Skip to main content

Desist from academic censorship, stop threatening scholars: Letter to ICMR

Counterview Desk 
In a letter to the Indian Council of Medical Research (ICMR) director, the Universal Health Organisation (UHO) which consists of prominent health experts, has insisted that the Government of India’s top medical research agency should lead high quality research on vaccine safety and “desist from academic censorship”.
Objecting to the ICMR asking the Journal of Drug Safety retract the peer-reviewed study by two Benaras Hindu University (BHU) scholars, UHO said, the study, in fact, has “filled an important gap in terms of field data analyzing the long-term safety of the widely administered Covid vaccine Covaxin.”
Insisting that the two authors of the study are being threatened, the letter, addressed to Dr Rajiv Bahl, said, “Privately addressed letters to the authors and the journal editor have been leaked to the press and in social media. This amounts to harassment and intimidation of the study authors. ICMR must investigate this transgression of professional conduct.”

Text:

A recent research study [link] was published on 13 May 2024 in the Journal of Drug Safety by a research group from IMS-BHU. This filled an important gap in terms of field data analyzing the long-term safety of the widely administered Covid vaccine Covaxin. While we were hoping and expecting a research institution of repute such as ICMR to build upon this study, address its shortcomings, and elevate the standards of vaccine safety, we are aghast to come across letters sent by ICMR (a) asking for the retraction of the paper, and (b) threatening the authors of the study. Several aspects are amiss in this context.
  1. In its letters, ICMR has pointed out that the published study lacks a control group. This is indeed a shortcoming of the study – but is admitted in the study itself, in the “limitations” section. No scientific study is without limitations, and the study must be used to further improve vaccine safety studies. To the contrary, calling for its retraction is unbecoming of a scientific institution of ICMR’s stature.
  2. While a study with a control group would certainly be of higher quality, this immediately points to the fact that it is researchers from ICMR who have access to the data with the control group, i.e. the original phase-3 trials of Covaxin – as well publicized in “The Vaccine War” movie. ICMR thus owes it to the people of India, that it publishes the long-term follow-up of phase-3 trials. It is to be noted that interim results [link] of the phase-3 trial, also cited by Dr. Priya Abraham in “The Vaccine War” movie, had a mere 56 days of safety follow-up, much shorter than the one-year follow-up in the IMS-BHU study. Furthermore the ICMR phase-3 trial study did not include adolescents below 18 years, which the IMS-BHU study does. While Bharat Biotech has claimed in the media [link] that “safety monitoring was continued”, neither Bharat Biotech nor ICMR has published the long-term safety results.
  3. In Sep 2022, Bharat Biotech, the manufacturer of Covaxin, had published a study on Covaxin for ages 2-18 [link]. This study too lacked a control group. Furthermore, it had a mere 175 adolescents in the 12-18 age-group, likely around just 80-90 in the 15-18 age-group, and it too had only 56 days of follow-up. In comparison, the IMS-BHU study has 635 adolescents in the 15-18 age-group followed-up for a year. These aspects further underscore the intrinsic value of the IMS-BHU study despite its stated limitations.
  4. Privately addressed letters to the authors and the journal editor have been leaked to the press and in social media. This amounts to harassment and intimidation of the study authors. ICMR must investigate this transgression of professional conduct.
  5. The letter addressed to the authors is spreading a falsehood about the first author Dr. Upinder Kaur. Dr. Kaur has not acknowledged ICMR at all. While “The Vaccine War” movie is celebrating women scientists, this ICMR letter is spreading a falsehood about a woman researcher. ICMR must thus issue a note of apology in this regard to Dr. Kaur.
  6. On the issue of use of telephonic interview for safety follow-up, it is certainly a limitation, as also admitted by the authors in the “limitations” section. However, it is to be noted that the same research group also published a safety follow-up study on Covishield in Jul 2021 [link]. This study was later cited by a study on Covishield with several authors from ICMR [link], including the then director Dr. Balram Bhargava. Therefore, ICMR researchers acknowledged then that telephonic interview is a valid process, although not most desirable. Furthermore, telephonic interviews for follow-up is part of ICMR’s own Covaxin rollout plan [link]. Thus, citing telephonic interviews as a reason to call for retraction of the IMS-BHU study is unsound and inconsistent.
  7. The issue of author acknowledgement itself has been blown out of proportion. If ICMR does not wish to be acknowledged, it can communicate this privately to the authors and the editor and an erratum can be issued – a routine matter in scientific publications.
  8. The above appears all the more stark in light of the following. On 29 Aug 2022, the Hon’ble Supreme Court of India had issued a notice [link] to ICMR, in the case of “Rachana Gangu & ANR vs Union of India & ORS”, involving Covid vaccine safety. However, even after nearly 21 months, ICMR has not found time to respond to this notice, while it has found time within a few days to raise issue with author acknowledgement in a publication. ICMR must invert its priorities and give more weightage to the notice from the Indian Supreme Court.
In summary, we reiterate that ICMR must lead the country in giving vaccine safety its due priority. It must publish data from the original phase-3 trial with long-term follow-up, as well as lead other high quality research studies on long-term safety. It must certainly desist from academic censorship of the already small number of studies on Covaxin long-term safety. ICMR owes this to the lakhs of Indian children to whom Covaxin has been administered, for these children have their entire life ahead of them.
In anticipation of a positive response,
Yours Sincerely,
Managing Committee of Universal Health Organisation (UHO) – https://uho.org.in/
Dr. Amitav Banerjee, MD, Clinical Epidemiologist, Pune
Dr. Arvind Singh Kushwaha, Community Medicine, Auraiya
Dr. Veena Raghava, MBBS, DA, Clinical Nutrition (NIN), Bengaluru
Dr. Praveen K Saxena, MBBS, DMRD, FCMT, Hyderabad
Dr. Maya Valecha, MD, DGO, Vadodara
Dr. Gayatri Panditrao, BHMS (Homoeopathic Consultant), PGDEMS, Pune
Mr. Ashutosh Pathak, Journalist, QVIVE, Delhi
Mr. Prakash Pohare, Journalist, Deshonnati, Akola
Prof. Bhaskaran Raman, Professor of Computer Science and Engineering, Mumbai

