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1.  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.
Background
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.
Conclusions
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
Background.
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 http://dx.doi.org/doi:10.1371/journal.pmed.0040017.
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
doi:10.1371/journal.pmed.0040017
PMCID: PMC1769413  PMID: 17227132
2.  Awareness and reported violations of the WHO International Code and Pakistan's national breastfeeding legislation; a descriptive cross-sectional survey 
Background
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.
Methods
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).
Results
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).
Conclusion
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.
doi:10.1186/1746-4358-3-24
PMCID: PMC2577086  PMID: 18928524
3.  Emergency preparedness for those who care for infants in developed country contexts 
Emergency management organisations recognise the vulnerability of infants in emergencies, even in developed countries. However, thus far, those who care for infants have not been provided with detailed information on what emergency preparedness entails. Emergency management authorities should provide those who care for infants with accurate and detailed information on the supplies necessary to care for them in an emergency, distinguishing between the needs of breastfed infants and the needs of formula fed infants. Those who care for formula fed infants should be provided with detailed information on the supplies necessary for an emergency preparedness kit and with information on how to prepare formula feeds in an emergency. An emergency preparedness kit for exclusively breastfed infants should include 100 nappies and 200 nappy wipes. The contents of an emergency preparedness for formula fed infants will vary depending upon whether ready-to-use liquid infant formula or powdered infant formula is used. If ready-to-use liquid infant formula is used, an emergency kit should include: 56 serves of ready-to-use liquid infant formula, 84 L water, storage container, metal knife, small bowl, 56 feeding bottles and teats/cups, 56 zip-lock plastic bags, 220 paper towels, detergent, 120 antiseptic wipes, 100 nappies and 200 nappy wipes. If powdered infant formula is used, an emergency preparedness kit should include: two 900 g tins powdered infant formula, 170 L drinking water, storage container, large cooking pot with lid, kettle, gas stove, box of matches/lighter, 14 kg liquid petroleum gas, measuring container, metal knife, metal tongs, feeding cup, 300 large sheets paper towel, detergent, 100 nappies and 200 nappy wipes. Great care with regards hygiene should be taken in the preparation of formula feeds. Child protection organisations should ensure that foster carers responsible for infants have the resources necessary to formula feed in the event of an emergency. Exclusive and continued breastfeeding should be promoted as an emergency preparedness activity by emergency management organisations as well as health authorities. The greater the proportion of infants exclusively breastfed when an emergency occurs, the more resilient the community, and the easier it will be to provide effective aid to the caregivers of formula fed infants.
doi:10.1186/1746-4358-6-16
PMCID: PMC3225303  PMID: 22059481
disasters; emergencies; infant formula; artificial feeding; breastfeeding; emergency preparedness
4.  Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review 
PLoS Medicine  2010;7(10):e1000352.
Geoff Spurling and colleagues report findings of a systematic review looking at the relationship between exposure to promotional material from pharmaceutical companies and the quality, quantity, and cost of prescribing. They fail to find evidence of improvements in prescribing after exposure, and find some evidence of an association with higher prescribing frequency, higher costs, or lower prescribing quality.
Background
Pharmaceutical companies spent $57.5 billion on pharmaceutical promotion in the United States in 2004. The industry claims that promotion provides scientific and educational information to physicians. While some evidence indicates that promotion may adversely influence prescribing, physicians hold a wide range of views about pharmaceutical promotion. The objective of this review is to examine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing.
Methods and Findings
We searched for studies of physicians with prescribing rights who were exposed to information from pharmaceutical companies (promotional or otherwise). Exposures included pharmaceutical sales representative visits, journal advertisements, attendance at pharmaceutical sponsored meetings, mailed information, prescribing software, and participation in sponsored clinical trials. The outcomes measured were quality, quantity, and cost of physicians' prescribing. We searched Medline (1966 to February 2008), International Pharmaceutical Abstracts (1970 to February 2008), Embase (1997 to February 2008), Current Contents (2001 to 2008), and Central (The Cochrane Library Issue 3, 2007) using the search terms developed with an expert librarian. Additionally, we reviewed reference lists and contacted experts and pharmaceutical companies for information. Randomized and observational studies evaluating information from pharmaceutical companies and measures of physicians' prescribing were independently appraised for methodological quality by two authors. Studies were excluded where insufficient study information precluded appraisal. The full text of 255 articles was retrieved from electronic databases (7,185 studies) and other sources (138 studies). Articles were then excluded because they did not fulfil inclusion criteria (179) or quality appraisal criteria (18), leaving 58 included studies with 87 distinct analyses. Data were extracted independently by two authors and a narrative synthesis performed following the MOOSE guidelines. Of the set of studies examining prescribing quality outcomes, five found associations between exposure to pharmaceutical company information and lower quality prescribing, four did not detect an association, and one found associations with lower and higher quality prescribing. 38 included studies found associations between exposure and higher frequency of prescribing and 13 did not detect an association. Five included studies found evidence for association with higher costs, four found no association, and one found an association with lower costs. The narrative synthesis finding of variable results was supported by a meta-analysis of studies of prescribing frequency that found significant heterogeneity. The observational nature of most included studies is the main limitation of this review.
