‘Not Enough Evidence of Effectiveness’: Experts on Plasma Therapy
US FDA has given emergency approval for the treatment after a push by President Donald Trump.
The US Food and Drug Administration (FDA) issued an emergency approval for plasma therapy as COVID-19 treatment, a week after putting the treatment on hold. The US President Donald Trump has been pushing for approvals, often overriding the advice of medical experts.
Top scientists, including Dr Anthony S. Fauci, had argued the current data was “too weak”, reported The New York Times.
In India, despite our own preliminary studies showing little benefit, the treatment has been actively pushed as an experimental treatment option.
FIT speaks to Dr Sumit Ray, a senior consultant of Critical Care Medicine at Holy Family Hospital in Delhi, to find out more.
But first: What is Plasma Therapy/Treatment?
Convalescent plasma treatment is an investigational therapy for off-label use in coronavirus infected patients. In this, antibodies from the blood of patients who have recovered from coronavirus are used to treat severely infected COVID-19 patients.
Does it Work?
“The theoretical benefit of plasma therapy is in helping boost immunity if not enough is developed in the patient. But, the problem with COVID-19 is not an inadequate immune response, but in severe patients, the immune response goes haywire.”Dr Sumit Ray, a senior consultant of Critical Care Medicine at Holy Family Hospital
Our immune system works in complicated ways, and the issue with COVID is that it is causing patients to have a disregulated immune response rather than no immune response at all.
“A study from the Netherlands showed that 76 per cent of COVID-19 patients already had antibodies, so what is the point of giving more antibodies through plasma therapy?” asks Dr Ray. “The problem with COVID is not antibodies but a messed up immune response.”
The Problems of Plasma Therapy
This means that at best, plasma therapy is not getting at the crux of the problem.
At worst? It could have harmful side effects that can prove dangerous.
One of the oft-repeated lines about plasma therapy is that it has been used in other diseases and therefore is safe. “But all diseases are not the same,” says Dr Ray. “Here you are giving plasma (which increases clotting) for a disease which is procoagulant or prone to causing clots.”
Convalescent plasma was used in certain diseases where the immune response was poor or antibodies were not produced. It has a long history (“of a 100 years,” says Dr Ray), especially when there were no antibiotics for certain infections.
“Viral infections rarely have convalescent plasma - Ebola it did not work. The grounds on which it stood is itself very weak.”
Dr Ray explains that the problems are three-fold.
- First - “COVID is primarily a respiratory disease, and plasma treatment can often cause TRALY or transfusion-related acute lung injury. So if there is already lung damage due to COVID, and you give plasma which can cause - in a subset- further lung damage.”
- Second - “Plasma therapy is normally given to increase clotting of the blood but in COVID-19 more clotting is already a problem - a pro-thrombotic state is on and we are giving blood thinners for the same,” says Dr Ray. So giving blood thinners and then plasma seems counter-intuitive for COVID-19 patients.
- Third - “There are adequate antibodies, and so giving plasma is not needed.”
An interim analysis of a randomised controlled trial on convalescent plasma therapy done at AIIMS, Delhi, has found that the treatment does not reduce the risk of death in COVID-19 patients, The Times of India reported.
Dr Neeraj Nischal, associate Professor in the department of medicine at AIIMS, said that the findings highlight that relatives of the patients should not insist on plasma therapy until and unless the treating doctor considers the patient fit for it and where they may think that the mode of treatment would be beneficial.
"This therapy also carries risks such as inadvertent transfer of blood-borne infections and reactions to serum constituents, including immunological reactions such as serum sickness, that may worsen the clinical condition," Dr Nischal said, according to the PTI report.
The Indian Council of Medical Research is also conducting trials on the therapy, but they are not releasing the findings to the public yet despite still allowing the experimental treatment to go on. Read more about the available evidence on the treatment in our explainer here.
So What Helps Treat COVID-19 Patients?
"What we are getting back to in COVID-19 is old-school, good quality critical care,” says Dr Ray. “The only difference in COVID is we use blood thinners and a little bit of steroids. Other than that, treatment is mainly what we used to do for Acute respiratory distress syndrome (ARDS).”
He adds that this conclusion is the result of “good research, particularly from the UK’s NHS recovery trail and studies. They did not panic, they did consistent work and since they are a public health service, they did so without any pressure from pharmaceutical companies to prove or disprove any particular drug.”
Most rapid acute viral infections have no direct therapy. H1N1 doesn't, influenza doesn't. You treat the symptoms - a large percentage will recover but yes, a small percentage will not. Giving these kinds of therapies will not help.”
“Those who go on a ventilator for ARDS have a mortality of 45 per cent for any disease, he adds. In the beginning, there was panic, but now, the mortality rate of COVID-19 is coming down. “It is being managed, and our outcomes have come down to where it usually is in ARDS. For now, this is a good achievement.”
“No therapy has so far proven mortality below what it is for severe ARDS.” The solution? Hopefully, improvements in the treatment of ARDS for the long-term.
“It’s bad science to just use any treatment in the hopes that it will work.”Dr Sumit Ray, a senior consultant of Critical Care Medicine at Holy Family Hospital
He added that in the beginning, many were using experimental treatments and drugs, and those could have caused complications too.
Why is India Pushing Plasma Therapy?
Despite not enough scientific backing, US President Donald Trump pushed HCQ, similarly so did the Delhi government push plasma therapy. In a pandemic, political leaders are on the lookout to provide hope - but this cannot come at the cost of real solutions like investing in ICU beds, improving infrastructure and increasing the health budget. Plasma therapy only seems to offers a neat, eye-catching solution to the crisis.
“There is no point promoting something that is not effective just for the optics.”Dr Sumit Ray, a senior consultant of Critical Care Medicine at Holy Family Hospital
So how has this been touted as promising when no enough data is out? Simply put - we’re in unchartered territories. It’s a once-in-a-lifetime pandemic (we hope) and there is panic, fear and misinformation. “Unfortunately, this has also meant a lot of unscientific data has come through because everyone wants to claim some therapy - both the pharmaceutical company and the scientist or researcher.”
While everyone is on edge and wants more information, surely scientific journals can't lower their strict publishing standards and allow for under-researched, plagiarized or incomplete studies. A study in NCBI charts the challenging rise of publishing in the pandemic, and how to expedite checks for accuracy.
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