Health

SCOTUS ruling on mifepristone could have lasting impact on FDA regulation: Experts

Anna Moneymaker/Getty Images

(NEW YORK) — While experts and advocacy groups applauded the U.S. Supreme Court’s decision Thursday to not restrict nationwide access to the abortion pill mifepristone, they warn access to medication abortion remains at risk — as does the very foundation of the Food and Drug Administration’s regulation of all medications.

The court unanimously struck down a lawsuit seeking to restrict nationwide access to mifepristone, one of the two pills used in an abortion medication regimen. The court ruled that a group of doctors have no grounds to bring the lawsuit that sought to roll back the FDA’s approval of mifepristone.

While it is only recommended for up to 11 weeks of pregnancy, the abortion pill regimen is the least expensive form of abortion care and has become the most common form of abortion care in the U.S.

Medication abortion accounted for 63% of U.S. abortions in 2023, according to a study from the Guttmacher Institute in March, and its use is growing. Medication abortions accounted for just 53% of all abortions in the U.S. in 2020, according to Guttmacher, a research and policy group that advocates for reproductive health.

Women in states where abortion care has ceased or is restricted can still access the pills by mail under Thursday’s ruling — the biggest impact from the Supreme Court’s decision.

“The idea of limiting access to mifepristone will just further exacerbate disparities that we’re already seeing in terms of reproductive health care,” said Dr. Reshma Ramachandran, a family physician, health services researcher and assistant professor at Yale University School of Medicine.

Women who take the abortion pill can also go back to work or their daily lives quicker and patients see less days of bleeding and the likelihood of profound blood loss, Ramachandran said. The need to be seen by a physician is also reduced with the abortion pill regimen, compared to surgical abortions, she added.

At least 17 states have ceased nearly all abortion care since the U.S. Supreme Court overturned Roe v. Wade nearly two years ago.

Impact on abortion care
Ramachandran called the Supreme Court decision “a relief.”

“While it is great that they dismissed it, the rationale for it is not as comforting because that just introduces the possibility that other groups where standing can be established could raise the same challenge and could work to limit access to mifepristone,” said Ramachandran.

“I’m very cognizant that this still allows for additional challenges to come forward before the courts,” Ramachandran said.

The American Civil Liberties Union also warned that the ruling was not the end of challenges to the abortion pill.

“Although the Court refused to allow these particular people to bring this case, anti-abortion politicians are waiting in the wings to attempt to continue pushing this case before an extremist judge in Texas in an effort to deny people access to medication abortion care,” Jennifer Dalven, director of the ACLU Reproductive Freedom Project, said in a statement.

The Guttmacher Institute also warned that mifepristone plays a key role in ensuring that many people safely self-manage their abortions, saying people need to remain “vigilant” with the anti-abortion movement continuing to try and risk care nationwide.

“We are relieved by this outcome, but we are not celebrating. From the start, this case was rooted in bad faith and lacking any basis in facts or science. This case never should have reached our nation’s top court in the first place and the Supreme Court made the only reasonable decision by leaving access to medication abortion using mifepristone unchanged,” Destiny Lopez, the acting co-CEO of the Guttmacher Institute, said in a statement.

The Supreme Court has not yet issued a decision on another case on its docket this term that could have a wider impact on lifesaving emergency abortion care across the country, including states that ban the procedure. The other case — Moyle v. U.S. — centers on Idaho’s total abortion ban, which prohibits the procedure at all stages of pregnancy, with exceptions to save the life of a pregnant woman or in cases of rape or incest.

A Biden administration lawsuit challenging the ban argues that it violates the Emergency Medical Treatment and Labor Act — a federal law that requires emergency room physicians at hospitals that receive Medicare funds to provide stabilizing health care to all patients whose health is in jeopardy.

It is now up to the court to determine whether the law, known as EMTALA, supersedes Idaho’s abortion ban and protects physicians’ ability to provide lifesaving abortion care. A decision in that case will be more consequential to abortion access across the country.

Impact on FDA approval process
At the heart of FDA v. Alliance for Hippocratic Medicine — the case decided Thursday — was a fear that a Supreme Court decision could inject judges into decisions made by the experts at the FDA, not just for mifepristone but potentially other drugs.

“A number of us have been watching these court cases, and have been worried about the idea that judges — without clinical or technical expertise — would be weighing in on the scientific decisions that are being made by the FDA,” said Ramachandran, who is also the chair of Doctors for America’s task force on FDA policy.

At least for now, the ruling keeps the power in the hands of the FDA.

“It’s a very lengthy process to be able to get drug approval. There’s multiple review teams of scientists, doctors, statisticians, basic scientists, they’re all involved in looking at the data and making a determination if the drug is safe and effective for the indicated use before it comes into the market,” Ramachandran said.

“As a doctor, I look to the FDA and providing reassurance that what they approve is truly safe and effective. … It’s very much a rubber stamp,” Ramachandran said.

The FDA is also then responsible for ensuring the safety of drugs once they are on the market, according to Sanket Dhruva, an assistant professor at the University of San Francisco School of Medicine who studies FDA regulation of drugs and medical devices.

The FDA went “above and beyond in terms of regulatory standards approval for mifepristone,” because of the politicization of abortion care and the anticipation that there would be a number of different stakeholders looking at the drug, Ramachandran said.

