United States of America

US patients typically stop using Wegovy after six months, Novo Nordisk reveals

Patients in the United States are typically discontinuing their use of Novo Nordisk’s weight-loss medication Wegovy after approximately six months, according to an executive’s statement on Wednesday, 7th of July, 2024. Doug Langa, who oversees Novo’s operations in North America, disclosed this during a discussion with analysts following the pharmaceutical company’s decision to lower its annual profit forecasts, driven by Wegovy’s sales falling below expectations.

This revelation about the duration of Wegovy use contrasts sharply with statements from March at Novo’s capital markets day, where it was noted that 32% of users in the US continued the treatment for over a year. Langa highlighted the significant discrepancy in the anticipated versus actual usage times of this in-demand weight-loss therapy amidst ongoing discussions about its affordability for individuals, employers, and public health services.

Last month, a report by Reuters using data from US pharmacy claims indicated a decline in patient adherence over the long term: only one in four patients prescribed Wegovy or Ozempic for weight management were still on the medication two years later.

When queried about these figures in a post-earnings release interview with Reuters, Novo Nordisk’s Chief Financial Officer, Karsten Munk Knudsen, acknowledged the variability in patient commitment to the treatment. “Yes, there are some patients who are on and off, but there are also a lot of patients that stay on therapy for a long period of time,” he explained. Knudsen expressed optimism regarding the adherence data from the US and other countries, including Denmark, suggesting a nuanced picture of patient engagement with the therapy.

Novo Nordisk has introduced Wegovy in 12 markets globally, with the United States emerging as the most significant and profitable among them. The brief duration of treatment in the US, however, raises questions about the long-term viability and impact of this medication on Novo Nordisk’s financial performance and on the broader public health agenda.

Bridging the gap: From obesity research to effective clinical practice

Recent advances in obesity research have considerably deepened our understanding of the condition’s underlying causes and the optimal strategies for its management. Despite these advances, a significant disparity exists in the application of this knowledge within clinical settings. This challenge has been meticulously outlined in the American Heart Association’s (AHA) scientific statement, “Implementation of Obesity Science Into Clinical Practice,” published in the Association’s leading journal, Circulation.

The statement asserts that obesity remains a critical public health issue, both in the United States and globally, affecting nearly all populations and imposing severe strains on healthcare systems. Obesity is a significant risk factor for heart disease, thus hindering progress in reducing heart disease rates. “Obesity is undeniably a critical public health concern in the U.S. and around the world, affecting nearly all populations and straining our health care systems. As a major risk factor for heart disease, obesity has significantly hindered progress in reducing heart disease rates. Despite advancements in understanding the complexities of obesity and newer treatment options, major gaps remain between obesity research and real-world implementation in clinical practice,” explains Deepika Laddu, Ph.D., FAHA, chair of the statement writing committee and senior research scientist at Arbor Research Collaborative for Health in Ann Arbor, Michigan.

The evidence strongly favours intensive lifestyle therapy, which is markedly more effective for weight loss than brief advice from healthcare professionals. However, the more common approach involves offering general educational information rather than directing patients toward specific classes, programmes, or tangible resources that facilitate lifestyle changes. One study highlighted that only 16% of healthcare professionals were knowledgeable about evidence-based lifestyle treatments for obesity, including diet and nutrition, physical activity, and intensive behavioural therapy referral. The barriers to effective weight management are further exacerbated by socioeconomic, racial, and ethnic disparities, with people of diverse backgrounds and those covered by Medicare or Medicaid less likely to be referred to or have weight management programs covered by their insurance.

Globally, the prevalence of obesity has been on the rise for around 30 years. Current estimates from the U.S. Centers for Disease Control and Prevention indicate that more than 40% of U.S. adults aged 20 and older are living with obesity. Research has elucidated the multifactorial causes of obesity, which include sociological and physiological determinants. Treatments have evolved to include more effective strategies for lifestyle modifications, medication therapy, and bariatric (weight-loss) surgery. Despite these advancements, each treatment approach faces its own set of challenges.

“Significant strides have been made in advancing the science to help us understand obesity, yet there remains a considerable gap between what we know and what happens in the doctor’s office,” Laddu observes. She emphasises the need for healthcare professionals and systems to better incorporate cutting-edge knowledge about obesity into practical applications so that more individuals can access appropriate support and treatment. This might include adopting new technologies and telemedicine, making referrals to community-based weight management programmes, providing social support, and enhancing the reach and access to treatments.

The statement discusses the FDA-approved Glucagon-like peptide-1 (GLP-1) agonists, such as high-dose semaglutide and tirzepatide, which are associated with an average weight loss of more than 10% at six months in clinical studies. Despite a large portion of the adult U.S. population meeting the BMI criteria for obesity and being eligible for these medications, a relatively small percentage currently use them. The historical lack of insurance coverage and high costs were significant barriers until recent policy changes by the Centers for Medicare and Medicaid Services allowed for the coverage of anti-obesity medications like semaglutide.

