Injectable Contraceptive Launched In West African Nation, Burkina Faso

Dr. Enrique Jacome

Women in the West African nation Burkina Faso today have access to an additional family planning option. Sayana® Press has the potential to increase access to contraception at all levels of the health system and in communities by combining a lower-dose formulation of a widely used contraceptive - Pfizer's Depo-Provera® (depot medroxyprogesterone acetate) - with the BD Uniject™ injection system.

Burkina Faso is the first of four African countries expected to begin introducing Sayana® Press in 2014, followed shortly by Niger. Senegal and Uganda also plan to introduce the contraceptive at the community level in select areas later this year.

"Family planning is vital if girls and women are to have voice, choice, and control in their lives," said UK International Development Minister Lynne Featherstone. "Sayana® Press will help expand the contraceptive options available in developing countries, giving more girls and women the chance to make their own decisions about whether and when to have children."

The introductions are being led by each country's ministry of health and supported by a consortium of public and private partners that includes the UK's Department for International Development (DFID), the US Agency for International Development (USAID), the United Nations Population Fund (UNFPA), Pfizer, PATH, and the Bill & Melinda Gates Foundation.

"Strong public-private partnerships are playing a critical role in expanding contraceptive access and options for women around the world," said Chris Elias, President of Global Development at the Bill & Melinda Gates Foundation. "This innovative initiative brings us one step closer to ensuring that family planning is available to women when and where they want it."

The launches follow the regulatory approval of Sayana® Press in each of the four introduction countries. Indicated for long-term female contraception, the product has also received approval by regulatory authorities in the European Union and several countries around the world.

Information gathered in these countries will enable health program planners to make informed decisions regarding whether and how to include Sayana® Press among their family planning offerings.

Family planning could prevent up to one-third of all maternal deaths by allowing women to delay motherhood, space births, avoid unintended pregnancies and unsafe abortions, and stop childbearing when they reach their desired family size.

"This initiative is a major innovation in family planning service delivery," said PATH President and CEO Steve Davis. "By making injectable contraceptives available at the community level, it offers more women control over the timing and spacing of their children and a better chance at a healthy life."

Injectable contraception is a popular family planning method among women in developing countries. In some places, women must return to a clinic every three months for a new injection, limiting access in remote and other hard-to-reach areas. The contraceptive's delivery system allows injections to be provided by health workers to women at home or in other convenient settings.

The BD Uniject prefilled autodisable injection system was originally developed by PATH, with support from USAID, and has been licensed to Becton, Dickinson and Company (BD). The system allows the contraceptive to be delivered via subcutaneous injection, in the fat layer between the skin and muscle. It also eliminates the need to prepare a needle and syringe.

"At the right price, Sayana® Press will expand contraceptive choice and increase access to family planning, especially in rural and hard-to-reach communities in low-resource settings," said Ellen Starbird, Director of the Office of Population and Reproductive Health at USAID.

This initial introduction of Sayana® Press in Burkina Faso brings injectable contraceptives to the most peripheral level of the health system and integrates them for the first time into regular community health outreach. Sayana® Press will be delivered by mobile health workers in four regions where a large proportion of women have expressed a desire to prevent or delay pregnancy, but have limited access to contraceptives. The initiative aims to help Burkina Faso meet its goal of increasing contraceptive use among married women from 15 percent in 2010 to 25 percent by 2015.

Burkina Faso's introduction activities are being implemented by the country's Ministry of Health and key partner organizations, including UNFPA, Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ), Marie Stopes International (MSI), and the Association Burkinabé pour le Bien-Etre Familial (ABBEF), with technical support from PATH.

The global initiative to support Sayana Press introduction was launched at the 2012 London Summit on Family Planning as part of a larger effort to ensure that voluntary family planning information, contraceptives, and services reach 120 million more women and girls in the world's poorest countries by 2020.

The Sayana® Press introductions, which are coordinated by PATH, are based on the principle that all women, no matter where they live, should have access to a range of contraceptive options that enables them to make an informed choice and meets their needs.

Pfizer's Chief Medical Officer Dr. Freda Lewis-Hall remarked, "At Pfizer we strive to improve the health of people worldwide, and, as part of that, we're committed to increasing access in developing countries to our portfolio. While the industry can take the lead in developing products suited to the needs of the market, it is largely through innovative private-public partnerships such as this that we can ensure the long-term viability of supply and distribution."

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Contraceptive Coverage In The Affordable Care Act Will Benefit Women

Dr. Enrique Jacome

Women will benefit greatly from the Affordable Care Act's mandate for contraceptive coverage, according to Penn State College of Medicine researchers. 

