European regulators find no evidence of link between new obesity medication and suicidal thoughts
Following an extensive nine-month investigation, European medical regulators have concluded that there is no evidence to suggest that GLP-1 receptor agonists, such as Ozempic and Wegovy, contribute to suicidal ideation or behaviours. This conclusion by the European Medicines Agency (EMA) aligns with a similar assessment conducted by the U.S. Food and Drug Administration (FDA) earlier in January, which also found no causal connection between these widely used medications for weight loss and diabetes and the risk of suicidal thoughts.
The investigation by the EMA began in July, 2023, after anecdotal instances were reported where patients exhibited self-harm thoughts while being treated with GLP-1 receptor agonists, specifically liraglutide (marketed as Saxenda by Novo Nordisk) and semaglutide (known commercially as Ozempic and Wegovy, also by Novo Nordisk). The concern prompted the EMA’s Pharmacovigilance Risk Assessment Committee to demand further information from the manufacturers of these medications in November.
Throughout the investigation, the committee meticulously analysed various sources including medical records, clinical trial data, post-marketing surveillance reports, and other academic studies. Notably, a study published in Nature Medicine indicated that the risk of suicidal ideation was actually lower in patients using GLP-1 drugs compared to those treated with other medications for obesity and diabetes. Ultimately, the EMA committee concluded that the evidence does not support a causal link between the use of GLP-1 receptor agonists and increased suicidal risk.
Despite these findings, the EMA has mandated continuous monitoring by manufacturers of GLP-1 based medications for any future incidents of suicidal thoughts or actions. This ongoing vigilance reflects a cautious approach, particularly given the historical context where earlier obesity treatments, such as rimonabant, were withdrawn from the European market in 2008 due to their association with increased suicidal ideation risks.
GLP-1 based treatments, including Ozempic, Wegovy, Eli Lilly’s Mounjaro, and Zepbound, have seen a surge in popularity recently. However, this increase in usage has coincided with sporadic anecdotal reports linking the drugs to suicidal thoughts, thus prompting these detailed investigations.
The FDA, in its preliminary review statement in January, mentioned that while a definitive exclusion of any risk is challenging, it is committed to further investigation to clarify this potential link. It is important to note that while the FDA’s approvals for Wegovy and Zepbound for obesity management include advisories for physicians to monitor for signs of suicidal thoughts, similar advisories are not included on the labels of Ozempic and Mounjaro, which are approved for managing type 2 diabetes.
This comprehensive review by regulatory bodies underscores a significant step in ensuring the safety and efficacy of GLP-1 medications, reaffirming their use in clinical practice amidst growing concerns over possible psychiatric side effects.
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Revolutionising obesity treatment with new gender-specific microbiome findings
Recent investigations to be unveiled at the European Congress on Obesity (ECO) held in Venice, Italy, from the 12th to the 15th of May, 2024, have shed light on the pivotal role that variations in gut microbiota composition play in the genesis and evolution of obesity, revealing notable distinctions between genders. This differentiation may significantly influence the metabolism of various nutrients, thereby affecting the presence of bioactive molecules within the gut that are crucial in the progression of metabolic diseases.
The gut microbiota encompasses a complex consortium of microorganisms, including bacteria, viruses, fungi, and protozoa, that reside within the gastrointestinal tract. A state of imbalance within this microbial community, known as dysbiosis, has profound effects on metabolic health, altering the risk of developing diseases such as obesity. Yet, the specific microbial species that contribute to a higher or lower risk of obesity and their exact impact on metabolic health remain subjects of ongoing research.
In an effort to deepen understanding of the role these microorganisms play in obesity, researchers conducted an analysis of metagenomic and metabolomic data from a Spanish cohort. This analysis aimed to decipher the mechanisms through which gut microbes contribute to obesity’s development.
The study involved examining the faecal metabolome—the vast array of metabolites found in the gut and excreted in faeces, produced by gut bacteria as they metabolise food. These metabolites enter the bloodstream, where they can have significant health impacts.
A total of 361 adults (251 women and 110 men, with a median age of 44 years) from the Spanish Obekit study—a randomised trial exploring the relationship between genetic variants and responses to a hypocaloric diet—were included in the analysis. Participants were categorised based on their obesity (OB) index into LOW (BMI ≤ 30 kg/m²; fat mass percentage ≤ 25% for women or ≤ 32% for men; waist circumference ≤ 88 cm for women or ≤ 102 cm for men) or HIGH (BMI > 30 kg/m²; fat mass > 25% for women or > 32% for men; waist circumference > 88 cm for women or > 102 cm for men) obesity levels. This grouping ensured a balanced representation of sexes and ages within each category.
