HHS Archives - ºÚÁϳԹÏÍø News /tag/hhs/ ºÚÁϳԹÏÍø News produces in-depth journalism on health issues and is a core operating program of KFF. Mon, 08 Jun 2026 09:14:29 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.5 /wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=32 HHS Archives - ºÚÁϳԹÏÍø News /tag/hhs/ 32 32 161476233 MAHA’s Treatments for Autism: Camel’s Milk, Stem Cell Injections — And Spelling Therapy /health-industry/autism-controversial-treatment-spelling-maha-telepathy/ Mon, 08 Jun 2026 09:00:00 +0000 /?p=2240522 Elizabeth Bonker is a silent woman with a loud mission. She wants government agencies to cover the costs of training people with autism in a form of communication called assisted spelling. One problem: Leading professional organizations don’t believe it works.

“All nonspeakers above the age of 5 should be given the opportunity,” typed Bonker, who is 28 and cannot talk. Her mother, Virginia Breen, held a wireless keyboard for her. They sat on a hotel patio before an April 27 meeting with a senior aide to Health and Human Services Secretary Robert F. Kennedy Jr.

“We are misunderstood and underestimated,” Bonker typed, occasionally humming or lightly groaning as she considered where to place a slender forefinger on the keyboard.

Assisted spelling is used to help nonverbal people communicate by pointing to letters on boards or using keyboards with physical help from another person.

Supporters say assisted spelling has improved the lives of thousands of people with autism, such as Bonker, and they have powerful allies. Kennedy appointed Bonker and another autistic “speller,” as they call themselves, to a 20-member autism panel made up largely of parents with children whose autism they attribute to vaccinations.

At the reconfigured panel’s first public session on April 28, three other members said their nonspeaking adult children were learning to communicate through spelling. The panel issued a resolution with  stating that “robust” communications programs are essential for autistic people. Bonker has urged the Department of Health and Human Services to support training in assisted spelling for those who want it.

But leading for , as well as those representing and , that these methods — premised on the idea that people with autism have the normal range of cognitive powers but are imprisoned in malfunctioning bodies — are flawed or fraudulent.

Other, validated methods enable nonspeakers to communicate through digital and analog pictures and letter boards. But assisted spelling isn’t autonomous communication, critics say: Consciously or not, the board holder may be influencing or responsible for the typed or pointed-at words — as with a Ouija board.

For many parents in Kennedy’s Make America Healthy Again community, the spelling controversy is angrily ringing the same bells as the notion that vaccines cause autism — which they refuse to consider debunked. As some people see it: Established medicine damaged them with vaccines and now refuses to accept a helpful treatment.

People with autism are “trapped in bodies that have betrayed them because the medical establishment has betrayed them,” said Louis Conte, who has a child with autism, in a of a Kennedy-allied MAHA publication.

By limiting access to spelling, “you are not just limiting expression, you are erasing identity,” said Katie Sweeney, the mother of an autistic adult who is affiliated with an anti-vaccine , at the autism panel meeting.

Mainstream autism experts and advocates in March convened the Independent Autism Coordinating Committee as a counter to Kennedy’s panel. At the new group’s meeting, one member spoke out against the spelling methods.

“In this underfunded disability environment, I don’t want a single penny diverted to debunked interventions like spelling,” said , a senior lecturer in history at the University of Pennsylvania and an who described her 27-year-old son as “profoundly autistic.”

It’s not only a waste of time, she said later in an interview, but “people subjected to spelling are not given access to evidence-based education. Every interaction turns someone like my son into a puppet, and I find that very objectionable.”

A Patchwork of Perspectives

The universe of autistic people, their parents, researchers, advocates, and service providers is a broad, acrimonious spectrum. Some say that vaccines or chemical exposures caused a massive increase in autism, others that diagnostic changes account for most of the increase. Some seek mainstream or alternative treatments, some demand classroom inclusion, and others want residential treatment. Some people with autism say it’s a difference, not a disability.

“When I tell the parents of a young child they have autism, it’s a tragedy,” said Audrey Brumback, a child neurologist at Dell Medical School at the University of Texas-Austin. “When I give the same diagnosis to a teenager, it’s good news. It means, ‘There’s nothing wrong with you; you’re just autistic.’”

Scientific medicine has failed to deliver good treatments for autism. After four decades of concerted research, “the results have for the most part been very disappointing,” said David Mandell, a professor of psychiatry and pediatrics at the University of Pennsylvania.

Severely autistic children — those requiring round-the-clock care with ailments like epilepsy and generally lacking in verbal language — account for of all U.S. autism diagnoses. Caring for them may mean dropping careers and spending vast sums on therapy. “They ought to spell special education with a dollar sign,” said Tracy Simmons, whose 17-year-old son, Noah, has autism.

Many parents of autistic children have tried vitamins and diets that exclude wheat, soy, or dairy. Some have turned to hyperbaric oxygen chambers, others to pig hormones to repair damage spuriously attributed to measles-mumps-rubella vaccines, and infusions of metal-leaching chemicals to remove traces of heavy metals in childhood shots. Recent regimens include camel milk, broccoli extract, and stem cell injections obtained at great expense in Panama and India.

In September, the White House touted leucovorin, used in some cancer care and for an ultra-rare genetic condition. Marty Makary, then-commissioner of the FDA, said the drug could help 50% to 60% of kids with autism.

There’s little evidence behind any of these treatments, Brumback said. Many parents try multiple remedies at once; if a child’s condition improves, it’s hard to tell what worked — or whether the child simply grew out of a problem.

Noah Simmons has spent two years learning to spell and type. At a climbing center in Gaithersburg, Maryland, he communicated with the aid of his mother, Tracy Simmons, who is holding a laminated sheet with the alphabet. (Arthur Allen/ºÚÁϳԹÏÍø News)
Noah Simmons glides down the rope at a climbing center. He high-fived his instructor and then beamed as he spelled out, “Im going to crush it again!” (Arthur Allen/ºÚÁϳԹÏÍø News)

Noah the Speller

During a Zoom session in which he typed on a keyboard held by his mother, Noah Simmons wrote glowingly about the world opened to him by two years of learning to spell and type.

“Im a new person. I have friends, I write, climbing,” he typed. “Conversation. I can have one. I have a say. Im human now.”

Later, at an indoor climbing center in Gaithersburg, Maryland, Noah scrambled nearly to the top of the wall before he slipped. He glided down the rope and slapped a high five with his climbing instructor as his mother approached. She carried a laminated sheet with the alphabet on it.

Tracy Simmons held the paper while Noah stabbed at the letters one by one, ending with a flourishing swipe at the exclamation mark: “Im going to crush it again!”

There, and at a later keyboard session at home, Noah seemed in control. But when Tracy stopped offering verbal prompts and encouragement, or stopped holding the board, Noah often got lost and signaled a need for help.

Tracy Simmons acknowledges that whoever holds the board could be steering a speller’s words. Despite his climbing prowess, Noah lacks fine motor skills, is anxious, and has trouble controlling his body, she said.

“He’s working on becoming an independent typer. He can do it short amounts of time,” she said. “But at times he gets overwhelmed.”

The method used by Noah and his mother came into use in the United States in the early 1990s. At first, trainers guided the arms or hands of the spellers as they pointed to a letter board. The idea was that the intelligence or literacy of severely autistic people was trapped in bodies they couldn’t control. They needed help physically learning to spell, first with a pencil or finger pointing at stenciled or printed letters, and eventually by typing on a keyboard.

Within a few years, however, dozens of experiments had shown that the facilitators, not the autistic people, were doing the spelling. A that the spellers could identify words or objects without their facilitators.

In addition, the technique has resulted in — sometimes in the autistic person’s life skeptical of the spelling process.

Next came the Rapid Prompting Method, devised by Soma Mukhopadhyay, an Indian mother of a boy with profound autism, who brought her system to the United States in 2001. Elizabeth Vosseller, a speech pathologist in Herndon, Virginia, launched a nearly identical method, Spelling to Communicate. In both, the facilitator, not the speller, holds the letter board. But each method relies on prompts.

Mukhopadhyay and Vosseller, who did not respond to requests for comment, have each declined to submit their systems to the kind of testing that disproved facilitated communication. Bonker said calls for such tests show a lack of respect for the disabled.

Asked why, after 23 years as a speller, she couldn’t communicate alone or without her mother holding the board, Bonker typed, “I can do it in certain environments that don’t include interviews with strangers.” Severely autistic people need coaches to help control their anxiety, Breen said.

Another star of the speller world, Woody Brown, spoke through his mother with Jenna Bush Hager on the Today show on April 1. The Browns were promoting his novel, Upward Bound, which became an immediate New York Times bestseller after its March release. During the segment, Mary Brown spoke in complete sentences that she said came from Woody, but the letters he typed, as far as the program’s viewers could see, did not correspond to her words and often looked like gibberish.

This raised questions about how Woody Brown could be the author of what critics described as a brilliant, sensitive novel. They pointed out that Mary Brown has worked as a Hollywood script analyst. The Browns did not respond to efforts to reach them for comment.

“Spellers” are best known to the public through the success of The Telepathy Tapes, which briefly unseated The Joe Rogan Experience as the country’s most popular podcast early last year. In The Telepathy Tapes’ first season, people with profound autism were allegedly revealed as clairvoyant superhumans.

The evidence for their telepathic abilities was produced through spelling. The host showed spellers and facilitators two things, and the speller, with the facilitator present, typed out what the facilitator saw. Viewers had to wonder whether this was evidence of telepathy or confirmation of what critics have said all along: that the facilitator is the one controlling the words, often by feeding the speller subtle cues.

Bonker said she appreciated the Telepathy Tapes’ host for including her nonprofit group’s information on its website. As for telepathic skills, “I believe nonspeakers have many gifts,” she said. “And I believe what they say.”

The debate over spelling is playing out in boards of education and courtrooms, where parents of autistic children seek aid for their children’s spelling lessons.

In New York state in March, anti-vaccine on state Sen. Patricia Fahy, the Democratic chair of the disabilities committee, after she inserted language into a disability rights bill requiring that payments go to “verified” communication methods that assured patient autonomy.