The Affordable Care Act requires private insurance plans - except those grandfathered or exempted due to employers' religious beliefs - to provide women with access to all FDA-approved contraceptive methods without cost-sharing. This first-dollar coverage "has the potential to dramatically shift contraceptive use patterns, to reduce the U.S. unintended pregnancy rate ... and to improve the health of women and families," wrote Carol S. Weisman, Distinguished Professor of Public Health Sciences and Obstetrics and Gynecology, and Cynthia H. Chuang, associate professor of medicine and public health sciences.

"First-dollar coverage" means that women will not pay anything out-of-pocket for their office visits or contraceptive methods - no copays and no deductibles - because these costs will be covered by health insurance.

Challenges beyond employer objections that could slow privately insured women's full use of contraceptive benefits are the focus of a recent commentary co-authored by Weisman and Chuang that is now online, and also in the September/October print edition of Women's Health Issues. The researchers also offer suggestions for "making the most of first-dollar contraceptive coverage."

In particular, evidence suggests more women will choose highly effective long-acting reversible contraceptives (LARCs), such as intrauterine devices (IUDs), that previously would have been too expensive.

However, cost is not the only barrier women face when considering their contraceptive options. Many women may be uncertain about what their plans cover or unaware of the attributes of various methods now within their financial reach, according to Weisman and Chuang. Their primary care providers may not be trained in the provision of LARCs, and insertion of IUDs and implants may require referrals to obstetrician-gynecologists.

To address these challenges, the researchers recommend clear communication to the public about the Affordable Care Act contraceptive coverage mandate and to private-plan enrollees about their plans' contraceptive coverage. They also recommend training primary-care providers and creating seamless referral arrangements between these providers and those who can provide LARCs.

In addition, Weisman and Chuang call for the "design, assessment and dissemination of woman-centered information and decision tools to help women make optimal contraceptive choices in the context of their own life circumstances and preferences." Their commentary offers examples of current initiatives in Massachusetts and Pennsylvania to develop and disseminate such decision tools.

"All of the publicity about the Supreme Court's Hobby Lobby decision may have confused women who have first-dollar coverage through their employer's health insurance or through the new exchanges," said Weisman. "Women need accurate information about their coverage and about their contraceptive options so that they can obtain whatever contraceptive method best meets their needs. Avoiding unintended pregnancy is a key component of women's health that we should not lose sight of."

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Avastin Approved By The FDA To Treat Patients With Aggressive And Late-Stage Cervical Cancer

Dr. Enrique Jacome

The U.S. Food and Drug Administration recently approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer. Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It commonly occurs when human papillomaviruses (HPV), a virus that spreads through sexual contact, cause cells to become cancerous. Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.

Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

"Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA's priority review program, demonstrating the agency's commitment to making promising therapies available to patients faster."

The FDA reviewed Avastin for treatment of patients with cervical cancer under its priority review program because the drug demonstrated the potential to be a significant improvement in safety or effectiveness over available therapy in the treatment of a serious condition. Priority review provides an expedited review of a drug's application.

The safety and effectiveness of Avastin for treatment of patients with cervical cancer was evaluated in a clinical study involving 452 participants with persistent, recurrent, or late-stage disease. Participants were randomly assigned to receive paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with Avastin as compared to 12.9 months for those receiving chemotherapy alone.

The most common side effects associated with use of Avastin in patients with cervical cancer include fatigue, decreased appetite, high blood pressure (hypertension), increased glucose in the blood (hyperglycemia), decreased magnesium in the blood (hypomagnesemia), urinary tract infection, headache and decreased weight. Perforations of the gastrointestinal tract and abnormal openings between the gastrointestinal tract and vagina (enterovaginal fistula) also were observed in Avastin-treated patients.

Avastin is marketed by South San Francisco, California-based Genentech, a member of the Roche Group.

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Research Shows Postmenopausal Breast Cancer Risk Decreases Rapidly After Starting Regular Physical Activity

Dr. Enrique Jacome

Postmenopausal women who in the past four years had undertaken regular physical activity equivalent to at least four hours of walking per week had a lower risk for invasive breast cancer compared with women who exercised less during those four years, according to data published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

"Twelve MET-h [metabolic equivalent task-hours] per week corresponds to walking four hours per week or cycling or engaging in other sports two hours per week and it is consistent with the World Cancer Research Fund recommendations of walking at least 30 minutes daily," said Agnès Fournier, PhD, a researcher in the Centre for Research in Epidemiology and Population Health at the Institut Gustave Roussy in Villejuif, France. "So, our study shows that it is not necessary to engage in vigorous or very frequent activities; even walking 30 minutes per day is beneficial."

Postmenopausal women who in the previous four years had undertaken 12 or more MET-h of physical activity each week had a 10 percent decreased risk of invasive breast cancer compared with women who were less active. Women who undertook this level of physical activity between five and nine years earlier but were less active in the four years prior to the final data collection did not have a decreased risk for invasive breast cancer.

