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1.  Violations of the international code of marketing of breast milk substitutes: prevalence in four countries 
BMJ : British Medical Journal  1998;316(7138):1117-1122.
Objective: To estimate the prevalence of violations of the international code of marketing of substitutes for breast milk in one city in each of Bangladesh, Poland, South Africa, and Thailand.
Design: Multistage random sampling was used to select pregnant women and mothers of infants ⩽6 months old to interview at health facilities. Women were asked whether they had received free samples of substitutes for breast milk (including infant formula designed to meet the nutritional needs of infants from birth to 4 to 6 months of age, follow on formula designed to replace infant formula at the age of 4 to 6 months, and complementary foods for infants aged ⩽6 months), bottles, or teats. The source of the free sample and when it had been given to the women was also determined. 3 health workers were interviewed at each facility to assess whether the facility had received free samples, to determine how they had been used, and to determine whether gifts had been given to health workers by companies that manufactured or distributed breast milk substitutes. Compliance with the marketing code for information given to health workers was evaluated using a checklist.
Setting: Health facilities in Dhaka, Bangladesh; Warsaw, Poland; Durban, South Africa; and Bangkok, Thailand.
Subjects: 1468 pregnant women, 1582 mothers of infants aged ⩽6 months, and 466 health workers at 165 health facilities.
Main outcome measures: Number of free samples received by pregnant women, mothers, and health workers; number of gifts given to health workers; and availability of information that violated the code in health facilities.
Results: 97 out of 370 (26%) mothers in Bangkok reported receiving free samples of breast milk substitutes, infant formula, bottles, or teats compared with only 1 out of 385 mothers in Dhaka. Across the four cities from 3 out of 40 (8%) to 20 out of 40 (50%) health facilities had received free samples which were not being used for research or professional evaluation; from 2 out of 123 (2%) to 21 out of 119 (18%) health workers had received gifts from companies involved in the manufacturing or distribution of breast milk substitutes. From 6 out of 40 (15%) to 22 out of 39 (56%) health facilities information that violated the code had been provided by companies and was available to staff.
Conclusion: Violations of the code were detected with a simple survey instrument in all of the four countries studied. Governmental and non-governmental agencies should monitor the prevalence of code violations using the simple methodology developed for this study.
Key messages A simple multistage random sampling procedure can be used to interview women and health professionals to assess whether violations of the international code of marketing of substitutes for breast milk are occurring 3050 women and 466 health professionals were interviewed at 165 health facilities in Bangladesh, Poland, South Africa, and Thailand 97 out of 370 mothers in Bangkok reported receiving free samples of breast milk substitutes, infant formula, bottles, or teats compared with only 1 out of 385 mothers in Dhaka. In Bangkok health workers reported that 20 out of 40 health facilities had also received free samples. Most free samples were distributed by health facilities In Warsaw 56% of facilities surveyed were found to have information available for health workers that had been provided by manufacturers or distributors of breast milk substitutes in contravention of the code; 18% of health workers in Warsaw had received free gifts from manufacturers
PMCID: PMC28512  PMID: 9552947
2.  Markets, breastfeeding and trade in mothers’ milk 
This introduction to a special issue on the economics of breastfeeding draws attention to the lack of economic justice for women.
Human milk is being bought and sold. Commodifying and marketing human milk and breastfeeding risk reinforcing social and gender economic inequities. Yet there are potential benefits for breastfeeding, and some of the world’s poorest women might profit. How can we improve on the present situation where everyone except the woman who donates her milk benefits?
Breastfeeding is a global food production system with unsurpassed capacity to promote children’s food security and maternal and child health, but it is side-lined by trade negotiators who seek instead to expand world markets for cow’s milk-based formula. Regulators focus on potential risks of feeding donated human milk, rather than on health risks of exposing infants and young children to highly processed bovine milk. Similarly, policymakers aspire to provide universal health care access that may be unaffordable when two thirds of the world’s children are not optimally nourished in infancy, resulting in a global double burden of infectious and chronic disease. Universal breastfeeding requires greater commitment of resources, but such investment remains lacking despite the cost effectiveness of breastfeeding protection, support and promotion in and beyond health services. Women invest substantially in breastfeeding but current policy - epitomised by the G20 approach to the ‘gender gap’ - fails to acknowledge the economic value of this unpaid care work. Economic incentives for mothers to optimally breastfeed are dwarfed by health system and commercial incentives promoting formula feeding and by government fiscal policies which ignore the resulting economic costs.
‘The market’ fails to protect breastfeeding, because market prices give the wrong signals. An economic approach to the problem of premature weaning from optimal breastfeeding may help prioritise global maternity protection as the foundation for sustainable development of human capital and labour productivity. It would remove fiscal subsidies for breast milk substitutes, tax their sale to recoup health system costs, and penalise their free supply, promotion and distribution. By removing widespread incentives for premature weaning, the resources would be available for the world to invest more in breastfeeding.
PMCID: PMC4380115  PMID: 25829943
Breast feeding/economics; Infant formula; Formula feeding; Cost-benefit analysis; Cost of illness; Health priorities; Health promotion/economics; Child health; Infant mortality; National health programs/economics; Maternity leave; Maternal employment
3.  Food security for infants and young children: an opportunity for breastfeeding policy? 
Increased global demand for imported breast milk substitutes (infant formula, follow-on formula and toddler milks) in Asia, particularly China, and food safety recalls have led to shortages of these products in high income countries. At the same time, commodification and trade of expressed breast milk have fuelled debate about its regulation, cost and distribution. In many economies suboptimal rates of breastfeeding continue to be perpetuated, at least partially, because of a failure to recognise the time, labour and opportunity costs of breast milk production. To date, these issues have not figured prominently in discussions of food security. Policy responses have been piecemeal and reveal conflicts between promotion and protection of breastfeeding and a deregulated trade environment that facilitates the marketing and consumption of breast milk substitutes.
The elements of food security are the availability, accessibility, utilization and stability of supply of nutritionally appropriate and acceptable quantities of food. These concepts have been applied to food sources for infants and young children: breastfeeding, shared breast milk and breast milk substitutes, in accordance with World Health Organization (WHO)/United Nations Children’s Fund (UNICEF) guidelines on infant feeding. A preliminary analysis indicates that a food security framework may be used to respond appropriately to the human rights, ethical, economic and environmental sustainability issues that affect the supply and affordability of different infant foods.
Food security for infants and young children is not possible without high rates of breastfeeding. Existing international and national instruments to protect, promote and support breastfeeding have not been implemented on a wide scale globally. These instruments need review to take into account the emerging trade environment that includes use of the internet, breast milk markets and globalised supply chains for breast milk substitutes. New approaches are required to handle the long-standing policy conflicts that surround infant and young child feeding. Placing breastfeeding in a food security framework may achieve the political attention and policy co-ordination required to accelerate breastfeeding rates in a range of economies.
PMCID: PMC4352266  PMID: 25750657
Food security; Breastfeeding; Breast milk; Breast milk substitutes; Infant; Nutrition; Trade; Policy; Markets; Regulation
4.  Monitoring compliance with the International Code of Marketing of Breastmilk Substitutes in west Africa: multisite cross sectional survey in Togo and Burkina Faso 
BMJ : British Medical Journal  2003;326(7381):127.
To monitor compliance with the International Code of Marketing of Breastmilk Substitutes in health systems, sales outlets, distribution points, and the news media in Togo and Burkina Faso, west Africa.
Multisite cross sectional survey.
Staff at 43 health facilities and 66 sales outlets and distribution points, 186 health providers, and 105 mothers of infants aged ⩽5 months in 16 cities.
Six (14%) health facilities had received donations of breast milk substitutes. All donations were being given to mothers free of charge. Health providers in five (12%) health facilities had received free samples of breast milk substitutes for purposes other than professional research or evaluation. Health professionals in five (12%) health facilities had received promotional gifts from manufacturers. Promotional materials of commercial breast milk substitutes were found in seven (16%) health facilities. Special displays to market commercial breast milk substitutes were found in 29 (44%) sales and distribution points. Forty commercial breast milk substitutes violated the labelling standards of the code: 21 were manufactured by Danone, 11 by Nestlé, and eight by other national and international manufacturers. Most (148, 90%) health providers had never heard of the code, and 66 mothers (63%) had never received any counselling on breast feeding by their health providers.
In west Africa manufacturers are violating the code of marketing of breast milk substitutes. Comparable levels of code violations are observed with (Burkina Faso) or without (Togo) regulating legislation. Legislation must be accompanied by effective information, training, and monitoring systems to ensure that healthcare providers and manufacturers comply with evidence based practice and the code.
