Supreme Court to take up abortion pill case that could impact access nationwide

Supreme Court to take up abortion pill case that could impact access nationwide
Supreme Court to take up abortion pill case that could impact access nationwide
joe daniel price/Getty Images

(WASHINGTON) — The U.S. Supreme Court on Wednesday granted petitions from the Food and Drug Administration and Danco Labs to hear their appeal of a ruling that would reinstate restrictions on the abortion pill mifepristone and sharply roll back access nationwide.

The court will likely hear oral arguments next spring and issue a ruling by the end of June. A date has not yet been set.

The court’s decision to hear the case ensures abortion access and reproductive rights will be front and center well into the 2024 campaign.

Earlier this year, the 5th Circuit Court of Appeals upheld some, but not all, of Texas District Court Judge Matthew Kasmaryk’s controversial decision against the legality of mifepristone’s FDA approval and regulation.

The 5th Circuit ruled that the drug should be more regulated, with limits at seven weeks of gestation and requirements that the patient obtain the medication in person rather than by mail. Under current guidelines from the FDA, the drug can be used up to 10 weeks of gestation and sent to patients following a telehealth appointment.

Those court decisions remain on hold and access to the pill will be unchanged as this case is heard.

Mifepristone is one of the most common methods of abortion in the country, and became the target of multiple lawsuits after the Supreme Court overruled its decision in Roe v. Wade.

The White House, reacting to the Supreme Court’s announcement, said the Biden administration “will continue to stand by the FDA’s independent approval and regulation of mifepristone as safe and effective.”

“As the Department of Justice continues defending the FDA’s actions before the Supreme Court, President Biden and Vice President Harris remain firmly committed to defending women’s ability to access reproductive care,” White House press secretary Karine Jean-Pierre said in a statement. “We continue to urge Congress to pass a law restoring the protections of Roe v. Wade — the only way to ensure the right to choose for women in every state.”

Abortion rights groups are closely monitoring this case. Had the Supreme Court decided not to take up the case, the lower court ruling would stand and new restrictions would be put on the drug.

Copyright © 2023, ABC Audio. All rights reserved.

Pharmacies are sharing private data with police without a warrant, lawmakers say

Pharmacies are sharing private data with police without a warrant, lawmakers say
Pharmacies are sharing private data with police without a warrant, lawmakers say
nano/Getty Images

(WASHINGTON) — Americans’ prescription drug records are being shared with law enforcement agencies in some cases without the customer’s knowledge and without a judge first signing off on a warrant, according to three U.S. lawmakers.

The finding has Democrats worried that the policies by major retail pharmacy chains — which are allowed under federal rules — could help prosecutors in states that have banned or restricted abortion go after residents who help women travel to get abortions.

In a letter to Health and Human Services Secretary Xavier Becerra, the lawmakers said they want the federal government to tighten the rules so pharmacies only release medical records to investigators with a judge’s approval.

“Through briefings with the major pharmacies, we learned that each year law enforcement agencies secretly obtain the prescription records of thousands of Americans without a warrant,” they wrote. “In many cases, pharmacies are handing over sensitive medical records without review by a legal professional. Although pharmacies are legally permitted to tell their customers about government demands for their data, most don’t.”

The letter, first reported by The Washington Post, followed a lengthy congressional investigation by Democrats into medical privacy following the U.S. Supreme Court decision to overrule Roe vs. Wade. It was signed by Senate Commerce Committee Chairman Ron Wyden, D-Oregon, and Democratic Reps. Pramila Jayapal of Washington and Sara Jacobs of California.

The pharmacies mentioned in the letter say they are following privacy laws and federal health rules, which don’t require a judge-signed warrant. In many cases, law enforcement present subpoenas signed by a government agency but not reviewed by a judge.

CVS Health, which is among the pharmacies named in the letter, said it has suggested a warrant or judge-issued subpoena requirement be considered by regulators. And, the company notes, it relies on a legal team to ensure all requests are compliant with the law.

“Most investigative requests from regulatory agencies and law enforcement require us by law to keep the request confidential,” CVS wrote in a statement provided to ABC News. “If a request does not have a confidentiality directive, we consider on a case-by-case basis whether it’s appropriate to notify the individual who is the subject of the request.”

According to the letter to Becerra, pharmacies are dealing with tens of thousands of requests a year, mostly tied to civil litigation, not criminal cases.

