Endocrine Disrupting Chemicals and Me

What Are EDCs? Why Should I Be Concerned?

What Are EDCs? Why Should I Be Concerned?

Endocrine disrupting chemicals (EDCs) are all around you. If you are going to take control over your endocrine health, you will have to understand what these are and what they may be doing to your body.

Endocrine Disruptors: A Denial of the State of the Science

Part 2 of 3 – The European Commission relies on studies financed by industry

This article by Stéphane Horel was originally published by Le Monde on November 29. This version is translated by the Health and Environment Alliance and republished with permission on Environmental Health News first. This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. “Spray” Image Will Fuller.

The current scientific knowledge:” It is this that the European Commission assures it is using to justify its much criticized choices in the regulation of endocrine disruptors. Yet, the Endocrine Society, a major scholarly society, believes that the Commission “ignores [the] state of science.” How can such a hiatus be explained?

To document its considerations, the Directorate-General for Health and Food Safety, responsible for the file at the Commission, carried out an impact assessment of more than 400 pages, which was published in June after having been under lock and key as a state secret. To what specific “scientific knowledge” does it refer?

The decision-making process began in 2009 and the “scientific knowledge” on endocrine disruptors has evolved considerably since then.

Above all, the Commission cites the opinion issued by one of its official agencies, the European Food Safety Authority, in 2013. This opinion is indeed the basis of its regulatory proposal. But the decision-making process began in 2009 and the “scientific knowledge” on endocrine disruptors has evolved considerably since then.

The Endocrine Society produced a review of the science in 2015. It examined 1,322 publications that had been published since its last review, which was actually in 2009. Conclusion? They do not leave “any doubt that EDCs [endocrine disruptors] are contributing to increased chronic disease burdens related to obesity, diabetes mellitus, reproduction, thyroid, cancers, and neuroendocrine and neurodevelopmental functions.”

In 2013, some 20 researchers working for nearly two years under the auspices of the World Health Organization (WHO) and the United Nations Environment Program (UNEP) had reached similar conclusions. Their report sounded the alarm bell on a “global threat that needs to be resolved.

“Controversial interpretation”

These recent additions to “scientific knowledge” are indeed mentioned in the Commission’s impact assessment but disqualified on the basis that they do not deserve to be taken into consideration. “Evidence is scattered and its interpretation controversial,” the assessment report says, “so that a causal link or even a possible association between ED [endocrine disruptors] exposure at environmental levels and the diseases is not agreed among experts.”

In the wake of this damning reception, it reduces the Endocrine Society to a “stakeholder” who has issued a “statement.” As for the WHO/UNEP report, “scientific criticism to the general methodology used … was raised,” it indicates, citing a number of publications which it says show that the controversy “seems not resolved.” But what publications would be sufficiently authoritative as to be able to knock down the work carried out by the most respected specialists in the field?

Notably, the Commission’s negative comments are based on “critical comments,” published in 2014, challenging the methods and conclusions of the WHO/UNEP report. Among the ten authors of the comments, seven are working for two consulting companies, Exponent and Gradient Corp, which specialize in scientific issues and are known as “product-defense firms.”

But, most importantly, it was industry that sponsored the article through its lobbying organizations: the chemical sector with the European Chemical Industry Council (Cefic) and the American Chemistry Council and the pesticides sector with CropLife America, CropLife Canada, CropLife International and the European Crop Protection Association.

“Urban legend”

None of this can be unknown to the Commission services. Not only do these sponsors appear clearly in the declaration of interests at the end of the article, but industry itself sent it to them. Cefic sent it by e-mail to about 30 European officials involved in the case on March 17, 2014. In a message consulted by Le Monde, the industrialists explain that they have “commissioned a consortium of scientific experts to independently review the WHO-UNEP report,” fearing, in particular, that “despite its serious shortcomings it was being used to call for more precautionary chemicals policy.

