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.
One in five Australian clinical guideline writers have potentially relevant undisclosed links to drug companies
To investigate the proportion of potentially relevant undisclosed financial ties between clinical practice guideline writers and pharmaceutical companies.
Cross-sectional study of a stratified random sample of Australian guidelines and writers.
Guidelines available from Australia’s National Health and Medical Research Council guideline database, 2012–2014, stratified across 10 health priority areas.
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.
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).
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.
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.
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.
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
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.
First author on the Cochrane HPV vaccines review, Marc Arbyn, has not declared his conflicts of interest related to the manufacturers https://t.co/WnrRXhNm64. According to Cochrane policy, he is not allowed to be first author on the review. #dkpol#sundpol#cochranecollab
The Cochrane HPV vaccine review did not find an increase in serious harms, based on published trial reports. Researchers from the Nordic Cochrane Centre used clinical study reports from EMA, which are more reliable (submitted for publication). #vaccines#sundpol#HPV#Cochrane
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
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.
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 https://t.co/diMkOSUOuj
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.
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 2009; Macleod 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.