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Contraception for men has been an area of dashed dreams for many years, so the ongoing trials of potentially reversible vas deferens occlusion by polymer injection represents an interesting development. Reported in the UK press as an “injectable contraceptive for men”, a description that seems grossly inaccurate in some respects as it’s not equivalent to the injectable contraceptives for women which work using high dose progestrogen; although it is injected into the vas itself, Valsagel is currently undergoing testing in animal models with hopes to begin trials in humans if this is deemed to be a success.
Valsagel is not the first polymer injected vas-affecting agent to be developed, and the work was inspired by the ongoing trials of RISUG in India, covered by Wired in 2010 in an extensive article that also details how Valsagel came to be and containing an account of a consenting process that seems less than entirely rigorous. RISUG was passed over by the WHO after phase II trials in 1997, due to production problems, but interest in the project was renewed in India in recent years and Phase III trials continue locally.
Valsagel works slightly differently to RISUG, by occluding the vas deferens using the polymer. Theoretically, the polymer can be subsequently dislodged using another injectable agent; although whether this is true in humans, only time will tell. Interested clinicians can follow the Valsagel trials through the Parsemus Foundation, who are partly funding the trials through crowdsourcing initiatives.
This is not the first crowd-sourced initiative in medial research discussed in the blog, and it also remains to be seen whether this will represent a useful source of funding for medical research in future, by bringing patients and small donors into contact with large-scale projects.
Those following developments in this field may also be interested in the attempt of an American woman, known only as Bailey, who attempted to crowd-fund her termination of pregnancy through the website GoFundMe (which the website subsequently revoked; although she did receive the funds allocated). Bailey was interviewed about her decision in the fashion and design magazine Vice*, where she discusses that her decision to crowd-fund donations was due to being unable to finance the procedure herself, and the use of crowd-funding to help people achieve their goals. She makes reference to the $50,000 raised to produce a single serving of potato salad, something that suggests the world has not yet run out of ways to waste money.
*This magazine contains content, including nudity and profanity, which is probably in violation of your work internet use policy, but you can read the interview here.
WCD 2012 focuses on empowering young people to think ahead and build contraception into their plans, in order to prevent an unplanned pregnancy or sexually transmitted infection (STI).
World Contraception Day (WCD) takes place on September 26 every year. This annual worldwide campaign centres around a vision for a world where every pregnancy is wanted
Every year, countries and regions around the world organize events to mark World Contraception Day and to demonstrate their commitment to raising awareness of contraception and improving education regarding reproductive and sexual health.
Launched in 2007, WCD’s mission is to improve awareness of all contraceptive methods to enable young people around the world to make informed decisions on their sexual and reproductive health
One of the most effective ways for young people to prevent an unplanned pregnancy or STI is to think ahead and consider the best contraceptive option for them – before having sex
An important part of planning for the future is knowing where to access accurate and unbiased information about contraception.
The WCD website, www.Your-Life.com, contains up to date information on contraception to help young people and educational material with some useful quizzes under the ‘Media Center’ tab.
WCD is supported by a coalition of 11 international NGOs, scientific and medical societies with an interest in sexual health and is sponsored by Bayer HealthCare Pharmaceuticals. The NGOs and societies involved in WCD are:
Asian Pacific Council on Contraception (APCOC)
Centro Latinamericano Salud y Mujer (CELSAM)
European Society of Contraception and Reproductive Health (ESC)
German Foundation for World Population (DSW)
International Federation of Pediatric and Adolescent Gynecology (FIGIJ)
International Planned Parenthood Federation (IPPF)
Marie Stopes International (MSI)
Population Services International
The Population Council
The United States Agency for International Development (USAID)
The website/blog Impatient Optimists, which is supported by the Bill & Melinda Gates Foundation, documents some of the difficulties people and countries around the world face trying to implement these aims.
http://www.londonfamilyplanningsummit.co.uk/ On 11 July 2012 the UK Government and the Bill & Melinda Gates Foundation with UNFPA and other partners hosted a groundbreaking summit that will mobilize global policy, financing, commodity, and service delivery commitments to support the rights of an additional 120 million women and girls in the world’s poorest countries to use contraceptive information, services and supplies, without coercion or discrimination, by 2020.