Other publications cited in the impact study include a two-page article, one of whose signatories is a person better known for his role as a consultant to the tobacco industry than for his competence on this topic. Among its co-authors are toxicologists paid by the chemical, pesticides and plastic industries.

Another article has again two consultants out of the three authors and talks about endocrine disruptors as an “urban legend” posing “imaginary health risks.” Making fun of the “hypothetical” effects of endocrine disruptors, such as the “reduced penis length and size,” they pose the question of “whether the whole issue of EDC is more within the competence of Dr. Sigmund Freud than that of toxicology.”

Can these texts really be incorporated into “scientific knowledge?” Why does the Commission give so much credit to documents that resemble lobbying material?

In a momentous editorial published today [November 29, 2016] in Le Monde, independent scientists express concerns about a “distortion of the evidence by industrially sponsored actors.” Signed by a hundred experts from two very different fields – endocrine disruption and climate change – their text notes the “dangerous consequences for the health of people and the environment” of this strategy of “manufacturing of doubt.”

MORE INFORMATION

The Investigation
    1. The Manufacture of a Lie.
    2. A Denial of the State of the Science.
    3. The Interference of the United States.
    4. The Discreet but Major Gift to the Pesticides Lobby.

 

Endocrine Disruptors

2016 Changes to how NICE appraises drugs and other health technologies

The National Institute for Health and Care Excellence is an executive non-departmental public body of the Department of Health in the UK

The recent proposals by NICE and NHS England to change arrangements for evaluating and funding drugs and other health technologies not only tidy up the processes, but introduce some important new elements.

The four proposed elements are to:

  1. Introduce a “fast track” NICE technology appraisal process for the most promising new technologies, which fall below an incremental cost-effectiveness ratio of £10,000 per QALY (quality adjusted life year).
  2. Operate a “budget impact threshold” of £20 million, set by NHS England, to signal the need for a dialogue with companies to agree special arrangements to better manage the introduction of new technologies recommended by NICE.
  3. Vary the timescale for the funding requirement when the budget impact threshold is reached or exceeded, risking disruption to the funding of other services.
  4. Automatically fund, from routine commissioning budgets, treatments for very rare conditions (highly specialised technologies) up to £100,000 per QALY (5 times greater than the lower end of NICE’s standard threshold range), and provide the opportunity for treatments above this range to be considered through NHS England’s process for prioritising other highly specialised technologies.

James Raftery: Changes to how NICE appraises drugs and other health technologies, BMJ Blog, 2 Dec, 16.

The first of these is non-contentious and probably should have been introduced long ago. It is estimated to reduce appraisal time by 25%. Some interventions are likely to be cost effective if they are even mildly effective and incur low cost. From 2007 to 2014, around 15% of NICE’s technology appraisals fell at or below £10k per QALY.

Specialised services, of which 146 exist, cover a diverse range of disparate and complex services, from services for long-term conditions, such as renal and mental health problems, to services for uncommon conditions such as rare cancers. Funded by a variety of means and lacking standard data, responsibility for commissioning specialised services was shunted from agency to agency until 2013 when NHS England took on responsibility.

Proposals two and three, which are to do with specialised services, reflect the recent rows over funding drugs for hepatitis C when NICE’s approval of sofosbufir led to delays by NHS England due their total cost impact. Besides a BMJ investigation, this led to a considered review by the House of Commons Public Accounts Committee (PAC).

The PAC showed that between 2013–14 and 2015–16, the budget for specialised services increased from £13 billion to £14.6 billion, or 6.3% a year, well above that for the NHS. By 2020–21, the budget for these services is expected to rise to £18.8 billion, 16% of the total NHS budget.

In 2013–14, NHS England overspent on specialised services by £377 million (2.9%) and in 2014–15, it overspent by £214 million (1.5%). In 2014–15, the Cancer Drugs Fund accounted for £136 million of the overspend.

NHS England told the PAC that about three-quarters of NICE recommended drugs apply to specialised services and that most of the budget increase for 2016–17 was related to NICE approved drugs.

