Prévention des conflits d’intérêts en matière d’expertise sanitaire: premier bilan peu flatteur

Conflits d’intérêts : la loi est facile à contourner

La Cour des comptes rend public, le 23 mars 2016, un rapport sur la prévention des conflits d’intérêts en matière d’expertise sanitaire, demandé par la commission des affaires sociales du Sénat, qui dresse un premier bilan de la loi du 29 décembre 2011en ce domaine.

Malgré son ambition, le dispositif de transparence institué par ce texte présente des failles majeures:

  • absence de contrôle des informations déclarées,
  • sanctions pénales sans réelle portée,
  • interprétation très restrictive des avantages consentis par les industriels aux professionnels de santé.

La prévention des conflits d’intérêts en matière d’expertise sanitaire, ccomptes, 23/03/2016.

La vérification de sa mise en œuvre dans cinq organismes (HAS, ANSM, INCa, CEPS, Oniam) met en lumière de fréquentes anomalies, qu’il s’agisse du respect des obligations éclaratives, de l’analyse des liens ’intérêts et des modes de gestion des conflits d’intérêts, de la publicité des séances ou du contenu financier des conventions passées avec les professionnels de santé, sur lequel un premier éclairage est apporté.

Ce bilan appelle, en complément de la loi du 26 janvier 2016, des mesures pour mieux organiser l’administration centrale et les agences sanitaires, soutenir l’indépendance et la qualité de l’expertise sanitaire, renforcer l’efficacité du dispositif de déclarations d’intérêts et instaurer un contrôle effectif de leur véracité par une instance indépendante.

Conflits d’intérêts : la loi est facile à contourner, allodocteurs, 24/03/2016.

La Cour formule dix recommandations en ce sens.

Les recommandations de l’IGAS ont donné lieu à un plan d’action en sept axes:

  1. instaurer un comité de déontologie ministériel couvrant dans un premier temps les trois directions sanitaires, les instances dont elles assurent le secrétariat, le secrétariat général et le CEPS ;
  2. instaurer un dispositif incitatif invitant l’ensemble des agents exposés au risque de conflit d’intérêts à remplir une déclaration d’intérêts non publique ;
  3. soumettre préalablement à leur recrutement tout nouvel entrant au renseignement d’une pré-déclaration ;
  4. pour les instances collégiales, faire évoluer les pratiques par la désignation préalable de deux représentants et la traçabilité de la mise en œuvre des déports ;
  5. mettre en place un référent « déontologie » au sein de chaque direction sanitaire ;
  6. instaurer une application rigoureuse et une traçabilité de la doctrine de gestion des conflits d’intérêts.
  7. mettre en ligne sur le site Internet du ministère les déclarations d’intérêts des membres de commissions et conseils.

Vaccins, médicaments, médecins : la défiance

Complément d’enquête diffusé sur France 2 le jeudi 25 février 2016

  • Vaccinés contre les vaccins… >  Vaccins: quels effets secondaires?
  • Le blues des blouses blanches >  Généralistes : le burn-out.
  • Les croisés de la Dépakine >  Dépakine: “inertie” des autorités sanitaires.

Sur le même sujet

Medicine is Broken > we need Your Help to Fix it

Why clinical trial transparency matters to patients in the US

Why patients and patient advocates like AnneMarie Ciccarella and Gregg Gonsalves support AllTrials, a patient-led campaign seeking to have all clinical trials registered, and their results reported.

Video published on 17 Mar 2016 by Sense About Science USA.

About All Trials

Sex is not genetically determined via X & Y chromosomes

Sex redefined

Sex can be much more complicated than it at first seems. According to the simple scenario, the presence or absence of a Y chromosome is what counts: with it, you are male, and without it, you are female. But doctors have long known that some people straddle the boundary – their sex chromosomes say one thing, but their gonads (ovaries or testes) or sexual anatomy say another. Parents of children with these kinds of conditions – known as intersex conditions, or differences or disorders of sex development (DSDs) – often face difficult decisions about whether to bring up their child as a boy or a girl. Some researchers now say that as many as 1 person in 100 has some form of DSD.

Claire Ainsworth, Sex redefined, nature, 18 February 2015.