What is already known on this topicAll member states of the World Health Assembly have reaffirmed their support for the International Code of Marketing of Breastmilk SubstitutesViolations by manufacturers of breast milk substitutes have been reported in industrialised and developing countriesWhat this study addsManufacturers of breast milk substitutes are violating the code in Togo and Burkina FasoThe levels of code violations are similar in a country with (Burkina Faso) and one without (Togo) legislation on the marketing of breast milk substitutesLegislation must be accompanied by effective information, training, and monitoring systems to ensure compliance with the code
PMCID: PMC140002  PMID: 12531842
5.  Investing in breastfeeding – the world breastfeeding costing initiative 
Despite scientific evidence substantiating the importance of breastfeeding in child survival and development and its economic benefits, assessments show gaps in many countries’ implementation of the 2003 WHO and UNICEF Global Strategy for Infant and Young Child Feeding (Global Strategy). Optimal breastfeeding is a particular example: initiation of breastfeeding within the first hour of birth, exclusive breastfeeding for the first six months; and continued breastfeeding for two years or more, together with safe, adequate, appropriate, responsive complementary feeding starting in the sixth month. While the understanding of “optimal” may vary among countries, there is a need for governments to facilitate an enabling environment for women to achieve optimal breastfeeding. Lack of financial resources for key programs is a major impediment, making economic perspectives important for implementation. Globally, while achieving optimal breastfeeding could prevent more than 800,000 under five deaths annually, in 2013, US$58 billion was spent on commercial baby food including milk formula. Support for improved breastfeeding is inadequately prioritized by policy and practice internationally.
The World Breastfeeding Costing Initiative (WBCi) launched in 2013, attempts to determine the financial investment that is necessary to implement the Global Strategy, and to introduce a tool to estimate the costs for individual countries. The article presents detailed cost estimates for implementing the Global Strategy, and outlines the WBCi Financial Planning Tool. Estimates use demographic data from UNICEF’s State of the World’s Children 2013.
The WBCi takes a programmatic approach to scaling up interventions, including policy and planning, health and nutrition care systems, community services and mother support, media promotion, maternity protection, WHO International Code of Marketing of Breastmilk Substitutes implementation, monitoring and research, for optimal breastfeeding practices. The financial cost of a program to implement the Global Strategy in 214 countries is estimated at US $17.5 billion ($130 per live birth). The major recurring cost is maternity entitlements.
WBCi is a policy advocacy initiative to encourage integrated actions that enable breastfeeding. WBCi will help countries plan and prioritize actions and budget them accurately. International agencies and donors can also use the tool to calculate or track investments in breastfeeding.
PMCID: PMC4396713  PMID: 25873985
Breastfeeding; Costs and cost analysis; Breastfeeding investment; Child survival; Health plan implementation; Health promotion/Economics/*Organization & administration; National health programs/economics/*Organization & administration; Program development/Economics
6.  Two-Year Morbidity–Mortality and Alternatives to Prolonged Breast-Feeding among Children Born to HIV-Infected Mothers in Côte d'Ivoire 
PLoS Medicine  2007;4(1):e17.
Little is known about the long-term safety of infant feeding interventions aimed at reducing breast milk HIV transmission in Africa.
Methods and Findings
In 2001–2005, HIV-infected pregnant women having received in Abidjan, Côte d'Ivoire, a peripartum antiretroviral prophylaxis were presented antenatally with infant feeding interventions: either artificial feeding, or exclusive breast-feeding and then early cessation from 4 mo of age. Nutritional counseling and clinical management were provided for 2 y. Breast-milk substitutes were provided for free. The primary outcome was the occurrence of adverse health outcomes in children, defined as validated morbid events (diarrhea, acute respiratory infections, or malnutrition) or severe events (hospitalization or death). Hazards ratios to compare formula-fed versus short-term breast-fed (reference) children were adjusted for confounders (baseline covariates and pediatric HIV status as a time-dependant covariate). The 18-mo mortality rates were also compared to those observed in the Ditrame historical trial, which was conducted at the same sites in 1995–1998, and in which long-term breast-feeding was practiced in the absence of any specific infant feeding intervention. Of the 557 live-born children, 262 (47%) were breast-fed for a median of 4 mo, whereas 295 were formula-fed. Over the 2-y follow-up period, 37% of the formula-fed and 34% of the short-term breast-fed children remained free from any adverse health outcome (adjusted hazard ratio [HR]: 1.10; 95% confidence interval [CI], 0.87–1.38; p = 0.43). The 2-y probability of presenting with a severe event was the same among formula-fed (14%) and short-term breast-fed children (15%) (adjusted HR, 1.19; 95% CI, 0.75–1.91; p = 0.44). An overall 18-mo probability of survival of 96% was observed among both HIV-uninfected short-term and formula-fed children, which was similar to the 95% probability observed in the long-term breast-fed ones of the Ditrame trial.
The 2-y rates of adverse health outcomes were similar among short-term breast-fed and formula-fed children. Mortality rates did not differ significantly between these two groups and, after adjustment for pediatric HIV status, were similar to those observed among long-term breast-fed children. Given appropriate nutritional counseling and care, access to clean water, and a supply of breast-milk substitutes, these alternatives to prolonged breast-feeding can be safe interventions to prevent mother-to-child transmission of HIV in urban African settings.
Given appropriate nutritional counseling and care, access to clean water, and supply of breast milk substitutes, replacing prolonged breast-feeding with formula-feeding appears to be a safe intervention to prevent mother-to-child transmission of HIV in this setting.
Editors' Summary
The HIV virus can be transmitted from infected mothers to their babies during pregnancy and birth as well as after birth through breast milk. Mother-to-child transmission in developed countries has been all but eliminated by treatment of mothers with the best available combination of antiretroviral drugs and by asking them to avoid breast-feeding. However, in many developing countries, the best drug treatments are not available to mothers. Moreover, breast-feeding is generally the best nutritional choice for infants, especially in areas where resources such as clean water, formula feed, and provision of healthcare are scarce. And even if formula feed is available, formula-fed babies might be at higher risk of dying from diarrhea and chest infections, which are more common in infants who are not breast-fed. International guidelines say that HIV-positive mothers should avoid all breast-feeding and adopt formula feeding instead if this option is practical and safe for them, which would require that they can afford formula feed and have easy access to clean water. If formula-feeding is not feasible, guidelines recommend that mothers should breast-feed only for the first few months and then stop and switch the baby to solid food. One of these two alternative options should be feasible in most African cities if mothers are given the right support.
Why Was This Study Done?
Several completed and ongoing studies are assessing the relative risks and benefits of the two recommended strategies for different developing country locations, and this is one of them. The study, the “Ditrame Plus” trial by researchers from France and Côte d'Ivoire, was conducted in Abidjan, an urban West African setting. The goal was to compare death rates and rates of certain diseases (such as diarrhea and chest infections) between babies born to HIV-positive mothers that were formula-fed and those that were breast-fed for a short time after birth.
What Did the Researchers Do and Find?
HIV-positive pregnant women were invited to enter the study, and they received short-term drug treatments intended to reduce the risk of HIV transmission to their babies. Women in the trial were then asked to choose one of the two feeding options and offered support and counseling for either one. This support included free formula, transport, and healthcare provision. Babies were followed up to their second birthday, and data were collected on death rates and any serious illnesses. A total of 643 women were enrolled into the study, and safety data were collected for 557 babies, of whom 295 were in the formula group and 262 were in the short-term breast-feeding group. The researchers corrected for HIV infection in the babies and found no evidence that the risk of other negative health outcomes and death rates was any different between the formula-fed babies and short-term breast-fed babies. Looking specifically at individual diseases, the researchers found that the risks for diarrhea and chest infections were slightly higher among formula-fed babies, but this did not translate into a greater risk of death or worse overall health. They also compared the death rates in this study with some historical data from a previous research project done in the same area on children born to HIV-positive mothers who had practiced long-term breast-feeding. The mother-to-child transmission rate of HIV had been much higher in that earlier trial, but looking only at the HIV-negative children, the researchers found no difference in risk for death or serious disease between the formula-fed or short-term breast-fed babies from the Ditrame Plus trial and the long-term breast-fed babies from the earlier trial.
What Do These Findings Mean?
This study shows that if HIV-positive mothers are well supported, either of the two feeding options currently recommended (formula-only feed, or short-term breast-feeding) are likely to be equivalent in terms of the baby's chances for survival and health. However, women in this study were offered a great deal of support and the findings may not necessarily apply to real-life situations in other settings in Africa, or outside the context of a research project. In addition to routine care after birth, access to better drugs to prevent mother-to-child transmission in developing countries remains an important goal.
Additional Information.
Please access these Web sites via the online version of this summary at
Resources from Avert (an AIDS charity) on HIV and infant feeding.
Information from the US Centers for Disease Control on mother-to-child transmission of HIV
Guidelines from the World Health Organization on mother-to-child transmission of HIV
AIDSMap pages on breast-feeding and HIV
HIV Care and PMTCT in Resource-Limited Setting contains monthly bulletins and a database devoted to HIV/AIDS infections and prevention of the mother-to-child transmission of HIV
The Ghent group is a network of researchers and policymakers in the area of prevention of mother-to-child transmission of HIV
PMCID: PMC1769413  PMID: 17227132
7.  Awareness and reported violations of the WHO International Code and Pakistan's national breastfeeding legislation; a descriptive cross-sectional survey 
National legislation in Pakistan adopted the International Code of Marketing of Breastmilk Substitutes in 2002 to restrict the promotion of infant formula feeding. Our objectives were to assess health professionals' awareness of this law in urban government hospitals and describe their reports of violations, including receiving free samples, gifts and sponsorship.
