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.

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.
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.
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.
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.
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.
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.
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.
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

Mergers and privatisation: The Finance Minister’s misguided banking agenda

By Thomas Franco The Finance Minister has once again revived talk of merging two or three large public sector banks to make them globally competitive. Reports also suggest that the government is considering appointing Managing Directors in public sector banks from the private sector. Both moves would strike at the heart of India’s public banking system . Privatisation undermines the constitutional vision of social and economic justice, and such steps could lead to irreversible damage.

Buddhist shrines were 'massively destroyed' by Brahmanical rulers: Historian DN Jha

Nalanda mahavihara By Rajiv Shah Prominent historian DN Jha, an expert in India's ancient and medieval past, in his new book , "Against the Grain: Notes on Identity, Intolerance and History", in a sharp critique of "Hindutva ideologues", who look at the ancient period of Indian history as "a golden age marked by social harmony, devoid of any religious violence", has said, "Demolition and desecration of rival religious establishments, and the appropriation of their idols, was not uncommon in India before the advent of Islam".

Political misfires in Bihar: Reasons behind the Opposition's self-inflicted defeat

By Vidya Bhushan Rawat* The Bihar Vidhansabha Election 2025 verdict is out. I maintained deliberate silence about the growing tribe of “social media” experts and their opinions. Lately, these do not fascinate me. Anyone forming an opinion solely on the basis of these “experts” lives in a fool’s paradise. I do not watch them, nor do I follow them on Twitter. I stayed away partly because I was not certain of a MahaGathbandhan victory, even though I wanted it. But my personal preference is not the issue here. The parties disappointed.

Celebrating 125 yr old legacy of healthcare work of missionaries

Vilas Shende, director, Mure Memorial Hospital By Moin Qazi* Central India has been one of the most fertile belts for several unique experiments undertaken by missionaries in the field of education and healthcare. The result is a network of several well-known schools, colleges and hospitals that have woven themselves into the social landscape of the region. They have also become a byword for quality and affordable services delivered to all sections of the society. These institutions are characterised by committed and compassionate staff driven by the selfless pursuit of improving the well-being of society. This is the reason why the region has nursed and nurtured so many eminent people who occupy high positions in varied fields across the country as well as beyond. One of the fruits of this legacy is a more than century old iconic hospital that nestles in the heart of Nagpur city. Named as Mure Memorial Hospital after a British warrior who lost his life in a war while defending his cou...

New RTI draft rules inspired by citizen-unfriendly, overtly bureaucratic approach

By Venkatesh Nayak* The Department of Personnel and Training , Government of India has invited comments on a new set of Draft Rules (available in English only) to implement The Right to Information Act, 2005 . The RTI Rules were last amended in 2012 after a long period of consultation with various stakeholders. The Government’s move to put the draft RTI Rules out for people’s comments and suggestions for change is a welcome continuation of the tradition of public consultation. Positive aspects of the Draft RTI Rules While 60-65% of the Draft RTI Rules repeat the content of the 2012 RTI Rules, some new aspects deserve appreciation as they clarify the manner of implementation of key provisions of the RTI Act. These are: Provisions for dealing with non-compliance of the orders and directives of the Central Information Commission (CIC) by public authorities- this was missing in the 2012 RTI Rules. Non-compliance is increasingly becoming a major problem- two of my non-compliance cases are...

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...

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.

From fake interviewer to farmer’s advocate: Akshay Kumar’s surprising role in 'Jolly LLB 3'

By Prof. Hemantkumar Shah* At the luxurious INOX theatre in Sky City Mall, Borivali East, Mumbai, around seventy upper-middle-class viewers attended the 10:45 a.m. screening of Jolly LLB 3. In the film’s concluding courtroom sequence, Arshad Warsi’s character asks the judge whether he would willingly surrender one of his own homes to the government for a development project in Delhi.

Whither GIFT City push? Housing supply soars in Mumbai, Hyderabad, Pune, not Ahmedabad

By Rajiv Shah A new report by a firm describing itself as a "digital real estate transaction and advisory platform," Proptiger , states that the Mumbai Metropolitan Region (MMR) has been the largest contributor to housing units among India's top eight cities currently experiencing a real estate boom. Accounting for 26.9% of all new launches, it is followed by Pune with 18.7% and Hyderabad with 13.6%. These three cities collectively represented 59.2% of the new inventory introduced during the third quarter (July to September 2025), which is the focus of the report’s analysis.

Search This Blog