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Scientific data are often used in lawsuits to prove, or dismiss, causation by a claimed factor of a claimed disease. Recent media reports of million-dollar compensations awarded to some cancer patients who had been exposed to certain chemical substances motivated me to examine how solid the causal links really were. Here, I discuss the limitations of epidemiological research on cancer causation and highlight how new knowledge of cancer genetics makes it unrealistic to expect that cancer causation can be clearly demonstrated. I then present two exposure–cancer cases, namely talcum powder–ovarian cancer and glyphosate–non-Hodgkin lymphoma, that led to civil lawsuits decided, in the United States, in favor of the claimants. Both these cancers have several risk factors, among which the claimed exposure presents only a minor, if any, increased risk. Through these cases, I explain why the use of epidemiological data is inappropriate to define causal associations in complex diseases like cancer. I close by suggesting a fairer approach, called proportional liability, to resolving future cancer litigation cases. [ABSTRACT FROM AUTHOR]

Importance: The relationship between use of powder in the genital area and ovarian cancer is not established. Positive associations reported in case-control studies have not been confirmed in cohort studies.Objective: To estimate the association between use of powder in the genital area and ovarian cancer using prospective observational data.Design, Setting, and Participants: Data were pooled from 4 large, US-based cohorts: Nurses' Health Study (enrollment 1976; follow-up 1982-2016; n = 81 869), Nurses' Health Study II (enrollment 1989; follow-up 2013-2017; n = 61 261), Sister Study (enrollment 2003-2009; follow-up 2003-2017; n = 40 647), and Women's Health Initiative Observational Study (enrollment 1993-1998; follow-up 1993-2017; n = 73 267).Exposures: Ever, long-term (≥20 years), and frequent (≥1/week) use of powder in the genital area.Main Outcomes and Measures: The primary analysis examined the association between ever use of powder in the genital area and self-reported incident ovarian cancer. Covariate-adjusted hazard ratios (HRs) and 95% CIs were estimated using Cox proportional hazards models.Results: The pooled sample included 252 745 women (median age at baseline, 57 years) with 38% self-reporting use of powder in the genital area. Ten percent reported long-term use, and 22% reported frequent use. During a median of 11.2 years of follow-up (3.8 million person-years at risk), 2168 women developed ovarian cancer (58 cases/100 000 person-years). Ovarian cancer incidence was 61 cases/100 000 person-years among ever users and 55 cases/100 000 person-years among never users (estimated risk difference at age 70 years, 0.09% [95% CI, -0.02% to 0.19%]; estimated HR, 1.08 [95% CI, 0.99 to 1.17]). The estimated HR for frequent vs never use was 1.09 (95% CI, 0.97 to 1.23) and for long-term vs never use, the HR was 1.01 (95% CI, 0.82 to 1.25). Subgroup analyses were conducted for 10 variables; the tests for heterogeneity were not statistically significant for any of these comparisons. While the estimated HR for the association between ever use of powder in the genital area and ovarian cancer risk among women with a patent reproductive tract was 1.13 (95% CI, 1.01 to 1.26), the P value for interaction comparing women with vs without patent reproductive tracts was .15.Conclusions and Relevance: In this analysis of pooled data from women in 4 US cohorts, there was not a statistically significant association between use of powder in the genital area and incident ovarian cancer. However, the study may have been underpowered to identify a small increase in risk. [ABSTRACT FROM AUTHOR]

The article offers news briefs including significant link between use of talcum powder and risk of ovarian cancer; racial and ethnic minority groups are underrepresented, though the proportion of nurses from minority groups increased; and many female teenagers in the U.S. may be receiving unnecessary bimanual pelvic examinations (BPVs) and Pap tests.

The article discusses a previous study on ambient asbestos fibers concentrations and long-term trends in pleural mesothelioma incidence between U.S. urban and rural areas between 1973 and 2012, and its findings. A letter in response to the findings had pointed out that asbestos exposures arising from the use of body and baby powders had been not been taken into account, the response to which is lack of any scientific evidence to support the hypotheses of contamination by cosmetic talc products.