Structured interviews were conducted with health staff between July and August 2006 at 12 urban government hospitals in Islamabad, Rawalpindi and Peshawar including paediatricians, obstetricians, nurses, resident doctors, midwives and lady health visitors (LHVs).
Of the 427 health workers interviewed, the majority were not aware of the national breastfeeding law (70.5%; n = 301) or the International Code (79.6%; n = 340). Paediatricians, and staff who had been working for 10 years or more, were more likely to be aware of the law [OR = 7.00, 95% CI 3.12, 15.7 (paediatricians); OR = 2.48, 95% CI 1.45, 4.24 (10 years working)].
More than one third (38.4%, n = 164) had received small gifts such as pens, pencils and calendars; 12.4% (n = 53) had received sponsorship for training or conferences; and 15.9% (n = 68) had received free samples of infant formula from the Companies. Staff who were aware of the law were also more likely to report receiving gifts (OR = 1.64, 95% CI 1.08, 2.51) and free samples (OR = 1.86, 95% CI 1.09, 3.19).
Most hospital health professionals were unaware of national breastfeeding legislation in Pakistan, and infant formula companies were continuing to flout the ban on gifts, free samples and sponsorship for health staff.
PMCID: PMC2577086  PMID: 18928524
8.  Differences in perception of the WHO International Code of Marketing of Breast Milk Substitutes between pediatricians and obstetricians in Japan 
The World Health Organization International Code of Marketing of Breast-Milk Substitutes (WHO Code) aims to protect and promote breastfeeding. Japan ratified the WHO Code in 1994, but most hospitals in Japan continue to receive free supplies of infant formula and distribute discharge packs to new mothers provided by infant formula companies. The aim of this study was to explore the knowledge and attitudes of pediatricians and obstetricians in Japan to the WHO Code.
A self-completion questionnaire was sent to 132 pediatricians in the 131 NICUs which belonged to the Neonatal Network of Japan, and to 96 chief obstetricians in the general hospitals in the Kanto area of Japan, in 2004.
Responses were received from 68% of pediatricians and 64% of obstetricians. Sixty-six percent of pediatricians agreed that "Breastmilk is the best", compared to only 13% of obstetricians. Likewise, pediatricians were more likely to be familiar with the WHO Code (51%) than obstetricians (18%).
In Japan, pediatricians and obstetricians, in general, have low levels of support for breastfeeding and low levels of familiarity with the WHO Code. To increase the breastfeeding rates in Japan, both pediatricians and obstetricians need increased knowledge about current infant feeding practices and increased awareness of international policies to promote breastfeeding.
PMCID: PMC1560113  PMID: 16925828
9.  Determinants of suboptimal breastfeeding practice in Debre Berhan town, Ethiopia: a cross sectional study 
Optimal breastfeeding is inextricably linked to the achievement of Millennium Development Goals (MDGs) of eradicating extreme poverty and hunger, reducing child mortality and improving maternal health. Breastfeeding is safe, promotes sensory and cognitive development and contains antibodies that protect infants from common childhood illnesses. The objective of this study was to assess suboptimal breastfeeding and its determinants factors among mothers who have children below 23 months old in Debre Berhan, Ethiopia.
A community based cross sectional study was conducted from 1 March 2015 until 30 March 2015. Five hundred forty eight mothers were included in the study using a two stage sampling technique. The data was collected by trained data collectors through pretested semi structured questionnaire. The collected data were cleaned, coded, entered and then analyzed using SPSS version 20 windows program. Descriptive statistics, binary and multivariable regression analysis with 95 % confidence interval was carried out and p value less than 0.05 used to determine the significant association. Late initiation of breastfeeding was defined as initiation of breastfeeding after one hour of delivery while early cessation of breastfeeding was to stop breastfeeding before 24 months of age. According to World Health Organization exclusive breastfeeding was defined as the practice of feeding breast milk only, including expressed breast milk, to infants and excluding water, other liquids, breast milk substitutes, and solid foods. Vitamin drops, minerals, oral rehydrating solution (ORS) and medicines may be given.
The prevalence of late initiation of breastfeeding, not exclusively breastfeeding and early cessation of breastfeeding were 17.5 % (95 % Confidence Interval [CI] 15.2 %, 19.4), 49.8 % (95 % CI 46.3, 50.5) and 12.8 % (95 % CI 11.7, 14.1) respectively. Birth at home was significantly associated with late initiation of breastfeeding (Adjusted Odds Ratio [AOR] 3.0; 95 % CI 1.5, 6.0). No advice during antenatal care was a predictor of not exclusively breastfeeding (AOR1.7; 95 % CI 1.2, 2.5). Being illiterate (AOR 3.2; 95 % CI 1.2, 8.3) and no advice during antenatal care about breastfeeding (AOR 1.9; 95 % CI 1.0. 3.4) were significantly associated with early cessation of breastfeeding.
Educational status, age, antenatal and postnatal follow up, resident and place of delivery were predictors of suboptimal breastfeeding. Integrated and targeted interventions were recommended to achieve a better outcome in minimizing the late initiation, non-exclusive and early cessation of breastfeeding.
PMCID: PMC4802615  PMID: 27006686
Breastfeeding; Debre Berhan; Community based; Determinants; Weaning
10.  Pervasive promotion of breastmilk substitutes in Phnom Penh, Cambodia, and high usage by mothers for infant and young child feeding 
Maternal & Child Nutrition  2016;12(Suppl Suppl 2):38-51.
In 2005, Cambodia passed the Sub‐Decree on Marketing of Products for Infant and Young Child Feeding (no. 133) to regulate promotion of commercial infant and young child food products, including breastmilk substitutes. Helen Keller International assessed mothers' exposure to commercial promotions for breastmilk substitutes and use of these products through a cross‐sectional survey among 294 mothers of children less than 24 months of age. Eighty‐six per cent of mothers reported observing commercial promotions for breastmilk substitutes, 19.0% reported observing infant and young child food product brands/logos on health facility equipment and 18.4% reported receiving a recommendation from a health professional to use a breastmilk substitute. Consumption of breastmilk substitutes was high, occurring among 43.1% of children 0–5 months and 29.3% of children 6–23 months of age. Findings also indicated a need to improve breastfeeding practices among Phnom Penh mothers. Only 36.1% of infants 0–5 months of age were exclusively breastfed, and 12.5% of children 20–23 months of age were still breastfed. Children that received a breastmilk substitute as a prelacteal feed were 3.9 times more likely to be currently consuming a breastmilk substitute than those who did not. Despite restriction of commercial promotions for breastmilk substitutes without government approval, occurrence of promotions is high and use is common among Phnom Penh mothers. In a country with high rates of child malnutrition and pervasive promotions in spite of restrictive national law, full implementation of Cambodia's Sub‐Decree 133 is necessary, as are policies and interventions to support exclusive and continued breastfeeding.
Key messages Despite prohibition without specific approval by the national government, companies are pervasively promoting breast‐milk substitutes in Phnom Penh, particularly on television and at points of sale.Strengthened implementation and enforcement of Cambodia's subdecree 133 are needed to better regulate promotion in order to protect breastfeeding for the nutrition and health of infants and young children in Cambodia.Mothers who used a breast‐milk substitute as a prelacteal feed were 3.9 times more likely to currently feed this same child a breast‐milk substitute, as compared with mothers who did not provide breast‐milk substitute as a prelacteal feed. Supporting breastfeeding among mothers after delivery is critical to establish and sustain optimal breastfeeding practices.Use of breast‐milk substitutes is also very common among mothers of children under 2 years of age in Phnom Penh. We recommend promoting exclusive and continued breastfeeding as beneficial to children's health and development, and supporting policy and workplace environments that enable breastfeeding up to and beyond 24 months of age.
PMCID: PMC5071766  PMID: 27061955
breastfeeding; breastmilk substitutes; Cambodia; promotion; prelacteal feedinginfant feeding; infant feeding
11.  Breast-feeding policies and practices in Canadian hospitals providing maternity care. 
OBJECTIVE: To determine the extent to which policies and practices of Canadian hospitals providing maternity care are consistent with the World Health Organization (WHO)/UNICEF 10 Steps to Successful Breastfeeding, the WHO International Code of Marketing of Breast-Milk Substitutes and the WHO/UNICEF Baby Friendly Hospital Initiative. DESIGN: Cross-sectional mailed survey. SETTING: Canada. PARTICIPANTS: Representatives of 572 hospitals providing maternity care across Canada were sent a questionnaire in the spring and summer of 1993, 523 (91.4%) responded. OUTCOME MEASURES: Self-reported implementation of policies and practices concerning infant feeding; hospitals were grouped according to location, size (number of live births per year) and university affiliation status. MAIN RESULTS: Although 58.4% (296/507) of the respondents reported that their hospital had a written policy on breast-feeding, only 4.6% (21/454) reported having one that complied with all of the WHO/UNICEF steps surveyed. This figure dropped to 1.3% (6/453) when compliance with the WHO code (distribution of free samples of formula to formula-feeding and breast-feeding mothers) was added. Hospitals in Quebec and the Prairie provinces were significantly more likely than those in Ontario to give free samples of formula to both breast-feeding (OR 2.39 [95% confidence interval (Cl) 1.39 to 4.09] and 20.22 [95% Cl 9.27 to 44.33] respectively) and formula-feeding mothers (OR 1.82 [95% Cl 1.07 to 3.11] and 8.03 [95% Cl 3.29 to 19.6] respectively), after adjustment for hospital size and university affiliation status. CONCLUSION: There are considerable variations in the implementation of individual WHO steps and provisions of the WHO code according to hospital location, size and university affiliation status. Very few Canadian hospitals meet all of the criteria that would enable them to be considered "baby friendly" according to the WHO/UNICEF definition.
