FDA approves Eli Lilly’s obesity medication for obstructive sleep apnea
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(NEW YORK) — The FDA has expanded the approval of Eli Lilly’s obesity medication Zepbound to include treating moderate to severe obstructive sleep apnea for people with obesity — the first medication approved for the condition.
The new, expanded Zepbound approval means that insurance providers, including Medicare, will likely cover the medication for people with sleep apnea and obesity. Some insurance providers, including Medicare, do not offer reimbursement to treat obesity alone.
The new approval is for people with moderate to severe obstructive sleep apnea who are also living with obesity. Eli Lilly estimates that is about 15-20 million adults in the U.S.
Obstructive sleep apnea isn’t just an inconvenience, it’s a serious medical condition that impairs breathing and sleep quality. Obesity and obstructive sleep apnea are linked. People tend to see their obstructive sleep apnea get better when they lose a significant amount of weight. It’s likely the weight loss associated with the medication is helping improve the sleep apnea.
Right now, there is no medicine to treat obstructive sleep apnea — it’s only treated with a positive airway pressure device.
In a study, people who took Zepbound had at least 25 fewer breathing interruptions per hour while they slept. They also lost an average of 20% of their body weight.
The study also followed people over a year, and found that up to half of the adults taking Zepbound no longer had obstructive sleep apnea symptoms at the end of the year.
Obstructive sleep apnea is more common in men than women. Up to 34% of U.S. men have OSA compared to 17% of U.S. women, according to the American Academy of Family Physicians.
Common signs of sleep apnea include heavy snoring at night, long pauses in breathing while sleeping as well as excessive daytime sleepiness, forgetfulness and morning headaches. The symptoms of the disorder can lead to significant medical problems.
(WASHINGTON) — Vice President Kamala Harris said former President Donald Trump will roll back health care protections if he wins the presidential election.
Speaking to reporters on Thursday in Madison, Wisconsin, Harris said Trump unsuccessfully tried to repeal the Affordable Care Act (ACA), the landmark law signed by then-President Barack Obama in 2010, while he was president.
“Insurance companies could go back to a time where they would deny you coverage for health insurance based on pre-existing conditions, such being a survivor of breast cancer, asthma, diabetes,” Harris said. “The American people, regardless of who they are voting for, know the importance of Obamacare in terms of expanding coverage to health care, based on the fundamental principle I hold deeply: access to health care should be a right and not just a privilege for those who can afford it.”
“Health care for all Americans is on the line in this election,” Harris continued.
In a post on his social media platform Truth Social, Trump falsely claimed not wanting to end the ACA, even though he repeatedly tried to do so while president.
Here is what we know about Trump’s health care agenda if he is elected to a second term:
‘Concepts’ of a heath care plan
During the ABC News presidential debate in September, Trump said he was interested in replacing the ACA — also known as “Obamacare” — but implied that he didn’t have any specific plans in place.
“Obamacare was lousy health care. Always was,” Trump said. “It’s not very good today and, what I said, that if we come up with something, we are working on things, we’re going to do it and we’re going to replace it.”
When asked to clarify if he had a health care plan, the former president said he had “concepts of a plan” to replace the ACA but provided no details.
“If we can come up with a plan that’s going to cost our people, our population, less money and be better health care than Obamacare, then I would absolutely do it,” Trump said.
After Harris’ press conference on Thursday, Trump took to Truth Social to deny wanting to end the ACA.
“Lyin’ Kamala is giving a News Conference now, saying that I want to end the Affordable Care Act. I never mentioned doing that, never even thought about such a thing,” he wrote Thursday morning.
Trump made several attempts to repeal the ACA during his presidency but failed to do so.
He attempted to partially repeal the ACA by passing the American Health Care Act (ACHA). The plan would have repealed the individual mandate and the employer mandate, amended Medicaid eligibility and weakened protections for patients with pre-existing conditions.
The ACHA passed the House in May 2017 but failed to pass in the Senate. Perhaps mostly infamously, the Senate attempted to pass a so-called “skinny repeal” in late July 2017 but it was rejected, with Republican Sens. John McCain, Susan Collins and Lisa Murkowski siding with Senate Democrats to kill the bill.
