The Revolving Door Between The FDA and Big Pharma

Big Pharma’s Bad Influence Over The FDA

Ben Swann‘s channel, 8 Jun 2016.

Episode 1 of 4 in Truth in Media series on Big Pharma manipulation of healthcare.

More Information

  • The first segment of this episode, Big Pharma’s Influence Over The FDA, examines how the pharmaceutical industry exerts heavy influence over the FDA as well as the media and the medical community.
  • Big Pharma’s Influence Over The FDA, Truth In Media, Jun 8, 2016.
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Possible relationship between endocrine disrupting chemicals and hormone dependent gynecologic cancers

Approximately 800 chemicals are known or suspected to have the potential to function as EDC

Abstract

The effects of the natural and synthetic estrogens have been studied for a long time but the data regarding estrogen related chemicals (endocrine disrupting chemicals, EDCs) and their effects on reproductive system are scarce. EDCs are hormone like agents that are readily present in the environment, which may alter the endocrine system of humans and animals.

Approximately 800 chemicals are known or suspected to have the potential to function as EDC.

Medical hypotheses, NCBI PubMed PMID: 27241264, 2016 Jul;92:84-7. doi: 10.1016/j.mehy.2016.04.041. Epub 2016 Apr 25

Expression of Estrogen by Libertas Academica.

Potential role of EDCs on reproductive disease has gained attention in medical literature in recent years. We hypothesize that exposure to low doses of EDCs in a chronic manner could cause hormone dependent genital cancers including ovarian and endometrial cancer. Long term exposure to low concentrations of EDCs may exert potentiation effect with each other and even with endogenous estrogens and could inhibit enzymes responsible for estrogen metabolism. Exposure time to these EDCs is essential as we have seen from Diethylstilbestrol experience. Dose-response curves of EDCs are also unpredictable. Hence mode of action of EDCs are more complex than previously thought. In the light of these controversies lower doses of EDCs in long term exposure is not harmless.

Possibility of this relationship and this hypothesis merit further investigation especially through in vivo studies that could better show the realistic environmental exposure. With the confirmation of our hypothesis, possible EDCs could be identified and eliminated from general use as a public health measure.

DES DiEthylStilbestrol Resources

La maladie, un marché qui rapporte gros

Le prix indécent des médicaments, ça va durer encore longtemps?

Certains médicaments arrivant sur le marché, comme les nouveaux traitements anti-cancéreux ou ceux pour soigner l’Hépatite C, atteignent aujourd’hui des prix exorbitants.

Le danger ? Que notre assurance-maladie ne puisse plus supporter le remboursement de traitements aux prix si élevés dont doivent pourtant bénéficier des milliers de malades.

LA Campagne de Médecins du monde

En savoir plus

Can Phthalates Exposure in Utero affect Lifelong Physical Activity?

Avoid endocrine disruptors as much as possible, especially if you are pregnant

A common chemical found in many cosmetics and personal care products may influence our will to exercise…

Mice exposed prenatally to benzyl butyl phthalate (B.B.P.) were less likely than other mice (control group) to exercise as adults.

Male mice exposed to B.B.P. in utero had notably lower levels of testosterone – than the other animals – in young adulthood.
Exposed females similarly developed during young adulthood low estrogen levels and other reproductive system abnormalities that then produced a profound desire, it seems, to sit for most of the day…

Exposure to environmental toxins before birth might change babies’ physiology in ways that affect their interest in exercise throughout their lives.

Sources – Press Releases
  • Could Environmental Chemicals Shape Our Exercise Habits?, The Times, 2016/06/29.
  • Study: Common Chemicals Might Affect Exercise Habits, opposingviews, June 29, 2016.

Can Phthalates program your Baby to be Obese?

Phthalates may cause fat accumulation and program the stem cell to become obese via an epigenetic balance

Benzyl butyl phthalate (BBP), a chemical commonly used in the food manufacturing process, can increase fat stores in the body even before we’re born.

Abstract

Benzyl butyl phthalate induces epigenetic stress to enhance adipogenesis in mesenchymal stem cells, Molecular and Cellular Endocrinology, sciencedirect, 2016.04.

Endocrine disruptors, phthalates, may have contributed to recent global obesity health crisis. Our study investigated the potential of benzyl butyl phthalate (BBP) to regulate the mesenchymal stem cell epigenome to drive adipogenesis.

BBP exposure enhanced lipid accumulation and adipogenesis in a dose-dependent manner compared to control (P < 0.001).

Can Plastic Program Your Baby To Be Obese?, vitalrecord, May 17, 2016.

Babies by Aimee Ray.

  • Adipogenesis markers, PPARγ (P < 0.001), C/EBPα (P < 0.01), and aP2 (P < 0.001) were significantly upregulated by increasing concentrations of BBP when compared to DMSO.
  • BBP enhanced H3K9 acetylation while decreasing H3K9 dimethylation. Fifty μM BBP increased histone acetyltransferases, p300 (P < 0.05) and GCN5 (P < 0.01) gene expression.
  • Furthermore, histone deacetylases (HDACs), HDAC3 (P < 0.01) and HDAC10 (P < 0.01, 10 μM BBP; P < 0.001, 50 μM BBP) and histone methyltransferases, SETDB1 (P < 0.01) and G9a (P < 0.01), were significantly downregulated by BBP exposure.
  • BBP acts, in part, through PPARγ, as PPARγ knockdown led to decreased H3K9ac and rescued H3K9me2 during BBP exposure.

