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Tag: Medication

  • Hims & Hers drops plan for knockoff of Novo Nordisk’s new Wegovy weight loss pill

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    Telehealth company Hims & Hers dropped its plan to offer a knockoff version of the weight-loss pill Wegovy on Saturday — two days after it announced the new drug and one day after the Food and Drug Administration threatened to restrict access to the ingredients needed to copy popular weight-loss medications.

    Hims had said Thursday that it would offer a compounded version of the new Wegovy pill that drugmaker Novo Nordisk just began selling last month. Novo immediately threatened to sue Hims, and then the FDA said Friday that it plans to take decisive steps to limit access to the active ingredients in popular GLP-1 drugs like Wegovy, Ozempic and Zepbound.

    Hims’ own website still touted the new semaglutide pill offering Saturday afternoon — hours after it announced on X that it will no longer sell the medicine. Semaglutide is the chemical name for Wegovy.

    “Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment,” Hims said in its statement. “We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.”

    Hims didn’t say Saturday whether it will make any changes to the compounded versions of injectable weight-loss medications it has been selling as a result of the FDA action.

    The San Francisco-based company had planned to significantly undercut Novo’s price of $149 per month for the Wegovy pill by selling its version at $49 for the first month and $99 per month thereafter. Hims and other similar companies got started several years ago by offering cheap generic versions of drugs for hair loss, erectile dysfunction and other health issues before branching out into the multibillion market for obesity medications.

    Novo plans to tout its new FDA-approved Wegovy pill in a celebrity-filled Super Bowl ad on Sunday. The Danish pharmaceutical giant didn’t immediately comment Saturday on Hims’ decision to drop the knockoff. Rival drugmaker Eli Lilly has said that it expects the FDA to approve an oral version of its orforglipron weight loss medication later this spring. But Wegovy is the first pill to hit the market.

    The compounded medicine that Hims had planned to sell wasn’t approved and had not gone through trials to demonstrate that it would be effective.

    The FDA permits specialty pharmacies and other companies to make compounded versions of brand name drugs when they are in short supply. And the booming demand for GLP-1 drugs in recent years prompted companies like Hims to jump into the multibillion-dollar market for the drugs, with many patients willing to pay cash.

    In 2024, the FDA said that GLP-1 drugs were no longer in a shortage, which was expected to put an end to the compounding. But companies like Hims relied on an exception to keep selling their versions of the medications because the practice is still permitted when a prescription is customized for the patient.

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  • Newly obtained emails undermine RFK Jr.’s testimony about 2019 Samoa trip before measles outbreak

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    Over two days of questioning during his Senate confirmation hearings last year, Robert F. Kennedy Jr. repeated the same answer.

    He said the closely scrutinized 2019 trip he took to Samoa, which came before a devastating measles outbreak, had “nothing to do with vaccines.”

    Documents obtained by The Guardian and The Associated Press undermine that testimony. Emails sent by staffers at the U.S. Embassy and the United Nations provide, for the first time, an inside look at how Kennedy’s trip came about and include contemporaneous accounts suggesting his concerns about vaccine safety motivated the visit.

    The documents have prompted concerns from at least one U.S. senator that the lawyer and activist now leading America’s health policy lied to Congress over the visit. Samoan officials later said Kennedy’s trip bolstered the credibility of anti-vaccine activists ahead of the measles outbreak, which sickened thousands of people and killed 83, mostly children under age 5.

    The revelations, which come as measles outbreaks erupt across the U.S., build on previous criticism that Kennedy’s anti-vaccine record makes him unfit to serve as health secretary, a role in which he has worked to radically reshape immunization policy and public perceptions of vaccines.

    The newly disclosed documents also reveal previously unknown details of the trip, including that a U.S. Embassy employee helped Kennedy’s team connect with Samoan officials. Kennedy, then running his anti-vaccine group Children’s Health Defense, did not publicly discuss the trip at the time, but he has since said his “purpose” for going there was not related to vaccines and “I ended up having conversations with people, some of whom I never intended to meet.” Besides meeting with anti-vaccine activists, Kennedy met with Samoan officials, including the health minister at the time, who told NBC News that Kennedy shared his view that vaccines were not safe. Kennedy has said he went there to introduce a medical data system.

    The U.S. State Department turned over the emails — many of which are heavily redacted — as a result of an open records lawsuit brought with the assistance of the Reporters Committee for Freedom of the Press.

    These disclosures come at a time when Kennedy, as President Donald Trump’s health secretary, has used his power and enormous public influence to overhaul federal immunization guidance and raise suspicion about the safety and importance of vaccines, including the measles vaccine. Meanwhile, measles outbreaks in multiple U.S. states have rolled back decades of success in eliminating the highly contagious disease, putting the country on the verge of losing its elimination status. The latest figures show more than 875 people in South Carolina have been infected.

    Kennedy addressed questions about his trip to Samoa during two Senate confirmation hearings for his appointment as health secretary.

    “My purpose in going down there had nothing to do with vaccines,” he said under questioning by Democratic Sen. Edward Markey of Massachusetts in his Jan. 30, 2025, hearing.

    “Did the trip have nothing to do with vaccines as you told my colleagues in Senate Finance yesterday?” Markey asked later.

    “Nothing to do with vaccines,” Kennedy replied.

    One of the senators who questioned Kennedy about Samoa during his confirmation hearings, Sen. Ron Wyden, a Democrat from Oregon, responded to the records by saying, “Kennedy’s anti-vaccine agenda is directly responsible for the deaths of innocent children.”

    “Lying to Congress about his role in the deadly measles outbreak in Samoa only underscores the danger he now poses to families across America,” Wyden said in an email. “He and his allies will be held responsible.”

    Taylor Harvey, a spokesman for Wyden and other Democrats on the Senate Finance Committee, said it is a crime to make a false statement to Congress and “casual, false denials to Congress will not be swept under the rug.”

    A spokesman for the U.S. Department of Health and Human Services did not respond to questions sent by email and text message.

    Kennedy has said his visit did not influence people’s decisions on whether to get themselves or their children immunized.

    “I had nothing to do with people not vaccinating in Samoa. I never told anybody not to vaccinate,” he told the 2023 documentary “Shot in the Arm.” “I didn’t, you know, go there for any reason to do with that.”

    Anti-vaccine activists in the United States became interested in Samoa in July 2018, when two babies died after being injected with a tainted measles, mumps and rubella, or MMR, vaccine that had been improperly prepared. The government halted the vaccine program for 10 months, until the following April. Vaccination rates plummeted.

    The records show that during the time when no vaccines were being administered, Kennedy’s group, Children’s Health Defense, was trying to connect Kennedy with Samoa’s prime minister. A January 2019 email from the group’s then-president, Lyn Redwood, to Samoan activist Edwin Tamasese asked him to “please share this letter with the Honorable Prime Minister Tuilaepa Aiono Sailele Malielegaoi for Robert Kennedy, Jr.”

    About two months later, Tamasese wrote back to Redwood, with a cc: to Kennedy and others.

    “Hope all is well, organizing logistics with the PMs office and wanted to confirm how many people are coming? Also just wanted to confirm costs etc for the visit and how this will be handled,” he wrote.

    Tamasese immediately forwarded the chain of messages to the personal and government email accounts of Benjamin Harding, at the time an employee of the U.S. Embassy in Apia, Samoa.

    “just sent this. expecting an answer tomorrow as I think it is Sunday there. your letter looks good,” Tamasese told Harding.

    While the U.S. Embassy in the past has acknowledged that an unnamed staffer attended an event with Kennedy and anti-vaccine activists while he was in Samoa, the records show that Harding wasn’t a passive attendee: He helped arrange Kennedy’s visit and connected Kennedy’s delegation with Samoan government officials.

    In a May 23, 2019, email to Harding’s personal email address, a staffer for the Samoan Ministry of Foreign Affairs and Trade wrote: “Hi Benj, Currently awaiting the official bio-notes for Mr Kennedy and Dr Graven to convey to the Hon. Prime Minister and Hon. Minister of Health for their reference. Please note, that this needs to be sent with our official letter when requesting an appointment.”

    Harding forwarded the ministry’s request to Dr. Michael Graven, then the chief information officer at Children’s Health Defense.

    Harding did not respond to messages seeking comment sent to several listed email addresses, social media accounts, a phone number listed to his parents and a general mailbox at a company he lists as a current workplace on his LinkedIn profile.

    Embassy staffers got a tip about Harding’s involvement in the trip from Sheldon Yett, then the representative for Pacific island countries at UNICEF, the United Nations Children’s Fund.

    “We now understand that the Prime Minister has invited Robert Kennedy and his team to come to Samoa to investigate the safety of the vaccine,” Yett wrote in a May 22, 2019, email to an embassy staffer based in New Zealand. “The staff member in question seems to have had a role in facilitating this.”

    Two days later, a top embassy staff member in Apia wrote to Scott Brown, then the Republican U.S. president’s ambassador to New Zealand and Samoa, alerting him to Kennedy’s trip and Harding’s involvement.

    “The real reason Kennedy is coming is to raise awareness about vaccinations, more specifically some of the health concerns associated with vaccinating (from his point of view),” the embassy official, Antone Greubel, wrote. “It turns out our very own Benjamin Harding played some role in a personal capacity to bring him here.” Greubel wrote that he told Harding to “cease and desist from any further involvement with this travel,” though the rest of the sentence is redacted.

    Yett did not respond to questions, though he said in an email, “that was a very grim time in Samoa.”

    Brown, who is running for the U.S. Senate in New Hampshire, declined to comment. Greubel referred questions to a press office at the State Department. A State Department spokesperson would not answer questions about the records, saying that as a general practice they do not comment on personnel matters.

    Harding left the embassy in July 2020, though he remains in Samoa, according to his LinkedIn account.

    Kennedy ultimately visited in June 2019. While there, he and his wife, actor Cheryl Hines, were photographed greeting the prime minister during an Independence Day celebration. He also met with government health officials as well as a group of figures who have cast doubt on vaccines, including Tamasese.

    The Guardian and the AP could find no record of Kennedy publicly discussing the purpose of his trip until after measles struck. In 2021, he wrote that he went there to discuss “the introduction of a medical informatics system” to track drug safety. He said Samoan officials “were curious to measure health outcomes following the ‘natural experiment’ created by the national respite from vaccines.”

    Since then, he has said his reason for going to Samoa was not related to vaccines.

    Redwood, the former Children’s Health Defense president who made early outreach to Samoa, is now an employee at HHS, reportedly working on vaccine safety.

    During the measles outbreak, Kennedy wrote a four-page letter to Samoa’s prime minister suggesting without evidence that the measles infections were due to a defective vaccine and floating other unfounded theories.

    ___

    This story was jointly reported and published by The Guardian and The Associated Press.

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  • Fear among Minnesota’s Somali community compounds a public health woe: Low measles vaccination rates

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    MINNEAPOLIS — Public health officials and community leaders say that even before federal immigration authorities launched a crackdown in Minneapolis, a crisis was brewing.

    Measles vaccination rates among the state’s large Somali community had plummeted, with the myth that the shot causes autism spreading. Not even four measles outbreaks since 2011 made a dent in the trend. But recently, immunization advocates noted small victories, including mobile clinics and a vaccine confidence task force.

    Now, with the U.S. on the verge of losing its measles elimination status, those on the front lines of the battle against vaccine misinformation say much progress has been lost. Many residents fear leaving home at all, let alone seeking medical advice or visiting a doctor’s office.

    “People are worried about survival,” said nurse practitioner Munira Maalimisaq, CEO of the Inspire Change Clinic, near a Minneapolis neighborhood where many Somalis live. “Vaccines are the last thing on people’s minds. But it is a big issue.”

    A discussion group for Somali mothers at Inspire Change has shifted online indefinitely. In community WhatsApp groups and other channels, parents have more pressing priorities: Who will care for kids when they can’t go to school? How can we safely get groceries and prescriptions?

    In 2006, 92% of Somali 2-year-olds were up-to-date on the measles vaccine, according to the Minnesota Department of Health. Today’s rate is closer to 24%, according to state data. A 95% rate is needed to prevent outbreaks of measles, an extremely contagious disease.

    Community vaccination efforts go through cycles, Maalimisaq said, with initiatives starting and stopping.

    Imam Yusuf Abdulle said immigration enforcement has put everything on hold.