Had the court ruled differently, there was wide concern that it would set the dangerous precedent that judges — who may not have the requisite expertise — would limit patient access to products, Ramachandran said.

“It would also rather politicize the FDA’s approval process, [for] drugs for gender-affirming care, for instance, and other reproductive health care — medications, contraception — which is kind of bizarre,” Ramachandran said.

Had the Supreme Court ruled differently it could have been “catastrophic” for drug development and regulation in the U.S., Dhruva said.

“It could have potentially cast out on the FDA being the determinant of what drugs meet the safety and effectiveness threshold to be on the United States market,” Dhruva said.

“There could have been larger issues for the drug development ecosystem because the industry might also have been more reluctant to invest in the whole process of drug development if there was this risk that the FDA might approve it. But then stakeholders — whoever had whatever interest — might come to the courts and the courts might invalidate the FDA’s ability to approve a device,” Dhruva said.

If the court had determined that the FDA’s authority over safety and fitness of drugs could be overturned, it would have led to a “significant thawing of industry investment in pharmaceuticals,” and threatened the development of new drugs, Dhruva said.

“I think it would have significantly threatened the development of drugs for conditions that we really need,” Dhruva said.

Copyright © 2024, ABC Audio. All rights reserved.

Health

Challenges to the abortion pill will continue – with potential wider consequences ahead, experts say

Anna Moneymaker/Getty Images

(NEW YORK) — While experts and advocacy groups applauded the U.S. Supreme Court’s decision Thursday to not restrict nationwide access to the abortion pill mifepristone, they warn access to medication abortion remains at risk — as does the very foundation of the Food and Drug Administration’s regulation of all medications.

The court unanimously struck down a lawsuit seeking to restrict nationwide access to mifepristone, one of the two pills used in an abortion medication regimen. The court ruled that a group of doctors have no grounds to bring the lawsuit that sought to roll back the FDA’s approval of mifepristone.

While it is only recommended for up to 11 weeks of pregnancy, the abortion pill regimen is the least expensive form of abortion care and has become the most common form of abortion care in the U.S.

Medication abortion accounted for 63% of U.S. abortions in 2023, according to a study from the Guttmacher Institute in March, and its use is growing. Medication abortions accounted for just 53% of all abortions in the U.S. in 2020, according to Guttmacher, a research and policy group that advocates for reproductive health.

Women in states where abortion care has ceased or is restricted can still access the pills by mail under Thursday’s ruling — the biggest impact from the Supreme Court’s decision.

“The idea of limiting access to mifepristone will just further exacerbate disparities that we’re already seeing in terms of reproductive health care,” said Dr. Reshma Ramachandran, a family physician, health services researcher and assistant professor at Yale University School of Medicine.

Women who take the abortion pill can also go back to work or their daily lives quicker and patients see less days of bleeding and the likelihood of profound blood loss, Ramachandran said. The need to be seen by a physician is also reduced with the abortion pill regimen, compared to surgical abortions, she added.

At least 17 states have ceased nearly all abortion care since the U.S. Supreme Court overturned Roe v. Wade nearly two years ago.

Impact on abortion care
Ramachandran called the Supreme Court decision “a relief.”

“While it is great that they dismissed it, the rationale for it is not as comforting because that just introduces the possibility that other groups where standing can be established could raise the same challenge and could work to limit access to mifepristone,” said Ramachandran.

“I’m very cognizant that this still allows for additional challenges to come forward before the courts,” Ramachandran said.

The American Civil Liberties Union also warned that the ruling was not the end of challenges to the abortion pill.

“Although the Court refused to allow these particular people to bring this case, anti-abortion politicians are waiting in the wings to attempt to continue pushing this case before an extremist judge in Texas in an effort to deny people access to medication abortion care,” Jennifer Dalven, director of the ACLU Reproductive Freedom Project, said in a statement.

The Guttmacher Institute also warned that mifepristone plays a key role in ensuring that many people safely self-manage their abortions, saying people need to remain “vigilant” with the anti-abortion movement continuing to try and risk care nationwide.

“We are relieved by this outcome, but we are not celebrating. From the start, this case was rooted in bad faith and lacking any basis in facts or science. This case never should have reached our nation’s top court in the first place and the Supreme Court made the only reasonable decision by leaving access to medication abortion using mifepristone unchanged,” Destiny Lopez, the acting co-CEO of the Guttmacher Institute, said in a statement.

The Supreme Court has not yet issued a decision on another case on its docket this term that could have a wider impact on lifesaving emergency abortion care across the country, including states that ban the procedure. The other case — Moyle v. U.S. — centers on Idaho’s total abortion ban, which prohibits the procedure at all stages of pregnancy, with exceptions to save the life of a pregnant woman or in cases of rape or incest.

A Biden administration lawsuit challenging the ban argues that it violates the Emergency Medical Treatment and Labor Act — a federal law that requires emergency room physicians at hospitals that receive Medicare funds to provide stabilizing health care to all patients whose health is in jeopardy.

It is now up to the court to determine whether the law, known as EMTALA, supersedes Idaho’s abortion ban and protects physicians’ ability to provide lifesaving abortion care. A decision in that case will be more consequential to abortion access across the country.

