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A recent analysis from our group ( https://pubmed.ncbi.nlm.nih.gov/37014400/ ) has shown that the immense costs of the 20 protein kinase inhibitors for oncology approved from 2015 to 2019 are largely caused by drugs whose additional benefit has not been proven. We updated our analysis by adding the newly approved protein kinase inhibitors of the years 2020 and 2021. Based on the 2021 and 2022 Arzneiverordnungsreport (AVR), we expanded our analysis to include a total of nine protein kinase inhibitors newly approved by the European Medicines Agency (EMA) in 2020 and 2021. As a result, 29 protein kinase inhibitors were identified for an update of our analysis. For these 29 drugs, all additional benefit assessments published by the Gemeinsamer Bundesausschuss (GBA) were analyzed. The additional benefit assessments of the GBA were compared with the corresponding assessments of the European Society for Medical Oncology (ESMO), the Deutsche Gesellschaft für Hämatologie und Onkologie (DGHO, German Society for Hematology and Oncology) and the Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ, Drug Commission of the German Medical Association). In addition, a total number of 91 drug advertisements published in the journal Oncology Research and Treatment in 2022 were analyzed. The number of protein kinase inhibitors for which no additional benefit can be found by the GBA is increasing, whereas the number of drugs for which a considerable additional benefit can be found is decreasing. Thus, in the current 2022 (re)assessment of additional benefit by the GBA, no additional benefit was identified for 50% of the drugs (2020, 46%). Nineteen percent were assessed with a minor additional benefit (2020, 18%) and also 19% with a considerable additional benefit (2020, 27%). For 12% of the drugs, the additional benefit could not be quantified by the GBA (2020, 9%). The benefit assessments by other medical societies often differ significantly from those of the GBA, mainly due to different evaluations of various endpoint parameters. In addition, more and more protein kinase inhibitors are being approved as orphan drugs. However, their additional benefit cannot be quantified by the GBA in most cases (78%). In 38% of the advertisements of an oncology journal, protein kinase inhibitors are promoted, which shows the pharmacoeconomic importance of these drugs. In summary, the current additional benefit assessment procedure in Germany is very questionable, and reforms are urgently needed to maintain the stability of the German healthcare system, which is being undermined by the high cost of medicines, particularly for drugs whose additional benefits have not been proven.
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Antibacterial drugs are vital in modern medicine, and understanding the factors influencing their prescriptions is essential for maintaining their effectiveness and accessibility. This study investigates the hypothesis that costs significantly impact the prescriptions of antibacterial drugs, a factor previously underrecognized. To investigate this, we conducted correlation analyses on defined daily dose (DDD-) prescriptions and DDD-costs for the 15 most prescribed antibacterial drugs in Germany in 2022, using data from the Arzneimittelverordnungsreport (Drug Prescription Report) (1985-2022). The analysis focused on the periods 1985-2022, 1985-2011, and 2012-2022. Our findings revealed significant correlations between DDD-prescriptions and -costs for nearly all drugs over the entire period (1985-2022), with strong negative correlations for amoxicillin (- 0.941), cefuroxime axetil (- 0.900), clindamycin (- 0.800), nitrofurantoin (- 0.895), and cefaclor (- 0.819). From 1985 to 2011, only significant negative correlations were observed. In 2012-2022, significant correlations included both negative and positive, with strong positive correlations for ciprofloxacin (0.950) and clarithromycin (0.962). Overall, DDD-costs showed a persistent and strong correlation with DDD-prescriptions, particularly in the earlier period. This influence appears to diminish slightly in recent years, suggesting other factors might become more significant as DDD-costs plateau. Notably, amoxicillin, amoxicillin clavulanic acid, and nitrofurantoin consistently exhibited strong cost-prescription correlations throughout the entire period. While correlation does not imply causation, the significant and strong correlations, coupled with logical explanations, support the hypothesis that costs are a primary factor in prescribing patterns. Further research is needed to establish causality and examine other potential systemic factors affecting antibacterial drug prescriptions.