    “People are stuck in their homes, cannot go to work,” he said. “It is madness. And the last thing to think about is talking about autism, talking about childhood vaccination. Adults cannot get out of the house, forget about kids.”

    Estimated autism rates in Somali 4-year-olds are 3.5 times higher than those of white 4-year-olds in Minnesota, according to University of Minnesota data. Researchers say they don’t know why. And in this vacuum of scientific certainty, inaccurate beliefs thrive.

    Many blame the measles, mumps and rubella shot — a single injection proven to safely protect against the three viruses, with the first dose recommended when children are 12 to 15 months old.

    In November, at one of Maalimisaq’s last Motherhood Circle gatherings, Somali mothers and grandmothers volleyed questions at facilitators. Won’t a shot for three viruses overwhelm a baby? Why does autism seem more prevalent here than back home?

    Vaccines are tested for safety, Maalimisaq and her panel explained. Delaying a shot is risky, they warned, because of what measles — which is seeing its highest spread in the country in more than three decades — can do.

    Local health officials have long followed best practices: enlisting community members to champion vaccines, hosting mobile clinics and uplifting the work of Somali health providers like Maalimisaq.

    But initiatives have been start-and-stop. Federal funding cuts affected efforts, and public health officials admit their outreach could be more consistent and comprehensive.

    Most parents here vaccinate their children eventually. Many Somali families prefer to wait until a child is 5, despite a lack of evidence that doing so cuts autism rates. Measles is endemic in Somalia, where war and international aid cuts have crippled the medical system, and elsewhere in East Africa where residents here often travel.

    “Measles is just a plane ride away, and measles is going to find the unvaccinated,” said Carly Edson, the state health department’s immunization outreach coordinator. “We are always at risk.”

    About 84,000 Somalis live in the Twin Cities area, of 260,000 nationwide. The community is the country’s largest, and most are U.S. citizens. Before the immigration crackdown, mosques and malls buzzed, with people gathering during evenings to sip chai or have henna drawn on their hands.

    Now, many in the community want to lie low. People are afraid to seek routine medical care. Without those touchpoints, trust quickly erodes, Maalimisaq said.

    Among the last cohort of Somali moms at the clinic, 83% had vaccinated their kids by the end of the 12-month program, she said. Some were making 10-second videos explaining why they vaccinated. But efforts have paused.

    Parents here have long dealt with racism and isolation, though they’ve built a strong community. They want answers for the autism rates, but science has no simple answers for what causes the lifelong neurological condition, said Mahdi Warsama, the Somali Parents Autism Network’s CEO.

    Warsama said Trump’s unproven claims last fall that taking Tylenol during pregnancy could cause autism sparked fears and questions here. The idea that the MMR shot should be split into three vaccines — one backed, with no scientific basis, by acting Centers for Disease Control and Prevention Director Jim O’Neill, though no standalone shots are available in the U.S. — has spread, too.

    Warsama traces the issue back more than a decade, when discredited researcher Andrew Wakefield published his study — since retracted — claiming a link between autism and the MMR vaccine. Wakefield visited with Twin Cities Somalis in 2011.

    “The misinformers will always fill the void,” Warsama said.

    Parents want to be heard, not debated — that’s why short doctor appointments don’t work, said Fatuma Sharif-Mohamed, a Somali community health educator.

    “That 15 minutes will not change the mind of a parent,” she said.

    Some doctors are pushing beyond the exam room — work they describe as slow and taxing. Changing one family’s mind can take multiple visits, even years.

    Dr. Bryan Fate, leader of a Children’s Minnesota vaccine confidence committee, said new strategies are underway, including social media videos from doctors and possibly a prenatal classes for expectant parents.

    “I’m going to call you in five days,” Fate said he tells hesitant parents, “and there’ll be no changes to this speech.”

    Overall, Minnesota’s kindergarten MMR vaccination rate has dropped more than 6 percentage points in the past five years, compared with a 2-point drop nationwide.

    State data suggests the effort to catch kids up may be effective: While less than 1 in 4 Somali kids in Minnesota is vaccinated against measles by age 2, 86% get at least one dose by age 6 — just short of the statewide rate, 89%.

    Doctors worry in particular about unprotected young children, for whom severe complications — pneumonia, brain swelling and blindness — are more common.

    Imam Abdulle said when parents ask him about the vaccine, he tells his own story. He wasn’t opposed to it but decided to err on the side of waiting. His son was diagnosed with autism at age 3, Abdulle said, and later was vaccinated.

    Correlation, he reminds parents, is not causation.

    The community doesn’t want to be painted as a source of disease, Abdulle said. But after outbreaks in 2011, 2017, 2022 and 2024, there’s also open acknowledgment that measles isn’t going away.

    “Our kids are the ones who are getting sick,” Abdulle said. “Our community is suffering.”

    Last year, Minnesota logged 26 measles cases. The state health department said the cases were across several different communities with pockets of unvaccinated people.

    In Maalimisaq’s Motherhood Circles, the most effective words often come not from doctors but fellow parents, such as Mirad Farah. Farah’s daughter was born premature. She worried the MMR shot would be too much and delayed vaccination. Her daughter still developed autism.

    “So what did that tell me?” she asked the room. “It confirmed that autism is not from the MMR.”

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • Wegovy injections vs. pills: Doctors explain the differences

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    Wegovy injections vs. pills: Doctors explain the differences

    When it comes to GLP-1 pills vs. injections, doctors share which form may be best for you.

    Updated: 3:01 PM PST Jan 15, 2026

    Editorial Standards ⓘ

    GLP-1 (glucagon-like peptide-1 receptor agonists) like Ozempic and Wegovy continue to make headlines as more research points to the benefits of taking these medications. Traditionally, patients administer these via injection, but now, one medication in particular is available to take in pill form. So, which works best: Wegovy injection vs. pill? And is the answer the same for all GLP-1s?First, GLP-1s are a class of drugs that mimic the GLP-1 hormone that’s naturally released in your GI tract when you eat, explains Mir Ali, M.D., medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA. These medications help to moderate blood sugar levels, reduce feelings of hunger in the brain, and delay emptying in the stomach, making you feel fuller, longer. As a result, a side effect is weight loss. There are some buzzy GLP-1 medications that have become household names, like Wegovy and Ozempic, but there are also other options you may not have heard about.Ultimately, the best GLP-1 medication is one that you and your healthcare provider agree will best serve your needs. But learning more about the medication you intend to use can’t hurt. Here, find the major differences between GLP-1 injections and pills.There are a lot of medications that fall into the GLP-1 class, including injectable drugs and pills. Some popular ones include Ozempic, Rybelsus, and Wegovy.It’s worth noting that Wegovy (the main active ingredient of which is semaglutide) is the only GLP-1 pill that’s approved for weight loss by the U.S. Food and Drug Administration (FDA). While Rybelsus is sometimes used off-label for weight loss, it’s technically FDA-approved for blood sugar management in people with type 2 diabetes (the same goes for Ozempic). So, keep in mind that the information ahead speaks primarily to Wegovy.Wegovy injection vs. pill: How does each work? GLP-1 injectable medications are usually injected into the belly. “GLP-1 injections deliver the medication into the subcutaneous fat, where it is slowly absorbed,” explains Christoph Buettner, M.D., Ph.D., chief of the division of endocrinology at Rutgers Robert Wood Johnson Medical School. “These drugs have a long half-life, about five to seven days, which is why they only need to be taken once a week.”After they’re injected, the medication steadily enters the bloodstream and activates the GLP-1 receptor, Dr. Buettner explains. Once it’s in your body, the medication signals to your brain to take in less food, says Martin Binks, Ph.D., professor and chair of the Department of Nutrition and Food Studies at George Mason University College of Public Health. “They also help delay stomach emptying, which ultimately improves satiety and reduces hunger,” he says. “The combined influences of these medicines regulate metabolism and appetite.”The GLP-1 pills work similarly, but these contain a higher dose of medication to compensate for absorption into the digestive tract, Dr. Binks says. (The injectable medications have lower doses of medication because they’re slowly released into the bloodstream and bypass the gastrointestinal tract, Dr. Ali explains.)These medications are taken by mouth once a day. They usually need to be taken on an empty stomach, and you can’t eat or take most other medications for up to an hour afterward, Dr. Buettner points out. “These requirements can be inconvenient for many patients,” he says.Which is most effective for weight loss?It depends. There have been a few clinical trials on the impact of GLP-1 injectable medications on weight loss with different results. However, People usually lose about 15% of their body weight while using semaglutide medications like Wegovy.Meanwhile, during clinical trials for the Wegovy oral route, people who took the pill lost about 16.6% of their body weight. (That’s compared to 3% weight loss achieved by people who used a placebo.)While Rybelsus isn’t FDA-approved for weight loss, people typically lose around eight pounds while taking this medication.Which works best?There are a few things to consider. “Both injectables and pill forms can be helpful,” says Dina Hagigeorges, PA.-C., a physician assistant who specializes in weight and wellness at Tufts Medicine Weight + Wellness – Stoneham. “Unfortunately, cost and insurance coverage are a huge deciding factor, as not all insurance plans cover these medications for people.” When paid for out of pocket, injectable GLP-1 medications are usually much more expensive than their oral counterparts.There’s a larger body of research to support injectable medications for weight loss, although the Wegovy pill shows promise, Dr. Ali says. “If someone can tolerate injections, it’s usually the better way to go—they’re taken less frequently,” he says. But these medications aren’t a good fit for people who are scared of needles, and they have to be refrigerated, Dr. Ali points out.“The pills are a good option for people who don’t like injections, and you can easily take them with you when you travel,” Dr. Ali says. “But they have to be taken daily, which is not for everyone.”Side effectsThe side effects are similar for both medications, Dr. Buettner says.These side effects may include:NauseaVomitingDiarrheaConstipationUpset Stomach “The most important thing is choosing a medication that you can use consistently and that aligns with your personal priorities—whether that’s maximum weight loss, convenience, avoiding injections, or simplifying your routine,” he says. “Many patients try one form first and later switch based on their experience.”So, talk to your healthcare provider and keep the line of conversation open. You may find one form of GLP-1 feels like a more natural fit over another.

    GLP-1 (glucagon-like peptide-1 receptor agonists) like Ozempic and Wegovy continue to make headlines as more research points to the benefits of taking these medications. Traditionally, patients administer these via injection, but now, one medication in particular is available to take in pill form. So, which works best: Wegovy injection vs. pill? And is the answer the same for all GLP-1s?

    First, GLP-1s are a class of drugs that mimic the GLP-1 hormone that’s naturally released in your GI tract when you eat, explains Mir Ali, M.D., medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, CA. These medications help to moderate blood sugar levels, reduce feelings of hunger in the brain, and delay emptying in the stomach, making you feel fuller, longer. As a result, a side effect is weight loss.

    There are some buzzy GLP-1 medications that have become household names, like Wegovy and Ozempic, but there are also other options you may not have heard about.

    Ultimately, the best GLP-1 medication is one that you and your healthcare provider agree will best serve your needs. But learning more about the medication you intend to use can’t hurt. Here, find the major differences between GLP-1 injections and pills.

    There are a lot of medications that fall into the GLP-1 class, including injectable drugs and pills. Some popular ones include Ozempic, Rybelsus, and Wegovy.

    It’s worth noting that Wegovy (the main active ingredient of which is semaglutide) is the only GLP-1 pill that’s approved for weight loss by the U.S. Food and Drug Administration (FDA). While Rybelsus is sometimes used off-label for weight loss, it’s technically FDA-approved for blood sugar management in people with type 2 diabetes (the same goes for Ozempic). So, keep in mind that the information ahead speaks primarily to Wegovy.

    Wegovy injection vs. pill: How does each work?

    GLP-1 injectable medications are usually injected into the belly. “GLP-1 injections deliver the medication into the subcutaneous fat, where it is slowly absorbed,” explains Christoph Buettner, M.D., Ph.D., chief of the division of endocrinology at Rutgers Robert Wood Johnson Medical School. “These drugs have a long half-life, about five to seven days, which is why they only need to be taken once a week.”

    After they’re injected, the medication steadily enters the bloodstream and activates the GLP-1 receptor, Dr. Buettner explains. Once it’s in your body, the medication signals to your brain to take in less food, says Martin Binks, Ph.D., professor and chair of the Department of Nutrition and Food Studies at George Mason University College of Public Health. “They also help delay stomach emptying, which ultimately improves satiety and reduces hunger,” he says. “The combined influences of these medicines regulate metabolism and appetite.”

