Tag: experimentation and research

FDA advisers narrowly vote in favor of experimental gene therapy for rare muscle disease | CNN

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CNN
 — 

Most parents wouldn’t be thrilled with the idea of their kids getting hooked up to an IV bag filled with trillions of viruses.

But for Melanie Hennick, whose son, Connor, has Duchenne muscular dystrophy, it was an opportunity she hoped would change his life.

“We knew this wasn’t a cure,” Hennick said. “But it was a chance.”

Connor is one of just dozens of kids to have received SRP-9001, an experimental gene therapy that aims to slow or stop the progression of Duchenne muscular dystrophy, or DMD. Current treatments for the disease – which primarily affects boys because of the way it’s inherited – include steroids and, later, heart drugs. But none stop it.

SRP-9001 uses viruses to ferry a copy of a gene to muscles to help make up for one that’s causing the disease. Hennick and many other parents like her advocated for the treatment’s accelerated approval Friday in a meeting of outside advisers to the US Food and Drug Administration.

The advisers voted 8-6 in favor of approving the treatment, and the FDA will now decide whether to follow their advice.

“The decision the FDA has to make doesn’t just affect the patients in study 301 [an ongoing confirmatory trial that Sarepta is running]; it affects the entire field of drug development for Duchenne,” said Dr. Caleb Alexander, a professor of epidemiology and medicine in the Bloomberg School of Public Health at Johns Hopkins University, who voted against recommending approval. “The totality of evidence … simply doesn’t rise to the threshold that’s required for accelerated approval.”

Dr. Raymond Roos, a neurology professor at the University of Chicago Medical Center, voted in favor. “The downside of the gene therapy here is relatively small compared to whether it really helps the patient, and for this reason, I voted yes,” he said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said his agency will take the recommendation and “do something that we have to do every day at FDA. … We have to manage through the uncertainty here.”

The FDA’s decision, expected by the end of the month, will have implications not just for families like Connor’s but for how the agency regulateths treatments like this one more broadly: It would be the first of its kind of medicine – one-time treatments delivering a gene to try to fix a disease – to get accelerated approval, a faster track through the regulatory process. Its approval would set a precedent for other drugs like this based on so-called surrogate endpoints, a measure of what the drug does in the body, before further clinical evidence is available.

“Approval of a gene therapy for Duchenne muscular dystrophy will be huge,” said Jeffrey Chamberlain, a professor at the University of Washington School of Medicine who helped pioneer gene therapy approaches for the disease. “This, I think, will spur further research and further development of gene therapies for other diseases.”

DMD patients don’t have a lot of time to wait. Kids with Duchenne typically lose the ability to walk before they’re teenagers and often don’t live well into their 30s, Chamberlain said. He’s not directly involved with SRP-9001, which is being developed by Sarepta Therapeutics, and is on the scientific advisory board for another company working on DMD gene therapies, Solid Biosciences.

“Gene therapy appears to be a really good approach to try to treat this disease, because it’s a genetic disease,” Chamberlain said. “The cause of the disease is a mutation in a single gene.”

That gene is responsible for the production of dystrophin, a protein key to the structure of muscle cells.

“It’s kind of like the two-by-fours that make up your house,” Chamberlain said. “It’s really important for just holding everything together.”

SRP-9001, invented at Nationwide Children’s Hospital in Columbus, Ohio, before being licensed for development by Sarepta, delivers a miniaturized version of the dystrophin gene to cells, aiming to help them make a version of the muscle-preserving protein.

In a key clinical trial, the therapy appeared to do that. But it didn’t meet another main goal: showing a benefit on a measure of muscle function, complicating SRP-9001’s path through the FDA.

Sarepta blamed the outcome on an imbalance in how the trial separated patients into the placebo and treatment groups. But key FDA reviewers appear unconvinced.

“The clinical studies conducted to date do not provide unambiguous evidence that SRP-9001 is likely beneficial for ambulatory patients with DMD,” agency reviewers wrote in briefing documents released ahead of Friday’s meeting, referring to patients who can still walk – the group who will initially be eligible for the treatment if it gets approved.