Vikram Jaswal, a University of Virginia psychologist who works with spellers, said he’s seen people with severe autism who can type independently, though only a handful have that ability out of the couple of hundred spellers he’s met. More research is needed to figure out who can best benefit from the technique, he said.

Tracy Simmons believes in the method, and so does her son — assuming he’s in control of what he types.

On a recent morning, Tracy read aloud a beautiful escape-from-Alcatraz story she said Noah had written with her help and that of his spelling trainer. “He writes all the time in his head,” she said, but it could take years for her son to consistently type independently.

ºÚÁϳԹÏÍø News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This <a target="_blank" href="/health-industry/autism-controversial-treatment-spelling-maha-telepathy/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2240522&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]> 2240522 RFK Jr. Seeks To Peek at Americans’ Medical Records for Clues on Autism and Vaccines /mental-health/sharing-patients-medical-records-access-rfk-jr-project-link-autism-vaccine-injuries/ Thu, 04 Jun 2026 09:00:00 +0000 /?p=2245892 U.S. health secretary Robert F. Kennedy Jr. is pursuing federal government access to most Americans’ medical records, in a quest to research a link between vaccines and autism — a connection the medical establishment studied for decades and flatly rejects.

The Department of Health and Human Services is seeking data from little-known state systems that allow hospitals and clinics to exchange detailed, identifiable patient information, ºÚÁϳԹÏÍø News has learned.

In private meetings, some public health leaders have objected to giving Kennedy’s team access to such data, raising doubts that it’s legal or that the information would even be useful.

They have also expressed concerns about allowing the federal government to peer into the minutiae of Americans’ medical records, which could mean viewing anything from doctors’ notes to prescription history. HHS has offered no insight into how it will protect or handle the personal health information it obtains.

But Kennedy told ºÚÁϳԹÏÍø News that medical records are key to investigating the cause of autism, vaccine safety, and chronic diseases. And millions of dollars in grant money has poured into a Nebraska nonprofit that has assisted Kennedy’s effort, according to state records.

He and his advisers have been frustrated that federal access to Americans’ medical records has been limited.

“We need a good health record system, and one of the things that really surprised me most when I came into office is that there is — that the systems are broken,” Kennedy said in a May interview. “We’ve had to go to the states and, luckily, we’ve got a lot of cooperation from the states, but we now have databases together that we can actually do the studies on. Those studies are in motion.”

HHS has not publicly announced any new projects involving medical records and autism or vaccine research. Kennedy faced blowback last year when he proposed compiling the medical records of people with autism to create a federal disease registry — which health department officials .

But Kennedy said in May, “We have a whole pipeline of studies that will be done over the next year.”

Though the White House has steered Kennedy away from further changes to U.S. vaccine policy ahead of November’s crucial midterm elections, President Donald Trump has regularly echoed Kennedy’s doubts about vaccine safety and last week signed an executive order calling for the U.S. to reduce the number of vaccines recommended for children.

Kennedy’s political appointees and allies — including William “Reyn” Archer III, a former Texas health official and whom Kennedy hired as a senior adviser — have led the initiative for the health department to collect and examine medical records.

A man sits at a table with a placard with his name on it. Other faces are seen blurred in the foreground in front of him.
William “Reyn” Archer III, a former Texas health commissioner, attends the Advisory Committee on Immunization Practices meeting at Centers for Disease Control and Prevention headquarters on Sept. 20. (Mary Conlon/AP)

Federal officials met with leaders of the state-run health information exchange systems several times over the past year and asked how the personal medical records they maintain could be used for vaccine research, according to seven people who participated in the discussions or were familiar with them.

Craig Behm, who runs the Maryland health information exchange, said Kennedy’s team asked about how the vast trove of medical records they store from hospitals and health systems could be used to study vaccines.

“If this administration wants to conduct research on the effectiveness of vaccines, are you saying you all can help us conduct that research?” Behm recalled being asked by a top official at HHS’ health information technology office.

Last June, Behm and leaders of other state exchanges met with Kennedy’s top advisers to discuss sharing more medical data with federal agencies. The state organizations followed up with a pitch in October for a new surveillance system that would give the federal health department “real-time, 24-hour data feeds on opioid and chronic disease trends” within a year, according to a presentation reviewed by ºÚÁϳԹÏÍø News. Under the proposal, HHS would get data from 90% of the population’s medical records by 2028.

Administration officials regularly asked during the meetings how the records could be used to monitor vaccine safety. Kennedy has rejected the federal government’s current vaccine-monitoring systems; decades of research has shown immunizations are safe and effective for most people.

“Vaccine safety, or whatever words you want to use, has come up pretty consistently in those conversations,” said John Kansky, CEO of the Indiana Health Information Exchange.

Kansky sees the potential value of sharing information from the exchanges for public health but is worried about the focus on vaccines: “It’s like, oh man, I wish you would have picked something that pushed fewer buttons for people.”

A System To Monitor Chronic Disease

Nearly every state has at least one health information exchange — often regulated by state laws and run by private companies or nonprofits — that enables hospitals and health systems to immediately share patients’ medical records with one another. The systems allow doctors and nurses to quickly pull up nearly anyone’s medical history and records at emergency rooms or share after-visit summaries and notes with patients’ primary care providers, for example.

In certain circumstances — most often dealing with cases of infectious diseases such as measles or flu — the exchanges notify public health authorities, like the state health department or the Centers for Disease Control and Prevention. Using the exchanges for broader public health purposes is not an unusual idea in itself. But it can present privacy, legal, and ethical complications, health officials say.

In the end, Behm said his organization in Maryland declined to share more data with the federal government for vaccine research, noting that sharing medical records for that purpose would require a rash of approvals from hospitals, state political leaders, and research boards. Any new data-sharing agreement should also have a clear, detailed framework outlining what would be shared and with whom, he added.

“A number of us said, ‘We can’t do anything our agreements don’t allow us to do, so no,’” Behm said. Indeed, most health information exchanges have contractual restrictions on who can access clinical data.

Kansky said Indiana is still weighing whether to provide additional data for Kennedy’s project, and that nothing has yet been shared.

HHS spokesperson Emily Hilliard did not answer questions about how many states are participating in Kennedy’s project, what new data the agency is collecting, how much the federal government is spending on the initiative, how it is protecting patient privacy, or who has access to the data.

“HHS is strengthening public health surveillance and modernizing data systems to better understand and combat the childhood chronic disease epidemic as part of Secretary Kennedy’s Make America Healthy Again agenda,” Hilliard said in an emailed statement. “Americans deserve robust systems to monitor the drivers of chronic illness.”

Kennedy has asserted, without evidence, that vaccines can cause chronic illness.

A Kennedy Partner in Nebraska

At least one state has been cooperative.

The former leader of Nebraska’s state health information exchange has led the effort to share data from medical records with the federal government.

Jaime Bland, former CEO of CyncHealth — the Nebraska health information exchange used by in the state — said several states are looking to “open up channels” to provide more analysis to Kennedy’s team.

“They’re looking at the data differently and providing some insights back to the CDC,” Bland told ºÚÁϳԹÏÍø News.

Bland was among a group who proposed that CyncHealth would help kick off the initiative, according to a 43-slide PowerPoint presented to federal officials during an October meeting.

CyncHealth and other state health information exchanges would “ingest data from hospitals, clinics, laboratories, pharmacies, payers, and social services agencies,” then “link claims and clinical records through a master patient index.”

Data from the exchanges “will be deidentified where appropriate,” according to one slide.

The federal government would pay the exchanges for furnishing the records, according to the proposal: $3 a person, annually.

Officials would “frame publicly that this is not a new database, but a federated trust model that delivers real-time data for all HHS missions,” the presentation reads.

After the meeting, Nebraska’s health department was awarded a large grant from the CDC, and CyncHealth in turn got millions of dollars from the state.

On Dec. 19, the CDC announced new funding under its , which sends money to state and local health departments for lab work, health information enhancements, and solutions for outbreaks.

Nebraska’s state health department was awarded $18.7 million — the most of any state last year, though Nebraska is the 38th most populous state. By comparison, Texas received $9.2 million, and California got $10.8 million.

CyncHealth was then awarded three contracts totaling $13.6 million from the state health department just weeks later, on Jan. 9 and Jan. 16, according to a publicly accessible database of state contracts.

Grace McNamara, a spokesperson for CyncHealth, said it retained $2.4 million of the funding for Kennedy’s project; the remaining money was distributed to “other participating states and various vendor organizations for implementation support.”

A former CDC official who was aware of the transaction, but not authorized to speak publicly about it, confirmed the money was intended for CyncHealth to supply data for Kennedy’s initiative to look at vaccines and autism. McNamara said that the “work is focused on improving outcomes related to acute and chronic illnesses.”

“The referenced project is not research, but rather a proof-of-concept project on how health information exchange and public health can work together to improve health outcomes and is not specific to autism,” she said in an emailed statement.

McNamara did not answer questions about what type of medical data is being provided to the federal health department or whether patients’ identifying information is removed.

Bland left her post at CyncHealth — where she was paid nearly — in December. She was named in April as the chief data strategist for the MAHA Institute — a think tank founded by allies of Kennedy and Trump to advance their Make America Healthy Again movement.

Bland agreed with Kennedy that data from state health information exchanges could provide more insight into autism’s causes or vaccine injuries.

“The data is so fragmented, so modeled when it comes to population health and public health, that we lose sight of the individual stories,” Bland said. She told a story she had heard about a woman who had a seizure after receiving the HPV vaccine.

“You know, the vaccine is safe — it absolutely is — but it wasn’t safe for her,” Bland said. “As public health officials, we say the vaccine is safe. But there are cases where it is not.”

Daniel Jernigan, a former top CDC official who left the agency last summer, said he tried to point Kennedy to data that would help the health secretary study vaccine safety and autism.

Dan Jernigan shakes the hand of a man off screen outside of the CDC headquarters.
Former CDC official Daniel Jernigan greets a supporter after resigning from the agency on Aug. 28. (Elijah Nouvelage/Getty Images)

After 31 years at the CDC overseeing public health surveillance, emerging infectious diseases, and the influenza divisions, Jernigan thought the solution was simple. The secretary could work with researchers to obtain huge databases pulled from health systems nationwide and maintained by major electronic health records companies.