    The GLP-1 pills work similarly, but these contain a higher dose of medication to compensate for absorption into the digestive tract, Dr. Binks says. (The injectable medications have lower doses of medication because they’re slowly released into the bloodstream and bypass the gastrointestinal tract, Dr. Ali explains.)

    These medications are taken by mouth once a day. They usually need to be taken on an empty stomach, and you can’t eat or take most other medications for up to an hour afterward, Dr. Buettner points out. “These requirements can be inconvenient for many patients,” he says.

    Which is most effective for weight loss?

    It depends. There have been a few clinical trials on the impact of GLP-1 injectable medications on weight loss with different results. However, People usually lose about 15% of their body weight while using semaglutide medications like Wegovy.

    Meanwhile, during clinical trials for the Wegovy oral route, people who took the pill lost about 16.6% of their body weight. (That’s compared to 3% weight loss achieved by people who used a placebo.)

    While Rybelsus isn’t FDA-approved for weight loss, people typically lose around eight pounds while taking this medication.

    Which works best?

    There are a few things to consider. “Both injectables and pill forms can be helpful,” says Dina Hagigeorges, PA.-C., a physician assistant who specializes in weight and wellness at Tufts Medicine Weight + Wellness – Stoneham. “Unfortunately, cost and insurance coverage are a huge deciding factor, as not all insurance plans cover these medications for people.” When paid for out of pocket, injectable GLP-1 medications are usually much more expensive than their oral counterparts.

    There’s a larger body of research to support injectable medications for weight loss, although the Wegovy pill shows promise, Dr. Ali says. “If someone can tolerate injections, it’s usually the better way to go—they’re taken less frequently,” he says. But these medications aren’t a good fit for people who are scared of needles, and they have to be refrigerated, Dr. Ali points out.

    “The pills are a good option for people who don’t like injections, and you can easily take them with you when you travel,” Dr. Ali says. “But they have to be taken daily, which is not for everyone.”

    Side effects

    The side effects are similar for both medications, Dr. Buettner says.

    These side effects may include:

    • Nausea
    • Vomiting
    • Diarrhea
    • Constipation
    • Upset Stomach

    “The most important thing is choosing a medication that you can use consistently and that aligns with your personal priorities—whether that’s maximum weight loss, convenience, avoiding injections, or simplifying your routine,” he says. “Many patients try one form first and later switch based on their experience.”

    So, talk to your healthcare provider and keep the line of conversation open. You may find one form of GLP-1 feels like a more natural fit over another.

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  • Popular weight-loss drugs shouldn’t carry suicide warnings, FDA says

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    Federal regulators on Tuesday told drugmakers Novo Nordisk and Eli Lilly to remove label warnings about potential suicidal thoughts and behaviors from their blockbuster weight-loss medications.

    The U.S. Food and Drug Administration said a comprehensive review “found no increased” risk related to suicide among users of the GLP-1 drugs for obesity, including Novo Nordisk’s Wegovy and Saxenda and Eli Lilly’s Zepbound.

    A preliminary review in January 2024 showed no link between the drugs and suicidal thought or actions, the FDA said. At that time, however, officials said they could not rule out that “a small risk may exist.” The new analysis puts those concerns to rest.

    Labeling for other drugs known as GLP-1 receptor agonists approved to treat diabetes carried no such warnings, the agency noted.

    “Today’s FDA action will ensure consistent messaging across the labeling for all FDA-approved GLP-1 RA medications,” officials said.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • Doctors say changes to US vaccine recommendations are confusing parents and could harm kids

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    Dr. Molly O’Shea has noticed growing skepticism about vaccines at both of her Michigan pediatric offices and says this week’s unprecedented and confusing changes to federal vaccine guidance will only make things worse.

    One of her offices is in a Democratic area, where more of the parents she sees are opting for alternative schedules that spread out shots. The other is in a Republican area, where some parents have stopped immunizing their children altogether.

    She and other doctors fear the new recommendations and the terminology around them will stoke vaccine hesitancy even more, pose challenges for pediatricians and parents that make it harder for kids to get shots, and ultimately lead to more illness and death.

    The biggest change was to stop blanket recommendations for protection against six diseases and recommend those vaccines only for at-risk children or through something called “shared clinical decision-making” with a health care provider.

    The phrase, experts say, is confusing and dangerous: “It sends a message to a parent that actually there’s only a rarefied group of people who really need the vaccine,” O’Shea said. “It’s creating an environment that puts a sense of uncertainty about the value and necessity or importance of the vaccines in that category.”

    Health Secretary Robert F. Kennedy Jr., who helped lead the anti-vaccine movement for years, said in announcing the changes that they better align the U.S. with peer nations “while strengthening transparency and informed consent.”

    But doctors say they are sowing doubt — the vaccines have been extensively studied and proven to be safe and effective at shielding kids from nasty diseases — at a time when childhood vaccination rates are already falling and some of those infectious diseases are spreading.

    On Friday, the American Academy of Pediatrics and more than 200 medical, public health and patient advocacy groups sent a letter to Congress about the new childhood immunization schedule.

    “We urge you to investigate why the schedule was changed, why credible scientific evidence was ignored, and why the committee charged with advising the HHS Secretary on immunizations did not discuss the schedule changes as a part of their public meeting process,” they wrote.

    O’Shea said she and other pediatricians discuss vaccines with parents at every visit where they are given. But that’s not necessarily “shared clinical decision-making,” which has a particular definition.

    On its website, the Advisory Committee on Immunization Practices says: “Unlike routine, catch-up, and risk-based recommendations, shared clinical decision-making vaccinations are not recommended for everyone in a particular age group or everyone in an identifiable risk group. Rather, shared clinical decision-making recommendations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian.”

    In this context, health care providers include primary care physicians, specialists, physician assistants, nurse practitioners, registered nurses and pharmacists.

    A pair of surveys conducted last year by the Annenberg Public Policy Center at the University of Pennsylvania suggested that many people don’t fully understand the concept, which came up last year when the federal government changed recommendations around COVID-19 vaccinations.

    Only about 2 in 10 U.S. adults knew that one meaning behind shared decision-making is that “taking the vaccine may not be a good idea for everyone but would benefit some.” And only about one-third realized pharmacists count as health care providers to talk with during the process, even though they frequently administer vaccines.

    As of this week, vaccines that protect against hepatitis A, hepatitis B, rotavirus, RSV, flu and meningococcal disease are no longer universally recommended for kids. RSV, hepatitis A, hepatitis B and meningococcal vaccines are recommended for certain high-risk populations; flu, rotavirus, hepatitis A, hepatitis B and meningococcal vaccines are recommended through shared decision-making — as is the COVID-19 vaccine, although that change was made last year.

    Shortly after the federal announcement Monday, Dr. Steven Abelowitz heard from half a dozen parents. “It’s causing concern for us, but more importantly, concern for parents with kids, especially young kids, and confusion,” said Abelowitz, founder of Ocean Pediatrics in Orange County, California.

    Though federal recommendations are not mandates — states have the authority to require vaccinations for schoolchildren — they can affect how easy it is for kids to get shots if doctors choose to follow them.

    Under the new guidelines, O’Shea said, parents seeking shots in the shared decision-making category might no longer bring their kids in for a quick, vaccine-only appointment with staff. They’d sit down with a health care provider and discuss the vaccine. And it could be tougher to have a flu clinic, where parents drive up and kids get shots without seeing a doctor.

    Still, doctors say they won’t let the changes stop them from helping children get the vaccines they need. Leading medical groups are sticking with prior vaccine recommendations. Many parents are, too.

    Megan Landry, whose 4-year-old son Zackary is one of O’Shea’s patients, is among them.

    “It’s my responsibility as a parent to protect my child’s health and well-being,” she said. “Vaccines are a really effective and well-studied way to do that.”

    She plans to keep having the same conversations she’s always had with O’Shea before getting vaccines for Zackary.

    “Relying on evidence and trusted medical guidance really helps me to make those decisions,” she said. “And for me, it’s not just a personal choice for my own son but a way to contribute to the health of everybody.”

    But for other families, confidence about vaccines is waning as trust in science erodes. O’Shea lamented that parents are getting the message that they can’t trust medical experts.

    “If I take my car to the mechanic, I don’t go do my own research ahead of time,” she said. “I go to a person I trust and I trust them to tell me what’s going on.”

    Abelowitz, the California doctor, likened the latest federal move to pouring gasoline on a fire of mistrust that was already burning.

    “We’re worried the fire’s out of control,” he said. “Already we’ve seen that with measles and pertussis, there are increased hospitalizations and even increasing deaths. So the way that I look at it — and my colleagues look at it — we’re basically regressing decades.”

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    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • Earlier 911 calls to Rob Reiner’s home could loom large in legal battle over son’s mental condition

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    In the years before Rob and Michele Reiner were killed, Los Angeles police made at least two visits to their home in Brentwood.

    On Feb. 25, 2019, officers conducted a welfare check after someone called 911 at 9:51 p.m. According to LAPD records reviewed by The Times, officers arrived at the address at 10:12 p.m., completed the call and reported the incident to an unidentified supervisor.

    Then on Sept. 27, 2019, police responded at 4:24 p.m. to a mental health–related call for service involving an unidentified man. Officers later informed a supervisor that they found “no indication of mental illness,” according to department records.

    The calls were fairly innocuous and typically would not raise eyebrows.

    But authorities now allege the couple’s son, who lived in the guesthouse on their property, fatally stabbed them in their master bedroom last month.

    The mental state of Nick Reiner, who struggled for years with substance abuse and had been prescribed a schizophrenia drug, has now taken center stage in his legal battle.

    Prosecutors have not detailed their case, and Reiner’s legal team has not provided his own story. It is still possible his defense could present compelling evidence that Nick Reiner did not commit the killings. But if the case is strong, the trial could revolve around Reiner’s mental state and the length of sentence.

    Prosecutors charged Nick Reiner, 32, with two counts of first-degree murder with special circumstances for the killings in the early hours of Dec. 14. Authorities have not offered a possible motive in the case.

    Reiner is back in court Wednesday and is no longer considered to be a suicide risk. He has not yet entered a plea.

    Legal experts say Reiner’s attorney, Alan Jackson, is likely now working to evaluate his client’s history of mental health and state of mind at the time of the crime. Those findings could be the basis for discussions of a plea deal or the beginning of an insanity defense, attorneys say.

    There are also other defenses that Jackson could pursue based on his mental history and possible changes in his medication and other factors that might not have been made public yet, including what might have triggered the killings, said Laurie Levenson, professor of law at Loyola Law School and a former federal prosecutor.

    “There’s a lot still to be done to work this case up,” Levenson said. “He can either try to go for a not guilty by reason of insanity, or he might have testimony that he wasn’t able to form the mental state for the crime because of his medication and his prior mental background.”

    If his defense can prove that Reiner couldn’t form the “intent to kill because of what’s happening with his medication or with his disease” then it could be a way to get a lesser charge such as second-degree murder, Levenson said. With first-degree murder charges, prosecutors must show that the accused acted with premeditation or malice.

    “It is just way too early to say that this is an all or nothing case — that he’s going to be found guilty of murder one or found not guilty. There are likely to be other options,” Levenson said.

    If convicted of first-degree murder, Reiner is facing possible life in prison without the possibility of parole or the death penalty. Prosecutors have not made a decision about whether they will seek capital punishment in the case.

    If Reiner is found not guilty by reason of insanity then he would likely be committed to a mental health facility. And he might at some point be able to show that his condition has improved and have outpatient status or be released, Levenson said.

    Saul Faerstein, a clinical and forensic psychiatrist and professor of psychiatry at UCLA, said doctors will likely try to piece together the days leading up to the killings to determine what kind of mental state Reiner was in at the time.

    “We’d want to know what was happening on Friday or Saturday. Was he beginning to decompensate? Was he acting out of character? Was he doing and saying things that surprised people or frightened people? Was he saying things that made no sense?” Faerstein said.

    Reiner’s ability to check into a hotel and travel across Los Angeles where he was seen at a gas station and ultimately arrested isn’t necessarily a sign that he was of sound mind, Faerstein said.

    “Those things don’t require a lot of cognitive function, and they can be done even in a delusional state,” he said.

    There have been a few examples of cases in California in which charges have been reduced because of mental health factors.