Microbiota profiling through genetic analysis was employed to ascertain the diversity, composition, and relative abundance of bacteria in participants’ stool samples.
Key findings indicated that individuals with a HIGH OB index displayed significantly reduced levels of Christensenella minuta—a bacterium associated with leanness and health. In men, an increased presence of Parabacteroides helcogenes and Campylobacter canadensis was strongly linked to elevated BMI, fat mass, and waist circumference. Conversely, in women, a higher abundance of Prevotella micans, Prevotella brevis, and Prevotella sacharolitica was strongly indicative of increased BMI, fat mass, and waist circumference, but these associations were not observed in men.
Further analyses, examining a broader spectrum of metabolic compounds in the blood, identified variations in certain metabolites, particularly elevated levels of bioactive lipids—phospholipids and sphingolipids—which are implicated in metabolic disease development and are key modulators of insulin sensitivity and contributors to diabetes and vascular complications in individuals with a HIGH OB index.
Dr. Paula Aranaz, the study’s lead author from the Centre for Nutrition Research at the University of Navarra in Spain, explained, “Our findings underscore the significant role of bacterial imbalance in the onset and progression of obesity, highlighting notable differences between genders. This imbalance affects the metabolism of bioactive molecules in the metabolome, which in turn influences metabolic disease development.”
Dr. Aranaz further elaborated on the protective role of the Christensenella minuta bacterium against obesity and noted that the microbial species influencing obesity risk differ by sex. This necessitates gender-specific interventions to prevent an obesity-promoting microbiome. She emphasised the need for additional research to pinpoint when the shift to an obesity-favourable gut microbiota occurs, to better time potential interventions.
She concluded with optimism, stating, “This study demonstrates the utility of combining metagenomics with metabolomics to unravel the mechanisms at play in metabolic disease development, such as obesity. This innovative, comprehensive approach has the potential to foster the creation of nutritionally precise strategies for weight management that alter specific bacterial strains or bioactive molecule levels.”
However, the authors acknowledged certain limitations of their study, including its relatively small sample size—particularly for men—and its geographical limitation to one region in Spain. Given that factors such as climate, geography, diet, and culture can influence the gut microbiome, the applicability of these findings to other populations may be limited.
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Novo Nordisk’s $2.3 billion French investment to enhance obesity drug output
Novo Nordisk has declared a substantial $2.3 billion investment aimed at amplifying the output of its highly sought-after obesity and diabetes medications at its Chartres facility in France, in a move to satiate the escalating demand. This financial injection will notably enhance the manufacturing capabilities for existing products such as Ozempic and Wegovy, alongside other burgeoning obesity treatments, according to the Danish pharmaceutical giant.
Europe is currently grappling with a supply crisis of the diabetes medication Ozempic, which shares the active ingredient semaglutide with the widely acclaimed weight management drug Wegovy—yet to be broadly distributed across Europe.
In response to the off-label consumption of Ozempic, Novo Nordisk has imposed restrictions within the European Union. Concurrently, Germany is considering export prohibitions, while Belgium has already enacted a ban on prescribing the weekly injection for non-diabetes purposes.
Despite efforts by the UK government to restrict the use of Ozempic to non-weight loss purposes in July, a Reuters investigation discovered the drug is still being acquired by individuals without diabetes for weight management.
This announcement follows Novo Nordisk’s recent proclamation of a $6 billion expenditure in Denmark to augment production capabilities. Additionally, this venture represents a significant endorsement for French President Emmanuel Macron’s economic strategies amidst a looming global downturn, aiming to sustain the momentum in reducing French unemployment figures.
President Macron had advocated for this investment during his “Choose France” summit, which reportedly persuaded Novo Nordisk’s CEO Lars Fruergaard Jorgensen to commit to the expansion. The investment also echoes Eli Lilly’s recent decision to construct a $2.5 billion manufacturing plant in Germany, similarly motivated by heightened demand for diabetes and obesity treatments.
Analysts predict the obesity drug market could reach a staggering $100 billion by 2030. Novo Nordisk’s French investment will notably expand its capacity for intricate manufacturing processes, specifically the intricate filling of injection pens with semaglutide, and the subsequent assembly and packaging of these pens.
