New guidance suggests skipping Ozempic before surgery

New guidance suggests skipping Ozempic before surgery
New guidance suggests skipping Ozempic before surgery
Mario Tama/Getty Images

(NEW YORK) — In recent years, Ozempic and other similar drugs, called GLP-1 agonists, have grown in popularity for weight loss. However, doctors are now cautioning people against taking these medications before undergoing surgery or a procedure that requires them to be sedated.

The American Society of Anesthesiologists (ASA) said in a recent statement that people who take the GLP-1 agonists every day should stop the medication on the day of the surgery. If the person takes the medicine weekly, they should hold it a week before the surgery.

The new guidance was issued after “many reports from medical literature and anesthesia leaders about people who fasted but still vomited either going to sleep or waking up from anesthesia,” said Dr. Ronald L. Harter, MD, fellow and incoming president of the ASA and Professor of Anesthesiology at The Ohio State University Wexner Medical Center.

“This was very concerning and something we needed to address and communicate to the public like we are doing right now,” Harter said.

Anesthesiologists are doctors who help ensure patients are sedated during surgical procedures. For decades, anesthesiologists have discouraged eating or drinking before surgery so that the stomach is empty, reducing the chance of vomiting during the procedure, which can be dangerous.

“This is really a fairly unique situation where you have a relatively new class of drugs that are very, very quickly being taken up by and are being used by a fairly significant portion of the population,” Harter said. “One of the potential side effects of these medications is to delay gastric emptying, which has a unique risk or potential for aspiration for patients undergoing anesthesia. It was a combination of all those factors that really prompted us to give guidance, really to our anesthesiologist and to our patients who are on these medications.”

“This drug reduces gastric emptying of food and slows down the absorption of calories,” says Dr. Louis J. Aronne, M.D., director of the Comprehensive Weight Control Center and Sanford I. Weill professor of metabolic research at Weill-Cornell Medical College in New York City.

The drug also has adverse side effects such as diarrhea and vomiting, “but because these medications are titrated, meaning that the dose is increased gradually, we find a rate at which we can cease that side effect,” according to Aronne.

Aronne says he is familiar with GLP-1 agonists, stating that he has been following similar management guidance released by the ASA even before the statement was officially issued.

He says that people who are taking this medication can safely temporarily stop. If a person is taking this medication for weight management, as the medication wears off, the person will start finding themselves hungrier, and the process of weight loss will stop. “That’s not going to happen very quickly. It literally takes a month before we see things,” Aronne says.

If the person is taking the medication for diabetes, they may need to switch to another medication but safely with consultation with a doctor before the surgery, he says.

Alina Mitina, DO, is an emergency medicine chief resident at St. John’s Riverside and a member of the ABC News Medical Unit.

Copyright © 2023, ABC Audio. All rights reserved.

Mom who documented ovarian cancer battle on TikTok dies at 30: What to know about the deadly disease

Mom who documented ovarian cancer battle on TikTok dies at 30: What to know about the deadly disease
Mom who documented ovarian cancer battle on TikTok dies at 30: What to know about the deadly disease
taylorodlozil/Instagram

(NEW YORK) — The death of a 30-year-old mom who battled ovarian cancer for eight years has put a spotlight on the deadly disease, and its impact on young women.

Haley Odlozil’s death was announced last week on social media by her husband, Taylor Odlozil.

“It is with unbelievable sadness that I tell all of you my sweet Haley has passed away,” he wrote in a post shared on Instagram and TikTok. “I cannot begin to describe the amount of heart ache & grief myself & our entire family is experiencing.”

According to her obituary, Haley Oldozil, a Texas native, passed away on July 14.

He continued, “One thing I can tell you, she suffered greatly fighting this disease that slowly tore her body apart for the last 8 years. The thought of her being completely healed in a body with no pain & no scars in heaven makes me so incredibly happy for her but so overwhelmingly sad Im not there to see it.”

The Odlozils, parents of a 4-year-old son, said previously they shared Haley’s battle with ovarian cancer with their over 2 million followers on social media to raise awareness of the disease, which originates in a woman’s ovaries or in the nearby areas of the fallopian tubes and the peritoneum, the tissue that lines the abdominal wall, according to the U.S. Centers for Disease Control and Prevention.

Ovarian cancer is the second most common gynecologic cancer in the U.S., and it causes more deaths “than any other cancer of the female reproductive system,” according to the CDC.

“Obviously this is not easy to be very vocal and have your whole life, especially your death, splattered across the camera, but all the people who have been impacted by it and who have reached out to us, we really appreciate it,” Haley Oldozil said in a TikTok video from March. “That’s the reason why we’re being so transparent about everything, to bring awareness to ovarian cancer and help people see that please be thankful for each day.”

Haley Oldozil shared previously with her followers that she was diagnosed with advanced stage ovarian cancer in late 2015, shortly before her wedding.

She said the diagnosis came after a long struggle with symptoms including weight gain, fatigue, pain during intercourse and lower back pain, as well as a lump in her abdomen. After visiting multiple doctors and undergoing many tests over the years, Haley Oldozil said that in the fall of 2015, she asked for an ultrasound.

“By the time they did an ultrasound they found a mass in my abdomen and by the time they did a CT scan, I got a call from my gynecologist saying, ‘You have an appointment with an oncologist today. You need to go today,'” she said in a video shared last December on TikTok. “That’s when our whole entire world was shattered. Two months before our wedding. I went in and she said, ‘You have advanced ovarian cancer.'”

Ovarian cancer can often be hard to diagnose because there is currently no reliable way to screen for the disease.

While early signs of ovarian cancer can be vague, the main symptoms are abdominal pain or pelvic pain, bloating and an increase in urination, according to Dr. Jennifer Ashton, ABC News chief medical correspondent and a board-certified OB-GYN.

“If these symptoms or others last for more than half the month you want to alert a gynecologist and, again, talk about the fact that it could possibly be ovarian cancer,” Ashton said previously on Good Morning America, after Christiane Amanpour, chief international anchor for CNN, announced her own ovarian cancer diagnosis.

