ICMR director-general Balram Bhargava. Source: YouTube
- A conflict of interest in science typically refers to a situation in which financial or political interests appear to influence the research output.
- If a parent is actually impartial while grading her son’s board exam answer sheet, the people’s trust in the credibility of the examination may not be remarkable.
- ICMR may have been in a tricky situation due to collaborations with industry while under political pressure, but it should have disclosed these issues in advance.
In the late 2000s, Willie Soon of the Harvard Smithsonian institute became a hero among climate change deniers. Soon’s research suggested the possibility that greenhouse-gas emissions may not be the cause for climate change. Some American senators even went to the extent of citing his work in attempts to block climate action.
Later, an investigation by Greenpeace brought to light that Soon’s research had been funded by oil companies, including Exxon Mobil. This led experts to flag undisclosed conflict of interests in their work, and confront the possibility that Soon’s research outputs were compromised by his financial interests.
A conflict of interest in science typically refers to a situation in which financial or political interests appear to influence the research output. It is not uncommon today to have researchers and research institutions with such conflicts of interest. Especially in industry-sponsored research, researchers may be influenced to report findings that are favourable to the sponsor.
Sometimes, the resulting bias may be unintended, far from a crime or limited to being misconduct. But in the space of biomedical research, like that of COVID-19 vaccines, managing conflicts of interest is important so that the health and lives of the millions of people involved are protected. The public may tend to distrust vaccines if the development and evaluation processes involve poorly managed conflicts of interest.
Public trust is also why research agencies take conflict of interests seriously, and have a responsibility to ensure vaccine evaluations are unbiased.
The Indian Council of Medical Research (ICMR) and private pharmaceutical company Bharat Biotech jointly developed India’s homegrown COVID-19 vaccine, called Covaxin. As the country’s nodal medical research body, ICMR has been spearheading India’s COVID-19 response since the start of the pandemic last year.
In May 2021, ICMR revealed that it was receiving a 5% royalty from Bharat Biotech for Covaxin’s sales, in response to a media query. Even though this money may not directly go to researchers at ICMR, the body may benefit from it towards research grants and equipment. Covaxin’s success also means more prestige for ICMR as a research institute and more influence over policy decisions of the government.
ICMR thus has an institutional conflict of interest when it comes to Covaxin studies, where its secondary interests include money and power. The new revelations by the New York Times, that ICMR’s work during the pandemic has been influenced by political considerations, point to the possibility that these conflicting interests have been poorly managed as well.
ICMR already enjoys considerable heft in policy decisions regarding COVID-19 vaccines, considering ICMR members are present in the National Expert Group on Vaccine Administration for COVID-19 (better known as NEGVAC).
If a parent grades her son’s board exam answer sheets, her impartiality as an examiner would be suspect. Even if she actually is impartial as an examiner, the people’s trust in the credibility of the examination may not be remarkable. We are in a similar situation now: ICMR is an organisation with conflicting interest regarding Covaxin, and it has been studying its efficacy and providing policy suggestions vis-à-vis its use.
ICMR may have been in a tricky situation, with industry collaboration and political pressure, and where it would have been difficult to fully avoid conflicts of interest. So the real questions are about the way ICMR has managed these secondary interests, and what it can do now and in future to manage them more effectively.
Some of the accepted norms in the realm of managing conflicts of interest include disclosure, critical evaluation and designing experiments that are unaffected by secondary interests. It is worth analysing how ICMR fared on each of these counts with regard to Covaxin.
Most ICMR studies of Covaxin have been published as preprint papers and are yet to be published in peer-reviewed journals. In these papers, researchers disclose their conflicts of interest as employees of ICMR and Bharat Biotech. But the fact that ICMR was receiving 5% royalty for Covaxin sales came to light only after media reports – giving the false impression of a shady deal. ICMR should have disclosed this by themselves in their routine press conferences.
Similarly, ICMR should have been more open about the political pressure, which would have been better than exposés by investigative journalists.
The initial clinical trials of the vaccine were conducted by its developers, Bharat Biotech and ICMR – this is the industry norm. But the same entities also later probed Covaxin’s immunogenicity against various novel coronavirus variants, and the effects of mixing Covaxin and Covishield shots.
Note that vaccines like the one developed by Pfizer/BioNTech are being independently evaluated by multiple agencies in different countries for immunogenicity against different variants. These studies determine the policy evolution of the state, which prioritises the vaccines to be used depending on the variant dominating in different regions.
The ICMR and the government could rope in more agencies, including laboratories of the Council of Scientific and Industrial Research, to independently study Covaxin’s effectiveness. ICMR and Bharat Biotech should also invest more efforts to publish more of their studies in peer-reviewed journals, where reviewers could also independently analyse conflicts of interest and their potential impact on findings.
Further, ICMR can appoint independent committees, which could periodically assess conflicts of interest in their research and devise management strategies.
Covaxin represents a great achievement of Indian science and we can’t underplay that. But the edifice of scientific research depends on foundations of credibility and public trust. So it is in the best interests of India’s scientific community to avoid controversies like the ones ICMR is going through now.
A. Janardhana is a freelance science journalist based in France.