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Scientific fake papers, containing manipulated or completely fabricated data, are a problem that has reached dramatic dimensions. Companies known as paper mills (or more bluntly as "criminal science publishing gangs") produce and sell such fake papers on a large scale. The main drivers of the fake paper flood are the pressure in academic systems and (monetary) incentives to publish in respected scientific journals and sometimes the personal desire for increased "prestige." Published fake papers cause substantial scientific, economic, and social damage. There are numerous information sources that deal with this topic from different points of view. This review aims to provide an overview of these information sources until June 2024. Much more original research with larger datasets is needed, for example on the extent and impact of the fake paper problem and especially on how to detect them, as many findings are based more on small datasets, anecdotal evidence, and assumptions. A long-term solution would be to overcome the mantra of publication metrics for evaluating scientists in academia.
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Traditional and alternative medicines are widely used around the world and include for example herbal medicine, Ayurveda, traditional Chinese medicine, and indigenous therapies. Due to the long history and the mostly natural origin of traditional remedies, it is often assumed that they are harmless, but in recent decades more and more case reports have been published in which traditional medicine has caused metal poisoning. This paper provides an analysis of published cases in which patients have suffered metal poisoning due to traditional or alternative medicines. A systematic literature search was performed on PubMed, whereby 210 patient cases from a total of 102 case reports and 30 case series were identified and then analyzed about various aspects. Most of the traditional medicines involved come from Asia and are mainly contaminated with lead and arsenic. The analyzed patient cases show a high degree of heterogeneity with regard to age, sex, intake reason, symptoms, and severity of intoxication. The metal intoxication itself and the cause of the poisoning often remained unrecognized for a long time, which resulted in many patients undergoing unnecessary diagnostic methods and ineffective therapeutic approaches before the correct diagnosis was made. The evaluation of the available patient cases revealed a higher sensitivity to metal poisoning in children compared to adults and a higher sensitivity in men compared to women. Anemia and basophilic stippling were frequently observed and became more common as the metal content in the blood increased. Hopefully, this paper raises awareness of the potential dangers of traditional and alternative medicines, both from the patient's and the doctor's perspective, so that in case of intoxication, treatment can be initiated quickly using the correct diagnostic methods. As ingested metals do not only circulate in the blood but also accumulate in soft tissues and bones, long-term monitoring is necessary to ensure that patients make a full recovery. Doctors should be aware that, in contrast to common belief, men are more sensitive to this type of intoxication than women, necessitating particular attention for diagnosis and treatment.
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Clozapine has been considered the "gold standard" in the treatment of schizophrenia for many years. Clozapine has a superior effect, particularly in the treatment of negative symptoms and suicidal behaviour. However, due to its numerous adverse reactions, clozapine is mainly used for treatment-resistant schizophrenia. The aim of this paper is to analyze the results of clinical studies on clozapine from 2012-2022. PubMed was used as the database. Sixty-four studies were included and categorised by topic. The pharmacokinetic properties of clozapine tablets and a clozapine suspension solution did not differ markedly. Clozapine was superior to olanzapine and risperidone in reducing aggression and depression. A long-term study showed that metabolic parameters changed comparably with olanzapine and clozapine after 8 years. Risperidone and ziprasidone can be used as an alternative to clozapine. Scopolamine, atropine drops, and metoclopramide are effective in the treatment of clozapine-induced hypersalivation. Eight drugs, including liraglutide, exenatide, metformin, and orlistat, are potentially effective in the treatment of clozapine-induced weight gain. Ziprasidone, haloperidol, and aripiprazole showed a positive effect on symptoms when added to clozapine. No investigated drug was superior to clozapine for the treatment of schizophrenia. Ziprasidone and risperidone can also be used well for the treatment of schizophrenia. In the treatment of clozapine-induced hypersalivation and weight gain, some drugs proved to be effective.