The PAC showed that the arrangements for pricing (Department of Health), appraising (NICE) and funding (NHS England) of specialized services were misaligned. It recommended that the Department of Health and NHS England should, in collaboration with NICE, ensure affordability is considered when making decisions that have an impact on specialised services. Proposals 2 and 3 formalise arrangements between NICE and NHS England for appraising and funding these services.

The fourth proposal marks the most radical change by setting the cost per QALY threshold for highly specialised (as opposed to specialised) technologies at £100k, which is five times greater than the lower end of NICE’s standard threshold range. Although this reflects the higher thresholds that have been allowed for some extreme “orphan drugs,” it lacks any coherent rationale besides political necessity. This leaves NICE with at least three cost per QALY thresholds, one of £20k-30k for standard technologies, one of around £50k for end of life technologies and one of £100k for highly specialised technologies.

Hormones and Endocrine Disrupting Chemicals

Hormone Health Network infographic to learn more about EDCs, 2016

Endocrine disrupting chemicals (EDCs) can trigger hormonal responses in your body that throw off the proper hormone balance.

More Information

Endocrine Disruptors: The Manufacture of a Lie

Part 1 of 3 – The European Commission has developed its own evidence to avoid an overly stringent regulation of these hazardous substances

This article by Stéphane Horel was originally published by Le Monde on November 29. This version is translated by the Health and Environment Alliance and republished with permission on Environmental Health News first. This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Image JULIE BALAGUE POUR LE MONDE.

Everything, or almost everything, is contained in a few words: “(Endocrine disruptors) can … be treated like most other substances of concern for human health and the environment.” It is on this simple phrase, which comes from the conclusion of an opinion from the European Food Safety Authority (EFSA) in 2013, that Brussels bases its plan to regulate endocrine disruptors, these ubiquitous substances capable of interfering with the hormonal system, often at low doses.

The proposal, which is due to be voted on by the Member States soon, has not only France, Denmark and Sweden united against it but also all the non-governmental organizations (NGOs) who consider that it does not protect public health and the environment.

The key phrase on which the regulatory edifice proposed by the Commission is built had been drafted even before any scientific expertise had really begun.

The expert scientific community, embodied by the Endocrine Society – a scholarly society that brings together some 18,000 researchers and clinicians specializing in the hormonal system – is also battling against the proposal. This opposition is surprising given that the European Commission insists that it relies on science, in the form of the scientific expertise of EFSA.

The explanation for this singular hiatus is found in a series of internal documents of the European administration obtained by Le Monde. They show, without ambiguity, that the key phrase on which the regulatory edifice proposed by the Commission is built had been drafted even before any scientific expertise had really begun.

Written conclusions in advance

In December 2012, EFSA was already presenting “conclusions/recommendations” in an e-mail to the experts it had assembled to carry out this work.

It said: “…endocrine disruptors and their adverse effects should be treated just like any other chemical of concern for human health or the environment.” The key phrase is already there. Yet, the very first meeting to set up work was held only a few days before. At the end of March 2013, three months later, the phrase figures in the conclusions of the opinion published by the agency.

For sure, the conclusions were written beforehand, if not on paper, but in the heads of some of the participants,” a source close to the file at the time told Le Monde. The Commission itself did not respond to our questions. EFSA reacted with an assurance that it had properly fulfilled its mandate.

EFSA’s “Scientific Committee took stock of the various views from a number of experts and forums,” the European agency said when questioned.

The “EFSA phrase,” harmless for the uninitiated, has, in fact, a considerable weight. Because if endocrine disruptors were actually substances that are just like any others, then there would be no need for strict regulation.

The pesticide industry, which is most affected by the issue, has clearly understood the point. Its main lobbying organizations – the European Crop Protection Association (ECPA), CropLife International, CropLife America – or the German agrochemical groups BASF or Bayer, repeat ad libitum the “EFSA phrase” in arguments and correspondence with the European institutions that Le Monde has seen.

