The Myth of Scientific Objectivity

Dr. Terence Kealey during a CrossFit Health event on March 9, 2019

“I think there is a vast myth that scientists are somehow objective and honest.”

~Dr. Terence Kealey~

Kealey is a former vice-chancellor of the University of Buckingham, a professor of clinical biochemistry, a scholar affiliated with the Cato Institute, and author of the book Breakfast Is a Dangerous Meal. During his presentation, he discussed the myth of scientific objectivity, drawing examples widely from history as well as his personal experiences within many of the most reputable scientific institutions.

Video published on 12 Aug 2019. Reference. Full transcript.

Primodos survivors take on drugs firm

Primodos: Firms and govt face legal action over claims pregnancy drug ‘damaged babies’, Sky News, Aug 2019

“Parents who say their babies were damaged by a pregnancy test drug have warned manufacturers and the government that they are preparing to take legal action.”

Primodos, a pregnancy test drug, has led to a decades-long campaign by parents and children who claim it has caused a range of devastating birth defects.

In 2017, Sky News revealed how documents were destroyed and information withheld about the drug that may have deformed and killed babies in the womb.

Now, parents who say their babies were damaged by the drug have warned manufacturers and the government they are preparing to take legal action.

Lawyers representing more than 200 claimants accuse two drug companies and UK regulators of putting patients at risk.

More information

Spin in Published Biomedical Literature : A Systematic Review

Medical research publications : how to modify (abstracts) perception of results

Quinn Grundy presents original research that explores the nature and prevalence of spin in the biomedical literature. Video published on 11 Oct 2017. Reference.

Objective
To explore the nature and prevalence of spin in the biomedical literature.

Design
In a systematic review and meta-analysis, we searched MEDLINE, PreMEDLINE, Embase, Scopus, and handsearched reference lists for all articles published between 1946 and 24 November 2016 that included the quantitative measurement of spin in the biomedical literature for at least 1 outcome. Two independent coders extracted data on the characteristics of articles and included studies, methods for assessing spin, and all spin-related results. The data were heterogeneous; results were grouped inductively into outcome-related categories. We had sufficient data to use meta-analysis to analyze the association of industry sponsorship of research with the presence of spin.

Results
We identified 4219 articles after removing duplicates and included 35 articles that investigated spin: clinical trials (23/35, 66%); observational studies (7/35, 20%); diagnostic accuracy studies (2/35, 6%); and systematic reviews and meta-analyses (4/35, 11%), with some articles including multiple study designs. The nature and manifestations of spin varied according to study design. We grouped results into the following categories: prevalence of spin, level of spin, factors associated with spin, and effects of spin on readers’ interpretations. The highest, but also greatest variability in the prevalence of spin was present in trials (median, 57% of main texts containing spin; range, 19%-100% across 16 articles). Source of funding was hypothesized to be a factor associated with spin; however, the meta-analysis found no significant association, possibly owing to the heterogeneity of the 7 included articles.

Conclusions
Spin appears to be common in the biomedical literature, though this varies by study design, with the highest rates found in clinical trials. Spin manifests in diverse ways, which challenged investigators attempting to systematically identify and document instances of spin. Widening the investigation of factors contributing to spin from characteristics of individual authors or studies to the cultures and structures of research that may incentivize or deincentivize spin, would be instructive in developing strategies to mitigate its occurrence. Further research is also needed to assess the impact of spin on readers’ decision making. Editors and peer reviewers should be familiar with the prevalence and manifestations of spin in their area of research to ensure accurate interpretation and dissemination of research.

Identification of Spin in Clinical Studies Evaluating Biomarkers in Ovarian Cancer

Medical research publications : how to modify (abstracts) perception of results

Mona Ghannad presents a systematic review which documents and classifies spin or overinterpretation, as well as facilitators of spin, in recent clinical studies evaluating performance of biomarkers in ovarian cancer. Video published on 11 Oct 2017. Reference.

Objective
The objective of this systematic review was to document and classify spin or overinterpretation, as well as facilitators of spin, in recent clinical studies evaluating performance of biomarkers in ovarian cancer.