The issue is likely to take on increased urgency for Democrats as states remain divided on abortion access and some counties pursue laws against what they call “abortion trafficking,” or helping a woman travel out of state for an abortion.

Under new federal rules, mifepristone can be prescribed virtually to patients up to 10 weeks of gestation and picked up at a local pharmacy so long as the pharmacy follows certain rules. While the patient must be located in a state where abortion is legal to obtain the drug, pharmacy access has enabled overwhelmed abortion providers in states like California, Colorado and Illinois to serve more patients via virtual clinics.

Meanwhile, anti-abortion rights groups have sued to try to remove mifepristone from the market. The Supreme Court on Wednesday agreed to take up the case, likely ruling on by next summer.

Among the concerns by lawmakers and privacy experts is that big pharmacy chains have access to a person’s medical records across multiple states and could be pulled by prosecutors seeking to clamp down on people who help women travel.

Wyden and the other lawmakers say the Biden administration should require under health privacy law — the Health Insurance Portability and Accountability Act, or HIPAA — that a warrant be presented before sensitive information is shared by a pharmacy. They also want pharmacies to alert customers when that happens, unless a judge agrees that would hinder an investigation.

Copyright © 2023, ABC Audio. All rights reserved.

Pediatric ER doctor shares top gifts to avoid giving kids this holiday season

Pediatric ER doctor shares top gifts to avoid giving kids this holiday season
Pediatric ER doctor shares top gifts to avoid giving kids this holiday season
Pramote Polyamate/Getty Images

(NEW YORK) — A pediatric doctor is sharing the holiday gifts parents should avoid giving kids – and it’s not because she wants to be a Grinch.

Dr. Meghan Martin, a pediatric emergency medicine physician at Johns Hopkins All Children’s Hospital in St. Petersburg, Florida who shared her expert advice in an Instagram video, told “Good Morning America” the products that tend to cause the most injuries seen in pediatric emergency departments, both during and after the holiday season.

Here are Martin’s top five kids’ gifts to skip:

Any toy with button batteries

Button batteries are typically about 20 millimeters in diameter, or between the size of a penny and a nickel, according to the National Capital Poison Center. They’re used in a wide variety of household items and products, including hearing aids, key fobs – and children’s toys.

“The majority of the injuries from button batteries are going to be from swallowing them,” Martin explained, adding that the screws typically used to secure the batteries inside products can easily loosen.

“A lot of times, it doesn’t go all the way to the stomach [after swallowing],” Martin said of button batteries. “It gets stuck in the esophagus or occasionally the airway and then in that position, it starts to create burns in those tissues and a lot of tissue damage in that area.”

That tissue damage in the esophagus and chest, Martin said, puts children particularly at risk of developing “blood vessel injuries [and] airway issues.”

“These can be very dangerous and this can absolutely be fatal,” Martin added.

If parents are concerned a child has swallowed a button battery, Martin recommends calling 911 and, if the child is older than twelve months, giving the child honey while waiting for emergency medical care.

“You can administer small sips of honey every couple of minutes on the way to the emergency department,” Martin explained. “It can decrease the risk of burns and tissue damage, and it can actually be lifesaving.”

In addition to battery consumption, Martin said young kids can also “occasionally stick smaller button batteries, like watch batteries or hearing aid batteries, into their ears or to their nose.”

“You can also have injuries in those locations – again, that kind of tissue damage, tissue breakdown from the battery itself,” she said.

Any toy with water beads

Water beads, according to Martin, are often marketed as “sensory toys,” but the risks they pose can be extremely significant.

“They’re polymers that if ingested, they can swell,” Martin explained. “They can cause things like bowel obstructions, even perforations. They can get stuck in airways because they’re about the size of a small child’s airway, so it’s also a choking hazard.”

Electric scooters

The main reason Martin doesn’t recommend electric scooters and other similar toys, like electric bicycles, is their speed potential.

“They really can get going pretty quickly and if you hit a crack in the sidewalk or a bump in the road, you can easily become dislodged from that scooter,” Martin said. “And if you’re going fast, your face is also going to be going fast as you come towards the road or the sidewalk.”

Martin said they often see head injuries, facial injuries and forearm fractures with electric scooter accidents.

Overall, Martin said she doesn’t recommend giving any electric scooter to a kid. “These can be really dangerous,” she said. “And we’re seeing a lot of injuries with kids crashing on these.”