Today the SRY gene is understood as one among the many essential mammalian sex-determining factors that are involved in the genetic pathways of both testicular and ovarian determination. Mammals require cascades of gene product in proper dosages and at precise times to produce functioning male and female gonads, and researchers recognize a variety of healthy sexual phenotypes and sex determination pathways in humans.

Sarah Richardson, Sex Itself, University of Chicago Press.

In fact, the sex you develop as isn’t directly genetically determined at all, but instead depends on the action of gonadal hormones during the critical period when your prenatal development is taking place. All the X and Y chromosomes do is determine whether you develop testicles or ovaries, it’s the hormones produced by those organs that actually determine whether you develop as male or female.

Unfortunately, most doctors and pharmaceutical industry decision makers also subscribe to the myth that sex is genetically determined, which is why they’ve not appreciated the dangers of giving hormones to pregnant women, and why we’ve ended up in a situation we’re in today (where large numbers of people have been born who’ve undergone partial or complete opposite-sexed brain development, as a result of being exposed to hormone-disrupting drugs such as DES – find out more about DES studies on gender identity).

Hugh Easton, DES Son.

Sex isn’t chromosomes: the story of a century of misconceptions about X & Y, newstatesman, 23 FEBRUARY 2015. Chromosomes by C. Smith.

The influence of the XX/XY model of chromosomal sex has been profound over the last century, but it’s founded on faulty premises and responsible for encouraging reductive, essentialist thinking. While the scientific world has moved on, its popular appeal remains.

Pesticide Action Week 2016 Poster

Call for a pesticide-free Spring! Join us!

The Pesticide Action Week is an annual and international event, open to everyone, with the aim to promote alternatives to pesticides. The campaign takes place during the first ten days of every spring (20th-30th of march) when usually the spreading of pesticides resumes.

Call for a pesticide-free Spring!
Pesticide Action Week,
20th-30th of march.

The public is invited to get better informed about the sanitary and environmental challenges caused by pesticides and learn more about possible alternatives to pesticides by taking part in one of the hundreds of organised activities: conferences, panel discussions, film showings, workshops, open days at organic farms, information stands, exhibitions, shows…

The goals of this event are:

  • Raising awareness on the health and environment risks of synthetic pesticides
  • Highlighting and promoting alternative solutions
  • Building a global grassroots movement for a pesticide-free world

More Information

High bisphenol-A concentration increases the risk of spontaneous preterm delivery

Common plastics chemical BPA linked to premature babies

“During the past decade, there has been an increasing appreciation of how exposure to industrial chemicals in widespread use may increase the risk of adverse pregnancy outcomes”

Abstract

Objective
The objective of this study is to determine if BPA exposure, as measured by maternal plasma (MP) and amniotic fluid (AF) BPA concentrations is associated with an increased risk of spontaneous preterm birth (PTB) and preterm premature rupture of membranes (pPROM).

High bisphenol A (BPA) concentration in the maternal, but not fetal, compartment increases the risk of spontaneous preterm delivery, The Journal of Maternal-Fetal & Neonatal Medicine, DOI:10.3109/14767058.2016.1139570, March 23, 2016.

Methods
In this nested case–control study, MP samples from women in term labor (n = 30), preterm labor that ended with preterm delivery (n = 25), or who had pPROM (n = 30) and amniotic fluid samples from term labor (n= 45), preterm labor (n = 60), and pPROM (n = 35) were assayed for BPA by enzyme immunoassay.

Results
BPA was detectible in 100% of MP and AF samples. Women with MP BPA concentrations in the fourth quartile were at increased risk of PTB (cOR = 4.12, 95% CI = 1.32–12.87; aOR = 4.78, 95% CI = 1.14–20) but not pPROM. High (fourth quartile) AF BPA values also tended to increase the risk of pPROM (cOR = 2.47, 95% CI = 0.96–6.37) but results were not statistically significant.

Conclusions
Increased BPA concentration is associated with an increased risk for PTB or pPROM depending on the maternal–fetal compartment(s) affected. High MP plasma BPA concentrations are associated with PTB with intact membranes but high AF BPA concentrations may weakly be associated with pPROM.

Stilbestrol prescription tablets 0.25 mg

DES prescription tablets manufactured by Eli Lilly & Co, Indianapolis, USA

stilbestrol
Stilbestrol prescription tablets manufactured by Eli Lilly & Co, Indianapolis, USA.