Family after family who participated in Sarepta’s trials, like the Hennicks, disagree with the reviewers. They say they believe that the treatment has helped keep their kids walking and running in ways they never would have without it.

“It’s really miraculous,” said Nate Plasman, whose son Andrew got SRP-9001 as part of the trial in January 2019, at age 4.

Sara, left, Andrew and Nate Plasman on the day he was dosed in the trial in January 2019.

Andrew was away from school for more than two months when he got the experimental therapy, Plasman said, and when he returned, “his teachers at the preschool were blown away,” he recalled. “They’re like, ‘Who is this kid?’ He’s running. He’s jumping. He’s pedaling the tricycle. He’s getting up and down off the ground” – all things he couldn’t do as well before the therapy.

Marit Sivertson, mom to 9-year-old Brecken, agrees.

“We’ve seen the incredible changes with our son,” she said. “He’s not just walking around. He’s running; he’s swimming; he’s diving. He’s truly living the life that every 9-year-old boy ought to be living.”

Dr. Jerry Mendell of Nationwide Children's Hospital in Ohio, who developed the gene therapy, left, with Brecken Kinney.

Sivertson and Plasman also spoke at Friday’s meeting. Their goal isn’t to secure the therapy for their own kids; because it’s designed as a one-time treatment, they wouldn’t take it again. They say they’re speaking up on behalf of children who are still waiting.

That wait is especially painful for Daniel and Lindsey Flessner, who have two sons with DMD. Their 5-year-old son, Mason, is in the SRP-9001 clinical trial. Their 2-year-old, Dawson, is still too young.

“With every trip, every fall, every time he stands up by walking up his legs using his hands to help stabilize him, it just keeps chipping away at us,” Flessner said. “It’s very painful as the parents watching your children struggling knowing all you can do is wait, when waiting is what you don’t have time for.”

Lindsey and Daniel Flessner's sons, Mason and Dawson, both have DMD.

In addition to questions about how well the treatment works, the FDA reviewers raised concerns about safety, particularly “related to the possibility of administering an ineffective gene therapy.”

The reviewers focused on opportunity cost: Because of the viruses used to deliver the gene, patients can develop an immune response that could render future doses ineffective.

Chamberlain said work is underway to find ways to be able to administer more doses, if needed, but it’s currently a one-and-done treatment.

For now, he thinks this approach is the best hope for DMD patients.

“It’s not perfect,” he acknowledged. “It’s not a complete cure, but from what I can gauge from the clinical results that have been released by Sarepta and some of the other companies, I think the micro-dystrophin gene therapy is working better than any other drug that’s been tried for Duchenne muscular dystrophy.”

It’s unclear how long the effects will last; Sarepta is continuing trials, and a confirmatory study would be required as part of accelerated approval. Sarepta has proposed a trial that it’s already running to satisfy that requirement, with results expected later this year.

For families facing DMD, there’s an opportunity cost to waiting, too. In its briefing documents for the FDA meeting, Sarepta estimated that accelerated approval would speed up broad access to SRP-9001 by at least a year, a time in which about 400 boys could lose the ability to walk and another 400, whose disease is more advanced, would die.

Melanie Hennick said Connor was admitted to the trial just weeks before he’d have aged out, at 8 years old. She said she believes the therapy is the reason Connor’s doing so well.

“We had the opportunity to see Connor grow as an 8-, 9-, 10-, 11- and 12-year-old with more capacity than we ever dreamed,” she said. “He climbs stairs unaided; he runs around; he plays football; he plays hockey; he plays on a baseball team. … Those are things that we never thought we would be able to see him do, especially at 12.”

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Covid-sniffing dogs can help detect infections in K-12 schools, new study suggests | CNN

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CNN
 — 

Elementary students lined up behind a white curtain in the middle of a grand gymnasium at their school in northern California. They stood still as a dog handler walked a yellow Labrador along the other side of the curtain.