Elongate mineral particles, including asbestos, have long been screened in talc and other mineral powders. In recent years, there has been a renewed scrutiny of talc containing asbestos due to allegations in civil litigation in the United States as well as reports, proposals, and white papers by international laboratories and government bodies related to this subject. This study demonstrates the importance of the fundamental understanding of both mineralogy and its application, using microscopy with empirical examples from conflicting analyses of the same talc powders by two independent laboratories in civil litigation in the United States. Methods include polarized light microscopy (PLM), scanning electron microscopy (SEM), and transmission electron microscopy (TEM) in the accurate measurement of morphological, optical, compositional, and structural data to characterize mineral-based samples. Discussions in this study include: 1) contrasting the interlaboratory findings of amphibole and amphibole asbestos by PLM and TEM using various preparation techniques, 2) the use of multiple analytical tools on a singular particle for identification, 3) the misidentification of anthophyllite asbestos by inexpert use of electron diffraction using TEM, and 4) the misidentification of chrysotile in talc by PLM. These examples emphasize the importance of not only maintaining the existing requirements, but of the need for even more rigorous analytical requirements in routine monitoring of elongate mineral particles that may occur in mineral-based powders. • Amphibole, biopyribole, talc, chrysotile, asbestos, amphibole asbestos, talcum powder, TEM, PLM, SEM, EBSD, SAED, zone axis index, asbestos testing, asbestiform, non-asbestiform. [ABSTRACT FROM AUTHOR]

An editorial is presented which addresses the author's views about the expert peer review process in relation to the adverse effects of environmental and occupational agents such as talcum powder and the herbicide glyphosate, and it mentions the possibility that these products and talc could be causing cancer in human beings. The World Health Organization's International Agency for Research on Cancer (IARC) is assessed, along with ovarian cancer risks and IARC Monographs.

The article discusses a previous study on the relationship between ambient asbestos fiber concentrations and long-term trends in pleural mesothelioma incidence between urban and rural areas in the U.S. The study aimed at determining a possible influence of variations in ambient asbestos concentrations on pleural mesothelioma risk in females, and discusses the findings thereof. It discusses the asbestos exposures arising from the use of body and baby powders, and the conclusions thereof.

Background: Malignant pleural effusions (MPEs) remain a common problem, with 40,000 new cases in the United Kingdom each year and up to 250,000 in the United States. Traditional management of MPE usually involves an inpatient stay with placement of a chest drain, followed by the instillation of a pleural sclerosing agent such as talc, which aims to minimise further fluid build-up. Despite a good success rate in studies, this approach can be expensive, time-consuming and inconvenient for patients. More recently, an alternative method has become available in the form of indwelling pleural catheters (IPCs), which can be inserted and managed in an outpatient setting. It is currently unknown whether combining talc pleurodesis with IPCs will provide improved pleural symphysis rates over those of IPCs alone. Methods/Design: IPC-PLUS is a patient-blind, multicentre randomised controlled trial (RCT) comparing the combination of talc with an IPC to the use of an IPC alone for inducing pleurodesis in MPEs. The primary outcome is successful pleurodesis at five weeks post-randomisation. This study will recruit 154 patients, with an interim analysis for efficacy after 100 patients, and aims to help to define the future gold standard for outpatient management of patients with symptomatic MPEs. Discussion: IPC-PLUS is the first RCT to examine the practicality and utility of talc administered via an IPC. The study remains in active recruitment and has the potential to significantly alter how patients requiring pleurodesis for MPE are approached in the future. [ABSTRACT FROM AUTHOR]