Conclusions
With rare exceptions, studies of exposure to information provided directly by pharmaceutical companies have found associations with higher prescribing frequency, higher costs, or lower prescribing quality or have not found significant associations. We did not find evidence of net improvements in prescribing, but the available literature does not exclude the possibility that prescribing may sometimes be improved. Still, we recommend that practitioners follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
A prescription drug is a medication that can be supplied only with a written instruction (“prescription”) from a physician or other licensed healthcare professional. In 2009, 3.9 billion drug prescriptions were dispensed in the US alone and US pharmaceutical companies made US$300 billion in sales revenue. Every year, a large proportion of this revenue is spent on drug promotion. In 2004, for example, a quarter of US drug revenue was spent on pharmaceutical promotion. The pharmaceutical industry claims that drug promotion—visits from pharmaceutical sales representatives, advertisements in journals and prescribing software, sponsorship of meetings, mailed information—helps to inform and educate healthcare professionals about the risks and benefits of their products and thereby ensures that patients receive the best possible care. Physicians, however, hold a wide range of views about pharmaceutical promotion. Some see it as a useful and convenient source of information. Others deny that they are influenced by pharmaceutical company promotion but claim that it influences other physicians. Meanwhile, several professional organizations have called for tighter control of promotional activities because of fears that pharmaceutical promotion might encourage physicians to prescribe inappropriate or needlessly expensive drugs.
Why Was This Study Done?
But is there any evidence that pharmaceutical promotion adversely influences prescribing? Reviews of the research literature undertaken in 2000 and 2005 provide some evidence that drug promotion influences prescribing behavior. However, these reviews only partly assessed the relationship between information from pharmaceutical companies and prescribing costs and quality and are now out of date. In this study, therefore, the researchers undertake a systematic review (a study that uses predefined criteria to identify all the research on a given topic) to reexamine the relationship between exposure to information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing.
What Did the Researchers Do and Find?
The researchers searched the literature for studies of licensed physicians who were exposed to promotional and other information from pharmaceutical companies. They identified 58 studies that included a measure of exposure to any type of information directly provided by pharmaceutical companies and a measure of physicians' prescribing behavior. They then undertook a “narrative synthesis,” a descriptive analysis of the data in these studies. Ten of the studies, they report, examined the relationship between exposure to pharmaceutical company information and prescribing quality (as judged, for example, by physician drug choices in response to clinical vignettes). All but one of these studies suggested that exposure to drug company information was associated with lower prescribing quality or no association was detected. In the 51 studies that examined the relationship between exposure to drug company information and prescribing frequency, exposure to information was associated with more frequent prescribing or no association was detected. Thus, for example, 17 out of 29 studies of the effect of pharmaceutical sales representatives' visits found an association between visits and increased prescribing; none found an association with less frequent prescribing. Finally, eight studies examined the relationship between exposure to pharmaceutical company information and prescribing costs. With one exception, these studies indicated that exposure to information was associated with a higher cost of prescribing or no association was detected. So, for example, one study found that physicians with low prescribing costs were more likely to have rarely or never read promotional mail or journal advertisements from pharmaceutical companies than physicians with high prescribing costs.
What Do These Findings Mean?
With rare exceptions, these findings suggest that exposure to pharmaceutical company information is associated with either no effect on physicians' prescribing behavior or with adverse affects (reduced quality, increased frequency, or increased costs). Because most of the studies included in the review were observational studies—the physicians in the studies were not randomly selected to receive or not receive drug company information—it is not possible to conclude that exposure to information actually causes any changes in physician behavior. Furthermore, although these findings provide no evidence for any net improvement in prescribing after exposure to pharmaceutical company information, the researchers note that it would be wrong to conclude that improvements do not sometimes happen. The findings support the case for reforms to reduce negative influence to prescribing from pharmaceutical promotion.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000352.
Wikipedia has pages on prescription drugs and on pharmaceutical marketing (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The UK General Medical Council provides guidelines on good practice in prescribing medicines
The US Food and Drug Administration provides information on prescription drugs and on its Bad Ad Program
Healthy Skepticism is an international nonprofit membership association that aims to improve health by reducing harm from misleading health information
The Drug Promotion Database was developed by the World Health Organization Department of Essential Drugs & Medicines Policy and Health Action International Europe to address unethical and inappropriate drug promotion
doi:10.1371/journal.pmed.1000352
PMCID: PMC2957394  PMID: 20976098
5.  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
6.  A randomised multicentre study of human milk versus formula and later development in preterm infants. 
Whether breast milk influences later neurodevelopment has been explored in non-randomised studies, potentially confounded by social and demographic differences between feed groups. Here in a strictly randomised prospective multicentre trial, Bayley psychomotor and mental development indices (PDI and MDI) were assessed at 18 months postterm in survivors of 502 preterm infants assigned to receive, during their early weeks, mature donor breast milk or a preterm formula. These diets were compared as sole enteral feeds or as supplements to the mother's expressed breast milk. No differences in outcome at 18 months were seen between the two diet groups despite the low nutrient content of donor milk in relation to the preterm formula and to the estimated needs of preterm infants. These results contrast with those reported from our parallel two centre study that compared infants randomly assigned a standard term formula or the preterm formula during their early weeks; those fed standard formula, now regarded as nutritionally insufficient for preterm infants, were substantially disadvantaged in PDI and MDI at 18 months post-term. It is shown here that infants from that study fed solely on standard formula had significantly lower developmental scores at 18 months than those fed on donor breast milk in the present study; yet the standard formula had a higher nutrient content than the donor milk. Thus, donor milk feeding was associated with advantages for later development that may have offset any potentially deleterious effects of its low nutrient content for preterm infants. As these outcome advantages were not confounded by the social and educational biases usually associated with mothers' choice to breast feed, our data add significant support to the view that breast milk promotes neurodevelopment.