Weight loss surgery, or bariatric surgery, has seen improvements in safety, expertise, and understanding of its health benefits. A comprehensive review of studies on weight loss surgeries indicated that patients undergoing these procedures experienced lower risks of cardiovascular disease and reductions in other obesity-associated conditions such as Type 2 diabetes and high blood pressure. However, ensuring that the populations most in need have access to bariatric surgery remains a challenge due to cost, resource availability, and social support factors.

The statement further elaborates on the need for a comprehensive approach to obesity care, highlighting strategies to improve integration of obesity science into clinical practice and to develop solutions that manage obesity at the community level. The importance of education for healthcare professionals on the complex origins and clinical consequences of obesity is discussed, alongside the necessity for health policy changes to make obesity treatment more affordable, particularly for high-risk patients.

Specific approaches are highlighted in the statement to help bridge the gap between the science about obesity and clinical care, such as:

• To reach and successfully impact populations in need, healthcare professionals may consider how social determinants of health, including insurance type, household income, race and ethnicity, environment, health literacy, access to health-promoting resources, and social supports all influence the likelihood of successful patient treatment.
  
• Education for healthcare professionals explaining the complex origins and clinical consequences of obesity is discussed. Such training should emphasise information about diagnosis, prevention, and treatment of obesity. Despite the high prevalence of obesity around the world, there is a lack of education programmes centred on obesity for medical professionals.
  
• Further evaluation of health policy changes that healthcare systems and insurance plans can implement and scale in order to make obesity treatment affordable for patients, especially those at high risk for adverse outcomes such as cardiovascular disease.
  
• A framework for delivering obesity care into clinical practice settings is reviewed, as well as efforts by some professional societies for developing interventions that make obesity treatment more accessible.

“The statement emphasises the importance of a comprehensive approach across different levels of health care delivery and public policy, along with the adoption of feasible, evidence-based strategies in clinical settings,” said Laddu. “It also underscores the need for future research and policy changes to improve current patient care models and ensure equitable access to obesity-related care for people in underrepresented groups.”

The scientific statement also provides possible solutions for how to help people in their day-to-day lives, including interventions with digital technology and access through telemedicine. However, more research is needed in obesity science and treatment. Limited understanding of the cost-effectiveness of obesity prevention and the long-term health outcomes for established therapies has hindered the implementation of obesity science into clinical settings. Cross-collaborative obesity science research between stakeholders and health economists may serve as the bridge to developing and scaling cost-effective prevention programmes.

Further research into Food Is Medicine approaches in health care, such as medically tailored meals and produce prescriptions, to prevent and treat cardiovascular disease and other diet-related diseases are also being explored in several settings including the Association’s Health Care by FoodTM initiative.

This scientific statement was prepared by a dedicated volunteer group on behalf of various AHA councils, highlighting the critical need for increased awareness and informed healthcare decisions regarding obesity. While it outlines current knowledge and research needs, it refrains from making specific treatment recommendations, which are covered in the AHA’s official guidelines. This comprehensive approach underscores the necessity of closing the gap between advanced obesity research and its practical application in healthcare.

Integrating obesity experts into primary care clinics enhances patient weight loss outcomes

A novel study conducted by the University of Michigan reveals significant benefits in integrating obesity specialists into primary care settings, resulting in substantial weight loss for high-risk patients. This approach, piloted by Michigan Medicine’s academic medical centre through the Weight Navigation Program (WNP), has been proven to facilitate access to evidence-based weight management treatments and support patients in achieving notable weight reduction within a year.

Primary care practitioners often find it challenging to devise personalised weight management plans during brief consultations. Earlier investigations by the University have indicated that a majority of primary care patients with obesity fail to lose at least 5% of their body weight—an outcome that substantially decreases obesity-related health risks.

To address this, the Weight Navigation Program was established in the autumn of 2020, pairing obesity specialists with patients and their primary care providers to collaboratively develop tailored obesity treatment plans. The effectiveness of this initiative was evaluated in a study recently published in JAMA Network Open, carried out by a multidisciplinary team responsible for initiating the WNP.

Results from the first year of the programme indicated an average weight loss of about 12 pounds (approximately 4.4% of body weight) among participants, compared to minimal weight loss in a similar group from another clinic without access to the WNP. Participants typically started with a body mass index (BMI) around 40 kg/m^2, with eligibility for the WNP requiring a BMI over 30 kg/m^2 and at least one weight-related health condition such as high blood pressure, sleep apnea, type 2 diabetes, or high cholesterol.

More than 40% of WNP participants succeeded in losing at least 5% of their body weight, contrasting sharply with less than 20% in the non-WNP group. Additionally, 22% of WNP participants lost at least 10% of their body weight, compared to less than 4% in the comparison group. These outcomes suggest the potential for wider application and testing of the WNP approach in larger clinical trials.

Currently, the WNP is accessible to all eligible adult patients receiving primary care through U-M Health clinics, serving as an entry point to a variety of treatment options. This programme is a part of an extensive array of weight management services offered across various U-M Health departments.

