News – INFANT NUTRITION
Infant formula marketing decision welcomed
The Infant Nutrition Council (INC) welcomes the Commerce Commission confirmation of the authorisation of the INC’s Code of Practice for marketing infant formula.
The Code of Practice restricts the advertising and marketing of infant formula by members.
It has been in place since 2012 and is consistent with New Zealand’s commitment to the World Health Organisation’s International Code of Marketing of Breast Milk Substitutes (WHO Code).
INC Chief Executive Jan Carey says INC applied to the commission for authorisation of the Code to reassure its members that it was the appropriate response in New Zealand to the WHO Code and that they comply with the law.
“Commerce Commission Chair Dr Mark Berry said ‘After considering the feedback from a number of interested parties, the commission has reached the view that the public benefits arising from higher breastfeeding rates outweigh any lessening of competition from the arrangement”, and INC agrees totally with that.
“That’s why we’re pleased the Code has been authorised.”
The Code applies to the marketing of infant formula products suitable for infants up to the age of six months.
not advertising infant formula
not distributing gifts or free samples to pregnant mothers or caregivers
not offering inducements to health professionals to promote infant formula.
These restrictions give effect to the WHO Code, which aims to protect and promote breastfeeding, and to restrict the marketing of breast milk substitutes in ways that would undermine that aim.
Ms Carey says the authorisation of the Code does not mean there will be any further restrictions on the availability of infant formula.
“There will be no change at all to the current restrictions on infant formula marketing or selling in New Zealand, or to the price promotion of infant formula.
“I must also stress that mothers and carers still need to make sure they get sufficient information from health practitioners and organisations such as Plunket about formula and feeding their babies in order to make informed decisions.
“INC believes breastfeeding is best, but that when needed, infant formula is the only suitable alternative.”
The New Zealand Code of Practice was developed by INC in consultation with the Ministry of Health and applies to INC-member marketers of infant formula.
Ms Carey says INC is responsible for liaising with and educating the industry sector to ensure the Code is adhered to. All health workers and other interested parties are encouraged to be aware of its content.
Drug shows promise for preventing pre-term birth
Researchers from the University of Adelaide have successfully tested a drug that is showing some early promise in efforts to prevent pre-term birth.
The findings, published in the Nature journal Scientific Reports, are a step forward in understanding the inflammatory mechanisms that lead to pre-term birth and how they can be suppressed.
Researchers in the University's Robinson Research Institute tested a drug known for its abilities to switch off pro-inflammatory pathways. Using the drug in pregnant mice, the researchers found that pre-term birth was entirely prevented, infant fatalities were significantly reduced, and the low birth weight normally associated with pre-term birth was also reversed.
Pre-term birth (being born at less than 37 weeks' gestation) is the major cause of death in children under five years of age, accounting for 1.1 million deaths annually. Pre-term births represent 12% of all births worldwide.
"New interventions are urgently needed to tackle the underlying causes of pre-term birth, prevent infant deaths and reduce the impact of a wide range of developmental impairments which can have lifelong health consequences," says lead author and Director of the Robinson Research Institute Professor Sarah Robertson.
The main causes of pre-term birth are bacterial infection (in around 50% of cases), physical injury or stress causing placental damage, carrying twins or triplets, or from environmental toxins such as air pollution. Each of these is associated with what researchers describe as an "inflammatory cascade," which can activate the mother's immune response and ultimately lead to spontaneous pre-term birth.
This inflammatory cascade is triggered by an immune receptor known as Toll-Like receptor 4 (TLR4), responding to infection, physical injury or stress. TLR4 is critical to the body's immune response but it also produces a number of pro-inflammatory effects that are harmful to pregnancy.
"TLR4 is a trigger of spontaneous pre-term birth," Professor Robertson says. "For this reason, we wanted to test a drug known for its ability to block the actions of TLR4, to see if that would also prevent pre-term birth."