PMCID: PMC1061016  PMID: 8154907
7.  Corporate Social Responsibility and Access to Policy Élites: An Analysis of Tobacco Industry Documents 
PLoS Medicine  2011;8(8):e1001076.
Gary Fooks and colleagues undertook a review of tobacco industry documents and show that policies on corporate social responsibility can enable access to and dialogue with policymakers at the highest level.
Background
Recent attempts by large tobacco companies to represent themselves as socially responsible have been widely dismissed as image management. Existing research supports such claims by pointing to the failings and misleading nature of corporate social responsibility (CSR) initiatives. However, few studies have focused in depth on what tobacco companies hoped to achieve through CSR or reflected on the extent to which these ambitions have been realised.
Methods and Findings
Iterative searching relating to CSR strategies was undertaken of internal British American Tobacco (BAT) documents, released through litigation in the US. Relevant documents (764) were indexed and qualitatively analysed. In the past decade, BAT has actively developed a wide-ranging CSR programme. Company documents indicate that one of the key aims of this programme was to help the company secure access to policymakers and, thereby, increase the company's chances of influencing policy decisions. Taking the UK as a case study, this paper demonstrates the way in which CSR can be used to renew and maintain dialogue with policymakers, even in ostensibly unreceptive political contexts. In practice, the impact of this political use of CSR is likely to be context specific; depending on factors such as policy élites' understanding of the credibility of companies as a reliable source of information.
Conclusions
The findings suggest that tobacco company CSR strategies can enable access to and dialogue with policymakers and provide opportunities for issue definition. CSR should therefore be seen as a form of corporate political activity. This underlines the need for broad implementation of Article 5.3 of the Framework Convention on Tobacco Control. Measures are needed to ensure transparency of interactions between all parts of government and the tobacco industry and for policy makers to be made more aware of what companies hope to achieve through CSR.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In the past, companies and multinational corporations were judged on the profits they made. Nowadays, though, much is made of corporate social responsibility (CSR). CSR is the commitment by business to behave ethically and to contribute to economic development while improving the quality of life of the workforce, their families, the local community, and society at large. Put simply, companies and corporations now endeavor to show that they have a positive impact on the environment, consumers, employees, and society in addition to making money for their shareholders. Large tobacco companies are no exception. British American Tobacco (BAT, the world's second largest publicly traded tobacco company), for example, began working on a wide-ranging CSR program more than a decade ago. Given that tobacco is responsible for an estimated 5.4 million deaths worldwide annually, this program was initially met with hostility and dismissed as an image management exercise. However, large parts of the investment and CSR communities now approve of BAT's CSR program, which has won numerous awards.
Why Was This Study Done?
But what do BAT and other tobacco companies actually hope to achieve through their CSR initiatives and how successful have they been in achieving these aims? Few studies have addressed these important questions. In particular, there has been little research into the extent to which tobacco companies use CSR initiatives as a form of corporate political activity that can help them gain “access” to policymakers and define the legitimate concerns and optimal alternatives of public policy (“issue definition”). Access is defined as taking place when policymakers consider the views of policy advocates such as tobacco company employees and is a crucial component of issue definition, which refers to the strategies adopted by bodies such as multinational corporations to influence the policy agenda by defining what issues public policy should concern itself with and how it should approach them. In this case study, the researchers explore whether BAT's CSR program works as a form of corporate political activity by systematically examining internal BAT documents made publicly available as a result of US litigation. Specifically, the researchers examine BAT's efforts through its CSR program to reestablish access with the UK Department of Health following the department's decision in the late 1990s to restrict contact with major tobacco companies.
What Did the Researchers Do and Find?
Using iterative searching, the researchers identified 764 documents in the Legacy Tobacco Documents Library (a large collection of internal tobacco company documents released as a result of US litigation cases) that contain information relevant to BAT's CSR strategies. Their analysis of these documents indicates that one of the key aims of the CSR program actively developed over the past decade by BAT was to help secure access to policymakers and shows how BAT used CSR to renew and maintain dialogue with policymakers at a time when contact between government and tobacco companies was extremely restricted. The documents also show that BAT employees used CSR initiatives as a means of issue definition to both optimize the probability of subsequent discussions taking place and to frame their content. Finally, the documents illustrate how BAT used its CSR program to expand the number of access points across government, thereby providing BAT with more opportunities to meet and talk to officials.
What Do These Findings Mean?
These findings suggest that CSR is a form of corporate political activity that potentially has important implications for public health given the documented impact of the political activity of tobacco companies in delaying and blocking health-related tobacco control policies. In practice, the impact of the political use of CSR is likely to be context specific and will depend on factors such as whether senior policymakers regard companies as reliable sources of information. Importantly, these findings underline the need for broad implementation of Article 5.3 of the World Health Organization's Framework Convention on Tobacco Control (FCTC), an international treaty that calls for the introduction of multiple measures to reduce tobacco consumption, including tobacco advertizing bans and relevant taxation policies. Article 5.3 aims to protect public-health policies on tobacco control from tobacco industry influence. The findings of this study indicate that implementation of Article 5.3 will require measures that ensure transparency in interactions between all parts of government and the tobacco industry and will need an increased awareness across government of what tobacco companies hope to achieve through CSR.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001076.
