IASbhai Daily Editorial Hunt | 13th Jan
“If you don’t value your time, neither will others. Stop giving away your time and talents–start charging for it.” —Kim Garst
EDITORIAL HUNT #313 :“Side-effects of a flawed Vaccine Trial | UPSC ”
Side-effects of a flawed Vaccine Trial | UPSC
The debilitating side-effect of a flawed vaccine trial
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
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)
- HPV Controversy Vs COVAXIN
- Many Missteps in Vaccine Trials
- How to Act Quickly ?
- Way Forward
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- RESTORING CONFIDENCE : Only a thorough and impartial probe will restore confidence in clinical trials.
- 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.