In some cases, targeted use of pelvic scans and sonograms or a CA-125 blood test may be used to detect ovarian cancer, but additional testing is “not one size fits all and it is not recommended for all women,” explained Ashton.

Treatment for ovarian cancer usually involves a combination of surgery and chemotherapy, according to the CDC.

During her eight-year battle with the disease, Haley Oldozil underwent both surgery and chemotherapy, the impacts of which she shared with her followers.

The Oldozils shared on social media that they learned earlier this year that Haley had run out of treatment options.

With a diagnosis in her 20s, Haley Oldozil was part of a small but present minority of women who are diagnosed with ovarian cancer at a younger age.

Around 13% of all cases of ovarian cancer in the U.S. from 2016 to 2020 occurred in women under the age of 45, according to the National Cancer Institute. Just over 4% of cases occurred in women between the ages of 20 to 34.

The most common age of diagnosis for ovarian cancer is between 55 and 64 years of age, according to the institute.

A woman’s risk for developing ovarian cancer at a younger age increases if they have a family history of breast, ovarian, uterine or colorectal cancer, or have a specific genetic mutation like the BRCA1 or BRCA2 genes.

In addition, other risk factors for ovarian cancer include being middle age or older, having a close family member who has had ovarian cancer, having endometriosis, having never given birth and having breast, uterine or colorectal cancer, according to the CDC.

While there is no known way to prevent ovarian cancer, the CDC notes there are things associated with lowering the risk of getting ovarian cancer, including using birth control for five or more years, having given birth, breastfeeding, having had a hysterectomy, having had your ovaries removed and having had a tubal litigation.

Copyright © 2023, ABC Audio. All rights reserved.

How AI is being used to detect, treat cancer — and the potential risks for patients

How AI is being used to detect, treat cancer — and the potential risks for patients
How AI is being used to detect, treat cancer — and the potential risks for patients
ATU Images/Getty Images

(NEW YORK) — Artificial intelligence, or AI, is continuing to expand into many areas of our lives and one of those is cancer detection.

Researchers are using machine-learning to build tools in the realm of cancer detection and diagnosing, potentially catching tumors or lesions that doctors could miss.

AI is also being used to help treat patients or communicate with patients about the complexities surrounding their cancer treatments.

Despite the advancements that have been made, experts warn that there are drawbacks such as real fears that cancers could be over diagnosed and that there are biases when it comes to detecting cancers in white patients versus of patients of color.

“If you’re on the lookout for something, then, if you look in enough places, you’ll start to see it,” Dr. Brittany Fasy, an associate professor of computational topology at Montana State University, told ABC News. “So, I think how and when to use computer-assisted diagnosis is an important conversation that needs to happen between clinicians doing the diagnosis, the researchers developing the methods to assist them, and the patients who it affects the most.”

At MIT and Mass General Cancer Center, a team developed and tested an AI tool known as Sybil. Sybil was trained on low-dose chest computed tomography scans, which is recommended for those between ages 50 and 80 who either have a significant history of smoking or currently smoke.

For patients undergoing screening for lung cancer, Sybil was able to look at an image and accurately predict the risk of a patient developing lung cancer within six years.

Lung cancer is the number one leading cause of cancer death among men and women in the U.S. and around the world, but researchers said it’s a cancer not often talked about due to the stigma of it being considered a self-inflicted cancer.

“The incidence of lung cancer and people who have never smoked is rising and so lung cancer is really a disease that could affect anyone, anyone with lungs, which essentially means anyone is at risk for getting lung cancer,” Dr. Lecia Sequist, program director of the Cancer Early Detection and Diagnostics Clinic at the Mass General Cancer Center, told ABC News.

She said the goal with AI tools like Sybil is to detect cancer when it’s early and is more treatable rather than in the late stages.

“We’re not doing a good job of screening for lung cancer and like with other screening tests, the reason it’s important to do screening is to find cancers when they’re early stage and still curable,” Sequist said. “If you find a lung cancer, when it’s stage I or II, the patient can have surgery, and then has a high chance of being cancer free up to that point.”

That was the similar goal of an AI tool built and studied by investigators at Harvard Medical School, the University of Copenhagen and the Dana-Farber Cancer Institute.

Solely using patients’ medical records, the tool was able to identify those at the highest risk of pancreatic cancer up to three years before an actual diagnosis.

“Most pancreatic cancers just present much too late and therefore, patients have a very, very bad survival, which is why we’re working on this,” Dr. Chris Sander, study co-senior investigator and professor in residence of cell biology at Harvard Medical School, told ABC News. “Less than 20% survival, but if you see it, then the five-year survival goes up to 50%. If you see it, you can cut it out.”

He added that tools like this also have an economic benefit because if cancers are caught early, patients don’t have to potentially risk struggling to pay for late-stage cancer treatment.

“The more we can do gradually to move cancer treatment to an earlier stage where it’s detected earlier and treated earlier, that would be a major change in the way we deal with the cancer problem,” Sander said.

How AI could be used

Sequist says that the U.S. is not doing a good job of screening people for lung cancer, even those who are traditionally at risk, like smokers.

She would like to use a tool like Sybil to make lung cancer screenings available for everyone like colon cancer screening are, with people recommended to get colonoscopies at age 45.

“What I imagine Sybil being able to do for lung cancer screening is really make lung cancer screening something that everyone could qualify for and then Sybil is used to help us understand who is at high risk and who’s not,” she said.

Sequist continued, “I mean, that’s how we screen for other cancers. It’s only lung cancer, that we have all these barriers up around, ‘Well, you have to have smoked this much, or else you can’t access this test’ and so it can be very off-putting to people who are just trying to, do the best for their health.”

AI could also help patients undergoing cancer treatment. Penn Medicine developed an AI chatbot named Penny that exchanged text messages with patients to help guide them through their complex cancer treatment regimens and reduce the risk of mistakes.