As an alternative, she recommends giving “kid-powered” scooters, without electricity or motors.

Aside from getting kids active, Martin said kid-powered scooters may also be “good for development of those kinds of fine motor skills, gross motor skills, strength [and] endurance.”

It is always recommended that all children wear helmets when riding scooters.

Hoverboards

Self-balancing scooters, more commonly known as hoverboards, can also land a child in the emergency room.

“The most common injuries I see from hoverboards are forearm fractures and elbow fractures,” Martin said. “We have seen some head injuries from it. We have seen some lower extremity, like ankle and knee injuries, too.”

Plus, Martin pointed out, hoverboards and their batteries have been reported to cause fires and electrical issues.

Trampolines

Of all the hazardous toys she has seen cause injuries in children, Martin said trampolines are the worst offender. Martin said in the pediatric ER, they see trampoline injuries “probably a couple times a week.”

“We see kids getting hurt in all different ways on trampolines,” Martin said. “Mostly it’s going to be leg injuries. But we do see things like arm injuries, elbow injuries – even head injuries and back injuries, sometimes, when doing backflips, neck injuries. So there are a variety of injuries that kids can get on trampolines. And we do see them relatively commonly.”

Martin said she doesn’t recommend trampolines for home use at all because of the risks they pose.

In general, Martin advises parents and caregivers to inspect any toy thoroughly before buying or giving it to a child.

“It’s important to just make sure that the toy is made with quality and the parts are secure and that all the pieces are there that need to be there,” Martin said.

 

Copyright © 2023, ABC Audio. All rights reserved.

Sun-dried tomatoes recalled over ‘undeclared sulfites’

Sun-dried tomatoes recalled over ‘undeclared sulfites’
Sun-dried tomatoes recalled over ‘undeclared sulfites’
FDA

(NEW YORK) — Global Veg Corp has issued a recall of all lots and codes of its 5-pound packages of Aviator brand Sundried Tomato Halves (Lot #060923/1) due to the possibility of “undeclared sulfites,” according to an announcement from the New York-based company dated Dec. 4 and posted Friday on the U.S. Food & Drug Administration website.

The company said in a statement to ABC News that it was aware of affected products being sold in New York and New Jersey, and not nationwide, as the statement on the FDA website indicated.

Products were distributed in “4x5lbs cartons,” according to the company.

The label on each product includes language stating the product’s origin — Turkey — as well as the phrase “Imported and distributed by GLOBAL VEG CORP NEW YORK.”

According to the company announcement posted to the FDA website, the recall was initiated following routine sampling of the product by New York State Department of Agriculture and Markets Food inspectors, followed by analysis by “Food Laboratory personnel” that the company said “revealed that the sulfite containing product was distributed in packages that did not reveal the presence of sulfites.”

The announcement highlighted the potential health risk of sulfites to the consumer, noting that those “who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume this product.”

The company said no incidents of illness or adverse reactions have been reported to date.

Global Veg Corp told ABC News in an email Tuesday that “a few dozen sun-dried tomato cartons were mislabeled in New York” and have since been relabeled, in addition to any boxes the company had left in stock. The company said the products were otherwise “safe” and that the issue was solely connected to labeling.

The company asked consumers who purchased the recalled sun-dried tomato products to return them to the place of purchase to be refunded in full.

Consumers can contact the company at 201-367-0517 with questions.

Copyright © 2023, ABC Audio. All rights reserved.

Arizona’s Supreme Court hears case on state’s 1864 abortion ban

Arizona’s Supreme Court hears case on state’s 1864 abortion ban
Arizona’s Supreme Court hears case on state’s 1864 abortion ban
fstop123/Getty Images

(NEW YORK) — The Arizona State Supreme Court began hearing oral arguments Tuesday over whether a centuries-old near-total abortion ban will be reinstated.

Currently, abortion is banned at 15 weeks or later in Arizona. Patients are required to make two appointments, the first for an in-person counseling session and the second at least 24 hours later for the abortion, according to the Guttmacher Institute, a research group that focuses on sexual and reproductive health.

When the U.S. Supreme Court overturned Roe v. Wade last summer, ending a federally protected right to have an abortion and giving states the right to make their own laws, Arizona providers weren’t sure which abortion law took precedent.

One option was the 15-week ban, which was signed into law by then Gov. Doug Ducey in 2022 and enforced after Roe fell. The other, from 1864, when Arizona was still a territory, would essentially ban abortion in the state.

