(ATLANTA) — The Georgia state Supreme Court reinstated the state’s six-week abortion ban on Monday after a lower court allowed abortions to resume in the state.
The ruling goes into effect at 5 p.m. ET and will remain in place while the court hears the state’s appeal, which was filed by Christopher Carr, the state’s Republican attorney general.
Justice John J. Ellington dissented in part, arguing against the ban being reinstated before the state’s appeal is heard.
“Fundamentally, the State should not be in the business of enforcing laws that have been determined to violate fundamental rights guaranteed to millions of individuals under the Georgia Constitution,” he wrote. “The ‘status quo’ that should be maintained is the state of the law before the challenged laws took effect.”
On Sept. 30, Fulton County Superior Court Judge Robert McBurney ruled that the ban was unconstitutional, writing in his decision that the Georgia state constitution guaranteed the right to “liberty,” which includes a “woman’s right to control what happens to and within her body.” The state appealed the decision two days later.
The ban, which was signed into law in 2019 by Gov. Brian Kemp, prevents abortions from being performed once fetal cardiac activity can be defected, which typically occurs at about six weeks’ gestation — before many women know they’re pregnant — and redefines the word “person” in Georgia to include an embryo or fetus at any stage of development.
There are exceptions for rape or incest until 20 weeks of pregnancy as long as the victim has reported the crime to the police. Additionally, a patient can have an abortion up until 20 weeks if the fetus has defects and would not be able to survive or if the patient’s life is in danger.
The ban was blocked in court but was reinstated after the U.S. Supreme Court overruled Roe v. Wade in 2022.
“Seeing state politicians show such little empathy or respect for Georgians’ health and lives only doubles our resolve to keep fighting until every person has the freedom to make personal medical decisions during pregnancy and the power to chart the course of their own lives,” Julia Kaye, senior staff attorney with the ACLU Reproductive Freedom Project, a litigator on the case, said in a statement.
(NEW YORK) — Dr. Lisa Newman, the chief of the section of breast surgery at New York-Presbyterian/Weill Cornell Medical Center, sat down with ABC News to discuss breast cancer prevention, early screenings and diagnosis discrepancies.
A new American Cancer Society report, released in October, which is Breast Cancer Awareness Month, finds that breast cancer mortality rates overall have dropped by 44% since 1989, averting about 517,900 breast cancer deaths. However, not all women have benefited from this progress.
ABC News discussed the issue with Newman, who provided more context.
ABC NEWS: Dr. Lisa Newman, chief of the section of breast surgery at New York Presbyterian/Weill Cornell Medical Center. Dr. Newman, thank you so much for joining us. So overall, are you encouraged or concerned by this report?
DR. LISA NEWMAN: Well, thank you for this attention to such a major problem of breast cancer. As you mentioned, it is rising in incidence in American women. So we are very gratified to see these continued declines in breast cancer mortality rates. This is a testimony to our successes with breast health awareness, early detection through screening mammography programs and wonderful advances that we’ve made in treatment.
But as you also noted, we are still seeing some rather appalling and disturbing trends in the breast cancer statistics. It’s very concerning to us that the rates of breast cancer are rising for young women, women younger than the age of 50. And this is for a variety of reasons. We are also seeing very concerning disparities in the burden of breast cancer and, in particular, breast cancer death rates continue to be significantly higher for African-American women and for Black women younger than the age of 50.
ABC NEWS: As far as the disparities with regard to ethnic groups, which we also discussed, why the increase there as well?
NEWMAN: Yeah. The disparities in breast cancer burden are also secondary to some complex factors with the disproportionate mortality rates that we see in Black women. We know that this is going to be explained heavily by socioeconomic disadvantages that are more prevalent in the African-American community, and African-American women are more likely to be diagnosed with more advanced breast cancers because of delays in diagnosis.
Black women are more likely to have delays in initiation of treatment, and there are some tumor biology questions that we need to evaluate in research, as well. A lot of the research that I do actually looks at the breast cancer burden of women with African ancestry. And we do know that African ancestry in and of itself increases the likelihood of getting biologically aggressive forms of breast cancer and getting breast cancer at younger ages. So we need to address that, these socioeconomic disparities, but we also need more research to understand these biological differences.
