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Most men with prostate cancer can avoid or delay harsh treatments, long-term study confirms | CNN

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CNN
—

Most men who are diagnosed with prostate cancer can delay or avoid harsh treatments without harming their chances of survival, according to new results from a long-running study in the United Kingdom.

Men in the study who partnered with their doctors to keep a close eye on their low- to intermediate-risk prostate tumors – a strategy called surveillance or active monitoring – slashed their risk of the life-altering complications such as incontinence and erectile dysfunction that can follow aggressive treatment for the disease, but they were no more likely to die of their cancers than men who had surgery to remove their prostate or who were treated with hormone blockers and radiation.

“The good news is that if you’re diagnosed with prostate cancer, don’t panic, and take your time to make a decision” about how to proceed, said lead study author Dr. Freddie Hamdy, professor of surgery and urology at the University of Oxford.

Other experts who were not involved in the research agreed that the study was reassuring for men who are diagnosed with prostate cancer and their doctors.

“When men are carefully evaluated and their risk assessed, you can delay or avoid treatment without missing the chance to cure in a large fraction of patients,” said Dr. Bruce Trock, a professor of urology, epidemiology and oncology at Johns Hopkins University.

The findings do not apply to men who have prostate cancers that are scored through testing to be high-risk and high-grade. These aggressive cancers, which account for about 15% of all prostate cancer diagnoses, still need prompt treatment, Hamdy said.

For others, however, the study adds to a growing body of evidence showing that surveillance of prostate cancers is often the right thing to do.

“What I take away from this is the safety of doing active monitoring in patients,” said Dr. Samuel Haywood, a urologic oncologist at the Cleveland Clinic in Ohio, who reviewed the study, but was not involved in the research.

Results from the study were presented on Saturday at the European Association of Urology annual conference in Milan, Italy. Two studies on the data were also published in the New England Journal of Medicine and a companion journal, NEJM Evidence.

Prostate cancer is the second most common cancer in men in the United States, behind non-melanoma skin cancers. About 11% – or 1 in 9 – American men will be diagnosed with prostate cancer in their lifetime, and overall, about 2.5% – or 1 in 41 – will die from it, according to the National Cancer Institute. About $10 billion is spent treating prostate cancer in the US each year.

Most prostate cancers grow very slowly. It typically takes at least 10 years for a tumor confined to the prostate to cause significant symptoms.

The study, which has been running for more than two decades, confirms what many doctors and researchers have come to realize in the interim: The majority of prostate cancers picked up by blood tests that measure levels of a protein called prostate-specific antigen, or PSA, will not harm men during their lifetimes and don’t require treatment.

Dr. Oliver Sartor, medical director of the Tulane Cancer Center, said men should understand that a lot has changed over time, and doctors have refined their approach to diagnosis since the study began in 1999.

“I wanted to make clear that the way these patients are screened and biopsied and randomized is very, very different than how these same patients might be screened, biopsied and randomized today,” said Sartor, who wrote an editorial on the study but was not involved in the research.

He says the men included in the study were in the earliest stages of their cancer and were mostly low-risk.

Now, he says, doctors have more tools, including MRI imaging and genetic tests that can help guide treatment and minimize overdiagnosis.

The study authors say that to assuage concerns that their results might not be relevant to people today, they re-evaluated their patients using modern methods for grading prostate cancers. By those standards, about one-third of their patients would have intermediate or high-risk disease, something that didn’t change the conclusions.

When the study began in 1999, routine PSA screening for men was the norm. Many doctors encouraged annual PSA tests for their male patients over age 50.

PSA tests are sensitive but not specific. Cancer can raise PSA levels, but so can things like infections, sexual activity and even riding a bicycle. Elevated PSA tests require more evaluation, which can include imaging and biopsies to determine the cause. Most of the time, all that followup just isn’t worth it.

“It is generally thought that only about 30% of the individuals with an elevated PSA will actually have cancer, and of those that do have cancer, the majority don’t need to be treated,” Sartor said.

Over the years, studies and modeling have shown that using regular PSA tests to screen for prostate cancer can do more harm than good.

By some estimates, as many as 84% of men with prostate cancer identified through routine screening do not benefit from having their cancers detected because their cancer would not be fatal before they died of other causes.

Other studies have estimated about 1 to 2 in every five men diagnosed with prostate cancer is overtreated. The harms of overtreatment for prostate cancer are well-documented and include incontinence, erectile dysfunction and loss of sexual potency, as well as anxiety and depression.

In 2012, the influential US Preventive Services Task Force advised healthy men not to get PSA tests as part of their regular checkups, saying the harms of screening outweighed its benefits.

Now, the task force opts for a more individualized approach, saying men between the ages of 55 and 69 should make the decision to undergo periodic PSA testing after carefully weighing the risks and benefits with their doctor. They recommend against PSA-based screening for men over the age of 70.

The American Cancer Society endorses much the same approach, recommending that men at average risk have a conversation with their doctor about the risks and benefits beginning at age 50.

The trial has been following more than 1,600 men who were diagnosed with prostate cancer in the UK between 1999 and 2009. All the men had cancers that had not metastasized, or spread to other parts of their bodies.

When they joined, the men were randomly assigned to one of three groups: active monitoring or using regular blood tests to keep an eye on their PSA levels; radiotherapy, which used hormone-blockers and radiation to shrink tumors; and prostatectomy, or surgery to remove the prostate.

Men who were assigned monitoring could change groups during the study if their cancers progressed to the point that they needed more aggressive treatment.

Most of the men have been followed for around 15 years now, and for the most recent data analysis, researchers were able get follow-up information on 98% of the participants.

By 2020, 45 men – about 3% of the participants – had died of prostate cancer. There were no significant differences in prostate cancer deaths between the three groups.

Men in the active monitoring group were more likely to have their cancer progress and more likely to have it spread compared with the other groups. About 9% of men in the active monitoring group saw their cancer metastasize, compared with 5% in the two other groups.

Trock points out that even though it didn’t affect their overall survival, a spreading cancer isn’t an insignificant outcome. It can be painful and may require aggressive treatments to manage at that stage.

Active surveillance did have important benefits over surgery or radiation.

As they followed the men over 12 years, the researchers found that 1 in 4 to 1 in 5 of those who had prostate surgery needed to wear at least one pad a day to guard against urine leaks. That rate was twice as high as the other groups, said Dr. Jenny Donovan of the University of Bristol, who led the study on patient-reported outcomes after treatment.

Sexual function was affected, too. It’s natural for sexual function to decline in men with age, so by the end of the study, nearly all the men reported low sexual function, but their patterns of decline were different depending on their prostate cancer treatment, she said.

“The men who have surgery have low sexual function early on, and that continues. The men in the radiotherapy group see their sexual function drop, then have some recovery, but then their sexual function declines, and the active monitoring group declines slowly over time,” Donovan said.

Donovan said that when she presents her data to doctors, they point out how much has changed since the study started.

“Some people would say, ‘OK, yeah, but we’ve got all these new technologies now, new treatments,’ ” she said, such as intensity-modulated radiation therapy, brachytherapy and robot-assisted prostate surgeries, “but actually, other studies have shown that the effects on these functional outcomes are very similar to the effects that we see our study,” she said.