Dr. Dina Hafez Griauzde, the study’s lead author and an assistant professor of internal medicine at U-M Medical School, emphasised the programme’s foundation on safe and effective obesity care integration into primary care settings. This model promotes a collaborative team approach to evaluate patients, explore treatment options including cost considerations, and facilitate access to specialised care and follow-up.

Senior author Dr. Andrew Kraftson, an endocrinologist specialising in obesity medicine, highlighted the need for such programmes due to a shortage of obesity specialists. The WNP builds upon the successes of other chronic disease programmes by fostering a closer partnership between specialists and primary care providers. Notably, two-thirds of the current obesity medicine specialists also serve as primary care physicians.

Patients referred to the WNP consult with obesity specialists knowledgeable about the comprehensive treatment offerings at U-M Health, including community diabetes prevention programmes and understanding of insurance coverage. Following these consultations, specialists provide personalised treatment recommendations tailored to each patient’s medical needs, financial situation, and preferences.

The WNP team closely monitors progress and coordinates ongoing care, offering treatments ranging from specialised dietary plans and anti-obesity medications to weight loss surgery. The initial study tracked 132 people enrolled in the WNP and a matched group of 132 receiving usual care, studying their health outcomes over a year.

This extensive research, backed by funding from the National Institute of Diabetes and Digestive and Kidney Diseases and other grants, supports the feasibility and efficacy of integrating specialised obesity care within primary care frameworks, aiming to enhance overall patient outcomes in weight management.

How Continuous Glucose Monitors (CGMs) are changing the fight against obesity

Continuous Glucose Monitors (CGMs), initially developed for diabetes management, are gaining recognition for their role in aiding individuals with obesity, especially those at risk of developing diabetes. With these devices soon to be available over-the-counter in the United States, there is a new frontier in proactive health monitoring.

Lori Wenz, a nurse practitioner at Western Colorado Weight Care in Grand Junction, Colorado, discussed the expanding use of CGMs beyond their traditional scope during her presentation at the 2024 Obesity Medicine Association conference. She emphasised that CGMs not only enhance patient motivation by improving awareness of how diet and activity impact metabolic health but also play a crucial role in adherence to nutritional guidance and pharmacotherapy.

A significant proportion of the American adult population remains unaware of their pre-diabetic or diabetic status. According to the Centers for Disease Control and Prevention, approximately 38% of adults have pre-diabetes, of which up to 80% are unaware. Additionally, around 23% of the 11.6% of Americans diagnosed with diabetes are also ignorant of their condition. Notably, up to 90% of those diagnosed with diabetes have either overweight or obesity, highlighting the intertwined nature of obesity and diabetes.

The off-label use of CGMs in obesity management is gaining acceptance as both clinicians and patients become increasingly proactive in monitoring potential diabetes risks and overall health. Wenz reported a significant increase in the off-label application of CGMs over the past three to five years, attributed largely to technological advancements that have reduced costs and enhanced device integration with mobile technology.

CGMs are particularly useful in diagnosing pre-diabetes and managing glucose levels to delay or even reverse the progression to diabetes. The devices provide real-time glucose readings, revealing the impact of lifestyle choices on glucose fluctuations, which can be a revelation for many users. This encourages more informed decisions about diet and exercise, leading to better health outcomes.

In a significant development, the FDA recently approved the Dexcom Stelo Glucose Biosensor System, the first over-the-counter CGM, for individuals over 18 who are not on insulin therapy. This device, which provides glucose measurements every 15 minutes and can be worn for up to 15 days, represents a major step forward in making glucose monitoring more accessible.

Despite the advantages, the use of CGMs in non-diabetic patients presents unique challenges. There are no established glucose norms for individuals without diabetes, and interpreting CGM data can be complicated. Moreover, alarms designed for diabetic users can be bothersome for those without the condition, potentially disrupting sleep and causing undue stress.

Alaina Vidmar, MD, at the Keck School of Medicine of the University of Southern California, discussed the benefits of CGMs in paediatric obesity interventions. Real-time glucose data helps educate young patients about their body’s reactions to different foods and reinforces adherence to dietary restrictions, which is crucial for effective weight management and prevention of diabetes.

The advent of over-the-counter CGMs is poised to transform the landscape of obesity management and diabetes prevention. As the market expands and prices become more competitive, these devices offer a promising tool for individuals to take control of their health, potentially averting the progression to diabetes and improving overall metabolic health. The holistic integration of CGMs with innovative health strategies, pharmacotherapy, and even surgery holds the promise of enhancing life quality and longevity for individuals with obesity.

California healthcare giant drives digital health forward with innovative AI centre in San Francisco

Nestled within a spacious and modern environment, boasting stunning vistas of the Bay Bridge, a dynamic team that could easily be mistaken for a tech startup’s brightest is on the brink of revolutionising health care delivery. Sutter Health has inaugurated an “innovation centre” at the iconic Pier 1 in San Francisco, situated just a few strides from the bustling Ferry Building. This centre is the crucible where the future of healthcare, infused with the latest in mobile technology and artificial intelligence (AI), is being forged.

