Dangerous disregard for science
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.
"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).