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

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

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

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

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

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

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

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

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

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

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

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

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

A Patchwork of Perspectives

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

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

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

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

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

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

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

Noah the Speller

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

And the Trump administration has taken notice.

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

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

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

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

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

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

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

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

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

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

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

A Mixed Reputation

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

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

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

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

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

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

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

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

Compatriots Grow Skeptical

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

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

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

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

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

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

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

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

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

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

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

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

The Big Controversy

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

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

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

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

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

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

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

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

The Danish Influence in America

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

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

Ackman did not respond to requests for comment.

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

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

Aaby’s History

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Makary did not respond to requests for comment.

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

A Doomed Cancer Drug

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

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

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

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

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

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

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

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

Vinay Prasad’s Final Days at FDA

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

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

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

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

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

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

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

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

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

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

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No surprise. About are “worried about being able to afford prescription drug costs for themselves or their families,” a recent 麻豆女优 nationwide poll showed. More than 80% consider the price of prescription drugs “unreasonable,” and most support increased regulation to lower costs. Americans pay about three times as much as people in other countries for the same prescription drugs.

Last July, Trump sent letters to 17 drugmakers, demanding they voluntarily lower drug prices. Then the president said he’d negotiated one by one at the White House. In December, that he had compelled them to agree to on Medicaid, the government coverage for low-income Americans.

Then came the , a site where cash-paying patients could find discounted medicines, and a promise to speed biosimilar products — generic versions of certain high-priced specialty drugs — by cutting through FDA red tape.

The scope of these grand gestures remains uncertain. But it’s certainly less than what the announcement promised, partly because many details of the negotiations, even which drugs are covered, are hazy.

White House spokesperson Kush Desai did not answer queries about TrumpRx.

Medicaid already buys drugs at deep discounts. And other patients may well have better options through commercial drug discount programs, which offer far more products, or through their insurance and associated drug company copayment cards.

So, for all Trump’s showmanship, the share of Americans likely to benefit from these options remains slim, even if some people do come out ahead.

“If it makes a difference to any patient, it’s a win,” said Mark Cuban, a billionaire investor on his own mission to bring down drug prices. He pointed to discounted pricing on TrumpRx for branded fertility drugs and GLP-1 weight loss drugs for people without insurance or whose plans don’t include coverage. Cuban launched the Mark Cuban Cost Plus Drug Co., known as Cost Plus Drugs, in 2022 to sell drugs cheaply by eliminating middlemen — buying from factories and selling directly to consumers. Most of the drugs he sells are generics.

Aaron Kesselheim, a professor of medicine at Harvard Medical School whose research focuses on drug prices, said the Trump announcements are “one-off agreements made for publicity purposes. They don’t change anything about the way drugs are priced.”

He added: “The agreements are opaque and unenforceable.”

It was unclear, for example, which drugs would be sold at “most favored nation” prices or how exactly that was defined. But, clearly, not all were.

Doing the Math

46brooklyn, a consulting firm and data project that tracks brand-name drug prices, found that close to 1,000 brand drugs went up in price in January 2026. What’s more, 2025 had the highest number of list price increases ever. “This is not a material change, it’s business as usual,” said Antonio Ciaccia, the company’s co-founder.

In the first week of 2026, Pfizer raised the list prices of 71 drugs by an average of 5% and lowered the price of only one, by 9.8%, the data project found.

The biggest win for patients has likely been the Trump administration’s quiet continuation of a Biden administration program: Medicare drug price negotiation for expensive drugs. The negotiated discounts on the — from blood thinners to insulins to medicines for inflammatory disorders — went into effect Jan. 1. With reductions in price of on some products, the estimated $6 billion in annual savings allowed the program to cap Medicare patients’ out-of-pocket spending on Part D prescription drugs at $2,000 for 2025 and beyond.

An additional 15 high-priced drugs — including popular weight loss and cancer drugs — were subject to negotiation in 2025, with discounted Medicare prices taking effect next year. And 15 more high-priced drugs are . All told, the 40 negotiated drug prices are expected to save Medicare well over $20 billion a year.

Even as these discounts take effect, drug industry lobbyists have been working to limit the impact, with some success. For example, the One Big Beautiful Bill Act from negotiations.

Still, “this is historic because it’s the first time the United States has negotiated prices, like every other developed country,” Kesselheim said. “And guess what? Innovation didn’t stop.”

Of course, these discounts benefit only Medicare enrollees. The newer Trump administration initiatives help some other patients, but they are limited and require knowledge of how to access the discounts.

Trump’s One-on-Ones

The president’s televised appearances with the heads of major drug companies resulted in deals, but few, if any, will mean much to patients. For example, after Trump met with Albert Bourla, CEO of Pfizer, the company announced discounts on 30-plus drugs. Bourla “a win for American patients, a win for American leadership, and a win for Pfizer.”

The discounts are offered via TrumpRx, which, in turn, offer coupons co-branded on GoodRx.com, which already offers discount coupons for many hundreds of medicines.

Pfizer made hay of the deal, announcing it was part of Pfizer’s broader, landmark with the U.S. government, enabling patients to pay lower prices for their prescription medicines “while strengthening America’s role as the global leader in biopharmaceutical innovation.”

Pfizer spokesperson Steven Danehy cited a press release from September noting that the TrumpRx site offers patients savings that “range as high as 85%.”

Most of the list features brand-name drugs, competing with far cheaper generic versions from other manufacturers, such as the cholesterol-lowering drug Colestid, which TrumpRx lists for “50% off” at $127.91. Generic versions cost about $17 on the Cost Plus site.

This means the branded companies aren’t making a sacrifice by offering them at lower costs as reflected on Trump’s portal, said Sean Tu, a patent law expert at the University of Alabama. “That’s a sale they would not have made if not for TrumpRx.”

Others are very old drugs, such as Cortef, or hydrocortisone, whose 5-milligram branded Pfizer version is listed at $45 on TrumpRx, half its list price of $91.80. It sells for far less on Cuban’s Cost Plus site. Still others, such as the $607.20 HIV treatment Viracept, are useful only in combination with other drugs that are not discounted.

Last week, TrumpRx added AbbVie’s Humira, for years the world’s best-selling drug, at $950 a dose, down from a list price of nearly $7,000. But Humira lost its patent protection in 2023, and biosimilars — essentially generic equivalents — have since come to market. More to the point, two of those biosimilars are listed on TrumpRx for as little as $207.60 a dose.

Since most of the TrumpRx products are available only to customers without insurance who pay cash, the arthritis drug Xeljanz’s drop from $2,277 to $1,518 a month would still leave it unaffordable.

