Julie Rovner Ñî¹óåú´«Ã½Ò•îl Health News Read Julie's stories. Julie Rovner is chief Washington correspondent and host of Ñî¹óåú´«Ã½Ò•îl Health News’ weekly health policy news podcast, "What the Health?" A noted expert on health policy issues, Julie is the author of the critically praised reference book "Health Care Politics and Policy A to Z," now in its third edition.

Congress is running out of time to avert a huge increase in health care premium payments for millions of Americans who buy insurance through the Affordable Care Act marketplaces. Dec. 15 is the deadline to sign up for coverage that begins Jan. 1, and some consumers are waiting to see whether the credits will be extended, enabling them to afford coverage next year.

Meanwhile, a federal vaccine advisory panel handpicked by Health and Human Services Secretary Robert F. Kennedy Jr. voted last week to end the universal recommendation for a hepatitis B vaccine dose at birth. It’s just the start of what are expected to be major changes in childhood vaccine recommendations overall.

This week’s panelists are Julie Rovner of Ñî¹óåú´«Ã½Ò•îl Health News, Anna Edney of Bloomberg News, Maya Goldman of Axios, and Sheryl Gay Stolberg of The New York Times.

Panelists

Anna Edney Bloomberg News

Maya Goldman Axios

Sheryl Gay Stolberg The New York Times

Among the takeaways from this week’s episode:

• As of Thursday morning, the Senate was preparing to vote on competing health proposals, neither of which was expected to pass: one, from Democrats, that would extend the enhanced ACA premium tax credits and a second, from Republicans, that would instead add money to health savings accounts for some ACA enrollees. With the credits set to expire and time running out to sign up for plans, it is likely that coverage will be unaffordable for some Americans, leaving them uninsured.
• The Advisory Committee on Immunization Practices’ decision to end its recommendation that newborns be immunized against hepatitis B is a major development in the federal government’s shift away from promoting vaccines. While the panel coalesced around the claim that babies are most likely to contract hepatitis B from their mothers, the reality is that the virus can live on household items, posing a threat of chronic disease and death to unvaccinated children.
• In reproductive health news, House Speaker Mike Johnson removed insurance coverage of fertility treatment for service members from the National Defense Authorization Act before the legislation’s passage, and anti-abortion groups are calling for the firing of Food and Drug Administration head Marty Makary over reports he is slow-walking policy changes on medication abortion.

Also this week, Rovner interviews Georgetown University professor Linda Blumberg about what the GOP’s health plans have in common.

Plus, for “extra credit” the panelists suggest health policy stories they read (or wrote) this week that they think you should read, too: 

Julie Rovner: The Washington Post’s “,” by David Ovalle.  

Anna Edney: Bloomberg News’ “,” by Anna Edney.  

Sheryl Gay Stolberg: The New York Times’ “,” by Katie J.M. Baker.

Maya Goldman: ProPublica’s “,” by Aliyya Swaby.

Also mentioned in this week’s podcast:

• Politico’s “,” by Alice Miranda Ollstein, Ruth Reader, and Liz Crampton.
• The New York Times’ “,” by Sheryl Gay Stolberg and Christina Jewett.
• Bloomberg News’ “,” by Charles Gorrivan, Riley Griffin, and Rachel Cohrs Zhang.
• The Associated Press’ “,” by Ali Swenson and Nicky Forster.

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And subscribe to “What the Health? From Ñî¹óåú´«Ã½Ò•îl Health News” on , , , , , or wherever you listen to podcasts.

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

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 — an entirely vaccine-preventable illness — 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 — 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 — a negative one — 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” — 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 — brewer’s yeast — 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 — “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.

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

Working out of a in Anchorage, Alaska, liver specialist Brian McMahon has spent decades treating the long shadow of hepatitis B. Before a vaccine became available in the 1980s, he saw the virus claim young lives in western Alaskan communities with stunning speed.

One of his patients was 17 years old when he first examined her for stomach pain. McMahon discovered she had developed liver cancer caused by hepatitis B, just weeks before she was set to graduate from high school as valedictorian. She died before the ceremony.

McMahon thinks often of an 8-year-old boy who showed no signs of illness until he complained of pain from what turned out to be a rapidly growing tumor on his liver.

McMahon can still hear his voice.

“He was moaning in pain, saying, ‘I know I am going to die soon,’” he recalled. “We were all crying.” The boy died at home a week later.

The hepatitis B virus is transmitted through blood and bodily fluids, even in microscopic amounts, and the virus can survive on surfaces for a week. Like many of his patients, McMahon said, both children contracted hepatitis B at birth or in early childhood.

That outcome is now preventable. A birth dose of the vaccine, recommended for newborns since 1991, is up to in preventing infection from the mother if given in the first 24 hours of life. If babies receive all three doses, have immunity from the incurable virus, with the protection lasting at least .

In the communities of western Alaska, years of targeted testing and widespread vaccination efforts led to .

“Liver cancer has disappeared in children,” McMahon said. “We haven’t seen a case since 1995. Nor do we have any children under 30 that have gotten infected that we know of.”

He worries those hard-won gains could soon be rolled back.

Pushing Back the Dose?

A Centers for Disease Control and Prevention vaccine advisory panel appointed by Health and Human Services Secretary Robert F. Kennedy Jr. is scheduled the hepatitis B birth dose recommendation during its two-day meeting starting Dec. 4, potentially limiting children’s access.

On Tucker Carlson’s podcast in June, Kennedy falsely claimed that the hepatitis B birth dose is a “likely culprit” of autism.

He also said the hepatitis B virus is not “casually contagious.” But shows the virus can be transmitted through indirect contact, when traces of infected fluids like blood enter the body when people share personal items like razors or toothbrushes.

The committee’s recommendations carry weight. Most private insurers must cover the vaccines the Advisory Committee on Immunization Practices endorses, and many state vaccination policies are directly linked to its guidelines.

Neither ACIP nor the CDC is regulatory. They cannot mandate immunizations. It’s to do that. But keeping the recommendation for a hepatitis B vaccine at birth preserves the widest range of options for families. They can choose to vaccinate at birth, wait until later in childhood, or not vaccinate at all, and insurance will continue to cover the cost of the shot as long as it remains approved by the Food and Drug Administration.

Two senior FDA officials — Commissioner Marty Makary and top vaccine regulator Vinay Prasad — suggested at the end of November that the vaccine approval process may be coming. Vaccines must be approved by the FDA to be administered in the United States.

