Diclegis: what about NOT to prescribe the only Pregnancy Category A Medication for Morning Sickness?

Pharma targeting cu$tomer$ and doctors directly by mail…

Diclegis: why not NOT prescribe the only Pregnancy Category A Medication for Morning Sickness?
If I were a doctor, I would definitely not prescribe the Diclegis drug

Amazingly, I received an email today, from Diclegis Duchesnay USA – MedIntel@hcpconnects.com – with the subject: “Why Not Prescribe the Only Pregnancy Category A Medication for Morning Sickness?” !!! wow, those guys are targeting cu$tomer$ and doctors directly by mail… they are not selling enough yet? Here are few thoughts regarding why, if I were a doctor, I would definitely not prescribe the Diclegis drug:

When Scientists attack: a Laurel to Stephane Horel

Scientists critical of EU chemical policy found to have industry ties

Scientists critical of EU chemical policy have industry ties
Officials from the European Commission stressed that the best available science will guide their endocrine disruptor regulations

Alexis Sobel Fitts, Editor for CJR.org confirms Stéphane Horel and Brian Bienkowski deserve a laurel for their article investigating a group of scientists who authored a controversial editorial condemning a proposed regulatory policy for endocrine disruptors.
Indeed the two EHN reporters chronicled the scientists’ financial and political affiliations – weaving a comprehensive story of the influences behind science policy.

What is this about?
Seventeen scientists who have criticized plans in Europe to regulate endocrine-disrupting chemicals have past or current ties to regulated industries. An investigation by Environmental Health News reveals that of 18 toxicology journal editors who signed a controversial editorial, 17 have collaborated with the chemical, pharmaceutical, cosmetic, tobacco, pesticide or biotechnology industries. Some have received research funds from industry associations, while some have served as industry consultants or advisors. The stakes are high in the controversy because it involves the European Union’s strategy to regulate hormone-altering chemicals – the first attempt in the world to do so. The new rules would have sweeping, global ramifications because all companies that sell a variety of products in Europe would have to comply.

Exposure to AntiEpileptic Drugs in Utero and Child Development

Prospective population-based study, 2013

Abstract

Exposure to antiepileptic drugs in utero and child development: a prospective population-based study
Exposure to antiepileptic drugs during pregnancy is associated with adverse development at 18 and 36 months of age, measured as low scores within key developmental domains rated by mothers

PURPOSE:
Antiepileptic drugs may cause congenital malformations. Less is known about the effect on development in infancy and childhood. The aim of this study was to examine whether exposure to antiepileptic drugs during pregnancy has an effect on early child development.

METHODS:
From mid-1999 through December 2008, children of mothers recruited at 13-17 weeks of pregnancy were studied in the ongoing prospective Norwegian Mother and Child Cohort Study. Information on birth outcomes were obtained from the Medical Birth Registry (108,264 children), and mothers reported on their child’s motor development, language, social skills, and autistic traits using items from standardized screening tools at 18 months (61,351 children) and 36 months (44,147 children) of age. The relative risk of adverse outcomes in children according to maternal or paternal epilepsy with and without prenatal exposure to antiepileptic drugs was estimated as odds ratios (ORs), using logistic regression with adjustment for maternal age, parity, education, smoking, depression/anxiety, folate supplementation, and child congenital malformation or low birth weight.

KEY FINDINGS:
A total of 333 children were exposed to antiepileptic drugs in utero. At 18 months, the exposed children had increased risk of abnormal scores for gross motor skills (7.1% vs. 2.9%; OR 2.0, 95% confidence interval [CI] 1.1-3.7) and autistic traits (3.5% vs. 0.9%; OR 2.7, CI 1.1-6.7) compared to children of parents without epilepsy. At 36 months, the exposed children had increased risk of abnormal score for gross motor skills (7.5% vs. 3.3%; OR 2.2, CI 1.1-4.2), sentence skills (11.2% vs. 4.8%; OR 2.1, CI 1.2-3.6), and autistic traits (6.0% vs. 1.5%; OR 3.4, CI 1.6-7.0). The drug-exposed children also had increased risk of congenital malformations (6.1% vs. 2.9%; OR 2.1, CI 1.4-3.4), but exclusion of congenital malformations did not affect the risk of adverse development. Children born to women with epilepsy who did not use antiepileptic drugs had no increased risks. Children of fathers with epilepsy generally scored within the normal range.

