A New Contraceptive and HarvestPlus

The U.S. Food and Drug Administration has approved a new contraceptive for women developed by the Population Council.  Annovera; (segesterone acetate and ethinyl estradiol vaginal system) is a combined hormonal contraceptive for women of reproductive age and is the first vaginal ring contraceptive that can be used for an entire year. It is a reusable donut-shaped (ring), non-biodegradable, flexible vaginal system that is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every four weeks for one year (thirteen 28-day menstrual cycles).  It is not felt during sex.  It does not prevent sexually transmitted diseases.  

Annovera is washed and stored in a compact case for the seven days not in use. It does not require refrigeration prior to dispensing and can withstand storage temperatures up to 30°C (86°F).  This new contraceptive is considered suitable for women who do not always remember to take the pill regularly, or who used the previously available contraceptive ring that had to be replaced every month. Women in developing countries may find this method convenient, as they are often unable to find other contraceptives on a regular basis.  The Population Council plans to make it available in Latin America, Asia and Africa as well as in the US.   It will be released in 2019.

The efficacy and safety of Annovera were studied in three, open label clinical trials with healthy women ranging from 18 to 40 years of age. Based on the results, about two to four women out of 100 women may get pregnant during the first year they use Annovera.

All hormonal contraception carries serious risks. Annovera carries a boxed warning relating to cigarette smoking and serious cardiovascular events. Women over 35 who smoke should not use Annovera. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.

HarvestPlus is an international organization that uses ‘biofortification’ to make plants more nutritious. Its work is in Asia, Africa and Latin America. It uses conventional plant breeding rather than genetic modification, and focuses on three crucial micronutrients that are most limited in the diets of the poor—vitamin A, zinc, and iron, breeding these into key staple crops. Harvest Plus screens thousands of different types of crop seeds stored in seed banks that have naturally higher amounts of iron, zinc, and vitamin A. They use these more nutritious seeds to breed new crop varieties with higher micronutrient content that are also high yielding and have other traits farmers want. Together with farmers, they test these new varieties in the target region. The national government then officially releases the best-performing varieties of micronutrient-rich crops for farming communities to grow, eat, and sell in local markets.

Iron deficiency during childhood and adolescence impairs mental development and learning capacity. In adults, it reduces the ability to do physical labor. Severe anemia increases the risk of women dying in childbirth. Five hundred million women aged 15 to 49, at the peak of their productive years, are anemic due to iron deficiency. This condition reduces their productivity, decreases their economic potential, and affects their reproductive health outcomes.

Zinc is involved in more body functions than any other mineral. Its role includes acting as a necessary component of more than 200 enzyme systems, normal growth and development, the maintenance of body tissues, sexual function, vision, and the immune system. Zinc is essential for survival, and zinc deficiency has serious consequences for health, particularly during childhood when zinc requirements are increased. In addition, zinc deficiency also causes stunting. Randomized controlled trials showed that zinc supplementation can reduce the severity of morbidity from a number of common childhood infections, including diarrhea, pneumonia, and possibly malaria, by one-third. 

Vitamin A is essential for good vision and cell differentiation. Deficiency results in growth retardation, damage to mucous membrane tracts, reproductive disorders, eye damage—and ultimately blindness. Children with vitamin A deficiency are often deficient in multiple micronutrients and are likely to be anemic, have impaired growth, and be at increased risk of severe morbidity from common childhood infections such as diarrheal diseases and measles. Pregnant women with vitamin A deficiency may be at increased risk of mortality.

Today, biofortified crops, including vitamin A orange sweet potato, iron beans, iron pearl millet, vitamin A yellow cassava, vitamin A orange maize, zinc rice, and zinc wheat, have been grown in more than 40 counties in Asia, Africa and Latin America. Crop improvement continues to develop varieties with higher levels of vitamins and minerals that are adapted to a wide range of agro-ecological conditions, and ensuring that the best germplasm for climate-adaptive and consumer-preferred traits continues to be used in breeding biofortified crops.

The take home message from this column is: despite the suffering in our world due to climate change and political chaos, efforts to improve situations of poverty are underway. As far as iron, zinc and Vitamin A are concerned – do not start to take these micronutrients as supplements, get them from your healthy diet and possibly a multi vitamin/mineral pill – not more! Talk to your health-care provider.

HarvestPlus is supported by several sources: the UK Government, the Bill & Melinda Gates Foundation, the US government’s Feed the Future Initiative, the European Commission and donors to the CGIAR Research Program on Agriculture for Nutrition and Health. HarvestPlus is also supported by the John D. and Catherine T. MacArthur Foundation.

Sadja Greenwood MD, MPH   Sub