During a closed-door campaign event for a fellow Republican House candidate earlier this week, House Speaker Mike Johnson said that there will be “no Obamacare.”
“We want to take a blowtorch to the regulatory state,” Johnson said in footage first reported by NBC News. “Health care is one of the sectors, but we need this across the board.”
“No Obamacare?” an attendee of the event asked Johnson.
“No Obamacare,” Johnson replied. “The ACA is so deeply ingrained, we need massive reform to make this work, and we got a lot of ideas on how to do that.”
Trump’s campaign has worked to separate itself from the speaker’s comments with Karoline Leavitt, national press secretary for the Trump campaign, telling ABC News in a statement that repealing the ACA is “not President Trump’s policy position.”
“As President Trump has said, he will make our health care system better by increasing transparency, promoting choice and competition, and expanding access to new affordable health care and insurance options. Kamala Harris broke our health care system, President Trump will fix it,” the statement continued.
The 2024 GOP platform currently calls for expanding access to “new” affordable health care and prescription drug access as well as protecting Medicare and increasing transparency in the health care sector.
Trump enlists Kennedy to oversee health care policy
Trump has also suggested that he intends to tap Robert F. Kennedy, Jr. — who dropped out of the presidential race in August and endorsed Trump — to help shape health care policies if he wins a second term.
During the Alfred E. Smith Memorial Foundation Dinner — an annual white-tie dinner to raise money for Catholic charities — earlier this month, Trump said Kennedy will “make us a healthier place.”
“We’re gonna let him go wild for a little while, then I’m gonna have to maybe reign him back, because he’s got some pretty wild ideas, but most of them are really good,” Trump said at the dinner. “I think he’s a — he’s a good man, and he believes, he believes the environment, the healthy people. He wants healthy people, he wants healthy food. And he’s going to do it. He’s going to have a big chance to do it, because we do need that.”
Kennedy said Trump has “promised” him “control of the public health agencies,” but Trump’s team said no decisions have been made yet on who will be leading these agencies if he wins the election.
However, Trump implied during a rally in Henderson, Nevada, on Thursday that Kennedy would play a role in shaping women’s health care policies.
“Robert F. Kennedy Jr., we have,” Trump said. “And he’s gonna work on health, and women’s health, and all of the different reasons ’cause we’re not really a wealthy or a healthy country. We’re not.”
There are currently no women’s health care issues listed in the 2024 GOP platform aside from keeping “men out of women’s sports.”
“The only thing President Trump and his campaign team are focused on is winning on November 5th. Everything after that is after that, and President Trump has made clear that Bobby Kennedy will play an important role,” Jason Miller, senior adviser to the Trump campaign told ABC News in a statement.
In response to Trump saying Kennedy will oversee women’s health, Harris reposted a clip of Trump’s comments on X with the caption “No” followed by a heart emoji.
The Harris campaign did not immediately respond to ABC News’ requests for comment.
ABC News’ Lalee Ibssa, Soorin Kim, Will McDuffie, Lauren Peller and Kelsey Walsh contributed to this report.
(NEW YORK) — California Attorney General Rob Bonta announced the state is suing a hospital in Eureka for allegedly refusing emergency abortion care to women whose lives are in danger.
The lawsuit, filed Monday in Humboldt County Superior Court, alleges Providence St. Joseph Hospital violated multiple California laws due to its refusal to provide urgent abortion care to people experiencing obstetric emergencies.
Providence St. Joseph’s is a Catholic hospital and the primary hospital services provider in Eureka, the largest coastal city between San Francisco and Oregon in northern California.
The lawsuit names one particular patient, Anna Nusslock, who had her water break when she was 15 weeks pregnant with twins in Feb. 2024.
Nusslock, a 35-year-old healthcare professional, claimed in the lawsuit that doctors at Providence St. Joseph’s told her the only option was abortion, but they could not provide her the service, based on hospital policy.