Comments

Post a Comment

TRENDING

A comrade in culture and controversy: Yao Wenyuan’s revolutionary legacy

By Harsh Thakor*  This year marks two important anniversaries in Chinese revolutionary history—the 20th death anniversary of Yao Wenyuan, and the 50th anniversary of his seminal essay "On the Social Basis of the Lin Biao Anti-Party Clique". These milestones invite reflection on the man whose pen ignited the first sparks of the Great Proletarian Cultural Revolution and whose sharp ideological interventions left an indelible imprint on the political and cultural landscape of socialist China.
Post a Comment
»

1857 War of Independence... when Hindu-Muslim separatism, hatred wasn't an issue

"The Sepoy Revolt at Meerut", Illustrated London News, 1857  By Shamsul Islam* Large sections of Hindus, Muslims and Sikhs unitedly challenged the greatest imperialist power, Britain, during India’s First War of Independence which began on May 10, 1857; the day being Sunday. This extraordinary unity, naturally, unnerved the firangees and made them realize that if their rule was to continue in India, it could happen only when Hindus and Muslims, the largest two religious communities were divided on communal lines.
Post a Comment
»

N-power plant at Mithi Virdi: CRZ nod is arbitrary, without jurisdiction

By Krishnakant* A case-appeal has been filed against the order of the Ministry of Environment, Forest and Climate Change (MoEF&CC) and others granting CRZ clearance for establishment of intake and outfall facility for proposed 6000 MWe Nuclear Power Plant at Mithi Virdi, District Bhavnagar, Gujarat by Nuclear Power Corporation of India Limited (NPCIL) vide order in F 11-23 /2014-IA- III dated March 3, 2015. The case-appeal in the National Green Tribunal at Western Bench at Pune is filed by Shaktisinh Gohil, Sarpanch of Jasapara; Hajabhai Dihora of Mithi Virdi; Jagrutiben Gohil of Jasapara; Krishnakant and Rohit Prajapati activist of the Paryavaran Suraksha Samiti. The National Green Tribunal (NGT) has issued a notice to the MoEF&CC, Gujarat Pollution Control Board, Gujarat Coastal Zone Management Authority, Atomic Energy Regulatory Board and Nuclear Power Corporation of India Limited (NPCIL) and case is kept for hearing on August 20, 2015. Appeal No. 23 of 2015 (WZ) is filed, a...
Post a Comment
»