Hidden from the children’s view, the 2-year-old female pup sniffed each child’s shoes from beneath that curtain barrier. After each sniff, the dog looked back up at the handler. Then the handler brought the dog to the next tiny pair of feet beneath the curtain, and the dog curiously brought her snout close to those toes, then a young girl’s lavender tennis shoes and then another child’s white high-tops.

The dog was smelling for what are called volatile organic compounds that are known to be associated with Covid-19 infections.

While watching the Covid-sniffing dog in action, Dr. Carol Glaser saw her vision come to life.

Months prior, Glaser and her team were implementing the school’s Covid-19 testing program, using antigen nasal swab tests. Around that same time, Glaser heard about reports of dogs being used to screen for Covid-19 infections in sports venues, airports and other public settings.

That’s when Glaser had her “aha” moment – incorporating canines into Covid-19 testing programs at schools, nursing homes or other public facilities could help save time, personnel, possibly even costs, and “would be a lot more fun,” she said.

“I thought if we had dogs in schools to screen the students it would be so much faster and less burdensome for schools,” said Glaser, assistant deputy director in Central Laboratory Services and medical officer for infectious disease laboratories at the California Department of Public Health.

“Remember when an antigen test is done at school, as opposed to home, there’s a whole bunch of rules and regulations that run under that. It’s not as simple as just handing those things out at school and having the kids do them,” said Glaser, who oversaw antigen testing programs at some California public schools.

For now, Glaser and her colleagues described in a new study the lessons they learned from the Covid-19 dog screening pilot program that they launched in some California K-12 public schools.

In their research, published Monday in the journal JAMA Pediatrics, they wrote that the goal was to use dogs for screening and only use antigen tests on people whom the dogs screened as positive – ultimately reducing the volume of antigen tests performed by about 85%.

They wrote that their study supports the “use of dogs for efficient and noninvasive” Covid-19 screening and “could be used for other pathogens.”

The dogs used in the pilot program – two yellow Labradors named Rizzo and Scarlett – trained for a couple of months in a laboratory, sniffing donated socks that were worn by people who either had Covid-19 or didn’t. The dogs alerted their handlers when they detected socks that had traces of the disease – and received a reward of either Cheerios or liver treats.

“The one thing we do know for sure is when you’re collecting a sample off of a human being, you want to go where the most scent is produced. That is the head, the pits, the groin and the feet. Given those options, I went with feet,” said Carol Edwards, an author of the study and executive director of the nonprofit Early Alert Canines, which trains medical alert service dogs, including Rizzo and Scarlett.

“We collected some socks from people willing to donate socks, and we taught the dogs, by smelling the socks, which ones were the Covid socks and they picked it up very quickly,” Edwards said. “Then we moved into the schools and started sniffing the kids at the ankles.”

Last year, from April to May, the dogs visited 27 schools across California to screen for Covid-19 in the real world. They completed more than 3,500 screenings.

Rizzo acted as an energized worker, performing tasks with eagerness, Edwards said, while Scarlett tended to have more of a mellow and easygoing personality.

The screening process involves people – who voluntarily opted in to participate – standing 6 feet apart while the dogs, led by handlers, sniff each person’s ankles and feet. The dogs are trained to sit as a way of alerting their handlers that they detect a potential Covid-19 infection.

To protect each person’s privacy, sometimes the people face away from the dogs and toward a wall or behind a curtain, so that they can’t see the dogs or when a dog sits. If the dog sits in between two people, the handler will verbally ask the dog, “Show me?” And the dog will move its snout to point toward the correct person.

“Our dogs can come in, they can screen 100 kids in a half hour, and then only the ones the dog alerts on have to actually do a test,” Edwards said. “There’s no invasive nasal swab unless the dog happens to indicate on you.”

The researchers found that the dogs accurately alerted their handlers to 85 infections and ruled out 3,411 infections, resulting in an overall accuracy of 90%.

However, the dogs inaccurately alerted their handlers to infections in 383 instances and missed 18 infections, which means the dogs demonstrated 83% sensitivity and 90% specificity when it came to detecting Covid-19 infections in the study.

