The harmful effects of hormone use: no NHS test yet…

Some non-NHS screening tests at the cutting edge of medical science

With all the DES studies on epigenetics and transgenerational effects, when will we have a test to determine if a person has been exposed to DES?

” The NHS does not rule the world or even the UK. While there is no justification for spurious and unhelpful screening tests, the NHS does not provide many important tests for common conditions or the harmful effects of hormone use. So far few of the revealing tests I have used since 1962 are routinely available except from some private laboratories or specialist university departments.

For example, Acumen laboratory was set up by Dr John McLaren-Howard to offer tests that are not available elsewhere although supported by significant numbers of medical and scientific publications and which would otherwise remain in the research domain. The most important areas of investigation concern ATP metabolism (energy provision) and DNA adducts (exogenous or endogenous chemical effects of DNA) such as those containing nickel which are potentially carcinogenic. ”

Ellen C G Grant
Physician and medical gynaecologist, Retired

Sources: Some non-NHS screening tests at the cutting edge of medical science Re: Margaret McCartney: The unacceptable cost of non-NHS screening, The BMJ BMJ 2016;354:i3959, 26 July 2016 – in reply to Margaret McCartney: The unacceptable cost of non-NHS screening, The BMJ BMJ 2016;354:i3959, 20 July 2016. Image via nasamarshall.

Some Salmon we eat are on Drugs : Prozac, Advil, Benadryl, Lipitor, even Cocaine

Drugs found in Puget Sound salmon from tainted wastewater

Drugs found in Puget Sound salmon from tainted wastewater, seattletimes, February 23, 2016.

From Prozac to caffeine to cholesterol medicine, from ibuprofen to bug spray, researchers found an alphabet soup of drugs and other personal-care products in sewage-treatment wastewater and in the tissue of juvenile chinook in Puget Sound.

Abstract

This study was designed to assess the occurrence and concentrations of a broad range of contaminants of emerging concern (CECs) from three local estuaries within a large estuarine ecosystem. In addition to effluent from two wastewater treatment plants (WWTP), we sampled water and whole-body juvenile Chinook salmon (Oncorhynchus tshawytscha) and Pacific staghorn sculpin (Leptocottus armatus) in estuaries receiving effluent.

Contaminants of emerging concern in a large temperate estuary, sciencedirect, doi:10.1016/j.envpol.2016.01.088, June 2016.

We analyzed these matrices for 150 compounds, which included pharmaceuticals, personal care products (PPCPs), and several industrial compounds.

Collectively, we detected 81 analytes in effluent, 25 analytes in estuary water, and 42 analytes in fish tissue. A number of compounds, including sertraline, triclosan, estrone, fluoxetine, metformin, and nonylphenol were detected in water and tissue at concentrations that may cause adverse effects in fish. Interestingly, 29 CEC analytes were detected in effluent and fish tissue, but not in estuarine waters, indicating a high potential for bioaccumulation for these compounds.

Although concentrations of most detected analytes were present at relatively low concentrations, our analysis revealed that overall CEC inputs to each estuary amount to several kilograms of these compounds per day.

This study is unique because we report on CEC concentrations in estuarine waters and whole-body fish, which are both uncommon in the literature. A noteworthy finding was the preferential bioaccumulation of CECs in free-ranging juvenile Chinook salmon relative to staghorn sculpin, a benthic species with relatively high site fidelity.

Why many sperm banks are getting sued

It’s terrifying to imagine a health care business being operated so recklessly

” Frozen sperm has become a major industry, dominated by a few large sperm banks, but with smaller stocks of sperm maintained at hundreds of assisted-reproduction centers nationwide. “

” Some of the new cases accuse sperm banks of careless record-keeping, or mishandling or misappropriation of sperm banked for a client’s personal use. Others say the banks use hyped, misleading descriptions to market their donors. “

Cancer prevention: we can take some control

Evidence has increasingly accumulated that cancer may be preventable, too

Helpless to Prevent Cancer? Actually, Quite a Bit Is in Your Control, NY Times, JULY 5, 2016.
Image Dominic Kesterton.

