Environmental Health Concerns From Unconventional Natural Gas Development

After a decade of research, here’s what scientists know about the health impacts of fracking

Hydraulic fracturing, also known as fracking, is a process of extracting oil and gas from the Earth by drilling deep wells and injecting a mixture of liquids and chemicals at high pressure. According to a new study, fracking has been linked to preterm births, high-risk pregnancies, asthma, migraine headaches, fatigue, nasal and sinus symptoms, and skin disorders over the last 10 years, Environmental Health News reports. Image Victoria Buchan-Dyer.

Summary and Keywords

Unconventional natural gas development (UNGD), which includes the processes of horizontal drilling and hydraulic fracturing to extract natural gas from unconventional reservoirs such as shale, has dramatically expanded since 2000. In parallel, concern over environmental and community impacts has increased along with the threats they pose for health. Shale gas reservoirs are present on all continents, but only a small proportion of global reserves has been extracted through 2016. Natural gas production from UNGD is highest in the United States in Pennsylvania, Texas, Louisiana, Oklahoma, and Arkansas. But unconventional production is also in practice elsewhere, including in eighteen other U.S. states, Canada, and China. Given the rapid development of the industry coupled with its likelihood of further growth and public concern about potential cumulative and long-term environmental and health impacts, it is important to review what is currently known about these topics.

The environmental impacts from UNGD include chemical, physical, and psychosocial hazards as well as more general community impacts. Chemical hazards commonly include detection of chemical odors; volatile organic compounds (including BTEX chemicals [benzene, toluene, ethylbenzene, and xylene], and several that have been implicated in endocrine disruption) in air, soil, and surface and groundwater; particulate matter, ozone, and oxides of nitrogen (NOx) in air; and inorganic compounds, including heavy metals, in soil and water, particularly near wastewater disposal sites. Physical hazards include noise, light, vibration, and ionizing radiation (including technologically enhanced naturally occurring radioactive materials [TENORMs] in air and water), which can affect health directly or through stress pathways. Psychosocial hazards can also operate through stress pathways and include exposure to increases in traffic accidents, heavy truck traffic, transient workforces, rapid industrialization of previously rural areas, increased crime rates, and changes in employment opportunities as well as land and home values. In addition, the deep-well injection of wastewater from UNGD has been associated with increased seismic activity.

These environmental and community impacts have generated considerable concern about potential health effects and corresponding political debate over whether UNGD should be promoted, regulated, or banned. For several years after the expansion of the industry, there were no well-designed, population-based studies that objectively measured UNGD activity or associated exposures in relation to health outcomes. This delay is inherent after the introduction of new industries, but hundreds of thousands of wells were drilled before any health studies were completed. By 2017, there were a number of important, peer-reviewed studies published in the scientific literature that raised concern about potential ongoing health impacts. These studies have reported associations between proximity to UNGD and pregnancy and birth outcomes; migraine headache, chronic rhinosinusitis, severe fatigue, and other symptoms; asthma exacerbations; and psychological and stress-related concerns. Beyond its direct health impacts, UNGD may be substantially contributing to climate change (due to fugitive emissions of methane, a powerful greenhouse gas), which has further health impacts. Certain health outcomes, such as cancer and neurodegenerative diseases, cannot yet be studied because insufficient time has passed in most regions since the expansion of UNGD to allow for latency considerations. With the potential for tens of thousands of additional wells across large geographic areas, these early health studies should give pause about whether and how UNGD should proceed. Citing health concerns, several U.S. states and nations in Europe have already decided to not allow UNGD.

The Primodos Issue ; debated by Lord Alton of Liverpool

UK Parliament, House of Lords Hansard, 28 February 2019

“They have faced the implacable determination of regulatory bodies spending huge amounts of public money on ad hoc scientific reviews to cast doubt on the work of highly reputable scientists. Those who have suffered so grievously deserve much better than this.”

Safety of Medicines and Medical Devices, House of Lords Hansard Debate, 28 February 2019.

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Primodos, Sodium Valproate, Surgical Mesh : Baroness Cumberlege Talks

UK Parliament, House of Lords Hansard, 28 February 2019

“For the families involved, it is life-changing and extremely distressing. For those women who took Primodos and sodium valproate, there is an intense feeling of guilt. They took the medication and they blame themselves. However hard one tries to persuade them that it was not their fault, the guilt remains.”

“That tells me something is seriously wrong; the system is not working as it should. People who have been harmed should not have to fight to be heard or to access the care they need.”

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Lords debate Safety of Medicines and Medical Devices

UK Parliament, House of Lords Hansard, 28 February 2019

Lords debates medicinal safety in ref to the public health scandals involving the hormone-based pregnancy test drug Primodos, the use of vaginal mesh implants and the anti-epilepsy drug sodium valproate.

  • Interventions from Lord O’Shaughnessy, Lord Hunt of Kings Heath, Baroness Walmsley, Baroness Masham of Ilton, Baroness Cumberlege 36:28 , Lord Brennan, Lord Carrington, Lord Bethell, Baroness Bryan of Partick, Lord Alton of Liverpool 1:17:29 , Lord Suri, Baroness Finlay of Llandaff, The Earl of Dundee, Baroness Jolly, Baroness Thornton, The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford).
  • Read the Lords Hansard transcript.
  • Parliamentary news, research briefing.
  • Parliament news, press release.
  • Video source, Parliament Tv.

