Primodos EWG Report : Hannah Bardell MP Talks

Will the Primodos victims, and the new science evidence, be at the heart of the Government report ?

On 21 February 2018, Hannah Bardell, SNP MP for Livingston, raised concerns about the Primodos hormone pregnancy test drug, and asked important questions to the Health Secretary.

Primodos EWG Report : Emma Reynolds MP Talks

Will all Primodos victims be listened to ?

On 24 October 2018, Emma Reynolds, Labour MP for Wolverhampton North East, asked Health Secretary to guarantee women who took hormone pregnancy test Primodos will have time to tell their stories to review into claims it caused birth defects and miscarriages.

Families, including one in Reynolds’ constituency, must have confidence in the review. Answers long overdue.

Mental Health Medication Trends in the US, an Overview

Flooding the world with psychiatric drugs could boost the burden of mental disorders

Today in the United States, more than one in five adults — and more than one in 20 children and adolescents — take a psychiatric drug on a daily basis.

Overall, the number of Americans on medications used to treat psychological and behavioral disorders has substantially increased since 2001; more than one‐in‐five adults was on at least one of these medications in 2010, up 22 percent from ten years earlier. Women are far more likely to take a drug to treat a mental health condition than men, with more than a quarter of the adult female population on these drugs in 2010 as compared to 15 percent of men.

Women ages 45 and older showed the highest use of these drugs overall. Yet surprisingly, it was younger men (ages 20 to 44) who experienced the greatest increase in their numbers, rising 43 percent from 2001 to 2010.

The trends among children are opposite those of adults: boys are the higher utilizers of these medications overall but girls’ use has been increasing at a faster rate.

Read America’s State of Mind report and Flooding the world with psychiatric drugs could boost the burden of mental disorders on stat, OCTOBER 22, 2018.

Unbiased information on medicines : Why is it needed?

Pharmaceutical promotion practices HAI webinar, Oct 2018

Dr Barbara Mintzes (University of Sydney) joins Health Action International for an expert webinar on pharmaceutical promotion practices.

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.

Why did Primodos remain on the British market for so long ?

A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests

Abstract

The drug Primodos and other hormone pregnancy tests (HPTs) remained on the British market for about a decade after they were first implicated, in 1967, as a possible cause of birth defects.

In November 2017, an expert working group (EWG) set up by the Medicines and Healthcare Products Regulatory Agency (MHRA) concluded against such an association.

However, it was explicitly ‘not within the remit of the EWG to make formal conclusions or recommendations on the historical system or regulatory failures’, a situation that has left many stakeholders dissatisfied.

Placing the question of a teratogenicity to one side, this article takes a more contextual and comparative approach than was possible under the auspices of MHRA. It asks why an unnecessary and possibly even harmful drug was allowed to remain on the British market when a reliable and perfectly safe alternative existed: urine tests for pregnancy.

Based on archival research in several countries, this article builds a historical argument for regulatory failure in the case of HPTs.

It concludes that the independent review which campaigners are calling for would have the potential to not only bring them a form of closure, but would also shed light on pressing issues of more general significance regarding risk, regulation and communication between policy makers, medical experts and patients.

Read the full paper (free access) A historical argument for regulatory failure in the case of Primodos and other hormone pregnancy tests on rbmsociety,

MHRA has approved the brand name Xonvea® to be used for marketing Diclectin® in the UK

New NHS drug for “morning sickness”, approved July 2018

Alliance Pharma plc (AIM: APH), the specialty pharmaceutical company, announces that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the UK Marketing Authorisation Application for Diclectin®, a prescription product for the treatment of nausea and vomiting of pregnancy.

Alliance also confirms that the MHRA has approved the brand name Xonvea®, which will be used for marketing Diclectin in the UK. As previously indicated, Alliance anticipates Xonvea’s launch in autumn this year as the only medicine licensed in the UK for the treatment of nausea and vomiting of pregnancy.

Xonvea was in-licensed from Duchesnay Inc. of Canada (“Duchesnay”) for the UK in 2015 and for a further nine European countries in 2016 – Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Republic of Ireland and Switzerland.

