Health

(WASHINGTON) — The U.S. Food and Drug Administration approved the first medication to treat severe frostbite on Wednesday.

Aurlumyn, manufactured by Actelion Pharmaceuticals US, Inc., is an injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.

“This approval provides patients with the first-ever treatment option for severe frostbite,” Dr. Norman Stockbridge, director of the division of cardiology and nephrology in the FDA’s Center for Drug Evaluation and Research, said in a release. “Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.”

Frostbite is an injury that occurs when the skin and the underlying tissues are damaged by cold temperatures. Treatment typically involves placing the skin in warm water or placing blankets over affected skin area.

Frostbite typically occurs in three stages, with the final stage being severe frostbite, which results in numbness and skin that turns hard and black due to skin cells dying. Large blisters will appear on the skin a day or two after cold exposure and skin may be permanently damaged, according to the Cleveland Clinic.

If underlying tissues are frozen and blood flow has stopped, the frostbitten extremity may need to be amputated.

Iloprost is the active ingredient in Aurlumy and is a vasodilator, a type of drug that dilates vessels so blood can flow easily and prevents clotting. It was originally approved in 2004 for the treatment of pulmonary arterial hypertension.

In a controlled trial, researchers examined 47 adults with severe frostbite, all of whom received aspirin by vein and standard of care. They were separated into three groups.

The first group received the drug intravenously for six hours daily for up to six days. The two remaining groups received medications that are unapproved for frostbite. The second group was given those medications with iloprost and the third group without it.

The patients received bone scans seven days after their initial frostbite to predict the need for amputation of at least one finger or toe.

On the seventh day, none of the patients in the first group receiving iloprost alone had bone scans that indicated potentially needing an amputation compared to 19% of patients in group two and 60% of patients in group three.

Additionally, abnormalities in the bone scan were significantly lower in the groups receiving iloprost alone or the iloprost combination.

“Most patients had follow-up information on whether they subsequently underwent at least one finger or toe amputation,” the FDA release said. “The need for amputation was consistent with the bone scan findings.”

During the trial, the most common side effects of Aurlumyn included flushing, headache, nausea, vomiting, dizziness, heart palpations, increased heart rate and low blood pressure.

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(NEW YORK) — COVID-19 patients are at least four times more likely to develop chronic fatigue than someone who has not had the virus, a new federal study published Wednesday suggests.

Researchers from the Centers for Disease Control and Prevention (CDC) looked at electronic health records from the University of Washington of more than 4,500 patients with confirmed COVID-19 between February 2020 and February 2021.

They were followed for a median of 11.4 months and their health data was compared with the data of more than 9,000 non-COVID-19 patients with similar characteristics.

Fatigue developed in 9% of the COVID patients, the team found. Among COVID-19 patients, the rate of new cases of fatigue was 10.2 per 100 person-years and the rate of new cases of chronic fatigue was 1.8 per 100 person-years.

Person-years is a type of measurement that multiplies the number of people in a study and the amount of time each person spends in a study. It is useful for evaluating risk.

Compared with non-COVID-19 patients, those who has tested positive were 68% at risk of fatigue and were 4.3 times more likely to develop chronic fatigue in the follow-up period, the study found.

Fatigue following COVID-19 infection was more common among women, older people and those who had other medical conditions including diabetes, chronic obstructive pulmonary disease and a history of mood disorders.

There was no strong evidence of racial or ethnic differences when it came to developing fatigue after COVID-19 except a slightly lower incidence among Black patients, results also showed.

Additionally, researchers found that patients with COVID-19 who developed fatigue after the infection had far worse outcomes such as hospitalization or death than patients without fatigue.

Among 434 COVID-19 patients in whom fatigue developed, 25.6% were hospitalized more than one time during the follow-up period compared to 13.6% of 4,155 patients without fatigue who were hospitalized.

What’s more, COVID-19 patients with fatigue were at higher risk of dying. During the follow-up period, 5.3% with fatigue died compared to 2.3% of those without fatigue.