PMCID: PMC1487952  PMID: 8800076
12.  HIV: prevention of mother-to-child transmission  
BMJ Clinical Evidence  2011;2011:0909.
Over 2 million children are thought to be living with HIV/AIDS worldwide, of whom over 80% live in sub-Saharan Africa. Without antiretroviral treatment, the risk of HIV transmission from infected mothers to their children is 15% to 30% during gestation or labour, with an additional transmission risk of 10% to 20% associated with prolonged breastfeeding. HIV-1 infection accounts for most infections; HIV-2 is rarely transmitted from mother to child. Transmission is more likely in mothers with high viral loads, advanced disease, or both, in the presence of other sexually transmitted diseases, and with increased exposure to maternal blood. Mixed feeding practices (breast milk plus other liquids or solids) and prolonged breastfeeding are also associated with increased risk of mother-to-child transmission of HIV.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of measures to reduce mother-to-child transmission of HIV? We searched: Medline, Embase, The Cochrane Library, and other important databases up to October 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). We performed a GRADE evaluation of the quality of evidence for interventions.
We found 53 systematic reviews, RCTs, or observational studies that met our inclusion criteria.
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antiretroviral drugs, different methods of infant feeding, elective caesarean section, immunotherapy, micronutrient supplements, vaginal microbicides, and vitamin supplements.
Key Points
Without active intervention, the risk of mother-to-child transmission (MTCT) of HIV-1 is high, especially in populations where prolonged breastfeeding is the norm. Without antiviral treatment, the risk of transmission of HIV from infected mothers to their children is approximately 15% to 30% during pregnancy and labour, with an additional transmission risk of 10% to 20% associated with prolonged breastfeeding.HIV-2 is rarely transmitted from mother to child.Transmission is more likely in mothers with high viral loads, advanced HIV disease, or both.Without antiretroviral treatment (ART), 15% to 35% of vertically infected infants die within the first year of life.The long-term treatment of children with ART is complicated by multiple concerns regarding the complications associated with life-long treatment, including adverse effects of antiretroviral drugs, difficulties of adherence across the developmental trajectory of childhood and adolescence, and the development of resistance.From a paediatric perspective, successful prevention of MTCT and HIV-free survival for infants remain the most important focus.
Antiretroviral drugs given to the mother during pregnancy or labour, to the baby immediately after birth, or to the mother and baby reduce the risk of intrauterine and intrapartum MTCT of HIV-1 and when given to the infant after birth and to the mother or infant during breastfeeding reduce the risk of postpartum MTCT of HIV-1.
Reductions in MTCT are possible using multidrug ART regimens. Longer courses of ART are more effective, but the greatest benefit is derived from treatment during late pregnancy, labour, and early infancy.Suppression of the maternal viral load to undetectable levels (below 50 copies/mL) using highly active antiretroviral therapy (HAART) offers the greatest risk reduction, and is currently the standard of care offered in most resource-rich countries, where MTCT rates have been reduced to 1% to 2%. Alternative short-course regimens have been tested in resource-limited settings where HAART is not yet widely available. There is evidence that short courses of antiretroviral drugs have confirmed efficacy for reducing MTCT. Identifying optimal short-course regimens (drug combination, timing, and cost effectiveness) for various settings remains a focus for ongoing research.The development of viral resistance in mothers and infants after single-dose nevirapine and other short-course regimens that include single-dose nevirapine is of concern. An additional short-course of antiretrovirals with a different regimen during labour and early postpartum, and the use of HAART, may decrease the risk of viral resistance in mothers, and in infants who become HIV-infected despite prophylaxis.World Health Organization guidelines recommend starting prophylaxis with antiretroviral drugs from as early as 14 weeks' gestation, or as soon as possible if women present late in pregnancy, in labour, or at delivery.
Elective caesarean section at 38 weeks may reduce vertical transmission rates (apart from breast-milk transmission). The potential benefits of this intervention need to be balanced against the increased risk of surgery-associated complications, high cost, and feasibility issues. These reservations are particularly relevant in resource-limited settings.
Immunotherapy with HIV hyperimmune globulin seems no more effective than immunoglobulin without HIV antibody at reducing HIV-1 MTCT risk.
Vaginal microbicides have not been demonstrated to reduce HIV-1 MTCT risk.
There is no evidence that supplementation with vitamin A reduces the risk of HIV-1 MTCT, and there is concern that postnatal vitamin A supplementation for mother and infant may be associated with increased risk of mortality.
We don't know whether micronutrients are effective in prevention of MTCT of HIV as we found no RCT evidence on this outcome.
Avoidance of breastfeeding prevents postpartum transmission of HIV, but formula feeding requires access to clean water and health education. The risk of breastfeeding-related HIV transmission needs to be balanced against the multiple benefits that breastfeeding offers. In resource-poor countries, breastfeeding is strongly associated with reduced infant morbidity and improved child survival. Exclusive breastfeeding during the first 6 months may reduce the risk of HIV transmission compared with mixed feeding, while retaining most of its associated benefits.In a population where prolonged breastfeeding is usual, early, abrupt weaning may not reduce MTCT or HIV-free survival at 2 years compared with prolonged breastfeeding, and may be associated with a higher rate of infant mortality for those infants diagnosed as HIV-infected at <4 months of age. Antiretrovirals given to the mother or the infant during breastfeeding can reduce the risk of HIV transmission in the postpartum period. World Health Organization guidelines recommend that HIV-positive mothers should exclusively breastfeed for the first 6 months, after which time appropriate complementary foods can be introduced. Breastfeeding should be continued for the first 12 months of the infant's life, and stopped only when an adequate diet without breast milk can be provided. Heat- or microbicidal-treated expressed breast milk may offer value in particular settings.
PMCID: PMC3217724  PMID: 21477392
13.  Determinants of exclusive breastfeeding practice to infants aged less than six months in Offa district, Southern Ethiopia: a cross-sectional study 
World Health Organization (WHO) recommends timely initiation of breastfeeding after birth and only feeding breast milk to infants during the first 6 months of life. It was estimated that exclusive breastfeeding can reduce infant deaths by 13%. The practice of exclusive breastfeeding is suboptimal in many parts of Ethiopia to a varied extent. Factors associated with exclusive breastfeeding practice and the proportion of its practice was not well documented in Offa district. Therefore, this study was aimed to assess the determinants of exclusive breastfeeding in the first 6 months of life in Offa district, Southern Ethiopia.
A community-based cross-sectional study was carried out in 396 mothers of infants younger than 6 months using random sampling. Data were collected from mothers of the infants by trained interviewers. Exclusive breastfeeding was measured by the history of infant feeding in the prior 24 h. Pretested and structured questionnaires adopted from standard questionnaires and Ethiopia linkages modules were used. Multivariate logistic regression was used to identify factors significantly influencing exclusive breastfeeding practice.
Based on findings of this study of 396 participants, the proportion of exclusive breastfeeding was 78.0% and awareness of exclusive breastfeeding and bottle feeding were 85.6 and 6.1% respectively. About 6% of infants were given prelacteal feeds. The number of infants fed cow milk was 12.9%, formula 7.8%, water 8.5%, fruits and semisolids 1.5%, over 24 h prior to the survey. The initiation of breastfeeding within one h (AOR 2.2; 95% CI 1.1, 4.27), attending formal education (AOR 4; 95% CI 2.20, 7.25), having an awareness on the benefits of exclusive breastfeeding (AOR 6; 95% CI 3.10, 11.70) and knowledge of colostrum feeding (AOR 2.1; 95% CI 1.11, 4.27) had a statistically significant association with exclusive breastfeeding in the study area.
The practice of exclusive breastfeeding as well as awareness was worthy in Offa district. Additionally the proportion of bottle feeding use was small. However, feeding other than breast milk was associated with the perception that breast milk alone was insufficient for their child. Strategies on promoting exclusive breastfeeding practice must focus on strengthening women’s education and awareness creation activities further.
PMCID: PMC5148885  PMID: 27990174
Determinants; Exclusive breastfeeding; Southern Ethiopia
14.  WIC's promotion of infant formula in the United States 
The United States' Special Supplemental Nutrition Program for Women, Infants and Children (WIC) distributes about half the infant formula used in the United States at no cost to the families. This is a matter of concern because it is known that feeding with infant formula results in worse health outcomes for infants than breastfeeding.
The evidence that is available indicates that the WIC program has the effect of promoting the use of infant formula, thus placing infants at higher risk. Moreover, the program violates the widely accepted principles that have been set out in the International Code of Marketing of Breast-milk Substitutes and in the human right to adequate food.
