First, decide the conclusion you want and then pay bogus scientists $1.6 million to make up the proof
According to a notice in the Federal Register posted
yesterday, the CDC is paying the University of Southern Denmark to conduct a
single-blind clinical trial of the hepatitis B vaccine in newborns in
Guinea-Bissau, a small country in West Africa with exceptionally high rates of
maternal and infant mortality, where nearly one in five people are infected with the
hepatitis B virus.
The CDC is an agency within HHS. The study aims to assess
the optimal timing and delivery of hepatitis B vaccinations, according to the
notice.
‘Appearance of blatant cronyism’
The new study was awarded without any competition from any
other scientists, giving it “the appearance of blatant cronyism,” said Angela
Rasmussen, PhD, a virologist and professor at the University of Saskatchewan.
Although the federal announcement did not include the names
of the researchers, the Danish university’s Bandim Health Project, which has
conducted vaccine research in the developing African country for decades, has acknowledged being
awarded the CDC grant.
The Bandim project leaders have claimed to find
“non-specific effects” from vaccines—some good and some bad—that
they say should change how vaccine
safety studies are conducted.
Their message has resonated with Kennedy, a
long-time anti-vaccine activist.
In June, Kennedy used
a single study by the Bandim group to justify canceling more
than $1 billion in funding for childhood vaccinations in developing countries.
The observational study found an increased risk of death in children who
received a combined vaccine for diphtheria, tetanus and pertussis (DPT) that
hasn’t been used in the United States in three decades.
Scientists say people shouldn’t put too much faith in that
study, which is an outlier and conflicts with hundreds of studies showing that
vaccines are safe and save lives. Researchers and policy makers normally
consider the totality of scientific evidence on vaccines, rather than a single
study, which may be flawed.
Also, observational studies, in which scientists merely follow patients but do not randomly assign them to undergo different medical interventions, are not able to prove cause and effect.
Yet Children’s Health Defense, the anti-vaccine organization
Kennedy founded, cites the Danish group’s
research on multiple pages of
its website. One article praises the Bandim Health’s
founder, Danish anthropologist Peter Aaby, casting him as a martyr
who lost his funding when he suggested vaccines cause more harm than good.
Multiple scientists have criticized the Bandim group’s
methodology and conclusions.
A review published in Vaccine last
month found that Bandim Health researchers “have systematically
over-interpreted the findings from their randomized trials” for 25 years.
In 23 out of 25 articles, the researchers highlighted
secondary findings as support for their theories, but in 22 of these cases the
evidence disappeared after proper statistical handling.
The group “systematically selected and highlighted results
that supported their theories, while downplaying the fact that they did not
confirm the primary hypothesis the trials were actually designed to test,” said
Henrik Stovring, PhD, a professor of biomedicine at Denmark’s Aarhus University
who led the new review, in a press release.
“In 23 out of 25 articles, the researchers highlighted
secondary findings as support for their theories, but in 22 of these cases the
evidence disappeared after proper statistical handling,” said Stovring said,
who is also a professor at the Steno Diabetes Center Aarhus. “When you
look at the overall picture, there are almost no real findings left.”
Two reviews commissioned by the World Health
Organization concluded that the evidence
for non-specific effects “remains weak and vulnerable to biases.”
Danish media also have criticized Aaby
and Christine Stabell Benn, MD, PhD, his wife and research partner, for touting the findings of
their observational study while failing to publish the
results of a randomized controlled trial—considered the gold
standard of medical evidence—on the DPT vaccine, conducted 14 years ago.
By commissioning the new vaccine study, the Trump
administration’s is trying “to do anything they can to discredit all vaccines,”
said Peter Hotez, MD, PhD, endowed chair of tropical pediatrics at Texas
Children’s Hospital and co-director of its Center for Vaccine Development.
“This is so self-defeating for the country.”
Danish researchers have influenced US vaccine policy
Yet Aaby and Stabell Benn have found an audience in an
influential federal advisory group whose members were handpicked by Kennedy,
who fired all of the previous members. The Advisory Committee on Immunization
Practices, which advises the CDC, cited the Guinea-Bissau
research multiple times in a presentation at its September
meeting.
Stabell Benn has served as an expert source for
ACIP and has collaborated on
a Substack post and a series of podcasts with a senior leader at the Food and
Drug Administration (FDA), Tracy Beth Hoeg, MD, PhD, who attends the
committee’s meetings on behalf of agency. Hoeg previously worked as an adjunct associate professor
at the University of Southern Denmark.