“Once we stepped into the schools, we saw a drop in their specificity and sensitivity due to the change,” Edwards said, referring to the distractions that children in a school setting can bring. However, Edward said, accuracy improved as the dogs spent more times in schools.

In comparison, Covid-19 BinaxNOW antigen tests have been shown in one real-world study to demonstrate 93.3% sensitivity and 99.9% specificity. That study was conducted in San Francisco and published in 2021 in The Journal of Infectious Diseases.

“We never said the dogs will replace the antigen. This was a time for us to learn how they compared,” Glaser said. “We will always plan on doing some amount of backup testing, but the idea would be that the actual antigen testing would be a fraction of what it would currently be because of the dogs.”

“To run these antigen testing programs at school, it’s taking a lot of school personnel resources, test cards as well as biohazard waste. So, I have no doubt in the long-run once it can be perfected, dogs will be cheaper, but I don’t have a great cost comparison,” she said.

This isn’t the first time that dogs’ abilities to detect traces of Covid-19 infections in real-time have been studied in the scientific literature.

“What we have learned in this work is that the dogs in general are capable of discriminating samples from individuals testing,” said Dr. Cindy Otto, professor and director of the Penn Vet Working Dog Center at the University of Pennsylvania, who was not involved in the new study.

Regarding the new research, Otto said, “On the surface their results are encouraging and with the appropriate selection of dogs, rigorous training and impeccable quality control, there is the potential for dogs to be incorporated in threat monitoring.”

Now that Glaser and her colleagues have published research about their Covid-19 dog screening pilot program, she is eager to implement the approach in nursing home settings.

“Honestly, schools aren’t that interested in testing anymore. The outbreaks just aren’t what they used to be, but what we have done is we’ve transitioned to nursing homes, because there is a tremendous need in nursing homes,” Glaser said, adding that many residents may prefer to undergo screening with a dog than with uncomfortable nasal swabs. “What would you rather have: A swab in your nose or something that just maybe tickles your ankle at most for testing?”

Covid-sniffing dogs Scarlett and Rizzo at a skilled nursing home in California.

In skilled nursing homes, the dogs visit each resident’s room to sniff their feet, calmly smelling for Covid-19 volatile organic compounds as the resident lies in bed or sits in a chair.

“Thinking about where dogs would be deployed, I do really think nursing homes and residential care facilities and even schools – if they were ever to have a big outbreak – would be the natural next fit for this,” Glaser said.

“We think we’ll probably end up primarily using them in nursing homes,” she said. “But we’re still doing a little bit of both – there was a school that asked us to come back last week.”

The pilot program within California public schools also has left Edwards with hope for future opportunities in which canines can help detect disease in humans.

“I really do think it’s the tip of the iceberg. This is the door swinging wide open, and now we need to collaborate with those in the science world and figure out where we can take this,” Edwards said.

“There’s been a lot of chatter, even in the very beginning of this project, talking about what other diseases they could do. We’ve talked about TB, we’ve talked about flu A and B, possibly for this next flu season, seeing if we can get the dogs to alert on that,” she said, as volatile organic compounds are also produced by people with influenza. “It’s just a matter of being able to figure out how to collect samples, how to train the dogs, and then to be safe and effective around those diseases too.”

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New study suggests Black women should be screened earlier for breast cancer | CNN

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CNN
 — 

A new study on breast cancer deaths raises questions around whether Black women should screen at earlier ages.

An international team of researchers wrote in the study, published Wednesday in the journal JAMA Network Open, that clinical trials may be warranted to investigate whether screening guidelines should recommend Black women start screening at younger ages, around 42 instead of 50.

The US Preventive Services Task Force – a group of independent medical experts whose recommendations help guide doctors’ decisions – recommends biennial screening for women starting at age 50. The Task Force says that a decision to start screening prior to 50 “should be an individual one.” Many medical groups, including the American Cancer Society and Mayo Clinic, already emphasize that women have the option to start screening with a mammogram every year starting at age 40.

Even though Black women have a 4% lower incidence rate of breast cancer than White women, they have a 40% higher breast cancer death rate.