In conclusion, BBP regulated MSCs towards adipogenesis by tipping the epigenomic balance.

La toxicité financière des nouveaux traitements anti-cancéreux

Le prix indécent des médicaments, ça va durer encore longtemps?

Certains médicaments arrivant sur le marché, comme les nouveaux traitements anti-cancéreux ou ceux pour soigner l’Hépatite C, atteignent aujourd’hui des prix exorbitants.

Le danger ? Que notre assurance-maladie ne puisse plus supporter le remboursement de traitements aux prix si élevés dont doivent pourtant bénéficier des milliers de malades.

LA Campagne de Médecins du monde

En savoir plus

Pesticide glyphosate disrupts uterine development

Neonatal exposure to a glyphosate based herbicide alters the development of the rat uterus

Glyphosate herbicide disrupts the development of the uterus of female rats when they are exposed for 7 days after birth.

A new study showed glyphosate caused cell proliferation and structural changes in the rats’ uterus, in spite of the fact that no signs of chronic or acute toxicity or differences in weight gain were seen in treated pups.

Glyphosate pesticide also disrupted the expression of proteins involved in uterine development.

The Argentine researchers conclude that glyphosate exposure may affect female fertility ; promote the development of uterine cancer.

Abstract

Neonatal exposure to a glyphosate based herbicide alters the development of the rat uterus, Toxicology NCBI PubMed PMID: 27287056, 2016 Jun 7.

Roundup “probably causing cancer”  image by Global Justice Now.

Glyphosate-based herbicides (GBHs) are extensively used to control weeds on both cropland and non-cropland areas. No reports are available regarding the effects of GBHs exposure on uterine development.

We evaluated if neonatal exposure to a GBH affects uterine morphology, proliferation and expression of proteins that regulate uterine organogenetic differentiation in rats.

Female Wistar pups received saline solution (control, C) or a commercial formulation of glyphosate (GBH, 2mg/kg) by sc injection every 48h from postnatal day (PND) 1 to PND7. Rats were sacrificed on PND8 (neonatal period) and PND21 (prepubertal period) to evaluate acute and short-term effects, respectively.

The uterine morphology was evaluated in hematoxylin and eosin stained sections. The epithelial and stromal immunophenotypes were established by assessing the expression of luminal epithelial protein (cytokeratin 8; CK8), basal epithelial proteins (p63 and pan cytokeratin CK1, 5, 10 and 14); and vimentin by immunohistochemistry (IHC). To investigate changes on proteins that regulate uterine organogenetic differentiation we evaluated the expression of estrogen receptor alpha (ERα), progesterone receptor (PR), Hoxa10 and Wnt7a by IHC.

  • The GBH-exposed uteri showed morphological changes, characterized by an increase in the incidence of luminal epithelial hyperplasia (LEH) and an increase in the stromal and myometrial thickness.
  • The epithelial cells showed a positive immunostaining for CK8, while the stromal cells for vimentin.
  • GBH treatment increased cell proliferation in the luminal and stromal compartment on PND8, without changes on PND21.
  • GBH treatment also altered the expression of proteins involved in uterine organogenetic differentiation. PR and Hoxa10 were deregulated both immediately and two weeks after the exposure. ERα was induced in the stromal compartment on PND8, and was downregulated in the luminal epithelial cells of gyphosate-exposed animals on PND21.
  • GBH treatment also increased the expression of Wnt7a in the stromal and glandular epithelial cells on PND21.

Glyphosate herbicide disrupts uterine development, gmwatch, 21 June 2016.

Neonatal exposure to GBH disrupts the postnatal uterine development at the neonatal and prepubertal period. All these changes may alter the functional differentiation of the uterus, affecting the female fertility and/or promoting the development of neoplasias.

Faut-il se vacciner ou se revacciner tous les ans contre la grippe?

Le prix indécent des médicaments, ça va durer encore longtemps?

Certains médicaments arrivant sur le marché, comme les nouveaux traitements anti-cancéreux ou ceux pour soigner l’Hépatite C, atteignent aujourd’hui des prix exorbitants.

Le danger ? Que notre assurance-maladie ne puisse plus supporter le remboursement de traitements aux prix si élevés dont doivent pourtant bénéficier des milliers de malades.

  • Faut-il se vacciner contre la grippe? atoute, 28 Sep 2012.
  • Faut-il ou non se faire vacciner contre la grippe? atoute, 12 Jan 2010.

LA Campagne de Médecins du monde

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Les opportunités diverses de la e-santé et le positionnement du leem

Des avantages et intérêts divers selon les acteurs

La e-santé couvre des applications très variées (télémédecine, télésanté, dispositifs connectés avec ou sans molécule ou classe thérapeutique associée…) et doit être distinguée, sur des critère de finalité, des applications de bien-être (nombre de pas, nutrition, qualité du sommeil…).