ABC NEWS: And we saw that we’re just seeing that trend of an increase year after year. What can we do to, to try and bring these numbers down?
NEWMAN: Being aware of breast health is very important and making sure that you get screened regularly. For average risk women, The American Society of Breast Surgeons advocates in favor of getting yearly mammograms starting at age 40. If you have a strong family history, you should consider getting genetic testing, because if you do have inherited predisposition for breast cancer, you may need to start getting your mammograms at even younger ages.
ABC NEWS: The good news that we see here in this report: The mortality rate has dropped in the last year compared to 35 years ago. What do you attribute that to?
NEWMAN: Yeah. Very exciting to see that the mortality rates are declining. This is secondary to women advocating more forcefully for themselves and getting screened regularly. Women also, we want to remind women that mammograms aren’t perfect. And so women do indeed need to be aware of the potential danger signs of breast cancer, such as a new lump in the breast, lump in the underarm, bloody nipple discharge, changes in the skin appearance of the breast like swelling, a rash.
ABC NEWS: And what are some basic things that all women can do to protect themselves? You mentioned diet, for example. What kinds of food or diet would be helpful with this?
NEWMAN: Well, a good way to look at it is in terms of the holistic picture and in general, the dietary patterns that are good for cardiovascular health are good for breast health. So a diet that has lots of fresh fruits and vegetables in it, minimizing fat intake, minimizing alcohol intake, alcohol has also been associated with breast cancer risk.
ABC NEWS: Such important and lifesaving information. Dr. Newman, thank you very much for coming on the show.
(DURHAM, N.C.) — As hospitals and health care facilities work to get back up and running after Hurricane Helene slammed into Florida’s Big Bend, affecting several states, the medical supply chain could be at risk.
Baxter International, a health care and medical technology company, announced this week that it must close its largest plant in North Carolina due to flooding and destruction caused by the hurricane.
The plant, located in North Cove, 60 miles northeast of Asheville, primarily manufactures IV fluids and peritoneal dialysis solutions, according to Baxter. It is the largest manufacturer of such solutions in the U.S., employing more than 2,500 people, the company said.
“Our hearts and thoughts are with all those affected by Hurricane Helene,” José Almeida, chair, president and CEO of Baxter, said in a statement. “The safety of our employees, their families, and the communities in which we operate remains our utmost concern, and we are committed to helping ensure a reliable supply of products to patients.”
“Remediation efforts are already underway, and we will spare no resource – human or financial – to resume production and help ensure patients and providers have the products they need,” the statement continued.
Baxter said it implemented a hurricane preparedness plan ahead of Helene, which included evacuation plans for staff and moving products to higher ground or to secure storage. However, heavy rainfall and storm surge “triggered a levee breach,” which led to flooding in the facility.
Among those impacted by the Baxter plant closing is Duke University Health System (DUHS), in Durham, North Carolina, according to William Trophi, DUHS interim president vice president of supply chain.
“[Baxter has] published their action items, and they have announced to us that they’re putting a hold on all distribution for 48 hours to understand what they have in their supply line, and then they’re going to be setting up pretty strict allocations based on prior usage to make sure that everyone is getting their fair share based on their volume and their needs,” he told ABC News.
Trophi said DUHS and Duke University have not seen major disruption to their supply chain following Helene’s landfall, but notes there may be delays in the future if the Baxter plant closure lasts for several weeks, if more plants close, and depending on how long the dockworkers’ strike on the East Coast and the Gulf Coast lasts.
“What we’re doing internally is we’re looking at conservation models, so similar with our IV solutions, we’re going to look at what can we be doing differently to treat our patients in a safe, effective manner to conserve IV solutions,” he said. “And we’ll start to look at other high, critical, sensitive items that could be impacted by this, and look at what can we be doing differently to conserve the way in which we treat our patients in a safe, effective manner.”
Paul Biddinger, chief preparedness and continuity officer for the Boston-based Mass General Brigham health care system, told ABC News that facilities typically begin stockpiling and taking inventory of supplies prior to a natural disaster. After the event has happened, health care centers will work to identify what products are affected by supply chain issues and which patients are using the products.
