Chana A. Sacks

Paradigm Shifts in Heart-Failure Therapy — A Timeline

As we enter a new era of treatment for heart failure with reduced ejection fraction, historical perspective is provided in a timeline (at NEJM.org) of 26 randomized, controlled trials in heart-failure treatment that have been published in the Journal since 1986.

The Failure of Solanezumab — How the FDA Saved Taxpayers Billions

The failure of solanezumab offers a window into the U.S. drug regulatory system, particularly in the context of the 21st Century Cures Act and the national debate about the role of the FDA. The solanezumab story is an important case of a regulatory system that worked.

Pilot Testing of a Parent-Directed Intervention (Project ASPIRE) for Underserved Children Who Are Deaf or Hard of Hearing.

This pilot study explored the potential for Project ASPIRE to effect behavior change in a sample of 11 parents of children with hearing loss who were from typically underserved populations, such as families from backgrounds of low socioeconomic status or families who speak English as a second language. The study consisted of one education session, five 16-hour home audio environment recordings, and four linguistic feedback reviews. The educational session focused on child language development and early language environment enrichment strategies. Parents received ‘quantitative linguistic feedback’ on the home audio recordings to further support behavior change through increased awareness of linguistic behaviors. The audio recordings were completed with the Language ENvironment Analysis system. This system measured parental linguistic behavior (adult word count or AWC), child linguistic behavior (child vocalization count or CVC), and child–parent interactive linguistic behavior (conversational turn count or CTC). Post-intervention both CTC and CVC had increased significantly compared to pre-intervention recording counts (p < 0.01; p < 0.05). Increase in AWC trended towards significance between pre- and post-intervention recordings (p < 0.1). These preliminary findings support ‘quantitative linguistic feedback’ as a viable behavior change strategy for enriching children’s early language environments through parental linguistic behaviors.

Rethinking the Ban — The U.S. Blood Supply and Men Who Have Sex with Men

The U.S. ban on blood donations from men who have sex with men was instituted at a time of great uncertainty, but advances in testing and in understanding of disease transmission offer better ways than a sweeping ban to minimize the risk of transfusion-related HIV.

Foreseeable Risks? Informed Consent for Studies within the Standard of Care

The Office for Human Research Protections has drafted guidelines on disclosing reasonably foreseeable risks in trials involving interventions that are within the standard of care. But what risks, aside from those already seen in clinical care, are reasonably foreseeable?

Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents

Importance Brand-name combination drugs can be more expensive than the sum of their components, especially when the constituent products are available as generic medications. The potential savings that could be achieved using generic components is not known. Objective To estimate the additional cost to Medicare of prescribing brand-name combination medications instead of generic constituents. Design, Setting, and Participants Retrospective analysis for 2011 through 2016 using the Medicare data set of Part D beneficiaries prescribed any of the 1500 medications that accounted for the highest total spending in 2015. Brand-name combination drugs that had identical or therapeutically equivalent generic constituents were included. Exposures Brand-name, oral combination medications with constituents available either as generic drugs or therapeutically equivalent generic substitutes. Main Outcomes and Measures The estimated difference between the amount spent by Medicare on brand-name combination drugs and the estimated amount that would have been spent on substitutable generic components. Results Among the 1500 medications evaluated, 29 brand-name combination medications were separated into 3 mutually exclusive categories: constituents available as generic medications at identical doses (n = 20), generic constituents at different doses (n = 3), and therapeutically equivalent generic substitutes (n = 6). For the constituents available as generic medications at identical doses category, total spending by Medicare in 2016 on the brand-name combination products was

After the Mass Shooting in Las Vegas — Finding Common Ground on Gun Control

303 million and the estimated spending for the generic constituents would have been

The Role of Physicians in Preventing Firearm Suicides

68 million, which is an estimated difference of

The Shortage of Normal Saline in the Wake of Hurricane Maria

235 million. For the generic constituents at different doses category, total spending by Medicare in 2016 on the brand-name combination products was

Stop Posturing and Start Problem Solving: A Call for Research to Prevent Gun Violence

232 million and the estimated spending for the generic constituents would have been