Editorial 1 : Publish and Perish
Context: A study on side-effects of Covaxin and three lessons in public trust and research
Recent Events and Controversy
- Study: Authored by the faculty and students of the Banaras Hindu University and titled ‘Long-term safety analysis of the BBV152 coronavirus vaccine in adolescents and adults: Findings from a 1-year prospective study in North India’ the study and research paper has snowballed into a huge controversy.
- The study was published in May 2024 in a peer-reviewed international journal, Drug Safety.
- ICMR flagged the flawed methodology and found the use of the term adverse events of special interest (AESIs) to be inconsistent with its globally accepted definition.
- ICMR demanded the retraction of the paper.
- Covaxin’s manufacturer, Bharat Biotech, filed a suit against the journal’s editors and authors for causing shock, alarm, and hesitancy about the safety and efficacy of Covaxin.
- Academicians and members of civil society opposed the suit and strongly backed the need to promote independent research.
- The journal removed the disputed paper and Bharat Biotech withdrew the suit against the editors, which leaves the authors to fend for themselves.
- The whole episode raises important questions, which go beyond the paper.
Editorial Accountability
- The researchers had followed a protocol approved by the BHU’s ethics committee and had acted on the advice of the journal’s peer reviewers.
- The paper was published within four months of submission, signifying extraordinary editorial receptivity.
- The journal’s u-turn needs an answer
Role of ICMR
- ICMR is the co-owner of the Covaxin patent for Covid-19, along with Bharat Biotech, it needs to remind the public about that role.
- ICMR’s National Institute of Virology had provided the virus strains to Bharat Biotech.
- Conflict of interest questions were raised in 2021 but died down once Covaxin began to be used and was acknowledged as a great achievement of Indian science.
- But now, questions are being raised again in the wake of the BHU paper’s controversy.
Researchers’ Role
- Advising caution and monitoring is easy. The difficult part is to answer how and who should be cautioned, and who should supervise the exercise.
- The researchers identified upper respiratory infections (URIs) for cautionary recommendations but failed to address to whom the recommendations are aimed at.
- Coughs, colds, sinuses and sore throats largely constitute URIs.
- Even more absurd are the cases of acne, myopia, hair loss and skin problems which have been placed under the rubric of safety monitoring.
- The paper has not drawn any causal link with the vaccine but for the average reader such links were implied.
Larger Concerns in India’s Research Space and Way Forward
- Increased Defamation Cases: If defamation cases against academics become a trend, as is happening in other countries, it will hurt independent research, especially on drugs and vaccines.
- The biggest losers would be consumers and that’s a huge concern.
- ICMR and universities must see that medical research proposals are screened institutionally to avoid causing public mistrust or impacting the delivery of essential public health services, including vaccination.
Medical research methodology must expect research to be mindful of drawing unworkable conclusions. Pursuing medical research is critical, but so also is staying down-to-earth.
Editorial 2 : Delhi Must Listen to Himalayas
Context: Sonam Wangchuk’s protest and Himalayan Policy
Introduction: Protest in Ladakh
- The protest of the people of Ladakh, led by the Leh Apex Body and Kargil Democratic Alliance, has been going on for months now, without drawing much national attention.
- The historic Leh to Delhi padyatra led by Sonam Wangchuk must serve as a reminder that India needs a Himalayan policy.
Recent Situation in Himalayas
- Protest in Ladakh, Abrogation of Article 370, massive landslides in Uttarakhand, regime change in Nepal, flash floods in Sikkim, Bhutan’s proximity to China, NPR trouble in Assam and civil war in Manipur.
- These incidents are placed under different heads i.e. geo-politics, terrorism, internal security, natural disaster, ethnic violence and so on.
- Seventy years ago, Rammanohar Lohia asked for an integral view, by recognising the interconnections among the Himalayan states and their issues.
Post Independence and Lohia’s Views
- In the early post-Independence years, with the threat of Chinese aggression looming large, Lohia’s principal concern was with the political dimensions of the Himalayan policy, on how the external and internal challenges were intertwined.
- Lohia stood for the democratic rights of the Himalayan people within and outside India, advocated India’s support to peoples’ struggles against their rulers in Tibet and Nepal, argued for democratic dialogues with the rebels in Kashmir and Nagaland and vehemently opposed Verrier Elwin’s tribal policy of social and physical segregation of Adivasis from non-Adivasis in the North-east.
- Opposition to Nehru: His sharpest difference was with Nehru, on his foreign policy that closed its eyes to Chinese expansionism and its aggressive designs on India.
- Himalayan Policy: Lohia’s reflections on a Himalayan policy envisioned multiple unities:
- Of the people living in different states of the Himalayan region.
- Of the citizens of neighbouring countries with Indian citizens across the border.
- Of the culture and society of the Himalayan region with the rest of India.
Demands from Ladakh
- Wangchuk and his colleagues demand democratic governance for Ladakh either as a full state or as a Union Territory with an elected legislature, as in Delhi or Puducherry.
- After decades of remaining the invisible and neglected L in J&K, the people of Ladakh wish to be ruled by a government elected by and accountable to them.
- They want their democracy to be decentralised.
- Sixth Schedule: Sixth Schedule status for Ladakh would allow each of the eight districts inhabited by different tribal communities to have their own Autonomous District Councils and be responsible for their internal governance.
- This would empower each of the smaller communities to preserve their culture and identity.
- Ecological Democracy: People in Ladakh want to ensure land, jobs and cultural rights for the local population in a frame that may be described as ecological democracy.
- They are asking for a new model of development.
Advocacy for Himalayan Policy
- Himalayan policy is now an established wisdom in the academic and activist world.
- The lazy poetic image of the Himalayas as our sentry has given way to an understanding of it as a young and vulnerable mountain range that cannot support unlimited roads, bridges and buildings.
- National Security View: The national security perspective centred on armies and geo-politics has given way to a focus on human security, on the needs and aspirations of the people and communities that live in the Himalayas.
- Resource Focused View: The tourist-eye-view of the Himalayas as a source of natural beauty has shifted in favour of the Himalayas as a source of water, medicinal plants, bio-diversity, sustainable livelihood practices and knowledges.
Conclusion: Sonam Wangchuk and his colleagues do not just remind us of need to pay attention to Himalayan region, they also deepen our understanding of what Himalayan policy might mean in our times. The Indian state must come to terms with the idea that Himalaya is not just places, it’s also people.