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Sex selection in India

  1. Top of page
  2. Sex selection in India
  3. HPV vaccine and genital warts
  4. Increasing access to HPV vaccine protection
  5. Contraception in the USA
  6. Do n-3 fatty acids protect you?
  7. New reports and guidelines
  8. Innovations and Patents
  9. Legal matters
  10. Clinical trials

The latest Indian census shows that the practice of sex selection is continuing unabated. In the last 10 years the numbers of girls born per 1000 boys has dropped from 927 to 914. This is further evidence of termination of pregnancies because the fetus is female.

Using ultrasound or maternal serum fetal DNA sampling, pregnancies are illegally sexed and terminated despite ‘waves’ of doctors being suspended for violating the law, which prohibits early sex determination other than for genetically linked indications (Jain BMJ 2013;346:f1957). The problem now is that the state is tightening termination of pregnancy (TOP) laws and access to legitimate means of termination such as mifepristone plus misoprostol are being reviewed. There may be as many as 6 million TOPs in India annually and the prospect of many of these being carried out in an unsafe fashion is retrogressive in the extreme. The repeal of liberal TOP laws may come back to haunt the country. What is needed is a change in the under-valuing of women by Indian society. It is nothing less than a cultural cancer.

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Source: Drawn from Jain BMJ 2013;346;f1957.

HPV vaccine and genital warts

  1. Top of page
  2. Sex selection in India
  3. HPV vaccine and genital warts
  4. Increasing access to HPV vaccine protection
  5. Contraception in the USA
  6. Do n-3 fatty acids protect you?
  7. New reports and guidelines
  8. Innovations and Patents
  9. Legal matters
  10. Clinical trials

In 2007 Australia initiated a national vaccination programme against human papillomavirus (HPV) infections. It started with all schoolgirls aged 12 years plus a catch-up scheme for women up to 26 years old using the quadrivalent vaccine. The population cover was 80% for all three doses so that, theoretically, there should be a marked reduction in Australian women presenting to sexual health clinics with genital warts, which are caused by HPV types 6 and 11 but against which the vaccine is effective.

The data for 2011 now published by Ali et al. (BMJ 2013;346:f2032) show no change in the incidence of genital warts in women over the age of 30 years, a decline from 11 to 3% in women in their 20s and a decline from 11 to <1% in women under the age of 21 years. Vaccination appeared to offer complete protection, with the few cases that did present occurring in nonvaccinated women.

For men there were also considerable declines in those presenting with genital warts. There was no change in men over 30 years old, a decline from 18 to 9% in men in their 20s and a decline from 12 to 2% in men under the age of 21 years.

Barton and O'Mahony (BMJ 2013;346:f2184) see this as a cause for celebration and make the case for more quadrivalent vaccine programmes in other countries and for including boys—as the Australians have from this year. Such campaigns could see not only reductions in female genital cancers but also falling rates of anogenital, oropharyngeal and head and neck tumours with concomitant savings in the treatment of these diseases.

The Australian results show proof of ‘bench-to-bedside’ success and indications of the power of herd immunity in the potential eradication of HPV oncogenic virus pathology to everyone's benefit.

Increasing access to HPV vaccine protection

  1. Top of page
  2. Sex selection in India
  3. HPV vaccine and genital warts
  4. Increasing access to HPV vaccine protection
  5. Contraception in the USA
  6. Do n-3 fatty acids protect you?
  7. New reports and guidelines
  8. Innovations and Patents
  9. Legal matters
  10. Clinical trials

Three doses of HPV vaccine at 0, 2 and 6 months of the bivalent and quadrivalent types have been shown to provide immunogenic responses in girls and boys. Both are safe and highly protective against the HPV infections for which they are created with almost 100% seroconversion after the full set of injections.

Despite this efficacy and consequent major reduction in cervical cancer risk, immunisation programmes have not been universally successful for reasons of cost, acceptability, capacity, infrastructure and compliance. There have been suggestions that two-dose regimens might be as effective as the full courses so two doses were compared with three doses in a Canadian trial in a test of noninferiority (Dobson et al. JAMA 2013;309:1793–802). They found that the antibody response 1 month after the last injection of both regimens was similar but this was not the case for some subtypes at 2 and 3 years follow up. More long-term data may shed light on whether protection is sustained or not and what the implications are. Meanwhile fewer doses are useful, if not ideal.

