Health

Washington, D.C. — In a new letter to Government Accountability Office Comptroller General Gene Dodaro, House Energy and Commerce Committee Republicans have requested an examination of the structure of laboratory safety programs at the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH).  The letter was signed by Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA).  KEY LETTER EXCERPT :  This committee remains concerned about the effectiveness of the oversight HHS and its agencies provide to the laboratories they own and operate. In addition to numerous GAO recommendations that remain unimplemented by the FDA, both the CDC and the FDA recently announced organizational reforms to their laboratory safety and security functions, and it is not clear whether these changes will strengthen oversight or create new undue risk. The FDA has, for example, reorganized several of its laboratories such that they now fall within the Office of the Chief Scientist. This raises potential independence concerns, as the FDA’s laboratory safety and security functions report to the same office.  BACKGROUND :  The mission of the U.S. Department of Health and Human Services (HHS) is to enhance the health and well-being of all Americans.   As such, HHS is most directly involved in leading public health preparedness and response efforts, as well as associated research.   However, past safety lapses involving the CDC, the FDA, and the NIH have been the result of multiple breakdowns in compliance with established policies coupled with inadequate oversight.   For example, in July 2014, boxes containing decades-old vials of smallpox and other hazardous biological agents were found in a storage space of an FDA laboratory on the NIH’s campus. GAO and other reviews resulted in numerous findings and recommendations to strengthen laboratory safety and security, which led to changes to the way HHS and its agencies oversee their laboratories.   Likewise, GAO and other reviews have highlighted the importance of laboratory science and security in the handling of federal select agents and other dangerous pathogens in research.  CLICK HERE to read the full letter.

Washington, D.C. — Republican Members of the House Energy and Commerce Committee issued the following statements regarding a report that results from a National Institutes of Health (NIH) funded research project are being withheld from the public due to political motives. “This is a clear example of the politicization of science at the expense of children. Research funded by taxpayer dollars through the NIH should be publicly disclosed regardless of the results, and Americans deserve access to the truth,” said Committee Chair Cathy McMorris Rodgers (R-WA) . “For a scientist to withhold findings deliberately because the findings don’t substantiate a preferred outcome further erodes public trust in the NIH and its programs. Our Committee will be launching an investigation into the matter.”  “These recent revelations are a great example of why Congress and the American people are demanding more transparency and accountability from the U.S. public health community,” said Subcommittee on Health Chair Brett Guthrie (R-KY) . “Not publishing the results of taxpayer-funded research in fear of political blowback not only further erodes trust in our public health institutions, but also fundamentally undermines the very nature of scientific research. Most importantly, failing to publish these results to protect one’s own political agenda puts vulnerable children at risk of serious self-harm. I call on the NIH to immediately suspend funding of this study and to immediately publish the study’s results for the American people to see for themselves.” “Delaying the publication of clinical trial studies, funded in part by the federal government, for fear that its findings would be ‘weaponized’ by those who are opposed to invasive transgender procedures in juveniles is irresponsible and inappropriate,” said Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) . “The American people should be allowed to follow the science even when it leads to a conclusion that the scientist doing the study doesn’t like.” “Puberty blockers and sex-change operations harm children, period. It’s outrageous for taxpayer-funded research to be hidden from the public, especially when it is being suppressed by a transgender advocate simply because the findings don’t fit their political agenda,” said Representative Diana Harshbarger (R-TN) . “This is a glaring example of why NIH must be reformed with measures like those initiated by Chair Rogers to ensure transparency, standards of objectivity, and the removal of conflicts of interest in federal taxpayer-funded scientific and medical research. The NIH must release the results of this taxpayer-funded study immediately.”  BACKGROUND : As reported in the New York Times , an NIH-funded researcher and vocal advocate for hormonal gender treatments on minors, who receives millions of dollars of taxpayer funding, is withholding the results of studies because they do not demonstrate clinical benefit of providing such treatments. The United States remains an outlier by providing hormonal-based therapies that delay puberty to minors for the purposes of gender transitioning, while many other developed nations are moving away from the practice. 

