be a part of official protocol despite this clear understanding.
He also revealed another interesting fact. Preliminary studies on equine serum conducted in labs in India had shown it produced required antibodies against the SARS-CoV-2 virus.
What is the relation between convalescent plasma and equine serum? Convalescent plasma of a COVID-19-recovered patient is transfused due to the belief that it would contain antibodies developed after infection. This, in turn, would prove useful for another COVID-19 patient.
Equine serum also contains antibodies and has been used for treatment in cases of snakebite.
A trial done by a few agencies in Argentine laboratories has showed that equine serum, generated after horses were inoculated with SARS-CoV-2, contained 50 times more antibodies than convalescent plasma. However, its widespread use in other countries is not heard of; neither has the World Health Organization talked about it.
Bharagava said since animal models had shown positive results for this therapy, human clinical trials would now be conducted. He, however, did not clarify whether equine serum would be used as an alternative to convalescent plasma if the results in the clinical trials on the former were positive.
Ayush protocol without trials
The Union Ministry of Ayurveda, Unani, Siddha and Homeopathy (Ayush) released a detailed protocol October 6 not only for the treatment of COVID-19 patients but also to prevent the disease. A host of Ayurveda drugs are a part of it.
Ayush ministry secretary V R Kotecha claimed at the press conference that the drugs had been included on the basis of clinical evidence. However, the clinical evidence about the utility of those drugs has been established in the context of other diseases and not COVID-19.
“Various clinical trials of Ayush drugs for use in COVID-19 are going on. The protocol has been released on the basis of trends of these studies that has emerged so far,” Kotecha said in this regard. He used ‘trends’ several times in his answers but could not cite a single clinical study that has been completed in the context of COVID-19.
“We are not claiming the results are final. But we have got positive, strong trends,” Kotecha added.
A number of preparations ranging from Giloy to Chyawanprash to Ashwangandha, kaadha, ginger and turmeric figure in a detailed prepared by a committee headed by former ICMR head, VM Katoch.
However, experts have advised caution. “Trends are never used to introduce drugs in a management protocol. The drug may or may not be safe and the trends may very well change. How can we trust them? Had clinical trials been completed and published, we could have inferred anything,” Anant Bhan, an expert in bioethics, said.
Kotecha, in his defence, said many modern medical drugs too have been used before their clinical trials could be completed. “It is true. We have used many such drugs during COVID but all of them subsequently underwent trials in multiple countries and a large-scale effort was undertaken. A study done in one country gave hints to clinicians and experts globally. Here, we have a single agency doing such trials for Ayurveda drugs and therefore, it would be a long time till we really know the results,” Bhan said.
There are many reports that say an overdose of kaadha or Ayurveda products have led to liver problems and other ailments in the last few months.
“The ingredients of kaadha have anti-viral properties for many infections. We don’t have a sound evidence of their usage in COVID-19 at the moment as the studies are going on. But it is a wrong belief that it adversely affects the liver,” Kotecha said.
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