In obtained by and , Prasad questioned the routine practice of “giving multiple vaccines at the same time.” It’s not clear whether he was referring to combination vaccines that offer immunity against multiple diseases with a single shot. Three of the nine hepatitis B vaccines currently approved by the FDA are combination vaccines. The of the hepatitis B vaccine is given only as a stand-alone vaccine.

Contacted for comment, Health and Human Services spokesperson Emily Hilliard said in a statement that “ACIP will review the evidence at its meeting this week and issue recommendations based on gold standard, evidence-based science and common sense.”

‘Sowing Distrust’

If private insurers opt to still cover the shot, misinformation from the meeting still could lead families to falsely believe the vaccine could harm their babies, said , chair of the Committee on Infectious Diseases for the American Academy of Pediatrics and an assistant professor of pediatrics at the University of Colorado School of Medicine.

“Whatever comes out of this disaster of a meeting in December is going to be mainly designed around sowing distrust and spreading fear,” he said.

President Donald Trump, Kennedy, and some newly appointed ACIP members have mischaracterized how the liver disease spreads, ignoring or downplaying the risk of transmission through indirect contact. The hepatitis B virus is than HIV. Unvaccinated people, including children, can get infected from microscopic amounts of blood on a tabletop or toy, even when the infected person is asymptomatic.

McMahon has cared for children who tested negative at birth and later became infected through indirect contact. In a , nearly a third of such children went on to develop chronic hepatitis B without ever showing symptoms, he said.

“It’s a very infectious virus,” McMahon said. “That’s why giving everybody the birth dose is the best way to prevent it.”

The CDC recommends that all pregnant people be screened for hepatitis B, but it estimates that up to 16% are not tested and fall through the cracks. O’Leary and other experts say testing mothers for the virus shortly before or after delivery is unfeasible, because most hospitals lack the staff and resources.

The three-dose vaccine has a of safety. Numerous studies show it is not associated with an increased risk of , , , or , and severe reactions are rare.

“We have an incredible safety profile,” O’Leary said. “No one expects to get in a car wreck, right? And yet we all put our seat belts on. This is similar.”

The CDC estimates that 2.4 million people in the U.S. have hepatitis B and that half they are infected. The disease can range from an acute infection to a chronic one, often with . If the disease is left untreated, it can lead to serious conditions such as cirrhosis, liver failure, and liver cancer. There is no cure.

Expert’s Advice to Parents: Talk to a Doctor

, a professor of preventative medicine at the Vanderbilt University School of Medicine and a former voting member of ACIP, said some parents struggle to understand why a healthy newborn needs a vaccine so soon after birth, especially for a virus they feel certain they don’t have and often wrongly associate only with risky behaviors. Those perceptions, he said, mix with declining trust in public health and rising skepticism about vaccines.

His advice to expectant parents who are on the fence is to talk to their doctor about the shots. Even if the pregnant woman has tested negative, he said, it’s still important to give the baby the birth dose, because false negatives are possible and because the virus can spread so easily from surface contact. Babies who receive the full vaccine series starting from birth have their chance of .

“If you wait a month and if the mom happens to be positive, or the baby picks it up from a caregiver, by that time the infection is established in that baby’s liver,” Schaffner said. “It’s too late to prevent that infection.”

He said that if fewer people get vaccinated, hepatitis B will circulate at higher rates in American communities and the risk of contracting the virus will rise for everyone who doesn’t get the shots.

And more hepatitis B cases could mean higher costs for patients and the broader health care system. The CDC estimates treating someone with a less severe form of the disease costs $25,000 to $94,000 per year. For patients who require a liver transplant, annual medical expenses can climb above $320,000, depending on their treatment.

Over the past 30 years, the parents have reported from their babies receiving the birth dose have been fussiness and crying, both of which pass quickly. Schaffner said that’s a very strong safety profile — for a newborn vaccine with a track record of protecting babies from an incurable disease.

“The data are so clear about this,” Schaffner said. “A whole array now of other countries have initiated this program. They’ve modeled it on us.”

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

Both President Donald Trump and some newly appointed ACIP members have mischaracterized how the liver disease spreads, according to medical experts, including those working at the CDC. The ACIP panel’s recommendations can determine insurance coverage for immunizations.

At a White House press conference on Sept. 22, Trump, in advocating for delaying the newborn vaccine dose, falsely claimed that hepatitis B is solely a sexually transmitted infection.

“Hepatitis B is sexually transmitted. There’s no reason to give a baby that’s almost just born hepatitis B. So I would say wait till the baby is 12 years old and formed and take hepatitis B,” Trump said.

Hepatitis B is a highly infectious virus that attacks the liver and is transmitted through contact with infected bodily fluids, including blood. It can also be passed from mother to baby.

A reporter asked if Trump had spoken with Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the CDC, about making the change, and Trump said he had, as Kennedy looked on.

Although hepatitis B is often associated with high-risk behaviors such as injection drug use or having multiple sexual partners, , including career CDC scientists, note that the virus can be transmitted in ordinary situations too, including among young children.

At the latest ACIP meeting, held Sept. 18 and 19, members debated postponing the hepatitis B newborn dose until 1 month of age.

CDC scientist outlined research showing incidences of unvaccinated children born in the U.S. to mothers who tested negative, later becoming infected with hepatitis B. Langer serves as acting principal deputy director for the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention.

Langer told the vaccine advisory panel that the virus can survive for outside the body on surfaces. During that time, contact with even microscopic traces of infected blood on a is enough for a child to be infected. This means unvaccinated children not considered at high risk can still be exposed in everyday environments, or by an infected caregiver.

“We do have data that says that it can happen and that it is likely to happen,” he said. Though the exact cause of infection may not be clear in documented cases of children of hepatitis B-negative mothers becoming infected, “I can tell you that it didn’t come from the mother and it didn’t come from injection drug use and it didn’t come from sexual contact, so that means that it had to have been some kind of casual contact,” Langer said.

Yet during the debate, some members gave little credence to the risk of transmission to children through household contact.

“This is a very, very important vaccine that should be given to the high-risk populations,” said ACIP voting member , a professor of operations management at the MIT Sloan School of Management. “The high-risk populations seem to be babies born to hep B-positive mothers, drug addicts, and other populations at high risk,” he said, despite Langer’s presentation highlighting other avenues of possible transmission.

Contrary to research that was presented, Levi later said the risk of not vaccinating children of hepatitis B-negative mothers was “probably close to zero” in the first few years of life.