Under the law, anyone who performs an abortion, or supplies medication to induce an abortion, faces between two and five years in prison. There are no exceptions for rape or incest, only if the mother’s life is in danger, according to the language of the bill.

The law was blocked in 1972 after Planned Parenthood Center of Tucson, the predecessor of Planned Parenthood Arizona, sued, arguing it was a violation of the state and U.S. Constitution.

When Roe v. Wade was passed in 1973, it overrode the 1864 law, but that near-total ban was never taken off the books.

In December 2022, the Arizona Court of Appeals “harmonized” the two laws, writing in an opinion that the 1864 law would only apply to non-physicians and that doctors could follow the newer law.

In August of this year, the State Supreme Court agreed to consider a petition regarding the ruling. The court will decide whether the older or newer law, or a combination of the two, will be enforced.

Attorneys representing the so-called “intervenors” — Yavapai County Attorney Dennis McGrane.and Dr. Eric Hazelrigg, medical director of a chain of anti-abortion clinics — argued the two bans work in tandem because the 1864 ban has an exception to save the mother’s life.

Planned Parenthood Arizona argued that the Civil War era law should not dictate the reproductive rights of Arizonans in the present day and to affirm the Court of Appeals’ decision to preserve abortion access.

“A near-total ban on abortion in our state would be catastrophic to the well-being of our communities and deeply out of touch with the will of the majority of Arizonans,” Dr. Jill Gibson, chief medical officer of Planned Parenthood Arizona, said in a statement on Tuesday. “Arizonans deserve the freedom to make their own decisions about their reproductive health”

“The Arizona Supreme Court has the opportunity to refuse this bleak future and reject this egregious threat to reproductive health care. Our community deserves better – we deserve a right to make our own decisions about our bodies and our health. And I will not stop fighting for my patients and our communities,” the statement continued.

At the same time, abortion advocates are trying to get a ballot measure approved for the 2024 election that would enshrine abortion right in Arizona’s constitution.

 

Copyright © 2023, ABC Audio. All rights reserved.

Massachusetts officials report cluster of hepatitis A cases they say resembles 2018 outbreak

Massachusetts officials report cluster of hepatitis A cases they say resembles 2018 outbreak
Massachusetts officials report cluster of hepatitis A cases they say resembles 2018 outbreak
Maskot/Getty Images

(NEW YORK) — Massachusetts health officials are warning that a hepatitis A outbreak has hit the state, and it resembles a similar outbreak that occurred several years ago.

Six cases have been reported across four counties between Nov. 1 and Nov. 29, with more infections under investigation, according to an alert issued Monday by the Massachusetts Department of Public Health (MDPH).

Some of the cases have been severe, with four requiring hospitalization, the department said. However, no deaths have been reported.

Four of the six individuals are men between the ages of 36 and 60, the MDPH said. No other demographic information was given.

Several of the patients reported being recently homeless or having unstable housing, as well as a history of injection or other drug use, according to the MDPH. The department also said many of these patients had sought services at Boston-area clinics, shelters and substance use treatment facilities.

The patients do not have a history of travel outside of Massachusetts and do not share any common sources of food, drink or drugs.

The MDPH said the cluster of cases is similar to a hepatitis outbreak that began in Massachusetts in April 2018 and ended in May 2020, which resulted in 563 cases and nine deaths. That outbreak mostly affected people experiencing homelessness or unstable housing and/or substance use disorder, the department said.

During that period, there were also large clusters of hepatitis A in California, Indiana, Kentucky, Michigan, Tennessee, Utah and West Virginia, according to the department.

The MDPH did not immediately respond to ABC News’ request for comment.

Hepatitis A is a very contagious liver infection caused by the hepatitis A virus, according to the Centers for Disease Control and Prevention.

The virus is found in the stool and blood of infected people and is spread through close, personal contact with an infected patient or by eating contaminated food and drink, even in microscopic amounts, the CDC says.

“This is one that, unlike the other hepatitis viruses that we are familiar with, this is one that is transmitted through the fecal-oral route,” Dr. Shira Doron, chief infection control officer for Tufts Medicine, told ABC News. “So, it’s not transmitted through blood and other body fluids like hepatitis C, for example.”