In fact, the famous phrase is of major importance for European regulation on plant protection products. It was in 2009 that the European Parliament voted a new “pesticides regulation.” According to this legislation, pesticides a priori identified as “endocrine disruptors” would no longer be allowed to enter or remain on the market except when the exposure is considered negligible.

This provision only needs one thing if it is to be applied: the adoption of scientific criteria to define endocrine disruptors – that is, what Brussels is proposing today. But since endocrine disruptors are chemical substances like any others – it’s the “EFSA phrase” that prompts the question: why prohibit them a priori?

“Major breach” in health protection

The Commission has therefore made an amendment to the text. Now, it is sufficient to assess the risk that they present on a case-by-case basis if problems arise after they have been placed on the market – and therefore a posteriori. Is this change at the cost of the spirit of the 2009 regulation?

This amendment would open a “major loophole” in the protection of health and the environment, says EDC-Free Europe. This coalition of NGOs accuses the Commission of wanting to distort the intention of European law.

But above all, this amendment to the 2009 regulation poses a democratic problem: it is much as if the officials have taken the initiative to draft an implementing decree that had nothing to do with the intention of the elected representatives.

The European Parliament is also of this opinion. In a copy of a letter seen by Le Monde and dated September 15, the chairman of the Parliament’s Environment Committee wrote to the Health Commissioner, Vytenis Andriukaitis, who is responsible for the file, saying that the project: “exceeds the implementing powers of the Commission” by amending “essential elements” of the law. Similarly, in their note of October 10, France, Denmark and Sweden do not say anything different, judging that the Commission has no right to change “a policy choice by the legislator.”

This rebuke is all the more unfortunate because it comes when the Commission is already in a state of illegality on this issue. The European Court of Justice actually condemned the Commission in December 2015 for violating EU law: the Commission had been required to settle the question of the criteria to identify endocrine disrupters before the end of 2013.

However, the Commission remains unfazed by the shower of criticism. It offers an assurance that it has fulfilled the condition which authorizes it to “update” the regulation: to take into account the evolution of “scientific knowledge,” namely the famous little phrase of EFSA. It is that phrase on which its justification rests.

But why should EFSA have written, in advance, a conclusion in breach of the scientific consensus? An internal Commission document obtained by Le Monde sheds some light on the intentions of the Directorate General for Health and Food Safety (DG Health), which is now responsible for the matter at the Commission.

“What we see here is policy-based evidence-making.”

Axel Singhofen, Greens-European Free Alliance.

A meeting report records in black and white that, as of September 2012, DG Health intends to disregard the will of elected representatives in Europe. The health directorate said then that it “did not oppose even the idea to go back to regulating based on risk assessment” and was “ready to change entirely” the part of the regulation concerned.

The same document states further on that DG Health will have to “talk with EFSA to try and accelerate the preparation” of its opinion. At this point, EFSA’s opinion did not exist … The agency had only just been asked to set up a working group on endocrine disruptors.

A “mortified” message

The very special conditions in which this working group operated can be read in e-mails exchanged by EFSA experts and officials. One month before the release of the EFSA report, the World Health Organization (WHO) and the United Nations Environment Program (UNEP) published a joint report on endocrine disruptors.

A mortified EFSA expert sent a message to the whole group: “It is almost embarrassing to compare the current draft report with the WHO-UNEP report … when WHO-UNEP comes to the conclusion that traditional risk assessment of chemicals is not fit for purpose to assess (endocrine disruptors), we are exactly coming to the opposite conclusion.”

This scientist considered it essential that the conclusions be radically changed. The EFSA official overseeing the work of the expert group agreed.

The “current conclusions where we explain that [endocrine disruptors] should be considered like most other chemicals […] puts us in isolation compared to the rest of the world, and may be hard to defend,” he writes. However, when EFSA’s opinion is published on March 20, 2013, it continued to include, unperturbed, the little phrase.