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Lithium is the gold standard drug in the treatment of bipolar disorder. Despite increasing scientific interest, relatively few patients with bipolar disorder receive lithium therapy. Lithium is the only drug that is effective in the prophylaxis of manic, depressive, and suicidal symptoms. Lithium therapy is also associated with a variety of adverse drug reactions and the need for therapeutic drug monitoring. Numerous studies have focussed on the efficacy and safety of both lithium-monotherapy and lithium-add-on therapy. The aim of this study is to provide a systematic overview of clinical studies on lithium therapy for bipolar disorder from the last 7 years and to present a critical analysis of these studies. The results provide an up-to-date overview of the efficacy, tolerability, and safety of lithium therapy for bipolar disorder and thus improve the pharmacotherapy of bipolar disorder. A total of 59 studies were analysed using various analysis parameters. The studies were also categorised into different subgroups. These are lithium-monotherapy, lithium vs. placebo/drug, and lithium + adjunctive therapy. The majority of the studies (N = 20) had a duration of only 3-8 weeks. Only 13 studies lasted for > 40 weeks. Lithium was superior to aripiprazole, valproic acid, and quetiapine in terms of improving manic symptoms. Lithium therapy resulted in a lower relapse rate compared to valproic acid therapy. Lithium was more neuroprotectively effective than quetiapine. Fourteen of the 22 add-on therapies to lithium showed a predominantly positive effect on the treatment outcome compared to lithium-monotherapy. Only the add-on therapy with sertraline led to a higher rate of study discontinuations than lithium-monotherapy. Lithium is a safe and effective treatment option for children. However, risperidone and quetiapine were superior to lithium in some aspects, which is why these drugs should be considered as an alternative treatment option for children. Collectively, current clinical studies highlight the relevance of lithium in the treatment of bipolar disorder.
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In recent years, several threatening developments regarding antibacterial drugs, such as rising bacterial resistance and delivery bottlenecks, have occurred. Since antibacterial drugs are crucial for modern medicine, understanding events and influencing factors relevant for long-term developments is essential. Therefore, we analyzed the number of prescriptions and costs, defined daily dose (DDD) and DDD costs of antibacterial drugs in Germany, based on the Arzneiverordnungsreport (AVR, Drug description report) between 1985 and 2022. Based on prescription rates in 2022, we selected the TOP15 and TOP5. For a more in-depth analysis, we analyzed data from the wissenschaftliches Institut der AOK (WidO, scientific institute of the AOK). The number of prescriptions increased between 1985 and 2013, but since 2014, there has been a declining trend with a noticeable COVID-related dip. Over the years, a shift in drug classes occurred. Once very popular drugs like penicillins and tetracyclines are no longer as important. Conversely, aminopenicillins and cephalosporins have become more relevant. Particularly, the TOP5 drugs have seen an increasing proportion. DDD costs have decreased in most substance classes over time. There is a strong association between decreasing costs and rising prescriptions. Falling costs have a stronger immediate impact on prescriptions that rising costs. When costs are very low, drugs might be prescribed excessively. Supply bottlenecks can also result. The main prescribers are mainly in primary care. Their share of prescription has changed little over the years, but is decreasing regarding total consumption. In comparison to other European countries, Germany ranks in the lower third regarding prescriptions. In most countries, the COVID pandemic has led to a reduced prescription of antibacterial drugs. In conclusion, we provided a comprehensive overview of the antibacterial drug market in Germany over the past four decades and identified costs as a major driver of antibacterial drug prescriptions. Increased costs may reduce uncritical prescription of antibacterial drugs, development of bacterial resistance, supply shortages and occurrence of adverse effects.
