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A child (C) watches a healthcare worker (L) take a nasal swab from his mother during a COVID-19 … [+]
The decision by the US Food and Drug Administration to authorize the investigational use of convalescent plasma therapy for the treatment of Covid-19 last week is having international repercussions. The decision, experts predict, could accelerate the use of plasma therapy in India, where it has already gained immense popularity.
“Most people feel that it was approved in response to political pressure from President Trump,” said Dr. Ashish Jha, director of the Harvard Institute for Global Health, adding that it is still unknown if it works to treat Covid- 19. “The FDA did not realize its global influence. When the FDA makes decisions that are politically motivated, unfortunately it ends up not only having negative effects on Americans, but also on people everywhere. “
So far, India has 3.62 million Covid-19 infections, and has an average of more new cases per day, than any other country, including the United States or Brazil. Almost 65,000 people in India have died from the virus, with half of the deaths recorded in three states, Maharashtra, Andhra Pradesh and Karnataka.
While the government of India is currently conducting a convalescent plasma research trial at 53 medical centers, the main flash point is whether there is enough clinical research to support immediate widespread use of the therapy, which involves drawing blood plasma. of patients who have recovered from Covid-19. and inject it into patients with severe cases of the virus.
The Indian Council for Medical Research, which is conducting the trial, says it “does not recommend this treatment option outside of clinical trials.” But there is also momentum among state governments that are creating their own plasma banks. The first was inaugurated in the capital of India, Delhi, by its prime minister Arvind Kejriwal. And social media is full of posts from people requesting donations for their loved ones who are in treatment for Covid-19.
“I am reasonably confident that if you choose your patient correctly, it works. The patients who will benefit the most are those who are in the early stages and could suffer life-threatening complications, ”said Dr. Om Srivastava, an infectious disease specialist from Mumbai. He has administered the therapy to 20 patients under the Indian government clinical trial and has treated another 20 patients with an off-label use.
The rationale behind performing a plasma transfusion is that it can initiate an immune response in recipients to fight the infection and prevent its progression. The practice dates back almost a century and was even used during the Ebola pandemic. However, it is not without risks. “Plasma is not trivial. It is not like giving a small oral pill that has no side effects. Plasma can contain infectious agents and needs careful handling, ”Dr. Jha said, adding that investing so many resources in a therapy that has not been shown to work may not be prudent.
Dr. Prashant Chhajed, a Mumbai-based pulmonologist, said the US FDA’s decision will likely push physicians who were hesitant to give the therapy to patients. “If you look at previous studies where plasma therapy was used in trials to treat diseases like H1N1, no significant reactions were seen, which gives reason to offer it to Covid-19 patients,” said the Dr. Chhajed, adding that it is generally given as an add-on therapy to antivirals.
But no significant adverse reaction is very far from being a proven clinically effective therapy. Other clinicians have questioned the use and ‘aggressive marketing’ of the therapy in the absence of large-scale randomized controlled trials. This is similar to the debate that has taken place in the United States. So far, only two randomized controlled trials have been conducted in Wuhan, China, and the Netherlands, both of which ended prematurely.
“It has been concerning for some of us,” said Dr. Anant Bhan, a researcher in bioethics, health and global policy and adjunct professor at Yenepoya University, Mangaluru, in southern India. “The private sector is aggressively pushing it and governments are supporting it by creating plasma banks. All in the absence of data that can support the benefits. ”
Dr Bhan added that the use of convalescent plasma outside of the government clinical trial falls into a gray area and is fraught with potential for misuse and overselling. FDA clearance, he said, will be yet another defense used by healthcare professionals who are aggressively pushing for plasma therapy.
Dr. Lancelot Pinto, a pulmonologist at PD Hinduja Hospital in Mumbai, said that people who have recovered from COVID-19 are sometimes embarrassed for not donating their plasma. “It became a kind of cult that everyone who had recovered must donate plasma and that it is a kind of magical cure,” he said. “This is all based on the lack of adequate scientific data that is of concern.”
