Leah Z. Rand, Daniel P. Carpenter, Aaron S. Kesselheim, Anushka Bhaskar, Jonathan J. Darrow, and William B. Feldman Reply.

The authors respond to a letter by Mitchell Berger in the March-April 2024 issue of the Hastings Center Report concerning their essay "Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines."

Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines.

The Covid-19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions.

Symptomatic aseptic loosening of a short humeral stem following anatomic total shoulder arthroplasty.

Introduction: The rate of aseptic humeral component loosening with standard-length stems is historically so low (0.3%) that presence of humeral loosening was given substantial weight in defining periprosthetic shoulder infection by the International Consensus Meeting (ICM) in 2018. This study aims to confirm that the historically low rate of humeral stem aseptic loosening is not affected by the adoption of a novel short humeral stem.

Trends in open shoulder surgery among early career orthopedic surgeons: who is doing what?

Background: The incidence of various open shoulder procedures has changed over time. In addition, various fellowships provide overlapping training in open shoulder surgery. There is a lack of information regarding the relationship between surgeon training and open shoulder procedure type and incidence in early career orthopedic surgeons.

Spontaneous Healing of a Bucket-Handle Posterior Labral Detachment After Hip Dislocation in a Five-Year-Old Child: A Case Report.

Case: We report the case of a 5-year-old girl who sustained a traumatic hip dislocation and a spontaneous reduction that was complicated by nonconcentric reduction and a large bucket-handle labral detachment. This injury was managed, via an anterior approach, with capsulotomy and reduction of the large interposed labral tear with an attached osteochondral fragment from the posterior aspect of the acetabulum. No additional surgical treatment was employed for the labral tear.

Neurogenic Edema from Complex Regional Pain Syndrome Resulting in Fulminant Infection Necessitating Below Elbow Amputation.

We report a case of severe upper extremity complex regional pain syndrome type 1 (CRPS-1) and neurogenic edema that ultimately led to a medically necessary below-elbow amputation. The patient presented with a history of remote bilateral carpal tunnel release complicated by debilitating and recalcitrant bilateral CRPS-1. Following years of severe neurogenic edema of the left upper extremity, the patient had full-thickness skin sloughing on the dorsum of her hand due to massive edema.

Novel Antibiotic-loaded Point-of-care Implant Coating Inhibits Biofilm.

Background: Orthopaedic biomaterials are susceptible to biofilm formation. A novel lipid-based material has been developed that may be loaded with antibiotics and applied as an implant coating at point of care. However, this material has not been evaluated for antibiotic elution, biofilm inhibition, or in vivo efficacy.

Time series analyses of the effect of FDA communications on use of prescription weight loss medications.

Objective: To determine the impact of FDA safety communications regarding the weight loss medications sibutramine and orlistat.

Methods: The 2008 to 2011 pharmacy claims data from CVS Caremark were used to determine the effect of the relevant FDA warnings on (1) use of sibutramine and orlistat, (2) their rates of discontinuation, and (3) substitution to an alternate weight loss medication in the 3-month period following discontinuation.

Results: The use of sibutramine, orlistat, or phentermine declined from 45 users per 100,000 Caremark enrollees in May 2008 to 24 users per 100,000 enrollees in December 2010.

Whose deaths matter? Mortality, advocacy, and attention to disease in the mass media.

Diseases capture public attention in varied ways and to varying degrees. In this essay, we use a unique data set that we have collected about print and broadcast media attention to seven diseases across nineteen years in order to address two questions. First, how (if at all) is mortality related to attention? Second, how (if at all) is advocacy, in the form of organized interest group activity, related to media attention? Our analysis of the cross-disease and cross-temporal variation in media attention suggests that who suffers from a disease as well as how many suffer are critical factors in explaining why some diseases get more attention than others.

Defending submission-year analyses of new drug approvals.

In response to the critique of Mary Olsen, Daniel Carpenter, on behalf of his co-authors, addresses the issue of analysis based on the year a new drug is submitted for Food and Drug Administration (FDA) approval, not the year it is approved. Both substantive knowledge of the FDA drug review process and sound social science theory favor submission-year averaging. The history and bureaucratic mechanics of the Center for Drug Evaluation and Review (CDER) conform to the author's assumption.

The political economy of FDA drug review: processing, politics, and lessons for policy.

U.S. Food and Drug Administration (FDA) drug review bears a structural similarity to many decisions made by other regulatory agencies: high uncertainty, low reversibility, avoidance of observable error, and high political stakes that induce lobbying by interested parties.