At an ACIP meeting this month, Hoeg presented slides about
vaccination practices in Denmark, suggesting that the United States follow
that country’s approach.
Within hours, President Donald Trump called for the US to align its
childhood vaccination schedule with those of countries such as Denmark.
Neither Stabell Benn nor Aaby responded to a request for an
interview by deadline.
An HHS spokesman said the study in Guinea-Bissau will fill a
vital need.
“This award supports an independent study designed to answer
important questions about the broader health effects of the hepatitis B birth
dose,” said Andrew Nixon. “This research aims to fill existing evidence gaps to
help inform global hepatitis B vaccine policy and we will ensure the
highest scientific and ethical standards are met.”
In spite of strenuous objections from three physicians on
the committee, ACIP earlier this month voted
to abandon a 34-year-old recommendation to vaccinate all newborns
for hepatitis B, a practice that has reduced infections in children and
adolescents by 99%. Since 1991, the universal HBV birth dose has
prevented an estimated 90,100 childhood deaths. Its safety has
been demonstrated in hundreds of studies over the past four
decades.
The acting CDC director this week followed
ACIP advice, recommending a birth dose of hepatitis B vaccine only for
babies who mothers are infected with the virus or whose infection status is
unknown. The change will
lead more babies to develop hepatitis B, which can lead to liver
cancer, liver failure and death, wrote Jake Scott, MD, a clinical associate
professor of infectious disease and geographic medicine at Stanford University
School of Medicine, in an editorial for CIDRAP News.
Cherry-picking studies and researchers
Multiple researchers who spoke to CIDRAP News questioned the
need for another study of hepatitis B vaccines, which have
been proven safe and effective in more than 400 studies over 40
years.
“The data that supports the safety advocacy of the current
hepatitis B vaccines is very robust,” said Amesh A. Adalja, MD, a senior
scholar at the Johns Hopkins Center for Health Security.
“Given the stance of the CDC under RFK Jr’s control, one can
assume that the results of this study will be preordained to be against the
hepatitis B vaccines,” Adalja said. “Continuing to do studies on a question
that is already been answered sufficiently is a waste of resources that could
better be used answering new questions.”
Some researchers question where the Trump administration
found $1.6 million for the study, given that it has cut billions of dollars in
federal support for science.
“NIH is in crisis, grants are being terminated, labs are
closing, researchers are being laid off,” Scott told CIDRAP News. “But they
found $1.6 million for an unsolicited proposal to study whether we should delay
a vaccine we’ve been safely giving for 40 years, in a country where infants are
at high risk of infection. The money exists. It’s the priorities that have
changed.”
Scientists said the new study raises ethical concerns on
several fronts.
Awarding money to an organization without allowing other
scientists to compete for the grant is very unusual, Rasmussen said. When this
happens, the study protocol typically undergoes rigorous review.
HHS has not released details of the study, noting only that
the research will involve a “comparable study of the optimal timing and
delivery of … hepatitis vaccinations on newborns in Guinea-Bissau. Activities
will include conducting a randomized controlled trial to assess the effects of
neonatal hepatitis B vaccination on early-life mortality, morbidity, and
long-term developmental outcomes.”
Rasmussen notes that it would not be ethical to provide a
birth dose of the hepatitis B vaccine to some babies but not others, given that
doctors know the immunization saves lives, both in the early newborn period and
decades later.
Exposing thousands of babies to “a significant risk” of
hepatitis B “in a low-income country with limited health care resources” would
be “wildly unethical and a disgraceful use of American taxpayer money,”
Rasmussen said.
Researchers note that Guinea-Bissau, has a poverty rate of 60% and
a population of 2.2 million, about 150 times smaller than the United States.
When you commission research after making a decision,
you're not looking for answers—you're looking for validation.
The Guinea-Bissau study’s findings are unlikely to be
relevant to US vaccine policy, given the nation “has very different population
demographics from the US and has a health system which is very different from
the US,” said Robert H. Hopkins Jr., MD, medical director of the National
Foundation for Infectious Diseases (NFID).
Scott said the study’s announcement suggests that the CDC
isn’t truly looking for answers.
“In evidence-based policy, you gather data and then make a
decision,” Scott said. “This is the reverse. CDC made the policy decision and
then funded research to back it up. When you commission research after making a
decision, you're not looking for answers—you're looking for validation.”