Melinda Gates’ New Crusade: Investing Billions in Women’s Health
Melinda Gates this week pledged billions of dollars to be spent on improving access to contraception. In her many travels she repeatedly met women who were unable to gain access to something which most of the rest of the world take for granted. In an interview with Newsweek she recounted stories from the women many of whom were unable, for example, to get repeat injections of Depo Provera. In July she is teaming up with the British government to cosponsor a summit of world leaders in London, to start raising the $4 billion the Foundation says it will cost to get 120 million more women access to contraceptives by 2020. And in a move that could be hugely significant for American women, the Foundation is pouring money into the long-neglected field of contraceptive research, seeking entirely new methods of birth control. Ultimately Gates hopes to galvanize a global movement. “When I started to realize that that needed to get done in family planning, I finally said, OK, I’m the person that’s going to do that,” she says. More from the Gates Foundation website.
Paper confirms EC IUD failure rate less than 1 per 1000
Authors of the first ever systematic review of all available data from the last 35 years argue that IUDs should be routinely offered and available to those requesting emergency contraception. They found that the failure rate was less than 1 per 1000 when they analysed data from 42 studies involving 7034 women using 8 different IUDs. They also found that 85% clinicians in one study never offered this as an option. In a press release this week one of the authors, Professor James Trussell, said:
“This is an extremely difficult problem to deal with, especially as in many countries women can just go to their local pharmacy to obtain the ‘morning after pill’, but virtually no women know to ask for an IUD and many family planning clinics and surgeries do not offer same-day insertion. Offering same-day insertion would remove a huge barrier to the greater use of IUDs.”
Online First – Postnatal contraceptive choices in HIV-positive women [Duncan et al.]
Gillian Robinson (Associate Editor) writes:
“This paper describes an exciting example of how an integrated contraception and sexual health service can work to provide holistic care for women. This clinic provides women living with HIV with prenatal, antenatal and postnatal care in a community setting. The paper is a retrospective case note review. Uptake of postnatal contraception was high yet more than 20% of women were not seen postnatally. The authors suggest that the reasons for this are explored to ensure all women with HIV receive contraception in the early postnatal period to prevent unwanted pregnancy.”
NAT calls for new health bodies to tackle late diagnosis of HIV
“Halve It”, a broad coalition of leading experts and advocates in HIV and AIDS, welcomes the renewed call by the National AIDs Trust (NAT) for the urgent prioritisation of HIV testing in its new ‘HIV testing action plan’ which provides vital strategic guidance to health bodies on tackling the serious issue of late HIV diagnosis in the UK.
FDA Approves first pill for Heavy Menstrual Bleeding (HMB)
Natazia is a combination oral contraceptive (COC) consisting of estradiol valerate and estradiol valerate/dienogest. The US Food and Drug Administration (FDA) first approved Natazia in May 2010 to prevent pregnancy. On March 14, 2012, the FDA also approved Natazia to treat heavy menstrual bleeding (HMB), making it the first and only OC indicated for this purpose. One interesting thing is that until now we have known Natazia, in the UK, as Qlaira and until now it has not been widely used. More details at Medscape.
UK women misdiagnosing genital infections
To mark National BV Day on 18th April a study found that one in four British women has misdiagnosed themselves on the internet. Researchers found Dr Google is now the first port of call for women with genuine health concerns who are almost twice as likely to check online before consulting a doctor or even talking to Mum. But searching their symptoms online and self-medicating has led a tenth of the country’s women to endure unpleasant side effects as a result of their misdiagnosis.
new audit reveals shocking truth as 3.2m women face restrictions in access to contraceptives or services
A new audit of the commissioning of contraceptive and abortion services in England has revealed a stark picture of inequality in women’s healthcare, with a third of women of reproductive age unable to choose from the full range of contraceptives or services in their local area.