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EWG Primodos review criticised for ‘not assessing risks properly’

Sky News’ Exclusive, 4 Apr 2019

“Somebody, somewhere, has performed a meta-analysis.
At some point, there was a decision not to include that in the EWG report.”

Oxford University professor Carl Heneghan has told Sky News the evidence against the pregnancy drug Primodos suggests a significant link between it and birth deformities (see below).

On 23 April 2019, during the Westminster Hall debate on the Expert Working Group report on hormone pregnancy tests, some MPs also questioned the methodology used and asked why not use meta-analysis to assess primodos evidence ? Some others clarified the difference between correlation vs causation (in ref to primodos link to births defects), or said : with pharma funding the MHRA, can the EWG report be fully independent ?

More information

  • 2018 Studies :
    • Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
    • The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, Nature, 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • Westminster Hall debate pack : CDP-2019/0095, 18 April 2019.

FDA bans sales of transvaginal mesh

FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

April 16, 2019 – The U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP.

The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since the agency reclassified them in class III (high risk) in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the U.S. The companies will have 10 days to submit their plan to withdraw these products from the market.

continue reading the FDA press announcement.
Read the meshCNN press release. Image credit leakylily.

In the UK

 

Developmental Origins of Endometriosis

a Swedish cohort study, Journal of epidemiology and community health, 2019

Abstract

Background
Endometriosis is a chronic condition affecting women of reproductive age and is associated with multiple health burdens. Yet, findings regarding its ‘developmental origins’ are inconsistent. We aimed to investigate the associations of birth characteristics with endometriosis. We also explored potential mediation by adult social and reproductive factors.

Methods
This cohort study consisted of 3406 women born in Uppsala, Sweden, between 1933 and 1972. We used data from archived birth records and endometriosis diagnoses at ages 15–50 recorded in the national patient registers. Socioeconomic and reproductive characteristics were obtained from routine registers. HRs were estimated from Cox regression.

Results
During the follow-up, 111 women have been diagnosed with endometriosis, and most cases are external endometriosis (ie, outside the uterus, n=91). Lower standardised birth weight for gestational age was associated with increased rate of endometriosis (HR 1.35 per standard deviation decrease; 95% CI 1.08 to 1.67). This increased rate was also detected among women with fewer number of live births (HR 2.38; 95% CI 1.40 to 4.07 for one child vs ≥2 children; HR 6.09; 95% CI 3.88 to 9.57 for no child vs ≥2 children) and diagnosed infertility problem (HR 2.00; 95% CI 1.10 to 3.61) prior to endometriosis diagnosis. All the observed associations were stronger for external endometriosis. However, no evidence was found that number of births was the mediator of the inverse association between standardised birth weight and endometriosis.

Conclusion
This study supports the developmental origins theory and suggests that exposure to growth restriction during the fetal period is associated with increased risk of endometriosis during reproductive years.
Image credit hellomagazine.

DES Exposure and Endometriosis

With Pharma funding the MHRA, can the EWG Report be Fully Independent ?

Westminster Hall debate, 23 April 2019

” Yes we had a (Primodos) review, but I’m not sure we can call that ‘independant’ “

Yasmin Qureshi MP calls into question the independence of the MHRA in its central role on the expert working group (EWG), for their report on the use of hormone pregnancy tests (HPTs) and adverse effects relating to pregnancy including possible birth defects.

Westminster Hall debate, 23 April 2019. Video reference.

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Vulvar Cancer is on the Rise in the UK, study shows

Relationship between vulvar symptoms and incidence of vulvar cancer in women referred to a rapid access clinic

Abstract

Objective
We performed a study to estimate incidence of vulvar cancer in women with vulvar symptoms (irritation, pain, bleeding +/− presence of lesion) referred to a secondary care, rapid‐access clinic.

Methods
Prospective data collection of all direct referrals from a primary to a secondary care gynecological oncology clinic from 2011 to 2016, for women with suspicious vulvar symptoms.

Results
32/393 (8.1%) women had vulvar cancer, and 24/393 (6.1%) had a premalignant lesion. Multivariate logistic regression showed that women referred without a specific lesion had considerably lower odds of a diagnosis of vulvar cancer than those with a lesion (OR=0.11, 95% CI: 0.03–0.49). In total, 30/234 (12.8%) women with a vulvar lesion (mass or ulcer), had vulvar cancer, compared with 2/159 (1.3%) of those referred without a lesion (these patients had vulvar irritation and bleeding but had a visible lesion on examination). None of the 140 women with irritation alone, in the absence of a visible lesion or bleeding, had pre‐invasive disease or cancer.

Conclusion
Presence of a vulvar lesion, especially if painful/bleeding, has a high positive predictive value for vulvar cancer and 12.8% of women presenting with any vulvar lesion to secondary care had cancer.

