A lot has been heard about Convalescent Plasma Therapy (CPT) for treating Covid-19, let’s overview the framework in which the therapy is permissible.
When plasma therapy is in Prism, we should put forward the argument that we are sailing uncharted waters. An explosion of healthcare institutions across the world is scrambling to try this therapy.
Fortunately or unfortunately, Pakistan has been a couple of steps ahead of the world, where CPT has begun, not only by the public at large but also by the medical community, which is taking CPT as the magic elixir against Covid-19.
Even one will find numerous posts on social media, imploring people who have recovered from the virus with the help of plasma, people are donating to save their loved ones and others.
Not only this, but several websites/groups have also cropped up to facilitate connecting donors with recipients – at least here, our humanitarian side has emerged, similar to those people of Pakistan responded to the economic woes by distributing ration, the same spirit of altruistic individuals have joined hands again to bring plasma donors and recipients on board
No matter what, there is little debate in that.
As the number of COVID patients started to mount rapidly and depletion of hospital resources, especially beds, has heightened, then the state of panic with calls being witnessed from every platform, asking recovered patients to donate their plasma.
You can say, desperate times call for urgent actions.
However, all those non-standard forms of treatment whose scientific merit has still not proven anywhere, by any authentic organization, then there, caution is in order.
Ensure that the CPT is one of the globally-experimented efforts to combat the disease, but only within strict research parameters; don’t think that plasma therapy is an over the counter drug like paracetamol, which anyone can take if having a fever.
Nonetheless, from the moment the CPT experiment started showing positive results – that was around mid of April – the therapy has become a household name.
Let’s review the framework in which this therapy is possible.
Possibilities for administering CPT – a non-standard treatment
In emergencies like Covid-19, when there are no proven remedies, non-standard treatments may get approval from experts but only under strict parameters, ensuring that they are not provided randomly, or on request/demand, preferably within strictly monitored research practices so that their utility may be assessed.
Talking about the CPT, the research is permitted worldwide but under the pathway known as “Monitored Emergency Use of Unregistered and Investigational Interventions” (MEURI). That is why this kind of intervention requires strict monitoring, and only permitted in approved centers, following strict eligibility criteria, and diligence monitoring.
CPT Situation in Pakistan
In Pakistan, there is a two-tiered structure for the regulation of clinical research; each proposal must be approved by the National Bioethics Committee (NBC) and Research Ethics Committee (REC). Once approved by both, the study starts recruiting patients, only at the authorized centers.
Checking out the NBC website, you will see two approved CPT studies following the MEURI framework. Typically, to conclude, these trials should enroll around 50 to 500 patients to dictate the further course of action. Then comes the role of regulatory bodies, who review the interim analysis and the analysis after full recruitment to determine the additional course of action.
To the best of reported knowledge, CPT is still in its final or even notable interim conclusions that have not been published.
However, the media has eagerly lapped this up, applauding the claims that plasma therapy is the beacon of hope among the researchers worldwide, actually, they have enjoyed unlimited air time to declare success before concluding the trial, computing and verifying results.
Even without verified results, campaigns have started to seek plasma donations, using emotive appeals to solicit plasma from the recovered patients; even the prime minister made it mandatory for all recovered patients to donate their plasma.
Appeals have also been made from the National Disaster and Management Authority (NDMA), bandwagoning to “facilitate” donations, again without any evidence that this therapy should be rolled out to all who test positive.
The current state of CPT regulation
There is evidence that CPT is offered across an increasing number of hospitals in the country, without any verified proof of success, how is it possible to roll out so widely?
With multiple centers involved, and the popularity of trial surfing, patients on whom it may not be suitable may end up getting it.
Plasma transfusion, like any transfusion, has its hazards, and must be undertaken until medically needed; sadly the media hype may end up losing sight of this cardinal rule – both the public and the physicians.
Plasma therapy – A celebrated miracle, and a window of opportunity for a quick profit
With being so magical, coupled with unregulated promotion across different platforms, CPT is now being seen as a business venture; reportedly, convalescent plasma is being sold for up to Rs 800,00 to desperate patients, even the wave of fake donors who get money from recipients and disappear, has also started.
Commercialization of human plasma is not only illegal internationally, but even commodification of hope is also an unethical act.
In times of chaos and despair, it is more important to remember that medicine, particularly drugs and other treatments, are supposed to be regulated correctly, primarily when the stakes are so high.
Therefore, while providing non-standard treatments in times of infectious disease, it is essential to adhere to both scientific and ethical guidelines, the first and foremost of them is transparency. Sadly, such transparency is missing in Pakistan.