    In 2023, Bryn Spejcher was convicted of involuntary manslaughter for killing Chad O’Melia, a man she’d been dating, with kitchen knives inside his home in Thousand Oaks. They had been smoking marijuana out of O’Melia’s bong, which caused Spejcher to suffer from cannabis-induced psychosis.

    The Ventura County District Attorney’s Office had originally filed a murder charge against her, but reduced the charge to involuntary manslaughter after the prosecution’s experts agreed that she was in a psychotic state brought on by the marijuana intoxication. Prosecutors could not prove malice in the case.

    Spejcher was sentenced to probation and community service. She’s in the process of appealing her conviction, court records show.

    Michael Goldstein, a Los Angeles defense attorney who represented Spejcher, said that if Reiner attorneys can document a history of mental health issues, it could help his chances.

    “Based on facts that have been revealed publicly, [not guilty by reason of insanity] appears to be a viable defense,” Goldstein said. “If successful, that would result in long-term hospitalization. It is still early in the process and Mr. Jackson made it clear there are significant issues being explored. Time will tell.”

    In a case in 2010, Jennifer Lynn Bigham was found not guilty of murder and child abuse by reason of insanity after authorities said she drowned her 3-year-old daughter in a bathtub at a relative’s home in the Central Valley.

    Doctors had determined Bigham was suffering from severe mental illness at the time of her daughter’s death. After roughly three years of treatment in 2013, a judge ordered her to be released from custody because doctors said she was no longer insane.

    It’s possible, Levenson said, that the defense will be able to present compelling evidence of mental disorder to prosecutors to resolve the case before trial. It’s also possible the case will go to trial and he could be found not guilty by reason of insanity and committed as opposed to serving jail time.

    Even if he’s committed, one day any disorders he’s diagnosed with could be treated and he could be released, Levenson said.

    Though insanity defenses in many cases are not successful, based on the facts known at the time, this case could be an exception, experts say.

    “It’s a pretty classic of a situation where you have what looks like a really horrific, maybe premeditated murder, and then you start learning more about his background, that it doesn’t look like he’s making this up, that there seems to be some medical history of this, the change in medication, and all of a sudden you say, ‘Wow, this might be that rare case where mental defense, or an insanity defense, will succeed,” Levenson said.

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  • US regulators approve Wegovy pill for weight loss

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    U.S. regulators on Monday gave the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication to treat obesity.

    The U.S. Food and Drug Administration’s approval handed drugmaker Novo Nordisk an edge over rival Eli Lilly in the race to market an obesity pill. Lilly’s oral drug, orforglipron, is still under review.

    Both pills are GLP-1 drugs that work like widely used injectables to mimic a natural hormone that controls appetite and feelings of fullness.

    In recent years, Novo Nordisk’s injectable Wegovy and Lilly’s Zepbound have revolutionized obesity treatment globally and in the U.S., where 100 million people have the chronic disease.

    The Wegovy pills are expected to be available within weeks, company officials said. Availability of oral pills to treat obesity could expand the booming market for obesity treatments by broadening access and reducing costs, experts said.

    About 1 in 8 Americans have used injectable GLP-1 drugs, according to a survey from KFF, a nonprofit health policy research group. But many more have trouble affording the costly shots.

    “There’s an entire demographic that can benefit from the pills,” said Dr. Fatima Cody Stanford, a Massachusetts General Hospital obesity expert. “For me, it’s not just about who gets it across the finish line first. It’s about having these options available to patients.”

    The Novo Nordisk obesity pill contains 25 milligrams of semaglutide. That’s the same ingredient in injectables Wegovy and Ozempic and in Rybelsus, a lower-dose pill approved to treat diabetes in 2019.

    In a clinical trial, participants who took oral Wegovy lost 13.6% of their total body weight on average over about 15 months, compared with a 2.2% loss if they took a placebo, or dummy pill. That’s nearly the same as injectable Wegovy, with an average weight loss of about 15%.

    Chris Mertens, 35, a pediatric lung doctor in Menomonee Falls, Wisconsin, joined the Novo Nordisk trial in 2022 and lost about 40 pounds using the Wegovy pill. The daily medication worked to decrease his appetite and invasive thoughts of food, he said.

    “If there were days where I missed a meal, I almost didn’t realize it,” Mertens said.

    Participants in a clinical trial who took the highest dose of Lilly’s orforglipron lost 11.2% of their total body weight on average over nearly 17 months, compared with a 2.1% loss in those who took a placebo.

    Both pills resulted in less weight loss than the average achieved with Lilly’s Zepbound, or tirzepatide, which targets two gut hormones, GLP-1 and GIP, and led to a 21% average weight loss.

    All the GLP-1 drugs, oral or injectable, have similar side effects, including nausea and diarrhea.

    Both daily pills promise convenience, but the Wegovy pill must be taken with a sip of water in the morning on an empty stomach, with a 30-minute break before eating or drinking.

    That’s because Novo Nordisk had to design the pill in a way that prevented the drug from being broken down in the stomach before it could be absorbed by the bloodstream. The drugmaker added an ingredient that protects the medication for about 30 minutes in the gut and makes it easier to take effect.

    By contrast, Lilly’s orforglipron has no dosing restrictions. That drug is being considered under the FDA’s new priority voucher program aimed at cutting drug approval times. A decision is expected by spring.

    Producing pills is generally cheaper than making drugs delivered via injections, so the cost for the new oral medications could be lower. The Trump administration earlier this year said officials had worked with drugmakers to negotiate lower prices for the GLP-1 drugs, which can cost upwards of $1,000 a month.

    The company said the starting dose would be available for $149 per month from some providers. Additional information on cost will be available in January.

    It’s not clear whether daily pills or weekly injections will be preferred by patients. Although some patients dislike needles, others don’t seem to mind the weekly injections, obesity experts said. Mertens turned to injectable Zepbound when he regained weight after the end of the Wegovy pill clinical trial.

    He said he liked the discipline of the daily pill.

    “It was a little bit of an intentional routine and a reminder of today I’m taking this so that I know my choices are going to be affected for the day,” he said.

    Dr. Angela Fitch, an obesity expert and chief medical officer of knownwell, a health care company, said whatever the format, the biggest benefit will be in making weight-loss medications more widely accessible and affordable.

    “It’s all about the price,” she said. “Just give me a drug at $100 a month that is relatively effective.”

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    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • Trump announces lower drug price deals with 9 pharmaceutical companies

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    U.S. President Donald Trump announced Friday that nine drugmakers have agreed to lower the cost of their prescription drugs in the U.S.

    Pharmaceutical companies Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, Novartis and Sanofi will now rein in Medicaid drug prices to match what they charged in other developed countries.

    As part of the deal, new drugs made by those companies will also be charged at the so-called “most-favored-nation” pricing across the country on any newly launched medications for all, including commercial and cash pay markets as well as Medicare and Medicaid.

    Drug prices for patients in the U.S. can depend on a number of factors, including the competition a treatment faces and insurance coverage. Most people have coverage through work, the individual insurance market or government programs like Medicaid and Medicare, which shield them from much of the cost.

    Patients in Medicaid, the state and federally funded program for people with low incomes, already pay a nominal co-payment of a few dollars to fill their prescriptions, but lower prices could help state budgets that fund the programs.

    Lower drug prices also will help patients who have no insurance coverage and little leverage to negotiate better deals on what they pay. But even steep discounts of 50% found through the administration’s website could still leave patients paying hundreds of dollars a month for some prescriptions.

    William Padula, a pharmaceutical and health economics professor at USC, said Medicaid already has the most favorable drug rates which in some cases will be close to what the “most-favored-nation” price is so it remains to be seen what other impacts it could have, such as more research and development.

    “It can’t be bad. I don’t see much downside but it’s hard to judge what the upside is,” Padula said.

    And while it is significant that Trump was able to get big drugmakers to the table to negotiate lower prices, it will take years to gage how effective this initiative is in terms of more people obtaining more of the medicines they need.

    “It’s good for their stock and it’s good for their future” research and development, Padula said of the pharmaceutical companies. “It’s clearly influential but will all this add up to a major effect? Nothing really matters here unless our health gets better as a country.”

    Trump administration officials said the drugmakers will also sell pharmacy-ready medicines on the TrumpRx platform, which is set to launch in January and will allow people to buy drugs directly from manufacturers.

    Companies such as Merck, GSK and Bristol Myers Squibb also agreed to donate significant supplies of active pharmaceutical ingredients to a national reserve and to formulate and distribute them into medications such as antibiotics, rescue inhalers and blood thinners as needed in an emergency.

    The New Jersey-based Bristol Myers Squibb further announced that it will be giving for free to the Medicaid program its signature blood thinner prescribed to reduce the risk of blood clots and stroke. Known as Eliquis, it is the company’s top prescribed drug as well as being one of Medicaid’s most widely-used medicines.

    Padula said the donations — which encompass some of the world’s most critical medicines — are a significant step toward health equity and an acknowledgement that the drugmakers can afford to seek profits elsewhere in their operations. Eliquis already has been one of the most profitable drugs ever made.

    “It’s a thoughtful health equity move that they can afford given that it’s been such a blockbuster,” Padula said of the Eliquis donation.

    Other major drugmakers including Pfizer, AstraZeneca, EMD Serono, Novo Nordisk and Eli Lilly struck similar deals with the Trump administration earlier this year.

    Though individual terms were not disclosed, the administration has now negotiated lower drug prices with 14 companies since Trump publicly sent letters to executives at 17 pharmaceutical companies about the issue, noting that U.S. prices for brand-name drugs can be up to three times higher than averages elsewhere.

    Trump said he effectively threatened the pharmaceutical companies with 10% tariffs to get them to “do the right thing.”

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  • What are parents to do as doctors clash with Trump administration over vaccines?

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    It’s normal for parents, or anyone, to have questions about vaccinations — but what happens if your pediatrician urges a shot that’s under attack by the Trump administration?

    That’s getting more likely: The nation’s leading doctors groups are in an unprecedented standoff with federal health officials who have attacked long-used, lifesaving vaccines.

    The revolt by pediatricians, obstetricians, family physicians, infectious disease experts and internists came to a head when an advisory panel handpicked by Health Secretary Robert F. Kennedy Jr. urged an end to routine newborn vaccination against hepatitis B, a virus that can cause liver failure or liver cancer.

    That vaccine saves lives, helped child infections plummet and has been given safely to tens of millions of children in the U.S. alone, say the American Academy of Pediatrics and other doctors groups that vowed Tuesday to keep recommending it.

    But that’s not the only difference. That Advisory Committee on Immunization Practices now is examining possible changes to the entire childhood vaccination schedule, questioning certain ingredients and how many doses youngsters receive.

    Pushing back, the American Academy of Pediatrics has issued its own recommendations for youngsters. Other medical groups — plus some city and state public health departments that have banded together — also are issuing their own advice on certain vaccines, which largely mirrors pre-2025 federal guidance.

    This article is part of AP’s Be Well coverage, focusing on wellness, fitness, diet and mental health. Read more Be Well.

    “We owe our patients a consistent message informed by evidence and lived experience, not messages biased by political imperative,” Dr. Ronald Nahass, president of the Infectious Diseases Society of America, told reporters Tuesday.

    But Nahass acknowledged the inevitable consumer confusion, recounting a relative calling him last weekend for advice about hepatitis B vaccination for her new grandbaby.

    “Most Americans don’t have a Cousin Ronnie to call. They are left alone with fear and mistrust,” he said, urging parents to talk with their doctors about vaccines.

    New guidelines without new data concern doctors

    Hepatitis B isn’t the only vaccine challenge. Kennedy’s health department recently changed a Centers for Disease Control and Prevention webpage to contradict the longtime scientific conclusion that vaccines don’t cause autism. Federal agencies also moved to restrict COVID-19 vaccinations this fall, and are planning policy changes that could restrict future flu and coronavirus shots.

    But when it comes to vaccine advice, “for decades, ACIP was the gold standard,” said Dr. Jake Scott, an infectious disease physician and Stanford University researcher.

    The panel once routinely enlisted specialists in specific diseases for long deliberations of the latest science and safety data, resulting in recommendations typically adopted not only by the CDC but by the medical field at large, he said.

    Last week’s meeting of Kennedy’s panel, which includes vaccine skeptics, marked a radical departure. CDC specialists weren’t allowed to present data on hepatitis B, the childhood vaccine schedule or questions about vaccine ingredients. Few of the committee members have public health experience, and some expressed confusion about the panel’s proposals.