There is no good reason for an agency of government to distribute large quantities of free infant formula. It is recommended that the large-scale distribution of free infant formula by the WIC program should be phased out.
PMCID: PMC1481608  PMID: 16722534
15.  Infant feeding, poverty and human development 
The relationship between poverty and human development touches on a central aim of the International Breastfeeding Journal's editorial policy which is to support and protect the health and wellbeing of all infants through the promotion of breastfeeding. It is proposed that exclusive breastfeeding for 6 months, followed by continued breastfeeding to 12 months, could prevent 1,301,000 deaths or 13% of all child deaths under 5 years in a hypothetical year. Although there is a conventional wisdom that poverty 'protects' breastfeeding in developing countries, poverty actually threatens breastfeeding, both directly and indirectly. In the light of increasingly aggressive marketing behaviour of the infant formula manufacturers and the need to protect the breastfeeding rights of working women, urgent action is required to ensure the principles and aim of the International Code of Breastmilk Substitutes, and subsequent relevant resolutions of the World Health Assembly, are implemented. If global disparities in infant health and development are to be significantly reduced, gender inequities associated with reduced access to education and inadequate nutrition for girls need to be addressed. Improving women's physical and mental health will lead to better developmental outcomes for their children.
PMCID: PMC2048939  PMID: 17953747
16.  Promotion of exclusive breastfeeding among HIV-positive mothers: an exploratory qualitative study 
Exclusive breastfeeding has the potential to reduce infant and under-five mortality, but research shows the practice is not widespread in resource-poor settings of sub-Saharan Africa. We explored factors influencing the decision to exclusively breastfeed among HIV-positive mothers accessing interventions for prevention of mother-to-child transmission of HIV in selected sites of Zambia.
This exploratory qualitative study was embedded in research conducted on: HIV and infant feeding; choices and decision-outcomes in the context of prevention of mother-to-child transmission among HIV-positive mothers in Zambia. Thirty HIV-positive mothers and six key informants were recruited from two health facilities providing mother-to-child HIV transmission prevention services. A semi-structured guide was used to conduct interviews, which were digitally recorded and simultaneously transcribed. Data coding and analysis was done with the support of QRS Nvivo 10 version software.
Despite the known benefits of exclusive breastfeeding, gaps in understanding and potential for behaviour change remained. We found that information promoting exclusive breastfeeding may have been understood by mothers as instructions from the health care workers indicating how to feed their HIV-exposed babies rather than as an option for the mothers’ own informed-decision. This understanding influenced a mother’s perceptions of breast milk safety while on antiretroviral medicine, of the formula feeding option, and of the baby crying after breastfeeding. The meanings mothers attached to exclusive breastfeeding thus influenced their understanding of breast milk insufficiency, abrupt weaning and mixed feeding in the context of preventing mother-to-child transmission of HIV.
In order to enhance feeding practices for HIV-exposed infants, our study suggests a broader health campaign supporting all mothers to exclusively breastfeed.
PMCID: PMC4839145  PMID: 27103938
Exclusive breastfeeding; Formula feeding; Promotion; HIV-positive; Informed-decision; Zambia
17.  Do infants fed directly from the breast have improved appetite regulation and slower growth during early childhood compared with infants fed from a bottle? 
Behavioral mechanisms that contribute to the association between breastfeeding and reduced obesity risk are poorly understood. The purpose of this study was to evaluate the hypothesis that feeding human milk from the breast (direct breastfeeding) has a more optimal association with subsequent child appetite regulation behaviors and growth, when compared to bottle-feeding.
Children (n = 109) aged 3- to 6- years were retrospectively classified as directly breastfed (fed exclusively at the breast), bottle-fed human milk, or bottle-fed formula in the first three months of life. Young children's appetite regulation was examined by measuring three constructs (satiety response, food responsiveness, enjoyment of food) associated with obesity risk, using the Child Eating Behavior Questionnaire. Multinomial logistic regression analyses were used to test whether children bottle-fed either human milk or formula had reduced odds of high satiety and increased odds of high food responsiveness and high enjoyment of food compared to children fed directly from the breast. Current child weight status and growth trends from 6-36 months were also examined for their relation to direct breastfeeding and appetite regulation behaviors in early childhood.
Children fed human milk in a bottle were 67% less likely to have high satiety responsiveness compared to directly breastfed children, after controlling for child age, child weight status, maternal race/ethnicity, and maternal education. There was no association of bottle-feeding (either human milk or formula) with young children's food responsiveness and enjoyment of food. There was neither an association of direct breastfeeding with current child weight status, nor was there a clear difference between directly breastfed and bottle-fed children in growth trajectories from 6- to 36-months. More rapid infant changes in weight-for-age score were associated with lower satiety responsiveness, higher food responsiveness and higher enjoyment of food in later childhood
While direct breastfeeding was not found to differentially affect growth trajectories from infancy to childhood compared to bottle-feeding, results suggest direct breastfeeding during early infancy is associated with greater appetite regulation later in childhood. A better understanding of such behavioral distinctions between direct breastfeeding and bottle-feeding may identify new pathways to reduce the pediatric obesity epidemic.
PMCID: PMC3170240  PMID: 21849028
bottle-feeding; direct breastfeeding; satiety; obesity; child eating behaviors
18.  Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation 
PLoS Medicine  2015;12(2):e1001785.
In many European countries, medicines promotion is governed by voluntary codes of practice administered by the pharmaceutical industry under its own system of self-regulation. Involvement of industry organizations in policing promotion has been proposed to deter illicit conduct, but few detailed studies on self-regulation have been carried out to date. The objective of this study was to examine the evidence for promotion and self-regulation in the UK and Sweden, two countries frequently cited as examples of effective self-regulation.
Methods and Findings
We performed a qualitative content analysis of documents outlining the constitutions and procedures of these two systems. We also gathered data from self-regulatory bodies on complaints, complainants, and rulings for the period 2004–2012. The qualitative analysis revealed similarities and differences between the countries. For example, self-regulatory bodies in both countries are required to actively monitor promotional items and impose sanctions on violating companies, but the range of sanctions is greater in the UK where companies may, for instance, be audited or publicly reprimanded. In total, Swedish and UK bodies ruled that 536 and 597 cases, respectively, were in breach, equating to an average of more than one case/week for each country. In Sweden, 430 (47%) complaints resulted from active monitoring, compared with only two complaints (0.2%) in the UK. In both countries, a majority of violations concerned misleading promotion. Charges incurred on companies averaged €447,000 and €765,000 per year in Sweden and the UK, respectively, equivalent to about 0.014% and 0.0051% of annual sales revenues, respectively. One hundred cases in the UK (17% of total cases in breach) and 101 (19%) in Sweden were highlighted as particularly serious. A total of 46 companies were ruled in breach of code for a serious offence at least once in the two countries combined (n = 36 in the UK; n = 27 in Sweden); seven companies were in serious violation more than ten times each. A qualitative content analysis of serious violations pertaining to diabetes drugs (UK, n = 15; Sweden, n = 6; 10% of serious violations) and urologics (UK, n = 6; Sweden, n = 13; 9%) revealed various types of violations: misleading claims (n = 23; 58%); failure to comply with undertakings (n = 9; 23%); pre-licensing (n = 7; 18%) or off-label promotion (n = 2; 5%); and promotion of prescription drugs to the public (n = 6; 15%). Violations that go undetected or unpunished by self-regulatory bodies are the main limitation of this study, since they are likely to lead to an underestimate of industry misconduct.
The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry. We discuss regulatory reforms that may improve the quality of medicines information, such as pre-vetting and intensified active monitoring of promotion, along with larger fines, and giving greater publicity to rulings. But despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone are insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias.
In a document analysis, Shai Mulinari and colleagues examine the evidence for promotion and self-regulation by the pharmaceutical industry in the UK and Sweden.
Editors' Summary
Making and selling medicines is big business. In 2013, the global revenue of pharmaceutical companies was nearly US$1 trillion. And every year, a large proportion of this revenue—maybe as much as one-third—is spent on drug promotion. The pharmaceutical companies claim that drug promotion (for example, advertisements in journals and visits from pharmaceutical sales representatives) helps to inform and educate health care professionals about the risks and benefits of medicines. However, drug promotion also has the potential to encourage health care professionals to prescribe inappropriate or needlessly expensive drugs and to encourage the public to buy unnecessary over-the-counter (OTC) drugs (medicines that, unlike prescription drugs, can be bought without a written instruction from a physician or other licensed health care professional). In many countries, including the US, government bodies regulate the promotion of medicines but in other countries, including many in Europe, the pharmaceutical industry self-regulates medicines promotion through voluntary codes of practice.
Why Was This Study Done?
