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Breast cancer vaccine update from Cleveland Clinic: ‘A new era’

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Breast cancer vaccine update from Cleveland Clinic: ‘A new era’

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A breast cancer vaccine could be closer to reality, according to Cleveland Clinic, as its researchers have announced some encouraging results.

At the Society for Immunotherapy of Cancer earlier this month in Texas, researchers shared updated findings from a study of a new vaccine designed to target triple-negative breast cancer, a press release stated.

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Triple-negative breast cancer (TNBC) is a highly aggressive type of breast cancer, according to the American Cancer Society (ACS).

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TNBC grows and spreads faster than less aggressive types and is more difficult to treat.

G. Thomas Budd, M.D., lead study researcher, is pictured in the Cleveland Clinic lab. “The investigational vaccine represents a potential new way to combat breast cancer,” he said. (Courtesy of Cleveland Clinic)

The breast cancer vaccine that Cleveland Clinic is studying is the first that aims to prevent triple-negative breast cancer from developing, according to G. Thomas Budd, M.D., principal investigator of the phase 1 study at Cleveland Clinic’s Cancer Institute.

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The vaccine uses a protein found in breast tissue that is dedicated to lactation — called α-lactalbumin — which is no longer created after a woman is past childbearing age, Budd told Fox News Digital.

“Employing a retired lactation protein as a breast cancer vaccine autoantigen made sense because most breast cancers occur in women ages 40 and older, and the vast majority of those women no longer breastfeed,” he said.

A researcher conducts a breast cancer vaccine-related experiment in a lab at Cleveland Clinic. The vaccine uses a protein found in breast tissue that is dedicated to lactation, called α-lactalbumin. (Courtesy of Cleveland Clinic)

This protein was selected because it is no longer found in detectable amounts in normal, aging breast tissues, but is expressed at high levels in more than 70% of triple-negative breast cancers, Budd shared.

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“The investigational vaccine represents a potential new way to combat breast cancer,” he said.

“It represents a paradigm shift in how we approach cancer care — focusing on prevention rather than treatment after the fact.”

In the Phase 1 trial, the researchers found that the investigational vaccine was “generally well-tolerated and produced an immune response in most patients,” according to a Cleveland Clinic press release. 

The team also presented the vaccine’s side effects, highest tolerated dose and immunologic effects, the release stated.

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The Phase 1 trial, funded by the U.S. Department of Defense, was conducted at Cleveland Clinic’s main campus in partnership with Anixa Biosciences, Inc., a California-based biotechnology company focused on treating and preventing cancer. 

It included 26 patients in three separate groups.

A pharmacy research technican demonstrates a mock preparation of the new breast cancer vaccine. (Courtesy of Cleveland Clinic)

These findings come after nearly two decades of research by the late Vincent Tuohy, PhD, of Cleveland Clinic Lerner Research Institute, Budd noted.  

Next year, Anixa plans to launch a Phase 2 study to gauge the vaccine’s effectiveness.

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“Our hope is that future studies will demonstrate that the antigen-specific T cell responses we observed translate to the prevention of triple-negative breast cancer recurrence,” Budd said.

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Fox News medical contributor Dr. Nicole Saphier called the development of breast cancer vaccines “groundbreaking and exciting.”

“It represents a paradigm shift in how we approach cancer care — focusing on prevention rather than treatment after the fact,” Saphier, who was not involved in the research, told Fox News Digital. 

A vial of the breast cancer vaccine is pictured in the lab. “The entire cancer community eagerly awaits further advancements in this area, as it could usher in a new era of cancer prevention strategies,” a doctor said. (Courtesy of Cleveland Clinic)

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“If successful, such vaccines could significantly reduce the incidence of breast cancer, saving countless lives and reducing the emotional, physical and financial burdens associated with cancer treatment.”

 

Breast cancer vaccine development is particularly important for high-risk individuals, the doctor noted — “but also presents a potential for broader public health benefits, helping to ease the societal and economic impact of cancer.”

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Added Saphier, “The entire cancer community eagerly awaits further advancements in this area, as it could usher in a new era of cancer prevention strategies.”

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ChatGPT could miss your serious medical emergency, new study suggests

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ChatGPT could miss your serious medical emergency, new study suggests

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This story discusses suicide. If you or someone you know is having thoughts of suicide, please contact the Suicide & Crisis Lifeline at 988 or 1-800-273-TALK (8255).

Artificial intelligence has been touted as a boon to healthcare, but a new study has revealed its potential shortcomings when it comes to giving medical advice.