DES was sold under many names including Distilbène®, Stilbetin®, Stilboestrol-Borne®, Benzestrol®, Chlorotrianisene®, Estrobene® and Estrosyn® to name just a few.

Many different companies manufactured and marketed this drug under more than 200 different brand names.

These Stilbestrol prescription drugs – 40 tablets of 0.25 mg – were manufactured by: Eli Lilly & Co, Indianapolis, USA.

DES drugs pictures
More DES DiEthylStilbestrol resources

Chemical Exposure linked to 1.4 Billion Euros in Women’s Health Care Costs

Endocrine-disrupting chemicals may raise risk of developing endometriosis, uterine fibroids

Washington, DC – Endocrine-disrupting chemicals may contribute to reproductive health problems experienced by hundreds of thousands of women, costing European Union an estimated €1.4 billion ($1.5 billion) a year in health care expenditures and lost earning potential, according to a new study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism, Female Reproductive Disorders, Diseases, and Costs of Exposure to Endocrine Disrupting Chemicals in the European Union.

Chemical Exposure Linked to 1.4 Billion Euros in Women’s Health Care Costs, The Endocrine Society, March 22, 2016.

The study examined rates of uterine fibroids – benign tumors on the uterus that can contribute to infertility and other health problems – and an often painful condition called endometriosis where the tissue that normally lines the uterus develops elsewhere in the body. The two conditions are common, with as many as 70 percent of women affected by at least one of the disorders.

Research has linked the development of uterine fibroids and endometriosis to chemicals found in pesticides, cosmetics, toys and food containers. Past studies suggest a byproduct of the pesticide DDT, a chemical known as DDE, can raise the risk of developing uterine fibroids. Another group of chemicals called phthalates, which are found in plastic products and cosmetics, have been tied to growing risk of endometriosis.

DDT and phthalates are known endocrine-disrupting chemicals (EDCs). EDCs can contribute to health problems by mimicking, blocking or otherwise interfering with the body’s hormones – the signaling system the body uses to determine how cells develop and grow. Unborn children are particularly vulnerable because exposure during key points in development can raise the risk of health problems later in life.

“The data shows that protecting women from exposure to endocrine-disrupting chemicals could substantially reduce rates of disease and lower health care and other social costs of these conditions”

said Leonardo Trasande, MD, MPP, Associate Professor of Pediatrics, Environmental Medicine & Population Health at NYU Langone Medical Center.

Female Reproductive Disorders, Diseases, and Costs of Exposure to Endocrine Disrupting Chemicals in the European Union, Endocrine Society, dx.doi.org/10.1210/jc.2015-2873, March 22, 2016.

The study is part of a series of economic analyses that found endocrine-disrupting chemical exposure may be costing the European Union upwards of €157 billion ($173 billion) a year. Prior studies in the series examined the costs associated with infertility and male reproductive dysfunctions, birth defects, obesity, diabetes, cardiovascular disease, and neurobehavioral and learning disorders.

To assess the economic burden of EDC exposure, a group of scientists convened a panel of global EDC experts to adapt existing environmental health cost models, relying on the Institute of Medicine’s 1981 approach of assessing the contribution of environment factors in causing illness. Based on the body of established literature, the researchers evaluated the likelihood that EDCs contributed to various medical conditions and dysfunctions.

Researchers only considered endometriosis and uterine fibroids in the analysis because there is robust data on their incidence and association with endocrine-disrupting chemical exposure. The researchers estimated that 145,000 cases of endometriosis and 56,700 cases of uterine fibroids in Europe could be attributed to exposure to endocrine-disrupting chemicals.

“Although these two gynecological conditions affect millions of women worldwide, we recognize that this analysis only reflects the tip of the iceberg,” “A growing body of evidence suggests EDC exposure is linked to a broader range of female reproductive problems, including polycystic ovary syndrome, infertility and pregnancy complications. These disorders also place a significant cost burden on women, their families and society as a whole.”

Trasande said.

The economic analysis included direct costs of hospital stays, physician services, and other medical costs. The researchers also calculated estimates of indirect costs such as lost worker productivity associated with these often painful disorders.