As many as 3.2 million women of reproductive age (15-44) are living in areas where fully comprehensive contraceptive services, through community and/or primary care services, are not provided
Those PCTs restricting access to contraceptives or contraceptive services had a higher abortion rate than the national average
Over a quarter (28%) of PCTs responding to the audit did not have a strategy in place or under development to address unintended pregnancy and the need for abortion or repeat abortion
The audit also uncovered evidence of PCTs introducing access restrictions based on cost rather than choice or quality:
NHS North Lancashire confirmed one method of contraception was not prescribed “due to lack of funding/training for staff”
NHS Brighton and Hove confirmed that its “GP-led health centre will only prescribe Long Acting Reversible Contraceptive (LARC) methods to residents of Brighton and Hove. Non-residents attending with a filled prescription for LARC will be provided with a fitting”
NHS Haringey Teaching said that from the 1 October 2011 “women aged over 25 do not receive contraception pills from the local CaSH [Contraception and Sexual Health] Service; they receive this service from their GP”
NHS Barnet stated that “In 2010 the PCT introduced a restriction on over 25’s accessing integrated services for generic contraceptive advice… Only patients within this age group who have complex needs can be seen by an integrated service”
Dr Connie Smith, Consultant in Sexual and Reproductive Healthcare, said:
“Contraception is a very personal issue. What is right for one woman may not be right for another. That is why the national NICE guidelines on contraception are built around the importance of choice.
“PCTs that are restricting choice are getting worse outcomes. As a result of flouting national guidance, women are paying a big personal cost and the NHS is bearing a huge financial cost. Unintended pregnancy costs the NHS more than £755 million every year. For every £1 spent on contraception the NHS saves £12.50, so restricting access and choice is a complete false economy, harming women and the NHS. Those PCTs with restrictions in place need to have an urgent rethink.”
Dr Anne Connolly, a GP with a special interest in sexual health, added:
“As a GP I know how important it is to get contraception right. We must take a personal approach to meeting women’s needs and operating a blanket ban on some services or contraceptives goes completely against this.
“It is very concerning that so many PCTs have no strategy in place to address unintended pregnancy and that some are introducing restrictions on contraceptives or services. The Department of Health should urgently publish a sexual health strategy showing how the needs of women of all ages can be met, alongside clear standards about the quality of service women have a right to expect.”
The AGC has made a series of recommendations for how sexual health and contraceptive services could be more effectively planned, commissioned and delivered. These include:
The Department of Health should publish its planned sexual health policy document without further delay and ensure that it sets out clearly the expectation for commissioners to commission comprehensive, open access services that reflect a life-course approach for people of all ages
NICE should prioritise the development of the quality standard on contraceptive services
Contraceptive services must be commissioned based on the principles of the NHS Constitution. Commissioners should remove any policies or contracts in place which limit an individual’s access to contraceptive services based on reasons of age or place of residence
Commissioners should ensure that up-to-date strategies are in place to reduce unintended pregnancy, and the need for abortion and repeat abortions, and these strategies should focus on addressing the needs of women of all ages
The Course of 5 (C5) is the 2nd stage of the new DFSRH blended learning training package – it provides a link between the theory element (e-SRH) and the practical, clinical assessments (ACP).
What is involved in C5? 5 one-hour, assessed workshops in groups of no more than 4 per facilitator. These are usually offered as a one-day or 2 half day package organised locally by Faculty Registered Trainers. They can also be done as 5 individual sessions.
When can I do this? C5 cannot be undertaken until you have registered for the diploma and e-portfolio and have completed the e-SRH sessions. It must be passed before moving on to clinical practice.
What is covered? The content is fixed by the Faculty and covers:
Session 1 – Taking a Sexual History and HIV pre test discussion and testing
Session 2 – STI Screening and Testing and Teaching the use of Condoms
Session 3 – Practical Aspects of Contraception – including diaphragm and implant fitting
Session 4 – Young people; Consent, Confidentiality, Fraser Guidelines and Safeguarding children
Session 5 – Managing Sensitive Scenarios – dealing with unwanted pregnancy, psycho sexual problems and referral for sterilisation.