“It’s often a result of situations where they may be poor sanitation, overcrowding, poor bathroom facilities, things like that,” she continued. “It’s not entirely surprising that we’re seeing another outbreak in a similar way to the last time we had this in Massachusetts, and it’s affecting people who are homeless or have unstable housing because they experience risk factors of the virus.”

Not all hepatitis A patients experience symptoms, but when they do, it usually occurs between two and seven weeks after infection, according to the CDC. Symptoms can include loss of appetite, fever, diarrhea, fatigue, stomach pain, nausea and vomiting, the CDC says.

“You can have a change in the color of your stool where it becomes grey or loses color. That’s a pretty distinct sign that should send you right to the doctor,” Doron said.

The CDC says a person can transmit hepatitis A without showing symptoms and can do so up to two weeks before symptoms appear.

There are no specific treatments for hepatitis A, with doctors typically recommending rest, adequate nutrition and fluids, according to the CDC.

In rare cases, hepatitis A can lead to liver failure and death, but this is more common in those with underlying conditions such as chronic liver disease, the federal health agency said.

If someone has been exposed, there’s a hepatitis A vaccine that can help prevent the virus from taking hold with a single shot given within two weeks of exposure.

There are also two types of hepatitis A vaccines that can be given as a preventative measure: One given as two shots six months apart, and the other being a combination vaccine that protects against hepatitis A and B and is given as three shots over six months.

Doron said vaccination is key to helping prevent the spread of hepatitis A. Currently, the CDC recommends children receive the vaccine at 1 year old and through age 18 if not previously vaccinated.

Additionally, the CDC recommends that high-risk adult groups — including international travelers, men who have sexual contact with other men, people who use injection or non-injection drugs, people experiencing homelessness, people with chronic liver disease, people with HIV, people with occupational risk and people with close contact with an international adoptee — get vaccinated.

Adults without a risk factor who want to avoid hepatitis A infection can also be vaccinated.

“This is important because we don’t want this outbreak to grow to the size of the last one,” Doron said, referring to the current outbreak in Massachusetts. “Anyone in these categories should be getting vaccinated now and we should be doing all we can to identify people anywhere we see them.”

Doron and the CDC say another important prevention measure is making sure hygiene and sanitation standards are up to par, including encouraging hand hygiene at facilities that serve high-risk populations and regular disinfection of high-touch surfaces and bathrooms facilities.

Experts also recommend educating high-risk populations and the agencies that serve them on the signs and symptoms of hepatitis A, the need for vaccination and hygiene measures to limit spread.

 

Copyright © 2023, ABC Audio. All rights reserved.

Mom opens up about heart attack she thought was the flu

Mom opens up about heart attack she thought was the flu
Mom opens up about heart attack she thought was the flu
ATU Images/Getty Images

(NEW YORK) — A mom who thought she was experiencing flu symptoms but was really having a heart attack is opening up about her experience and sharing a warning for other women.

Jenna Tanner, who first shared her story with “Business Insider,” sat down with “Good Morning America” to recount her close call.

“I thought I was coming down with the flu or the upper respiratory infection or something,” Tanner told “GMA.”

Last year, a bout of both COVID-19 and the flu spread through Tanner’s Oklahoma household and soon enough, the 48-year-old came down with something, too.

“I was having fleeting pains in my chest that I really thought was my … lungs,” Tanner recounted.

At first, Tanner dismissed seeking medical care. “I didn’t want to tell my husband because I knew he would say we have to go straight to the hospital. And I didn’t want to go spend any more time in waiting rooms at the doctor’s office, so I ignored it,” she said.

But ignoring her pain almost cost Tanner her life. After two days, she said, she passed out and when she regained consciousness, she knew instantly she was having a massive heart attack.

“It felt like an elephant sitting on me. I couldn’t move,” Tanner recalled. “I couldn’t move at all. It was very scary.”

Why women tend to dismiss heart attack symptoms

Heart attack is the number-one killer of women in the U.S., according to the American Heart Association. However, experts say women are more likely to ignore or downplay heart attack symptoms.

“Women can typically present with symptoms unrelated to chest pain and I think that’s one of the reasons why they get downplayed, mainly because it doesn’t feel typically like what you think a heart attack would feel like,” ABC News medical correspondent Dr. Darien Sutton explained.

According to the American Heart Association, the most common symptom of a heart attack for both men and women is chest pain, but women may also experience other symptoms, such as shortness of breath, nausea, or back, shoulder or jaw pain.

