Why nobody knows what’s really going into your food

Massive legal loophole means companies can add new ingredients to foods with no government safety review

The industry can declare on their own that added ingredients are safe without ever consulting the Food and Drug Administration about potential health risks.

References : publicintegrity and belowthesaltnews, 2015.

La désinformation organisée par les firmes doit cesser, dit Maître Lafforgue

Comment Monsanto assure sa défense et nie en bloc toute responsabilité devant la justice

“Les médecins qui mettent en doute les troubles de M. François ne sont pas des experts judiciaires, ce sont des consultants payés par Monsanto.”

dénonce Maître François Lafforgue, l’avocat de Paul François.

La Cour d’appel de Lyon doit se prononcer sur la responsabilité présumée de Monsanto dans les troubles médicaux de Paul François, céréalier charentais. Depuis douze ans, il accuse la firme d’avoir exposé les utilisateurs du Lasso, puissant herbicide, à de graves dangers.

France 3 Auvergne-Rhône-Alpes, un reportage de Yaëlle Marie et Laure Crozat publié sur YouTube le 6 février 2019.

Référence : Lyon : Comment Monsanto assure sa défense et nie en bloc toute responsabilité devant la justice ?

How the U.S. system is fundamentally broken

Alexandria Ocasio-Cortez at the House Committee, February 6, 2019

Reference. @AOC.

Comment les députés n’ont pas pu voter l’inscription dans la loi de l’interdiction du glyphosate

.Le vote impossible. Un hémicycle presque vide

Envoyé spécial” décrypte les coulisses de cette soirée du 28 mai 2018 à l’Assemblée nationale. Et a demandé aux 577 députés pourquoi la plupart d’entre eux n’ont pas pris part au vote.

Le glyphosate, l’herbicide le plus vendu au monde, a fait couler beaucoup d’encre en 2017 et 2018.

Envoyé spécial, un reportage de Laura Aguirre de Carcer, Tristan Waleckx, Olivier Gardette, Marielle Krouk et Karim Annette publié sur YouTube le 22 janvier 2019.

Référence : “Envoyé spécial”. Glyphosate : comment s’en sortir ?.

(Bayer), Monsanto, et la fabrique du doute

Une firme, qui ne s’estime ni responsable ni coupable, et fait appel de ses condamnations ?

Les “Monsanto Papers” ont révélé comment le géant américain a fait rédiger en secret, par ses propres scientifiques, des études pour prouver que le glyphosate n’était pas dangereux.

Le glyphosate, l’herbicide le plus vendu au monde, a fait couler beaucoup d’encre en 2017 et 2018.

Envoyé spécial, un reportage de Tristan Waleckx, Guillaume Beaufils et Mikael Bozo publié sur YouTube le 22 janvier 2019.

Référence : “Envoyé spécial”. Glyphosate : comment s’en sortir ?.

Undisclosed financial ties between guideline writers and pharmaceutical companies

One in five Australian clinical guideline writers have potentially relevant undisclosed links to drug companies

Abstract

Objectives
To investigate the proportion of potentially relevant undisclosed financial ties between clinical practice guideline writers and pharmaceutical companies.

Design
Cross-sectional study of a stratified random sample of Australian guidelines and writers.

Setting
Guidelines available from Australia’s National Health and Medical Research Council guideline database, 2012–2014, stratified across 10 health priority areas.

Population
402 authors of 33 guidelines, including up to four from each area, dependent on availability: arthritis/musculoskeletal (3); asthma (4); cancer (4); cardiovascular (4); diabetes (4); injury (3); kidney/urogenital (4); mental health (4); neurological (1); obesity (1). For guideline writers with no disclosures, or who disclosed no ties, a search of disclosures in the medical literature in the 5 years prior to guideline publication identified potentially relevant ties, undisclosed in guidelines. Guidelines were included if they contained recommendations of medicines, and writers included if developing or writing guidelines.

Main outcome measures
Proportions of guideline writers with potentially relevant undisclosed financial ties to pharmaceutical companies active in the therapeutic area; proportion of guidelines including at least one writer with a potentially relevant undisclosed tie.

