Within an hour of receiving a covid vaccination in November 2020, Utah preschool teacher Brianne Dressen felt pins and needles through her arms and legs. In the medical odyssey that followed, she suffered double vision, chronic nausea, brain fog, and profound weakness. Once a rock climber, she became a couch potato.

Although Dressen’s symptoms were rare in that season of hundreds of millions of covid vaccinations, they were common enough to draw the attention of a National Institutes of Health neuroscientist named Avindra Nath, who examined Dressen and more than 30 other people with a similar syndrome in 2021. He recommended Dressen take steroids and antibodies — treatments that saved her life, she said.

And then, according to emails reviewed by KFF Health News, Nath said he couldn’t help anymore. His clinical study was ending. He directed the patients to seek local help. But, Dressen said, there wasn’t any.

Nath declined to speak to KFF Health News for this article. The FDA searched international vaccine safety databases for small-fiber neuropathy, one of the most common symptoms he mentioned in a write-up of the patients, and found it was less prevalent in vaccinated than in unvaccinated patients, said Peter Marks, who led the FDA division responsible for vaccines until Health and Human Services Secretary Robert F. Kennedy Jr. forced him out in May.

While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome.

But for Dressen and others convinced the vaccines injured them, their experiences were symptomatic of a well-intentioned but flawed U.S. system for monitoring the rare ill effects of vaccines. The system isn’t well-funded enough to answer questions that people urgently want answered, and that can feed vaccine hesitancy, safety experts say.

Its shortcomings were on particular display during the mass vaccination campaigns of the pandemic, when even rare, serious side effects could affect thousands of people.

Now some leading vaccine scientists are calling for more resources to research vaccine safety and support people with claims of injury — and asking Kennedy, who has a history as an anti-vaccine activist, to step up.

“Spending money on vaccine safety is not saying vaccines aren’t safe; it’s showing a commitment to continued improvement,” said Y. Tony Yang, a professor of health policy at George Washington University’s Milken Institute School of Public Health.

So far, they’ve been disappointed. While Kennedy gives the public the impression that vaccines are harmful, he hasn’t talked about ways to make them safer. And he’s made the problem worse by cutting programs and dismissing scientists who are most knowledgeable of the problems, according to numerous vaccine experts.

“The reduction in emphasis on the unbiased ascertainment of vaccine safety signals, and redirection toward certain specific issues like autism in vaccines, which we know is not true — that is what’s dangerous,” Marks said.

In March, the Trump administration abruptly canceled a contract with researchers just as they began a massive covid vaccine study aimed at discovering the genetic traits that make certain people vulnerable to vaccine-triggered myocarditis. That condition struck about 1 in 13,000 teenage boys and young men who received two doses of the Pfizer or Moderna mRNA vaccine in 2020 and 2021.

Then, on June 9, Kennedy sacked the entire 17-member Advisory Committee on Immunization Practices, or ACIP, which during the pandemic impaneled a group of experts that reviewed safety data from nearly 700 million covid vaccinations.

The new ACIP contains members who have said most vaccines are dangerous and improperly tested. Sen. Bill Cassidy (R-La.), who chairs the Senate committee with oversight of HHS, said on X on June 23 that the ACIP meeting scheduled for June 25-26 should be delayed until ACIP is staffed with less biased, more knowledgeable members.

HHS officials have suggested that Kennedy intends to throw out the whole vaccine safety system and start over. In a statement to KFF Health News, spokesperson Emily Hilliard accused the Centers for Disease Control and Prevention of “suppressing information about vaccine injuries” and said the Vaccine Adverse Event Reporting System, or VAERS, and the Vaccine Safety Datalink, monitoring systems in place since the early 1990s, were “designed to fail” and “templates of regulatory malpractice.”

She said HHS was “building surveillance systems that will accurately measure vaccine risks as well as benefits.” Asked for details, Hilliard did not respond. The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs.

The current U.S. vaccine safety system began with passage of the 1986 National Childhood Vaccine Injury Act, which aimed at stabilizing the vaccine supply by stopping lawsuits against drug companies. At the time they were getting out of the vaccine business, finding it less risky and more profitable to produce drugs for chronic diseases. The act set up the National Vaccine Injury Compensation Program and VAERS.

CDC vaccine safety officer Robert Chen built on VAERS to create the Vaccine Safety Datalink, which looks for evidence of vaccine harms in electronic health records. In 2001, the CDC set up the Clinical Immunization Safety Assessment project, through which a network of eight U.S. centers study rare vaccine reactions.

But the vaccine safety system’s budget has been stuck at around $20 million most years. That hasn’t been enough to study rare but recurring vaccine injuries in a serious way.

“$20 million to look at all the licensed vaccines in this country is woefully inadequate,” Dan Salmon, director of Johns Hopkins University’s Institute for Vaccine Safety, said at a recent conference. Without a more serious commitment, he said, “our products won’t be as safe as they could be.”

As an HHS vaccine safety official during the Clinton, Bush, and Obama administrations, Salmon helped write two plans that called for expanded safety work, including examinations of whether the vaccine schedule might be contributing to an increase in allergic diseases.

A little-publicized CDC-led 2022 study suggested that the aluminum salts added to make some pediatric vaccines more effective might cumulatively be linked to an increased incidence of asthma. Salmon thinks it merits further research — to refute or confirm the results. The issue “should have been studied decades ago,” he said.

A Failed Compensation Program

Vaccine advocates and skeptics agree that the government program established to compensate people injured by vaccines or other public health measures during emergencies — the Countermeasures Injury Compensation Program — has miserably failed those with covid vaccine-related injuries. As of June 1, the program has compensated only 39 of nearly 14,000 people who have filed covid vaccine injury claims. Only five have gotten awards of more than $10,000.

The program is far less generous and user-friendly than the National Vaccine Injury Compensation Program, funded since 1988 by an excise tax on vaccines. It has paid out about 12,000 awards worth a total of $4.8 billion, mostly to care for vaccine-injured children.

People with covid vaccine injuries, however, are stuck in a kind of limbo, often without clear medical options. It’s unfair and “very bad for public confidence in vaccines,” said Amy Pisani, CEO of Vaccinate Your Family, a nonprofit that promotes vaccination, speaking on a panel with Salmon at the April conference.

Kennedy has condemned the injury compensation system for shielding drug companies from lawsuits, but if he wants to help patients he should move covid vaccines into the program, said Renée Gentry, who runs a law clinic for vaccine injuries at George Washington University Law School.

“The longer you hang these people out to dry, you are creating a perfect storm where nobody’s going to want to get vaccinated,” she said.

A Curtailed Vaccine Injury Investigation

In December 2021, the NIH’s Nath emailed Dressen and the other patients suffering from postvaccine problems that he could no longer help them. He told Science magazine that investigating vaccine side effects was a delicate business when public health leaders were urging everyone to get their shots.

“You have to be very careful. You can make the wrong conclusion,” he said. “The implications are huge.”

Nath published an article in 2023 calling for more investigation of vaccine-related neurological conditions. His lab also released preliminary results from its study of Dressen and the other patients, which pointed to helpful treatments. But the paper has not been published in a peer-reviewed journal.

And none of the federal agencies recognized that her condition might be vaccine-related, said Dressen, who received her shot in an AstraZeneca clinical trial. (FDA officials were concerned about the vaccine’s side effect profile, and it was never distributed in the United States.)

Dressen said Nath’s withdrawal left her distraught.

“They reassure everyone there’s a safety net, but every one of those things is a complete failure,” she said. “I didn’t speak out because of my injury. The reason I spoke out is because of what happened after my injury.”

“People are suffering, and we don’t yet understand why or how to help them,” said Harlan Krumholz, a cardiologist who is part of a research project at Yale University led by immunobiologist Akiko Iwasaki that includes hundreds of patients with postvaccine issues. “Worse, many of them have felt ignored or dismissed by the very institutions meant to help and support them.”

The NIH appears not to have funded studies of postvaccine syndrome, whose symptoms mimic those of long covid. Yet genetic studies could help “to determine who might be more susceptible to this condition,” Iwasaki said in an email.

Such research appears ideal for the Clinical Immunization Safety Assessment, established to examine rare vaccine reactions. But the network has published nothing on covid vaccines, nor are any trials related to the issue listed on government websites.

German researchers have studied postvaccine syndrome in more depth. Germany’s Paul-Ehrlich-Institut, a sort of FDA for vaccines, reported in December that it had reviewed 919 cases of postvaccine syndrome that were similar to long covid — a rate of about 1 in 100,000 vaccinations. It said causality was hard to establish because of the diverse symptoms reported.

Can Vaccine Safety Move Out of HHS?

In 1999, Chen, the CDC scientist, published an article suggesting that to speed studies and boost public confidence, vaccine safety should be moved to an independent agency, perhaps modeled on the National Transportation Safety Board, that could subpoena records from industry or other government agencies for its crash investigations.

Although HHS did not respond to a query about the idea, vaccine litigant Aaron Siri, who has been a personal attorney to Kennedy, told KFF Health News that Kennedy supported it.

In the meantime, some vaccinologists hope they can persuade Kennedy to spend more money on good vaccine safety research.

While it is “very painful to watch” what Kennedy is doing to HHS vaccine policy, “it would behoove us to find common ground,” Salmon said at the conference. That doesn’t mean “funding terrible studies to confirm hypotheses that some people believe,” he added.

Though that is what many see Kennedy doing. One of his first moves as secretary was to hire David Geier, whose previous publications are considered junk science by many in the field, to conduct a review of vaccine links to autism. Studies around the world have thoroughly debunked such a connection.

Building on an Existing System

When HHS’ Vaccine Safety Datalink was set up in the early 1990s, it was the envy of the world. There are now also good systems in Denmark, England, Israel, and Australia, but the U.S. system has worked pretty well, said Steve Black, who co-directed the Kaiser Permanente Vaccine Study Center from 1985 until 2007.

The Vaccine Safety Datalink was largely responsible for the 1999 removal of a rotavirus vaccine that triggered rare intestinal disorders in babies. And its discovery of a rare but deadly side effect helped keep the AstraZeneca covid vaccine off the U.S. market and led to the removal of the Johnson & Johnson vaccine, Black said. It also helped pinpoint myocarditis soon after young men began getting mRNA shots in 2021.

Since 2019, Black has co-directed an ambitious, 30-country consortium called the Global Vaccine Data Network, which enables vaccine safety analyses across massive, diverse populations around the world.

The group was just beginning its study of genetic predispositions to myocarditis when the Trump administration withdrew a $2 million CDC payment, halting the work.

An email from the Department of Government Efficiency, or DOGE, “asked a bunch of irrelevant questions like, Had we ever been funded by China? Did we have collaborators in Europe?” It ordered the network to cease and desist with no due process or means of appeal, Black said.

Research funded by the grant had progressed to the point of finding seven genetic variants known to be related to cardiac inflammation in people who got myocarditis postvaccination, said Bruce Carleton, the lead investigator, at the University of British Columbia. Work remains, but the data suggests a $6 test could clear vulnerable patients before they are vaccinated, Carleton said.

“Millions got mRNA vaccines. Very few got myocarditis,” Black said. “The public would like to know, ‘Am I at risk?’ Genetics can answer that.”

The CDC has been an honest broker of vaccine safety information, Black added, but if taking the issue out of HHS would improve public confidence, he’s for it.

Vaccines need to be safer, Dressen said, but the idea of banning them doesn’t sit well with her.

“There’s the crowd that wants mRNA vaccines to be pulled off the market, but that’s not going to fix the problem. Vaccines are not going to go away,” she said.

As of June 5, a patient group she leads had provided $1.2 million to 162 people needing medical care for injuries they attributed to vaccination.

Meanwhile, the federal countermeasures program, which doles out covid vaccine injury awards through a trust, has committed $2.6 million for one patient and $370,376 for another. As of June 1, it had granted an additional 37 claimants a grand total of $198,809.92.

This article first appeared on KFF Health News and is republished here under a Creative Commons license.

