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Letter - Health Updates


Jan 18, 2023
Press Release

Chair Rodgers: GAO Gain-of-Function Research Report Affirms Our Concerns with HHS P3CO Framework

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) offered the following statement after the Government Accountability Office issued a report titled “ HHS Could Improve Oversight of Research Involving Enhanced Potential Pandemic Pathogens ,” which is commonly referred to as “gain-of-function" research.  “Today’s watchdog report affirms many of my concerns with the secretive HHS board that purportedly reviews risky research projects from federal agencies. So far, the risky research proposals of concern only appear to be funded by the National Institutes of Health, specifically by the National Institute of Allergy and Infectious Diseases. The American public deserve to know to what extent their tax dollars are being used to fund pathogenic research that has the potential to cause a pandemic. Whether or not the U.S. government played any role—directly or indirectly—in the creation of COVID-19, our committee’s investigation is uncovering a host of issues that require more attention. Thankfully, we were able to enact some commonsense prohibitions regarding where and how this type of research is funded, but we will continue pushing for more accountability and oversight to start rebuilding public trust in these research agencies.”  KEY EXCERPT FROM GAO REPORT : By working with its funding agencies to identify and share non-sensitive information about how HHS, in coordination with its funding agencies, conducts reviews and makes funding recommendations, researchers, Congress, and the public would have greater assurance that departmental review provides meaningful and effective suggestions to address biosafety and biosecurity concerns about research involving enhanced potential pandemic pathogens. Moreover, doing so could enhance public confidence in the department’s oversight as well as ensure the agency’s goal to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.  Chair Rodgers, along with Reps. Brett Guthrie (R-KY) and Morgan Griffith (R-VA) wrote to Department of Health and Human Services Secretary Xaiver Becerra in April of 2022, raising concerns on the “flawed and overly secretive review process of whether risky research for potential pandemic pathogens can be conducted safely and have a justifiable benefit.”  KEY LETTER EXCERPT : “Dr. Chris Hassell, the HHS Deputy Assistant Secretary for Preparedness and Response and the chair of the HHS P3CO review committee, briefed the committee staff twice during the summer of 2021. During the briefings, when asked about the identities of the members, Dr. Hassell did not provide the names of the members of the review group. However, he indicated which agencies or departments were represented on the HHS P3CO Review Committee. Dr. Hassell noted there were members from the NIH on the review committee, but he specifically pointed out that the NIH members were from the Office of the Director and not from any of the NIH institutes or centers that would be funding entities to avoid conflict-of-interest concerns.   “The minority committee staff requested that HHS provide the names and affiliations of all members of the HHS P3CO review committee. In response, HHS provided some of the names of the HHS P3CO review committee, but on a confidential basis because of personal security concerns.”  You can read the full letter here . 



E&C Republicans to NIH: Turn Over Previously Requested Information Ahead of New Congress

