Physicians share concerns over IVF treatments pausing after Alabama court ruling

Physicians share concerns over IVF treatments pausing after Alabama court ruling
Physicians share concerns over IVF treatments pausing after Alabama court ruling
ABC News

(MONTGOMERY, Ala.) — Dr. Beth Malizia, an Alabama physician, went through 12 years of training to provide patients with fertility care. But the doctor and co-owner of Alabama Fertility says her hands are tied after the Alabama Supreme Court issued a decision that frozen embryos are considered children.

The clinic is one of three facilities in the state that have halted in vitro fertilization (IVF) treatments amid concerns that their practices could run into legal troubles.

“Patients come first. That’s what we’re taught all the way through from the time we decide to go into medicine, and this is a decision that sort of takes that away from us,” Malizia said.

“The counsel, our lab director and all the physicians at Alabama Fertility have struggled with this for many hours and some made some really, really hard phone calls over the last couple of days,” said Malizia.

The clinic has paused all frozen embryo transfers, but will continue new patient visits, other standard fertility care, surgeries and continue care for patients currently on medications who are in the middle of a cycle, Malizia said.

Making calls to patients whose treatment the clinic paused has been “absolutely horrible” and “heart-wrenching,” she said.

In the ruling, the court said it would open door to civil and potentially criminal lawsuits over the mishandling of embryos. Physicians like Malizia say they are now fearful they could face wrongful death lawsuits — or potentially criminal charges — for discarding unused embryos, a routine part of IVF, or unintentionally mishandling embryos.

The ruling came as part of a lawsuit filed by couples whose embryos were destroyed after a patient wandered into a fertility clinic and dropped them. The couples tried to file a wrongful death suit, but a lower court had thrown out the case. The state Supreme Court then reversed that decision and set a new precedent that embryos are children.

In a concurring opinion, Alabama Chief Justice Tom Parker – who has a long record of issuing anti-abortion opinions – cited Scripture, writing that “human life cannot be wrongfully destroyed without incurring the wrath of a holy God.”

Among the three fertility providers that suspended IVF treatment is the state’s largest healthcare system, UAB Hospital. Four remaining providers have not suspended IVF treatment.

“We are in a position where we just don’t know what the legal ramifications are of an embryo that gets thawed. Embryos don’t always survive [transfer],” Malizia said.

Signs of more clarity began to surface on Friday, after a week of pushback on the ruling from families trying to conceive through IVF and an outpouring of criticism, particularly from Democrats and moderate Republicans.

Alabama Attorney General Steve Marshall, the state’s top law enforcement official, said he has no intention of “using the recent Alabama Supreme Court decision as a basis for prosecuting IVF families or providers,” the office’s Chief Counsel Katherin Robertson said in a statement Friday.

Alabama Governor Kay Ivey also said Friday that she’s “working on a solution” with Republican colleagues in the House and Senate to pass legislation that would guard IVF treatments in the state.

“Following the ruling from the Alabama Supreme Court, I said that in our state, we work to foster a culture of life. This certainly includes some couples hoping and praying to be parents who utilize IVF,” Governor Kay Ivey said in a statement to ABC News.

But the legal ruling has shown the fragility of IVF treatment in a post-Roe vs. Wade America, where the debate over when life begins has led many abortion rights advocates to speculate that IVF could become collateral damage.

Some physicians could be deterred from working in fertility in Alabama, said Sean Tipton, chief advocacy and policy officer at the American Society for Reproductive Medicine.

Tipon said physicians in the state are scared. “They are also angry, which is understandable, and they are also tremendously sad for their patients, in part because they don’t know what to tell their patients,” said Tipton.

“Just imagine being a physician who you’ve built your career on being able to help these people have babies, and you spend a lot of time reassuring, explaining, helping them understand and feel better about the process they’re going through — and now you can offer none of that,” Tipton said of physicians.

The fallout from the court ruling could spread beyond IVF treatment, Tipton said.

“I think the first impact with physicians is going to be young physicians choosing not to go there for their training. [And] University of Alabama Birmingham is one of the top public medical schools in the country,” Tipton said.

Tipton said the decision and risk of being sued could also discourage other medical workers, including nurses, from working in fertility clinics in the state; they would likely consider working in other specialties or even leaving the state.

Tipton heavily criticized the decision and its consequences.

“It absolutely makes no sense that people who loudly proclaim themselves to be ‘pro-life’ somehow oppose the use of what is the most ‘pro-life’ medical procedure there is out there. The only thing that in vitro fertilization does is help people have children,” Tipton said.

Patients struggle with news IVF has been paused

Patients interviewed by ABC News shared their heartbreak and concerns over not being able to continue their IVF treatments. For fertility patients in Alabama looking to start or expand their families, the past week has brought a lot of sudden changes to the carefully laid plans often required by the IVF process.

Gabbie Price, 26, and her husband have been financially planning to begin IVF for over a year, downsizing from a house to a camper van to cut costs and getting a new job because of the fertility benefits.

But their plan to start treatment in March has been halted by the ruling. Price said they’re now exploring options out-of-state because even if they found a clinic in Alabama to handle her care, she would be concerned about the potential liabilities.