In January, OpenAI launched ChatGPT Health, the medical-focused version of the popular chatbot tool. 

The company introduced the tool as “a dedicated experience that securely brings your health information and ChatGPT’s intelligence together, to help you feel more informed, prepared and confident navigating your health.”

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But researchers at the Icahn School of Medicine at Mount Sinai have found that the tool failed to recommend emergency care for a “significant number” of serious medical cases.

The study, published in the journal Nature Medicine on Feb. 23, aimed to explore how ChatGPT Health — which is reported to have about 40 million users daily — handles situations where people are asking whether to seek emergency care.

Artificial intelligence has been touted as a boon to healthcare, but a new study has revealed its potential shortcomings when it comes to giving medical advice. (iStock)

“Right now, no independent body evaluates these products before they reach the public,” lead author Ashwin Ramaswamy, M.D., instructor of urology at the Icahn School of Medicine at Mount Sinai in New York City, told Fox News Digital.

“We wouldn’t accept that for a medication or a medical device, and we shouldn’t accept it for a product that tens of millions of people are using to make health decisions.”

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Emergency scenarios

The team created 60 clinical scenarios across 21 medical specialties, ranging from minor conditions to true medical emergencies.

Three independent physicians then assigned an appropriate level of urgency for each case, based on published clinical practice guidelines in 56 medical societies.

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The researchers conducted 960 interactions with ChatGPT Health to see how the tool responded, taking into account gender, race, barriers to care and “social dynamics.”

While “clear-cut emergencies” — such as stroke or severe allergy — were generally handled well, the researchers found that the tool “under-triaged” many urgent medical issues.  

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The team created 60 clinical scenarios across 21 medical specialties, ranging from minor conditions to true medical emergencies. (iStock)

For example, in one asthma scenario, the system acknowledged that the patient was showing early signs of respiratory failure — but still recommended waiting instead of seeking emergency care.

“ChatGPT Health performs well in medium-severity cases, but fails at both ends of the spectrum — the cases where getting it right matters most,” Ramaswamy told Fox News Digital. “It under-triaged over half of genuine emergencies and over-triaged roughly two-thirds of mild cases that clinical guidelines say should be managed at home.”

PARENTS FILE LAWSUIT ALLEGING CHATGPT HELPED THEIR TEENAGE SON PLAN SUICIDE

Under-triage can be life-threatening, the doctor noted, while over-triage can overwhelm emergency departments and delay care for those in real need.

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Researchers also identified inconsistencies in suicide risk alerts. In some cases, it directed users to the 988 Suicide and Crisis Lifeline in lower-risk scenarios, and in others, it failed to offer that recommendation even when a person discussed suicidal ideations.

“ChatGPT Health performs well in medium-severity cases, but fails at both ends of the spectrum.”

“The suicide guardrail failure was the most alarming,” study co-author Girish N. Nadkarni, M.D., chief AI officer of the Mount Sinai Health System, told Fox News Digital.

ChatGPT Health is designed to show a crisis intervention banner when someone describes thoughts of self-harm, the researcher noted.

OpenAI launched ChatGPT Health, the medical-focused version of the popular chatbot tool, in January 2026. (Gabby Jones/Bloomberg via Getty Images)

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“We tested it with a 27-year-old patient who said he’d been thinking about taking a lot of pills,” Nadkarni said. “When he described his symptoms alone, the banner appeared 100% of the time. Then we added normal lab results — same patient, same words, same severity — and the banner vanished.” 

“A safety feature that works perfectly in one context and completely fails in a nearly identical context … is a fundamental safety problem.”

CHATGPT HEALTH PROMISES PRIVACY FOR HEALTH CONVERSATIONS

The researchers were also surprised by the social influence aspect.

“When a family member in the scenario said ‘it’s nothing serious’ — which happens all the time in real life — the system became nearly 12 times more likely to downplay the patient’s symptoms,” Nadkarni said. “Everyone has a spouse or parent who tells them they’re overreacting. The AI shouldn’t be agreeing with them during a potential emergency.”

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Fox News Digital reached out to Open AI, creator of ChatGPT, requesting comment.

Physicians react

Dr. Marc Siegel, Fox News senior medical analyst, called the new study “important.” 

“It underlines the principle that while large language models can triage clear-cut emergencies, they have much more trouble with nuanced situations,” Siegel, who was not involved in the study, told Fox News Digital. 

ChatGPT and other LLMs can be helpful tools, a doctor said, but they “should not be used to give medical direction.” (iStock)

“This is where doctors and clinical judgment come in — knowing the nuances of a patient’s history and how they report symptoms and their approach to health.”

