On Thursday, Senators Rick Scott, Roger Marshall and Rand Paul sent a letter to Health and Human Services (HHS) Secretary Xavier Becerra highlighting concerns with Potential Pandemic Pathogen Care and Oversight (P3CO) review. NIH funds taxpayer-funded research grants, and any grant focused on viruses that may become highly transmissible, such as COVID-19, are supposed to be subject to P3CO review. However, a recent Senate Homeland Security and Governmental Affairs (HSGAC) Emerging Threats and Spending Oversight Subcommittee hearing found that the P3CO review group lacks basic transparency and HHS is failing to operate the P3CO review effectively as it was intended. Alarmingly, only three projects have undergone review since its inception in 2017, and concerns are being raised in Congress that HHS and the NIH failed to complete critical review of research related to pandemic-level viruses.
Senator Rick Scott said, “The American people deserve nothing less than full accountability and transparency from their government, especially when their tax dollars are being used. It is critical we finally get answers on the origins of COVID-19 so that we can prevent another global pandemic in the future—but HHS and NIH must be transparent. I thank Senators Marshall and Paul for joining me in demanding these answers from Secretary Becerra; he has a duty to the American people and he must promptly and fully answer our questions.”
Senator Roger Marshall, M.D. said, “Oversight should not be an optional process with self-selected participation and that is exactly what the NIH created in the ineffective P3CO gain-of-function research risk analysis procedure. It remains a mystery if anyone in the White House approved it. NIH and this dangerous research require legitimate, independent oversight by qualified individuals who do not have conflicts of interest.”
Senator Rand Paul, M.D. said, “The American people deserve full transparency as to the federal government’s role in overseeing dangerous gain-of-function research. Having convened the first-ever congressional hearing on gain-of-function research, I am committed to providing that transparency. The secretive P3CO Review Group – which is supposed to provide a layer of much-needed oversight of this dangerous gain-of-function research – has largely been ineffective. I am glad to join Senators Rick Scott and Roger Marshall in sending this letter, and I’m hopeful that the NIH will respond to these critical questions promptly and in full.”
Read the full letter HERE or below.
We write today regarding the troubling issues raised by the recent Senate Committee on Homeland Security and Governmental Affairs’ Emerging Threats and Spending Oversight Subcommittee hearing Revisiting Gain of Function (GOF) Research: What The Pandemic Taught Us and Where Do We Go From Here. This hearing revealed concerning issues associated with the Potential Pandemic Pathogen Care and Oversight (P3CO) review that must be addressed to protect the country from another deadly pandemic.
The hearing found that although the P3CO Review Group is supposed to add a layer of oversight for GOF research, its effectiveness to-date has been questionable, primarily because it is a voluntary process in which U.S. Department of Health and Human Services (HHS) agencies self-select research projects for the P3CO risk assessment review. Additionally, the P3CO Review Group operates largely in secret, lacking critical transparency required when evaluating potential hazardous research, unless that research is classified. Senators heard during the recent hearing that the P3CO review process amounts to self-policing on the part of NIH, and only evaluates the estimated results of proposed research in all HHS operations.
According to the HHS website, only three research projects have undergone review since its inception in 2017. However, the website was last updated in September 2021, so the current number of research project reviews is unknown. We are concerned that some projects should have been reviewed were not.
Gain-of-function research is paid for by American tax dollars both domestically and internationally. The operations of this secret review panel embodies the center of the subcommittee’s two primary responsibilities – monitoring emerging threats and conducting oversight of federal dollars.
We are also aware that the Ranking Members of the House Energy and Commerce Committee and the Health and Oversight subcommittees wrote to you in April 2022 and have not yet received a reply. Please provide to us a copy of your response to the Energy and Commerce ranking members and also provide written responses to the following questions:
- Please provide a list of all members on the P3CO Review Group, including the federal agencies for which such members work
- Why has NIH not publicly disclosed the names of members of the P3CO Review Group, and does NIH have plans to publish their names?
- What safeguards are in place to ensure and protect the independence of the members of the P3CO Review Group to guard against potential conflicts of interest? Are reviews of NIH grants solely performed by HHS permanent or contract staff members?
- In 2014, the HHS framework required a review of certain flu or coronavirus strains that would be “transmissible among mammals” and might accidentally cause human infections. In 2017, the P3CO policy was announced which narrowed to cover only pathogens “likely capable of wide and uncontrollable spread in human populations.” Why were references to transmissibility among mammals removed in the 2017 revision?
- Other than HHS personnel, which national security agencies are represented on the P3CO panel?
- Please provide a full list of all P3CO experiments that have been reviewed, approved or denied.
- What was funded, who received funding, and how much funding was provided to the researchers?
- Please describe all research project inquiries that did not continue through the P3CO process, including dates and status of those projects.
- Please describe the process by which the P3CO’s recommendations are reviewed for proper implementation by HHS divisions, such as NIH.
- Please provide all documents, meeting notes, and calendar dates of P3CO Review Group meetings.
- Are members of the P3CO review process required to sign nondisclosure agreements (NDA)?
- Did the P3CO approve grants for research that was conducted at the Wuhan Laboratory of Virology?
- Please provide a list of all Gain-of Function research currently being funded by the U.S. taxpayer domestically and internationally.
- For each research project listed, please identify the city, state, province, and country where the research is being performed, as applicable.
The American people deserve nothing less than full accountability and transparency from their government. I appreciate your attention to this sensitive matter.