Discussion

Overall, 32/393 (8.1%) women referred with vulvar symptoms were diagnosed with a malignancy and a further 24/393 (6.1%) were diagnosed with a pre‐malignant lesion. The presence of a suspicious vulvar lesion, especially if symptomatic, was associated with a cancer diagnosis in 30/234 (12.8%) women. Unless the lesion is obviously benign (which in this series included: sebaceous inclusion cyst; urethral caruncle; inspissated sebaceous material trapped under the clitoral hood; and ecchymosis on a background of lichen sclerosus), a rapid‐access clinic referral is appropriate to exclude a malignancy in these women. A larger cohort would be required to stratify risk by age. However, as the incidence of vulvar cancer is increasing, especially in younger women, it would be important not to dismiss suspicious symptoms based on age alone.

Women without a visible lesion were extremely unlikely to have cancer, based on this cohort of patients (<1.3% depending on whether presence of lesion was defined by patient/primary care [0/159] vs secondary care (2/159). However, these findings would need to be applied to a larger population to test this hypothesis and with wider generalization to other healthcare populations. One strength of this dataset is that the population is well‐defined and relatively stable, so re‐referrals, subsequently diagnosed with a cancer, would have been referred back to the same clinic. In the present series, six women were re‐referred during the study period (one woman was seen three times and five women were seen twice). None of these women had a cancer diagnosis. Unfortunately, we were not able to define an average lead time from onset of symptoms to diagnosis from our data, since this was not reliably recorded.

Many women with symptoms of vulvar soreness and irritation, in the absence of a specific lesion, were diagnosed with an inflammatory condition; half had lichen sclerosus or lichen planus. Primary care physicians should be reassured that, in the absence of a suspicious lesion, a cancer diagnosis or a pre‐malignant condition was unlikely. As per dermatology guidelines, if there are classical signs of lichen sclerosis, a diagnostic biopsy is not needed if there is a response to high‐potency topical steroids. Women whose symptoms do not start to improve after 2–3 weeks of treatment, should be re‐assessed and referred if symptoms persist or a lesion develops.

The overall incidence of vulvar cancer in this series was slightly lower than in those in the literature. This is perhaps surprising, as the local population is relatively elderly; in the 2011 census 29.1% of West Somerset were aged 65 years or over compared with a UK average of 16.4%. However, this series is nearly 10‐fold larger than those previously published, so may reflect the increased statistical power of this study. It may also reflect a difference in local referral patterns and criteria, since women may be referred to a general gynecology clinic or a dermatologist in other areas. One study from an urban area in the South East of England looked at cancer diagnosis rates in women referred to a gynecologic fast‐track clinic. They included a total of 335 women referred to secondary care. Only 18 women had symptoms suggestive of vulvar cancer, of whom only two (11.1%) were diagnosed with vulvar cancer. A similar study, also from the South East of England, included only 13 women with vulvar symptoms and found a positive predictive value of a cancer diagnosis of 15.4% in this subset. A further series of women with suspected gynecologic malignancy, also from the South East of England, included 1105 women referred to secondary care. Forty‐four of these women were referred with suspected vulvo‐vaginal cancer and 13.6% were diagnosed with a malignancy.

These data help to differentiate between those who should be referred via a fast‐track clinic and those who could be treated more conservatively for vulvar symptoms, and could help to inform national guidance—including future updates of NICE guidelines. Further data would be required to determine whether these data had wider applicability in other, more diverse populations, and these data are limited by the secondary care focus of this study. It would be interesting to compare rates of women presenting with vulvar symptoms in a primary care population with secondary care referrals and cancer incidence in that population over the same time period to provide evidence for triage of those requiring rapid assessment. This is important in the face of the increasing incidence of vulvar cancer, due to changes in demographics and HPV prevalence.

Finally, many women delay presentation and may have significant symptoms for many months, due to fear, embarrassment or lack of awareness of vulvar conditions generally, and vulvar cancer in particular. Many women in our series had inappropriate treatment for vulvar skin conditions or suspicious lesions with low potency steroids, topical estrogens, anti‐fungal agents, antibiotics, or no treatment at all for prolonged periods. This may be due to ‘home remedy’ self‐treatment (possibly fueled by lack of knowledge and advertisements for ‘intimate itching’), avoidance of doctors, or reluctance to use adequate courses of high potency topical steroids, by both physicians and the women affected. Research is also needed to inform us about barriers to presentation, especially in older women, who are most at risk of vulvar cancers, and to improve health education for this under‐resourced area.
Feature image credit @DiggerGraham (see below).

Fichage Généralisé Organisé par Monsanto et une Société de Lobbying

Révélations, Le 20Heures France2, 9 May 2019

“Elus, hauts fonctionnaires, journalistes… Ils auraient été fichés et notés en fonction de leur degré de soutien à loMonsanto. Même Ségolène Royal, alors ministre de l’Environnement. Elle est dite “à marginaliser” Référence.

Une fuite de documents confidentiels, qui portent la signature d’une agence de communication travaillant pour Monsanto, a permis aux journalistes de l’Œil du 20 heures de mettre la main sur des documents inédits.

Des pratiques vraisemblablement illégales. Des plaintes ont été déposées.