Over the past decade, several whistleblower cases have spotlighted the illicit marketing practices of pharmaceutical companies in the US but relatively few similar cases have been brought in Europe. The reason for this discrepancy is unclear but one possibility is that the wider use of self-regulation in Europe encourages the industry to comply with drug promotion rules and deters illicit conduct. To date, however, self-regulation of medicines promotion has been poorly studied. Here, the researchers undertake a quantitative (numerical) and qualitative (descriptive) study of pharmaceutical self-regulation in the UK and Sweden, two countries often cited as places where self-regulation is effective. In both countries, the rules on medicines promotion are codified in the Code of Practice of the national industry trade group and are overseen by self-regulatory bodies that operate independently of the trade groups; the Swedish code applies to the promotion of both prescription and OTC drugs whereas the UK code applies only to the promotion of prescription drugs.
What Did the Researchers Do and Find?
The researchers first undertook a qualitative content analysis of the documents outlining the rules and procedures governing the self-regulatory bodies overseeing medicines promotion in the two countries. Both bodies, they report, are required to actively monitor promotional items and to impose sanctions on companies that violate the rules. However, a wider range of sanctions, which includes the audit and public reprimand of offending companies in addition to economic sanctions, can be imposed in the UK than in Sweden. Analysis of numerical data collected by the self-regulatory bodies on complaints, complainants, and rulings revealed that between 2004 and 2012 the Swedish and UK bodies ruled that 536 and 597 cases, respectively, were in breach of the country’s rules on medicines promotion; many of the violations in both countries concerned misleading claims about a drug’s effects. In Sweden, nearly half the complaints resulted from active monitoring of promotional items compared to only 0.2% in the UK. Charges incurred by companies because of violations of the medicines promotion code were equivalent to about 0.014% and 0.0051% of annual sales revenue in Sweden and the UK, respectively. Notably, nearly 20% of the cases in breach of the code of practice in both countries were serious breaches, and seven companies were in serious violation more than ten times each in the two countries combined.
What Do These Findings Mean?
These findings indicate that, between 2004 and 2012, there were numerous violations of the pharmaceutical industry codes regulating medicines promotion in both the UK and Sweden. That is, there was a clear discrepancy between the ethical standard codified in the pharmaceutical industry Codes of Practice in these two countries and the actual conduct of the industry. Importantly, the discrepancy may be larger than reported here because the researchers only considered violations that were detected and punished by the self-regulatory bodies in their analysis; some violations that occurred during the study period probably went undetected or unpunished. Given their findings, the researchers suggest that regulatory reforms, including pre-vetting of promotional materials, intensified active monitoring of promotion, larger fines, and the introduction of other sanctions such as greater publicity following rulings, may help to improve the quality of medicines information for health care professionals and the public in Sweden, the UK, and other countries where the pharmaceutical industry self-regulates drug promotion.
Additional Information
Please access these websites via the online version of this summary at
Wikipedia provides information on pharmaceutical marketing (mainly in the US) (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US Food and Drug Administration Office of Prescription Drug Promotion aims to protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated; the FDA’s Bad Ad Program aims to educate health care professionals about the role they can play in ensuring that drug advertising and promotion is truthful and not misleading
Information on the UK regulatory framework is available from the UK Medicines and Healthcare Products Regulatory Agency (MHRA); the MHRA website also includes information on MHRA vetting of advertising material.
Information on the UK self-regulatory body, the Prescription Medicines Code of Practice Authority (PMCPA), is available; the PMCPA website includes information about the UK Code of Practice for medicines promotion
Details of the Swedish Code are also available; codes for other European countries are provided by the European Federation of Pharmaceutical Industries and Associations
Healthy Skepticism is an international non-profit membership association that aims to improve health by reducing harm from misleading health information
The World Health Organization provides information about drug promotion and attitudes to it in “Drug Promotion—What We Know, What We Have Yet to Learn—Reviews of Materials in the WHO/HAI Database on Drug Promotion”
PMCID: PMC4331559  PMID: 25689460
19.  HIV-1 Drug Resistance Emergence among Breastfeeding Infants Born to HIV-Infected Mothers during a Single-Arm Trial of Triple-Antiretroviral Prophylaxis for Prevention of Mother-To-Child Transmission: A Secondary Analysis 
PLoS Medicine  2011;8(3):e1000430.
Analysis of a substudy of the Kisumu breastfeeding trial by Clement Zeh and colleagues reveals the emergence of HIV drug resistance in HIV-positive infants born to HIV-infected mothers treated with antiretroviral drugs.
Nevirapine and lamivudine given to mothers are transmitted to infants via breastfeeding in quantities sufficient to have biologic effects on the virus; this may lead to an increased risk of a breastfed infant's development of resistance to maternal antiretrovirals. The Kisumu Breastfeeding Study (KiBS), a single-arm open-label prevention of mother-to-child HIV transmission (PMTCT) trial, assessed the safety and efficacy of zidovudine, lamivudine, and either nevirapine or nelfinavir given to HIV-infected women from 34 wk gestation through 6 mo of breastfeeding. Here, we present findings from a KiBS trial secondary analysis that evaluated the emergence of maternal ARV-associated resistance among 32 HIV-infected breastfed infants.
Methods and Findings
All infants in the cohort were tested for HIV infection using DNA PCR at multiple study visits during the 24 mo of the study, and plasma RNA viral load for all HIV-PCR–positive infants was evaluated retrospectively. Specimens from mothers and infants with viral load >1,000 copies/ml were tested for HIV drug resistance mutations. Overall, 32 infants were HIV infected by 24 mo of age, and of this group, 24 (75%) infants were HIV infected by 6 mo of age. Of the 24 infants infected by 6 mo, nine were born to mothers on a nelfinavir-based regimen, whereas the remaining 15 were born to mothers on a nevirapine-based regimen. All infants were also given single-dose nevirapine within 48 hours of birth. We detected genotypic resistance mutations in none of eight infants who were HIV-PCR positive by 2 wk of age (specimens from six infants were not amplifiable), for 30% (6/20) at 6 wk, 63% (14/22) positive at 14 wk, and 67% (16/24) at 6 mo post partum. Among the 16 infants with resistance mutations by 6 mo post partum, the common mutations were M184V and K103N, conferring resistance to lamivudine and nevirapine, respectively. Genotypic resistance was detected among 9/9 (100%) and 7/15 (47%) infected infants whose mothers were on nelfinavir and nevirapine, respectively. No mutations were detected among the eight infants infected after the breastfeeding period (age 6 mo).
Emergence of HIV drug resistance mutations in HIV-infected infants occurred between 2 wk and 6 mo post partum, most likely because of exposure to maternal ARV drugs through breast milk. Our findings may impact the choice of regimen for ARV treatment of HIV-infected breastfeeding mothers and their infected infants.
Trial Registration NCT00146380
Please see later in the article for the Editors' Summary
Editors' Summary
Globally, more than 2 million children are infected with the human immunodeficiency virus (HIV) that causes acquired immunodeficiency syndrome (AIDS), and half a million children are newly infected every year. These infections are mainly the result of mother-to-child transmission (MTCT) of HIV during pregnancy, labor and delivery, or through breastfeeding. MTCT can be greatly reduced by treating HIV-positive mothers and their babies with antiretroviral drugs (ARVs). Without ARVs, up to half of babies born to HIV-positive mothers become infected with HIV. This rate of transmission falls to below 5% if a combination of three ARVs is given to the mother throughout pregnancy. Unfortunately, this triple-ARV therapy is too expensive for use in the resource-limited countries where most MTCT occurs. Instead, many such countries have introduced simpler, shorter ARV regimens such as a daily dose of zidovudine (a nucleoside reverse transcriptase inhibitor or NRTI) given to HIV-positive women during late pregnancy coupled with single-dose nevirapine (a non-nucleoside reverse transcriptase inhibitor or NNRTI) at the onset of labor, zidovudine and lamivudine (another NRTI) during labor and delivery, and single-dose nevirapine given to the baby at birth.
Why Was This Study Done?
More than 95% of HIV-exposed children are born in resource-limited settings where breastfeeding is the norm and is crucial for child survival even though it poses a risk of HIV transmission. Consequently, several recent studies have investigated whether MTCT can be further reduced by giving the mother ARVs while she is breastfeeding. In the Kisumu Breastfeeding Study (KiBS), for example, researchers assessed the effects of giving zidovudine, lamivudine, and either nevirapine or nelfinavir (a protease inhibitor) to HIV-infected women from 34 weeks of pregnancy through 6 months of breastfeeding. The results of KiBS indicate that this approach might be a safe, feasible way to reduce MTCT (see the accompanying paper by Thomas and colleagues). However, low amounts of nevirapine and lamivudine are transferred from mother to infant in breast milk and this exposure to ARVs could induce the development of resistance to ARVs among HIV-infected infants. In this KiBS substudy, the researchers investigate whether HIV drug resistance emerged in any of the HIV-positive infants in the parent study.
What Did the Researchers Do and Find?
In KiBS, 32 infants were HIV-positive at 24 months old; 24 were HIV-positive at 6 months old when their mothers stopped taking ARVs and when breastfeeding was supposed to stop. The researchers analyzed blood samples taken from these infants at various ages and from their mothers for the presence of HIV drug resistance mutations (DNA changes that make HIV resistant to killing by ARVs). They detected no resistance mutations in samples taken from 2-week old HIV-positive infants or from the infants who became infected after the age of 6 months. However, they found resistance mutations in a third and two-thirds of samples taken from 6-week and 6-month old HIV-positive infants, respectively. The commonest mutations conferred resistance to lamivudine and nevirapine. Moreover, resistance mutations were present in samples taken from all the HIV-positive infants whose mothers who had received nelfinavir but in only half those taken from infants whose mothers who had received nevirapine. Finally, most of the mothers of HIV-positive infants had no HIV drug resistance mutations, and only one mother-infant pair had an overlapping pattern of HIV drug resistance mutations.