HPV vaccination is potentially one of the greatest medical advances in women's health but its wider uptake is not occurring where it is needed most. One way of increasing coverage, is to lower the price. From initial costs of over $300 for three injections both Merck and GlaxoSmithKline (makers of Gardasil® and Cervarix®, respectively) have reached arrangements with the GAVI Alliance to reduce the price to less than $5 per dose. As the two companies made $1.6 billion and $400 million from the vaccines in 2012 these are affordable moves but they are also bold and hugely positive steps, which must be matched by the governments and health structures in the countries where the most at-risk live—the poorest and least developed countries.

Contraception in the USA

  1. Top of page
  2. Sex selection in India
  3. HPV vaccine and genital warts
  4. Increasing access to HPV vaccine protection
  5. Contraception in the USA
  6. Do n-3 fatty acids protect you?
  7. New reports and guidelines
  8. Innovations and Patents
  9. Legal matters
  10. Clinical trials

The Affordable Care Act at present being implemented in the USA requires that primary healthcare services become available to all. These services include contraception, which is a problem for certain religious groups who have ethical objections to artificial means of birth control. They have objected to providing contraceptive services because such actions would ‘violate their collective moral conscience’.

The arguments are led by the Catholic Church, which has entered the medical debate. They control institutions that cater for 15% of patient admissions in the whole of the USA so a substantial number of women will be affected by the Church's decision if they refuse to comply with the Act. Catholic institutions argue that it would be against their ethical tenets to provide these services whereas others believe that withholding legislated provision of designated aspects of health care is a ‘sectarian incursion into private healthcare decisions’ (Zimmer et al. JAMA 2013;309;1999–2000; Gossett et al. JAMA 2013;309:1997–8).

Religious views are based on beliefs other than science but both those for and against contraception seem happy to take their arguments into the medical and social science domains. Some of the points of contention are as follows.

Both sides argue the fact that contraception is, or is not a ‘preventive service’.

For example the opponents say that it is not truly a ‘preventive service’ in the same way immunisation and mammography are preventive services. They point out that pregnancy is not an illness and therefore does not fall into the ambit of preventive health services. The proponents say half of all pregnancies in the USA are unintended, which costs the country $10 billion per year, never mind the terminations of pregnancy, which all agree should be avoided. Also teenage birth rates in the USA are considerably higher than other developed countries with a fifth being to teenagers who already have one child (Voelker JAMA 2013;309:1987). The most disadvantaged are the most at risk and most in need of this service no matter whether it is technically preventive or not.

Those opposed to contraception say it has hazards, for example the dangers of thrombosis posed by oral combined contraceptive pills, whereas the proponents say this (in young women) is as likely as being struck by lightning (Trussell and Jordan Contraception 2006;73:437–9) and far less dangerous than pregnancy, which has a maternal mortality in the USA of 15 per 100 000 live births.

Two-thirds of Catholic women in the USA report using some form of highly effective contraception so clearly they do not comply with what their (presumably male) leaders have to say.

Where medicine and religion conflict there are seldom smooth interfaces. Contraception and the Catholic faith are a case in point. Most women and their partners wish to limit their family size and it is most difficult for the poor to do so. Well-off people have access to many contraceptive options and those better educated can exercise their choices more readily. Making contraception morally wrong adds to the difficulties faced by those already disadvantaged. It must be a challenge that most people would much rather not make—deciding whether religious beliefs trump practical choices and now, their health rights.

Do n-3 fatty acids protect you?

  1. Top of page
  2. Sex selection in India
  3. HPV vaccine and genital warts
  4. Increasing access to HPV vaccine protection
  5. Contraception in the USA
  6. Do n-3 fatty acids protect you?
  7. New reports and guidelines
  8. Innovations and Patents
  9. Legal matters
  10. Clinical trials

Polyunsaturated fatty acids derived from fish have been shown to be beneficial in people surviving a myocardial infarction and in people with heart failure. They have positive effects on arrhythmic, atherosclerotic inflammatory and thrombotic processes so it would seem logical to promote their intake in people at cardiovascular risk who have not had an infarct.

Sadly for the proponents of omega 3 supplementation the theory does not work in practice. A group from Italy gave over 12 000 people who were considered by their GPs to be at risk from cardiovascular events either 1 g of n-3 fatty acids daily or placebo and monitored them for 5 years. There was no difference in primary or secondary outcomes, leading the Collaborative Group (NEJM 2013;368:1800–8) to conclude that treating a cohort of women and men with multiple cardiovascular risk factors did not protect them from cardiovascular mortality or morbidity by regular n-3 fatty acid supplementation.