Results showed about more than 90% of messages were accurately interpreted by the tool and there was at least a 70% adherence rate of participants taking their medications. However, Sander said people should not worry that AI is going to replace humans in the medical field.

“AI will be used in decision support. The AI tools will run and provide information and maybe make recommendations to the physicians, but the physician will be the ultimate decider,” he said. “So, this is decision support for the human expert, who is trained with ethical standards, and then together with patients, the physicians will make a decision as to what to do in particular.”

Drawbacks and pitfalls

For all the progress that has been made when it comes to AI cancer detection and treatment, there are also things to consider.

While AI has become advanced at detecting possible skin cancers, it is also heavily biased. Research has shown that AI systems for diagnosing skin cancer risk being less accurate for people with darker skin.

Dr. Adewole Adamson, an assistant professor in the department of internal medicine at the University of Texas at Austin Dell Medical School, told ABC News that, historically, the medical field has not done a good job gathering images of skin conditions, including cancer, in diverse skin.

“If you train an algorithm on a data set that inherently in itself is biased and does not have within it enough examples of cancer or whatever skin manifestation of disease, it will not be able to then accurately make that diagnosis once it’s fully trained,” he said.

This could mean that people with darker skin who have skin cancer could slip through the cracks or, conversely, every skin abnormality on people with darker skin is seen as a sign of skin cancer.

Adamson has been working to get a wider array of data sets to help make AI tools for skin cancer detection more accurate for all patients.

“The problem is this is the canary in the coal mine” he said. “If you’re going to already start building algorithms in dermatology that are biased, then it just only emboldens you to continue down that road, without actually equity being a fundamental part of building an algorithm, which I think is important if you’re going to unleash it on the general population.”

Additionally, Adamson says we need to be careful about making sure we are not overdiagnosing cancer.

A study partly conducted by Google in 2020 trained AI to spot breast cancer in mammogram scans. Researchers said the tool was able to do so at the level of — and even better than — a board-certified radiologist. However, past research has shown not every tumor in a person with cancer will become deadly and there are many people with cancers that don’t lead to death, Adamson explained.

“The problem with finding cancer, particularly finding early cancer, is that we have difficulty picking out which cancer is extra destined to progress and grow and metastasize and kill patients versus those cancers that would never be destined to grow progress, and actually harm patients,” he said.

“The point of cancer detection is not to find more cancer, it is to find more cancer that can potentially kill people and prevent that,” he continued. “It’s the prevention of cancer death, not finding more cancer.”

Adamson said his critiques do not mean he’s against AI being a useful tool but that these are considerations researchers needs to have before the technology is utilized broadly.

“This doesn’t mean that this technology isn’t promising, isn’t really powerful, isn’t something that is going to be important in the future,” Adamson continued. “It just needs to be responsibly developed and deployed.”

 

Copyright © 2023, ABC Audio. All rights reserved.

Headers linked to memory issues, raising questions about soccer safety as the World Cup kicks off

Headers linked to memory issues, raising questions about soccer safety as the World Cup kicks off
Headers linked to memory issues, raising questions about soccer safety as the World Cup kicks off
The Good Brigade/Getty Images

(NEW YORK) — With the Women’s World Cup kicking off this week, the focus of the sports world turns to soccer — the most popular sport in the world and one continuing to grow in the United States. However, new research is calling attention to one of the risks of the game, heading the ball, which studies find may be linked to brain problems later in life.

The newly released study, published in the journal JAMA Network Open, found that professional male soccer players who headed the ball more frequently during their career were more likely to develop memory issues. The study builds on prior studies from Scotland and France that also showed a link between playing soccer and the development of dementia.

The research was done on professional male athletes, but can guide how athletes at all levels approach the sport, Dr. Joel Salinas, an assistant professor of neurology at NYU Langone and chief medical officer of Isaac Clinic, an online memory clinic, told ABC News. It may be especially important for children, he says. “If you have a child, especially a child whose brain is still in the early developing phases, maybe hold off on how often you head the ball.”

The new study included over 400 retired professional male soccer players that were an average of 63 years old. The athletes played soccer for an average of 14 years. Those that reported heading a soccer ball six to 15 times a game were found to have a 2.71 increased risk for memory issues, such as those seen with dementia. Players who reported heading the ball greater than 15 times a game were found to have a 3.53 increased risk of memory issues, the highest among all studied players.

The researchers said that may be because repeated headers can cause sub-concussive injuries, which are low-grade injuries that don’t lead to the symptoms of a concussion but can build up over time and cause problems later in life.

“I think information like this is increasingly valuable for players and their parents,” says Dr. Leah Croll, an assistant professor of neurology at the Lewis Katz School of Medicine at Temple University.

Croll says she thinks research such as this will continue to shape the rules and regulations of the game at every level.

“Some leagues have introduced policies where they restrict heading the ball for this reason, and that may be something that becomes increasingly prevalent as we learn more and more about the risk of dementia and minor traumatic brain injuries earlier in life,” she says.

For example, the U.S. Soccer Federation, the governing body for soccer in the U.S., banned heading for players 10 and under in 2015.

This new study revealed that certain positions on the field had more significant risks for the development of memory issues when compared to others. Goalkeepers had the lowest risk, while defenders had the highest risk of developing memory issues. That may be because defenders head the ball more frequently than other positions on the field, the researchers said in the study.

Most research studies on headers and risk to the brain have been done on male athletes, which is a significant limitation to the data, and reflects longstanding gaps in sports medicine research around female athletes. Additionally, experts believe that female athletes face similar risks — or maybe higher risks, according to some research — from heading the ball. “There is some research to suggest that women might be more likely to have concussions and might have more severe symptoms from concussions, but we just don’t have enough information to say anything definitive at this point,” Croll says.

There’s still more to learn about headers and dementia risks, including the risks to athletes who may not play soccer for as many years as the professionals. But for now, experts say athletes at all ages should learn proper heading technique and take a break from playing if they’re having any concussion-like symptoms after headers, including headaches, dizziness, or confusion.