This should be a science-based procedure … evidence-based policy-making,” says Axel Singhofen, an adviser to the Greens-European Free Alliance in the European Parliament. “But what we see here is policy-based evidence-making.”

MORE INFORMATION

The Investigation
    1. The Manufacture of a Lie.
    2. A Denial of the State of the Science.
    3. The Interference of the United States.
    4. The Discreet but Major Gift to the Pesticides Lobby.

 

Endocrine Disruptors

Your Hormones and Cancer – Prevention

Hormone Health Network infographic
Healthy lifestyle = hormone health = cancer prevention

If you are concerned about your hormones and cancer risk, consider lifestyle changes that can help.

Testosterone treatment and risk of venous thromboembolism

Population based case-control study, The BMJ, November 2016

Abstract

Objective
To determine the risk of venous thromboembolism associated with use of testosterone treatment in men, focusing particularly on the timing of the risk.

Design
Population based case-control study

Setting
370 general practices in UK primary care with linked hospital discharge diagnoses and in-hospital procedures and information on all cause mortality.

Testosterone treatment and risk of venous thromboembolism: population based case-control study, The BMJ 2016;355:i5968, 30 November 2016.

Participants
19 215 patients with confirmed venous thromboembolism (comprising deep venous thrombosis and pulmonary embolism) and 909 530 age matched controls from source population including more than 2.22 million men between January 2001 and May 2013.

Exposure of interest
Three mutually exclusive testosterone exposure groups were identified: current treatment, recent (but not current) treatment, and no treatment in the previous two years. Current treatment was subdivided into duration of more or less than six months.

Main outcome measure
Rate ratios of venous thromboembolism in association with current testosterone treatment compared with no treatment were estimated using conditional logistic regression and adjusted for comorbidities and all matching factors.

Results
The adjusted rate ratio of venous thromboembolism was 1.25 (95% confidence interval 0.94 to 1.66) for current versus no testosterone treatment. In the first six months of testosterone treatment, the rate ratio of venous thromboembolism was 1.63 (1.12 to 2.37), corresponding to 10.0 (1.9 to 21.6) additional venous thromboembolisms above the base rate of 15.8 per 10 000 person years. The rate ratio after more than six months’ treatment was 1.00 (0.68 to 1.47), and after treatment cessation it was 0.68 (0.43 to 1.07). Increased rate ratios within the first six months of treatment were observed in all strata: the rate ratio was 1.52 (0.94 to 2.46) for patients with pathological hypogonadism and 1.88 (1.02 to 3.45) for those without it, and 1.41 (0.82 to 2.41) for those with a known risk factor for venous thromboembolism and 1.91 (1.13 to 3.23) for those without one.

Conclusions
Starting testosterone treatment was associated with an increased risk of venous thromboembolism, which peaked within six months and declined thereafter.

Your Hormones and Cancer – Facts

Hormone Health Network infographic
Healthy lifestyle = hormone health = cancer prevention

Hormones regulate some of our body’s most important functions, such as metabolism and sexual development. When your hormonal balance is off, negative effects can occur sometimes leading to cancer.

Bilan 2016 des médicaments à écarter

Pour mieux soigner, Prescrire a recensé 74  médicaments dont la balance bénéfices-risques est défavorable

En 2016, le bilan porte sur les médicaments analysés dans Prescrire durant six ans, de 2010 à 2015. Cette analyse a recensé 74 médicaments dont la balance bénéfices-risques est défavorable dans toutes les situations cliniques pour lesquelles ils sont autorisés.

Pour mieux soigner : des médicaments à écarter – actualisation 2016, prescrire, Tome 36 N° 388, 2016. PDF complet.