“All of these symptoms, when they happen suddenly, you have to pay attention because they might be a sign of something more sinister,” Sutton said.

Sutton said if anyone experiences unexplained chest, jaw or shoulder pain that gets progressively worse, they should see a doctor immediately or visit an urgent care clinic to request an electrocardiogram (ECG or EKG) test.

When she regained consciousness, Tanner said she dragged herself to her cellphone, which was two rooms away, and managed to call for help.

Tanner had to undergo three surgeries and receive two stents during her treatment after the heart attack. But a year later, she said she’s doing better, and urged other women to pay attention to their own bodies and not ignore symptoms, like she had done.

“Heart health for women is important. Don’t ignore heart pain,” Tanner said. “Even if you think it’s your lungs, even if you’ve been to the doctor 20 times in the last two months with your children, just make sure you take it seriously.”

 

Copyright © 2023, ABC Audio. All rights reserved.

What to know as Arizona’s centuries-old near-total abortion ban heads to the state’s Supreme Court

Arizona’s Supreme Court hears case on state’s 1864 abortion ban
Arizona’s Supreme Court hears case on state’s 1864 abortion ban
fstop123/Getty Images

(NEW YORK) — The Arizona State Supreme Court will begin hearing oral arguments Tuesday over whether a centuries-old near-total abortion ban will be reinstated.

Currently, abortion is banned at 15 weeks or later in Arizona. Patients are required to make two appointments, the first for an in-person counseling session and the second at least 24 hours later for the abortion, according to the Guttmacher Institute, a research group that focuses on sexual and reproductive health.

When the U.S. Supreme Court overturned Roe v. Wade last summer, ending a federally protected right to have an abortion and giving states the right to make their own laws, Arizona providers weren’t sure which abortion law took precedent.

One option was the 15-week ban, which was signed into law by then Gov. Doug Ducey in 2022 and enforced after Roe fell. The other, from 1864, when Arizona was still a territory, would essentially ban abortion in the state.

Under the law, anyone who performs an abortion, or supplies medication to induce an abortion, faces between two and five years in prison. There are no exceptions for rape or incest, only if the mother’s life is in danger, according to the language of the bill.

The law was blocked in 1972 after Planned Parenthood Center of Tucson, the predecessor of Planned Parenthood Arizona, sued, arguing it was a violation of the state and U.S. Constitution.

When Roe v. Wade was passed in 1973, it overrode the 1864 law, but that near-total ban was never taken off the books.

In December 2022, the Arizona Court of Appeals “harmonized” the two laws, writing in an opinion that the 1864 law would only apply to non-physicians and that doctors could follow the newer law.

In August of this year, the State Supreme Court agreed to consider a petition regarding the ruling. The court will decide whether the older or newer law, or a combination of the two, will be enforced.

Planned Parenthood Arizona plans to argue that the Civil War era law should not dictate the reproductive rights of Arizonans in the present day and to affirm the Court of Appeals’ decision to preserve abortion access.

“This archaic abortion ban the intervenors are trying to revive is cruel, harmful, and unpopular with the majority of Arizonans,” Kelley Dupps, Planned Parenthood Arizona senior director of public policy & government relations, said in a statement back in August. “It has no place dictating our reproductive freedom and how we live our lives today.”

“We are confident that the Supreme Court will affirm the court of appeals’ well-reasoned decision that preserved access to abortion care. We will not stop fighting for our patients at the courthouse and beyond,” the statement continued.

At the same time, abortion advocates are trying to get a ballot measure approved for the 2024 election that would enshrine abortion right in Arizona’s constitution.

Copyright © 2023, ABC Audio. All rights reserved.

Breast cancer vaccine now in early clinical trials: What to know

Breast cancer vaccine now in early clinical trials: What to know
Breast cancer vaccine now in early clinical trials: What to know
Elijah Nouvelage/Bloomberg via Getty Images

(NEW YORK) — A new vaccine being studied in early clinical trials may hold the potential to help some women with breast cancer, a disease that affects one in every eight women in the United States, according to the Centers for Disease Control and Prevention.

The vaccine, which has not yet been named, targets triple-negative breast cancer, the most aggressive and deadliest form of breast cancer.

The vaccine’s first clinical trial, the results of which were published last week, found that the vaccine caused no significant side effects and achieved a good immune response in 75% of patients in the trial.