“Our data indicate that COVID-19 is associated with a significant increase in new fatigue diagnoses, and physicians should be aware that fatigue might occur or be newly recognized [more than] one year after acute COVID-19,” the authors of the study wrote. “Future study is needed to better understand the possible association between fatigue and clinical outcomes.”

The authors added that the high rates of fatigue “reinforce the need for public health actions to prevent infections, to provide clinical care to those in need, and to find effective treatments for post–acute COVID-19 fatigue.”

The team said it also hopes that increased awareness of fatigue and other long COVID symptoms helps COVID patients seek early care when needed to reduce their risk.

The results build upon those seen in previous reports including a joint U.S.-U.K. study of electronic health records that found 12.8% of patients received a new fatigue diagnosis within six months of COVID-19 infection.

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(NEW YORK) — A pet owner has caught a rare case of the bubonic plague, health officials in central Oregon say, and it’s believed they may have caught it from their cat.

The Deschutes County Health Services confirmed the case of the plague in a local resident last week. The resident was likely “infected by their symptomatic pet cat,” health officials said in a Feb. 7 press release.

“All close contacts of the resident and their pet have been contacted and provided medication to prevent illness,” Dr. Richard Fawcett, Deschutes County health officer, said in the release.

The case is the first example of the bubonic plague in Oregon since 2015, according to the state’s health authority, and plague is “rare” in the state.

Deschutes County Health officials said the case was “fortunately” identified and treated in its early stages, “posing little risk to the community.”

“No additional cases of plague have emerged during the communicable disease investigation,” health officials said in the release.

How does bubonic plague spread?

The plague spreads to humans or animals through a bite from an infected flea or by contact with an animal sick with the disease, according to the Oregon Health Authority.

To prevent the spread of the plague, Deschutes County Health Services urged residents to avoid all contact with rodents and their potential fleas, and to never touch sick, injured or dead rodents.

Residents should also not allow pets to approach sick or dead rodents or explore rodent burrows, county health officials said.

What are symptoms of bubonic plague?

Symptoms of plague usually begin in humans two to eight days after exposure to an infected animal or flea, according to the health authority.

Symptoms may include a sudden onset of fever, nausea, weakness, chills, muscle aches and/or visibly swollen lymph nodes called buboes, the state health authority said.

Is bubonic plague treatable?

The plague is a very serious illness but is treatable with antibiotics, usually taken for seven to 14 days, according to the Centers for Disease Control and Prevention. If left untreated, people can still die from the plague, the CDC says.

The bubonic plague dates back to the Middle Ages, when it killed millions in Europe, before the age of antibiotics. At the time, people didn’t realize the plague was carried by the fleas who lived on rats.

According to the CDC, the plague was first introduced in the United States in 1900 by rat-infested steamships. It is most common in the western U.S.

In August 2020, a California resident tested positive for a case of the plague, marking the first human occurrence of the disease in the state in five years.

The resident in South Lake Tahoe who tested positive for the plague was an avid walker, and officials believed they may have been bitten by an infected flea while walking their dog along the Truckee River Corridor, El Dorado County said in a statement at the time.

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(NEW YORK) — In a special council report released last week, President Joe Biden was described as an “elderly man with a poor memory,” but doctors say it’s impossible to use isolated examples to diagnose a memory problem, as memories can be impacted by more than aging, and memories don’t solely determine a person’s cognitive fitness.

The president has a team of medical professionals from a number of subspecialties including neurology who evaluated him last year and deemed him “fit to successfully execute the duties of the Presidency.”

“There are different variables that have to be taken into account when you try and understand whether a slip up is worrisome or not,” Dr. Leah Croll, board-certified neurologist, and assistant professor of neurology at Temple University, told ABC News.

This report has since sparked criticism of Biden’s memory, to which Biden has responded in an interview that, “my memory is fine.” Adding that the most recent interviews with the special council were also in the immediate aftermath of the Oct. 7 Hamas terror attack in Israel when Biden said he was “in the middle of handling an international crisis.”