In the dim basement of a Salt Lake City pharmacy, hundreds of amber-colored plastic pill bottles sit stacked in rows, one man’s defensive wall in a tariff war.

Independent pharmacist Benjamin Jolley and his colleagues worry that the tariffs, aimed at bringing drug production to the United States, could instead drive companies out of business while raising prices and creating more of the drug shortages that have plagued American patients for several years.

Jolley bought six months’ worth of the most expensive large bottles, hoping to shield his business from the 10% across-the-board tariffs on imported goods that President Donald Trump announced April 2. Now with threats of additional tariffs targeting pharmaceuticals, Jolley worries that costs will soar for the medications that will fill those bottles.

In principle, Jolley said, using tariffs to push manufacturing from China and India to the U.S. makes sense. In the event of war, China could quickly stop all exports to the United States.

“I understand the rationale for tariffs. I’m not sure that we’re gonna do it the right way,” Jolley said. “And I am definitely sure that it’s going to raise the price that I pay my suppliers.”

Squeezed by insurers and middlemen, independent pharmacists such as Jolley find themselves on the front lines of a tariff storm. Nearly everyone down the line — drugmakers, pharmacies, wholesalers, and middlemen — opposes most tariffs.

Slashing drug imports could trigger widespread shortages, experts said, because of America’s dependence on Chinese- and Indian-made chemical ingredients, which form the critical building blocks of many medicines. Industry officials caution that steep tariffs on raw materials and finished pharmaceuticals could make drugs more expensive.

“Big ships don’t change course overnight,” said Robin Feldman, a UC Law San Francisco professor who writes about prescription drug issues. “Even if companies pledge to bring manufacturing home, it will take time to get them up and running. The key will be to avoid damage to industry and pain to consumers in the process.”

Trump on April 8 said he would soon announce “a major tariff on pharmaceuticals,” which have been largely tariff-free in the U.S. for 30 years.

“When they hear that, they will leave China,” he said. The U.S. imported $213 billion worth of medicines in 2024 — from China but also India, Europe, and other areas.

Trump’s statement sent drugmakers scrambling to figure out whether he was serious, and whether some tariffs would be levied more narrowly, since many parts of the U.S. drug supply chain are fragile, drug shortages are common, and upheaval at the FDA leaves questions about whether its staffing is adequate to inspect factories, where quality problems can lead to supply chain crises.

On May 12, Trump signed an executive order asking drugmakers to bring down the prices Americans pay for prescriptions, to put them in line with prices in other countries.

Meanwhile, pharmacists predict even the 10% tariffs Trump has demanded will hurt: Jolley said a potential increase of up to 30 cents a vial is not a king’s ransom, but it adds up when you’re a small pharmacy that fills 50,000 prescriptions a year.

“The one word that I would say right now to describe tariffs is ‘uncertainty,’” said Scott Pace, a pharmacist and owner of Kavanaugh Pharmacy in Little Rock, Arkansas.

To weather price fluctuations, Pace stocked up on the drugs his pharmacy dispenses most.

“I’ve identified the top 200 generics in my store, and I have basically put 90 days’ worth of those on the shelf just as a starting point,” he said. “Those are the diabetes drugs, the blood pressure medicines, the antibiotics — those things that I know folks will be sicker without.”

Pace said tariffs could be the death knell for the many independent pharmacies that exist on “razor-thin margins” — unless reimbursements rise to keep up with higher costs.

Unlike other retailers, pharmacies can’t pass along such costs to patients. Their payments are set by health insurers and pharmacy benefit managers largely owned by insurance conglomerates, who act as middlemen between drug manufacturers and purchasers.

Neal Smoller, who employs 15 people at his Village Apothecary in Woodstock, New York, is not optimistic.

“It’s not like they’re gonna go back and say, well, here’s your 10% bump because of the 10% tariff,” he said. “Costs are gonna go up and then the sluggish responses from the PBMs — they’re going to lead us to lose more money at a faster rate than we already are.”

Smoller, who said he has built a niche selling vitamins and supplements, fears that FDA firings will mean fewer federal inspections and safety checks.

“I worry that our pharmaceutical industry becomes like our supplement industry, where it’s the wild West,” he said.

Narrowly focused tariffs might work in some cases, said Marta Wosińska, a senior fellow at the Brookings Institution’s Center on Health Policy. For example, while drug manufacturing plants can cost $1 billion and take three to five years to set up, it would be relatively cheap to build a syringe factory — a business American manufacturers abandoned during the covid-19 pandemic because China was dumping its products here, Wosińska said.

It’s not surprising that giants such as Novartis and Eli Lilly have promised Trump they’ll invest billions in U.S. plants, she said, since much of their final drug product is made here or in Europe, where governments negotiate drug prices. The industry is using Trump’s tariff saber-rattling as leverage; in an April 11 letter, 32 drug companies demanded European governments pay them more or face an exodus to the United States.

Brandon Daniels, CEO of supply chain company Exiger, is bullish on tariffs. He thinks they could help bring some chemical manufacturing back to the U.S., which, when coupled with increased use of automation, would reduce the labor advantages of China and India.

“You’ve got real estate in North Texas that’s cheaper than real estate in Shenzhen,” he said at an economic conference April 25 in Washington, referring to a major Chinese chemical manufacturing center.

But Wosińska said no amount of tariffs will compel makers of generic drugs, responsible for 90% of U.S. prescriptions, to build new factories in the U.S. Payment structures and competition would make it economic suicide, she said.

Several U.S. generics firms have declared bankruptcy or closed U.S. factories over the past decade, said John Murphy, CEO of the Association for Accessible Medicines, the generics trade group. Reversing that trend won’t be easy and tariffs won’t do it, he said.

“There’s not a magic level of tariffs that magically incentivizes them to come into the U.S.,” he said. “There is no room to make a billion-dollar investment in a domestic facility if you’re going to lose money on every dose you sell in the U.S. market.”

His group has tried to explain these complexities to Trump officials, and hopes word is getting through. “We’re not PhRMA,” Murphy said, referring to the powerful trade group primarily representing makers of brand-name drugs. “I don’t have the resources to go to Mar-a-Lago to talk to the president myself.”

Many of the active ingredients in American drugs are imported. Fresenius Kabi, a German company with facilities in eight U.S. states to produce or distribute sterile injectables — vital hospital drugs for cancer and other conditions — complained in a letter to U.S. Trade Representative Jamieson Greer that tariffs on these raw materials could paradoxically lead some companies to move finished product manufacturing overseas.

Fresenius Kabi also makes biosimilars, the generic forms of expensive biologic drugs such as Humira and Stelara. The United States is typically the last developed country where biosimilars appear on the market because of patent laws.

Tariffs on biosimilars coming from overseas — where Fresenius makes such drugs — would further incentivize U.S. use of more expensive brand-name biologics, the March 11 letter said. Biosimilars, which can cost a tenth of the original drug’s price, launch on average 3-4 years later in the U.S. than in Canada or Europe.

In addition to getting cheaper knockoff drugs faster, European countries also pay far less than the United States for brand-name products. Paradoxically, Murphy said, those same countries pay more for generics.

European governments tend to establish more stable contracts with makers of generics, while in the United States, “rabid competition” drives down prices to the point at which a manufacturer “maybe scrimps on product quality,” said John Barkett, a White House Domestic Policy Council member in the Biden administration.

As a result, Wosińska said, “without exemptions or other measures put in place, I really worry about tariffs causing drug shortages.”

Smoller, the New York pharmacist, doesn’t see any upside to tariffs.

“How do I solve the problem of caring for my community,” he said, “but not being subject to the emotional roller coaster that is dispensing hundreds of prescriptions a day and watching every single one of them be a loss or 12 cents profit?”

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The Trump administration’s unprecedented $500 million grant for a broadly protective flu shot has confounded vaccine and pandemic preparedness experts, who said the project was in early stages, relied on old technology, and was just one of more than 200 such efforts.

Health and Human Services Secretary Robert F. Kennedy Jr. shifted the money from a pandemic preparedness fund to a vaccine development program led by two scientists whom the administration recently named to senior positions at the National Institutes of Health.

While some experts were pleased that Kennedy had supported any vaccine project, they said the May 1 announcement contravened sound scientific policy, appeared arbitrary, and raised the kinds of questions about conflicts of interest that have dogged many of President Donald Trump’s actions.

Focusing vast resources on a single vaccine candidate “is a little like going to the Kentucky Derby and putting all your money on one horse,” said William Schaffner, a Vanderbilt University professor and past president of the National Foundation for Infectious Diseases. “In science we normally put money on a number of different horses because we can’t be entirely sure who’s going to win.”

Others were mystified by the decision, since the candidate vaccine uses technology that was largely abandoned in the 1970s and eschews techniques developed in recent decades through funding from the Department of Health and Human Services and the Defense Department.

“This is not a next-generation vaccine,” said Rick Bright, who led HHS’ Biomedical Advanced Research and Development Authority, or BARDA, in the first Trump administration. “It’s so last-generation, or first-generation, it’s mind-blowing.”

The vaccine is being developed at the National Institute for Allergy and Infectious Diseases by Jeffery Taubenberger, whom Trump named as acting chief of the institute in late April, and his colleague Matthew Memoli, a critic of U.S. covid-19 policy whom Trump picked to lead the NIH until April 1, when Jay Bhattacharya took office. Bhattacharya named Memoli his principal deputy.

Taubenberger gained fame as an Armed Forces Institute of Pathology scientist in 1997 when his lab sequenced the genome of the 1918 pandemic influenza virus, using tissue samples from U.S. troops who died in that plague. He joined the NIH in 2006.

In a May 1 news release, HHS called the Taubenberger-Memoli vaccine initiative “Generation Gold Standard,” saying it represented “a decisive shift toward transparency, effectiveness, and comprehensive preparedness.” Bhattacharya said it represented a “paradigm shift.”

But the NIH vaccine-makers’ goal of creating a shot that protects against multiple or all strains of influenza — currently vaccines must be given each year to account for shifts in the virus — is not new.

Then-NIAID Director Anthony Fauci launched a network of academic researchers in pursuit of a broadly protective flu vaccine in 2019. In addition to that NIH-led consortium, more than 200 flu vaccines are under development in the U.S. and other countries.

Many use newer technologies, and some are at more advanced stages of human testing than the Taubenberger vaccine, whose approach appears basically the same as the one used in flu vaccines starting in 1944, Bright said.

In the news release, HHS described the vaccine as “in advanced trials” and said it would induce “robust” responses and “long-lasting protection.” But Taubenberger and his colleagues haven’t published a complete human study of the vaccine yet. A study showing the vaccine protected mice from the flu appeared in 2022.

For Operation Warp Speed, which led to the creation of the covid vaccine during Trump’s first term, government scientists reviewed detailed plans and data from academic and commercial laboratories vying for federal money, said Greg Poland, a flu expert and president of the Atria Health Academy of Science and Medicine. “If that’s happening here, it’s opaque to me,” he said.

When asked what data beyond its press release supported the decision, HHS spokesperson Andrew Nixon pointed to the agency’s one-page statement. Asked whether the decision would curtail funding for the Fauci-created consortium or other universal vaccine approaches, Nixon did not specifically respond. “Generation Gold Standard is the most promising,” he said in an email.

Taubenberger did not respond to a request for comment. Nixon and NIH spokesperson Amanda Fine did not respond to requests for an interview with Taubenberger or Memoli.

The HHS statement stressed that by developing the vaccine in-house, the government “ensures radical transparency, public accountability, and freedom from commercial conflicts of interest.” While any vaccine would eventually have to be made commercially, NIH involvement through more stages of development could give the government greater influence on any vaccine’s eventual price, Schaffner said.

If the mRNA-based covid shots produced by Moderna and Pfizer-BioNTech represented the cutting edge of vaccine technology, applying ultra-sophisticated approaches never before seen in an inoculation, the approach by Taubenberger and Memoli represents a blast from the past.