A Few Notable Deals

The much-touted TrumpRx site, launched Feb. 6, consists largely of Pfizer’s 30 drugs (30 of roughly 85) with a smattering of discounts likely to generate headlines.

These include three fertility drugs from EMD Serono, a subsidiary of the pharmaceutical giant Merck KGaA, the most expensive of which, Gonal-F, has a list price of $966 but is only $168 per IVF cycle using a TrumpRx coupon.

They will save women thousands of dollars — although the overall cost of fertility treatment will continue to put them beyond the reach of many, since drugs represent only a portion of the payment.

The TrumpRx discounts could reduce the $15,000-to-$25,000 cost of a single fertility treatment cycle — women typically need two or three cycles to become pregnant — by about 10%, said Sean Tipton, spokesperson for the American Society for Reproductive Medicine. In some European countries, each cycle costs about $3,000.

In exchange for lowering those prices, EMD Serono got tariffs lifted on its mostly overseas-produced medications. It also won the right to a sped-up FDA approval process for a fertility drug it’s been marketing heavily in Europe.

Another newsworthy offering on the site resulted from a deal with Novo Nordisk for Wegovy, its GLP-1 drug for weight loss and diabetes, with the price reduced to as little as $199 a month for the pen. (Many insurers cover such drugs only for diabetes, leaving those who are interested in losing weight paying out-of-pocket. Zepbound, Wegovy’s Lilly & Co. competitor, is also on the list, at $299.)

Pressure has been building on Novo and Lilly to lower the U.S. price of their GLP-1 drugs. The compounds have lost patent protection in India, and pressure from customers buying overseas will likely increase when generic Wegovy goes on sale in Canada, for as low as $73 a month, possibly this year.

In the United States, meanwhile, dozens of patents should keep Wegovy generics off the market until 2039, said professor Robin Feldman, a patent expert at the University of California Law-San Francisco. A from the research group I-Mak delved into several ways patent manipulation keeps generics off the U.S. market long after they are available in European countries and Canada.

And while the Trump administration has vowed to approve biosimilars more rapidly to ensure more competition and lower prices, that may not have much impact. The big hurdle in getting generics and biosimilars to market is often not FDA approval, but the time it takes to override the thickets of patents that U.S. law allows manufacturers to deploy to protect their intellectual property.

For example, in 2021, the FDA approved a generic of Otezla, a popular drug for psoriatic arthritis, but it will not hit the market until 2028. Its entry would to Medicare if they charged the program more than other developed countries for “single source” drugs and biologics. That would essentially allow the Medicare program to piggyback on other countries that negotiate the prices of some of the most expensive medicines. Those programs are still going through the rulemaking process and, again, would benefit only those covered by the Medicare program and only indirectly.

The average patient-consumer, if willing to pay cash, may find some bargains. But getting the best deal could take a lot of mixing and matching, forcing patients to become choosy shoppers, eyeing deals for essential medicines as they would for a carton of milk or eggs.

Data reporter Maia Rosenfeld contributed to this article.

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When federal immigration agents descended on their city, officers deported Gabi’s father and detained her aunt.

Gabi was born in the U.S. and is an American citizen. Her best chance to stand, or even walk, someday is a complex surgery on her legs and feet that was scheduled for January. But her mother, too terrified to take out the garbage let alone venture through the city to a hospital, canceled the procedure. 麻豆女优 Health News agreed to only partially identify the patients and their families in this article because they fear becoming targets of President Donald Trump’s immigration crackdown.

“I want more than anything for my baby to walk,” her mother said in Spanish, as Gabi cooed and wriggled in her arms, a feeding tube snaking from her stomach to an IV pole. “But with the situation that’s happening, I canceled the surgery and all the physical therapy appointments” that would have followed. “Because I’m afraid to leave.”

The Department of Homeland Security has declared an end to what it called Operation Metro Surge, carried out by officers with the Immigration and Customs Enforcement and Customs and Border Protection agencies. Even so, health care workers say, immigration agents are still camping out in hospital parking lots. And drones fly overhead in agricultural areas beyond Minneapolis, where Somali and Latino immigrants have settled in recent years.

The Minnesota crackdown revealed the sweep of the surveillance and capture system the Trump administration is using to uproot immigrant communities in the United States, and the effect of its powerful brake on the medical system.

Similar health crises surfaced wherever immigration officers massed in the past year. In Dallas, public health clinics administered about 6,000 vaccinations to Latinos last August, half as many as during a similar program a year earlier. In Chicago, doctors rerouted patients daily from clinic to clinic depending on ICE activity. Across the country, crackdowns suppressed immigrants’ health care visits.

In Minnesota, medical systems have reported cancellation and no-show rates of up to 60% since December.

Tricia McLaughlin, a spokesperson for the Department of Homeland Security, blamed protesters for the disruption. “If anyone is impeding Americans from making appointments or picking up prescriptions,” she said, “its [sic] violent agitators who are blocking roadways, ramming vehicles, and vandalizing property.”

While Minnesotans rose up to oppose the surge in the streets, doctors and nurses have quietly operated informal, underground medical networks, dodging detection to care for patients at home.

“I used to look somebody in the eyes and say, with good faith, 鈥榊ou will be fine at the hospital,’” said Emily Carroll, a nurse practitioner at HealthFinders Collaborative, a community clinic in Faribault, some 50 miles south of Minneapolis. “But now, I can’t make that guarantee.”

As thousands of federal agents move on from Minneapolis, other communities need to prepare, said Minnesota Democratic state Sen. Alice Mann, a physician.

“I know it sounds crazy,” she said, but health care providers “need to start an underground network of how to get people care in their homes. Because letting people die at home or come close to death because they are terrified to go into the hospital, in 2026, is outrageous.”

The Surge Delivers Harm

Home visits, clinicians say, may be the only way to reach those who still feel under siege. In Los Angeles, starting last June, St. John’s Community Health brought medical care to some 2,000 immigrant families too frightened to leave home during an immigration sweep after the clinic’s no-show rates ballooned to more than 30%, said Jim Mangia, the organization’s president.

Many of Minnesota’s large health institutions have relied on telemedicine and only dabbled in home care.

Not Munira Maalimisaq, co-founder of Inspire Change Clinic in Minneapolis’ Ventura Village neighborhood. After about one-third of her patients stopped showing up for appointments, “I was like, 鈥榃e have to do something,’” the nurse practitioner said. So she called a physician friend. What if they just started seeing patients at home?

“And she’s like, 鈥榊ou know what? Let’s do it.’”