ABC News spoke to several doctors in the field of medicine, neurology and psychiatry to understand how memory, aging and executive functioning relate, and they all agree that simply forgetting dates or timelines in the past does not imply anything specific about a person’s level of cognitive fitness, decision-making, judgement or executive functioning.

Doctors say a number of factors influence memory, independent of aging

“There are so many different factors that affect how well your memory and cognition are working in any given moment,” Croll said.

These include things like stress, sleep, hunger, multi-tasking and situational circumstances that can act against someone’s memory, independent of their age.

“When we think about how someone’s memory and cognition function in any given moment, the reality is that they don’t function at a constant level,” Croll said. “They’re always changing and fluctuating depending on what factors or variables are on board at that time.”

Dr. Louise Aronson, board-certified geriatrician, and professor of medicine at UCSF, told ABC News that internal processing functions like recalling specific memories naturally decline to an extent with age but can also be impaired by high-pressure situations.

Dr. Yalda Safai, a board-certified psychiatrist, told ABC News that memory lapses are different that memory problems and even in cases where memory problems exist, this cannot be used alone to determine cognitive fitness.

“Just because somebody has problems remembering things from the past, it doesn’t mean they don’t have the ability to make good decisions or it doesn’t mean that their executive function is impaired with aging,” Safai said.

Memory and cognitive evaluation require more extensive assessments

Doctors say isolated examples of memory lapses can’t replace more in-depth assessments of memory and cognitive functioning, and it’s more than just one assessment at one point in time and there is no one test to determine if a person is fit to hold office.

“If we could [just use isolated examples] we wouldn’t need the detailed neurocognitive testing,” Aronson said.

These assessments are extensive, may take multiple visits to fully complete and require a detailed history to fully understand and assess someone’s level of function.

Dr. Richard Isaacson, a preventive neurologist at the Institute of Neurodegenerative Diseases Florida, told ABC News, “it’s impossible to accurately judge whether a brain change may be due to the normal aging process versus compared to a neurodegenerative disease or just due to a disease without a formal evaluation, examination, cognitive assessments, and when needed, brain imaging.”

In these assessments, doctors are evaluating for any warning signs that show patterns of behavior or memory lapses that prevent them from carrying out their daily responsibilities.

“Things like being unable to do your finances and stay on top of your monthly bills or consistently having a pattern of memory problems that pose safety concerns,” Croll said.

Doctors say there are some cognitive benefits of aging

“When people are younger, [in their] 20s and 30s, they often have worse impulse control and ability to integrate information,” Aronson said.

Doctors say as people age, impulse control tends to improve, and they may better integrate more information into their decision-making.

“As we age, there are aspects of cognitive function, specifically related to judgment and wisdom that actually improve over time. And you know, when a person is seasoned and has experience dealing with complex problems, that experience may come in handy when either dealing under pressure or having to make a decision,” Isaacson said.

“These [traits] can manifest as having a better handle on your reactions to various situations and being able to think before you act which can be extremely useful as we get older,” Croll said. “Having wisdom from many lived experiences, of course, is another form of knowledge and cognitive fitness.”

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(NEW YORK) — An Alaska resident has died from complications of a relatively new and rare virus known as Alaskapox, according to a bulletin posted by Alaska state public health officials.  

The Alaskapox virus was first identified in Fairbanks, Alaska, in 2015, according to the Alaska Department of Health. Since then, there have been only seven cases reported in the state, according to the state health department.

This is the first case of an Alaskapox infection resulting in hospitalization and death ever reported. State public health officials noted the patient was an elderly man who was immunocompromised, putting him at higher risk for severe illness.

“Alaskapox remains rare,” Dr. Joe McLaughlin, state epidemiologist and chief of the Alaska Division of Public Health Section of Epidemiology, told ABC News. “For the vast majority of people who may come in contact with this virus, the clinical course will likely be mild.”