    At one point, a doctor called in to say the panel was misrepresenting her study’s findings. And the panel’s chairman wondered why one dose of yellow fever vaccine protected him during a trip to Africa when U.S. children get three doses of hepatitis B vaccine. The hepatitis B vaccine is designed to protect children for life from a virus they can encounter anywhere, not just on a trip abroad. And other scientists noted it was carefully studied for years to prove the three-dose course offers decades of immunity — evidence that a single dose simply doesn’t have.

    “If they’ve got new data, I’m all for it — let’s see it and have a conversation,” said Dr. Kelly Gebo, an infectious disease specialist and public health dean at George Washington University, who watched for that. “I did not see any new data,” so she’s not changing her vaccine advice.

    Committee members argued that most babies’ risk of hepatitis B infection is very low and that earlier research on infant shot safety was inadequate.

    Especially unusual was a presentation from a lawyer who voiced doubt about studies that proved benefits of multiple childhood vaccines and promoted discredited research pointing to harms.

    “I don’t think at any point in the committee’s history, there was a 90-minute uninterrupted presentation by someone who wasn’t a physician, a scientist, or a public health expert on the topic — let alone someone who, who makes his living in vaccine litigation,” said Jason Schwartz, a vaccine policy expert at Yale University.

    By abandoning data and the consensus of front-line doctors, the ACIP is “actively burning down the credibility that made its recommendations so powerful,” added Stanford’s Scott. “Most parents will still follow their pediatricians, and AAP is holding the line here. But the mixed messages are precisely what erode confidence over time.”

    Parents already have a choice — they need solid guidance

    Trump administration health officials say it’s important to restore choice to parents and to avoid mandates. That’s how the panel’s hepatitis B recommendation was framed — that parents who really want it could get their children vaccinated later.

    Parents already have a choice, said Dr. Aaron Milstone of the American Academy of Pediatrics. The government makes population-wide recommendations while families and their doctors tailor choices to each person’s health needs.

    But many doctors don’t — or can’t — do their own lengthy scientific review of vaccines and thus had relied on the ACIP and CDC information, Yale’s Schwartz noted.

    They “rely on trusted expert voices to help navigate what is, even in the best of times, a complicated landscape regarding the evidence for vaccines and how best to use them,” he said.

    That’s a role that the pediatricians and other doctors groups, plus those multistate collaborations, aim to fill with their own guidelines — while acknowledging it will be a huge task.

    For now, “ask your questions, bring your concerns and let us talk about them,” said Dr. Sarah Nosal, of the American Academy of Family Physicians, urging anyone with vaccine questions to have an open conversation with their doctor.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • Trump administration says lower prices for 15 Medicare drugs will save taxpayers billions

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    NEW YORK — Pharmaceutical companies have agreed to slash the Medicare prices for 15 prescription drugs after months of negotiations, reductions that are expected to produce billions in savings for taxpayers and older adults, the Trump administration said.

    But the net prices it unveiled for a 30-day supply of each drug are not what Medicare recipients will pay at their pharmacy counters, since those final amounts will depend on each individual’s plan and how much they spend on prescriptions in a given year.

    Health Secretary Robert F. Kennedy Jr. touted the deals as part of the administration’s efforts to address affordability concerns among Americans. The Medicare drug negotiation program that made them possible is mandated by law and began under President Joe Biden’s administration.

    “President Trump directed us to stop at nothing to lower health care costs for the American people,” Kennedy said in a statement Tuesday evening. “As we work to Make America Healthy Again, we will use every tool at our disposal to deliver affordable health care to seniors.”

    The announcement marks the completion of a second round of negotiations under a 2022 law that allows Medicare to haggle over the price it pays on the most popular and expensive prescription drugs used by older Americans, bringing the total number of negotiated drug prices to 25. The new round of negotiated prices will go into effect in 2027. Reduced prices for the inaugural round of 10 drugs negotiated by the Biden administration last year will go into effect in January.

    The latest negotiated prices apply to some of the prescription medications on which Medicare spends the most money, including the massively popular GLP-1 weight-loss and diabetes drugs Ozempic, Rybelsus and Wegovy. Some of the other drugs involved in the negotiations include Trelegy Ellipta, which treats asthma; Otezla, a psoriatic arthritis drug; and various drugs that treat diabetes, irritable bowel syndrome and different forms of cancer.

    Dr. Mehmet Oz, Centers for Medicare and Medicaid Services administrator, said the administration delivered “substantially better outcomes for taxpayers and seniors in the Medicare Part D program” than the previous year’s deals.

    Under the first round of Medicare price negotiations, the Biden administration said the program would have saved about $6 billion on net covered prescription drug costs, or about 22%, if it had been in effect the previous year. The Trump administration said its latest round would have saved the government about $8.5 billion in net spending, or 36%, if it had been in effect last year.

    It’s unclear exactly how much money the newly announced deals could save Medicare beneficiaries when they are buying prescription drugs at the pharmacy because those costs are determined by various individual factors.

    A new rule that kicked off this year also caps out-of-pocket drug costs for Medicare beneficiaries at $2,000, giving some relief to older adults affected by high-cost prescriptions. The administration said estimated out-of-pocket savings for Medicare beneficiaries with drug plans is about $685 million.

    Spencer Perlman, director of health care research at Veda Partners, said the Trump administration’s improved outcomes probably resulted from the mix of drugs being negotiated and lessons learned from the first year of negotiations.

    Net drug prices are proprietary, he said, but “if we take the administration at their word, I think it demonstrates that they have secured meaningful price concessions for seniors, meaning the Medicare Drug Price Negotiation Program is working as intended.”

    The GLP-1 weight-loss drugs that were part of the negotiations have been especially scrutinized for their high out-of-pocket costs. Yet it’s still unclear to what extent Medicare beneficiaries who want to use the drugs to treat obesity will be able to do so.

    Medicare has long been prohibited from paying for weight-loss treatments, but a separate deal recently announced between the Trump administration and two pharmaceutical companies included plans for a pilot program that will expand coverage for the drugs to additional high-risk obese and overweight people.

    The Trump administration this year has also negotiated several unrelated deals with drug companies to lower the cost of their products for the wider population.

    Pharmaceutical companies, meanwhile, have sued over the Medicare drug negotiations enabled by the 2022 Inflation Reduction Act and remain opposed to them.

    “Whether it is the IRA or MFN, government price setting for medicines is the wrong policy for America,” Alex Schriver, senior vice president of public affairs at the Pharmaceutical Research and Manufacturers of America, or PhRMA, said in a statement. “These flawed policies also threaten future medical innovation by siphoning $300 billion from biopharmaceutical research, undermining the American economy and our ability to compete globally.”

    Next year, Medicare will negotiate prices for another round of 15 drugs, including physician-administered drugs for the first time.

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  • RFK Jr. says he’s following ‘gold standard’ science. Here’s what to know

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    The message is hammered over and over, in news conferences, hearings and executive orders: President Donald Trump and his health secretary, Robert F. Kennedy Jr., say they want the government to follow “gold standard” science.

    Scientists say the problem is that they are often doing just the opposite by relying on preliminary studies, fringe science or just hunches to make claims, cast doubt on proven treatments or even set policy.

    This week, the nation’s top public health agency changed its website to contradict the scientific conclusion that vaccines do not cause autism. The move shocked health experts nationwide.

    Dr. Daniel Jernigan, who resigned from the Centers for Disease Control and Prevention in August, told reporters Wednesday that Kennedy seems to be “going from evidence-based decision making to decision-based evidence making.”

    It was the latest example of the Trump administration’s challenge to established science.

    U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. speaks during the Western Governors’ Association meeting Thursday, Nov. 20, 2025, in Scottsdale, Ariz. (AP Photo/Rebecca Noble)

    In September, the Republican president gave out medical advice based on weak or no evidence. Speaking directly to pregnant women and to parents, he told them not to take acetaminophen, the active ingredient in Tylenol. He repeatedly made the fraudulent and long-disproven link between autism and vaccines, saying his assessment was based on a hunch.

    “I have always had very strong feelings about autism and how it happened and where it came from,” he said.

    At a two-day meeting this fall, Kennedy’s handpicked vaccine advisers to the CDC raised questions about vaccinating babies against hepatitis B, an inoculation long shown to reduce disease and death drastically.

    “The discussion that has been brought up regarding safety is not based on evidence other than case reports and anecdotes,” said Dr. Flor Munoz, a pediatric infectious disease expert at Baylor College of Medicine and Texas Children’s Hospital.

    During the country’s worst year for measles in more than three decades, Kennedy cast doubt on the measles vaccine while championing unproven treatments and alleging that the unvaccinated children who died were “already sick.”

    Scientists say the process of getting medicines and vaccines to market and recommended in the United States has, until now, typically relied on gold standard science. The process is so rigorous and transparent that much of the rest of the world follows the lead of American regulators, giving the OK to treatments only after U.S. approval.

    This April 1, 2025 photo shows the Centers for Disease Control and Prevention building in Atlanta. (AP Photo/Ben Gray, file)

    This April 1, 2025 photo shows the Centers for Disease Control and Prevention building in Atlanta. (AP Photo/Ben Gray, file)

    Gold standard science

    The gold standard can differ because science and medicine is complicated and everything cannot be tested the same way. That term simply refers to the best possible evidence that can be gathered.

    “It completely depends on what question you’re trying to answer,” said Dr. Jake Scott, an infectious disease physician and Stanford University researcher.

    What produces the best possible evidence?

    There are many different types of studies. The most rigorous is the randomized clinical trial.

    It randomly creates two groups of subjects that are identical in every way except for the drug, treatment or other question being tested. Many are “blinded studies,” meaning neither the subjects nor the researchers know who is in which group. This helps eliminate bias.

    It is not always possible or ethical to conduct these tests. This is sometimes the case with vaccine trials, “because we have so much data showing how safe and effective they are, it would be unethical to withhold vaccines from a particular group,” said Jessica Steier, a public health scientist and founder of the Unbiased Science podcast.

    Studying the long-term effect of a behavior can be impossible. For example, scientists could not possibly study the long-term benefit of exercise by having one group not exercise for years.

    Instead, researchers must conduct observational studies, where they follow participants and track their health and behavior without manipulating any variables. Such studies helped scientists discover that fluoride reduces cavities, and later lab studies showed how fluoride strengthens tooth enamel.

    But the studies have limitations because they can often only prove correlation, not causation. For example, some observational studies have raised the possibility of a link between autism risk and using acetaminophen during pregnancy, but more have not found a connection. The big problem is that those kinds of studies cannot determine if the painkiller really made any difference or if it was the fever or other health problem that prompted the need for the pill.

    Real world evidence can be especially powerful

    Scientists can learn even more when they see how something affects a large number of people in their daily lives.

    That real-world evidence can be valuable to prove how well something works — and when there are rare side effects that could never be detected in trials.

    Such evidence on vaccines has proved useful in both ways. Scientists now know there can be rare side effects with some vaccines and can alert doctors to be on the lookout. The data has proved that vaccines provide extraordinary protection from disease. For example, measles was eliminated in the U.S. but it still pops up among unvaccinated groups.

    That same data proves vaccines are safe.

    “If vaccines caused a wave of chronic disease, our safety systems — which can detect 1-in-a-million events — would have seen it. They haven’t,” Scott told a U.S. Senate subcommittee in September.

    The best science is open and transparent

    Simply publishing a paper online is not enough to call it open and transparent. Specific things to look for include:

    — Researchers set their hypothesis before they start the study and do not change it.

    — The authors disclose their conflicts of interest and their funding sources.

    — The research has gone through peer review by subject-matter experts who have nothing to do with that particular study.

    — The authors show their work, publishing and explaining the data underlying their analyses.

    — They cite reliable sources.

    This transparency allows science to check itself. Dr. Steven Woloshin, a Dartmouth College professor, has spent much of his career challenging scientific conclusions underlying health policy.

    “I’m only able to do that because they’re transparent about what they did, what the underlying source resources were, so that you can come to your own conclusion,” he said. “That’s how science works.”

    Know the limits of anecdotes and single studies

    Anecdotes may be powerful. They are not data.

    Case studies might even be published in top journals, to help doctors or other professionals learn from a particular situation. But they are not used to making decisions about how to treat large numbers of patients because every situation is unique.