The Phase 1 trial was composed of 16 women who received three vaccinations administered once every two weeks, according to Anixa Biosciences, Inc., the California-based company that is developing the vaccine.

The trial was conducted at the Cleveland Clinic and was supported by a grant from the U.S. Department of Defense, according to Anixa.

“This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development,” Dr. Amit Kumar, chairman and CEO of Anixa Biosciences, said in a statement announcing the trial’s results. “We look forward to reviewing additional data as the trial continues to completion, and we are in the planning stages of the Phase 2/3 studies of this vaccine.”

The vaccine is currently being designed to stop the recurrence of cancer in patients who have already been treated for triple-negative breast cancer, according to Kumar. He said the next phase of research will focus on utilizing the vaccine to prevent the onset of triple-negative breast cancer.

ABC News chief medical correspondent Dr. Jennifer Ashton, who was not involved in the research, said that while the vaccine is a promising development in the field of breast cancer research, it will be years before it is available to the general public.

“This could, and I want to emphasize could, start to be available in about five years or so,” Ashton said of the breast cancer vaccine.

Ashton noted that vaccines already exist for several different types of cancers, including cervical, liver, and metastatic prostate cancer.

Those vaccines, and the new potential new vaccine for breast cancer, all focus on immunotherapy, Ashton explained. When a person develops cancer, the immune system doesn’t attack the tumor on its own because the tumor is formed from the person’s own cells, according to Ashton.

“Using the concept of immunotherapy now, there are clinical trials in progress that take a snippet from a person’s actual tumor and then kind of fold it into, in a lot of cases, MRNA vaccine technology,” Ashton said. “So, it lets that loose so that the person’s immune system can actually fight its own cancer.”

The breast cancer vaccine currently being researched targets a lactation protein, known as α-lactalbumin, that is present in the majority of triple-negative breast cancer patients, according to Anixa.

When breast cancer develops, the vaccine instructs the immune system to fight off the tumor and keep it from growing.

Copyright © 2023, ABC Audio. All rights reserved.

Companies say they’re exploring high-protein products for customers using medications to lose weight

Companies say they’re exploring high-protein products for customers using medications to lose weight
Companies say they’re exploring high-protein products for customers using medications to lose weight
CRISTINA PEDRAZZINI/SCIENCE PHOTO LIBRARY/Getty Images

(NEW YORK) — Medications for weight loss like Ozempic, Mounjaro and Wegovy have soared in popularity recently. And that’s prompted some major food companies to prepare for a potential shift in what, and how much, consumers who are taking these medication are eating.

Nestle and General Mills are developing companion products, like high-nutritional snacks and supplement shakes, for people taking these drugs.

“There’s probably about 1% of U.S. adults that are on these drugs today. But we can already see how that’s affecting their eating patterns at a very high level,” Alexia Howard, senior food research analyst at Bernstein, told ABC News. “I don’t think we’re going to see a massive collapse in the number of calories that are eaten across America. But things like protein shakes, cottage cheese, supplements to fortify, vitamins and minerals are probably going to do quite well out of this.

Abbott Laboratories, the company behind Ensure Shakes, told ABC News they will have a protein drink on the market by next year that’s designed to help with muscle mass in people who are using the drugs to help shed pounds. Losing muscle mass is a concern with any type of weight loss.

Rachael Knight Gullette said she’s lost 150 pounds since she started taking Mounjaro last year in July and enjoys the convenience that protein shakes provide.

“I have usually a shake every day – it’s the best way to start my day,” she said.

“The smartest thing for food companies to do honestly is to figure out how to help us, and we definitely need help,” Gullette said. “I would love to have a shake that could be a meal replacement that has enough calories in it.”

Experts say that while supplement shakes are a quick way for people trying to lose weight to take in nutrients, they should also consider sourcing protein through eating lean meats and vegetables.

“It’s understandable why a protein shake would be seen as a reasonable option to help fulfill those high-value needs of wanting to increase the amount of protein that you’re eating,” ABC News medical correspondent Dr. Darien Sutton said. “As physicians, we always advise that these protein shakes can be hiding a lot of added sugar. They’re also not tightly controlled and regulated by the FDA.”

Weight-loss medications are not a complete solution on their own. Doctors advise pairing their use with a healthy diet and physical activity for best results, and to develop healthy habits.

 

Copyright © 2023, ABC Audio. All rights reserved.