NIH’s Lack of Transparency at Odds with Its Stated Mission  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) Senior Official Lawrence Tabak following up on 12 unanswered or insufficiently addressed letters that requested information and were sent between March 12, 2021 and October 31, 2022. The letter also serves as a formal notice for NIH to preserve all records and materials related to the topics in the previous letters. Key Excerpt:  “We write to urge the National Institutes of Health (NIH) to respond to our longstanding requests to provide us information related to the origins of the COVID-19 pandemic, including matters related to National Institute of Allergy and Infectious Diseases’ (NIAID) grant to EcoHealth Alliance and subgrant to the Wuhan Institute of Virology (WIV), and other subjects. Some of these requests have been outstanding for more than a year. NIH’s persistent lack of transparency with members of its authorizing committee of jurisdiction is troubling. According to its mission statement, a goal of the National Institutes of Health (NIH) is ‘to exemplify […] the highest level of scientific integrity and public accountability.’ However, given the overall lack of adequate responsiveness to our oversight letters, the NIH is falling short of the goal set forth in its mission statement.” […] “Furthermore, this letter serves as a formal request to preserve all existing and future records and materials in your agency’s possession relating to the topics addressed in this letter. You should construe this preservation notice as an instruction to take all reasonable steps to prevent the destruction or alteration, whether intentionally or negligently, of all documents, communications, and other information, including electronic information and metadata, that are or may be responsive to this congressional inquiry. This instruction includes all electronic messages sent using official and personal accounts or devices, including records created using text messages, phone-based message applications, or encryption software.” CLICK HERE  to read the full November 30, 2022, letter to Dr. Tabak.   Full copies of the 12 above mentioned letters are available below: March 18, 2021, Letter to Dr. Francis Collins On March 18, 2021, the Republican Leaders sent an eleven-page letter, based on what was known at that time, requesting information related to where SARS CoV-2 originated and how NIH grant dollars at the WIV were used. While documents released in response to Freedom of Information Act requests suggest that NIH had prepared a draft written response, NIH never sent a written response to our questions. June 10, 2021, Letter to Dr. Francis Collins On June 10, 2021, Committee members wrote to strongly express support for a “comprehensive investigation into the origins of the COVID-19 pandemic, including the possibility of an accidental laboratory leak.” To date, NIH has not provided a written response. July 21, 2021, Letter to Dr. Francis Collins On July 21, 2021, Committee Leaders sent another letter reiterating our request for information to our March 2021 letter, which NIH failed to provide written, substantive responses to. NIH has not provided a written response to the specific questions outlined in the July 2021 letter. August 24, 2021, Letter to Dr. Francis Collins   Republican Leaders submitted an August 2021 letter again requesting information about NIAID’s coronavirus grant to EcoHealth Alliance. To date, NIH has not provided a written response. October 27, 2021, Letter to Dr. Francis Collins Based on documents the Department of Health and Human Services arranged for the Committee to review in camera, Republican Leaders highlighted in an October 27, 2021, letter our concerns about NIH’s oversight of EcoHealth Alliance’s research proposal that purported it was not conducting gain-of-function research. NIH has not submitted a written response to this letter. February 14, 2022, Letter to Dr. Francis Collins On February 14, 2022, we sent a letter about concerns that Dr. Collins, while Director of NIH, may have taken steps to actively suppress scientific discussion that COVID-19 could have originated from a research-related incident, not just from natural transmission. A similar letter was also sent to Dr. Anthony Fauci, the Director of the NIAID. To date, neither NIH nor NIAID have not sent any written responses to these letters. February 24, 2022, Letter to Dr. Lawrence A. Tabak On February 24, 2022, Republican Leaders raised concerns that NIH failed to effectively enforce its policies and regulations over EcoHealth Alliance. To date, NIH has not sent a written response. April 25, 2022, Letter to Dr. Lawrence A. Tabak On April 25, 2022, Republican Leaders wrote a letter raising concerns that EcoHealth Alliance was potentially omitting key information in research allegedly conducted at WIV in order to obtain a renewal of federal grant funding. While NIH has provided some information in a bipartisan briefing, many questions remain unanswered. NIH has not provided a written response to this letter. July 21, 2022, Letter to Dr. Lawrence A. Tabak   Although required by the NIH Reform Act of 2006, NIH has failed to convene the Scientific Management Review Board (SMRB) since 2015. Republican Leaders wrote asking why this Board, intended to make NIH more efficient and effective, inexplicably stopped convening seven years ago. To date, NIH has not provided a written response. August 11, 2022, Letter to Dr. Lawrence A. Tabak   As highlighted in an August 11, 2022, letter, Republican Leaders received inadequate responses in 2021 as to why NIH failed to remove an alleged sexual perpetrator disciplined in three states from co-chairing an NIH steering committee, even after receiving complaints from female scientists alleging the misconduct. To date, NIH has not provided a written response. October 24, 2022, Letter to Dr. Lawrence A. Tabak   Last month Republican Leaders sent NIH a letter raising concerns about how NIH could contemplate funding a new EcoHealth Alliance grant considering this organization’s past noncompliance with regulatory requirements and grant terms. To date, they have not received a written response from NIH to this letter. October 31, 2022, Letter to Dr. Lawrence A. Tabak Last month Republican Leaders sent a letter requesting information related to a NIAID intramural experiment that would enhance the more dangerous version of the monkeypox virus by making the disease about 1000 percent more lethal in mice. To date, they have not received a response.