“The take-home message for US clinicians and health policy makers is simple. Clinicians and radiologists should consider race and ethnicity when determining the age at which breast cancer screening should begin,” Dr. Mahdi Fallah, an author of the new study and leader of Risk Adapted Cancer Prevention Group at the German Cancer Research Center in Heidelberg, Germany, said in an email.

“Also, health policy makers can consider a risk-adapted approach to breast cancer screening to address racial disparities in breast cancer mortality, especially the mortality before the recommended age of population screening,” said Fallah, who is also a visiting professor at Lund University in Sweden and an adjunct professor at the University of Bern in Switzerland.

Breast cancer screenings are typically performed using a mammogram, which is an X-ray picture taken of the breast that doctors examine to look for early signs of breast cancer developing.

“Guidelines for screening actually already do recommend basing a woman’s time to initiate screening on the risk of developing cancer, though race and ethnicity have not been traditional factors that go into these decisions,” Dr. Rachel Freedman, a breast oncologist at Dana-Farber Cancer Institute, who was not involved in the new study, said in an email.

The American Cancer Society currently recommends that all women consider mammogram screenings for breast cancer risk starting at the age of 40 – and for women 45 to 54, it’s recommended to get mammograms every year. Those 55 and older can switch to screening every other year if they choose.

But “we are in the process of updating our breast cancer screening guidelines, and we are examining the scientific literature for how screening guidelines could differ for women in different racial and ethnic groups, and by other risk factors, in a way that would reduce disparities based on risk and disparities in outcome,” Robert Smith, senior vice president for cancer screening at the American Cancer Society, who was not involved in the new study, said in an email. “We are examining these issues closely.”

The American Cancer Society’s recommendations appear to align with the findings in the new study, as the research highlights how screening guidelines should not be a “one-size-fits-all policy,” but rather help guide conversations that patients and their doctors have together.

“We, here at the American Cancer Society, strongly recommend that all women consider a screening mammogram from the age of 40 onwards, and that means having a discussion with their doctor,” said Dr. Arif Kamal, the American Cancer Society’s chief patient officer, who was not involved in the new study.

“The authors highlight that age 50 can be a little late,” Kamal said about the study’s findings on when to begin breast cancer screening. “We are in agreement with that, particularly for women who may be at slightly higher risk.”

The researchers – from China, Germany, Sweden, Switzerland and Norway – analyzed data on 415,277 women in the United States who died of breast cancer in 2011 to 2020. That data on invasive breast cancer mortality rates came from the National Center for Health Statistics and was analyzed with the National Cancer Institute’s SEER statistical software.

When the researchers examined the data by race, ethnicity and age, they found that the rate of breast cancer deaths among women in their 40s was 27 deaths per 100,000 person-years for Black women compared with 15 deaths per 100,000 in White women and 11 deaths per 100,000 in American Indian, Alaska Native, Hispanic and Asian or Pacific Islander women.

“When the breast cancer mortality rate for Black women in their 40s is 27 deaths per 100,000 person-years, this means 27 out of every 100,000 Black women aged 40-49 in the US die of breast cancer during one year of follow-up. In other words, 0.027% of Black women aged 40-49 die of breast cancer each year,” Fallah said in the email.

In general, for women in the United States, their average risk of dying from breast cancer in the decade after they turn 50, from age 50 to 59, is 0.329%, according to the study.

“However, this risk level is reached at different ages for women from different racial/ethnic groups,” Fallah said. “Black women tend to reach this risk level of 0.329% earlier, at age 42. White women tend to reach it at age 51, American Indian or Alaska Native and Hispanic women at age 57 years, and Asian or Pacific Islander women later, at age 61.”

So, the researchers determined that when recommending breast cancer screening at age 50 for women, Black women should start at age 42.

Yet “the authors didn’t have any information on whether the women included in this study actually had mammographic screening and at what age. For example, it is possible that many women in this study actually had screening during ages 40-49,” Freedman, of the Dana-Farber Cancer Institute, said in her email.