The drug tested in this study is known as (+)-naloxone (pronounced: PLUS nal-OX-own).
"We found that by treating pregnant mice with (+)-naloxone, it provided complete protection against pre-term birth triggered by bacteria. It also protected against stillbirth and infant death shortly after birth, and led to a correction in birth weight among infants that would otherwise be born at very low birth weight," Professor Robertson says.
"The babies born to mothers treated with (+)-naloxone developed normally and were mostly indistinguishable from those born to the control group."
Professor Robertson says that while other drugs are currently in use to help prevent pre-term birth, they are used at much later stages of the process leading to birth.
"By the time the conditions for pre-term birth have already arisen, it's often too late for current treatments to do anything about it. What we really need is to stop the train at the station, as it were, before it can head down that track. Once it's left the station it's usually too late to stop it.
"Our studies give us some encouragement that it may be possible to prevent many pre-term births, by using drugs that target the body's inflammatory mechanisms, probably in combination with antibiotics as well," she says.
Professor Robertson says more research will be needed to determine if (+)-naloxone or similar drugs could be used in human clinical trials.
Source: Scientific Reports, 2016; 6: 36112 DOI: 10.1038/srep36112
Among very low-birth-weight (VLBW) infants, the use of suppleamental donor milk compared with formula did not improve neurodevelopment at 18 months, according to a study appearing in the November 8 issue of JAMA
For many VLBW (less than 3.3 lbs.) infants, there is insufficient mother's milk, and a supplement of pasteurized donor human milk (donor milk) or preterm formula is required. With an increasing awareness of the benefits of mother's milk, use of donor milk as a supplement has increased substantially in North America. The Human Milk Banking Association of North America estimated that its members dispensed 3.8 million ounces of donor milk in 2015. Despite this shift in practice, there are limited data evaluating the efficacy of "nutrient-fortified" donor milk compared with preterm formula.
Deborah L. O'Connor, Ph.D., R.D., of the Hospital for Sick Children, Toronto, and colleagues randomly assigned VLBW infants to be fed either nutrient-enriched donor milk or formula for 90 days or to discharge when mother's milk was unavailable. Infants were from 4 neonatal units in Ontario, Canada.
Of 840 eligible infants, 363 (43 percent) were randomized (181 to donor milk and 182 to preterm formula); of survivors, 299 (92 percent) had neurodevelopment assessed. Average birth weight and gestational age of infants was 2.2 lbs. and 28 weeks, respectively, and 54 percent were male. The researchers found that there were no statistically significant differences in average composite scores on measures of cognitive, language, or motor skills between groups.
"If donor milk is used in settings with high provision of mother's milk, this outcome [neurodevelopment] should not be considered a treatment goal," the authors write.
The researchers note that a recent systematic analysis of randomized studies found that donor milk as a supplement to mother's milk did however reduce the risk of necrotizing enterocolitis, a severe gastrointestinal emergency. A similar reduction was found in the current study with the use of nutrient-enriched donor milk.
Source: JAMA, 2016; 316 (18): 1897 DOI: 10.1001/jama.2016.16144
Blood test may help identify fetal alcohol spectrum disorders
Study authors say the findings could facilitate early intervention to improve the health of infants and children who were prenatally exposed to alcohol.
Fetal alcohol syndrome is a severe form of a spectrum of mental and physical disabilities called fetal alcohol spectrum disorders (FASD) that can affect children's development with long-lasting consequences. In the United States and Western Europe, it's estimated that 2 to 5 percent of school-age children are affected by FASD. In some parts of the world, the number is higher.
Children and adults affected by FASD may experience a range of symptoms, from physical changes like a small head and subtle differences in facial characteristics to learning difficulties and behavioral issues.
Despite widespread prevention guidelines, drinking during pregnancy still occurs, in part because roughly half of pregnancies in the United States are unplanned and many women may not realize that they need to stop consuming alcohol before harm occurs.