Both Donovan and Hamby feel the study’s conclusions still merit careful consideration by men and their doctors as they weigh treatment decisions.

“What we hope that clinicians will do is use these figures that we’ve produced in these papers and share them with the men so that newly diagnosed men with localized prostate cancer can really assess those tradeoffs,” Donovan said.

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Medical tourism to Mexico is on the rise, but it can come with risks | CNN

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CNN
—

One of the four Americans who were kidnapped in Mexico last week was traveling for medical tourism, a friend said. A growing number of US residents are traveling internationally to seek more affordable medical care, more timely care or access to certain treatments or procedures that are unapproved or unavailable in the United States.

Latavia “Tay” Washington McGee, 33, drove to Mexico with Shaeed Woodard, Zindell Brown and Eric Williams for cosmetic surgery that was scheduled to take place Friday, according to a close friend of Washington McGee’s who did not want to be identified.

The four Americans were found Tuesday near the border city of Matamoros, officials said. Washington McGee and Williams were found alive, and Woodard and Brown were found dead, a US official familiar with the investigation told CNN. Investigators are still piecing together what happened after they were abducted.

Medical tourism takes people all over the world, including to Mexico, India and Eastern Europe. Violence against medical tourists is generally thought to be rare, but the US Centers for Disease Control and Prevention warns about other risks such as quality of care, infection control and communication challenges with medical staff.

“It’s on the daily, without a doubt. There are people going daily to get this kind of stuff done,” said Dr. Nolan Perez, a gastroenterologist in Brownsville, Texas, which is across the border from Matamoros. “Whether it’s primary care provider visits or dental procedures or something more significant, like elective or weight loss surgery, there’s no doubt that people are doing that because of low cost and easier access.”

One study published in the American Journal of Medicine estimated that fewer than 800,000 Americans traveled to other countries for medical care in 2007, but by 2017, more than 1 million did.

More current estimates suggest that those numbers have continued to grow.

“People travel because there may be a long waiting time, wait lists or other reasons why they can’t get treatment as quickly as they would like it. So they explore their options outside the United States to see what’s available,” said Elizabeth Ziemba, president of Medical Tourism Training, which provides training and accreditation to international health travel organizations.

Also, “price is a big issue in the United States. We know that the US health care system is incredibly expensive,” she added. “Even for people with insurance, there may be high deductibles or out-of-pocket costs that are not covered by insurance, so that people will look based on price for what’s available in other destinations.”

The most common procedures that prompt medical tourism trips include dental care, surgery, cosmetic surgery, fertility treatments, organ and tissue transplants and cancer treatment, according to the CDC.

“With Mexico and Costa Rica, it’s overwhelmingly dental and cosmetic surgery. However, certain countries are known for specialties. For example, in Singapore, stem cell and oncology is huge. In India, South India and Chennai Apollo hospitals does incredible work with hip and knee surgeries,” said Josef Woodman, founder of Patients Beyond Borders, an international health care consulting company.

“In Eastern Europe, a lot of people from the UK – but also people from the United States – travel to Hungary, Croatia and Turkey for everything from dental to light cosmetic surgery,” he said.

Mexico is the second most popular destination for medical tourism globally, with an estimated 1.4 million to 3 million people coming into the country to take advantage of inexpensive treatment in 2020, according to Patients Beyond Borders.

Matamoros – where officials said the four kidnapped Americans were found – is “not considered a primary medical travel destination,” Woodman said, “largely because there are no internationally accredited medical centers/specialty clinics there or in the immediate region.”

Mexico City, Cancun and Tijuana are more frequented and reliable destinations in the country, Woodman said.

On average, Americans can save 40% to 60% across the most common major procedures received by medical tourists in Mexico, according to an analysis of 2020 health ministry data conducted by Patients Beyond Borders.

Woodman said that violence against medical tourists was extremely rare, but he added that “price shopping” – searching for the cheapest location for a procedure – is a “blueprint for trouble,” namely substandard medical care.

Medical tourism can be dangerous, depending on the destination and the person’s condition.

“There are the complexities of traveling if you have a medically complex situation. There are fit-to-fly rules. And your health care providers should take into consideration the impact of traveling if you have orthopedic injuries or issues,” Ziemba said.

“The quality of care may be an unknown,” she said. “It may be that the quality of care is not up to the standards that you would like. So there’s a bit of an unknown there, and then the last thing I would say is, if something goes wrong, what’s going to happen?”

Perez said he commonly manages complications from medical tourism in his practice.

“There are a lot of bad outcomes. There are a lot of infections and a lot of botched procedures gone wrong, and patients have to come back to the United States and then have a revision of the surgery,” he said. “So it’s really unfortunate.”

Yet Ziemba added that there can be benefits to medical tourism, including that someone could receive a service that they need faster overseas than locally.

“And price: If you simply can’t afford the out-of-pocket costs of health care in the United States, and assuming the risks involved, it may make much more sense for you financially to travel outside the United States,” she said.

Medical tourism is not just for people traveling around the world. Many living along the US-Mexico border, where access to health care can be scarce, cross into Mexico for care.

The Rio Grande Valley, at the southernmost point of Texas, is considered to be a medically underserved area. The region has some of the nation’s highest rates of comorbidities, including obesity and diabetes, and one of the lowest physician-to-patient ratios.

There is a “dire need” for health care professionals along the border, Perez said.

“There are not as many doctors given our big and our growing population down here. So the demands on primary care doctors and specialists are very high because there are not enough of us for this population,” he said. “So that’s one reason why people end up going to Mexico to visit with physicians, because of easier access.”

People interested in medical tourism can take some steps to help minimize their risk, the CDC says.

Those planning to travel to another country for medical care should see their health care provider or a travel medicine provider at least four to six weeks before the trip and get international travel health insurance that covers medical evacuation back to the United States.

The CDC advises taking copies of your medical records with you and checking the qualifications of the providers who will be overseeing your medical care. Also, make sure you can get any follow-up care you may need.

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Elite athletes with genetic heart disease can safely return to play with diagnosis and treatment, early study suggests | CNN

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CNN
—

In a new study, most elite athletes with a diagnosed genetic heart disease did not experience serious or fatal symptoms of their condition, such as sudden cardiac death. The research suggests it can be “feasible” and “safe” for athletes to continue to participate in their sport.

Among a sample of 76 elite athletes with a genetic heart disease who had competed or are still competing in either Division I university or professional sports, 73 out of the 76 did not experience a cardiac event triggered by their disease during the study period, according to researchers behind a late-breaking clinical trial presented Monday at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology.

Among those elite athletes with a genetic heart disease, 40 of them – 52% – were asymptomatic, the study abstract finds.

Over the years, researchers have become more aware of alarming reports about elite athletes experiencing heart problems, or even suddenly collapsing during games.

“For athletes with genetic heart conditions, and I would add non-athletes, the tragedies occur when we don’t know of their condition,” said Dr. Michael Ackerman, a genetic cardiologist at Mayo Clinic in Rochester, Minnesota, who was a senior author of the new research. “When we know of their condition, and we assess the risk carefully and we treat it well, these athletes and non-athletes, they can expect to live and thrive despite their condition.”