The Corporate Responsibility (CORE) coalition, an alliance of voluntary organizations, trade unions, and companies, maintains a Web site that contains useful material on corporate social responsibility
The European Coalition for Corporate Justice (ECCJ) promotes corporate accountability by bringing together national platforms of civil society organizations (including NGOs, trade unions, consumer advocacy groups, and academic institutions) from all over Europe
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages), details of the Framework Convention on Tobacco Control (in several languages), and guidelines for the implementation of Article 5.3 of the FCTC
The Framework Convention Alliance provides more information about the FCTC
For information about tobacco industry influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
doi:10.1371/journal.pmed.1001076
PMCID: PMC3160341  PMID: 21886485
8.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
9.  Prevalence and dietetic management of mild gastrointestinal disorders in milk-fed infants 
AIM: To assess the prevalence of mild gastrointestinal disorders in milk-fed infants in paediatric practice, and to evaluate the effectiveness and satisfaction with dietetic treatment.
METHODS: A cross-sectional epidemiological study was first carried out. A total of 285 paediatricians included 3487 children seen during a period of one week. In a second phase an observational, prospective and multicentre study was conducted and 2069 milk-fed infants with mild gastrointestinal disorders (colic, constipation, regurgitation and diarrhoea) were included. There was a baseline visit (start of treatment) and a final visit four weeks later. The effectiveness of the various Novalac formulas, as well as the satisfaction of the parents/tutors and paediatricians with the dietetic treatment were assessed at the final visit.
RESULTS: The prevalence of mild gastrointestinal disorders was 27.8% of all paediatrician consultations (9.2%, 7.8%, 6.1% and 4.6% in relation to colic, constipation, regurgitation and diarrhoea, respectively). The several Novalac adapted milk formulas resolved 88.4% of the mild gastrointestinal disorders. Depending on the type of disorder, differences in response rate were observed. The highest effectiveness was recorded with respect to diarrhoea (92.6%), followed by constipation (91.6%), colic (87.6%) and regurgitation (81%). Overall, 91% of the paediatricians and 88.8% of the parents/tutors were satisfied or very satisfied with the Novalac adapted milk formulas.
CONCLUSION: Mild gastrointestinal disorders show a high prevalence in paediatric practice. The Novalac adapted milk formulas have been shown to be effective in treating mild gastrointestinal disorders in milk-fed infants in the context of routine clinical practice.
doi:10.3748/wjg.14.248
PMCID: PMC2675122  PMID: 18186563
Mild gastrointestinal disorders; Prevalence; Adapted infant formulas; Effectiveness; Satisfaction
10.  Iron supplemented formula milk related to reduction in psychomotor decline in infants from inner city areas: randomised study 
BMJ : British Medical Journal  1999;318(7185):693-698.
Objective
To compare the effect of unmodified cows’ milk and iron supplemented formula milk on psychomotor development in infants from inner city areas when used as the main milk source.
Design
Double blind, randomised intervention trial.
Setting
Birmingham health centre.
Subjects
100 infants, mean age 7.8 months (range 5.7 to 8.6 months), whose mothers had already elected to use unmodified cows’ milk as their infant’s milk source.
Intervention
Changing to an iron supplemented formula milk from enrolment to 18 months of age, or continuing with unmodified cows’ milk.
Main outcome measures
Developmental assessments using Griffiths scales at enrolment and at 18 and 24 months.
Results
85 participants completed the trial. There were no significant differences in haemoglobin concentration between the two groups at enrolment, but by 18 months of age 33% of the unmodified cows’ milk group, but only 2% of the iron supplemented group, were anaemic (P<0.001). The experimental groups had Griffiths general quotient scores that were not significantly different at enrolment, but the scores in both groups declined during the study. By 24 months the decrease in the mean scores in the unmodified cows’ milk group was 14.7 whereas the decrease in the mean scores in the iron supplemented group was 9.3 (P<0.02, 95% confidence interval 0.4 to 10.4). Mean subquotient scores were considerably lower in the unmodified cows’ milk group at 24 months; significantly so for personal and social scores (P<0.02, −5.4 to 17.2).
Conclusion
Replacing unmodified cows’ milk with an iron supplemented formula milk up to 18 months of age in infants from inner city areas prevents iron deficiency anaemia and reduces the decline in psychomotor development seen in such infants from the second half of the first year.
Key messagesIron deficiency anaemia is common in infants from inner cities who are given unmodified cows’ milk in the first year of lifeGiving an infant iron supplemented formula milk instead of cows’ milk not only prevents anaemia but reduces the decline in developmental performance observed in those given only cows’ milkAn iron supplemented formula milk rather than cows’ milk should be provided free of charge for infants up to the age of 18 months who are living in inner cities and who are not receiving breast milk
PMCID: PMC27777  PMID: 10074011
11.  Human Breast Milk Provides Better Antioxidant Capacity than Infant Formula 
Human milk contains all of the constituents that are required for the optimal growth and development of a neonate. It supports the development of brain, immune, and physiological systems. This study aimed to consider the significance of breast milk in preventing oxidative stress by comparing total antioxidant capacity (TAC) in breast and formula milk for premature infants, demonstrating the relationship between TAC in breast milk and postnatal age in days.
The Ferric reducing antioxidant power assay (FRAP) method was used to spectophotometrically measure of TAC in breast and formula milk. One hundred and fourty (n = 140) lactating mothers agreed to participate in the study. TAC was also measured in two brands of formula milk (n = 80).