What Do These Findings Mean?
These findings indicate that, in this KiBS substudy, the emergence of HIV drug resistance mutations in HIV-infected infants whose mothers were receiving ARVs occurred between 2 weeks and 6 months after birth. The pattern of mutations suggests that drug resistance most likely arose through exposure of the infants to low levels of ARVs in breast milk rather than through MTCT of drug-resistant virus. These findings need confirming but suggest that infants exposed to ARVs through breast milk—a situation that may become increasingly common given the reduction in MTCT seen in KiBS and other similar trials—should be carefully monitored for HIV infection. Providers should consider the mothers' regimen when choosing treatment for infants who are found to be HIV-infected despite maternal triple drug prophylaxis. Infants exposed to a maternal regimen with NNRTI drugs should receive first-line therapy with lopinavir/ritonavir, a protease inhibitor. The significance of the NRTI mutations such as M184V with regard to response to therapy needs further evaluation. The M184V mutation may result in hypersensitization to other NRTI drugs and delay or reverse zidovudine resistance. Given the limited availability of alternative drugs for infants in resource-limited settings, provision of the standard WHO-recommended first-line NRTI backbone, which includes 3TC, with enhanced monitoring of the infant to ensure virologic suppression, could be considered. Such an approach should reduce both illness and morbidity among infants who become HIV positive through breastfeeding.
Additional Information
Please access these Web sites via the online version of this summary at 10.1371/journal.pmed.1000430.
The accompanying PLoS Medicine Research article by Thomas and colleagues describes the primary findings of the Kisumu Breastfeeding Study
Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS
HIV InSite has comprehensive information on HIV/AIDS
Information is available from Avert, an international AIDS charity, on many aspects of HIV/AIDS, including information on children, HIV, and AIDS and on preventing mother-to-child transmission of HIV (in English and Spanish)
UNICEF also has information about children and HIV and AIDS (in several languages)
The World Health organization has information on mother-to-child transmission of HIV (in several languages), and guidance on the use of ARVs for preventing MTCT
PMCID: PMC3066134  PMID: 21468304
20.  Breastfeeding in Iran: prevalence, duration and current recommendations 
The need to promote breastfeeding is unquestionable for the health and development of infants. The aim of this study was to investigate prevalence, duration and promotion of breastfeeding status in Iran with respect to the Baby Friendly Hospital, government actions and activities by the Breastfeeding Promotion Society including comparison with European countries.
This retrospective study is based on data from 63,071 infants less than 24 months of age in all the 30 urban and rural provinces of Iran. The data of breastfeeding rates were collected in 2005-2006 by trained health workers in the Integrated Monitoring Evaluation System in the Family Health Office of the Ministry of Health to evaluate its subordinate offices. A translated version of a questionnaire, used to assess the current breastfeeding situation in Europe, was used.
At a national level, 90% and 57% of infants were breastfed at one and two-years of age, respectively. Exclusive breastfeeding rates at 4 and 6 months of age at national level averaged 56.8% and 27.7%. Exclusive breastfeeding rates at 4 and 6 months of age in rural areas were 58% and 29%, and in urban areas 56% and 27%, respectively. The policy questionnaire showed that out of the 566 hospitals across the country 466 hospitals were accredited as Baby Friendly Hospitals, covering more than 80% of the births in 2006. A national board set standards and certified pre-service education at the Ministry of Health. Iran officially adopted the WHO International Code of Marketing of Breast Milk Substitutes in 1991. The legislation for working mothers met the International Labour Organization standards that cover women with formal employment. The Ministry of Health and Breastfeeding Promotion Society were responsible for producing booklets, pamphlets, breastfeeding journal, CD, workshops and websites. Monitoring of breastfeeding rates was performed every four years and funded by the Ministry of Health within the budgets assigned to the health care system.
In comparison to many European Union countries, Iran showed a favorable situation in terms of breastfeeding rates and promotion of breastfeeding. Iran still needs to increase the rate of exclusive breastfeeding during the first six months.
PMCID: PMC2734342  PMID: 19656361
21.  Breast-Milk Substitutes: A New Old-Threat for Breastfeeding Policy in Developing Countries. A Case Study in a Traditionally High Breastfeeding Country 
PLoS ONE  2012;7(2):e30634.
Developing countries with traditionally breastfeeding are now experiencing the increasing pressure of formula milk marketing. This may endanger lives and undermine the efforts of national policies in achieving the objectives of the Millennium Development Goals. We examined the use of, and factors for use, of all available breast-milk substitutes (BMS) in a country with a traditionally high rate of breastfeeding.
Randomised multi-stage sampling surveys in 90 villages in 12/17 provinces in Laos.
Participants: 1057 mothers with infants under 24 months of age.
Tools: 50-query questionnaire and a poster of 22 BMS (8 canned or powdered milk; 6 non-dairy; 6 formulas; 2 non-formulas).
Outcome measures included: prevalence of use and age of starting BMS in relation to socio-demographic characteristics and information sources, by univariate and multivariate analyses.
Of 1057 mothers: 72.5% currently breastfed; 25.4% gave BMS (10.6% infant formula); 19.6% gave BMS before 6 months of age (of them: 83% non-dairy or cereals; mean age: 2.9 months; 95% Confidence interval: 2.6–3.2). One formula and one non-formula product accounted for 85% of BMS. BMS were considered as milk by the majority of mothers. Thai TV was the main source of information on BMS for mothers. Lao Loum mothers (the main ethnic group) living in concrete houses with good sanitary conditions, were more likely than others to use BMS before 6 months (OR: 1.79, (1.15–2.78), p<0.009). Mothers who fed their infants colostrum at birth were less likely to use BMS before 6 months of age (OR: 0.63, (0.41–0.99), p = 0.04). Unemployed mothers living in rural areas were less likely to consider BMS better than breast milk.
In Laos, mothers with the highest socio-economic status are showing a tendency to give up breastfeeding. Successful educational strategies and advocacy measures should be urgently developed to promote and sustain breastfeeding in developing countries.
PMCID: PMC3276495  PMID: 22347392
22.  Association of Breastfeeding With Maternal Control of Infant Feeding at Age 1 Year 
Pediatrics  2004;114(5):e577-e583.
Previous studies have found that breastfeeding may protect infants against future overweight. One proposed mechanism is that breastfeeding, compared with bottle-feeding, may promote maternal feeding styles that are less controlling and more responsive to infant cues of hunger and satiety, thereby allowing infants greater self-regulation of energy intake. The objective of this study was to examine whether preponderance of breastfeeding in the first 6 months of life and breastfeeding duration are associated with less maternal restrictive behavior and less pressure to eat.
We studied 1160 mother–infant pairs in Project Viva, an ongoing prospective cohort study of pregnant mothers and their children. The main outcome measures were mothers’ reports of restricting their children’s food intake and of pressuring their children to eat more food, as measured by a modified Child Feeding Questionnaire (CFQ) at 1 year postpartum. Restriction was defined by strongly agreeing or agreeing with the following question from the modified CFQ: “I have to be careful not to feed my child too much.” We derived a continuous pressure to eat score from 5 questions of the modified CFQ. We used multiple logistic regression to examine the association between preponderance of breastfeeding in the first 6 months of life, breastfeeding duration, and mothers’ restriction of children’s access to food. We used multiple linear regression, both before and after adjusting for several groups of confounders, to predict the effects of breastfeeding on the mothers’ scores for pressuring their children to eat.
The mean (SD) age of the women was 32.4 (4.8) years; 24% of the women were nonwhite, and 32% were primigravidas. At 6 months postpartum, 24% of the mothers were exclusively breastfeeding, 25% were mixed feeding, 41% had weaned, and 10% had fed their infants formula only. The mean (SD) duration of breastfeeding was 6.3 (4.5) months. Thirteen percent of the mothers strongly agreed or agreed with the restriction question. The mean (SD) score on the pressure to eat scale was 5.3 (3.7), and the range was 0 to 20. After adjusting for mothers’ preexisting concerns about their children’s future eating and weight status, as well as sociodemographic, economic, and anthropometric predictors of breastfeeding duration, we found that the longer the mothers breastfed, the less likely they were to restrict their children’s food intake at age 1 year. The adjusted odds ratio was 0.89 (95% confidence interval [CI]: 0.84–0.95) for each 1-month increment in breastfeeding duration. In addition, we found that compared with mothers who were exclusively formula feeding, mothers who were exclusively breastfeeding at 6 months of age had much lower odds of restricting their children’s food intake at 1 year (odds ratio: 0.27; 95% CI: 0.10–0.72). Preponderance of breastfeeding in the first 6 months of life and breastfeeding duration (β = −0.01 points on the 0–20 scale for each additional 1 month of breastfeeding [95% CI: −0.07 to 0.05]) were not related to mothers’ pressuring their children to eat more.