E&C GOP to Walensky: CDC’s Faulty Monkeypox Diagnostic Information Puts Americans in Danger; Further Erodes Public Trust in Agency

Americans must be able to trust accuracy of viral tests during outbreaks  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) sent a letter to Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky regarding faulty Monkeypox tests, which may have left Americans infected with the virus believing they were healthy and non-contagious:  “From the CDC’s fiasco in rolling out effective COVID-19 tests in early 2020, to the recent faulty Monkeypox test information, this further highlights another example of why Americans have lost trust in our public health agencies and their ability to keep individuals safe and contain outbreaks. If the Biden administration is serious about restoring trust, public health agencies must be transparent and accountable to the American people,” said Republican Leader Rodgers, Guthrie, and Griffith.  CLICK HERE  to read more on the letter and E&C Republicans’ oversight agenda. KEY EXCERPT : “We write to request information about the flawed CDC diagnostic testing procedures for monkeypox virus. This follows a similar CDC breakdown during the pandemic response when CDC distributed faulty and contaminated COVID-19 test kits in February 2020.”  The members asked for specific answers to the following questions by November 17, 2022:  Why were CDC’s published primers and probes specifically targeting Monkeypox unable to detect the virus in some cases?  Were the CDC’s published primers and probes based on currently circulating monkeypox strains?  How did the CDC become aware that its published primers and probes led to false negatives?  What action has CDC taken to correct this problem? Is CDC re-designing and reworking its published primers and probes?  Is CDC actively performing in silico analysis of this assay against the most current monkeypox sequence database?  If yes, did CDC observe any potential limitation with the assay to give a potential false negative result?  If yes, is CDC developing new signatures and assays to counter the limitations?  If yes, when will these new signatures and assays be available to the public health/laboratory community?  Has CDC thought about developing RT-PCR assays for multiple regions or loci to enhance sensitivity and eliminate false negative results? If not, why not?  Monkeypox virus has two clades. Clade 1 or Congo Basin clade monkeypox virus has about a 10 percent fatality rate in unvaccinated persons. Clade 2 or West African clade monkeypox virus (the version currently circulating in humans) is associated with less than one percent mortality.10 Does CDC have a monkeypox specific assay that detects both clade 1 and clade 2 viruses? If not, why not?  The non-variola orthopoxvirus assay cross-reacts with other viruses. Is this a concern to CDC? If not, why not?  CLICK HERE to read the full letter to Director Walensky. 



Nov 1, 2022
Letter - Health

E&C Republicans Question NIH Over Experiment Using More Lethal Monkeypox Virus Listed as Federal Select Agent

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: All proposals and progress reports discussing the clade 1 monkeypox virus experiment (clade 1 study). For NIH award 1ZIAAI000979, please provide a copy of the grant terms. 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? What review did this research undergo at NIH? Who reviewed the research proposal? What was the basis of the review decision? What are the risks from this research? What are the benefits from this research? What is the potential benefit to human health from this research? Is there an aim to find a treatment or vaccine? Any correspondence related to whether the clade 1 study should be referred to P3CO review. Was the clade 1 study referred for P3CO review? If not, why not? 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? Why must clade 1 genes be transferred to clade 2 genes? Why not delete the genes from Clade 1 to determine effects on virulence? 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.



E&C Republicans Seek Details from Boston University about Controversial Experiment with Potential Gain-of-Function Research Concerns

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 the following letter to Boston University President Robert Brown, requesting information related to reports that researchers at his university are conducting potentially risky gain-of-function research with coronaviruses: KEY EXCERPT : “BU has stated that the work was approved by the institutional biosafety committee (IBC) of BU’s NEIDL, and by the Boston Public Health Commission. However, the research work was not cleared with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). BU has stated that the research did not have to be cleared with NIAID because the experiments were carried out with funds from BU, and that there was no gain of function with this research. “Nevertheless, Dr. Emily Erbelding, director of NIAID’s division of microbiology and infectious diseases, said the BU team’s original grant applications did not specify that the scientists wanted to do this precise work. Nor did the group make clear that it was doing experiments that might involve enhancing a pathogen of pandemic potential in the progress reports it provided to NIAID. Asked if the research team should have informed NIAID of its intention to do the work, Dr. Erbelding said: ‘We wish that they would have, yes.’ Recent news reports indicate that the NIH is examining whether experiments in the study should have triggered a federal review.” The members requested the following information by November 8, 2022: All proposals and progress reports cited in the pre-print. All proposals and progress reports sent to the NIAID related to the pre-print study. For each of the NIH grants referenced in the pre-print, please provide a copy of the grant terms for each grant. Any correspondence related to whether the study should be referred to P3CO review. A listing of all funding streams to the BU NEIDL related to the pre-print study, including support for facilities, equipment, and personnel. A copy of the submission on the research sent to the IBC and the Boston Public Health Commission According to STAT News: “[Dr. Ronald] Corley [Director of NEIDL] said that BU safety protocols require that if researchers produce a pathogen that is more virulent than the Wuhan strains, they must immediately report it to the Institutional Biosafety Committee (IBC). [Dr. Mohan] Saeed’s study protocol further stipulated that if such an event occurred, he would immediately stop the work and destroy the viruses, Corley noted.” Please provide a copy of the BU safety protocols including the reporting requirement to the IBC and a copy of the study protocol on research stoppage. CLICK HERE  to read the full letter.



