NIH must clearly demonstrate public benefit to justify risky research 

Washington, D.C. — House Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA), Subcommittee on Health Republican Leader Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Republican Leader Morgan Griffith (R-VA) today sent a letter to National Institutes of Health (NIH) Acting Director Lawrence Tabak requesting information related to a National Institute of Allergy and Infectious Diseases (NIAID) monkeypox virus enhancement, which has reportedly made the disease 1000 percent more lethal in mice. The more lethal monkeypox virus has about a 10 percent mortality rate in unvaccinated people. The less lethal monkeypox virus circulating in the U.S. has a mortality rate less than one percent.

KEY EXCERPT: “It appears that the project is reasonably anticipated to yield a lab-generated monkeypox virus that is 1,000 times more lethal in mice than the monkeypox virus currently circulating in humans and that transmits as efficiently as the monkeypox virus currently circulating in humans. The risk-benefit ratio indicates potentially serious risks without clear civilian practical applications. Based on available information, this experiment would seem to involve risks reasonably anticipated to create, transfer, or use potential pandemic pathogens (PPPs) resulting from the enhancement of a pathogen’s transmissibility or virulence in humans (enhanced PPPs). Under the circumstances, we are interested in learning whether this experiment was reviewed under the HHS P3CO (Potential Pandemic Pathogens) framework used to review risky research proposals. We recently received a letter from HHS implicitly confirming that the HHS P3CO review committee has been inactive since 2019, without any indication that the Biden administration is reactivating this committee. (See attachment). Nevertheless, it is important to know whether NIAID itself conducted any internal review on this issue.”

The members specifically asked for information as well as answers to below questions by November 14,2022:

1. All proposals and progress reports discussing the clade 1 monkeypox virus experiment (clade 1 study).
2. For NIH award 1ZIAAI000979, please provide a copy of the grant terms.
3. When did the clade 1 experiment start? Is the experiment ongoing? If not, when did it stop? If ongoing, what is the status of the experiment?
4. What review did this research undergo at NIH? Who reviewed the research proposal? What was the basis of the review decision?
5. What are the risks from this research?
6. What are the benefits from this research?
7. What is the potential benefit to human health from this research? Is there an aim to find a treatment or vaccine?
8. Any correspondence related to whether the clade 1 study should be referred to P3CO review.
9. Was the clade 1 study referred for P3CO review? If not, why not?
10. Was the clade 1 study referred to the Federal Select Agent Program for review? If not, why not? If so, was the clade 1 study further reviewed by the ISATTAC?
11. Why must clade 1 genes be transferred to clade 2 genes? Why not delete the genes from Clade 1 to determine effects on virulence?
12. A copy of the submission on the clade 1 study sent to the NIAID Institutional Biosafety Committee (IBC) or to an NIH IBC.

CLICK HERE to read the full letter to Acting Director Tabak.