Despite the mounting evidence linking head impacts to the development of issues with the brain, Croll says there is a lot left to understand, especially around how we can help people who have already developed issues. “Looking into treatments could potentially be a very, very exciting future direction,” she says.

Alexander Garcia, D.O., is an internal medicine resident at Cooper University Hospital in Camden, New Jersey, and a member of the ABC News Medical Unit.

Copyright © 2023, ABC Audio. All rights reserved.

US halts funding access to Wuhan lab at heart of COVID-19 origins debate

US halts funding access to Wuhan lab at heart of COVID-19 origins debate
US halts funding access to Wuhan lab at heart of COVID-19 origins debate
Jasmin Merdan/Getty Images

(NEW YORK) — The virus lab at the heart of the contentious debate around COVID-19’s origins has been cut off from U.S. funding opportunities for likely violating National Institutes of Health’s biosafety rules, according to a memo shared with ABC News.

The Department of Health and Human Services has suspended the Wuhan Institute of Virology’s access to federal funding, and proposed banning them longer-term after the lab failed to provide sufficient documentation on their biosafety protocols and security measures, despite repeated requests from the NIH for their lab notebooks, files, financials and other records of their research, the memo, signed by an HHS official, states. According to the memo, “immediate action is necessary to protect the public interest.”

Because of the WIV’s “disregard” of NIH’s numerous requests to “provide the required materials” to back up the research in their grant progress reports, the “NIH’s conclusion that WIV research likely violated protocols of the NIH regarding biosafety is undisputed,” the memo states.

“As such, there is risk that WIV not only previously violated, but is currently violating, and will continue to violate, protocols of the NIH on biosafety,” the memo states.

The WIV received NIH funding through its partnership with EcoHealth Alliance, a nonprofit and longtime collaborator with the WIV on coronavirus research.

The WIV hasn’t received any federal funding from NIH since the summer of 2020, according to HHS. Still, their continued noncompliance has shown that they “lack the present responsibility to participate” in federal funding programs altogether, the memo states.

This move now makes the WIV ineligible for future federal awards from any U.S. agency, including new contracts, grants and other transactions.

The WIV has 30 days to respond to the notice. If they don’t respond, proceedings will begin to ban them longer term.

An HHS spokesperson tells ABC News they have yet to receive a response from the WIV.

There is “adequate evidence in the record” to ban them longer term, and “immediate action is necessary to protect the public interest,” the memo said.

HHS sent a letter to the WIV’s director general informing the institution of their suspension and possible long-term federal funding ban. The Monday-dated letter, shared with ABC News and signed by an HHS official, was sent via email, fax and UPS. The suspension was effective immediately, the letter said.

This suspension is a temporary action, but meanwhile, “immediate action is necessary to protect the integrity of federal procurement and non-procurement activities,” the letter to WIV’s director general said.

The WIV’s “affiliation with, or relationship to, any organization doing business” with the U.S. government “will be carefully examined to determine the impact of those ties on the responsibility of that organization” on their work with the government.

How long a long-term ban would last is not definitive: HHS’ letter to WIV’s director general noted longer-term funding bans are “generally” no more than three years. It could, however, be shorter or longer as “circumstances warrant” based on mitigating or aggravating factors and the seriousness of the situation.

An HHS spokesperson said in a statement to ABC News that this move comes after a lengthy review, noting the agency “took action” on cutting the WIV’s funding access “after a monthslong review conducted by the Biden administration. The move was undertaken due to WIV’s failure to provide documentation on WIV’s research requested by NIH related to concerns that WIV violated NIH’s biosafety protocols. In short, HHS finds ‘that WIV is not compliant with federal regulations and is not presently responsible.’”

“This formal process began in September 2022, with new information continuing to be provided to the HHS official in charge until June 2023,” the statement continued. “Throughout this time, WIV did not receive any federal funding from NIH and has not received any federal funding from NIH since July 2020.”

It’s not the first time this lab has come under scrutiny for its lack of cooperation and questionable biosafety standards.

Renowned for its massive collection of, and advanced research on, bat coronaviruses, the WIV has been central to one of the leading COVID-19 origin theories — that an accidental research-related incident at the lab could have first unleashed the virus on the world and sparked the pandemic.

The nine-page memo outlines nearly 10 years of correspondence with EcoHealth regarding their grant and research at the WIV which then informed the suspension, and which span before, during and after the pandemic. It makes no referendum on where the pandemic began in the decision to cut funding — whether a lab leak or a natural animal spillover — however the ongoing mystery over COVID-19’s origins exposed urgent questions over biosafety and transparency that have are core to the issues behind the WIV’s suspension now.

Since the pandemic’s inception, as Beijing and the WIV have stonewalled numerous investigations and COVID-19’s origins remained unresolved, the lab has become a symbol of the still-inscrutable source of the virus that has killed nearly seven million people worldwide, per the World Health Organization.

The Biden administration has focused on the lab in their probe into COVID-19’s origins, and the White House, the U.S. intelligence community, and many in the international public health community have consistently and vociferously criticized Beijing and WIV for stonewalling their investigations.

The WIV has also become highly politicized and used as a polemic cudgel, with GOP members using NIH’s funding to WIV to attack, among others, former National Institute of Health Director Dr. Anthony Fauci.

In their summary on potential links between the WIV and COVID-19’s origins declassified last month, the Office of the Director of National Intelligence noted that while they didn’t know of a specific biosafety incident that spurred the pandemic, they concluded the WIV did not always use adequate safety precautions for the risky research they were carrying out — which could increase the risk of “accidental exposure” to viruses.

In January, a report from HHS’ inspector general found that “despite identifying potential risks associated with research being performed under the EcoHealth awards, NIH did not effectively monitor or take timely action to address” their compliance with research requirements.

“WIV’s lack of cooperation with the international community following the COVID-19 outbreak—consistent with the response from China—limited EcoHealth’s ability to monitor its subrecipient, and greater transparency is needed about information from WIV,” OIG’s report read.

Copyright © 2023, ABC Audio. All rights reserved.

