# Background Lung dust fibre analyses have been used by some pathologists to estimate past asbestos exposure in the workplace and its related health risks. Asbestos, however, especially the predominately applied chrysotile asbestos type, undergoes translocation, clearance and degradation in the lungs. # Objectives We quantified the asbestos fibre and ferruginous (asbestos) body (FB) content in human tissue with respect to the German asbestos ban in 1993 and the interim period of more than 20 years in order to evaluate the diagnostic evidence of these analyses for asbestos-related diseases (ARD). # Methods Lung dust analyses have been used in empirical assessments of ARD since 1982. Tissue samples of about 2 cm^3^ were used and processed in standardized manner. FB was analysed by light microscopy and asbestos fibres by scanning transmission electron microscopy (STEM). # Results Chrysotile and amphibole fibre concentrations in the lung tissue depend roughly on the cumulative asbestos exposure levels in the workplace. However, the concentration of lung asbestos fibre and FB depends on the year of examination and especially on the interim period. As the interim period increases, the asbestos fibre burden decreases. There is no relationship between FB and chrysotile asbestos fibre concentrations and only a weak correlation between FB and crocidolite fibre concentrations. There was no significant difference in chrysotile and amphibole fibre concentrations as well as in FB counts between the different ARD. # Conclusions Due to the length of interim periods, a past exposure to chrysotile or amphibole asbestos can no longer be detected with FB or asbestos fibre measurement in lung tissue. This means that negative results of such measurements cannot disprove a qualified occupational case history of asbestos exposures and the related health risks due to the fibrogenic and carcinogenic potential of asbestos.
Malignant mesothelioma (MM) is a highly aggressive and difficult-to-diagnose tumor that is almost always caused by asbestos or other asbestiform fibers. Chapter 2 in the Fourth (2015) and Fifth (2021) Editions of the WHO/IARC Classification of Tumours is devoted to the classification and pathologic diagnosis of MM. The authors of these Chapters state that most of the cases of MM in females do not show asbestos as the cause when, in fact, the epidemiologic literature shows that the risk of MM in females exposed to asbestos approaches that in males. While it is correct that the overall incidence of MM in females is lower than in males, the view that MM in females is not caused by asbestos is unsupported. This view results from an inadequate occupational history, the failure to recognize the importance of environmental exposures, and the misrepresentation of published literature by the selection of limited literature and biased bibliographies, often by authors with financial conflicting interests. In this article, we present an example of the institutional failure (1) to protect the public health by permitting the publication of inaccurate statements about the adverse health effects of exposure to asbestos among females, and (2) to make suggested corrections that more accurately reflect reality. Responsibility for correcting the misinformation lies, in our assessment, both with the authors of the erroneous statements and with the editors and publisher of the books that contain these statements. At issue is nothing less than scientific accuracy, the fate of at-risk females for whom early diagnosis could result in improved health outcome, a missed opportunity to promote primary and secondary prevention, and the social injustice of the loss of compensation for females so affected. We describe the steps that we took to correct the inaccuracies, and to expose the dereliction of duty among responsible parties based, at least in part, on what we believe to be undisclosed conflicting interests. Our efforts failed.
Many African countries are involved in complex plans to improve health professions education as part of health sector strengthening. Global health ventures have joined in, to address the scarce human health resources through either research and/or service. These enterprises of global health have come at a huge cost to careers of trained citizens and the countries at large. Botswana is no exception. In 2010, the University of Botswana was awarded the US NIH medical education grant and partnered with excellent and well-established universities to capacitate the newly established School of Medicine. Within the Botswana health-care-sector, these same universities had established affiliate institutions to contribute to the Botswana health systems. Rather than empowering citizens, these partnerships have instead become conduits for career development of faculty and researchers from the west. Tipping the scale further, the University of Botswana leadership places the western institutions’ interests far above the interests and development of the local faculty and thereby the country at large, stalling the country’s nation building vision thereby, sustainable development goals.
Decades before the COVID outbreak when Americans first began hearing of dangerous “gain of function” virus studies, US bioweapons researchers were juicing up bugs to make them more deadly and contagious. Combing through historical military records, writer Kris Newby found evidence that this research may have fueled the rise of patients with Lyme disease—a sometimes chronic condition, with almost half a million new infections every year.
