Massachusetts Breastfeeding Coalition

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FDA proposes accurate labeling for drugs in lactation

May 29, 2008

The U.S. Food and Drug Administration (FDA) is proposing major revisions to prescription drug labeling to provide more complete information about the effects of medicines used during pregnancy and breast-feeding. The lactation information proposed would now be an evidence-based risk assessment of the effects of the drug on milk production, how much of the drug is present in milk compared to the amount present when standard infant doses would be administered, and the effects of the drug on the infant.

A study published last year in Annals of Pharmacotherapy found that less than 25% of drugs studied from retail pharmacies had accurate safety information. “This FDA proposal would be a huge advance for breastfeeding,” said Melissa Bartick, MD, a Massachusetts internist and one of the authors of the Annals study. “Typically, retail pharmacies paste on labels saying not to use the drug in breastfeeding, or to ask one’s doctor or pharmacist — even for drugs well known to be safe.”

The FDA action follows in the heels of the establishment in the spring of 1996 of of LactMed, a free online safety database from the National Library of Medicine. LactMed is a very reliable source, according to the Annals study.

To learn how to submit comments to the FDA, read the full FDA press release.

New randomized trial links hospital practices with breastfeeding success and childhood intelligence

May, 2008

A new study out this month found that hospital practices that support breastfeeding boost a child’s IQ at six years of age.

The PROBIT trial randomized hospitals in Belarus to follow pro-breastfeeding guidelines or traditional hospital practice. Mothers who delivered at the breastfeeding-friendly hospitals had much longer durations of total and exclusive breastfeeding, and their children had both higher IQs and better school performance in first grade.

The authors of the study note that it is the largest ever conducted in the lactation field. It provides strong evidence that prolonged and exclusive breastfeeding improves children’s cognitive development.

Numerous studies have linked breastfeeding with intelligence, but they have been limited by concerns that more intelligent mothers, or mothers who are better educated, might also be more likely to breastfeed. Critics have argued that these factors, rather than breastfeeding itself, were responsible for higher intelligence scores in breastfed children.

In the current study, however, hospitals were randomly assigned to World Health Organization practices that support breastfeeding. In this type of study, there should be no differences in intelligence or education between the mothers who did or did not get extra breastfeeding support. In fact, mothers at the pro-breastfeeding hospitals completed slightly less education than mothers at the control hospitals. If anything, this difference would decrease the estimated effect of breastfeeding on intelligence

Mothers who gave birth at the hospitals modeled on the WHO Baby-Friendly Hospital Initiative (BFHI) breastfed exclusively for much longer than the other mothers. At 3 months, 43% of BFHI mothers were giving only breast milk, compared to just 6.4% from the other hospitals. The number of children breastfeeding at 12 months was almost double in the babies born at the BFHI-modeled hospitals.

Worldwide, more than 19,000 maternity hospitals participate in the Baby Friendly Initiative, helping to boost breastfeeding rates and improve health around the globe. Only 63 of more than 3,000 US maternity hospitals participate in the program.

“American hospitals are shortchanging mothers,” said Dr. Alison Stuebe, a Boston OB-GYN and member of MBC. “These results suggest that the vast majority of American babies could be giving up six IQ points because their mothers aren’t receiving appropriate breastfeeding support immediately after birth.”

This study further supports existing evidence that hospital practices can significantly impact breastfeeding through the first year of life – and perhaps more significantly, impact health outcomes far into the future.

Read more about the study.

American Public Health Association approves new breastfeeding position paper

November 6, 2007

Washington, DC — At its annual meeting, the American Public Health Association approved a sweeping position paper on breastfeeding, its first comprehensive stance on the topic since 1982. Citing recent research and policy statements from other leading heath organizations, “A Call to Action on Breastfeeding, a Fundamental Public Health Issue” argues forcefully that the US falls well short of globally recognized imperatives.

The APHA breastfeeding position paper is available on APHA’s website.

The policy affirms “that exclusive breastfeeding for 6 months with continued breastfeeding for at least the first one to two years of life, is the biologic norm, and that all alternative feeding methods carry health risks in comparison, with rare exceptions.”

Highlights include a call for more hospitals and health centers to achieve the Baby-friendly Hospital Initiative, better workplace protections, and a curb on the aggressive marketing of infant formula, in compliance with the WHO International Code of Marketing of Breast-milk Substitutes. The statement notes that fewer than 3% of US hospitals are certified Baby-friendly, a WHO/UNICEF initiative that endorses ten evidence-based practices that support breastfeeding.

The position paper supports legislation and programs that would enable women to succeed at breastfeeding in the US, including: “protection for breastfeeding in public, paid maternity leave and worksite lactation protection, access to skilled lactation care and services covered by third party payers, adequate funding to meet Healthy People goals across all socioeconomic sectors of the US, adequate funding and support to carry out the recommendations from the HHS Blueprint for Action on Breastfeeding, [and] compliance with ethical formula marketing as set forth in the International Code . . .”

The policy had broad-based support in APHA, and its three authors came from three different sections of APHA: Melissa Bartick, MD, MS of Massachusetts (Maternal/Child Health), Miriam Labbok, MD, MPH of UNC Chapel Hill (International Health), and Lissa Ong, RD, MPH, a nutritionist in San Francisco (Food and Nutrition). Bartick is also current chair of the Massachusetts Breastfeeding Coalition. The full policy will be available online at APHA’s website in January, 2008.

See APHA’s press release on its website.

Expert panel on cancer recommends exclusive breastfeeding

November, 2007

A joint report issued last month by the World Cancer Research Fund and the American Cancer Research Institute has incorporated breastfeeding as one of its pillars of recommendation to prevent cancer. Like all major medical authorities, the report recommends exclusive breastfeeding for about six months. The report recommends continued breastfeeding after six months, with complementary feeding in accordance with UN Global Strategy on Infant and Young Child Feeding. Significantly, it notes that “policies and actions designed to prevent cancer need to be directed throughout the whole life course, from the beginning of life.”

The panel states that “there is no completely adequate substitute” for human milk. On a public health level, the report recommends “mothers to breastfeed; children to be breastfed.” The recommendations come from “convincing” evidence that breastfeeding by the mother lowers her “risk of breast cancer at all ages thereafter.” The report describes the quality of the evidence on breastfeeding and breast cancer as “strong and consistent”, and that there is a plausible biological mechanism.

The Panel also judges that sustained breastfeeding probably protects infants and young children against overweight and obesity, which tend to track into later childhood and adult life. Because of “convincing evidence” that body fatness is one cause of colorectal cancer, breastfeeding is recommended on this basis also.

The breastfeeding recommendations also come as part of other bold nutritional recommendations to prevent cancer, such as “Eat mostly foods of plant origin,” and “Limit intake of red meat and avoid processed meat.” Such recommendations are in contrast to the more mild recommendations from US Department of Agriculture, which has been widely criticized for to succumbing to influences from the powerful meat and dairy industries.

The report is available here.

Reference

World Cancer Research Fund and American Institute for Cancer Research.
Food, Nutrition, Physical Activity, and the Prevention of Cancer: A Global Perspective
Washington DC: AICR 2007

Evenflo to become Code-complaint

October 25, 2007

As part of its purchase of the Ameda breast pump company, Evenflo has committed to complying with the WHO International Code of Marketing of Breast-Milk Substitutes. Evenflo, a maker of bottles and nipples as well as other baby goods, will change the packaging and advertising on all its products so that it will comply with the Code.

Evenflo’s decision to become compliant with the Code came as it was considering the purchase of Ameda, which has been Code-compliant. The change occurred after Nancy Mohrbacher, an IBCLC who works for Ameda, informed Evenflo that failure to comply with the Code would result in significant damage to Ameda’s brand-credibility, and may suffer a loss of many lactation consultants from the Ameda staff. Evenflo then considered changing its policies. They then asked for information from the US Code monitoring organization, the National Alliance for Breastfeeding Advocacy, on how to become Code-compliant. With a basic explanation of the Code to Evenflo and the ramifications of remaining non-Code compliant, Evenflo decided that the right thing to do was to seek complete Code compliance.

“Evenflo’s action is highly significant,” states Marsha Walker, RN, IBCLC, executive director of the National Alliance for Breastfeeding Advocacy, and board member of the Massachusetts Breastfeeding Coalition. “It’s a step in the right direction for corporate responsibility to the health of mothers and babies.”

As a result, Evenflo will discontinue all bottle/nipple advertising directed to consumers, change the packaging of their products to come into alignment with Code requirements, and remove all bottle and nipple images and sales from their website. It will probably take a few months for all of the packaging changes to be seen. In order to be Code-compliant, the packaging of materials related to artificial feeding cannot include idealized images of infants, or images of bottles or nipples.

See Evenflo’s press release.

Court rejects medical student’s plea for time to express milk

September 20, 2007

A Norfolk county judge has rejected Sophie Currier’s request for additional break time to express milk during a medical licensing exam. Currier, a student at Harvard Medical School, must take the exam by the end of September in order to graduate and begin her residency. The National Board of Medical Examiners has refused to grant her more than its standard 45 minutes of break time during her 9-hour exam.

“It is deeply ironic that the board that licenses physicians is undermining breastfeeding,” said Dr. Alison Stuebe, an obstetrician and member of the Massachusetts Breastfeeding Coalition. “Half of examinees are women of child-bearing age, and the Board’s refusal to accommodate nursing mothers create an unnecessary barrier for women pursuing medical careers.”

In a press release, the Board indicated that it is reviewing its policy for break time for all examinees.

“A longer break time for all test-takers would be a major step forward,” said Melissa Bartick, an internist and chair of the Massachusetts Breastfeeding Coalition.

National advocacy group joins campaign for breastfeeding medical student

September 4, 2007

Sophie Currier wants to be a doctor and a nursing mother, but the National Board of Medical Examiner say she can’t. They’ve denied the Massachusetts student breaks to pump during her nine-hour medical licensing exam. She’s taking the NBME to court. Sign a petition now to support Sophie at MomsRising, a national campaign for mothers.

CDC releases new state breastfeeding report card

August 1, 2007

The Centers for Disease Control and Prevention has released a new national breastfeeding Report Card, which not only includes state breastfeeding statistics from the National Immunization Survey, but also new process indicators for each state. In this new set of indicators, states are evaluated for measures including the percentage of infants born in a Baby-Friendly hospital, the number of International Board Certified Lactation Consultants per 1000 live births, the number of full-time equivalent employees working on breastfeeding in the state public health department, and the presence breastfeeding legislation. Massachusetts scored at about the national average for various breastfeeding rates. We are below average in the number of Baby Friendly births, and are one of the four states with no breastfeeding legislation.