SIGNIFICANCE:
Exposure to antiepileptic drugs during pregnancy is associated with adverse development at 18 and 36 months of age, measured as low scores within key developmental domains rated by mothers. Exposures to valproate, lamotrigine, carbamazepine, or multiple antiepileptic drugs were associated with adverse outcome within different developmental domains.

Sources: Exposure to antiepileptic drugs in utero and child development: a prospective population-based study
NCBI, July 2013

For Related Posts, see our Tags:
AEDsEpilepsyNCBIPregnancy
DrugsDépakineEpilimValproate

Perturbateurs Endocriniens et conflits d’intérêts: 17 scientifiques en dérapage incontrôlé

Dans quel camp se situe la Commission Européenne?

Perturbateurs endocriniens : conflits d’intérêts à haute dose
Face à l’influence des lobbies, la Commission Européenne doit clarifier sa position sur les perturbateurs endocriniens.

Le Réseau Environnement Santé s’étonne de la tournure que prennent les discussions sur la future réglementation des perturbateurs endocriniens. Alors que se confirme le non-respect de l’échéance d’élaboration des critères d’identification des perturbateurs endocriniens, fixée par les règlements biocides et pesticides de 2009 à fin décembre 2013, il semble que tous les coups soient permis pour tenter de déstabiliser les fondements mêmes de l’action européenne contre ces substances chimiques dangereuses pourtant qualifiées de “menace mondiale” par les plus hautes instances internationales.

Selon une enquête d’Environmental Health News, la quasi totalité – dix-sept sur dix-huit – des auteurs d’un éditorial controversé sur le projet de réglementation européenne des perturbateurs endocriniens sont liés à l’industrie. Ces dix-sept rédacteurs et rédacteurs en chef de plusieurs revues de toxicologie ont collaboré avec l’industrie chimique, pharmaceutique, cosmétique, et celles du tabac, des pesticides ou des biotechnologies. Certains ont bénéficié de financements d’associations industrielles. D’autres ont travaillé comme consultants ou conseillers…

En savoir plus:

Un tout grand merci à Michel Detry pour son tweet informatif  🙂

Exposure to Synthetic Estrogens at different Times during the Life and their Side Effects on Health

Synthetic Estrogens exposures induce epigenetic modifications for multiple generations

2013 Study Abstract:

Exposures to Synthetic Estrogens at Different Times During the Life, and Their Effect on Breast Cancer Risk
Synthetic Estrogens exposures induce epigenetic modifications for multiple generations

Women are using estrogens for many purposes, such as to prevent pregnancy or miscarriage, or to treat menopausal symptoms. Estrogens also have been used to treat breast cancer which seems puzzling, since there is convincing evidence to support a link between high lifetime estrogen exposure and increased breast cancer risk. In this review, we discuss the findings that maternal exposure to the synthetic estrogen diethylstilbestrol during pregnancy increases breast cancer risk in both exposed mothers and their daughters. In addition, we review data regarding the use of estrogens in oral contraceptives and as postmenopausal hormone therapy and discuss the opposing effects on breast cancer risk based upon timing of exposure. We place particular emphasis on studies investigating how maternal estrogenic exposures during pregnancy increase breast cancer risk among daughters. New data suggest that these exposures induce epigenetic modifications in the mammary gland and germ cells, thereby causing an inheritable increase in breast cancer risk for multiple generations.