Those databases are deidentified, meaning they don’t include patient names or other information that can identify individuals. Jernigan said Kennedy didn’t seem interested.

Instead, as The New York Times first reported, the health secretary dispatched two top advisers — Archer and Hannah Anderson, his former deputy chief of staff — to the CDC’s headquarters in Atlanta last July to download millions of identifiable patient records directly from the Vaccine Safety Datalink, the system the health agency uses to investigate complications from vaccines. The records, though, were decades old.

Jernigan said the federal government has limited legal authority to access medical records from state health information exchanges. In any case, examining those records may provide a view of a person’s medical history that will not necessarily produce answers to Kennedy’s questions about vaccines and autism.

“If they’re just using the electronic health record data, there are limits to that,” Jernigan said. “If they’re only looking at electronic health record data, all you’re going to get is what was captured in the encounter. It’s not going to be very satisfying.”

ºÚÁϳԹÏÍø News data reporter Maia Rosenfeld contributed to this article.

ºÚÁϳԹÏÍø News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This <a target="_blank" href="/mental-health/sharing-patients-medical-records-access-rfk-jr-project-link-autism-vaccine-injuries/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2245892&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]> 2245892 Trump’s Medicaid Work Rules Force States To Scrap Plans and Rework Systems /medicaid/trump-law-medicaid-work-rules-states-overhaul-eligibility-systems/ Wed, 03 Jun 2026 19:53:14 +0000 /?p=2246301 The Trump administration’s rollout of a federal mandate that millions of Americans on Medicaid must work or risk losing health benefits will force states to scrap months of preparation, according to advocates for Medicaid enrollees and consultants advising states.

And they say an overhaul — less than seven months before states must start enforcing the requirement — will be costly.

by the Centers for Medicare & Medicaid Services dictate many granular details about how the new work requirements will play out. They cover how states should check whether Medicaid enrollees are following the rules, and how people can claim an exemption so that their health benefits don’t hinge on work, community service, or going to school.

Next year, President Donald Trump’s One Big Beautiful Bill Act could require roughly across 42 states and the District of Columbia who receive Medicaid benefits to prove they’re working or participating in a similar activity to keep their health coverage — unless they qualify for an exemption.

Much of the verification will run through state computer systems that assess whether low-income people qualify for Medicaid and other safety net programs — technology often built and run by private companies under contracts routinely worth hundreds of millions of dollars. Many of those systems have a history of errors that can cut off benefits to eligible people.

For months, states have been communicating with federal regulators and rushing to build systems to comply with the looming mandates, said Kinda Serafi, a partner at the Manatt Health consulting and legal firm. The rules released this week represent a “significant policy pivot” from what states were expecting, Serafi said.

“The administration has actually taken what we know to be a tough situation and has just made it even worse,” Serafi said. States had already committed to paying contractors tens of millions to adjust their systems.

After Trump signed his signature tax-and-spending bill into law last July, one of the most significant remaining questions was how much discretion the federal government would give states to define exemptions for people too sick to work. The “medical frailty” exemption allows a person to claim they have a health condition that prevents them from working at least 80 hours a month, as the law requires.

To qualify, a person generally must fit into at least one of five categories: They must be blind or disabled; have a substance use disorder; have a disabling mental disorder; have a physical, intellectual, or developmental disability that significantly impairs their daily life; or have a serious medical condition. States are not allowed to add categories.

Under the new regulations, CMS said having a medical condition alone isn’t sufficient to exempt someone from the work requirements. States must assess “the severity of an individual’s condition” to determine whether they can stay on Medicaid without working — a standard that makes it more difficult for enrollees to meet the criteria.

CMS officials did not list specific conditions that qualify for exemptions, but the agency did say homelessness can’t be a reason to claim that exemption because it is not a medical condition.

To implement the law, states “will have to undo work that they did,” said , deputy director of Princeton University’s State Health and Value Strategies program, which works with state governments on various health coverage issues.

The Trump administration previously acknowledged that the work to upgrade state Medicaid eligibility systems to comply with the law is coming at a cost. In January, top CMS officials said government contractors, including Deloitte, Accenture, and Optum, and reduced rates through 2028 to help states adjust their systems.

The discounts “may be helpful” in some states, but they’re “not going to be helpful across the board” due to variations in state contracts, said , director of the State Health and Value Strategies program.

“Anytime you have to go back and say, ‘Oops, we need to reprogram this one thing,’ there’s a cost,” Howard said.

States were prepared to create lists of conditions and diseases to qualify people for work requirement exemptions, according to health care experts advising them. Mining data to verify someone’s illness was already a tall order for states because the computer systems that determine whether someone is eligible for Medicaid often do not communicate with the systems that track medical claims.

America’s health care payment systems rely on a set of standardized codes that correspond to specific diagnoses.

But there’s no “code that designates that someone is too sick to work — that’s a subjective assessment,” said Rachel Klein, deputy executive director of , a nonpartisan advocacy group for people with HIV. “This is a recipe for disaster.”

The new federal standards pose immediate issues for Nebraska, which launched its Medicaid work requirement on May 1, eight months before the federally mandated deadline. Nebraska handles decisions on medical frailty differently than the Trump administration does.

Nebraska officials had already released a nearly of medical conditions that qualify as exemptions, such as types of cancer, dementia, autism, epilepsy, HIV, and Parkinson’s disease. The state, which relies on government workers to check Medicaid eligibility, doesn’t require a person to prove how sick they are.

But under Trump’s rules, people will have to show their qualifying illness is impeding their ability to work.

Now, Nebraska is “going to have to go back and figure out how to assess whether all of these people are too sick to meet the requirement,” Klein said.

Medicaid enrollees are slated to start losing coverage this summer under Nebraska’s early rollout.

Sarah Maresh, a program director with , an advocacy organization for people with low incomes, said the state should refrain from terminating people’s coverage until next year because of the changes it will need to make. State residents are already confused and scared, she said, and the new rule “makes matters much worse.”

In response to several questions, Jeff Powell, a spokesperson for Nebraska’s Department of Health and Human Services, said the state is reviewing the new federal regulation to determine potential impacts.

The new federal standards will limit people’s ability to attest that they are medically frail starting in 2028 and will require documentation as proof, another change states weren’t expecting, Meuse said. had planned to allow applicants and enrollees to declare conditions themselves to get exemptions, according to KFF.

Striking the right balance of flexibility was an important part of deliberations when crafting these rules, CMS Administrator Mehmet Oz said on a June 1 call with reporters. “The mantra we kept coming back to was that we’re forgiving, but we’re not foolish,” he said.

Trump officials wrote in the regulation that Medicaid work requirements have “the potential to empower Medicaid beneficiaries” by allowing them to “escape isolation and dependency, build confidence, achieve self-sufficiency and prosperity, and improve health.”

Stephanie Burdick, a leader of the Protect Medicaid Utah coalition, disputed the premise.

“If they want to improve work opportunities or connection and decrease isolation and loneliness, they would be starting job programs and volunteer service programs,” Burdick said. “They wouldn’t just be forcing more administrative burden onto people and then saying that it’s good for them.”

An estimated will become uninsured by 2034 due to Medicaid work requirements, according to the nonpartisan Congressional Budget Office.

But with the new regulations, Howard said, there’s a risk of “that number being even higher.”

ºÚÁϳԹÏÍø News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This <a target="_blank" href="/medicaid/trump-law-medicaid-work-rules-states-overhaul-eligibility-systems/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2246301&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]> 2246301 Colorado Charts Its Own Course on Vaccines Amid Federal Pullback /public-health/colorado-vaccine-law-coalition-cdc-acip-infectious-disease-prevention-polio/ Thu, 21 May 2026 09:00:00 +0000 /?p=2238762 In response to abrupt and politicized , concerned Coloradans have taken several steps to shore up support for vaccine science.

A bill in March then by Democratic Gov. Jared Polis allows Colorado to further uncouple itself from federal guidance.

The law allows health officials to follow the recommendations of national medical groups when making decisions such as purchasing bulk vaccines for the Medicaid program.

“We are insulating our state from the dysfunction coming out of Washington,” said Democratic state , a co-sponsor of the bill and a registered nurse. “We’re going to rely on science.”

“From fighting during the pandemic for Coloradans to get vaccines as quickly as possible to combating the Trump Administration’s barriers to getting vaccinated, we have expanded access to vaccines for Coloradans who want them,” Polis said in a statement when he signed the law.

Colorado is one of that, along with Washington, D.C., have taken steps to bypass the new federal recommendations amid worries that the changes could chip away at public trust in vaccines and erode .

Previously, Colorado, like most states, had followed federal guidance set by the Centers for Disease Control and Prevention. In January, CDC advisory panelists, selected by Health and Human Services Secretary Robert F. Kennedy Jr., from the agency’s universal recommendation list.

Last year, doctors, scientists, local leaders, and other supporters came together to form an outreach and advocacy coalition called .

The group aims to offer a clear, unified voice on the proven benefits of vaccines and reassure residents confused by the many federal changes.

, a former Denver City Council member, joined the group because she wants more people to hear her own chilling story about vaccine-preventable illness.

“Every summer everybody got sick,” Boigon said, recounting her childhood in 1950s Detroit.

The illness was polio, a highly contagious viral disease that , sometimes causing partial or full paralysis.

During the summer of 1953, “the whole block was sick and some of us got crippled, and that was just the way it was,” she said.

New Group Steps Up

Boigon’s personal history will be part of the new generations about the dangers of infectious diseases that were once common in the U.S. but are now relatively rare.

The group, which formed last September, will also compile vaccine information from medical groups and the state health department and advocate for policy proposals with the state government.

Several pieces of paper are arranged on a table. One is a professional biography of Carol Boigon from the Denver City Council. Next is a clipping from The Detroit Times. Last is a 1985 Colorado Press Award.
Boigon shows memorabilia from her life and career. (Kevin J. Beaty/Colorado Public Radio/Denverite)

“It was in direct response to the federal threats,” said another coalition member, former state lawmaker . She leads the nonprofit .