Though details were scant earlier this month regarding the augmentation of in-house production for Ozempic and Wegovy’s European variant, Novo Nordisk has confirmed that the Chartres expansion has commenced, with completion slated between 2026 and 2028, promising the creation of 500 new job opportunities, adding to the near 2,000-strong workforce currently employed at the factory.
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Eli Lilly announces multibillion-euro German plant to scale up obesity drug production
Eli Lilly and Company, the American pharmaceutical giant, has announced plans to establish its first production facility in Germany, situated in the western town of Alzey, with an investment of 2.3 billion euros ($2.5 billion). This move, initially reported by Reuters, comes in response to the rapidly escalating demand for innovative diabetes and obesity treatments. The strategic investment will expand the production capabilities for key diabetes and obesity medications, including Mounjaro and Trulicity, as well as the injection devices required for their administration.
On Friday, Eli Lilly highlighted the significant role Germany’s skilled workforce will play in enhancing the company’s supply of incretin-based treatments, with the site expected to become operational in 2027. Incretins, a class of peptide-based medications like Mounjaro, are designed to mimic intestinal hormones that curb appetite and promote insulin release.
The expansion of Eli Lilly’s manufacturing footprint into Germany aligns with broader industry trends, where pharmaceutical companies are facing mounting political pressure to localise the production of critical healthcare products. The COVID-19 pandemic brought to light the fragility of global supply chains, prompting a reevaluation of manufacturing strategies to better serve market demands.
The German Health Minister, Karl Lauterbach, expressed his support for the investment at a press briefing in Berlin. He underscored the importance of this development for Germany’s stature as a pharmaceutical hub, emphasising the potential for more rapid access to novel treatments and reduced reliance on precarious supply chains.
The selection of Alzey as the site for this new production complex was influenced by several factors, including the availability of a skilled workforce, the existing infrastructure, and the prospect of creating a manufacturing nexus in conjunction with Eli Lilly’s existing site in Fegersheim, France. Edgardo Hernandez, the head of manufacturing at Eli Lilly, pointed out Germany’s rich heritage in engineering and science, as well as the proximity to numerous equipment manufacturers, as pivotal in the site selection process.
Mounjaro is on the cusp of gaining approval for weight loss treatment in the European Union, following the EU drugs regulator’s recommendation for its approval. However, Germany’s public health insurance currently does not cover weight-loss medications, meaning that patients seeking Mounjaro for non-diabetic weight loss will likely have to bear the costs independently. Minister Lauterbach indicated that there are no immediate plans to reassess these regulations.
Over the past three years, Eli Lilly has made public commitments exceeding $11 billion towards global manufacturing. In their third-quarter financial disclosure, the company earmarked over $8 billion for expansion projects in Indiana, North Carolina, and Limerick, Ireland, over the coming years. Despite this, Eli Lilly anticipates continued supply constraints while it ramps up manufacturing capacity. Concurrently, the firm has appealed to medical professionals outside the United States to halt new patient prescriptions of Trulicity due to heightened demand.
This investment announcement occurs amidst vigorous debate over the European Union’s proposal to reduce the standard period for market exclusivity, prompting Eli Lilly to invest strategically in the region and partake in shaping industry dialogue.
Eli Lilly, with a longstanding presence in Germany since 1960 and a current workforce of 1,000 employees in various domains, anticipates the new Alzey facility will create up to 1,000 high-calibre jobs for engineers, technicians, and scientists, further reinforcing the company’s commitment to innovation and healthcare advancement.
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Survey reveals Ireland has second highest rate of obesity in EU
New data indicates that Ireland ranks second within the European Union (EU) for obesity rates, with over a quarter of its adult population falling into this category.
Statistics released by Eurostat, the EU’s statistical office, show that in 2019, obesity was prevalent in 26% of the Irish adult population. This figure significantly overshadows the EU average of 16%, with only Malta recording a higher rate at 28%. Comparatively, Ireland ranked seventh in a similar survey in 2014, with an obesity rate of 18%.
However, when examining the combined data for those classified as overweight, including individuals identified as having obesity and “pre-obesity,” Ireland presents a better picture. Over half of the adults in the country, about 56%, are categorised as having overweight, which positions Ireland near the middle among the 27 EU nations. Croatia and Malta top this list with 64% of their adults having overweight, while Italy and France record the lowest figures, with 45% of adults in these countries classified as having overweight.
Body Mass Index (BMI), a metric that measures body fat in relation to an individual’s height and weight, is used to determine whether a person has overweight. A BMI of 25 or above classifies a person as having overweight, while a BMI of 30 or higher indicates obesity. A BMI range of 18.5-25 is considered normal.