The Range of TAC in human breast milk was 234.27-1442.31 μM and in two formula was 160.04-630.92 μM. The average TAC was significantly higher in breast milk (642.94 ± 241.23 μM) compared to formula milk (280.986 ± 100.34 μM) p < 0.0001. The TAC of breast milk was increased with some nutritional parameter such as increased consumption of cheese, vegetables, fruits, bread and nuts. Infants’ height at the birthday was directly correlated with antioxidant capacity of breast milk, whilst a reversed correlation was observed between TAC in breast milk and infant age.
Based on our results, it is concluded that the TAC of breast milk is varied and affected by nutrition. It is alo observed that TAC is significantly higher in breast milk than formula, which means that breast milk provides better antioxidant potency than infant formula.
PMCID: PMC3870070  PMID: 24381611
Total antioxidant capacity; Human breast milk; nfant formula; FRAP
12.  DoMINO: Donor milk for improved neurodevelopmental outcomes 
BMC Pediatrics  2014;14:123.
Background
Provision of mother’s own milk is the optimal way to feed infants, including very low birth weight infants (VLBW, <1500 g). Importantly for VLBW infants, who are at elevated risk of neurologic sequelae, mother’s own milk has been shown to enhance neurocognitive development. Unfortunately, the majority of mothers of VLBW infants are unable to provide an adequate supply of milk and thus supplementation with formula or donor milk is necessary. Given the association between mother’s own milk and neurodevelopment, it is important to ascertain whether provision of human donor milk as a supplement may yield superior neurodevelopmental outcomes compared to formula.
Our primary hypothesis is that VLBW infants fed pasteurized donor milk compared to preterm formula as a supplement to mother’s own milk for 90 days or until hospital discharge, whichever comes first, will have an improved cognitive outcome as measured at 18 months corrected age on the Bayley Scales of Infant Development, 3rd ed. Secondary hypotheses are that the use of pasteurized donor milk will: (1) reduce a composite of death and serious morbidity; (2) support growth; and (3) improve language and motor development. Exploratory research questions include: Will use of pasteurized donor milk: (1) influence feeding tolerance and nutrient intake (2) have an acceptable cost effectiveness from a comprehensive societal perspective?
Methods/Design
DoMINO is a multi-centre, intent-to-treat, double blinded, randomized control trial. VLBW infants (n = 363) were randomized within four days of birth to either (1) pasteurized donor milk or (2) preterm formula whenever mother’s own milk was unavailable. Study recruitment began in October 2010 and was completed in December 2012. The 90 day feeding intervention is complete and long-term follow-up is underway.
Discussion
Preterm birth and its complications are a leading cause long-term morbidity among Canadian children. Strategies to mitigate this risk are urgently required. As mother’s own milk has been shown to improve neurodevelopment, it is essential to ascertain whether pasteurized donor milk will confer the same advantage over formula without undue risks and at acceptable costs. Knowledge translation from this trial will be pivotal in setting donor milk policy in Canada and beyond.
Trial registration
ISRCTN35317141; Registered 10 August 2010.
doi:10.1186/1471-2431-14-123
PMCID: PMC4032387  PMID: 24884424
Human milk; Donor milk; Neurodevelopment; Very low birth weight infants
13.  Infant feeding in the second 6 months of life related to iron status: an observational study 
Archives of Disease in Childhood  2007;92(10):850-854.
Objective
To investigate the relationship between iron status in infancy and type of milk and weaning solids consumed.
Design
An observational cohort study.
Setting
928 term infants from the Avon Longitudinal Study of Parents and Children in 1993–94.
Methods
Haemoglobin and ferritin concentrations at 8 and 12 months were assessed in relation to type and quantity of milk intake at 8 months.
Results
By WHO criteria, 22.7% of the infants were anaemic at 8 months and 18.1% at 12 months. More breast‐ than formula‐fed infants were anaemic at 8 and 12 months. Cows' milk as the main drink was associated with increased anaemia at 12 months and low ferritin at 8 and 12 months. No association was found between any nutrients and haemoglobin concentrations. Protein and non‐haem iron intakes were positively associated with ferritin concentrations and calcium intake negatively. This effect was more marked in infants being fed cows' milk. More than 25% of infants in the breast milk and cows' milk groups and 41% of infants having >6 breast feeds per day had iron intakes below the lower reference nutrient intake. Feeding cows' milk or formula above 600 ml or >6 breast feeds per day was associated with lower intakes of solids.
Conclusions
Both breast and cows' milk feeding were associated with higher levels of anaemia. Satisfactory iron intake from solids in later infancy is more likely if formula intake is <600 ml per day and breast feeds are limited to <6 feeds per day. Cows' milk should be strongly discouraged as a main drink before 12 months.
doi:10.1136/adc.2006.114074
PMCID: PMC2083241  PMID: 17537759
ALSPAC; cows' milk; breast milk; formula; iron deficiency
14.  Comparative analysis of ascorbic acid in human milk and infant formula using varied milk delivery systems 
Background
The expression of human milk for later use is on the rise. Bottle systems are used to deliver the expressed milk. Research has shown that storage of both human milk and artificial baby milk, or infant formula, leads to a loss of ascorbic acid (commonly called Vitamin C). As milk is removed from the bottle during feeding and replaced by ambient air, it is unknown if loss of ascorbic acid occurs during the course of a feeding. The purpose of this study is to investigate the effect of the milk delivery system on levels of ascorbic acid in human milk and infant formula. The objectives are to 1) determine changes in ascorbic acid concentration during a 20 minute "feed," 2) determine if there is a difference in ascorbic acid concentration between delivery systems, and 3) evaluate if any differences are of clinical importance.
