Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern. The inverse benefit law, inspired by Hart's inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through 6 basic marketing strategies: reducing thresholds for diagnosing disease, relying on surrogate endpoints, exaggerating safety claims, exaggerating efficacy claims, creating new diseases, and encouraging unapproved uses. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing.
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http://dx.doi.org/10.2105/AJPH.2010.199844 | DOI Listing |
Cochrane Database Syst Rev
January 2025
Department of Pharmacy Practice, University of Connecticut, Storrs, CT 06269, USA.
Background: Guideline-recommended strategies to interrupt chronic anticoagulation with warfarin or direct oral anticoagulants (DOAC) during the perioperative period of cardiac implantable electronic device (CIED) surgery differ worldwide. There is uncertainty concerning the benefits and harms of interrupted and uninterrupted anticoagulation in patients undergoing CIED surgery.
Objectives: To assess the benefits and harms of interrupted anticoagulation (IAC) with either warfarin or DOAC in the perioperative period of CIED surgery versus uninterrupted anticoagulation (UAC), with or without heparin bridging, during an equivalent time frame, for CIED surgery.
BMC Cancer
January 2025
Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands.
Background: This paper describes the rationale and design of the RECOVER study. Currently, there is no consensus regarding the optimal treatment for high-risk, non-metastatic prostate cancer (PCa). The study primarily aims to evaluate and compare the impact of treatment with robot-assisted radical prostatectomy (RP) versus external beam radiation therapy (EBRT) with androgen deprivation therapy (ADT) for men with high-risk, non-metastatic PCa regarding health-related quality of life (HRQoL) and functional outcomes.
View Article and Find Full Text PDFCochrane Database Syst Rev
January 2025
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Background: People from lower socioeconomic groups are more likely to smoke and less likely to succeed in achieving abstinence, making tobacco smoking a leading driver of health inequalities. Contextual factors affecting subpopulations may moderate the efficacy of individual-level smoking cessation interventions. It is not known whether any intervention performs differently across socioeconomically-diverse populations and contexts.
View Article and Find Full Text PDFAnn Thorac Surg
January 2025
Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, WV.
Background: As percutaneous therapeutic options expand, the optimal management of severe aortic stenosis (AS) and concomitant coronary artery disease (CAD) is being questioned between coronary artery bypass grafting and surgical aortic valve replacement (CABG+SAVR) versus percutaneous coronary intervention and transcatheter aortic valve replacement (PCI+TAVR). We sought to compare perioperative and longitudinal risk-adjusted outcomes between patients undergoing CABG+SAVR versus PCI+TAVR.
Methods: Using the United States Centers for Medicare and Medicaid Services inpatient claims database, we evaluated all patient age 65 and older with AS and CAD undergoing CABG+SAVR or PCI+TAVR (2018-2022).
Am J Cardiol
January 2025
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address:
Background: The benefit of mechanical circulatory support (MCS) with Impella (Abiomed, Inc, Danvers, MA) for patients undergoing non-emergent, high-risk percutaneous coronary intervention (HR-PCI) is unclear and currently the subject of a large randomized clinical trial (RCT), PROTECT IV. While contemporary registry data from PROTECT III demonstrated improvement of outcomes with Impella when compared with historical data (PROTECT II), there is lack of direct comparison to the HR-PCI cohort that did not receive Impella support.
Methods: We retrospectively identified patients from our institution meeting PROTECT III inclusion criteria (left ventricular ejection fraction [LVEF] <35% with unprotected left main or last remaining vessel or LVEF <30% undergoing multivessel PCI), and compared this group (NonIMP) to the published outcomes data from the PROTECT III registry (IMP).
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