Preventing disease through healthy environments

An estimated 12.6 million deaths each year are attributable to unhealthy environments

Quantifying environmental health impacts

Preventing-disease-through-The main message emerging from this new comprehensive global assessment is that premature death and disease can be prevented through healthier environments – and to a significant degree. Analysing the latest data on the environment-disease nexus and the devastating impact of environmental hazards and risks on global health, backed up by expert opinion, this report covers more than 100 diseases and injuries.

An estimated 12.6 million deaths each year are attributable to unhealthy environments, WHO, MARCH 2016

The analysis shows that 23% of global deaths (and 26% of deaths among children under five) are due to modifiable environmental factors. Sixty-eight percent of these attributable deaths and 56% of attributable DALYs could be estimated with evidence-based comparative risk assessment methods, the assessments of other environmental exposures were completed through expert opinion. Stroke, ischaemic heart disease, diarrhoea and cancers head the list. People in low-income countries bear the greatest disease burden, with the exception of noncommunicable diseases.

Preventing disease through healthy environments: a global assessment of the burden of disease from environmental risks, WHO, MARCH 2016

These assessments should add impetus to coordinating global efforts to promote healthy environments – often through well-established, cost-effective interventions. This analysis will inform those who want to better understand the transformational spirit of the Sustainable Development Goals agreed by Heads of State in September 2015. The results of the analysis underscore the pressing importance of stronger intersectoral action to create healthier environments that will contribute to sustainably improving the lives of millions around the world.

Comment remplacer les pesticides : une semaine pour s’informer

Les alternatives aux pesticides existent!

Les alternatives aux pesticides existent ! Elles sont mises à l’honneur dans le cadre de la Semaine pour les alternatives aux pesticides qui débute, alors que les épandages reprennent au cours de ces premiers jours du printemps et que leur caractère cancérogène inquiète de plus en plus. Grâce à des centaines d’événements, le public est invité à mieux s’informer sur les enjeux tant sanitaires qu’environnementaux des pesticides et sur les alternatives. Ou comment entrevoir un avenir sans produits toxiques.

La Semaine pour les alternatives aux pesticides (SPAP), qui a débuté le 20 mars, est devenue un évènement incontournable : il s’agit du temps fort de mobilisation citoyenne sur le dossier pesticidespestipest en France. En 2016, des centaines d’évènements ont été programmés vont se dérouler dans toute la France et dans une vingtaine d’autres pays en Europe, Afrique, Amérique Latine et Asie. Le succès croissant de cet événement montre que la société civile ne veut pas être tenue à l’écart du dossier des pesticides.

Quels sont ses objectifs ?

Quel public ?

Tout le monde peut participer à la Semaine pour les alternatives aux pesticides : des agriculteurs aux cuisiniers en passant par les enfants, les citoyens, les élus, les entreprises, les jardiniers amateurs, les militants, les médecins, les étudiants, les simples curieux ou encore les consommateurs, les instituteurs, les agents techniques…cet événement s’adresse au plus grand nombre !

Que se passe-t-il ?

Des centaines d’événements ont lieu un peu partout pendant dix jours : des conférences, des débats, des ateliers de jardinage naturel, des projections de films, des collectes de pesticides à supprimer, des visites de fermes, des marchés bio, des dégustations, des expositions, des ateliers cuisine et/ou de fabrication, des stands de sensibilisation, des balades découvertes… L’imagination est au rendez-vous quand il s’agit de se mobiliser pour démontrer que les alternatives existent et qu’il est possible d’entrevoir un avenir sans produits toxiques.

Qui coordonne ?

Lancée en 2006 par l’association Générations Futures et l’ACAP, un collectif de 170 organisations (Action Citoyenne pour une Alternative aux Pesticides), la Semaine pour les alternatives aux pesticides est aujourd’hui soutenue par une cinquantaine d’organisations nationales et internationales, dont de nouveaux partenaires nationaux pour 2016 : WECF, Fermes d’avenir, Terre de liens et Slow Food International participeront pour la première fois cette année. D’autres partenaires internationaux comme PAN Africa ou Quercus (Portugal), qui ont déjà participé mais qui n’ont pas participé l’an dernier, nous rejoignent pour 2016 !

Comment remplacer les pesticides : une semaine pour s’informer, bastamag, 21 MARS 2016.

En savoir plus