They now have about 150 doctors 鈥� a volunteer “rapid response” team that has made more than 135 home visits. The first call was a woman whose husband had been deported. She was home with her children, was 39 weeks pregnant, and was in labor. Maalimisaq called an obstetrician volunteer, and they rushed to the patient’s house.

“She was 8 centimeters dilated,” Maalimisaq said, “and did not want us to call an ambulance. She says, 鈥楥an I have the baby here?’”

The woman was not a good candidate for a home birth, Maalimisaq said. They persuaded her to ride to the hospital in Maalimisaq’s car, a “small Tesla, white seats. Everything that could go wrong was there.”

But they made it to the hospital in time, and the woman had a safe, healthy delivery. “If we were not there, I can only imagine what would have happened.”

Maalimisaq’s caregiving follows a Hippocratic logic: “Someone was in need. I cannot just do nothing. And we cannot call an ambulance against her will and have her shoved in there. We had no choice but to do something, and that was the only thing that we could do safely.”

In other visits, she has seen “people so stressed out they pulled the hair out of their skull.” She said she met a mother who’d been rationing her child’s seizure medicine despite the child having experienced “one seizure after another.”

The Trump administration says its Minnesota operation improved public safety. “Since Operation Metro Surge began, our brave DHS law enforcement have arrested over 4,000 criminal illegal aliens including vicious murderers, rapists, child pedophiles and incredibly dangerous individuals,” according to McLaughlin, the DHS spokesperson. DHS announced last month that McLaughlin was leaving her post.

Minnesota correctional officials say many people accused of crimes were released directly to ICE by state or county prisons and jails. And of people arrested by ICE nationwide in January had criminal convictions, according to DHS data. Far fewer were convicted of violent crimes.

Agents Outside Hospitals, Clinics

On the first day of his second term, President Donald Trump rescinded a 2011 policy that prohibited immigration enforcement in “sensitive locations” such as schools, hospitals, and churches.

In Northfield, about 45 miles south of Minneapolis, ICE agents have been sitting in their cars for hours at least twice a week outside health clinics, including one run by the local hospital, said Carroll, the nurse practitioner. Agents have made arrests in the area almost every day, Carroll and her colleagues said.

“ICE does not conduct enforcement at hospitals 鈥� period,” McLaughlin said.

One recent morning, three ICE vehicles sat in a Baptist church parking lot across the street from an elementary school in Northfield as volunteers ferried 35 children of immigrants back and forth to the school so their parents could avoid going out, Carroll said.

“ICE is not going to schools to arrest children 鈥� we are protecting children,” McLaughlin said.

Drones that Carroll and others believe are operated by immigration agents hover most nights, and sometimes during the day, over a trailer park that mostly houses immigrants who have moved to the area to work in agriculture and manufacturing over the past 15 years. Families paper over trailer windows, Carroll said.

“You cannot feel safe anywhere,” she said. “On the way to school, on the way to clinic, you might pass ICE. The sort of crushing fear and feeling of being trapped that these families are going through is outrageous.”

That fear means patients with diabetes and heart disease are missing blood sugar and blood thinner tests. Patients aren’t getting exercise, and the chronically ill are getting sicker, said Calla Brown, a Minneapolis pediatrician.

At the Faribault clinic where Carroll works, staff members deliver medicine, food, and other necessities to patients. A staffer drives 12 middle and high school kids to and from class every day in a clinic van.

Some patients are treated at home. Carroll recently diagnosed a baby with influenza, telling the parents it wasn’t an immediate threat 鈥� yet.

“鈥業f you see the baby struggling to breathe, if the baby’s not eating, if the baby isn’t making wet diapers, you have to go to the hospital,’” Carroll said she told them. “鈥業 cannot promise it’s safe. But you’ve got to go.’”

鈥榃e’re Nice to Each Other’

In Minneapolis, nurse-midwife Fernanda Honebrink spends most of her daylight hours calling, coordinating, and shuttling between a ballooning group of fearful people stuck in their homes. She prefers not to call it a medical underground.

“It’s more like, that’s how we function in Minnesota,” said Honebrink, a U.S. citizen who emigrated from Ecuador 23 years ago. “We’re nice to each other.”

Honebrink spent a recent afternoon at the home of a family with a baby boy. His parents, Alex and Isa, desperately want him to receive vaccinations and blood tests at his one-year well-child appointment.

But they haven’t left their apartment for more than a month. “You don’t know what is most important: whether to go out for his well-being, or to go out and think that you might not come back,” Alex said.

The couple, who were interviewed in Spanish, entered the U.S. legally from Venezuela in 2024 under a program called Humanitarian Parole, which Trump ended in May. Since then, federal agents have detained and deported workers at a company where Alex, a mechanical engineer by training, worked in construction.

Alex and Isa have seen government vehicles outside their home. They knew of a man, they said, who had legitimate work papers but was picked up while walking to church one Sunday, flown to Texas, then put on a plane to Venezuela. It was a terrifying prospect for those who’ve fled that country’s dictatorship and economic chaos.

“It feels like a psychological attack,” Alex said. “The possibility of being separated from your family.”

Isa, a lawyer back in Venezuela, has endured postpartum depression, cooped up for weeks in their apartment. The state program that provided health insurance to all immigrants ended Jan. 1. A therapist checks in occasionally by phone, free of charge.

She has tried to keep the family afloat by selling homemade cakes and necklaces, and babysitting.

Her worst fear is being separated from her son, who was born in the U.S. and is a citizen. The possibility hadn’t occurred to her until an acquaintance urged her to to designate someone to have temporary custody if she were deported.

“It was something I never imagined,” said Isa, who sobbed as she recalled the moment. “He’s my baby! He’s not someone else’s! What? My baby would remain here with someone?’’

Honebrink suddenly piped up: “I will guarantee him. I’ll sign the form.”

She later told a reporter, “I told my husband I wouldn’t do that. I’ve already signed as a sponsor for four kids.”

As soon as she left the apartment, Honebrink jumped back on the phone and traded favors with local pediatricians, clinic schedulers, and volunteers. Within hours, she’d set up a new well-child visit for the baby and found a vetted driver to transport the family.

“A white person,” Honebrink explained.

Two days later, Honebrink sent a picture of her small victory: Alex and Isa’s baby boy with a Band-Aid on his legs. “He got his vaccines,” she said via text. “I’m so happy.”

But other medical needs cannot be as swiftly addressed. One February evening, Honebrink greeted Gabi and her mother with a trunk full of donated baby wipes, diapers, and toys.

Gabi’s surgery is rescheduled for August. Her mother said she hoped by then it would be safe to leave home.