“I’m terrified to have embryos here,” Price said at her home in Leeds, Alabama.

“I don’t know what that’s gonna look like, I don’t know what sort of rights we’re going to have over the embryos that we create,” she said.

Tucker Legerski and his wife, who live in nearby Tuscaloosa, Alabama, have been trying to have children since they got married in 2021. They began IVF about a year ago.

Their first embryo transfer ended with a miscarriage at eight weeks.

They were planning their second embryo transfer for some time in April, but the court decision upended their plans.

“Those embryos are our best hope for making kids right now. So that’s what hurts the most, I think,” Legerski said.

“If we aren’t able to use those embryos, then we have a much lower chance of having children,” Legerski said.

Angela Granger, 41, a Georgia resident who traveled to Alabama for IVF treatment to conceive her son, told ABC News she turned to the procedure after an ectopic pregnancy almost cost her one of her fallopian tubes.

Granger, who delivered her son in May 2021, and has been hoping to add another child to her family, decided after the state Supreme Court ruling that she wouldn’t pursue IVF in Alabama. While encouraged by lawmakers who say they will take action to protect the procedure, Granger said she needs to see legislation “in writing” before she is comfortable enough to undergo treatment or even store embryos there.

On Thursday, she was offered a job nearly 2,000 miles west, in Las Vegas, Nevada. She accepted.

“A big part of that is to get out of the south. If I wanted to really push and wait, I’m sure I could find a job down here. But this is just too much. I take it as a sign,” Granger said.

Copyright © 2024, ABC Audio. All rights reserved.

Small study shows a possible reason some long COVID patients experience ‘brain fog’

Small study shows a possible reason some long COVID patients experience ‘brain fog’
Small study shows a possible reason some long COVID patients experience ‘brain fog’
SONGPHOL THESAKIT/Getty Images

(NEW YORK) — According to a new study published in Nature Neuroscience, researchers at Trinity College in Ireland used blood tests to measure certain biological markers and specialized brain images to discover that long COVID patients with brain fog had more permeability or “leakiness” of their blood-brain barrier – offering the first biological evidence that this symptom may be due to underlying changes in the brain.

“A lot of long COVID symptoms, especially brain fog, are often written off as ‘oh that’s all in your head’ but this study is suggesting an actual biological mechanism behind it,” Dr. Leah Croll, neurologist and assistant professor at Temple University, told ABC News. “Knowing this is real can be very validating for people who experience this symptom.”

While this study is small, it could help inform ongoing research to better understand how to diagnose and treat long COVID that impacts millions of Americans. There is currently no test or treatment for this condition that can be disabling to those who have it.

In the study, researchers selected 32 patients who had COVID-19 in March or April of 2020 to undergo specialized brain imaging called a dynamic contrast-enhancing MRI – 10 had recovered from COVID-19, 11 had long COVID, and 11 had long COVID with brain fog. They found that the brain images showed more permeability or “leakiness” of the blood-brain barrier in patients who had long COVID with brain fog compared to the other groups. They also conducted cognitive tests and showed that six of the participants with brain fog had mild-to-moderate cognitive impairment and specifically showed problems with recall, executive functioning and word finding.

The researchers also measured blood markers of inflammation and blood clotting, and some markers related to the blood-brain barrier in 76 people who were hospitalized with an acute COVID-19 infection in March and April of 2020. It revealed that patients who specifically said they had brain fog with their acute infection had a statistically significant increase in a marker that is indirectly associated with blood-brain barrier dysfunction. Researchers say these findings suggests that inflammation impacting the blood-brain barrier may contribute to people experiencing brain fog with both acute and long COVID, but brain imaging was not done on the patients with an acute infection in the study.

There are limitations of the study. It was only done with a few people at one hospital in Ireland in the first stages of the COVID-19 pandemic before vaccines were available, so it may not be generalizable across all people who currently have long COVID, but it does provide new insights. More research is needed to confirm this finding and understand the implications of it, but experts say it may help researchers as better tests and treatments are developed for long COVID in the future.

“Right now, we’re beginning to understand the biological underpinnings of COVID-related brain fog. Gaining that understanding is the vital first step we need to advance future research.” Croll said. “I am hopeful that we are on a path towards effective tests and treatments, one study at a time.”

Dr. Jade A Cobern, board-certified physician in pediatrics and preventive medicine, is a fellow of the ABC News Medical Unit.

Copyright © 2024, ABC Audio. All rights reserved.

Children’s MMR vaccine rate drops 2%, 250,000 kindergarteners vulnerable to measles: CDC

Children’s MMR vaccine rate drops 2%, 250,000 kindergarteners vulnerable to measles: CDC
Children’s MMR vaccine rate drops 2%, 250,000 kindergarteners vulnerable to measles: CDC
Courtney Perry/For the Washington Post

(NEW YORK) — National MMR coverage has dropped 2% from the 2019-2021 school year to the 2022-2023 school year, which means approximately 250,000 kindergartners are at risk for measles infection around the country, according to the Centers for Disease Control and Prevention.

The 93.1% rate during the 2022–23 school is 2% lower than the 95% rate in the 2019-2020 school year and leaves measles coverage below the national target of 95% for the third consecutive year.