Simple changes to people’s behaviors have the potential to make sure many cancers never occur. They have a side benefit of preventing health problems in many other areas, too. Investment in these efforts may not be as exciting, but it may yield greater results.

Preventable Incidence and Mortality of Carcinoma Associated With Lifestyle Factors Among White Adults in the United States

Abstract

JAMA Oncology, doi:10.1001/jamaoncol.2016.0843, May 19, 2016.

Importance
Lifestyle factors are important for cancer development. However, a recent study has been interpreted to suggest that random mutations during stem cell divisions are the major contributor to human cancer.

Objective
To estimate the proportion of cases and deaths of carcinoma (all cancers except skin, brain, lymphatic, hematologic, and nonfatal prostate malignancies) among whites in the United States that can be potentially prevented by lifestyle modification.

Design, Setting, and Participants
This prospective cohort study analyzes cancer and lifestyle data from the Nurses’ Health Study, the Health Professionals Follow-up Study, and US national cancer statistics to evaluate associations between lifestyle and cancer incidence and mortality.

Exposures
A healthy lifestyle pattern was defined as never or past smoking (pack-years <5), no or moderate alcohol drinking (≤1 drink/d for women, ≤2 drinks/d for men), BMI of at least 18.5 but lower than 27.5, and weekly aerobic physical activity of at least 75 vigorous-intensity or 150 moderate-intensity minutes. Participants meeting all 4 of these criteria made up the low-risk group; all others, the high-risk group.

Main Outcomes and Measures
We calculated the population-attributable risk (PAR) by comparing incidence and mortality of total and major individual carcinomas between the low- and high-risk groups. We further assessed the PAR at the national scale by comparing the low-risk group with the US population.

Results
A total of 89 571 women and 46 339 men from 2 cohorts were included in the study: 16 531 women and 11 731 men had a healthy lifestyle pattern (low-risk group), and the remaining 73 040 women and 34 608 men made up the high-risk group. Within the 2 cohorts, the PARs for incidence and mortality of total carcinoma were 25% and 48% in women, and 33% and 44% in men, respectively. For individual cancers, the respective PARs in women and men were 82% and 78% for lung, 29% and 20% for colon and rectum, 30% and 29% for pancreas, and 36% and 44% for bladder. Similar estimates were obtained for mortality. The PARs were 4% and 12% for breast cancer incidence and mortality, and 21% for fatal prostate cancer. Substantially higher PARs were obtained when the low-risk group was compared with the US population. For example, the PARs in women and men were 41% and 63% for incidence of total carcinoma, and 60% and 59% for colorectal cancer, respectively.

Conclusions and Relevance
A substantial cancer burden may be prevented through lifestyle modification. Primary prevention should remain a priority for cancer control.

Substantial contribution of extrinsic risk factors to cancer development

Abstract

Nature 529, 43–47, doi:10.1038/nature16166, 07 January 2016.

Recent research has highlighted a strong correlation between tissue-specific cancer risk and the lifetime number of tissue-specific stem-cell divisions. Whether such correlation implies a high unavoidable intrinsic cancer risk has become a key public health debate with the dissemination of the ‘bad luck’ hypothesis.

Here we provide evidence that intrinsic risk factors contribute only modestly (less than ~10–30% of lifetime risk) to cancer development.

  • First, we demonstrate that the correlation between stem-cell division and cancer risk does not distinguish between the effects of intrinsic and extrinsic factors.
  • We then show that intrinsic risk is better estimated by the lower bound risk controlling for total stem-cell divisions.
  • Finally, we show that the rates of endogenous mutation accumulation by intrinsic processes are not sufficient to account for the observed cancer risks.
  • Collectively, we conclude that cancer risk is heavily influenced by extrinsic factors.

