Morning Briefing
Summaries of health policy coverage from major news organizations
Covid Vaccine Boosted Pharma's Trustworthiness
Stat: Thanks To Covid-19, Pharma’s Reputation Improved Among Patient Groups. But Can It Last?
Thanks to its response to the Covid-19 pandemic, the pharmaceutical industry has greatly improved its controversial image among patient advocacy groups, according to a new survey. Specifically, 59% of patient groups thought brand-name drugmakers developed an “excellent” or “good” reputation last year, up from 50% in 2020. This was also the best showing since the survey was started in 2011 by PatientView, a research firm that canvassed 2,150 patient groups from 89 countries between November 2021 and February 2022. The firm rated the reputations of 47 companies. (Silverman, 4/26)
In other pharmaceutical news —
CIDRAP: Study Finds Disparities In Improper Antibiotic Prescribing
A study to be presented at the upcoming European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022) shows high rates of inappropriate antibiotic prescribing for older Americans, Blacks, and Hispanics. ... When the researchers broke down the data on inappropriate prescribing, they found that nearly three quarters of the antibiotic prescriptions (73.9%) written for patients 65 and older were inappropriate. They also found high rates of inappropriate antibiotic prescribing for Black patients (63.8%), Hispanic patients (57.5%), and men (57.7%). (Dall, 4/21)
CIDRAP: Antibiotic Resistance Is Making Neonatal Sepsis Harder To Treat
A large observational study of newborn babies with sepsis shows the impact that antimicrobial resistance (AMR) is having on this vulnerable population. The study, led by the Global Antibiotic Research & Development Partnership (GARDP), looked at mortality, antibiotic treatments, and resistance among more than 3,200 newborns with suspected neonatal sepsis at hospitals in 11 countries and found that more than 11% died during the study period. The mortality rate ranged from 1% to as high as 27%. (Dall, 4/26)
Stat: Nkarta Studies Show Complete Remissions In Patients With Blood Cancers
Nkarta said Monday that two experimental, off-the-shelf treatments, both made from engineered natural killer cells, induced complete responses in patients with advanced forms of blood cancer. The results marked the first reveal of clinical data from its research programs. In one of the clinical trials, three of five patients with acute myeloid leukemia achieved complete remissions. Two of those patients showed no evidence of residual disease — the best response possible following treatment with the highest-tested dose of the Nkarta engineered natural killer, or NK, cells. (Feuerstein, 4/25)
Stat: Biden Urged To Pursue March-In Rights For A Pricey Cancer Drug
Citing arguments by more than two dozen legal experts, Sen. Elizabeth Warren (D-Mass.) is urging the Biden administration to use a controversial provision of federal law to widen access to a cancer drug. The move comes just days after the National Institute of Health disclosed it has not yet begun a widely anticipated review of a petition that requested using the law in connection with the medicine. In a letter to the U.S. Department of Health and Human Services, Warren maintained the White House can use executive powers — and specifically, rely on so-called march-in rights and another federal law known colloquially as Section 1498 — to counter high prescription drug prices. And she pointed to a fresh position paper written by legal and public health academics to back up her assertion. (Silverman, 4/25)
ScienceDaily: Micronutrients (Vitamins + Minerals) Show Benefit For Children With ADHD And Emotional Dysregulation
A study reports that children with ADHD and emotional dysregulation randomized to take a micronutrient formula were three times more likely to show symptomatic improvement on blinded clinician ratings, compared to those in the placebo group (54% versus 18%). The micronutrient formula, consisting of all known vitamins and essential minerals, was administered for eight weeks. (Elsevier, 4/26)
Also —
Stat: Right To Try 2.0: Advocates Want To Reduce Oversight Of ‘N Of 1’ Therapies
The libertarian think tank behind the federal “right-to-try” law is back at it again. Its new legislation, which became law in Arizona on Monday, is meant to speed patients’ access to bespoke treatments that target issues with patients’ own genomes. It focuses on more experimental drugs than the first right-to-try laws, which let dying patients access drugs that had cleared early clinical trials without the blessing of the Food and Drug Administration. (Florko, 4/26)
Stat: One In Four Pharma Status Reports On Follow-Up Trials Are Late Or Aren't Filed
Drug companies failed to submit 11% of status reports for clinical trials they were required or had agreed to conduct when their medicines were initially approved, according to a new analysis that tracked more than 700 reports during the 12-month period ending September 2020. Another 13% of those follow-up trials were submitted late. Meanwhile, a quarter of nearly 1,600 of these so-called post-marketing requirements and commitments were not progressing on schedule, which means the follow-up trials were either delayed or ended. And three dozen trials that were required as a condition for receiving accelerated approval were also delayed or ended, the U.S. Food and Drug Administration report found. (Silverman, 4/25)