This study examined commercial talc deposits in the U.S. and their amphibole-asbestos content. The study found that the talc-forming environment directly influenced the amphibole and amphibole-asbestos content of the talc deposit. Large talc districts in the U.S. have mined hydrothermal talcs that replaced dolostone. Hydrothermal talcs, created by siliceous fluids heated by magmas at depth, consistently lack amphiboles as accessory minerals. In contrast, mineable talc deposits that formed by contact or regional metamorphism consistently contain amphiboles, locally as asbestiform varieties. Examples of contact metamorphic deposits occur in Death Valley, California; these talc-tremolite deposits contain accessory amphibole-asbestos. Talc bodies formed by regional metamorphism always contain amphiboles, which display a variety of compositions and habits, including asbestiform. Some industrial mineral deposits are under scrutiny as potential sources of accessory asbestos minerals. Recognizing consistent relations between the talc-forming environment and amphibole-asbestos content may be used in prioritizing remediation or monitoring of abandoned and active talc mines. [ABSTRACT FROM AUTHOR]

An editorial is presented which addresses the author's views about independent health risk assessments and the potentially adverse impacts that talc and glyphosate (Roundup) might have on human health, and it mentions a link between baby powder use and ovarian cancer. The U.S. Food and Drug Administration and lawsuits involving the Johnson & Johnson consumer goods firm are examined, along with carcinogens and American public health.

An editorial is presented which addresses the author's views about the American government agencies' system for public health protection, and it mentions the U.S. Food and Drug Administration, the nation's Environmental Protection Agency, and the Cosmetic, Toiletry, and Fragrance Association. Another article about the measurement of asbestos in talc, which appears in the same issue of the journal, is examined.

The article covers issues related to medication errors in the U.S. as of December 2007. It emphasizes that the lack of standardization makes the selection of appropriate dosing method difficult and errors are common. It discusses the case of a nurse who misadministered the talc intravenously, which was intended to be used in performing a pleurodesis on a patient with a pleural effusion.

Introduction: Indwelling pleural catheters (IPC) are effective at palliating benign and malignant pleural effusions (MPE). They have also been found to be cost effective from a third-party payor perspective. Little is known of the impact IPCs have on patient-centered quality of life outcomes such as financial burden and patient and caregiver burden. We performed a cross-sectional survey study evaluating the impact of IPCs on multiple patient and caregiver quality of life metrics., Methods: Patients ≥ 18 years old with an IPC in place for 2 months were eligible. Twenty patients were recruited over a 10-month period. Patients completed the CDC-Health Related Quality of Life (HRQOL)-4 and a HRQOL-financial questionnaire. The primary objective was to describe the socio-economic impact of IPCs. Demographic and IPC specific data were collected. Descriptive statistics were used., Results: The mean (SD) age was 64.3 (0.70). The indication was MPE in 19/20. All patients had medical insurance. Medicare or Medicaid (CMS) comprised 10/20 of payors. The median (IQR) copay for private insurers was $238.45 (72-875); 11/20 had additional costs related to the IPC; 4/20 had significant life changes after the IPC; 17/20 received assistance from a non-paid caregiver; 6/20 patients could not do activities because of the IPC and this negatively impacted QOL in 3/6 of those patients., Conclusion: Patients with IPCs may experience negative life consequences, incur additional medical expenses, and require assistance from a non-paid caregiver. Activities may be negatively impacted by IPC. Discussion of alternative means of symptom palliation and pleurodesis would be beneficial.

The authors discusses on the medical talc and seroma formation after ventral hernia repair. They say that based on the retrospective view of Parameswaran and colleagues on the use of 8 grams medical talc for seromadesis, 21 patients were treated with talc. The state that ventral hernia repair is the most common procedures where in there are 300,000 performed in U.S. every year. They add that talc is a hydrous magnesium silicate that us safe and effective in the treatment of pleural effusions.

The article discusses a study that developed a risk score which could be used to quantify the risk of ovarian cancer. The model was used by researchers from the U.S. to determine which patients should be offered prophylactic oophorectomy at the time of hysterectomy. Factors conferring higher risk of developing ovarian cancer include polycystic ovary syndrome obesity, Jewish ethnicity and habitual application of talc to the genital area.

