Anesthesiologists and Capital Punishment.

Physician professional organizations in all Western countries consistently hold that it is unethical for physicians to participate in judicial executions. Physician participation in capital punishment is of particular concern for anesthesiologists, who have been identified by the courts as ideal candidates to participate in executions, particularly lethal injection executions. Arguments in favor of participation are based on flawed interpretations of the ethical principle of double-effect, mistaken analogies with physician aid-in-dying, and ignore evidence of prisoner suffering in the execution process.

Writing the Roadmap for Medical Practice: Ethics of Medical Authorship.

The medical literature guides ethical clinical care by providing information on medical innovations, clinical care, the history of medical advances, explanations for past mistakes and inspiration for future discoveries. Ethical authorship practices are thus imperative to preserving the integrity of medical publications and fulfilling our obligations to ethical patient care. Unethical authorship practices such as plagiarism, guest authorship, and ghost authorship are increasing and pose serious threats to the medical literature.

Conscientious Objection.

Physicians may under some circumstances decline to provide a clinical service that is within accepted medical standards due to a deeply held moral belief that to do so would be wrong. Conscience objection in medicine is legally protected, but ethically limited by physician obligations to put patient interests first. Accommodation to conscientious objections, when possible, recognizes the diverse moral perspectives and benefits for both the objectors and the profession as a whole.

Ethics of Preanesthesia Mandatory Laboratory Testing.

Some practices require mandatory preoperative laboratory testing for select patients presenting for anesthesia and surgery. Such mandatory preanesthesia laboratory testing has significant ethical implications related to informed consent and patient autonomy. Assumptions that a patient provides "presumed consent" by merely presenting for a test are flawed because such consents are often not informed and do not acknowledge patient autonomy.

Ethical Principles Do Not Support Mandatory Preanesthesia Pregnancy Screening Tests: A Narrative Review.

Respect for patient autonomy is a pillar of medical ethics, manifested predominantly through informed consent. Mandatory (routine) nonconsented preoperative urine pregnancy testing does not adequately respect patient autonomy, is potentially coercive, and has the potential to cause harm medically, psychologically, socially, and financially. Inaccuracies in pregnancy testing can result in false-positive and false-negative results, especially in early pregnancy.

Off-Label Use vs Off-Label Marketing of Drugs: Part 1: Off-Label Use-Patient Harms and Prescriber Responsibilities.

Once medical drugs and devices are approved for marketing by the FDA they can legally be used for purposes and in ways other than the ones for which they have been tested and approved. However, it is illegal for manufacturers to advertise or promote such unapproved uses of the drugs and devices. Part 1 of this review focuses on off-label use of FDA-approved therapies.

Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials.

Phase I and II clinical trials increasingly combine therapeutic and toxicity endpoints. Recently, therapeutic agents have even achieved U.S.

Update to Drugs, Devices, and the FDA: How Recent Legislative Changes Have Impacted Approval of New Therapies.

Two major legislative actions since 2015, the 21st Century Cures Act of 2016 and the U.S. Food and Drug Administration (FDA) Reauthorization Act of 2017, contain significant provisions that potentially streamline drug development times, and by extension, may reduce costs.

"Warp Speed" Operations in the COVID-19 Pandemic: Moving Too Quickly?

The COVID-19 (coronavirus disease-2019) pandemic has presented unprecedented challenges to regulatory organizations, the biotech and pharmaceutical industry, and the publishing industry. This Translational Perspectives paper attempts to highlight some of the challenges and perils of moving extraordinarily fast in an effort to save human lives in the midst of a global pandemic. As with the development of all new therapeutic approaches, it will take time to assess the risks and benefits of developing new therapies at "warp speed".

The anesthesiologist and global climate change: an ethical obligation to act.

Purpose Of Review: Pollution and global warming/climate change contribute to one-quarter of all deaths worldwide. Global healthcare as a whole is the world's fifth largest emitter of greenhouse gases, and anesthetic gases, intravenous agents and supplies contribute significantly to the overall problem. It is the ethical obligation of all anesthesiologists to minimize the harmful impact of anesthesia practice on environmental sustainability.

Limitations of Animal Studies for Predicting Toxicity in Clinical Trials: Part 2: Potential Alternatives to the Use of Animals in Preclinical Trials.

Dramatically rising costs in drug development are in large part because of the high failure rates in clinical phase trials. The poor correlation of animal studies to human toxicity and efficacy have led many developers to question the value of requiring animal studies in determining which drugs should enter in-human trials. Part 1 of this 2-part series examined some of the data regarding the lack of concordance between animal toxicity studies and human trials, as well as some of the potential reasons behind it.

Ethical Issues in Organ Transplantation at End of Life: Defining Death.

End-of-life vital organ transplantation involves singular ethical issues, because survival of the donor is impossible, and organ retrieval is ideally as close to the death of the donor as possible to minimize organ ischemic time. Historical efforts to define death have been met with confusion and discord. Fifty years on, the Harvard criteria for brain death continue to be problematic and now face significant legislative efforts to limit their authority.

Phase II Trials in Drug Development and Adaptive Trial Design.

Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design.

Expanded Patient Access to Investigational New Devices: Review of Emergency and Nonemergency Expanded Use, Custom, and 3D-Printed Devices.

U.S. Food and Drug Administration (FDA) approval of Class III medical devices can take from 3 to 7 years.

Self-reported functional status predicts post-operative outcomes in non-cardiac surgery patients with pulmonary hypertension.

Background: Pulmonary hypertension (PHTN) is associated with increased post-procedure morbidity and mortality. Pre-procedure echocardiography (ECHO) is a widely used tool for evaluation of these patients, but its accuracy in predicting post-procedure outcomes is unproven. Self-reported exercise tolerance has not been evaluated for operative risk stratification of PHTN patients.

Expanding Patient Access to Investigational New Drugs: Overview of Intermediate and Widespread Treatment Investigational New Drugs, and Emergency Authorization in Public Health Emergencies.

Individual patients with life-threatening or severely debilitating diseases can petition the U.S. Food and Drug Administration (FDA) through their physicians to have expanded access (EA) to drugs that are in clinical trials but have not reached full FDA approval (the "single-patient" investigational new drug [IND] application).

Expanding Patient Access to Investigational Drugs: Single Patient Investigational New Drug and the "Right to Try".

With drug approval times taking an average of 8 years from entry into clinical trials to full U.S. Food and Drug Administration (FDA) approval, patients with life-threatening and severely debilitating disease and no reasonable therapeutic options are advocating for expanded access (EA) to investigational drugs prior to approval.

Overcoming the Declining Trends in Innovation and Investment in Cardiovascular Therapeutics: Beyond EROOM's Law.

Eroom's law (Moore's law spelled backwards), describes adverse trends towards declining innovation and rising costs of drug development over the last several decades. Therapeutics for cardiovascular diseases (CVD) appear to have been particularly sensitive to these trends. Thirty-three percent fewer CVD therapeutics were approved between 2000 and 2009 compared to the previous decade, and the number of CVD drugs starting all clinical trial stages declined in both absolute and relative numbers between 1990 and 2012.