Doctors said this nationwide trend is a concerning backdrop to measles outbreaks in Florida and Philadelphia so far this year.

Exemptions for school vaccines are also at an all-time high. Ten states now report exemptions that exceed 5%, which leaves both vaccinated and unvaccinated children vulnerable to disease outbreaks like measles, experts say.

As of Feb. 15, a total of 20 measles cases were reported by 11 jurisdictions across Arizona, California, Georgia, Maryland, Minnesota, Missouri, New Jersey, New York City, Ohio, Pennsylvania, and Virginia, according to the CDC.

A current outbreak at an elementary school in Florida has led to six kids testing positive for measles so far, school officials said. Thirty-three out of 1,067 students at the school have not received any of the two doses of the MMR vaccine, Dr. Peter Licata, the Broward County Public Schools Superintendent, noted Wednesday during a board meeting. Health care professionals were first notified of a measles case, a third grader with no travel history, on Friday February 16.

“The absence of travel history in the measles cases suggests we are likely seeing local transmission, underscoring the serious risk to the community,” Dr. John Brownstein, epidemiologist and Chief Innovation Officer at Boston Children’s Hospital and ABC News contributor, told ABC News. “Measles is highly contagious, and with its long incubation period of 11 to 12 days, there’s a high likelihood that more children are infected without showing symptoms yet. This situation is alarming and requires immediate public health intervention to prevent further spread.”

If an unvaccinated child is exposed to measles, an MMR (measles, mumps and rubella) vaccine should be given as soon as possible. It is not harmful to get MMR vaccine after being exposed to measles and doing so could prevent later disease, according to the CDC. When the MMR vaccine is given within 72 hours of initially being exposed to measles, it may provide some protection against the disease, or help someone have milder illness.

Measles can be prevented with MMR vaccine, according to the CDC. The vaccine protects against three diseases: measles, mumps, and rubella. Two doses of MMR vaccine are about 97% effective at preventing measles; one dose is about 93% effective. The first shot is recommended for kids 12-15 months old and the second is given at 4-6 years of age.

CDC data shows that an overwhelming majority of measles cases are typically among unvaccinated people. Nearly 90% of the 1,249 measles cases in 2019 – greatest number of cases reported since 1992 – were unvaccinated.

Dr. Jade A Cobern, MD, MPH, is a physician board-certified in pediatrics and preventive medicine, is a fellow of the ABC News Medical Unit.

Copyright © 2024, ABC Audio. All rights reserved.

Nearly 3 million asthma attacks could be prevented among children with cleaner energy: Report

Nearly 3 million asthma attacks could be prevented among children with cleaner energy: Report
Nearly 3 million asthma attacks could be prevented among children with cleaner energy: Report
P Deliss/Getty Images

(NEW YORK) — Nearly three million asthma attacks in children could be prevented by 2050 if the United States transitioned to electric vehicles and clean power, according to a new report published Wednesday.

Researchers from the American Lung Association (ALA) say these goals would also avert millions of other respiratory symptoms and save hundreds of infant lives over the next two-and-a-half decades.

“That [zero-emission] future, it’s really important for lung health, both because emissions from dirty sources of transportation and electricity are harming our lungs right now and also because it’s critical for addressing climate change,” Laura Kate Bender, assistant vice president of Nationwide Healthy Air for the ALA, told ABC News.

Asthma, which is chronic inflammation of the lung airways, affects about 4.6 million children in the U.S., according to the Centers for Disease Control and Prevention.

Symptoms — including cough, tightness in the chest, shortness of breath and wheezing — led to more than 270,000 emergency department visits and more than 27,000 hospital inpatient stays among children in 2020, the CDC said.

The report looked at the potential impacts if all new passenger cars sold were zero-emission by 2035, all new trucks were zero-emission by 2040 and the electric grid will be powered by clean, non-combustion energy by 2035.

By 2050, the U.S. would prevent up to 2.79 million pediatric asthma attacks and 147,000 pediatric acute bronchitis cases, the study said.

Additionally, there would be 2.67 million pediatric upper respiratory symptoms and 1.87 million pediatric lower respiratory symptoms prevented as well as 508 infant mortality cases.

Bender noted that children are at a greater risk, both from air pollution and from climate change. Their still-developing lungs are more likely to suffer life-long impacts from exposure to air pollution, researchers said.

The report also found that every state in the continental U.S. would see asthma attacks prevented among children with California seeing the biggest drop at more than 440,000.

These potential health benefits are just estimates and made under the assumption that certain wide-ranging climate goals are met, Bender said.

“We would call that ambitious but achievable,” he added. “We know that there’s a lot of progress already being made, both at the federal level and in many key states to get toward these goals.”

She continued, “There’s lots of investment happening across the country, in electricity, in electric vehicle infrastructure, and so we’re using this report to call for more to call for the finalization of strong standards that help us get closer to the zero-emission future.”

Bender said at the federal level, the U.S. Environmental Protection Agency is close to finalizing two new sets of standards, one that would make future cars and medium-duty vehicles cleaner and one that would make future heavy-duty vehicles, such as trucks and buses, more green.