The CDC estimates 2.4 million people in the U.S. have hepatitis B and half they are infected. The disease can range from an acute, mild infection to a chronic infection, often with . The disease has no cure and, if left untreated, can lead to serious conditions like cirrhosis, liver failure, and liver cancer later in life.

During debate on the vote to delay the newborn dose, ACIP member said that the proposed one-month gap would leave some children vulnerable to the virus, even if their mothers test negative for hepatitis B.

“This assumes implicitly that all the infections are coming from moms,” Hibbeln said. “You can’t decide on that simply by the mother’s status. You would have to look at the entire household’s status.”

ACIP member Evelyn Griffin, an obstetrician and gynecologist, asserted that doctors could ascertain an entire household’s hepatitis B status by asking the mother.

“How are they going to know?” Hibbeln said. “If 50% of people don’t know that they are hepatitis B-positive, you can ask all you want, and nobody knows.”

The committee members, all handpicked by Kennedy, ultimately decided to table the vote on whether to delay the newborn dose after Hibbeln brought up inconsistencies in the wording of the text of the resolution.

“The notion that hepatitis B is only confined to transmission for prostitutes, drug users, etc. is such an ignorant and uninformed way of approaching infectious disease,” internist , the president of the American College of Physicians and its liaison to ACIP, said when reached after the meeting.

“The virus does not care what your behavior or lifestyle is. The virus goes from person to person through bodily fluids,” Goldman said. It can be transmitted when an unvaccinated person touches infected bodily fluids on common surfaces and then accidentally touches the eyes or mouth. “What if someone was in a car accident and got exposed to blood?”

“It is not only mother-to-fetus transmission, it is not only certain risk groups,” he said. “This is why it’s universal; everyone should get this for their protection, and it is unfortunate that it is being politicized into a sexually transmitted disease and that’s it. That’s not an appropriate way to evaluate science.”

Pediatric vaccination recommendations are widely credited with nearly eliminating the virus in American-born children.

Babies infected at birth have a 90% chance of developing chronic hepatitis B, and a quarter of those children go on to have severe complications, like liver cancer, or to die from the disease.

In 1991, federal health officials determined newborns should receive their first dose of a hepatitis B vaccine within , which can block the virus from taking hold if transmitted during delivery. From 1990 to 2022, case rates of hepatitis B declined by more than 99%. While parents may opt out of the shots, many day care centers and school districts of hepatitis B vaccination for enrollment.

The next meeting of the ACIP is scheduled to begin Oct. 22. Agendas are usually posted weeks in advance, but so far, no information on the substance of the upcoming meeting has appeared on the CDC’s website. The agenda for the September meeting was posted less than a week before the meeting’s start.

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

Susan Monarez, the former director of the Centers for Disease Control and Prevention, testified before the Senate Health, Education, Labor and Pensions Committee on Sept. 17 in her first public remarks since she was fired. Some Republicans on the committee accused her of lying and said she hadn’t been on board with the administration’s agenda.

As in earlier hearings concerning Robert F. Kennedy’s performance as secretary of the Department of Health and Human Services, the focus was on Sen. Bill Cassidy (R-La.), who cast the deciding vote as HELP Committee chair to confirm Kennedy early this year. Since that vote, Cassidy has repeatedly expressed skepticism about Kennedy’s leadership.

Cassidy noted that when Kennedy swore in Monarez on July 31, he extolled her “unimpeachable scientific credentials.” Less than a month later, she was fired. “What happened?” Cassidy said. “Turmoil at the top of the nation’s top public health agency is not good for the health of the American people.”

Monarez said she came into the job aligned with Kennedy’s goals of improving America’s health and was open to changing the policies and structures at the CDC. She wasn’t ready to compromise her scientific judgment, however.

“I could have kept the office, the title, but I would have lost the one thing that cannot be replaced: my integrity,” she said.

Monarez said that at an Aug. 25 meeting, Kennedy demanded she fire senior scientists and agree to approve all changes in vaccine policy put forward by the new members of the Advisory Committee on Immunization Practices. In June, Kennedy fired its members and replaced them with a smaller group that includes leading opponents of the U.S. vaccination program.

When Monarez refused both requests, she said, Kennedy told her to resign. She refused, and the White House fired her, she said.

Kennedy, in testimony this month, denied he’d made the ultimatums and said Monarez had lied. Republican senators repeated that claim at Wednesday’s hearing. Markwayne Mullin of Oklahoma said a recording of the Aug. 25 meeting contradicted Monarez’s account. But later in the hearing, Cassidy said that Mullin had retracted his statement, saying there was no such recording.

The hearing appeared to confirm reports that Kennedy intends to change the childhood vaccine schedule, moving initially against recommending a hepatitis B vaccination shortly after birth, a practice the CDC has supported for more than three decades.

The that children be vaccinated against 16 pathogens with about 25 shots, sprays, or oral vaccinations in their first two years of life. The vaccines protect kids against such diseases as influenza, measles, whooping cough, meningitis, diarrhea, chickenpox, cancer, and pneumonia. It’s up to states to decide which vaccinations are required for schoolchildren.

Sen. Lisa Blunt Rochester (D-Del.) noted that for decades universal vaccination of newborns for hepatitis B has reduced case rates of the disease among young people by 99%, as reported by Ñî¹óåú´«Ã½Ò•îl Health News. Sens. Ashley Moody (R-Fla.), Ed Markey (D-Mass.), and Cassidy (R-La.) asked about plans, first reported by Ñî¹óåú´«Ã½Ò•îl Health News, for ACIP to vote to recommend pushing the first dose of the hepatitis B vaccine from the hours after birth to age 4.

Cassidy, in closing the hearing, spoke gravely of the dangers of ending the hepatitis B dose for newborns. He noted that before 1991 as many as 20,000 babies would become infected with hepatitis B, often leading to liver disease and sometimes death. Today, fewer than 20 babies a year contract the virus from their mothers, he said.

“That is an accomplishment to make America healthy again, and we should stand up and salute the people that made that decision,” he said.

Asked by reporters after the hearing whether the American public should have confidence in the advisory committee if it votes to delay the hepatitis B dose for newborns, he replied, “No.”

This article first appeared on Ñî¹óåú´«Ã½Ò•îl Health News and is republished here under a .

A key federal vaccine advisory panel whose members were recently replaced by Health and Human Services Secretary Robert F. Kennedy Jr. is expected to vote to recommend delaying until age 4 the hepatitis B vaccine that’s currently given to newborns, according to two former senior Centers for Disease Control and Prevention officials.