Another member, public relations specialist Elizabet Garcia, wants more outreach to Hispanics, whose vaccination rates .

“A lot of time it’s this fear that they’re going to have to pay out-of-pocket, that their insurance doesn’t cover it, that they might not even have insurance in general,” Garcia said.

Boigon was 5 when she got sick and was hospitalized for six weeks with a fever. The virus attacked her spine.

“None of my limbs worked immediately afterwards,” Boigon said.

Although she regained function in her other limbs, her right arm never fully recovered. She had to adapt, relearning everyday tasks such as reaching out to shake hands with people with her left hand.

In 1955, not long after she got sick, the new polio vaccine became more widely available to the public. As vaccinations took off, U.S. cases of polio, once one of the nation’s most feared diseases, .

Increasing Public Trust

State leaders have taken other steps to promote public health. After the Trump administration pulled the U.S. out of the World Health Organization, several states, including Colorado, the WHO’s Global Outbreak Alert and Response Network on their own.

Colorado also challenging the Trump administration’s changes to the childhood vaccine schedule.

And the new state law has provisions besides allowing the state to diverge from federal recommendations. It codifies pharmacists’ ability to prescribe and give vaccines themselves. It also increases legal protections for healthcare workers who give vaccines.

“This law will provide more clarity to guide all Coloradans, including providers who administer vaccines,” Lontine said.

But the legislation has opponents who say it would interfere with parental choice and claim vaccines might be unsafe or ineffective.

“I just want to make sure we’re not just getting into a big political dispute between the federal recommendations — the CDC and so forth — and different political views in Colorado here,” said Republican state , who voted against the vaccine bill.

NPR contacted the U.S. Department of Health and Human Services about Colorado’s new law. Spokesperson Emily Hilliard answered in an email: “The updated CDC childhood schedule continues to protect children against serious diseases.”

Preventable Illnesses Surge

The flurry of statewide activity comes as Colorado and the nation have seen surges in illnesses .

As of mid-May, Colorado had recorded 22 measles cases this year. In 2025, it registered , according to the state health department, far surpassing totals from previous years.

Across Colorado, for measles were 88% last school year — with only a few counties achieving rates of 95%, the level needed for herd immunity, according to data in December.

This has also been Colorado’s worst flu season in recent years.

Vaccination rates for both flu and covid-19 have dropped slightly in Colorado, according to the state health department.

Eight children in Colorado have died this season ; one from covid; and one from RSV, or respiratory syncytial virus. are available for children and recommended by the state’s health department.

Kennedy, a longtime anti-vaccine activist, has defended his decisions to overhaul the recommended schedule for childhood vaccinations.

In March, a federal judge many of the changes.

“We’re not taking vaccines away from anybody. If you want to get the vaccine, you could get it. It’s going to be fully covered by insurance just like it was before,” Kennedy in January.

When a reporter suggested the new changes could result in fewer people getting a flu vaccine, Kennedy said: “Well, that may be, and maybe that’s a better thing.”

Boigon is sometimes incredulous at everything that has happened.

“It’s like we’re going backwards,” she said. “It’s like we have decided we don’t want a modern life; we want to be back in the 1950s, where children are sick and dying.”

Carol Boigon sits on her sofa at home.
Boigon at home in Denver. (Kevin J. Beaty/Colorado Public Radio/Denverite)

This article is from a partnership that includes ,Ìý, and ºÚÁϳԹÏÍø News.

ºÚÁϳԹÏÍø News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This <a target="_blank" href="/public-health/colorado-vaccine-law-coalition-cdc-acip-infectious-disease-prevention-polio/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2238762&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]> 2238762 A Danish Couple’s Maverick African Research Finds Its Moment in RFK Jr.’s Vaccine Policy /public-health/rfk-kennedy-vaccines-denmark-danish-scientists-africa-aaby-benn-dtap-dtp/ Mon, 18 May 2026 09:00:00 +0000 /?p=2228870 In 1996, Guinea-Bissau seemed like an ideal research post for budding pediatrician Lone Graff Stensballe. Her supervisor, a fellow Dane named Peter Aaby, had spent on 100,000 people living in the mud brick homes of the West African country’s capital.

Aaby and his partner, Christine Stabell Benn, believed that the years of research in the impoverished country had yielded a major discovery about vaccines — and what they described as “non-specific effects”: The measles and tuberculosis vaccines, which were derived from live, weakened viruses and bacteria, they said, boosted child survival beyond protecting against those particular pathogens.

But, the scientists said, shots made from deactivated whole germs, or pieces of them, such as the diphtheria-tetanus-pertussis shot, caused more deaths — especially in little girls — than getting no vaccine at all.

The World Health Organization repeatedly and inconclusively examined these astonishing findings, which tended to elicit shrugs from the researchers’ colleagues in global health.

Then came Donald Trump, covid, and the administrative reign of anti-vaccine advocate Robert F. Kennedy Jr.

Suddenly, Aaby and Benn weren’t just sending up distant smoke signals from a far corner of the planet. They were and policy prescriptions online and in medical journals. The “framework” for “testing, approving, and regulating vaccines needs to be updated to accommodate non-specific effects,” their team wrote in .

And the Trump administration has taken notice.

“They became more strident in saying that their findings were real and that the world needed to do something about it,” said Kathryn Edwards, a Vanderbilt University vaccinologist who has been aware of Aaby’s work since the 1990s. “And they became more aligned with RFK.”

Kennedy, as secretary of the Department of Health and Human Services, to justify slashing $2.6 billion in U.S. support for Gavi, a global alliance of vaccination initiatives. The cut could result in 1.2 million preventable deaths over five years in the world’s poorest countries, the nonprofit agency has estimated. Kennedy has in current Gavi funding over largely debunked vaccine safety claims.

Kennedy described as a “landmark study” by “five highly regarded mainstream vaccine experts” that found that girls who received a diphtheria-tetanus-pertussis, or DTP, shot were 10 times as likely as unvaccinated children to die from all causes.

In fact, the study was far too small to confidently make such assertions, as Benn later acknowledged. In a study of historical data that included about 500 girls, four of those vaccinated against DTP in a three-month period of infancy died of unrelated causes, while one unvaccinated girl died during that period. A in 2022 found that the DTP shot by itself had no effect on mortality. Critics say the 2017 study, rather than being a landmark, exemplified the troubling shortfalls they perceive in the Danish team’s research.

As Aaby and Benn’s U.S. profile has risen, scientists in Denmark have set upon the work of their compatriots. In news and journal published over the past 18 months, Danish statisticians and infectious disease experts have said the duo’s methods were , even , and structured to support . A national scientific board is investigating their work.

A Danish woman walks down a dirt road.
Christine Stabell Benn has led a vaccine research project in Guinea-Bissau for nearly three decades with her husband, Peter Aaby. (Thomas Lekfeldt/Ritzau Scanpix/Sipa USA)

Stensballe, who worked with Aaby and Benn for 20 years, has been among those voicing doubts.

“It took years to see what I see clearly today, that there is a strange concerning pattern in their work,” Stensballe said in a phone interview from Copenhagen, where she treats children at Rigshospitalet, the city’s largest teaching hospital. She said their work is full of confirmation bias — favoring interpretations that fit their hypotheses.

Those hypotheses overlap, in important areas, with the notions of Kennedy and other vaccine-skeptical officials at HHS.

In December, HHS announced the agency would award the scientists’ Bandim Health Project in Guinea-Bissau $1.6 million to study whether the birth dose of hepatitis B vaccine weakens babies’ immune systems or causes neurological issues.

The researchers plan to withhold the vaccine from half of the 14,000 newborns in the study, although the long-established vaccine is 90% effective in preventing infection. The Bandim group justifies this decision by noting that impoverished Guinea-Bissau does not yet routinely vaccinate infants against hepatitis B. Given that 1 in 5 Guinea-Bissauan adults carry the hepatitis B virus, however, and many say it is unethical to withhold the birth dose.

Aaby and Benn did not respond to repeated requests for comment. They have elsewhere.

A Mixed Reputation

Many Danes admire the two for their decades of work in Guinea-Bissau, a nation of over 2 million people where, as in much of Africa, infant mortality has plunged over the past five decades. There’s even a novel, the 2013 Danish thriller The Arc of the Swallow, featuring a corporate plot to murder a scientist character clearly based on Aaby. The company’s goal: to keep him from publishing data showing deadly effects from the DTP shot. Benn the idea for the book.

Aaby and Benn have trained around 30 scientists through their Bandim Health Project, named for a district of Bissau, Guinea-Bissau’s capital. The research group has published over 1,000 academic papers and won scientific prizes. The Danish king knighted Benn last year. Their notion of non-specific vaccine effects gained enough traction to merit a short chapter in the 2023 edition of Plotkin’s Vaccines, the authoritative text of vaccinology.

Yet Danish health authorities have never followed Aaby and Benn’s vaccine advice. They still offer vaccines based on inactivated viruses and bacteria, that Kennedy largely shifted the U.S. to in January. (A federal judge on March 16 temporarily blocked those changes.) Danish vaccine authorities are considering the addition of two of the shots Kennedy sought to drop from the U.S. schedule — against rotavirus and respiratory syncytial virus, or RSV.

“What’s important is that Christine doesn’t have influence on our vaccine policy,” said Anders Hviid, chief epidemiologist at Statens Serum Institut, the Danish equivalent of the Centers for Disease Control and Prevention.

Hviid — who knows Benn, as do most members of the tiny Danish vaccine fraternity — has contributed to many vaccine safety studies, including a that found no link between measles-mumps-rubella, or MMR, vaccination and autism. Kennedy to get a journal to retract showing no link between aluminum-adsorbed vaccines and allergies or neurodevelopmental disorders.

In a with Tracy Beth Høeg, the Danish American sports medicine doctor and covid vaccine skeptic who led the FDA’s drug regulation from December until she was , Benn said she had vaccinated her son and daughter, now in their late 20s, under the complete Danish schedule of vaccines. Like the U.S. schedule, Denmark’s includes a less reactive form of the DTP shot known as DTaP.

