Considering the Patient in Pediatric Drug Development: How Good Intentions Turned Into Harm

The book "Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm" addresses the challenge of ambiguous terminology in drug development and healthcare for young patients. It outlines the demand for, support of, and performance of pediatric drug studies by regulatory authorities, pediatric academia, and the pharmaceutical industry, despite their flaws. It also highlights the lack of medical sense in most pediatric regulatory studies and the conflicts of interest behind them. The book discusses the maturation of the human body regarding absorption, distribution, metabolism, and excretion of food and drugs, as well as the differences between newborns, infants, older children, and adolescents.

Format: Paperback / softback
Length: 414 pages
Publication date: 20 November 2020
Publisher: Elsevier Science Publishing Co Inc

Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm is a comprehensive exploration of a critical issue in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is often used ambiguously to assign physiological characteristics to a chronological age limit, which, in reality, does not exist. This book delves into the reasons why regulatory authorities in the United States (US) and European Union (EU), pediatric academia, and the pharmaceutical industry demand, support, and conduct pediatric drug studies. It also highlights the inherent flaws in this demand, which blur the distinct administrative and physiological meanings of the term "child." Furthermore, the book sheds light on why most pediatric regulatory studies lack medical rationale and can even harm young patients. It provides valuable insights into the maturation of the human body regarding the absorption, distribution, metabolism, and excretion of food and drugs, as well as the significant differences between newborns, infants, older children, and adolescents.

Introduction:
The term "children" is used to describe a wide range of individuals, from newborns to adolescents, with varying physiological characteristics and developmental stages. However, the ambiguity surrounding the use of this term in clinical trials and clinical practice has led to significant challenges in drug development and healthcare for young patients. In this book, we will explore why the United States (US) and European Union (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support, and perform pediatric drug studies. We will also examine the key flaws in this demand that blur the different administrative and physiological meanings of the term "child."

Why Do Regulatory Authorities, Pediatric Academia, and the Pharmaceutical Industry Demand Pediatric Drug Studies?:
Regulatory authorities, pediatric academia, and the pharmaceutical industry argue that conducting pediatric drug studies is necessary to ensure the safety and efficacy of drugs used in children. They argue that children are unique in their physiological and developmental characteristics, and that their responses to drugs may differ from those of adults. Therefore, it is essential to conduct pediatric drug studies to obtain data that can inform the development of safe and effective treatments for children.

Key Flaws in the Demand for Pediatric Drug Studies:
However, there are several key flaws in the demand for pediatric drug studies. First, the term "children" is used ambiguously to refer to a chronological age limit, which does not exist in reality. Children are not a homogenous group, and their physiological and developmental characteristics vary widely. Therefore, using a single age limit to define "children" is not appropriate and can lead to misleading results.

Second, the demand for pediatric drug studies is driven by the desire to increase the market share of pharmaceutical companies. Pharmaceutical companies are interested in developing drugs that can be used to treat a wide range of patients, including children. However, the financial incentives for conducting pediatric drug studies may outweigh the potential benefits to young patients. This can lead to the development of drugs that are not safe or effective for children, or to the under-testing of drugs that are already safe and effective for children.

Third, the demand for pediatric drug studies is often influenced by political and social factors. Pediatric academia and regulatory authorities may be influenced by the pressure from advocacy groups, parents, and other stakeholders to conduct pediatric drug studies. However, these pressures may not always be in the best interest of young patients.

Why Do Most Pediatric Regulatory Studies Lack Medical Sense and Even Harm Young Patients?:
Most pediatric regulatory studies lack medical sense and can even harm young patients. This is because the studies are often designed to evaluate the safety and efficacy of drugs in a small number of children with specific conditions. However, these studies may not be generalizable to the broader population of children. Furthermore, the studies may be conducted with inadequate sample sizes, which can lead to misleading results.

In addition, the studies may be conducted with inadequate study designs, which can lead to bias and confounding. For example, studies may be designed to compare the safety and efficacy of a new drug with a placebo or with an existing drug. However, if the existing drug is not effective or safe for children, the study may not be able to detect any differences between the new drug and the placebo.

Furthermore, the studies may be conducted with inadequate follow-up periods, which can lead to missing data and incomplete information. This can make it difficult to assess the long-term safety and efficacy of the drugs.

Conflicts of Interest Behind Pediatric Drug Studies:
Conflicts of interest behind pediatric drug studies are a significant concern. Pharmaceutical companies may have financial incentives to conduct studies that favor their products. Researchers may have financial incentives to conduct studies that support their research interests. Regulatory authorities may have financial incentives to approve drugs that are safe and effective for children.

These conflicts of interest can lead to biased research results and the under-testing of drugs that may be unsafe or ineffective for children. For example, pharmaceutical companies may conduct studies that favor their products, or researchers may conduct studies that support their research interests. Regulatory authorities may approve drugs that are safe and effective for children, even if they are not the best available treatment option.

In conclusion, considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm is a critical exploration of a critical issue in drug development and healthcare for young patients. The term "children" is used ambiguously to refer to a chronological age limit, which does not exist in reality. The demand for pediatric drug studies is driven by financial incentives, political and social factors, and the desire to increase the market share of pharmaceutical companies. However, these demands have led to the development of drugs that are not safe or effective for children, the under-testing of drugs that are already safe and effective for children, and conflicts of interest behind pediatric drug studies. It is essential to address these flaws and ensure that pediatric drug studies are conducted with medical sense.

Weight: 650g
Dimension: 152 x 228 x 24 (mm)
ISBN-13: 9780128238882