The virus typically occurs in small animals, commonly identified in voles and shrews, according to the Alaska State Department of Health. There have been no reports of human-to-human spread, according to the state health agency.

“There’s no evidence so far [of] person-to-person transmission for the cases that have been identified,” Julia Rogers, Ph.D., epidemic intelligence service officer at the Centers for Disease Control and Prevention embedded with the Alaska Department of Health, told ABC News.

“Given the rarity of Alaskapox and its generally mild course in healthy individuals, the risk to the general public remains low,” said John Brownstein, Ph.D., chief innovation officer at Boston Children’s Hospital and an ABC News medical contributor.

It remains unclear how the deceased resident was infected with the virus. They lived alone in a forested area and reported caring for a stray cat, which later tested negative for the virus, according to the state’s bulletin, issued Friday.

“It could be that the cat was catching voles or shrews and eating them and then have viable virus in its claws, and that was the route of [infection], through a scratch,” McLaughlin said.

Over a span of six weeks, the patient had visited his doctor and local emergency room for a lesion and was prescribed antibiotic drugs, according to the bulletin. Eventually, as his situation deteriorated, he was hospitalized, where doctors sent in tests to the CDC, according to state health officials, which eventually identified the viral infection as Alaskapox. He succumbed to the virus a few weeks later, state health officials said.

“The most recent [fatal] case was in an elderly man that was immunocompromised, so his immune system was already not going to be able to handle infection,” Rogers said.

Public health officials in Alaska are recommending doctors become familiar with the signs and symptoms of the virus and consider testing for patients they may suspect contracted the illness.

What to look for

If patients develop lesions, they should avoid touching them and keep them dry and covered, while practicing good hand hygiene and avoid sharing cloth and linen with others, according to the state health department.

Those in regular contact with wildlife may need to take extra precautions, officials said.

“There’s lots of things that you can pick up from wildlife animals, and just try to take the best precautions you can and be safe and hygienic with contact with them,” Rogers said.

Alaska public health officials hope awareness of the relatively new virus will allow for potential future cases to be identified easier.

“What we’re expecting is that over time, as more clinicians become not only aware that Alaskapox virus is out there, but also aware of what to look for and how to actually test for it, that we are going to see more Alaskapox diagnoses in the months and years ahead,” McLaughlin said.

“The recent unfortunate death of an immunocompromised individual underscores the potential severity of Alaskapox in vulnerable populations, highlighting the critical need for heightened awareness and diagnostic readiness among health care providers,” Brownstein said.

“This case emphasizes the importance of monitoring wildlife diseases and their potential to impact human health, especially as human activities increasingly encroach on natural habitats,” Brownstein added.

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(WASHINGTON) — Two of the studies cited in a ruling that suspended federal approval of the abortion pill mifepristone were retracted by a medical journal earlier this week.

Sage Publishing said it issued the retractions from the journal Health Services Research and Managerial Epidemiology because of methodology issues and conflicts of interest. The Supreme Court is hearing oral arguments in March on the case — about access to mifepristone, the drug used in medication abortions — which cited the studies.

Medicated abortions account for about half of all abortions, according to according to Guttmacher Institute, an organization committed to advancing reproductive rights.

U.S. District Judge Matthew Kacsmaryk cited these now-retracted studies in his decision to suspend the Food and Drug Administration’s authorization of mifepristone. A federal appeals court overturned parts of the ruling, only keeping restrictions that prohibit patients from receiving the pill in the mail.

Kacsmaryk primarily cited one of the studies from 2021 to justify that anti-abortion rights medical groups and physicians had a right to bring their case to the court. In his order, he wrote that they have that right because “they allege” that the effects of “chemical abortion drugs” can put a lot of pressure on doctors during complications and emergencies. Along with some other key findings, the cited study alleged that “chemical abortion significantly increased the risk of an emergency room visit.”

A 2022 study that Kacsmaryk also used in his order is based on the same dataset as the 2021 study and has most of the same authors. It analyzes the increased risks of concealed medical abortion during an emergency room visit. The judge used the study to illustrate what he argued were the dangerous side effects of the approved drug.