Additionally, the ALA is encouraging state-level lawmakers to have their states adopt standards to transition to zero-emission vehicles.

“Climate change is a health emergency, but it’s also a health opportunity,” Bender said. “We know that we need to reduce these emissions from vehicles and electricity urgently to address the climate crisis, but it’s also an opportunity because at the same time — as we’re switching away from those sources of greenhouse gas emissions — we also can clean up the other pollution that comes from gas- and diesel-powered vehicles and from fossil fuel fire powered plants. So we really see this as a win-win.”

Copyright © 2024, ABC Audio. All rights reserved.

Sixth case of measles linked to Florida elementary school outbreak

Sixth case of measles linked to Florida elementary school outbreak
Sixth case of measles linked to Florida elementary school outbreak
DIGICOMPHOTO/SCIENCE PHOTO LIBRARY/Getty Images

(NEW YORK) — The number of measles cases linked to an elementary school outbreak in South Florida has risen to six.

The outbreak at Manatee Bay Elementary School in Weston — 20 miles west of Fort Lauderdale and located in Broward County — was first reported on Friday with the initial patient being a third-grade student without a history of travel, according to the Florida Department of Health (DOH).

On Tuesday, Broward County Public Schools was notified of one additional confirmed measles case at the elementary school, bringing the total number of confirmed cases to six, according to a statement from John Sullivan, chief communications and legislative affairs officer for Broward County Public Schools.

“We expect to receive further guidance from the Florida Department of Health tomorrow and will continue to keep the school and its families updated with the latest information,” Sullivan said.

It’s unclear what grade the other infected students are in as well as other identifying information about them including age, sex and race/ethnicity.

“The District is maintaining close coordination with the Health Department to address this ongoing situation,” Sullivan said in a statement to ABC News.

“Over the weekend, the District took further preventive measures by conducting a deep cleaning of the school premises and replacing its air filters,” the statement continued.

Sullivan added that the school’s principal is “actively communicating with families, ensuring they are kept up to date with the latest information.”

Measles was declared eliminated in the U.S. in 2000, meaning the disease “is no longer constantly present in this country.” The dip in routine childhood vaccinations in recent years — as well as travelers bringing measles into the country — has resulted in outbreaks.

It’s unclear if the students who contracted measles are unvaccinated. The current two-dose measles, mumps and rubella (MMR) vaccine recommended by the Centers for Disease Control and Prevention is 93% effective after one dose and 97% effective after two doses.

“It is very likely that this outbreak is among unvaccinated students, given that nearly 90% of measles cases in past outbreaks were among those not vaccinated,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor. “This pattern aligns with historical data showing that measles primarily spreads among unvaccinated populations.”

The first measles vaccine, a single-dose vaccine, was introduced in the U.S. in 1963. In the prior decade, there were 3 to 4 million cases annually, which led to 48,000 hospitalizations and 400 to 500 deaths.

While two doses of the MMR vaccine are required to attend public schools in Florida, parents are allowed to seek exemptions for religious reasons, according to the National Conference of State Legislatures.

In Florida, at least 90.6% of kindergartners were fully vaccinated with the MMR vaccine for the 2022-23 school year, according a November 2023 CDC report. However, at least 4.5% of children were exempted from one or more vaccines.

The overwhelming majority of cases in outbreaks are typically the unvaccinated. Nearly 90% of the 1,249 measles cases in 2019, which was the greatest number of cases reported since 1992, were people who were unvaccinated.

“DOH-Broward is continuously working with all partners, including Broward County Public Schools and local hospitals, to identify contacts that are at risk of transmission. Health care providers in the area have been notified,” according to a weekend alert from the Florida DOH in Broward County.

Brownstein said it is very possible that the number of cases could rise because measles spreads rapidly among those who are not immune.

“An outbreak like this is very concerning because measles is a highly infectious disease that can lead to serious health complications, especially in children and immunocompromised individuals,” he said. “It indicates potential gaps in herd immunity, which are vital to preventing the spread of such diseases.”

Health officials said if anyone suspects or notices symptoms, to contact their health care provider to receive instructions on how to seek medical care without exposing others and to not visit the health department or a doctor’s office without contacting officials ahead of time.

The Florida DOH did not immediately reply to ABC News’ request for comment.

Weston is the most recent city in the U.S. to face a measles outbreak over the last few months.

Since December 2023, there have been eight confirmed cases in Philadelphia among unvaccinated individuals. Cases have also been identified in Delaware, New Jersey and Washington state, according to local reports.

ABC News’ Youri Benadjaoud contributed to this report.

Copyright © 2024, ABC Audio. All rights reserved.

Fifth case of measles linked to Florida elementary school outbreak

Sixth case of measles linked to Florida elementary school outbreak
Sixth case of measles linked to Florida elementary school outbreak
DIGICOMPHOTO/SCIENCE PHOTO LIBRARY/Getty Images

(NEW YORK) — The number of measles cases linked to an elementary school outbreak in southern Florida has risen to five.

The outbreak at Manatee Bay Elementary School in Weston — 20 miles west of Fort Lauderdale and located in Broward County — was first reported on Friday with the initial patient being a third-grade student without a history of travel, according to the Florida Department of Health (DOH).

