Correction to: Cross-sectional study of medical advertisements in a national general medical journal: evidence, cost, and safe use of advertised versus comparative drugs.
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ABSTRACT:
SUBMITTER: Boesen K
PROVIDER: S-EPMC8196460 | biostudies-literature | 2021 Jun
REPOSITORIES: biostudies-literature
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Correction to: Cross-sectional study of medical advertisements in a national general medical journal: evidence, cost, and safe use of advertised versus comparative drugs.
Boesen Kim K Simonsen Anders Lykkemark AL Jørgensen Karsten Juhl KJ Gøtzsche Peter C PC
Research integrity and peer review 20210611 1
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Project description:BackgroundHealthcare professionals are exposed to advertisements for prescription drugs in medical journals. Such advertisements may increase prescriptions of new drugs at the expense of older treatments even when they have no added benefits, are more harmful, and are more expensive. The publication of medical advertisements therefore raises ethical questions related to editorial integrity.MethodsWe conducted a descriptive cross-sectional study of all medical advertisements published in the Journal of the Danish Medical Association in 2015. Drugs advertised 6 times or more were compared with older comparators: (1) comparative evidence of added benefit; (2) Defined Daily Dose cost; (3) regulatory safety announcements; and (4) completed and ongoing post-marketing studies 3 years after advertising.ResultsWe found 158 medical advertisements for 35 prescription drugs published in 24 issues during 2015, with a median of 7 advertisements per issue (range 0 to 11). Four drug groups and 5 single drugs were advertised 6 times or more, for a total of 10 indications, and we made 14 comparisons with older treatments. We found: (1) 'no added benefit' in 4 (29%) of 14 comparisons, 'uncertain benefits' in 7 (50%), and 'no evidence' in 3 (21%) comparisons. In no comparison did we find evidence of 'substantial added benefit' for the new drug; (2) advertised drugs were 2 to 196 times (median 6) more expensive per Defined Daily Dose; (3) 11 safety announcements for five advertised drugs were issued compared to one announcement for one comparator drug; (4) 20 post-marketing studies (7 completed, 13 ongoing) were requested for the advertised drugs versus 10 studies (4 completed, 6 ongoing) for the comparator drugs, and 7 studies (2 completed, 5 ongoing) assessed both an advertised and a comparator drug at 3 year follow-up.Conclusions and relevanceIn this cross-sectional study of medical advertisements published in the Journal of the Danish Medical Association during 2015, the most advertised drugs did not have documented substantial added benefits over older treatments, whereas they were substantially more expensive. From January 2021, the Journal of the Danish Medical Association no longer publishes medical advertisements.
| S-EPMC8108346 | biostudies-literature
Project description:The Deutsche Apotheker Zeitung (DAZ, German Pharmacist Journal) is an independent pharmaceutical newspaper focusing on science and practice, mainly for the profession of pharmacist. In this study, drug advertising in the DAZ was analysed. To our knowledge, there is little scientific data available on drug advertising in professional journals. We assumed that professional journals provide particularly good background information on the advertised drugs because they are targeted to specialists. All non-prescription medicines and preparations that fall under the Medicines Advertising Law (Heilmittelwerbegesetz, HWG) were studied. The Medicines Advertising Law regulates the legal procedure for advertising medicinal products in Germany. The 167 product advertisements from the 52 issues of 2021 were analysed and checked for compliance with the Medicines Advertising Law. We identified significant deficiencies in compliance with the legislation. These included the lack of mandatory information required by the Medicines Advertising Law, for example the indication of adverse drug reactions and the listing of contraindications. There are very few peer-reviewed references on the efficacy of the advertised preparations. A scientific validation was carried out using the PubMed database, with the result that scientific information was available only for 1/3 of the advertisements. In addition, the appearance and target groups as well as social structures, images and feelings conveyed by the advertising were analysed. This study provides insights into the mechanisms of drug advertising in professional journals, which have not yet been researched to any great extent. Even in professional journals, pharmacological evidence plays a much smaller role than marketing, psychology and traditional social values. It seems that drug manufacturers deliberately ignore the German Medicines Advertising Law to advertise their products in the best possible way. Stricter legal controls should be put in place to prevent this practice and protect consumers from misinformation. This will increase drug safety.
| S-EPMC11920363 | biostudies-literature
Project description:BackgroundPhysician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.Methods and findingsCross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192 advertisements for 82 unique products; median 2 per product (range 1-14). Six "teaser" advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.ConclusionsFew physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.
| S-EPMC3157354 | biostudies-literature
Project description:To help authors design rigorous studies and prepare clear and informative manuscripts, improve the transparency of editorial decisions, and raise the bar on educational scholarship, the Deputy Editors of the Journal of General Internal Medicine articulate standards for medical education submissions to the Journal. General standards include: (1) quality questions, (2) quality methods to match the questions, (3) insightful interpretation of findings, (4) transparent, unbiased reporting, and (5) attention to human subjects' protection and ethical research conduct. Additional standards for specific study types are described. We hope these proposed standards will generate discussion that will foster their continued evolution.