    Even single studies should be considered in the context of previous research. A new one-off blockbuster study that seems to answer every question definitively or reaches a conclusion that runs counter to other well-conducted studies needs a very careful look.

    Uncertainty is baked into science.

    “Science isn’t about reaching certainty,” Woloshin said. “It’s about trying to reduce uncertainty to the point where you can say, ‘I have good confidence that if we do X, we’ll see result Y.’ But there’s no guarantee.”

    Doing your own research? Questions to ask

    If you come across a research paper online, in a news story or cited by officials to change your mind about something, here are some questions to ask:

    — Who did the research? What is their expertise? Do they disclose conflicts of interest?

    — Who paid for this research? Who might benefit from it?

    — Is it published in a reputable journal? Did it go through peer review?

    — What question are the researchers asking? Who or what are they studying? Are they making even comparisons between groups?

    — Is there a “limitations” section where the authors point out what their research cannot prove, other factors that could influence their results, or other potential blind spots? What does it say?

    — Does it make bold, definitive claims? Does it fit into the scientific consensus or challenge it? Is it too good or bad to be true?

    ___

    AP Medical Writers Lauran Neergaard in Washington and Mike Stobbe in New York contributed to this report.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • The Miami Project to Cure Paralysis follows science and steady funding to a broader mission

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    Marc Buoniconti said his father, the late NFL Hall of Famer Nick Buoniconti, explained the secret to the success of their nonprofit and its fundraising efforts simply: “We’re just not good listeners.”

    In the 40 years since Marc Buoniconti, then a college football linebacker at the Citadel, was paralyzed during a routine tackle, they have been told countless times that it was a problem that couldn’t be fixed. The Buonicontis didn’t listen.

    Instead, through the fund that bears their name, they have helped raise more than $550 million for The Miami Project to Cure Paralysis, and improved the lives of millions with spinal cord and brain injuries.

    “The Buoniconti Fund has lasted because we’re relentless,” Marc Buoniconti recently told The Associated Press. “We never give up. When we see a challenge, we face it head-on and don’t stop until we find a solution. It’s that determination, that refusal to quit that’s kept us going all these years.”

    That drive has also led The Miami Project to expand its work beyond curing paralysis. Its research center at the University of Miami Miller School of Medicine now also studies neurological diseases and disorders including Alzheimer’s disease and Parkinson’s disease, and it is testing the brain-computer interface implant from Elon Musk’s technology company Neuralink.

    Dr. Barth A. Green, chairman of The Miami Project, who co-founded the organization in 1985 with Nick Buoniconti, says the most surprising developments from the center have been the broadest ones.

    “Every operating room in the world that puts people to sleep monitors their nervous system for safety,” Dr. Green said. “That was all developed at The Miami Project.”

    Therapeutic hypothermia, where the body is cooled after an injury to protect the brain and spinal cord, is another widely used treatment developed at the center.

    Dr. Green said that before Buoniconti’s accident he had been working on helping those who had been paralyzed for 20 years. Yet there wasn’t a hub for that work until The Miami Project was established.

    It provided a home for him and “thousands of scientists and researchers in Miami and around the world, who were equally engaged by the opportunity to change people’s everyday quality of life and their opportunities to have more function and a better opportunity to be mobile and do things they never dreamt they could before.”

    Miami Project Scientific Director W. Dalton Dietrich III said gathering those people from a variety of disciplines – neuroscientists, researchers, clinicians, biomedical engineers – into one building has led to unexpected advances.

    “Not one particular treatment is going to cure paralysis,” Dietrich said. “So I’ve tried to look at other disciplines to bring into the project to help us achieve that goal.”

    One new, multidisciplinary area, neuromodulation, is “something we never thought about five years ago,” Dietrich said. “It’s just an exciting area where you can stimulate these residual circuits after brain injury or spinal cord injury in patients and they start moving their limbs.”

    The Buoniconti Fund’s support for the center helps accelerate research in these areas by funding early trials. That, in turn, makes it easier to eventually receive grants from government agencies like the National Institutes of Health or the Department of Defense, Dietrich said.

    Marc Buoniconti says “it’s hard to put into words” seeing so many people rally behind him and the millions of others who have been paralyzed.

    “What started as a promise to help me walk again became a mission to help millions,” he said. “Every resource, every dollar, every hour given is a testament to the belief that we can change lives.”

    Mark Dalton, chairman and CEO of Tudor Investment Corp., said that belief resonated with him and made him want to get involved with The Buonicontis even before he met them.

    “I had tremendous admiration for him as a father who was never going to give up on finding a cure for what ailed his son,” Dalton said. “And his son was a representation of millions of other people.”

    Once he learned more about The Miami Project, Dalton said he was impressed by its science-driven approach. Its setting on a university campus was also important to the former chairman of the board of trustees at Denison and Vanderbilt universities.

    “They put the line in the water,” said Dalton, who now chairs the Buoniconti Fund’s biggest annual fundraiser, The Great Sports Legends Dinner. “They hooked me. I’m all in.”

    That’s a common feeling around The Miami Project, which counts legendary golfer Jack Nicklaus and Grammy winner Gloria Estefan among its supporters. And it’s something Marc Buoniconti says he does not take for granted.

    He hopes The Miami Project’s work will continue to expand.

    “My biggest dream is for our researchers to find a way to fully repair the nervous system,” Buoniconti said. “When we do that, we’ll change the entire landscape for paralysis and so many other neuro conditions. We’ll give so many people their lives back. That’s what keeps me going, and that’s what makes every struggle to this point worth it.”

    _____

    Associated Press coverage of philanthropy and nonprofits receives support through the AP’s collaboration with The Conversation US, with funding from Lilly Endowment Inc. The AP is solely responsible for this content. For all of AP’s philanthropy coverage, visit https://apnews.com/hub/philanthropy.

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  • FACT FOCUS: There’s no proof each strike on alleged drug boats saves 25,000 lives, as Trump claims

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    President Donald Trump has repeatedly claimed that military strikes on suspected drug boats his administration has been carrying out for more than two months in the Caribbean Sea and Pacific Ocean are saving the lives of hundreds of thousands of people in the U.S.

    He most recently cited these numbers on Monday while answering questions from reporters after announcing a new initiative that will allow foreigners traveling to the U.S. for the World Cup next year to get interviews for visas more quickly.

    But experts say that this is a grossly simplistic interpretation of the situation.

    Here’s a closer look at the facts.

    TRUMP: “Every boat we knock out, we save 25,000 American lives.”

    THE FACTS: The numbers to support Trump’s claim don’t add up, and sometimes don’t exist. For example, people in the U.S. who die from drug overdoses each year are far fewer than the amount Trump suggests have been saved by the boat strikes his administration has carried out since September.

    “The statement that each of the administration’s strikes on alleged drug-smuggling boats saves 25,000 lives is absurd,” said Carl Latkin, a professor of public health at Johns Hopkins University who studies substance use. “The evidence is similar to that of the moon being made of blue cheese. If you look carefully, you will see a resemblance. However, a close analysis of this claim suggests that it lacks all credibility.”

    According to the latest preliminary data from the Centers of Disease Control and Prevention, there were about 97,000 drug overdose deaths in the U.S. during the 12-month period that ended June 30. That’s down 14% from the estimated 113,000 for the previous 12-month period.

    Final CDC data reports 53,336 overdose deaths in 2024 and 75,118 in 2023.

    The U.S. military has attacked 21 boats in the Caribbean Sea and eastern Pacific Ocean since strikes began on Sept. 2, most recently on Nov. 15. Using Trump’s numbers, that would mean the strikes have prevented 525,000 fatal drug overdoses in the U.S — far more than the number of overdose deaths that have occurred in recent two-month periods. This essentially implies that the administration is saving more lives than would have ever been lost.

    Lori Ann Post, the director of the Institute for Public Health and Medicine at Northwestern University, explained that “there’s no empirically sound way to say a single strike ‘saves 25,000 lives,’” even if the statement is interpreted more broadly to mean preventing substance use disorders and resulting ripple effects. Among the issues she pointed to are a lack of verifiable cargo data or published models linking such boat strikes to changes in drug use, as well as markets that will adapt to isolated supply losses.

    “The math and the data are not there,” said Post, who studies drug overdose deaths and economic drivers of the opioid crisis.

    Latkin added that claiming one lethal dose of a drug automatically translates to one death is a “very simple way of looking at it,” as different people have different tolerances.

    Trump has justified the attacks by saying the U.S. is in “armed conflict” with drug cartels and claiming the boats are operated by foreign terror organizations that are flooding America’s cities with drugs. Neither Trump nor his administration have publicly confirmed the amount of drugs allegedly destroyed in the strikes.

    White House spokesperson Anna Kelly reiterated Trump’s numbers when asked for evidence to support his claims about how many lives are being saved. She wrote in an email: “President Trump is right — any boat bringing deadly poison to our shores has the potential to kill 25,000 Americans or more. The President is prepared to use every element of American power to stop drugs from flooding in to our country and to bring those responsible for justice.”

    Latkin noted that this estimate also ignores the reality that even if the Trump administration manages to shut off one source of illegal drugs with its boat strikes, there will still be others. He offered a comparison to the fast food industry, explaining that getting rid of a couple of restaurants would not greatly improve Americans’ health since there are so many other sources where consumers could get the same or similar products.

    “It’s incredibly naive to think that reducing the supply in one place will eradicate the problem because it’s such a massive business,” he said.

    Opioids accounted for 73.4% of drug overdose deaths in 2024, according to the CDC. That includes 65.1% from illegally made fentanyls. But while the boat strikes have targeted vessels largely in the Caribbean Sea, fentanyl is typically trafficked to the U.S. overland from Mexico, where it is produced with chemicals imported from China and India.

    Overdose death rates began steadily climbing in the 1990s because of opioid painkillers, followed by waves of deaths led by other opioids like heroin and — more recently — illicit fentanyl. New numbers from the CDC show that a decline that began in 2023 has continued. Experts aren’t certain about the reasons for the decline, but they cite a combination of possible factors. Among them are the end of the COVID-19 pandemic; years of efforts to increase the availability of the overdose-reversing drug naloxone and addiction treatments; and changes to the drugs themselves.

    ___

    Find AP Fact Checks here: https://apnews.com/APFactCheck

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  • Babies who drank ByHeart formula got sick months before botulism outbreak, parents say

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    As health officials investigate more than 30 cases of infant botulism linked to ByHeart baby formula since August, parents who say their children were sickened with the same illness months before the current outbreak are demanding answers, too.

    California public health officials confirmed late Friday that six babies in that state who consumed ByHeart formula were treated for botulism between November 2024 and June 2025, up to nine months before the outbreak that has sickened at least 31 babies in 15 states.

    At the time, there was “not enough evidence to immediately suspect a common source,” the California Department of Public Health said in a statement.

    Even now, “we cannot connect any pre-August 1 cases to the current outbreak,” officials said.

    Parents of at least five babies said that their infants were treated for the rare and potentially deadly disease after drinking ByHeart formula in late 2024 and early 2025, according to reports shared with The Associated Press by Bill Marler, a Seattle food safety lawyer representing the families.

    Amy Mazziotti, 43, of Burbank, California, said her then-5-month-old son, Hank, fell ill and was treated for botulism in March, weeks after he began drinking bottles filled with ByHeart formula.

    Katie Connolly, 37, of Lafayette, California, said her daughter, M.C., then 8 months old, was hospitalized in April and treated for botulism after being fed ByHeart formula in hopes of helping the baby sleep.

    For months, neither mother had any idea where the infections could have originated. Such illnesses in babies typically are caused by spores spread in the environment or by contaminated honey.

    Then ByHeart recalled all of its products nationwide on Nov. 11 in connection with growing cases of infant botulism.

    As soon as she heard it was ByHeart, Mazziotti said she thought: “This cannot be a coincidence.”

    ByHeart officials this week confirmed that laboratory tests of previously unopened formula found that some samples were contaminated with the type of bacteria that leads to infant botulism.

    Marler said at least three other cases that predate the outbreak involved babies who drank ByHeart and were treated for botulism, according to their families. One consumed ByHeart formula in December 2024. The other two were sickened later in the spring, he said.

    An official with the U.S. Centers for Disease Control and Prevention said federal investigators were aware of reports of earlier illnesses but that efforts are focused now on understanding the unusual surge of dozens of infections documented since Aug. 1.