The new research has not yet been published in a peer-reviewed journal, but the findings suggest that many athletes with a genetic heart disease can decide with their health care professionals on whether to continue competing in their sport and how to do so safely, instead of being automatically disqualified due to their health conditions.

“In sports, historically, we’ve been paternalistic and de-emphasize patient preference and risk tolerance, but we know that athletes come from all walks of life. They are intelligent and when there’s scientific uncertainty, their values should be incorporated in medical decision-making,” Dr. J. Sawalla Guseh, cardiologist at Massachusetts General Hospital, who was not involved in the new study, said during Monday’s scientific session.

“Shared decision-making when done well can have very favorable outcomes,” he said.

Elite basketball, hockey, soccer and football players, were among the 76 athletes included in the new study, conducted by researchers at Mayo Clinic and other institutions in the United States. They wrote in their study abstract that this is the first study to their knowledge describing the experience of athletes competing at the NCAA Division I level or in professional sports with a known genetic heart disease that puts them at risk of sudden cardiac death.

The athletes in the study were cleared for return-to-play at either a NCAA Division I school or at the professional level. They were studied over an average of seven years, and all had been diagnosed with a genetic heart disease in the past 20 years, being treated at either Mayo Clinic, Morristown Medical Center, Massachusetts General Hospital or Atrium Health Sports Cardiology Center.

“Only three of them had a breakthrough cardiac event, which means after they were diagnosed and treated, they were still having an event,” said Katherine Martinez, an undergraduate student at Loyola University in Baltimore, who helped conduct the research as an intern in the Mayo Clinic’s Windland Smith Rice Sudden Death Genomics Laboratory.

Fainting was the most common event, and one athlete received a shock with an implantable cardioverter defibrillator, or ICD. None of the athletes died.

“The majority of these athletes went on to continue their career with no events at all,” Martinez said. But most of the athletes in the study – 55 of them, or 72% – were initially disqualified from competing by their primary provider or institution after their diagnosis. Most ultimately opted to return to play with no restrictions after undergoing comprehensive clinical evaluations and talking with their doctors.

While each sports league has its own set of rules, historically, some people diagnosed with a genetic heart disease that puts them at an increased risk for sudden cardiac death have been restricted from competitive sports, the researchers wrote in their study abstract.

“Just because you were given this diagnosis, doesn’t mean that your life, your career, the future that you see for yourself is over, but taking a second opinion from an expert who knows what they’re doing and is comfortable with shared decision-making is the next step,” said Martinez, who worked on the new research alongside her father, Dr. Matthew Martinez, director of Atlantic Health System Sports Cardiology at Morristown Medical Center and an author of the new research.

Regarding the new study, “the take-home message is, if you have one of these findings, seek out an expert who’s going to help you identify a safe exercise plan for you and determine what level you can continue to safely participate in,” he said. “This is the next best step – the next evolution – of how we manage athletes with genetic heart disease.”

Leaving their sport due to a genetic heart disease can be “very destructive” for athletes who have devoted their lives to excelling in competitions, said Dr. Lior Jankelson, director of the Inherited Arrhythmia Program at NYU Langone Heart in New York, who was not involved in the new research.

Yet he added that these athletes still need to consult with their doctors and be watched closely because some genetic diseases could be more likely to cause a serious cardiac event than others.

The new study highlights that “the majority of athletes with genetic heart disease could probably – after careful, meticulous expert risk-stratification and care strategy – participate in sports,” Jankelson said. “But at the same time, this is exactly the reason why these patients should be cared only in high-expertise genetic cardiology clinics, because there are other conditions that are genetic, that could respond very adversely to sports, and have a much higher risk profile of developing an arrhythmia during intense activity.”

Separately, the NCAA Sports Science Institute notes on its website, “Though many student-athletes with heart conditions can live active lives and not experience health-related problems, sudden fatality from a heart condition remains the leading medical cause of death in college athletes.”

For athletes with a genetic heart disease, their symptoms and their family history of cardiac events should be considered when determining their risks, said Dr. Jayne Morgan, a cardiologist with Piedmont Healthcare in Atlanta, who was not involved in the new research.

“Certainly, there is concern with elite athletes competing and whether or not they are being screened appropriately,” Morgan said. But she added that the new research offers “some understanding” to the mental health implications for athletes with a genetic heart disease who may be required to step away from a competitive sport that they love.

“This study, I think, begins to go a long way in identifying that we may not need to pull the trigger so quickly and have athletes step away from something that they love,” Morgan said.

The new study is “timely” given the recent national attention on athletes and their risk of sudden cardiac death, Dr. Deepak Bhatt, director of Mount Sinai Heart in New York City, who was not involved in the research, said in an email.

“These are some of the best data showing that the risk of return to play may not be as high as we fear,” Bhatt said about the new research.

“Some caveats include that the majority of these athletes were not symptomatic and about a third had an implantable defibrillator,” he added. “Any decision to return to the athletic field should be made after a careful discussion of the potential risks, including ones that are hard to quantify. Input from experts in genetic cardiology and sports cardiology can be very helpful in these cases.”

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Bempedoic acid improved heart health in patients who can’t tolerate statins, study finds | CNN

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CNN
—

Bempedoic acid may be an alternative for people who need to lower their cholesterol but can’t or won’t take statins, according to a large study published Saturday in the New England Journal of Medicine.

Statins are the most commonly prescribed cholesterol-lowering drugs that help lower what’s known as the “bad” cholesterol, or low-density lipoprotein (LDL) cholesterol in the blood; more than 90% of adults who take a cholesterol-lowering medicine use a statin, according to the US Centers for Disease Control and Prevention.

Statins are considered safe and effective, but there are millions of people who cannot or will not take them. For some people it causes intense muscle pain. Past research has shown anywhere between 7% and 29% of patients who need to lower cholesterol do not tolerate statins, according Dr. Steven Nissen, a cardiologist and researcher at the Cleveland Clinic and co-author of the new study.

“I see heart patients that come in with terrible histories, multiple myocardial infarction, sometimes bypass surgery, many stents and they say, ‘Doctor, I’ve tried multiple statins, but whenever I take a statin, my muscles hurt, or they’re weak. I can’t walk upstairs. I just can’t tolerate these drugs,’ ” Nissen said. “We do need alternatives for these patients.”

Doctors have a few options, including ezetimibe and a monoclonal antibody called a proprotein convertase subtilisin/kexin type 9, or PCSK9 inhibitors for short.

Bempedoic acid, sold under the name Nexletol, was designed specifically to treat statin-intolerant patients. The FDA approved it for this purpose in 2020, but the effects of the drug on heart health had not been fully assessed until this large trial. The new study was funded in part by Esperion Therapeutics, the maker of Nexletol.

For the study, which was presented Saturday at the American College of Cardiology’s Annual Scientific Session with the World Congress of Cardiology, Nissen and his colleagues enrolled 13,970 patients from 32 countries.

All of the patients were statin intolerant, typically due to musculoskeletal adverse effects. Patients had to sign an agreement that they couldn’t tolerate statins “even though I know they would reduce my risk of a heart attack or stroke or death,” and providers signed a similar statement.