2013 Study Conclusion:

Women use estrogens for many purposes. During pregnancy, synthetic strogen DES was used to prevent miscarriage and promote healthy pregnancy, although it turned out to cause the opposite. During the reproductive years when a woman’s own estrogen levels are high, women use synthetic estrogens as contraceptives. Since estrogens play an important role in normal physiological functions in women, some menopausal and postmenopausal women use estrogen supplementation to regain the benefits of natural estrogens.

The effects of estrogens on breast cancer risk differ depending upon when during a woman’s life time they are used. Maternal exposure to DES during pregnancy increases breast cancer risk in mothers and their daughters. The adverse effects of synthetic estrogen exposure during pregnancy may not be limited to mothers and their daughters. Our preclinical study in rodents showed that maternal exposure to EE2 increases breast cancer risk in daughters, granddaughters, and great granddaughters. The first generation of OCs increased breast cancer risk at the time women were taking them, but the increase in risk was not permanent. The current, third generation contraceptives do not increase breast cancer risk. Menopausal and postmenopausal HT, if it contains both estrogens and progestin, increases a woman’s breast cancer risk, and recent data suggest that tumors developing during therapy are more aggressive than those in women not using HT. Estrogen-only HT does not increase breast cancer risk, and might even reduce it. However, due to other adverse effects of estrogen-only HT, it is not recommended beyond using it to control the most severe menopausal symptoms.

We are beginning to understand how the increase in breast cancer risk following in utero exposures to synthetic estrogens occurs. It most likely involves long-term epigenetic changes in genes that are important in determining the risk for breast cancer development, such as tumor suppressor genes, PcTGs and oncogenes. Briefly, an exposure to synthetic estrogens during the fetal period induces modifications in the epigenetic reprogramming of the genome, leading to changes in mammary gland morphology, and gene and protein expression. Some of these changes are transient, such as an increase in the number of TEBs in rodents, and some persist, such as an altered gene and protein expression involving tumor suppressor genes and oncogenes. Together, epigenetically induced modifications in the mammary gland morphology and gene expression increase the likelihood that environmental carcinogens and radiation induce malignant transformation, and evetually breast cancer. The next challenge is to determine whether the increase in risk can be reversed by reversing epigenetic changes that occur as a consequence of early life exposure to synthetic estrogens.

Additional Information : Exposures to Synthetic Estrogens at Different Times During the Life, and Their Effect on Breast Cancer Risk, Springer, Journal of Mammary Gland Biology and Neoplasia, Volume 18, Issue 1, March 2013, Special Issue: Environmental Risk Factors. Full text on NCBI PMC3635108.

More DES DiEthylStilbestrol Resources

Why Endocrine Disruptors, other Disrupting Chemicals and Pesticides should be banned

Call for ban on endocrine disrupting pesticides in Europe

In this short video clip, Lisette van Vliet (HEAL) and Hans Muilerman (PAN Europe) explain why endocrine disrupting pesticides and other endocrine disrupting chemicals (EDCs) in Europe should be banned, the goals of the multi NGO ‘EDC Free Campaign‘ and urge organisations to join them.

Toxic Time is Up!

Sign Breast Cancer Action’s Petition

Think Before You Pink®: Toxic Time Is Up!
Demand an end to toxic pinkwashing

Take a stand to protect all of us from toxic chemicals that are making us sick, because the manufacturers of pink ribbon products certainly won’t.

If you think chemicals should be proven safe before entering the marketplace – and our bodies – then join Breast Cancer Action’s campaigns and demand an end to toxic pinkwashing.

“Tijden veranderen. Het DES Centrum ook.”

Interview met Maria Zwart, Directeur van het DES Centrum

Tijden veranderen. Het DES Centrum ook
Follow @DESCentrum on Twitter

“We werken hard aan een DES Centrum met een nieuwe organisatiestructuur”, zegt Maria Zwart, directeur van het DES Centrum. “Mensen gaan dat merken, bijvoorbeeld in onze bereikbaarheid. Maar ons streven is om de dienstverlening op pijl te houden. Tijden veranderen. Wij ook“

  • Tijdlijn
  • Vrijwilligers en het netwerk
  • Waakhond
  • Donateurs
  • Blijf in contact!