$900 million taxpayer dollars used to amplify the Biden-Harris administration’s flawed messaging on COVID-19 pandemic Washington, D.C. — In a new report , House Energy and Commerce Committee Republicans unveiled the failings of a $900 million COVID-19 public relations campaign, issued and overseen by the U.S. Department of Health and Human Services (HHS). It is the culmination of the Committee’s investigation , which was launched in April 2023. “While the Biden-Harris administration’s public health guidance led to prolonged closures of schools and businesses, the NIH was spending nearly a billion dollars of taxpayer money trying to manipulate Americans with advertisements—sometimes containing erroneous or unproven information. By overpromising what the COVID-19 vaccines could do—in direct contradiction of the FDA’s authorizations—and over emphasizing the virus’s risk to children and young adults, the Biden-Harris administration caused Americans to lose trust in the public health system,” said Committee Chair Cathy McMorris Rodgers (R-WA). “Our investigation also uncovered the extent to which public funding went to Big Tech companies to track and monitor Americans, underscoring the need for stronger online data privacy protections.” “I am proud to see this report uncover the truth behind the Biden-Harris administration’s use of $900 million of taxpayer funds to further their own political agenda that sowed distrust in our public health institutions, kept kids out of the classroom, and crushed local economies,” said Subcommittee on Health Chair Brett Guthrie (R-KY ). “American trust in the CDC is at an all time low because the Biden-Harris administration’s flawed pandemic messaging, and this report is the first step in holding CDC and other agencies to account for the harms caused throughout the pandemic and ensure these institutions are operating openly and transparently with the American public during future pandemics.”  “The entire premise of the Biden-Harris ‘Stop the Spread’ campaign was that if you got vaccinated for COVID-19, you could resume daily activities because they said vaccinated people would not spread the disease,” said Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) . “Despite lacking scientific basis, the administration bought into this CDC claim and misled the American public. As a result, vaccination coverage with other vaccines appears to have declined, I believe because of a growing distrust of information coming from our public health institutions.”  BACKGROUND :  The overall goal of this report is to understand why, with the extent of these resources, the HHS public relations campaign (Campaign) and the Biden-Harris administration’s response to the pandemic resulted in a collapse of trust in public health messaging.   Much of the scientific content directly featured in or alluded to in Campaign ads and other promotional material was drawn from CDC recommendations, guidance, and research, critical parts of which proved to be deeply flawed. The CDC’s errors and failures to update recommendations and guidance were reflected in the “We Can Do This” ads and promotional materials:  CDC’s guidance, which the Campaign relied on, went beyond the terms of FDA’s Emergency Use Authorization (EUA) to state, without evidence, that COVID vaccines were highly effective against transmission. This ultimately had a negative impact on vaccine confidence and the CDC’s credibility when proven untrue.   The CDC had inconsistent and flawed messaging about the effectiveness of masks.  The CDC consistently overstated the risk of COVID-19 to children. The CDC continues to recommend COVID-19 vaccines for all Americans ages six months and older, which has made the United States a global outlier in COVID-19 policy.  RECOMMENDATIONS :  Americans cannot afford another botched government response to a future pandemic. To prevent a recurrence of HHS’s failures in public relations management for the COVID-19 pandemic response and to strengthen the nation’s public health preparedness system, the Committee makes the following recommendations:  Congress should consider formally authorizing the CDC and clearly define the agency’s core mission.  HHS and its agencies should abide by the FDA’s product labeling guidelines. HHS and its agencies should be barred from promoting information regarding an FDA-regulated product that does not reflect the FDA-approved label. Congress should consider clarifying responsibility for evaluating the safety of vaccines and streamline existing reporting systems for capturing vaccine injuries and adverse reactions. HHS and its agencies should embrace a culture of transparency and accountability. The CDC and federal public health officials should not attempt to silence dissenting scientific opinions. HHS and its agencies should overhaul their website archival process to mimic that of prior White House administrations. CLICK HERE to read the full report and complete list of recommendations. 

Washington, D.C. — In a new letter to Government Accountability Office Comptroller General Gene Dodaro, House Energy and Commerce Committee Republicans have requested an examination of the structure of laboratory safety programs at the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH).  The letter was signed by Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA).  KEY LETTER EXCERPT :  This committee remains concerned about the effectiveness of the oversight HHS and its agencies provide to the laboratories they own and operate. In addition to numerous GAO recommendations that remain unimplemented by the FDA, both the CDC and the FDA recently announced organizational reforms to their laboratory safety and security functions, and it is not clear whether these changes will strengthen oversight or create new undue risk. The FDA has, for example, reorganized several of its laboratories such that they now fall within the Office of the Chief Scientist. This raises potential independence concerns, as the FDA’s laboratory safety and security functions report to the same office.  BACKGROUND :  The mission of the U.S. Department of Health and Human Services (HHS) is to enhance the health and well-being of all Americans.   As such, HHS is most directly involved in leading public health preparedness and response efforts, as well as associated research.   However, past safety lapses involving the CDC, the FDA, and the NIH have been the result of multiple breakdowns in compliance with established policies coupled with inadequate oversight.   For example, in July 2014, boxes containing decades-old vials of smallpox and other hazardous biological agents were found in a storage space of an FDA laboratory on the NIH’s campus. GAO and other reviews resulted in numerous findings and recommendations to strengthen laboratory safety and security, which led to changes to the way HHS and its agencies oversee their laboratories.   Likewise, GAO and other reviews have highlighted the importance of laboratory science and security in the handling of federal select agents and other dangerous pathogens in research.  CLICK HERE to read the full letter.