“I used to take the kids to the park, but now we don’t leave at all,” she said. “They grab people, they mistreat them. How I wish it would end soon!”

麻豆女优 Health News’ Jackie Fortiér contributed to this report.

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Just three of those that the Centers for Disease Control and Prevention says it will no longer routinely recommend 鈥� against hepatitis A, hepatitis B, and rotavirus 鈥� have prevented nearly 2 million hospitalizations and 90,000 deaths in the past 30 years, according to . 

Federal and private insurance . 

Experts on childhood disease were baffled by the change, which the Department of Health and Human Services said followed “a scientific review of the underlying science.” 

The vaccines are “held to a safety standard higher than any other medical intervention that we have,” said , a pediatric infectious disease specialist at the Children’s Hospital of Philadelphia. “The value of routine recommendations is that it really helps the public understand that this has been vetted upside down and backwards in every which way.”

Public health officials say the guidance puts the onus on parents to research each vaccine and its importance. Here’s what they prevent: 

RSV. Respiratory syncytial virus is the most common cause of hospitalization for infants in the U.S. It spreads in fall and winter, producing cold-like symptoms and causing tens of thousands of hospitalizations and hundreds of deaths yearly. 

Hepatitis A. Hepatitis A vaccination, recommended for all toddlers since 2006, has led to a more than 90% drop in the disease since 1996. The foodborne virus, which causes a wretched illness, still plagues adults, particularly people who are homeless or abuse drugs or alcohol, with  reported in 2023. 

Hepatitis B. The disease causes liver cancer, cirrhosis, and other serious illnesses and is particularly dangerous when contracted by babies and young children. The hepatitis B virus is transmitted through blood and other bodily fluids, even in microscopic amounts, and can survive on surfaces for a week. From 1990 to 2019, vaccination resulted in a 99% decline in reported cases of acute hepatitis B among children and teens. Liver cancer among American children also plummeted with universal childhood vaccination. 

Rotavirus. Before routine administration of the current rotavirus vaccines began in 2006, 70,000 young children were hospitalized and 50 died yearly from the virus, known as “winter vomiting syndrome,” said Sean O’Leary, a University of Colorado pediatrician. “It was a miserable disease that we hardly see anymore.” 

Meningococcal disease.聽About 600 to 1,000 U.S. cases of meningococcal disease聽are reported聽yearly, killing more than 10% of those it sickens and聽leaving聽1 in 5 survivors聽with a聽disability.聽

Flu. The virus has killed hundreds of children in recent years, though it tends to be much more severe in older adults.

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Just three of the six immunizations the Centers for Disease Control and Prevention says it will no longer routinely recommend 鈥� against hepatitis A, hepatitis B, and rotavirus 鈥� have prevented nearly 2 million hospitalizations and more than 90,000 deaths in the past 30 years, according to .

Vaccines against the three diseases, as well as those against respiratory syncytial virus, meningococcal disease, flu, and covid, are now recommended only for children at high risk of serious illness or after “shared clinical decision-making,” or consultation between doctors and parents.

The CDC maintained its recommendations for 11 childhood vaccines: measles, mumps, and rubella; whooping cough, tetanus, and diphtheria; the bacterial disease known as Hib; pneumonia; polio; chickenpox; and human papillomavirus, or HPV.

Federal and private insurance will still cover vaccines for the diseases the CDC no longer recommends universally, according to a Department of Health and Human Services ; parents who want to vaccinate their children against those diseases will not have to pay out-of-pocket.

Experts on childhood disease were baffled by the change in guidance. HHS said the changes followed “a scientific review of the underlying science” and were in line with vaccination programs in other developed nations.

HHS Secretary Robert F. Kennedy Jr., an anti-vaccine activist, pointed to Denmark as a model. But the schedules of most European countries are closer to the U.S. standard upended by the new guidance.

For example, Denmark, which does not vaccinate against rotavirus, registers around 1,200 infant and toddler rotavirus hospitalizations a year. That rate, in a country of 6 million, is about the same as it was in the United States before vaccination.

“They’re OK with having 1,200 or 1,300 hospitalized kids, which is the tip of the iceberg in terms of childhood suffering,” said Paul Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a co-inventor of a licensed rotavirus vaccine. “We weren’t. They should be trying to emulate us, not the other way around.”

Public health officials say the new guidance puts the onus on parents to research and understand each childhood vaccine and why it is important.

Here’s a rundown of the diseases the sidelined vaccines prevent:

RSV. Respiratory syncytial virus is the most common cause of hospitalization for infants in the U.S.

The respiratory virus usually spreads in fall and winter and produces cold-like symptoms, though it can be deadly for young children, causing tens of thousands of hospitalizations and hundreds of deaths a year. According to the National Foundation for Infectious Diseases, roughly 80% of children younger than 2 who are hospitalized with RSV have no identifiable risk factors. Long-awaited vaccines against the disease were introduced in 2023.

Hepatitis A. Hepatitis A vaccination, which was phased in beginning in the late 1990s and recommended for all toddlers starting in 2006, has led to a more than 90% drop in the disease since 1996. The foodborne virus, which causes a wretched illness, continues to plague adults, particularly people who are homeless or who abuse drugs or alcohol, with of 1,648 cases and 85 deaths reported in 2023.

Hepatitis B. The disease causes liver cancer, cirrhosis, and other serious illnesses and is particularly dangerous when contracted by babies and young children. The hepatitis B virus is transmitted through blood and other bodily fluids, even in microscopic amounts, and can survive on surfaces for a week. From 1990 to 2019, vaccination resulted in a 99% decline in reported cases of acute hepatitis B among children and teens. Liver cancer among American children has also plummeted as a result of universal childhood vaccination. But the hepatitis B virus is still around, with 2,000-3,000 acute cases reported annually among unvaccinated adults. More than 17,000 chronic hepatitis B diagnoses were reported in 2023. The CDC estimates about half of people infected don’t know they have it.

Rotavirus. Before routine administration of the current rotavirus vaccines began in 2006, about 70,000 young children were hospitalized and 50 died every year from the virus. It was known as “winter vomiting syndrome,” said Sean O’Leary, a pediatrician at the University of Colorado. “It was a miserable disease that we hardly see anymore.”

The virus is still common on surfaces that babies touch, however, and “if you lower immunization rates it will once again hospitalize children,” Offit said.

Meningococcal disease. Vaccines have been required mainly for teenagers and college students, who are notably vulnerable to critical illness caused by the bacteria. About 600 to 1,000 cases of meningococcal disease are reported in the U.S. each year, but it kills more than 10% of those it sickens, and 1 in 5 survivors have permanent disabilities.