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Bibliometric rankings of researchers are increasingly important for academic hiring and for making grant application decisions in the biomedical sciences. As a case study, we performed a comprehensive bibliometric analysis of German pharmacology and toxicology. The 42 members of the German Society for Experimental and Clinical Pharmacology and Toxicology (DGPT) represented in the German 'best scientist' ranking in biology and biochemistry on www.research.com for the year 2022 were analyzed according to various aspects. The scientist ranking on Research.com is based on the Hirsch Index (h-Index). In the comparatively small field of pharmacology, which accounts for only 4.2% of the scientists in the ranking on Research.com, there are only two women. This shows that female pharmacologists are highly underrepresented in elite pharmacology. To achieve a high h-Index, a pharmacologist must publish more papers than a biochemist or biologist. Furthermore, German elite pharmacology was compared in the three sub-societies of the DGPT. There are no significant differences between elite pharmacologists and toxicologists in terms of productivity. Two large German pharmacology schools (Günter Schultz and Franz Hofmann) are similar in all bibliometric parameters except for number of total publications. Age-specific factors were also defined for the analysis: 'academic age' and the quotient of the h-Index by 'academic age'. Any given bibliometric parameter (or combination of parameters) yielded different ranking results. This became even more evident when additionally considering the highly popular and widely used Laborjournal ranking of top pharmacology and toxicology researchers with only very few DGPT members listed. We unmasked 7 types of publication patterns of pharmacologists, an age-dependent publication peak at around 55 years and different trajectories for high- and low-volume publishing pharmacologists. In the future, less emphasis should be paid to bibliometric parameters in academic hiring and grant decisions than to the authentic societal and scientific impact of the research. Bibliometric parameters are very arbitrary within a very large segment of pharmacologists. Studies according to the paradigm of this account should be made for other countries, other learned societies, and other scientific fields. The different cultures among related scientific fields must be considered in bibliometric analyses as exemplified here for pharmacology versus biochemistry. Conversely, the bibliometric similarities between pharmacology and toxicology show that both fields belong together and have a very similar culture.
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Little is known about how pharmacological and toxicological knowledge evolves. The aim of this study was to investigate the changes in the presentation of the poison hydrogen cyanide in sixteen German-language pharmacology and toxicology textbooks from 1878 to 2020. The categories of structure, molecular mechanism of action, occurrence, effects, resorption, areas of application, lethal dose, acute symptoms of intoxication, treatment of hydrogen cyanide poisoning, and recommended therapeutic preparations were evaluated. The knowledge on the structure, lethal dosage, and occurrence of hydrogen cyanide has remained constant. In contrast, knowledge on molecular mechanism of action and recommended preparations of the poison has changed dramatically. Until 1944, the binding of hydrogen cyanide to hemoglobin was considered the mechanism of action, whereas from 1951 onwards, the interaction of hydrogen cyanide with the Fe3+ of cytochrome oxidase was described. The number of preparations containing hydrogen cyanide decreased into obsolescence until 1951. The areas of application of hydrogen cyanide also show a change, as from 1919 onwards, mainly industrial areas of application of the poison are described instead of medical ones, and from 1951 onwards, criminalistic areas of application are also mentioned. Thus, pharmacological and toxicological knowledge develops non-linearly, molecular mechanism and uses being the most dynamic areas, whereas the knowledge about hydrogen cyanide's chemical structure, lethal dose, and occurrence remained constant. Older pharmacology and toxicology textbooks were better than newer ones at discussing changes in scientific concepts. Pharmacology and toxicology textbooks also mostly failed to discuss the misuse of hydrogen cyanide (Zyklon B) during the Nazi regime, missing an important opportunity to showcase the ethical responsibility of pharmacology and toxicology. Thus, future pharmacology and toxicology textbooks should improve on discussing the development of pharmacological and toxicological concepts and the ethical responsibility of the discipline.
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After World War II, Berlin was divided into the West, controlled by The United States, the UK, and France, and the East, controlled by the Soviet Union, resulting in a Cold War for decades. This bibliometric study analyzes the influence of the Cold War on pharmacological research in Berlin by evaluating publication patterns in Naunyn-Schmiedeberg's Archives of Pharmacology from 1947 to 1974 (n = 383). The publications highlight the political disparities in scientific output, exacerbated by the founding of the Free University of Berlin (FUB) as a countermeasure to Soviet repression, promoting academic freedom in West-Berlin. Researchers in West-Berlin published many more papers in Naunyn-Schmiedeberg's Archives of Pharmacology than researchers in East-Berlin and received much more citations. West-Berlin adopted English as a scientific language much more rapidly than East-Berlin. West-Berlin and East-Berlin focused on totally different research topics. This paper demonstrates how political freedom, financial support, and internationalization boosted research productivity in West-Berlin. In contrast, political suppression, financial scarcity, and restricted international ties hindered scientific development in East-Berlin.
