Health
F.D.A. Expands Access to Clozapine, a Key Treatment for Schizophrenia
The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the most devastating of mental illnesses.
The agency announced on Monday that it was eliminating a requirement that patients submit blood tests before their prescriptions can be filled.
Clozapine, which was approved in 1989, is regarded by many physicians as the most effective available treatment for schizophrenia, and research shows that the drug significantly reduces suicidal behavior. Clozapine is also associated with a rare side effect called neutropenia, a drop in white blood cell counts that, in its most severe form, can be life-threatening.
In 2015, federal regulators imposed a regimen known as risk evaluation and mitigation strategies, or REMS, that required patients to submit to weekly, biweekly and monthly blood tests that had to be uploaded onto a database and verified by pharmacists.
Physicians have long complained that, as a result, clozapine is grossly underutilized.
Dr. Frederick C. Nucifora, director of the Adult Schizophrenia Clinic at the Johns Hopkins School of Medicine, said he believed that around 30 percent of patients with schizophrenia would benefit from clozapine — far more than the 4 percent who currently take it.
“I have had many patients who were doing terribly, who struggled to function outside the hospital, and cycled through many medications,” he said. “If they go on clozapine, they really tend to not be hospitalized again. I’ve had people go on to finish college and work. It’s quite remarkable.”
The F.D.A.’s shift came after years of lobbying by pharmacists, clinicians and relatives of people with schizophrenia, who cataloged the cases of patients who deteriorated after losing access to clozapine.
“There were patients who ended up relapsing into psychosis, patients who ended up hospitalized, patients who became violent,” said Raymond C. Love, a professor emeritus at the University of Maryland School of Pharmacy, who helped organize the effort.
When an advisory committee to the F.D.A. reviewed the requirement at a meeting in November, he said, the agency had to expand the public docket to accommodate the number of people who wanted to speak.
“That was how much the outcry was,” he said. “There were people in tears.”
In a statement published on its website on Monday, the F.D.A. said it had determined that the testing regimen was “no longer necessary to ensure that the benefits of the medicine outweigh” the risk of severe neutropenia. Its prevalence is estimated at around 0.9 percent worldwide and decreases after the first six months of treatment.
But Dr. John M. Kane, a leading schizophrenia researcher, said he did not expect a substantial shift in prescribing as a result of the change. Even without the testing regimen, he said, many physicians are hesitant to prescribe clozapine because it requires close monitoring during the early months of treatment.
“Probably 1 in 8 patients in the U.S. who might benefit from clozapine are getting it,” said Dr. Kane, a professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell. For a portion of them, he said, the medication is “life-changing.”
Psychotic disorders like schizophrenia affect 1 percent to 3 percent of the adult population, but the disease is a crushing burden to society. The illness typically emerges in late adolescence and is characterized by psychotic symptoms, like hallucinations or delusions, as well as by social withdrawal, cognitive impairment and a lack of motivation.
Studies suggest that the risk of suicide for people with schizophrenia is at least 10 times as high as that for the general population.
Though many people manage their symptoms with the help of their families, others cycle through incarcerations, homelessness and brief hospitalizations. A 2022 analysis of the economic burden associated with the disease published in The Journal of Clinical Psychiatry estimated the yearly cost at $343.2 billion, largely from caregiving, premature mortality and unemployment.
The first antipsychotic medication, chlorpromazine, became available 70 years ago, and was followed by two waves of new treatments designed to alter dopamine pathways in the brain. But the pace of discovery slowed after that, as vast sums of research funding were devoted to investigating the genetics of the disease. Last September, the F.D.A. approved Cobenfy, the first novel antipsychotic treatment in decades.
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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.
“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.
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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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.
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.
“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.
“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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