Author: GMDP Academy Editorial Board

An Age of Uncertainty: Mental Health in Young People

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Mental health spans across generations. For adolescents, mental health challenges are driven in large part by environmental factors. Check out this editorial from the Lancet, which reminds us of such. “Young people face a world with multiple crises and much uncertainty. A person born in 2006 will have gone through the great recession and the subsequent austerity measures, a pandemic with disrupted schooling and social isolation, a cost-of-living crisis, war in Europe, and a world coming to terms with the magnitude of climate change. There have been many tumultuous times in history, but evidence on the mental wellbeing of young people during those periods is scant.”

News from the World: India at 75 years- Progress, Challenges, and Opportunities

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The pharmaceutical industry has seen a remarkable contribution from our colleagues from India, and a large part of our Academy community either live and work in India, or are from there and have since relocated internationally. Additionally, India is set to become the world’s most populous country in 2023. As such, we are thrilled to share this editorial from the Lancet which celebrates a significant anniversary of the country, its 75th year of independence from British rule.

News from the EMA: The Pharmaceutical Development of Medicines for Use in the Older Population

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All professionals involved in the long process of medicines development are familiar with the fact that usually the majority of clinical trials are performed in adult populations. Some 20 years ago both the EMA and the FDA, accepting the suggestions of many pediatricians and their scientific associations, made compulsory, for all new drugs, the execution of clinical trials also in the pediatric population.

Viral Hepatitis Elimination: A Challenge, but Within Reach

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July 28 marked World Hepatitis Day. Hepatitis B and C are the two major forms of viral hepatitis, causing inflammation, damage to the liver, and sometimes cancer. Their burden is huge—more men acquired hepatitis B (890000 cases) in 2019–20 than HIV (720000 cases). In 2019 HIV caused 0.·7 million deaths, whereas hepatitis B and C combined caused 1.1 million deaths. Despite these large numbers, there is cause for optimism. The past decade has transformed viral hepatitis care. The development of direct-acting antivirals that can cure chronic hepatitis C and the rollout of hepatitis B vaccines at birth to prevent vertical transmission have ushered in a new phase in eliminating these diseases. According to this editorial in the Lancet, “Human-induced climate change has made extreme heatwaves, wildfires, and flash floods substantially more likely and more severe. Yet, health impacts are widely underestimated. Most countries have failed to adequately plan, adapt, and use evidence-based information to protect their populations. For some countries, this is a dangerous failure of action, but others lack the adequate human and financial resources to respond. So far this year, India, Pakistan, the USA, China, and Europe have experienced extreme and dangerous heatwaves that damaged vital infrastructure and threatened to overwhelm emergency service capacity. The mortality toll is staggering. According to WHO, there were at least 1700 premature and avoidable deaths in Spain and Portugal alone. For each of these deaths, many more people will have suffered serious ill health.”

2022 Heatwaves: A Failure to Proactively Manage the Risks

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We are all experiencing important climate changes, regardless of where we live on the planet. The consequences of these vast climate changes can be very severe for global health.
According to this editorial in the Lancet, “Human-induced climate change has made extreme heatwaves, wildfires, and flash floods substantially more likely and more severe. Yet, health impacts are widely underestimated. Most countries have failed to adequately plan, adapt, and use evidence-based information to protect their populations. For some countries, this is a dangerous failure of action, but others lack the adequate human and financial resources to respond. So far this year, India, Pakistan, the USA, China, and Europe have experienced extreme and dangerous heatwaves that damaged vital infrastructure and threatened to overwhelm emergency service capacity. The mortality toll is staggering. According to WHO, there were at least 1700 premature and avoidable deaths in Spain and Portugal alone. For each of these deaths, many more people will have suffered serious ill health.”

Antibiotic-Resistant Bacteria Emerging in Community Settings

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A new study from the Centers for Disease Control and Prevention (CDC) found that a surprising proportion of cases of carbapenem-resistant Enterobacterales (CRE) are found in isolates from patients in the community (CA-CRE). They had previously been thought to be healthcare-associated infections (HCA-CRE). Traditionally, CRE has been thought of as a nosocomial infection, acquired in a hospital or other healthcare facility (nursing home, long-term acute care hospital, dialysis center). This is the first population-level study to show otherwise, with fully 10% of the CRE isolates found to be community-acquired.

News from the EMA: EMA Reviewing Data on Sabizabulin for COVID-19 

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EMA’s Emergency Task Force (ETF) has started a review of data on the use of sabizabulin for treating COVID-19. The review will look at all available data, including data from a study involving hospitalized patients with moderate-to-severe COVID-19 who are at high risk of acute respiratory distress syndrome and death.1 The results of this study indicate that sabizabulin treatment could reduce the number of deaths in these patients compared with placebo.

News from the FDA: Final Guidance for Clinical Pharmacology Studies in Neonates Announced

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In the last two decades of the 21st century, many pediatricians and all scientific associations related to pediatrics, started a campaign to make regulatory authorities aware that most drugs that had marketing authorization had no clinical trials in children. Because of this lack of scientific evidence, all pediatricians were obliged to prescribe drugs to pediatric patients based only on their personal experience. This pressure was successful and all regulatory authorities, first of all, the FDA and the EMA, made it mandatory to submit, at the time of the NDA application, the results of clinical trials performed both in adults and in children.

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