The patients were then randomized into two groups. One was treated with bempedoic acid, the other was given a placebo, which does nothing. Researchers then followed up with those patients for up to nearly five years. The number of men and women in the trial were mostly evenly divided, and most participants, some 91%, were White, and 17% were Hispanic or Latino.

The drug works in a similar way that statins do, by drawing cholesterol out of a waxy substance called plaque that can build up in the walls of the arteries and interfere with the blood flow to the heart. If there is too much plaque buildup, it can lead to a heart attack or stroke.

But bempedoic acid is only activated in the liver, unlike a statin, so it is unlikely to cause muscle aches, Nissen said.

In the trial, investigators found that bempedoic acid was well-tolerated and the percent reduction in the “bad” cholesterol was greater with bempedoic acid than placebo by 21.7%.

The risk of cardiovascular events – including death, stroke, heart attack and coronary revascularization, a procedure or surgery to improve blood flow to the heart – was 13% lower with bempedoic acid than with placebo over a median of 3.4 years.

“The drug worked in primary and secondary prevention patients – that is, patients that had had event and patients who were very high risk for a first event. There were a lot of diabetics. These were very high risk people,” Nissen said. “So the drug met its expectations and probably did a lot better than a lot of people thought it would do.”

In the group that took bempedoic acid, there were a few more cases of gout and gallstones, compared with people who took a placebo.

“The number is small, and weighing that against a heart attack, I think most people would say, ‘OK I’d rather have a little gout attack,’ ” Nissen said.

Bempedoic acid had no observed effect on mortality, but that may be because the observation period was too short to tell if it had that kind of impact. Earlier trials on statins showed the same; it was only after there were multiple studies on statins that scientists were able to show an impact on mortality.

Dr. Howard Weintraub, a cardiologist at NYU Langone Health who did not work on this study, said that while he knows some people will not consider a medication successful unless it reduces mortality, he thinks that is short-sighted.

“I think there’s more to doing medicine then counting body bags,” Weintraub said.”Preventing things that can be life changing, crippling, and certainly change your quality of life forever going forward, and your cost of doing things going forward, I think is a good thing.”

He was pleased to see the results of this trial, especially since the people in this study are often what he called “forgotten individuals” – the millions who could benefit from lowering their cholesterol, but can’t take statins.

“It’s not like their LDL was 180 or 190 or 230, their LDL was 139. This is about average in our country,” Weintraub said. He said often doctors will just tell those patients to watch their diet, but he thinks this suggests they would benefit from medication.

“Both groups primary and secondary prevention got benefit, which I think is impressive with the modest amount of LDL reduction,” Weintraub said.

There are some limitations to this trial. It was narrowly focused on patients with a known statin intolerance. Nissen said the trial was not designed to determine whether bempedoic acid could be an alternative to statins.

“Statins are the gold standard. They are the cornerstone. The purpose of this study was not to replace statins, but to allow an alternative therapy for people who simply cannot take them,” Nissen said.

Bempedoic acid is a much more expensive drug than a statin. There are generic versions of statins and some cost only a few dollars. Bempedoic acid, on the other hand, has no generic alternative and a 30-day supply can cost more than $400, according to GoodRx.

“I think what insurance companies need to recognize that even though this drug is going to cost more than statins, having a heart attack or a stroke or needing a stent is expensive. A 23% reduction in (myocardial infarctions) is a considerable reduction,” Weintraub said.

In an editorial in the New England Journal of Medicine that accompanied the study, Dr. John H. Alexander, who works in the division of cardiology at Duke Clinical Research Institute, Duke Health, Durham said that doctors should take these results into consideration when treating patients with high cholesterol who can’t take statins.

“The benefits of bempedoic acid are now clearer, and it is now our responsibility to translate this information into better primary and secondary prevention for more at-risk patients, who will, as a result, benefit from fewer cardiovascular events,” Alexander wrote.

Dr. Manesh Patel, a cardiologist and volunteer with the American Heart Association who was not a part of the study, said that providers are already prescribing bempedoic acid for some patients, but with this new research, he thinks they will quickly be used with more statin-intolerant patients.

“We continue to see that if we can lower your LDL significantly, we improve people’s cardiovascular health. And so we need as many different arrows in our quiver to try to get that done,” Patel said.

Heart disease is the No. 1 killer for men and women in the world. One person dies every 34 seconds in the US from cardiovascular disease, according to the CDC. About 697,000 people in the US died from heart disease in 2020 alone – about the same number as the population of Oklahoma City.

“Given the number of people that are eligible for statins, which are tens of millions of patients already, the number of people who cannot tolerate statins is in the millions,” Nissen said. “This is a big public health problem and I think we’ve come up with something that directly addresses this.”

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Report shows ‘troubling’ rise in colorectal cancer among US adults younger than 55 | CNN

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CNN
—

Adults across the United States are being diagnosed with colon and rectal cancers at younger ages, and now 1 in 5 new cases are among those in their early 50s or younger, according to the American Cancer Society’s latest colorectal cancer report.

The report says that the proportion of colorectal cancer cases among adults younger than 55 increased from 11% in 1995 to 20% in 2019. There also appears to be an overall shift to more diagnoses of advanced stages of cancer. In 2019, 60% of all new colorectal cases among all ages were advanced.

“Anecdotally, it’s not rare for us now to hear about a young person with advanced colorectal cancer,” said Dr. William Dahut, chief scientific officer for the American Cancer Society. For example, Broadway actor Quentin Oliver Lee died last year at 34 after being diagnosed with stage IV colon cancer, and in 2020, “Black Panther” star Chadwick Boseman died at 43 of colon cancer.

“It used to be something we never heard or saw this, but it is a high percentage now of colorectal cancers under the age of 55,” Dahut said.

Although it’s difficult to pinpoint a cause for the rise in colorectal cancers among younger adults, he said, some factors might be related to changes in the environment or people’s diets.

“We’re not trying to blame anybody for their cancer diagnosis,” Dahut said. “But when you see something occurring in a short period of time, it’s more likely something external to the patient that’s driving that, and it’s hard not to at least think – when you have something like colorectal cancer – that something diet-related is not impossible.”

The new report also says that more people are surviving colorectal cancer, with the relative survival rate at least five years after diagnosis rising from 50% in the mid-1970s to 65% from 2012 through 2018, partly due to advancements in treatment.

That’s good news, said Dr. Paul Oberstein, a medical oncologist at NYU Langone Perlmutter Cancer Center, who was not involved in the new report. The overall trends suggest that colorectal cancer incidence and death rates have been slowly declining.

“If you look at the overall trends, the incidence of colon cancer in this report has decreased from 66 per 100,000 in 1985 to 35 per 100,000 in 2019 – so almost half,” Oberstein said.

“Changes in the mortality rate are even more impressive,” he said. “In 1970, which was a long time ago, the rate of colorectal cancer death was 29.2 per 100,000 people, and in 2020, it was 12.6 per 100,000. So a dramatic, over 55% decline in deaths per 100,000 people.”

Colorectal cancer is the second most common cause of cancer death in the United States, and it is the leading cause of cancer-related deaths in men younger than 50.

Dahut said the best way to reduce your risk of colorectal cancer is to follow screening guidelines and get a stool-based test or a visual exam such as a colonoscopy when it’s recommended. Any suspicious polyps can be removed during a visual exam, reducing your risk of cancer.