Impact on FDA approval process
At the heart of FDA v. Alliance for Hippocratic Medicine — the case decided Thursday — was a fear that a Supreme Court decision could inject judges into decisions made by the experts at the FDA, not just for mifepristone but potentially other drugs.

“A number of us have been watching these court cases, and have been worried about the idea that judges — without clinical or technical expertise — would be weighing in on the scientific decisions that are being made by the FDA,” said Ramachandran, who is also the chair of Doctors for America’s task force on FDA policy.

At least for now, the ruling keeps the power in the hands of the FDA.

“It’s a very lengthy process to be able to get drug approval. There’s multiple review teams of scientists, doctors, statisticians, basic scientists, they’re all involved in looking at the data and making a determination if the drug is safe and effective for the indicated use before it comes into the market,” Ramachandran said.

“As a doctor, I look to the FDA and providing reassurance that what they approve is truly safe and effective. … It’s very much a rubber stamp,” Ramachandran said.

The FDA is also then responsible for ensuring the safety of drugs once they are on the market, according to Sanket Dhruva, an assistant professor at the University of San Francisco School of Medicine who studies FDA regulation of drugs and medical devices.

The FDA went “above and beyond in terms of regulatory standards approval for mifepristone,” because of the politicization of abortion care and the anticipation that there would be a number of different stakeholders looking at the drug, Ramachandran said.

Had the court ruled differently, there was wide concern that it would set the dangerous precedent that judges — who may not have the requisite expertise — would limit patient access to products, Ramachandran said.

“It would also rather politicize the FDA’s approval process, [for] drugs for gender-affirming care, for instance, and other reproductive health care — medications, contraception — which is kind of bizarre,” Ramachandran said.

Had the Supreme Court ruled differently it could have been “catastrophic” for drug development and regulation in the U.S., Dhruva said.

“It could have potentially cast out on the FDA being the determinant of what drugs meet the safety and effectiveness threshold to be on the United States market,” Dhruva said.

“There could have been larger issues for the drug development ecosystem because the industry might also have been more reluctant to invest in the whole process of drug development if there was this risk that the FDA might approve it. But then stakeholders — whoever had whatever interest — might come to the courts and the courts might invalidate the FDA’s ability to approve a device,” Dhruva said.

If the court had determined that the FDA’s authority over safety and fitness of drugs could be overturned, it would have led to a “significant thawing of industry investment in pharmaceuticals,” and threatened the development of new drugs, Dhruva said.

“I think it would have significantly threatened the development of drugs for conditions that we really need,” Dhruva said.

Copyright © 2024, ABC Audio. All rights reserved.

Health

What to know about mifepristone after Supreme Court strikes down legal challenge to abortion pill

Anna Moneymaker/Getty Images

(WASHINGTON) — The U.S. Supreme Court unanimously rejected on Thursday a bid by a group of antiabortion doctors that would have potentially blocked widespread access to a common abortion pill.

In the opinion, written by Justice Brett Kavanaugh, the court determined that the group had no legal standing to challenge the U.S. Food and Drug Administration’s (FDA) regulation of mifepristone.

Here’s what to know about the mifepristone, including how it works and how common it is.

Mifepristone is an oral drug typically used in combination with another drug, misoprostol, to induce an abortion or to help manage an early miscarriage.

The medication works by blocking progesterone, a hormone that the body needs to continue a pregnancy.

This causes the uterine lining to stop thickening and to break down, detaching the embryo. The second drug, misoprostol, taken 24 to 48 hours later, causes the uterus to contract and dilates the cervix, which will expel the embryo.

The FDA authorized mifepristone — sometimes called by the brand name Mifeprex — for medication abortion in September 2000 for up to seven weeks’ gestation, which was then extended to 10 weeks’ gestation in 2016.

However, the World Health Organization says the two drug-regimen can be taken up until the 12-week mark of pregnancy.

In 2019, the FDA approved a generic version of the drug.

Medication abortion now accounts for more than half of all abortions in the U.S., according to the Guttmacher Institute, a research group focusing on sexual and reproductive health.

As of 2023, medication abortions account for 63% of abortions performed in the U.S., up from 24% in 2011, the data from Guttmacher shows.

Mifepristone is safe and effective when used as indicated and directed by the FDA, the agency said. When used in combination, mifepristone and misoprostol are nearly 97% effective at terminating a pregnancy, according to a 2015 systematic review from the University of California, Davis.

In December 2021, the FDA announced it permanently lifted its restriction that abortion pills had to be dispensed in-person. In January 2023, it went further by allowing retail pharmacies to provide the drug too, either by mail or in person, so long as they meet certain requirements.

Mifepristone is not recommended if a woman is more than 70 days out from their last menstrual period or if they have an ectopic pregnancy, have problems with glands near the kidney, have bleeding problems, are taking blood thinning medication, have an IUD in place or have had an allergic reaction to mifepristone.

Copyright © 2024, ABC Audio. All rights reserved.

Health

FDA had ‘inadequate’ policies to heed warnings about infant formula, probe finds

AlasdairJames/Getty Images

(NEW YORK) — The Food and Drug Administration failed to heed warning signs that there were mounting concerns with one of the nation’s largest infant formula makers, as a series of babies’ severe illnesses and whistleblower complaints began to accumulate ahead of a critical shortage in 2022, the agency’s watchdog has found.