Flu and covid. The two respiratory viruses have each killed hundreds of children in recent years 鈥� though both tend to be much more severe in older adults. Flu is currently on the upswing in the United States, and last flu season the virus killed 289 children.

What is shared clinical decision-making?

Under the changes, decisions about vaccinating children against influenza, covid, rotavirus, meningococcal disease, and hepatitis A and B will now rely on what officials call “shared clinical decision-making,” meaning families will have to consult with a health care provider to determine whether a vaccine is appropriate.

“It means a provider should have a conversation with the patient to lay out the risks and the benefits and make a decision for that individual person,” said , a pediatric infectious disease specialist at the Children’s Hospital of Philadelphia.

In the past, the CDC used that term only in reference to narrow circumstances, like whether a person in a monogamous relationship needed the HPV vaccine, which prevents a sexually transmitted infection and certain cancers.

The CDC’s new approach doesn’t line up with the science because of the proven protective benefit the vaccines have for the vast majority of the population, Handy said.

In their report justifying the changes, HHS officials Tracy Beth Høeg and Martin Kulldorff said the U.S. vaccination system requires more safety research and more parental choice. Eroding trust in public health caused in part by an overly large vaccine schedule had led more parents to shun vaccination against major threats like measles, they said.

The vaccines on the schedule that the CDC has altered were backed up by extensive safety research when they were evaluated and approved by the FDA.

“They’re held to a safety standard higher than any other medical intervention that we have,” Handy said. “The value of routine recommendations is that it really helps the public understand that this has been vetted upside down and backwards in every which way.”

, a pediatrician in Orange County, California, said the change in guidance will cause more confusion among parents who think it means a vaccine’s safety is in question.

“It is critical for public health that recommendations for vaccines are very clear and concise,” Ball said. “Anything to muddy the water is just going to lead to more children getting sick.”

Ball said that instead of focusing on a child’s individual health needs, he often has to spend limited clinic time reassuring parents that vaccines are safe. A “shared clinical decision-making” status for a vaccine has no relationship to safety concerns, but parents may think it does.

HHS’ changes do not affect state vaccination laws and therefore should allow prudent medical practitioners to carry on as before, said , an attorney and a George Washington University lecturer who is leading litigation against Kennedy over vaccine changes.

“You could expect that any pediatrician is going to follow sound evidence and recommend that their patients be vaccinated,” he said. The law protects providers who follow professional care guidelines, he said, and “RSV, meningococcal, and hepatitis remain serious health threats for children in this country.”

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But in the upside-down world of Health and Human Services Secretary Robert F. Kennedy Jr., vaccines are on the ropes. A vaccine committee dominated by skeptics he chose for the panel voted 8-to-3 Friday to end a 34-year recommendation to inoculate newborns against hepatitis B, a practice that helped reduce childhood infections of the virus by 99%, from around 16,000 in 1991 to only seven in 2023.

While the committee went about its deliberations, the peril of abandoning vaccines was plain to see. The country’s worst year since 1992 for measles 鈥� an entirely vaccine-preventable illness 鈥� continued with flare-ups in Utah, Arizona, and South Carolina. A two-year outbreak of whooping cough, which vaccines can also check, has caused about 60,000 reported cases 鈥� including at least six infant deaths.

But neither of those diseases was discussed on the first day of the meeting by members of the Advisory Committee on Immunization Practices. The panel’s chartered purpose is to determine vaccination policies to counter such risks, but under Kennedy, it has focused on responding to doubts from vaccine skeptics and opponents.

Like previous gatherings of the committee, which was handpicked by Kennedy after he fired the panel’s 17 incumbent experts in June, the session was chaotically at odds with past practices of the Centers for Disease Control and Prevention. Kennedy has described the agency as a “cesspool of corruption.”

The committee’s chair, epidemiologist Martin Kulldorff, left three days before the meeting and was named to a senior HHS position. His successor, Kirk Milhoan, a pediatric cardiologist who that the mRNA technology used to make covid vaccines is “the biggest threat to humanity,” was on a plane or in Asia for most of the meeting, leaving Vice Chair Robert Malone holding the reins. Malone opposes vaccine mandates and became a darling of the anti-vaccine movement when he told podcast host Joe Rogan in 2021 that Americans were “basically being hypnotized” into taking the covid vaccine.

Typically, slides and data for the panel’s meetings are posted on the CDC’s website several days beforehand. This time they weren’t posted at all.

The committee’s working group that studied hepatitis B vaccines did not include recognized hepatitis experts. When a few panel members expressed reservations during the ACIP meeting, CDC hepatitis specialist Adam Langer was brought in to answer questions. He frowned on the proposed changes.

Surprising Choice of Experts

At 8 a.m. Dec. 4, the CDC finally listed the names of the meeting’s presenters. Aaron Siri, one of Kennedy’s former lawyers and a strident legal foe of vaccination, was set to headline Friday’s discussion of the pediatric immunization schedule.

Sen. Bill Cassidy, a Louisiana Republican and physician who cast a deciding vote for Kennedy to win confirmation to his job, said on the social platform X: “Aaron Siri is a trial attorney who makes his living suing vaccine manufacturers. He is presenting as if an expert on childhood vaccines. The ACIP is totally discredited. They are not protecting children.”

In replies to his post, some people demanded to know what Cassidy planned to do about it. While he has publicly criticized some of Kennedy’s moves on vaccines, the senator has made no visible effort to reverse them.

As the meeting began, Malone revealed that Vicky Pebsworth, a senior officer at the National Vaccine Information Center, a four-decade-old cornerstone of vaccine skepticism, was chairing a committee that is reviewing the entire childhood vaccine schedule. That’s the repository of ACIP recommendations that protect American children from measles, pertussis, influenza, tetanus, chickenpox, meningitis, and a host of other diseases.

Typically, seasoned CDC and FDA experts on vaccines and infectious disease present data about a disease and the options for its prevention before ACIP votes on a policy. Instead, Pebsworth, vaccine-skeptical climate scientist , and businessperson Mark Blaxill, who helped lead another anti-vaccine group, presented the case 鈥� a negative one 鈥� on the hepatitis B vaccine on Dec. 4.

Sports medicine doctor Tracy Beth Høeg, who parlayed a year working with University of California-San Francisco epidemiologist Vinay Prasad, now the FDA’s vaccine chief, into a leading role at the agency, frequently chimed in. Nevison and Blaxill were co-authors of a 2021 autism study retracted for data misrepresentation and other problems.

Unsurprisingly, the picture they painted Dec. 4 suggested that the hepatitis B birth dose wasn’t necessary, and might be dangerous, notwithstanding years of scientific consensus to the contrary.

