Hospitals shelved ICMR's reports that plasma therapy wasn't good. It was still rolled out, and people paid the price writes DR KABIR SARDANA in The Print
Plasma therapy was administered to Covid-19 patients during the second wave in India | Wikipedia
The closing pages of the 18th-century masterpiece fiction The Story of the Stone revealed the essence of the Tao’s message. In Lao Tzu’s words, it means that “Things are not as they seem, that the Eloquent may Stammer, that Perfection may seem Flawed, that Truth is Fiction, Fiction Truth.”
The truth is neither black nor white, it’s grey—the handling of the second wave of Covid-19 is a testimony to that fact.
Disaster that escaped public eye
In the midst of the second wave of Covid-19 with panic all around, a lot of therapeutic disasters were played out, and without a doubt, they were inspired by a lack of knowledge. Instead, they were fueled with a desire for one-upmanship and copycat fame. Some of the doctors unwittingly orchestrated this therapeutic mess. On one side, we had the armchair experts who were not running Covid-19 centres and had shut down their institutes. On the other, doctors in central government hospitals like the Ram Manohar Lohia Hospital in Delhi were running Out Patient Departments (OPDs) and wards. They were possibly following half-baked regimens with little proof, as there were lives at stake.
While some medications were possibly harmless and cheap like Ivermectin or HCQS, the others were ridiculously expensive, and no one was wiser about their efficacy. One of them was plasma therapy. Of course, the Indian medical system and healthcare did not have the time for a randomised trial to test a placebo. But the origin of the mess was thus created right here in the capital of the country.
One may ask—who would be the expert to decide on its efficacy? The clear answer is a clinician in a hospital, handling patients with an active plasma extraction centre. But what transpired is that a centre dedicated to liver care with nil experience in Covid-19 treatment proposed the idea that plasma might help. Then came the now-famous statement of Chief Minister Arvind Kejriwal, saying that Delhi opened the first plasma bank in the world. That set off a chain reaction, and within a few weeks, hospitals followed suit.
It wasn’t the solution
Plasma is a component of the blood that is believed to have antibodies to diseases. Here, it was believed that Covid-19 patients would benefit from such therapy. This was when even the use of Intravenous immunoglobulin (IV IgG), a related plasma-based therapy that had been available for years, wasn’t effective in most disorders. This was also when we all knew that the so-called antibody tests of Covid-19 patients are negative or low positive. In fact, what is even more comical is that the quantity of antibodies in plasma is probably too little to do anything. And the ultimate irony is that therapy works in isolation, but here we had a plethora of medicines being administered, and it was not possible to pinpoint what was working behind the treatment.
Plasma does not come cheap, as it has to be extracted from patients. Thanks to the CM calling for plasma donation with great zeal and fanfare, the concept spread like wildfire. Intermediaries and ‘scamsters’ came in, and patients paid lakhs to get treatment, that too with dubious efficacy. Most doctors were inundated with calls for plasma, and we didn’t know what and where to arrange it for so many patients.
I know of patients who sold their belongings and went broke, partly because of plasma therapy and of course, Remdesivir, which has now been yanked off from all the guidelines. One of the members of our department, who had recovered from Covid-19, needed to give plasma to her own grandfather. He was admitted to the hospital, administered plasma but to no avail.
Trading fact for fame
Therefore, it is a must to understand the value of a placebo trial. Here, an identical-looking therapy is given to assess whether the active therapy—plasma, in this case—does anything substantial. A 30 per cent response rate is considered to be mostly placebo, or inactive, and that is the value of a placebo-controlled study.
There are numerous variables that determine the success of therapy in Covid-19, and assigning the credit to plasma showed a remarkable lack of foresight. At this juncture, the Indian Council of Medical Research (ICMR), in a multicentric study published in the British Medical Journal (BMJ), found that plasma wasn’t so good. But the public opinion swayed by the hospitals who pioneered the concept pilloried the paper and trashed it. Such was the distrust in our own country’s research that none wanted to get off the plasma bandwagon. Countless patients spent their life savings on what was a highly questionable therapy. And the charade continued till the second wave subsided.
The breakthrough
As always, we waited for a foreign journal to agree to a local finding, which was not surprising to a lot of us in the government hospitals. The landmark paper in the New England Journal of Medicine (NEJM) showed that there was “No significant differences in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo.” It has been cited 455 times since it was published in February 2021. The number exceeds the citations of any of the papers published by the ‘experts’ who rolled out an untried therapy on the nation.
To add insult to injury, a section of the print media, which studiously avoided criticising them because their publications were the benefactors of full pages advertisements on plasma banks. To make it worse, some of the names suggested for the Padma awards this year included the plasma therapy pioneers.
Who takes the responsibility?
In retrospect, what needs to be asked is—who will pay for the loss of life savings and the death of patients who were given plasma therapy? Who will fill in the gaps for the distrust in medical care? Will the experts apologise? Who will apologise for pillorying the ICMR’s report that could have nipped this in the bud? But no one really apologises for such things in India.
As Donald Keough said, “The truth is, we are not that dumb and we are not that smart.” The plasma blitzkrieg was neither dumb nor smart; it was callous, and someone should be paying for the negligence today or tomorrow.