How is it assessed? There are 9 assessment criteria in which you must demonstrate active and appropriate participation in all the sessions.
How do I access a C5? A list of local contact details is available from the Faculty website.
How much does it cost? The courses are costed locally and will vary according to set up.
I am a nurse – can I do the Course? The simple answer is yes, but it may depend where you live and who is organising C5 in your area. Nurses cannot gain the Faculty diploma but can do the e-SRH sessions and C5. In some areas nurses are using this to access training in SRH and some clinics may then be happy to offer clinical assessment too.
Last year the Royal College of Obstetricians and Gynaecologists published ‘High Quality Women’s Health Care: a Proposal for Change’ that proposed a radical change to the structure of UK women’s health services. Andrew Horne and Johannes Bitzer discuss this exciting document from both a UK and a European perspective, commenting on its implications for sexual health provision. See page 68
Gonorrhoea infection is increasing in the UK with a 3% increase in cases between 2009 and 2010. Last year there was a report of a ceftriaxone-resistant isolate; there is a growing concern that gonorrhoea may become incurable. The commentary by Taylor and Bignell is timely. It reviews the current position and provides clear guidelines on screening and treatment, which may prove challenging for some community services that rely exclusively on the use of nucleic acid amplification tests. See page 70
At last, a COC licensed for use in a flexible extended regimen
Data are presented from Phase III studies of a 20 µg ethinylestradiol/3 mg drospirenone combined pill, designed to be used in a flexible regimen. The studies evaluated the efficacy of the regimen, bleeding patterns, safety (ie, metabolic and endometrial parameters) and effect on dysmenorrhoea. Comparisons were with a fixed extended regimen and the conventional 24-day regimen. Results show good efficacy, tolerability and safety with the flexible regimen, and a significant reduction in both bleeding and dysmenorrhoea. See pages 73, 84, 94
Does hormone replacement therapy cause breast cancer? Part 4. The Million Women Study
Shapiro et al. continue their review of breast cancer and hormone replacement therapy papers, this time focusing on the Million Women Study. They conclude that despite its massive size, this study did not satisfy causal criteria. The online version of this paper has already been the focus of a great deal of media publicity and both a news piece and an editorial in the BMJ. Readers should also look at the Letters section for related correspondence that the Journal has received as a result. See page 102
A new aid to diagnosis
Ultrasound imaging has been of value to our specialty for over two decades and skills and equipment have steadily become more available within sexual and reproductive health clinics. In their article on hysterosonography using a local anaesthetic gel, Pillai and Shefras present their experience with a simple and effective new technique that takes imaging a step further, allowing clear diagnosis of intrauterine abnormalities, particularly causes of abnormal bleeding or failed intrauterine device/system (IUD/IUS) insertion, as well as aiding location and easier retrieval of IUDs with missing threads. Many readers will be familiar with the use of lidocaine gel to aid IUD insertion: not surprisingly, uterine instrumentation in conjunction with scanning was reported to be less painful with this technique. This is a promising approach to simplifying and improving the cost-effectiveness of care for women presenting with some complex contraception problems. See page 110
Abortion legislation in a changed world
In his latest Legal Opinion article, Sam Rowlands reviews legislation governing early medical abortion (EMA) and the licensing of EMA drugs in the UK and in other jurisdictions. He then looks at the ways in which such legislation has been used – or in some cases circumvented. EMA has helped to fulfil the crucial need for safe abortion worldwide, but in the author’s view the laws governing abortion in most countries are out of step with scientific advances. Readers may find the author’s conclusions and suggestions for future changes to our own abortion laws thought-provoking. See page 117
Role of doulas in abortion care
Doulas, or lay support persons, have had a longstanding role in supporting women in labour. Chor et al. argue that their role should be extended to caring for women having abortions, where they can help women relax and provide information. They suggest that engagement of the medical community will be instrumental in successfully expanding the role of abortion doula programmes within abortion provision. See page 123
Abortion in the classical world
Lesley Smith continues her series on the history of contraception and reproductive health with a look at attitudes to and practices of abortion in ancient times. It appears that even then, abortion was at the heart of much medical ethical debate. See page 125
Status of health professionals in the 21st century
Has the status of health professionals in society today fallen? If so, why? And is it a good or a bad thing? The Journal’s Consumer Correspondent, Susan Quilliam, explores the issue in her latest article. See page 127
Twenty-five years on: HIV remains a concern
In his latest ‘Then and Now’ article, Lindsay Edouard looks at topics covered by this Journal in 1987. New approaches to contraception were emerging. But was there a threat to community family planning services and would litigation faced by USA manufacturers restrict contraceptive choice? However, the major concern was the emergence of HIV/AIDS, with reinforcement of the advice that barriers should be used in addition to hormonal methods. In 2012, in the light of controversial research suggesting a possible association between hormonal contraception and increased HIV risk in some settings, Edouard draws our attention to the WHO very recent guidance regarding dual protection: 25 years on, advice has not changed. See page 131
Plus – Online Poll
Will the recent article on hormone replacement therapy and breast cancer alter your prescribing practice with regard to HRT?