It’s unclear what grade the other infected students are in as well as other identifying information about them including age, sex and race/ethnicity.

“The District is maintaining close coordination with the Health Department to address this ongoing situation,” John Sullivan, chief communications and legislative affairs officer for Broward County Public Schools, said in a statement to ABC News.

“Over the weekend, the District took further preventive measures by conducting a deep cleaning of the school premises and replacing its air filters,” the statement continued.

Sullivan added that the school’s principal is “actively communicating with families, ensuring they are kept up to date with the latest information.”

Measles was declared eliminated in the U.S. in 2000, meaning the disease “is no longer constantly present in this country.” The dip in routine childhood vaccinations in recent years — as well as travelers bringing measles into the country — has resulted in outbreaks.

It’s unclear if the students who contracted measles are unvaccinated. The current two-dose measles, mumps and rubella (MMR) vaccine recommended by the Centers for Disease Control and Prevention is 93% effective after one dose and 97% effective after two doses.

“It is very likely that this outbreak is among unvaccinated students, given that nearly 90% of measles cases in past outbreaks were among those not vaccinated,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor. “This pattern aligns with historical data showing that measles primarily spreads among unvaccinated populations.”

The first measles vaccine, a single-dose vaccine, was introduced in the U.S. in 1963. In the prior decade, there were 3 to 4 million cases annually, which led to 48,000 hospitalizations and 400 to 500 deaths.

While two doses of the MMR vaccine are required to attend public schools in Florida, parents are allowed to seek exemptions for religious reasons, according to the National Conference of State Legislatures.

In Florida, at least 90.6% of kindergartners were fully vaccinated with the MMR vaccine for the 2022-23 school year, according a November 2023 CDC report. However, at least 4.5% of children were exempted from one or more vaccines.

The overwhelming majority of cases in outbreaks are typically the unvaccinated. Nearly 90% of the 1,249 measles cases in 2019, which was the greatest number of cases reported since 1992, were people who were unvaccinated.

“DOH-Broward is continuously working with all partners, including Broward County Public Schools and local hospitals, to identify contacts that are at risk of transmission. Health care providers in the area have been notified,” according to a weekend alert from the Florida DOH in Broward County.

Brownstein said it is very possible that the number of cases could rise because measles spreads rapidly among those who are not immune.

“An outbreak like this is very concerning because measles is a highly infectious disease that can lead to serious health complications, especially in children and immunocompromised individuals,” he said. “It indicates potential gaps in herd immunity, which are vital to preventing the spread of such diseases.”

Health officials said if anyone suspects or notices symptoms, to contact their health care provider to receive instructions on how to seek medical care without exposing others and to not visit the health department or a doctor’s office without contacting officials ahead of time.

The Florida DOH did not immediately reply to ABC News’ request for comment.

Weston is the most recent city in the U.S. to face a measles outbreak over the last few months.

Since December 2023, there have been eight confirmed cases in Philadelphia among unvaccinated individuals. Cases have also been identified in Delaware, New Jersey and Washington state, according to local reports.

ABC News’ Youri Benadjaoud contributed to this report.

Copyright © 2024, ABC Audio. All rights reserved.

Medical experts sound the alarm on growing diabetic amputations among Black patients

Medical experts sound the alarm on growing diabetic amputations among Black patients
Medical experts sound the alarm on growing diabetic amputations among Black patients
Sorrasak Jar Tinyo/Getty Images

(NEW YORK) — In operating rooms across the country, more and more diabetics are receiving amputations due to complications from type-2 diabetes.

The life-altering procedures are more common among Black and Latino patients who are more likely to be diagnosed with the disease, according to health data.

Despite the grim figures, medical professionals said that diabetics can avoid losing a limb, but due to a lack of awareness of treatments, many minorities are missing out on this critical care.

“The reason I did not go to the doctor or anything, [is because] I didn’t want to hear the doctor say ‘We have to take your leg,'” Shelton Echols, a diabetic amputee, told ABC News.

Health experts, however, said that there is a new push to get the right medications and treatment to these patients earlier and avoid going under the knife.

Echols said that he was well aware of his diabetes and health problems but never really took action on it.

He said his hemoglobin A1C tests showed his levels were 14%, well above normal. A normal A1C is considered to be below 5.7%, according to medical experts.

“So I was playing Russian roulette with my life at the time because I was in denial,” he said.

Things changed one day when Echols noticed a cut on his left leg that wasn’t healing. Doctors discovered that his diabetes cut off circulation to his legs and they needed to amputate his left leg.

“I really had a sense of peace for the simple fact that I knew in my heart everything was my fault. Everything was my fault,” Echols said.

His story is becoming far too common among Black and Latino diabetics, according to health data.

Complications from the disease, specifically peripheral artery disease (PAD), can cause decreased blood flow and lead to wounds that remain open, according to health experts. And it’s this complication that can lead to the affected limb needing to be severed.

The number of diagnosed diabetics nationwide is up more than 7%, since 2001, according to data from the National Institute of Diabetes and Digestive and Kidney Diseases.