The world pandemic of asbestos-related diseases results from inadequate prevention and late bans on asbestos use. For years in Germany there has been an annual average of about ten thousand new claims. Many countries deny compensation due to unsound diagnostic applications that have entered into the literature and are used to deny compensation. One such well-established incorrect scientific strategy is the use of quantifying asbestos bodies or fibers in lung tissue and setting restrictive thresholds on the findings in tissues of workers who had been exposed primarily to chrysotile which shows low bio-persistence, movement to the pleura, and rarely forms asbestos bodies. The so called one thousand asbestos body hypothesis for the diagnosis of asbestosis, originating from the German Mesothelioma Register run by the employers’ statutory accident insurance institutions, has been applied in Germany and similarly in several other western countries. As opposed to the well-substantiated hit and run phenomena that has been predominantly applied to chrysotile asbestos, low asbestos body or fiber counts in tissue had been systematically misinterpreted. This, combined with restrictive histopathology definitions, have been used for the manipulation not only of diagnostic criteria but also of science and has had an effect on laws governing compensation. The counting of asbestos bodies or fibers in human lungs should under no circumstances invalidate a qualified occupational history of exposure as the hallmark requisite tool for assessing asbestos exposure and acceptance of asbestos-related diseases in compensation schemes. An outcome suggested by this paper is the need to broaden the WHO beneficial initiative to eliminate ARD worldwide by establishment of an international board of independent scientists on remedial action that would recommend standards for acknowledgement and compensation. Such a board should be supported by national legal branches recognizing possible regional differences and initiating compliance with the recommendations.
By Paul D. Thacker, Jay Bhattacharya. Professor Bhattacharya defends himself, colleagues, and family from attacks, and details apparent commercial interests driving Stanford science and media hit pieces.
Pressures on epidemiologists, toxicologists, and on public health scientists to suppress their work are known to occur worldwide. In this article, we share six stories from environmental health scientists about the pressures they faced in their jobs after bringing public health problems to light. The method used to document each of the stories was to invite scientists who attended meetings of the International Society for Environmental Epidemiology to tell their own stories of having experienced research suppression. We then extracted the salient features of each experience into a coherent story, providing references as corroboration where possible. The specific purpose in going public with the six stories presented in this article is to open a conversation to better equip colleagues to stand up to pressures to suppress their work. By publicly sharing the pressures experienced by these scientists in attempts to suppress their scientific work, including intimidation, harassment, threats and/or bullying, other scientists may be better able to withstand such pressures. In the absence of a larger collection of stories, we are unable to identify common approaches taken against suppression. It appears that a focus on scientific excellence and tenacity are two major factors likely to have contributed to the ability to withstand pressure. We encourage others to tell their stories. Bringing examples of these instances to attention will make them familiar enough to be less intimidating should others experience anything similar. Additional documented experiences will expand the base of stories and thus help colleagues to withstand the pressures wielded by special interests. Shining a light on these pressures will remove barriers, not only to advancing the science, but also to protecting the public interest.
Research integrity is of interest across disciplines, although reported on more frequently by health sciences researchers. This study investigated the experiences and attitudes of academic staff and postgraduate students to scientific misconduct in a South African health sciences institution. An anonymous self-administered, structured questionnaire conducted online was addressed to academic staff and postgraduate students. While the response rate was low (11.4%), it reflects the diversity of the health sciences institution. While fabricating, falsifying, plagiarizing, or presenting results in a misleading way was self-reported as low, 9% of staff reported knowing of cases where misleading results had been presented and approximately 10% of respondents had witnessed misconduct. Authorship misconduct was concerning, with more staff (35.2%) than students (8.8%) reporting unethical pressure regarding inclusion or ordering of authors (p<0.001). The incidence of data altering by staff, and of clinicians who were uncertain about reporting scientific misconduct although low, is disquieting. Institutions should ensure that adequate research integrity training is provided if the standard and veracity of its science is to be upheld.
Background We surveyed addiction journal editorial board members to better understand their opinions towards data-sharing. Methods Survey items consisted of Likert-type (e.g., one to five scale), multiple-choice, and free-response questions. Journal websites were searched for names and email addresses. Emails were distributed using SurveyMonkey. Descriptive statistics were used to characterize the responses. Results We received 178 responses (of 1039; 17.1%). Of these, 174 individuals agreed to participate in our study (97.8%). Most respondents did not know whether their journal had a data-sharing policy. Board members “somewhat agree” that addiction journals should recommend but not require data-sharing for submitted manuscripts [M=4.09 (SD=0.06); 95% CI: 3.97-4.22]. Items with the highest perceived benefit ratings were “secondary data use (e.g., meta-analysis)” [M=3.44 (SD=0.06); 95% CI: 3.31-3.56] and “increased transparency” [M=3.29 (SD=0.07); 95% CI: 3.14-3.43]. Items perceived to be the greatest barrier to data-sharing included “lack of metadata standards” [M=3.21 (SD=0.08); 95% CI: 3.06-3.36], “no incentive” [M=3.43 (SD=0.07); 95% CI: 3.30-3.57], “inadequate resources” [M=3.53 (SD=0.05); 95% CI: 3.42-3.63], and “protection of privacy”[M=3.22 (SD=0.07); 95% CI: 3.07-3.36]. Conclusion Our results suggest addiction journal editorial board members believe data-sharing has a level of importance within the research community. However, most board members are unaware of their journals’ data-sharing policies, and most data-sharing should be recommended but not required. Future efforts aimed at better understanding common reservations and benefits towards data-sharing, as well as avenues to optimize data-sharing while minimizing potential risks, are warranted.