“There is going to likely be a discussion about hepatitis B vaccine, very specifically trying to dislodge the birth dose of hepatitis B vaccine and to push it later in life,” said Demetre Daskalakis, of the National Center for Immunization and Respiratory Diseases. “Apparently this is a priority of the secretary’s.”

The vote was expected to take place during the next meeting of the CDC’s Advisory Committee on Immunization Practices, scheduled for Sept. 18-19.

For more than 30 years, the first of three shots of hepatitis B vaccine has been recommended for infants shortly after birth. In that time, the potentially fatal disease has been virtually eradicated among American children. Pediatricians warn that waiting four years for the vaccine opens the door to more children contracting the virus.

“Age 4 makes zero sense,” pediatrician Eric Ball said. “We recommend a universal approach to prevent those cases where a test might be incorrect or a mother might have unknowingly contracted hepatitis. It’s really the best way to keep our entire population healthy.”

In addition to the hepatitis B vaccine, the panel and vote on recommendations for the combined measles, mumps, rubella, and varicella vaccine and covid-19 vaccines. Pediatricians worry changes to the schedules of these vaccines will limit access for many families, leaving them vulnerable to vaccine-preventable diseases.

Typically, ACIP would undertake an analysis of the data before recommending a change to vaccine guidelines. As of the end of August, this process had not begun for the hepatitis B vaccines, Daskalakis and another former official said.

“This is an atypical situation. There’s been no work group to discuss it,” Daskalakis said.

The second former senior official spoke to NPR and Ñî¹óåú´«Ã½Ò•îl Health News on the condition of anonymity.

In response to questions from Ñî¹óåú´«Ã½Ò•îl Health News, HHS spokesperson Andrew Nixon wrote, “ACIP exists to ensure that vaccine policy is guided by the best available evidence and open scientific deliberation. Any updates to recommendations will be made transparently with gold standard science.”

The draft agenda for the upcoming ACIP meeting was released to the public less than a week before it is scheduled to begin.

At the last ACIP meeting, in June, Martin Kulldorff, the chair and one of seven new members handpicked by Kennedy, questioned the need to vaccinate every newborn, citing only two of the many ways the virus can spread. Kulldorff is a former Harvard Medical School professor who became known for during the pandemic.

“Unless the mother is hepatitis B positive, an argument could be made to delay the vaccine for this infection, which is primarily spread by sexual activity and intravenous drug use,” he said.

The virus spreads via direct exposure to an infected bodily fluid like blood or semen. The disease has no cure and can lead to serious conditions like cirrhosis and liver cancer later in life. The CDC advisory panel may maintain the recommendation to inoculate newborns whose mothers have hepatitis B or are considered at high risk of the disease, the former officials said.

Protection From Birth

In 1991, federal health officials determined it was advisable for newborns to receive their first dose of the hepatitis B vaccine within , which blocks the virus from taking hold if transmitted during delivery. While parents may opt out of the shots, many day care centers and school districts of hepatitis B vaccination for enrollment.

The prospect of ACIP’s altering the recommendation has left some people living with the virus deeply unsettled.

“I am goddamn frustrated,” said Wendy Lo, who has lived with the liver disease, likely since birth. Years of navigating the psychological, monetary, medical, and social aspects of chronic hepatitis B has touched almost every aspect of her life.

“I would not want anyone to have to experience that if it can be prevented,” she said. Lo learned she had the disease due to a routine screening to study abroad in college.

Lo credits the vaccines with protecting her close family members from infection.

“I shared with my partner, ‘If you get vaccinated, we can be together,’” she said. He got the vaccine, which protects him from infection, “so I’m grateful for that,” she said.

The CDC estimates half of people with hepatitis B they are infected. It can range from an acute, mild infection to a chronic infection, often with . Most people with chronic hepatitis B were born outside of the U.S., and Asians and Pacific Islanders Black people have the highest rates of newly reported chronic infections.

When her children were born, Lo was adamant that they receive the newborn dose, a decision she says prevented them from contracting the virus.

The earlier an infection occurs, , according to the CDC. When contracted in infancy or early childhood, hepatitis B is far more likely to become a chronic infection, silently damaging the liver over decades.

Those who become chronic carriers can also unknowingly spread the virus to others and face an increased risk of long-term complications including cirrhosis and liver cancer, which may not become evident until much later in life.

“Now I’m in my 50s, one of my big concerns is liver cancer. The vaccine is safe and effective, it’s lifesaving, and it protects you against cancer. How many vaccines do that?” Lo said.

Thirty Years of Universal Vaccination

Treatments like the antivirals Lo now takes weren’t available until the 1990s. Decades of the virus’s replicating unchecked damaged her liver. Every six months she gets scared of what her blood tests may reveal.

After a vaccine was approved in the 1980s, public health officials initially focused vaccination efforts on people thought to be at highest risk of infection.

“I, and every other doctor, had been trained in medical school to think of hepatitis B as an infection you acquired as an adult. It was the pimps, the prostitutes, the prisoners, and the health care practitioners who got hepatitis B infection. But we’ve learned so much more,” said , a professor of infectious diseases at the Vanderbilt University School of Medicine and a former voting member of ACIP.

As hepatitis B rates remained stubbornly high in the 1980s, scientists realized an entire vulnerable group was missing from the vaccination regime — newborns. The virus is from an infected mother to baby in late pregnancy or during birth.

“We may soon hear, ‘Let’s just do a blood test on all pregnant women.’ We tried that. That doesn’t work perfectly either,” Schaffner said.

Some doctors didn’t test, he said, and some pregnant women falsely tested negative while others acquired hepatitis B after they had been tested earlier in their pregnancies.

In 1991, Schaffner was a liaison representative to ACIP when it voted to for hepatitis B before an infant leaves the hospital.

“We want no babies infected. Therefore, we’ll just vaccinate every mom and every baby at birth. Problem solved. It has been brilliantly successful in virtually eliminating hepatitis B in children,” he said.

In 1990, there were 3.03 cases of hepatitis B per 100,000 people 19 years old or under in the U.S., according to the CDC.

Since the federal recommendation to vaccinate all infants, cases have dramatically decreased. shows that in 2022 the rate among those 19 or under was less than 0.1 per 100,000.

While hepatitis B is often associated with high-risk behaviors such as injection drug use or having multiple sexual partners, note that it is possible for the virus to be transmitted in ordinary situations too, including among young children.