E&C Republicans to NIH: Why Resume Taxpayer-Supported Grant Funding to EcoHealth?

NIH Had Found EcoHealth in Violation of Safety and Stewardship Rules 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) sent a letter to National Institutes of Health (NIH) Acting Director Lawrence Tabak requesting information regarding why the agency reportedly awarded a new grant and planned on resuming a suspended grant to EcoHealth Alliance, which had been funding coronavirus research at the Wuhan Institute of Virology. “EcoHealth Alliance shouldn’t get a dime of taxpayer funding unless it comes clean about its well-documented failures and can clearly demonstrate it can be trusted to oversee risky research that has potential to start a pandemic,” said Leaders Rodgers, Guthrie, and Griffith. “The NIH has a responsibility to the American people to ensure research supported by taxpayer dollars is conducted with the highest standard of integrity, transparency, and safety. To that end, agency officials must answer why they are considering restoring funding to EcoHealth Alliance.” Key Excerpt: “In an October 4, 2022, interview with the Washington Post, in response to a question about funding of this new grant by the National Institute of Allergy and Infectious Diseases (NIAID) to EcoHealth, NIAID Director Dr. Anthony Fauci stated that EcoHealth ‘adequately addressed’ NIH ‘administrative things’ presumably related to noncompliance in the R01 award. He pointed this out to show there would be no mechanism to arbitrarily cut off funding for EcoHealth and that NIH could be legally vulnerable if it took such an action (‘If they [EcoHealth] ever brought that to court, they could sue us, and win that in a microsecond.’). However, this assertion begs the question of how NIH determined EcoHealth had adequately addressed noncompliance issues given the history of this grant. […] “NIH’s own findings and EcoHealth’s own statements and actions suggest EcoHealth violated the False Claims Act (FCA) when it accepted NIH grant terms by drawing down NIH grant funds but materially failed to comply with the terms of the grant. Recent Department of Justice (DOJ) FCA settlements with an NIH grantee demonstrate that these ‘administrative things; include requirements on NIH grantees to make factual representations to NIH without deliberate ignorance or reckless disregard. In addition, NIH grantees must make full disclosure to the NIH. As DOJ has noted, ‘Full disclosure is essential not only in validating scientific research, but also in the intense competition for scientific funding from the federal government. NIH’s application process is intended to yield information that is critical to the agency’s responsible stewardship of billions of taxpayer dollars.’  We are troubled that NIH has not provided, and we are not aware of, any evidence of how EcoHealth provided full disclosure of the experiment without substantiating records and thus adequately addressed these critical requirements with the R01 award.” The members also raised specific concerns about Dr. Fauci’s assertions given that: In 2020, NIH suspended the EcoHealth’s award over avowed concerns about the adequacy of EcoHealth’s oversight of its sub-grantee, the Wuhan Institute of Virology (WIV) and its noncompliance with specific regulatory and NIH grant policy requirements. In 2021, NIH confirmed that EcoHealth did not comply with the NIH’s safety rule on excessive virus growth in an experiment involving humanized mice infected with chimeric viruses. In 2022, NIH stated that EcoHealth failed to include the terms and conditions required in Federal awards in WIV’s subaward agreement to ensure access to any documents, papers, or other records of the non-Federal entity (WIV) pertinent to the Federal award. Ultimately, NIH found that EcoHealth’s deficient subaward agreement represented “material failures to comply with the terms of its award.” As a result of these failures, EcoHealth did not secure lab notebooks and electronic files associated with the humanized mice experiment and did not obtain these materials from the WIV after NIH requested them. NOTE: Neither of these violations can be remedied by corrective actions. EcoHealth has yet to provide evidence that it can comply with what a former NIH senior official has described as the “three basic cornerstones” of the covenant between research institutions and the American people. The members asked the Acting Director to respond to questions by November 7, 2022 regarding EcoHealth’s non-compliance with NIH grant regulations. Name each and every lawyer or law firm(s) involved in advising Dr. Fauci in the legal ramifications associated with not renewing the R01 award. What is the NIH precedent for resuming funding to suspended grantees under these circumstances? Please provide details on specific examples. How much was EcoHealth paid under the grant to oversee the laboratory work of the WIV during Year 4 and Year 5 of the R01 award? Isn’t it true that under the terms and conditions, EcoHealth’s drawdown of grant funds constitutes a claim that EcoHealth would monitor its sub-grantee in compliance with the terms of the grant? What certifications did EcoHealth make to the NIH? Did EcoHealth comply with the requirements to monitor the WIV? If so, what is the basis for this conclusion? If not, what is the basis for this conclusion? Why has NIH continued to provide funding for EcoHealth Alliance’s international research activities? How will NIH validate the information regarding EcoHealth Alliance’s oversight and compliance activities for its subawardees? It is unclear how the additional terms and conditions that NIH has described will ensure that future issues with obtaining laboratory notebooks and data resulting from NIH funded activities will not reoccur. How will NIH ensure that EcoHealth Alliance will comply with these additional terms and conditions? Did the NIH ever ask EcoHealth why it failed to include the terms and conditions required in Federal awards in WIV’s subaward agreement to ensure access to any documents, papers, or other records of the non-Federal entity (WIV) pertinent to the Federal award? If so, what was EcoHealth’s rationale? Did EcoHealth ever attempt to include such terms and conditions? Did the WIV refuse to agree to the inclusion of the terms and conditions? Did EcoHealth proceed with the subaward despite such a refusal if it occurred? If the NIH did not ask EcoHealth about the rationale for not including these terms and conditions, why did the NIH not ask? Did the NIH confer with any other federal agency about EcoHealth Alliance before making the most recent award? If so, please identify the agencies, the date of contact, and the issues discussed. CLICK HERE  to read the letter to Acting Director Tabak.