The CDC notes that they have changed the way they reported breastfeeding data on the National Immunization Survey, which began in 2004. In the past, breastfeeding rates were reported by the year the data was collected, using children up to 3 years old. This year, they are reported by birth cohort. This year, breastfeeding histories are reported for children born in the year 2004 and are reported as the 2007 data. Because 3 year old children are studied, there is a lag, so that many states whose breastfeeding rates appeared to improve on previous NIS survey now appear lower. This is true for Massachusetts, whose initiation rates improved from 70% to 77% between the 2004 and 2006 surveys, but now are reported as 70%. This different numbers are a reflection of the new reporting process, not necessarily a reflection on progress in breastfeeding.

There are several other new breastfeeding features. The CDC has introduced a cribcard that can be downloaded for free, which can replace the formula industry cribcards used in many hospitals. The CDC crib card includes tips on breastfeeding. The CDC Yellow Book (on Traveler’s Health), now includes a breastfeeding chapter. There is also a summary of CDC data on breastfeeding and pediatric overweight.

For complete information, visit here on the CDC’s website.

Study shows that most breastfeeding medication resources are inaccurate

July 25, 2007

Cambridge, MA – Pharmacies give mothers inaccurate advice when it comes to medication safety in breastfeeding, according to a new study in the Annals of Pharmacotherapy.

The study’s authors examined the safety information used by two large retail pharmacy chains on the East Coast, looking at 14 commonly-prescribed medications. For 75 percent of drugs that are considered unequivocally safe for breastfeeding, pharmacies were inappropriately advising mothers to stop nursing.

“We were surprised by the results, when we looked at all the resources systematically,” said lead author, Monica Akus, PharmD, a pharmacist at Cambridge Health Alliance and Assistant Professor of Pharmacy at University of Rhode Island. Several well-respected sources used out of date information, most commonly resulting in inappropriate advice to stop breastfeeding. “As pharmacists, our training in drugs and lactation is often limited, so it’s critical to spread the word to other pharmacists. Our knowledge is only as good as our resources,” notes Akus.

The study compared the assessments of ten commonly used resources for medication information, including resources used by pharmacists and physicians.

The authors found that the most reliable resource at this time is LactMed, a free online resource from the National Library of Medicine, which was introduced in the spring of 2006. This resource used the most complete and up-to-date research, and was closely followed by the 2006 print edition of Thomas Hale’s Medications and Mothers Milk.

The authors highlighted the public health aspect of breastfeeding, and the increased risk to maternal and child health when breastfeeding is discontinued earlier than medically recommended. “In essence, medication advice becomes a risk management issue and a quality issue,” said Melissa Bartick, MD, the study’s other author and the current chair of the Massachusetts Breastfeeding Coalition.

“Often pharmacists and clinicians mistakenly think that if one doesn’t know the safety information for a drug, it is safest to advise the patient to stop breastfeeding. Clinicians and pharmacists need to appreciate that such advice may carry serious health risks, too, often much worse than the risk of taking a drug,” Fortunately, it’s now easy for any pharmacist to look up accurate information on a medication. “All you need is internet access,” says Bartick, an internist. Most retail pharmacies have access to the internet, says Akus.

The study is published electronically ahead of print, which will appear in the September 2007 issue. The abstract is available here.

Nestlé recommends unsafe preparation practices for its probiotic formula

July 24, 2007

A Nestlé formula marketing blitz targeting health care providers contradicts CDC and World Health Organization guidelines on formula safety, putting infants at risk of life-threatening infections.

The brochure features a new Nestlé formula that contains a probiotic Bifidobacterium lactis. In a mailing to US health care providers, the company instructs caregivers to make sure that the water used to reconstitute formula is not heated above 37.8°C (100°F), so as not to inactivate the added bacteria. This contradicts guidelines on powdered infant formula published by the World Health Organization, which say that water must be heated above 70°C (158°F). The WHO recommendation was issued after multiple outbreaks of serious infant infections from bacterial contamination of powdered formula from Enterobacter sakazakii.

E. sakazakii is a bacterial contaminant commonly introduced during the manufacturing process of powdered formula, according to the World Health Organization. This bacteria has led to serious illness and death in infants, including meningitis and sepsis. If caregivers follow Nestlé’s instructions not to heat water above 37.8°, any E. sakazakii contaminants in the formula will remain active. Formula-based outbreaks of serious infant infections with E. sakazakii have occurred throughout North America.

Younger infants and premature infants are most at risk for serious infection from this bacteria. This is why CDC researchers recommend that powdered formula should not be fed to any infant under four weeks of age. This recommendation is not mentioned in Nestlé’s promotional materials. E. sakazakii infections occur almost exclusively in infants exposed to contaminated formula.

As part of its marketing blitz, Nestlé has contacted radio stations throughout the US, offering an interview with a pediatrician entitled, “Do You Feel Fearful of Formula Feeding? ‘Don’t be scared,’ say experts!” The interview promised new information on formula, especially the “benefits” of anyone being able to feed the baby, not having to pump or schedule work and activities around the baby’s feeding schedule, and not having to feed the baby so frequently. However, the company later retracted this part of its campaign, saying it was not sure it would move forward with the interviews. Nestlé has timed the launch of its product, Bifidus BL, to coincide with World Breastfeeding Week, which begins August 1.

The intestinal tracts of breastfed babies are usually colonized with harmless bifidus bacteria, such as the kind Nestlé is putting their new product. The intestinal tract of formula fed babies are colonized with the same species of bacteria found in the intestinal tracts of adults, including many bacteria that have the potential to cause invasive and serious infections.

References:

Bowen AB, Braden CR. Invasive Enterobacter sakazakii disease in infants. Emerg Infect Dis 2006; 12(8):1185-1189

WHO/FAO. Safe preparation, storage and handling of powdered infant formula: guidelines. Link

TSA to allow unlimited quantities of breastmilk in airplane cabins.

July 22, 2007

Washington, DC – In an overdue policy change, the Transportation Safety Administration is modifying the procedures associated with carrying breastmilk through security checkpoints, according to a TSA press release from July 20. Mothers flying with or without their child will be permitted to bring breastmilk in quantities greater than three ounces as long as it is declared for inspection at the security checkpoint. Breast milk is in the same category as liquid medications. The policy goes into effect on August 4, 2007, along with changes to the policies on lighters.

Here is an excerpt from frequently asked questions about the new policy, available here:

Q. Why is breast milk not a threat?

A. Breast milk is a medical necessity and it is being classified as such. It must be declared at the checkpoint.

Q. How do you ensure liquid explosives disguised as breast milk or medications are not brought through the checkpoint?

A. Since September 2006, certain liquid medications have been permitted at the checkpoint as long as they are declared to security officers and are subject to additional screening.

Q. Do passengers carrying breast milk need to taste it to prove it is not a liquid explosive?

A. No. We will not ask a traveler to taste breast milk.

Formula industry backs bill to protect hospital marketing

June 25, 2007

Boston, MA – Touting “maternity patients’ rights,” an International Formula Council-backed bill is under consideration by the Joint Committee on Public Health. The bill would legislate a mother’s “right” to formula samples and equipment in the hospital, protecting industry interests at the expense of public health.

Strong scientific data shows that formula marketing in health care facilities undermines mothers who wish to breastfeed. In testimony submitted to the Public Health Committee, Geoff Wilkinson, executive director of the Massachusetts Public Health Association, writes, “The bill, which lay readers might consider a benign measure to ensure access to information about infant feeding formula, actually constitutes a threat to maternal and child health and could exacerbate health disparities in the Commonwealth.”

H 2257 begins by paying lip-service to the benefits of breastfeeding. The bill then states that “formula is a safe and recommended alternative to breastmilk,” directly contradicting both scientific data and recommendations of all major medical organizations.

“This bill has nothing to do with maternity patients’ rights, and everything to do with formula company marketing strategies,” said Alison Stuebe, MD, an obstetrician at Brigham and Women’s Hospital in Boston.

“Formula companies use hospitals and health care professionals to sell their product. A sales training manual for Ross Pediatrics puts it plainly: ‘Never underestimate the importance of nurses. If they are sold and serviced properly, they can be strong allies. A nurse who supports Ross is like an extra salesperson.'”

To garner support for the marketing legislation, the International Formula Council has launched a web site titled “MomsFreedingFreedom.com.” The site describes H2257 as a bill to “ensure moms’ feeding choices are protected.” (see related article)

Testimony on the bill was heard on June 13 before the Joint Committee on Public Health, immediately following the close of testimony on bills to protect breastfeeding in public and in the workplace. Committee co-chair Sen. Susan Fargo had introduced two of the pro-breastfeeding bills, and her staff had assembled an esteemed group of experts to testify in favor of the legislation.

In addition to the testimony of Representative Harriet Stanley, who introduced H 2257, testimony was heard from five women who said that the formula samples and marketing materials were helpful.

Following the women’s testimony, breastfeeding advocates rose to the microphone to testify against H 2257: Stuebe, nurse Marsha Walker, and Dr. Melissa Bartick, an internist who chairs the Massachusetts Breastfeeding Coalition. They rebutted the women’s assertion that the marketing materials do not influence breastfeeding, citing scientific data to the contrary.

Walker expressed concern that bill appears to “handcuff” the ability of the Department of Public Health to write regulations banning hospital-based formula marketing. Bartick testified that when DPH submitted regulations to ban formula company discharge bags last year, the proposal had the support of leading state and national health authorities.

The proposed regulation banning the bags was rescinded in May 2006 after interference from Gov. Romney. Romney overturned the regulation despite letters from leading health organizations urging him to uphold the ban. Ten days later, he announced a $66 million deal with Bristol-Myers Squibb, the nation’s largest formula manufacturer, to build a pharmaceutical plant in Massachusetts. The deal was widely perceived as bolstering Romney’s presidential ambitions.

Romney’s efforts to defeat the ban included a carefully timed overhaul of the Public Health Council. As a result of his efforts, the 1989 regulatory language stayed in the new regulations. Like H 2257, the regulations state that a nursing mother can get the formula company materials only at her request or with a doctor’s order.

In practice, however, these regulations are difficult to enforce, and nursing mothers routinely receive the marketing materials. “I got the bags with both my children,” said Bartick, whose children are now 6 and 8. “I neither expected the bags, nor wanted them. By the time my second child was born, I knew enough to leave the bag behind. A nurse ran after me as I was being discharged and called out, ‘You forgot your bag!’ I told her, ‘I don’t want it.'”

Currently, fifteen of the fifty maternity units in Massachusetts have banned commercial discharge bags, as they are contrary to their mission of health. If H 2257 passes, breastfeeding advocates are concerned that the bags would then have to be made available, despite the best judgment of the medical staff.