Nausea and vomiting of pregnancy is the most common medical condition in pregnancy affecting approximately 690,000 women in the UK each year according to the Office of National Statistics and the Royal College of Obstetricians and Gynaecologists. Research shows that up to 40% of pregnant women report symptoms of nausea and vomiting of pregnancy sufficiently severe to interfere with daily life whilst NHS data shows that at least 33,000 women with the condition are hospitalised each year.

The Group estimates peak sales for Xonvea in the UK of approximately £10m and across the other nine European countries a further £30m approximately at peak sales. The Group will incur both upfront costs ahead of the launches in the UK and EU markets and further incremental costs to support in-market growth in these countries. Alliance expects to generate meaningful sales of Xonvea from H2 2019.

Xonvea is the most studied medicine in pregnancy, with a proven efficacy and safety profile from use in more than 30 million women over more than 30 years. Following marketing authorisation in the UK, Alliance is preparing to file the necessary applications for regulatory approvals in continental Europe.

Related : read What you don’t know about a leading morning-sickness drug, by Anne Kingston Oct 23, 2015 on macleans.

Is it possible to remove most of pharmaceuticals from waste water ?

Effects of recirculation in a three-tank pilot-scale system for pharmaceutical removal with powdered activated carbon

The release of pharmaceutically active compounds (PhACs) in waste water from treatment plants (WWTPs) is currently not regulated anywhere in the world, with the exception of a few plants in Switzerland. Yet thousands of PhACs or their by-products — excreted by humans — can be found in waste water and some of these may harm biodiversity when released into waterways. For example diclofenac and oxazepam may have negative effects on aquatic species.

This study presents a pilot design that seeks to deliver an alternative to less effective technologies, in particular by optimising the use of activated carbon, Science for Environment Policy reports.

Abstract

The removal of pharmaceutically active compounds by powdered activated carbon (PAC) in municipal wastewater is a promising solution to the problem of polluted recipient waters. Today, an efficient design strategy is however lacking with regard to high-level overall, and specific, substance removal in the large scale. The performance of PAC-based removal of pharmaceuticals was studied in pilot-scale with respect to the critical parameters; contact time and PAC dose using one PAC product selected by screening in bench-scale. The goal was a minimum of 95% removal of the pharmaceuticals present in the evaluated municipal wastewater. A set of 21 pharmaceuticals was selected from an initial 100 due to their high occurrence in the effluent water of two selected wastewater treatment plants (WWTPs) in Sweden, whereof candidates discussed for future EU regulation directives were included. By using recirculation of PAC over a treatment system using three sequential contact tanks, a combination of the benefits of powdered and granular carbon performance was achieved. The treatment system was designed so that recirculation could be introduced to any of the three tanks to investigate the effect of recirculation on the adsorption performance. This was compared to use of the setup, but without recirculation. A higher degree of pharmaceutical removal was achieved in all recirculation setups, both overall and with respect to specific substances, as compared to without recirculation. Recirculation was tested with nominal contact times of 30, 60 and 120 min and the goal of 95% removal could be achieved already at the shortest contact times at a PAC dose of 10-15 mg/L. In particular, the overall removal could be increased even to 97% and 99%, at 60 and 120 min, respectively, when the recirculation point was the first tank. Recirculation of PAC to either the first or the second contact tank proved to be comparable, while a slightly lower performance was observed with recirculation to the third tank. With regards to individual substances, clarithromycin and diclofenac were ubiquitously removed according to the set goal and in contrast, a few substances (fluconazole, irbesartan, memantine and venlafaxine) required specific settings to reach an acceptable removal.

Long-Term Dangers of Birth Control Pills

Dr. Elizabeth Plourde, Clinical Laboratory Scientist, Author, talks, 2011

Dr. Elizabeth Plourde talks about the dangers of using birth control pills for many years and why they are dangerous.

  • Video published on 26 Sep 2011 by iHealthTube.com.

Sweetening the pill : Could some birth-control drugs kill you?

Could some pharmaceutical birth-control methods be having side-effects that are much more dangerous than women realise ?

Featuring interviews with parents and friends of those who’ve died after complications related to some birth control hormones, Abby Epstein and Holly Grigg-Spall question how much the public really know about their medical effects.

  • Find out more about the Sweetening the Pill documentary on Kickstarter.
  • Video published on 22 Jun 2015 by The Guardian.