Eventually Abbott, that formula maker, would institute a massive recall and shutdown of their plant — but by that time, the FDA’s lack of communication or sufficient oversight systems had hampered their response, according to the findings of an investigation by the inspector general of the Department of Health and Human Services.

The IG’s findings, scheduled to be released Thursday, were revealed in an exclusive interview with ABC News. The audit, announced in June 2022, assessed how the agency responsible for the safety of the nation’s food and medication supply responded to complaints of infants’ illnesses after eating formula from industry titan Abbott’s plant in Michigan — and strains of the same rare but deadly bacteria had been detected inside that facility.

“If FDA had adequate policies and procedures, it could have identified underlying problems at the Abbott facility and required Abbott to correct them,” the audit concluded. While the agency “took some action” on facility inspections and follow-up, “more could have been done leading up to” Abbott’s formula recall two years ago.

Carla Lewis, the assistant inspector general who led the investigation, told ABC News that time was critical.

“What happens when you don’t immediately address risks is that you can’t mitigate and address them timely. And that’s what we were seeing,” Lewis, Assistant Inspector General for Audit Services, said. “We know that millions of babies each year may rely on infant formula as their sole source of nutrition. So being proactive and ensuring that infant formula is safe, and working with manufacturers to produce safe infant formula, is very critical in the role that FDA plays.”

The IG probe took 17 months of fieldwork and included a review of over 1,600 files consisting of approximately 10,000 pages, Lewis said. The audit team held 19 meetings with FDA officials and made over 60 requests for documentation and information.

There were “gaps and deficiencies” in the FDA’s oversight of infant formula, Lewis said.

“Improvements in [FDA’s] inspection and recall processes are needed to better ensure the safety of the infant formula supply,” the report said, finding the agency “had inadequate policies and procedures,” or had lacked them altogether, “to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes.”

In response to the findings, the FDA said it “strongly agrees that adequate policies, procedures, and authorities are needed, and delays due to poor procedures are unacceptable and must be corrected.”

“FDA takes seriously its duty to ensure the safety of the infant formula supply, with effective policies and procedures for preventing and timely responding to foodborne illnesses and food contamination events,” noting the IG’s audit “represents a snapshot in time, and the FDA continues to make progress.”

“We are committed to implementing the OIG’s recommendations for strengthening our program,” the FDA said, adding they have already “begun several steps to improve policies and procedures for complaints, recalls, and infant formula inspections.”

Abbott agreed to temporarily shutter their Sturgis, Michigan, facility in mid-February 2022, prompted by contamination concerns and the hospitalization of four infants diagnosed with a rare bacterial infection, Cronobacter sakazakii. Two of the babies ultimately died.

The FDA said it could not conclusively confirm that Abbott products caused the infants’ illnesses or deaths — something the company has also maintained. But the impact of that recall ricocheted from coast to coast, leaving a serious void in the market and forcing families to face empty shelves and scramble for alternatives. The report found that more could have been done ahead of time to potentially soften that impact.

Coming as it did amid other supply chain problems connected with the COVID-19 pandemic, the formula recall plunged many American families into crisis mode and prompted serious questions from policymakers and the public about whether a communication breakdown at the agency had abetted a sluggish response to the growing problem.

The FDA “did not have adequate policies and procedures” for crucial oversight systems, the IG’s report found — mechanisms meant to identify risks to infant formula, such as whistleblower and consumer complaints red-flagging issues.

A whistleblower complaint was sent by email to the FDA in mid-February 2021, alleging Abbott’s facility had violated laws, regulations and other guidance that FDA administered and enforced. But it took “more than 15 months” for the agency to identify that whistleblower’s warning — or forward it to an office that could investigate it, HHS-OIG’s audit found.

At that time, the IG was told by agency officials that there was no one permanently in the role responsible for “identifying and accounting for whistleblower complaints” that came in over email, the report said. Those duties were “covered” by other people who also had “other responsibilities,” and one of them “inadvertently archived the February 2021 whistleblower complaint” without forwarding it for investigation. FDA officials only identified that complaint more than a year later.

“FDA did not have adequate policies and procedures to identify and investigate the February 2021 Abbott facility whistleblower complaint,” the audit determined – even when those complaints came to the “dedicated FDA email inbox” set up to receive them.

And when it came to whistleblower complaints, IG’s report found, FDA “did not develop an organizational structure or assign responsibilities to enable the organization to operate in an efficient and effective manner.”

The FDA “implemented new whistleblower complaint procedures” a few days after the first complaint was finally forwarded in June 2022, the report said, adding, “although we did not audit the effectiveness of the complaint procedures that FDA adopted in June 2022, if effectively implemented they should assist in identifying and accounting for whistleblower complaints.”

A second whistleblower complaint came in October 2021, sent by hardcopy via courier to seven senior FDA employees and additionally emailed to multiple relevant regulatory personnel, including those at the office responsible for investigating complaints, who “acknowledged receipt of the email,” the audit said. But it took nearly four months for that complaint to get to FDA leadership, including the top brass at food policy and response, who were notified in mid-February 2022.