Formula industry enlists PR agencies to defend marketing tactics

June 25, 2007

The formula industry has enlisted two international PR firms to defend hospital-based marketing of infant formula.

Two websites, babyfeedingchoice.org and Momsfeedingfreedom.com, were registered in early March, just a week after The Wall Street Journal reported that more and more hospitals are abandoning hospital-based formula marketing. Both sites are funded by the Infant Formula Council.

Babyfeedingchoice.org was registered by Kellen Communications, an international PR firm whose “success stories” include responding to the Alar apple scare and promoting the health benefits of margarine, a source of trans-fats.

Babyfeedingchoice.org links to MomsFeedingFreedom.com, describing it as a grass-roots site launched by a concerned mother in Massachusetts. In fact, MomsFeedingFreedom.com is registered to E Nilsson LLC, an international web consulting firm whose clients include Romney for President and Pfizer. The mother is Kate Kahn, a corporate communications strategist based in Boston.

Both sites use classic formula company strategies, paying lip service to benefits of breastfeeding even as they promote formula. When breastfeeding is mentioned, it’s a chore and a bother. For example, MomsFeedingFreedom.com asks visitors to share personal stories, such as advice from “A sister who filled you in on the age-old remedy of ace bandages to ease aching breasts.” The language deliberately describes breastfeeding as primitive, messy, and painful.

When it comes to talking about formula marketing, host Kate Kahn dismisses scientific evidence that hospital-based marketing as “ridiculous,” arguing that women are too smart to be swayed by a gift bag.

Online readers aren’t buying the argument. Posting in the site’s online discussion group, one visitor writes, “One meme of these formula-industry shills is that ‘women are too smart’ to be swayed by advertising. Isn’t it ironic that this tired and deeply flawed rhetoric is being touted on a website that is nothing more than an extension of the formula industry’s advertising/lobbying efforts?”

The industry’s public relations campaign reflects the powerful influence of hospital-based formula marketing on consumer behavior. As a Ross Pediatrics sales manual states, “Never underestimate the importance of nurses. If they are sold and serviced properly, they can be strong allies. A nurse who supports Ross is like an extra salesperson.” (Abbott Labs v. Segura, 1995).

Formula companies count on hospital-based marketing to establish brand loyalty and undermine breastfeeding. “The data are clear: when hospitals distribute formula samples, women are less likely to breastfeed successfully,” says Dr. Alison Stuebe, an obstetrician and women’s health researcher at Brigham and Women’s Hospital in Boston, MA.

As one blog visitor writes, “Name one other hospital ward where the nurses promote a product and send you home with a gift bag. You don’t go in for lung cancer treatment and walk out with a carton of cigarettes. You don’t go in for obesity surgery and walk out with a box of donuts. If breastfeeding is best, why should a mother leave the hospital with baby junk food?”

Harvard Medical Student denied accommodation for breastfeeding

June 23, 2007

Boston, MA – Administrators for a required board examination have told Sophie Currier, a Harvard Medical School graduate, that she has to make a choice: complete her medical training, or breastfeed her new baby.

According to a report in The Boston Globe, exam administrators won’t allow her extra break time to express milk during the test, because breastfeeding is not a disability, according to the Americans with Disabilities Act.

This logic misses the point, said Dr. Melissa Bartick, an internist and chair of the Massachusetts Breastfeeding Coalition. “Breastfeeding is normal and necessary for healthy mothers and healthy babies,” Bartick said. “Nursing mothers need to express milk every two to three hours. The medical profession should be leading by example.”

The USMLE is required to earn a medical license. Other professional exams, including the Bar Exam that is required for lawyers, allow nursing mothers break time to express milk.

“It’s deeply ironic that the Bar Exam accommodates nursing mothers, but the USMLE does not,” said Dr. Alison Stuebe, an obstetrician at Brigham and Women’s Hospital. “Apparently, lawyers know more about maternal-child health than doctors.”

AHRQ releases breastfeeding evidence report.

April 19, 2007

The federal Agency for Healthcare Research and Quality issued its review on the evidence of the health impacts of breastfeeding. Highlights are as follows:

There is good evidence that breastfeeding reduced infants risk of ear infections by up to 50 percent, serious lower respiratory tract infections by 72 percent, and a skin rash similar to eczema by 42 percent. Children with a family history of asthma who had been breastfed were 40 percent less likely to have asthma, and children who were not prone to asthma had a 27 percent reduced risk compared to those children who were not breastfed. The risk of developing type1 diabetes was reduced by about 20 percent. These benefits were seen in infants who were breastfed for three or more months. Breastfeeding also reduced the risk of type 2 diabetes by 39 percent compared to those who were not breastfed.

The report also found that breastfeeding was associated with fewer episodes of diarrhea during infancy, decreased incidence of childhood leukemia, and decreased deaths from sudden infant death syndrome. The report found no clear relationship between breastfeeding and improvement in IQ. In premature infants, breastfeeding decreased the occurrence of necrotizing enterocolitis, a serious gastrointestinal infection that often results in death.

For health outcomes in mothers, there is good evidence that women who breastfed their infants had up to a 12 percent reduced risk of type 2 diabetes for each year they breastfed. Breastfeeding decreased the risk of ovarian cancer by up to 21 percent. Breastfeeding also decreased the risk of breast cancer by up to 28 percent in those whose lifetime duration of breastfeeding was 12 months or longer. Women who did not breastfeed their infants were more likely to have postpartum depression, but unmeasured factorssuch as depression that was undiagnosed prior to giving birthmay have increased the rate of depression seen in this group. Breastfeeding did not increase the risk of fractures due to osteoporosis. The effect of breastfeeding on a womans weight could not be determined based on the available studies.

The report was nominated and funded by the U.S. Department of Health and Human Services Office on Women’s Health and prepared by Stanley Ip, M.D., Joseph Lau, M.D., and colleagues at AHRQs Tufts-New England Medical Center Evidence-based Practice Center in Boston, Massachusetts. AHRQs EPCs develop evidence reports and technology assessments on topics relevant to clinical, social science/behavioral, economic, and other health care organization and delivery issues – specifically those that are common, expensive, and/or significant for the Medicare and Medicaid populations.

The Breastfeeding and Maternal and Infant Outcomes in Developed Countries report is available here on the AHRQ website.

Major Medical Organizations Join Forces to Stop Formula Marketing in Hospitals.

Jan. 3, 2007

Health care providers for mothers and babies joined forces today in a letter asking Massachusetts hospitals to make a New Years resolution: Move formula marketing bags out of maternity wards. “New mothers deserve our support,” the letter reads. “Hospitals should market health, and nothing else. We would be pleased to work with you on helping to eliminate this practice.”

Signed by the Massachusetts chapters of the American Academy of Pediatrics (AAP), the American College of Obstetrics and Gynecology (ACOG), the Association of Womens Health, Obstetric and Neonatal Nurses (AWHONN), and the Massachusetts Breastfeeding Coalition (MBC), the letter went to the directors of clinical services, CEOs and marketing divisions for the 39 maternity hospitals that currently distribute the bags.

“Its a conflict of interest,” said Melissa Bartick, MD, chair of MBC. “The only way to sell more formula is to sell less breastfeeding,” said Bartick. Studies show that nursing mothers who take home a bag are more likely to start using formula. The US accounts for half of the $8 billion a year global formula market.

Medical authorities recommend babies get only breast milk for the first six months. “The bags undermine the advice we are giving to our patients,” says Dr. Lauren Hanley, one of the obstetricians who signed the letter for Massachusetts ACOG.

Massachusetts made national headlines last year, when the Public Health Council voted to ban the marketing bags from maternity hospitals, becoming the first state in the country to do so. The decision was reversed by Gov. Romney, who fired three members of the Public Health Council just before a repeat vote.

In response, the Massachusetts Breastfeeding Coalition launched Ban the Bags, a national campaign to rid all US maternity wards of the bags. “Ban the Bags has gathered tremendous momentum in removing this unethical marketing practice from US Hospitals,” said Marsha Walker, RN, IBCLC, co-chair of the Ban the Bags Campaign. In addition, Walker says, “The bags advertise only the priciest brands, so even bottle-feeding parents end up spending more money because the bags really cultivate brand-loyalty.”

“Breastfeeding is a public health challenge,” says Dr. Susan Browne, one of the pediatricians who signed the letter for the state AAP chapter. “Marketing campaigns for baby formula have no place in our states hospitals.” In infants, not breastfeeding is linked increased rates of ear infections, diarrhea and hospitalization, as well as chronic illnesses, including such costly diseases as obesity and type 1 diabetes. Mothers who stop nursing early face higher risks of ovarian cancer, breast cancer, and type 2 diabetes.

Eleven of the states 50 maternity units are bag-free, four of which went bag free since January 2006, even without a state mandate. The current bag-free hospitals are: Boston Medical Center, Brigham and Womens Hospital, Cambridge Birth Center, Cambridge Hospital, Caritas St. Elizabeths Medical Center of Boston, Franklin Medical Center, Lowell General Hospital, Massachusetts General Hospital, Melrose-Wakefield Hospital, North Shore Birth Center, and Newton Wellesley Hospital.

View the text of the letter here

Study on breastfeeding and intelligence is flawed.

October 15, 2006

On October 4, the BMJ (formerly known as British Medical Journal), published a study by Der, Batty, and Deary concluding that breastfeeding has no effect on intelligence.

(Effect of breast feeding on intelligence in children: prospective study, sibling pairs analysis, and meta-analysis, 4 Oct 2006)

The conclusion, however, suffers from a serious methodologic flaw often present in other breastfeeding studies. It does not describe the amount of breastfeeding, judging “dose” only by duration, and even that the authors admit was “less reliable than whether a child was breastfed or not.”

In this study, a breastfed child could mean anything from child who breastfeeds only once a day, all the way to a child who breastfeeds 8-12 times a day, and gets no other food or drink besides breastmilk. In determining the effects of any drug or diet, the medical community does not generally tolerate publishing data without fully determining dose and duration. Why is breastfeeding often treated differently than any other factor? The degree of breastfeeding per day must be determined; duration alone is not a proxy for dose.

Furthermore, 3 months duration, the median in this study, is not very long, so it is premature to conclude whether breastfeeding has an effect or not. All major medical authorities recommend that babies get no other food or drink besides breastmilk for the first 6 months, with continued breastfeeding for the first 1-2 years of a child’s life. In this study, not only was median duration well below recommended levels, but the 95th percentile was only 14 months. Interestingly, a table in the study lists a significant association with intelligence for children breastfed more than 29 weeks, but that finding was not mentioned in the text of the paper.