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As there is lack of research on how drugs are presented in crime literature, we read nearly 25,000 pages of crime literature written between 1890 and 2023 to provide an overview on the pharmacological content in this genre. Correct presentation of pharmacological information decreased over time. Misconceptions about certain substances, especially narcotics and anesthetics appear in many of the analyzed examples. Also, in comparison with crime TV series, books are inferior in providing the reader with additional information and pharmacological plausibility. This especially applies for the newer books which contained less additional information than the older ones. In contrast, some books educate their readers. Newer books show a greater variety of substances also introducing recently developed drugs or new ways of application. On the contrary, older books stick to a small selection of well-known substances during that time, especially metals like arsenic and toxins like strychnine. Gender involvement in poisoning is not realistically presented in the novels. Male victims are overrepresented compared to reality. Also, the etiology is commonly presented incorrectly. Poisoning by accident or for suicidal purposes are rarely presented in the novels, despite their significance in reality. Overall, crime novels educate but also misinform their readers. We discuss the consequences of our findings for the individual reader and public health.
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Naunyn-Schmiedeberg's Archives of Pharmacology is the oldest pharmacological journal, founded in 1873. This bibliometric analysis examines the pivotal transformations within Naunyn-Schmiedeberg's Archives of Pharmacology from 1947 to 1974, identifying significant shifts from a national focus to a period of extensive internationalization and English-language adoption. Employing Python and Beautiful Soup for data extraction from SpringerLink, the study maps the journal's trajectory through post-World War II development, highlighting the decline in publication rates due to its initial emphasis on German-language articles predominantly from Germany. The transition towards English publications in the late 1960s is marked as a turning point, catalyzing an increase in global citations, publications, and recognition. This period witnesses the journal broadening its scientific horizon, with a notable emphasis on the cholinergic, adrenergic, and dopaminergic systems, reflecting their central role in the journal's scientific discourse and citation prominence. The analysis demonstrates how shifting to English for academic publishing played a crucial role in revitalizing the journal's impact and visibility on the international stage.
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The Nobel Prize is an annual honor awarded to the researchers who have made the greatest contribution to humanity with their work in the year in question. Nobel Prizes for physiology or medicine and chemistry most often have direct or indirect pharmacological relevance. In this study, we performed a bibliometric analysis of Nobel Prize laureates from 2006 to 2022. The parameters include the nationalities and age of the laureates, age at their productivity peaks, the research locations, the H-index, the age-adjusted H-index, and the number of citations and publications, and, for each parameter, a comparison of female and male award laureates. Men were much more often awarded the Nobel Prize than women. Surprisingly, women were younger than their male colleagues at the time of the award although the productivity peak was similar. There was a correlation between all publications and the H-index, which was slightly stronger for women than for men. The age-adjusted H-index showed no difference among genders. The USA were the country with the highest number of Nobel Prize laureates, both male and female. Overall, the bibliometric characteristics of male and female Nobel Prize laureates are similar, indicating that among the group of Nobel Prize laureates, there is no bias against women. Rather, the achievements of women are recognized earlier than those of men. The major difference is that the number of women becoming Nobel Prize laureates is much smaller than the number of men. This study provides a starting for future studies with larger populations of scientists to analyze disparities.