“Without whistleblower complaint escalation policies and procedures, FDA senior leadership was unable to make informed decisions to minimize risks related to the Abbott facility and the infant formula supply chain,” the report said.

Amid scrutiny over their process in May of that year, the FDA released a “timeline of infant formula related activities” which admitted that a second whistleblower complaint wasn’t received by FDA leadership “due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues.”

“That whistleblower complaint was sent by Fed-Ex, hard copies, to multiple individuals in multiple offices, so that means it would’ve been lost at multiple offices,” FDA’s former Deputy Commissioner for Food Policy and Response Frank Yiannas said at a March 2023 congressional hearing.

“Some individuals received copies by emails and in hindsight, those should have been escalated to my office very rapidly,” said Yiannas, who just months before, had resigned from the agency.

In an interview with ABC News in April, Yiannas reflected on the lack of communication he grew frustrated with during his FDA tenure.

“I was just surprised that something like that hadn’t been elevated,” Yiannas said of the monthslong mislaid whistleblower report, noting the issues at Abbott had already been brewing for months by the time he “found out about the series of events” ensuing.

“One of the reasons I decided that it was time for me to leave the agency in the current posture that I was in, it was a very decentralized organization with a culture of very siloed mentalities,” Yiannas said. “A culture of silos is always a dangerous culture. There was this idea of accountability without responsibility. And we need some structural change.”

The IG audit stresses the need for clear communication, noting FDA’s own investigators tasked with inspecting formula facilities weren’t always armed with the most current and relevant information — such as new complaints from consumers coming in.

For example, it detailed that the FDA began an inspection at Abbott’s facility on September 20, 2021, and while that investigator had reviewed the plant’s consumer complaint history beforehand, on that very day, a new consumer complaint was entered into the system: “an infant who was diagnosed with a Cronobacter infection after consuming infant formula manufactured at the Abbott facility.”

But the FDA’s personnel “reviewing the new consumer complaint were not aware of the inspection taking place at the Abbott facility and did not communicate the complaint to the investigator” during the week of Abbott’s inspection, the report continued — so “the investigation team conducting the inspection at the Abbott facility was not informed of the new consumer complaint until after the inspection closed.”

The FDA found sanitation issues at Abbott’s Sturgis plant in September 2021, according to an inspection report previously obtained by ABC News. By January 2022, the FDA had received three of what would ultimately grow to four complaints from consumers of infants getting sick with cronobacter “potentially associated” with Abbott’s formula. By mid-February, the FDA had collected samples at the plant confirming the presence of Cronobacter in the environment, according to their timeline. Though the agency has not been able to definitively link the illnesses or deaths to the facility, Abbott agreed to voluntarily recall their products and cease production.

Lewis said they were “very concerned” when they began to realize what their probe was finding.

“Because we were seeing vulnerabilities in FDA carrying out its policies and procedures to oversee infant formula,” Lewis said, “and just overall, their engagement to ensure that risks were being mitigated and addressed.”

In the wake of the 2022 formula debacle, the FDA has overhauled their foods program, aiming to strengthen their oversight and unify the division.

Some of the actions they’ve taken include conducting their own review of their infant formula response; establishing an Office of Critical Foods, like formula; beginning steps to improve their policies for complaints, recalls and infant formula inspections; and developing policies for how and when to conduct timely mission-critical inspections — even during public health emergencies.

Outlining his agency’s overhaul in January 2023, FDA Commissioner Robert Califf told ABC News that “we really believe that with the reorganization, the system of safety and inspections will be much more preemptive.” 

“We hope that with the information that we’ve shared with FDA, and the actions that they’re going to take – that the public, the American people, can build trust in terms of the infant formula that they’re buying for their babies,” Lewis said.

“There will always be risks,” Lewis added. “The key is to mitigate those risks.”

Copyright © 2024, ABC Audio. All rights reserved.

Health

Usher advocates for diabetes awareness at Capitol Hill

Singer songwriter Usher walks through the Rayburn Room outside of House Minority Leader Hakeem Jeffries’ office at the Capitol Building in Washington, D.C., June 12, 2024. (Anna Moneymaker/Getty Images)

(WASHINGTON) — Eight-time Grammy award winner Usher Raymond made a surprise appearance on Capitol Hill Wednesday, urging lawmakers to make Medicare’s Diabetes Prevention Program more accessible to Americans.

“Today, just talking about type 1 diabetes and early screening for type 1 diabetes,” Usher, the Super Bowl LVIII performer, told ABC News after his meetings.

Usher’s son, Cinco, was diagnosed with type 1 diabetes (T1D) in 2014. Before leaving, Usher acknowledged the issue was personal to him.

“Yeah, I’ve been able to share my story today. Hopefully, you’ll get a chance to hear more about it,” he said.

According to the Centers for Disease Control and Prevention, Type 1 diabetes was once called insulin-dependent or juvenile diabetes, and it often develops in children, teens, and young adults, but it can happen at any age.

The CDC said the disease is thought to be caused by an autoimmune reaction. 

“This reaction destroys the cells in the pancreas that make insulin, called beta cells,” the agency wrote on its website. “This process can go on for months or years before any symptoms appear.”