To study whether breastfeeding has any effect on intelligence, one must not only control for the factors these authors controlled for, but must study the true “dose” of breastmilk, including at least a subset of infants who are exclusively breastfeeding, and the median duration must be at least 6 months.

This the second well-publicized study in recent years to suffer from a flaw in neglecting breastfeeding exclusivity, the other being the 2002 study by Sears et al. in the Lancet, on asthma. In that study, a presumably large but unspecified number of babies received formula in the first days of life, yet the authors concluded breastfeeding did not affect asthma risk, even though other literature clearly shows even a small exposure to formula in neonates can affect the body’s immune system.

We must demand consistent standards in research on breastfeeding, and the gold standard must be complete exclusivity.

CDC launches new worksite initiative.

October 11, 2006

Recognizing that breastfeeding duration is often linked to the length of maternity leave, the Centers for Disease Control has launched the Lactation Support Program as part of its Healthier Worksite Initiative. The CDC notes that about 70% of women with children under the age of 3 work full-time, and a Lactation Support Program is important to support these employees. A complete toolkit is available on its website.

Numerous studies note that employers benefit when they give their breastfeeding employees space and time to pump their milk or feed their babies nearby. Cohen, Mrtek, and Mrtek (1995) found that formula feeding moms have three times as many one-day absences from work to care for sick children in the first year of life than do breastfeeding moms. Ball and Wright (1999) estimated that, for every 1000 formula feeding babies, their mothers would miss a total of one full year of employment in excess of breastfeeding mothers, because their children are sick so much more often.

In addition to lower rates of absenteeism, the CDC notes that employers also will have lower health care costs, improved staff productivity and loyalty, lower employee turnover. In addition mothers will have longer breastfeeding duration and so can better meet recommended medical guidelines to breastfeed exclusively for six months and continue for at least 1-2 years thereafter.

Lactation support can save employers money. Aetna found a $2.8 return for every $1 invested to support lactation, according to Dr. Audrey Naylor, in a September letter in the New York Times.

Some mothers may blame themselves for having to wean their babies when they return to work. The problem, however, is not with mothers themselves, but with a culture that does not support breastfeeding, and does not provide worksite lactation support. Unless a state has legislation protecting lactation in the workplace, mothers must advocate for support from their employers.

Oftentimes, the employer simply does not realize there is a need to support lactating employees, and usually does not realize that it is in their best interest to do so. The CDC also notes that it is important that an employer create a policy for its lactating employees, and not just a room, so that support can continue successfully. CDC notes that everyone wins when employers support their lactating employees.

CDC Data Shows Massachusetts Breastfeeding Rates are Improving

August 1, 2006

The Centers for Disease Control and Prevention just released its 2005 data on breastfeeding rates from the National Immunization Survey. Massachusetts can celebrate World Breastfeeding Week this year (Aug 1-7) with the news that some Massachusetts breastfeeding rates are up significantly from 2003 and 2004. Each years data reflect a random-digit telephone survey of households of children ages 19 to 35 months old, thus reflecting infant breastfeeding rates from up to 35 months before. The NIS data is considered the most accurate data on breastfeeding rates in the US, as it is not biased by commercial interests. The survey began collecting breastfeeding data in 2003, in addition to immunization data.

Breastfeeding has had increased public attention in Massachusetts in recent years. Despite our progress, Massachusetts, like the rest of the US, still falls quite short of the widely held medical recommendation to breastfeed exclusively for six months, indicating that mothers need more support from hospitals and health care providers, employers, lawmakers and insurers.

View this years national data..

The Massachusetts data is as follows:

2004 2005
Breastfeeding initiation: 74.0 77.5
6 months: 38.8 45.2
12 months: 19.7 24.7
Exclusive 3 months: 42.6 43.1
Exclusive 6 months: 14.4 16.6

Ban on gift bags gets a second chance

Boston, Feb. 22, 2006

In a surprise setback for Governor Mitt Romney, the Public Health Council yesterday decided to study the proposed ban on formula gift bags for three more months, rather than completely rescind it, as Romney had requested. Yesterday, the Massachusetts Breastfeeding Coalition continued to make its strong case for the ban to PHC members, two of whom openly voiced their support for the ban.

Romney views the ban as the “heavy arm of government” being used to influence health choices. Instead, he wants the heavy arm of corporate America to peddle bottles of formula in mothers hospital room as they recover from childbirth.

The governor also demonstrated his ignorance of the importance of breastfeeding. He likened formula gifts to “Q-tips and baby lotion,” failing to understand that formula is linked with adverse health outcomes, unlike other baby products. Other comments on weaning indicated a lack of understanding that public health authorities recommend 6 months of exclusive breastfeeding, followed by at least 1-2 years of continued breastfeeding.

The American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC) have both called for an end to the distribution of formula-company sponsored bags. No other unit in a hospital engages in a marketing campaign for a product that is known to be deleterious to the health of its patients. MBC considers the practice akin to other aggressive marketing practices that adversely affect the health of children, such as the intrusion of soft-drink industry into schools.

Internal documents from the formula industry illustrate that the bags are an effective marketing tool, increasing sales of formula at the expense of breastfeeding. This finding is consistently shown by medical research, and confirmed in a recent GAO report. Key to the bags success is that health care providers give them out, providing implicit endorsement of bottle-feeding. In fact, the sales training manual for formula-maker Ross states that “a nurse who supports Ross is like another salesman.”

Also key to the bags success is the perception that they will save families money, an argument which the governor has also bought into. Poor women are at the highest risk of poor health outcomes that can be prevented by breastfeeding. The formula in a gift bag contains less than a weeks worth of feedings and will hardly help stretch the budget of low income families. Boston Medical Center, which cares for a high proportion of low income women, stopped distributing these bags almost a decade ago because they consider the practice unethical. Every container of formula lists a toll-free number which families can call to receive free bags, coupons, or samples.

Research shows that mothers make their feeding choice during pregnancy, not as they are leaving the hospital with a formula bag. In fact, women deserve to be free from aggressive marketing tactics during the vulnerable time following childbirth. Feeding choice is between a mother and her doctor, and marketing practices intrude upon the privacy of the doctor-patient relationship. Formula marketing parallels marketing efforts by the pharmaceutical industry to gain undue access to our patients and influence medical decisions.

The American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC) have both called for an end to this practice.

Massachusetts lags behind 17 other states in the percentage of women who even try to breastfeed. A quarter of our birthing hospitals have given breastfed babies formula without a medical reason. One in four do not require postpartum nurses to have formal breastfeeding training. “We have plenty of barriers to breastfeeding without the governor adding one more,” say MBC Board member Dr. Alison Stuebe, a Boston obstetrician.

Massachusetts Breastfeeding Coalition Condemns Governor’s Attempt to Rescind Ban on Formula Gift Bags

Boston, Feb. 21, 2006

The Massachusetts Breastfeeding Coalition today called upon the Public Health Council to override pressure from Governor Romney, and save a proposed ban on infant formula gift bags. The coalition condemns the Governor’s attempt to make the Public Health Council rescind the ban, which prevents Massachusetts hospitals from distributing infant formula gift bags to new mothers.

Melissa Bartick, MD, president of MBC says, “This is the third time Gov. Romney has tried to overrule the recommendations of his own public health agency. In this case, he caved in to industry pressure and put the interests of formula makers above the health of mothers and babies, while camouflaging it in the language of freedom of choice. The American Academy of Pediatrics and the Centers for Disease Control and Prevention have both called for an end to this distribution of industry-sponsored bags. It is unethical, and it should be stopped.”

“Multiple studies show that formula marketing tactics cause women to stop breastfeeding earlier. When a women stops nursing, she unnecessarily puts herself and her baby at risk for diseases ranging from breast cancer to ear infections,” says MBC board member Dr. Alison Stuebe of Brigham and Womens Hospital. “Hospitals should not participate in marketing schemes that hurt women and children. They should market health, and nothing else.”

Romney has tried to justify the policy change by saying that the bags save money for new families. Board member Marsha Walker, RN, IBCLC says, “The formula in a gift bag contains fewer than a week’s worth of feedings and will hardly help stretch the budget of low income families.” Moreover, poor women are at the highest risk of poor health outcomes that can be prevented by breastfeeding. “Boston Medical Center, which cares for a high proportion of low income women, stopped distributing these bags almost a decade ago because they consider the practice unethical,” says Anne Merewood, MPH, IBCLC of Boston Medical Center.

Massachusetts lags behind 17 other states in the percentage of women who even try to breastfeed. Evidence-based practices that support breastfeeding are routinely ignored in our hospitals. A quarter of our birthing hospitals have given breastfed babies formula without a medical reason. One in four do not require postpartum nurses to have formal breastfeeding training. We have plenty of barriers to breastfeeding without the governor adding one more.

The Massachusetts Breastfeeding Coalition (MBC) is an alliance of organizations and individuals involved in maternal/child health whose purpose is to promote, protect and support breastfeeding in the Commonwealth.

Read the relevant sections of the new regulations, and DPHs memorandum about them to the Public Health Council.

Massachusetts Becomes First State to Prohibit Formula Marketing in Hospitals

Boston, Dec 20, 2005

In a groundbreaking step for mothers and babies, Massachusetts became the first state to prohibit hospitals from giving out free formula company diaper bags to new parents. Giving out these bags reduces the duration and exclusivity of breastfeeding and is considered unethical by many national and international groups, including the World Health Organization. Multiple studies, even from prestigious medical journals such as the Lancet, have shown that the bags interfere with breastfeeding, causing moms to switch to formula sooner, or quit nursing altogether– even when the bags do not contain formula samples. (See references below)

For decades, formula companies used hospitals to hand out diaper bags stocked with coupons and free samples. Most parents see these as a “free gift,” but the bags are a marketing technique that implies that the hospital endorses the product, successfully boosting sales of formula at the expense of breastfeeding. “One day, formula marketing in hospitals will go the way of cigarette ads on TV,” said Melissa Bartick, MD, Chair of the Massachusetts Breastfeeding Coalition.

The new rules on formula marketing are part of a much larger update of existing perinatal regulations written by the Department of Public Health and today approved by the Public Health Council. Hospitals must follow DPH regulations in order to be allowed to operate in the state. The regulations contain many other mandates that help promote and support breastfeeding and otherwise limit formula marketing.

