About healthcare quality and safety
Burden of serious harms from diagnostic error in the USA “An estimated 795 000 Americans become permanently disabled or die annually across care settings because dangerous diseases are misdiagnosed. Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined.”
FDA announces Class I recall of nearly 8,000 heart attack tests due to inaccurate results “The U.S. Food and Drug Administration (FDA) has announced that Quidel Cardiovascular Inc. is recalling certain blood tests used to detect myocardial infarctions. The agency has categorized this as a Class 1 recall, which means using these devices “may cause serious injuries or death.”
The Quidel Triage Cardiac Panel is a blood test designed to identify amounts of different enzymes and proteins associated with a heightened risk of myocardial infarctions or other potentially fatal cardiac conditions. The recall is in place because there have been multiple reports of inaccurate tests.”
About hospitals and healthcare systems
Ochsner Health, Novant Health Announce Partnership to Expand Patient-Centered Senior Care “The partners plan to build 65 Plus clinics throughout the Southeast, giving older adult patients access to extended visits with their primary care physician and a multidisciplinary team to design a customized care plan to meet individual needs. Each clinic will have several service offerings to encourage patients to live active, healthier lives well into their senior years. Beyond medical needs, 65 Plus clinics will offer a community environment with regular social events, fitness centers, health coaching and more.”
About pharma
Donanemab in Early Symptomatic Alzheimer Disease The TRAILBLAZER-ALZ 2 Randomized Clinical Trial “Question Does donanemab, a monoclonal antibody designed to clear brain amyloid plaque, provide clinical benefit in early symptomatic Alzheimer disease?
Findings In this randomized clinical trial that included 1736 participants with early symptomatic Alzheimer disease and amyloid and tau pathology, the least-squares mean change in the integrated Alzheimer Disease Rating Scale score (range, 0-144; lower score indicates greater impairment) at 76 weeks was −6.02 in the donanemab group and −9.27 in the placebo group for the low/medium tau population and −10.19 in the donanemab group and −13.11 in the placebo group in the combined study population, both of which were significant differences.
Meaning Among participants with early symptomatic Alzheimer disease and amyloid and tau pathology, donanemab treatment significantly slowed clinical progression at 76 weeks.”
In a related article: Eli Lilly’s experimental Alzheimer’s drug slows disease, data show
An innovation supply chain: Pfizer taps Flagship for 10-program pipeline pact worth $7B in biobucks “Pfizer and Flagship Pioneering have each put down $50 million to build a new pipeline of 10 programs, with the Big Pharma offering the VC firm and its bioplatform companies the chance to make up to $700 million in biobucks for each successful drug.”
Sanofi taps Scribe for in vivo partnership worth more than $1.2B biobucks aimed at sickle cell and beyond “The new collaboration gives Sanofi exclusive access to Scribe’s gene editing tech to develop new therapies, including for sickle cell disease, in exchange for $40 million in upfront cash and up to $1.2 billion in biobucks. Back in September 2022, Sanofi tapped up Scribe to develop ex vivo therapies—where edits are made to cells in a lab before being given to patients—handing over $25 million upfront.”
Johnson & Johnson sues to stop Medicare negotiation “Pharmaceutical giant Johnson & Johnson on Tuesday became the third drugmaker to sue the Biden administration over its new Medicare drug price negotiation program.”
About healthcare IT
EHR vendor NextGen to pay $31 million to settle False Claims Act allegations “Electronic health record vendor NextGen Healthcare on Friday agreed to pay $31 million to settle allegations that it violated the False Claims Act by misrepresenting versions of its product and providing illegal incentives to induce referrals to its software, according to the Department of Justice.
In a complaint filed along with the settlement, the DOJ contends that NextGen improperly sought HHS certification for its software by using an “auxiliary product” designed only to perform the certification, thereby concealing that its product lacked “critical functionality.”
NextGen also violated the Anti-Kickback Statute by providing “remuneration” to clients — with tickets to sporting events and credits worth up to $10,000 — to incentivize purchases and referrals of NextGen’s software, according to the DOJ.”
PETERSON CENTER ON HEALTHCARE LAUNCHES NEW $50 MILLION INSTITUTE TO EVALUATE DIGITAL HEALTH TECHNOLOGIES “The Peterson Center on Healthcare today launched the Peterson Health Technology Institute (PHTI), a nonprofit organization that provides independent evaluations of innovative healthcare technologies to improve health and lower costs. Launched with a commitment of $50 million, PHTI will deliver rigorous, evidence-based assessments that will analyze the clinical benefits and economic impact of digital health solutions, as well as their effects on health equity, privacy, and security.”
About healthcare finance
FTC Sues to Block IQVIA’s Acquisition of Propel Media to Prevent Increased Concentration in Health Care Programmatic Advertising “The Federal Trade Commission is seeking to block IQVIA Holdings Inc. (IQVIA), the world’s largest health care data provider, from acquiring Propel Media, Inc. (PMI), alleging in an administrative complaint (link to redacted complaint when made available) that the proposed acquisition would give IQVIA a market- leading position in programmatic advertising for health care products, namely prescription drugs, to doctors and other health care professionals. The merger would also increase IQVIA’s incentive to withhold key information to prevent rival companies and potential entrants from effectively competing, the complaint states.”