Washington, D.C. — In a letter today to Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., a bipartisan group of House Energy and Commerce Committee Leaders requested a briefing about the presence of counterfeit Ozempic and other semaglutide products in the United States’ medical supply chain.  The letter was signed by Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr. (D-NJ); Subcommittee on Health Chair Brett Guthrie (R-KY) and Ranking Member Anna G. Eshoo (D-CA); and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) and Ranking Member Kathy Castor (D-FL).   KEY LETTER QUOTE : “In addition to concerns about integrity gaps in the legitimate supply chain, we are also concerned about counterfeit Ozempic entering through illegal channels. For example, in June of this year, Eli Lilly issued an open letter expressing concern that counterfeit versions of its own drugs, Mounjaro and Zepbound, were being sold online, through social media and at medical spas. On May 1, 2024, a Department of Justice press release reported that work by FDA’s Office of Criminal Investigations resulted in the arrest of an individual for selling misbranded and adulterated weight loss drugs on TikTok. The Committee fully supports these continued investigations of unlawful sales.”   BACKGROUND :   The FDA alerted the public on December 21, 2023, to the presence of counterfeit Ozempic injection products in the legitimate drug supply; an investigati ve article l ater found that thousands of counterfeit Ozempic pens had arrived in a warehouse in Elmira, New York, as early as the fall of 2023. The fact that counterfeit medications made it into the legitimate medical supply chain raises concern about potential gaps in our supply chain security infrastructure.    This threat continues to grow.   CLICK HERE to read the full letter.

Washington, D.C — In a new letter to Advanced Research Projects Agency for Health (ARPA-H) Director Renee Wegrzyn, the House Committee on Energy and Commerce (E&C) and House Committee on Education and the Workforce (E&W) request information on how ARPA-H is ensuring that institutions and individuals involved in the research projects it funds comply with Title VI to ensure a harassment and discrimination-free environment.  This letter comes after a rise in antisemitism on college and university campuses, including Columbia University and the University of California, San Francisco where ARPA-H currently funds research. It is signed by E&C Chair Cathy McMorris Rodgers (R-WA), E&C Subcommittee on Health Chair Brett Guthrie (R-KY), E&C Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), E&W Chair Virginia Foxx (R-NC), and E&W Subcommittee on Higher Education and Workforce Development Chair Burgess Owens (R-UT).  KEY EXCERPT :  “Due to ongoing reports of antisemitism across colleges and universities, federal and congressional investigations into potential civil rights violations at these institutions, and an ongoing congressional investigation into HHS’s and NIH’s handling of these concerns at HHS-funded institutions, the Committees are seeking more information about how ARPA-H ensures that those involved in projects it funds comply with Title VI and relevant civil rights laws to ensure a research environment free of harassment and discrimination, especially towards those of Jewish faith and heritage.”  BACKGROUND :  ARPA-H is an independent agency of the U.S. Department of Health and Human Services (HHS) within the National Institutes of Health (NIH).  ARPA-H reports directly to the Secretary of HHS.  In the last year, ARPA-H has funded more than $595 million in research projects through ISOs and BAA with more than $506 million going to universities and research institutions and the rest to companies or organizations. Some of these research projects include:  August 30, 2024: Up to $39.5 million to Columbia University   August 22, 2024: Up to $7 million to the University of Pennsylvania   August 13, 2024: Up to $18.4 million to the University of Illinois Urbana-Champaign  July 10, 2024: Up to $27 million to the Wyss Institute at Harvard University  June 12, 2024: Up to $24 million to Yale University School of Medicine  April 1, 2024: Up to $35 million to the University of California, San Francisco  September 26, 2023: Up to $104 million to Harvard Medical School  September 25, 2023: Up to $26 million to Stanford University  Of the fourteen university-based projects ARPA-H funded in the last year, eleven (including the eight listed above) are at universities that were recently or are currently under federal and/or congressional investigation for potential Title VI violations and/or are being sued in federal court for permitting antisemitic behavior on campus.  Columbia University has been sued in federal court, is currently undergoing several investigations by the U.S. Department of Education Office for Civil Rights, and is undergoing investigation by congressional committees, for complaints of antisemitism.  The Committee on Energy and Commerce is currently investigating the University of California, San Francisco regarding concerns of antisemitism at the university, medical school, and associated medical centers.  The U.S. Department of Education recently closed its investigation into the University of Illinois-Urbana Champaign with a resolution agreement that found the university was not meeting its obligation under Title VI as it relates to complaints of shared ancestry discrimination—including 135 complaints of anti-Jewish discrimination.  CLICK HERE to read the full letter.