These results are important for strategizing cancer prevention, research and public health.

Fracking associated with increased risk of asthma exacerbation

First study of hydraulic fracturing and objective respiratory outcomes

Fracking is linked to asthma increase, study finds, The BMJ, dx.doi.org/10.1136/bmj.i3992, 19 July 2016.

To date, most health concerns regarding fracking – a controversial method of extracting gas from the ground – have centred on groundwater contamination as a by-product of the procedure, which involves drilling 2000-3000 m down into the ground and then 600-3000 m across. A high pressure water mixture is then directed at the rock.

The first study associating hydraulic fracturing with an increased risk of asthma exacerbation has been published.

Abstract

Association Between Unconventional Natural Gas Development in the Marcellus Shale and Asthma Exacerbations, JAMA Internal Medicine, doi:10.1001/jamainternmed.2016.2436, July 18, 2016.

Importance
Asthma is common and can be exacerbated by air pollution and stress. Unconventional natural gas development (UNGD) has community and environmental impacts. In Pennsylvania, UNGD began in 2005, and by 2012, 6253 wells had been drilled. There are no prior studies of UNGD and objective respiratory outcomes.

Objective
To evaluate associations between UNGD and asthma exacerbations.

Design
A nested case-control study comparing patients with asthma with and without exacerbations from 2005 through 2012 treated at the Geisinger Clinic, which provides primary care services to over 400 000 patients in Pennsylvania. Patients with asthma aged 5 to 90 years (n = 35 508) were identified in electronic health records; those with exacerbations were frequency matched on age, sex, and year of event to those without.

Exposures
On the day before each patient’s index date (cases, date of event or medication order; controls, contact date), we estimated activity metrics for 4 UNGD phases (pad preparation, drilling, stimulation [hydraulic fracturing, or “fracking”], and production) using distance from the patient’s home to the well, well characteristics, and the dates and durations of phases.

Main Outcomes and Measures
We identified and defined asthma exacerbations as mild (new oral corticosteroid medication order), moderate (emergency department encounter), or severe (hospitalization).

Results
We identified 20 749 mild, 1870 moderate, and 4782 severe asthma exacerbations, and frequency matched these to 18 693, 9350, and 14 104 control index dates, respectively. In 3-level adjusted models, there was an association between the highest group of the activity metric for each UNGD phase compared with the lowest group for 11 of 12 UNGD-outcome pairs: odds ratios (ORs) ranged from 1.5 (95% CI, 1.2-1.7) for the association of the pad metric with severe exacerbations to 4.4 (95% CI, 3.8-5.2) for the association of the production metric with mild exacerbations. Six of the 12 UNGD-outcome associations had increasing ORs across quartiles. Our findings were robust to increasing levels of covariate control and in sensitivity analyses that included evaluation of some possible sources of unmeasured confounding.

Conclusions and Relevance
Residential UNGD activity metrics were statistically associated with increased risk of mild, moderate, and severe asthma exacerbations. Whether these associations are causal awaits further investigation, including more detailed exposure assessment.

Medical error is the third leading cause of death in the US

Today in the US there are more medications, diagnoses and procedures than ever ; overtreatment is endemic

Medical error—the third leading cause of death in the US, The BMJ, dx.doi.org/10.1136/bmj.i2139, 03 May 2016.

Medical error is not included on death certificates or in rankings of cause of death.

Martin Makary and Michael Daniel assess its contribution to mortality and call for better reporting.
.
Press Play > to listen to the recording.

Medical error has been defined as an unintended act (either of omission or commission) or one that does not achieve its intended outcome, the failure of a planned action to be completed as intended (an error of execution), the use of a wrong plan to achieve an aim (an error of planning), or a deviation from the process of care that may or may not cause harm to the patient. Patient harm from medical error can occur at the individual or system level. The taxonomy of errors is expanding to better categorize preventable factors and events. We focus on preventable lethal events to highlight the scale of potential for improvement. “…

…Continue reading: Medical error—the third leading cause of death in the US, The BMJ, 03 May 2016. See also the responses.