| S-EPMC2517930 | biostudies-literature
Project description:ImportanceAlthough peer review is an important component of publication for new research, the viability of this process has been questioned, particularly with the added stressors of the COVID-19 pandemic.ObjectiveTo characterize rates of peer reviewer acceptance of invitations to review manuscripts, reviewer turnaround times, and editor-assessed quality of reviews before and after the start of the COVID-19 pandemic at a large, open-access general medical journal.Design, setting, and participantsThis retrospective, pre-post cohort study examined all research manuscripts submitted to JAMA Network Open between January 1, 2019, and June 29, 2021, either directly or via transfer from other JAMA Network journals, for which at least 1 peer review of manuscript content was solicited. Measures were compared between the period before the World Health Organization declaration of a COVID-19 pandemic on March 11, 2020 (14.3 months), and the period during the pandemic (15.6 months) among all reviewed manuscripts and between pandemic-period manuscripts that did or did not address COVID-19.Main outcomes and measuresFor each reviewed manuscript, the number of invitations sent to reviewers, proportions of reviewers accepting invitations, time in days to return reviews, and editor-assessed quality ratings of reviews were determined.ResultsIn total, the journal sought review for 5013 manuscripts, including 4295 Original Investigations (85.7%) and 718 Research Letters (14.3%); 1860 manuscripts were submitted during the prepandemic period and 3153 during the pandemic period. Comparing the prepandemic with the pandemic period, the mean (SD) number of reviews rated as high quality (very good or excellent) per manuscript increased slightly from 1.3 (0.7) to 1.5 (0.7) (P < .001), and the mean (SD) time for reviewers to return reviews was modestly shorter (from 15.8 [7.6] days to 14.4 [7.0] days; P < .001), a difference that persisted in linear regression models accounting for manuscript type, study design, and whether the manuscript addressed COVID-19.Conclusions and relevanceIn this cohort study, the speed and editor-reported quality of peer reviews in an open-access general medical journal improved modestly during the initial year of the pandemic. Additional study will be necessary to understand how the pandemic has affected reviewer burden and fatigue.
| S-EPMC10851144 | biostudies-literature
Project description:BACKGROUND: Assessment of authorship contribution is often based on unreliable questionnaires. OBJECTIVE: To assess if the use of different formats for the disclosure of authorship contributions influences authors' compliance with the criteria of the International Committee of Medical Journal Editors (ICMJE). DESIGN: Randomized study. PARTICIPANTS AND MEASUREMENTS: Eight hundred sixty-five authors of 181 manuscripts submitted to the Croatian Medical Journal from January to July 2005 were randomly allocated into 2 groups: 456 authors (94 manuscripts) received an ordinal rating form to rate their contributions to the submitted manuscript in 12 categories on a scale from 0 (none) to 4 (full), whereas 409 authors (87 manuscripts) received a binary rating form to tick the categories in which they made a contribution. RESULTS: The ordinal rating form identified twice as many authors (87.9%) as meeting the ICMJE criteria than the binary rating form (39.2%, P < .001). The group answering the ordinal rating form also had 5 times more manuscripts (71.6%) with all authors meeting the ICMJE criteria than the binary rating form group (15.5%, P < .001). The fraction of authors who reported contributions on each item on the binary rating form was similar to the fraction of authors who reported at least moderate participation to the same items on the ordinal rating form except "Final approval of the article." CONCLUSIONS: Ordinal scales for reporting authors' contributions to manuscripts were more sensitive than tick boxes for assessing the appropriateness of authorship. The exception is "Final approval of the article," which should be considered a dichotomous variable and may not be appropriate for the ICMJE definition of authorship.
| S-EPMC2518038 | biostudies-other
Project description:ObjectiveThe objective of this study was to determine whether, where and when manuscripts were published following rejection by the Journal of the Danish Medical Association, a general medical journal published in Danish. Similar previous studies have focused on specialty/subspecialty journals published in English.DesignManuscripts rejected during a 4-year period were searched for in PubMed and Embase in order to assess the percentage of manuscripts subsequently published in other journals. In addition, characteristics of both the published manuscripts and the journals in which they were evaluated.ResultsOf 198 rejected manuscripts, 21 (10.6%) were eventually published after a median of 685 days (range 209-1463). The majority of these were original research, published in English-language specialty/subspecialty journals. The median number of citations per article was 2-3 (IQR 0.5-9.5, depending on the database searched).Conclusions10.6% of the rejected manuscripts were eventually published in other journals, mainly English-language specialty journals. This proportion was considerably lower than that for other journals that have studied the fate of rejected manuscripts. Manuscript translation could be a barrier for resubmitting to English-language journals with larger readerships, thus hindering the dissemination of knowledge to the international community.
| S-EPMC3191426 | biostudies-literature
Project description:ObjectiveTo evaluate the consistency of causal statements in observational studies published in The BMJ.DesignReview of observational studies published in a general medical journal.Data sourceCohort and other longitudinal studies describing an exposure-outcome relationship published in The BMJ in 2018. We also had access to the submitted papers and reviewer reports.Main outcome measuresProportion of published research papers with 'inconsistent' use of causal language. Papers where language was consistently causal or non-causal were classified as 'consistently causal' or 'consistently not causal', respectively. For the 'inconsistent' papers, we then compared the published and submitted version.ResultsOf 151 published research papers, 60 described eligible studies. Of these 60, we classified the causal language used as 'consistently causal' (48%), 'inconsistent' (20%) and 'consistently not causal'(32%). Eleven out of 12 (92%) of the 'inconsistent' papers were already inconsistent on submission. The inconsistencies found in both submitted and published versions were mainly due to mismatches between objectives and conclusions. One section might be carefully phrased in terms of association while the other presented causal language. When identifying only an association, some authors jumped to recommending acting on the findings as if motivated by the evidence presented.ConclusionFurther guidance is necessary for authors on what constitutes a causal statement and how to justify or discuss assumptions involved. Based on screening these papers, we provide a list of expressions beyond the obvious 'cause' word which may inspire a useful more comprehensive compendium on causal language.
| S-EPMC8141434 | biostudies-literature
Project description:[This corrects the article DOI: 10.1371/journal.pone.0294071.].
| S-EPMC11781652 | biostudies-literature