Two more "aadhaar-linked" Jharkhand deaths: 17 die of starvation since Sept 2017

Kaleshwar's sons Santosh and Mantosh Counterview Desk A fact-finding team of the Right to Feed Campaign, pointing towards the death of two more persons due to starvation in Jharkhand, has said that this has happened because of the absence of aadhaar, leading to “persistent lack of food at home and unavailability of any means of earning.” It has disputed the state government claims that these deaths are due to reasons other than starvation, adding, the authorities have “done nothing” to reduce the alarming state of food insecurity in the state.
1 comment
»

Spirit of leadership vs bondage: Of empowered chairman of 100-acre social forestry coop

By Gagan Sethi*  This is about Khoda Sava, a young Dalit belonging to the Vankar sub-caste, who worked as a bonded labourer in a village near Vadgam in Banskantha district of North Gujarat. The year was 1982. Khoda had taken a loan of Rs 7,000 from the village sarpanch, a powerful landlord doing money-lending as his side business. Khoda, who had taken the loan for marriage, was landless. Normally, villagers would mortgage their land if they took loan from the sarpanch. But Khoda had no land. He had no option but to enter into a bondage agreement with the sarpanch in order to repay the loan. Working in bondage on the sarpanch’s field meant that he would be paid Rs 1,200 per annum, from which his loan amount with interest would be deducted. He was also obliged not to leave the sarpanch’s field and work as daily wager somewhere else. At the same time, Khoda was offered meal once a day, and his wife job as agricultural worker on a “priority basis”. That year, I was working as secretary...
Post a Comment
»

Epic war against caste system is constitutional responsibility of elected government

Edited by well-known Gujarat Dalit rights leader Martin Macwan, the book, “Bhed-Bharat: An Account of Injustice and Atrocities on Dalits and Adivasis (2014-18)” (available in English and Gujarati*) is a selection of news articles on Dalits and Adivasis (2014-2018) published by Dalit Shakti Prakashan, Ahmedabad. Preface to the book, in which Macwan seeks to answer key questions on why the book is needed today: *** The thought of compiling a book on atrocities on Dalits and thus present an overall Indian picture had occurred to me a long time ago. Absence of such a comprehensive picture is a major reason for a weak social and political consciousness among Dalits as well as non-Dalits. But gradually the idea took a different form. I found that lay readers don’t understand numbers and don’t like to read well-researched articles. The best way to reach out to them was storytelling. As I started writing in Gujarati and sharing the idea of the book with my friends, it occurred to me that while...
Post a Comment
»

Proposed Modi yatra from Jharkhand an 'insult' of Adivasi hero Birsa Munda: JMM

Counterview Desk  The civil rights network, Jharkhand Janadhikar Mahasabha (JMM), which claims to have 30 grassroots groups under its wings, has decided to launch Save Democracy campaign to oppose Prime Minister Narendra Modi’s Vikasit Bharat Sankalp Yatra to be launched on November 15 from the village of legendary 19th century tribal independence leader Birsa Munda from Ulihatu (Khunti district).
Post a Comment
»

Fate of Yamuna floodplain still hangs in "balance" despite National Green Tribunal rap on Sri Sri event

By Ashok Shrimali* While the National Green Tribunal (NGT) on Thursday reportedly pulled up the Delhi Development Authority (DDA) for granting permission to hold spiritual guru Sri Sri Ravi Shankar's World Culture Festival on the banks of Yamuna, the chief petitioners against the high-profile event Yamuna Jiye Abhiyan has declared, the “fate of the floodplain still hangs in balance.”
Post a Comment
»

Hyderabad Cong leader hospitalized after alleged AIMIM-linked mob attack; party demands justice

By A Representative   A group of Congress leaders and activists have written to the Hyderabad Commissioner of Police, urging immediate action over what they describe as a “mob lynching murderous attack” on party functionary Mohammed Hamed at the Congress Party office in New Kishan Nagar, Asifnagar, on July 21.
Post a Comment
»