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EDCs ability to alter reproductive function and health in females

Endocrine disrupting chemicals and disease susceptibility

The ability of EDCs to alter reproductive function and health in females has been clearly demonstrated by the consequences of DES use in pregnant women. The daughters of women given DES while pregnant were shown to have rare cervicovaginal cancers, decreased fertility and increases in rates of ectopic pregnancy , and early menopause. Many of these disorders have been replicated in laboratory animals treated with DES during gestation. As Newbold points out, the lessons learned from 40 years of DES research in humans and animals are that the female fetus is susceptible to environmentally induced reproductive abnormalities,that gonadal organogenesis is sensitive to synthetic hormones and hormone mimics during critical exposure windows, and that reproductive disease may not appear until decades after exposures.

Endocrine disrupting chemicals and disease susceptibility, Journal of Steroid Biochemistry & Molecular Biology,
doi:10.1016/j.jsbmb.2011.08.007, 6 August 2011.

Proper development of ovarian follicles in the fetus is dependent on estrogen exposure during critical periods of development. For instance, mice treated with DES on postnatal day 1–5 develop multioocytic follicles as adults. Therefore,maintaining a homeostatic balance of local and systemic hormones during follicle development is necessary for normal follicle development and germ cell quality. Perturbations in hormone signaling resulting from chemical exposures during developmental periods could contribute to ovarian disorders and declining conception rates in human populations.And while the mechanisms by which EDCs alter follicle development are not fully understood, there is evidence that these chemicals are contributing to increased rates of aneuploidy, polycyctic ovary syndrome (PCOS), premature ovarian failure (POF), and altered cyclicity and fecundity. For example, studies have shown that prenatal exposure to BPA causes irregular cycles in mice, which is likely due to hypothalamic alterations in the circuitry that controls luteinizing hormone (LH) secretion and ovulation. In humans, altered cyclicity has been reported in individuals exposed to organochlorine pesticides. Indeed, cycle irregularities have been noted in women whose mothers were exposed in utero to DES.

Uterine fibroids (leiomyomas) are the most common tumor of the female reproductive system, occurring in 25–50% of all women. The risk of the development of uterine fibroids increases with age during premenopausal years, but tumors typically regress with the onset of menopause. Obesity, age at menarche and unopposed estrogen signaling have been shown to increase the risks for fibroids. The best characterized animal model for the study of uterine fibroids is the Eker rat. A mutation of the tuberous sclerosis complex 2 (Tsc2) tumor suppressor gene causes females to develop spontaneous uterine fibroids at a high frequency. Studies using this model have shown that exposure to EDCs increases the incidence of fibroids in these animals. Developmental exposure to DES causes rats that are genetically predisposed to uterine tumors to develop even more tumors of a larger size, but fails to induce tumors in wild-type rats. Importantly, DES exposure imparts a hormonal imprint on the developing uterus that causes an increase in estrogen-responsive gene expression. The potential for DES to cause uterine fibroids in humans is less clear. Two studies on DES daughters came to different conclusions. In a study of 2570 women born during the period DES was prescribed, no association was found between prenatal exposure and uterine fibroids. Another study of 1188 women found a significant relationship between DES exposure and uterine fibroids. On analysis of these studies, Baird and Newbold concluded that there was a definitive increase in uterine fibroids in DES daughters and the discrepancies between the studies was due to the differences and sensitivities of the methods used to detect the tumors.

In summary, both animal and human studies suggest a role of EDCs in altering female reproductive development. Data from animal experiments show that EDC exposure during critical periods of development, both prenatal and neonatal, can induces functional changes that appear later in life. There are data gaps in understanding the mechanisms by which EDCs carry out their action, but it is clear that to reduce the risk of reproductive disorders we must take action to reduce exposure to these chemicals.