Both studies analyzed Medicaid data that tracked patients’ emergency room visits 30 days after having an abortion.

The FDA has said that “mifepristone is safe when used as indicated and directed.”

Alliance Defending Freedom, a Christian conservative legal advocacy group working to outlaw abortion, filed the initial lawsuit that Kacsmaryk ruled on. Its legal counsel said the group isn’t concerned about the retractions’ impact on the case.

“ADF has never relied on these studies for the issues that are currently before the Supreme Court,” ADF Senior Counsel Erik Baptist said to ABC News in an email. “So this will not have any impact on the court’s consideration.”

Mary Ziegler, University of California, Davis law professor and expert on law, history and politics of reproduction, said the study retractions likely won’t impact the case headed before the Supreme Court next month.

“I don’t think the fact that it was retracted would necessarily even change the justices’ reasoning,” she said.

There’s already been suspicion in some parts of the court about the academic data and reasoning, Ziegler said.

“This is likely to be sort of a non-story for the justices and for Judge Kacsmaryk, because it’s sort of baked in for a lot of people that there’s going to be differing perception of fact,” she said.

Sage referred to “fundamental problems” with the methodology, errors in the analysis of the data and “misleading presentations of the data,” that served as the basis for the retractions. The publisher noted in the retraction notice that those findings “invalidate the authors’ conclusions in whole or in part.”

In addition to those issues, Sage found that most of the authors, including principal author James Studnicki, were affiliated with Charlotte Lozier Institute, an anti-abortion rights advocacy organization. The initial peer reviewer was also affiliated with the same institute. These conflicts of interest were not disclosed when the study was first released, according to Sage’s notice.

In an email statement to ABC News, Studnicki, vice president and director of data analytics at Lozier Institute, said they “fully complied with Sage’s conflict disclosure requirements” and didn’t withhold any information they were required to share.

He added that Sage hasn’t required authors from pro-abortion rights organizations, including the Guttmacher Institute, to report their employment affiliations as conflicts of interest.

Journal “editors rely on the authors to self-declare” their potential conflict of interest, a Sage spokesperson told ABC News in an email. “If a reader inquires about an author’s potential conflict of interest in a published article,” Sage conducts an investigation to look into those concerns, which is what happened in this case, according to the retraction notice.

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(NEW YORK) — Brooklyn-based boxing instructor Nancy Chen said her Apple Watch was able to hone in on the effectiveness of her workouts.

But it wasn’t until her watch broke that she said she realized it ended up exacerbating some unhealthy behaviors.

“I really struggled with disordered eating, pretty much like off and on throughout college,” Chen told ABC News. “I realized that after like three months of not wearing [the watch], it really helped confirm that I was like moving past my eating disorder.”

Chen’s experience is not uncommon among the users of those devices, according to medical experts who point to some of the potential downsides posed by relying on the devices and data.

“There is a drawback for some, and we see this is more common in individuals that really seek perfection in a lot of aspects of our lives,” Dr. Rebecca Robbins assistant professor of medicine at Harvard Medical School, told ABC News.

Many users may experience benefits from knowing their fitness levels, sleep quality, and other general health metrics.

In August 2021, Christopher Oakley, a professor at University of North Carolina at Asheville, said readings from his Apple Watch were able to convince skeptical doctors that he was having a heart attack even though it appeared his heart had calmed down between the time he left his home and got to the hospital, according to ABC affiliate WLOS.

Apple did not provide a comment to ABC News when asked about its devices.

The company’s website said the Apple ECG app can not detect cannot detect a heart attack, blood clots, strokes or other heart conditions and users should consult emergency services or a medical professional if they are not feeling well.

While some of the tech companies behind the devices said their goal is to help their users have the best information about their workout they said they have been working to create a better balance.

“Being able to have visibility into what your body is doing and how your health is going. I think that’s only good,” Shelton Yuen, the director of research at Fitbit, told ABC News.

