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MorningMed is the best way to keep up with the world of health and medicine through curated round-ups, useful insights and other practical resources.

The European Medicines Agency (EMA) is investigating Novo Nordisk's diabetes drug Ozempic and weight-loss treatment Saxenda after three cases of patients reporting suicidal thoughts or self-harm were flagged by Iceland's health regulator. The investigation focuses on medicines containing semaglutide or liraglutide, including Novo's obesity treatment Wegovy. Novo Nordisk stated that it treats all reports of adverse events seriously and that its safety monitoring has found no causal association between the drugs and self-harming thoughts. The EMA will consider whether the review should be extended to other GLP-1 receptor agonist medicines.

President Joe Biden announced new actions aimed at lowering health care costs and limiting "junk fees" in the insurance industry. The administration's efforts include proposed rules to close loopholes that allow companies to offer misleading insurance products and discriminate based on pre-existing conditions. The new rules would require insurance companies to provide clear upfront disclaimers about coverage and further curb surprise medical billing. The administration will also address issues related to facility fees and consumer protections when signing up patients for third-party medical credit cards. These actions are part of President Biden's economic vision, known as "Bidenomics," which aims to restore the American dream and reduce costs for everyday Americans.

Dozens of cases of dangerous and potentially deadly viral sepsis in babies across Europe have raised concerns among pediatric infectious diseases experts in the United States. The World Health Organization (WHO) confirmed at least 26 cases of infants infected with a rare type of enterovirus, called echovirus-11, in countries including Croatia, France, Italy, Spain, Sweden, and the United Kingdom. Eight of the infected babies have died. While enteroviruses typically cause mild illness, they can severely affect newborns whose immune systems are not mature enough to fight off infection. Experts in the U.S. are urging pediatricians and families to be aware of the potential for enterovirus infections, especially as viral activity is expected to increase during the summer and early fall. The Centers for Disease Control and Prevention (CDC) does not have an active reporting system for neonatal enteroviral disease, but they are monitoring any changes in enterovirus transmission. Treatment for enterovirus infections in newborns is limited to supportive care, and there is currently no approved antiviral medication. Researchers are studying tissue samples to better understand the disease and develop effective treatments.

The study conducted by Portuguese researchers delves into the relationship between coffee, caffeine, and brain activity. By analyzing MRI scans of coffee drinkers, the researchers found that both coffee and caffeine trigger decreased activity in a brain region associated with resting state, indicating readiness to start the day. However, drinking coffee specifically led to increased activity in brain regions linked to memory, attention, and focus, whereas caffeine alone did not elicit the same response. These findings suggest that factors beyond caffeine, such as the sensory experience and ritualistic aspect of drinking coffee, may contribute to the feeling of alertness reported by coffee drinkers. The researchers caution that the study has limitations and is not meant to influence coffee consumption habits, but rather to explore the underlying brain mechanisms involved. Additionally, they highlight the potential health benefits of coffee, including its antioxidant content and natural compounds that may improve metabolism and overall well-being.

In an op-ed for the American Journal of Nursing, Angelina Jolie, the actor and humanitarian, has spoken out about racial disparities in healthcare and how they have put her children of color at risk. Jolie, who has children from different racial backgrounds, shared her concerns about misdiagnosis and inadequate treatment due to the focus on white skin in medical research and training. She highlighted the issue of detecting bruises on darker skin colors and the lack of proper tools for documenting them. Jolie also shared a personal experience when her daughter Zahara was hospitalized, and a nurse's comment revealed the lack of understanding about healthcare disparities. She emphasized the need for new solutions to address racial disparities in healthcare, from technology to improved diversity and representation in medical research and training. Jolie's op-ed sheds light on the impact of systemic racism on health outcomes and calls for change in the healthcare system.

'Adoption, not abortion?' How the Dobbs decision is affecting adoption in the U.S.

• The nonprofit National Council for Adoption has observed variances among adoption agencies in states with strict abortion laws. The Gladney Center for Adoption has seen a 30% increase in domestic adoptions, while inquiries from pregnant women exploring adoption options have risen by 55%.
• However, there are concerns about potential challenges, such as an increase in babies with medical conditions being put up for adoption, the involvement of predatory "baby brokers," and the need for better support for birth mothers, including postpartum care and mental health services. Adoption trends and their relationship to the Dobbs decision remain complex and multifaceted.

Robert Lamarche, the director of ACF Adoptions, an agency based in Florida: “We used to typically get calls from women in their second trimester,” Lamarche said. “Now we get calls from women when they’re four weeks pregnant, five weeks pregnant, calling to figure out their options… A lot of those genetic anomalies are not detected until the second trimester, and these might have been pregnancies people would choose to terminate,” he said. “If the number goes up 25 to 30%, we’re going to have a problem, because we’re not going to have families for all the children,” he said.

DR. SARAH PICKLE: “Medicine is playing catch-up in a lot of ways. ... I get some really seasoned, experienced physicians who come up to me and say, ‘I never had a chance to learn about this, yet I know this is something I need to learn.’”