The article comments on the study which recognized that the talc used in the U.S. and Great Britain to have serious effects due to systemic dissemination of small particles. It notes that a significant experimental study that used large talc particles and demonstrated that this talc does not disseminate in organs is not considered. It is mentioned that the experimental study explains the preference of respiratory physicians to use talc as a pleurodesing agent.

Abstract: Amphiboles are hydrated mineral silicates five of which occur in asbestiform habits as asbestos grunerite (amosite) asbestos, riebeckite (crocidolite) asbestos, anthophyllite asbestos, tremolite asbestos and actinolite asbestos] and non-asbestiform habits (grunerite, riebeckite, anthophyllite, tremolite and actinolite). The asbestiform varieties are characterized by long, thin fibers while non-asbestiform varieties such as cleavage fragments form short fibers with larger widths. The U.S. regulatory method for counting asbestos fibers (aspect ratio ⩾3:1, length ⩾5μm) does not distinguish between asbestos and cleavage fragments. The method biases toward increased counts of non-asbestiform cleavage fragments compared to long, thin asbestos fibers. One consequence of this regulatory approach is that workers can be erroneously classified as exposed to concentrations of asbestos (asbestiform amphiboles) above the U.S. 0.1f/mL exposure standard when in fact they are not exposed to asbestos at all but non-asbestiform amphibole cleavage fragments. Another consequence is that the known carcinogenic effects of asbestos may be falsely attributed to non-asbestiform amphibole cleavage fragments of the same mineral. The purpose of this review is to assess whether amphibole cleavage fragments pose the same risk of lung cancer and mesothelioma characteristic of amphibole asbestos fibers. We identified three groups of workers exposed to non-asbestiform amphiboles: two groups exposed to grunerite (Homestake gold miners and taconite miners) and one group exposed to industrial talc containing non-asbestiform tremolite and anthophyllite in St. Lawrence County, NY. In addition to assessing strength of association and exposure–response trends in the non-asbestiform amphibole cohorts, comparisons were also made with cohorts exposed to the asbestiform counterpart (positive control) and cohorts exposed to the mineral (e.g. talc) that does not contain amphiboles (negative controls). The cohorts exposed to non-asbestiform amphiboles had no excesses of lung cancer or mesothelioma. Similar results were observed in the negative control groups, in stark contrast to the excess risks of asbestos-related disease found in the asbestos cohorts. The only possible exception is the twofold increased risk of lung cancer where exposure was to industrial talc containing cleavage fragments of tremolite and anthophyllite. However, this risk is not considered attributable to the talc or amphibole cleavage fragments for several reasons. A similar increased risk of lung cancer was found in Vermont talc workers, studied in the same time period. Their exposure was to relatively pure talc. There was no relationship between lung cancer mortality and exposure measured as mg/m3 years and years worked. A case–control study reported that all the lung cancer cases were smokers (or former smokers) and attributed the excess to smoking. There were two mesothelioma cases among the NY State talc workers exposed to cleavage fragments of tremolite and anthophyllite, but talc is not a plausible cause because of too short latency and potential for previous asbestos exposure. The positive controls of tremolite asbestos and anthophyllite asbestos exposed workers showed excess risks of both lung cancer and mesothelioma and positive exposure–response trends. St. Lawrence, NY talc does not produce mesotheliomas in animals while amphibole asbestos does. In sum, the weight of evidence fully supports a conclusion that non-asbestiform amphiboles do not increase the risk of lung cancer or mesothelioma. [Copyright &y& Elsevier]

Examines the prevalence of pulmonary fibrosis in a talc mining region in New York, New York. Effect of asbestiform mineral exposure on respiratory health; Analysis of mineral talc samples for presence of asbestiform properties; Factors influencing the prevalence rate of pulmonary fibrosis.