Over that same period, the number of those people needing to have a limb removed has grown by 18%, the data showed. Roughly 154,000 toes, arms, legs, and feet are cut off every year, according to the National Institute of Diabetes and Digestive and Kidney Diseases.

Across all racial and ethnic groups, the number of diabetic Americans is rising, and so is the number of them needing amputations. But a health study published in September found Black and Latino diabetics are four times more likely to get an amputation than other ethnicities.

Dr. Richard Browne, a Charlotte, North Carolina-based cardiologist, told ABC News that one of the factors behind the problem is the fact that many Black patients are not getting the right information about their diabetes early on.

“Very often, their symptoms are ignored,” Browne, who is also a senior medical executive at Johnson & Johnson, said.

Browne and his wife Lauren, who is also a physician, said they experienced this problem firsthand with Lauren’s diabetic father.

Russel Nandlal was a boxing coach for world champion Julian “The Hawk” Jackson. Doctors had to amputate both of his legs and an arm before he died in 2003.

Browne said looking back, his father-in-law was not given options to treat his PAD.

“And I also feel that there is what we call unconscious bias, where sometimes you get in front of a patient and you make your own determination that, ‘Hey, you know, maybe he can’t come back three or four times for the appropriate care for his PAD. So I’m going to do him a favor and just amputate, delay and get it over with at this point,'” he said.

Richard and Lauren Browne said that with the right treatment severe amputations can be avoided altogether.

Six years ago, Jay Bradley Starks said he was told by a doctor that they needed to amputate below his left knee after a bout with frostbite led him to a surprise diagnosis of PAD.

Starks said he went to another physician, who was also Black, and he was able to just amputate his foot due to stents and diabetes medication.

“My surgeon had a great understanding of who I was, as opposed to the initial one. There was a class difference, a race difference, a socio-economic distance,” Starks said.

“Controlling your A1C matters when you’re at the onset of the disease, you have an opportunity to do it,” he added.

Among the medications Starks is taking is Ozempic, an FDA-approved drug that is prescribed for diabetes patients. The drug mimics a hormone in the body that makes you feel full.

The drug has been shown to drop blood sugar levels and one medical study found that Ozempic and similar drugs can lower the risk of amputations by as much as 50%.

Despite these advantages, medical experts say some Black diabetic patients are hesitant to use them.

Dr. Veronica Johnson told ABC News that many of her patients have a distrust of medications.

“Even though they’re not insulin because of [some patients’] previous experiences and things that they found in the past or their family members who are placed on insulin and they were like, ‘That’s the end,'” she said.

Johnson and other doctors recommend a simple screening for all Diabetics concerned about losing a limb.

The ankle brachial index, or ABI test, compares the blood pressure in the upper and lower limbs If the differences are too great, then there’s a problem with circulation and doctors can advise a treatment.

The procedure is not covered by Medicaid or Medicare for patients who aren’t already showing symptoms. There are legislative efforts underway to try and change that.

Dr. Richard Browne has been traveling the country with Johnson & Johnson raising awareness of the issue and imploring Black patients to not wait on treatment before it gets too late. He said he hopes that when patients hear him and his personal family story, they will seek help.

“Quite frankly, there is evidence that if you are taken care of by someone who looks like you, you’re more likely to comply with their recommendations,” he said.

 

Copyright © 2024, ABC Audio. All rights reserved.

FDA approves Xolair, first medicine for kids, adults with food allergies

FDA approves Xolair, first medicine for kids, adults with food allergies
FDA approves Xolair, first medicine for kids, adults with food allergies
ATU Images/Getty Images

(NEW YORK) — The U.S. Food and Drug Administration has approved Xolair as the first and only medicine for people with one or more food allergies after the clinical trial data for the injectable asthma medication showed it helped people curb food-related allergic reactions.

“The FDA approval is based on positive data from the Phase III OUtMATCH study,” Genentech announced on Friday.

The study showed “a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo.”

“The FDA approval of Xolair for food allergies is meaningful to me on a personal level, not only as a physician, but as a patient and a parent of a child with food allergies, too,” Dr. Larry Tsai, VP and global head of respiratory, allergy and infectious disease product development at Genentech told ABC News. “For the first time, people with one or more food allergies have a treatment option with Xolair that can help reduce allergic reactions that may occur with an accidental exposure.”

Dr. Levi Garraway, Genentech’s chief medical officer and head of Global Product Development, added in a press release that “Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma … We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”

The studies first showed promising results in late December, experts at the time said they were hopeful that the injection would eventually win FDA approval as an allergy treatment for children.

Pharmaceutical developers Genentech and Novartis first announced in December 2023 that the FDA was prioritizing the review of its application for use of Omalizumab, an allergy-induced asthma medicine, in cases of accidental exposure to foods like peanuts, eggs or milk.

The small study, which needs more research before a potential FDA approval, combined with prior research points to how alternate use of the medication marketed as Xolair could potentially help to prevent allergic reactions in people who have multiple food allergies, especially anaphylaxis.

The federally funded trial backed by the National Institute of Allergy and Infectious Diseases is set to finish in 2026.