Millions could soon have access to life-saving tuberculosis drug following online uproar

Millions could soon have access to life-saving tuberculosis drug following online uproar
Millions could soon have access to life-saving tuberculosis drug following online uproar
Sheldon Cooper/SOPA Images/LightRocket via Getty Images

(NEW YORK) — In a move welcomed by advocates, a treatment for multi-drug resistant tuberculosis could soon become more accessible for millions of people worldwide.

Although tuberculosis is uncommon in the U.S., it is the top infectious disease killer worldwide after COVID-19, claiming an estimated 1.6 million lives in 2021, according to the World Health Organization.

A life-saving drug called bedaquiline, when used along with other medications, works to kill the bacteria that causes multi-drug resistant tuberculosis (MDR-TB). While the drug’s primary patent was set to expire this week, allowing less-expensive generic versions to be manufactured and distributed, Johnson & Johnson, which makes and markets bedaquiline under the brand name Sirturo, had planned to utilize a secondary patent to extend their control of it until the end of 2027, advocates say.

In a now-viral YouTube video, author and advocate John Green protested Johnson & Johnson’s patent extension on bedaquiline and rallied his 4.5 million Twitter followers to pressure the company to change course.

Amid the Twitter uproar, Stop TB Partnership – a United Nations-hosted organization that works to address tuberculosis worldwide – announced a partnership with the pharma giant to “tender, procure, and supply generic versions of SIRTURO® (bedaquiline) for the majority of low-and middle-income countries, including countries where patents remain in effect.”

Researchers have estimated prices of generic versions of bedaquiline could be up to 94% lower than current costs, with large-scale manufacturing.

The availability of the generic drug could provide six million people with treatment over the next four years, according to Carole Mitnick, Sc.D., a professor of global health and social medicine at Harvard Medical School and a senior research associate at Partners in Health.

While advocates celebrated the news, Johnson & Johnson said the partnership was already in the works prior to the media uproar and that it was “false to suggest” that patents were being used to prevent broader access to bedaquiline.

“We’ve been in lengthy discussions with the Global Drug Facility regarding access to bedaquiline. We had our first meeting with them at the beginning of this year and reached an agreement on June 13,” a Johnson & Johnson spokesperson told ABC News via email.

Pharmaceutical companies often file for patent extensions on their drugs to prevent market competition, a strategy called ‘evergreening.’ However, advocates say this system hinders access to affordable medicines globally, sometimes for many years after a drug is first launched.

“Patents are supposed to last for a limited period of time. After that, competitors should enter the market to drive prices down. But that’s not what’s happening,” said Robin Feldman, professor of law at University of California Law San Francisco. “Instead, drug companies pile new protections onto their drug to extend that protection.”

Patents serve a key role, however, by incentivizing innovation. “Companies fund an extraordinary amount in researching and producing and we want to encourage companies to engage in that research. The patent is a reward for that successful research,” Feldman added.

But Feldman’s research shows that here in the U.S., an estimated 78% of drugs with new patents in the Food and Drug Administration’s records were evergreening extensions for existing drugs.

John Green, who created the YouTube video addressing the bedaquiline issue, told ABC News he was first exposed to the devastation of tuberculosis during a trip to Sierra Leone.

“When I was there, I met a young man who looked to be my son’s age, who looked 9 at the time but was in fact 16 and was just really emaciated, stunted by really severe multi-drug resistant tuberculosis,” said Green.

“Then when I got home, I started to wonder why I didn’t know more about this disease that kills more people than HIV. Kills more people than malaria and war and cholera combined, every year,” he added.

“Despite causing millions of deaths each year and the avail of treatment and vaccines, tuberculosis remains a largely ignored global health issue,” said John Brownstein, Ph.D., ABC News contributor and chief innovation officer at Boston Children’s Hospital.

The disease is much rarer in the U.S. compared to other countries. There were an estimated 8,300 reported cases of tuberculosis in 2022, with rates steadily declining since the early 1990s, according to the Centers for Disease Control and Prevention.

A vaccine exists to protect against tuberculosis and is typically given to young children in countries where the disease is more common. But the vaccine does not always fully protect against infection.

“[Tuberculosis] disproportionately affects people who are most impoverished and most marginalized. It is highly stigmatized and has a lot of overlap with important chronic diseases like HIV and diabetes,” Harvard Medical School’s Carole Mitnick said.

Tuberculosis is curable with antibiotics. However, people in lower-income countries have a higher risk of developing an infection that is resistant to multiple medications.

Nearly 500 thousand new cases of MDR-TB occur each year and only about one in three people with the disease accessed treatment in 2021, according to the World Health Organization. Those infection numbers have been trending upward, which scientists attribute to the impact of the COVID-19 pandemic.

Advocacy groups like Doctors Without Borders and Partners in Health, who for years have been pushing for greater access to tuberculosis medications, called for more action to ensure patients have better access to them.

“We reiterate our call on [Johnson & Johnson] to publicly announce it will not enforce any secondary patents on bedaquiline in any country with a high burden of TB, and withdraw and abandon all pending secondary patent applications for this lifesaving drug,” Doctors Without Borders said in a press release.

In answer to an ABC News request to respond to the Doctors Without Borders statement, Johnson & Johnson said, in part, that it was “deeply committed to patient needs around the world, particularly in providing access to innovation for the most vulnerable populations in low- and middle-income countries,” and highlighted what it said were the company’s “broad access efforts” in providing bedaquiline to those who need it.

“This includes entering into a collaboration in June this year with the Stop TB Partnership’s Global Drug Facility (“GDF”) – the largest procurer of TB medicines – which enables them to invite potential generic suppliers and purchase generic versions of SIRTURO® 100mg,” the statement further declared.

The Johnson & Johnson statement did not specifically address bedaquiline patents and patent applications.

“I think it’s a profoundly unacceptable injustice,” Green said of the overall bedaquiline access issue. “And we need to react appropriately. And to see that over the last few days has been extremely encouraging to me.”

Copyright © 2023, ABC Audio. All rights reserved.