Their vaccine is made by inactivating influenza viruses with a carcinogenic chemical called beta-propiolactone. Scientists have used the chemical to neutralize viruses since at least the 1950s. This whole-virus inactivation method, mostly using other chemicals, was the standard way to make flu vaccines into the 1970s, when it was modified, partly because whole-virus vaccines caused high fevers or even seizures in children.

The limited published data from the Taubenberger vaccine, from an initial safety trial involving 45 patients, showed no major side effects. The scientists are testing the vaccine as a regular shot and as an intranasal spray with the idea of stopping the virus in the respiratory tract before it causes a broad infection.

“The notion of a universal influenza A pandemic vaccine is a good one,” said Poland, who called Taubenberger an excellent scientist. But he added: “I’m not so sure about the platform, and the dollar amount is a puzzler. This vaccine’s in very early development.”

Paul Friedrichs, a retired Air Force general who led the Office of Pandemic Preparedness and Response Policy in President Joe Biden’s White House, said that “giving $500 million upfront with very little data to support it is unlike anything I’ve ever seen.”

“The technology for developing vaccines has tremendously evolved over many decades,” Friedrichs said. “Why would we go back to an approach historically associated with greater or more frequent adverse events?”

The government appeared to be transferring the money for the Taubenberger vaccine development from an existing $1.3 billion vaccine fund at Project NextGen, a mostly covid-focused program at BARDA, Friedrichs said. Most of that money was earmarked to support advanced research on covid and other viral vaccines, including those protecting against emerging diseases.

It is “very concerning that we’re de-emphasizing covid, which we may live to regret,” Poland said. “It assumes we won’t have a covid variant that escapes the current moderately high levels of covid immunity.”

Nixon said Project NextGen, for which some funds were earmarked for mRNA research, is under review. Kennedy is critical of mRNA vaccines, once claiming, falsely, that they are the deadliest vaccines in history.

Ted Ross, director of global vaccine development at the Cleveland Clinic, said he was “happy to see them investing in respiratory vaccines, including a universal flu vaccine, with all the programs they’ve been cutting.”

“But I don’t think this is the only approach,” Ross said. “Other universal flu vaccines are in progress, and their success and failure are not known yet.”

His team, part of the NIAID-funded flu vaccine consortium, is using artificial intelligence and computer modeling to design vaccines that produce the broadest immunity to influenza, including seasonal and pandemic strains.

As interim director, Memoli oversaw the start of the administration’s massive cuts at the NIH, with the elimination of some 800 agency grants worth over $2 billion. More than 1,200 NIH employees have been fired, and many researchers, including Ross, are in limbo.

His lab is close to testing a candidate vaccine on people, Ross said, while waiting to find out about its NIH funding. “I’m not sure whether my contract is on the chopping block,” he said.

KFF Health 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 KFF.

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President Donald Trump’s firings at the Department of Health and Human Services included the entire office that sets federal poverty guidelines, which determine whether tens of millions of Americans are eligible for health programs such as Medicaid, food assistance, child care, and other services, former staff said.

The small team, with technical data expertise, worked out of HHS’ Office of the Assistant Secretary for Planning and Evaluation, or ASPE. Their dismissal mirrored others across HHS, which came without warning and left officials puzzled as to why they were “RIF’ed” — as in “reduction in force,” the bureaucratic language used to describe the firings.

“I suspect they RIF’ed offices that had the word ‘data’ or ‘statistics’ in them,” said one of the laid-off employees, a social scientist whom KFF Health News agreed not to name because the person feared further recrimination. “It was random, as far as we can tell.”

Among those fired was Kendall Swenson, who had led development of the poverty guidelines for many years and was considered the repository of knowledge on the issue, according to the social scientist and two academics who have worked with the HHS team.

The sacking of the office could lead to cuts in assistance to low-income families next year unless the Trump administration restores the positions or moves its duties elsewhere, said Robin Ghertner, the fired director of the Division of Data and Technical Analysis, which had overseen the guidelines.

The poverty guidelines are “needed by many people and programs,” said Timothy Smeeding, a professor emeritus of economics at the La Follette School of Public Affairs at the University of Wisconsin. “If you’re thinking of someone you fired who should be rehired, Swenson would be a no-brainer,” he added.

Under a 1981 appropriations bill, HHS is required annually to take Census Bureau poverty-line figures, adjust them for inflation, and create guidelines that agencies and states use to determine who is eligible for various types of help.

There’s a special sauce for creating the guidelines that includes adjustments and calculations, Ghertner said. Swenson and three other staff members would independently prepare the numbers and quality-check them together before they were issued each January.

Everyone in Ghertner’s office was told last week, without warning, that they were being put on administrative leave until June 1, when their employment would officially end, he said.

“There’s literally no one in the government who knows how to calculate the guidelines,” he said. “And because we’re all locked out of our computers, we can’t teach anyone how to calculate them.”

ASPE had about 140 staff members and now has about 40, according to a former staffer. The HHS shake-up merged the office with the Agency for Healthcare Research and Quality, or AHRQ, whose staff has shrunk from 275 to about 80, according to a former AHRQ official who spoke on the condition of anonymity.

HHS has said it laid off about 10,000 employees and that, combined with other moves, including a program to encourage early retirements, its workforce has been reduced by about 20,000. But the agency has not detailed where it made the cuts or identified specific employees it fired.

“These workers were told they couldn’t come into their offices so there’s no transfer of knowledge,” said Wendell Primus, who worked at ASPE during the Bill Clinton administration. “They had no time to train anyone, transfer data, etc.”

HHS defended the firings. The department merged AHRQ and ASPE “as part of Secretary Kennedy’s vision to streamline HHS to better serve Americans,” spokesperson Emily Hilliard said. “Critical programs within ASPE will continue in this new office” and “HHS will continue to comply with statutory requirements,” she said in a written response to KFF Health News.

After this article published, HHS spokesperson Andrew Nixon called KFF Health News to say others at HHS could do the work of the RIF’ed data analysis team, which had nine members. “The idea that this will come to a halt is totally incorrect,” he said. “Eighty million people will not be affected.”

Secretary Robert F. Kennedy Jr. has so far declined to testify about the staff reductions before congressional committees that oversee much of his agency. On April 9, a delegation of 10 Democratic members of Congress waited fruitlessly for a meeting in the agency’s lobby.

The group was led by House Energy and Commerce health subcommittee ranking member Diana DeGette (D-Colo.), who told reporters afterward that Kennedy must appear before the committee “and tell us what his plan is for keeping America healthy and for stopping these devastating cuts.”

Matt VanHyfte, a spokesperson for the Republican committee leadership, said HHS officials would meet with bipartisan committee staff on April 11 to discuss the firings and other policy issues.

ASPE serves as a think tank for the HHS secretary, said Primus, who later was Rep. Nancy Pelosi’s senior health policy adviser for 18 years. In addition to the poverty guidelines, the office maps out how much Medicaid money goes to each state and reviews all regulations developed by HHS agencies.

“These HHS staffing cuts — 20,000 — obviously they are completely nuts,” Primus said. “These were not decisions made by Kennedy or staff at HHS. They are being made at the White House. There’s no rhyme or reasons to what they’re doing.”

HHS leaders may be unaware of their legal duty to issue the poverty guidelines, Ghertner said. If each state and federal government agency instead sets guidelines on its own, it could create inequities and lead to lawsuits, he said.

And sticking with the 2025 standard next year could put benefits for hundreds of thousands of Americans at risk, Ghertner said. The current poverty level is $15,650 for a single person and $32,150 for a family of four.

“If you make $30,000 and have three kids, say, and next year you make $31,000 but prices have gone up 7%, suddenly your $31,000 doesn’t buy you the same,” he said, “but if the guidelines haven’t increased, you might be no longer eligible for Medicaid.”

The 2025 poverty level for a family of five is $37,650.

As of October, about 79 million people were enrolled in Medicaid or the related Children’s Health Insurance Program, both of which are means-tested and thus depend on the poverty guidelines to determine eligibility.

Eligibility for premium subsidies for insurance plans sold in Affordable Care Act marketplaces is also tied to the official poverty level.

One in eight Americans rely on the Supplemental Nutrition Assistance Program, or food stamps, and 40% of newborns and their mothers receive food through the Women, Infants, and Children program, both of which also use the federal poverty level to determine eligibility.

Former employees in the office said they were not disloyal to the president. They knew their jobs required them to follow the administration’s objectives. “We were trying to support the MAHA agenda,” the social scientist said, referring to Kennedy’s “Make America Healthy Again” rubric. “Even if it didn’t align with our personal worldviews, we wanted to be useful.”

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Panelists at a covid conference last fall were asked to voice their regrets — policies they had supported during the pandemic but had come to see as misguided. Covid contact tracing, one said. Closing schools, another said. Vaccine mandates, a third said.

When Marty Makary’s turn came, the Johns Hopkins University surgeon said, “I can’t think of anything,” adding, “The entire covid policy of three to four years felt like a horror movie I was forced to watch.”

It was a characteristic response for Makary, President Donald Trump’s nominee to lead the Food and Drug Administration, who looks set to be confirmed after a Senate committee hearing on Thursday. A decorated doctor and a brash critic of many of his medical colleagues, Makary drew Trump’s attention during the pandemic with frequent appearances on Fox News shows such as “Tucker Carlson Tonight,” in which he excoriated public health officials over their handling of covid.

Many former FDA officials and scientists with knowledge of the agency are optimistic about Makary — to a degree.

“He’s a world-class surgeon, and he has health policy expertise,” said Jennifer Nuzzo, a Brown University professor of epidemiology and former colleague of Makary’s at Johns Hopkins. “If you have pancreatic cancer, he’s the person you want to operate on you. The university is probably losing a lot of money to not have him doing that work.”

His critics say he at times exaggerated the harms of the covid vaccine and undersold the dangers of the virus, contributing to a pandemic narrative that led many Americans to shun the shots and other practices intended to curb transmission and reduce hospitalizations and deaths.

Should he take the reins at the FDA, transitioning from gadfly to the head of an agency that regulates a fifth of the U.S. economy, Makary would have to engage in the thorny challenges of governing.

“Makary spent the pandemic raving against the medical establishment as if he were an outsider, which he wasn’t,” said Jonathan Howard, a New York City neurologist and the author of “We Want Them Infected,” a book that criticizes Makary and other academics who opposed government policies. “Now he really is the establishment. Everything that happens is going to be his responsibility.”

At his confirmation hearing, Makary sounded a lower-key tone, extolling the FDA’s professional staff and promising to apply good science and common sense in the service of attacking chronic disease in the U.S., including by studying food additives and chemicals that could be contributing to poor health.

“We need more humility in the medical establishment. You have to be willing to evolve your position as new data comes in,” he testified. What makes a great doctor “is not how much you know; it’s your humility and your willingness to learn, as you go, from patients.”

Colleagues have applauded Makary’s skill and intelligence as a surgeon and medical policy thinker. He contributed to a 2009 surgery checklist believed to have prevented thousands of mistakes and infections in operating rooms. He wrote a widely cited 2016 paper claiming that medical errors were the third-leading cause of death in the United States, although some researchers said the assertion was overblown. He’s also founded or been a director for companies and said in the hearing that a surgical technique he invented eventually could help cure diabetes.

Humility, however, has not been Makary’s most obvious trait.

During the pandemic, he took to op-eds and conservative media with controversial positions on public health policy. Some proved astute, while others look less prescient in hindsight.

In December 2020, Makary defied established scientific knowledge and said that vaccination of 20% of the population would be enough to create “herd immunity.” In a February 2021 Wall Street Journal piece, he predicted that covid would virtually disappear by April because so many people would have become immune through infection or vaccination. The U.S. death toll from covid stood at 560,000 that April, with an additional 650,000 deaths to come. In June 2021, he said he had been unable to find evidence of a single covid death of a previously healthy child. By then there were many reports of such deaths, although children were much less likely than older people to suffer severe disease.

In February 2023, Makary testified in Congress that the lab-leak theory of covid’s origin was a “no brainer,” a surprisingly unequivocal statement for a scientist discussing a scientifically unresolved issue.

Some public health officials felt Makary gratuitously attacked authorities working in difficult circumstances.