“At the ACS, we recommend if you’re at average risk, you start screening at age 45,” Dahut said. “Usually, then your subsequent screening is based on the results of that screening test.”

For the new report, researchers at the American Cancer Society analyzed data from the National Cancer Institute and the US Centers for Disease Control and Prevention on cancer screenings, cases and deaths.

The researchers found that from 2011 through 2019, colorectal cancer rates increased 1.9% each year in people younger than 55. And while overall colorectal cancer death rates fell 57% between 1970 and 2020, among people younger than 50, death rates continued to climb 1% annually since 2004.

“We know rates are increasing in young people, but it’s alarming to see how rapidly the whole patient population is shifting younger, despite shrinking numbers in the overall population,” Rebecca Siegel, senior scientific director of surveillance research at the American Cancer Society and lead author of the report, said in a news release. “The trend toward more advanced disease in people of all ages is also surprising and should motivate everyone 45 and older to get screened.”

Some regions of the United States appeared to have higher rates of colorectal cancers and deaths than others. These rates were lowest in the West and highest in Appalachia and parts of the South and the Midwest, the data showed. The incidence of colorectal cancer ranged from 27 cases per 100,000 people in Utah to 46.5 per 100,000 in Mississippi. Colorectal cancer death rates ranged from about 10 per 100,000 people in Connecticut to 17.6 per 100,000 in Mississippi.

There were some significant racial disparities, as well. The researchers found that colorectal cancer cases and deaths were highest in the American Indian/Alaska Native and Black communities. Among men specifically, the data showed that colorectal cancer death rates were 46% higher in American Indian/Alaska Native men and 44% higher in Black men compared with White men.

The report also says that more left-sided tumors have been diagnosed, meaning an increasing percentage of tumors are happening closer to the rectum. The proportion of colorectal cancers in that location has steadily climbed from 27% in 1995 to 31% in 2019.

“Historically, we’ve been worried more about the tumors on what we call the right side,” said NYU Langone’s Oberstein.

“But the incidence increasing, especially among young people, seems to be happening not only in those worse tumors but the ones that we think are not as bad,” he said, referring to left-sided tumors. “It’s raising questions about whether something is changing about the risks and the future people who are going to get colon cancer.”

Looking forward, the researchers estimate that there will be 153,020 colorectal cancer cases diagnosed in the US this year and an estimated 52,550 colorectal cancer deaths, with 3,750 of them – or 7% – among people younger than 50.

“These highly concerning data illustrate the urgent need to invest in targeted cancer research studies dedicated to understanding and preventing early-onset colorectal cancer,” Dr. Karen Knudsen, CEO of the American Cancer Society, said in the news release. “The shift to diagnosis of more advanced disease also underscores the importance of screening and early detection, which saves lives.”

The report’s findings, including the rise in colorectal cancer in younger adults, are “troubling,” Dr. Joel Gabre, an expert in gastrointestinal cancers at Columbia University Irving Medical Center, said in an email.

“It reflects other recent published findings demonstrating a rising incidence of colorectal cancer in young people. Most concerning to me, however, is a lack of clear cause and patients being diagnosed late. I think this is an area where more funding for research is needed to understand this really concerning rise,” wrote Gabre, who was not involved in the report.

Gabre says he knows what it’s like to look into his young patients’ eyes and tell them they have colorectal cancer, and “it’s devastating.”

“They have young families and so much of their life ahead of them. That’s why I encourage my patients who are age 45 years and older to get screened,” Gabre said. “I also encourage people to let their doctor know if they have a family history of colon cancer. There is genetic testing we can do to identify some at-risk patients early before they develop cancer.”

The findings highlight the importance of colorectal cancer screening, Dr. Robin Mendelsohn, gastroenterologist and co-director of the Center for Young Onset Colorectal and Gastrointestinal Cancers at Memorial Sloan Kettering Cancer Center, said in an email.

“The age to start screening was recently decreased to 45, which will help in an effort to screen more people, but we still need to understand more why we are seeing this increase which is something we are actively looking into,” wrote Mendelsohn, was not involved in the new report.

Mendelsohn says she has seen an increase in advanced colorectal cancers and diagnoses among her younger patients, and she says to watch for symptoms such as rectal bleeding, abdominal pain and changes in bowel habits.

“Until we understand more, it is important that patients and providers recognize these symptoms so they can be evaluated promptly,” she said. “And, if you are at an age to get screened, please get screened.”

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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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11 minutes of daily exercise could have a positive impact on your health, large study shows | CNN

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Sign up for CNN’s Fitness, But Better newsletter series. Our seven-part guide up will help you ease into a healthy routine, backed by experts.

CNN
—

When you can’t fit your entire workout into a busy day, do you think there’s no point in doing anything at all? You should rethink that mindset. Just 11 minutes of moderate-to-vigorous intensity aerobic activity per day could lower your risk of cancer, cardiovascular disease or premature death, a large new study has found.

Aerobic activities include walking, dancing, running, jogging, cycling and swimming. You can gauge the intensity level of an activity by your heart rate and how hard you’re breathing as you move. Generally, being able to talk but not sing during an activity would make it moderate intensity. Vigorous intensity is marked by the inability to carry on a conversation.

Higher levels of physical activity have been associated with lower rates of premature death and chronic disease, according to past research. But how the risk levels for these outcomes are affected by the amount of exercise someone gets has been more difficult to determine. To explore this impact, scientists largely from the University of Cambridge in the United Kingdom looked at data from 196 studies, amounting to more than 30 million adult participants who were followed for 10 years on average. The results of this latest study were published Tuesday in the British Journal of Sports Medicine.

The study mainly focused on participants who had done the minimum recommended amount of 150 minutes of exercise per week, or 22 minutes per day. Compared with inactive participants, adults who had done 150 minutes of moderate-to-vigorous aerobic physical activity per week had a 31% lower risk of dying from any cause, a 29% lower risk of dying from cardiovascular disease and a 15% lower risk of dying from cancer.

The same amount of exercise was linked with a 27% lower risk of developing cardiovascular disease and 12% lower risk when it came to cancer.

“This is a compelling systematic review of existing research,” said CNN Medical Analyst Dr. Leana Wen, an emergency physician and public health professor at George Washington University, who wasn’t involved in the research. “We already knew that there was a strong correlation between increased physical activity and reduced risk for cardiovascular disease, cancer and premature death. This research confirms it, and furthermore states that a smaller amount than the 150 minutes of recommended exercise a week can help.”

Even people who got just half the minimum recommended amount of physical activity benefited. Accumulating 75 minutes of moderate-intensity activity per week — about 11 minutes of activity per day — was associated with a 23% lower risk of early death. Getting active for 75 minutes on a weekly basis was also enough to reduce the risk of developing cardiovascular disease by 17% and cancer by 7%.

Beyond 150 minutes per week, any additional benefits were smaller.

“If you are someone who finds the idea of 150 minutes of moderate-intensity physical activity a week a bit daunting, then our findings should be good news,” said study author Dr. Soren Brage, group leader of the Physical Activity Epidemiology group in the Medical Research Council Epidemiology Unit at the University of Cambridge, in a news release. “This is also a good starting position — if you find that 75 minutes a week is manageable, then you could try stepping it up gradually to the full recommended amount.”