The presentations stunned Cody Meissner, an infectious disease specialist and one of the only vaccinologists on the CDC panel. “There were so many statements that I don’t agree with that it’s hard to be succinct,” he said.

Yvonne Maldonado, a Stanford University infectious disease specialist and one of the former ACIP members ejected in June, said she found it horrifying to watch unvetted presentations by nonexpert nonphysicians.

“Almost every statement made by this committee was misinformation, disinformation, or outright lies,” she said. “They are cherry-picking data, pulling up fringe papers, misunderstanding good papers. They are not the right people to be making decisions.”

Pebsworth said the committee was taking up the birth dose issue because of “pressure coming from stakeholder groups” 鈥� presumably including Kennedy and his allies. The U.S. is an “outlier” in its universal recommendation, she erroneously said.

In fact, the birth dose of the hepatitis B vaccine is given in 115 countries and is recommended by the World Health Organization. Many Western European countries limit the birth dose to targeted groups, however.

Arguments for the Birth Dose

Nevison said targeted measures to stop the virus in the 1980s, including promoting safer sex, increasing blood screening, and vaccinating the babies of hepatitis B-positive mothers, had achieved most of the reduction in cases since then. But most experts say the birth dose played a key role. And the virus remains a threat, with an in the U.S.

The birth dose “is a safety net,” Meissner said. “It’s really for chronically infected mothers who for one reason or another do not get tested.”

“Where is the evidence of harm?” asked another panelist, psychiatrist Joseph Hibbeln.

In the years since the birth dose of hepatitis B vaccine was recommended, it has caused vanishingly few confirmed major side effects.

Blaxill, who 25 years ago helped advance the since-disproven theory that traces of mercury in vaccines were causing an epidemic of autism, said that hepatitis B vaccines were inadequately studied. He pointed to a study that showed high fevers in some children after the shot, which he said suggested brain inflammation.

Maldonado said that’s wrong. “I’ve seen thousands of children with fevers,” she said. “It’s not the same as encephalitis.”

Nevison said that a small number of vaccine court awards proved at least some harm by hepatitis B vaccinations. Reed Grimes, director of the Division of Injury Compensation Programs at the Health Resources and Services Administration, explained that an award does not necessarily signify proof of injury, but rather that the government decided not to contest a claim.

Speculation bloomed. Panelist Evelyn Griffin, an obstetrician, posited that rising cases of inflammatory bowel disease might be related to a medium 鈥� brewer’s yeast 鈥� used in the production of the hepatitis B vaccine. She did not cite a source for the idea.

Babies born with hepatitis B infections have a 90% chance of chronic liver infection later in life, and 25% of those with a chronic infection will die prematurely with chronic liver disease.

Panel members pushing to end the universal birth dose argued that blood tests of pregnant women should show who needs the shot. But only 35% of women who test positive receive all recommended follow-up care, and the virus can spread easily through contacts as common as a toothbrush or a bath towel. Ending the birth dose could result in nearly 500 deaths a year, according to a recent study.

The meeting was preceded by a heavy round of briefings for journalists and from established medical experts who view the new ACIP as a sounding board for anti-vaccine views 鈥� “inflating speculative risks while downplaying well-established vaccine benefits,” as three recent .

They noted that the hepatitis B birth dose is already optional, although doctors strongly recommend it. But recommending that it be a shared decision based on individual choice, as the ACIP voted Dec. 5, could add paperwork for doctors and introduce doubts in parents’ minds.

ACIP recommendations aren’t binding but have been used by health insurers in the past to establish coverage decisions. Federal agencies and private insurers will in most cases continue to pay for the hepatitis B vaccination if parents want it, said Andrew Johnson, who represented the Centers for Medicare & Medicaid Services during the meeting. But studies have shown that ambiguous advice leads to lower vaccination rates, said Kathryn Edwards, a Vanderbilt University vaccinologist.

Anti-vaccine activists have long targeted the hepatitis B birth dose. At one time they baselessly claimed it caused sudden infant death syndrome.

But within a decade of the universal dose implementation, the rate of SIDS had . That was thanks to an HHS-American Academy of Pediatrics’ “back to sleep” campaign, which urged parents to avoid suffocation risk by not letting their babies go to sleep on their stomachs.

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Many scientists and public health officials fear that the Centers for Disease Control and Prevention’s website, which now baselessly claims that health authorities previously ignored evidence of a vaccine-autism link, foreshadows a larger, dangerous attack on childhood vaccination.

“This isn’t over,” said Helen Tager-Flusberg, a professor emerita of psychology and brain science at Boston University. She noted that Kennedy hired several longtime anti-vaccine activists and researchers to review vaccine safety at the CDC. Their study is due soon, she said.

“They’re massaging the data, and the outcome is going to be, 鈥榃e will show you that vaccines do cause autism,’” said Tager-Flusberg, who leads an of more than 320 autism scientists concerned about Kennedy’s actions.

Kennedy’s handpicked vaccine advisory committee is set to meet next month to discuss whether to abandon recommendations that babies receive a dose of the hepatitis B vaccine within hours of birth and make other changes to the CDC-approved vaccination schedule. Kennedy has claimed 鈥� falsely, scientists say 鈥� that like asthma and peanut allergies, in addition to autism.

The revised CDC webpage will be used to support efforts to ditch most childhood vaccines, said Angela Rasmussen, a virologist at the University of Saskatchewan and co-editor-in-chief of the journal Vaccine. “It will be cited as evidence, even though it’s completely invented,” she said.

Kennedy personally ordered the website’s alteration, . The CDC’s developmental disability group was not asked for input on the changes, said Abigail Tighe, executive director of the National Public Health Coalition, a group that includes current and former staffers at the CDC and HHS.

Scientists ridiculed the site’s declaration that studies “have not ruled out the possibility that infant vaccines cause autism.” While upward of 25 large studies have shown no link between vaccines and autism, it is scientifically impossible to prove a negative, said David Mandell, director of the Center for Autism Research at Children’s Hospital of Philadelphia.

The webpage’s new statement that “studies supporting a link have been ignored by health authorities” apparently refers to work by vaccine opponent David Geier and his father, Mark, who died in March, Mandell said. Their research has and even ridiculed. David Geier is Kennedy hired to review safety data at the CDC.

Asked for evidence that scientists had suppressed studies showing a link, HHS spokesperson Andrew Nixon pointed to , some of which called for more study of a possible link. Asked for a specific study showing a link, Nixon did not respond.