Even though there is no evidence of omega 3 fatty acid advantage in low-risk and now high-risk individuals, many healthy people will continue to take them just as they continue to take unnecessary vitamins. Negative trial findings take longer to be accepted than positive ones but both are equally important. Apart from folic acid supplementation periconceptually there is very little evidence that supplements enhance health in those with a balanced diet.

New reports and guidelines

  1. Top of page
  2. Sex selection in India
  3. HPV vaccine and genital warts
  4. Increasing access to HPV vaccine protection
  5. Contraception in the USA
  6. Do n-3 fatty acids protect you?
  7. New reports and guidelines
  8. Innovations and Patents
  9. Legal matters
  10. Clinical trials

European perinatal health report: health and care of pregnant women and babies in Europe in 2010

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This Euro-Peristat report, the first of a two-stage report, brings together comprehensive comparable data from 29 countries, regarding the health and care of pregnant women and their babies from across Europe to ensure that reliable indicators are used to monitor and evaluate perinatal health across the European Union. The report aims to encourage information sharing among health professionals, service users and health planners, to provide performance benchmarks for individual countries and to reveal the strengths and weaknesses of individual countries in collecting data. It is hoped that this will provide the impetus for countries with poor perinatal health information systems to invest in better systems to help improve their ability to make evidence-based public policy decisions. The report discusses ten core and twenty recommended indicators, which have been grouped into four key areas: fetal, neonatal and child health; maternal health; population characteristics and risk factors; and health services.

Available online at www.europeristat.com.

Closing the deadly gap between what we know and what we do: investing in women&#x0027;s reproductive health

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This report, published by the World Bank and Women Deliver, highlights evidence indicating that investing in reproductive health care brings economic benefits; it discusses determinants of poor reproductive health outcomes, investigates the multitude of factors that can influence poor reproductive health outcomes and assesses the effectiveness of key policies that aim to accelerate improvements to reproductive health among women in low-resource countries. A number of case studies are included, such as the impact of declining maternal mortality rates on schooling in Sri Lanka and how Peru improved reproductive health outcomes by expanding entitlements and strengthening public sector management. The lack of comprehensive data (with only a third of countries completing civil registration systems) is highlighted as an issue that impacts upon obtaining a complete understanding of the effect of the burden of disease associated with maternal mortality. Recent efforts to address this problem such as the Interagency and Expert Group on the Development of Gender Statistics and the high-level Commission on Information and Accountability for Women's and Children's Health are emphasised. The report's key message is that a lack of investment in reproductive health is a ‘major missed opportunity for development’.

Available online at www.womendeliver.org

Global nutrition policy review: what does it take to scale up nutrition action?

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This report, published by the World Health Organization (WHO), summarises the results of a review (conducted during 2009/10) assessing the presence and implementation of policies addressing nutrition in 119 WHO Member States and four territories. The review is part of the Comprehensive Implementation Plan on Maternal, Infant and Young Child Nutrition, which was endorsed by the 65th session of the World Health Assembly in May 2012. The review includes data on maternal, infant and young child feeding and nutrition, maternal undernutrition and low birthweight and the international code of marketing of breast milk substitutes. Findings include: that many nutrition policies do not adequately consider or address the underlying and basic causes of malnutrition; nutrition interventions (including interventions for maternal, infant and young child nutrition) are seldom implemented at scale; the International Code of Marketing of Breast-milk Substitutes, World Health Assembly resolutions and the Global Strategy on Infant and Young Child Feeding are not being implemented adequately. The Comprehensive Implementation Plan on Maternal, Infant and Young Child Nutrition, of which this review is part, has set the following global targets for 2025: 40% reduction in childhood stunting; 50% reduction in anaemia in women of reproductive age; 30% decrease in low birthweight; 0% increase in childhood obesity; an increase in the rate of exclusive breastfeeding in the first 6 months to at least 50%; a reduction in childhood wasting to less than 5%.

Available online at www.who.int.