In banning the distribution of these items, the DPH acknowledges that there is no medical justification for the institutional marketing of formula products to new parents. The vast majority of hospitals in Massachusetts and the US give out free diaper bags containing formula to new moms, and also accept free formula for in-hospital use. This marketing practice deviates from the standards followed by health care providers and hospitals in every other respect. For example, hospitals do not give out coupons for name-brand clothing, name-brand foods outside of maternity. “Wed never tolerate the thought of hospitals giving out coupons for Big Macs on the cardiac unit,” said Dr. Bartick, an internist. Since lack of breastfeeding is clearly associated with multiple adverse health outcomes in children and mothers, distribution of formula marketing materials by hospitals and health care providers has been recognized as unethical since at least 1981, when the World Health Organization approved the International Code of Marketing of Breastmilk Substitutes.

Members of MBC on the taskforce that drafted the new regulations helped make the case for eliminating the diaper bags. The formula bags may actually cost families money: “Not only is there the expense of formula, but parents and society end up paying for medications and time lost from work to care for a sick child,” says Dr. Kimberly Lee, a neonatologist at Beth Israel Deaconess Medical Center in Boston.

As proof of the companies influence, Dr. Lee notes that parents almost always continue to use the brand of formula their baby got in the hospital – and those formulas are typically the most expensive. These new regulations will go far in improving the quality of care to mothers and their newborns.

See How We Did It (click here)
(Click here to view the DPH summary of the formula marketing testimony.)

Read the relevant sections of the new regulations, and DPHs memorandum about them to the Public Health Council.

References:

Breastfeeding Cuts Maternal Diabetes Risk

Boston, Nov 23, 2005

Moms who breastfeed may be protected from type 2 diabetes, according to a new study from Boston’s Brigham and Women’s Hospital, published today in the Journal of the American Medical Association. Researchers demonstrated that breastfeeding a child for one year may reduce a woman’s risk of developing Type 2 diabetes by 15 percent.

“We’ve known for a long time that breastfeeding is good for babies,” said lead author and BWH researcher, Alison Stuebe, MD. “In this study, we found that it’s good for moms too.” Dr. Stuebe is also on the Massachusetts Breastfeeding Coalition’s Board of Directors.

The production of milk requires a breastfeeding mother to use an average of 500 calories each day-the equivalent of running four to five miles. According to Stuebe, the additional energy required for lactation is associated with short-term changes in insulin, and glucose. Her study was among the first to look at the long-term association between breastfeeding and incidence of Type 2 diabetes. “Our study supports the theory that breastfeeding may be associated with important metabolic changes that influence diabetes risk,” she said. “However more research is needed to determine what hormonal and biological factors are involved.” The researchers found that women who breastfed for at least one year were less likely to develop Type 2 diabetes than woman who did not breastfeed. Specifically, they report:

  • One year of breastfeeding was associated with a 15 percent drop in a woman’s risk of developing Type 2 diabetes. This protective effect appeared to last up to 15 years after a woman’s last birth.
  • Each additional year of breastfeeding was associated with a greater reduction in risk. For example, according to Stuebe, if a woman had two children and breastfed each child for a year, the data suggest that the mother may reduce her risk of diabetes by a third.
  • Women with gestational diabetes did not appear to lower their risk of Type 2 diabetes, even if they breastfed intensely.
  • In addition, the data suggest that women who used medications to prevent lactation had an increased risk for Type 2 diabetes.

“Based on these findings, we have one more reason to encourage mothers to breastfeed,” Stuebe said. “Ensuring strong support for nursing mothers – from doctors and nurses to family members and employers – isn’t just important for babies. It’s a women’s health issue, too.”

The study included more than 157,000 nurses who were enrolled in the Nurses’ Health Studies, two cohorts of women who ranged from age 26 to 71 at the start of the study. The nurses responded to questionnaires regarding how many children they breastfed and for how long, as well as numerous questions about their health, including whether or not they had been diagnosed with Type 2 diabetes by a physician. The researchers controlled for multiple factors including diet, exercise, weight, and multivitamin use.

AAP releases controversial guidelines on SIDS prevention

Oct 15, 2005

On October 10, the American Academy of Pediatrics released new recommendations aimed at further reducing the incidence of Sudden Infant Death Syndrome (SIDS). Press coverage emphasized new recommendations on the avoidance of bedsharing and the recommendation to use pacifiers, and downplayed widespread concerns among researchers, infant sleep and breastfeeding experts. The media also largely overlooked other aspects of the AAP statement which, while less controversial than bed-sharing and pacifiers, are areas that also need to be addressed in SIDS prevention. SIDS, also known as crib death, is diagnosed when an otherwise healthy infant is found dead, and no other obvious cause can be found after thorough investigation. Death by suffocation, for example, is ruled out.

It is estimated that 2300 babies die of SIDS each year. The incidence has been reduced by the “back to sleep” campaign. Other known risk factors for SIDS are maternal smoking during pregnancy, overheating the infant, use of soft sleeping surfaces such as couches or waterbeds, and use of pillows, sheets, and blankets in the infants sleep environment. The Academy of Breastfeeding Medicine, an international organization of physicians, has also released a statement noting that breastfeeding itself is protective against SIDS, and strongly disagrees with the AAP recommendations.

In the new recommendations, the five-member task force strengthened the Academys advice that infants be put “back to sleep” – that is, that newborns not be put down to sleep prone (on their tummies or sides). This advice is well supported by empirical evidence, not least by the decline in SIDS rates in the US since the “back to sleep” recommendation was initiated in the 1990s. The task force also notes that 20% (or 1 in 5) SIDS deaths occurs when the infant is not being cared for by a parent – and reports that as many as one quarter of childcare providers, including licensed daycare centers, are not aware of the “back-to-sleep” recommendation.

The group goes on to recommend that parents “consider offering a pacifier at night and at naptime,” although use of pacifiers should be delayed until one month of age in breastfeeding infants, until breastfeeding can be well-established. They also recommend that babies should sleep near parents, but in a separate sleep environment such as crib, bassinet, or cradle. They note that safety standards for attachable “co-sleepers” have yet to be established by the Consumer Product Safety Commission. Other recommendations include a firm sleep surface; avoiding smoke exposure to baby both pre- and postnatally; avoiding overheating; avoiding commercial devices marketed to reduce the risk of SIDS, including home monitors; encouraging tummy time while awake; and ensuring that all involved in a babys care are aware of these recommendations.

The new recommendations on pacifiers and bedsharing, upon which so much attention has been focused, are controversial. Many health care providers, breastfeeding authorities, and infant sleep experts question the strength of some of the underlying evidence. Pacifiers are linked with dental problems, fungal infections, ear infections, gastrointestinal infections, and breastfeeding difficulties. Bedsharing facilitates breastfeeding. If the public follows these recommendations, some women may avoid breastfeeding or wean prematurely due to fatigue, difficulties with milk supply, and other problems.

Evaluating the strength of the evidence: Pacifiers

Both the pacifier and bed-sharing recommendations are based on case-control studies. In this type of study, researchers compare babies who died from SIDS to other “control” babies who did not die from SIDS. Its difficult to choose “control” babies in a way that is truly representative of the general population. In addition, this type of study cannot prove cause and effect.

The recommendation on pacifiers is based on case-control studies showing lower rates of SIDS in babies who went to sleep with pacifiers. In the same issue of Pediatrics in which the recommendations were issued, a large meta-analysis on pacifier use and SIDS was published by Fern Hauck et al. Dr. Hauck was also one of the five members of AAP panel, and her meta-analysis put together the most definitive data on pacifiers and SIDS. Of 384 studies, the group analyzed only 7 studies which met quality inclusion criteria. All 7 studies were case-control; that is, known cases of SIDS were compared to matched babies without SIDS. Parents were asked questions about pacifier use after the babys death. The meta-analysis found that babies whose parents reported that they usually used pacifiers, but did not use one on the night in question, were more likely to have had SIDS. The AAP task force extrapolated this finding to recommend that ALL babies be put to sleep with pacifiers.

One problem with this approach is that the association with SIDS was not found in babies who did not usually use pacifiers. We do not know if pacifiers themselves decrease the risk. We also do not know why these babies were using pacifiers to begin with – did they already have breathing problems and thus needed pacifiers or did the pacifiers create a dependency on them for breathing and arousal regulation? Were they breastfed or not? Breastfed babies may be less likely to use pacifiers and some data link breastfeeding, itself, to a lower risk of SIDS. The articles from the meta-analysis do not distinguish whether it is the absence of a pacifier (eg, babies who never use them) or whether it is being accustomed to or dependent on a pacifier but then being denied it that puts the baby at risk.

One theory about SIDS is that it arises from a deficit in arousal responses to a life-threatening situation. Infants dying of SIDS typically have less mature autonomic function and delayed neuronal maturation that affects the arousal pathway in the brain. Using a pacifier increases arousability, something which is already present in a breastfed infant. Arousal thresholds from sleep are different between breastfed and bottle-fed babies. Breastfed babies are more easily aroused from active sleep at 2-3 months of age than formula fed babies. This age coincides with the peak incidence of SIDS. Breastfeeding a baby during the critical risk period for SIDS (2-4 months) “covers” the period of time when reduced arousal capability impairs the infant’s ability to respond to life threatening situations.

The retrospective nature of the studies means that parents of SIDS babies may be likely to remember things differently than parents of control babies. There were many things the studies did not ask, such as whether parents were using any of the sleep training programs (Ezzo, Ferber, Baby Whisperer, etc) that deliberately train babies to sleep soundly through the night, especially during the peak time of night when SIDS occurs.

While the AAP task force acknowledged data linking pacifiers to ear infections and dental problems, it was unconvinced by data associating pacifiers with breastfeeding difficulties. However, because pacifiers can mask signs of hunger, it is possible for a mother to put a baby to bed with a pacifier before he is done nursing. On an ongoing basis this may lead to a diminishing milk supply, an increased likelihood of formula supplementation, and increased risks of illnesses associated with lack of breastfeeding.

Even though the statement advises that breastfed babies not be given a pacifier until one month of age, and that babies not be “forced” to take a pacifier, the weight of the advice to “prevent SIDS by using pacifiers” may be uppermost in many parents minds.

Evaluating the Evidence: Bedsharing

Bedsharing is very common. An Oregon study published in October 2005 (Lahr et al, Pediatrics) found that 35.2% of new mothers bedshared always or almost always, and an additional 41.4% bedshared sometimes. While mothers who smoke are advised not to bedshare, this study found that they bedshared just as often as nonsmokers.

Many case-control studies have shown an association (not causality) with SIDS only in certain situations, such as families where mothers smoke. A July 2005 study from Scotland (Tappin et al, J. Pediatrics) found that SIDS risk was increased in babies who slept with 2 adults, especially if the baby was between two parents, and found the risks were highest in babies under 11 weeks of age. This study, like many others, assessed bed-sharing alone as a risk factor (rather than the environment within which the bed-sharing occurred), did not assess the presence of parental alcohol use at the time of bed-sharing, and did not include breastfeeding in the analysis. (It did note that only “16 [of 46] SIDS infants who bedshared for some time during their last sleep were still being breastfed.”) Other studies have linked breastfeeding with a lower incidence of SIDS.