“This study confirms that the age of breast cancer-mortality is younger for Black women, but it doesn’t confirm why and if screening is even the main reason. We have no information about the types of cancers women developed and what treatment they had either, both of which impact mortality from breast cancer,” she said.

The harm of starting mammograms at a younger age is that it raises the risk of a false positive screening result – leading to unnecessary subsequent tests and emotional stress.

But the researchers wrote in their study that “the added risk of false positives from earlier screenings may be balanced by the benefits” linked with earlier breast cancer detection.

They also wrote that health policy makers should pursue equity, not just equality, when it comes to breast cancer screening as a tool to help reduce breast cancer death rates.

Equality in the context of breast cancer screening “means that everyone is screened from the same age regardless of risk level. On the other hand, equity or risk-adapted screening means that everyone is provided screening according to their individual risk level,” the researchers wrote. “We believe that a fair and risk-adapted screening program may also be associated with optimized resource allocation.”

The new study is “timely and relevant,” given the overall higher mortality rate for breast cancer in Black women and that Black women are more likely to be diagnosed at a younger age compared with other ethnic groups, Dr. Kathie-Ann Joseph, surgical oncologist at NYU Langone’s Perlmutter Cancer Center and professor of surgery and population health at the NYU Grossman School of Medicine, said in an email.

“While some may argue that earlier screening may lead to increased recalls and unnecessary biopsies, women get recalled for additional imaging about 10% of the time and biopsies are needed in 1-2% of cases, which is quite low,” said Joseph, who was not involved in the new study.

“This has to be compared to the lives saved from earlier screening mammography,” she said. “I would also like to point out that while we certainly want to prevent deaths, earlier screening can have other benefits by allowing women of all racial and ethnic groups to have less extensive surgery and less chemotherapy which impacts quality of life.”

Breast cancer is the most common cancer among women in the United States, except for skin cancers. This year, it is estimated that about 43,700 women will die from the disease, according to the American Cancer Society, and Black women have the highest death rate from breast cancer.

Even though Black women are 40% more likely than White women to die from the disease, Kamal of the American Cancer Society said that the disparity in deaths is not a result of Black women not following the current mammogram guidelines.

Rather, implicit bias in medicine plays a role.

“In the United States, across the country, there are not differences in mammogram screening rates among Black women and White women. In fact, across the entire country, the number is about 75%. We see about 3 in 4 women – Black, White, Hispanic, and Asian – are on time with their mammograms,” Kamal said.

Yet there are multiple timepoints after a patient is diagnosed with breast cancer where they may not receive the same quality of care or access to care as their peers.

“For example, Black women are less likely to be offered enrollment in a clinical trial. That is not because of a stated difference in interest. In fact, the enrollment rate in clinical trials is equal among Black women and White women, if they’re asked,” Kamal said.

“What we have to understand is where the implicit and systemic biases held by patients and their caregivers and their families may exist – those that are held within health systems and even policies and practices that impede everyone having fair and just access to high quality health care,” he said.

Additionally, Black women have nearly a three-fold increased risk of triple-negative breast cancers. Those particular type of cancers tend to be more common in women younger than 40, grow faster than other types of invasive breast cancer and have fewer treatment options.

Black women also tend to have denser breast tissue than White women. Having dense tissue in the breast can make it more difficult for radiologists to identify breast cancer on a mammogram, and women with dense breast tissue have a higher risk of breast cancer.

But such biological differences among women represent just a small part of a much larger discussion around racial disparities in breast cancer, Kamal said.

“There are systemic issues, access to care issues that really go beyond biology,” he said. “The reality is cancer affects everybody and it does not discriminate. Where the discrimination sometimes occurs is after the diagnosis, and that’s really what we need to focus on.”

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Among seniors, Black men more likely to die after surgery than their peers, new study suggests | CNN

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CNN
 — 

Among older patients, Black men may have a higher chance of dying within 30 days following surgery than their peers, according to a new study.

The study, published Wednesday in the medical journal BMJ, suggests that this inequity could be driven by outcomes following elective surgery, for which death was 50% higher for Black men than for White men – information that can be helpful for physicians as they plan procedures for patients.