Accountability for maternal, newborn and child survival: the 2013 Update

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This report, produced by Countdown to 2015, aims to highlight individual country's achie-vements in improving access to key interventions and to ascertain challenges and barriers preventing countries from achieving the Millennium Development Goals (MDGs) related to women and children. Summary data are presented for the 75 Countdown priority countries including data regarding intervention coverage levels (2007–12), prevention of mother-to-child transmission of HIV, women attended at birth by a skilled attendant and stunting prevalence. Comprehensive country profiles are included providing detailed information regarding demographics, maternal and newborn health, child health, equity and nutrition. Five key findings from the report include: levels of maternal and child mortality have been dropping in most Countdown countries apart from in Sub-Saharan Africa; child deaths are increasingly occurring during the first month of life; undernutrition and infectious disease account for almost half of all child deaths; issues of inequity in the coverage of interventions remain; high levels of fertility and unmet needs for family planning also remain a challenge. The report states that there are fewer than 1000 days until the deadline for meeting the MDGs.

Available online at www.countdown2015mnch.org

Clinical guidelines updates

The American Congress of Obstetricians and Gynecologists (ACOG)

The following guidelines are now available online at www.acog.org.

Hormone therapy and heart disease, Number 565, June 2013

The Society of Obstetricians and Gynaecologists of Canada (SOGC)

The following guideline is now available online at www.sogc.org.

Innovations and Patents

  1. Top of page
  2. Sex selection in India
  3. HPV vaccine and genital warts
  4. Increasing access to HPV vaccine protection
  5. Contraception in the USA
  6. Do n-3 fatty acids protect you?
  7. New reports and guidelines
  8. Innovations and Patents
  9. Legal matters
  10. Clinical trials

Patent applications

The following patents can be found online at www.epo.org.

Substituted 16, 17-annellated steroid compounds for use in women&#x0027;s health (US2013150337 (A1)). This US patent application outlines use of steroid compounds that have a 16, 17-annellated carbocyclic ring for the treatment and prevention of women's health conditions such as uterine fibroids, endometriosis, dysfunctional uterine bleeding, hormone therapy during the perimenopausal and postmenopausal periods and for contraception. This patent specifically relates to the formula wherein R1 is H or halogen; R2 is H, (1C–4C)alkyl, (1C–4C)acyl, glucuronyl or sulfamoyl; R3 is H or halogen; R4 is H, (1C–4C)alkyl, (2C–4C)alkenyl or (2C–4C)alkynyl; R5 is methyl or ethyl; R6 is H or methyl; R7 is H or methyl; R8 is H or acyl. Dijcks FA., Loozen HJJ., Addo S., Ederveen AGH. 13 June 2013.

Fertility preservation device (EP2600810 (A2)). This European patent application discusses the invention of a device for regulating the temperature of the ovary and protecting it from exposure to radiation. The device is designed to be used during chemotherapy treatment in women to preserve fertility by shielding the ovary to protect it from radiation and by lowering the temperature of the ovary to limit the toxic effects of the treatment. Nasser, N. 12 June 2013.

Drug delivery device for ovarian cancer (US2013144163 (A1)). This US patent relates to the development of a drug delivery system that can deliver drugs direct to the ovaries. It has been designed as a single-use device and is similar in shape to a tampon to allow insertion through the vagina and into the uterus and consists of three main parts: a tubular inserter, a cylindrical chamber and a plunger. It is intended that ultrasound would be used to ensure correct insertion and placement of the device at the entrance to each fallopian tube ready for the drug to be released by means of the plunger. Kumar A., Lai-Yuen SK., Mohapatra SS. June 2013.

Treatment of polycystic ovary syndrome using renal neuromodulation and associated systems and methods (US2013144283 (A1)). This US patent application outlines methods to partially inhibit sympathetic neural activity in nerves proximate to the renal artery of a kidney in women with polycystic ovary syndrome. Specifically, this patent discusses the modulation of renal sympathetic nerve activity along the afferent and efferent pathways using an intravascularly positioned catheter with a therapeutic device attached, which can, for example, cryotherapeutically cool the renal nerve or deliver an energy field to the renal nerve. Barman, N. 6 June 2013.

Legal matters

  1. Top of page
  2. Sex selection in India
  3. HPV vaccine and genital warts
  4. Increasing access to HPV vaccine protection
  5. Contraception in the USA
  6. Do n-3 fatty acids protect you?
  7. New reports and guidelines
  8. Innovations and Patents
  9. Legal matters
  10. Clinical trials

Take action to improve conditions for Dalit women

Four international non-governmental organisations (IMADR, Human Rights Watch, Minority Rights Group International, and the International Dalit Solidarity Network) have recently called for United Nations member states to support efforts designed to eradicate both gender-based and caste-based discrimination. The organisations particularly highlighted the current discrimination involving violence, rape, forced prostitution and slavery faced by millions of Dalit women. Despite laws being in place in many countries to protect the rights of Dalit women, such as in India, implementation of the law remains problematic.