As noted, one theory on the cause of SIDS is that babies are not arousable enough, and stop breathing as a result. James McKenna, a leading investigator in mother/infant sleep patterns, has found that babies who bedshare and breastfeed have more regular arousals which are coordinated with those of their mothers. He holds that from an anthropological perspective, co-sleeping is the evolved context of human infant sleep development in which mother and baby respond to each others breathing and movements. In their acknowledgments, the AAP task force authors note that they received reports from consultants including Dr. McKenna, but that “the consultants do not necessarily agree with the evidence, analysis and recommendations set forth in this document.”

Its unclear whether the advice not to bedshare will adversely affect breastfeeding. However, when a baby is nursing every two hours during the night, the mother can be expected to suffer significantly more fatigue if she has to get up after each feed and put the baby back in a crib. Conceivably, some women may stop breastfeeding, and others may keep the baby in bed with them against recommendations, as they can get considerably more rest this way.

Potential Public Health Implications

It is not possible to predict from available evidence that SIDS would be reduced if parents followed all of the new AAP recommendations.

However, since media coverage of the new guidelines highlighted only the recommendations to avoid bed-sharing and introduce pacifiers, it is possible that some families will follow only these two guidelines. Unfortunately, both of these interventions have potential adverse effects on breastfeeding.

Public health interventions might better target other areas, including the alarmingly high rate of prone sleeping in daycare centers. Similarly, infant bedding manufacturers continue to market crib bumpers, pillows, quilts and blankets that have been associated with SIDS risk.

It is also important to note that SIDS is a rare occurrence, albeit a devastating one, and one whose cause is not well understood.

However, breastfeeding affects many aspects of maternal and child health, and absence of exclusive breastfeeding or early weaning is linked with higher rates of other serious diseases such as obesity and its complications, diabetes, childhood cancers, and serious infections. In mothers, absence of breastfeeding or early weaning is linked with increased rates of breast cancer, ovarian cancer, and diabetes.

Thus, if this new AAP policy discourages sustained exclusive breastfeeding, it may not be entirely beneficial for public health.

Public Accountability and Conflicts of Interest:

The new AAP statement raises many questions: Why do so many licensed childcare providers engage in the known, dangerous practice of putting babies to sleep on their bellies? When the parents hire licensed care providers, arent the licensing organizations accountable for ensuring that providers do not engage in unsafe practices?

Next, we know that sheets, pillows and blankets in a childs sleep environment increase risk of death, and yet such products for babies are routinely sold, and packaged with crib bumpers. Why is this allowable?

Next, why hasnt the Consumer Product Safety Commission yet evaluated the safety of co-sleeper devices?

Finally, SIDS organizations such as CJ SIDS and FirstCandle, for which Dr. Hauck is a board member, have received funding from pacifier manufacturers and formula companies such as Ross and Mead-Johnson. The AAP itself has also received millions of dollars from formula companies. Its unclear if these donations have resulted in any conflict of interest with the researchers or with AAP, but it is clear that the new recommendations could increase sales of infant formula and pacifiers.

References:

  • Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and breastfeeding: collaborative reanalysis of individual data from 47 epidemiological studies in 30 countries, including 50302 women with breast cancer and 96973 women without the disease. Lancet. 2002 Jul 20; 360(9328):187-95.
  • The Changing Concept of Sudden Infant Death Syndrome: Diagnostic Coding Shifts, Controversies Regarding the Sleeping Environment, and New Variables to Consider in Reducing Risk. Pediatrics. 2005 Oct 10
  • Fleming PJ, Blair PS, Pollard K, et al. Pacifier use and sudden infant death syndrome: results from the CESDI/SUDI case control study. Arch Dis Child 1999; 81:112-116
  • Hauck, FR et al. Do pacifiers reduce the risk of sudden infant death syndrome? A met-analysis. Pediatrics, 2005, Oct 10.
  • Horne RSC, Parslow PM, Ferens D, et al. Comparison of evoked arousability in breast and formula fed infants. Arch Dis Child 2004; 89:22-25
  • Labbok MH. Effects of breastfeeding on the mother. Pediatr Clin North Am. 2001 Feb;48(1):143-58.
  • Lahr MB, Rosenberg KD, Lapidus JA. Bedsharing and maternal smoking in a population-based survey of new mothers. Pediatrics. 2005 Oct;116(4):e530-42.
  • L’Hoir MP, Engelberts AC, van Well GTJ, et al. Dummy use, thumb sucking, mouth breathing and cot death. Eur J Pediatr 1999; 158:896-901
  • McKenna JJ, McDade T. Why babies should never sleep alone: a review of the co-sleeping controversy in relation to SIDS, bedsharing and breast feeding. Paediatr Respir Rev. 2005 Jun;6(2):134-52
  • Moreland J, Coombs J. Promoting and supporting breast-feeding. Am Fam Physician. 2000 Apr 1;61(7):2093-100, 2103-4.
  • Tappin D, Ecob R, Brooke H. Bedsharing, roomsharing, and sudden infant death syndrome in Scotland: a case-control study. J Pediatr. 2005 Jul;147(1):32-7.
  • Vennemann MMT, Findeisen M, Butterfab-Bahloul T, et al. Modifiable risk factors for SIDS in Germany: results of GeSID. Acta Paediatr 2005;

For some differing points of view regarding the above issue, check out the following links:

Hurricane Katrina – the importance of breastfeeding during times of disaster

Sept 2, 2005

Hurricane Katrina brought about widespread destruction and displacement of tens of thousands of people, leaving them at risk for disease, malnutrition, and dehydration. Babies are at particular risk, especially if they are bottle-fed. Baby formula and clean water may be scarce, and breastfeeding may be the best way to ensure survival of this vulnerable population. It is important that babies who are breastfeeding continue to do so– their survival may depend on it.

In addition, in emergencies, women who are not breastfeeding and have recently delivered a baby can be assisted to “relactate”– and this can be successful in establishing a milk supply. Relactation may be challenging, even in the best of circumstances. Breastfeeding rates in US Gulf Coast area are some of the lowest in the country already, and thus there is a shortage of women who are experienced in breastfeeding even in normal circumstances.

Each area sheltering people should establish a clear section where mothers are gathered to continue breastfeeding and receive food and water to assure an abundant milk supply. Recently delivered mothers who are not breastfeeding should be assisted to relactate. During the transition time, ready-to-feed formula in disposable glass or plastic bottles with disposable nipples should be used until full lactation is established. Relief staff should include someone knowledgeable in lactation during emergencies.

It is important to remember that stress, by itself, does not cause a woman’s milk to “dry up.” Human survival has depended on the ability of women to breastfeed even during famines or natural disasters. Every effort should be made to support breastfeeding women with adequate fluids and nutrition.

Additional information on breastfeeding during disasters is available from the World Health Organization, the US Breastfeeding Committee, the International Lactation Consultant Association, and from La Leche League:

Still more information and guidelines can be found at the following web pages:

National Survey Shows Breastfeeding Acceptance is Up

Aug 1, 2005

The National Breastfeeding Awareness Campaign surveyed almost 1000 people before and after the Campaigns 2004 launch. According to its new survey released at the start of World Breastfeeding Week today, more Americans in 2005 endorse breastfeeding, and are comfortable with women breastfeeding in public, than one year ago. Men in particular are more savvy about breastfeeding. The national Campaign was funded and sponsored by the US Department of Health and Human Services, and included a variety of public service announcements focusing on the health risks of not breastfeeding. To gauge the effectiveness of the messages, the project included this survey, which found the following results:

  • 69% of men were comfortable seeing a baby breastfed in public in 2005, compared to only 59% of
    men in 2004
  • 63% of men said they would be willing to have their own baby breastfed in public in 2005, compared to
    just 53% of men in 2004
  • In 2005, 67% of women and 62% of men felt the best way to feed a baby was to give only breast
    milk – up from 60% (women) and 50% (men) in 2004
  • In 2005, 59% of women and 65% of men agreed that babies should be breastfed exclusively for the
    first 6 months, up from 55% (women) and 53% (men) in 2004.

The Breastfeeding Center at Boston Medical Center is one of 15 community-based demonstration sites funded by the DHHS Office on Womens Health, to support the Campaign, which has received several awards, most recently from La Leche League International. The Campaign, with the slogan, Babies Were Born to be Breastfed, is designed to increase breastfeeding awareness, and to promote exclusive breastfeeding for six months.

“It seems that the Campaign messages have really gotten out, and seeing and hearing more about breastfeeding has made it more acceptable to people everywhere,” said Anne Merewood, Research Director for the Breastfeeding Center, and a public health researcher at Boston Medical Center. “Its interesting that men have really come on board. Perhaps in the past theyve thought this was a womens thing – but Dads support is critical when a mother breastfeeds.”

The Campaign was launched in June 2004, and relied on Ad Council public service announcements on radio, TV, and in the print media, to get its message across. The tracking report, based on telephone interviews across the US, showed that those who had seen at least one of the Campaigns TV ads were more likely to agree that breastfeeding decreased a childs risk of ear infections, obesity, respiratory illness, and diarrhea. More results showed:

  • 75% of people who had seen the TV ads disagreed that formula is as good as breast milk, compared to 59% of those who had not seen the ads
  • 59% of women who had seen the TV ads were more likely to be comfortable breastfeeding in public, compared to 39% of those who did not see the ads
  • 73% of women who had seen the TV ads were more likely to be comfortable seeing other women breastfeed their babies in public compared to 55% of those who had not

These results are particularly interesting in the light of recent controversy over Barbara Walters comments about breastfeeding in public on ABCs TV show, the View.

Breastfeeding-based events are planned all over the country during World Breastfeeding Week. Clinicians (doctors, nurses) and patients – including supportive breastfeeding Dads will also be available to speak to the press at BMC, during World Breastfeeding Week.

To learn more about World Breastfeeding Week and the National Breastfeeding Awareness Campaign, visit www.WomensHealth.gov, rated #1 among all breastfeeding Web sites by the Journal of Human Lactation, or call the Helpline at 1-800-994-WOMAN (9662), Monday through Friday, from 9 a.m. to 6 p.m., EDT, or 617 414 3500.

Is it safe to share breastmilk?