    “That doesn’t mean that they’re not necessarily part of this,” said Dr. Jennifer Cope, a CDC scientist leading the probe. “It’s just that right now, we’re focusing on this large increase.”

    Because so much time has passed and because parents of babies who got sick earlier may not have recorded lot numbers of product or kept empty cans of formula, “it will make it harder to definitively link them” to the outbreak, Cope said.

    Connolly said it feels like her daughter has been forgotten.

    “What I want to know is why did the cases beginning in August flag an investigation, but the cases that began in March did not?” Connolly said.

    Cope and other health officials said the strong signal connecting ByHeart to infant botulism cases only became apparent in recent weeks.

    Before this outbreak, no powdered infant formula in the U.S. had tested positive for the type of bacteria that leads to botulism, California health officials said. The number of cases also were within an expected range. A test of a can of open formula fed to a sick baby in the spring did not detect the bacterium.

    Then, beginning in August and through October, more cases were identified on the East Coast involving a type of toxin rarely detected in the region, officials said. More cases were seen in very young infants and more cases involved ByHeart formula, which accounts for less than 1 percent of infant formula sold in the U.S.

    Earlier this month, after a sample from a can of ByHeart formula fed to a sick infant tested positive for the germ that leads to illness, officials notified the CDC, the U.S. Food and Drug Administration and the public.

    Less than 200 cases of infant botulism are reported in the U.S. each year. The disease is caused when babies ingest spores that germinate in the gut and produce a toxin. The bacterium that leads to illness is ubiquitous in the environment, including soil and water, so the source is often unknown.

    Officials at the California Infant Botulism Treatment and Prevention Program track reports of botulism and the distribution of the only treatment for the illness, an IV medication called BabyBIG.

    Outside food safety experts said the CDC should count earlier cases as part of the outbreak if babies consumed ByHeart formula and were treated for botulism.

    “Absolutely, yes, they should be included,” said Frank Yiannas, former deputy commissioner for food policy and response at the U.S. Food and Drug Administration. “Why wouldn’t they be included?”

    Sandra Eskin, chief executive of STOP Foodborne Illness, an advocacy group, agreed.

    “This outbreak is traumatic for parents,” she said. “They may have fed their newborns and infants a product they assumed was safe. And now they’re dealing with hospitalization and serious illness of their babies.”

    Connolly and Mazziotti said their babies are improving, though they still have some lingering effects. Botulism causes symptoms that include constipation, poor feeding, head and limb weakness and other problems.

    After months of uncertainty about the potential cause of the infection, Connolly said she “became completely obsessed” with the link to ByHeart formula. Now, she just wants answers.

    “We deserve to know the data that can help us understand how our babies got sick,” she said.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • As infant botulism cases climb to 31, recalled ByHeart baby formula is still on some store shelves

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    As cases of potentially deadly botulism in babies who drank ByHeart infant formula continue to grow, state officials say they are still finding the recalled product on some store shelves.

    Meanwhile the company reported late Wednesday that laboratory tests confirmed that some samples of formula were contaminated with the type of bacteria that has sickened more than 30 babies in the outbreak.

    Tests by an independent food safety laboratory found Clostridium botulinum, a bacterium that produces toxins that can lead to potentially life threatening illness in babies younger than 1, the company said on its website. ByHeart officials said they notified the U.S. Food and Drug Administration of the findings but did not specify how many samples were tested or how many were positive.

    “We are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again,” ByHeart said on its website.

    The FDA did not immediately respond to questions about the findings.

    The lab results come as investigators in at least three states found ByHeart formula still for sale even after the New York-based company recalled all products nationwide, officials told The Associated Press.

    At least 31 babies in 15 states who drank ByHeart formula have been hospitalized and treated for infantile botulism since August, federal health officials said Wednesday. They range in age from about 2 weeks to about 6 months, with the most recent case reported on Nov. 13.

    No deaths have been reported.

    In Oregon, nine of more than 150 stores checked still had the formula on shelves this week, a state agriculture official said. In Minnesota, investigators conducted 119 checks between Nov. 13 and Nov. 17 and removed recalled products from sale at four sites, an agriculture department official said. An Arizona health official also said they found the product available.

    Businesses and consumers should remain alert, Minnesota officials said in a statement. “No affected product should be sold or consumed,” they wrote.

    Investigators with the U.S. Food and Drug Administration conducted inspections at ByHeart manufacturing plants in Allerton, Iowa, and Portland, Oregon. No results from the inspections have been reported.

    California officials previously confirmed the germ that can lead to illness in an open can of ByHeart formula fed to a baby who fell ill.

    Infant botulism, which can cause paralysis and death, is caused by a type of bacteria that forms spores that germinate in a baby’s gut and produce a toxin.

    Symptoms can take up to 30 days to develop and include constipation, poor feeding, a weak cry, drooping eyelids or a flat facial expression. Babies can develop weakness in their limbs and head and may feel “floppy.” They can have trouble swallowing or breathing.

    ByHeart had been manufacturing about 200,000 cans of formula per month. It was sold online or at retail stores such as Target and Walmart. A Walmart spokesperson said the company swiftly issued a restriction that prevented sale of the formula, removed the product from stores and notified consumers who had bought it. Customers can visit any store for a refund of the formula, which sold for about $42 per can.

    Federal and state health officials are concerned that some parents and caregivers may still have ByHeart products in their homes. They are advising consumers to stop using the product — including formula in cans and any single-serve sticks. They also suggest marking it “DO NOT USE” and keeping it for at least a month in case a baby develops symptoms. In that case, the formula would need to be tested.

    The California health department operates the Infant Botulism Treatment and Prevention Program, which tracks cases and distributes treatment for the disease. Officials there have launched a public hotline at 833-398-2022, which is staffed with health officials from 7 a.m. to 11 p.m. Pacific Standard Time.

    The new hotline was created after calls from hundreds of parents and caregivers flooded a different, longstanding hotline for doctors to discuss suspected infant botulism cases, officials said.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • An autoimmune disease stole this man’s memory. Here’s how he’s learning to cope

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    “My year of unraveling” is how a despairing Christy Morrill described nightmarish months when his immune system hijacked his brain.

    What’s called autoimmune encephalitis attacks the organ that makes us “us,” and it can appear out of the blue.

    Morrill went for a bike ride with friends along the California coast, stopping for lunch, and they noticed nothing wrong. Neither did Morrill until his wife asked how it went — and he’d forgotten. Morrill would get worse before he got better. “Unhinged” and “fighting to see light,” he wrote as delusions set in and holes in his memory grew.

    Of all the ways our immune system can run amok and damage the body instead of protecting it, autoimmune encephalitis is one of the most unfathomable. Seemingly healthy people abruptly spiral with confusion, memory loss, seizures, even psychosis.

    But doctors are getting better at identifying it, thanks to discoveries of a growing list of the rogue antibodies responsible that, if found in blood and spinal fluid, aid diagnosis. Every year new culprit antibodies are being uncovered, said Dr. Sam Horng, a neurologist at Mount Sinai Health System in New York who has cared for patients with multiple forms of this mysterious disease.

    And while treatment today involves general ways to fight the inflammation, two major clinical trials are underway aiming for more targeted therapy.

    Still, it’s tricky. Symptoms can be mistaken for psychiatric or other neurologic disorders, delaying proper treatment.

    “When someone’s having new changes in their mental status, they’re worsening and if there’s sort of like a bizarre quality to it, that’s something that kind of tips our suspicion,” Horng said. “It’s important not to miss a treatable condition.”

    With early diagnosis and care, some patients fully recover. Others like Morrill recover normal daily functioning but grapple with some lasting damage — in his case, lost decades of “autobiographical” memories. This 72-year-old literature major can still spout facts and figures learned long ago, and he makes new memories every day. But even family photos can’t help him recall pivotal moments in his own life.

    “I remember ‘Ulysses’ is published in Paris in 1922 at Sylvia Beach’s bookstore. Why do I remember that, which is of no use to me anymore, and yet I can’t remember my son’s wedding?” Morrill wonders.

    Encephalitis means the brain is inflamed and symptoms can vary from mild to life-threatening. Infections are a common cause, typically requiring treatment of the underlying virus or bacteria. But when that’s ruled out, an autoimmune cause has to be considered, Horng said, especially when symptoms arise suddenly.

    The umbrella term autoimmune encephalitis covers a group of diseases with weird-sounding names based on the antibody fueling it, such as anti-NMDA receptor encephalitis.

    While they’re not new diseases, that one got a name in 2007 when Dr. Josep Dalmau, then at the University of Pennsylvania, discovered the first culprit antibody, sparking a hunt for more.

    That anti-NMDA receptor encephalitis tends to strike younger women and, one of the bizarre factors, it’s sometimes triggered by an ovarian “dermoid” cyst.

    How? That type of cyst has similarities to some brain tissue, Horng explained. The immune system can develop antibodies recognizing certain proteins from the growth. If those antibodies get into the brain, they can mistakenly target NMDA receptors on healthy brain cells, sparking personality and behavior changes that can include hallucinations.

    Different antibodies create different problems depending if they mostly hit memory and mood areas in the brain, or sensory and movement regions.

    Altogether, “facets of personhood seem to be impaired,” Horng said.

    Therapies include filtering harmful antibodies out of patients’ blood, infusing healthy ones, and high-dose steroids to calm inflammation.

    Those cyst-related antibodies stealthily attacked Kiara Alexander in Charlotte, North Carolina, who’d never heard of the brain illness. She’d brushed off some oddities — a little forgetfulness, zoning out a few minutes — until she found herself in an ambulance because of a seizure.

    Maybe dehydration, the first hospital concluded. At a second hospital after a second seizure, a doctor recognized the possible signs, ordering a spinal tap that found the culprit antibodies.

    As Alexander’s treatment began, other symptoms ramped up. She has little clear memory of the monthlong hospital stay: “They said I would just wake up screaming. What I could remember, it was like a nightmare, like the devil trying to catch me.”

    Later Alexander would ask about her 9-year-old daughter and when she could go home — only to forget the answer and ask again.

    Alexander feels lucky she was diagnosed quickly, and she got the ovarian cyst removed. But it took over a year to fully recover and return to work full time.

    In San Carlos, California, in early 2020, it was taking months to determine what caused Morrill’s sudden memory problem. He remembered facts and spoke eloquently but was losing recall of personal events, a weird combination that prompted Dr. Michael Cohen, a neurologist at Sutter Health, to send him for more specialized testing.

    “It’s very unusual, I mean extremely unusual, to just complain of a problem with autobiographical memory,” Cohen said. “One has to think about unusual disorders.”

    Meanwhile Morrill’s wife, Karen, thought she’d detected subtle seizures — and one finally happened in front of another doctor, helping spur a spinal tap and diagnosis of LGI1-antibody encephalitis.

    It’s a type most common in men over age 50. Those rogue antibodies disrupt how neurons signal each other, and MRI scans showed they’d targeted a key memory center.

    By then Morrill, who’d spent retirement guiding kayak tours, could no longer safely get on the water. He’d quit reading and as his treatments changed, he’d get agitated with scary delusions.

    “I lost total mental capacity and fell apart,” Morrill describes it.

    He used haiku to make sense of the incomprehensible, and months into treatment finally wondered if the “meds coursing through me” really were “dousing the fire. Rays of hope?”

    The nonprofit Autoimmune Encephalitis Alliance lists about two dozen antibodies — and counting — known to play a role in these brain illnesses so far.

    Clinical trials, offered at major medical centers around the country, are testing two drugs now used for other autoimmune diseases to see if tamping down antibody production can ease encephalitis.

    More awareness of these rare diseases is critical, said North Carolina’s Alexander, who sought out fellow patients. “That’s a terrible feeling, feeling like you’re alone.”

    As for Morrill, five years later he still grieves decades of lost memories: family gatherings, a year spent studying in Scotland, the travel with his wife.

    But he’s making new memories with grandkids, is back outdoors — and leads an AE Alliance support group, using his haiku to illustrate the journey from his “unraveling” to “the present is what I have, daybreaks and sunsets” to, finally, “I can sustain hope.”

    “I’m reentering some real time of fun, joy,” Morrill said. “I wasn’t shooting for that. I just wanted to be alive.”

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • An autoimmune disease stole this man’s memory. Here’s how he’s learning to cope

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    “My year of unraveling” is how a despairing Christy Morrill described nightmarish months when his immune system hijacked his brain.