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ChatGPT and other LLMs can be helpful tools, Siegel said, but they “should not be used to give medical direction.”

“Machine learning and continued input of data can help, but will never compensate for the essential problem – human judgment is needed to decide whether something is a true emergency or not.”

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Dr. Harvey Castro, an emergency physician and AI expert in Texas, echoed the importance of the study, calling it “exactly the kind of independent safety evaluation we need.”

“Innovation moves fast. Oversight has to move just as fast,” Castro, who also did not work on the study, told Fox News Digital. “In healthcare, the most dangerous mistakes happen at the extremes, when something looks mild but is actually catastrophic. That’s where clinical judgment matters most, and where AI must be stress-tested.”

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Study limitations

The researchers acknowledged some potential limitations in the study design.

“We used physician-written clinical scenarios rather than real patient conversations, and we tested at a single point in time — these systems update frequently, so performance may change,” Ramaswamy told Fox News Digital.

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Additionally, most of the missed emergencies happened in situations where the danger depended on how the condition was changing over time. It’s not clear whether the same problem would happen with acute medical emergencies.

Because the system had to choose just one fixed urgency category, the test may not reflect the more nuanced advice it might give in a back-and-forth conversation, the researchers noted. 

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ChatGPT Health is designed to show a crisis intervention banner when someone describes thoughts of self-harm. (iStock)

Also, the study wasn’t large enough to confidently detect small differences in how recommendations might vary by race or gender.

“We need continuous auditing, not one-time studies,” Castro noted. “These systems update frequently, so evaluation must be ongoing.”

‘Don’t wait’

The researchers emphasized the importance of seeking immediate care for serious issues.

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“If something feels seriously wrong — chest pain, difficulty breathing, a severe allergic reaction, thoughts of self-harm — go to the emergency department or call 988,” Ramaswamy advised. “Don’t wait for an AI to tell you it’s OK.”

The researchers noted that they support the use of AI to improve healthcare access, and that they didn’t conduct the study to “tear down the technology.”

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“These tools can be genuinely useful for the right things — understanding a diagnosis you’ve already received, looking up what your medications do and their side effects, or getting answers to questions that didn’t get fully addressed in a short doctor’s visit,” Ramaswamy said. 

“That’s a very different use case from deciding whether you need emergency care. Treat them as a complement to your doctor, not a replacement.”

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“This study doesn’t mean we abandon AI in healthcare.”

Castro agreed that the benefits of AI health tools should be weighed against the risks.

“AI health tools can increase access, reduce unnecessary visits and empower patients with information,” he said. “They are not inherently unsafe, but they are not yet substitutes for clinical judgment.”

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“This study doesn’t mean we abandon AI in healthcare,” he went on. “It means we mature it. Independent testing and stronger guardrails will determine whether AI becomes a safety net or a liability.”

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Diabetes surge among Americans could be driven by ‘healthy’ breakfasts, doctor warns

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Diabetes surge among Americans could be driven by ‘healthy’ breakfasts, doctor warns

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Americans consume foods every day that are marketed as “healthy,” when they could be quietly destroying their health, one doctor warns.

Dr. Mark Hyman, physician and co-founder of Function Health in California, says that much of America’s daily diet is filled with unhealthy ingredients.

“The amount of refined starches and sugars that are everywhere is just staggering to me, given what we know about how harmful they are,” he shared in an interview with Fox News Digital. “I don’t think people really understand.”

Hyman, author of the new book “Food Fix Uncensored,” said he’s “astounded” by what people are eating, especially for breakfast.

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“People just eat sugar for breakfast,” he said. “They have muffins, they have bagels, they have croissants, they have sugar-sweetened coffees and teas.”

Dr. Mark Hyman is the author of the new book “Food Fix Uncensored.” (Function Health; Little, Brown Spark)

In addition to the traditionally sweet options for breakfast, some cereal brands and breakfast staples have adopted new “protein-packed” menu items and products, following health trends that encourage eating more protein.

“Highly processed food is not food.”

“Now, we’re seeing this halo of protein in certain things,” Hyman said, mentioning that many protein smoothies are “full of sugar.”

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The doctor also noted that some popular cereals are now marketed as having protein in them. “My joke is, if it has a health claim on the label, it’s definitely bad for you,” he said.

Instead of starting the day with a “quick fix” or processed food, Hyman suggests choosing whole sources of protein and fat for breakfast, adding that “if there’s a little carbohydrate in there, it’s fine.”