Methods
Commonly available bottles were used for comparison of bottle delivery systems. Mature human milk was standardized to 42 mg/L of ascorbic acid. Infant formula with iron and infant formula with docosahexanoic acid were used for the formula samples. Each sample was analyzed for ascorbic acid concentration at baseline (0), 5, 10, 15, and 20 minutes. Each collection of samples was completed in triplicate. Samples were analyzed for ascorbic acid using normal-phase high performance liquid chromatography.
Results
Ascorbic acid concentration declined in all bottle systems during testing, Differences between the bottle systems were noted. Ascorbic acid concentrations declined to less than 40% of recommended daily intake for infants in 4 of the bottles systems at the 20 minute sampling.
Conclusion
The bottle systems used in this study had measurable decreases in the mean concentration of ascorbic acid. More research is needed to determine if the observed decreases are related to lower plasma ascorbic acid concentration in infants exclusively bottle fed. The decrease of ascorbic acid concentration observed in both human milk and infant formula using varied milk delivery systems may be of clinical importance. For infants who rely solely on bottle feeds there may be increased risk of deficiency. Bottle shape, size, and venting should be considered.
doi:10.1186/1746-4358-3-19
PMCID: PMC2526073  PMID: 18694505
15.  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.
Background
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.
Methods
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.
Results
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.
Conclusion
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.
doi:10.1371/journal.pone.0030634
PMCID: PMC3276495  PMID: 22347392
16.  Evaluation and treatment of the human immunodeficiency virus-1-exposed infant 
Paediatrics & Child Health  2004;9(6):409-417.
In developed countries, care and treatment are available for pregnant women and infants that can decrease the rate of perinatal human immunodeficiency virus type 1 (HIV-1) infection to 2% or less. The paediatrician has a key role in the prevention of mother-to-child transmission of HIV-1 by identifying HIV-exposed infants whose mothers’ HIV infection was not diagnosed before delivery, prescribing antiretroviral prophylaxis for these infants to decrease the risk of acquiring HIV-1 infection, and promoting avoidance of HIV-1 transmission through human milk. In addition, the paediatrician can provide care for HIV-exposed infants by monitoring them for early determination of HIV-1 infection status and for possible short- and long-term toxicities of antiretroviral exposure, providing chemoprophylaxis for Pneumocystis pneumonia, and supporting families living with HIV-1 infection by providing counselling to parents or caregivers.
PMCID: PMC2721159  PMID: 19657433
Antiretroviral; Diagnosis; HIV-1; HIV-exposed infants; Mother-to-child transmission
17.  Complementary Foods and Flavor Experiences: Setting the Foundation 
Annals of Nutrition & Metabolism  2012;60(Suppl 2):40-50.
Increased fruit and vegetable consumption early in life may lead to life-long intake of fruits and vegetables, which in turn may be beneficial for weight control and other health outcomes in later life. Although health officials worldwide recommend delaying solid foods until 6 months of age, younger infants often receive solid food, which may affect later obesity rates. The timing of introduction to solid foods is important both nutritionally and developmentally and may affect acceptance of foods both in infancy and later in life. Infants can clearly discriminate the flavors of different fruits and vegetables. Repeated flavor experiences promote the willingness to eat a variety of foods: infants will consume more of foods that have a familiar flavor and are more accepting of novel flavors if they have experience with flavor variety. Many flavors that the mother either ingests or inhales are transmitted to her milk and/or amniotic fluid. Mothers can help the transition from a diet exclusively of milk or formula to a mixed diet by providing the infant familiar flavors in both milk or formula and solid foods. Exposure to a variety of flavors during and between meals appears to facilitate acceptance of novel foods. Providing novelty in the context of a familiar food might prove to be an optimal combination to progressively accustom infants to a diversity of novel foods. When repeatedly exposing infants to flavors of some vegetables that have bitter tastes, mothers should focus not on infants' facial expressions but on their willingness to eat the food and should continue to provide repeated opportunities to taste the food. Introducing children repeatedly to individual as well as a variety of fruits and vegetables, both within and between meals, might help them be more accepting of fruits and vegetables, which is difficult to enhance beyond toddlerhood.
doi:10.1159/000335337
PMCID: PMC3363345  PMID: 22555188
Breastfeeding; Complementary feeding; First-food acceptance; Flavor variety; Health outcomes; Infant nutrition; Taste
18.  Breastfeeding and Infant Temperament at Age Three Months 
PLoS ONE  2012;7(1):e29326.
Background & Methods
To examine the relationship between breastfeeding and maternally-rated infant temperament at age 3 months, 316 infants in the prospective Cambridge Baby Growth Study, UK had infant temperament assessed at age 3 months by mothers using the Revised Infant Behavior Questionnaire, which produces scores for three main dimensions of temperament derived from 14 subscales. Infant temperament scores were related to mode of infant milk feeding at age 3 months (breast only; formula milk only; or mixed) with adjustment for infant's age at assessment and an index of deprivation.