Mar 4, 2005

On January 6, 2005, the Wall Street Journal published a story on the growing trend of mothers sharing breastmilk, either by selling it or donating it, including offering milk over internet sites such as Craigs List. The Massachusetts Breastfeeding Coalition is offering some suggestions to help mothers make their decision.

The superiority of human milk is well-established, and it is particularly important for premature babies. The American Academy of Pediatrics, the World Health Organization, and the American Academy of Family Physicians all recommend exclusive breastfeeding for the first six months of life, and use of complementary foods, with continued breastfeeding, for a year or beyond. This confirms the need for and importance of breastmilk. Many women who cannot otherwise breastfeed wish their children to have breastmilk and avoid the inadequacies and problems associated with infant formula. Some breastfeeding mothers have an abundance of milk and may be reluctant to throw away their own milk, preferring to see it put to good use.

There are several considerations to sharing breastmilk, however. The most important risks are HIV and the possibility of transmitting maternal medications in milk that can be unsafe for the baby. HIV can be transmitted in mother’s milk, and thus it is recommended that women with known HIV infection in the US should not breastfeed nor share breastmilk. One may not know if source milk may have HIV, and milk at milk banks is routinely pasteurized. HIV is inactivated by heating. There has been research in Africa into using a home pasteurization method known as Pretoria pastuerization, which has been shown to effectively inactivate HIV in breastmilk in one study by Jeffrey et al. Home pastuerization of milk is not routinely done in the US.

There is a theoretical risk of Hepatitis B transmission, but this would occur only if the milk were contaminated by an infected mothers blood (if, for example, she had an abrasion on her nipple). The risk of tuberculosis through shared breastmilk is negligible, unless the mother has a localized tuberculosis infection in the breast itself, which is exceedingly rare. The risk of TB to a nursing infant occurs when an infected mother breathes or coughs infected particles onto an infant, not through her milk.

It is important to know if the donor mother smokes, drinks alcohol, or uses any drugs or medications. It is generally accepted that it is safer for a child to be breastfed by a mother who smokes, than to be formula fed. However, smoking significantly diminishes milk supply and it relatively unlikely that a mother who smokes would have excess milk to donate or sell. Small amounts of alcohol are generally considered safe – less than one drink a day, but alcohol can cause sleeping problems or feeding problems in an infant. Large amounts of caffeine may cause irritability, especially if very young or preterm infants, but one or two cups of coffee a day is generally considered safe. All illegal drugs, such as marijuana and cocaine, are considered unsafe. If there is a strong family of peanut allergy in the babys family, it recommended that the (source) mother refrain from eating peanut products.

Most medications are safe, and the list of unsafe medications in breastfeeding mothers is relatively short. Examples of safe medications include all antibiotics, medications for asthma, thyroid replacement, and most antidepressants. The best reference for determining the safety of drugs in breastmilk is Thomas Hales Medications and Mothers Milk, or the list published by the American Academy of Pediatrics: The Transfer of Drugs and Other Chemicals Into Human Milk — Committee on Drugs 108 (3): 776 — AAP Policy. Of note, milk banks do not generally allow milk from women taking most medications or from women who use tobacco.

Herbal medicines may pose a risk, because their labels may not accurately reflect their true contents, and they may also contain toxic materials. A recent study from the Journal of the American Medical Association (Saper et al) found that 20% of South Asian herbals purchased in the Boston area contained toxic levels of lead, mercury, or arsenic.

Often people ask if there may be environmental toxins in breastmilk that may be unsafe. The risk from mercury is negligible, with dangerous levels only being reached if there is exposure from a mercury spill or ingestion, but not from dental fillings. Another recent study, (Jensen et al), found that even when mothers milk contained methylmercury from ingesting contaminated whalemeat, breastfeeding was still associated with marginally better scores on neurobehavioral tests,

Of note, a toxin may cause harm to the developing fetus child from exposure during pregnancy, and this may be of significantly more consequence to the child than breastmilk exposure. This particular study controlled for the amount of prenatal exposure by measuring methylmercury levels in cord blood.

It is also important to realize that formula may also be subject to contaminants, environmental toxins, and bacterial contamination. Powdered infant formula is not sterile and has been recalled for bacterial contamination on multiple occasions. The cows whose milk provide the basis for making formula are subject to the same environmental toxins as the people who live near them.

Finally, milk from family or friends may not necessarily be safer than milk from someone unknown. As with designated blood donation, family and friends may be reluctant to reveal important personal facts that may put their milk at risk.

In sum, there are risks of sharing breastmilk. Most risks can be minimized by obtaining an accurate history from the donor mother, bearing in mind one can never obtain a history that is completely trustworthy. Unknown HIV infection represents the most serious risk, and while heating breastmilk through an effective home pasteurization process could inactivate HIV, this is not routinely done in the US. Both the American Academy of Pediatrics and La Leche League discourage sharing breastmilk. It is suggested that donor mothers be screened using the protocol developed by the Human Milk Banking Association of North America.
Milk Donations: www.hmbana.org/donations.htm

Massachusetts Breastfeeding Coalition, March 2005

AAP urges nursing mothers to sleep near their babies.

Feb 9, 2005

On February 7, The American Academy of Pediatrics issued new guidelines on breastfeeding, which include the recommendation that mothers sleep close enough to their babies to sense the earliest signs of hunger. Babies who feed at the first sign of hunger feed more easily and this is one of many factors that help establish adequate milk production. The AAP also reiterated its previous recommendation that babies should be exclusively breastfed for the first six months of life, with supplemental foods thereafter.

The new guidelines also describe hospital policies that help promote breastfeeding, such as placing the infant on the mother immediately after birth, drying and assessing the baby while it is on the mother, and delaying all unessential assessments and procedures until after the first feed.

The original AAP statement can be viewed on the AAP website. USA Today ran a story on this new policy, as did the Today Show.

The Massachusetts Breastfeeding Coalition has long supported the recommendation to “Sleep Near Your Baby.” Our Discharge Instructions handout includes guidelines for safe co-sleeping, available in English and Spanish, available from our homepage at http://www.massbfc.org.

New National Breastfeeding Data from the CDC

August 15, 2004

Recently, the Centers for Disease Control announced the results of breastfeeding data from the National Immunization Survey. This survey, conducted by the CDC, includes breastfeeding data in addition to vaccination data. Prior to this survey, detailed national data on breastfeeding practices came from the formula industry, and had methodologic flaws and was subject to commercial bias.

Massachusetts figures show that 70.6% of infants experience breastfeeding for varying lengths of time. Exclusive breastfeeding at 3 months is 39% and at 6 months is 14%. Even though many infants are put to breast early in life, breastfeeding is soon supplemented or abandoned, removing disease protection and access to the nutrients that contribute to optimal cognitive and developmental outcomes. All states, including Massachusetts, are far from supporting mothers to breastfeed exclusively for any substantial length of time. For example, only one state, Oregon, achieved an exclusive breastfeeding rate above 25% at six months, even though six months of exclusive breastfeeding is the recommendation set by the American Academy of Pediatrics, The American Academy of Family Physicians, and the World Health Organization.

This CDC data will help health instituions and policy makers document where we are and where we need to go in order to assure that mothers and babies in Massachusetts receive the support needed to reach the federal breastfeeding goals set by Healthy People 2010. The best summary of the NIS breastfeeding data is located on the CDC website.

National Breastfeeding Awareness Campaign will be Launched
Despite Protests from Infant Formula Industry

AdCouncil B&W

January 26, 2004 – WASHINGTON, DC.

The US Breastfeeding Committee is announcing today that the $40 million National Breastfeeding Awareness Campaign will launch this spring in spite of infant formula company protests. The USBC met with Dept. of Health and Human Services Assistant Secretary Kevin Keane on January 22, to discuss the HHS decision on the revised content and theme of the campaign. The DHHS campaign, originally due to be launched in December 2003, was postponed after a concerted lobbying effort from the formula industry, who targeted Tommy Thompson, Lamar Alexander, Bill Frist, and the American Academy of Pediatrics, among others. The Massachusetts Breastfeeding Coalition, which includes several members of the USBC, is pleased that the campaign will go on after concerns about possible cancellation, and that it will contain strong statements about the importance of exclusive breastfeeding for the first six months of life.

The Ad Council who developed the campaign for DHHS, conducted research which found that women are most likely to respond to information on the risks of not breastfeeding, rather than the more traditional “benefits of breastfeeding” approach. The Ad Council research showed that traditional messages lead people to think of breastfeeding like vitamins, as a healthy supplement to a standard diet. Currently, US breastfeeding rates fall well below federal goals set by Healthy People 2010. Despite enormous pressure from the infant formula industry, DHHS will stick to the original risk-based message. However, DHHS will soften the tone of the original message.

For the creation of the ads, an advisory panel of nationally known experts came up with conservative numbers for the risks of not breastfeeding, in the process reviewing scientific papers quite rigorously. These risk numbers were removed, in part because the researchers believed that the range of risk cannot be communicated accurately in a single number for one condition. Yet, single numbers are necessary for an effective marketing format. According to the original ad campaign, children who are not exclusively breastfed for six months are:

  • about 40% more likely to develop type 1 diabetes (also known as juvenile-onset diabetes)
  • about 25% more likely to become overweight or obese
  • about 60% more likely to suffer from recurrent ear infections
  • about 30% more likely to suffer from leukemia
  • about 100% more likely to suffer from diarrhea
  • about 250% more likely to be hospitalized for respiratory conditions like asthma and pneumonia

The infant formula industry has traditionally framed infant feeding as a lifestyle choice rather than a public health issue. They said they do not like the campaign because they fear it will make mothers feel guilty, and they question the science behind the ads. The risk-based campaign puts infant feeding back into the domain of public health. In spite of industry pressure, the ad campaign will go on. If you share these concerns, you can write to the following places:

Dr. Joe Sanders, Executive Dir.

Dr. Carden Johnston, President

American Academy of Pediatrics

141 Northwest Point Boulevard

Elk Grove Village, IL 60069

kidsdocs@aap.org

Office on Women’s Health

Department of Health and Human Services

200 Independence Avenue SW, Room 730B

Washington, DC 20201

Phone: 202-690-7650

Fax: 202-205 2631

GCiagne@osophs.dhhs.gov

Office of the Inspector General

Office of Public Affairs

Room 5541 Cohen Building

330 Independence Avenue SW

Washington, DC 20201

paffairs@oig.hhs.gov

Peggy Conlon, President

Ad Council

261 Madison Avenue, 11th Floor

New York, NY 10016

comments@adcouncil.org

You may also write your US Senators and Representatives in Congress.