In the case of the Baxter plant, the products are primarily used by kidney patients, cardiac patients and urologic patients, Biddinger said, adding that hospitals and other health care facilities will typically try to conserve as much of the affected product as possible, and will also investigate any alternatives or substitutions for the product.
“If the shortage is so severe that we just can’t continue with normal usage, even with conservation, then we have to start a process of allocating across our clinical services, of course, prioritizing lifesaving care and emergency care, and then going down our list for more scheduled or more elective kinds of procedures,” Biddinger said.
Samantha Penta, an associate professor of emergency management and homeland security at the University at Albany in New York, said one really important factor to consider when understanding the implications of Hurricane Helene is just how large the affected area is.
“We’re not just talking about a couple of counties. We’re not even just talking about one state. This has affected multiple states very significantly,” she told ABC News. “One of the things that organizations, in general, including hospitals, long-term care facilities and like – really, anything in the health care sector – does, is you can rely on neighboring facilities.”
Penta said if health care facilities need to send patients to a neighboring facility because they’re running low on supplies or space, or if their facility is damaged, they typically can do so. The same holds true if one facility is running low on supplies; another facility might send them some of their reserves as part of a mutual aid agreement.
But in the case of Helene, “effectively, the people who need help, their neighbors are also being affected. So, any given hospital, the closest hospitals to them, are likely dealing with the same issues,” Penta said. “That further complicates it, because things have to come from even farther away, whether that’s working within a network or ordering from different vendors.”
Over the weekend, North Carolina became the latest state to have a public health emergency declared by the U.S. Department of Health & Human Services (HHS) in response to Hurricane Helene.
The HHS’s Administration for Strategic Preparedness and Response deployed about 200 personnel to the state, including Health Care Situational Assessment teams to evaluate the storm’s impact on health care facilities such as hospitals, nursing homes and dialysis centers, and Disaster Medical Assistance teams to help state and local health workers provide care.
(NEW YORK) — Breast cancer deaths have fallen by 44% compared to 35 years ago, saving nearly 520,000 lives, according to a new report by the American Cancer Society.
The dramatic decrease is a major milestone in the fight against breast cancer, according to Dr. Lisa Newman, a co-author of the report, released on Tuesday, the start of Breast Cancer Awareness Month.
“This decline is evidence of our success in better treatments for breast cancer, especially with targeted treatments,” Newman, chief of the section of breast surgery at NewYork-Presbyterian/Weill Cornell Medical Center, told ABC News.
Beyond advances in care, Newman noted that mammography has also played a crucial role in detecting cancer earlier.
In April, the U.S. Preventive Services Task Force updated their guidelines, recommending that women at average risk for breast cancer get a mammogram every two years starting at age 40.
However, screening isn’t perfect, Newman stressed.
Women should watch for new lumps, skin changes, and nipple changes, including unusual discharge, pain, and redness.
Even if the last mammogram is clear, women should discuss any changes with a healthcare provider.
Steepest rise in new cases among women under 50
Though breast cancer deaths have dropped, new cases continue to rise.
From 2012 to 2021, breast cancer diagnoses increased by 1% each year, with the steepest rise among women under 50.
The reasons for the increase in diagnoses at a younger age remain unclear, Newman said.
“We speculate that it is related to differences in lifestyle and environment given the obesity epidemic and more women delaying their childbearing years and having fewer pregnancies over their lifetime,” she said.
Racial disparities in breast cancer persist
Yet despite lower overall death rates, racial disparities in breast cancer persist.
American Indian and Alaska Native (AIAN) women have seen no improvement in death rates, while Asian American/Pacific Islander (AAPI) women face the fastest uptick in new cases, with a nearly 3% annual increase.
And despite having 10% fewer cases than white women, AIAN women are 6% more likely to die from the disease and receive fewer regular mammograms.
Black women face a 38% higher chance of dying from breast cancer and have worse outcomes at every stage and subtype, except for localized cancers, compared to white women.
“Studies show that Black women are more likely to receive mammograms at lower-quality facilities, face delays in diagnosing abnormalities, and experience delays in starting and completing treatment,” Newman explained.
Because African American women are more prone to triple negative breast cancer, a particularly deadly form of the disease, Newman said there is a strong push to improve the diversity in clinical trials.
In May of 2024, the ACS launched the VOICES of Black Women Study which will enroll 100,000 Black women aged 25 to 55 and follow them for 30 years.