"Physical activity is thought to decrease a woman's risk for breast cancer after menopause," said Fournier. "However, it was not clear how rapidly this association is observed after regular physical activity is begun or for how long it lasts after regular exercise stops.

"Our study answers these questions," Fournier continued. "We found that recreational physical activity, even of modest intensity, seemed to have a rapid impact on breast cancer risk. However, the decreased breast cancer risk we found associated with physical activity was attenuated when activity stopped. As a result, postmenopausal women who exercise should be encouraged to continue and those who do not exercise should consider starting because their risk of breast cancer may decrease rapidly."

Fournier and colleagues analyzed data obtained from biennial questionnaires completed by 59,308 postmenopausal women who were enrolled in E3N, the French component of the European Prospective Investigation Into Cancer and Nutrition (EPIC) study. The mean duration of follow-up was 8.5 years, during which time, 2,155 of the women were diagnosed with a first primary invasive breast cancer.

The total amount of self-reported recreational physical activity was calculated in MET-h per week. The breast cancer risk-reducing effects of 12 or more MET-h per week of recreational physical activity were independent ofbody mass index, weight gain, waist circumference, and the level of activity from five to nine years earlier.

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Research Shows Postpartum Mood Swings Correlated With High Monoamine Oxidase

Dr. Enrique Jacome

Many women suffer from baby blues after giving birth. Some even develop full-blown postpartum depression in the weeks that follow. Monoamine oxidase A, an enzyme responsible for the breakdown of neurotransmitters like dopamine and serotonin, plays an important role in this condition. In comparison to healthy women, women who experience postpartum depression present strongly elevated levels of the enzyme in their brains. This was discovered by a Canadian-German research team including Julia Sacher from the Max Planck Institute for Human Cognitive and Brain Sciences in Leipzig. Their findings could help in the prevention of postpartum depression and in the development of new drugs for its treatment.

For most women, the birth of their baby is one of the most strenuous but also happiest days in their lives. However, joy and happiness are often followed by fatigue and exhaustion. The vast majority of women experience a temporary drop in mood for a few days after birth. These symptoms of "baby blues" are not an illness; however, in some cases they can represent early signs of an imminent episode of depression: in 13 percent of mothers, the emotional turmoil experienced after childbirth leads to the development of a full-blown postpartum depression. Postpartum depression is harmful not only to the mother, but also to the baby. It is difficult to treat this condition effectively, as its precise neurobiological causes have remained unidentified to date.

The new study shows that postpartum depression is accompanied by strongly elevated monoamine oxidase A in the brain, particularly in the prefrontal cortex and in the anterior cingulate cortex. In women with postpartum depression, the values recorded were 21 percent higher than those of women who were not plagued by negative feelings after giving birth. Women who did not develop full-blown depression but found themselves crying more often than usual due to depressed mood also presented moderately elevated values.

"Therefore, we should promote strategies that help to reduce monoamine oxidase A levels in the brain, and avoid everything that makes these values rise," explains Sacher. Such factors include heavy smoking, alcohol consumption and chronic stress, for example when the mother feels neglected and abandoned by her partner and family. "My ultimate goal is to provide women and their families with very concrete lifestyle recommendations that will enable them to prevent postpartum depression," explains the psychiatrist.

A new generation of long-established drugs could also play an important role in the treatment of postpartum depression in future. Up to now, depressed mothers are mainly given drugs that increase the concentration of serotonin in the brain. However, because monoamine oxidase A breaks down not only serotonin but also other monoamines like dopamine and noradrenaline, a treatment that directly targets monoamine oxidase A could have a higher success rate, particularly in very serious cases: this alternative is provided by selective and reversible monoamine-oxidase- A inhibitors. "The first monoamine oxidase inhibitors often had severe side effects, for example hypertensive crises, which necessitated adherence to a strict diet," explains Sacher. "However, the new selective and reversible drugs are better tolerated," she adds. In the next stage of this research involving clinical trials, the scientists intend to test the effectiveness of these reversible monoamine oxidase A inhibitors in the treatment of postpartum depression.

Because the measurement of this enzyme in the brain requires complex technology, it is not suitable for routine testing. Thus, the researchers are also looking for a peripheral marker of this enzyme that can be detected in saliva or blood.

Four years ago, Julia Sacher and her colleagues at the Centre for Addiction and Mental Health CAMH in Toronto already succeeded in showing that, in the first week postpartum, the concentration of the enzyme monoamine oxidase A in the brain is on average 40 percent higher than in women who had not recently given birth. "The monoamine oxidase A values behave in the opposite way to oestrogen levels. When oestrogen levels drop acutely after childbirth, the concentration of monoamine oxidase A rises. This drastic change also influences serotonin levels, known as the happiness hormone," explains Dr. Sacher. In most women, the values quickly return to normal. In others, they remain raised - and thereby promote the development of depression.

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