Sarah Madaus of Brooklyn told ABC News she first started tracking her workouts and health with a Fitbit.

“For a while, it made me feel successful because I was like looking at my weekly stats and it was like, ‘Look that you crushed it,'” she said.

She later asked her parents for an Apple Watch which she now admits became a “chokehold” for her.

“It’d be like, ‘Oh, you didn’t close your rings today.’ And I’m like, ‘You better hustle. Sorry, guys can’t come to the party, can’t go to dinner,'” Madaus said.

A 2017 study of college students published in the medical journal “Eating Behaviors” found that using a fitness tracker is linked with a higher rate of eating disorder symptoms in some, but didn’t necessarily cause the behaviors.

Anxiety around wearables isn’t limited to food, according to studies.

In one case study, one woman who was diagnosed with atrial fibrillation developed health anxiety after she ran nearly 1,000 ECG recordings through her smartwatch.

“When you’re bombarded with all of this constant information about your heart, your sleep, your weight, your fitness level, all of this stuff… I think a lot of times of trouble comes from we’re putting a lot of that understanding or expectation for understanding on the individual,” Dr. Tom Hildebrant, an associate professor of psychiatry Ichan School of Medicine, told ABC News.

Some tech companies are taking different approaches to the trackers.

The Oura Ring sits on a user’s finger and doesn’t have a screen that displays their workout and health information. Users can check the data on their phone or computer.

Shyamal Patel, the head of science for Oura Ring, told ABC News that his company’s devices and apps are made with user control in mind.

“You want to calibrate your activity goals or you can actually turn off calorie tracking,” he said.

Yuen also told ABC News that Fitbit devices also allow users to stop tracking certain metrics.

“We try to meet our users where they are so that we can help them establish and meet the goals that they care about,” he said.

Hildebrant said that if anyone is feeling too overwhelmed by the trackers and apps they should stop using them for one or two weeks and see how they feel mentally and physically.

Chen and Madaus told ABC News that they were able to have better workouts once they stopped using their Apple Watches.

“I think I was able to really focus on the workout and be very private,” Chen said,

“It’s really like you can focus so much more on the mind-muscle connection to and like how you’re actively feeling,” Madaus said.

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(NEW YORK) — Most weight loss drugs were linked to a lower likelihood of depression and anxiety diagnoses, according to research published by Epic Research.

The researchers looked at over three million diabetic patients and nearly one million non-diabetic patients taking GLP-1 medications, which is the class of drugs representing popular name brands such as Ozempic, Wegovy, Zepbound, and Mounjaro in the study that was published Tuesday.

Semaglutide is the active ingredient found in Ozempic, which is used for type 2 diabetes, and Wegovy, which is used for weight loss.

Diabetic patients taking Semaglutide were 45% less likely to be diagnosed with depression and 44% less likely to be diagnosed with anxiety, according to the study.

Tirzepatide is the active ingredient found in Mounjaro, which is used for type 2 diabetes, and Zepbound, which is used for weight loss.

Diabetic patients taking Tirzepatide were 65% less likely to be diagnosed with depression and 60% less likely to be diagnosed with anxiety, according to the study.

The drugs approved to treat type 2 diabetes may be prescribed “off-label” for weight loss.

“These results show that these medications may serve a dual purpose for patients, but we do not understand them well enough yet to say these medications should be given as a treatment for anxiety or depression outside of diabetes or weight management,” researcher Kersten Bartelt told ABC News.

These results come weeks after a preliminary review by the Food and Drug Administration (FDA) that found no evidence linking weight loss drugs to suicidal thoughts.

The study used electronic patient records, meaning patients needed to be diagnosed with anxiety and/or depression — which may exclude those that had symptoms of the mental conditions but never received a diagnosis.

It remains unclear if the lower diagnoses of depression and anxiety were a direct result of the medications, weight loss in general, or a potential combination of both.

