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Elmo's big lift-and-look book
Sesame Street's Elmo uses more than 60 easy-to-flip flaps to teach children about simple objects, numbers, opposites, and more.
Book
Cell and Gene Therapies — Improving Access and Outcomes for Medicare and Medicaid Beneficiaries
State Medicaid agencies can now apply to participate in a new model that supports voluntary, outcomes-based agreements between Medicaid programs and manufacturers of gene therapies for sickle cell disease.
Journal Article
Patterns and predictors of off-label prescription of psychiatric drugs
Off-label prescribing of psychiatric drugs is common, despite lacking strong scientific evidence of efficacy and potentially increasing risk for adverse events. The goal of this study was to characterize prevalence of off-label prescriptions of psychiatric drugs and examine patient and clinician predictors of off-label use. This manuscript presents a retrospective, cross-sectional study using data from the 2012 and 2013 National Ambulatory Medical Care Surveys (NAMCS). The study examined all adult outpatient visits to psychiatric practices for chronic care management with a single listed visit diagnosis in which at least one psychiatric drug was prescribed. The main outcome measure was off-label prescribing of at least one psychiatric drug, defined as prescription for a condition for which it has not been approved for use by the FDA. Among our sample representative of 1.85 billion outpatient visits, 18.5 million (1.3%) visits were to psychiatrists for chronic care management in which at least one psychiatric drug was prescribed. Overall, the rate of off-label use was 12.9% (95% CI: 12.2-15.7). The most common off-label uses were for manic-depressive psychosis treated with citalopram and primary insomnia treated with trazodone. Several patient and clinician characteristics were positively associated with off-label prescribing, including seeing a psychiatrist (OR: 1.06, 95% CI, 1.01-1.12; p = 0.03) instead of another type of clinician, the office visit taking place in the Western region of the country (OR: 1.09, 95% CI, 1.01-1.17; p = 0.02), and the patient having 3 or more chronic conditions (OR: 1.12, 95% CI, 1.02-1.14; p = 0.003). In contrast, having Medicare coverage (OR: 0.93, 95% CI, 0.84-0.97; p = 0.04) and receiving payment assistance from a medical charity (OR: 0.91, 95% CI, 0.88-0.96; p = 0.03) instead of private insurance were negatively associated with off-label prescribing. These results suggest that certain classes of psychiatric medications are being commonly prescribed to treat conditions for which they have not been determined by the FDA to be clinically efficacious and/or safe.
Journal Article
Genetic architecture and temporal analysis of Caenorhabditis briggsae hybrid developmental delay
Identifying the alleles that reduce hybrid fitness is a major goal in the study of speciation genetics. It is rare to identify systems in which hybrid incompatibilities with minor phenotypic effects are segregating in genetically diverse populations of the same biological species. Such traits do not themselves cause reproductive isolation but might initiate the process. In the nematode Caenorhabditis briggsae , a small percent of F2 generation hybrids between two natural populations suffer from developmental delay, in which adulthood is reached after approximately 33% more time than their wild-type siblings. Prior efforts to identify the genetic basis for this hybrid incompatibility assessed linkage using one or two genetic markers on chromosome III and suggested that delay is caused by a toxin-antidote element. Here, we have genotyped F2 hybrids using multiple chromosome III markers to refine the developmental delay locus. Also, to better define the developmental delay phenotype, we measured the development rate of 66 F2 hybrids and found that delay is not restricted to a particular larval developmental stage. Deviation of the developmental delay frequency from hypothetical expectations for a toxin-antidote element adds support to the assertion that the epistatic interaction is not fully penetrant. Our mapping and refinement of the delay phenotype motivates future efforts to study the genetic architecture of hybrid dysfunction between genetically distinct populations of one species by identifying the underlying loci.
Journal Article
US healthcare gap is growing
Government policies will exacerbate rates of underinsurance and workforce challenges
Journal Article
Adoption of the voluntary conflict of interest statement on PubMed
In 2017, the National Library of Medicine (NLM) added a voluntary field for conflict of interest (COI) statements (“posted COI”) on the abstract page of PubMed, but the extent to which it is used is unknown. This repeated cross-sectional study examined journals and articles indexed on PubMed from 2016 through 2021. We described the proportion of all journals with at least one article that included a posted COI and the percentage of all articles that included a posted COI over time. We also examined 100 randomly selected articles published between June 2021 and May 2022 from each of the 40 highest impact journals. For these, we established whether the articles had published COIs, and, of these, the proportion that included a posted COI. Among approximately 7,000 journals publishing articles each year, the proportion of journals with at least one article with a posted COI statement increased from 25.9% in 2016 to 33.2% in 2021. Among nearly 400,000 articles published each year, the proportion of articles that included a posted COI also increased from 9.0% in 2016 to 43.0% in 2021. Among 3,888 articles published in the 40 highest impact journals in 2021–2022, 30.2% (95% CI: 28.7%-31.6%) had published COIs; of these, 63.3% (95% CI: 60.4%-66.0%) included a posted COI. Use of the PubMed COI statement has increased since it became available in 2017, but adoption is still limited, even among high impact journals. NLM should carry out additional outreach to journals that are not using the statement to promote greater transparency of COIs.