“Without abortion care, I risked infection or hemorrhage, both of which are so dangerous to my health and my life, and increased with every minute that passed,” Nusslock said during a press conference Monday.
Nusslock said she was told by doctors that they were prohibited from offering an emergency abortion if her twins still had any signs of heart tones, despite her own life being at risk and the pregnancy no longer being viable.
“I was told I could not receive emergency abortion care while at Providence because of hospital policy,” Nusslock said.
Instead, Nusslock alleges Providence staff gave her a bucket and towels “in case something happens in the car” and told her to drive 12 miles to a small community hospital where doctors were allowed to perform the procedure.
Once at that smaller hospital, Nusslock said she was actively hemorrhaging when she was placed on an operating table and the pregnancy was aborted.
In the state’s lawsuit, Attorney General Rob Bonta argues Providence has been violating multiple California laws by refusing emergency abortion care to women in need.
California is requesting a court order to force the hospital to perform prompt emergency care including abortions.
“Pregnant patients have the same rights to health care, including emergency care, that any other patient has,” said Bonta.
Bonta claims Providence is barring doctors from providing lifesaving or life-stabilizing emergency abortion treatment even when a pregnancy is not viable and when doctors have determined that immediate abortion care is necessary to save the life of the mother.
The lawsuit alleges that Providence only allows the procedure if the mother’s life is in immediate danger of death by which time intervention can be too late.
“This policy, let’s make no mistake, is draconian,” Bonta said. “It has no place in institutions that are charged with delivering accessible and equitable healthcare.”
While Bonta argues Providence must provide the care under California law, federal law on the topic is less clear.
The Emergency Medical Treatment and Labor Act requires every hospital in the United States that operates an emergency department and participates in Medicare to provide life-stabilizing treatment to all patients, but in a recent case, the U.S. Supreme Court did not confirm that the act includes abortion care.
In a statement to ABC News, a spokesperson for Providence St. Joseph Hospital said, “Providence is deeply committed to the health and wellness of women and pregnant patients and provides emergency services to all who walk through our doors in accordance with state and federal law. We are heartbroken over Dr. Nusslock’s experience earlier this year.”
“This morning was the first Providence had heard of the California attorney general’s lawsuit, and we are currently reviewing the filings to understand what is being alleged. Because this case is in active litigation and due to patient confidentiality, we cannot comment on the matter,” the spokesperson added.
“As part of our pledge to delivering safe, high-quality care, we review every event that may not have met our patient needs or expectations to understand what happened and take appropriate steps to meet those needs and expectations for every patient we encounter,” the spokesperson said.
(WASHINGTON) — The U.S. Food and Drug Administration authorized the first over-the-counter combination COVID-19 and flu test outside of emergency use on Monday evening.
This means the Healgen Rapid Check COVID-19/Flu A&B Antigen Test is available without a prescription. The FDA said the test is for those who are experiencing respiratory symptoms.
While there are other over-the-counter combination tests currently available, this is the first to be marketed to consumers using the traditional approval pathway outside of a public health emergency.
The new combination test uses a nasal swab sample to deliver at-home results for COVID-19 and influenza in approximately 15 minutes.
Healgen’s test detects proteins from both SARS-CoV-2, which is the virus that causes COVID-19, and influenza A and B, which are the viruses that cause flu.
“As we enter this year’s annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives,” said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in a statement. “Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.”
“The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions,” the statement continued.
The test is for use by people 14 and older who can take their own sample, or those 2 and older, who have a sample taken by an adult, according to the federal health agency.
Data reviewed by the FDA found the test correctly identified 99% of negative and 92% of positive COVID samples. Additionally, the test correctly identified 99.9% of negative flu samples, and 92.5% and 90.5% of positive flu samples, respectively.
Like other over-the-counter COVID-19 antigen tests, the FDA says a positive test result likely means a patient is positive while a negative rest result may require a confirmation test.
However, people who test negative and continue to experience symptoms including cough, fever and shortness of breath should follow up with their health care provider, the FDA says. Similarity, the FDA says those who test positive should take appropriate precautions to avoid spreading either virus and should also follow up with their health care provider.