In 2019, according to Eurostat data, slightly over half of all adults in the EU had overweight. Of this population, 45% maintained normal weight, 53% were classified as having overweight, and nearly 3% were considered underweight.
A representative from Eurostat emphasised the serious public health implications of obesity, which notably elevates the risk of chronic diseases such as cardiovascular disease, type-2 diabetes, hypertension, and certain types of cancer. The spokesperson further explained that obesity could also be linked with various psychological issues. “The societal implications of obesity are significant, resulting in substantial direct and indirect costs that place considerable burden on healthcare and social resources,” they said.
The study discovered that in all 27 EU member states, more men than women had overweight. In Ireland, this discrepancy was evident with 61% of males having overweight compared to 49% of females. However, the rates of obesity were relatively equal, with 26% of Irish men and 25% of Irish women categorised as having obesity.
Eurostat’s data also highlighted a correlation between age and weight, with higher rates of individuals with overweight in older age groups, excluding those aged 75 and above. The highest rate of individuals with obesity in Ireland (32%) was documented among individuals aged between 65-74.
Moreover, a clear link was identified between educational attainment and weight, with a decreasing prevalence of individuals with overweight as education levels increased.
Geographically, in Ireland, people residing in the Border region, which includes counties Cavan, Donegal, Leitrim, Louth, Monaghan, and Sligo, exhibited the highest likelihood of having overweight or obesity. Around 59% of adults in this region had overweight, and 30% had obesity. In contrast, the west region (counties Galway, Mayo, and Roscommon) and the south-west region (Cork and Kerry) recorded the lowest rates of individuals with overweight, at 53%.
The Central Statistics Office compiled these Irish figures by analysing a survey of approximately 7,600 individuals, conducted as part of the Irish Health Survey 2019.
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WHO: Obesity in Europe at ‘epidemic proportions’
The World Health Organization (WHO) Regional Office for Europe has released a report warning that obesity rates in the European Region have reached “epidemic proportions.”
The report states that the number of adults and children who have overweight or obesity is increasing, with 59% of adults and nearly one in three children affected. The report also highlights that no country in the European region is currently on track to halt the rise of obesity by 2025. Early studies from some countries showed that the prevalence of having overweight or obesity increased in children and teenagers during the pandemic.
The report highlights meal delivery apps as a potential contributor to the obesity problem, as they may encourage sedentary behaviour. The use of these apps was accelerated during the pandemic when people were advised to stay at home. The report recommends policies to ensure that restaurants that are required to display nutrition information also do so on apps. It also suggests that, where applicable, meal delivery companies be classified as food businesses to be held accountable in the same way.
The report finds that obesity and overweight are responsible for more than 1.2 million deaths across the region each year. Kremlin Wickramsinghe, ad interim head of the WHO European Office for the Prevention and Control of Noncommunicable Diseases, called for the attention of the highest level of governments during a briefing, highlighting that obesity is linked to at least 13 different types of cancer and is likely directly causing at least 200,000 new cancer cases every year in the region. In some countries, the report predicts that obesity will overtake smoking as the leading risk factor for preventable cancer in the decades ahead.
The WHO report warns that if action is not taken to address the issue, the burden of obesity-related illnesses and the associated healthcare costs will continue to rise, placing significant strain on healthcare systems and national budgets.
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France sees a surprising surge in obesity
An article in The Economist titled “France sees a surprising surge in obesity” highlights the recent increase in obesity rates in France. The article notes that despite being known for its healthy eating habits and cuisine, France is experiencing a rise in obesity levels, particularly among children, and attributes the increase to a shift towards more sedentary lifestyles, as well as the availability of unhealthy food options. The article also discusses the potential health consequences of the trend and the need for public health initiatives to address the issue. The article concludes by stating that the obesity epidemic is a growing concern in many countries, and addressing the issue will require a multi-faceted approach, including changes in government policies, increased access to healthy food, and increased physical activity.
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Europe set to miss global heart health targets as obesity skyrockets
According to a paper published in European Heart Journal, the flagship journal of the European Society of Cardiology, the prevalence of obesity in Europe has more than doubled over the past 35 years, with over one in five adults affected.
The third report from the ESC Atlas Project updates and expands upon the previous edition with cardiovascular disease (CVD) statistics to 2019, or the latest available year, for the 57 ESC member countries.