Results
Infant temperament dimension scores differed across the three infant feeding groups, but appeared to be comparable between exclusive breast-fed and mixed-fed infants. Compared to formula milk-fed infants, exclusive breast-fed and mixed-fed infants were rated as having lower impulsivity and positive responses to stimulation (adjusted mean [95% CI] “Surgency/Extraversion” in formula-fed vs. mixed-fed vs. breast-fed groups: 4.3 [4.2–4.5] vs. 4.0 [3.8–4.1] vs. 4.0 [3.9–4.1]; p-heterogeneity = 0.0006), lower ability to regulate their own emotions (“Orienting/Regulation”: 5.1 [5.0–5.2], vs. 4.9 [4.8–5.1] vs. 4.9 [4.8–5.0]; p = 0.01), and higher emotional instability (“Negative affectivity”: 2.8 [2.6–2.9] vs. 3.0 [2.8–3.1] vs. 3.0 [2.9–3.1]; p = 0.03).
Conclusions
Breast and mixed-fed infants were rated by their mothers as having more challenging temperaments in all three dimensions; particular subscales included greater distress, less smiling, laughing, and vocalisation, and lower soothability. Increased awareness of the behavioural dynamics of breastfeeding, a better expectation of normal infant temperament and support to cope with difficult infant temperament could potentially help to promote successful breastfeeding.
doi:10.1371/journal.pone.0029326
PMCID: PMC3254612  PMID: 22253712
19.  Association between Total Antioxidant Capacity in Breast Milk and Postnatal Age in Days in Premature Infants 
This study aimed to consider the significance of breast milk in preventing oxidative stress by comparing total antioxidant capacity (TAC) in breast milk and formula milk for premature infants, demonstrating the relationship between TAC in breast milk and postnatal age in days. We used the biological anti-oxidant potential test, a new method to measure TAC in breast milk. Breast milk for premature infants were stored at −20°C and thawed within 48 h of collection. We measured TAC in two types of formula milk in the same way. TAC was clearly higher in breast milk than formula milk. Although a negative correlation was observed between TAC in breast milk and age when collected, TAC was always higher than the average TAC in formula milk. TAC in breast milk is higher than TAC in formula milk. We suggest the importance of breast milk for preventing oxidative stress and starting breastfeeding early.
doi:10.3164/jcbn.2008019
PMCID: PMC2266054  PMID: 18385830
breast milk; total antioxidant capacity; premature infant
20.  Intestinal Permeability in Preterm Infants by Feeding Type: Mother's Milk Versus Formula 
Breastfeeding Medicine  2009;4(1):11-15.
Abstract
Background and Objective
Intestinal permeability in preterm infants represents a critical balance between absorption of nutritional agents and protection from dangerous pathogens. This study identified the relationship between feeding type (human milk and formula) and intestinal permeability as measured by lactulose to mannitol ratio in preterm infants in the first postnatal month.
Study Design
Sixty-two preterm (≤32 weeks of gestation) infants had assessment of feeding type and evaluation with enteral lactulose and mannitol administration and urinary measurement at three time points in the first postnatal month.
Results
Infants who received the majority of feeding as human milk (>75%) demonstrated significantly lower intestinal permeability when compared to infants receiving minimal or no human milk (<25% or none) at postnatal days 7, 14, and 30 (p = 0.02, 0.02, and 0.047, respectively). When infants receiving any human milk were compared to infants receiving formula only, a significant difference existed at day 7 and day 14 but not for day 30 (p = 0.04, 0.02, and 0.15, respectively). With evaluation over the complete study period, exclusively formula-fed infants demonstrated a 2.8-fold higher composite median lactulose/mannitol ratio when compared with those who received any human milk. Infants who received >75% of enteral feeding as mother's milk demonstrated a 3.8-fold lower composite median ratio when compared to infants receiving <25% or no mother's milk.
Conclusion
Preterm infant intestinal permeability was significantly decreased for those receiving human milk versus formula in a dose-related manner in the first postnatal month.
doi:10.1089/bfm.2008.0114
PMCID: PMC2932544  PMID: 19196035
21.  Low level of galacto-oligosaccharide in infant formula stimulates growth of intestinal Bifidobacteria and Lactobacilli 
AIM: To investigate the effect of a new infant formula supplemented with a low level (0.24 g/100 mL) of galacto-oligosaccharide (GOS) on intestinal micro-flora (Bifidobacteria, Lactobacilli and E. coli) and fermentation characteristics in term infants, compared with human milk and a standard infant formula without GOS.
METHODS: Term infants (n = 371) were approached in this study in three hospitals of China. All infants started breast-feeding. Those who changed to formula-feeding within 4 wk after birth were randomly assigned to one of the two formula groups. Growth and stool characteristics, and side effects that occurred in recruited infants were recorded in a 3-mo follow-up period. Fecal samples were collected from a subpopulation of recruited infants for analysis of intestinal bacteria (culture technique), acetic acid (gas chromatography) and pH (indicator strip).
RESULTS: After 3 mo, the intestinal Bifidobacteria, Lactobacilli, acetic acid and stool frequency were significantly increased, and fecal pH was decreased in infants fed with the GOS-formula or human milk, compared with those fed with the formula without GOS. No significant differences were observed between the GOS formula and human milk groups. Supplementation with GOS did not influence the incidence of crying, regurgitation and vomiting.