More products marketed as “high protein” have cropped up on supermarket shelves. (iStock)

For his own breakfast, Hyman said he has a protein shake with whey protein, avocado and frozen berries. Eggs and avocados are also a great protein-and-fat combo option, he added.

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“It’s not that complicated — people need to just think about their breakfast not being dessert,” he said. “No wonder we’re in this cycle of obesity and diabetes. One in three teenage kids now has type 2 diabetes or pre-diabetes. That’s just criminal.”

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Instead of counting calories and being in a caloric deficit as a way to lose weight and stay healthy, Hyman instead suggests focusing on how certain foods make you feel and how they impact your health.

“When you look at the way in which different types of calories affect your biology, you can just choose what you’re eating, and then you don’t have to worry about how much,” he told Fox News Digital.

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In addition to the traditionally sweet options for breakfast, some cereal brands and breakfast staples have adopted new “protein-packed” menu items and products. (iStock)

“For example, if you eat a diet that doesn’t cause your insulin to spike — which is low in starch and sugar, higher in protein and fat — you won’t develop those swings in blood sugar, you won’t develop the spikes in insulin, you won’t deposit hungry fat … You will break that cycle.”

People are more likely to “self-regulate when they eat real food” instead of processed foods, which “bypasses the normal mechanisms of satiety, fullness and brain chemistry,” according to Hyman.

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“Ultraprocessed food and junk food or highly processed food is not food,” he said. “It doesn’t support the health and well-being of an organism. It doesn’t do that. It does the opposite.”

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Scientists make startling discovery when examining prostate cancer tissue

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Scientists make startling discovery when examining prostate cancer tissue

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Small fragments of plastic were found in the tumors of most prostate cancer patients, according to a new study from NYU Langone Health. 

In past studies, microplastics have been found in almost every human organ and in bodily fluids, but their impact on human health still isn’t fully understood.

The researchers analyzed tissue samples from 10 patients with prostate cancer who underwent surgery to remove the entire organ. 

Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples, according to the study press release.

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In past studies, microplastics were found in almost every single human organ along with bodily fluids, even the placenta. (iStock)

The cancerous tissue contained on average more than double the amount of plastic as healthy prostate tissue samples, the study found. This equates to about 40 micrograms of plastic per gram of tissue compared to 16 micrograms.

Researchers avoided contaminating the samples with other plastics by substituting standard tools with those made of aluminum, cotton and other non-plastic material, the release noted.

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The scientists say this is the first direct evidence linking microplastics to prostate cancer.

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“By uncovering yet another potential health concern posed by plastic, our findings highlight the need for stricter regulatory measures to limit the public’s exposure to these substances, which are everywhere in the environment,” said senior study author Vittorio Albergamo, assistant professor in the department of pediatrics at NYU Grossman School of Medicine, in the release.

Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples. (iStock)

The study findings were presented during the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco on Feb. 26.

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“What is most striking is not that microplastics were detected, but that they were found embedded within tumor tissue itself,” Dr. David Sidransky, oncologist and medical advisor at SpotitEarly, a startup that offers an at-home breath-based test to detect early-stage cancer, told Fox News Digital.

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“While complete avoidance is unrealistic, people can take practical steps to reduce exposure.”

“We already know microplastics are present in water, air, blood and even placental tissue. Their detection in prostate tumors suggests systemic distribution and long-term bioaccumulation,” added Maryland-based Sidransky, who was not involved in the study.

Study limitations

Albergamo cautioned that a larger sample is needed to confirm the findings. Additionally, Sidransky noted that the presence of microplastics alone does not prove they cause cancer.

“Tumors can act as ‘biologic sinks,’ meaning they may accumulate circulating particles simply because of altered vasculature and permeability,” he said.

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A key unanswered question, according to the doctor, is whether microplastics are biologically active in ways that “promote DNA damage, immune modulation or chronic inflammation within the prostate.”

About one in eight men in the U.S. will be diagnosed with prostate cancer at some point in their lifetime, according to the Centers for Disease Control and Prevention.

The most actionable step men can take is appropriate screening and early detection, according to doctors. (iStock)

For those concerned about microplastics, Sidransky offered some insights.

“I believe the appropriate response is curiosity, not panic, and a commitment to understand more,” he said.

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“While complete avoidance is unrealistic, people can take practical steps to reduce exposure, such as minimizing heating food in plastic containers, reducing bottled water consumption when possible, and favoring glass or stainless steel alternatives.”

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The most actionable step men can take, however, is getting appropriate screenings to help ensure early detection, according to the doctor. Screening discussions should be individualized based on age, family history and other risk factors.

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