    What’s called autoimmune encephalitis attacks the organ that makes us “us,” and it can appear out of the blue.

    Morrill went for a bike ride with friends along the California coast, stopping for lunch, and they noticed nothing wrong. Neither did Morrill until his wife asked how it went — and he’d forgotten. Morrill would get worse before he got better. “Unhinged” and “fighting to see light,” he wrote as delusions set in and holes in his memory grew.

    Of all the ways our immune system can run amok and damage the body instead of protecting it, autoimmune encephalitis is one of the most unfathomable. Seemingly healthy people abruptly spiral with confusion, memory loss, seizures, even psychosis.

    But doctors are getting better at identifying it, thanks to discoveries of a growing list of the rogue antibodies responsible that, if found in blood and spinal fluid, aid diagnosis. Every year new culprit antibodies are being uncovered, said Dr. Sam Horng, a neurologist at Mount Sinai Health System in New York who has cared for patients with multiple forms of this mysterious disease.

    And while treatment today involves general ways to fight the inflammation, two major clinical trials are underway aiming for more targeted therapy.

    Still, it’s tricky. Symptoms can be mistaken for psychiatric or other neurologic disorders, delaying proper treatment.

    “When someone’s having new changes in their mental status, they’re worsening and if there’s sort of like a bizarre quality to it, that’s something that kind of tips our suspicion,” Horng said. “It’s important not to miss a treatable condition.”

    With early diagnosis and care, some patients fully recover. Others like Morrill recover normal daily functioning but grapple with some lasting damage — in his case, lost decades of “autobiographical” memories. This 72-year-old literature major can still spout facts and figures learned long ago, and he makes new memories every day. But even family photos can’t help him recall pivotal moments in his own life.

    “I remember ‘Ulysses’ is published in Paris in 1922 at Sylvia Beach’s bookstore. Why do I remember that, which is of no use to me anymore, and yet I can’t remember my son’s wedding?” Morrill wonders.

    Encephalitis means the brain is inflamed and symptoms can vary from mild to life-threatening. Infections are a common cause, typically requiring treatment of the underlying virus or bacteria. But when that’s ruled out, an autoimmune cause has to be considered, Horng said, especially when symptoms arise suddenly.

    The umbrella term autoimmune encephalitis covers a group of diseases with weird-sounding names based on the antibody fueling it, such as anti-NMDA receptor encephalitis.

    While they’re not new diseases, that one got a name in 2007 when Dr. Josep Dalmau, then at the University of Pennsylvania, discovered the first culprit antibody, sparking a hunt for more.

    That anti-NMDA receptor encephalitis tends to strike younger women and, one of the bizarre factors, it’s sometimes triggered by an ovarian “dermoid” cyst.

    How? That type of cyst has similarities to some brain tissue, Horng explained. The immune system can develop antibodies recognizing certain proteins from the growth. If those antibodies get into the brain, they can mistakenly target NMDA receptors on healthy brain cells, sparking personality and behavior changes that can include hallucinations.

    Different antibodies create different problems depending if they mostly hit memory and mood areas in the brain, or sensory and movement regions.

    Altogether, “facets of personhood seem to be impaired,” Horng said.

    Therapies include filtering harmful antibodies out of patients’ blood, infusing healthy ones, and high-dose steroids to calm inflammation.

    Those cyst-related antibodies stealthily attacked Kiara Alexander in Charlotte, North Carolina, who’d never heard of the brain illness. She’d brushed off some oddities — a little forgetfulness, zoning out a few minutes — until she found herself in an ambulance because of a seizure.

    Maybe dehydration, the first hospital concluded. At a second hospital after a second seizure, a doctor recognized the possible signs, ordering a spinal tap that found the culprit antibodies.

    As Alexander’s treatment began, other symptoms ramped up. She has little clear memory of the monthlong hospital stay: “They said I would just wake up screaming. What I could remember, it was like a nightmare, like the devil trying to catch me.”

    Later Alexander would ask about her 9-year-old daughter and when she could go home — only to forget the answer and ask again.

    Alexander feels lucky she was diagnosed quickly, and she got the ovarian cyst removed. But it took over a year to fully recover and return to work full time.

    In San Carlos, California, in early 2020, it was taking months to determine what caused Morrill’s sudden memory problem. He remembered facts and spoke eloquently but was losing recall of personal events, a weird combination that prompted Dr. Michael Cohen, a neurologist at Sutter Health, to send him for more specialized testing.

    “It’s very unusual, I mean extremely unusual, to just complain of a problem with autobiographical memory,” Cohen said. “One has to think about unusual disorders.”

    Meanwhile Morrill’s wife, Karen, thought she’d detected subtle seizures — and one finally happened in front of another doctor, helping spur a spinal tap and diagnosis of LGI1-antibody encephalitis.

    It’s a type most common in men over age 50. Those rogue antibodies disrupt how neurons signal each other, and MRI scans showed they’d targeted a key memory center.

    By then Morrill, who’d spent retirement guiding kayak tours, could no longer safely get on the water. He’d quit reading and as his treatments changed, he’d get agitated with scary delusions.

    “I lost total mental capacity and fell apart,” Morrill describes it.

    He used haiku to make sense of the incomprehensible, and months into treatment finally wondered if the “meds coursing through me” really were “dousing the fire. Rays of hope?”

    The nonprofit Autoimmune Encephalitis Alliance lists about two dozen antibodies — and counting — known to play a role in these brain illnesses so far.

    Clinical trials, offered at major medical centers around the country, are testing two drugs now used for other autoimmune diseases to see if tamping down antibody production can ease encephalitis.

    More awareness of these rare diseases is critical, said North Carolina’s Alexander, who sought out fellow patients. “That’s a terrible feeling, feeling like you’re alone.”

    As for Morrill, five years later he still grieves decades of lost memories: family gatherings, a year spent studying in Scotland, the travel with his wife.

    But he’s making new memories with grandkids, is back outdoors — and leads an AE Alliance support group, using his haiku to illustrate the journey from his “unraveling” to “the present is what I have, daybreaks and sunsets” to, finally, “I can sustain hope.”

    “I’m reentering some real time of fun, joy,” Morrill said. “I wasn’t shooting for that. I just wanted to be alive.”

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • Judge approves opioid settlement for Purdue Pharma and Sackler family members who own the company

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    A federal bankruptcy court judge on Tuesday formally approved OxyContin maker Purdue Pharma’s plan to settle thousands of lawsuits over the harms of opioids.

    U.S. Bankruptcy Judge Sean Lane gave reasoning Tuesday for approving the plan, which requires members of the Sackler family who own the company to contribute up to $7 billion over 15 years. Most of the money is to go to government entities to fight the opioid crisis that has been linked to 900,000 deaths in the U.S. since 1999.

    A portion of the money is to be distributed next year to some people who had OxyContin prescriptions and their survivors.

    “My heart goes out to all those who have suffered such pain,” Lane said.

    The new agreement replaces one the U.S. Supreme Court rejected last year, finding it would have improperly protected members of the family against future lawsuits. Under the current agreement, entities that do not opt into the payments can still sue members of the family.

    The deal, which the judge said he would accept last week, is among the largest in a series of opioid settlements brought by state and local governments against drugmakers, wholesalers and pharmacies that totaled about $50 billion.

    Sackler family members agreed to pay up to $7 billion over 15 years, providing most of the cash involved in the settlement.

    The funds distributed to state, local and Native Americans is to be used mostly to address the opioid crisis, as has been the case with other opioid settlements.

    About $850 million of that is to go to individual victims, including children born with opioid withdrawal.

    People with addiction and survivors of those who died must prove they were prescribed OxyContin to participate. Those who do could receive payments of around $8,000 or around $16,000, depending on how long they received the drug and how many other people qualify. The money for individual victims is to be distributed next year.

    Members of the Sackler family are agreeing to give up ownership of Purdue.

    For them, that won’t be a major change since no family member has served on Purdue’ board or received money from the company since 2018. The plan calls for Purdue to be replaced with a new company, Knoa Pharma, to be controlled by a board appointed by states and with a mission of benefiting the public.

    Sackler family members are also agreeing not to have their name put on institutions in exchange for contributions — something they’ve done often in the past, though many institutions have cut ties with them.

    The company has also agreed to make public a trove of internal documents that could shed additional light into how the company promoted and monitored opioids.

    One feature that won’t be repeated under this new deal that was in a previous one: forcing members of the Sackler family to hear directly from people harmed by OxyContin.

    Purdue filed for bankruptcy protection in 2019 when it was facing thousands of opioid-related lawsuits from state and local governments and others.

    A judge approved a settlement two years later. But the U.S. Supreme Court later rejected that plan because it gave members of the Sackler family protection from lawsuits over opioids even though they were not personally declaring bankruptcy.

    The latest plan allows lawsuits against Sackler family members by those who don’t opt into the deal. That change was a key to getting the new version approved in the aftermath of the high court’s ruling.

    This time, few parties objected to the settlement, although some people who represented themselves and who were addicted to opioids — or had loved ones who were — raised concerns during the three-day confirmation hearing last week.

    One of those self-represented people told Lane during the virtual hearing Tuesday that she planned to appeal.

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  • Novo cuts Wegovy prices, but doctors still see cost challenges for patients

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    Novo Nordisk is chopping prices again for Wegovy, but doctors say the expense will remain challenging for patients without insurance.

    The drugmaker said Monday that it has started selling higher doses of the injectable obesity treatment for $349 a month to patients paying the full bill. That’s down from $499, and in line with terms of a drug pricing agreement outlined earlier this month by President Donald Trump’s administration.

    Novo also started a temporary offer of $199 a month for the first two months of low doses of Wegovy and the drug’s counterpart for diabetes, Ozempic. The new pricing will be available at pharmacies nationwide, through home delivery and from some telemedicine providers.

    Rival Eli Lilly also plans price breaks for its weight-loss drug Zepbound once it gets a new, multi-dose pen on the market. Lilly has said it will sell a starter dose of Zepbound for $299 a month and additional doses at up to $449. Both represent $50 reductions from current prices for sales directly to patients.

    Obesity treatments like Zepbound and Wegovy have soared in popularity in recent years. Known as GLP-1 receptor agonists, the drugs work by targeting hormones in the gut and brain that affect appetite and feelings of fullness.

    In clinical trials, they helped people shed 15% to 22% of their body weight — up to 50 pounds or more in many cases. But affordability has been a persistent challenge for patients.

    A recent poll by the nonprofit KFF found that about half of the people who take the treatments say it was hard to afford them.

    Both Lilly and Novo announced price cuts earlier this year that brought the cost of higher doses of their treatments down to around $500 a month.

    Previous research has shown that people have difficulty paying for a medication when the cost rises above $100 per month, said Stacie Dusetzina, a Vanderbilt University Medical Center professor and prescription drug pricing expert.

    She said Novo’s new prices are “not going to really move the needle for a person who doesn’t have a pretty reasonable amount of disposable income.”

    Dr. Laura Davisson said the medication would still be unaffordable for patients on Medicaid in states where the government-funded program for people with low incomes doesn’t cover the drug.

    The bigger issue is expanding coverage of the treatments, said Davisson, a West Virginia University obesity specialist.

    “We’ve had hundreds of people lose coverage over the last couple of years, and we keep seeing more and more insurers drop coverage,” she said, adding that her practice has started a group support program to help those who have lost coverage.

    Coverage is slated to improve starting next year for at least one big payer under a deal announced by the Trump administration. The federally funded Medicare program, mainly for people ages 65 and older, will begin covering the treatments for people who have severe obesity and others who are overweight or obese and have serious health problems.

    Those who qualify will pay $50 copays for the medicine.

    Administration officials also said lower prices for the drugs that they negotiated for Medicare also will be provided for Medicaid programs.

    That will help expand coverage, according to Dave Moore, Novo’s executive vice president for U.S. operations. He said Medicaid programs in 20 states cover the drug for obesity.

    Novo officials expect around 40 million more Americans will gain access to their drug through coverage expansions for Medicaid and Medicare.

    Neither Moore nor representatives for Eli Lilly would say whether they plan additional price cuts. Both companies also are seeking approval of pill versions of the drugs, which would come with new prices.

    Lilly spokesperson Courtney Kasinger said the company believes obesity treatments should be covered just like those for any other chronic condition.

    “We’re going to continue to work to improve coverage as much as we can across all channels, all stakeholders,” she said.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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