Oral hormone pregnancy tests and the risks of congenital malformations

A systematic review and meta-analysis, October 2018.
Includes Primodos drug victims testimonials.

Overview

  • Sources :
    • read and/or download the full study (free access) Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, First published 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
    • read and/or download the full study (free access) The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, nature, Published 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • Testimonials : read some real stories told by the Primodos victims, see the post comment section.
  • Commenting : scroll down this page until you reach the header “Have your say! Share your views” and the box “Enter your comment here…“.

Abstract

Background
Oral hormone pregnancy tests (HPTs), such as Primodos, containing ethinylestradiol and high doses of norethisterone, were given to over a million women from 1958 to 1978, when Primodos was withdrawn from the market because of concerns about possible teratogenicity. We aimed to study the association between maternal exposure to oral HPTs and congenital malformations.

Methods

I am fully supportive of this article on the effects of hormone pregnancy tests as it stands. I have no substantive criticism of the content or methods.

Dr David Healy, professor of psychiatry, psychopharmacologist, scientist and author.

We have performed a systematic review and meta-analysis of case-control and cohort studies that included data from pregnant women and were exposed to oral HPTs within the estimated first three months of pregnancy, if compared with a relevant control group. We used random-effects meta-analysis and assessed the quality of each study using the Newcastle–Ottawa Scale for non-randomized studies.

Results
We found 16 case control studies and 10 prospective cohort studies, together including 71 330 women, of whom 4209 were exposed to HPTs.

Exposure to oral HPTs was associated with a 40% increased risk of all congenital malformations: pooled odds ratio (OR) = 1.40 (95% CI 1.18 to 1.66; P<0.0001; I2 = 0%).

Exposure to HPTs was associated with an increased risk of

  • congenital heart malformations: pooled OR = 1.89 (95% CI 1.32 to 2.72; P = 0.0006; I2=0%);
  • nervous system malformations OR = 2.98 (95% CI 1.32 to 6.76; P = 0.0109 I2 = 78%);
  • gastrointestinal malformations, OR = 4.50 (95% CI 0.63 to 32.20; P = 0.13; I2 = 54%);
  • musculoskeletal malformations, OR = 2.24 (95% CI 1.23 to 4.08; P= 0.009; I2 = 0%);
  • the VACTERL syndrome (Vertebral defects, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal anomalies, and Limb defects), OR = 7.47 (95% CI 2.92 to 19.07; P < 0.0001; I2 = 0%).

Conclusions
This systematic review and meta-analysis shows that use of oral HPTs in pregnancy is associated with increased risks of congenital malformations.

Reactions

Prof. Henegan’s systematic analyses of epidemiological studies, is a scientific review which members of the Association for children damaged by HPT’s have waited over 45 years for. The findings are incredible and mirror the congenital abnormalities suffered by our members. It is a scandal that this epidemiological study was not commissioned by the Government Health Authorities and we cannot thank Prof. Heneghan and his colleagues enough, for the comprehensive and utterly compelling review.

Marie Lyon,
Assocation for Children Damaged by Hormone Pregnancy Tests, UK

Important Note

Are you a Primodos-victim ?
Send a request to join the group Primodos (The Forgotten Thalidomide) ACDHPT on Facebook.

Personal care product use and breast cancer risk

Associations between Personal Care Product Use Patterns and Breast Cancer Risk among White and Black Women in the Sister Study

New Research from USA NIEHS sister study of 47,000 women, suggests a link between frequent and moderate use of beauty products and breast cancer. The study reviews effects of environment and endocrine disruptors on risks of breast cancer and fibroids.

2018 Study Abstract

Background
Many personal care products include chemicals that might act as endocrine disruptors and thus increase the risk of breast cancer.

Objective
We examined the association between usage patterns of beauty, hair, and skin-related personal care products and breast cancer incidence in the Sister Study, a national prospective cohort study (enrollment 2003–2009).

Methods
Non-Hispanic black (4,452) and white women (n=42,453) were examined separately using latent class analysis (LCA) to identify groups of individuals with similar patterns of self-reported product use in three categories (beauty, skin, hair). Multivariable Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for associations between product use and breast cancer incidence.