“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” Garraway, said in the December press release. “We are proud to partner with the National Institutes of Health and leading research institutions on this groundbreaking study. The FDA’s Priority Review designation acknowledges the unmet need for these patients, and we hope to make Xolair available to as many people as possible living with food allergies in the U.S.”

Data from the trial, which looked at 165 kids and adolescents — whose severity of reactions like hives or anaphylaxis was not included — showed those who received Xolair were able to eat more foods they have sensitivities to without triggering an allergic reaction, compared to participants who received a placebo.

While the preliminary data shows potential for this drug in this off-label application, there is not yet enough evidence to determine how great the impact could be for people with food allergies.

A Genentech spokeswoman told ABC News in December that the FDA was expected to decide on approval in the first quarter of 2024. If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure.

Tsai, previously told “GMA” that because food allergies hit close to him, this study feels like a step in the right direction for treatment options.

“While I am a physician, I am also a parent of a child with severe food allergies,” he said in an emailed statement. “I am all too familiar with the constant worry and fear that my child will have an accidental exposure at school or a friend’s house. For the roughly 17 million children who live with food allergies, the current standard of care treatment is for children to avoid the foods they are allergic to, and to learn to recognize and treat symptoms upon exposure to an allergen.”

Even with careful monitoring, he added that “accidental exposures are difficult to prevent and there is a significant need for new treatment options for children with food allergies.”

“The positive results from the OUtMATCH study bring us one step closer to providing a new treatment option for children and adults impacted by food allergies,” Tsai, who also has a food allergy himself, continued.

Updates for the trial on the Centers for Disease Control and Prevention website do not list how much more of the food participants were able to consume without having an allergic reaction.

The medication, marketed as Xolair, has been on the market since 2003 and helps treat chronic hives as well as chronic rhinosinusitis with nasal polyps — an inflammatory sinus disease.

People who take Xolair for allergic asthma, typically take the medicine for approximately 10 months and while price varies based on indication and dose, the cost is approximately $3,663 a month. That price also varies depending on the frequency as well as a person’s weight and their serum IgE levels.

An earlier version of this story was originally published on Dec. 27, 2023.

Copyright © 2024, ABC Audio. All rights reserved.

Amid rising measles cases, a new generation of doctors is being taught how to spot the disease

Amid rising measles cases, a new generation of doctors is being taught how to spot the disease
Amid rising measles cases, a new generation of doctors is being taught how to spot the disease
Penpak Ngamsathain/Getty Images

(NEW YORK) — Over the last several years, isolated outbreaks of measles have been popping up across the United States.

Most recently, between Dec. 1, 2023, and Jan. 23, 2024, there have been 23 confirmed cases of measles with infections reported in Pennsylvania, New Jersey, Delaware and the Washington, D.C. area.

Emergency medicine physicians and departments have to relearn how to rapidly detect and diagnose a disease that many have never had to treat before, only learning about it in school.

Measles was declared eliminated in the U.S. in 2000 because most Americans are vaccinated, and doctors told ABC News they and their colleagues may not even consider the disease as a possible diagnosis if a child comes in with a rash and a fever.

“The contemporary emergency physician or those in emergency departments, would they able to recognize measles initially the first time? And the answer is probably not,” Dr. Nicholas Cozzi, EMS medical director at Rush University Medical Center in Chicago, told ABC News.

The state of measles in the U.S.

Measles is a very contagious disease with the Centers for Disease Control and Prevention (CDC) saying every individual infected by the virus can spread it to up to 10 close contacts if they are unprotected including not wearing a mask or not being vaccinated.

The incubation period of measles from exposure to early symptoms averages 11 to 12 days with first signs including a fever that can peak from 103 F to 105 F, cough, and conjunctivitis.

Next, the measles rash will follow, which lasts five to six days. It will begin at the hairline and then proceed downward to the hands and feet. The rash will typically fade in order of appearance with severe lesions maybe peeling off in scales, the CDC said.

About one in five people in the U.S. who get measles will be hospitalized. Measles can cause serious health complications, especially in children younger than age 5 including ear infections, diarrhea, pneumonia, encephalitis (inflammation of the brain), and even death, according to the CDC.

The first measles vaccine, a single-dose vaccine, was introduced in the U.S. in 1963. In the decade prior, there were three to four million cases annually, which led to 48,000 hospitalizations and 400 to 500 deaths.

The CDC currently recommends people receive two vaccine doses, the first at 12 to 15 months and the second between 4 and 6 years old. One dose is 93% effective, and two doses are 97% effective.

Although hospitalizations and deaths due to measles have dropped dramatically, vaccination rates have been lagging and outbreaks have popped up in unvaccinated or under-vaccinated pockets of the U.S.

“What we’ve seen due to the rise of international travel and international migration, as well as global declining immunization rates, is the resurgence of a once eradicated — at the least in the United States — disease, and that is measles,” Cozzi said.

Doctors not recognizing measles

Despite measles being a once common childhood disease, most medical students, and even some emergency room doctors, have never seen measles or can recognize symptoms.

Doctors may remember what a textbook case of measles looks like but may also not be familiar with what a patient looks like in the early stages.