Usher was first spotted riding the Senate Subway with Georgia Sen. Raphael Warnock — then the Capitol press corps went on the hunt for the pop icon.

He made his way over to the House side, meeting with House Minority Leader Hakeem Jeffries and other lawmakers as a mix of reporters and staffers congregated outside of the meeting. They patiently waited for a selfie as minutes turned to hours.

At one point, emerging from the meeting in his tan suit, undershirt, and signature shades, Usher said, “I had a great time here in D.C.,” when asked about his conversations with lawmakers.

Throughout the day, the music superstar met with lawmakers in both chambers about the SCREEN for Type 1 Diabetes Act — introduced on Tuesday and led by Reps. Kim Schrier, Diana DeGette, John Joyce, and Gus Bilirakis in the House and Sens. Jeanne Shaheen and Susan Collins in the Senate. The act aims to increase public awareness of the disease, including early detection of type 1 Diabetes.

“He has a family relationship with the issue and he’s decided to speak out to raise awareness and I’m very, very grateful to him for doing that,” Rep. DeGette said after the meeting broke.

Her legislation is supported by the American Diabetes Association, American Heart Association, and the American Medical Association, according to a release from DeGette.

Prior to leaving the Capitol, Usher shared his plan to continue fighting for the cause in the future.

“It was my first time [up here] but it won’t be my last,” he said.

Copyright © 2024, ABC Audio. All rights reserved.

Health

Oklahoma girl becomes first pediatric patient to undergo robotic deep brain stimulation

Getty Images – STOCK

(BETHANY, Okla.) — An Oklahoma girl has become the first pediatric patient in the world to have robotic deep brain stimulation performed on her, two hospitals have announced.

The patient, 8-year-old Karliegh Fry, suffers from rapid-onset primary dystonia, a neurological movement disorder that causes involuntary muscle contractions.

Karleigh’s condition initially left her paralyzed, unable to walk, eat or sit up on her own. She was put on several medications, which improved her condition slightly, but she was also left at times with involuntary movements that caused her to injure herself.

A joint team at Oklahoma Children’s Hospital OU Health and Bethany Children’s Health Center began exploring options and decided she might be a good candidate for deep brain stimulation (DBS).

“This marked the global debut of using a robot from our operating rooms to perform DBS in a child, setting a precedent not only in Oklahoma but also across the United States and worldwide,” Dr. Andrew Jea, a pediatric neurosurgeon at Oklahoma Children’s Hospital, said in a press release.

Deep brain stimulation is a procedure in which a surgeon implants one or more small wires knows as electrodes, or leads, in the brain. The electrodes are connected to a small device called a neurostimulator implanted in the upper chest.

It is used in the treatment of neurological conditions including Parkinson’s disease, epilepsy and Tourette’s syndrome. These conditions are caused by disorganized electrical signals in the parts of the brain that control movement, according to Johns Hopkins Medicine.

DBS works by interrupting the irregular signals that causes tremors or other involuntary movements. It does not cure these conditions but can improve a patient’s quality of life.

Using a robot to perform the procedure enhances “surgical precision and safety,” according to OU Health.

“So it was like trying to decide if we thought that the surgery would be worth the risk … but I think anything to give her her best shot,” Karleigh’s mother, Trisha Fry, said in an interview with OU Health.

Karleigh’s surgery was split into two separate parts, according to her mother. The surgery was performed at Oklahoma Children’s Hospital and Karleigh was transferred to Bethany Children’s Health Center for post-operative care and pediatric rehabilitation.

Within a few minutes of the neurostimulator being activated, OU Health said Karleigh was able to lower and relax her arms, which she couldn’t do prior to the procedure.

She is able to exhibit more control over her movements and her speech is also improving, the hospital said.

“Her arms used to lock up to the point we would put socks on her hands because she would scratch her neck,” Trisha Fry said. “There’s definitely been some improvements, even from the moment they turned it on. She is even using her voice a little bit more, and we can make out some of her words. I think she’s going to have a great future for sure.”

The team said Karleigh is continuing to show progress and that this could pave the way for more robotic DBS procedures performed on pediatric patients.
 

Copyright © 2024, ABC Audio. All rights reserved.

Health

US surgeon general warns about the dangers of loneliness

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(NEW YORK) — Last year, U.S. Surgeon General Dr. Vivek Murthy declared a national loneliness and social isolation epidemic throughout the country.

He warned that about half of U.S. adults are experiencing considerable levels of loneliness, which can affect physical, mental and societal health

To mark Loneliness Awareness Week from June 10 to June 16, Murthy spoke to ABC News stations across the U.S. about the causes and solutions for combating feelings of isolation:

How do you define loneliness?

Loneliness is like hunger or thirst. It’s a feeling that we experience when something we’re lacking for survival is missing from our life. And if we respond to it, relatively quickly, it may go away. But just like hunger or thirst, it’s when it persists for a long period of time, when we’re not able to figure out how to address it, that is when we start to worry.

Loneliness is a subjective feeling — that the connections that we need in our life are greater than the connections we actually have.

Is it normal to experience loneliness occasionally?

We all may feel temporarily lonely from time to time. If I go on a trip, for example, without my wife and my two kids, I may miss them, and I may feel lonely if I don’t really know anyone in the work trip that I’m going on. But if I come home, then I may feel better because I reconnect with them.