The virus can survive for outside the body. During that time, even microscopic traces of infected blood on a can pose a risk. If the virus comes into contact with an open wound or the mucous membranes of the eyes, an infection can occur. This means that unvaccinated children not considered at high risk can still be exposed in everyday environments.

Future Access Uncertain

If the CDC significantly alters its recommendation, health insurers would no longer be required to cover the cost of the shots. That could leave parents to pay out-of-pocket for a vaccine that has long been provided at no charge. Children who get immunizations through the federal program would lose free access to the shot as soon as any new ACIP recommendations get approved by the acting CDC director.

The two former CDC officials said that plans were underway to push back the official recommendation for the vaccine as of August, when they both left the agency, but may have changed.

Schaffner is still an alternate liaison member of ACIP, and hopes to express his support for universal newborn vaccination at the next meeting.

“The liaisons have now been excluded from the vaccine work groups. They are still permitted to attend the full meetings,” he said.

Schaffner is worried about the next generation of babies and the doctors who care for them.

“We’ll see cases of hepatitis B once again occur. We’ll see transmission into the next generation,” he said, “and the next generation of people who wear white coats will have to deal with hepatitis B, when we could have cut it off at the pass.”

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The state is paying for the marketing campaign as part of a deal to give AbbVie the exclusive right to treat its citizens who have the potentially deadly liver disease. Armed with its medication, Mavyret, AbbVie beat out rivals Merck and Gilead Sciences in a blind bidding process.

It’s the second time this year that a state has struck a novel deal with a pharmaceutical company to obtain drugs that can cure hepatitis C ― with discounts from a price that came to market at $84,000 for a course of treatment.

The drugmakers are in a race to treat the . with the viral infection. Left untreated, its most chronic form can cause liver damage, including cirrhosis, as well as liver cancer and death. States are weighing the price of curing those infected with hep C using the new drugs against the medical and economic costs of long-term care for those with untreated infections. The state bears the medical expenses of the Medicaid and prison populations as well as public employees and retirees.

The money paid to AbbVie buys a package of services that includes outreach and testing to identify patients as well as the drugs to treat them. But the price and other details of the deal are secret under the Washington state Public Records Act, even though they involve massive commitment of taxpayer dollars.

Washington officials said they’re prohibited from releasing details by that hide drug pricing to protect what companies consider trade secrets. Lawyers for the three pharmaceutical firms that submitted bids vowed to go to court to halt the release of bid documents requested by Kaiser Health News under state public records laws.

Without transparency about the details, however, it is impossible to evaluate whether the spending amounts to smart public policy or a boondoggle that primarily benefits manufacturers hoping to lock down payments of perhaps $10,000 per patient for drugs from Medicaid. The same drugs from the same manufacturers can cost in other parts of the world.

The secrecy troubles Dr. John Scott, medical director of the University of Washington’s Hepatitis and Liver Clinic at Harborview Medical Center in Seattle, which treats most of the 65,000 hepatitis C patients in the state ― even as he welcomes the curative drugs and wider access to treatment.

“I absolutely support greater transparency,” Scott said. “I think the public needs to know how much these things cost.”

Many people don’t realize that such obscurity is “baked into the system,” said Pam Curtis, director of the Center for Evidence-Based Policy at Oregon Health & Science University.

“That definitely hamstrings our ability to weigh the facts in front of us,” she said. “You want policy to be driven by the highest-quality evidence.”

Other states are eyeing the experiments “with a healthy skepticism but a high level of interest,” said Jennifer Reck, project director for the National Academy for State Health Policy.

In Washington, officials would describe the terms of the AbbVie contract only in the broadest terms. After federal rebates, the state spent about $80.4 million in 2018 on the drugs, known as direct-acting antivirals, to treat more than 3,300 patients, figures show.

Under the new contract, officials expect to spend about the same amount of money per year, while treating twice as many patients, said Dr. Judy Zerzan, chief medical officer for the Washington State Health Care Authority.

That works out to more than $321 million to treat about 30,000 patients over four years, with options for two-year extensions.

But that would be an improvement over the nearly $387 million state officials have to treat just 10,377 people, according to state records. That works out to an average cost of $37,259 apiece, though actual fees vary by program.

Washington’s request for proposals included a provision that other states could join its program in the future ― also a potential benefit to AbbVie.

“There’s probably an alignment of interests all the way around here,” said Alan Carr, a senior analyst focusing on biotechnology with the Wall Street firm Needham & Co.

Another reason it’s a race for the drugmakers: The overall market for hepatitis C drugs has been “falling fast,” as more patients are treated and cured, Carr said.

“The companies are trying to find a way to ensure the remaining patients use their drug,” Carr said. “[They] have a lot less leverage than they once had, and that’s why they’re willing to do these deals.”

Many patients with hepatitis C have no symptoms and are silent carriers. Only a fraction of people with the virus will develop the serious consequence of the disease, liver failure or cancer. Still, most public health experts urge screening ― and treatment.

The new contracts ― sometimes because they ― call for capped costs or flat-rate subscriptions for cheap access to the drugs.

But the plan is much broader than creating a drug discount for the state, said Michael Staff, AbbVie’s vice president of U.S. market access.

“Simply stating you want to eradicate hepatitis C without a very detailed plan is probably not going to be effective,” he said. AbbVie’s contract includes payments for services that include outreach, such as the bus, to identify infected patients.

In Washington, would treat about half of those in the state infected with hepatitis C, but the average per-patient cost would be about 40% less than before the deal, Zerzan said.

In Louisiana, the first state to announce a flat-rate hepatitis C drug , Asegua, a subsidiary of Gilead, will provide an unlimited amount of its drug, Epclusa, for a set price — roughly $58 million a year for five years, or up to $290 million. Louisiana plans to treat about 31,000 of 39,000 Medicaid patients and prisoners believed to have the disease. Costs could drop to less than $10,000 per patient, according to the contract, which the state health agency made available after a public records request.

The was put forward by Dr. Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes, and his colleagues. Australia implemented a in its national health plan. England’s National Health Service has one as well.

In Egypt, which has the highest hepatitis C rate in the world, negotiations and generic pricing have reduced costs to

U.S. drugmakers likely wouldn’t have considered such a plan when they first introduced their medications. Gilead’s Sovaldi, the first antiviral for hepatitis C, launched at $84,000 for a course of treatment; the second, Harvoni, started at $94,500. Three years later, AbbVie introduced Mavyret at $26,400.

Now, Bach said, drugmakers are staring down a sharp decline of their once-hot market.