The authors’ findings affirm the World Health Organization’s position that doing some physical activity is better than doing none, even if you don’t get the recommended amounts of exercise.

“One in 10 premature deaths could have been prevented if everyone achieved even half the recommended level of physical activity,” the authors wrote in the study. Additionally, “10.9% and 5.2% of all incident cases of CVD (cardiovascular disease) and cancer would have been prevented.”

Important note: If you experience pain while exercising, stop immediately. Check with your doctor before beginning any new exercise program.

The authors didn’t have details on the specific types of physical activity the participants did. But some experts do have thoughts on how physical activity could reduce risk for chronic diseases and premature death.

“There are many potential mechanisms including the improvement and maintenance of body composition, insulin resistance and physical function because of a wide variety of favorable influences of aerobic activity,” said Haruki Momma, an associate professor of medicine and science in sports and exercise at Tohoku University in Japan. Momma wasn’t involved in the research.

Benefits could also include improvement to immune function, lung and heart health, inflammation levels, hypertension, cholesterol, and amount of body fat, said Eleanor Watts, a postdoctoral fellow in the division of cancer epidemiology and genetics at the National Cancer Institute. Watts wasn’t involved in the research.

“These translate into lower risk of getting chronic diseases,” said Peter Katzmarzyk, associate executive director for population and public health sciences at Pennington Biomedical Research Center in Baton Rouge, Louisiana. Katzmarzyk wasn’t involved in the research.

The fact that participants who did only half the minimum recommended amount of exercise still experienced benefits doesn’t mean people shouldn’t aim for more exercise, but rather that “perfect shouldn’t be the enemy of the good,” Wen said. “Some is better than none.”

To get up to 150 minutes of physical activity per week, find activities you enjoy, Wen said. “You are far more likely to engage in something you love doing than something you have to make yourself do.”

And when it comes to how you fit in your exercise, you can think outside the box.

“Moderate activity doesn’t have to involve what we normally think of (as) exercise, such as sports or running,” said study coauthor Leandro Garcia, a lecturer in the school of medicine, dentistry and biomedical sciences at Queen’s University Belfast, in a news release. “Sometimes, replacing some habits is all that is needed.

“For example, try to walk or cycle to your work or study place instead of using a car, or engage in active play with your kids or grand kids. Doing activities that you enjoy and that are easy to include in your weekly routine is an excellent way to become more active.”

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Zero-calorie sweetener linked to heart attack and stroke, study finds | CNN

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CNN
—

A sugar replacement called erythritol – used to add bulk or sweeten stevia, monkfruit and keto reduced-sugar products – has been linked to blood clotting, stroke, heart attack and death, according to a new study.

“The degree of risk was not modest,” said lead study author Dr. Stanley Hazen, director of the Center for Cardiovascular Diagnostics and Prevention at the Cleveland Clinic Lerner Research Institute.

People with existing risk factors for heart disease, such as diabetes, were twice as likely to experience a heart attack or stroke if they had the highest levels of erythritol in their blood, according to the study, published Monday in the journal Nature Medicine.

“If your blood level of erythritol was in the top 25% compared to the bottom 25%, there was about a two-fold higher risk for heart attack and stroke. It’s on par with the strongest of cardiac risk factors, like diabetes,” Hazen said.

Additional lab and animal research presented in the paper revealed that erythritol appeared to be causing blood platelets to clot more readily. Clots can break off and travel to the heart, triggering a heart attack, or to the brain, triggering a stroke.

“This certainly sounds an alarm,” said Dr. Andrew Freeman, director of cardiovascular prevention and wellness at National Jewish Health, a hospital in Denver, who was not involved in the research.

“There appears to be a clotting risk from using erythritol,” Freeman said. “Obviously, more research is needed, but in an abundance of caution, it might make sense to limit erythritol in your diet for now.”

In response to the study, the Calorie Control Council, an industry association, told CNN that “the results of this study are contrary to decades of scientific research showing reduced-calorie sweeteners like erythritol are safe, as evidenced by global regulatory permissions for their use in foods and beverages,” said Robert Rankin, the council’s executive director, in an email.

The results “should not be extrapolated to the general population, as the participants in the intervention were already at increased risk for cardiovascular events,” Rankin said.

The European Association of Polyol Producers declined to comment, saying it had not reviewed the study.

Like sorbitol and xylitol, erythritol is a sugar alcohol, a carb found naturally in many fruits and vegetables. It has about 70% of the sweetness of sugar and is considered zero-calorie, according to experts.

Artificially manufactured in massive quantities, erythritol has no lingering aftertaste, doesn’t spike blood sugar and has less of a laxative effect than some other sugar alcohols.

“Erythritol looks like sugar, it tastes like sugar, and you can bake with it,” said Hazen, who also directs the Cleveland Clinic’s Center for Microbiome and Human Health.

“It’s become the sweetheart of the food industry, an extremely popular additive to keto and other low-carb products and foods marketed to people with diabetes,” he added. “Some of the diabetes-labeled foods we looked at had more erythritol than any other item by weight.”

Erythritol is also the largest ingredient by weight in many “natural” stevia and monkfruit products, Hazen said. Because stevia and monkfruit are about 200 to 400 times sweeter than sugar, just a small amount is needed in any product. The bulk of the product is erythritol, which adds the sugar-like crystalline appearance and texture consumers expect.

The discovery of the connection between erythritol and cardiovascular issues was purely accidental, Hazen said: “We never expected this. We weren’t even looking for it.”

Hazen’s research had a simple goal: find unknown chemicals or compounds in a person’s blood that might predict their risk for a heart attack, stroke or death in the next three years. To do so, the team began analyzing 1,157 blood samples in people at risk for heart disease collected between 2004 and 2011.

“We found this substance that seemed to play a big role, but we didn’t know what it was,” Hazen said. “Then we discovered it was erythritol, a sweetener.”

The human body naturally creates erythritol but in very low amounts that would not account for the levels they measured, he said.

To confirm the findings, Hazen’s team tested another batch of blood samples from over 2,100 people in the United States and an additional 833 samples gathered by colleagues in Europe through 2018. About three-quarters of the participants in all three populations had coronary disease or high blood pressure, and about a fifth had diabetes, Hazen said. Over half were male and in their 60s and 70s.

In all three populations, researchers found that higher levels of erythritol were connected to a greater risk of heart attack, stroke or death within three years.

But why? To find out, researchers did further animal and lab tests and discovered that erythritol was “provoking enhanced thrombosis,” or clotting in the blood, Hazen said.

Clotting is necessary in the human body, or we would bleed to death from cuts and injuries. The same process is constantly happening internally, as well.

“Our blood vessels are always under pressure, and we spring leaks, and blood platelets are constantly plugging these holes all the time,” Hazen said.

However, the size of the clot made by platelets depends on the size of the trigger that stimulates the cells, he explained. For example, if the trigger is only 10%, then you only get 10% of a clot.

“But what we’re seeing with erythritol is the platelets become super responsive: A mere 10% stimulant produces 90% to 100% of a clot formation,” Hazen said.