Give A Mile donations get flights to see loved ones for the last time

Give A Mile donations get flights to see loved ones for the last time
Give A Mile donations get flights to see loved ones for the last time
Andrea Bryant applied for a Give A Mile flight to go see her mother who was in the hospital in Seattle. — Courtesy of Andrea Bryant

(NEW YORK) — When Ileen Paden’s husband was diagnosed with Parkinson’s disease and began showing signs of dementia, she knew she couldn’t give him the care he needed at home. After 36 years of marriage, Paden stayed in Indiana while Charles went to a nursing home in Dallas, Texas, aided by funding from the Veterans Administration.

“It was very hard to let him go,” Paden said of her husband, Charles. “But I knew I wasn’t doing him any good keeping him here.”

Over Charles’ three years in Texas, Paden visited as often as possible, but she didn’t have much money and was receiving disability benefits herself. As her husband’s condition began to deteriorate, she worried she might not get to see him again.

Then on TikTok, a hospice nurse she followed mentioned the organization Give A Mile, which used donated frequent flyer miles to help arrange flights for people separated from their loved ones. Paden applied immediately. Give A Mile responded within an hour, and in December, Paden, her daughter and her granddaughter flew to Dallas to be with her husband for the last time, she told ABC News.

During the December visit, Paden stayed overnight at Charles’ facility and they talked late into the night. Her granddaughter, who hadn’t seen him since she was a toddler, crawled up onto his bed and gave him a hug. They spent most of their three-day visit at the nursing home, helping out and spending time with him.

“That brought a lot of joy,” said Paden. “I can’t believe they actually had this kind of program because it was perfect. That’s what we needed: to see him one last time.”

Give A Mile also enabled Andrea Bryant to see her mother one last time. During an international trip, Bryant’s mother suffered a pulmonary embolism, leading to her being placed on life support in Istanbul. After lengthy and expensive dealings with the hospital in Turkey through an interpreter, Bryant and her sister arranged an international medical flight to bring her mother home. Her mother’s coworkers at Virginia Mason Medical Center in Seattle, where she worked as a nurse, got the hospital to accept her as a patient.

Bryant was following in mother’s footsteps and going to nursing school, and she had children and grandchildren to support. Through the ordeal, she spent tens of thousands of dollars from her savings to transport her mother back to the United States. She had no idea how she would afford the trip from her home in Houston to see her mother in Seattle for the last time.

One of the instructors at her school told her about Give A Mile. After she applied, Give A Mile quickly approved her application and sent her a flight within 12 hours.

“These people gave me the opportunity to see my mother for the very last time and hold her hand again and be with my sisters at the hospital by her side,” said Bryant. “If it would not have been for them, I don’t know that I would have seen my mom again.”

Give A Mile has made a difference for countless families like Paden’s and Bryant’s. Founded in 2013 by Canadian tech executive Kevin Crowe, Give A Mile is a non-profit organization with the mission of helping people get flights to travel and see their loved ones for the last time before they pass away. To arrange flights, Give A Mile asks for donations of frequent flyer miles or cash.

Crowe formed Give A Mile as a tribute to his friend Ryan, who died from brain cancer at the age of 37. Crowe cared for Ryan in his final months alongside his family, and he witnessed firsthand the value they found in spending time together before he died.

“It’s great to go to Super Bowls and it’s great to go on trips and hit up Vegas,” said Crowe. “But these are the moments of life that are really the prize, the little moments with our children, the people we love, our friends and family.”

After Ryan’s death, Crowe learned that trillions of frequent flyer miles go unused every year and came up with the concept for Give A Mile.

Since then, the organization has provided over 1,000 flights with over 36 million miles donated.

The process of applying for a flight through Give A Mile is simple. The application is short and asks for financial information, personal details and medical verification. From there, a flight review team looks at the application and moves as quickly as possible to approve it and arrange flights.

“We can’t help everybody,” said Crowe. “As applications come in, we assess them based on the resources we have at that moment. … If you meet the criteria, we’re going to do all our best to make that flight happen for you.”

To donate, people can pledge miles for long or short haul flights through major airlines and rewards programs. Give A Mile partners with United and Air Canada, which hold campaigns for the organization throughout the year, where people can donate any amount above 1,000 miles. The organization also accepts cash, which helps with flights to remote areas or when flights can’t be booked with miles.

For Crowe, the founder, a thousand flights and 36 million miles are just the start. He wants to reach a billion miles donated.

And some of the donors who will help him build toward that goal are people the organization has previously helped. After Paden’s husband passed away in Texas, her family decided to pay it forward. In lieu of flowers, they asked for donations to Give A Mile.

Copyright © 2023, ABC Audio. All rights reserved.

‘Difference between life and death’: Inside the staffing crisis at 911 dispatch centers

‘Difference between life and death’: Inside the staffing crisis at 911 dispatch centers
‘Difference between life and death’: Inside the staffing crisis at 911 dispatch centers
The Houston Chronicle via Getty Images

(NEW YORK) — Faced with an ongoing labor shortage, some 911 centers are rethinking how to hire and retain workers.

From increasing base pay to fostering a culture that elevates dispatching as a unique profession, industry leaders told ABC News that they hope the changes can help rebuild their workforces following widespread challenges during and after the pandemic.

Between 2019 and 2022, one in four jobs at public safety communications centers were vacant, according to a recent report from the National Association of State 911 Administrators and the International Academies of Emergency Dispatch.

Filling those jobs in a competitive work environment has been difficult, according to Andrew Dameron, Denver’s director of Emergency Communications, who described competing with companies like Uber and Grubhub for employees during and after the pandemic.

The stakes are high for 911 centers facing the ongoing work shortage, according to April Heinze, the 911 operations director for the National Emergency Number Association. Understaffed centers risk burning out their remaining employees, cutting additional services, or leaving callers with increased wait times.