“They were losing market share and price per share,” Bach said. “If payers [like state Medicaid programs] can give them the same revenue with much more certainty, they’ll prefer that to uncertainty over what’s happening now.”

Hepatitis C poses dilemmas for public health officials and drugmakers alike.

Louisiana has been from the American Civil Liberties Union regarding prisoners who said they were denied effective hepatitis C treatment. And Washington state’s Department of Corrections faces from a prisoner who said he was denied timely care for his disease.

In Washington, Gov. Jay Inslee last year to negotiate the best deal to eliminate hepatitis C in the state by 2030, which mirrors goals of global health agencies.

The federal Centers for Disease Control and Prevention warned last month that new hepatitis C infections are on the rise ― , the seventh consecutive annual increase. New cases of hepatitis C have spiked among adults in their 20s and 30s, largely because of the opioid epidemic, according to the CDC.

Between 15% and 25% of people with acute hepatitis C will clear the infection on their own; the rest become chronically infected with the virus.

Hundreds of thousands of people have been treated ― and cured ― since the drugs were introduced early this decade. Deaths from hepatitis C fell from almost 20,000 in 2014 to a little more than 17,000 in 2017, which could be an effect of the new drugs.

“It’s just been transformational,” said Scott, of the University of Washington’s Hepatitis and Liver Clinic. Previous treatments for hepatitis C had to be taken for a year, had toxic side effects and helped only 40% of patients, he added.

The Center for Evidence-Based Policy has advised Washington state in the effort to eradicate hep C, Curtis said. She noted that the arrangements Washington and Louisiana struck share an overall goal of reining in runaway drug prices, especially in state-run Medicaid programs, which can’t shift costs like the commercial market and would be forced instead to cut services.

“States are already struggling,” Curtis said. “A larger and larger part of their budget is being eaten up by these new high-cost drugs.”

“This is not a solution,” she said, “but it’s a step in the right direction.”

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Within days, the 40-year-old landed in the hospital, diagnosed with the highly contagious liver virus hepatitis A, which in Ohio has infected more than 3,220 people and killed at least 15.

Since 2016, the virus has spawned outbreaks in at least 29 states, starting with Michigan and California. It has sickened more than 23,600 people, sent the majority to the hospital and killed more than 230. All but California’s and Utah’s outbreaks are ongoing, and experts expect to eventually see the virus seep into every state.

Like a shadow, it follows the opioid epidemic, spreading mostly among drug users and the homeless. But anyone who hasn’t been vaccinated can get hepatitis A — as Akron health officials are finding out.

“It’s getting into the general public,” said Tracy Rodriguez, communicable disease supervisor for Summit County Public Health. “It’s scary.”

Hepatitis A thrives in unsanitary conditions and spreads as easily as a stomach virus: People ingest minuscule amounts of an infected person’s stool from food, drinks, drug equipment or objects as commonplace as doorknobs. Burrell, who used to live in a tent but now stays at a friend’s house, believes he contracted the virus cleaning up trash left by fellow drug users and not wearing gloves. More than two weeks after his hospital stay, he described still feeling weak and “worn out” visiting friends near the spot in Akron where he once pitched his tent.

The virus has stricken more people in Ohio than any other state but Kentucky, where it infected more than 4,800 people and killed at least 60. Kathleen Winter, a University of Kentucky epidemiologist, said more populous Ohio is on pace to surpass it as her state’s outbreak wanes.

Relentlessly, the virus continues its march across the nation. Pennsylvania declared an outbreak as recently as May. In early August, Florida and Philadelphia declared public health emergencies, which, among other things, signal to health care providers the need to vaccinate the vulnerable. Case counts now exceed 1,000 in six states.

And as in Akron, the virus reaches beyond homeless people and drug users. One in 5 Kentuckians sickened from August 2017 through mid-2019 fit neither group. Nearly 40% of Florida’s cases from 2018 and the first half of 2019 had no or unknown risk factors.

Simon Haeder, an assistant professor of public policy at Pennsylvania State University, said the outbreaks show how the addiction crisis and the diseases it fuels endanger everyone, while also revealing cracks in the nation’s patchwork, poorly funded public health system. found only 2.5% of U.S. health spending in 2017 went to public health.

“We have growing homeless and drug-using populations. We have a decreasing investment in public health. It doesn’t make me optimistic looking into the future,” Haeder said. “Once you reach a critical mass, eventually everyone is fair game.”

The Power Of A Vaccine

Hepatitis A, which infects liver cells and causes inflammation, can be mild or severe and in rare cases leads to liver failure and death, especially in older people and those with other liver diseases. There’s no cure; doctors advise rest, nutrition and fluids as it runs its course.

Cases dropped dramatically in the United States after a vaccine came out in 1995. The shots are recommended for babies, and federal figures from 2016 show 61% of children between 19 and 35 months old had gotten both of two doses. Only 9.5% of adults 19 and older had gotten the shots.

With so many unprotected adults, the disease roared back in 2016. Public health workers fought it by vaccinating those at greatest risk. In California’s San Diego County, they also opened hand-washing stations and distributed hygiene kits containing hand sanitizer, cleansing wipes, bottled water and other items. They even washed down streets with a bleach solution.

The next year, outbreaks appeared in five more states, including Kentucky, where it would ultimately metastasize into the nation’s largest.

The virus crept into neighboring Ohio in 2018, gradually infecting people in all but seven of 88 counties. By early this month, 111 cases had been reported in Summit County, among the state’s highest tallies.

Rodriguez and her colleagues in the northeastern Ohio county have mounted an all-out assault. They have administered more than 550 vaccinations, targeting people at the county jail, syringe services programs, drug treatment centers, post-incarceration support groups and homeless communities. When they identify cases, they work to find and vaccinate their families, friends and close contacts. Sage Lewis, an advocate for the homeless who owns land where a tent city once stood, said “the health department is saving lives.”

On a recent afternoon, Rodriguez and fellow health department nurse Rachel Flossie vaccinated 26 participants of a post-incarceration reentry program run by South Street Ministries. Participants lined up quickly to get their shots, some wincing at the prick of the needle.

Jessica Gilbert, 33, got her second dose of vaccine. She’d had her first in late May, providing most of her immunity. But she wanted to be extra cautious because she believes she may have been exposed by another woman in jail in a nearby county.

“I want full protection,” she said. “I don’t want to be sick.”

But health officials don’t reach everyone at risk. Some drug users are so focused on their next fix they don’t worry about protecting themselves from the virus. Many dealing with unstable housing or addiction are hard to find.