As the most expansive health system in Northern California, Sacramento-headquartered Sutter has embarked on this venture with a seven-year lease of an 11,000-square-foot office space, opened for its employees just this month. This initiative is not merely an expansion but a declaration of Sutter’s commitment to San Francisco and, more importantly, to AI as an indispensable component of future health care paradigms. This commitment comes at a critical juncture, contrasting sharply with the trend of businesses scaling down or exiting the city.

Sutter Health is no stranger to San Francisco, operating two significant hospitals within the city’s bounds – CPMC Van Ness and CPMC Mission Bernal. Although it previously maintained non-clinical office spaces in the city, the pandemic prompted a shift towards remote work, leading to the closure of its Battery Street office. The newly launched innovation centre, however, marks the first dedicated space for Sutter’s engineers, developers, and designers to collaborate closely with tech firms on digital health applications and remote monitoring systems aimed at integrating health care seamlessly into the fabric of daily life.

Chris Waugh, Sutter’s chief innovation officer, highlights the strategic importance of this centre as a significant leap forward. It will not only serve as a showcase for technologies developed in-house, such as the Scout mobile app for monitoring adolescent mental health and the Continuous Care Program for home-based blood pressure management for hypertension patients, but it will also feature futuristic concepts like a prototype “hospital room of the future”. This room will be equipped with devices that not only automate the updating of medical records but also offer a space where patients can receive assistance with digital health applications, reminiscent of a Genius Bar setup like in Apple stores.

The centre’s role extends beyond the confines of physical health examinations. It is envisaged as a virtual health care hub, where Sutter’s health coaches will provide tele-health services, from consultations to health management advice, through digital screens.

Moreover, Sutter is advancing the development of digital tools designed for home use. These include sensors for beds, refrigerators, and stoves that can detect changes in daily movement patterns, potentially alerting to health risks such as falls – a significant concern for the elderly population.

In a bid to further entrench itself in the digital health landscape, Sutter is cultivating partnerships with tech firms specialising in AI and other digital health innovations. One such partnership is with Ferrum, a Sunnyvale-based tech company that offers a secure platform for accessing a suite of AI tools, including an AI-assisted program for early lung cancer detection.

Pelu Tran, CEO and co-founder of Ferrum, envisions the innovation centre as a nexus for collaborative efforts with Sutter’s clinical leaders, fostering a more proactive and extensive engagement with the Bay Area’s AI ecosystem.

The decision to locate the innovation centre at Pier 1 was influenced by its accessibility for employees commuting from various parts of the Bay Area, according to Waugh. He expresses a bullish outlook on San Francisco’s future, positioning Sutter’s investment as a pledge to the city’s resurgence. “We’re optimistic and betting on the city,” he asserts, inviting others to join in shaping San Francisco’s revival narrative.

Through this pioneering innovation centre, Sutter Health is not just betting on AI and digital technology as the future of healthcare; it is actively shaping that future, making a profound investment in the health and wellbeing of the San Francisco community and beyond.

U.S. healthcare industry powers toward digital future

In an era marked by rapid technological evolution, the healthcare industry in the United States is making significant strides towards a digitally-enhanced future. A recent study conducted by Information Services Group (ISG), a prominent global technology research and advisory institution, sheds light on this transformative journey. The findings, encapsulated in the 2023 ISG Provider Lens™ Healthcare Digital Services report, underscore a concerted move by healthcare providers and insurers towards embracing digital health tools, aiming to bolster the efficiency, accessibility, and quality of healthcare services.

At the heart of this digital shift are integrated electronic health records (EHRs) and patient-centric applications. These innovations are enabling healthcare organisations to monitor patients with greater precision, facilitate seamless data exchange among healthcare professionals, and offer tailored wellness advice directly to patients. The implications of such advancements are profound, enhancing patient care and operational efficiencies across the board.

Bob Krohn, a healthcare partner at ISG, highlights the transformative impact of this trend. He points out that as the industry gains a deeper understanding of the social determinants of health, there is a growing emphasis on utilising technology to promote health equity and outcome-focused care. This modernisation wave is not only about adopting new technologies but also about rethinking approaches to healthcare to ensure it is more inclusive and outcome-oriented.

A critical aspect of this transformation is the collaboration between providers and insurance companies. This partnership is pivotal in identifying and supporting the most vulnerable segments of the population. By integrating technology with a deep understanding of the social factors influencing health, the sector aims to foster behavioural changes that could lead to significant improvements in public health. Technologies such as EHRs, machine learning, and predictive analytics are at the forefront of these efforts, enabling a more personalised, holistic approach to healthcare.

The report also highlights a shift towards more cost-effective healthcare services, particularly under Medicare, through partnerships between providers and insurance companies. This move towards value-based care, which prioritises quality over quantity, is not just improving patient outcomes but is also presenting providers with new growth and competitive opportunities.

Furthermore, Generative AI (GenAI) is identified as a burgeoning technological wave poised to redefine the healthcare industry. With many organisations planning substantial investments in GenAI solutions over the next five years, there is anticipation of significant impacts on healthcare technology and economics. ISG predicts that GenAI will prompt a reevaluation of current projects, with technology service providers ready to guide enterprises through these transitions.