CONCLUSION: A low level of GOS (0.24 g/100 mL) in infant formula can improve stool frequency, decrease fecal pH, and stimulate intestinal Bifidobacteria and Lactobacilli as in those fed with human milk.
doi:10.3748/wjg.14.6564
PMCID: PMC2773347  PMID: 19030213
Human milk; Prebiotic; Probiotic; Safety; Chinese
22.  Misperceptions and misuse of Bear Brand coffee creamer as infant food: national cross sectional survey of consumers and paediatricians in Laos 
Objective To investigate the use of Bear Brand coffee creamer as a food for infants and the impact on consumers of the logo of a cartoon baby bear held by its mother in the breastfeeding position.
Design Interviews with paediatricians throughout the country and a national survey of potential consumers regarding their perceptions and use of the Bear Brand coffee creamer.
Setting 84 randomised villages in south, central, and northern Laos.
Participants 26 Lao paediatricians and 1098 adults in households in a cluster sampling.
Results Of the 26 paediatricians, 24 said that parents “often” or “sometimes” fed this product to infants as a substitute for breast milk. In the capital city, paediatricians said that mothers used the product when they returned to work. In the countryside, they reported that poor families used it when the mother was ill or died. Of 1098 adults surveyed, 96% believed that the can contains milk; 46% believed the Bear Brand logo indicates that the product is formulated for feeding to infants or to replace breast milk; 80% had not read the written warning on the can; and over 18% reported giving the product to their infant at a mean age of 4.7 months (95% confidence interval 4.1 to 5.3).
Conclusion The Bear Brand coffee creamer is used as a breast milk substitute in Laos. The cartoon logo influences people’s perception of the product that belies the written warning “This product is not to be used as a breast milk substitute.” Use of this logo on coffee creamer is misleading to the local population and places the health of infants at risk.
doi:10.1136/bmj.a1379
PMCID: PMC2533525  PMID: 18782843
23.  Corporate Image and Public Health: An Analysis of the Philip Morris, Kraft, and Nestlé Websites 
Journal of Health Communication  2012;17(5):582-600.
Companies need to maintain a good reputation to do business; however, companies in the infant formula, tobacco, and processed food industries have been identified as promoting disease. Such companies use their websites as a means of promulgating a positive public image, thereby potentially reducing the effectiveness of public health campaigns against the problems they perpetuate. The author examined documents from the websites of Philip Morris, Kraft, and Nestlé for issue framing and analyzed them using Benoit’s typology of corporate image repair strategies. All three companies defined the problems they were addressing strategically, minimizing their own responsibility and the consequences of their actions. They proposed solutions that were actions to be taken by others. They also associated themselves with public health organizations. Health advocates should recognize industry attempts to use relationships with health organizations as strategic image repair and reject industry efforts to position themselves as stakeholders in public health problems. Denormalizing industries that are disease vectors, not just their products, may be critical in realizing positive change.
doi:10.1080/10810730.2011.635776
PMCID: PMC3362195  PMID: 22420639
24.  Health-promoting properties of bioactive peptides derived from milk proteins in infant food: a review 
Dairy Science & Technology  2013;94:91-101.
Milk proteins have attracted extensive interest in terms of their bioavailability following ingestion. Enzymatic digestion of dairy products generates numerous peptides with various biological activities. Both human milk and infant formulas based on cow's milk are potential sources of bioactive peptides. This review aims to present current knowledge on the formation and fate of bioactive peptides from milk feeds intended for infants. Emphasis is placed on the source of the bioactive peptides with the nutritional impact of human milk and cow milk-based formulas on infant health being critically discussed from that perspective. Furthermore, the effect of processing and in vitro or in vivo digestion on the release and availability of peptides with bioactive sequences is evaluated. Considerable differences with respect to bioavailability and metabolic effects between the biologically active fragments generated following ingestion of human milk and infant formulas are documented. Peptides from milk protein of bovine origin could be a valuable supplement to human milk as multiple health-promoting properties are attributed to peptide fractions identified in standard cow milk-based infant formulas.
doi:10.1007/s13594-013-0152-3
PMCID: PMC3912356  PMID: 24511365
Bioactive; Infant formula; Human milk; Peptide
25.  Outbreak of Necrotizing Enterocolitis Associated with Enterobacter sakazakii in Powdered Milk Formula 
Journal of Clinical Microbiology  2001;39(1):293-297.
We describe an outbreak of necrotizing enterocolitis (NEC) that occurred in the neonatal intensive care unit of our hospital. A total of 12 neonates developed NEC in June-July 1998. For two of them, twin brothers, the NEC turned out to be fatal. Enterobacter sakazakii, a known contaminant of powdered milk formula, was isolated from a stomach aspirate, anal swab, and/or blood sample for 6 of the 12 neonates. A review of feeding procedures revealed that 10 of the 12 patients were fed orally with the same brand of powdered milk formula. E. sakazakii was isolated from the implicated prepared formula milk as well as from several unopened cans of a single batch. Molecular typing by arbitrarily primed PCR (AP-PCR) confirmed, although partially, strain similarity between milk and patient isolates. No further cases of NEC were observed after the use of the contaminated milk formula was stopped. With this outbreak we show that intrinsic microbiological contamination of powdered milk formula can be a possible contributive factor in the development of NEC, a condition encountered almost exclusively in formula-fed premature infants. The use of sterilized liquid milk formula in neonatal care could prevent problems with intrinsic and extrinsic contamination of powdered milk formula.
doi:10.1128/JCM.39.1.293-297.2001
PMCID: PMC87717  PMID: 11136786

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