Design
We searched PubMed systematically for all studies published in 2015. Studies eligible for inclusion described 1 or more trial designs for identification and/or validation of prognostic, predictive, or diagnostic biomarkers in ovarian cancer. Reviews, animal studies, and cell line studies were excluded. All studies were screened by 2 reviewers. To document and characterize spin, we collected information on the quality of evidence supporting the study conclusions, linking the performance of the marker to outcomes claimed.

Results
In total, 1026 potentially eligible articles were retrieved by our search strategy, and 345 studies met all eligibility criteria and were included. The first 200 studies, when ranked according to publication date, will be included in our final analysis. Data extraction was done by one researcher and validated by a second. Specific information extracted and analyzed on study and journal characteristics, key information on the relevant evidence in methods, and reporting of conclusions claimed for the first 50 studies is provided here. Actual forms of spin and facilitators of spin were identified in studies trying to establish the performance of the discovered biomarker.

Actual forms of spin identified as shown (Table) were:

  1. other purposes of biomarker claimed not investigated (18 of 50 studies [36%]);
  2. incorrect presentation of results (15 of 50 studies [30%]);
  3. mismatch between the biomarker’s intended clinical application and population recruited (11 of 50 studies [22%]);
  4. mismatch between intended aim and conclusion (7 of 50 studies [14%]);
  5. and mismatch between abstract conclusion and results presented in the main text (6 of 50 studies [12%]).

Frequently observed facilitators of spin were:

  1. not clearly prespecifying a formal test of hypothesis (50 of 50 studies [100%]);
  2. not stating sample size calculations (50 of 50 studies [100%]);
  3. not prespecifying a positivity threshold of continuous biomarker (17 of 43 studies [40%]);
  4. not reporting imprecision or statistical test for data shown (ie, confidence intervals, P values) (12 of 50 studies [24%]);
  5. and selective reporting of significant findings between results for primary outcome reported in abstract and results reported in main text (9 of 50 studies [18%]).

Conclusions
Spin was frequently documented in abstracts, results, and conclusions of clinical studies evaluating performance of biomarkers in ovarian cancer. Inflated and selective reporting of biomarker performance may account for a considerable amount of waste in the biomarker discovery process. Strategies to curb exaggerated reporting are needed to improve the quality and credibility of published biomarker studies.

T-shaped uterus and subtle uterine variances

A need for reliable criteria, Fertility and Sterility, August 2019

Abstract

The ASRM Class VII, the ESHRE/ESGE Class U1, and the T-shaped uterus have a uniquely interesting history. The T-shaped uterus was first described as a diethylstilbestrol– (DES-) related congenital uterine anomaly based on findings from hysterosalpingography by Kaufman in 1977. Together with two similar morphologic forms of the uterus—constricting bands in the uterine cavity and a widening of the lower two-thirds of the uterus—this was included as a separate class of DES-related anomalies by the Buttram and Gibbons 1979 classification, and its further modification—the American Fertility Society classification.

In 2013, ESHRE/ESGE singled out a subtle uterine variance with a thickened lateral wall and a T-shaped uterus. As a result, the diagnosis of subtle uterine variances has increased with the designation of a T-shaped uterus or dysmorphic uterus and surgical repair is offered to enhance fertility. However, there is insufficient evidence to offer it in daily practice even in women with recurrent pregnancy loss, where historically metroplasty of the T-shaped uterus is rarely reported and its surgical correction is always questionable.

In this issue Alonso Pacheco et al. present a nicely done video using three-dimensional ultrasound and hysteroscopy in three cases of what they believe is a T-shaped uterus that is representative in distinguishing three of its subclasses. The authors used three-dimensional ultrasound and hysteroscopy to suggest that T-shaped uterus can be subclassified as T-shaped, Y-shaped, or I-shaped uterus. However, the division still remains arbitrary based on subjective impression of the presence of thickened wall and letter-shaped uterine cavities in these conditions. Discussion.

The shocking truth behind the widely used drug sodium valproate

Inside Out London, 22.01.2018 Full Version

We expose the government documents that we obtained concerning Sodium Valproate and the defect risk when taken during pregnancy and the worrying transgenerational link it will affect our grand children.

In a special edition of Inside Out London, Tarah Welsh investigates the shocking truth behind an anti-epilepsy drug which has harmed thousands of children. She uncovers new medical evidence suggesting that birth defects caused by the drug could be passed down through generations of the same family. Archives.