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Vitamin A supplements are used by many people, and the number of newly registered dietary supplements is continuously increasing. The preparations fall under food law and are not subject to the strict controls of pharmaceuticals. Risk indications and maximum quantity recommendations, e.g., from the Bundesinstitut für Risikobewertung (BfR) and the U.S. Food and Drug Administration (FDA) are not binding, which means that overdoses and potentially serious health problems can easily occur. The hepatotoxicity and teratogenicity of vitamin A are well documented, and other negative effects of high doses of vitamin A are also being discussed. Nevertheless, preparations with exorbitantly high doses are freely available for sale and unrestricted. In this study, 75 supplements containing vitamin A available in Germany and 26 available in the USA were critically examined on the basis of various parameters such as the recommended daily dose according to the manufacturer, daily therapy costs (DTC), the presence of warnings about overdose, use during pregnancy and breastfeeding, and information on adverse effects/interactions. The aim was to gain insights into their risk potential and to examine the need for closer monitoring and stricter guidelines for these preparations. The results show some considerable country-specific differences. Overall, there are serious deficiencies in compliance with the labeling requirements for both the German and the US preparations, and the dosages are often far too high in view of the applicable expert recommendations. Overall, these deficits can pose a risk for consumers that is difficult to assess in its entirety, especially for vulnerable consumer groups. It should be noted that the US preparations perform better overall than the German preparations. This suggests better regulation of dietary supplements in the US market. Based on the available data and literature research, it is doubtful whether the intake of vitamin A-containing preparations, without a diagnosed vitamin A deficiency, has a positive health benefit. Furthermore, it should be examined whether vitamin A should continue to be offered over-the-counter as a food supplement.
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The German weekly magazine DIE ZEIT (THE TIME) reaches more than one million readers per issue, mainly from high-income social classes. Pharmacological content is frequent in DIE ZEIT. As it therefore reaches many people who generally have no in-depth knowledge of pharmacology, it can be assumed that DIE ZEIT is an important primary source of information. It should be its task to depict the drugs widely used by the population and to present them correctly and comprehensibly. This study analyzes 71 articles from 2012 to 2022 in terms of form, content, and comprehensibility. The analysis shows that in DIE ZEIT, drug groups largely correspond to the prescription figures and disease prevalence in Germany, with cardiovascular, neuropsychiatric, and pain medications being frequently discussed. There are deviations in the case of oncological drugs, for example, which are discussed more frequently than prescribed. New drug approvals are reported less frequently, and when they are, it is usually about the research phase. DIE ZEIT often reports on findings that are less than a week old and frequently quotes trustworthy experts, but no scientific sources can be found in around a quarter of the articles. A COVID-19 effect can also be identified in the years 2020 to 2022, as reporting on drugs for the treatment of coronavirus disease 2019 (COVID-19) predominated. An important point of criticism was identified with regard to comprehensibility. Less than half of the articles achieved the cut-off value for general comprehensibility specified by the Textlab analysis program, and only one article achieved the value for target group-oriented comprehensibility. This analysis confirms the problem that science communication is often too complicated and incomprehensible. It discusses the tension between the prescribed drugs and the mission of DIE ZEIT to entertain and should serve as a basis for analyzing other newspapers. Finally, we make specific suggestions how presentation of pharmacological topics in lay media can be improved in the future.
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Farmacología , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Farmacología/historiaRESUMEN
The prescription of homeopathic remedies at the expense of the statutory health insurance (SHI) system in Germany has been criticized for years due to a lack of evidence. Now, on the planned abolition of the reimbursement of homeopathic medicines in Germany, the debate on this topic has been reignited. The aim of this paper is to show the costs and their development over time incurred by homeopathic remedies in the healthcare system from 1985 to 2021. For this purpose, 15 selected homeopathic medicines were chosen from the drug prescription report (Arzneiverordnungsreport) and analyzed with regard to their development of DDD (Defined Daily Dose) using data from the Wissenschaftliches Institut der Ortskrankenkassen (WidO, Scientific Institute of the General Local Health Insurance Funds) and compared with their respective rational pharmacological alternatives. The price comparison was based on the DDD costs and the pharmacy retail price of the smallest packaging in each case. The clinical study situation for the preparations was also analyzed. For this purpose, the clinical studies provided by the manufacturer and those on PubMed were divided into evidence levels and analyzed. In addition, the presentation of homeopathic remedies on company websites, in online pharmacies, in specialist information and package leaflets was analyzed with regard to side effects, interactions, indication, and information on the alleged effect/proof of efficacy. In many media, information on homeopathic medicines remained incomplete, and non-compliance with the Therapeutic Product Advertising Act (Heilmittelwerbegesetz) was noted. Naming of the products if often very suggestive, too. Manufacturers' claims of efficacy go far beyond what can be considered proven in terms of evidence-based medicine and the quality of most clinical studies is poor. Homeopathic remedies are on average significantly more expensive than their rational pharmacological alternatives. Furthermore, DDD costs have continued to rise over the years analyzed. In aggregate, from a pharmacoeconomic, legal, and scientific perspective, abolition of reimbursement of homeopathic medicines in Germany at the expense of the SHI system is well justified.