The latest edition of FSRH News is available on the website.
Susan Quilliam, Consumer Correspondent of the JFPRHC writes:
Last Friday saw the ‘Sexual Pleasures’ lecture, a regular annual event in the RSM’s Sexuality and Sexual Health section’s seminar calendar. The Journal was delighted to see that Lesley Smith, curator of Tutbury Castle, specialist in historical sexuality, and author of many a fascinating article for our own pages, was one of the speakers.
Her talk – Sex and the Tudors – was a total delight. Not only did she rampage through Tudor history (with, unsurprisingly, strong emphasis on Henry VIII) giving us fascinating details about the effect of culture, religion and contemporary science. She also told us – and showed us, with visual aids – exactly what the Tudors did about contraception and STIs, en route debunking a few myths about chastity belts; apparently they are a myth with most ‘examples’ being Victorian.
We were by turns fascinated, astonished and incapacitated with laughter. The coup de grace came with Lesley’s blow-by-blow description of how she had scientifically validated – and personally tested – the claim that lemons and limes at one time popularly served as a viable, cap-like contraceptive. (In case you’re wondering, limes are best, they’re very comfortable, and the juice protects against infection.)
Having witnessed at first hand Lesley’s ability to captivate an audience face-to-face, we look forward to her continuing to captivate Journal readers on our pages.
Amendments to FSRH Guidance Documents: Drug Interactions and Emergency Contraception Drug Interactions (2011): Page 9 of the original version of this CEU Guidance Document (issued in January 2011) incorrectly stated that the interaction between lamotrigine and combined hormonal contraception (CHC) only applies to lamotrigine monotherapy. CHC also reduces lamotrigine levels when lamotrigine is combined with antiepileptic drugs that
do not alter its metabolism.
Emergency Contraception (2011): The original version of this CEU Guidance Document (issued in August 2011) contained some inconsistencies that the CEU has corrected in this version. These amendments are as follows: additional recommendation regarding offering a Cu-IUD to eligible women presenting between 0 and 120 hours of UPSI or within 5 days of expected ovulation added (pages ii and 8); references 12 and 13 updated (page 11); and acknowledgement of chart designer added to Appendix 2 (page 15).
New Examiners for the Multiple Choice Question Paper (MCQ) The Examination Committee invites applications to join the MCQ Examiner Group of the MFSRH Panel of Examiners. Applicants should be accredited Members of the Faculty and active clinically in the sphere of the Faculty or, to be Clinicians, of equivalent status, with an interest in Sexual and Reproductive Healthcare but whose speciality is GUM, Public Health Medicine, Gynaecology or Primary Care. Further information and application forms from the Faculty website, closing date 29th February.