Oct 21, 2022
Letter - Health

Leader Rodgers: The Decision for COVID-19 Vaccines is For Parents to Make

CDC Must Rebuild Trust with Parents Washington, D.C. —  House Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA) is calling on America’s governors, like Governor Jay Inslee, to not mandate the COVID-19 vaccine for children following the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention’s (CDC) vote to add COVID-19 vaccinations to the recommended schedule of vaccines for both adults and children. In a statement, Leader Rodgers said: “Rather than work to rebuild the trust it has eroded with the American people, this is another example of the CDC issuing COVID-19 recommendations without being transparent with their data and the science. Like we’ve seen throughout the pandemic, these actions could be used by state governments to undermine a parent’s right to make the best decisions for their children. The CDC owes parents answers as to why its recommended vaccine schedule for COVID-19 is out of step with other countries who have said there is ‘no clear benefit’ to vaccinating young children. Today, I’m urging governors, like Jay Inslee in Washington state, to put parents first and resist the temptation to again abuse their power to issue unscientific, heavy-handed mandates that don’t fully take a child’s overall well-being into account. Our kids have suffered enough from government-enforced school closures and mask mandates during the COVID-19 pandemic.” In a  letter  to her home state of Washington’s Governor Jay Inslee today, she wrote: “I write to ask that you do not mandate COVID-19 vaccines for healthy children and leave that decision to parents and their pediatricians. “Existing law in Washington State cites the ACIP recommendations from 2019, and if that date was simply updated to 2022, families across the State may be forced to choose between either sending their children to public school or making the best decision for their health. CDC has made clear that the recommendations are not indicative of a support of a mandate on all children, and that decision is left to States. However, throughout the pandemic you have repeatedly used CDC guidance as justification for heavy-handed mandates that kept children out of school and masked them when they were finally allowed to go back. I am concerned that you will use the CDC’s latest action to continue your record of harmful government mandates on our children and strip parents of their rights.” CLICK HERE  to read Leader Rodgers’ full letter to Governor Inslee. CLICK HERE  to read Leader Rodgers’ August 17, 2022, statement on the need for CDC to rebuild trust.