More DES DiEthylStilbestrol Resources

Doctors misunderstand what FDA drug approval really means

Shouldn’t physicians and consumers hear about the negative studies?

Most doctors do not fully understand the drug approval process for the US Food and Drug Administration (FDA) or the FDA’s “breakthrough” drug classification.

” Physicians tended to overestimate the minimum evidence of efficacy required of new drugs.

Similarly, many misinterpreted the term breakthrough—believing these drugs were supported by stronger evidence than required by the statute. “

write Aaron S. Kesselheim, MD, JD, MPH, from Brigham and Women’s Hospital in Boston, Massachusetts

Abstract

This survey study examines how well physicians understand the US Food and Drug Administration’s (FDA’s) statutory definition of a “breakthrough” therapy, and whether the term breakthrough affects their perceptions of a drug’s efficacy.

Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation, JAMA. 2016; 315(14):1516-1518. , doi:10.1001/jama.2015.16984, April 12, 2016.

Before US patients can use new prescription drugs, the US Food and Drug Administration (FDA) reviews the clinical trial results to confirm that benefits outweigh harms for the indication. Approval may involve superiority to placebo, not to an active comparator or standard of care (although approval can be based on uncontrolled or historically controlled studies). Numerous pathways expedite drug development and approval for serious or life-threatening conditions. For example, since 2012, the FDA can designate a drug as a “breakthrough therapy” if preliminary clinical evidence—such as an improvement in a pharmacodynamic biomarker—suggests an advantage over existing options Through April 2015, the FDA designated 76 “breakthrough” drugs and the term is routinely used in press releases and prescribing resources.

Press releases
  • Inside the Sausage Factory of Drug Approval: Nuplazid (pimavanserin) coverage didn’t inspect closely enough, healthnewsreview, May 23, 2016.
  • Internists, Specialists Lack Knowledge About FDA Drug Approval Process, medscape, April 12, 2016.

Concerns about Nanoparticles Risks to the Environment

Toxicity depends on the type of particle

Nanoparticles are tiny particles under 100 nanometres in size — around 1 000 times smaller than the width of a human hair. Due to their large surface area-tovolume ratios, they can be used to produce materials with new functions and properties (compared to their conventional forms), such as very thin films, tubes, wires and coatings. Engineered nanoparticles are already widely used in the electronics, food technology, energy and pharmaceuticals sectors and have an estimated global market value of €20 billion.

Although nanoparticles have many beneficial applications, there is concern about what might happen if they are released into the environment (their ecological risk). Laboratory studies have shown that many nanoparticles — specifically those made of silver, copper and zinc — have anti-microbial properties. While these may be beneficial for medical applications, the introduction of such particles into the natural environment could pose a threat to beneficial microbial communities (bacteria, fungi and archaea), such as those found in soil.

Nanoparticles’ ecological risks: effects on soil microorganisms, , Science for Environment Policy News Alert, 15 July 2016.

Magnetic flux lines for nickel nanoparticles by brookhavenlab.

This is a growing concern, as models suggest that soil is a major receptor of nanoparticles — more so than air or water. Nanoparticles can enter the soil through industrial spills, landfill sites or when sewage sludge is used as a fertiliser. They can also be used intentionally to clean the soil. Nanoscale zerovalent iron (nZVI) particles, for example, have been used to remove a range of pollutants from soil (in a process known as bioremediation).

It is important that any potential adverse effects are detected early, as soil microorganisms provide essential ecosystem services, including nutrient cycling, crop production and climate regulation.

Impact of engineered nanoparticles on the activity, abundance, and diversity of soil microbial communities: a review, NCBI PubMed, PMID: 25647498, 2015 Sep.

To assess the effects of engineered nanoparticles on soil microbial communities, the researchers performed a comprehensive literature review. They noted the effects of three major types of nanoparticles — metal and metal oxide nanoparticles, carbon-based nanoparticles and nZVI — on the number of microorganisms (abundance), number of different species of microorganisms (diversity) and their activity.