The Medical Review document of the FDA is a rich source of data about clinical trials underlying the approval of a given drug. There are also other sources of information about clinical trials, such as trial registries and publications. However the data in the various sources may be erroneous or discrepant, and therefore there have been calls for audits of data in trial registries, in particular. The data in the Medical Review documents could be used as a source, to cross check data from other sources. However, it is extremely cumbersome to access the data in this document. We have analyzed the summary ‘Table of Clinical Studies’ of forty five Medical Reviews, and note significant differences in what information is presented in this table. We outline the details of an informative template Table, that would facilitate audits.
Background We previously described experiences of clinicians who published adverse drug reaction reports. We now report on threats and intimidations leveled against clinicians and scientists who received publicly documented threats after communicating safety, efficacy, or data integrity findings contrary to corporate interests. Methods Data on threats and intimidations were obtained from transcripts of governmental hearings or agencies, university-affiliated reports, media interviews, and investigative journalism articles. Content and timing of threats and intimidation, subsequent harms, numbers of persons seriously injured or who died from individual toxicities, financial payments from sponsors related to safety, efficacy, or data integrity concerns, and civil settlements and criminal findings were evaluated. Findings Twenty-six individuals who communicated safety, efficacy, or data integrity concerns were targets of threats and intimidation from corporate employees (twenty-three individuals) or regulatory personnel (three). Seventeen individuals identified instances where pharmaceutical sponsors submitted fraudulent data in support of regulatory approval of a drug or device. Scientist and clinician communications were followed by drug/device withdrawals (fourteen drugs/devices), black box warnings (six drugs), withdrawal of a sponsor’s application for regulatory approval (one device), and delay of approval of a sponsor’s application for regulatory approval (one drug). Actions mainly occurred after persons communicated with pharmaceutical employees (fourteen). Intimidation efforts by corporate personnel included threats of lawsuits (eighteen individuals), hiring private investigators (nine), and public disparagement at conferences (eleven). Related intimidation efforts carried out by academia or regulatory agency superiors included threats of: loss of positions (six), loss of grant funding (two), delays in decisions regarding tenure (two); or reassignment to a low-level position (one). Academic harms included lost: hospital or university appointments (nine and six, respectively), grant funding (two), chairperson title of an international clinical trial group (one), and journal editorial board position (one). Corporate harms included payment of $1 million to defense attorneys in three cases filed against clinicians. Interpretation Threats and intimidation carried out by corporate employees and/or academic supervisors followed public communication of concerns regarding patient safety, drug efficacy, or data integrity, including instances where sponsors were identified as having submitted fraudulent data to regulatory or government agencies. Consideration should be given to filing criminal charges against pharmaceutical executives who are discovered by scientists or clinicians to have knowingly submitted fraudulent data to regulatory or governmental agencies, rather than causing the scientists and clinicians who submit such reports to risk losing their reputations and occupations.
# Introduction Spin --- reporting in a way that exaggerates benefits or minimizes harm --- has been shown to affect a clinician's perceptions of treatment efficacy. It is necessary to identify if spin is used in systematic reviews and meta-analyses due to their high degree of scientific evidence and usefulness in identifying the most appropriate clinical interventions. We aim to quantify the prevalence of spin in the abstracts of systematic reviews focused on testicular cancer. # Design Systematic reviews related to testicular cancer were accessed using search strategies created for MEDLINE and Embase. To meet the inclusion criteria, a study must be a systematic review or meta-analysis examining testicular cancer screening, treatment, or quality of life. This cross-sectional study was performed in June of 2020. Investigators performed all screening, spin data extraction, and AMSTAR-2 appraisals in a masked, duplicate manner. In addition to evaluating spin in abstracts, associations between spin and particular study characteristics, and their methodological quality were analyzed. # Results Our initial search returned 900 articles, of which 50 were included. Spin was present in 32.0% of these abstracts (16/50). We identified 7 of the 9 defined types of spin. Selective reporting of or overemphasis on harm favoring the safety of the experimental intervention was most prevalent, identified in 18% of the abstracts (9/50). Additionally, we found no significant association between spin and AMSTAR-2 appraisals or any other evaluated study characteristics. # Conclusions Our findings illustrate the need for improved reporting accuracy in systematic reviews and meta-analyses related to testicular cancer. Because abstracts are often used by clinicians to guide clinical decisions, any misrepresentation of a systematic review's findings could influence patient care.