“For people who are at risk for clotting, heart attack and stroke – like people with existing cardiac disease or people with diabetes – I think that there’s sufficient data here to say stay away from erythritol until more studies are done,” Hazen said.

Oliver Jones, a professor of chemistry at RMIT University in Victoria, Australia, noted that the study had revealed only a correlation, not causation.

“As the authors themselves note, they found an association between erythritol and clotting risk, not definitive proof such a link exists,” Jones, who was not involved in the research, said in a statement.

“Any possible (and, as yet unproven) risks of excess erythritol would also need to be balanced against the very real health risks of excess glucose consumption,” Jones said.

In a final part of the study, eight healthy volunteers drank a beverage that contained 30 grams of erythritol, the amount many people in the US consume, Hazen said, according to the National Health and Nutrition Examination Survey, which examines American nutrition each year.

Blood tests over the next three days tracked erythritol levels and clotting risk.

“Thirty grams was enough to make blood levels of erythritol go up a thousandfold,” Hazen said. “It remained elevated above the threshold necessary to trigger and heighten clotting risk for the following two to three days.”

Just how much is 30 grams of erythritol? The equivalent of eating a pint of keto ice cream, Hazen said.

“If you look at nutrition labels on many keto ice creams, you’ll see ‘reducing sugar’ or ‘sugar alcohol,’ which are terms for erythritol. You’ll find a typical pint has somewhere between 26 and 45 grams in it,” he said.

“My co-author and I have been going to grocery stores and looking at labels,” Hazen said. “He found a ‘confectionery’ marketed to people with diabetes that had about 75 grams of erythritol.”

There is no firm “accepted daily intake,” or ADI, set by the European Food Safety Authority or the US Food and Drug Administration, which considers erythritol generally recognized as safe (GRAS).

“Science needs to take a deeper dive into erythritol and in a hurry, because this substance is widely available right now. If it’s harmful, we should know about it,” National Jewish Health’s Freeman said.

Hazen agreed: “I normally don’t get up on a pedestal and sound the alarm,” he said. “But this is something that I think we need to be looking at carefully.”

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Beware the budget butt lift, regulators warn amid social media-inspired boom | CNN

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In hindsight, Nikki Ruston said, she should have recognized the red flags.

The office in Miami where she scheduled what’s known as a Brazilian butt lift had closed and transferred her records to a different facility, she said. The price she was quoted – and paid upfront – increased the day of the procedure, and she said she did not meet her surgeon until she was about to be placed under general anesthesia.

“I was ready to walk out,” said Ruston, 44, of Lake Alfred in Central Florida. “But I had paid everything.”

A few days after the July procedure, Ruston was hospitalized due to infection, blood loss, and nausea, her medical records show.

“I went cheap. That’s what I did,” Ruston recalled recently. “I looked for the lowest price, and I found him on Instagram.”

People like Ruston are commonly lured to office-based surgery centers in South Florida through social media marketing that makes Brazilian butt lifts and other cosmetic surgery look deceptively painless, safe, and affordable, say researchers, patient advocates, and surgeon groups.

Unlike ambulatory surgery centers and hospitals, where a patient might stay overnight for observation after treatment, office-based surgery centers offer procedures that don’t typically require an inpatient stay and are regulated as an extension of a doctor’s private practice.

But such surgical offices are often owned by corporations that can offer discount prices by contracting with surgeons who are incentivized to work on as many patients per day as possible, in as little time as possible, according to state regulators and physicians critical of the facilities.

Ruston said she now lives with constant pain, but for other patients a Brazilian butt lift cost them their lives. After a rash of deaths, and in the absence of national standards, Florida regulators were the first in the nation to enact rules in 2019 meant to make the procedures safer. More than three years later, data shows deaths still occur.

Patient advocates and some surgeons – including those who perform the procedure themselves – anticipate the problem will only get worse. Emergency restrictions imposed by the state’s medical board in June expired in September, and the corporate business model popularized in Miami is spreading to other cities.

“We’re seeing entities that have a strong footprint in low-cost, high-volume cosmetic surgery, based in South Florida, manifesting in other parts of the country,” said Dr. Bob Basu, a vice president of the American Society of Plastic Surgeons and a practicing physician in Houston.

During a Brazilian butt lift, fat is taken via liposuction from other areas of the body – such as the torso, back, or thighs – and injected into the buttocks. More than 61,000 buttock augmentation procedures, both butt lifts and implants, were performed nationwide in 2021, a 37% increase from the previous year, according to data from the Aesthetic Society, a trade group of plastic surgeons.

As with all surgery, complications can occur. Miami-Dade County’s medical examiner has documented nearly three dozen cosmetic surgery patient deaths since 2009, of which 26 resulted from a Brazilian butt lift. In each case, the person died from a pulmonary fat embolism, when fat entered the bloodstream through veins in the gluteal muscles and stopped blood from flowing to the lungs.

No national reporting system nor insurance code tracks outcomes and patient demographics for a Brazilian butt lift. About 3% of surgeons worldwide had a patient die as a result of the procedure, according to a 2017 report from an Aesthetic Surgery Education and Research Foundation task force.

Medical experts said the problem is driven, in part, by having medical professionals like physician assistants and nurse practitioners perform key parts of the butt lift instead of doctors. It’s also driven by a business model that is motivated by profit, not safety, and incentivizes surgeons to exceed the number of surgeries outlined in their contracts.

In May, after a fifth patient in as many months died of complications in Miami-Dade County, Dr. Kevin Cairns proposed the state’s emergency rule to limit the number of butt lifts a surgeon could perform each day.

“I was getting sick of reading about women dying and seeing cases come before the board,” said Cairns, a physician and former member of the Florida Board of Medicine.

Some doctors performed as many as seven, according to disciplinary cases against surgeons prosecuted by the Florida Department of Health. The emergency rule limited them to no more than three, and required the use of an ultrasound to help surgeons lower the risk of a pulmonary fat clot.

But a group of physicians who perform Brazilian butt lifts in South Florida clapped back and formed Surgeons for Safety. They argued the new requirements would make the situation worse. Qualified doctors would have to do fewer procedures, they said, thus driving patients to dangerous medical professionals who don’t follow rules.

The group has since donated more than $350,000 to the state’s Republican Party, Republican candidates, and Republican political action committees, according to campaign contribution data from the Florida Department of State.

Surgeons for Safety declined KHN’s repeated interview requests. Although the group’s president, Dr. Constantino Mendieta, wrote in an August editorial that he agreed not all surgeons have followed the standard of care, he called the limits put on surgeons “arbitrary.” The rule sets “a historic precedent of controlling surgeons,” he said during a meeting with Florida’s medical board.

In January, Florida state Sen. Ileana Garcia, a Republican, filed a draft bill with the state legislature that proposes no limit on the number of Brazilian butt lifts a surgeon can perform in a day. Instead, it requires office surgery centers where the procedures are performed to staff one physician per patient and prohibits surgeons from working on more than one person at a time.

The bill would also allow surgeons to delegate some parts of the procedure to other clinicians under their direct supervision, and the surgeon must use an ultrasound.

Florida’s legislature convenes on March 7.

Consumers considering cosmetic procedures are urged to be cautious. Like Ruston, many people base their expectations on before-and-after photos and marketing videos posted on social media platforms such as Facebook, Snapchat, and Instagram.