The exploration of healthcare technology trends extends to integrated health platforms and the increasing need for electronic medical record migration services. Moreover, the report delves into challenges such as talent shortages and the integration of new technologies with existing systems, offering insights and recommendations for addressing these issues.

The 2023 ISG Provider Lens™ Healthcare Digital Services report evaluates 39 providers across three categories: Payer Digital Transformation Services, Provider Digital Transformation Services, and Healthcare Platform Implementation Services. It recognises leaders in the field, including Accenture, Cognizant, and HCLTech, among others, for their outstanding contributions across various segments. Additionally, companies like CitiusTech and Persistent Systems are acknowledged as Rising Stars, indicating their promising potential in the healthcare digital services landscape.
This comprehensive report, available for subscribers or through a one-time purchase, offers an invaluable resource for understanding the dynamic changes underway in the U.S. healthcare sector and the digital innovations driving these changes forward.

The first-ever “Obesity Bill of Rights” has been launched in the USA

In an unprecedented move to address the widespread and deeply rooted issue of obesity, which is the most prevalent and costly chronic disease across the United States, the National Consumers League (NCL) alongside the National Council on Aging (NCOA) have unveiled the nation’s inaugural Obesity Bill of Rights. This initiative, coupled with the establishment of the grassroots movement known as Right2ObesityCare, aims to instigate a profound shift in federal, state, and employer policies. The ultimate goal is to embed these rights within the framework of medical practice, ensuring that individuals with obesity receive comprehensive, non-discriminatory care as per medical guidelines.

Crafted through meticulous consultation with leading obesity experts and receiving endorsements from nearly 40 national bodies dedicated to obesity and chronic disease management, this Bill of Rights articulates eight fundamental entitlements. These entitlements guarantee that individuals with obesity are not only screened, diagnosed, and counselled but also treated in accordance with established medical guidelines. Moreover, it seeks to eradicate the pervasive issues of weight bias, ageism within healthcare settings, and the exclusionary practices of insurance providers and governmental bodies.

Sally Greenberg, the Chief Executive Officer of the National Consumers League, underscored the essence of the Obesity Bill of Rights, stating that it is designed to affirm the entitlement of all adults to quality obesity care. It empowers those afflicted by this disease to challenge and demand appropriate treatment free from any form of discrimination or prejudice, irrespective of their size or weight. Greenberg lamented the historical neglect and stigmatisation faced by individuals with obesity within the healthcare system, which has led to significant barriers in accessing care.

Echoing this sentiment, Patricia Nece, J.D., the Immediate Past Chair of the Obesity Action Coalition, shared her personal struggles with weight-related ridicule, highlighting the societal tendency to overlook the individual behind the weight.

Despite the American Medical Association’s recognition of obesity as a serious disease over a decade ago, a staggering number of American adults living with obesity remain undiagnosed. Out of an estimated 108 million adults, only 30 million have been diagnosed, and a mere 2% of those eligible for anti-obesity medications have received prescriptions. This lack of treatment has dire consequences, not only exacerbating the outcomes of over 230 obesity-related chronic conditions but also contributing to approximately 400,000 premature deaths annually and imposing an estimated $1.72 trillion burden on the U.S. economy.

The Obesity Bill of Rights introduces eight core rights aimed at catalysing transformative change and setting the standards for person-centred, quality care for individuals with obesity:

1. The Right to Accurate, Clear, Trusted, and Accessible Information on obesity as a treatable chronic disease.
2. The Right to Respect by all members of the integrated care team when screening, counselling, and providing treatment.
3. The Right to Make Treatment Decisions about one’s health goals and obesity care in consultation with the individual’s health providers.
4. The Right to Treatment from Qualified Health Providers including counselling and ongoing care from health providers with expertise in obesity care.
5. The Right to Person-Centred Care that is personalised, respects the individual’s cultural beliefs, meets their specific health goals, and considers the person’s whole health and not just their weight status.
6. The Right to Accessible Obesity Treatment from Health Systems, so those with severe obesity receive care in settings that allow for privacy, using size and weight-accessible equipment and diagnostic scans.
7. The Right for Older Adults to Receive Quality Obesity Care that comprises a respectful, comprehensive care approach consistent with their personalised medical needs.
8. The Right to Coverage for Treatment with access to the full range of treatment options for the person’s disease as prescribed by the individual’s health provider.
   

Ramsey Alwin, President and CEO of the NCOA, emphasised that these rights are foundational to ensuring that adults with obesity receive informed, respectful care, and comprehensive insurance coverage for treatments deemed necessary by their healthcare providers.

To promote the implementation of the Obesity Bill of Rights, the NCL and NCOA are spearheading the Right2ObesityCare movement. This campaign aims to engage a broad spectrum of stakeholders, including those with obesity, caregivers, health professionals, and policy-makers, through a variety of initiatives such as town halls, workshops, and advocacy forums. Additionally, efforts are underway to draft a model law that would facilitate the incorporation of the Obesity Bill of Rights into state legislation.

