In the wake of dramatic cuts to US Department of Health and Human Services (HHS) staff, cutbacks for state public health efforts, and mixed messages on battling measles and other infectious diseases, two public health groups called for HHS Secretary Robert F. Kennedy Jr. to resign or be fired.
Also, a group of biomedical developers and investors sent a letter to a top Senate health leader, raising concerns about the Food and Drug Administration's (FDA's) ability to function under Kennedy’s watch and the severe staff cuts that followed.
APHA cites dangerous disregard for science
In a statement yesterday from the American Public Health Association (APHA), its president, Georges Benjamin, MD, said concerns raised during Kennedy's confirmation hearings have been realized.
He referenced, for example, massive cuts to programs at the Centers for Disease Control and Prevention (CDC), the FDA, and the Health Resources and Services Administration, which undermine the work of public health agencies to keep Americans safe.
Benjamin also listed several instances since Kennedy’s confirmation that suggest that the secretary has a disregard for science, such as a haphazard reorganization of HHS, forcing the ouster of the FDA’s top vaccine official, refusing to strongly endorse vaccination in the wake of two children's measles deaths, promoting unproven measles treatments, and clawing back $11 billion in state and local public health funding.
I ask my colleagues to join me and speak up.
"As a physician, I pledged to first do no harm and to speak up when I see harm being done by others. I ask my colleagues to join me and speak up," he said. "Secretary Robert Kennedy is a danger to the public’s health and should resign or be fired."
Cuts upend programs for HIV, hep C, and TB
In a related development, the Treatment Action Group (TAG), which supports global efforts to boost research into and greater access to treatments for HIV, hepatitis C, and tuberculosis (TB), today joined Benjamin's call for Kennedy to resign or be dismissed. It added that many of the cuts are related to those three diseases.
TAG said further cuts in the National Institutes of Health (NIH) threaten critical TB research and terminations of research funding to South Africa, where up to one-third of research participants are enrolled in NIH-supported clinical trials for new TB interventions.
Lindsay R. McKenna, MPH, who codirects TAG’s TB project, said, "These terminations threaten to destroy years of research designed to bring the end of TB closer."
Biomedical group sends letter to lawmaker
Also, No Patient Left Behind (NPLB), a consortium of biomedical scientists, investors, economists, and patients who support new and affordable biomedical treatments, has sent a letter to Sen. Bill Cassidy (R-LA) that said they support a stronger and modernized FDA but are deeply concerned about the agency and its future.
Cassidy cast the tiebreaking vote that advanced Kennedy's HHS nomination to a full Senate vote in early February after getting specific promises from Kennedy. He also chairs the Senate Health, Education, Labor, and Pensions (HELP) committee.
"Specifically, we worry that the institutional knowledge that makes the FDA the world's leading regulatory body will be irretrievably lost due to the agency's recent reduction in force and wave of retirements," the group said. "The agency's ability to function is compounded by a hiring freeze. As a result, American patients, American industry, and American biomedical leadership will bear the consequences."
The letter said some companies are already encountering regulatory difficulties that NPLB believes are the result of the loss of experienced staff at FDA. It added that delays in FDA review reduces the ability of smaller companies to get funding to advance to the next stage of clinical development.
American patients, American industry, and American biomedical leadership will bear the consequences.
"The extreme turmoil in the biotech financial markets reflects that investors are worried about our ability to execute," the group said.
It asked Cassidy to assess FDA capacity impacts and to restore the agency's core functions, such as maintaining regulatory timelines.
Last week, media outlets reported that the FDA principal deputy commissioner took an unusual step in reviewing Novavax’s COVID-19 vaccine for full approval, which has led to a delay in clearing the vaccine, which was originally expected to occur this month.
In a CBS News interview yesterday, Kennedy said the FDA isn't proceeding with full approval because he claims that single-antigen vaccines don't work against respiratory viruses and that the FDA is shifting to multi-antigen vaccines.
Experts have pointed to Kennedy's statement as another example of spreading misinformation. Several vaccines against respiratory viruses are single-antigen, including all licensed COVID-19 products and vaccines against respiratory syncytial virus (RSV).
