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Unhappiness, sadness and 'depression' : antidepressants and the mental disorder epidemic
This book examines existing treatments, legislation and research methodology of depression and exposes their limitations, championing psycho-social support as an alternative. Depression, affecting 350 million people according to the World Health Organisation, is almost invariably diagnosed by the criteria of the American Psychiatric Association, a definition which encompasses those with normal emotional responses to stressful life events. Tullio Giraldi discusses recent developments in popular and academic dialogue related to the use of antidepressants and recent increases in depression diagnosis and laments the rise in prescribing antidepressants despite their links to suicide and unfulfilled promises of efficacy and safety. He argues that psychotherapy is a cost effective treatment devoid of drugs' adverse effects. This work presents psycho-social support as an alternative to antidepressants, particularly for less severe cases, and as a more effective strategy for coping with the emotional challenges of today's global reality. Patients, students of medicine and psychology, and professionals of mental health will find this work valuable.
BOOK
Phage Therapy Regulation: From Night to Dawn
After decades of disregard in the Western world, phage therapy is witnessing a return of interest. However, the pharmaceutical legislation that has since been implemented is basically designed for regulating industrially-made pharmaceuticals, devoid of any patient customization and intended for large-scale distribution. Accordingly, the resulting regulatory framework is hardly reconcilable with the concept of sustainable phage therapy, involving tailor-made medicinal products in the global perspective of both evolutionary and personalized medicine. The repeated appeal for a dedicated regulatory framework has not been heard by the European legislature, which, in this matter, features a strong resistance to change despite the precedent of the unhindered implementation of advanced therapy medicinal product (ATMPs) regulation. It is acknowledged that in many aspects, phage therapy medicinal products are quite unconventional pharmaceuticals and likely this lack of conformity to the canonical model hampered the development of a suitable regulatory pathway. However, the regulatory approaches of countries where phage therapy traditions and practice have never been abandoned are now being revisited by some Western countries, opening new avenues for phage therapy regulation. As a next step, supranational and international organizations are urged to take over the initiatives originally launched by national regulatory authorities.
Journal Article
Model‐Informed Drug Discovery and Development: Current Industry Good Practice and Regulatory Expectations and Future Perspectives
Good practices around model‐informed drug discovery and development (MID3) aim to improve the implementation, standardization, and acceptance of these approaches within drug development and regulatory review. A survey targeted to clinical pharmacology and pharmacometric colleagues across industry, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) was conducted to understand current and future roles of MID3. The documented standards were generally affirmed as a “good match” to current industry practice and regulatory expectations, with some identified gaps that are discussed. All have seen at least a “modest” step forward in MID3 implementation associated with greater organizational awareness and share the expectation for a future wider use and impact. The priority within organizations was identified as a limitation with respect to the future of MID3. Finally, potential solutions, including a global overarching MID3 regulatory guideline, to facilitate greater acceptance by industry and regulatory decision makers are discussed.
Journal Article
Drug wars : how big pharma raises prices and keeps generics off the market
\"While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs\"-- Provided by publisher.
Book
The unsteady state and inertia of chemical regulation under the US Toxic Substances Control Act
After 40 years, the 1976 US Toxic Substances Control Act (TSCA) was revised under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Its original goals of protecting the public from hazardous chemicals were hindered by complex and cumbersome administrative burdens, data limitations, vulnerabilities in risk assessments, and recurring corporate lawsuits. As a result, countless chemicals were entered into commercial use without toxicological information. Few chemicals of the many identified as potential public health threats were regulated or banned. This paper explores the factors that have worked against a comprehensive and rational policy for regulating toxic chemicals and discusses whether the TSCA revisions offer greater public protection against existing and new chemicals.
Journal Article
Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors
IntroductionMedications are compounded when a formulation of a medication is needed but not commercially available. Regulatory oversight of compounding is piecemeal and compounding errors have resulted in patient harm. We review compounding in the United States (US), including a history of compounding, a critique of current regulatory oversight, and a systematic review of compounding errors recorded in the literature.MethodsWe gathered reports of compounding errors occurring in the US from 1990 to 2020 from PubMed, Embase, several relevant conference abstracts, and the US Food and Drug Administration “Drug Alerts and Statements” repository. We categorized reports into errors of “contamination,” suprapotency,” and “subpotency.” Errors were also subdivided by whether they resulted in morbidity and mortality. We reported demographic, medication, and outcome data where available.ResultsWe screened 2155 reports and identified 63 errors. Twenty-one of 63 were errors of concentration, harming 36 patients. Twenty-seven of 63 were contamination errors, harming 1119 patients. Fifteen errors did not result in any identified harm.DiscussionCompounding errors are attributed to contamination or concentration. Concentration errors predominantly result from compounding a prescription for a single patient, and disproportionately affect children. Contamination errors largely occur during bulk distribution of compounded medications for parenteral use, and affect more patients. The burden falls on the government, pharmacy industry, and medical providers to reduce the risk of patient harm caused by compounding errors.ConclusionIn the US, drug compounding is important in ensuring access to vital medications, but has the potential to cause patient harm without adequate safeguards.
Journal Article
The poison eaters : fighting danger and fraud in our food and drugs
\"Formaldehyde, borax, salicylic acid. Today, these chemicals are used in embalming fluids, cleaning supplies, and acne medications. But in 1900, they were routinely added to food that Americans ate from cans and jars. Often products weren't safe because unregulated, unethical companies added these and other chemicals to trick consumers into buying spoiled food or harmful medicines. Chemist Harvey Washington Wiley recognized these dangers and began a relentless thirty-year campaign to ensure that consumers could purchase safe food and drugs, eventually leading to the creation of the U.S. Food and Drug Administration, or FDA. Acclaimed nonfiction and Sibert Honor winning author Gail Jarrow uncovers this intriguing history in her trademark style that makes the past enthrallingly relevant for today's young readers.\"--Amazon.
Book
The Myth of the Free Market for Pharmaceuticals
The Myth of the Free Market for PharmaceuticalsThe U.S. pharmaceutical market has always been influenced by government. The 2022 Inflation Reduction Act is the latest policy aiming to improve access and affordability while supporting innovation.
Journal Article