Results
A total of 2,326 women developed breast cancer during follow-up (average follow-up=5.4y). Among black women, none of the latent class hazard ratios was elevated, but there were <100 cases in any category, limiting power. Among white women, those classified as “moderate” and “frequent” users of beauty products had increased risk of breast cancer relative to “infrequent” users [HR=1.13 (95% CI: 1.00, 1.27) and HR=1.15 (95% CI: 1.02, 1.30), respectively]. Frequent users of skincare products also had increased risk of breast cancer relative to infrequent users [HR=1.13 (95% CI: 1.00, 1.29)]. None of the hair product classes was associated with increased breast cancer risk. The associations with beauty and skin products were stronger in postmenopausal women than in premenopausal women, but not significantly so.

Conclusions
This work generates novel hypotheses about personal care product use and breast cancer risk. Whether these results are due to specific chemicals or to other correlated behaviors needs to be evaluated.

The power of the placebo effect

The amazing power of the mind over the body

The placebo effect is an unexplained phenomenon wherein drugs, treatments, and therapies that aren’t supposed to have an effect — and are often fake — miraculously make people feel better. What’s going on?

  • Emma Bryce dives into the mystery of placebos’ bizarre benefits.
  • Video published on 4 April 2016 by TED-Ed.

How one scientist averted a national health crisis

Dr Frances Oldham Kelsey : 20th-century American heroine for her role in the Thalidomide case

In 1960, Frances Kelsey was one of the Food and Drug Administration’s newest recruits. Before the year was out, she would begin a fight that would save thousands of lives — though no one knew it at the time.

  • Andrea Tone explains how Kelsey was able to prevent a massive national public health tragedy by privileging facts over opinions, and patience over shortcuts.
  • Video published on 7 June 2018 by TED-Ed.

The Bleeding Edge, Trailer

A searing exposé of the medical device industry from Academy Award-nominated filmmakers Kirby Dick and Amy Ziering

Technological advances have been responsible for many groundbreaking developments in modern medicine. Countless individuals have seen their quality of life improve through research and development, from the advent of pacemakers to bionic limbs. But there is a dark side to the relentless pace of all this innovation.

    • Video published on 12 Jul 2018 by Netflix. About the documentary.

Thalidomide promotes degradation of SALL4, a transcription factor implicated in Duane Radial Ray Syndrome

After 60 years, scientists uncover how thalidomide produced birth defects

More than 60 years after the drug thalidomide caused birth defects in thousands of children whose mothers took the drug while pregnant, scientists at Dana-Farber Cancer Institute have solved a mystery that has lingered ever since the dangers of the drug first became apparent: how did the drug produce such severe fetal harm?
ScienceAlert reports, 2 AUG 2018.

Abstract

Frequently used to treat morning sickness, the drug thalidomide led to the birth of thousands of children with severe birth defects. Despite their teratogenicity, thalidomide and related IMiD drugs are now a mainstay of cancer treatment, however, the molecular basis underlying the pleiotropic biology and characteristic birth defects remains unknown.

Here we show that IMiDs disrupt a broad transcriptional network through induced degradation of several C2H2 zinc finger transcription factors, including SALL4, a member of the spalt-like family of developmental transcription factors.

Strikingly, heterozygous loss of function mutations in SALL4 result in a human developmental condition that phenocopies thalidomide induced birth defects such as absence of thumbs, phocomelia, defects in ear and eye development, and congenital heart disease.

We find that thalidomide induces degradation of SALL4 exclusively in humans, primates and rabbits, but not in rodents or fish, providing a mechanistic link for the species-specific pathogenesis of thalidomide syndrome.

RDD2018 : Research is Key !

Feb 28 is Rare Disease Day ! Official video 2018

Research brings hope to the millions of people living with a rare disease across the world and their families. About RDD2018 theme.

The main objective of Rare Disease Day (RDD) is to raise awareness among the general public and decision-makers about rare diseases and their impact on patients’ lives.

OrphaNet, portal for rare diseases and orphan drugs, includes the Diethylstilbestrol DES syndrome as rare disease ORPHA:1916.

MORE INFORMATION

How much do you know about DES?

NHIR Practical, Relevant Research

Welcome to the place that transforms research in the NHS

Modern healthcare raises lots of questions. We work with patients, clinicians, care commissioners and industry to ensure the NHS gets the evidence it needs to guide effective healthcare decision making.

NIHR Platform for Growth

Welcome to the place that transforms research in the NHS

People’s health also matters to the economy: 131 million working days were lost to sickness in 2013. World-class research doesn’t only make us healthier, it attracts international investment and skilled jobs.