“He went from being a pretty reasonable person to saying a lot of things that were over the top and unnecessary,” said Ashish Jha, dean of the Brown University School of Public Health, who was the White House covid-19 response coordinator under President Joe Biden.

And while almost everyone involved in fighting covid has admitted to getting things wrong during the pandemic, Jha said, “I never had any sense from Marty that he did.”

Makary did not respond to requests for comment.

Makary accused Biden administration officials of ignoring emerging evidence that previous infection with covid could be as or more effective against future infection than vaccination. While he was probably right, Nuzzo said, his statements seemed to encourage people to get infected.

“It’s reasonable to say that vaccine mandates weren’t the right approach,” she said. “But you can also understand that people were trying to blindly stumble our way out of the situation, and some people thought vaccine mandates would be expedient.”

At Johns Hopkins, for example, Nuzzo opposed a booster mandate for the campus in 2022 but understood the final decision to require it. School authorities were intent on bringing students back to campus and worried that outbreaks would force them to shut down again, she said.

“You can argue that seat belt laws are bad because they impinge on civil rights,” Howard said. “But a better thing to do would be to urge people to wear seat belts.”

Makary’s statements had “no grace,” he said. “These were people dealing with an overwhelming virus, and he constantly accused them of lying.”

Several public health officials were particularly upset by the way Makary cast aspersions on the Centers for Disease Control and Prevention’s vaccine safety program. In a Jan. 16, 2023, appearance on Tucker Carlson’s Fox News show, Makary said the CDC had “tried to quickly downplay” evidence of an increased risk of stroke in Medicare beneficiaries who got a covid booster. In fact, the CDC had detected a potential signal for additional strokes in one database, and in the interest of transparency it released that information, Nuzzo said. Further investigation found that there was no actual risk.

During Thursday’s hearing, Makary’s pandemic views were mostly left unexplored, but Democratic and Republican senators repeatedly probed for his views on the abortion drug mifepristone, which became easier to use without direct medical supervision because of a 2021 FDA ruling. Many Republicans want to reverse the FDA ruling; Democrats say there are reams of evidence that support the drug’s safety when taken by a woman at home.

Makary tried to satisfy both parties. He told Sen. Maggie Hassan (D-N.H.) he would be led by science and had no preconceived ideas about mifepristone’s safety. Questioned by Republican Bill Cassidy, chair of the Health, Education, Labor and Pensions Committee and an abortion foe, he said he would examine ongoing data on the drug from the FDA’s risk evaluation system, which gathers reports from the field.

The abortion pill question exemplifies the kind of dilemmas Makary will face at the FDA, Jha said.

“He’s going to have to decide whether he listens to the scientists in his administration, or his boss, who often disagrees with science,” he said. “He’s a smart, thoughtful guy and my hope is he’ll find his way through.”

“The two most important organs for the FDA commissioner are the brain and the spine,” said former FDA deputy commissioner Joshua Sharfstein. “The spine because there’s attempted influence coming from many directions, not just political but also commercial and from multiple advocacy communities. It’s very important to stand up for the agency’s success.”

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Last fall, before being named the senior U.S. health official, Robert F. Kennedy Jr. said the Trump administration would liberate Americans from the FDA’s “aggressive suppression” of vitamins, dietary supplements, and other substances — ending the federal agency’s “war on public health,” as he put it.

In fact, the FDA can’t even require that supplements be effective before they are sold. When Congress, at the agency’s urging, last considered legislation to require makers of vitamins, herbal remedies, and other pills and potions to show proof of their safety and worth before marketing the products, it got more negative mail, phone calls, and telegrams than at any time since the Vietnam War, by some accounts. The backlash resulted in a 1994 law that enabled the dietary supplement industry to put its products on the market without testing and to tout unproven benefits, as long as the touting doesn’t include claims to treat or cure a disease. Annual industry revenues have grown from $4 billion to $70 billion since.

With Kennedy now in the driver’s seat, the industry will likely expect more: It aims to make bolder health claims for its products and even get the government, private insurers, and flexible spending accounts to pay for supplements, essentially putting them on an equal footing with FDA-approved pharmaceuticals.

On Feb. 13, the day Kennedy was sworn in as secretary of Health and Human Services, President Donald Trump issued a “Make America Healthy Again” agenda targeting alleged corruption in health regulatory agencies and instructing them to “ensure the availability of expanded treatment options and the flexibility for health insurance coverage to provide benefits that support beneficial lifestyle changes and disease prevention.”

Kennedy has said exercise, dietary supplements, and nutrition, rather than pharmaceutical products, are key to good health. Supplement makers want consumers to be able to use programs like health savings accounts, Medicare, and even benefits from the Supplemental Nutrition Assistance Program, or SNAP, to pay for such items as vitamins, fish oil, protein powders, and probiotics.

“Essentially they’re seeking a government subsidy,” said Pieter Cohen, a Harvard University physician who studies supplements.

As the Senate Finance Committee questioned Kennedy during his Jan. 29 confirmation hearing, supporters in the Alliance for Natural Health lunched on quinoa salad in the U.S. Capitol Visitor Center and crowed that the moment had finally arrived for their health freedom movement, which has combined libertarian capitalism and mistrust of the medical establishment to champion unregulated compounds since the 19th century.

“The greatest opportunity of our lifetimes is before us,” said Jonathan Emord, the group’s general counsel, who has brought many successful lawsuits against the FDA’s restrictions on unproven health claims. “RFK has dedicated his whole life to opposing the undue influence” of the pharmaceutical industry and “assuring that our interests triumph,” Emord said.

In speeches and in a pamphlet called “The MAHA Mandate,” Emord and alliance founder Robert Verkerk said Kennedy would free companies to make greater claims for their products’ alleged benefits. Emord said his group was preparing to sue the FDA to prevent it from restricting non-pharmaceutical production of substances like biopeptides — complex molecules related to drugs like Ozempic.

HHS spokesperson Andrew Nixon did not respond to a request for comment on the agency’s plans vis-à-vis dietary supplements.

While the basic law governing the FDA establishes that a substance alleged to have treatment or curative effects is by definition a “drug,” and therefore comes under the agency’s requirements for high standards of scientific evidence, the new administration could reallocate money away from enforcement, said Mitch Zeller, former head of the FDA’s Center for Tobacco Products.

As a Senate aide early in his career, Zeller investigated a tainted L-tryptophan supplement that killed at least 30 people and sickened thousands in the U.S. in 1989. The scandal led the FDA to seek heavier regulation of supplements, but a powerful backlash resulted in the relatively weak supplements law of 1994.

Even that law’s enforcement could be undercut with a stroke of the pen that would keep FDA inspectors out of the field, Zeller said.

Sweeping changes couldn’t come too soon for Nathan Jones, founder and CEO of Xlear, a company that makes products containing xylitol, an artificial sweetener. The Federal Trade Commission sued Xlear in 2021 for making what it called false claims that its nasal spray could prevent and treat covid.

Jones points to a handful of studies evaluating whether xylitol prevents cavities and infections, saying the FDA would require overly expensive studies to get xylitol approved as a drug. Meanwhile, he said, dentists have been bought out by “Big Toothpaste.”

One can hardly find any products “without fluoride for oral health,” he said. “Crest and Colgate don’t want it to happen,” he said.

Kennedy’s desire to rid water supplies of fluoride because of its alleged impact on children’s IQ is welcome news, he said, and not only because it could highlight the value of his products. Jones stresses, as do many health freedom advocates, that clean air and water and unadulterated food do more to prevent and cure disease than vaccines and drugs. For example, he and other advocates claim, wrongly, that the United States eliminated the crippling disease polio through better sanitation, not vaccination.

The Alliance for Natural Health hopes that in lieu of strict FDA standards, Kennedy will enable companies to make expanded marketing claims based on evidence from non-FDA sources, Verkerk said, such as the National Institutes of Health’s nutritional information site, which describes the pros and cons of different supplements.

Kennedy has also called for relaxing the strictures on psychedelic drugs, which interest some veterans as potential remedies for such conditions as post-traumatic stress disorder. VETS, a San Diego-based organization, has paid for 1,000 veterans to get treatment with the powerful hallucinogen ibogaine at clinics in Mexico and other countries, said the group’s co-founder Amber Capone.

She got involved after her husband, a retired Navy SEAL, pulled out of a suicidal spiral after spending a week at an ibogaine clinic near Tijuana, Mexico, in 2017. She wants NIH, the Defense Department, and the Department of Veterans Affairs to fund research on the illegal substance — which can cause cardiac complications and is listed as a Schedule I drug, on par with heroin and LSD — so it can be made legally available when appropriate.

Coincidentally, the push for less onerous standards on supplements and psychedelics would come while Kennedy is demanding “gold-standard science” to review preservatives and other food additives that he has said could play a role in the country’s high rate of chronic diseases.

“Put aside the fact that there’s precious little evidence to support” that idea, said Stuart Pape, a former FDA food center attorney. “There’s been no indication they want the same rigor for supplements and nutraceuticals.”

Although most of these products don’t have major safety concerns, “we have no idea which products work, so in the best case people are throwing away a ton of money,” Zeller said. “The worst-case scenario is they are relying on unproven products to treat underlying conditions, and time is going by when they could have been using more effective FDA-authorized products for diseases.”

Supplement makers aren’t entirely unified. Groups such as the Consumer Healthcare Products Association and the Council for Responsible Nutrition have advocated for the FDA to crack down on products that are unsafe or falsely represented. The Alliance for Natural Health and the Natural Products Association, meanwhile, largely want the government to get out of the way.

“The time has come to embrace a radical shift — from reactive disease management to proactive health cultivation, from top-down public health diktats to personalized, individual-centric care,” Emord and Verkerk state in their “MAHA Mandate.”

We’d like to speak with current and former personnel from the Department of Health and Human Services or its component agencies who believe the public should understand the impact of what’s happening within the federal health bureaucracy. Please message KFF Health News on Signal at (415) 519-8778 or get in touch here.

KFF Health 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 KFF.

In October, Stanford University professor Jay Bhattacharya hosted a conference on the lessons of covid-19 in order “to do better in the next pandemic.” He invited scholars, journalists, and policy wonks who, like him, have criticized the U.S. management of the crisis as overly draconian.

Bhattacharya also invited public health authorities who had considered his alternative approach reckless. None of them showed up.

Now, the “contrarians” are seizing the reins: President Donald Trump has nominated Bhattacharya to lead the National Institutes of Health and Johns Hopkins University surgeon Marty Makary to run the Food and Drug Administration. Yet the polarized disagreements about what worked and what didn’t in the fight against the biggest public health disaster in modern times have yet to be aired in a nonpartisan setting — and it seems unlikely they ever will be.

“The whole covid discussion turned into culture war dialogue, with one side saying, ‘I believe in the economy and liberty,’ and the other saying, ‘I believe in science and saving people’s lives,’” said Philip Zelikow, a scholar and former diplomat based at Stanford’s Hoover Institution.

Frances Lee, a Princeton University political scientist, has a book coming out that calls for a national inquiry to determine the lockdown and mandate approaches that were most effective.

“This is an open question that needs to be confronted,” she said. “Why not look back?”

For now, even with the threat of an H5N1 bird flu pandemic on the horizon, and some other plague waiting in the wings of a bat or goose in a far-flung corner of the world, U.S. public health officials face ebbing public trust as well as a disruptive new health administration led by skeptics of established medicine. On Feb. 7, the Trump administration announced devastating NIH budget cuts, although a judge put them on hold three days later.

Zelikow led the 34-member Covid Crisis Group, funded by four private foundations in 2021, whose work was intended to inform an independent inquiry along the lines of the 9/11 Commission, which Zelikow headed.

The covid group published a book detailing its findings, after Congress and the Biden administration abandoned initiatives to create a commission.

That was a shame, said Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health, because “while there are some real ideological battles over covid, there’s also lots of stuff that potentially could be fixed related to government efficiency and policy.”