Previously, separate research published in 2020 came to similar findings among children, showing that, within 30 days from their surgeries, Black children were more likely to die than White children.

“While a fair bit is known about such inequities, we find in our analyses that it’s specifically Black men who are dying more, and they are dying more after elective surgeries, not urgent and emergent surgeries,” study lead Dr. Dan Ly, assistant professor of medicine in the division of general internal medicine and health services research at the David Geffen School of Medicine at the University of California, Los Angeles, said in a news release.

“Our findings point to possibilities such as poorer pre-optimization of co-morbidities prior to surgery, delays of care due to structural racism and physician bias, and worse stress and its associated physical burden on Black men in the United States,” Ly said in the news release.

Researchers at the University of California, Los Angeles analyzed Medicare data on more than 1.8 million beneficiaries, ages 65 to 99, who underwent one of eight common surgical procedures. The data came from 2016 to 2018, and the researchers examined how many patients died during their hospital stay or within 30 days after surgery.

The researchers found that dying after surgery overall was higher in Black men compared with White men, White women, and Black women. Dying after surgery was 50% higher for Black men than for White men after elective surgeries, the data suggest, but for non-elective surgeries, there was no difference between Black and White men, although mortality was lower for women of both races.

Among the Black men in the study, about 3% of them died following surgery overall compared with 2.7% of White men, 2.4% of White women and 2.2% of Black women. These differences were relatively larger for elective surgeries, and appeared within a week after surgery and persisted for up to 60 days after surgery, the researchers found. In a separate analysis, the researchers found that Hispanic men and Hispanic women showed a lower overall mortality than Black men.

“Our study has shed light on the fact that Black men experience a higher death rate after elective surgery than other subgroups of race and sex. Further research is needed to understand better the factors contributing to this observation, and to inform efforts to develop interventions that could effectively eliminate such disparity,” Dr. Yusuke Tsugawa, the senior author of the study and associate professor of medicine at UCLA David Geffen School of Medicine, said in an email.

The study did not explore what could be driving the disparity but Tsugawa said that “several factors” could potentially play a role.

“The structural racism may at least partially explain our findings. For example, Black patients living in neighborhoods with predominantly Black residents tend to live close to hospitals that lack resources to provide high quality healthcare,” Tsugawa said in the email. “It is possible that Black men in particular face especially high cumulative amounts of stress and allostatic load, which refers to the cumulative burden of chronic stress and life events, potentially leading to a higher death rate after surgery among this population.”

The new study “validates” that racial inequities exist in health care, said Dr. Georges Benjamin, executive director of the American Public Health Association, who was not involved in the study.

“Obviously it’s concerning when you see such a large disparity,” Benjamin said, referring to the differences in how many patients died after surgery in the study findings.

“Here’s another example that these disparities are real, and I think it helps inform people – physicians, health systems, providers of care – that the disparity is already there,” he said. “So, when they’re looking at providing surgical care to their patients, they should be informed that, statistically, some of their patients may not do well 30 days out after surgery, and so they need to put extra care in both providing care and understanding the health status of those patients when they go to surgery.”

The new study findings also raise many questions about health systems and what happens when a patient is discharged home after surgery and their ability to safely recover from a procedure, said Dr. Utibe Essien, assistant professor of medicine at the David Geffen School of Medicine at UCLA, who was not involved in the study.

“As a generalist, I’m really thinking about that part as well and how we can engage with our surgical colleagues to make sure our patients who are from underrepresented groups are leading healthy lives after they’ve gone under the knife so to speak,” Essien said, adding that more research could help determine which types of elective surgeries may have seen more significant disparities than other types – and what would be needed to reduce the disparities.

“Would we find something different with more rare, complicated surgeries? It’s possible and that goes back to the type of hospitals where patients are getting their care,” Essien said.

“How close is a hospital really connected to an academic medical center that knows the latest and greatest surgical procedures? Do they have the technology to be able to do some really innovative and safe work?” he said. “Looking into ways at the hospital level that we can address these disparities, I think, is going to be important.”

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