Tracy Beth Høeg sits at a table, a microphone and nameplate in front of her. A laptop is on the table to her left.
Tracy Beth Høeg, a sports medicine doctor and covid vaccine skeptic who emerged as the chief FDA drug regulator under Health and Human Services Secretary Robert F. Kennedy Jr., takes part in an Advisory Committee on Immunization Practices hearing in Atlanta in December. She was fired on May 15. (Megan Varner/Bloomberg via Getty Images)

These vaccines aren’t dangerous to kids in well-off countries like the U.S. and Denmark, she said. But she said she would “never vaccinate my child according to the U.S. program.” She singled out the hepatitis B vaccine birth dose, which her group plans to test in Guinea-Bissau, saying she was “appalled” that the CDC recommended a universal birth dose.

Kennedy’s handpicked vaccine advisory committee — which a federal judge in , questioning its members’ qualifications — withdrew the birth dose recommendation last year.

Compatriots Grow Skeptical

Kennedy’s championing of Aaby and Benn prompted criticism from Danish scientists that has extended to the . “It is disturbing that Danish researchers could carry out such actions involving African children,” Stensballe said.

As of early March, the study was paused while officials from Guinea-Bissau and the African Centers for Disease Control examined it. Public Health Minister Quinhin Nantote, who took office after a November coup in Guinea-Bissau, said in January he had no evidence that the six-member ethics committee that signed off on the study earlier had ever met to discuss it.

HHS spokesperson Andrew Nixon told ºÚÁϳԹÏÍø News the proposed study was “based on the highest scientific and ethical standards” and “represents the world’s first and perhaps only opportunity to test the overall health effects” of the hepatitis B vaccine.

It’s only one area of the couple’s research that is under scrutiny.

In 2024, Danish physician and journalist Charlotte Strøm noting that the Bandim group scientists had failed to publish data they’d collected that contradicted their frequent claims that the vaccine caused high mortality in infants.

Strøm called it “an ethical and scientific scandal,” and it led to an by the news outlet Weekendavisen. In February, the University of Southern Denmark forwarded its probe into the duo’s possible withholding of DTP data to the Danish Agency for Higher Education and Science’s Board on Research Misconduct.

In response to the Weekendavisen articles, Aaby and Benn pushed out a . They said they hadn’t sought to publish it earlier because one co-author died in a boating accident and another left the project after getting pregnant.

“This is a bit fishy,” said Henrik Støvring, a statistician at the University of Southern Denmark and Aarhus University who co-authored with Strøm and others an of clinical trials conducted by Benn and Aaby.

In January, a and three other Danish infectious disease researchers questioned whether Aaby and Benn had actually proved that vaccines had bad or good “non-specific effects” beyond preventing the diseases they were designed to counter.

Scholars also have questions about Aaby and Benn’s studies of the tuberculosis vaccine, BCG. The pair recently began a study in which babies received a second vaccination with the live bacterial vaccine, although a they conducted some 15 years earlier was stopped after , compared with four in the control group, during a four-month span.

The study was aimed at testing Aaby and Benn’s hypothesis that the alleged dangers of DTP vaccination could be ameliorated by a shot soon after with live BCG.

Although there is some evidence that BCG provides a systemic boost to infant immune systems, the WHO does not recommend a second BCG dose, Vanderbilt’s Edwards noted. “Given the suspicion engendered with this group, there should be heightened attention to this protocol, with meticulous review of their work in Africa by the African authorities,” she said.

The Big Controversy

Aaby and Benn’s most controversial position is their stance on DTP, perhaps the most widely provided vaccine in the world. True evidence of its harm would be vitally important. And experts argue that research by others has not supported Benn and Aaby’s thesis.

A syringe is inserted into a young Indonesian child's arm.
An elementary school student in Indonesia receives a diphtheria-tetanus-pertussis, or DTP, shot in 2018. (Aditya Irawan/NurPhoto via Getty Images)

One involving nearly 55,000 newborns in Ghana and Tanzania, found that both BCG and DTP vaccines enhanced the survival of babies. The authors of the paper submitted it to a journal and fought long and hard with Benn, who happened to be a peer reviewer. They eventually resubmitted the paper to another journal to get it published in 2022, said co-author Emily Smith, an assistant professor of global health at the Milken Institute School of Public Health at George Washington University.

Benn’s approach “involves splitting up trial data a bunch of different ways using a bunch of different methods,” she said.

“If you split up the data” enough ways, she said, “you’re going to end up with maybe thinking you found something.”

Hviid said that Benn and Aaby continuously modify their hypotheses to fit new data even when the patterns they detect may have popped up by chance. Most of the footnotes in their studies and opinion pieces refer to their own work, he noted.

“They’ve been talking about their paradigm for years,” Hviid said. “But when you look at the numbers, it’s just a house of cards. There’s nothing there.”

To examine their many hypotheses about the interactions of vitamins and vaccines, “hundreds of thousands of African babies have been tested,” Stensballe said. “Is that ethical?”

Aaby and Benn asked the editors of the journal Vaccine to retract Strøm and Støvring’s paper. The request was denied.

The Danish Influence in America

The Bandim group’s influence on U.S. policy has roots in the covid pandemic, when Benn befriended Høeg, who had earned a PhD in epidemiology and public health from the University of Copenhagen in 2014 for a study of eye disease. In a series of YouTube videos, they bonded over skepticism about covid vaccines and lockdowns. Benn argued that mRNA vaccines were insufficiently studied and that covid should be allowed to run its course among kids. Høeg landed an adjunct professorship at the University of Southern Denmark, where Benn holds a senior position, in April 2023.

Høeg did not respond to a question about whether she was involved in the CDC decision to fund Benn’s hepatitis B study. Benn and Aaby also received $1.8 million from the Pershing Square Foundation, co-founded by Bill Ackman, an ally of President Trump who .

Ackman did not respond to requests for comment.

from the University of Southern Denmark showed that Benn secured the grant after communicating with anti-vaccine CDC officials Lyn Redwood and Stuart Burns around the time the agency’s Advisory Committee on Immunization Practices was preparing to stop recommending hepatitis B vaccination for U.S. newborns.

Yet during a public debate with Støvring on Dec. 4, Benn said news reports had dried up all funding for her research. “You have literally closed our field station,” she said.

Aaby’s History

An anthropologist by training, Aaby, 81, has cultivated the image of a persecuted Galileo, Hviid said, “with us in the role of the dogmatic clergy.”

Aaby wrote in 1998 that he was “exploring and making sense of the unknown” while most of his colleagues’ work was “trivial.” At the December debate, he said Støvring’s work was “incredibly stupid.”

The Bandim Health Project’s study area covers six poor districts, now with about 200,000 inhabitants, around a third of the capital. The researchers say they have collected health and socioeconomic data from residents for more than 30 years.

A photo of two kids playing foosball as two others watch. A fifth walks by on the left.
Children play foosball in the Mindará neighborhood of Bissau, the capital of Guinea-Bissau, in 2018. Peter Aaby and Christine Stabell Benn have conducted childhood vaccine research in the West African city for decades. (Xaume Olleros/AFP via Getty Images)

Stensballe’s conflict with Benn and Aaby came to a head in 2015 as the team of 4,262 Danish babies comparing those who got a BCG vaccine at birth with those who didn’t. that his African research on vaccines would be duplicated in the developed world.

The Danish BCG study showed no difference in hospitalization rates between the two groups. But Benn and Aaby combed the data for other answers, known as secondary findings, and leaped upon a comparison that showed lower hospitalization rates in babies whose mothers had been vaccinated against BCG decades earlier, Stensballe recalled.

She found that troubling. “If the primary outcome is negative, the trial is negative,” she said.

The manner in which Aaby and Benn pose questions sows unnecessary doubt, said Arthur Reingold, a professor emeritus of epidemiology at the University of California-Berkeley.

“Some of the questions they propose to answer are important but can never be answered in my lifetime,” he said, “and not by an ethical study done in the real world.”

“And in the meantime,” he added, “babies will miss vaccines and get sick and die of preventable illness.”

ºÚÁϳԹÏÍø News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This <a target="_blank" href="/public-health/rfk-kennedy-vaccines-denmark-danish-scientists-africa-aaby-benn-dtap-dtp/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2228870&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]> 2228870 Trump Bought Stock in Drugmaker as His Government Boosted Its Obesity Drugs /health-industry/trump-stock-trades-eli-lilly-glp-1-weight-loss-drugs-invest-ethics-disclosures/ Mon, 18 May 2026 09:00:00 +0000 /?p=2238742 President Donald Trump earlier this year bought as much as $680,000 in stock of Eli Lilly, the maker of blockbuster obesity drugs, as the agencies he oversees undertook an agenda that largely benefited the company.

On May 14, the federal government released ethics disclosures revealing a list of and trades made on Trump’s behalf from January to March of this year. They included extensive trades across the economy, including investments in tech giants such as Microsoft and Nvidia, aerospace firms such as Boeing, and household-name companies such as Target and Chipotle.

In healthcare, however, the trades for Lilly — a company valued by the stock market at just under $1 trillion — stand out. That’s because the timing of Trump’s purchases coincides with several favorable government decisions benefiting the drugmaker’s GLP-1 business, including progress toward a long-held goal: qualifying the drugs for reimbursement from Medicare, the government health insurance program primarily serving seniors, when they are prescribed for weight loss.

The disclosure forms — which bear Trump’s distinct signature — give ranges rather than exact dollar amounts for the trades. They show seven purchases of Lilly stock made on the president’s behalf through the end of March, the first of which occurred on Jan. 6.

During that period, and just afterward, several Trump administration initiatives ultimately benefited Lilly. Perhaps the biggest was an initiative from the Centers for Medicare & Medicaid Services, which was proposing a pilot program — a temporary “bridge,” potentially followed by permanent reimbursement — through which Medicare patients would pay $50 a month for GLP-1 drugs.

The deadline for drug manufacturers to submit applications indicating their interest in participating was Jan. 8. Lilly has since been named as a participating manufacturer in the program, a “significant milestone.”

Another purchase on Feb. 10, of West Pharmaceutical Services stock valued between $250,000 and $500,000, was similarly a bet on the GLP-1 market. The company, which manufactures injectable devices for drugs, with driving increased revenue in its most recent quarter.