Results
344 of 402 writers (86%; 95% CI 82% to 89%) either had no published disclosures (228) or disclosed they had no ties (116). Of the 344 with no disclosed ties, 83 (24%; 95% CI 20% to 29%) had potentially relevant undisclosed ties. Of 33 guidelines, 23 (70%; 95% CI 51% to 84%) included at least one writer with a potentially relevant undisclosed tie. Writers of guidelines developed and funded by governments were less likely to have undisclosed financial ties (8.1%vs30.6%; risk ratio 0.26; 95% CI 0.13 to 0.53; p<0.001).

Conclusions
Almost one in four guideline writers with no disclosed ties may have potentially relevant undisclosed ties to pharmaceutical companies. These data confirm the need for strategies to ensure greater transparency and more independence in relationships between guidelines and industry.

Reference. Image credit sciencemag.

Shady Deals between Device Makers and Hospitals … Damages are on Patients

Newstapa investigates collusion between device makers-hospitals in Korea

Doctors should be free to choose the best medical device when treating their patients. But if the doc is paid with $ and fancy trips by MD makers, will his/her decision be objective ?

Korea Center for Investigative Jounalism (KCIJ)-Newstapa has investigated the problems of medical device industry as part of the cross-border investigation project with the International Consortium of Investigative Journalists(ICIJ) and its 58 member news organizations from 36 countries.

Video published on 27 Nov 2018, by newstapa.

Cochrane HPV vaccine review not found to be ‘Trusted Evidence’

The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias

In May 2018, the Cochrane Collaboration published its review of the human papillomavirus (HPV) vaccines. The review primarily assessed the vaccines’ effect on precursors to cervical cancer. Cochrane has high standards for its reviews; however, there were important limitations in its HPV vaccine review, which we address in this paper.

Key findings

  • The Cochrane human papillomavirus (HPV) vaccine review missed nearly half of the eligible trials
  • No included trial in the Cochrane review used a placebo comparator
  • The included HPV vaccine trials used composite surrogate outcomes for cervical cancer
  • The Cochrane review incompletely assessed serious and systemic adverse events
  • The Cochrane review did not assess HPV vaccine-related safety signals
  • Industry trial funding and other conflicts of interest
  • Cochrane’s public relations of the review were uncritical

Conclusion

Part of the Cochrane Collaboration’s motto is ‘Trusted evidence’. We do not find the Cochrane HPV vaccine review to be ‘Trusted evidence’, as it was influenced by reporting bias and biased trial designs. We believe that the Cochrane review does not meet the standards for Cochrane reviews or the needs of the citizens or healthcare providers that consult Cochrane reviews to make ‘Informed decisions’, which also is part of Cochrane’s motto. We recommend that authors of Cochrane reviews make every effort to identify all trials and their limitations and conduct reviews accordingly.

Read the author’s full paper on The BMJ.

On Twitter

 

Lessons learnt on transparency, scientific process and publication ethics

The short story of a long journey to get into the public domain unpublished data, methodological flaws and bias of the Cochrane HPV vaccines review

Abstract

Cochrane meta-analyses are considered the gold standard to assess public health interventions’ benefits and risks. Cochrane reviews shall apply evidence-based medicine (EBM) methodology on the best available evidence; they shall adhere to strict ethical guidelines as authors of Cochrane reviews are supposed to not have bias, nor conflicts of interest. Our 6 years’ documented case on the Cochrane human papillomavirus (HPV) vaccines review demonstrates that Cochrane guidelines can fail. According to EBM standards, such relevant methodological and ethical flaws void Cochrane positive conclusions on HPV vaccines efficacy.

Cochrane published a review of the human papillomavirus (HPV) vaccines on 9 May 2018. On 4 June, we submitted a detailed analysis of this review as a comment via the Cochrane website.

Our comment highlights serious methodological flaws in the review:

  • (A) studies’ quality not properly assessed;

  • (B) post hoc subgroup analyses presented as randomised controlled trial results;

  • (C) reporting bias not acknowledged;

  • (D) selective reporting not taken into consideration;

  • (E) biased trial designs;

  • (F) unpublished data not included;

  • (G) conflict of interests (COI) in the authors’ group;

  • (H) n=7 studies on Gardasil included, n=18 for Cervarix—the latter not being marketed in the USA anymore.

