New Delhi: Expressing concerns about the "irrational and non-scientific" use of convalescent plasma for treatment of Covid-19 patients in the country, a group of doctors have written to the Principal Scientific Advisor of India, Dr Vijay Raghavan requesting for rectification in the current guidelines.
A copy of the letter has been also sent to the Indian Council of Medical Research (ICMR), and All India Institute of Medical Sciences (AIIMS), New Delhi.
Pointing towards the current research evidence that unanimously indicates that there is no benefit offered by convalescent plasma for treatment of COVID-19, these doctors stated in the letter how it continues to be prescribed rampantly in hospitals across India. This naturally leads towards a situation where patients and their families get harassed to arrange plasma; even Covid-19 survivors get pressurized for donation. The issue gets coupled with short supply and reports of black marketing.
"This has stemmed from guidelines issued by government agencies," opined the doctors who have identified themselves as "concerned clinicians, public health professionals, and scientists from India."
"The problematic scenario arises because of guidelines issued by ICMR/AIIMS which currently recommends plasma therapy (April 2021 version) as 'off label" use. This is rather unusual as off-label use by its very definition implies "unapproved use". We would also like to point out that international guidelines such as those from National Institutes of Health (NIH), USA• and the IDSA guidelines' also recommend against the general use of plasma therapy for COVID-19," mentioned the doctors in the letter.
The convalescent plasma therapy aims at using antibodies from the blood of a recovered Covid-19 patient to treat those critically affected by the virus.
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However, stressing upon the fact that clinical guidelines must necessarily be based on existing research evidence, the doctors stated in the letter, "We, therefore, wish to bring to your attention the current evidence on plasma therapy in COVID-19 and how the ICMR guidelines are not based on the existing evidence:
• ICMR-PLACID Trial — The trial was the world's first randomized controlled trial on convalescent plasma in 39 public and private hospitals across India which found "convalescent plasma was not associated with a reduction in progression to severe covid-19 or all-cause mortality. This trial has high generalisability and approximates convalescent plasma use in real-life settings with limited laboratory capacity."'
• Recovery Trial — The large trial of 11,588 patients found no difference in death or proportion of patients discharged from hospital. Even for those patients who were not on ventilation initially, there was no difference "in the proportion meeting the composite endpoint of progression to invasive mechanical ventilation or death.'
• PlasmAr Trial - the trial from Argentina concluded that there is no significant difference in "clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo."
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Concerned about the rampant prescription of Convalescent plasma for the treatment of Covid-19 in India, the doctors mentioned, "Current research evidence unanimously indicates that there is no benefit offered by convalescent plasma for treatment of COVID-19. However, it continues to be prescribed rampantly in hospitals across India. Families of patients run from pillar-to-post for getting plasma, which is in short supply, and reports of black-marketing is common. You might already be aware of these issues which have been widely reported in the media, and experiences shared by ordinary Indians in social media. The desperation of patients and their families is understandable because they did like to try the best for their loved ones when a doctor has prescribed this."
"We would also like to point out some very early evidence' that indicates a possible association between emergence of variants with "lower susceptibility to neutralizing antibodies in immunosuppressed" people given plasma therapy. This raises the possibility of more virulent strains developing due to irrational use of plasma therapy which can fuel the pandemic," further added the letter.
Requesting the concerned authorities to urgently review the guidelines and remove this "unnecessary therapy", the doctors opined that "This should also be twinned with clear instructions to blood banks across the country on the same."
Willingness to help, and requesting rectification in the ICMR/AIIMS guidelines so that "they reflect the current research and scientific consensus on plasma therapy", the doctors further added, "We are also willing to assist, if required, to appraise the evidence critically, conduct evidence synthesis and develop recommendations based on GRADE (which are global standards and followed by WHO), which can enable better clinical decision making."
Sharing the copy of the letter, one of the doctors wrote on Twitter, "We talk about the pain we share with our patients, their families & survivors. The current "off label" recommendation is unusual - it implies "unapproved use". We need recommendations backed by publicly available evidence synthesis & GRADE profiles"
We talk about the pain we share with our patients, their families & survivors. The current "off label" recommendation is unusual - it implies "unapproved use".
We need recommendations backed by publicly available evidence synthesis & GRADE profiles
🔗https://t.co/VhiiBbYOkf pic.twitter.com/Bno4TTznRv
— Soumyadeep Bhaumik | সৌম্যদীপ ভৌমিক (@DrSoumyadeepB) May 10, 2021
Also Read: Patients having severe covid-19 best donors for convalescent plasma: Study