Lilly declined to comment. West Pharmaceutical Services did not immediately respond to a request for comment.

A spokesperson at the Department of Health and Human Services declined to comment, referring ºÚÁϳԹÏÍø News to the White House. A White House spokesperson referred questions to the Trump Organization — the holding company for most of the president’s businesses — which did not immediately respond to a request for comment.

In response to other outlets’ questions about Trump’s stock trades, the Trump Organization has said the investments are controlled by independent brokers.

It is unclear from the disclosures whether Trump directed any of the trades himself. Four of the Lilly stock purchases are marked “unsolicited,” though the Office for Government Ethics did not immediately respond to a request for clarification on the use of that term.

Trump’s assets are in a trust held by his children, and  have said in the past that neither the president nor his children play a role in “selecting, directing, or approving” specific investments.

Eric Trump, the president’s son and a Trump Organization executive, : “To suggest that individual stocks are being bought or sold, at the discretion of any member of the Trump family, would be a lie and blatantly false.”

He claimed the purchases of index funds account for the investments. The disclosures record purchases of funds and individual stocks.

Lilly had a strong 2025, finishing with $65 billion in revenue, up $20 billion from the year before. GLP-1 drugs accounted for a substantial portion of that total.

At the beginning of 2026, the drugmaker said it expected another surge in revenue this year, above $80 billion. It was a “stunning” projection, analysts at the bank Citi said.

Analysts for the financial services firm TD Cowen said the Medicare and Medicaid market would be critical to making it happen. “Guidance anticipates favorable impact from Medicare coverage of obesity medications by 7/1/26,” the analysts noted.

Historically, Medicare hasn’t covered obesity drugs. In a May 2025 , noting unfavorable reimbursement decisions across government and private-run insurance, Lilly said: “This isn’t about just one medicine, formulary, or insurance plan. It’s about a system that limits patients’ and health care providers’ ability to choose an obesity management treatment plan that is best for them.”

Key to that market was the pilot program rolled out by CMS, called , aimed at helping Medicare and Medicaid beneficiaries improve their health. Last fall, 12% of U.S. adults reported currently using GLP-1s, according to a , and 56% of those who had used GLP-1s found the medications — prescribed to treat diabetes and aid weight loss — hard to afford.

The appearance of a potential conflict of interest is enough to trouble ethics experts.

“A president who buys or sells the stock of a company whose value is affected by his administration’s actions undermines the public’s trust in two ways,” said Kathleen Clark, a legal ethicist at Washington University in St. Louis.

First, she said, the public should believe government actions are motivated by common good, not personal enrichment. And second, the public should believe that those within government aren’t benefiting from inside information.

A ban on stock trading by the president would require an act of Congress, though some lawmakers have resisted such legislation. Members of Congress are also permitted to buy and sell stocks.

Trump’s White House and HHS boosted GLP-1s throughout the first few months of the year. In February, the government unveiled TrumpRx, a web portal directing patients to lower-price versions of some drugs, with some terms and conditions.

The website offers Zepbound for as low as $299 a month and points patients to LillyDirect, the drug company’s telemedicine service prescribing the drug. Company executives haven’t commented on TrumpRx specifically, but they have touted the telemedicine service. Lilly’s 2025 to the Securities and Exchange Commission said LillyDirect was a “growing portion of our business.”

Also, in February the FDA intensified a broad crackdown on “compounded” GLP-1s — drugs manufactured by pharmacies that are cheaper and, critics charge, often unsafe alternatives to Lilly’s branded products.

The agency made another favorable decision for Lilly in April, approving its Foundayo weight loss pill under its Commissioner’s National Priority Voucher program. The program was launched by FDA Commissioner Marty Makary, who had promised to approve high-priority drugs in record time. Foundayo was approved in 50 days after filing.

“This approval demonstrates what the FDA can achieve when we eliminate delays and prioritize fast and thorough work from the agency and industry partners,” Makary, who stepped down last week, said in .

Not all agency decisions were favorable. The to provide additional safety data regarding liver toxicity in Foundayo, though analysts don’t appear particularly troubled. The company news outlets that no negative safety signals have been observed.

ºÚÁϳԹÏÍø News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This <a target="_blank" href="/health-industry/trump-stock-trades-eli-lilly-glp-1-weight-loss-drugs-invest-ethics-disclosures/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2238742&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]> 2238742 Kennedy Swaps Vaccine Rhetoric for Story Time but Can’t Quite Change the Subject /public-health/the-week-in-brief-rfk-jr-ohio-visit-maha-rhetoric/ Fri, 15 May 2026 18:30:00 +0000 /?p=2238096&preview=true&preview_id=2238096 Here in Washington, we’ve been hearing about tensions between the White House and one of its most controversial â€” but, at least in some circles, most popular â€” figures: Robert F. Kennedy Jr.

Polling of likely voters indicates that the Health and Human Services secretary can be an asset to Republicans when he’s talking about improving the nation’s food supply or labeling ultraprocessed foods. But when he’s talking about removing recommendations for routine childhood vaccinations, he can be a detriment.

So, when I learned Kennedy would be taking his show on the road to my home state of Ohio, where populist figures tend to perform well, I knew I had to be there.

How would a politician who built his reputation seeding widespread doubts about routine childhood immunizations stay away from one of the core messages he’s preached for years?

Well, it turns out, he starts by reading a book about a trash truck to preschoolers.

The trip took us across northern Ohio, from a regenerative farm in Huron owned by two brothers who grow colorful vegetables to the Cleveland Clinic, where Kennedy masked up entering an operating room of a heart surgery patient.

In the end, though, Kennedy couldn’t escape the vaccine talk.

Speaking at the City Club of Cleveland, Kennedy raised doubts about the safety of vaccines that had been â€” up until last year â€” universally recommended to prevent hepatitis B, an incurable disease.

He called for parents to “be given that choice” on administering the vaccine to newborns,Ìýa remark that gave way to cheers and applause from half the room.

The other half groaned and booed.

When I sat down with the health secretary for a few minutes in an Ohio farmhouse, Kennedy ticked off his accomplishments during his first year in office; redesigning federal nutrition guidelines and defining ultraprocessed foods for the American public were among them.

As his list grew longer, I thought about the mothers I’d talked to over the last year who had become increasingly nervous about taking their infants out in crowded places amid a raging measles outbreak and the growing threat from other infectious diseases.

What was his message for those parents, I asked?

“I would say everybody should be vaccinated â€” against measles,” Kennedy told me. “But we need to pay more and more attention to chronic disease. All of the vaccine-preventable, infectious diseases put together kill probably 10,000 Americans a year.” 

The number of deaths is , according to scientific researchers.

ºÚÁϳԹÏÍø News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This <a target="_blank" href="/public-health/the-week-in-brief-rfk-jr-ohio-visit-maha-rhetoric/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2238096&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]> 2238096 FDA Blocked Melanoma Drug as Confusion Reigned Under Makary /health-industry/fda-blocked-melanoma-drug-marty-makary-confusion-reigned/ Fri, 15 May 2026 09:00:00 +0000 /?p=2238195 The FDA’s to withhold approval of a new skin cancer treatment fell like a hammer on doctors who treat melanoma and patients who saw that the drug had prolonged the lives of a third of the participants in a clinical trial.

“It was devastating news,” said Trisha Wise-Draper, a dermatologist at the University of Cincinnati who had patients enrolled in the trial.

“This is life or death for maybe 2,000 patients,” added Eric Whitman, medical director of the Atlantic Health System’s oncology service. A assailed the ruling, noting that it “will have a chilling effect on drug development.”

Despite the benefit to some patients, oncologists and pharmaceutical industry analysts say there were legitimate concerns about the treatment, called RP1, that may have led the FDA to reject it in any event. The company, they noted, had ignored repeated FDA suggestions that it change the design of the trial used to seek approval for the medication.

The FDA’s decision would have raised few eyebrows before the current administration took power. But Marty Makary, who took charge as commissioner 13 months ago, altered the agency’s culture and damaged the trust it had built over decades while regulating 20% of U.S. consumer spending, said Steven Grossman, a regulatory consultant and former Health and Human Services official.

“People have to speculate about the standards and processes by which the agency makes decisions,” he said. “And that uncertainty is bad for everybody — patients and sponsors and investors.”

Under Makary — who resigned this week — senior officials have or some at the behest of President Donald Trump or HHS Secretary Robert F. Kennedy Jr., ignoring the advice of agency professionals. In defending his actions, Makary often eschewed the agency’s traditionally measured language about its decisions.

In response to criticism for rejecting the melanoma treatment, for example, Makary accused its manufacturer, Replimune, of “corruption,” saying it was “engaging in corporate spin” to make the FDA look bad.

“I don’t work for Replimune. I work for the American people,” Makary said in a May 5 interview on CNBC. Kennedy backed him up during a congressional budget hearing in which Kennedy mistakenly claimed that patients in Replimune’s clinical trial had also received chemotherapy.

Makary did not respond to requests for comment.

“All the norms have been thrown out the window, so we don’t know what underlines an agency decision,” said , a former FDA staffer and Senate aide to Sen. Edward Kennedy who’s now a pharmaceutical industry consultant in Boston. “Even when there are legitimate scientific and regulatory reasons why a drug will not be approved, we’re left guessing whether it’s legitimate grounds or just a political play.”

A Doomed Cancer Drug

Melanoma is the fifth most commonly diagnosed cancer in the United States, with about 112,000 new cases each year. The American Cancer Society projects that from melanoma this year in the U.S. If Replimune’s treatment, RP1, worked as well as it did in the clinical trial, Whitman said, as many as 2,500 of those patients could be saved.

RP1 is a genetically engineered virus designed to destroy tumor cells and alert the immune system to swing into action against them. Replimune sought accelerated approval — a sort of shortcut that allows a product to enter the market while a larger confirmatory trial takes place — by presenting data that showed a third of 140 people in the trial had their tumors shrink or disappear. But the agency had warned Replimune in July that it risked denial unless it changed its development plans. In particular, the FDA noted that the trial had no control arm to compare RP1 to an approved melanoma treatment. Instead, all patients were given RP1 along with Opdivo, a type of immunotherapy.

