Thorny ethical issues

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Thorny ethical issues

Friday, 17 July 2020 | Ajoy Kumar

Thorny ethical issues

It is important that India distances itself from China’s example of providing lax medical standards that have made the latter a popular territory for ethics dumping

The European Union (EU) sponsored an investigation and set up a commission called the European Emergency Trust Fund, which came to an end in 2018. Collaborators and researchers from different parts of the world were part of this study. The commission examined questions related to “ethics dumping,” typically practised by rich nations having strict legal regimes on poorer countries with more lax regulations. American screenwriter Doris Schroeder, who led the trust, said that while there were certain cases where there is a “lack of awareness”, there are also others “where there was a definite attempt to avoid legislation in European countries.”

It is noteworthy that one of the countries which is reportedly notorious for making itself available to this practice of ethics dumping is China. One such high-profile case was that of Sergio Canavero, an Italian neurosurgeon, who sought to perform head transplants on humans. Unable to attempt such a procedure in Europe, Canavero approached Ren Xiaoping, a Chinese orthopaedic surgeon from Harbin Medical University, and carried out his work on dogs and monkeys. Canavero also apparently planned to graft the head of a patient, who was paralysed from the neck down after being injured wrestling with a friend. He was reportedly stopped by China’s Health Ministry before he could attempt an experiment that had more in common with the fictional Frankenstein’s monster than anything related to medical science.

With tension along the Line of Actual Control (LAC) brewing and the Indian Government’s decision to ban 59 applications from China, it is more than obvious that India would like to distance itself from China and has hence increased focus on making the country aatmanirbhar (self-reliant). It is important that India distances itself from the Chinese example of providing lax medical standards that have made the latter a popular territory for “ethics dumping.” In this context, recent examples show that we are treading a dangerous path.

Take the example of Coronil, the ayurvedic medicine manufactured by Patanjali, which claimed that “those administered the medicine were fully cured and none died.” Patanjali further claimed that 69 per cent of those who were administered the medicine were cured within three days and a whopping 100 per cent recovered in seven days. It almost sounded as if we had  found a “miracle cure.” However, this excitement and enthusiasm were short-lived. On the face of mounting criticism from those outside Patanjali, including the common citizens and the Ministry of AYUSH among others, Patanjali came up with a clarification, saying it never claimed that Coronil was a cure for COVID-19. As more details began to emerge, the impossible nature of Patanjali’s claim was exposed.

As per reports that rely on research papers submitted by Patanjali to the AYUSH Ministry, it emerged that the Ayurveda firm “did not test  Coronil on any severe Coronavirus patient.” Clinical trials were conducted only on 120 asymptomatic, mildly symptomatic and moderately symptomatic patients between the 15-80 year age group.

As someone familiar with the sphere of medical science and one who knows about the process involved in approving a particular drug to be administered to patients, it was shocking that Patanjali made an outlandish claim on the basis of limited data. Watching such standards, I am afraid that a number of home remedies can qualify as “cures” for Coronavirus.

However, what’s more shocking is that such outlandish claims are allowed to go unpunished without such firms getting a serious rap on the knuckles. COVID-19 is one of the biggest threats to humanity in recent memory. Allowing such companies and individuals to earn profit by creating panic and fear among the citizens is something that history will not look kindly on.

Another example is that of Itolizumab, a drug used to cure skin ailment psoriasis, which was approved by India’s drug regulator to treat COVID-19 patients with moderate to severe acute respiratory distress. Typically, drugs are approved after trials on hundreds of patients. However, in this case, approval was given without any phase-3 trials. Randomised clinical trial of only 30 patients was conducted. Doctors from different parts of the country are using similar drugs that are already available in the market on patients who are experiencing moderate to severe Corona symptoms.

Doing away with the phase-3 trials for drugs could open the gates for the patients to be used as guinea pigs. It is also surprising that most of our discussions are focussed on wonder drugs that are expensive. But drugs like dexamethasone, which is deemed to be extremely effective on COVID-19 patients on ventilators, is available at a much more reasonable cost. There has been little discussion on television channels or newspapers about this drug.  

A large part of the responsibility falls on the manufacturers. We must demand more from them but is the Government acting with  restraint or responsibility? Unfortunately, expert bodies have allowed such laxity through their conduct.

The most obvious example is of a letter dated July 2 by the Indian Council of Medical Research (ICMR). In this letter to the select institutes, where the clinical trial pf COVID-19 is to be done, it states that it wants the institutions to “fast-track all approvals” and to ensure that participants in the trial of the vaccine are enrolled “no later than July 7” so that the launch of the vaccine can be done by August 15. The letter further goes on to state that any non-compliance to the order will be viewed “seriously.”

The contents of this letter are troubling. This, not merely because of the fact that by designating August 15 — which is the day we celebrate the independence day — as the date on which vaccine should be launched, the ICMR is reducing a serious medical crisis to a potential political gimmick.

It is all the more worrisome that the ICMR, an organisation that is meant to rely on science, has asked institutions to fast track all approvals. This would include getting relevant approvals from the ethics committees of these institutions.

This approach of potentially favouring a headline over obtaining relevant approvals must be criticised. Repercussions of such a move may outweigh possible benefits. It is time for the ICMR to speak to the Government and the citizens instead of setting such ludicrous timelines.

Even optimists in the scientific community do not realistically expect a vaccine to be available till early 2021. In the event, the ICMR needs to convince the Government of a more calibrated approach. It can cite the example of  Canavero and China and how India would do well to not go down that dark alley where medical ethics is considered “red tape” rather than a necessary check on reckless scientific pursuit.

(The writer is a former IPS officer, a former MP and currently a member of the AAP)

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