Bhattacharya, Makary, and others in 2023 called for a larger study of the pandemic. It’s not known whether the Trump administration would support one, Lee said.

The new CIA director, John Ratcliffe, however, has reopened the Wuhan lab leak theory, an issue that Republicans have used to try to cast blame on Anthony Fauci, an infectious disease expert and a top covid adviser to both the first Trump and Biden administrations. Sen. Ron Johnson (R-Wis.), the new head of the Senate’s Permanent Subcommittee on Investigations, says he’ll investigate what he described as a cover-up of covid vaccine safety problems.

Bhattacharya declined to respond to questions for this article. Makary did not respond to requests for comment.

Stanford epidemiologist John Ioannidis said his colleague Bhattacharya has an opportunity to advance understanding of the pandemic.

“Until now it has been mostly a war on impressions and media, kind of mobilizing the troops. That’s not really how science should be done,” Ioannidis said. “We need to move forward with some calm reflection, with no retaliation.”

Mistakes Were Made

In October 2020, Bhattacharya co-authored the “Great Barrington Declaration” with Trump White House support. It called for people to ignore covid and go about their business while protecting the old and vulnerable — without specifics about how.

Bhattacharya and Makary championed the policies of Sweden, which did not impose a harsh lockdown but emerged with a death rate far lower than that of the United States. The Swedes had advantages including lower poverty rates, greater access to health care, and high levels of social trust. For instance, by April 2022, 87% of Swedes ages 12 and over were vaccinated against covid — without mandates. The U.S. figure, for adults over 18, was 76% at the time.

After Bhattacharya’s earlier research was rebuffed by most of the public health establishment, he “curdled into a theological position that the risk wasn’t that severe and the economic costs were so high that we had to roll the dice, or segregate the elderly — which you cannot do,” Zelikow said.

Ten experts interviewed for this article largely agreed that the health establishment lost public trust after bungling the initial handling of the pandemic. Existing pandemic plans were faulty or ignored. Shortages of protective gear and inadequate testing rendered containment of the virus impossible. As time wore on, government scientists failed to emphasize that their recommendations would change as new data came in.

“We totally blew it,” former NIH Director Francis Collins said, in a discussion sponsored by Braver Angels, a group that promotes dialogue among political opponents. Though he blamed disinformation about vaccines for many deaths, he also wished public health officials had said “we don’t know” more often.

Collins said he didn’t pay enough attention to the socioeconomic impact of lockdowns. “You attach infinite value to stopping the disease and saving a life,” he said. “You attach zero value to whether this actually totally disrupts people’s lives, ruins the economy, and has many kids kept out of school in a way that they never quite recover from.”

While Fauci and other public health officials did express worries about collateral damage from mandates, U.S. measures were stricter than in much of the world. That’s left unresolved issues, such as how long schools should have been shuttered, whether mask mandates worked, and whether the public was misled about the efficacy of vaccines.

At the same time, U.S. officials failed to communicate clearly that vaccines prevented most deaths and hospitalizations. An estimated 232,000 unvaccinated Americans died from covid during the first 15 months in which shots were freely available.

Experiences with HIV control taught public health officials not to moralize about behavior, to focus on harm reduction, and to use the least restrictive methods possible, Nuzzo said. Yet politicization led to shaming of people who wouldn’t mask or refused vaccination.

Harm reduction was top of mind for infectious disease doctor Monica Gandhi when she defied lockdown orders by keeping open Ward 86, the clinic she runs for 2,600 HIV patients at Zuckerberg San Francisco General Hospital. Her patients — many poor or homeless — had to be treated in person to keep their HIV in check, she said.

In general, the lockdowns hurt low-income people most, she said. The wealthy “were happy to be shut down, and the poor struggled and struggled.” Gandhi’s two children attended a private school that quickly reopened, she said. Yet she recalled how a medical assistant burst into tears when asked how her family was doing.

“My 8-year-old is at home, on Zoom, all by himself,” the woman told Gandhi. “I have to work and he doesn’t know how to learn that way. There’s no one to give him food.”

Despite strictures, including school closures that were longer than in most European countries, the U.S.’ death rate from covid was the highest in the world, except for Bulgaria, according to an Ioannidis study of countries with reliable data.

Part of the blame lies with the first Trump administration, which “more or less just said, ‘You states manage this crisis,’” Zelikow said. “They went through a lot of somersaults. They did a lot of feckless things and then they basically just gave up,” he said. Pandemic deaths peaked in the four months after the November 2020 election that Trump lost.

Ioannidis, a critic of lockdowns, said the United States was doomed to a bad outcome in any case because of vulnerabilities in the population including poverty, inequality, lack of health care access, poorly protected nursing homes, high rates of obesity, and low levels of trust.

But the disappearance of viral diseases such as respiratory syncytial virus and flu in late 2020 showed how much worse it could have been without lockdowns, said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, who has noted that, while children were the least vulnerable to covid, it killed 1,700 of them by April 2023. More than a million American children had had long covid as of 2022, according to a new Centers for Disease Control and Prevention study.

Consensus Never Arrived

After arising by accidental passage from bats and other animals to humans (or, alternatively, from a Chinese lab accident), the coronavirus was uncannily adept at frustrating containment efforts — and aggravating political tensions. Its ability to infect up to 50% of people asymptomatically, infection outcomes ranging from sniffles to death, waning immunity after infection and vaccination, and the shifting health impact of new variants meant “the deck was stacked against public health,” said biology professor Joshua Weitz of the University of Maryland.

In the end, teams formed along political lines. Conservatives attacked governors for depriving them of liberty, and Trump’s erroneous ramblings about curing the disease with bleach and ultraviolet light inspired intolerance on the left.

“If anyone else was president we would have had a better result,” Gandhi said. “But if Trump said the sky was blue, then goddamn it, the infection disease doctors disagreed.”

The right and left don’t even agree on the correct questions to ask about the pandemic, said Josh Sharfstein, a vice dean of the Bloomberg School of Public Health at Johns Hopkins University.

“Everyone knew that 9/11 was a terrorist attack,” he said. “But what the pandemic was and represents — there’s so much disagreement still.”

“We let children down, we let poor people down,” Ioannidis said in closing remarks at the Stanford conference. “We let our future down.”

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President Donald Trump has nominated Robert F. Kennedy Jr., an environmental lawyer with no formal medical or public health expertise, as secretary of Health and Human Sciences. Two Senate committees will question Kennedy this week on how his disproven views of science and medicine qualify him to run the $1.7 trillion, 80,000-employee federal health system.

Here are four considerations for lawmakers on the Senate Finance and Senate Health, Education, Labor and Pensions committees, which will host Kennedy for questioning on Wednesday and Thursday, respectively:

1) Kennedy’s unconventional health claims.

For decades, Kennedy has advocated for health-related ideas that are scientifically disproven or controversial. He created and was paid hundreds of thousands of dollars by Children’s Health Defense, a group that champions the false idea that vaccines cause autism and other chronic diseases and has sued to take vaccines off the market. Kennedy has said covid vaccines are the deadliest in history, antidepressants lead children to commit mass shootings, environmental contaminants may cause people to become trans, and HIV is not the only cause of AIDS. He also pushes the use of products that regulators consider dangerous, such as raw milk, and for broader use of some medicines, such as ivermectin and hydroxychloroquine, to treat conditions without FDA approval. He says public health agencies oppose their use only because of regulatory capture by big drug and food interests.

“He believes you can avoid disease if you have a healthy immune system. He sees vaccines and antibiotics as toxins,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Top Trump health nominees — Kennedy, Marty Makary for FDA commissioner, Jay Bhattacharya for National Institutes of Health director, and former U.S. Rep. Dave Weldon for Centers for Disease Control and Prevention director — are generally disdainful of the agencies they’ll be leading, Offit said.

“They think they are going to go into office, pull back the curtain, find all this bad stuff, and reveal it to the American public,” he said.

During a measles epidemic in 2019 and 2020 that killed 83 people, mostly children, in Samoa, Kennedy, as chairman of Children’s Health Defense, warned the country’s prime minister against measles vaccination. This behavior alone “is disqualifying” for an HHS nominee, said Georges Benjamin, executive director of the American Public Health Association.

Equally problematic, in Benjamin’s view, was Kennedy’s legal effort in 2021 to get the covid vaccine pulled from the market. “He can’t say he’s not anti-vax,” Benjamin said. “He wasn’t following the evidence.”

A Kennedy spokesperson did not respond to a request for comment.

2) Kennedy’s chances appear good, despite opposition.

Kennedy’s nomination has emerged in a moment when Trump is on a roll and mistrust of public health and medical authority in the wake of the pandemic has created an opening for people with unorthodox views of science to seize the reins of the country’s health system.

After former Fox News personality Pete Hegseth was confirmed as Defense secretary last week despite his controversial qualifications for the job and stark warnings from former top military brass, many Washington observers think RFK Jr. is going to be hard to defeat. In a meeting on the Hill with Democratic senators and their aides last week, Offit said, “the feeling was that he would likely be confirmed.”

Trump has demanded that Republican senators line up behind his nominees and has so far succeeded. It’s thought that Sens. Lisa Murkowski of Alaska and Susan Collins of Maine could oppose Kennedy, based on their opposition to Hegseth. Sen. Mitch McConnell (R-Ky.), the other Hegseth “nay” vote, is a polio survivor who has not spoken publicly about Kennedy but said in December that opposing “proven cures” was dangerous. Other senators whose Kennedy votes are said to be in question include Sen. Bill Cassidy (R-La.), the HELP Committee chair, a physician who gave a lukewarm response after meeting Kennedy.

Others have reported that Sens. Cory Booker (D-N.J.), who shares Kennedy’s concern with the spread of obesity and chronic illness, and Sheldon Whitehouse (D-R.I.), who attended law school with Kennedy, might vote for him. Neither senator’s office responded to a request for comment. Advancing American Freedom, a conservative advocacy group founded by former Vice President Mike Pence, has fought Kennedy’s nomination with a major ad buy.

3) The hearings are going to be heated.

Democratic senators are coming with plenty of ammunition. Sen. Elizabeth Warren (D-Mass.) sent Kennedy a 34-page letter containing 175 questions on everything from his anti-vaccine statements and actions to his waffling positions on abortion to his stances on Medicare, drug prices, and the cause of AIDS.

While public health and medical groups did not coordinate with Pence’s conservative organization, questions about Kennedy’s earlier stance in support of abortion rights could raise hackles on the GOP side of the aisle. Although his group is far from Pence on reproductive rights, Benjamin said, “if it helps derail him, I hope some senators are listening to Pence. Any shelter in a storm.”

“The hearings are going to be very difficult for him because he’s told a web of untruths as he’s marched across the offices,” said Leslie Dach, executive chair of Protect Our Care, a Democratic-aligned advocacy group.

Public opinion reflects leeriness of Kennedy on health, though not excessively. In a poll released Tuesday by KFF, 43% of respondents said they trusted him to make the right health recommendations. About 81% of Republicans in the poll said they trusted Kennedy — almost as many as trust their own doctor.

4) What happens if Kennedy takes office.

At the NIH, FDA, and other federal health agencies, nervous scientists speak of early retirement or jumping to industry should Kennedy and his agency heads take office.

The pharmaceutical industry has kept quiet on the nomination, as has the American Medical Association. Many patient advocacy groups are worried, but wary of creating friction with an administration they can’t ignore or defeat.

Kennedy’s comments on AIDS — suggesting that gay men’s use of stimulants, rather than the HIV virus, were its cause — are troubling to Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. But “I don’t know if he’s going to get confirmed or not,” he said. “If he does, we look forward to working with him and educating him.”

At the J.P. Morgan Healthcare conference earlier this month, Emma Walmsley, CEO of GSK, a leading vaccine maker, said she’d “wait and see what the facts are” before predicting what Kennedy would do. Vaccines, she noted, are “not our biggest business.”

GSK is one of a handful of vaccine makers remaining on the U.S. market. That number could shrink further if the Trump administration and Congress undo a 1986 law that provided legal protection for vaccine makers — as Kennedy has advocated.