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Homeopatía , Alemania , Humanos , Homeopatía/economía , Economía Farmacéutica , Costos de los Medicamentos/tendencias , Costos de los Medicamentos/legislación & jurisprudencia , Seguro de Salud/economía , Prescripciones de Medicamentos/economíaRESUMEN
In Germany, the Apotheken Umschau (Pharmacy review) is a very popular health magazine for lay people, which is available free of charge in pharmacies. In this study, drug advertising in the Apotheken Umschau was critically analyzed. To our knowledge, studies on drug advertisements in such magazines are scarce. For the analyses, a total of 123 different advertisements from all 48 issues of Apotheken Umschau in 2020 and 2021 were compared. Since 2021 is the first year that was completely characterized by the COVID-19 pandemic, it was thus also possible to work out pandemic effects. More preparations from the categories immune system, eyes and sleep were advertised in 2021. Accordingly, typical complaints home office workers were addressed. Advertisements provided only very modest scientific information, if at all. The Therapeutic Products Advertising Act (Medicines Advertising Law; Heilmittelwerbegesetz (HWG)) provides regulations regarding the handling of drug advertising. However, in various categories, we noted substantial deficiencies of the advertisements to comply to regulations, e.g. the disclosure of adverse effects and omission of the mandatory statement "For risks and adverse effects, read the package insert and ask your doctor or pharmacist (Für Risiken und Nebenwirkungen fragen Sie Ihren Arzt oder Apotheker oder lesen Sie die Packungsbeilage)". Fifty-one of the 123 advertisements featured females to appeal particularly to this target group. Furthermore, a homogeneous ethnic (Caucasian) picture and a traditional image of German society were presented although this clearly deviates from reality. In conclusion, this study provides insights into the yet poorly studied mechanisms of drug advertisement for lay people. Pharmacological evidence plays a much smaller role than psychology, marketing and traditional societal models. It appears that drug companies intentionally use the "grey area" of the Medicines Advertising Law to optimally promote their products and ignore mandatory statements. This practice must be stopped by stricter legal control to protect the consumer from misinformation. In this way, drug safety will be increased.
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Farmacias , Farmacia , Médicos , Femenino , Humanos , Publicidad , PandemiasRESUMEN
Honesty of publications is fundamental in science. Unfortunately, science has an increasing fake paper problem with multiple cases having surfaced in recent years, even in renowned journals. There are companies, the so-called paper mills, which professionally fake research data and papers. However, there is no easy way to systematically identify these papers. Here, we show that scanning for exchanged authors in resubmissions is a simple approach to detect potential fake papers. We investigated 2056 withdrawn or rejected submissions to Naunyn-Schmiedeberg's Archives of Pharmacology (NSAP), 952 of which were subsequently published in other journals. In six cases, the stated authors of the final publications differed by more than two thirds from those named in the submission to NSAP. In four cases, they differed completely. Our results reveal that paper mills take advantage of the fact that journals are unaware of submissions to other journals. Consequently, papers can be submitted multiple times (even simultaneously), and authors can be replaced if they withdraw from their purchased authorship. We suggest that publishers collaborate with each other by sharing titles, authors, and abstracts of their submissions. Doing so would allow the detection of suspicious changes in the authorship of submitted and already published papers. Independently of such collaboration across publishers, every scientific journal can make an important contribution to the integrity of the scientific record by analyzing its own pool of withdrawn and rejected papers versus published papers according to the simple algorithm proposed in the present paper.