Newman also pointed out that breast cancer can affect men, especially African American men, who have double the risk compared to White men.
While the report revealed many promising trends in breast cancer, the disease remains the second most common cancer among women in the U.S. after skin cancer and the leading cause of cancer deaths for Black and Hispanic women. In 2024, experts predict over 300,000 new invasive (stage I and above) breast cancer cases with more than 40,000 deaths.
The report’s findings are based on data from the national cancer tracking programs that includes information from the National Cancer Institute and the Centers for Disease Control and Prevention.
(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.
(NEW YORK) — The number of kids dying from influenza in the 2023-2024 season has set a new record for a regular flu season, after one new death was reported last week, according to the Centers for Disease Control and Prevention (CDC).
There were 200 pediatric flu-related deaths in the 2023-2024 season, compared to the previous high of 199 during the 2019-2022 season.
About 80% of the kids that died from flu this season were not fully vaccinated against influenza, CDC data shows. Nearly half of the children had at least one pre-existing medical condition.
Everyone over the age of six months is recommended to get their annual flu vaccine before the end of October, according to the CDC.
Children up to 8 years old receiving their first flu shot should receive two doses if they previously have not, the CDC notes.
Older adults over the age of 65, who are at higher risk of severe illness including hospitalization and death, may opt for a higher dose flu shot for further protection.
“Vaccination remains our most effective tool to prevent illness and reduce the risk of serious complications in children,” said Dr. John Brownstein, chief innovation officer at Boston Children’s Hospital and an ABC News medical contributor.
Vaccination rates among children for flu have been declining in recent years. About 53.9% of children were vaccinated against influenza this season, about 2.2% points lower than last season and 8.5% points lower than pre-pandemic.
“The decline in flu vaccination rates among children is deeply concerning and is at least partly linked to the rise in pediatric cases we’re witnessing,” Brownstein said.
Estimates show that flu vaccination reduced the risk of flu medical visits by about two-thirds and halved the risk of hospitalization among kids, according to the CDC.
“We must address this drop in vaccinations to prevent further unnecessary and preventable loss of young lives,” Brownstein added.
The influenza virus spreads year-round, but flu activity typically picks up in the fall and winter, peaking between the months of December and February.
While the impact of flu varies from season to season, estimates from the CDC show the virus has resulted in up to 41 million illnesses, 710,000 hospitalizations and 51,000 deaths annually in the past decade, according to the CDC.
“The record number of pediatric flu deaths this season is a stark indicator of how severe influenza can be,” Brownstein said.
While the United States has made considerable progress fighting the HIV/AIDS crisis since its peak in the 1980s, headway has not been equal among racial/ethnic groups.
Overall, HIV rates have declined in the U.S. and the number of new infections over the last five years has dropped among Black Americans and white Americans. However, Hispanic and Latino Americans have not seen the same gains.
Between 2018 and 2022, estimated HIV infections among gay and bisexual men fell 16% for Black Americans and 20% for white Americans, according to data from the Centers for Disease Control and Prevention. Meanwhile, Hispanic Americans saw rates held steady, the CDC said.
There may be several reasons for the lack of decline, including Hispanic Americans facing health care discrimination, experts told ABC News. Some may also face the stigma that prevents patients from accessing services or makes them feel ashamed to do so. There is also a lack of material that is available in their native language or is culturally congruent, experts said.
“Where we are in the HIV epidemic is that we have better tools than ever for both treatment and for prevention, and we have seen a modest slowing in the rate of new infections, but we have seen a relative increase in the rate of new infections among Latino individuals, particularly Latino men who have sex with men,” Dr. Kenneth Mayer, a professor of medicine at Harvard Medical School and medical research director at Fenway Health in Boston, told ABC News.
“So, the trends are subtle, but they’re concerning because it does speak to increased health disparities in that population,” he continued.
Hispanic Americans make up more cases and more deaths
Although Hispanic and Latino Americans make up 18% of the U.S. population, they accounted for 33% of estimated new HIV infections in 2022, according to HIV.gov, a website run by the U.S. Department of Health and Human Services. This is in comparison with white Americans, who make up 61% of the U.S. population but just 23% of HIV infections.
