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What We're Reading: Safe Injection Site; Clinical Trial Data Release; Opioid Lawsuit Settlement
A nonprofit in Philadelphia can open a safe injection site for intravenous drug users; clinical trial sponsors could be deemed noncompliant for not posting their data; Mallinckrodt Pharmaceuticals agrees to pay $1.6 billion in ongoing opioid crisis lawsuit.
Final Ruling Handed Down on Philadelphia Nonprofit’s Proposal for a Safe Injection Site
Late Tuesday saw District Court Judge Gerald A. McHugh issue his final ruling on permitting nonprofit Safehouse to open its proposed safe injection site in South Philadelphia, reports The Hill. Opponents claimed the site would violate federal law, specifically the Controlled Substances Act, and “facilitate illegal drug use.” Proponents, meanwhile, tout that the medical personnel staffing the site will be able to connect their clients to social services and provide medical care—including naloxone, if needed—and clean needles. Judge McHugh previously ruled in October 2019 that Safehouse’s proposal would not violate federal law.
Decade’s Worth of Missing Clinical Trial Data Could Soon Publish
With claims of inconsistent reporting of clinical trial data to ClinicalTrials.gov, a federal judge from New York’s Southern District has ruled that previously unpublished clinical trial data must be released, according to Stat News. Two chief complaints from the lawsuit’s plaintiffs, a New York University journalism professor and a former FDA associate commissioner, are that the FDA has not fined trial sponsors and the National Institutes of Health has not withheld grant funding for not releasing the data, despite transparency requirements. A deadline for posting the data has not been determined.
Mallinckrodt Pharmaceuticals Agrees to $1.6-Billion Lawsuit Settlement
With thousands of lawsuits on the docket, the pharmaceutical behemoth and Attorney General Xavier Becerra of California jointly announced tentative plans for the $1.6 billion to be put into a trust over 8 years, says The New York Times. The US division of Mallinckrodt will also file for Chapter 11 bankruptcy under the plan. According to the CDC, close to 218,000 people died from opioid overdoses between 1999 and 2017, with the death rate 5 times higher in 1999 than 2017. Similar offers from Johnson and Johnson and McKesson remain in limbo.
Urticaria Diagnosis Challenged by Overlapping Pruritic Skin Conditions
April 23rd 2025Urticaria is complicated to diagnose by its symptomatic overlap with other skin conditions and the frequent misclassification in literature of distinct pathologies like vasculitic urticaria and bullous pemphigus.
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New Research Challenges Assumptions About Hospital-Physician Integration, Medicare Patient Mix
April 22nd 2025On this episode of Managed Care Cast, Brady Post, PhD, lead author of a study published in the April 2025 issue of The American Journal of Managed Care®, challenges the claim that hospital-employed physicians serve a more complex patient mix.
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Personalized Care Key as Tirzepatide Use Expands Rapidly
April 15th 2025Using commercial insurance claims data and the US launch of tirzepatide as their dividing point, John Ostrominski, MD, Harvard Medical School, and his team studied trends in the use of both glucose-lowering and weight-lowering medications, comparing outcomes between adults with and without type 2 diabetes.
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ACOs’ Focus on Rooting Out Fraud Aligns With CMS Vision Under Oz
April 23rd 2025Accountable care organizations (ACOs) are increasingly playing the role of data sleuths as they identify and report trends of anomalous billing in hopes of salvaging their shared savings. This mission dovetails with that of CMS, which under the new administration plans to prioritize rooting out fraud, waste, and abuse.
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