Journal Article
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
AbstractObjectiveTo characterize the therapeutic value of new drugs approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the association between these ratings and regulatory approval through expedited programs.DesignRetrospective cohort study.SettingNew drugs approved by the FDA and EMA between 2007 and 2017, with follow-up through 1 April 2020.Data sourcesTherapeutic value was measured using ratings of new drugs by five independent organizations (Prescrire and health authorities of Canada, France, Germany, and Italy).Main outcome measuresProportion of new drugs rated as having high therapeutic value; association between high therapeutic value rating and expedited status.ResultsFrom 2007 through 2017, the FDA and EMA approved 320 and 268 new drugs, respectively, of which 181 (57%) and 39 (15%) qualified for least one expedited program. Among 267 new drugs with a therapeutic value rating, 84 (31%) were rated as having high therapeutic value by at least one organization. Compared with non-expedited drugs, a greater proportion of expedited drugs were rated as having high therapeutic value among both FDA approvals (45% (69/153) v 13% (15/114); P<0.001) and EMA approvals (67% (18/27) v 27% (65/240); P<0.001). The sensitivity and specificity of expedited program for a drug being independently rated as having high therapeutic value were 82% (95% confidence interval 72% to 90%) and 54% (47% to 62%), respectively, for the FDA, compared with 25.3% (16.4% to 36.0%) and 90.2% (85.0% to 94.1%) for the EMA.ConclusionsLess than a third of new drugs approved by the FDA and EMA over the past decade were rated as having high therapeutic value by at least one of five independent organizations. Although expedited drugs were more likely than non-expedited drugs to be highly rated, most expedited drugs approved by the FDA but not the EMA were rated as having low therapeutic value.
Journal Article
Retracted papers originating from paper mills: cross sectional study
AbstractObjectivesTo describe retracted papers originating from paper mills, including their characteristics, visibility, and impact over time, and the journals in which they were published.DesignCross sectional study.SettingThe Retraction Watch database was used for identification of retracted papers from paper mills, Web of Science was used for the total number of published papers, and data from Journal Citation Reports were collected to show characteristics of journals.ParticipantsAll paper mill papers retracted from 1 January 2004 to 26 June 2022 were included in the study. Papers bearing an expression of concern were excluded.Main outcome measuresDescriptive statistics were used to characterise the sample and analyse the trend of retracted paper mill papers over time, and to analyse their impact and visibility by reference to the number of citations received.Results1182 retracted paper mill papers were identified. The publication of the first paper mill paper was in 2004 and the first retraction was in 2016; by 2021, paper mill retractions accounted for 772 (21.8%) of the 3544 total retractions. Overall, retracted paper mill papers were mostly published in journals of the second highest Journal Citation Reports quartile for impact factor (n=529 (44.8%)) and listed four to six authors (n=602 (50.9%)). Of the 1182 papers, almost all listed authors of 1143 (96.8%) paper mill retractions came from Chinese institutions and 909 (76.9%) listed a hospital as a primary affiliation. 15 journals accounted for 812 (68.7%) of 1182 paper mill retractions, with one journal accounting for 166 (14.0%). Nearly all (n=1083, 93.8%) paper mill retractions had received at least one citation since publication, with a median of 11 (interquartile range 5-22) citations received.ConclusionsPapers retracted originating from paper mills are increasing in frequency, posing a problem for the research community. Retracted paper mill papers most commonly originated from China and were published in a small number of journals. Nevertheless, detected paper mill papers might be substantially different from those that are not detected. New mechanisms are needed to identify and avoid this relatively new type of misconduct.
Journal Article
Tackling the excesses of pharmaceutical marketing and promotion
Ravi Gupta and colleagues argue that we need to reconsider standards for targeted pharmaceutical marketing to doctors through speaker programmes, consulting programmes, and advisory board positions
Journal Article