Strong associations between exposure to outdoor air contaminants and pediatric asthma in urban areas

Air Pollution and Pediatric Asthma, Collaborative on Health and the Environment, 2019

Listen to Dr. Michael Brauer and Dr. Erika Garcia giving an overview of their recent studies, which both demonstrated strong associations between exposure to outdoor air contaminants and pediatric asthma in urban areas. Reference.

Air pollution has been linked to the increased prevalence of pediatric asthma and reduced lung function growth in children. Children are more vulnerable to environmental contaminants including air pollution. They breathe more air per body weight than adults and their lungs and immune system are still developing. A number of studies have also shown that in utero exposure may be associated with the later development of pediatric asthma.

Current uses of BPA are safe – Not

Getting a Clear View : Lessons From The CLARITY-BPA Study, 2019

Listen to Dr. Laura Vandenberg, Associate Professor and Graduate Program Director in the Department of Environmental Health Sciences in the University of Massachusetts Amherst School of Public Health and Health Sciences, analyses The CLARITY-BPA study. Reference.

Bisphenol A (BPA) is produced in high volume and is still in use in a variety of products globally. Many independent, academic studies have demonstrated an association between exposure to BPA and multiple adverse health outcomes including endocrine-disrupting end-points. However, studies included in regulatory risk assessments have been cited as evidence that current uses of BPA are safe.

The U.S. National Institute of Environmental Health Sciences (NIEHS), the National Toxicology Program (NTP), and the Food and Drug Administration (FDA) sought to address these disparities in scientific findings and put together the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, otherwise known as CLARITY-BPA.

Glyphosate, Epigenetics and Transgenerational Inheritance of Disease

Assessment of Glyphosate Induced Epigenetic Transgenerational Inheritance of Pathologies and Sperm Epimutations: Generational Toxicology, 2019

Listen to Dr. Eric Nilsson, Research Assistant Professor in the School of Biological Sciences at Washington State University, presenting a recent study investigating exposure to the herbicide glyphosate in rats. The study found that the exposed rats’ subsequent grand-offspring and un-exposed great grand-offspring had higher rates of disease. Reference.

Abstract

Ancestral environmental exposures to a variety of factors and toxicants have been shown to promote the epigenetic transgenerational inheritance of adult onset disease. One of the most widely used agricultural pesticides worldwide is the herbicide glyphosate (N-(phosphonomethyl)glycine), commonly known as Roundup. There are an increasing number of conflicting reports regarding the direct exposure toxicity (risk) of glyphosate, but no rigorous investigations on the generational actions. The current study using a transient exposure of gestating F0 generation female rats found negligible impacts of glyphosate on the directly exposed F0 generation, or F1 generation offspring pathology. In contrast, dramatic increases in pathologies in the F2 generation grand-offspring, and F3 transgenerational great-grand-offspring were observed. The transgenerational pathologies observed include prostate disease, obesity, kidney disease, ovarian disease, and parturition (birth) abnormalities. Epigenetic analysis of the F1, F2 and F3 generation sperm identified differential DNA methylation regions (DMRs). A number of DMR associated genes were identified and previously shown to be involved in pathologies. Therefore, we propose glyphosate can induce the transgenerational inheritance of disease and germline (e.g. sperm) epimutations. Observations suggest the generational toxicology of glyphosate needs to be considered in the disease etiology of future generations.

Comprendre la perturbation endocrinienne

“Émission du Labo”, enregistrée en public au Lieu Unique, Nantes, le 14 mai 2019

Les sources d’exposition sont nombreuses et difficiles à maîtriser, tout comme leurs conséquences biologiques.

Historiquement, les perturbateurs endocriniens ont commencé à attirer l’attention des chercheur·euses dès les années 1950. Mais c’est l’affaire du distilbène qui, dans les années 1970, a fait exploser le sujet sur la scène scientifique et médiatique, alors même que le terme de “perturbateur endocrinien” n’était pas encore utilisé.

Aujourd’hui, c’est un enjeu majeur de santé publique, pour nous qui sommes vivants, mais aussi pour les générations futures, celles qui n’ont pas encore vu le jour. Référence.

Le Distilbène DES, en savoir plus