“That’s very dangerous,” said Basu, of the American Society of Plastic Surgeons. “They’re excited about a low price and they forget about doing their homework,” he said.

The average price of a buttocks augmentation in 2021 was $4,000, according to data from the Aesthetic Society. But that’s only for the physician’s fee and does not cover anesthesia, operating room fees, prescriptions, or other expenses. A “safe” Brazilian butt lift, performed in an accredited facility and with proper aftercare, costs between $12,000 and $18,000, according to a recent article on the American Society of Plastic Surgeons’ website.

Although Florida requires a physician’s license to perform liposuction on patients who are under general anesthesia, it’s common in the medical field for midlevel medical practitioners, such as physician assistants and nurse practitioners, to do the procedure in office settings, according to Dr. Mark Mofid, who co-authored the 2017 Aesthetic Surgery Education and Research Foundation task force study.

By relying on staffers who don’t have the same specialty training and get paid less, office-based surgeons can complete more butt lifts per day and charge a lower price.

“They’re doing all of them simultaneously in three or four different rooms, and it’s being staffed by one surgeon,” said Mofid, a plastic surgeon in San Diego, who added that he does not perform more than one Brazilian butt lift in a day. “The surgeon isn’t doing the actual case. It’s assistants.”

Basu said patients should ask whether their doctor holds privileges to perform the same procedure at a hospital or ambulatory surgery center, which have stricter rules than office surgery centers in terms of who can perform butt lifts and how they should be done.

People in search of bargains are reminded that cosmetic surgery can have other serious risks beyond the deadly fat clots, such as infection and organ puncture, plus problems with the kidneys, heart, and lungs.

Ruston’s surgery was performed by a board-certified plastic surgeon she said she found on Instagram. She was originally quoted $4,995, which she said she paid in full before surgery. But when she arrived in Miami, she said, the clinic tacked on fees for liposuction and for post-surgical garments and devices.

“I ended up having to pay, like, $8,000,” Ruston said. A few days after Ruston returned home to Lake Alfred, she said, she started to feel dizzy and weak and called 911.

Paramedics took her to an emergency room, where doctors diagnosed her with anemia due to blood loss, and blood and abdominal infections, her medical records show.

“If I could go back in time,” she said, “I wouldn’t have had it done.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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President Carter is on hospice care, but what is it? Our medical analyst explains | CNN

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On Saturday, the Carter Center announced that former US President Jimmy Carter will be receiving hospice care at his home in Georgia.

“After a series of short hospital stays, former US President Jimmy Carter today decided to spend his remaining time at home with his family and receive hospice care instead of additional medical intervention,” according to the statement. “He has the full support of his family and his medical team.”

The 98-year-old Carter is the oldest living US president in history. He has survived metastatic brain cancer and faced a number of health scares, including brain surgery following a fall in 2019.

As Carter opted for hospice care, CNN Medical Analyst Dr. Leana Wen and I thought that many people might be unfamiliar with hospice care beyond a vague understanding that some people receive it toward the end of life. There can be benefits and blessings for the person receiving the care and their loved ones, but there are also some common misconceptions about what it involves.

I asked Dr. Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health, to guide us through some questions.

CNN: What is hospice care and who qualifies for it?

Dr. Leana Wen: Hospice care is a type of specialty medical care for people near the end of their lives that focuses on maximizing comfort for the patient and support for the patient and their family. That includes reducing physical pain and tending to the psychological, emotional and spiritual needs of the patient and the family.

Generally, to qualify for hospice care, the patient must have an incurable medical condition with an anticipated life expectancy of less than six months. The types of medical conditions that patients have include end-stage cancer, advanced dementia, heart failure and chronic obstructive pulmonary disease.

CNN: Where do patients receive hospice care and who provides it?

Wen: Hospice care is an approach to medical care, not a specific place, so it can be provided in a number of different settings. The choice of settings is up to the patient and family. Providers are an interdisciplinary team of physicians, nurses, home health aides, pharmacists and others who will tend to the patient no matter what setting they choose.

Many patients opt to receive hospice care in their homes, where they can be in familiar surroundings. The hospice team helps to provide equipment, supplies and staff to assist the family to care for their loved one. They provide regular home visits and are generally available around the clock for concerns as they come up.

Hospice can also be delivered in a nursing home or at the hospital. In addition, there are specialized hospice centers.

CNN: What are some common misconceptions of hospice care?

Wen: There is a misconception that hospice care is “giving up” on medical care. Actually, hospice care is a specific type of compassionate medical care for patients in the last stages of incurable disease to live as fully and comfortably as they can. A primary aim of hospice care is to manage the patient’s symptoms so that the patient’s last days can be spent with their loved ones, with dignity and the highest quality possible.

A second misconception is that once a patient enters hospice care, they can no longer receive any medical treatment. This is not true. Patients receive medicines to help their symptoms and alleviate their pain. They and their families can also choose to leave hospice at any point and resume, say, active treatment for their cancer.

I’ve also heard people say that hospice care is only for people with a few days to live. This is also not the case. Often, patients don’t begin hospice care soon enough to take full advantage of the help it offers. Beginning it earlier may help provide months — rather than days — of quality time with loved ones.

CNN: What are the benefits and blessings of this type of care?

Wen: In modern medicine, the tendency is to approach diseases as something to be cured. Unfortunately, this is not always possible. The patient may choose not to continue certain treatments that cause severe pain when there is slim chance for a cure. When there is limited time left to live, that patient may wish to minimize suffering and to prioritize spending the remaining time with their loved ones.

I know the benefits and blessings of hospice care firsthand. My mother was diagnosed with metastatic breast cancer in her 40s. She fought her cancer valiantly, undergoing multiple rounds of surgery, radiation and chemotherapy for eight years. Unfortunately, she had multiple recurrences.

During the final recurrence, it became clear that a cure was not possible and that she had limited time — as it turns out, weeks — to live. She opted to enter hospice care, with the aim to spend her final days at home, rather than in the hospital, and with the aim of alleviating her pain and suffering rather going through yet another round of chemotherapy. I understood and supported her decision, and it was important to me and my family to give her what she wanted, which was the highest quality of life with the least amount of suffering.

CNN: Does insurance cover hospice care?

Wen: Most hospice patients are eligible for Medicare, which provides for hospice care through Medicare Hospital Benefit. Medicaid also pays for hospice care in many states, and many private insurers will cover it. For patients who don’t have insurance, there are some community programs that offer sliding scale coverage or free care.

CNN: What’s the difference between hospice and palliative care?

Wen: There are physicians, nurses and other medical professionals who specialize in hospice and palliative medicine; these are very much complementary and related fields of medicine that share a similar philosophy.

Palliative care, like hospice care, also prioritizes easing suffering, improving the quality for the patient, and delivering that care in a way that centers the patient and family. But differently from hospice care, the patient doesn’t have to forgo curative treatment – palliative care can be provided together with curative treatment. Over time, if it becomes apparent that the patient is likely to die within six months, palliative care can transition over to hospice care.

Both hospice and palliative care are important specialty medical services that are underutilized, and can offer much support and comfort to many more patients and families.

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