Hispanic and Latino gay men currently represent the highest number of new HIV cases in the U.S.
What’s more, Hispanic males were four times likely to have HIV or AIDS compared to white males in 2022 and Hispanic females were about three times more likely than white females to have HIV over the same period, according to the federal Office of Minority Health (OMH).
Additionally, Hispanics males were nearly twice as likely to die of HIV Infection as white males and Hispanic females to die of HIV Infection in 2022, the OMH said.
Erick Suarez, a nurse practitioner and chief medical officer of Pineapple Healthcare, a primary care and HIV/AIDS specialist located in Orlando, Florida, told ABC News that watching the lack of progress made in the HIV/AIDS crisis for the Hispanic and Latino population is like “traveling back in time.”
“When I say traveling back in time for the Hispanic/Latino population with HIV, I mean [it’s like] they are living before 2000,” he said, “Their understanding of treatment and how to access it is in that pre-2000 world. … The state of HIV and AIDS in the Hispanic/Latino population in the United States right now is a few steps back from the general American population.”
He said many Hispanic/Latino HIV patients come to the United States unaware of their HIV status. If they are aware of their status, they come from countries where prevention and pre-exposure prophylaxis (PrEP) is hard to find or doesn’t exist.
When they get to the United States, they be afraid or unsure of where or how to access health care. Even Hispanic/Latino Americans whose families have been here for generations, have trouble accessing health care due to racial and ethnic disparities, Suarez said.
Previous research has shown Hispanic/Latino Americans with HIV reported experiencing health care discrimination, which could be a barrier to accessing care.
Facing discrimination, stigma
Hispanic and Latino patients with HIV report facing discrimination in health care, experts told ABC News. A CDC report published in 2022 found between 2018 and 2020, nearly 1 in 4 Hispanic patients with HIV said they experienced health care discrimination.
Hispanic men were more likely to face discrimination than Hispanic women and Black or African American Hispanic patients were more likely than white Hispanic patients to face discrimination, according to the report.
There may also be stigma — both within the general population and within their own communities — associated with HIV infection that could prevent patients from accessing services, according to the experts.
Suarez said one of his most recent patients, who is Cuban, traveled two hours to a clinic outside of their city to make sure no one in their familial and social circles would know their status.
“The interesting part is that even though I speak with them like, ‘You understand that everything that happens within these walls is federally protected, that it is private information. No one will ever know your information, and our goal is for you to get access healthcare. You can do this in your own city,'” Suarez said.
“Now, because of the stigma, they will travel long distances to avoid contact with anyone and make sure that no one knows their status. So, stigma is a huge factor,” he continued.
Rodriguez said this stigma and mistrust has led to many Hispanic and Latino Americans to not seek medical care unless something is seriously wrong, which may result in missed HIV diagnoses or a missed opportunity to receive post-exposure prophylaxis, which can reduce the risk of HIV when taken within 72 hours after a possible HIV exposure.
Making resources ‘available, attainable and achievable’ Experts said one way to lower rates is to make information on how to reduce risk as well as how to get tested and treated available in other languages, such as Spanish, and making sure it is culturally congruent.
However, Rodriguez says translating documents is not enough. In the early 2010s, when the CDC was disseminating its national strategy to reduce HIV infection, the agency began to circulate materials on how to reduce HIV incidence, reducing stigma and increasing use of condoms for sex, Rodriguez said.
He said that of a compendium of 30 interventions, maybe one was in Spanish. When he took the materials back to his native Puerto Rico, many were having trouble understanding the materials because it has been translated by someone who is of Mexican heritage.
Secondly, rather than the materials being written in Spanish, they had been translated from English to Spanish, which doesn’t always translate well, Rodriguez said.
“When we talk about Hispanics, we have to talk about, first of all, the culture. Our culture is very complex. Not one Spanish language can speak to all of the Hispanic communities,” he said. “And then we also have to look at the generations of Hispanics. Are you first generation, second generation, third generation? “
He added that the key is making resources “available, attainable and achievable.”
This month, the White House convened a summit to discuss raising awareness of HIV among Hispanic and Latino Americans and to discuss strengthening efforts to address HIV in Hispanic and Latino communities.