Irish Government agrees on abortion legislation for women whose lives are at risk

The Irish government has passed legislation regarding termination of pregnancy (TOP). The Protection of Life during Pregnancy Bill 2013 sets out the legal circumstances for ending a pregnancy if a pregnant woman's life is at risk. The bill states that two doctors must confirm whether the life of a pregnant woman is at risk before a TOP will be allowed and that in the case of pregnant women at risk of suicide then an obstetrician and two psychiatrists must be involved in making the decision. Twenty-five hospitals in Ireland have been granted permission to perform legal TOP but the Minister of Health will have the right to suspend hospitals if they are believed to have broken this law.

Clinical trials

  1. Top of page
  2. Sex selection in India
  3. HPV vaccine and genital warts
  4. Increasing access to HPV vaccine protection
  5. Contraception in the USA
  6. Do n-3 fatty acids protect you?
  7. New reports and guidelines
  8. Innovations and Patents
  9. Legal matters
  10. Clinical trials

Clinicians keen to keep up-to-date regarding clinical studies that are currently recruiting may find the following informative.

Assisted exercise in obese endometrial cancer patients
Registration www.clinicaltrials.gov/ct2/show/NCT01870947
Description This pilot study aims to investigate, in women who have had early-stage endometrial cancer, whether taking part in a progressive, supervised assisted exercise programme using a stationary bike improves their quality of life, increases their motivation to continue exercising, improves their dietary behaviour or leads to sustained weight loss.
Outcome measures Primary: Weight change from pre- to post-intervention.Secondary: Change in body composition from baseline; change in motivation to exercise from baseline; change in eating behaviour from baseline; change in quality of life from baseline; change in depression from baseline; exercise session adherence.
Study site Ohio, USA.Anticipated study end date: November 2013. 
Comparison of surgical skin preps during caesarean deliveries
Registration www.clinicaltrials.gov/ct2/show/NCT01870583
Description This randomised study aims to determine, in women undergoing non-emergency caesarean section, which surgical skin preparation solution is the most effective in terms of prevention of surgical site infection. Women will be prospectively randomised to one of three groups and followed up until their postpartum visit at 6–8 weeks following delivery. The three solutions being investigated are: iodine povidone-based skin preparation solution; chlorhexidine-based skin preparation; combination usage of iodine povidone- and chlorhexidine-based skin preparation solutions.
Outcome measures Primary: Caesarean surgical site infectionSecondary: Not specified.
Study site New York, USA.Anticipated study end date: July 2014.
Ovarian tissue transplantation
Registration www.clinicaltrials.gov/ct2/show/NCT01870752
Description This study aims to investigate the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in women experiencing infertility or ovarian insufficiency following cancer treatment.
Outcome measures Primary: Number of adverse events.Secondary: Not specified.
Study site Pennsylvania, USA.Anticipated study end date: June 2018.
GnRH agonist pretreatment in hysteroscopic myomectomy
Registration www.clinicaltrials.gov/ct2/show/NCT01873378
Description This randomised study aims to determine, in women with uterine fibroids, whether gonadotrophin-releasing hormone agonist treatment (consisting of triptorelin 3.75 mg, intramuscular, monthly, three times) before cold loop hysteroscopic myomectomy is effective in terms of reducing operative time, fluid absorption and the difficulty of the procedure.
Outcome measures Primary: Minutes (surgical procedure time), millilitres (fluid absorption during the procedure), 0–3 scale (difficulty of the procedure), 0–3 scale (quality of image).Secondary: Not specified.
Study site Rome, Italy.Anticipated study end date: December 2013.
DNA clearance of uncomplicated Trichomonas vaginalis infections in HIV-negative women
Registration www.clinicaltrials.gov/ct2/show/NCT01874158
Description This observational study aims to establish for how long T. vaginalis DNA remains detectable after treatment and to investigate potential confounders to complete clearance such as the presence of bacterial vaginosis. T. vaginalis-positive women will be assessed for T. vaginalis on a weekly basis using culture and polymerase chain reaction (PCR) until they are cleared of the remnant DNA after their PCR is negative.
Outcome measures Primary: T. vaginalis-negative by PCR, post treatment.Secondary: Not specified.
Study site Louisiana, Alabama and Mississippi, USA.Anticipated study end date: December 2017.