ICMR was unable to share sero-survey data from access points: researchers


PM Narendra Modi at the Lok Sabha on the opening day of the monsoon session of parliament, September 14, 2020. Photo: LSTV / PTI.

Researchers who conducted and analyzed the results of India’s first national seroprevalence survey, to estimate the prevalence of COVID-19 in the population in May 2020, have alleged that they were not allowed to include data from disease hotspots in 10 cities in the document they published describing the survey.

Sources said The Telegraph that the director general of the Indian Council of Medical Research (ICMR), Balram Bhargava, had asked the researchers to delete the data, collected between May 11 and June 4, because the ICMR did not have the necessary approvals to publicize it. The article was published in Indian Journal of Medical Research this month.

The sources told the newspaper that Bhargava, who is also secretary of the Health Research Department, had not mentioned where the instruction originated. This has sparked a storm of concern among experts that India’s main medical research agency, which generally writes the ethical codes that doctors in India are expected to follow, violated medical ethics itself. “They told us: let’s remove the data from the access points or not publish it,” said a co-author. The TelegraphA statement reportedly corroborated by two others.

The 2019 ICMR Policy on Research Integrity and Publication Ethics specifies:

“Full research, regardless of results, should be published and shared on public databases such as Clinical Trials Research India, institute websites or other relevant available platforms.”

In order to determine what fraction of the Indian population had been infected by COVID-19, the researchers randomly surveyed respondents in 71 districts in 21 states, limiting their participation to 400 per district in non-hotspot areas and 500 per district. district at critical points. There were ten of the latter, in Ahmedabad, Bhopal, Kolkata, Delhi, Hyderabad, Indore, Jaipur, Mumbai, Pune, and Surat.

On June 12, Bhargava had announced the preliminary results of the survey at a press conference, during which he said that ICMR researchers had analyzed samples from 28,000 people in 83 districts. However, the published article mentioned only 71 districts. It was not clear which group of respondents had been left out of the final results, why and how their exclusion had skewed the data.

Sources said The Telegraph that samples from 36% of respondents in Dharavi of Mumbai, 48% of those in Ahmedabad and 30% of those in Kolkata had tested positive for COVID-19 antibodies, indicating that they had been previously exposed to the virus. In general, the results of the document announced the lowest prevalence in the other districts, between 0.62% and 1.03%, setting the national average at 0.73% in late April and early May.

Samiran Panda, head of the ICMR’s epidemiology division and a co-author of the article, defended the decision to omit data related to hot spots from the article because he said the information had been superseded by city-level seroprevalence surveys conducted in some of the the 10 cities.

However, DCS Reddy, another co-author of the article and a community medicine specialist, said that “data from the containment zone of the city’s hotspots” was important “for understanding the dynamics of transmission in areas with high infections.” . The Telegraph he quoted him saying. “As members of the surveillance group, we cannot say why the data was withheld. The council can answer that. “

The city-level seroprevalence surveys found the following prevalences (in the corresponding survey period):

  • Mumbai: 57% in slums, 16% in three other neighborhoods, as of June 29
  • Delhi – 23.48%, from June 27 to July 10
  • Pune – 60.8%, from July 20 to August 5
  • Ahmedabad – 23.24%, from August 15 to August 19

Of the 74 co-authors of the article, The Telegraph He spoke to seven researchers (including Dr. Reddy and Dr. Panda) and sent a questionnaire to Bhargava, to which the ICMR director has yet to respond.

“The pursuit of science is seeking the truth; suppressing research is illogical,” said Jayaprakash Muliyil, co-author and member of the council’s surveillance and epidemiology group for COVID-19. The Telegraph.

According to one of the other co-authors, there was a huge debate over whether the researchers should publish the incomplete data or make their protest over the deliberate burial of crucial data known. Many of them have also pointed to the violation of ethics that stems from having collected blood samples from volunteers only to publish a manipulated analysis of the situation at ground level.

Amar Jesani, physician and editor of the Indian Journal of Medical EthicsHe told the newspaper: “Keeping the selective data out of the results distorts the analysis of the newspaper; this is a violation of the integrity of the investigation. These 5,000 people would have volunteered to give their blood samples because they believed that the analysis would benefit science or society. Deleting your data for no good reason is worrisome. “

Data blindness has been in the news for the past few days and the Narendra Modi government claimed it has no data on the number of migrant workers who were killed during the first two months of the shutdown. The government also recently claimed that it has no data on the deaths of several frontline healthcare workers.

“Health is a matter of state. The Ministry of Health and Family Welfare does not keep such data centrally, ”Health Minister Harsh Vardhan said in parliament on September 15. This prompted a severe backlash from the Indian Medical Association, which published a list of 382 doctors who have died so far due to COVID-19.