Replimune’s scientists don’t entirely understand how the drug works, but research indicates that, in addition to destroying cancer cells, it releases chemicals that revive Opdivo’s capacity to stimulate the immune system. The company argued it would be unethical to give Opdivo alone as a control arm, because all the patients entered in the trial had already stopped getting better while taking only Opdivo or other drugs in its class.

“Having a control arm would have been unethical,” Wise-Draper said. Some of her patients responded extremely well to RP1 and no longer have evidence of melanoma, she said.

Replimune currently has a larger trial that includes a control arm, but “the bigger question is whether the company will survive,” Whitman said. The FDA-accelerated approval would have persuaded investors to provide enough cash to finish the larger trial, he said.

Replimune did not respond to repeated requests for comment. But it is firing more than half its staff and closing some operations in the wake of the FDA ruling.

RP1 wouldn’t have been the first melanoma drug approved based on a single-arm trial. Keytruda, the best-selling Merck cancer drug, was approved to treat melanoma some 12 years ago based on such a trial design. But in its denial statement, the FDA said it wasn’t convinced that the positive effects of the combination regimen were all due to RP1 and not partly to Opdivo.

Replimune arguably could have found an ethical way to set up a control arm for its treatment, Kim said. On the other hand, the FDA could have “given them a provisional yes” with accelerated approval, he said. The whole point of the three-decade-old accelerated approval program is to “take a gamble,” Kim said. The agency’s statement, stressing the company’s methodology over the result, “is a recalibration of how confident sponsors can be with similar studies,” he said.

Vinay Prasad’s Final Days at FDA

Much of the criticism of the FDA under Trump has focused on Vinay Prasad, who was fired then rehired last summer and held various leadership roles at the agency. Prasad, an oncologist known for critiquing the statistical bases of studies, repeatedly intervened in approval processes for drugs and vaccines normally decided by lower-ranking FDA professionals.

Prasad, who did not respond to requests for comment, resigned for good May 1, three weeks after the Replimune decision. “There’s this lingering question of whether this was Vinay’s last stand, or an objective decision made by careful scientists,” Kim said.

Makary ran afoul of Trump administration officials over various decisions, the last being his reluctance to approve flavored vapes for smoking cessation. Trump’s anti-abortion supporters wanted him ousted for allowing a generic form of mifepristone on the market, and for failing to speed up studies they hoped would lead to the abortion drug’s withdrawal from the market.

But in the industries regulated by the FDA, ranging from gene therapy to vaccines and cancer, officials are frustrated by the agency’s uncertain direction. In past administrations, the agency generally swung on a narrow arc between loosening and tightening requirements for drug approvals. Under Makary, “it’s been swinging in every conceivable direction,” Grossman said.

“It’s very inconsistent; it’s all over the place,” Whitman said. “The inconsistency is part of the concern.”

During his tenure, Makary made a series of categorical statements that either claim credit for progress made during earlier administrations or exaggerate the agency’s ability to move forward on goals.

For example, he set a goal of , which is considered impractical at the moment, Kim said, and moved to artificial intelligence at the FDA — prematurely, critics say. Makary and Prasad also promised to reduce the from two to one. FDA statutes require two well-controlled clinical trials for drug approvals, but exceptions to that rule are already frequent.

“The FDA is sending signals that it wants to even further reduce the evidence needed to support drug approval,” said Aaron Kesselheim, a Harvard Medical School professor and an expert on the drug industry. “Of course, if we’re talking about vaccines, the total opposite is the case. FDA has been taking real steps to make it harder to get vaccines approved.”

The FDA fired about 4,000 staffers at the start of the Trump administration. Makary promised to hire thousands back, but considering the upheavals at HHS and the FDA, these positions may be hard to fill. “What magic trick will get that done?” Grossman asked.

“The unfortunate thing is that there has been so much chaos at FDA that this Replimune decision, which may have needed to happen, has gotten mired in the controversy,” said Evan Seigerman, leader of healthcare research at BMO Capital Markets.

ºÚÁϳԹÏÍø News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This <a target="_blank" href="/health-industry/fda-blocked-melanoma-drug-marty-makary-confusion-reigned/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2238195&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]> 2238195 Trump and Kennedy Seek To Relax Safeguards for AI Healthcare Tools /health-industry/ai-artificial-intelligence-ambient-scribes-ehr-electronic-health-records-hhs-deregulation/ Wed, 13 May 2026 09:00:00 +0000 /?p=2234764 Paul Boyer, a psychotherapist for Kaiser Permanente in Oakland, California, is experiencing the AI revolution firsthand. He’s a little underwhelmed.

The health giant has rolled out a new suite of note-taking software, made by healthcare AI pioneer Abridge, intended to summarize a patient’s visit at supersonic speed. For many clinicians, the technology soothes one of the persistent headaches of their lives — administration and paperwork.

But the AI scribe caused another headache for Boyer and his colleagues: It is “not super useful.” They end up correcting the computer-written notes.

Abridge is “not good at picking up on clinical nuance, at picking up on the emotional tone” that can be critical in the mental health field, Boyer said. For example, for manic patients, what’s said is less important than how it’s said, Boyer said, and the software struggles with picking up on those cues.

Note-taking software isn’t the wave of the future; it’s the wave of the present. Hospitals nationwide are implementing it. And researchers are finding some benefits. A year after installation, doctors who used these products the most saved more than half an hour of work daily, according to published in April in the Journal of the American Medical Association.

Many doctors love the products where they’re deployed — several to the scribes.

Nevertheless, as Boyer’s example shows, there are persistent questions about the systems’ quality. While Boyer and his colleagues spend time correcting notes, safety researchers worry clinicians might not be diligent about catching errors. That might mean future doctors rely on bad information.

Abridge says it evaluates its scribes at every stage of deployment, including with head-to-head tests against previous versions of the software.

“Following deployment of a model, we monitor clinician edits, star ratings, and free-text feedback from clinician users about note quality,” the company’s director of applied science, Davis Liang, told ºÚÁϳԹÏÍø News in a statement.

Artificially intelligent scribe software is part of a swarm of AI-powered tools coming to healthcare. Clinicians and patient-safety advocates say government regulations are not well constructed to guard against the threat that the new technology will miss or obscure important details of patients’ conditions, potentially harming them.

“There is currently no safeguard in place” to vet scribe software at the federal level, said Raj Ratwani, a researcher specializing in human factors — that is, how people interact with technology — at MedStar Health, a large hospital system based in Columbia, Maryland.

Ratwani worries that safeguards on health software will relax even further. from the Office of the National Coordinator for Health IT — the body that regulates electronic health records, the central chronicle of care for patients — could weaken requirements to make medical records understandable, easy to use, and transparent about the use of AI, Ratwani said. And an incomprehensible record could confuse clinicians and lead to errors.

Beginning in the Obama administration, the Health and Human Services Department’s IT office , in which developers try their products on doctors and nurses. Regulators also sought to require more transparency from companies in the surging market in AI tools.

Both of those requirements are axed in the proposed rules from HHS Secretary Robert F. Kennedy Jr.’s health IT office.

Doctors and other health practitioners consult records for clinical information, such as scribe notes summarizing the history of patient care and lists of drugs and therapies their patients have used. Doctors also input orders for care.

Poor or cluttered design of a records system “might make the list of medications so complicated and confusing that the ordering provider selects the wrong medication,” Ratwani said.

Abridge’s general counsel, Tim Hwang, said the company “broadly supports” the government’s rules as a “necessary modernization” that “accommodates the speed at which AI is evolving.”

The old rules “put way too much burden” on electronic health record systems, said Ryan Howells, a principal at Leavitt Partners, which consults for digital health companies. Leavitt supports the proposals.

Dropping requirements, the administration argues, will result in more innovation and competition. The electronic health record market has steadily consolidated, with hospitals and other clinicians choosing from fewer vendors.

A 2022 study found the top two vendors, Epic and Oracle Health, of the hospital market. And Howells argued too many rules burdened providers looking for good record systems. Federal regulations, Howells said, are “the single biggest inhibitor to true clinical innovation.”

The Trump administration proposal to remove requirements governing records is overbroad, some critics say. It removes regulations intended to keep records secure. It also eliminates privacy protections for sensitive medical data they safeguard, overhauls standards governing the formats data is sent in, and more. The rule may give clinicians “more health IT choices to meet their needs through increased competition,” the government wrote in its proposal.

HHS’ health IT office declined comment, noting the proposal is still winding through the regulatory process. Public comment closed in February.

But most concerning to some — even in the hospital and developer sectors — are proposals to scotch prerequisites to ensure new products are tested on actual users, and to ensure AI tech’s decisions are transparent to doctors and nurses.

“Historically, hospitals and health systems have been challenged by the black box nature of certain AI tools and how the algorithms are developed,” the American Hospital Association’s Jennifer Holloman said. And with more AI tools flooding the market, the association , transparency is even more critical.

Complaints about the safety of electronic health records are long-standing, even for seemingly straightforward tasks. Ratwani likes the example of ordering medication for a given condition.

“The physician is trying to order Tylenol, and the medication list can be so confusing that there’s 30 different versions of Tylenol all at a different dose and for different purposes, when in reality that could be designed much more simply and make it easier for the physician to actually pick the right type of Tylenol that they’re ordering,” he said.

Real-world user testing was intended to simplify record design for doctors. But the administration is ending that requirement in a confusing way, said Leigh Burchell, vice president for policy and public affairs at Altera Digital Health, an EHR developer.

In Burchell’s interpretation of the rules, which refer to “enforcement discretion,” a principle in which the government can opt not to enforce certain rules, companies are still required to do the testing — the part that takes work — but are not mandated to report their results to the feds.

The administration is also ending a Biden-era idea to create AI transparency “model cards.” The concept was that clinicians could explore the data used to train AI tools that advise clinicians with a simple mouse click. But few took advantage of the year-old tool, Trump’s regulators say.

Still, hospitals and doctors are wary of removing it. The tool “provides information on how a predictive or generative AI application was designed, developed, tested, evaluated and should be used. These data are critical to foster trust in AI tools and ensure patient safety,” the AHA wrote in a comment letter to the HHS IT office. The American College of Physicians , saying a “lack of clarity could undermine clinician trust, increase liability expense, and erode the patient-physician relationship.”