By Mike Thorne, Simon Harris. A response by M C Thorne (Editor-in-Chief of the Journal of Radiological Protection) to the Editor regarding Dr. Tanimoto's paper "The mishandling of scientifically flawed articles about radiation exposure"
We discuss the editorial handling of two papers that were published in and then retracted from the *Journal of Radiological Protection* (JRP).^1,2^ The papers, which dealt with radiation exposure in Date City, were retracted because “ethically inappropriate data were used.”^3,4^ Before retraction, four Letters to the Editor pointing out scientific issues in the papers had been submitted to JRP. The Letters were all accepted or provisionally accepted through peer review. Nevertheless, JRP later refused to publish them. We examine the handling by JRP of the Letters, and show that it left the reader unapprised of a) the extent of the issues in the papers, which went far beyond the use of unconsented data, and b) the problems in the way the journal handled the matter. By its actions in this case, JRP has enabled unscientific, unfounded and erroneous claims to remain unacknowledged. We propose some countermeasures to prevent such inappropriate actions by academic journals in future.
Noncompliance or nonadherence to prescribed medication is common. Reasons given by patients for not taking medications as prescribed include cost, adverse effects, or perceived lack of effectiveness, all of which are important factors in shared decision-making between health care providers and patients. It has been assumed that better compliance with medication therapy would mean better control of disease, prevention of disease-associated health impairment, and cost savings, but these assumptions are questionable. Although adherence to some medications, including anti-tuberculosis drugs and oral contraception, is necessary for effectiveness, it is unclear whether adherence to many other medications improves outcomes. Patients who adhere to almost any medication, including placebo, have better health outcomes, but these benefits could be due to healthy behaviors for which adherence is a marker. On the other hand, compliance with treatments that are harmful increase harms. Efforts to increase compliance with new drugs may be risky because newer drugs have limited safety data. We recommend that practitioners use noncompliance as an opportunity to address problems identified by the patient, including medication cost, side effects, and lack of perceived benefits. We also argue that inadequate attention has been paid to the possible role of drug manufacturers in distorting information about the causes, benefits, and harms of adherence.
Gardasil (Merck’s quadrivalent HPV vaccine) is the first vaccine in history to have been granted the FDA’s accelerated approval and fast track. Using unpublished documents and data, we investigated the impact of US regulators’ choices on the quality of available evidence regarding the vaccine’s efficacy in preventing high-grade cervical lesions, which are precursors of cervical cancer. We found that, as early as 2001, the accelerated approval and fast track procedures prompted FDA advisory committees to make methodological choices such that only weak claims could be made regarding the vaccine’s efficacy and to approve a product whose benefit-to-harm ratio cannot be appropriately assessed. By giving more weight to the HPV vaccine’s hypothetical promises rather than to compliance with best methodological principles, regulatory authorities’ decisions turned out to be more favorable to commercial interests than to public health thereby allowing HPV vaccine manufacturers to escape the usual burden of proof while generating huge profits. Published and unpublished results of pre-marketing trials strongly suggest that introduction of the vaccine will not lead to the expected reduction in the incidence of high-grade cervical lesions, let alone of cervical cancer. The available HPV vaccines do not target all high-risk HPV strains. Consequently, screening must be maintained. The marketing of Gardasil has thus inaugurated a new form of medical overuse in the field of prevention: the introduction of a low-value primary prevention measure (vaccination) whose effectiveness can never be completely assessed since the secondary prevention measure (screening) cannot be removed. Meanwhile, health authorities promote the product and society bears the costs of vaccination campaigns and health risks. This is a concerning outcome. Such over-prevention creates a societal and individual burden of unnecessary medical expansion that undermines science.
Editorial independence is a bedrock principle of academic publishing. The growing domination of academic publishing by large, for-profit corporations threatens this independence. There is alarming evidence that large companies too often serve their own business interests and those of powerful clients rather than serving the scientific community and the general public. This evidence includes the publication of infelicitous commercial science and concealing scientific misconduct. We present two case studies in which the UK-based publisher Taylor & Francis interfered in the editorial process by blocking publication of legitimate criticism that had been reviewed and approved for publication by its specialized editors. The integrity of science depends in part on the transparency and intellectual honesty of all stakeholders. The widely-acknowledged inadequacies of English libel law are reviewed as context for some of Taylor & Francis’s fearful decisions.