Clinical Standards: for a doctor and a nurse
Workforce Planning: for an Associate member and a Fellow/Member/Diplomate
Information and details of how to apply are available from the committee’s page of the Faculty website
and in other news
Oral Ulipristal Proves Highly Effective for Uterine Fibroids According to 2 studies published this week in the New England Journal of Medicinethe oral selective progesterone receptor modulator, ulipristal, proved highly effective as a treatment for symptomatic uterine fibroids rapidly reducing excessive bleeding and reducing the size of uterine fibroids, and was well tolerated. The drug was approved for emergency contraception in 2010. Known as ella (HRA Pharma) in the United States and ellaOne in Europe, ulipristal works by interrupting ovulation. For emergency contraception, a 30-mg dose is used. By contrast, the newly-published studies tested 5-mg and 10-mg daily doses for fibroid treatment. In one of the studies (placebo-controlled) the drug controlled excess menstrual bleeding in over 90% of cases with a high incidence of amenorrhoea. If and when a product becomes available in the UK (Esmya is already approved and licensed in other countries) the issue of contraception will need to be highlighted to those that might use it because of the interaction with hormonal contraception.
The January edition of the Journal of Family Planning and Reproductive Health Care includes a number of articles previously available at Online First (the Dinger/Shapiro VTE commentary, Advances in IUD training by Connolly & Rybowski and Brown’s study looking at young mens’ views on contraception) as well as:
a thought-provoking commentary by Raine-Fenning et al on pregnancy of unknown location (PUL) which points out that a recent recommendation from CMACE to abandon the term is at odds with current scientific evidence and clinical experience;
a commentary by Wilkins of the Men’s Health Forum on men and sexual health;
a study by Draper et al on 525 GP fittings over a period of 30 years confirms that routine IUD checks confer no benefit. The paper suggested that current guidelines recommend annual checks though this is based on a statement from Australia dated 2007 and USA advice from 2000 and ignores more up to date FSRH and WHO guidance;
a questionnaire study of clinic attendees and staff about what we should call ‘attendees’. This appears to show that there is a preference to retain the term ‘patient’ but was based on the respondents picking from only 4 options (‘patient’, ‘client’, ‘user’ or ‘customer’ – ie didn’t include ‘women’ and ‘men’) or asking them what they would prefer to be called;
Kipp et al highlight the unmet need for effective methods of FP in HIV+ individuals in rural Uganda;
womens’ views of the use of their leftover LBC samples for research purposes (Cooper et al);
an important restrospective audit comparing unscheduled reattendance among women having EMA (early medical abortion) at home vs hospital (Astle et al);
a review of appropriate use of Co-cyprindiol in a general practice (Tandy);
a review of Clomifene use for ovulation induction in general practice (Wilkes & Murdoch)
Sharon Cameron and her colleagues in Edinburgh created a fast-track referral service so that women who had undergone early medical abortion who wished to use intrauterine contraception afterwards could be seen promptly for IUD/IUS fitting. However, only about half the women who were given appointments actually attended. In their article they analyse the differences between the attenders and the non-attenders and suggest ways to enhance the uptake of these effective methods for the prevention of further unwanted pregnancies. While some women would benefit from IUD/IUS insertion at the place of abortion, provision of a fast-track service to the family planning clinic may yet remain the best strategy for maximising uptake of intrauterine contraception in this specific client group. from David Horwell, Advisory Editor, JFPRHC
Journal Fiction Book Reviews for April 2012: The fiction book that has been reviewed for the next Journal is:“Sense of an Ending” by Julian Barnes. Read this and see if your views coincide with our reviewer. If anyone has read “The Marriage Plot” by Jeffrey Eugenides and would like to review it and see their review in print in the April issue please submit a maximum of 400 words to email@example.com by 12 February at the latest. In addition, let us know if there are any other books you have read recently that you feel would be of interest to readers.
New mobile website for Brook Brook, the young people’s sexual health charity, have launched a version of their website optimised for viewing on a mobile phone, funded by the JLS Foundation. See a screenshot of the new site below:
It has been a busy and eventful year in sexual and reproductive health:
saw the launch of the new-look Journal of Family Planning & Reproductive Health Care as it joined the BMJ family. Readers will have noticed many improvements, not least the website and early online publishing.