Expert Reaction

Infectious disease experts, pediatricians, and public health officials condemned the alteration of the CDC website. Although Kennedy has made no secret of his disdain for established science, the change came as a gut punch because the CDC has always dealt in unbiased scientific information, they said.

Kennedy and his “nihilistic Dark Age compatriots have transformed the CDC into an organ of anti-vaccine propaganda,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

“On the one hand, it’s not surprising,” said Sean O’Leary, a professor of pediatrics and infectious disease at the University of Colorado. “On the other hand, it’s an inflection point, where they are clearly using the CDC as an apparatus to spread lies.”

“The CDC website has been lobotomized,” Atul Gawande, an author and a surgeon at Brigham and Women’s Hospital, told 麻豆女优 Health News.

CDC “is now a zombie organization,” said Demetre Daskalakis, former director of the National Center for Immunization and Respiratory Diseases at the CDC. The agency has lost about a third of its staff this year. Entire divisions have been gutted and its leadership fired or forced to resign.

Kennedy has been “going from evidence-based decision-making to decision-based evidence making,” Daniel Jernigan, former director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, said at a news briefing Nov. 19. With Kennedy and his team, terminology including “radical transparency” and “gold-standard science” has been “turned on its head,” he said.

Cassidy Goes Quiet

The new webpage seemed to openly taunt Sen. Bill Cassidy (R-La.), a physician who chairs the Senate Health, Education, Labor, and Pensions Committee. Cassidy cast the tie-breaking vote in committee for Kennedy’s confirmation after saying he had secured an agreement that the longtime anti-vaccine activist wouldn’t make significant changes to the CDC’s vaccine policy once in office.

The agreement included a promise, he said, that the CDC would not remove statements on its website stating that vaccines do not cause autism.

The new autism page is still headed with the statement “Vaccines do not cause Autism,” but with an asterisk linked to a notice that the phrase was retained on the site only “due to an agreement” with Cassidy. The rest of the page contradicts the header.

“What Kennedy has done to the CDC’s website and to the American people makes Sen. Cassidy into a total and absolute fool,” said Mark Rosenberg, a former CDC official and assistant surgeon general.

On Nov. 19 at the Capitol, before the edits were made to the CDC website, Cassidy answered several unrelated questions from reporters but ended the conversation when he was asked about the possibility Kennedy’s Advisory Committee on Immunization Practices might recommend against a newborn dose of the hepatitis B vaccine.

“I got to go in,” he said, before walking into a hearing room without responding.

Cassidy has expressed dismay about the vaccine advisory committee’s actions but has avoided criticizing Kennedy directly or acknowledging that the secretary has breached commitments he made before his confirmation vote. Cassidy has said Kennedy also promised to maintain the childhood immunization schedule before being confirmed.

The senator criticized the CDC website edits in a Nov. 20 , although he did not mention Kennedy.

“What parents need to hear right now is vaccines for measles, polio, hepatitis B and other childhood diseases are safe and effective and will not cause autism,” he said in the post. “Any statement to the contrary is wrong, irresponsible, and actively makes Americans sicker.”

Leading autism research and support groups, including the Autism Science Foundation, the Autism Society of America, and the , issued statements condemning the website.

“The CDC’s web page used to be about how vaccines do not cause autism. Yesterday, they changed it,” ASAN said in a statement. “It says that there is some proof that vaccines might cause autism. It says that people in charge of public health have been ignoring this proof. These are lies.”

What the Research Shows

Parents often notice symptoms of autism in a child’s second year, which happens to follow multiple vaccinations. “That is the natural history of autism symptoms,” said Tager-Flusberg. “But in their minds, they had the perfect child who suddenly has been taken from them, and they are looking for an external reason.”

When speculation about a link between autism and the measles, mumps, and rubella vaccine or vaccines containing the mercury-based preservative thimerosal surfaced around 2000, “scientists didn’t dismiss them out of hand,” said Tager-Flusberg, who has researched autism since the 1970s. “We were shocked, and we felt the important thing to do was to figure out how to quickly investigate.”

Since then, studies have clearly established that autism occurs as a result of genetics or fetal development. Although knowledge gaps persist, studies have shown that premature birth, older parents, viral infections, and the use of certain drugs during pregnancy 鈥� , evidence so far indicates 鈥� are linked to increased autism risk.

But other than the reams of data showing the health risks of smoking, there are few examples of science more definitive than the many worldwide studies that “have failed to demonstrate that vaccines cause autism,” said Bruce Gellin, former director of the National Vaccine Program Office.

The edits to the CDC website and other actions by Kennedy’s HHS will shake confidence in vaccines and lead to more disease, said Jesse Goodman, a former FDA chief scientist and now a professor at Georgetown University.

This opinion was echoed by Alison Singer, the mother of an autistic adult and a co-founder of the Autism Science Foundation. “If you’re a new mom and not aware of the last 30 years of research, you might say, 鈥楾he government says we need to study whether vaccines cause autism. Maybe I’ll wait and not vaccinate until we know,’” she said.

The CDC website misleads parents, puts children at risk, and draws resources away from promising leads, said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “Kennedy thinks he’s helping children with autism, but he’s doing the opposite.”

Many critics say their only hope is that cracks in President Donald Trump’s governing coalition could lead to a turn away from Kennedy, whose team has reportedly tangled with some White House officials as well as Republican senators. Polling has also shown that much of the and does not consider him a health authority, and Trump’s own dramatically since he returned to the White House.

But anti-vaccine activists applauded the revised CDC webpage. “Finally, the CDC is beginning to acknowledge the truth about this condition that affects millions,” Mary Holland, CEO of Children’s Health Defense, the advocacy group Kennedy founded and led before entering politics, told . “The truth is there is no evidence, no science behind the claim vaccines do not cause autism.”

Céline Gounder, Amanda Seitz, and Amy Maxmen contributed to this report.

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These officials were thrilled Oct. 29 when FDA Commissioner Marty Makary announced the agency’s plan, which he said would halve the time and money needed to get what are called “biosimilar” drugs to market. Biosimilars are essentially generic versions of biologics 鈥� such as Humira, Keytruda, and Xolair 鈥� which are made from living organisms. Biosimilars can cost up to 90% less.

Under the guidance the FDA proposed, the agency would begin overseeing biosimilars similarly to the way it regulates generics, which are copies of simpler molecules, usually pills. This change in approach could allow companies to save up to $100 million for each drug they develop, enabling them to make more products for underserved patients, said Stefan Glombitza, CEO of Formycon AG, a maker of biosimilars based in Germany.