… continue reading on The BMJ, by Catherine Riva, December 2018.

visit re-check ref hpv-vaccination.

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Medical research often ignores relevant existing evidence and patient needs

Why comparisons must address genuine uncertainties

The design of treatment research often reflects commercial and academic interests; ignores relevant existing evidence; uses comparison treatments known in advance to be inferior; and ignores needs of users of research results (patients, health professionals and others).

A good deal of research is done even when there are no genuine uncertainties. Researchers who fail to conduct systematic reviews of past tests of treatments before embarking on further studies sometimes don’t recognise (or choose to ignore the fact) that uncertainties about treatment effects have already been convincingly addressed. This means that people participating in research are sometimes denied treatment that could help them, or given treatment likely to harm them.

When researchers continue to embark on (same) research for decades without reviewing existing evidence systematically.

The diagram that accompanies this and the following paragraph shows the accumulation of evidence from fair tests done to assess whether antibiotics (compared with inactive placebos) reduce the risk of post-operative death in people having bowel surgery (Lau et al. 1995). The first fair test was reported in 1969. The results of this small study left uncertainty about whether antibiotics were useful – the horizontal line representing the results spans the vertical line that separates favourable from unfavourable effects of antibiotics. Quite properly, this uncertainty was addressed in further tests in the early 1970s.

As the evidence accumulated, however, it became clear by the mid-1970s that antibiotics reduce the risk of death after surgery (the horizontal line falls clearly on the side of the vertical line favouring treatment). Yet researchers continued to do studies through to the late 1980s. Half the patients who received placebos in these later studies were thus denied a form of care which had been shown to reduce their risk of dying after their operations. How could this have happened? It was probably because researchers continued to embark on research without reviewing existing evidence systematically. This behaviour remains all too common in the research community, partly because some of the incentives in the world of research – commercial and academic – do not put the interests of patients first (Chalmers 2000).

Patients and participants in research can also suffer because researchers have not systematically reviewed relevant evidence from animal research before beginning to test treatments in humans. A Dutch team reviewed the experience of over 7000 patients who had participated in tests of a new calcium-blocking drug given to people experiencing a stroke. They found no evidence to support its increasing use in practice (Horn and Limburg 2001). This made them wonder about the quality and findings of the animal research that had led to the research on patients. Their review of the animal studies revealed that these had never suggested that the drug would be useful in humans (Horn et al. 2001).

The most common reason that research does not address genuine uncertainties is that researchers simply have not been sufficiently disciplined to review relevant existing evidence systematically before embarking on new studies. Sometimes there are more sinister reasons, however. Researchers may be aware of existing evidence, but they want to design studies to ensure that their own research will yield favourable results for particular treatments. Usually, but not always, this is for commercial reasons (Djulbegovic et al. 2000; Sackett and Oxman 2003; Chalmers and Glasziou 2009Macleod et al. 2014). These studies are deliberately designed to be unfair tests of treatments. This can be done by withholding a comparison treatment known to help patients (as in the example given above), or giving comparison treatments in inappropriately low doses (so that they don’t work so well), or in inappropriately high doses (so that they have more unwanted side effects) (Mann and Djulbegovic 2012). It can also result from following up patients for too short a time (and missing delayed effects of treatments), and by using outcome measures (‘surrogates’) that have little or no correlation with the outcomes that matter to patients.

It may be surprising to readers of this essay that the research ethics committees established during recent decades to ensure that research is ethical have done so little to influence this research malpractice. Most such committees have let down the people they should have been protecting because they have not required researchers and sponsors seeking approval for new tests to have reviewed existing evidence systematically (Savulescu et al. 1996; Chalmers 2002). The failure of research ethics committees to protect patients and the public efficiently in this way emphasizes the importance of improving general knowledge about the characteristics of fair tests of medical treatments.

This is a reprint from The James Lind Library 2.1 Why comparisons must address genuine uncertainties.