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(NEW YORK) — National shortage of over-the-counter and prescription drugs for health issues such as asthma, ADHD or cancer have been troubling patients and medical personnel for more than a year — and at a hearing this week, lawmakers and experts discussed the threats that patients face without having access to the drugs they need.

At the House Ways and Means Committee hearing earlier this week, expert witnesses — practitioners, researchers and pharmaceutical company executives — spoke about the pressing issue the shortages pose to patients’ lives and health and possible ways the Congress can tackle it.

“We could have patients — cancer patients or pediatric patients, or other patients — without the drugs they need,” Stephen Schondelmeyer, director of the PRIME Institute at the University of Minnesota’s College of Pharmacy, said at the hearing.

Shortages of some drugs have been an ongoing problem in the U.S. for more than a decade and were recently exacerbated by COVID-19, according to a report by the Senate Homeland Security Committee in March. Lack of necessary medication means patients have to get delayed treatments, substitutions or sometimes no treatment at all, the report found.

The shortage can hurt patients financially as well, Schondelmeyer said, as they have to turn to alternate products that can cost more.

There are more than 250 active pharmaceutical shortages as of early February, according to the American Society of Health-System Pharmacists. The state of chemotherapy and hormonal drug shortages were characterized as the most severe shortages in 2023.

Patients in the rural areas may experience even more difficulty with drug access, Tennessee Oncology Chief Medical Officer Dr. Stephen Schleicher said at the hearing. In remote regions it’s harder to find substitutions or reliable distributors, he added.

Overdependence on international suppliers — such as India and China — came up as a frequent cause of the shortages. Supplying raw materials and active pharmaceutical ingredients from other countries can be geopolitically risky, experts said.

Rep. Brad Wenstrup, R-Ohio, said the drug shortages are a national security concern.

“These drug shortages, these vulnerabilities in our supply chain, they put our national security at risk,” Wenstrup said. “They put our national health security at risk.”

The U.S. depends on foreign providers for some of the active pharmaceutical ingredients necessary to give medications their desire effect. Almost half of pharmaceutical products consumed in the U.S. come from India and China, Schondelmeyer said in his testimony.

“The U.S. has raw, raw materials, carbon and oxygen, and chemicals,” he said “But we don’t have a lot of the formulated ingredients to make the drugs that we have.”

While the number of U.S. production facilities has dropped by half in the past decade, the numbers of those plants in China, India, Israel and Taiwan have been growing.

India and China have been favorable for drug production because of low labor and production costs, Schondelmeyer said. They also have fewer environmental regulations that allow toxic pharmaceutical pollution — including explosive chemicals — caused by manufacturing, added Rep. David Schweikert, R-Ariz.

“We almost don’t have a disposal mechanism from the toxic byproducts,” he said. “And [manufacturers] produce some really nasty stuff.”

Another risk with supplying the materials from Asia is lack of U.S. supervision. The FDA, which has the authority to conduct inspections on U.S. production sites, has to jump through several hoops to inspect international suppliers’ sites, said Jeromie Ballreich, associate research professor at Johns Hopkins Bloomberg School of Public Health.

The limited regulation brings up quality issues, Schondelmeyer said, citing the recent incident where contaminated eye drops manufactured in India led to deaths, blindness and several people who had to have their eyeballs surgically removed.

“If [the FDA] is not in those labs in China — and especially since the pandemic — it is a problem,” Wenstrup said.

There’s also an issue with transparency: how much each manufacturing plant contributes to the production, said Dr. Julie Gralow of the American Society of Clinical Oncology. Without knowing how much raw material each manufacturer provides for production of a certain drug, it becomes hard to predict how an issue at one facility can impact drug availability, Gralow said.

Schondelmeyer likened it to relying on enemies in wartime.

“We don’t rely on other countries to make bullets … when we fight wars, especially our sworn enemies,” he said. “We want to make sure that the drugs we need to keep our public and our military healthy are coming from sources that we have control of.”

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(WASHINGTON) — The Environmental Protection Agency announced a new rule on Wednesday to significantly reduce the level of air pollution known as particulate matter (PM) by updating the national air-quality standards, citing negative health impacts of PM exposure.