"It's a huge problem," said Rajesh Miranda, PhD, professor in the Texas A&M College of Medicine and co-senior author of the study, "but we might not realize the full scope because infants born with normal-looking physical features may be missed, making many cases difficult to diagnose early."
Seeking to develop a predictive test using biomarkers, researchers looked at birth outcomes for 68 pregnant women enrolled in the study at two perinatal care clinics in western Ukraine. The team obtained detailed health and alcohol consumption histories and second and third trimester blood samples from each woman. The results indicated that moderate to high levels of alcohol exposure during early pregnancy resulted in significant differences in some circulating small RNA molecules called microRNAs (miRNAs) in maternal blood. These differences were particularly notable in mothers whose infants showed some physical or neurobehavioral signs of alcohol effects in the first 12 months of life.
"Collectively, our data indicate that maternal plasma miRNAs may help predict infant outcomes and may be useful to classify difficult-to-diagnose FASD subpopulations," Miranda said.
Part of the reason FASD can be difficult to diagnose is because infants with similar amounts of prenatal alcohol exposure may have vastly different outcomes.
"Although it is generally true that binge-drinking during pregnancy presents the greatest risk, not all women who consume substantial amounts of alcohol in pregnancy will have a child who is clearly affected," said Christina Chambers, PhD, professor of pediatrics at UC San Diego School of Medicine, principal investigator on the Ukraine project and co-senior author.
"That's why we examined specific biomarkers in the mother's blood in the second and third trimester of her pregnancy to determine if they are useful in identifying children who could benefit from early interventions."
Although FASD cannot be cured, early diagnosis is vital. "Early diagnosis is important because it permits early intervention to minimize the harm due to prenatal alcohol exposure," said Wladimir Wertelecki, MD, research team leader in Ukraine. "Good nutrition, better perinatal health care, lowering stress levels and infant care interventions can all improve the outcome of alcohol-affected pregnancies."
The scientists said their next steps will include repeating the investigation in other, larger samples of mothers and infants, and determining if these early markers are predictive of longer term developmental outcomes for children exposed to alcohol.
"If we can reset developmental trajectories earlier in life, it is a lot easier than trying to treat disabilities later in life," Miranda said. "We hope this work will lead to a test that can allow health care providers to identify the mothers and infants most at risk and provide them with extra care for the best outcome possible."
Source: PLOS ONE, 2016; 11 (11): e0165081 DOI: 10.1371/journal.pone.0165081
Infants receiving vaccines: what about hospitalization and death rate
A new study, published in Human and Experimental Toxicology, a peer-reviewed journal indexed by the National Library of Medicine, analyzed more than 38,000 reports of infant hospitalizations and deaths following vaccinations.(1) Researchers found statistically significant correlations between the number of vaccine doses administered to infants and infant hospitalization and mortality rates: babies who receive the most vaccines tend to have higher (worse) hospitalization and death rates.
Infants who received 2 vaccines simultaneously were significantly less likely to be hospitalized than infants who received 3 or more vaccines at the same time. Infants who received 3 vaccines simultaneously were significantly less likely to be hospitalized than infants who received 4 or more vaccines at the same time. Babies who received 6, 7, or 8 vaccines during a single pediatric well-baby visit were the most likely to be hospitalized following their injections. In fact, the hospitalization rate increased linearly from 11.0% for infants receiving 2 vaccine doses to 23.5% for infants receiving 8 vaccine doses.
The authors of the study, Dr. Gary Goldman and Neil Z. Miller, also discovered that younger infants were significantly more likely to be hospitalized after receiving vaccinations than older infants. In addition, infants who received 5-8 vaccines simultaneously were significantly more likely to die following their shots than infants who received 1-4 vaccines simultaneously.
Several factors could contribute to whether an infant will have an adverse reaction to vaccines, including a genetic predisposition, illness (which may be a contraindication to vaccine administration), quality of vaccines (which can vary by manufacturing methods), and sensitivity to one or more vaccine components. Some infants might be more likely to experience an adverse reaction due to biochemical or synergistic toxicity associated with concurrent administration of multiple vaccines.