“It’s the difference between life and death. It’s that simple,” Sharon McDonough, director of the 911 dispatch center in Tucson, Arizona, told ABC News about increased wait times due to understaffing. “We don’t know what’s on the other end of that phone, and that person might be dying right in that moment or about to be killed right in that moment.”

Beyond those material harms, Dameron described a broader concern that understaffing causing long wait times could contribute to the breakdown of trust between 911 centers and the communities they serve.

“If your residents lose faith that dialing 911 will enable them to get the help that they need, then you start to erode faith in the entire system,” Dameron said.

When did the staffing shortage peak?

Emergency departments, such as the ones in Denver and Tucson, are primarily staffed by civilians and employ two types of workers. Telecommunicators answer calls placed to 911 and other non-emergency lines while dispatchers communicate with first responders, McDonough said.

In smaller cities and towns, those roles are often handled by the same person and might work within the same building as first responders.

Generally, these positions only only require a high school diploma, passing a background check and training. According to the U.S. Bureau of Labor Statistics, the average pay for the work, which requires 24-hour staffing, averages around $46,670 a year.

“In some situations, individuals make more money at fast food restaurants than they could be serving the public and 911,” Brian Fontes, the CEO of the National Emergency Number Association (NENA), told ABC News.

Moreover, the high-pressure work often puts these professionals at risk of post-traumatic stress disorder, according to experts.

“They got to listen to this person screaming and crying on the phone, they maybe even heard them being assaulted, and then they have no idea what happened next,” McDonough told ABC News. “They have no idea what happened next, so there’s some real moral injury that happens.”

McDonough and Dameron added that the lack of flexibility to work remotely during the pandemic and job opportunities during the “Great Resignation” created a workforce shortage by 2021 as “staggering” numbers of workers left the job. Professionals listed the job’s stress and low wages as the top reasons for leaving the field, according to the NASNA/IAED report.

“I could go work at a GEICO call center and probably make more [with] a whole lot less trauma,” McDonough said.

As workers left the job, the remaining staffers at some call centers began taking on more overtime, creating a “miserable circle” of overworked employees, according to McDonough.

Addressing the workforce shortage

Denver centers have responded to the shortage by increasing the starting salary by 45% since 2020, according to Dameron.

Tucson’s 911 center improved its vacation policy and work schedule flexibility and pursued an intentional cultural shift to respect the profession of emergency telecommunication, McDonough said. For example, rather than displaying posters of first responders, their call center instead uses wall space to display call takers and dispatchers, which McDonough says places more importance on the role of 911 professionals separate from first responders like police and firefighters.

McDonough’s approach to improving the perception of 911 professionals to attract and retain candidates is not uncommon. In June, the Minnesota Department of Public Safety unveiled a new recruiting campaign – “911 Dispatcher: It’s Your Calling” – focusing on the importance of public safety telecommunicators.

“You’re talking to someone as they’re dying, or you’re talking to someone as they’re giving birth,” McDonough said. “These incredible moments bring anxiety and stress, but they’re also really incredibly meaningful.”

Other noticeable improvements include increasing the number of trainees to accommodate for turnover and hiring crisis call takers to handle calls not suited for an armed police response, according to McDonough. On average, she said her call center refers about 1,000 calls monthly to crisis professionals trained in psychology rather than police or fire departments.

What problems remain?

Even under the best of circumstances, these policies take time to work. Denver still has a roughly 27-second wait time, far from the preferred national standard of 15 to 20 seconds set by NENA. Dameron expects an improvement in the wait time once their larger class of new hires, who still need to be fully trained, become cleared for independent work.

Additionally, smaller dispatch centers often need more funding to compete in a competitive labor market or purchase better equipment.

“In the United States, we have haves and have-nots when it comes to funding,” Heinze said about the localized nature of funding for dispatch centers.

While 40% to 60% of departments have the money to deploy next-generation 911 technology — which works better with digital communications like smartphones — poorer departments struggle to work with outdated equipment, according to Heinze.

911 dispatchers and telecommunicators are also classified by the U.S. Bureau of Labor Statistics as clerical or secretarial workers, which limits the mental health and wellness services these workers can obtain, including workers’ compensation, according to Heinze.

“If they experience post-traumatic stress injuries, workman’s comp does not cover 911 professionals because they are not considered part of the protected services classification,” Heinze added.

Copyright © 2023, ABC Audio. All rights reserved.

Women suing Texas over abortion bans give emotional testimony

Women suing Texas over abortion bans give emotional testimony
Women suing Texas over abortion bans give emotional testimony
Witthaya Prasongsin/Getty Images

(AUSTIN, Texas) — Four women and an OB-GYN are expected to testify at hearings on Wednesday and Thursday as part of a lawsuit filed against the state of Texas over its abortion bans.

The women are some of the 15 individuals party to the lawsuit who have alleged that their lives were put at risk due to Texas’ abortion laws, claiming they were denied livesaving emergency care.

Lawyers representing the women are seeking a preliminary injunction on Texas’ abortion laws that would allow for lifesaving abortions. They are asking the court to provide a “remedy applied to patients whose life, health or fertility is at risk from an emergent medical condition,” Molly Duane, a lead attorney at the Center for Reproductive Rights, said during opening statements Wednesday.

“Tens of thousands of Texans have already been denied abortions. By any measure, Texas is in a health care crisis. The only issue in this case, however, is who should be getting abortions, under the medical exception to the abortion ban and two years later, still, no one knows,” Duane said.

“In the words of the state’s own expert, it is ‘the blind leading the blind on the ground,'” Duane said.

Prosecutors appearing on behalf of the state of Texas claimed the suit was due to dissatisfaction with medical care that the plaintiffs received and that they did not approve of Texas laws.

“Plaintiffs simply do not like Texas’ restrictions on abortion,” Cindy Fletcher, a representative for the state in the lawsuit, said.

