EcoHealth Alliance Statement Regarding GAO report on P3CO Oversight by Health and Human Services (GAO-23-105455) January 25, 2023

We welcome the GAO’s review and recommendations in Public Health Preparedness: HHS Could Improve Oversight of Research Involving Enhanced Potential Pandemic Pathogens (GAO-23-105455, January 2023)1. EcoHealth Alliance (EHA) appreciates the need to balance both the benefits and potential risks posed by research in this area. EHA is fully committed to responsible research with enhanced potential pandemic pathogens and follows all applicable U.S. policy frameworks and rules regarding such research.

The GAO report is correct to state (p. 35) that NIH’s review of our proposed recombinant virus research with SARS-like bat coronaviruses resulted in them finding that .. the experiments described by .. EcoHealth Alliance were not anticipated to increase the virulence or transmissibility of these viruses in humans. NIH funded the research and oversaw it using its standard grant oversight process.

However, a related statement on page 36 — According to NIH officials…EcoHealth Alliance did not adequately monitor the activities of its subawardees and took action to terminate this part of the grant award— is inaccurate. It is unfortunate that the GAO analysis only provides statements from NIH officials about our work, and did not reach out to EcoHealth Alliance to comment or provide information about the work in question. We could have explained to the GAO that EcoHealth Alliance strongly contests the NIH statement, and has written repeatedly to NIH to inform them of our concerns, providing substantial documentary evidence of our compliance with all grant award conditions.

It is a fact that EHA did monitor the subawardee experiments in question exactly as required by the conditions in the R01AI110964 year 3 Notice of Award sent to us by NIH. We reported findings in a timely way directly to NIH via their online portal, and to program staff. At no point did NIH inform us of any issues with our work during the 5 years of the grant award. It was only in August of 2022, two years and three months after the end of the award, based on a mischaracterization of what the experiment actually showed and under significant political pressure, that NIH retrospectively alleged that our work was not in compliance and terminated the subcontract. 

Notwithstanding this disagreement over interpretation of this one experiment with bat coronaviruses in mice (not infection in humans), EHA did agree with NIH to tighten oversight of subsequent work in this area. NIH has since agreed to renew grant support to EHA for continuing investigations into the natural history of bat coronaviruses.