Mayer said it’s also important to make sure information is disseminated on social media that is culturally tailored for Hispanic and Latino experiences.
“It’s important for social media to seem culturally relevant, to make sure that they understand that HIV is not just a disease of old white guys, and that they may have a substantial risk,” he said. “Make sure that they’re educated by what they can do to protect themselves since we have highly effective pre-exposure prophylaxis, and we have ways to decrease STIs with a doxycycline post-exposure prophylaxis.
The experts added that having more Hispanics and Latinos represented in medicine, research and public health may encourage more Hispanic and Latino Americans with HIV or at risk of HIV to seek care or treatment.
“Seeing and being able to recognize that your healthcare provider looks like you, sounds like you, in some way it represents you, is a key aspect of getting people on treatment and access,’ Suarez said. “And not only that, but keeping them in treatment and having them come back and stay and keep that going, that’s a key issue.”
(SILVER SPRING, Md.) — The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in more than 30 years.
Cobenfy, manufactured by Bristol Myers Squibb, combines two drugs, xanomeline and trospium chloride, and is taken as a twice-daily pill. In clinical trials, this combination helped manage symptoms such as hallucinations, delusions, and disorganized thinking, which are common in schizophrenia.
“Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the approval announcement.
“This drug takes the first new approach to schizophrenia treatment in decades,” Farchione continued. “This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
Cobenfy offers new hope for people with schizophrenia, providing an innovative treatment option that could change how this condition is managed, according to Jelena Kunovac, MD, a board-certified psychiatrist and adjunct assistant professor at the University of Nevada, Las Vegas, in the Department of Psychiatry.
“We are overdue for a medication that targets schizophrenia with a different mechanism of action,” Kunovac told ABC News.
The first drugs for schizophrenia, including chlorpromazine and haloperidol – also known by the brand names Thorazine and Haldol, respectively – were introduced in the 1950s and revolutionized treatment of the disease. However, there have been very few new medications since then, with most subsequent FDA approvals being for variations of these older drugs.
Most schizophrenia medications, broadly known as antipsychotics, work by changing dopamine levels, a brain chemical that affects mood, motivation, and thinking, Kunovac explained. Cobenfy takes a different approach by adjusting acetylcholine, another brain chemical that aids memory, learning and attention, she said.
By focusing on acetylcholine instead of dopamine, Cobenfy may reduce schizophrenia symptoms while avoiding common side effects like weight gain, drowsiness and movement disorders, clinical trials suggest. These side effects often become so severe and unpleasant that, in some studies mirroring real-world challenges, many patients stopped treatment within 18 months of starting it.
In clinical trials, only 6% of patients stopped taking Cobenfy due to side effects, noted Dr. Samit Hirawat, chief medical officer at Bristol Myers Squibb. “That’s a significant improvement over the 20-30% seen with older antipsychotic drugs,” he added.
The most common side effects of Cobenfy are nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, increased heart rate, dizziness and gastroesophageal reflux disease, according to the FDA announcement.
“It may prove advantageous to those who don’t tolerate what has been available,” Dr. Leslie Citrome, a clinical professor of psychiatry and expert in psychopharmacology at New York Medical College, told ABC News regarding Cobenfy. “This will provide a new approach that may work out quite nicely.”
Citrome emphasized that patients who have trouble tolerating the side effects of traditional schizophrenia medications may benefit most from Cobenfy, and that a different mechanism of action holds hope for those who have not responded adequately to existing treatments.
Schizophrenia is a mental health disorder that affects about 24 million people worldwide, or roughly one in 300 people, according to the World Health Organization (WHO). It often leads to significant challenges in daily functioning, work, and relationships, impacting both patients and their families.
The disorder typically begins in late adolescence or early adulthood and can lead to lifelong disability if not properly managed, according to the WHO, further highlighting the need for effective treatment options.
Following approval, doctors could start prescribing Cobenfy by the end of October, according to Adam Lenkowsky, executive vice president and chief commercialization officer at Bristol Myers Squibb.
Experts hope that the drug’s unique mechanism and reduced side effects will help set a new standard of care for schizophrenia patients. Studies for additional therapeutic uses, including the treatment of Alzheimer’s disease and bipolar disorder, are also underway.
Jake Goodman, MD, MBA is a psychiatry resident physician and a member of the ABC News Medical Unit.