Les enjeux et la finalité de la e-santé

Le développement de la e-santé contribue à encourager des opportunités diverses selon les acteurs:

  • Pour les patients, il s’agit d’outils favorisant une meilleure information, l’adhésion à un traitement, l’amélioration de leur expérience et de leur autonomie,
  • Pour les professionnels de santé, la e-santé permet notamment de fluidifier la coordination des soins entre professionnels de santé, de faciliter la prise de décision par la mise en réseau de différentes expertises, d’accélérer le diagnostic, d’optimiser les résultats cliniques attendus au travers d’un meilleur suivi de la prise en charge des patients,
  • Pour les pouvoirs publics, cette approche permet d’envisager une optimisation de l’organisation des soins et une efficience accrue du système de soins, par exemple en réduisant le nombre et la durée des hospitalisations,
  • Pour les industriels, la e-santé représente une possibilité d’optimiser la diffusion et l’usage d’une offre thérapeutique et de son impact. Elle représente ainsi un enjeu majeur en termes de recherche et de génération de nouvelles connaissances, par exemple par la production de données en vie réelle aussi bien que dans le cadre d’essais cliniques. Ces données, par leur nature, leur abondance et leur facilité de traitement, vont permettre des avancées majeures pour un meilleur référencement des pathologies, en médecine ciblée, en pharmaco-épidémiologie et en médico-économie.
    Du point de vue des industriels du médicament, les applications de e-santé peuvent être développées en association à un médicament, en accompagnement de médicaments dans une même aire thérapeutique, parfois comme une offre de service indépendante de la prise d’un médicament.

Positionnement du leem

Le positionnement du LEEM sur la e-santé, leem, 22 06 16.

Le leem – Les entreprises du médicament – encourage le déploiement de la e-santé dans la mesure où elle doit permettre de mieux accompagner le patient dans la prise en charge de sa pathologie, contribuant par la même occasion à améliorer son état de santé, et accroître l’efficience du système de soins. Le développement de la e-santé suppose un cadre règlementaire souple et un cadre économique qui lui soient adaptés.

Le développement réussi de la e-santé suppose de nouvelles formes de coopération entre tous les acteurs concernés (public / privé, industriels, start-up, payeurs, hôpitaux …) dans un schéma de co-création, co-développement et co-diffusion ; de la qualité de cette coopération dépendra le succès du déploiement de la e-santé en France.

  1. Les entreprises du médicament sont prêtes à une co-construction de la e-santé avec notamment les industriels des technologies de l’information et de la communication dont la complémentarité d’expertise est un atout.
  2. Compte tenu des enjeux d’appropriation de la e-santé par les patients et les professionnels de santé, le Leem propose une action pédagogique à destination de ces parties prenantes, y compris le grand public. Celle-ci pourra être menée à bien avec des partenaires tels que les pouvoirs publics, les associations de patients, les assureurs…
  3. Les entreprises du médicament souhaitent engager des échanges avec les autorités de santé pour définir un cadre réglementaire souple d’accompagnement du patient dans la prise en charge de sa pathologie ainsi qu’un cadre d’évaluation médico-économique des applications de e-santé défini et pertinent.
  4. Elles désirent aussi mener une réflexion avec les pouvoirs publics et les partenaires assurantiels sur le financement de ces solutions mixtes de santé, sur leur valeur ajoutée pour le système de soins et sur les modes de redistribution des marges budgétaires ainsi dégagées.

Energy and Air Pollution : IEA Report

IEA warning : air pollution to kill millions more without change of energy policy

Clean air is vital for good health. Yet despite growing recognition of this imperative, the problem of air pollution is far from solved in many countries, and the global health impacts risk intensifying in the decades to come.

The scale of the public health crisis caused by air pollution and the importance of the energy sector to its resolution are the reasons why the IEA is focusing on this critical topic for the first time.

” Clean air is a basic human right that most of the world’s population lacks “

Based on new data for pollutant emissions in 2015 and projections to 2040, this IEA special report, the latest in the World Energy Outlook series, provides a global outlook for energy and air pollution as well as detailed profiles of key countries and regions: the United States, Mexico, the European Union, China, India, Southeast Asia and Africa.

” We need to revise our approach to energy development so that communities are not forced to sacrifice clean air in return for economic growth “

In a Clean Air Scenario, the report proposes a pragmatic and attainable strategy to reconcile the world’s energy requirements with its need for cleaner air. Alongside the multiple benefits to human health, this strategy shows that resolving the world’s air pollution problem can go hand-in-hand with progress towards other environmental and development goals.

Key Figures

  • Around 6.5 million premature deaths each year can be attributed to air pollution.
  • Energy production and use are by far the largest man-made sources of air pollutants.
  • Technologies to tackle air pollution are well known.
  • Small increase in energy investment could cut premature deaths from air pollution in half by 2040.
Sources