ICMR denies release of Bhopal gas victims' study data

An ICMR institute has decided not to release the results of a scientific study on children born to women as well as their daughters who were exposed to the deadly methyl isocyanate gas released by the Union Carbide factory in Bhopal in December 1984 in the world's worst industrial disaster.

The National Institute for Research on Environmental Health, Bhopal neither published the findings in any peer-reviewed journal nor presented it in any scientific meeting on the advice of an expert panel, which opined the “study design was faulty.”

The same study, however, was approved by the Scientific Advisory Committee (SAC) of the NIREH in December 2014. The SAC also accorded six months extension to the principal investigator R Galgalekar in January 2007 to complete the work.

Before the SAC, the project was also approved by the epidemiological expert committee and the institutional ethics committee of the NIREH that comes under the Indian Council of Medical Research.

Asked to comment on why a study with design flaws was approved in the first place, NIREH director R R Tiwari told DH, “The SAC has approved the appropriate study design and methodology. However, flaws occurred during implementation of the same such as exposure status assessment, blinding, control of confounding factors, etc as suggested by the expert group.”

Titled “A hospital-based study of congenital malformation in the neonates of gas-exposed and non-exposed mothers and their first-generation progenies in Bhopal”, the study sought to examine 1,250 babies born to the mothers who were exposed to the poisonous gas and compared them with the same number of infants born to mothers who were not exposed.

Official documents obtained by Bhopal-based transparency activist Rachna Dhingra now showed the incidence of congenitally malformed children born to exposed mothers and their daughters was 9 per cent while the corresponding number for the non-exposed group was 1.3 per cent.

The scientists examined 1,048 gas-exposed mothers and their first-generation progeny (daughters) as against 1,247 unexposed mothers. The incidence of congenital anomalies was 2.8 per cent in the exposed group as against 0.5 per cent in the other group.

When the results showing a high-level of congenital deformities among the babies born to the MIC-exposed mothers and their daughters, were shared with the advisory panel in December 2017, it found problems with the findings and suggested independent scrutiny.

The independent panel, headed by S K Sharma, a professor at AIIMS reported: “The study design was faulty and with the design proposed in the study, the outcome could not be achieved.”

The Sharma committee also raised questions on various “methodological issues” and recommended that the “data, due to its inherent flaws, should not be put in public domain and shared at any platform.”

In its recommendations submitted in April 2018, the panel said if Galgalekar wished, she could propose a fresh project with a “robust study design” after correcting the flaws as the research topic was important. But a year and a half later, there was no such proposal on the table, confirmed Tiwari.

Galgalekar didn't respond to DH queries.