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Over the past 70 years, randomized, controlled trials (RCTs) have reshaped medical knowledge and practice. Popularized by mid-20th-century clinical researchers and statisticians aiming to reduce bias and enhance the accuracy of clinical experimentation, RCTs have often functioned well in that role. Yet the past seven decades also bear witness to many limitations of this new “gold standard.” The scientific and political history of RCTs offers lessons regarding the complexity of medicine and disease and the economic and political forces that shape the production and circulation of medical knowledge. The Rise of RCTs Physicians and medical researchers have attempted for millennia . . .

Explores the discovery, invention, science, and people behind today's major psychotropic drugs, from the earliest, Thorazine and Lithium, through Prozac and Ecstasy, to today's most cutting-edge memory drugs and neural implants.-- Source other than Library of Congress.

Valium. Paxil. Prozac. Prescribed by the millions each year, these medications have been hailed as wonder drugs and vilified as numbing and addictive crutches. Where did this \"blockbuster drug\" phenomenon come from? What factors led to the mass acceptance of tranquilizers and antidepressants? And how has their widespread use affected American culture? David Herzberg addresses these questions by tracing the rise of psychiatric medicines, from Miltown in the 1950s to Valium in the 1970s to Prozac in the 1990s. The result is more than a story of doctors and patients. From bare-knuckled marketing campaigns to political activism by feminists and antidrug warriors, the fate of psychopharmacology has been intimately wrapped up in the broader currents of modern American history. Beginning with the emergence of a medical marketplace for psychoactive drugs in the postwar consumer culture, Herzberg traces how \"happy pills\" became embroiled in Cold War gender battles and the explosive politics of the \"war against drugs\"—and how feminists brought the two issues together in a dramatic campaign against Valium addiction in the 1970s. A final look at antidepressants shows that even the Prozac phenomenon owed as much to commerce and culture as to scientific wizardry. With a barrage of \"ask your doctor about\" advertisements competing for attention with shocking news of drug company malfeasance, Happy Pills is an invaluable look at how the commercialization of medicine has transformed American culture since the end of World War II.

\"This book explores topics on the brain, psychoactive drugs, and a variety of human behaviors and experiences taking into consideration the importance of historical roots of neuroscience. It looks particularly at the importance of the Victorian era in the development of theories of the nervous system, which are still visible in today's discourse on brain and behavior\"--Provided by publisher.

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.

Public perceptions of mental health issues have changed dramatically over the last fifteen years, and nowhere more than in the rampant overmedication of ordinary Americans. In 2006, 227 million antidepressant prescriptions were dispensed in the United States, more than any other class of medication; that year, the United States accounted for 66% of the global market. Here, psychiatrist Barber provides a context for this disturbing phenomenon. He explores the ways in which pharmaceutical companies first create the need for a drug and then rush to fill it, and he reveals the increasing pressure Americans are under to medicate themselves. Most importantly, he argues that without an industry to promote them, non-pharmaceutical approaches that could have the potential to help millions are tragically overlooked by a nation that sees drugs as an instant cure for all emotional difficulties.--From publisher description.

Key Points Here, we present an analysis of the origins of all 113 first-in-class drugs approved by the US Food and Drug Administration (FDA) from 1999 to 2013, which shows that the majority (78) of these drugs were discovered through target-based approaches (45 small-molecule drugs and 33 biologics). Only eight of the 33 drugs identified in the absence of a target hypothesis were found by what we define here as 'phenotypic screening': the testing of a large number of compounds in a target-agnostic assay that monitors phenotypic changes. The discovery of the other 25 non-target-based drugs occurred through a chemocentric approach in which compounds with known pharmacology served as the starting point. The median time from first disclosure of the concept (target, pathway or chemotype) to FDA approval was 25 years for non-target-based drugs and 20 years for target-based drugs. All but four of the non-target-based drugs had their origins before 1985, the time around which the technologies necessary for target-based approaches were introduced. We conclude that target-based drug discovery is successful and recognize that high-throughput screening and other innovations applied in the past 25 years have only recently started to have a major impact on new approvals. We further suggest viewing phenotypic screening as a logical evolution of target-based approaches and consider it a novel discipline rather than a neoclassical approach. Previous analyses of new drug approvals have suggested that phenotypic screening strategies have been more productive than target-based approaches in the discovery of first-in-class small-molecule drugs. Eder and colleagues analysed the origins of the first-in-class drugs approved by the US Food and Drug Administration from 1999 to 2013, and found that target-based approaches have had a substantial impact in more recent years. They discuss the implications for drug discovery strategies, including viewing phenotypic screening as a novel discipline rather than as a neoclassical approach. Analysis of the origins of new drugs approved by the US Food and Drug Administration (FDA) from 1999 to 2008 suggested that phenotypic screening strategies had been more productive than target-based approaches in the discovery of first-in-class small-molecule drugs. However, given the relatively recent introduction of target-based approaches in the context of the long time frames of drug development, their full impact might not yet have become apparent. Here, we present an analysis of the origins of all 113 first-in-class drugs approved by the FDA from 1999 to 2013, which shows that the majority (78) were discovered through target-based approaches (45 small-molecule drugs and 33 biologics). In addition, of 33 drugs identified in the absence of a target hypothesis, 25 were found through a chemocentric approach in which compounds with known pharmacology served as the starting point, with only eight coming from what we define here as phenotypic screening: testing a large number of compounds in a target-agnostic assay that monitors phenotypic changes. We also discuss the implications for drug discovery strategies, including viewing phenotypic screening as a novel discipline rather than as a neoclassical approach.

In the eighteenth century, malaria was a prevalent and deadly disease, and the only effective treatment was found in the Andean forests of Spanish America: a medicinal bark harvested from cinchona trees that would later give rise to the antimalarial drug quinine. In 1751, the Spanish Crown asserted control over the production and distribution of this medicament by establishing a royal reserve of \"fever trees\" in Quito. Through this pilot project, the Crown pursued a new vision of imperialism informed by science and invigorated through commerce. But ultimately this project failed, much like the broader imperial reforms that it represented. Drawing on extensive archival research, Matthew Crawford explains why, showing how indigenous healers, laborers, merchants, colonial officials, and creole elites contested European science and thwarted imperial reform by asserting their authority to speak for the natural world.The Andean Wonder Druguses the story of cinchona bark to demonstrate how the imperial politics of knowledge in the Spanish Atlantic ultimately undermined efforts to transform European science into a tool of empire.