Sep 28, 2022
Letter

E&C Republicans Press NIH and CDC Over Safety Gaps with Virus Hunting to Prevent Next Pandemic

Concerns Arise That Human Researchers’ Interactions with Bats in the Wild May Have Caused COVID-19 Pandemic 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) are demanding the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) provide a briefing on gaps in safety standards for virus hunting and how policies can be improved to address these gaps. In a letter to NIH Acting Director Lawrence Tabak and CDC Director Rochelle Walensky, the Republican members show the gaps in oversight of safety during virus-hunting in bat caves. For example, journalists have documented lapses in wearing protective gear by both EcoHealth Alliance and its sub-grantee, the Wuhan Institute of Virology (WIV). A video even showed WIV researchers being bitten by bats. NIH’s grant to EcoHealth Alliance has been suspended since July 2020, spurred in part due to biosafety monitoring concerns. The NIH and CDC jointly publish the Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual, the guidance for lab safety standards. KEY EXCERPT:  “Since 1984, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) have issued editions of the overarching guidance document for the practice of biosafety in the U.S.—Biosafety in Microbiological and Biomedical Laboratories (BMBL)—to address the safe handling and containment of infectious microorganisms and hazardous biological materials. However, the BMBL and traditional biosafety practices have focused on laboratory settings.  We write to inquire about existing policies at the CDC and NIH on biosafety practices for virus hunting or field research (including through the BMBL) and for the agencies to discuss addressing any gaps in policies and best practices with committee staff. Safety concerns with virus-hunting raised in recent reports and articles and from our oversight into the origins of the COVID-19 pandemic suggest the need for enhanced training and oversight of biosafety practices in the field.” […] “Even if it is not connected to the origins of the pandemic, the risks are apparent and biosafety practices need to be strengthened as our oversight examines the risks and benefits of virus-hunting research to prevent pandemics.” The members ask the NIH and CDC to give Energy and Commerce Committee staff a briefing on biosafety guidelines for collecting and sampling viruses from animals in the wild. Currently, the BMBL doesn’t include field research, which has the members and experts with concerns that there’s currently a lack of biosafety standards over virus hunting practices that have the potential to start a pandemic. The request for a staff briefing arises from EcoHealth Alliance’s virus hunting in bat caves and its partnership with the Wuhan Institute of Virology (WIV). The members are investigating the possibility that the virus could have originated from bats in unsafe virus-hunting practices. KEY EXCERPT:  “Biosafety concerns over virus hunting have been elevated by the scrutiny over the origins of the COVID-19 pandemic, especially the suspicions about the possible role of the EcoHealth – WIV partnership. Both of these entities have a history of not always following safety precautions for virus hunting or in the laboratory. “In its grant proposal to the NIAID, EcoHealth acknowledged the high risks and need for specific safety requirements in its virus-hunting: “‘…Fieldwork involves the highest risk for exposure to SARS or other CoVs, while working in caves with high bat density overhead and the potential for fecal dust to be inhaled. There is also some risk of exposure to pathogens or physical injury while handling bats, civets, rodents or other animals, their blood samples or their excreta… We have strict procedures for handling bats and working with samples from them as they are secured in the field and transported to the lab. Field team members handling animals will be trained to utilize personal protective equipment and practice proper environmental disinfection techniques. This includes wearing coveralls or dedicated clothing, nitrile gloves, eye protection, and a P95 or P100 respirator. All field clothing and equipment will be disinfected using Virkon disinfectant. [Emphasis added.]’ “However, public reports indicate EcoHealth staff did not always adhere to their own safety requirements. A journalist along on one of EcoHealth’s expeditions to the bat-filled caves witnessed at least one EcoHealth staffer not following the requirements for using personal protective equipment (PPE). “EcoHealth’s research partner, the WIV, also had documented biosafety lapses. A video released two years before the start of the COVID-19 pandemic showed WIV scientists’ lax use of PPE and being bitten by bats that carry deadly viruses such as SARS.  The video revealed that they showed ‘a shocking disregard for safety when handling potentially infectious bats both in the wild and in the lab.’” In addition to requesting a briefing for staff, the members ask Acting Director Tabak and Director Walensky to answer the following questions by October 12, 2022: Groups of scientists are trying to discover new viruses to study their potential for pathogenesis in human and animals as well as their potential to cause an outbreak, an epidemic or a pandemic. Are there currently any policies or guidelines for such scientific work to be performed in a safe and secure manner? Do you think it is prudent for the U.S. government to establish appropriate policies and guidelines for safely working with such viruses and associated biological materials, since they may possess the potential for zoonosis and could contribute to the next outbreak, epidemic or a pandemic if handled inappropriately? Should the current BMBL devote a section to cover this concern and need? What are the risks associated with field-related activities, such as the collection of specimens from bats or other wildlife sources and the potential for SARS-like CoV infection of staff? During the processing of these samples for virus isolation, these materials might be subjected to multiple passages in a cell culture. Multiple passaging might contribute or lead to mutational events with adaptation resulting in a virus that is now capable of infecting humans or animals. How do you monitor for it and ensure such adaptation does not happen? CLICK HERE  to read the letter to NIH Acting Director Tabak and CDC Director Walensky. CLICK HERE  to read more about the investigation into the origins of COVID-19.