CVD is the most common cause of death in the region, accounting for 45% and 39% of fatalities in women and men, respectively. Unfortunately, the report paints a picture of ageing populations and low birth rates. Between 1970 and 2019 the proportion of individuals aged over 65 years increased from a median 9.2% to 17.2%, and the median age increased from 29.6 to 41.1 years. Alongside this, between 1970 and 2018 fertility rates fell from 2.6 to 1.6, below the average of 2.1 live births per woman needed for population replacement.
Each year, an estimated 48,000 new cases of coronary heart disease occur across Europe due to environmental noise pollution.
Professor Adam Timmis, chair of the report writing team, said, “Sociodemographic and environmental risk factors receive relatively little attention from cardiologists but make a substantial contribution to the risk of CVD. Europe now has top-heavy populations and this will exacerbate the growing burden of CVD. The situation is compounded by increasing urbanisation which threatens heart health due to dirty air, noise, social deprivation and stress. It is estimated that up to 40% of people living in the EU are exposed to noise levels beyond the region’s residential limits.”
According to the World Health Organisation (WHO), noncommunicable diseases kill 41 million people each year, equivalent to 71% of all deaths globally. CVD accounts for most of these deaths (17.9 million annually), followed by cancer (9.3 million). The WHO has set targets for noncommunicable diseases to be met by 2025 but the evidence in today’s report suggests that, across ESC member countries, most goals relating to heart health are unlikely to be achieved. For example, the WHO has called for a halt (with reference to 2010) to the rise in obesity. But between 2010 and 2016, the prevalence of obesity rose from 20.4% to 22.7% in women and from 19.2% to 22.2% in men.
Healthcare professionals will need to be properly trained to deal with the ever-increasing strain of this problem.
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Irish government steps up plans to tackle nation’s growing obesity crisis
The Irish government has stepped up its plans to tackle the nation’s growing obesity crisis through the establishment of a task force that will look at the ways saturated fat, salt, sugar and calories can be reduced in processed food that is prevalent in Ireland.
Along with the task force a ‘Roadmap for Food and Product Reformation in Ireland’ was also published by the Minister for Health Stephen Donnelly and the Minister of State for Public Health Frank Feighan.
Mr Donnelly highlighted the links between diet and non-communicable diseases and noted that it was “particularly evident in economically disadvantaged areas, where people tend to eat more processed food”. He also suggested that the new task force would work with the food industry “to combat inequality by improving the quality of the food available”.
Mr Feighan suggested that modern lifestyles were having a negative impact of people’s health and said that people were “living very busy lives and it’s not always easy, even with the best of intentions, to eat or buy the healthiest option”. He then suggested that the task force and road map were “important and positive steps forward for all of our health and wellbeing and will help to improve the nutritional quality of the processed food available to consumers and will have tangible benefits for public health”.
The Food Reformulation Task Force will sit within the Food Safety Authority of Ireland (FSAI) and will provide “a dedicated resource to work with all levels of industry to ensure progress and to address the difficulties that may arise in the highly technical process of reformulation”. FSAI chief executive Dr Pamela Byrne said the reformulation of foods has been proven to have a “positive impact on the quality of the diet and reducing salt, sugar and saturated fats in food products will positively contribute to a healthier population”. She said the FSAI would be engaging “with the food industry and other stakeholder” over the next four years.
The move comes as more retailers and producers move to make their products less harmful.
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Experts warn of obesity “pandemic” in Spain
On November 17, 2021, the Spanish Obesity Society (Seedo) launched a campaign asking for a new national multidisciplinary and transversal plan aimed at addressing Spain’s growing obesity epidemic.
According to recent data, more than 60 percent of Spanish adults are considered overweight, 24% of which have obesity and 40 percent of children between 6 and 9 years old are considered overweight, and this is unlikely to have improved during the pandemic. These figures have led specialists to predict what’s been described as a “tsunami of cases” in the coming decades.
“Obesity is a problem that will accompany us in the coming years if strong measures are not taken now,” warned the president of Seedo, Francisco Tinahones. “Strategies must be proposed to prevent and fight obesity because it is not an aesthetic problem but one of the most important diseases facing our health systems.” Tinahones clarified the need for a global plan to tackle obesity, and that the small specific actions taken so far had been merely “drops in the ocean of obesity,” and not useful.
Tinahones proposes that this new strategy include financing from the health system for obesity medication, a tax policy that penalises unhealthy food products and encourages healthy ones, food labelling that clearly reflects how healthy or unhealthy a product is, regulations that prohibit certain advertisements, urban planning that creates spaces for exercise, and the promotion of physical activity.
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