“Every medical student learns about measles during school, but that’s very different than seeing it on a daily basis and kind of understanding the ins and outs of the disease,” Dr. Keri Cohn, medical director of bioresponse and a pediatric emergency room physician at the Children’s Hospital of Philadelphia, told ABC News.

“And so, the vast majority of physicians in the emergency room that I work with has never seen measles before,” she continued. “And that is something that we’ve had to really kind of remind people, ‘This is how it presents; these are the things that you’re looking for.'”

Although Cohn has worked with measles cases before, due to past international work, she said she was surprised to be treating measles patients in Philadelphia.

Prior to the most recent outbreak in her city, which began in December, measles was not top of her list of possible diagnoses when a child visited the emergency room with certain symptoms.

“It is true that when a child comes in with fever and rash in Philadelphia, I’m not usually thinking about measles, and of course, in the setting of this outbreak, that has really changed the way that our physicians have thought about patients coming in with those symptoms,” Cohn said.

Teaching a new generation about measles

To make sure emergency room doctors are prepared in case they encounter a measles patient, hospitals have been developing response plans.

At Cohn’s hospital in Philadelphia, the bioersponse program had partnered with infection prevention and control, to develop a robust response.

“So the model is … we bring a large group of experts together in all different facets throughout the hospital system to kind of address the needs of the families, the patients, the physicians, the staff who are working against this outbreak,” she said.

Cohn has also worked to remind health care staff to take appropriate precautions such as making sure the patient is isolated and that staff entering the isolation room where N95s or a respirator with similar effectiveness.

In Cozzi’s case, he recently co-authored a paper in a recent issue of the Journal of the American College of Emergency Physicians, which includes reminders of what early-stage cases of measles look like and guidance on what information needs to be shared within hours of suspected cases.

“We wanted every emergency physician across the country to understand what measles looks like, how it presents, the life-threatening causes of it, why we’re seeing a resurgence, as well as the somewhat most of the deadly outcomes associated with it,” he said.

He also encouraged health care workers, both in and outside the U.S., to consider measles if a child arrives at a hospital or a clinic with a fever and a rash.

“If we don’t think of it, we’re not going to diagnose it,” Cozzi said. “If it’s not on top of our mind, we’re not going to consider it.”

Copyright © 2024, ABC Audio. All rights reserved.

Teen says he’s ‘doing great’ after undergoing experimental sickle cell treatment

Teen says he’s ‘doing great’ after undergoing experimental sickle cell treatment
Teen says he’s ‘doing great’ after undergoing experimental sickle cell treatment
skaman306/Getty Images

(NEW YORK) — Sixteen-year-old Jonathan Lubin loves basketball, playing the drums and going to the gym.

But until recently, his parents worried he wouldn’t live to see the age of 40.

Lubin was born with sickle cell disease, a genetic illness that causes abnormal ‘C’-shaped red blood cells that clog blood flow, causing severe pain episodes and organ damage.

More than two years ago, Lubin became one of the youngest patients to sign up for a still-experimental CRISPR gene editing therapy.

The treatment, which he received at New York-Presbyterian/Columbia, required chemotherapy and involved a complex months-long process of harvesting his own stem cells, editing them and then reintroducing them into his body.

But today, Lubin is able to do everyday activities that used to be risky.

The teen said he has not had a pain crisis or hospitalization in over two years, a stark contrast from his childhood, which has been characterized by hospital visits every few months.

“It’s been about two years and I’m doing great,” Lubin told “Good Morning America.” “Overall, I’m just feeling way better.”

For Lubin and other clinical trial volunteers, it’s been a major transformation.

And researchers say that thanks to the bravery of these volunteers, the U.S. Food and Drug Administration recently approved two new gene-editing therapies for sickle cell disease, including the CRISPR-based therapy Lubin received.

The CRISPR-based gene therapy Lubin received is made by Vertex Pharmaceuticals, and developed in partnership with CRISPR Therapeutics. The FDA approved a second gene therapy made by bluebird bio.

Sickle cell disease is a genetic condition that affects approximately 100,000 Americans – primarily Black Americans with African ancestry, according to the Centers for Disease Control and Prevention.

Researchers estimate that roughly 20 to 25% of those with the disease are sick enough that they would be good candidates for the newly approved treatments, which were approved for people aged 12 and older.

Jimi Olaghere and Victoria Grey – both in their 30s – said they volunteered to have a chance to be better parents to their children. Both travelled out of state to be treated at Sarah Cannon Research Institute and HCA Healthcare’s TriStar Centennial Children’s Hospital in Nashville.

Prior to his treatment, Olaghere said he felt like he was “living in a nightmare” with frequent hospitalizations and pain crisis.

“Now I wake up, I get the kids ready for school,” Olaghere said. “It is complete night and day. It is a completely different life.”

But the sticker shock of both newly-approved treatments – both multi-million dollars – has raised questions about access.

Given the high cost of treating repeat pain crisis over the lifetime of a person with sickle cell disease, some insurance providers have opted to cover the new treatments.

And the Biden Administration has created a new access model for Medicaid patients, designed to lower the medication cost and improve access to gene therapy.

The program is set to begin in January 2025.

 

Copyright © 2024, ABC Audio. All rights reserved.