Similarly, if I have a best friend who moves away to a new city and I no longer have that person in my life, I might feel lonely for a period of time. Those kinds of temporary bouts of loneliness are quite normal.

How many Americans are experiencing loneliness?

One in two adults in America are living with measurable levels of loneliness, but the numbers are even higher among young people.

So, this is an incredibly common challenge that we’re facing.

What is contributing to the loneliness epidemic?

I think there are a number of factors that are contributing to our loneliness.

Today, we tend to get together less for dinners with friends or with neighbors. We also have more of our time siphoned off by social media and online interactions, which can be helpful in some ways, but can be taking time away from the in-person interactions we used to have.

Even though there’s a lot of great benefits to technology, what we see is that the ability to get everything delivered to us where we are means that we also just encounter people less often in the grocery store, in the retail store, or in our neighborhoods.

This is an epidemic of loneliness and isolation that has been building for years. But the pandemic did make it worse.

The lingering effects of being separated from one another are still with us. But there are factors bigger than the pandemic. I think it’s really important for us to keep in mind too, that for nearly half a century, we’ve seen declining participation in the organizations that used to bring us together, like recreational leagues and service organizations and faith organizations.

How does loneliness impact health?

We know now that when people struggle with things socially disconnected, over time, that it can have an impact on their mental health, increasing their risk for anxiety and depression, but also in their physical health, increasing their risk for heart disease, as well as dementia and premature death.

It also turns out that if we can invest in social connection, and building our relationships with one another, that can help us be healthy in the long run and can also make us feel good in the short term.

The overall mortality impact of loneliness and isolation are on par with smoking daily, and they’re even greater than the mortality impact we see with obesity.

Have you experienced loneliness yourself?

I’ve struggled with loneliness as a child and many times as an adult.

The simple act of picking up the phone to call a friend to check on them…the act of picking up the phone when somebody else calls, even if you don’t have a lot of time just to say, “Hey, it’s great to hear your voice, is it okay if I call you back later today?” These small acts make a really big difference in how we feel.

Is it better to connect in person or over technology?

The most effective way for us to connect with another human being is still in-person. If we can’t have an in-person connection, even calling someone on the phone or video conferencing with them, so you can hear their voice and even see them — that can also be very powerful.

The more you’re able to get closer to that in-person interaction — the more powerful it is. It doesn’t have to be a lot of time; a couple of minutes spent in person with somebody can be more powerful than a half an hour spent in distracted conversation, texting back and forth.

How can we combat loneliness?

Even just spending a few minutes each day, reaching out to people we care about can make a real big difference in how connected we feel.

It doesn’t take massive transformations in your life; it can start with small steps that you take. For example, spending 15 minutes a day just to reach out to someone in your life, just to check on them to see how they’re doing. It could be an old friend, it could be a new friend, it could be a family member, it could be a work colleague.

Murthy has issued a five for five connection challenge to help people start down a path of building connections.

“It involves taking one active connection each day for the next five days,” he said. “That could be expressing gratitude to someone, it could be calling a friend to extend help to them at a time when they’re struggling, or it could be asking for help yourself. But doing this over five days will make you feel different. And my hope is that that will be a jumping off point to help people build these kinds of practices into their life for the long term.”

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Health

Moderna’s combo COVID and flu shot offers strong immunity in older adults during late stage trial

The Moderna Inc. headquarters in Cambridge, Massachusetts, US, on Tuesday, March 26, 2024. (PHOTO: Adam Glanzman/Bloomberg via Getty Images)

(NEW YORK) — Moderna’s combo flu and COVID vaccine provided a strong immune response in older adults, with levels comparable to getting the flu and COVID shots separately, according to the company’s results from a late-stage clinical trial.

There are still multiple steps required before the shot would become available. Moderna would need to apply to the FDA for approval, which may require input from the FDA’s independent panel of experts. If authorized or approved, the shot would also need to be greenlit by the CDC before becoming available.

The clinical trial was done in 8,000 adults. Half of those adults were 65 years and older and the other half were between the ages of 50 and 64. Older adults are especially at risk for severe illness from respiratory illnesses including hospitalization and death. The combo vaccine was compared to already approved and available flu and COVID vaccines.

Everyone over the age of 6 months was recommended to get a flu shot and updated COVID shot last season. The CDC is expected to make new recommendations again this fall for both the flu and COVID vaccine. While both the COVID and flu vaccine can be given separately during the same visit, a combination shot may be preferred for some patients.

The most commonly reported side effects of Moderna’s combo shot were injection site pain, fatigue, muscle pain and headache.

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Health

Study finds 1 in 5 young athletes meet criteria for pre-hypertension

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(NEW YORK) — Up to one in five young athletes ages 10 to 31 may have pre-hypertension, a precursor to high blood pressure, according to a new preliminary study.

More than 20% of athletes studied met the criteria for having high blood pressure, which can increase the risk of heart attack, stroke, and kidney disease.

Teenage boys appeared to be more at risk than teenage girls, according to the study, with more than double the rates of stage 1 and stage 2 hypertension. Twenty-eight percent of athletes who played multiple sports had high blood pressure, the study found.