Mothers who fed their infants breast milk in early infancy and who breastfed for longer periods reported less restrictive behavior regarding child feeding at 1 year. Additional longitudinal studies should examine the extent to which any protective effect of breastfeeding on overweight is explained by decreased maternal feeding restriction.
PMCID: PMC1989686  PMID: 15492358
23.  Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003–2012 
PLoS Medicine  2016;13(1):e1001945.
European Union law prohibits companies from marketing drugs off-label. In the United Kingdom—as in some other European countries, but unlike the United States—industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion.
Methods and Findings
We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%), using print material (70/72, 97%), for example, advertisements (21/70, 30%). Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%). Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%), payers (n = 2, 3%), or company staff (n = 2, 3%). Eight UK rulings (11%) pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US. However, while the UK cases typically related to only one or a few claims made in printed material, several complaints in the US alleged multifaceted and covert marketing activities. Because this study is limited to PMCPA rulings and whistleblower-initiated federal cases, it may offer a partial view of exposed off-label marketing.
The UK self-regulatory system for exposing marketing violations relies largely on complaints from company outsiders, which may explain why most off-label promotion rulings relate to plainly visible promotional activities such as advertising. This contrasts with the US, where Department of Justice investigations and whistleblower testimony have alleged complex off-label marketing campaigns that remain concealed to company outsiders. UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions. UK prescribers should be attentive to, and increasingly report, off-label promotion.
In a document analysis of legal cases, Shai Mulinari and colleagues characterize off-label drug promotion by pharmaceutical companies in the UK.
Editors' Summary
Before a pharmaceutical company can market a new prescription drug, the drug has to go through a long approval process. After extensive studies in the laboratory and in animals, the company must test the drug’s safety and efficacy in series of clinical trials in which patients with specific diseases receive the drug under carefully controlled conditions. Regulatory bodies such as the US FDA, the UK MHRA and the European Medicines Agency (EMA) then review the results of these trials and, when they are satisfied that the drug is safe and effective for the conditions in which it was tested, give the pharmaceutical company approval to market the drug in the relevant country. An important part of the approval process is the creation of the “drug label,” a detailed report that specifies the exact diseases and patient groups in which the drug can be used and the drug’s approved doses.
Why Was This Study Done?
Physicians can use approved drugs “off-label.” That is, they can prescribe drugs for a different disease, in a different group of patients, or at a different dose to that specified in the label. However, in the UK, the US, and other countries, national law prohibits the promotion of off-label uses of prescription drugs by pharmaceutical companies, which stand to benefit financially from off-label use through increased drugs sales. The primary rationale for banning off-label promotion is that it might encourage the widespread use of drugs in settings where they have not been rigorously tested, thereby exposing patients to uncertain benefits and possible adverse effects. In the US, the FDA regulates and prosecutes off-label promotion, but enforcement actions against companies can also be brought by federal and state prosecutors and private citizens. In the UK, the MHRA has delegated an important part of its responsibility for supervising off-label marketing to a self-regulatory body set up by the pharmaceutical industry—the PMCPA. Here, by reviewing off-label promotion rulings made by the PMCPA between 2003 and 2012, the researchers compare off-label promotion cases ruled on in the UK with whistleblower (company insider)-initiated cases from the US and shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion.
What Did the Researchers Do and Find?
The researchers identified 74 UK off-label promotion rulings over the ten-year study period involving 43 companies (including 19 that were ruled in breach more than once) and 65 drugs. They coded and analyzed each off-label promotion ruling using a typology (a classification according to general type) previously developed to analyze US whistleblower-initiated off-label promotion cases. Half of the rulings cited efforts to expand drug use to unapproved indications (for example, using a drug to treat all patients with MS rather than only patients with recent relapses); 39% and 38% of the rulings cited efforts to expand drug use beyond approved diseases and dosing strategies, respectively. The most commonly cited off-label promotional tactic was attempts to influence prescribers using advertisements and other print material; competing companies lodged 57% of complaints whereas prescribers (the prime target of off-label promotion) lodged only 22% of the complaints. Unlike US whistleblower complaints, which often alleged promotional tactics targeting consumers, payers and company staff, few UK rulings described practices targeting these classes of individuals. Finally, although several US whistleblower-initiated cases alleged multifaceted and covert marketing activities, the UK cases typically related to one or a few claims made in printed material.
What Do These Findings Mean?
Because this study only describes PMCPA rulings and whistleblower-initiated US cases of off-label promotion, these findings provide an incomplete view of off-label marketing violations (some of which may not be deliberate) in the UK and US. The findings suggest that the UK self-regulatory approach, which relies mainly on complaints from company outsiders, is capable of detecting and dealing with instances of off-label promotion with high visibility (for example, advertisements). However, the UK self-regulatory approach may be less capable of uncovering complex marketing campaigns than the US government-led approach. The researchers suggest, therefore, that the UK authorities should consider the introduction of increased incentives and protections for whistleblowers and of US-style governmental investigation (the PMCPA rulings are based on complainant and company submissions alone) and that both the MHRA and PMCPA should strengthen their regulatory oversight of promotional material. Finally, prescribers—the main target of off-label promotion in the UK—should be encouraged to identify and report off-label promotion.
Additional Information
This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at
The PLOS Medicine Research Article by Aaron Kesselheim and colleagues provides information about whistleblower-initiated cases on off-label promotion in the US
Wikipedia provides information on prescription drugs, pharmaceutical marketing (mainly in the US), and off-label drug use (mainly in the US) (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The US FDA Office of Prescription Drug Promotion aims to protect public health by assuring prescription drug information is truthful, balanced, and accurately communicated; the FDA’s Bad Ads Program aims to educate health care professionals about the role they can play in ensuring that drug advertising and promotion is truthful and not misleading
Information on the UK regulatory framework is available from the MHRA; the MHRA website also includes information on advertising investigations by the MHRA.
Information on the UK self-regulatory body, the PMCPA, is available; the PMCPA website includes information about the UK Code of Practice for medicines promotion
Healthy Skepticism is an international non-profit membership association that aims to improve health by reducing harm from misleading health information
PMCID: PMC4727894  PMID: 26812151
24.  Marketing Breastfeeding—Reversing Corporate Influence on Infant Feeding Practices 
Breast milk is the gold standard for infant nutrition and the only necessary food for the first 6 months of an infant’s life. Infant formula is deficient and inferior to breast milk in meeting infants’ nutritional needs. The infant formula industry has contributed to low rates of breastfeeding through various methods of marketing and advertising infant formula. Today, in New York City, although the majority of mothers initiate breastfeeding (~85%), a minority of infants is breastfed exclusively at 8 weeks postpartum (~25%). The article reviews the practices of the formula industry and the impact of these practices. It then presents the strategic approach taken by the NYC Department of Health and Mental Hygiene and its partners to change hospital practices and educate health care providers and the public on the benefits of breast milk, and provides lessons learned from these efforts to make breastfeeding the normative and usual method of infant feeding in New York City.
PMCID: PMC2443254  PMID: 18463985
Breastfeeding; Corporate influence; Infant; Nutrition; Infant feeding; Infant formula
25.  Breastfeeding in infancy: identifying the program-relevant issues in Bangladesh 
In Bangladesh, many programs and projects have been promoting breastfeeding since the late 1980 s. Breastfeeding practices, however, have not improved accordingly.
For identifying program-relevant issues to improve breastfeeding in infancy, quantitative data were collected through visits to households (n = 356) in rural Chittagong and urban slums in Dhaka, and qualitative data from sub-samples by applying semi-structured in-depth interviews (n = 42), focus group discussions (n = 28), and opportunistic observations (n = 21). Trials of Improved Practices (TIPs) (n = 26) were conducted in the above sites and rural Sylhet to determine how best to design further interventions. Our analysis focused on five breastfeeding practices recommended by the World Health Organization: putting baby to the breast within the first hour of birth, feeding colostrum and not giving fluids, food or other substances in the first days of life, breastfeeding on demand, not feeding anything by bottle, and exclusive breastfeeding for the first six months.
The biggest gaps were found to be in putting baby to the breast within the first hour of birth (76% gap), feeding colostrum and not giving other fluids, foods or substances within the first three days (54% gap), and exclusive breastfeeding from birth through 180 days (90% gap). Lack of knowledge about dangers of delaying initiation beyond the first hour and giving other fluids, foods or substances, and the common perception of "insufficient milk" were main reasons given by mothers for these practices. Health workers had talked to only 8% of mothers about infant feeding during antenatal and immunization visits, and to 34% of mothers during sick child visits. The major providers of infant feeding information were grandmothers (28%).
The findings showed that huge gaps continue to exist in breastfeeding behaviors, mostly due to lack of awareness as to why the recommended breastfeeding practices are beneficial, the risks of not practicing them, as well as how to practice them. Health workers' interactions for promoting and supporting optimal breastfeeding are extremely low. Counseling techniques should be used to reinforce specific, priority messages by health facility staff and community-based workers at all contact points with mothers of young infants.
PMCID: PMC3009955  PMID: 21118488

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