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Dr. Josie Tenore and Paul Hinds were introduced by a mutual friend in 2017 and hadn’t been going out long when she laid down the law: He had to get a physical.

“I don’t date people who don’t take care of their health,” said Tenore, who practices cosmetic dermatology and functional medicine in suburban Chicago.

One of Hinds’ blood tests that summer came back with an alarming result: His prostate-specific antigen, or PSA, level was very high. A biopsy confirmed he had advanced prostate cancer.

There aren’t a lot of comfortable alternatives for treating prostate cancer, which generally progresses as long as testosterone levels remain high. Marijuana appears to lower testosterone levels, so after his diagnosis, Paul dosed a liquid form of cannabis for several weeks. That cut his PSA in half, but Hinds, a cybersecurity expert who likes yoga and bicycling, “was stoned out of his mind and couldn’t function,” Tenore recalled.

With Tenore guiding his decisions, Hinds next tried a procedure called high-frequency ultrasound treatment, but it failed. And in summer 2019 doctors removed his prostate gland. Still, the PSA levels climbed again, and doctors assessed that the cancer had metastasized. The only alternative was to drastically lower Hinds’ testosterone levels — either via surgery or drugs that block all testosterone. In May 2021, Paul got his first intramuscular shot of Lupron Depot, a brand name for leuprolide, designed to suppress the prostate gland’s release of the hormone for three months. That August, he got his second shot.

And then the bills came.

The Patient: Paul Hinds, now 60, is covered by United Healthcare through a COBRA plan from his former employer.

Medical Service: Two three-month Lupron Depot injections for metastatic prostate cancer.

Service Provider: University of Chicago Medicine, a 900-physician nonprofit system that includes an 811-bed medical center, a suburban hospital, the Pritzker School of Medicine, and outpatient clinics and physician offices throughout the Chicago area.

Total Bill: $73,812 for the two shots ($35,414 for the first, $38,398 for the second), including lab work and physician charges. United Healthcare’s negotiated rate for the two shots plus associated fees was $27,568, of which the insurer paid $19,567. After Hinds haggled with the hospital and insurer for more than a year, his share of the bills was determined to be nearly $7,000.

What Gives: The first issue is unrelenting price increases on old drugs that have remained branded as manufacturers find ways to extend patents for decades and maintain sales through marketing.

Though Lupron was invented in 1973, its manufacturer got patent extensions in 1989 by offering a slow-release version. Drugmakers commonly use this tactic to extend their exclusive rights to sell a product.

The development of Lupron Depot as an intramuscular shot that suppressed testosterone for months at a time improved patient compliance and also enabled its maker, Abbott Laboratories, and its Japanese partner, Takeda, to extend their patents on the drug into the 2000s, said Dr. Gerald Weisberg, a former Abbott scientist who has been critical of the company’s pricing policies.

In subsequent years, Abbott and Takeda, in a joint venture called TAP Pharmaceuticals, steadily marked up the price of their slow-release product. In 2000, the average wholesale U.S. price for a three-month shot was $1,245; currently that figure is $5,866. (It is manufactured in the U.S. by AbbVie now.)

In the United Kingdom, where health care is generally free and Takeda sells the drug under the name Prostap, all physicians can purchase a three-month dose for about $260.

It’s likely that Chicago Medicine, where Hinds got his shots, paid something close to the British price. That’s because the health system’s hospital on Chicago’s South Side participates in a federal program called 340B, which allows hospitals that serve low-income populations to purchase drugs at deep discounts.

Lupron Depot is given as a simple injection into the muscle. It takes minutes for a nurse or doctor to administer. Yet hospital systems like Chicago Medicine can and typically do charge lavishly for such services, to enhance revenue, said Morgan Henderson, principal data scientist at the Hilltop Institute at the University of Maryland-Baltimore County. Chicago Medicine declined to say what it paid for the drug.

While U.S. drugmakers can price their drugs however they please, TAP has gotten into trouble for its Lupron sales policies in the past. In 2001, after a Justice Department probe, it paid an $875 million settlement for illegally stimulating sales by giving urologists free and discounted vials of the drug while enabling them to charge Medicare full price.

Since then, many other drugs aimed at lowering testosterone levels have entered the market, including a pill, relugolix (Orgovyx). So why wouldn’t a patient use them?

Lupron Depot is long-acting, is easy to prepare and store, and employs a small needle, which some patients prefer, said Dr. Brian McNeil, chief of urology at University Hospital of Brooklyn. Orgovyx is convenient, but “a patient has to be very compliant. They have to take it every day around the same time,” he said. “Some people just forget.”

But there is another important factor that may well explain Lupron Depot’s ongoing popularity among medical providers: Doctors and hospitals can earn tens of thousands of dollars each visit by marking up its price and administration fees — as they did with Hinds. If they merely write a prescription for a drug that can be taken at home, they earn nothing.

Asked about this high patient charge and the possibility of using alternatives, United spokesperson Maria Gordon Shydlo said payment was “appropriately based on the hospital’s contract and the member’s benefit plan,” adding that the insurer encourages customers to shop around for the best quality and price.

Resolution: In addition to leaving Hinds listless, the Lupron Depot shots were, literally, a pain in the rear end. “Each time he was miserable for two weeks,” Tenore said. After looking over his first bill for the Lupron shot, Tenore told Hinds he should ask his doctor whether there was a less expensive drug that was easier to take.

After the second shot, in August 2021, a pharmacist told him he could instead receive the pill. His doctor prescribed Hinds three months’ worth of Orgovyx last November, for which he paid $216 and the insurer paid over $6,000. The drug’s list price is about $2,700 a month. There is evidence that Orgovyx works a little better than leuprolide.

Orgovyx was a “no-brainer,” Hinds said. “Why would you want a sore ass for two weeks when you can take a pill that kicks in sooner, functions the same way, and clears your body of testosterone faster?”

While Orgovyx is increasingly used for prostate cancer, Lupron and other injections usually remain the standard of care, hospital spokesperson Ashley Heher said. Clinicians “work with patients to determine what treatments are the most medically effective and, when necessary, to find reasonable alternatives that may be less financially burdensome due to insurance coverage limitations,” she said.

Hinds was baffled by the size of the charges. During months of phone calls and emails, the hospital reversed and then reapplied part of the charge, and then in July agreed to a $666.34 monthly payment plan. After Hinds had made two payments, however, the hospital announced Aug. 29 it was canceling the agreement and sending the remainder of his bill to a collection agency. Two weeks later, the hospital reinstated the payment plan — after KHN asked about the cancellation.

As for Hinds, he remains active, though his bike rides have been shortened from 50 or 60 miles to about 30, he said.

He’s grateful to have Tenore as a free consultant and empathizes with those who lack a knowledgeable guide through their disease and health care’s financial maze.

“I’ve got Dr. Josie as an advocate who knows the system,” Hinds said.

The Takeaway: First tip: If you are prescribed an infusion or injection, ask your physician if there are cheaper oral medications to treat your condition. Also, many drugs that are given by injection — ones that are given “subcutaneously,” rather than into a muscle — can be administered by a patient at home, avoiding hefty administration fees. Drugs like Dupixent for eczema fall into this category.

Keep in mind that where you get treatment could make a big difference in your charges: A study found that leading U.S. cancer centers charge enormous markups to private insurers for drug injections or infusions. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions. And the percentage of cancer infusions done in hospital-operated clinics increased from 6% in 2004 to 43% in 2014, and has grown since.

Under a law that took effect in 2021, hospitals are required to list their charges, though they currently do so in a way that is not user friendly. But it’s worth taking a look at the price list — the hospital chargemaster — to try to decipher the pricing and markup for your medicine. If you’re about to get an injection, infusion, or procedure done in a hospital system, ask ahead of time for an estimate of what you will owe.

Dan Weissmann contributed the audio portrait with this story.

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

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The availability of safe, effective covid vaccines less than a year into the pandemic marked a high point in the 300-year history of vaccination, seemingly heralding an age of protection against infectious diseases.

Now, after backlash against public health interventions culminated in President-elect Donald Trump’s nominating Robert F. Kennedy Jr., the country’s best-known anti-vaccine activist, as its top health official, infectious disease and public health experts and vaccine advocates say a confluence of factors could cause renewed, deadly epidemics of measles, whooping cough, and meningitis, or even polio.

“The litany of things that will start to topple is profound,” said James Hodge, a public health law expert at Arizona State University’s Sandra Day O’Connor College of Law. “We’re going to experience a seminal change in vaccine law and policy.”

“He’ll make America sick again,” said Lawrence Gostin, a professor of public health law at Georgetown University.

State legislators who question vaccine safety are poised to introduce bills to weaken school-entry vaccine requirements or do away with them altogether, said Northe Saunders, who tracks vaccine-related legislation for the SAFE Communities Coalition, a group supporting pro-vaccine legislation and lawmakers.

Even states that keep existing requirements will be vulnerable to decisions made by a Republican-controlled Congress as well as by Kennedy and former House member Dave Weldon, should they be confirmed to lead the Department of Health and Human Services and the Centers for Disease Control and Prevention, respectively.

Both men — Kennedy as an activist, Weldon as a medical doctor and congressman from 1995 to 2009— have endorsed debunked theories blaming vaccines for autism and other chronic diseases. (Weldon has been featured in anti-vaccine films in the years since he left Congress.) Both have accused the CDC of covering up evidence this was so, despite dozens of reputable scientific studies to the contrary.

Kennedy’s staff did not respond to requests for comment. Karoline Leavitt, the Trump campaign’s national press secretary, did not respond to requests for comment or interviews with Kennedy or Weldon.

Kennedy recently told NPR that “we’re not going to take vaccines away from anybody.”

It’s unclear how far the administration would go to discourage vaccination, but if levels drop enough, vaccine-preventable illnesses and deaths might soar.

“It is a fantasy to think we can lower vaccination rates and herd immunity in the U.S. and not suffer recurrence of these diseases,” said Gregory Poland, co-director of the Atria Academy of Science & Medicine. “One in 3,000 kids who gets measles is going to die. There’s no treatment for it. They are going to die.”

During a November 2019 measles epidemic that killed 80 children in Samoa, Kennedy wrote to the country’s prime minister falsely claiming that the measles vaccine was probably causing the deaths. Scott Gottlieb, who was Trump’s first FDA commissioner, said on CNBC on Nov. 29 that Kennedy “will cost lives in this country” if he undercuts vaccination.

Kennedy’s nomination validates and enshrines public mistrust of government health programs, said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

“The notion that he’d even be considered for that position makes people think he knows what he’s talking about,” Offit said. “He appeals to lessened trust, the idea that ‘There are things you don’t see, data they don’t present, that I’m going to find out so you can really make an informed decision.’”

Targets of Anti-Vaccine Groups

Hodge has compiled a list of 20 actions the administration could take to weaken national vaccination programs, from spreading misinformation to delaying FDA vaccine approvals to dropping Department of Justice support for vaccine laws challenged by groups like Children’s Health Defense, which Kennedy founded and led before campaigning for president.

Kennedy could also cripple the National Vaccine Injury Compensation Program, which Congress created in 1986 to take care of children believed harmed by vaccines — while partially protecting vaccine makers from lawsuits.

Before the law passed, the threat of lawsuits had shrunk the number of companies making vaccines in the United States — from 26 in 1967 to 17 in 1980 — and the remaining pertussis vaccine producers were threatening to stop making it. The vaccine injury program “played an integral role in keeping manufacturers in the business,” Poland said.

Kennedy could abolish the CDC’s Advisory Committee on Immunization Practices, whose recommendation for using a vaccine determines whether the government pays for it through the 30-year-old Vaccines for Children program, which makes free immunizations available to more than half the children in the United States. Alternatively, Kennedy could stack the committee with allies who oppose new vaccines, and could, in theory at least, withdraw recommendations for vaccines like the 53-year-old measles-mumps-rubella shot, a favorite target of the anti-vaccine movement.