Sep 26, 2022
Big Tech

E&C Republican Leaders Demand Big Tech Does More to Stop Illegal Fentanyl Sales on their Platforms

Washington, D.C. —  House Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA), along with Health Subcommittee Republican Leader Brett Guthrie (R-KY), Communications and Technology Subcommittee Republican Leader Bob Latta (R-OH), Consumer Protection and Commerce Subcommittee Republican Leader Gus Bilirakis (R-FL), and Oversight and Investigations Subcommittee Republican Leader Morgan Griffith (R-VA) sent letters to TikTok, Snapchat, Instagram, and the U.S. Department of Justice on doing more to crack down on illegal fentanyl sales and prevent criminals from exploiting these platforms to sell this deadly poison. Excerpts and highlights from the letter to TikTok CEO Shou Zi Chew:   “We write with significant concerns regarding the use of TikTok by drug dealers to sell illicit and deadly substances, especially to children and minors.  We have read numerous reports and heard personal stories from parents who have tragically lost their children to fentanyl and fentanyl-related substances from pills purchased from drug dealers on TikTok. The loss of these young lives shows not enough is being done to crack down on this illegal activity and prevent criminals from exploiting your platform to sell this deadly poison.     “Our country’s communities and families are facing an unprecedented crisis due to the increasingly widespread presence of fentanyl and fentanyl-related substances.  In 2021, nearly 108,000 people died of drug overdoses; 71,000 of which were from fentanyl or fentanyl-related substances. Between FY2020 and FY2021, more than 10,000 pounds of illicit fentanyl were seized at our southern border, enough to kill every American seven times over. Law enforcement in communities across the country are seizing record amounts of illicit fentanyl pills, including a case earlier this summer where two Washington State men were arrested in California with 1 million pills containing fentanyl.    “The widespread availability and sale of these illicit pills containing fentanyl has led to record levels of overdose deaths. Every overdose is a tragedy and more must be done to facilitate access to treatment for those suffering from a substance use disorder (SUD).  However, many of these overdose deaths are unrelated to SUDs and have occurred in individuals taking a single pill they thought was prescription medication but was instead counterfeit and laced with fentanyl.  According to the Drug Enforcement Agency (DEA), these fake pills are often manufactured to resemble ‘real prescription opioid medications such as oxycodone (Oxycontin®, Percocet®), hydrocodone (Vicodin®), and alprazolam (Xanax®); or stimulants like amphetamines (Adderall®).’  “Tragically, in these instances, traditional methods to combat opioid addiction and overdoses, such as SUD treatment or distribution of fentanyl test strips, are not effective.  More must be done to combat this epidemic of tragic overdoses, and TikTok must do more to combat the illegal activity on its platform. A consistent theme of this crisis is the purchasing of pills believed to be something else by teenagers and youth using TikTok’s platform. TikTok must do more to combat the use of its platform for illegal activity, especially drug dealers peddling this dangerous poison.”   CLICK HERE  to read the full letter to TikTok. CLICK HERE  to read the full letter to Snapchat. CLICK HERE  to read the full letter to Instagram.  CLICK HERE  to read the full letter to the U.S. Department of Justice.