Prominent figures, including Rep. Brad Wenstrup and Rep. Gwen Moore, have voiced their support for legislative efforts to enhance obesity care and prevent associated health conditions. Their endorsements highlight the necessity of treating obesity as a chronic disease and ensuring that Americans can access holistic, high-quality care.

The development of the Obesity Bill of Rights was a comprehensive process that involved extensive research, community engagement, and expert consultations. The initiative has garnered initial support from 37 organisations, reflecting a wide endorsement from consumer, ageing, and public health sectors.

This groundbreaking initiative represents a pivotal step towards eradicating the stigma and discrimination faced by individuals with obesity, ensuring they receive the respect, care, and treatment they deserve.

FDA issues alert on counterfeit semaglutide products in the U.S.

The U.S. Food and Drug Administration (FDA) has recently issued a crucial warning to adults with diabetes in the United States about the presence of counterfeit semaglutide in the country’s drug supply chain. This alert comes following an ongoing FDA investigation into the distribution of fake versions of the 1 mg subcutaneous semaglutide, known commercially as Ozempic and manufactured by Novo Nordisk.

The FDA’s investigation has led to the seizure of thousands of units of these counterfeit products. Key identifiers of the fake medication include lot number NAR0074 and serial number 430834149057. These specific batches have been confirmed as counterfeit and are advised not to be used.

A further cause for concern highlighted by the FDA is the discovery of counterfeit needles accompanying the medication. The sterility of these needles cannot be assured, posing a heightened risk of infection for users. Additional counterfeit components identified by the FDA include the pen label, health care professional and patient information leaflets, and the packaging box.

The FDA is urging wholesalers, retail pharmacies, healthcare providers, and patients to diligently check their semaglutide products’ lot and serial numbers. While the FDA, in partnership with Novo Nordisk, is currently conducting tests on the seized counterfeit products, there is yet no comprehensive information about the content, quality, or safety of these fakes.

To date, the FDA has received reports of five adverse events associated with the use of these counterfeit semaglutide products. These incidents align with the typical side effects of authentic semaglutide, and thankfully, none of the reported cases have been serious. The FDA encourages reporting of any adverse events through its MedWatch Safety Information and Adverse Event Reporting Program, either via online submission or fax at (1-800) FDA-0178.

The FDA advises pharmacies to source genuine semaglutide only through Novo Nordisk’s approved distributors. Patients should obtain the drug strictly with a valid prescription from state-licensed pharmacies and are advised to inspect the product thoroughly for any signs of counterfeiting before use. Any suspicions or discoveries of counterfeit products should be promptly reported to the FDA. This can be done by calling the local FDA consumer complaint coordinator or by reporting directly via the FDA’s official website.

Rates of severe obesity in young American children are escalating, study reveals

A recent study published in the journal Pediatrics presents alarming evidence that severe obesity is on the rise among young children in the United States.

This concerning trend was initially hoped to be an exception for children participating in a government food programme, as earlier research indicated a slight decline in obesity rates about a decade ago among these children. However, the updated findings from 2020 show a rebound in the rate, countering the previous optimism.

National data align with these findings, suggesting that approximately 2.5% of preschool-aged children across the U.S. were classified as having severe obesity during the same period.

“We were doing well and now we see this upward trend,” stated Heidi Blanck of the U.S. Centers for Disease Control and Prevention, one of the authors of the study. “We are dismayed at seeing these findings.”

The study focused on children aged 2 to 4 who were enrolled in the Women, Infants and Children (WIC) programme, which offers healthy food and additional services to preschool-aged children from low-income families. Measurements and weights of the children were recorded for the study.

The researchers observed that 2.1% of children in the WIC programme had severe obesity in 2010. By 2016, this percentage had decreased slightly to 1.8%. However, by 2020, the rate had risen to 2%, equating to about 33,000 of the more than 1.6 million children in the WIC programme.

Twenty states recorded significant increases, with California exhibiting the highest rate at 2.8%. Notable rises were also seen in certain racial and ethnic groups, with the highest rate of approximately 2.8% found among Hispanic children.

Experts warn that severe obesity in early childhood is almost irreversible and is closely linked to chronic health issues and premature mortality.

The reasons for the increase in obesity rates remain unclear, according to Blanck. Some experts had previously attributed the decline in WIC obesity rates to policy changes in 2009, which included adjustments to food packages such as the removal of juice for infants, reduced saturated fat, and increased accessibility to fruits and vegetables.

Despite these policy changes remaining in effect, “the daily hardships that families living in poverty are facing may be harder today than they were 10 years ago, and the slight increases in the WIC package just weren’t enough,” suggested Dr. Sarah Armstrong, a Duke University childhood obesity researcher.

The study faced several challenges, including a decline in the number of children participating in the WIC programme over the past decade. Furthermore, the study period encompassed 2020, the year the COVID-19 pandemic began, leading to fewer parents taking their children for doctor visits and thus a reduction in the amount of complete data available.