Meanwhile, infectious disease threats are on the rise or on the horizon. Instead of preparing, as a typical incoming administration might, Kennedy has threatened to shake up the federal health agencies. Once in office, he’ll “give infectious disease a break” to focus on chronic ailments, he said at a Children’s Health Defense conference last month in Georgia.

The H5N1 virus, or bird flu, that has spread through cattle herds and infected at least 55 people could erupt in a new pandemic, and other threats like mosquito-borne dengue fever are rising in the U.S.

Traditional childhood diseases are also making their presence felt, in part because of neglected vaccination. The U.S. has seen 16 measles outbreaks this year — 89% of cases are in unvaccinated people — and a whooping cough epidemic is the worst since 2012.

“So that’s how we’re starting out,” said Peter Hotez, a pediatrician and virologist at the Baylor College of Medicine. “Then you throw into the mix one of the most outspoken and visible anti-vaccine activists at the head of HHS, and that gives me a lot of concern.”

The share prices of drug companies with big vaccine portfolios have plunged since Kennedy’s nomination. Even before Trump’s victory, vaccine exhaustion and skepticism had driven down demand for newer vaccines like GSK’s RSV and shingles shots.

Kennedy has ample options to slow or stop new vaccine releases or to slow sales of existing vaccines — for example, by requiring additional post-market studies or by highlighting questionable studies that suggest safety risks.

Kennedy, who has embraced conspiracy theories such as that HIV does not cause AIDS and that pesticides cause gender dysphoria, told NPR there are “huge deficits” in vaccine safety research. “We’re going to make sure those scientific studies are done and that people can make informed choices,” he said.

Kennedy’s nomination “bodes ill for the development of new vaccines and the use of currently available vaccines,” said Stanley Plotkin, a vaccine industry consultant and inventor of the rubella vaccine in the 1960s. “Vaccine development requires millions of dollars. Unless there is prospect of profit, commercial companies are not going to do it.”

Vaccine advocates, with less money on hand than the better-funded anti-vaccine advocates, see an uphill battle to defend vaccination in courts, legislatures, and the public square. People are rarely inclined to celebrate the absence of a conquered illness, making vaccines a hard sell even when they are working well.

While many wealthy people, including potion and supplement peddlers, have funded the anti-vaccine movement, “there hasn’t been an appetite from science-friendly people to give that kind of money to our side,” said Karen Ernst, director of Voices for Vaccines.

‘He’s Serious as Hell’

“RFK Jr. was a punch line for a lot of people, but he’s serious as hell,” Ernst said. “He has a lot of power, money, and a vast network of anti-vaccine parents who’ll show up at a moment’s notice.” That’s not been the case with groups like hers, Ernst said.

On Oct. 22, when an Idaho health board voted to stop providing covid vaccines in six counties, there were no vaccine advocates at the meeting. “We didn’t even know it was on the agenda,” Ernst said. “Mobilization on our side is always lagging. But I’m not giving up.”

The kaleidoscopic change has been jarring for Walter Orenstein, who persuaded states to tighten school mandates to fight measles outbreaks as head of the CDC’s immunization division from 1988 to 2004.

“People don’t understand the concept of community protection, and if they do they don’t seem to care,” said Orenstein, who saw some of the last cases of smallpox as a CDC epidemiologist in India in the 1970s, and frequently cared for children with meningitis caused by H. influenzae type B bacteria, a disease that has mostly disappeared because of a vaccine introduced in 1987.

“I was so naïve,” he said. “I thought that covid would solidify acceptance of vaccines, but it was the opposite.”

Lawmakers opposed to vaccines could introduce legislation to remove school-entry requirements in nearly every state, Saunders said. One bill to do this has been introduced in Texas, where what’s known as the vaccine choice movement has been growing since 2015 and took off during the pandemic, fusing with parents’ rights and anti-government groups opposed to measures like mandatory shots and masking.

“The genie is out of the bottle, and you can’t put it back in,” said Rekha Lakshmanan, chief strategy officer at the Immunization Partnership in Texas. “It’s become this multiheaded thing that we’re having to reckon with.”

In the last full school year, more than 100,000 Texas public school students were exempted from one or more vaccinations, she said, and many of the 600,000 homeschooled Texas kids are also thought to be unvaccinated.

In Louisiana, the state surgeon general distributed a form letter to hospitals exempting medical professionals from flu vaccination, claiming the vaccine is unlikely to work and has “real and well established” risks. Research on flu vaccination refutes both claims.

The biggest threat to existing vaccination policies could be plans by the Trump administration to remove civil service protections for federal workers. That jeopardizes workers at federal health agencies whose day-to-day jobs are to prepare for and fight diseases and epidemics. “If you overturn the administrative state, the impact on public health will be long-term and serious,” said Dorit Reiss, a professor at the University of California’s Hastings College of Law.

Billionaire Elon Musk, who has the ear of the incoming president, imagines cost-cutting plans that are also seen as a threat.

“If you damage the core functions of the FDA, it’s like killing the goose that laid the golden egg, both for our health and for the economy,” said Jesse Goodman, the director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University and a former chief science officer at the FDA. “It would be the exact opposite of what Kennedy is saying he wants, which is safe medical products. If we don’t have independent skilled scientists and clinicians at the agency, there’s an increased risk Americans will have unsafe foods and medicine.”

Outbreaks of vaccine-preventable illness could be alarming, but would they be enough to boost vaccination again? Ernst of Voices for Vaccines isn’t sure.

“We’re already having outbreaks. It would take years before enough children died before people said, ‘I guess measles is a bad thing,’” she said. “One kid won’t be enough. The story they’ll tell is, ‘There was something wrong with that kid. It can’t happen to my kid.’”

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Many scientists at the federal health agencies await the second Donald Trump administration with dread as well as uncertainty over how the president-elect will reconcile starkly different philosophies among the leaders of his team.

Trump announced Thursday he’ll nominate Robert F. Kennedy Jr. to be secretary of the Health and Human Services Department, after saying during his campaign he’d let the anti-vaccine activist “go wild” on medicines, food, and health.

Should Kennedy win Senate confirmation, his critics say a radical antiestablishment medical movement with roots in past centuries would take power, threatening the achievements of a science-based public health order painstakingly built since World War II.

Trump said in a post on the social platform X that “Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,” echoing Kennedy’s complaints about the medical establishment. The former Democratic presidential candidate will “end the Chronic Disease epidemic” and “Make American Great and Healthy Again!” Trump wrote.

Vaccine makers’ stocks dipped Thursday afternoon amid news reports ahead of Trump’s RFK announcement.

If Kennedy makes good on his vision for transforming public health, childhood vaccine mandates could wither. New vaccines might never win approval, even as the FDA allows dangerous or inefficient therapies onto the market. Agency websites could trumpet unproven or debunked health ideas. And if Trump’s plan to weaken civil service rights goes through, anyone who questions these decisions could be summarily fired.

“Never has anybody like RFK Jr. gotten anywhere close to the position he may be in to actually shape policy,” said Lewis Grossman, a law professor at American University and the author of “Choose Your Medicine,” a history of U.S. public health.

Kennedy and an adviser Calley Means, a health care entrepreneur, say dramatic changes are needed because of the high levels of chronic disease in the United States. Government agencies have corruptly tolerated or promoted unhealthy diets and dangerous drugs and vaccines, they say.

Means and Kennedy did not respond to requests for comment. Four conservative members of the first Trump health bureaucracy spoke on condition of anonymity. They eagerly welcomed the former president’s return but voiced few opinions about specific policies. Days after last week’s election, RFK Jr. announced that the Trump administration would immediately fire and replace 600 National Institutes of Health officials. He set up a website seeking crowdsourced nominees for federal appointments, with a host of vaccination foes and chiropractors among the early favorites.

At meetings last week at Mar-a-Lago involving Elon Musk, Tucker Carlson, Donald Trump Jr., Kennedy, and Means, according to Politico, some candidates for leading health posts included Jay Bhattacharya, a Stanford University scientist who opposed covid lockdowns; Florida Surgeon General Joseph Ladapo, who opposes mRNA covid vaccines and rejected well-established disease control practices during a measles outbreak; Johns Hopkins University surgeon Marty Makary; and Means’ sister, Stanford-trained surgeon and health guru Casey Means.

All are mavericks of a sort, though their ideas are not uniform. Yet the notion that they could elbow aside a century of science-based health policy is profoundly troubling to many health professionals. They see Kennedy’s presence at the heart of the Trump transition as a triumph of the “medical freedom” movement, which arose in opposition to the Progressive Era idea that experts should guide health care policy and practices.

It could represent a turning away from the expectation that mainstream doctors be respected for their specialized knowledge, said Howard Markel, an emeritus professor of pediatrics and history at the University of Michigan, who began his clinical career treating AIDS patients and ended it after suffering a yearlong bout of long covid.

“We’ve gone back to the idea of ‘every man his own doctor,’” he said, referring to a phrase that gained currency in the 19th century. It was a bad idea then and it’s even worse now, he said.

“What does that do to the morale of scientists?” Markel asked. The public health agencies, largely a post-WWII legacy, are “remarkable institutions, but you can screw up these systems, not just by defunding them but by deflating the true patriots who work in them.”

FDA Commissioner Robert Califf told a conference on Nov. 12 that he worried about mass firings at the FDA. “I’m biased, but I feel like the FDA is sort of at peak performance right now,” he said. At a conference the next day, CDC Director Mandy Cohen reminded listeners of the horrors of vaccine-preventable diseases like measles and polio. “I don’t want to have to see us go backward in order to remind ourselves that vaccines work,” she said.

Stocks of some the biggest vaccine developers fell after news outlets led by Politico reported that the RFK pick was expected. Moderna, the developer of one of the most popular covid-19 vaccines, closed down 5.6%. Pfizer, another covid vaccine manufacturer, fell 2.6%. GSK, the producer of vaccines protecting against respiratory syncytial virus, hepatitis A and B, rotavirus, and influenza, fell just over 2%. French drug company Sanofi, whose website boasts its products vaccinate over 500 million annually, tumbled nearly 3.5%.

Exodus From the Agencies?

With uncertainty over the direction of their agencies, many older scientists at the NIH, FDA, and Centers for Disease Control and Prevention are considering retirement, said a senior NIH scientist who spoke on the condition of anonymity for fear of losing his job.

“Everybody I talk to sort of takes a deep breath and says, ‘It doesn’t look good,’” the official said.

“I hear of many people getting CVs ready,” said Arthur Caplan, a professor of bioethics at New York University. They include two of his former students who now work at the FDA, Caplan said.

Others, such as Georges Benjamin, executive director of the American Public Health Association, have voiced wait-and-see attitudes. “We worked with the Trump administration last time. There were times things worked reasonably well,” he said, “and times when things were chaotic, particularly during covid.” Any wholesale deregulation efforts in public health would be politically risky for Trump, he said, because when administrations “screw things up, people get sick and die.”

At the FDA, at least, “it’s very hard to make seismic changes,” former FDA chief counsel Dan Troy said.

But the administration could score easy libertarian-tinged wins by, for example, telling its new FDA chief to reverse the agency’s refusal to approve the psychedelic drug MDMA from the company Lykos. Access to psychedelics to treat post-traumatic stress disorder has grabbed the interest of many veterans. Vitamins and supplements, already only lightly regulated, will probably get even more of a free pass from the next Trump FDA.

‘Medical Freedom’ or ‘Nanny State‘

Trump’s health influencers are not monolithic. Analysts see potential clashes among Kennedy, Musk, and more traditional GOP voices. Casey Means, a “holistic” MD at the center of Kennedy’s “Make America Healthy Again” team, calls for the government to cut ties with industry and remove sugar, processed food, and toxic substances from American diets. Republicans lampooned such policies as exemplifying a “nanny state” when Mike Bloomberg promoted them as mayor of New York City.

Both the libertarian and “medical freedom” wings oppose aspects of regulation, but Silicon Valley biotech supporters of Trump, like Samuel Hammond of the Foundation for American Innovation, have pressed the agency to speed drug and device approvals, while Kennedy’s team says the FDA and other agencies have been “captured” by industry, resulting in dangerous and unnecessary drugs, vaccines, and devices on the market.