Cancérologie – Hématologie

  • catumaxomab (Removab®)
  • défibrotide (Defitelio®)
  • panitumumab (Vectibix®)
  • trabectédine (Yondelis®)
  • vandétanib (Caprelsa®)
  • vinflunine (Javlor®)

Cardiologie

  • aliskirène (Rasilez®)
  • bézafibrate (Befizal®)
  • ciprofibrate (Lipanor® ou autre)
  • fénofibrate (Lipanthyl® ou autre)
  • ivabradine (Procoralan®)
  • nicorandil (Adancor® ou autre)
  • olmésartan (Alteis®, Olmetec®)
  • trimétazidine (Vastarel® ou autre)

Dermatologie – Allergologie

  • méquitazine (Primalan®)
  • omalizumab (Xolair®)
  • prométhazine injectable (Phénergan®)
  • tacrolimus dermique (Protopic®)

Diabétologie – Nutrition

  • linagliptine (Trajentav®)
  • saxagliptine (Onglyza®)
  • sitagliptine (Januvia®)
  • vildagliptine (Galvus®)
  • orlistat (Xenical® ou autre)

Douleur – Rhumatologie

Antalgie

  • célécoxib (Celebrex® ou autre)
  • étoricoxib (Arcoxia®)
  • parécoxib (Dynastat®)
  • diclofénac (Voltarène® ou autre)
  • acéclofénac (Cartrex® ou autre)
  • kétoprofène en gel (Ketum® gel ou autre)
  • piroxicam par voie générale (Feldène® ou autre)

Ostéoporose

  • dénosumab dosé à 60 mg dans l’ostéoporose (Prolia®)
  • ranélate de strontium (Protelos®)

Arthrose

  • diacéréine (Art 50® ou autre)
  • glucosamine (Voltaflex® ou autre)

Divers

  • méthocarbamol (Lumirelax®)
  • thiocolchicoside (Coltramyl® ou autre)
  • pégloticase (Krystexxa®)
  • quinine (Hexaquine®, Okimus®, Quinine vitamine C Grand®)
  • colchicine + poudre d’opium + tiémonium dans la spécialité Colchimax®
  • dexaméthasone + salicylamide + salicylate d’hydroxyéthyle dans la spécialité Percutalgine®
  • prednisolone + salicylate de dipropylène glycol dans la spécialité Cortisal®

Gastro-entérologie

  • dompéridone (Motilium® ou autre)
  • dropéridol (Droleptan®)
  • prucalopride (Resolor®)

Gynécologie – Endocrinologie

  • tibolone (Livial®)

Infectiologie

  • moxifloxacine (Izilox® ou autre)
  • télithromycine (Ketek®)

Neurologie

Maladie d’Alzheimer

  • donépézil (Aricept® ou autre)
  • galantamine (Reminyl® ou autre)
  • rivastigmine (Exelon® ou autre)
  • mémantine (Ebixa® ou autre)

Sclérose en plaques

  • natalizumab (Tysabri®)
  • tériflunomide (Aubagio®)

Divers

  • flunarizine (Sibelium®)
  • l’oxé- torone (Nocertone®)
  • tolcapone (Tasmar®)

Pneumologie – ORL

  • éphédrine
  • naphazoline
  • oxymétazoline
  • pseudoéphédrine
  • tuaminoheptane
  • omalizumab (Xolair®)
  • pholcodine
  • tixocortol (associé avec la chlorhexidine (Thiovalone® ou autre))

Psychiatrie – Dépendances

Antidépresseurs

  • agomélatine (Valdoxan®)
  • duloxétine (Cymbalta® ou autre)
  • citalopram (Seropram® ou autre)
  • escitalopram (Seroplex® ou autre)
  • milnacipran (Ixel® ou autre)
  • venlafaxine (Effexor® LP ou autre)
  • tianeptine (Stablon® ou autre)

Autres psychotropes

  • dapoxétine (Priligy®)
  • étifoxine (Stresam®)

Sevrage tabagique

  • bupropione (Zyban®)
  • varénicline (Champix®)

Téléchargez le bilan complet Prescrire 2016 en accès libre.