Part IV. Examines the effect of talc exposure on the respiratory morbidity of rubber workers in Akron, Ohio. Analysis of respiratory symptoms and pulmonary function of workers; Comparability of the control and talc workers; Prevalence of respiratory symptoms; Relationships between cross-sectional pulmonary function changes and talc exposure.

The objectives of this study were to evaluate mounting methods for fiber examination of air sample filters by phase contrast microscopy (PCM) and to evaluate differences in fiber counts that might be due to fiber movement. Acetone/triacetin (AT) with various amounts of triacetin and acetone/Euparal (AE) where the mounting medium was placed between the cleared filter wedge and the coverslip were tested as a function of time. Field sample slides collected from a taconite iron-ore processing mill, a tremolitic talc-ore processing mill, and from around a crusher in a meta-basalt stone quarry were prepared with relocatable coverslips to revisit the same field areas on the slides. For each slide, three or four field areas were randomly selected and pictures were taken every 2 weeks to determine any sign of fiber movement over time. For 11 AT slides (named as AT-3.5) prepared with 3.5 μl of the mounting medium according to the NIOSH 7400 method, no fiber movements were detected over 59 weeks. On the other hand, AT slides prepared with larger quantities (10, 15, and 20 μl) of the mounting medium (named as AT-10) and AE slides prepared with ∼10 μl mounting medium showed fiber movement from the eighth day at the earliest. Fiber movement began earlier for the slides mounted with excess triacetin than for those mounted with Euparal. The sample slide storage method, either vertically or horizontally, did not seem to accelerate fiber movement. Additionally, two other modified methods, dimethylformamide solution/Euparal (mDE) and dimethylformamide solution/triacetin (mDT), were also prepared where the mounting medium was placed between the cleared filter wedge and the glass slide. The findings of fiber movements were similar; when 3.5 μl of triacetin was used for the mDT slides, fiber movements were not detected, while fibers on slides prepared with 10 μl triacetin (mDT-10) moved around. No fiber movements were observed for the mDE slides at any time during 59 weeks. Once fiber movement started, fibers moved over distances measured from 4 μm and up to >1000 μm within 22 weeks. However, since then, no further fiber movements have been observed in any field sample slides. Additional sample slides, two Amosite and two chrysotile, were prepared from Union for International Cancer Control (UICC) samples using the AT method with 5 μl triacetin mounting medium. Fiber movements were also observed in these samples; chrysotile fibers began to migrate in 3 weeks, while Amosite fiber movement started after 3 months. Although fiber movement was observed for the AT-10, AE, and mDT-10 sample slides, fiber counts were not significantly different from AT-3.5 and mDE samples that exhibited no fiber movement. Although fiber counts would not be significantly changed by fiber movement, the type and amount of mounting medium for sample slide preparation remains critical for issues such as quality assurance and training of analysts by revisiting the same fibers.

A proportionate mortality study suggested that members of the International Brotherhood of Potters and Allied Workers in the United States had an elevated frequency of deaths from non-malignant respiratory disease (PMR = 1.54) and lung cancer (PMR = 1.21). The lung cancer excess occurred exclusively among pottery workers employed in the manufacture of plumbing fixtures (PMR = 1.80). A subsequent cohort study examined mortality among 2055 white men employed in three ceramic plumbing fixture factories. There was a significant excess of non-malignant respiratory disease (SMR = 1.73). Lung cancer mortality was also higher than expected (SMR = 1.43) and was highest among workers whose jobs involved simultaneous exposure to silica and non-fibrous talc (SMR = 2.54). Lung cancer mortality risk increased with increasing number of years of exposure to non-fibrous talc and showed no pattern by number of years of exposure to silica. Among men exposed to talc, lung cancer risk increased with years since first non-fibrous talc exposure and decreased with age at first exposure. The data suggested an association between exposure to non-fibrous talc and excess lung cancer risk; however, the role of silica as a co-factor or promoting agent could not be ruled out.