Kennedy and Casey Means want to end industry user fees that pay for drug and device rules and support nearly half the FDA’s $7.2 billion budget. It’s unclear whether Congress would make up the shortfall at a time when Trump and Musk have vowed to slash government programs. User fees are set by laws Congress passes every five years, most recently in 2022.

The industry supports the user-fee system, which bolsters FDA staffing and speeds product approvals. Writing new rules “requires an enormous amount of time, effort, energy, and collaboration” by FDA staff, Troy said. Policy changes made through informal “guidance” alone are not binding, he added.

Kennedy and the Means siblings have suggested overhauling agricultural policies so that they incentivize the cultivation of organic vegetables instead of industrial corn and soy, but “I don’t think they’ll be very influential in that area,” Caplan said. “Big Ag is a powerful entrenched industry, and they aren’t interested in changing.”

“There’s a fine line between the libertarian impulse of the ‘medical freedom’ types and advocating a reformation of American bodies, which is definitely ‘nanny state’ territory,” said historian Robert Johnston of the University of Illinois-Chicago.

Specific federal agencies are likely to face major changes. Republicans want to trim the NIH’s 27 research institutes and centers to 15, slashing Anthony Fauci’s legacy by splitting the National Institute of Allergy and Infectious Diseases, which he led for 38 years, into two or three pieces.

Numerous past attempts to slim down the NIH have failed in the face of campaigns by patients, researchers, and doctors. GOP lawmakers have advocated substantial cuts to the CDC budget in recent years, including an end to funding gun violence, climate change, and health equity research. If carried out, Project 2025, a policy blueprint from the conservative Heritage Foundation, would divide the agency into data-collecting and health-promoting arms. The CDC has limited clout in Washington, although former CDC directors and public health officials are defending its value.

“It would be surprising if CDC wasn’t on the radar” for potential change, said Anne Schuchat, a former principal deputy director of the agency, who retired in 2021.

The CDC’s workforce is “very employable” and might start to look for other work if “their area of focus is going to be either cut or changed,” she said.

Kennedy’s attacks on HHS and its agencies as corrupted tools of the drug industry, and his demands that the FDA allow access to scientifically controversial drugs, are closely reminiscent of the 1970s campaign by conservative champions of Laetrile, a dangerous and ineffective apricot-pit derivative touted as a cancer treatment. Just as Kennedy championed off-patent drugs like ivermectin and hydroxychloroquine to treat covid, Laetrile’s defenders claimed that the FDA and a profit-seeking industry were conspiring to suppress a cheaper alternative.

The public and industry have often been skeptical of health regulatory agencies over the decades, Grossman said. The agencies succeed best when they are called in to fix things — particularly after bad medicine kills or damages children, he said.

The 1902 Biologics Control Act, which created the NIH’s forerunner, was enacted in response to smallpox vaccine contamination that killed at least nine children in Camden, New Jersey. Child poisonings linked to the antifreeze solvent for a sulfa drug prompted the modern FDA’s creation in 1938. The agency, in 1962, acquired the power to demand evidence of safety and efficacy before the marketing of drugs after the thalidomide disaster, in which children of pregnant women taking the anti-nausea drug were born with terribly malformed limbs.

If vaccination rates plummet and measles and whooping cough outbreaks proliferate, babies could die or suffer brain damage. “It won’t be harmless for the administration to broadly attack public health,” said Alfredo Morabia, a professor of epidemiology at Columbia University and the editor-in-chief of the American Journal of Public Health. “It would be like taking away your house insurance.”

Sam Whitehead, Stephanie Armour, David Hilzenrath, and Darius Tahir contributed to this report.

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Last year alone, David Mitchell paid $16,525 for 12 little bottles of Pomalyst, one of the pricey medications that treat his multiple myeloma, a blood cancer he was diagnosed with in 2010.

The drugs have kept his cancer at bay. But their rapidly increasing costs so infuriated Mitchell that he was inspired to create an advocacy movement.

Patients for Affordable Drugs, which he founded in 2016, was instrumental in getting drug price reforms into the 2022 Inflation Reduction Act. Those changes are kicking in now, and Mitchell, 73, is an early beneficiary.

In January, he plunked down $3,308 for a Pomalyst refill “and that’s it,” he said. Under the law, he has no further responsibility for his drug costs this year — a savings of more than $13,000.

The law caps out-of-pocket spending on brand-name drugs for Medicare beneficiaries at about $3,500 in 2024. The patient cap for all drugs drops to $2,000 next year.

“From a selfish perspective, I feel great about it,” he said. But the payment cap will be “truly life-changing” for hundreds of thousands of other Medicare patients, Mitchell said.

President Joe Biden’s battle against high drug prices is mostly embodied in the IRA, as the law is known — a grab bag of measures intended to give Medicare patients immediate relief and, in the long term, to impose government controls on what pharmaceutical companies charge for their products. The law represents the most significant overhaul for the U.S. drug marketplace in decades.

With Election Day on the horizon, the president is trying to make sure voters know who was responsible. This month, the White House began a campaign to get the word out to seniors.

“The days where Americans pay two to three times what they pay for prescription drugs in other countries are ending,” Biden said in a Feb. 1 statement.

KFF polling indicates Biden has work to do. Just a quarter of adults were aware that the IRA includes provisions on drug prices in July, nearly a year after the president signed it. He isn’t helped by the name of the law, the “Inflation Reduction Act,” which says nothing about health care or drug costs.

Biden’s own estimate of drug price inflation is quite conservative: U.S. patients sometimes pay more than 10 times as much for their drugs compared with people in other countries. The popular weight loss drug Wegovy lists for $936 a month in the U.S., for example — and $83 in France.

Additional sections of the law provide free vaccines and $35-a-month insulin and federal subsidies to patients earning up to 150% of the federal poverty level, and require drugmakers to pay the government rebates for medicines whose prices rise faster than inflation. But the most controversial provision enables Medicare to negotiate prices for certain expensive drugs that have been on the market for at least nine years. It’s key to Biden’s attempt to weaken the drug industry’s grip.

Responding to Pressure

The impact of Medicare’s bargaining over drug prices for privately insured Americans remains unclear. States have taken additional steps, such as cutting copays for insulin for the privately insured.

However, insurers are increasing premiums in response to their higher costs under the IRA. Monthly premiums on traditional Medicare drug plans jumped to $48 from $40 this year, on average.

On Feb. 1, the Centers for Medicare & Medicaid Services sent pharmaceutical makers opening bids for the first 10 expensive drugs it selected for negotiation. The companies are responding to the bids — while filing nine lawsuits that aim to kill the negotiations altogether, arguing that limiting their profits will strangle the pipeline of lifesaving drugs. A federal court in Texas dismissed one of the suits on Feb. 12, without taking up the substantive legal issue over constitutionality.

The nonpartisan Congressional Budget Office predicted the IRA’s drug pricing elements would save the federal government $237 billion over 10 years while reducing the number of drugs coming to market in that period by about two.

If the government prevails in the courts, new prices for those 10 drugs will be announced by September and take effect in 2026. The government will negotiate an additional 15 drugs for 2027, another 15 for 2028, and 20 more each year thereafter. CMS has been mum about the size of its offers, but AstraZeneca CEO Pascal Soriot on Feb. 8 called the opening bid for his company’s drug Farxiga (which earned $2.8 billion in U.S. sales in fiscal year 2023) “relatively encouraging.”

Related Biden administration efforts, as well as legislation with bipartisan support, could complement the Inflation Reduction Act’s swing at drug prices.

The House and Senate have passed bills that require greater transparency and less self-serving behavior by pharmacy benefit managers, the secretive intermediaries that decide which drugs go on patients’ formularies, the lists detailing which prescriptions are available to health plan enrollees. The Federal Trade Commission is investigating anti-competitive action by leading PBMs, as well as drug company patenting tricks that slow the entry of cheaper drugs to the market.

‘Sending a Message’

Months after drug companies began suing to stop price negotiations, the Biden administration released a framework describing when it could “march in” and essentially seize drugs created through research funded by the National Institutes of Health if they are unreasonably priced.

The timing of the march-in announcement “suggests that it’s about sending a message” to the drug industry, said Robin Feldman, who leads the Center for Innovation at the University of California Law-San Francisco. And so, in a way, does the Inflation Reduction Act itself, she said.

“I have always thought that the IRA would reverberate well beyond the unlucky 10 and others that get pulled into the net later,” Feldman said. “Companies are likely to try to moderate their behavior to stay out of negotiations. I think of all the things going on as attempts to corral the market into more reasonable pathways.”

The IRA issues did not appear to be top of mind to most executives and investors as they gathered to make deals at the annual J.P. Morgan Healthcare Conference in San Francisco last month.

“I think the industry is navigating its way beyond this,” said Matthew Price, chief operating officer of Promontory Therapeutics, a cancer drug startup, in an interview there. The drugs up for negotiation “look to be assets that were already nearing the end of their patent life. So maybe the impact on revenues is less than feared. There’s alarm around this, but it was probably inevitable that a negotiation mechanism of some kind would have to come in.”

Investors generally appear sanguine about the impact of the law. A recent S&P Global report suggests “healthy revenue growth through 2027” for the pharmaceutical industry.

Back in Washington, many of the changes await action by the courts and Congress and could be shelved depending on the results of the fall election.

The restructuring of Medicare Part D, which covers most retail prescription drugs, is already lowering costs for many Medicare patients who spent more than $3,500 a year on their Part D drugs. In 2020 that was about 1.3 million patients, 200,000 of whom spent $5,000 or more out-of-pocket, according to KFF research.

“That’s real savings,” said Tricia Neuman, executive director of KFF’s Medicare policy program, “and it’s targeted to people who are really sick.”

Although the drug industry is spending millions to fight the IRA, the Part D portion of the bill could end up boosting their sales. While it forces the industry to further discount the highest-grossing drugs, the bill makes it easier for Medicare patients to pick up their medicines because they’ll be able to afford them, said Stacie Dusetzina, a Vanderbilt University School of Medicine researcher. She was the lead author of a 2022 study showing that cancer patients who didn’t get income subsidies were about half as likely to fill prescriptions.

States and foundations that help patients pay for their drugs will save money, enabling them to procure more drugs for more patients, said Gina Upchurch, the executive director of Senior PharmAssist, a Durham, North Carolina-based drug assistance program, and a member of the Medicare Payment Advisory Commission. “This is good news for the drug companies,” she said.

Relief for Patients

Lynn Scarfuto, 73, a retired nurse who lives on a fixed income in upstate New York, spent $1,157 for drugs last year, while most of her share of the $205,000 annual cost for the leukemia drug Imbruvica was paid by a charity, the Patient Access Network Foundation. This year, through the IRA, she’ll pay nothing because the foundation’s first monthly Imbruvica payment covered her entire responsibility. Imbruvica, marketed jointly by AbbVie and Janssen, a subsidiary of Johnson & Johnson, is one of the 10 drugs subject to Medicare negotiations.

“For Medicare patients, the Inflation Reduction Act is a great, wonderful thing,” Scarfuto said. “I hope the negotiation continues as they have promised, adding more drugs every year.”

Mitchell, a PR specialist who had worked with such clients as the Campaign for Tobacco-Free Kids and pharmaceutical giant J&J, went to an emergency room with severe back pain in November 2010 and discovered he had a cancer that had broken a vertebra and five ribs and left holes in his pelvis, skull, and forearm bones. He responded well to surgery and treatment but was shocked at the price of his drugs.

His Patients for Affordable Drugs group has become a powerful voice in Washington, engaging tens of thousands of patients, including Scarfuto, to tell their stories and lobby legislatures. The work is supported in part by millions in grants from Arnold Ventures, a philanthropy that has supported health care policies like lower drug prices, access to contraception, and solutions to the opioid epidemic.

“What got the IRA over the finish line in part was angry people who said we want something done with this,” Mitchell said. “Our patients gave voice to that.”

Arnold Ventures has provided funding for KFF Health News.

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