Overall, they found that toxic effects depend on the type of nanoparticle, with metal nanoparticles generally being more toxic than organic (carbon-based) nanoparticles. Metal and metal oxide nanoparticles can have toxic effects on activity, abundance and diversity even at concentrations below 1 milligram per kilogram (mg per kg). For example, silver nanoparticles have been shown to reduce some enzyme activities in microorganisms (which are important for their ability to break down organic matter in soil and contribute to crucial biogeochemical cycles), while copper- and zinc-based nanoparticles can reduce bacterial growth and biomass.

Metal nanoparticles can also affect the entire bacterial community; in one study, sewage sludge containing 0.14 mg per kg of silver nanoparticles changed the bacterial community structure, despite only a short-term exposure. However, very high concentrations of carbon nanoparticles, much higher than those predicted to be found in the environment (over 250 mg per kg), are required to have negative effects.

Surprisingly, nZVI (which is widely used to restore polluted soils) can have detrimental effects on the ability of microorganisms to biodegrade pollutants — the essence of soil bioremediation. The researchers say more work is needed to understand how nZVI treatments may be affecting these non-target populations and, therefore, soil functions.

As well as the type of nanoparticle, soil properties are also important in determining the toxic effects of nanoparticles. Organic matter content, pH and texture, for example, all influence the type of microorganisms living in the soil and the ability of pollutants to have toxic effects on them (bioavailability).

The researchers say that most studies to date have only analysed the impact of nanoparticle contamination using high concentrations and in a single type of soil. They recommend that future studies should use concentrations of nanoparticles that are likely to be found in natural settings (and over longer time periods) and should compare the toxicity of the same nanoparticles in different soils. This could facilitate the identification of the soil properties that influence the bioavailability and toxicity of nanoparticles, which they say is ‘fundamental’ for environmental risk assessment.

Further recommendations for risk assessment include studying nanoparticles in natural conditions (which is currently technically challenging) and investigating how nanoparticles interact with other pollutants in soil, such as heavy metals and pharmaceutical residues.

Glyphosate: one pesticide, many problems

EU extended the herbicide’s market authorisation

The latest episode in the glyphosate saga just took place, with the EU’s Health and Food Safety Commissioner, V. Andriukaitis, announcing that the European Commission would extend the current market authorisation of glyphosate by 18 months.

Time has ran out: the current market authorisation for glyphosate expires on 30 June 2016. Last Friday, the “Standing Committee on Plants, Animals, Food and Feed”, made up of representatives of EU States, met again in Brussels to vote a proposal by the European Commission to extend the current market authorisation of glyphosate (declared main ingredient of the herbicide Roundup) by 12-18 months. Again, the failed to agree or disagree, as they did during their previous meetings, so the European Commission was allowed to adopt its own proposal to extend glyphosate’s current market authorisation.

The European Commission just extended the pesticide’s market authorisation, Corporate Europe Observatory, June 28th 2016.

Image of a “green desert” in Argentina: kilometres of glyphosate-tolerant soy monocroppin, by Pedro Francisco Suarez.

Judging by comments from Commission vice-President F. Timmermans on June 15 to MEPs (“the Commission does not have the luxury to abstain” from 3h00’00” onwards , replying to a question by MEP Huitema on the current glyphosate gridlock at 2h37’58”), industry’s threats of lawsuits in case of non-renewal and the Commission’s own position, it was rather obvious it would do it.