But President Donald Trump’s patent office is working at cross-purposes with the FDA, biosimilar makers charge, by narrowing the opportunities for companies that try to challenge the throngs of patents that brand-name drugmakers file to protect their products from competition.

In the past, biosimilar makers have been able to invalidate some of those patents through a sped-up process called “inter partes review,” or IPR. But the new administration has denied most IPR requests and issued a in October that makes IPRs harder to get.

Heavyweights on Pricing

Biosimilars have the potential to nibble or even gouge away at a major U.S. health care cost. Only 5% of prescriptions are for biologic drugs, but they account for more than half of the the nation annually spends on medicines.

“Generic and biosimilar competition is the crucial way that we bring down prescription drug prices,” said William Feldman, a pharmaceuticals policy researcher at UCLA.

The FDA announcement “is a good thing that may ease barriers,” he added, “but there are a lot of caveats.”

In fact, biosimilar industry officials say, FDA regulation is often the least of the three major hurdles they face in marketing their products.

To protect their market share, brand-name biologics makers file scores or even hundreds of patents, continuing to do so long after their drugs hit the market. The “patent dance” that occurs when biosimilar makers seek to launch competitor drugs can drag on for many years.

For example, the FDA approved the first biosimilar of the rheumatoid arthritis drug Humira in 2016, but legal battles delayed competitors from entering the market 鈥� until nine FDA-approved products were . At his , Makary blamed FDA “red tape” for the delay, but it was mostly due to the baffling patent machinery, industry officials say.

The new rules, which could take effect next year, would formalize recent FDA practices aimed at speeding along approval for biosimilars. For example, the FDA has recently allowed drugmakers to waive expensive clinical testing contemplated under a 2009 law. The agency now lets companies employ less costly analytical tests, if they can show that the biosimilar has no clinically meaningful differences from the brand-name drug.

A 鈥楽witching’ Burden

Because biologic drugs are large molecules produced from live cells, copies of them cannot be chemically identical. So the FDA had required biosimilars to go through clinical studies like the ones required for the original drugs. But that analytic techniques can replace the need to test biosimilars on large numbers of patients.

The new rules would also confirm the FDA’s move away from requiring what are known as “switching” tests, in which patients first go on the brand-name drug and then the biosimilar, or vice versa, to see if their responses are the same. Such tests are required in many states for the biosimilar to obtain “interchangeable” status, which enables pharmacists to substitute an often cheaper version for the prescribed brand-name drug.

In short, the new rules would mean biosimilar makers would spend less money getting drugs to market, said Sean Tu, a law professor at the University of Alabama. “What that won’t do is get you on the market earlier,” he added.

After biosimilars launch, it can take years for them to gain a foothold. In 2023, Humira biosimilars made barely a dent in the market, and in 2024 they accounted for only about a quarter of sales, though they cost as little as 10% of the roughly $6,500 monthly price tag for the brand-name drug.

That’s because brand-name drug companies offer lucrative rebates for sales of their drugs to the go-between companies that design formularies 鈥� tiered lists that tell doctors and pharmacies which drugs are covered by insurance. These middlemen, pharmacy benefit managers, pass along some of that money to health plans.

Essentially, the insurance plans are “charging higher costs to people who require expensive drugs as a way to subsidize the whole population,” said Wayne Winegarden, an economist at the Pacific Research Institute.

The Patent Thicket Thickens

Biosimilar makers are particularly worried about the direction the U.S. Patent and Trademark Office has taken under Trump.

Patent challenges are already 10 to 20 times as expensive in the United States as in Europe, and restricting inter partes reviews is making it worse, said Formycon’s Glombitza.

The FDA recently gave his company a waiver from conducting a costly clinical trial of its biosimilar substitute for Keytruda, a blockbuster cancer drug. But Merck & Co., which got about half of its $17 billion third-quarter revenue from Keytruda, is expected to fight tooth and nail to protect its many patents on the drug. The Trump administration’s new obstacles to challenge them “counteract the waiver,” Glombitza said.

Merck protects its innovations, said spokesperson Julie Marie Cunningham. However, noting that Merck is touting a new, injectable Keytruda formulation, she said the company does not expect it to affect “the potential marketing” of biosimilars for the older, intravenous form of the drug.

The Pharmaceutical Research and Manufacturers of America, or PhRMA, the industry group representing most large brand-name companies, “welcomes the administration’s focus on increasing biosimilar access and affordability,” said spokesperson Alex Schriver.

But Big Pharma companies favor the patent office’s swing toward more protection of filed patents, according to attorneys who work in intellectual property litigation.

“I don’t think the Trump administration has any kind of coherent plan here,” said Mark Lemley, director of the Stanford Program in Law, Science & Technology. While Trump officials want to bring drug costs down, “they also want to make it more expensive to figure out whether patents are valid by effectively eliminating IPRs,” he said.

The patent office did not respond to repeated phone calls and emails.

Patents and patent litigation are the biggest impediments to getting biosimilars onto the market, UCLA’s Feldman said.

For instance, the FDA licensed Sandoz’s biosimilar for Enbrel, a popular drug to treat autoimmune disorders, in 2016, but Sandoz won’t be able to market its competitor in the U.S. until 2029 at the earliest because of patent challenges. Without insurance, Enbrel costs about $7,000 to $9,000 a month.

A Patient’s Perspective

Judy Aiken, a retired Portland, Maine, nurse who has taken Enbrel since 2007 to treat psoriatic arthritis, would be interested in trying the copycat if it costs her less. After retiring in 2019 and going on Medicare, she has spent thousands each year on the drug.

The Biden-era Inflation Reduction Act capped her out-of-pocket drug costs at $2,000 this year, and Aiken and her husband used the savings to replace their roof and furnace. But with health care changes on the horizon, “now I’m scared the other shoe is going to drop,” she said.

Only about 10% of the 118 biologics set to come off patent in the next decade have biosimilars in development, reflecting poor incentives in a system that biosimilar makers and patient advocates say is stacked against them.

But lower costs could enable companies like Formycon to expand their product lines 鈥� focused now on cancer and autoimmune diseases 鈥� to less common or even rare conditions, said CEO Glombitza.

“People have talked about the promise of biosimilars reducing out-of-pocket costs and creating more choices for consumers, and I feel like we’re still waiting,” said Anna Hyde, chief of advocacy and access for the Arthritis Foundation, which lobbies for research and treatment.

Although biosimilars could save everyone money, patients generally don’t care whether they get one or not, Hyde noted. Some don’t want to switch if they’ve found a brand-name drug that works for them, since the search can be grueling for people suffering from autoimmune diseases, she said.

“Generally, they can’t access them anyway,” she said, “because they are not available on the formulary.”

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