Deanna Hoelscher, a childhood obesity researcher at the UTHealth Houston School of Public Health, commended the study despite its limitations, noting that “it gives you a hint of what’s going on.”

Post-2020 developments in childhood obesity rates are yet to be fully understood. Some smaller studies have indicated a significant increase in childhood obesity, particularly during the pandemic, when children were homebound from schools, experiencing disrupted eating and bedtime routines, and reduced physical activity.

“We are thinking it’s going to get worse,” Hoelscher added, highlighting concerns about the trajectory of childhood obesity in the wake of the pandemic.

US panel of health experts advocate early interventions for childhood obesity from age 6

A panel of U.S. health experts has put forth a draft recommendation advocating for children with obesity to begin receiving comprehensive counselling aimed at fostering healthy eating and exercise habits, starting at the age of 6. This guidance, issued by the U.S. Preventive Services Task Force (USPSTF), builds upon their 2017 recommendation which suggested that obesity screening should commence from the same age.

Recent research underscores the value of intensive behavioural interventions, defined as a minimum of 26 hours of counselling with one or more health professionals, in aiding children and adolescents to achieve and maintain a healthy weight and enhance their overall quality of life. However, the recommendation does not set a specific timeframe for these interventions.

The USPSTF’s updated advice does not delve into the use of weight-loss medications like Novo Nordisk’s Wegovy, approved for use in children aged 12 and above, nor does it address surgical options. The Task Force reviewed evidence surrounding weight-loss medications but noted that further research is needed to fully grasp the long-term health impacts of such treatments.

According to Dr. Katrina Donahue from the University of North Carolina School of Medicine and a member of the Task Force, the proposed behavioural interventions encompass a combination of physical activity, behaviour change support, and education on healthy eating. Recognising that available resources vary by location, Donahue acknowledged that the implementation of these interventions might differ across cities.

The recommendation is backed by data from 58 randomised controlled trials involving over 10,000 children, which demonstrated the effectiveness of these interventions when a child engages in at least 26 hours of professional contact. The evidence for these intensive interventions received a “grade B” from the USPSTF, indicating high certainty of at least moderate benefit. The children in these trials lost an average of 4 to 6.5 pounds (approximately 2 to 3 kilograms), with the reductions being sustained for at least a year.

Childhood and adolescent obesity, through the age of 19, is defined as having a body mass index (BMI) – a weight-to-height ratio – higher than that of 95% of peers of the same age and gender. Nearly one in five U.S. children and teenagers are categorised as having obesity, based on data from the U.S. Centers for Disease Control and Prevention (CDC).

The American Academy of Pediatrics (AAP) guidelines also endorse lifestyle support, including over 26 hours of face-to-face, family-based, multicomponent treatment spanning 3 to 12 months. Additionally, the AAP recommends paediatricians consider weight-loss drugs for children with obesity aged 12 and over and to refer adolescents aged 13 and older with severe obesity for metabolic and bariatric surgery evaluation.

The USPSTF’s draft recommendation is open for public comment until the 16th of January 2023, inviting a wider discourse on the proposed approach to tackle childhood obesity.

The limited impact of Ozempic on the U.S. obesity epidemic

The term ‘obesity’ elicits a range of interpretations. Some view it as merely another way to describe excess weight, while others perceive it as a derogatory label for larger body sizes. Still, some consider it a reflection of personal failings, such as a lack of discipline or willpower. However, for over a decade, the medical field has acknowledged obesity as a chronic health condition, akin to diseases like cancer, diabetes, and hypertension. This disease significantly elevates the risk of severe COVID-19 outcomes, is connected to numerous health complications, and is responsible for approximately 4 million preventable deaths annually. Moreover, obesity manifests in various forms, with diverse origins, clinical signs, and treatment responses.

The surge in popularity of GLP-1 medications such as Ozempic, Wegovy, and Mounjaro has somewhat simplified this complex issue. These drugs are often hailed as the ultimate solution to obesity, a perspective that overlooks the multifaceted nature of the condition. Unfortunately, Ozempic alone cannot address America’s obesity crisis. Obesity extends beyond mere physical inactivity or excessive eating. It’s influenced by a range of factors including genetic predispositions, mental health, socio-economic conditions, and environmental factors.

In clinical settings, the variation in obesity cases is significant. For instance, a mutation in the MC4R gene is associated with an 18% increased likelihood of obesity, while certain antipsychotic medications can lead to substantial weight gain. Although GLP-1 medications can be beneficial, they primarily address hormonal imbalances and do not tackle other contributing factors. This reductionist approach is also evident in the use of Body Mass Index (BMI) to diagnose obesity. BMI, initially designed for white European males, often inaccurately represents obesity levels in different ethnic groups, leading the American Medical Association to advise against its sole use. Currently, a global commission of experts is redefining obesity, moving away from height and weight measurements to focus on specific symptoms and signs.