Clinical trials play a crucial role in advancing medical research and bringing innovative treatments to patients. As the field evolves, driven by technological advancements and a patient-centric approach, the future of clinical trials holds great promise. In this blog post, we will explore key trends shaping the future of clinical trials, drawing insights from various articles and experts. We will discuss the potential impact of virtual trials, pragmatic trial designs, data-driven approaches, and advancements in treating conditions like Long COVID and Parkinson’s disease psychosis.

FDA grants full approval to new Alzheimer's drug meant to slow disease

The Food and Drug Administration (FDA) has granted full approval to the Alzheimer's drug Leqembi, marking the first time a drug meant to slow the progression of the disease has received regulatory approval. Developed by Japanese drugmaker Eisai and US-based drugmaker Biogen, Leqembi targets beta-amyloid, a protein believed to be one of the underlying causes of Alzheimer's. In a phase 3 clinical trial, the drug showed a 27% slowing in the progression of the disease over an 18-month period. However, concerns have been raised about the drug's safety and its potentially life-threatening side effects, including brain swelling and hemorrhage.

Key takeaways

• The approval of Leqembi has generated mixed reactions. Advocates, such as the Alzheimer's Association, believe the drug could provide individuals in the early stages of Alzheimer's with more time to maintain their independence and improve their quality of life. However, critics, including some neurologists and experts, argue that the benefits of the drug may not be noticeable to patients and that the risks of side effects outweigh the potential advantages. There are also concerns about the high cost of the drug, which has a list price of $26,500 per year.
  
  
• Leqembi was approved for individuals with mild cognitive impairment or early-stage Alzheimer's disease. It is administered intravenously every two weeks, and patients will need to go to a hospital or clinic for the infusion. The Centers for Medicare & Medicaid Services (CMS) has planned to provide coverage for Leqembi and other drugs in its class, but physicians will be required to gather real-world performance data through a government database. Medicare will cover 80% of the drug's cost after patients meet their deductible, leaving patients responsible for the remaining 20% out-of-pocket.

• 1. Will patients notice a difference?
  
  
• 2. Who will benefit from Leqembi and for how long?
  
  
• 3. How safe is Leqembi?

Is There a Doctor in the House?

A 45-year-old limousine driver comes to the office for an initial appointment because he would like you to fill out and sign a legal document at the request of his attorney. The patient states that he is filing a lawsuit against the limousine company that employs him because he developed post-traumatic stress disorder following a motor vehicle collision. He appears irritable and tense as he provides his history. He relays his symptoms by reading them aloud from a written list.

At this time, which of the following is the most appropriate approach toward confirming the underlying diagnosis of this patient?

Heather Anderson, a female professional athlete, has become the first known case of chronic traumatic encephalopathy (CTE) in a female athlete. CTE is a degenerative brain disease associated with repeated head injuries. Anderson, an Australian rules footballer, passed away at the age of 28, and her brain was donated for analysis. Researchers are urging increased attention to the impact of head injuries on women in high-level sports and the need for further research on CTE in female athletes.

Kidney stones are increasingly being diagnosed in children and teens, particularly among teenage girls, according to emerging data. The reasons for this rise are not fully understood, but experts believe that factors such as diets high in ultraprocessed foods, overuse of antibiotics, and hotter summers may be contributing. The increase in kidney stones among children has prompted the opening of pediatric "stone clinics" in hospitals to provide specialized care. Diet, climate change, and antibiotic use are considered potential factors in the development of kidney stones in young individuals. Maintaining hydration, especially during warmer months, is recommended as a preventive measure.

A new study published in the journal Science Translational Medicine suggests that depression following a traumatic brain injury (TBI) may be a distinct condition, different from other types of depression. The research utilized advanced brain imaging technology to examine brain circuits associated with depression in people with and without a TBI. The study found that these circuits appeared to be affected in opposite ways in individuals with TBI-related depression compared to those without a TBI. The findings have led researchers to propose a new name for the condition: TBI affective syndrome. The study suggests that traditional depression treatments may not be as effective for individuals with TBI-related depression and highlights the potential of therapies like transcranial magnetic stimulation to provide targeted treatment. Further research is needed to identify which TBI patients are more likely to develop depression and determine the most effective treatments for them.

A new study conducted by researchers from the University of Texas Health Science Center in Houston has found that clinical overuse of marijuana is associated with complications and adverse outcomes after major elective surgery. The study analyzed data from over 12,000 hospitalizations for 11 types of major elective surgeries and found that patients with cannabis use disorder had a higher risk of complications such as blood clots, stroke, breathing difficulties, kidney issues, and even death. The study highlights the impact of marijuana on blood flow, respiration, body temperature, airway blockages, blood pressure, and heart rate, which can make recovery from surgery more challenging. The authors suggest that preoperative screening for cannabis use disorder should be considered given the increasing rates of cannabis use.

Thank you for reading! More next week,

My best wishes for a productive and idea-filled week ahead. Thanks for your ongoing efforts to improve the lives of the patients we all serve. Please send any news, comments, suggestions and ideas to hello@morningmed.email.

Quiz answer: The correct answer is B) "Ask the patient to provide a narrative with detailed description of the incident and of his symptoms"

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