Even developers aren’t totally sure about the idea. Burchell said the electronic health records trade group she’s part of had “a lot of different perspectives” on the issue. “Normally, we tend to be a bit more aligned on our responses.”

Still, Burchell’s group thought companies should be transparent about the data AI relies on to make decisions and how it comes up with recommendations.

Evidence for AI tools’ effectiveness or contradictory.

A comparing 11 AI scribes for potential use as a pilot in the Veterans Health Administration found the software performed worse than humans across five simulated scenarios. “Although ambient AI scribes can generate complete notes, the overall quality remains broadly below that of human-authored documentation,” the authors noted, with the omission of information being particularly concerning, given the potential to affect follow-up care.

The vendors in the VA study weren’t identified, for what the authors called “contractual reasons.”

And that’s just one type of AI tool. A wave of them is coming, each needing its own evaluation, to say nothing of tools that have already been installed.

Boyer said he can mostly ignore his AI scribe, for the moment. But he worries that management will design his job around the expected time savings and schedule more patients — meaning he’d need to spend more time both with patients and correcting the software’s errors.

A KP spokesperson, Vincent Staupe, said the company does not require its clinicians to use AI.

“When I am correcting that note, I feel like this is too much work,” Boyer said. “This is definitely making this worse, and this is taking up time that I need to not be spending on correcting an AI tool.”

ºÚÁϳԹÏÍø News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

This <a target="_blank" href="/health-industry/ai-artificial-intelligence-ambient-scribes-ehr-electronic-health-records-hhs-deregulation/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

<img id="republication-tracker-tool-source" src="/?republication-pixel=true&post=2234764&amp;ga4=G-J74WWTKFM0&quot; style="width:1px;height:1px;">]]> 2234764 RFK Jr. Swaps Vaccine Talk for Healthy Foods and Reading to Tots in Push To Woo Voters /public-health/rfk-make-america-healthy-again-tour-midterms-ohio-food-head-start-vaccines/ Wed, 13 May 2026 09:00:00 +0000 /?p=2237219 TOLEDO, Ohio — The little boy, dressed in a Toy Story sweatshirt, wrapped himself around the nation’s health secretary.

“What do you guys want to be when you grow up?” Health and Human Services Secretary Robert F. Kennedy Jr. asked a carpet full of preschoolers.

“A dinosaur!” the boy replied, squeezing tighter.

Just weeks ago, Kennedy sat before lawmakers on Capitol Hill and about a dangerous uptick in infectious diseases among American children.

Now, with midterm primaries underway, Kennedy was seated in a toddler-sized chair in Ohio, on a mission to change the subject.

Advised to stay away from the anti-vaccine rhetoric that rocketed him to political stardom, Kennedy has been dispatched by the White House to evangelize about the least controversial — and most popular — parts of his agenda. Republicans hope Kennedy’s “Take Back Your Health” tour will help them hang on to voters, many of whom are deeply .

So there Kennedy was in early May, crisscrossing a strip of northern Ohio that includes one of the few congressional districts that Republicans are confident they can flip in November, rotating through a wardrobe of blue suits and blue jeans.

He inspected the kitchen of a Toledo daycare center, where hundreds of the city’s tiniest residents learn and play through the federally funded Head Start program. Under the careful watch of a surgeon, and with the machine disconnected, Kennedy briefly tested the teaching console of the renowned Cleveland Clinic’s robotic hands with a live patient splayed open for heart surgery in the room. And he munched on pesticide-free squash blossoms from a 400-acre farm.

Robert F. Kennedy Jr. takes a bite of microgreens at a facility indoors.
Kennedy samples microgreens at a Huron, Ohio, farm that rejects chemical use in growing its produce. Reducing the use of chemicals in food production is a goal of many supporters of the Make America Healthy Again movement. (Amanda Seitz/ºÚÁϳԹÏÍø News)

“I am dismantling a corrupt system and replacing it with something better, replacing it with something that actually addresses the declining healthy American population,” Kennedy said from the dining room table of a farmhouse during an exclusive interview with ºÚÁϳԹÏÍø News. He pointed to what he views as his biggest accomplishments over the past year: pressuring some companies to remove dyes from certain foods, updating nutritional guidance, and defining ultraprocessed foods.

“People are paying attention to what they eat, and the industry is listening; the industry is changing.”

But hundreds of miles from Washington’s partisan interrogations, Kennedy couldn’t escape the uncomfortable contradictions and consequences of the Trump administration’s policies.

Taboo Budget Cuts

The classrooms of the Clever Bee Academy displayed freshly printed posters featuring Kennedy’s “Eat Real Food” slogan and the redesigned food pyramid.

Kennedy came with an offering, a $30,000 federal grant to help the center upgrade its kitchen and community garden.

Perched in front of staff and parents, he distanced himself from a last year that could have been devastating to many of Clever Bee’s young students, most of whom live in poverty: the proposal to eliminate the $12 billion Head Start program.

Robert F. Kennedy Jr. reads from a story book to children.
Most of the students at the Toledo childcare center Kennedy visited live in poverty and rely on the federally funded Head Start program, which the Trump administration proposed eliminating last year. (Amanda Seitz/ºÚÁϳԹÏÍø News)
A wall of posters. One of the posters says "Eat real food" and shows the redesigned food pyramid.
Classrooms at the childcare center displayed posters featuring the “Eat Real Food” slogan and the redesigned food pyramid. (Amanda Seitz/ºÚÁϳԹÏÍø News)

“We were asked to cut our agencies substantially,” Kennedy said. “The two programs that I went to the wall to protect, and find the money somewhere else, was the Indian Health Services, which is always starved for funding, and Head Start.”

The next day, Kennedy stood before goats on a farm in Medina, Ohio, cared for by people sobering up from drug or alcohol misuse at the Hope Recovery Community.

He was there to promise more investments from an administration that has steeply cut staff and budgets over the past year.

Kennedy, who still attends daily Alcoholics Anonymous meetings to cope with a heroin addiction that gripped him for 14 years, said he hopes to replicate the recovery center’s model nationwide, describing it as an “essential role of government to make sure those services are there.”

Broader access to addiction treatment is part of the Trump administration’s newly released . But recovery advocates are skeptical more people will get help, with millions expected to lose health insurance under Trump’s watch because of rising Affordable Care Act premiums and the nearly $900 billion in Medicaid cuts under the One Big Beautiful Bill Act.

Kennedy dismissed those challenges, pointing to a $100 million investment in addiction treatment services, including sober housing, announced this year.

“We’re trying to make it more accessible,” Kennedy told ºÚÁϳԹÏÍø News.

Trouble in MAHA Paradise

Rows of beds featuring green and purple microgreens awaited Kennedy at The Chef’s Garden, a Huron, Ohio, farm that rejects chemical use in growing its produce.

The health secretary plucked handfuls and tossed them into his mouth, quickly chewing before a new sample was brought before him.

“We are absolutely thrilled that someone at this level of government cares about how food is grown and where it is coming from,” said Bob Jones Jr., a co-owner of The Chef’s Garden.

Seeing more farmers produce chemical-free leafy greens has topped the wish list of those who support Kennedy and the Make America Healthy Again movement, and many who backed Trump in 2024. But in a move that’s threatening to fracture that constituency, Trump has pushed to protect the production of glyphosate, a weed-killing, potentially cancer-causing chemical commonly sprayed on crops and lawns.

Robert F. Kennedy Jr. stands next to a woman, as he grabs the stem of microgreens.
Kennedy with his principal deputy chief of staff, Stefanie Spear, as he munches on pesticide-free produce at The Chef’s Garden in Huron, Ohio. (Amanda Seitz/ºÚÁϳԹÏÍø News)

Though the group MAHA Ohio extols Kennedy’s agenda and endorses candidates aligned with his movement, director Elizabeth Frost acknowledged tensions between MAHA and conservative policies.

The glyphosate issue is an example “where you have the conservative interests to look out for the interests of the industry, and you have your MAHA interest to be cognizant of the downstream health impacts,” said Frost, who volunteered on Kennedy’s presidential campaign.

Some prominent MAHA influencers have suggested that Trump’s White House staffers are stopping Kennedy from implementing more aggressive policies on certain issues, including further limiting vaccine use, a notion he dismissed.

“To say the White House has tied my hands — the only people who could say that are people who haven’t been paying attention for a year,” Kennedy said. “President Trump has let me do more than any HHS secretary in history.”

He added: “The only thing that people in the MAHA movement complain about is the president’s glyphosate order.”

Staying on Message

Republicans consider Kennedy an asset in the recently redrawn northern Ohio congressional district that Democrat Marcy Kaptur has represented for more than 40 years, and which as one of the most competitive in the nation.

Fresh off winning the Republican primary for the district last week, Derek Merrin smiled as he shook hands with Kennedy.

“We discussed protecting Lake Erie, strengthening rural hospitals, and our shared vision to improve food quality,” Merrin later posted on Facebook. “Let’s Make America Healthy Again!”

Still, even with Kennedy under advisement to avoid anti-vaccine rhetoric, the issue found him in Ohio. At a forum in Cleveland, family doctor Patricia Kellner said the best way to prevent hepatitis B is by vaccinating newborns — a recommendation that under Kennedy. She told Kennedy about treating patients with the disease.

“Some of them didn’t know because it can be asymptomatic. Some of them found out when they got liver cancer,” Kellner said. “So why are you opposed to a birth dose of hepatitis B?”

Kennedy responded by suggesting that the hepatitis B vaccine was not safe for babies and was necessary only for certain people.

“Hepatitis B is for high-risk groups like drug addicts or prostitutes, or for promiscuous homosexuals,” he added, eliciting gasps from the crowd.

While the risk of contracting hepatitis B is higher for those who inject drugs or men who have sex with men, the disease can be transmitted in other ways, including through contact with contaminated surfaces or childbirth.

Public health researchers that dropping the universal hepatitis B recommendation will result in hundreds of new infections in children, costing millions of dollars in additional health care costs.

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This <a target="_blank" href="/public-health/rfk-make-america-healthy-again-tour-midterms-ohio-food-head-start-vaccines/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

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