While the rule is being praised by environmental and health groups, some industry groups have signaled that it could pose a political challenge for President Joe Biden this year as they claim it will hamper American manufacturing and eliminate jobs.

“Today’s action is a critical step forward that will better protect workers, families and communities from the dangerous and costly impacts of fine particle pollution,” EPA Administrator Michael Regan told reporters.

“The science is clear, soot pollution is one of the most dangerous forms of air pollution and it’s linked to a range of serious and potentially deadly illnesses, including asthma and heart attacks,” he said.

Particulate matter is made up of microscopic solid particles such as dirt, soot or smoke and liquid droplets in the air that are small enough to be inhaled. Those small particles can get into the lungs or bloodstream and contribute to health problems like asthma, respiratory symptoms, heart attacks, or premature death in people with heart or lung problems, according to the EPA.

This type of pollution comes from a variety of sources including power plants, cars, and construction sites. Wildfire smoke is also a significant source of particulate matter pollution.

“We know that particulate matter in the outside air leads to death. It kills people,” Patrice Simms, vice president of litigation for healthy communities at Earthjustice, told ABC News.

“And often that is a product of triggering heart attack, cardiopulmonary events or triggering asthma attacks that are fatal,” Simms said.

Regan said the updated standard will prevent up to 4,500 premature deaths and 290,000 lost workdays in the year 2032. On that same timeline, Biden administration officials also say the new standard will yield up to $46 billion in net health benefits.

“The impact of this pollution oftentimes disproportionately affects our most vulnerable communities, including low-income communities, communities of color, children, older adults and those who struggle with heart or lung conditions,” Regan said.

“Each one of these events — whether it’s someone’s death or hospitalization or heart attack or asthma attack — are traumatic experiences for the individuals,” Simms said. “They can be traumatic experiences for families and destabilizing for both families and communities.”

“There are both things that you can calculate numerically about what are the impacts [of PM pollution] and how many deaths and how many hospitalizations, but there also are really important kinds of impacts that are hard to quantify,” he added.

The previous annual standard for particulate matter was 12 micrograms per cubic meter of air. Under this new rule, the EPA is lowering the annual standard to 9 micrograms per cubic meter.

The updated rules do not revise the 24-hour standard which is meant to account for short-term spikes in pollution. That will remain at 35 micrograms per cubic meter.

President and CEO of the American Lung Association Harold Wimmer called the update “a step forward for public health,” but noted that the standards fall short of what his organization and others called for.

“While the stronger annual particle pollution standard will mean fewer asthma attacks, heart attacks, strokes and deaths, it is disappointing that EPA did not follow the strong science-based recommendations of the Clean Air Scientific Advisory Committee and the health community to also revise the 24-hour standard to more fully protect public health,” Wimmer added.

Industry groups like the American Forest & Paper Association, American Wood Council and the group’s member company CEOs sent a letter to the White House in October expressing their opposition to the now finalized rule, saying the move, “threatens U.S. competitiveness and modernization projects in the U.S. paper and wood products industry and in other manufacturing sectors across our country.”

“This would severely undermine President Biden’s promise to grow and reshore U.S. manufacturing jobs, and ultimately make American manufacturing less competitive,” the letter said. “It also would harm an industry that has been recognized as an important contributor to achieving the Administration’s carbon reduction goals, including in future procurement for federal buildings.”

Simms, who has worked in this space for 25 years, told ABC News these industry outcries aren’t new.

“I’ve been doing this work for 25 years in a variety of different capacities,” Simms said. “And I can say that every time that an agency like EPA has taken steps to protect people and to reduce pollution, I see this same playbook start to get utilized, which is ‘the sky is falling.’ ‘If we protect people this way, we’re going to destroy business and we’re going to undermine the economy.’ And there’s really good data to show that that’s just not true.”

“We do not have to sacrifice people to have a prosperous and booming economy,” Regan said.

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