The U.S. Food and Drug Administration’s decision to authorize the investigational use of convalescent plasma therapy for the treatment of Covid-19 last week is having international reverberations. The decision, experts predict, could accelerate the use of plasma therapy in India, where it has already gained immense popularity.
“Most people feel it was approved in response to political pressure from President Trump,” said Dr. Ashish Jha, the director of the Harvard Global Health Institute, 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 which are politically motivated, unfortunately it not just ends up having negative effects on Americans, but people everywhere.”
So far India has 3.62 million Covid-19 infections and is averaging more new cases per day—than any other country, including the United States or Brazil. Nearly 65,000 people in India have died from the virus, with half of the deaths reported from three states, Maharashtra, Andhra Pradesh, and Karnataka
While India’s government is currently conducting a convalescent plasma research trial at 53 medical centers, the main flashpoint is whether there is enough clinical research to support the immediate widespread use of the therapy, which involves removing blood plasma from patients who have recovered from Covid-19 and injecting it into patients with severe cases of the virus.
The Indian Council of Medical Research, which is conducting the trial, says “It does not recommend this treatment option outside of clinical trials.” But there is also a push among state governments that are setting up their own plasma banks. The first one was inaugurated in India’s capital city Delhi by its chief minister Arvind Kejriwal. And social media is rife with posts from people requesting donations for their loved-ones who are undergoing treatment for Covid-19.
“I am reasonably confident that if you pick your patient correctly, it works. Patients who are going to benefit the most are the ones in the early stages and might go into life threatening complications,” said Dr. Om Srivastava, a Mumbai-based infectious disease specialist. He has administered the therapy to 20 patients under the Indian government’s clinical trial and treated another 20 patients under off-label usage.
The rationale behind performing a plasma transfusion is that it can kick start an immune response in the recipients to fight off the infection and prevent its progression. The practice dates back to nearly a century and was even used during the Ebola pandemic. However it is not free of risks. “Plasma is not trivial. It is not like giving a little oral pill that has no side effects. Plasma can have infectious agents in it and needs careful handling,” Dr. Jha said, adding that putting so many resources into a therapy which has not proven to work may not be wise.
Dr. Prashant Chhajed, a Mumbai-based pulmonologist, said the decision by the U.S. FDA will likely push doctors who were on the fence towards giving the therapy to patients. “If you look at the earlier studies where plasma therapy was used for trials to treat diseases such as H1N1, there were no significant reactions seen, which gives the rationale to offer it to patients with Covid-19,” Dr. Chhajed said, adding that it is usually given as an add-on therapy to antivirals.
But no significant adverse reaction is still a far cry from a tried and tested clinically effective therapy. Other doctors have questioned the usage and “aggressive marketing” of the therapy in the absence large scale randomized controlled trials. This is similar to the debate that has been taking place in the United States. So far, only two randomized controlled trials have been conducted-in Wuhan, China and Netherlands, and both were prematurely terminated.
“It has been worrying for some of us,” said Dr. Anant Bhan, a researcher in bioethics, global health and policy and an adjunct professor at Yenepoya University, Mangaluru in the south of India. “The private sector is pushing it aggressively and governments are supporting by setting up plasma banks. All in the absence of data that can the support the benefits.”
Dr. Bhan added that the use of convalescent plasma outside of the government’s clinical trial falls in a grey zone and is rife with possibilities of being misused and oversold. The FDA authorization, he said, will be yet another defense used by health professionals who are aggressively pushing for plasma therapy.
Dr. Lancelot Pinto, a pulmonologist at PD Hinduja Hospital in Mumbai, said people who have recovered from COVID-19 are sometimes being shamed for not donating their plasma. “It became a cult kind of a thing that everyone who had recovered must donate plasma and that it is some sort of magic cure,” he said. “All of this is based on no proper scientific data is worrying.”