Plasma therapy was administered to Covid-19 patients during the second wave in India | WikipediaThe closing pages of the 18th-century masterpiece fiction The Story of the Stone revealed the essence of the Tao’s message. In Lao Tzu’s words, it means that “Things are not as they seem, that the Eloquent may Stammer, that Perfection may seem Flawed, that Truth is Fiction, Fiction Truth.”
The truth is neither black nor white, it’s grey—the handling of the second wave of Covid-19 is a testimony to that fact.
Disaster that escaped public eye
In the midst of the second wave of Covid-19 with panic all around, a lot of therapeutic disasters were played out, and without a doubt, they were inspired by a lack of knowledge. Instead, they were fueled with a desire for one-upmanship and copycat fame. Some of the doctors unwittingly orchestrated this therapeutic mess. On one side, we had the armchair experts who were not running Covid-19 centres and had shut down their institutes. On the other, doctors in central government hospitals like the Ram Manohar Lohia Hospital in Delhi were running Out Patient Departments (OPDs) and wards. They were possibly following half-baked regimens with little proof, as there were lives at stake.
While some medications were possibly harmless and cheap like Ivermectin or HCQS, the others were ridiculously expensive, and no one was wiser about their efficacy. One of them was plasma therapy. Of course, the Indian medical system and healthcare did not have the time for a randomised trial to test a placebo. But the origin of the mess was thus created right here in the capital of the country.
One may ask—who would be the expert to decide on its efficacy? The clear answer is a clinician in a hospital, handling patients with an active plasma extraction centre. But what transpired is that a centre dedicated to liver care with nil experience in Covid-19 treatment proposed the idea that plasma might help. Then came the now-famous statement of Chief Minister Arvind Kejriwal, saying that Delhi opened the first plasma bank in the world. That set off a chain reaction, and within a few weeks, hospitals followed suit.
It wasn’t the solution
Plasma is a component of the blood that is believed to have antibodies to diseases. Here, it was believed that Covid-19 patients would benefit from such therapy. This was when even the use of Intravenous immunoglobulin (IV IgG), a related plasma-based therapy that had been available for years, wasn’t effective in most disorders. This was also when we all knew that the so-called antibody tests of Covid-19 patients are negative or low positive. In fact, what is even more comical is that the quantity of antibodies in plasma is probably too little to do anything. And the ultimate irony is that therapy works in isolation, but here we had a plethora of medicines being administered, and it was not possible to pinpoint what was working behind the treatment.
Plasma does not come cheap, as it has to be extracted from patients. Thanks to the CM calling for plasma donation with great zeal and fanfare, the concept spread like wildfire. Intermediaries and ‘scamsters’ came in, and patients paid lakhs to get treatment, that too with dubious efficacy. Most doctors were inundated with calls for plasma, and we didn’t know what and where to arrange it for so many patients.
I know of patients who sold their belongings and went broke, partly because of plasma therapy and of course, Remdesivir, which has now been yanked off from all the guidelines. One of the members of our department, who had recovered from Covid-19, needed to give plasma to her own grandfather. He was admitted to the hospital, administered plasma but to no avail.
Trading fact for fame
Therefore, it is a must to understand the value of a placebo trial. Here, an identical-looking therapy is given to assess whether the active therapy—plasma, in this case—does anything substantial. A 30 per cent response rate is considered to be mostly placebo, or inactive, and that is the value of a placebo-controlled study.
There are numerous variables that determine the success of therapy in Covid-19, and assigning the credit to plasma showed a remarkable lack of foresight. At this juncture, the Indian Council of Medical Research (ICMR), in a multicentric study published in the British Medical Journal (BMJ), found that plasma wasn’t so good. But the public opinion swayed by the hospitals who pioneered the concept pilloried the paper and trashed it. Such was the distrust in our own country’s research that none wanted to get off the plasma bandwagon. Countless patients spent their life savings on what was a highly questionable therapy. And the charade continued till the second wave subsided.
The breakthrough
As always, we waited for a foreign journal to agree to a local finding, which was not surprising to a lot of us in the government hospitals. The landmark paper in the New England Journal of Medicine (NEJM) showed that there was “No significant differences in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo.” It has been cited 455 times since it was published in February 2021. The number exceeds the citations of any of the papers published by the ‘experts’ who rolled out an untried therapy on the nation.
To add insult to injury, a section of the print media, which studiously avoided criticising them because their publications were the benefactors of full pages advertisements on plasma banks. To make it worse, some of the names suggested for the Padma awards this year included the plasma therapy pioneers.
Who takes the responsibility?
In retrospect, what needs to be asked is—who will pay for the loss of life savings and the death of patients who were given plasma therapy? Who will fill in the gaps for the distrust in medical care? Will the experts apologise? Who will apologise for pillorying the ICMR’s report that could have nipped this in the bud? But no one really apologises for such things in India.
As Donald Keough said, “The truth is, we are not that dumb and we are not that smart.” The plasma blitzkrieg was neither dumb nor smart; it was callous, and someone should be paying for the negligence today or tomorrow.