Burrell said he never heard of hep A before he got it. Although he knew not to share drug equipment when he cooked crystal meth, he said, he didn’t think about the dangers of touching dirty needles or other trash. Burrell now warns others to be careful and spreads the word about vaccination.

Public health nurse Yvonne Demyan does the same when she brings vaccines to a syringe services program in a strip mall health department office.

After vaccinating two other clients on a recent afternoon, Demyan stepped into the waiting area and asked a client: “Your turn?”

Before he could reply, she answered for him: “Yes. Would you rather be sick for a month? Because that’s exactly what’s gonna happen if you get hepatitis A.”

Wave Of Illness Rolls On

News coverage in some places highlights infected restaurant workers, but transmission to restaurant patrons has been “extremely rare” during these outbreaks because of sanitation practices such as washing hands and wearing gloves.

Controlling the virus has proven especially challenging in rural areas, where there are fewer services such as homeless shelters and homelessness can mean couch-surfing with friends. Many small towns have small health departments, with just a couple of nurses and declining budgets. by the National Association of County and City Health Officials found 23% of local health departments serving populations under 50,000 — and 19% of all local health departments — expect budget cuts in the next fiscal year.

Against this backdrop, the CDC has injected federal resources. The agency spent roughly $9.1 million in fiscal 2018 to help curb outbreaks, which includes money for 150,000 federally funded vaccines.

Dr. Monique Foster, a medical officer in CDC’s Division of Viral Hepatitis, said vaccinating those at highest risk remains the best strategy. “Outbreaks will stop when we have effectively vaccinated the vulnerable people,” she said.

Although the federal government isn’t recommending universal vaccination, several experts said the more people vaccinated, the better.

“The risk is there. The disease is circulating,” said the University of Kentucky’s Winter. “It’s good for the general public to be vaccinated.”

With the virus continuing its advance, Penn State’s Haeder said, “it won’t be long before we have it everywhere.”

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One of the clinic’s regular visitors, a man with heavy black arrows tattooed on his arms, waited on the sidewalk to get clean needles.

“I’m Arrow,” he said, introducing himself. “Pleasure.”

This mobile unit in Miami-Dade County is part of the IDEA Exchange, the only legal needle exchange program operating in the state. But Florida’s Republican governor, Ron DeSantis, signed a new law last week that aims to change that.

Needle exchanges have been legal in many other states for decades, but Southern, Republican-led states like Florida have only recently started to adopt this public health intervention.

The timing of the statewide legalization of needle exchanges comes as Florida grapples with a huge heroin and fentanyl problem. When people share dirty needles to inject drugs, it puts them at high risk for spreading bloodborne infections like HIV and hepatitis C. For years, Florida has had America’s highest rates of HIV.

Even so, Arrow said, he and every user he knew always put the drugs first. Clean needles were an afterthought.

“Every once in a while, I did use someone else’s and that was a thrill ride — wondering whether or not I was going to catch anything. But I’m blessed; I’m 57 and I don’t have anything,” Arrow told a reporter at the mobile clinic over a year ago.

Kaiser Health News agreed not to use his full name because of his illegal drug use.

“Now I can shoot with a clean needle every time,” he said.

The Miami Experiment

According to the , needle exchanges prevent the spread of viruses among users of injection drugs.

But the advocates who want to offer needle exchanges face challenges. For example, carrying around loads of needles to hand out without prescriptions can violate drug paraphernalia laws.

Many states mapped out legal frameworks decades ago to allow needle exchanges as a public health intervention. But in Florida, it was illegal to operate exchanges. Then, in 2016, the state legislature gave Miami-Dade County temporary permission to pilot a needle exchange program for five years.

“This is more than just a needle exchange,” said Democratic state Sen. Oscar Braynon.

“This has become a roving triage and health center.”

In three years of operation, Miami’s pilot program has pulled more than a quarter-million used needles out of circulation, according to reports the program filed with the Florida Department of Health. By handing out Narcan — a — the exchange has prevented more than a thousand overdoses. The program also offers clients testing for HIV and hepatitis C. Finally, the program connects people to medical care and drug rehab.

This year, Braynon introduced to allow the rest of Florida’s counties to authorize similar programs.

“We have made it so easy for people to get into HIV care now, and we have so many people who we never would have known were infected — and would have infected countless other people — who are on their medications,” said Dr. Hansel Tookes, who heads Miami’s needle exchange pilot program.

Tookes was in Tallahassee, the state capital, in May when the expansion bill passed its final vote — a long shot in the conservative-dominated legislature that nonetheless passed by an overwhelming margin. He said he spent the return flight home to Miami staring out the window.

“I looked down at Florida the entire ride,” he said, “and I just had this overwhelming feeling like, ‘Oh, my God, we just did the impossible and we’re going to save so many people in this state.'”

Why Harm Reduction Trumped Politics

Six years ago, Republican state Sen. Rob Bradley cast a “no” vote after considering a proposal for needle exchanges.

“You’re trying to make sure the person has a clean needle, which is outweighing the idea of the person breaking the law,” he declared in 2013.

This is the primary objection of conservative lawmakers: the concern that these programs promote illegal drug abuse. Responding to this skepticism with data has been central to changing lawmakers’ minds.

Decades of research shows that needle exchanges do not encourage drug abuse, and that they lower other health risks for people who are vulnerable and often hard to reach. It’s part of a public health approach known as “harm reduction.”

In Miami, the needle exchange pilot project has also earned the support of law enforcement.

Officers say it’s a relief to know more injection drug users are keeping their syringes in special , provided by the exchange, to safely dispose of dirty needles.

“Now, for our officers, when they’re doing a pat-down … that sharps container is really protecting you from a loose needle,” said Eldys Diaz, executive officer to the Miami police chief. “That’s an extraordinary source of comfort for us.”

This year, when Bradley heard discussion of the needle exchange bill again, he had a different response.

“I just want to say, when I started my career in the Senate, I voted against the pilot project — and I was wrong,” he said as he voted for the bill this time. “And the results speak for themselves. It’s very good public policy.”

The bill passed unanimously in the Florida Senate and by a 111-3 vote in the Florida House. It took effect Monday.

Arrow Points To His Future

If it weren’t for the tattoos running down his arms, it would be hard today to recognize Arrow as the man who once slept under highway overpasses. His skin is now clear, and he has some meat on his bones. He looks healthier during a visit to a clinic where needle exchange clients get follow-up care, but it’s been a rough year.