Health Commissioner Andriukaitis referred to the Commission’s “legal obligations” to explain their decision to extend the licence in order to wait for the final assessment of the substance by the European Chemicals Agency (ECHA) of Helsinki. In charge of the file, he had been in a very uncomfortable position for months, squeezed between Member States’ unexpected resolution to not approve such a controversial herbicide and Juncker’s fury that the Commission would get the blame for taking the decision to keep such an unpopular product on the market at a time when the Brexit referendum puts the entire EU administration at very high political risk. Andriukaitis made clear that the Commission desperately wanted EU member states’ support for its proposal, but did not succeed in swaying them: there was no notable change in EU states’ respective positions since the last vote on June 6, lost under strong media attention by the Commission. France had already declared it would vote against the Commission proposal next Friday, Germany that it would abstain (although the battle was said to have resumed there in the days before the vote between the socialists and the conservatives). It looks like the European Commission preferred public fury to industry lawsuits.

Missed opportunities and bigger pictures

In our opinion, one of the most important – but less discussed – stakes in this process has been the possibility to put an end to the use of one the most used and efficient plant-killer on Earth while we’re experiencing the fastest biodiversity collapse ever measured. The glyphosate saga could have been an opportunity to at last discuss and regulate the use of wide-spectrum herbicides in agriculture, but this is yet to happen.

Similarly, little discussed too are the accompanying protection measures that EU farmers would need against their non-EU competitors in the case of a ban. Without these, farmers- rather than adopting healthier but more expensive weed management practices – were at a risk of exposing themselves to other herbicides with comparable or yet worse effects than those containing glyphosate, while having to pay a premium.

This was not lost however on the pesticide industry, which had been talking a lot lately about the need to help farmers keep buying glyphosate. In Brussels and in national capitals (and particularly in London), the largest farmers unions had upscaled their lobbying to keep glyphosate on the market since May, mainly using the argument of glyphosate being “too big too ban”, and trying to float their interests in the context of the UK’s referendum on EU membership taking place today. The glyphosate saga could have been an opportunity to discuss much-needed evolutions in European agriculture, currently facing a tragic race to the bottom at the expense of quality, labour conditions and sustainability, but it didn’t happen yet.

Up to now, the most discussed issue has remained whether glyphosate “probably causes” cancer to humans, as the International Agency for Research Against Cancer (IARC) found in 2015. Beyond the worrisome result, this qualification, under EU pesticides rules, would cause its ban regardless of exposure levels…. but the official EU process found the opposite (IARC’s evidence was linked to high exposure levels, so apparently more relevant for sprayers than for other citizens). Because this is the only argument that, under current rules, could trigger a legal ban, it has tended to monopolise the debate.

The pesticide industry and the EU administration argued that the normal risk assessment rules have been followed, that their assessment was better than IARC’s (the agency has been abundantly slandered since it published its conclusion), that previous and other recent official assessments point in the same direction, and therefore that there is no ground to oppose the re-licensing. They call the ongoing gridlock “political interference”, arguing for the need to follow existing “science-based” rules.

Science vs. politics, really?

There is a problem with this line of argumentation though: comparing the two processes puts the respect for the scientific method squarely in IARC’s camp. While it only used published scientific literature and worked with a panel of international cancer specialists whose independence had been confirmed, the EU’s official process, combining EU and national risk assessment agencies, relied heavily on unpublished industry-funded studies, themselves assessed by public officials 80% of whom refused to be identified.

So, the EU administrations and the pesticide industry defended a conclusion whose underlying evidence is only accessible to themselves, because the scientific studies at stake belong to companies such as Monsanto that threaten to sue the EU administration if it shares them with anyone else, “science-based” rules or not. Nevertheless, the European Commission always had the legal possibility to publish this evidence, invoking an overriding public interest which, considering the level of public attention and debate, would have been wholly justified, but seems not interested. The opposite is sadly true: the Commission is currently appealing, with the help of the pesticides industry, a judgment from the European Court of Justice that forced it to publish parts of the evidence used to deliver glyphosate’s previous market authorisation! Rumour has it that the European Commission’s Legal Service simply doesn’t like losing…

Data secrecy at the root of the political scandal

In any case, one could argue that data secrecy is the very reason this seemingly technical process became political and caused the 6-months gridlock. The unusual conflict between two major public health administrations, IARC and the European Food Safety Authority (EFSA), grew out of the impossibility for EFSA to follow the normal scientific method of sharing its evidence with IARC for cross-examination and discussion. Today, the two agencies have cut communication, an absurd situation.