The response to treatment among patients with obesity also varies greatly. For example, the GLP-1 drug Wegovy showed an average body weight reduction of 16% in a study, yet individual results ranged widely. This underscores the need for personalised treatment plans rather than a singular drug-based approach. However, the U.S. healthcare system faces significant challenges in this regard. With only a small number of physicians specialised in obesity treatment and federal restrictions on covering obesity medications, only a fraction of those who could benefit from such treatments receive them. Instead, many are advised to simply eat less and exercise more, a strategy that overlooks the complexity of obesity.

Effective obesity treatment involves a multidisciplinary approach, combining diet, exercise, behavioural therapy, medication, and sometimes surgery. Unfortunately, the scarcity of specialised physicians and the prevalence of misleading diet products and scams exacerbate the issue. The U.S. weight loss market, valued at $160 billion in 2023, is a testament to this. Moreover, misconceptions about GLP-1 medications, such as the idea that they are a cure-all for obesity, lead to unrealistic expectations and criticisms. Like insulin or hypertension treatments, discontinuing GLP-1 drugs can result in a reversal of their effects, a fact that should be recognised rather than criticised.

Addressing obesity, which costs the U.S. around $1.7 trillion annually, requires acknowledging the progress made with GLP-1 drugs while also understanding their limitations. A holistic, patient-centred, and empathetic approach to obesity treatment is essential. This approach should not only address the unique needs and circumstances of each individual but also aim to improve overall health and well-being. While medications like Ozempic, Wegovy, and Mounjaro offer significant potential, they are not the all-encompassing solution often portrayed in the media. A broader, more nuanced understanding and response to obesity is crucial for effective management and treatment.

CDC reports nearly half of US states have over 35% of adults living with obesity

Obesity continues to extend its grasp across an increasing number of states in the US, as recent data from the Centers for Disease Control and Prevention (CDC) underscores. According to the fresh batch of information, as of 2022, a minimum of 35% of the adult population in 22 states was categorised as having obesity. This signifies a growth from the 19 states documented in 2021.

Drawing a comparison to a decade prior, the CDC highlighted that no state had reported an adult obesity prevalence of 35% or above, underlining a troubling upward trajectory.

This data has been gleaned from the Behavioral Risk Factor Surveillance System, a meticulously conducted interview survey collaboratively administered by the CDC along with state health departments. The criteria for obesity was a Body Mass Index (BMI) of 30 or above, as ascertained through the survey.

Three states bore the brunt of obesity with more than 40% of their adult populace having obesity—Louisiana, Oklahoma, and West Virginia. The list further includes Alabama, Arkansas, Delaware, Georgia, Indiana, Iowa, Kansas, Kentucky, Mississippi, Missouri, Nebraska, North Dakota, Ohio, South Carolina, South Dakota, Tennessee, Texas, Virginia, and Wisconsin, all having an obesity prevalence of at least 35% among adults.

An in-depth examination of the 2022 Adult Obesity Prevalence Maps divulges certain demographic groups being disproportionately affected by obesity, with discernible discrepancies across racial and ethnic lines.

The data revealed that a minimum of 35% of American Indian or Alaska Native adults had obesity in 33 states, alongside black adults in 38 states, Hispanic adults in 32 states, while the corresponding figure for white adults stood at 14 states. Notably, the obesity rates among Asian adults did not cross the 35% threshold in any state.

Karen Hacker, MD, MPH, who helms the CDC’s National Center for Chronic Disease Prevention and Health Promotion, articulated the dire need for enhanced support directed towards obesity prevention and treatment, terming it an “urgent priority”. She elaborated on the multifaceted nature of obesity, being influenced by a gamut of factors including dietary habits, physical activity levels, sleep patterns, genetic factors, and certain medications.

Dr. Hacker emphasised that the solution doesn’t adhere to a one-size-fits-all approach, but acknowledged the effectiveness of certain key strategies like addressing core social determinants of health. These include better access to healthcare, the availability of healthy and affordable food, and safe venues for engaging in physical activity.

The CDC’s 2022 maps accentuate the necessity for population-centric interventions to ensure universal access to healthy foods, safe exercising environments, stigma-free obesity prevention and treatment initiatives, alongside evidence-backed healthcare services encompassing medication and surgery.

The repercussions of obesity extend beyond the societal stigma, with individuals suffering from obesity being at an escalated risk for severe health conditions like heart disease, stroke, Type 2 diabetes, certain types of cancer, deteriorated mental health, and aggravated repercussions from COVID-19, as per CDC’s observations.

In a bid to combat this escalating obesity epidemic, the CDC’s Division of Nutrition, Physical Activity, and Obesity is propelling a slew of proven strategies at the state and local levels. These strategies encompass making physical activity safer and more accessible, facilitating healthier food choices, promoting breastfeeding, fortifying obesity prevention standards in early care and education settings, and augmenting the availability and access to family healthy weight programs.

The CDC has been vociferous in endorsing supportive environments for healthy eating and active lifestyles across various settings. Among the suggested preventative strategies are increased consumption of fruits and vegetables, encouraging breastfeeding, embracing physical activity, averting sedentary lifestyles, and minimising screen time, all of which are projected to play a vital role in reversing the obesity trend sweeping the nation.