Lees! “Tijden veranderen. Het DES Centrum ook”, interview met Maria Zwart, directeur, over de veranderingen bij het DES Centrum.

More DES DiEthylStilbestrol Resources

Mortality in Women given DiEthylStilbestrol during Pregnancy

Association with breast cancer mortality more evident in trial participants who received high DES doses

DES Follow-up Study Summary

National Cancer Inst logo image
In this 2006 study, the association with breast cancer mortality was more evident in trial participants, who received high DES doses.

This analysis examined cause of death in women who were given Diethylstilbestrol (DES) during pregnancy. The mothers cohort has not been actively followed since 1994, so survival was assessed through a search of the National Death Index. The results suggested a modest increase in death from breast cancer in the DES exposed mothers, compared to the unexposed. We did not, however, see an excess of overall mortality in the DES-exposed mothers, or an excess of death from any specific cause other than breast cancer. In particular, DES was not associated with an increased mortality from gynecologic cancers.

2006 Study Abstract

Abstract:
We used Cox regression analyses to assess mortality outcomes in a combined cohort of 7675 women who received diethylstilbestrol (DES) through clinical trial participation or prenatal care. In the combined cohort,

  • the RR for DES in relation to all-cause mortality was 1.06 (95% CI = 0.98-1.16), and 1.11 (95% CI = 1.02-1.21) after adjusting for covariates and omitting breast cancer deaths.
  • The RR was 1.07 (95% CI = 0.94-1.23) for overall cancer mortality, and remained similar after adjusting for covariates and omitting breast cancer deaths.
  • The RR was 1.27 (95% CI = 0.96-1.69) for DES and breast cancer, and 1.38 (95% CI=1.03-1.85) after covariate adjustment.
  • The RR was 1.82 in trial participants and 1.12 in the prenatal care cohort, but the DES-cohort interaction was not significant (P = 0.15).
  • Diethylstilbestrol did not increase mortality from gynaecologic cancers.
  • In summary, diethylstilbestrol was associated with a slight but significant increase in all-cause mortality, but was not significantly associated with overall cancer or gynaecological cancer mortality. The association with breast cancer mortality was more evident in trial participants, who received high DES doses.

Sources

  • Mortality in women given diethylstilbestrol during pregnancy,NCBI, PMID: 16786044, 2006 Jul 3;95(1):107-11. Epub 2006 Jun 20. Full text Br J Cancer. Jul 3, 2006; 95(1): 107–111. PMCID: PMC2360488 link.
  • NCI, DES Follow-up Study Published Papers.
More DES DiEthylStilbestrol Resources

U.S. PSTF advise to use Hormone Replacement Therapy for only short periods of Time

U.S. Panel Warns Hormone Replacement Therapy Is Too Risky

Postmenopausal Hormone Replacement Therapy for Primary Prevention of Chronic Conditions: Recommendations and Rationale
Alexandra Sifferlin is a reporter for TIME Health and Family

In their November 2002 recommendations, the U.S. Preventive Services Task Force confirmed that the risk of HRT outweigh its potential benefits.

The USPSTF recommends against the routine use of estrogen and progestin for the prevention of chronic conditions in postmenopausal women ; advising women to use HRT to treat symptoms of menopause for only short periods of time.

Read U.S. Panel Warns Hormone Replacement Therapy Is Too Risky
by Alexandra Sifferlin, 23 Oct 2012

Read Panel Advises Against Hormones to Prevent Disease
by Brenda Goodman, WebMD Health News, 22 Oct 2012.

Sources: Postmenopausal Hormone Replacement Therapy for Primary Prevention of Chronic Conditions: Recommendations and Rationale
U.S. Preventive Services Task Force, 19 Nov 2002.

All our posts about EstrogenHRTMenopause.