Several MEPs and NGOs (including CEO) have officially called on EFSA to publish the studies, so far to no avail (CEO introduced its request more than seven months ago, we’re still waiting, see our companion piece on industry’s arguments to fight disclosure). The dire situation is acknowledged grudgingly by at least some in the European Commission, starting with Andriukaitis himself. Last March 4, in a press conference right after a meeting of Member States (Environment Council) where some EU States had made their opinion clear already, Andriukaitis made no mystery that this data secrecy was a major problem:

There is the possibility to disclose these studies because of overriding public interest, we’re ready to assess the legal environment…” “It is crystal clear there is a need to change today’s situation; we’re considering different options, but at the moment the idea is to change the rules, keeping in mind overriding public interest. Such ideas are on my table“.

Andriukaitis’ lonely good intentions

The Commissioner publicly asked industry for the publication of the studies on April 4. But there are doubts as to whether his services shared his resolution: industry reacted on the same day in a way that shows that the two documents were coordinated so as to not create a precedent which could endanger the Commission and industry’s court case against glyphosate data disclosure (see a critical open letter on the issue CEO co-signed).

CEO obtained a document showing that on 17 March 2016, DG SANTE, EFSA and the Glyphosate Task Force held a telephone conference together, “facilitated by ECPA” (the pesticide industry lobby group). A report of this meeting shows how the three parties discuss the idea to install a ‘reading room’ (just like for TTIP), to give a selected audience access to the studies. One can see why: no scrutiny to fear for industry, no huge redaction work to “sanitise” the studies by the EU administration. This is of course not a solution: it takes more than reading to assess scientific results.

Andriukaitis himself told just that to journalists from Arte VoxPop: “in my opinion, the reading room is not enough, it would be better to show the details of the scientific studies on internet”.

In any case, such a reading room has not even been put in place, so the secrecy continues. And since the “science” argument fails to convince for the above-mentioned reasons, what is left to the European Commission is political tactics.

Commission asks industry to lobby Member States

On 4th April 2016, another meeting happened between Commissioner Andriukaitis himself, DG SANTE officials, and lobbyists from ECPA, CEFIC (European chemical industry) and COPA-COGECA (EU-level union of big farmers, all too often siding with the pesticide industry) . According to the minutes released by the European Commission, the Commissioner “reminded the visitors [the industry lobbyists, red.] about their responsibility to talk to Member States and MEPs with a view to get their support for the renewal”. Another example of the old de facto alliance between the Commission and business groups against national administrations, but if convincing Member States of the safety of a product boils down to industry lobbying, then that does not exactly lead to more trust in the scientific integrity of this re-approval process.

Industry, on its side, said it was very worried: ECPA expressed concerns in this meeting that “if robust statements of BfR and EFSA are not followed that will be victory for opponents and set precedent for all future approvals”.

As we wrote at the beginning, glyphosate is indeed a substance entangled in much broader, and possibly more important, political debates: the integrity and trustworthiness of the EU’s chemicals assessment regulations, the relevance of still using wide-spectrum herbicides today, the sustainability of agriculture… But unfortunately all these points are brought up separately, as and when they do.

One observation to conclude on: Germany’s Bfr and EFSA recommended not only glyphosate’s re-approval, but also an increase in the acceptable daily intake (ADI) by 66% (from 0.3 to 0.5 mg per kg body weight per day). As a consequence, EFSA has already started to increase legally admissible exposure levels to glyphosate.

Corporate Europe Observatory Files

  • FW: BTO – Discussion re access to glyphosate information, corporateeurope, 17.03.2016.
  • BTO Meeting Commissioner Andriukaitis with ECPA, CEFIC, COPA-COGECA and Agri-Food Chain, corporateeurope, 4 April 2016.