IASbhai Daily Editorial Hunt | 13th Jan

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Dear Aspirants
IASbhai Editorial Hunt is an initiative to dilute major Editorials of leading Newspapers in India which are most relevant to UPSC preparation –‘THE HINDU, LIVEMINT , INDIAN EXPRESS’ and help millions of readers who find difficulty in answer writing and making notes everyday. Here we choose two editorials on daily basis and analyse them with respect to UPSC MAINS 2020-21.

EDITORIAL HUNT #313 :“Side-effects of a flawed Vaccine Trial | UPSC 

Side-effects of a flawed Vaccine Trial | UPSC

R.Prasad
Side-effects of a flawed Vaccine Trial | UPSC

      HEADLINES:

The debilitating side-effect of a flawed vaccine trial

      CENTRAL THEME:

A failure to investigate the conduct of the recent Covaxin phase-3 trial can affect the course of other studies under way

SYLLABUS COVERED: GS 4 : Medical Ethics

      MAINS QUESTION:

What are the ill consequences of a failed vaccine trial in the society ? How important it is that a vaccine undergoes third phase of trial in case of COVID-19 ? Discuss -(GS 4)

      LEARNING: 

  • HPV Controversy Vs COVAXIN
  • Many Missteps in Vaccine Trials
  • How to Act Quickly ?
  • Way Forward

      INTRODUCTION: 

  • A DECADE AGO : since the human clinical trial of the human papilloma virus (HPV) vaccine — it was controversial and carried out without proper consent on nearly 23,500 girls in the 10-14 age group.

Eight years later Supreme Court of India slugged the State for slipping into “deep slumber” in addressing the “menace” of illegal clinical trials carried out in India by multinational countries

  • COVAXIN TRIALS : The phase-3 clinical trial of Bharat Biotech’s COVID-19 vaccine, Covaxin in the Bhopal-based Peoples College of Medical Sciences & Research Centre appears to suffer from serious violations.
  • THE HPV VACCINE TRIAL : It was carried out by the Program for Appropriate Technology in Health (PATH), a NGO in collaboration with the Indian Council of Medical Research (ICMR).
  • ETHICAL GUIDELINES : Incidentally, the ICMR, tasked with promulgating research ethics guidelines, is the co-sponsor of the Covaxin trial.

      BODY: 

  • RIGHT TO BE INFORMED : The informed consent process, the cornerstone of ethics in clinical trials, was grossly violated during the HPV trial in Andhra Pradesh.

Consent forms of nearly 2,800 child participants were signed by a hostel warden or headmaster and not the parents
 

MANY MISSTEPS

  • IGNORANCE : During a press conference on January 10 , the Covaxin trial participants alleged that they were ignorant of what they were signing up for.
  • CONSENT AND APPROVAL : If true, it amounts to the consent nowhere close to being a truly informed one.

According to them, no efforts were apparently taken to explain and inform them of the pros and cons of taking part in the trial 
 

  • VACCINATION TRIALS : They told that they would either get a vaccine candidate or a placebo.
  • MISLEADING PARTICIPANTS : Instead, they were misled by the trial site to think they were getting a COVID-19 vaccine for free.
  • RIGHT TO FREE MEDICAL CARE : The participants were not made aware of their rights to free medical care in case of any adverse events.
  • CONSENT FORMS : They were not given any time or option to discuss with the family before signing the consent form, either.

As documents show, at least in a few instances, the consent was taken after vaccination, which amounts to a serious violation 

  • UNDOCUMENTED PROCESS : They also alleged that they were not given a copy of the consent form and other documents to prove their participation.
  • SUPREME COURT (2013) : The Indian regulator had in 2019 made mandatory an audio-video recording of the informed consent process of each vulnerable individual participant before conducting clinical trials.

A written consent from the participant had to necessarily be taken before the audio-video recording of the informed consent process

  • WITNESS : Since many of the 700-odd participants are illiterate, an impartial witness should have been present during the entire informed consent process to append his/her signatures to the consent form.
  • LURED FOR MONEY : In the Covaxin trial in Bhopal, over a dozen of the 700 adults from three-four communities living close to the hospital have told the media that they were lured with monetary benefits of ₹750.

Luring people to participate in clinical trials by offering money is unethical.

  • REIMBURSEMENT : However, the company in a press release states that a decision was taken to reimburse all participants at the rate of ₹750 for each study visit.

The company claims the reimbursement amount was approved by every institutional ethics committee at the study sites, and is not an inducement

  • PAYMENT ANNOUNCEMENT : While reimbursement for actuals, such as lost wages and cost of transportation to the trial site, is permissible, it amounts to inducement when a payment of ₹750 is openly announced.
  • STREET ANNOUNCEMENT : It is unclear if the institutional ethics committee even approved street announcements to be made inviting people to the trial.
  • ADVERTISEMENTS : Whether a site can advertise and even the content of such promotional material need prior approval from the institutional ethics committee.

FOLLOW-UP AND CARE

  • VIOLATIONS : While free medical care in case of any adverse event is a right of each trial participant, there have been at least a few documented instances of violation.
  • AWARENESS : In other cases, the participants, unaware that they were part of a clinical trial and hence entitled to free medical attention, had sought care from private practitioners.
  • MEDICAL FOLLOW UP PROCESS : With at least some participants not possessing their own mobile phones, medical follow-up over phone, even if there was one, was not actually possible.
  • BHARAT BIOTECH CLAIMS : While Bharat Biotech claims that all due processes were followed following this development.

It is still unclear why no information about the death of the trial participant, who belongs to a tribe, was made public by the Indian regulator

  • ASTRAZENECA’S VACCINE : In the case of serious adverse events following injection with AstraZeneca’s COVID-19 vaccine in a trial outside India, the information was made public, and the trial was halted at all sites.

      IASbhai Windup: 

ACT QUICKLY

  • RESTORING CONFIDENCE : Only a thorough and impartial probe will restore confidence in clinical trials.

All the more as a couple of COVID-19 trials have already progressed to the phase-3 trial stage and few more are in the early stages of testing

  • RECRUITMENTS PROCESS : With two vaccines already approved for restricted use and the virus spread slowing down, recruiting participants will prove to be all the more challenging.

The conduct of a highly unethical trial, if not thoroughly and quickly investigated, can adversely impact the conduct of these studies already under way.

       SOURCES:   THE HINDU EDITORIAL HUNT | Side-effects of a flawed Vaccine Trial | UPSC 

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