Normal blood pressure is considered to be 120/80 or below, according the American Heart Association. Stage 1 hypertension is considered to be a systolic, or upper number, reading of 130-139 and/or a lower, or diastolic, reading of 80-89. Stage 2 hypertension is a systolic reading of 140 or higher, and/or a diastolic reading of 90 or higher.

The doctors who led the research say young people should still be encouraged to play sports, because an active lifestyle reduces the risk of metabolic diseases like high blood pressure, diabetes, obesity, and heart disease. However, they say not enough people may be aware of their underlying condition.

“When we think of hypertension, we often think about older patients,” said lead author Dr. Aneeq Malik, a third-year internal medicine resident at Olive View-UCLA Medical Center in Los Angeles. Dr. Malik also co-founded the nonprofit Saving Hearts Foundation, which hosted free heart screening events where the study data was collected.

“Even people who we consider extremely healthy young adults, people who engage in physical activity, are still at increased risk,” Malik said.

Malik also stressed that the study results should not deter young people from being active: “Just because you are engaging in sports doesn’t necessarily mean that is the cause for why these people are at greater risk.”

The study is being presented at the American College of Cardiology’s Care of the Athletic Heart Conference. Though it has not gone through the typical scientific vetting process, some doctors say it still helps call attention to an often overlooked issue.

“There is a stark need for an increased focus on prevention as opposed to treatment alone,” said Dr. Anuradha Lala, a cardiologist at the Mount Sinai Fuster Heart Hospital in New York, who was not involved in the study. “A huge part of prevention is adequate and appropriate screening.”

Lala also said it’s important to understand the “influence of racial and ethnic background on the incidence and prevalence of hypertension at earlier ages.” The study found that African American and Hispanic participants, for example, had higher rates of hypertension.

She further noted that multiple factors can lead to high blood pressure, and recommends that parents can help address it by being “conscious about diet, sleep, and the psychological well-being that our children are exposed to and encountering.”

Michelle March, MD, MPH, MEd is a general pediatrics research fellow at Cincinnati Children’s Hospital Medical Center and a member of the ABC News Medical Unit.

Arifeen Rahman, MD is a resident in Otolaryngology-Head and Neck Surgery at Stanford Medicine and a member of the ABC News Medical Unit.

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Health

Mpox public health campaign was successful but cases still occur at low levels in US: Study

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(NEW YORK) — In summer 2022, the global mpox outbreak seemed poised to overwhelm the U.S. with cases rising exponentially every week and no signs of slowing.

A successful public health campaign — promoting behavior changes and vaccination — helped cases drop dramatically.

However, a new small study published Thursday and led by the University of California, Los Angeles (UCLA) says that mpox cases are still circulating at low levels in the U.S. and primarily among unvaccinated high-risk groups.

Dr. David Talaen, co-lead author and a professor of emergency medicine and infectious diseases at UCLA, said after the 2022 global outbreak, there were small, localized outbreaks seen in cities including Chicago and Los Angeles, so the team wanted to examine if mpox was remerging.

“The second thing was that mpox is not strictly a sexually transmitted infection,” he told ABC News. “It can be transmitted between people just with any skin-to-skin contact, and the rash can be on any part of the body. So, we were curious if cases might have been overlooked and in groups other than the risk group that was identified in 2022, which was gay and bisexual men who have sex with men.”

For the study, the team looked at data from 13 U.S. emergency departments between June 2023 and December 2023, specifically among patients who visited EDs with a rash that resembled the rash mpox patients have.

Of the 196 patients with a rash, mpox was diagnosed in just 1.5% of them. Each of the patients with mpox identified as gay or bisexual men who have sex with men and had not been vaccinated against mpox.

The mpox patients had also engaged in sex with one or more partners they met through smartphone dating apps, the study found.

No mpox cases were identified in other groups, including women, children or unhoused individuals.

Anyone can get or spread mpox regardless of their gender or sexual orientation, but the U.S. outbreak began spreading primarily among gay or bisexual men and has continued to do so at low levels.

Many public health experts credit this community with rapidly responding to the outbreak through awareness campaigns and high vaccine uptake, which likely helped prevent further spread.

The authors wrote that the findings “underscore the importance of educating persons at risk for mpox regarding behavioral risks and encouraging these persons to be vaccinated.”

Currently, the JYNNEOS vaccine, a two-dose vaccine approved by the Food and Drug Administration to prevent smallpox and mpox, is the only vaccine being used in the U.S.

Data from Africa has shown two doses of JYNNEOS are at least 85% effective in preventing mpox infection.

To increase the number of JYNNEOS doses available earlier in the outbreak, the FDA authorized a proven strategy in August 2022 to inject the vaccine intradermally, just below the first layer of skin, rather than subcutaneously, or under all the layers of skin.

This allows one vial of vaccine to be given out as five separate doses rather than a single dose.

Talaen said the public health campaign was successful due to the dramatic decline in cases related to the 2022 outbreak, but that it doesn’t mean the disease disappeared.

“There was an idea that after the 2022 outbreak and the decline of cases the disease is gone; it’s not gone,” he said. “Cases still continue. So, it’s important for people to protect themselves, both through their behaviors and if, at-risk, through vaccination.”

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