In 1990, infants received a total of 15 vaccine doses prior to their first year of life. By 2007, the Centers for Disease Control and Prevention (CDC) recommended 26 vaccine doses for infants: 3 DTaP, 3 polio, 3 Hib, 3 hepatitis B, 3 pneumococcal, 3 rotavirus, and 2 influenza vaccines.
The CDC's Childhood Immunization Schedule Was Not Tested for Safety, Lacks Scientific Veracity:
While each childhood vaccine has individually undergone clinical trials to assess safety, studies have not been conducted to determine the safety (or efficacy) of combining vaccines during a single physician visit as recommended by the Centers for Disease Control and Prevention's (CDC) guidelines. For example, 2-, 4-, and 6-month-old infants are expected to receive vaccines for polio, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, Haemophilus influenzae type B, and pneumococcal, all during a single well-baby visit -- even though this combination of 8 vaccines was never tested in clinical trials.
Although the CDC's recommended childhood immunization schedule a) requires infants to receive up to 8 vaccines simultaneously, b) affects millions of infants annually, and c) was never scientifically tested for safety, the CDC had prior knowledge that combining chemical substances, including prescribed pharmaceuticals, "can produce health consequences that are additive, synergistic, antagonistic, or can potentiate the response expected from individual component exposures."(2)
Administering 6, 7, or 8 vaccine doses to an infant during a single physician visit may certainly be more convenient for parents -- rather than making additional trips to the doctor's office -- but evidence of a positive association between infant adverse reactions and the number of vaccine doses administered confirms that vaccine safety must remain the highest priority.
The findings in this study show a positive correlation between the number of vaccine doses administered and the percentage of hospitalizations and deaths reported to the Vaccine Adverse Event Reporting System (VAERS). (The VAERS database is an important postmarketing safety surveillance tool that is periodically analyzed by the CDC, FDA, and other vaccine researchers to discover potentially adverse vaccination trends.) In addition, younger infants were significantly more likely than older infants to be hospitalized or die after receiving vaccines. These trends not only have a biological plausibility but are supported by evidence from case reports, case series, and other studies using entirely different methodologies and unique population cohorts. For example, in 2011, Miller and Goldman collaborated on another study showing that among developed nations infant mortality increased with an increase in the number of vaccine doses. (3)
Since vaccines are given to millions of infants annually, it is imperative that health authorities have scientific data from synergistic toxicity studies on all combinations of vaccines that infants might receive. Finding ways to increase vaccine safety should be the highest priority.
Agreement to restrict
advertising of infant formula
he Australian Competition and Consumer Commission has re-authorised an agreement between manufacturers and importers of infant formula that prohibits them from advertising and promoting formula for babies under 12 months of age directly to the public. This five-year agreement is designed to promote breastfeeding in Australia, which has significant public health benefits.
The Marketing in Australia of Infant Formula: Manufacturers and Importers Agreement (MAIF) has been authorised by the ACCC since 1992, and in assessing this most recent application for re-authorisation, the ACCC has taken into account a wide number of views from interested parties regarding ways the MAIF Agreement could be improved.
While most interested parties were of the view that the MAIF Agreement should continue to be authorised, views differed on the appropriate length of time for authorisation given anticipated changes to World Health Organisation recommendations on these issues. Views ranged from a two year authorisation period to a ten year period.
“After careful consideration and balancing the various views put forward, the ACCC has decided to grant authorisation of the MAIF Agreement for a further five years,” ACCC Commissioner Sarah Court said.
Authorisation provides statutory protection from court action for conduct that might otherwise raise concerns under the competition provisions of the Competition and Consumer Act 2010. Broadly, the ACCC may grant an authorisation when it is satisfied that the public benefit from the conduct outweighs any public detriment.