Plaintiffs testifying at the hearings include Amanda Zurawski, who developed sepsis and nearly died after being refused an abortion when her water broke at 18 weeks; Ashley Brandt, who was forced to leave the state for abortion care after one of the twins she was carrying was diagnosed with a fatal condition; Samantha Casiano, who was forced to carry a nonviable pregnancy to term and give birth to a baby who died four hours later; Dr. Austin Dennard, an OB-GYN who had to travel out of state to receive abortion care for a nonviable pregnancy; and Dr. Damla Karsan, a Houston-based OB-GYN representing her patients.

‘I went from feeling physically OK to shaking uncontrollably’

In her testimony Wednesday, Zurawski said she went into sepsis after doctors said they could not induce labor because her fetus still had a heartbeat. Zurawski said she was told she had an incompetent cervix, premature dilation of her cervix, and would miscarry.

Her water broke later that evening but she did not miscarry until three days later, she said.

“I went from feeling physically OK to shaking uncontrollably. I was freezing cold even though it was 110 degrees out. My teeth were chattering violently. I couldn’t get a sentence out. My husband Josh asked me how I was feeling on a scale from 1 to 10. I didn’t know the difference between 1 and 10 — which one was higher,” Zurawski said.

“[I was] completely devastated. I’d just been given the worst news of my life, and I was terrified because I didn’t know what was going to happen. Again, this was my first pregnancy. I didn’t know what labor would be like, I didn’t know if I would go into labor. I didn’t know if I’d get sick. It was terrifying,” Zurawski said.

She said she suffered two bouts of sepsis and one of her fallopian tubes has since been permanently closed. Zurawski also needed several procedures to remove scar tissue and reconstruct her uterus after it collapsed.

“I felt like I’d been hit by a truck. It felt like the worst flu I had ever had in my life. I was so sore. Every muscle in my body was so sore that I couldn’t sit up without assistance. I couldn’t roll over. I actually lost control of my bowels and soiled the bed multiple times, which was absolutely humiliating,” Zurawski said.

Zurawski said she did not feel comfortable traveling to receive care elsewhere.

“We looked into it briefly but we quickly learned that I would either have to drive at least eight hours to get to a state where they could provide an abortion or we would have to fly and we didn’t feel like that would be safe, especially since the physician had advised that we not be more than 15 to 20 minutes from a hospital,” Zurawski said during her testimony.

Zurawski — who has done three egg retrievals since going into sepsis — said she still wants to have children and is having difficulty getting pregnant due to complications from developing sepsis.

Texas’ abortion bans

The suit alleged that Texas’ abortion bans have denied the plaintiffs and countless other pregnant people necessary and potentially lifesaving medical care because physicians in the state fear liability, according to the suit.

Texas has several abortion laws in place, prohibiting all abortions after six weeks of pregnancy, except in medical emergencies, which the laws do not define. One of the bans — called SB 8 — prohibits abortions after cardiac activity is detected, which kept several plaintiffs from accessing care despite their pregnancies being nonviable, according to the suit.

Under Texas’ bans, it is a second-degree felony to perform or attempt an abortion, punishable by up to life in prison and a fine of up to $10,000. The law also allows private citizens to sue anyone who “aids or abets” an abortion.

The suit is the first to be filed by women impacted by the abortion bans since the U.S. Supreme Court overturned Roe v. Wade last year, ending federal protections for abortion rights.

The lawsuit is filed against the state of Texas, Attorney General Ken Paxton — who was recently impeached — and the Texas Medical Board. A date has not yet been set for a hearing, according to Duane.

Copyright © 2023, ABC Audio. All rights reserved.

Drug overdose deaths involving cocaine and opioids have spiked in last decade, CDC report finds

Drug overdose deaths involving cocaine and opioids have spiked in last decade, CDC report finds
Drug overdose deaths involving cocaine and opioids have spiked in last decade, CDC report finds
Thir Sakdi Phu Cxm / EyeEm/Getty Images

(NEW YORK) — Drug overdose deaths involving both cocaine and opioids have spiked over the last decade, new federal data suggests.

A new report published early Wednesday by the Centers for Disease Control and Prevention looked at mortality data from the National Vital Statistics System between 2011 and 2021.

Results showed that in 2021, 78.6% of drug overdose deaths involving cocaine also involved an opioid. What’s more, the rate of drug overdose deaths involving both cocaine and opioids was 5.9 per 100,000 deaths in 2021, more than seven times the rate in 2011 of 0.8 per 100,000.

Meanwhile, the rate of drug overdose deaths involving cocaine without opioids did not increase much over the study period, going from 0.7 per 100,000 in 2011 to 2.1 per 100,000 in 2021.

“From 2011 through 2021, the rate of overdose deaths involving both cocaine and opioids increased more quickly than overdose deaths that involved cocaine but no opioids,” the authors wrote in the report.

The report found the percentage of deaths involving cocaine and opioids varied by region. The Northeast had the highest percentage at 84.5% while the West had the lowest at 73.4%.

Researchers also looked at overdose deaths in which opioids were involved along with psychostimulants, which includes drugs such as methamphetamines.

They found the rate of drug overdose deaths involving both psychostimulants and opioids increased 22-fold from 0.3 per 100,000 in 2011 to 6.7 in 2021.

For the first half of the 2010s, the rate of overdose deaths from psychostimulants without opioids was higher but, by 2017, it was surpassed by the rate of psychostimulants with opioids.

Similarly, rates were highest in the Northeast with 80.6% of all overdose deaths involving psychostimulants and opioids, and lowest in the West at 57.5%.

Although the report did not discuss which opioids played a role in the overdose deaths, there has been a rise in drugs laced with the synthetic opioid fentanyl.

Fentanyl is a drug between 50 and 100 times stronger than morphine. State departments and the CDC have warned that drugs including prescription pills, cocaine, and heroin are often laced with fentanyl without users’ knowledge.

According to CDC provisional data, a record-high 108,500 people died from drug overdoses in the U.S.

This increase “highlights the need to ensure people most at risk of overdose can access care, as well as the need to expand prevention and response,” the federal health agency wrote on its website.

This includes making sure the opioid reversal drug naloxone is widely available, expanding awareness about treatment of substance use disorders, early intervention and detection of overdose outbreaks.

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