(NEW YORK) — A rise in rates of sudden unexpected infant deaths may have been linked to an off-season surge of respiratory syncytial virus (RSV) in 2021, according to a new study published Thursday in the journal JAMA Open Network.
Sudden unexpected infant deaths (SUID) includes deaths of infants under one year old without a known cause, deaths that are due to accidental suffocation or strangulation in bed and those from sudden infant death syndrome (SIDS), according to the Centers for Disease Control and Prevention (CDC).
“This is an important topic because SIDS and other unexpected deaths are still one of the leading causes of infant mortality, and there’s still a lot unknown,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor.
The most recent CDC data shows about 3,700 infants died from SUID in 2022 and 41% were from SIDS.
“There are very few things that are as horrific as a family experiencing a sudden infant death, and especially given the causes are so often unknown,” Brownstein said.
Using records from the CDC, researchers analyzed more than 14,000 cases of SUID and found that rates per 100,000 live births increased by 10% from 2019 to 2021.
Results showed the risk of SUID was highest from June to December 2021 — at the same time there was an off-season surge in hospitalizations due to RSV after the virus skipped its typical winter season in 2020.
Influenza hospitalizations were rare during this time and hospitalizations from COVID-19 did not have any clear association with monthly changes in SUID rates in the study.
These findings may indicate a connection between the risk of SUID and seasonal shifts in infections like RSV, but more research is needed to better understand this link.
“The findings underscore the importance of monitoring infant mortality during and after pandemics and obviously it puts big support for vaccinations and RSV prevention,” Brownstein said.
Currently, there are newer RSV shots available that doctors say are important to help prevent RSV and give babies the best protection against this virus that hospitalizes thousands of kids a year, mostly babies.
The American College of Obstetricians and Gynecologists recommends pregnant women get an RSV vaccine between 32 and 36 weeks of pregnancy to pass on antibody protection to newborns.
The CDC recommends an RSV antibody shot called nirsevimab for all babies less than 8 months old unless their mother received an RSV vaccine in pregnancy at least 2 weeks before birth.
While nirsevimab had supply constraints last year in its first season, Sanofi, the drug manufacturer, recently announced they have started shipping shots to doctors’ offices and anticipate having enough doses for all eligible babies in the US this RSV season.
Doctors say safe sleep is also important for SUID prevention. The American Academy of Pediatrics recommends that infants sleep alone, placed down on their back on a firm, flat surface, with nothing in the sleeping area other than a fitted sheet.
Scott Gummerson, MD, ScM, is an emergency medicine resident and member of the ABC Medical News Unit.
Jade A. Cobern, MD, MPH is a physician board-certified in pediatrics and preventive medicine and a medical fellow of the ABC News Medical Unit.
(NEW YORK) — Americans can once again order free at-home COVID-19 tests from the federal government starting Thursday ahead of the upcoming respiratory virus season.
This is the third year in a row the Biden-Harris administration has allowed Americans to order over-the-counter tests at no charge.
Anyone wanting to order tests can do so at COVID.gov/tests. Four tests will be shipped free by USPS, starting Sep. 30.
The U.S. Department of Health and Human Services (HHS) first made the announcement last month that the free COVID tests program was restarting.
“As families start to move indoors this fall and begin spending time with their loved ones, both very old and very young, they will once again have the opportunity to order up to four new COVID-19 tests free of charge and have them sent directly to their homes,” Dawn O’Connell, assistant secretary for preparedness and response at HHS, said during a media briefing at the time. “These tests will help keep families and their loved ones safe this fall and winter season.”
She added that the tests will be able to detect infection from currently circulating variants.
Currently, KP.3.1.1, an offshoot of the omicron variant, is the dominant variant in the U.S., accounting for an estimated 52.7% of cases, according to the Centers for Disease Control and Prevention (CDC).
During the same media briefing, CDC director Dr. Mandy Cohen said immunity from vaccination and previous COVID infection have helped limit the burden of COVID on the health care system.
“I do want to acknowledge that we continue to see a lot of COVID-19 activity across the country right now in tests coming back from labs,” Cohen said, adding, “Circulating COVID disease is not translating into similar increases in emergency room visits and hospitalizations or deaths.”