In May of last year, Arrow’s girlfriend died from a heart infection — a serious condition that can happen to people who inject drugs. After that, Arrow said, he overdosed on purpose. Narcan from the needle exchange brought him back.

But he kept using.

Arrow said he doesn’t remember a lot from that period but does remember using so much heroin that he ran out of fresh needles between visits to the exchange. So he grabbed other people’s used needles.

And then he tested positive for HIV and hepatitis C.

Tookes and his colleagues threw Arrow another life raft: They got him an inpatient drug treatment bed.

Now Arrow sports a string of keychains from Narcotics Anonymous.

“My chain of sobriety,” he said of the links. “I got 30-days, 60-days and 90-days chips,” he said.

Arrow’s HIV is under control. And he connected with health services for people living with HIV, including getting medication that cured his hepatitis C.

Now, he’s focused on staying sober, one day at a time. He has been sober for about six months.

Tookes, Braynon and other supporters hope additional needle exchanges across Florida will give more people the chance to recover from addiction — and protect themselves from needle-borne illnesses.

This story is part of a partnership that includes , and Kaiser Health News.

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But not in Puerto Rico. Medicaid patients in the American territory get no coverage for these drugs.

The joint federal-territory health care program for the poor — which covers about half the island’s population — does not pay for hepatitis C medications. They also do not cover liver transplants, a procedure patients need if the virus causes the organ to fail.

The Puerto Rico Department of Health created a separate pilot project in 2015 to provide hepatitis C medications to those sickened by the liver infection who also have HIV but expanded the program later to those with only hepatitis C. However, according to the Office of Patient Legal Services, an official territorial agency that advocates for consumers, the program ran out of funding and is no longer accepting patients only with hepatitis C.

The Puerto Rico Health Insurance Administration (ASES), which oversees Medicaid, said it is working with a pharmaceutical company to create a cost-effective system to provide these medications.

“Definitely, they need to be given coverage,” said ASES director Angela Ávila Marrero. “They need to be given care.”

Hepatitis C, a bloodborne infection, increases the risk of cirrhosis, liver cancer and death. Poor screening led many to contract the disease through tainted blood and organ transplants into the early 1990s. Today, intravenous drug use drives in the United States.

William Ramirez, executive director of the American Civil Liberties Union of Puerto Rico, said he is considering filing suit against Puerto Rico for failing to cover the cost of these medications for people enrolled in Medicaid.

“You’re holding back medication and thereby allowing certain people to die,” Ramirez said.

That reality is clear for Hector Marcano, 62, who stopped working roughly six years ago because of the illness. After recovering from a drug addiction, he was a case manager who worked to connect drug users to health resources.

His liver disease is leading to overall deterioration. He struggles with walking. A bout of pneumonia that left him hospitalized lingers in his racking coughs. He spends his days reading, listening to the radio and praying for the strength to keep searching for the cure.

He doesn’t understand why the government does not provide hepatitis C medications, he said, especially as there are so many people in need of them.

“So what are we waiting for?” asked Marcano. “For a pandemic to happen?”

Medicaid Costs Drive Island’s Debt Crisis

Hepatitis C afflicts approximately 3.5 million people in the United States. The virus can silently corrode the liver for years without causing symptoms.

Because of the condition’s stealthy nature and the absence of recent data, the number of people in Puerto Rico living with the virus is uncertain. Researchers on the island in 2010 2.3 percent of 21- to 64-year-old residents had the virus.

Documents provided by the Center for Health Law and Policy Innovation of Harvard Law School show medical providers reported more than 11,000 hepatitis C cases to the Puerto Rico Department of Health from 2010 to September 2016.

Cynthia Pérez Cardona, an epidemiology professor at the University of Puerto Rico and an author of multiple studies involving hepatitis C in Puerto Rico, said she is uncertain of how widespread the virus is on the island. But other statistics present a worrisome sign: A report from the island’s found the number of new liver cancer cases increased an average of 2.1 percent annually among men and 0.7 percent among women from 1987 to 2014. Hepatitis C can cause such cancers.

Despite these warnings, Puerto Rico has fewer resources than most of the nation to care for its impoverished.

Unlike states, Puerto Rico’s federal funding for Medicaid is capped. Historically, these federal dollars have fallen far short of covering the program’s costs on the island. The territory’s crushing Medicaid expenses helped drive the island into its $70 billion debt crisis.

Under these financial constraints, said Matt Salo, executive director of the National Association of Medicaid Directors, Puerto Rico’s officials are left with a difficult choice when considering covering hepatitis C drugs.

“Rather than blowing through their cap in six months,” Salo said, “they’d blow through their cap in one month.”

Pilot Project Falls Short

In the health department’s , patients with certain conditions like uncontrolled diabetes or an active mental health condition or those who could not prove they had been sober for six months were barred.

Such restrictions rankle patients and their advocates. “You know, we do not deny lung cancer treatment for a person who smokes or diabetes treatment to a person that doesn’t eat well,” said Robert Greenwald, a professor at Harvard Law School and faculty director of the Center for Health Law and Policy Innovation.

Dr. José Vargas Vidot, a member of Puerto Rico’s Senate and a physician, submitted a petition in 2017 to various territorial agencies questioning Medicaid’s coverage of hepatitis C medications.

The Office of Patient Legal Services responded to Vargas Vidot in a letter this year confirming that the island’s Medicaid program did not cover these drugs. It also noted the health department pilot project closed its wait list after reaching 100 patients because of a lack of funding. In November, Vargas Vidot submitted legislation to require that hepatitis C medication and treatment be part of basic coverage for insurance plans and Medicaid.

Ávila Marrero said ASES is in talks with a drugmaker to create a network separate from the Medicaid program to provide medications to the patients. She said she hopes the arrangement will allow the government to get lower prices for the drugs. But no agreements have yet been reached for such a program.

Despite its success in states, suing to get coverage may not be the best option for Puerto Rico because the debt rescue package passed by Congress in 2016 includes a provision that bars creditors from taking legal action to collect from the territory.

That could apply to a lawsuit filed against the territory for not covering hepatitis C treatment in its Medicaid program, said Phillip Escoriaza, a health and federal grants law attorney in Washington, D.C., who practiced in Puerto Rico. And even if the case can go forward, it would enter the docket for a special bankruptcy court with more than , as of Dec. 14. It may be in the Puerto Rican government’s interest for things to take a long time, said Escoriaza. Once there, it could stall for years — time hepatitis C patients such as Marcano might not have.

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