Additional news and contact info is available at: www.ilca.org/news/index.php

References and Links:

  • Campaign is Launched (June 09, 2004). View some of the ads.
  • Dr. Johnston’s letter to Tommy Thompson, Dr. Gartner’s letter to Tommy Thompson, and Dr. Gartner’s letter to his AAP colleagues are all reprinted with permission by Mothering Magazine, available on their website.
  • “Breastfeeding Ads Delayed by a Dispute Over Content” by Melody Petersen. NY Times, Dec. 4, 2003
  • “The Milky Way of Doing Business,” by Katie Allison Granju, www.hipmama.com/node/view/588 December 19, 2003.
  • A statement from the US Breastfeeding Committee is available on their website.

Ethical Conflicts Delay the National Breastfeeding Awareness Campaign

January 03, 2004

On December 4, 2003 The New York Times ran an article by Melody Petersen, “Breastfeeding Ads Delayed by a Dispute Over Content.” The article brought to light a serious ethical conflict of interest between the formula industry and several entities which promote public health, including the American Academy of Pediatrics and the Department of Health and Human Services. National Public Radio reported on December 26 that Christina Pearson, of the Office on Women’s Health from DHHS, says that the ads are now being revised, and won’t comment on when they will be released. The Massachusetts Breastfeeding Coalition takes a strong stand against the pervasive influence of the formula industry over this public health campaign.

The promotion of breastfeeding on a nationwide scale has been called for since the 1984 Surgeon General’s Workshop on Breastfeeding and Human Lactation. The Office on Women’s Health, an agency within the federal Department of Health and Human Services answered that call with a $40 million ad campaign designed to help mothers choose breastfeeding who would not normally have done so. The ads were carefully crafted through the expertise of the Ad Council, a nonprofit expert on risk-based social marketing campaigns designed to change behavior. Input for the ads was gathered from the USDA’s Breastfeeding Promotion Consortium, the US Breastfeeding Committee and 36 focus groups representing the general public.

The campaign reframes the issue of infant feeding in terms of the risks associated with not breastfeeding, as opposed to the more traditional messages which only tout the “benefits” of breastfeeding. The Ad Council reached its conclusion to frame the ads this way after its research found that many women think breastfeeding is like supplementing a “standard diet” with vitamins. The traditional “benefits of breastfeeding” messages thus ignore the copious scientific evidence showing a greater risk for a wide variety of illnesses in children who were not breastfed. Many of these illness are chronic or have life-long health effects, such as type 1 diabetes and inflammatory bowel disease.

In the early fall of 2003, the infant formula manufacturers became aware of the nature of the campaign and began their own campaign to neutralize the impact that these ads would have on the sale of their products. The Ad Council had sent out a print ad about diabetes and breastfeeding to thousands of public service announcement directors in early November, and had posted it on its website, yet clearly the formula companies had access to all the ads even before this, probably in October. Companies and their crisis management firms contacted the Secretary of Health and Human Services, Tommy Thompson, the senate majority leader Bill Frist, the chair of the Health Committee Senator Lamar Alexander, and the heads of numerous federal agencies such as the FDA, CDC, and NIH to complain that the ads were negative and would hurt their business.

Representatives from the formula industry also attended the national convention of the American Academy of Pediatrics in New Orleans, held October 31-November 4. They met with several leaders of the AAP, including its newly installed president, Dr. Carden Johnston. Dr. Johnston openly admitted that the formula representatives showed him many of the ads at the convention — itself of ethical concern because the AAP leaders had not previously seen the ads, and in fact, Dr. Johnston was admittedly unaware of the campaign. In other words, somehow, the formula industry had access to the DHHS ads before the leadership of the American Academy of Pediatrics. At the convention, the formula industry representatives brought their objections to the “negative” tone of the ads to the attention of the AAP leadership. Of note, the formula industry gives heavily to the AAP, and the New York Times estimates that one formula maker, Ross, gave over $500,000 to the AAP’s 2001 budget. The pharmaceutical industry, which owns several of the formula makers, also gives heavily to the Ad Council. Formula manufacturing is estimated to be a $3 billion a year industry in the US alone.

On November 6, shortly after his meeting with the formula industry representatives, the new president of the American Academy of Pediatrics, Dr. Carden Johnston, sent a letter to the Secretary of the Department of Health and Human Services, officially expressing AAP’s concern over the “negative approach” taken by the agency’s National Breastfeeding Awareness Campaign. News of this letter was not even publicly known until late November.

Dr. Johnston sent his letter to Secretary Thompson without consulting AAP’s own Section on Breastfeeding, an 800-member strong group of physicians with expertise in this area. The chair of this committee, Dr. Lawrence Gartner, subsequently sent a letter to Secretary Thompson disagreeing with Dr. Johnston, and urging that the ad campaign be released in its current form. In a letter to fellow pediatricians, he states, “There is every reason to believe that [the infant formula industry] are pulling out all the stops to get this ad campaign buried, or, at least, modified to be less effective .. . This entire affair is a very serious matter, which raises many questions about the leadership of the AAP and the influence of the formula industry on AAP activities.”

Dr. Johnston’s letter set off a cascade of action by breastfeeding advocates. In mid November, the chair of the US Breastfeeding Committee, Amy Spangler, briefed national breastfeeding leadership on the recent events. In a widely circulated email, she said that “[a] meeting was held with the directors of the CDC, NIH, and DHHS. Members of the CDC and NIH reviewed the science of the six conditions highlighted in the ads and determined that the relative risk statements should be removed from the ads and that those ads highlighting conditions wherein the science is either new or inconsistent be removed, ie, leukemia and diabetes.” The decision of the CDC and NIH is puzzling, because, when the ads were developed, a technical advisory group of researchers and breastfeeding experts had reviewed hundreds of published articles to assign the risk data to six diseases and conditions affected by not breastfeeding: diabetes, leukemia, obesity, ear infections, diarrhea, and respiratory infections like asthma and pneumonia.The references used in the risk assignments are publicly available and were stringently reviewed at the time.

One possible explanation for this decision may be the financial influence of the formula industry. According to reporter Katie Allison Granju, “several sources within the Ad Council” said that Mead Johnson, a maker of formula, threatened “to pull its millions” from the Ad Council’s budget if the references to specific risk numbers were not removed from the ads. The Ad Council relies heavily on funding by pharmaceutical companies which also produce infant formula. According to Granju, the Ad Council declined to comment on this report, and instead referred all inquires to Christina Pearson at the Office on Women’s Health, who says her agency can neither confirm nor deny this alleged incident. Granju wrote an extensively researched article posted on hipmama.com, in which Dr. Johnston described in detail his contact with the formula representatives at the AAP convention.

In around mid-December, the Office on Women’s Health issued its official reasons why the print ads on leukemia and diabetes aren’t running. According to OWH,the official reason the print ad involving diabetes is not running is because they believe that women will not know the difference between type 1 and type 2 diabetes [type 1 is also known as juvenile onset diabetes, or insulin-dependent diabetes]. According to OWH, the official reason the leukemia ads are not running is that pediatricians are generally unaware of the literature on leukemia and breastfeeding, and the numbers of the children affected by leukemia are small. According to the US Breastfeeding Committee, DHHS removed the relative risk statments because “numbers always invite controversy,” even though the expert committee who put these numbers together was “very conservative in their recommendations.” However, it is known the the formula industry approached DHHS and pressured DHHS to remove the risk numbers because they reportedly feared that consumer concern would decrease sales. It is important to emphasize that the science behind the ads has NOT been discredited.

One of the original ads is available for viewing, but only to limited audiences, so it is difficult to comment on all the pulled ads. The Massachusetts Breastfeeding Coalition notes that the AAP Section on Breastfeeding, in its 1997 position statement on breastfeeding, mentioned a “possible protective effect” of breastfeeding against lymphoma and of type 1 diabetes. Subsequent data have since emerged strengthening the evidence linking absence of breastfeeding to an increased risk of type 1 diabetes. In addition, there is now substantial data linking not breastfeeding to increased risk of all types of maternal breast cancer, from the large multinational study published in the Lancet in July 2002.

After this scandal became public, a massive letter-writing campaign began.This campaign, driven by breastfeeding advocates, was large enough to shut down Tommy Thompson’s email.

The Massachusetts Breastfeeding Coalition agrees with the Ad Council’s approach to the campaign, and respects the Ad Council’s expertise in the field of public service advertising. Previous ads about the “benefits of breastfeeding” have not been effective in convincing parents to breastfeed exclusively, and the US continues to fall short of the breastfeeding goals set by the federal government. The “benefits” type of campaign does a disservice to public health by framing infant feeding as a life style choice, rather than a health issue. We do not,for example, persuade people to wear seatbelts by saying they are “even safer” than wearing no seatbelt, or that using a car seat is “even safer” than holding an infant on one’s lap, or that quitting smoking is “even healthier” than not smoking. Nor is there any concern about inducing guilt in people who smoke, or don’t wear seatbelts or use carseats.

We are disturbed that the financial interests of the formula industry have significant influence over the health interests of women and children. We do not feel the formula industry should have any say in the National Breastfeeding Awareness Campaign, as this creates an obvious ethical conflict of interest, pitting private financial gain against public health. The public has a right to receive complete information that has not been suppressed, neutralized or censored to meet the approval of formula manufacturers.

Environmental Toxins and Breastfeeding

May 22, 2003

The Boston Herald recently published a story entitled “Tests show babies get doses of toxins in moms’ breast milk” by Kay Lazar (Tuesday, May 22, 2003), in which two women’s milk were analyzed and found to have toxins. The superiority of breastfeeding as the ideal feeding method for infants in their first year deserves added emphasis.

While this news implies that there may be harmful chemicals in the milk of some Massachusetts mothers, it is important to know that the greatest danger to babies from toxins comes from exposure during pregnancy. To protect our unborn babies, we must do everything we can to limit the harmful toxins in the environment. As Dr Schettler stated in the article, “breast milk monitoring is a way to measure what a baby was exposed to in the womb.” There may be other ways to assess prenatal toxin exposure: umbilical cord blood, for example.

Researchers looking for effects of toxin exposure through mothers’ milk have been able to find only benefits for breastfed babies, as opposed to formula-fed babies (e.g., Gladen et al, Journal of Pediatrics 1988; 133:991, Ribas-Fito et al, Pediatrics 2003; 111:e580.)

Infant formula, the only nutritionally appropriate substitute for human milk, is not a pure food — it is produced from cow’s milk or soy beans and many other substances that are grown or produced in the presence of chemicals. In fact, studies suggest that formula-fed infants may have a higher risk of certain cancers (Shu X-O et al, Int J Epidemiol. 1995; 24:27; Lucas A et al. Br Med J. 1990; 300:837). Further, since each mother’s milk is made to meet the needs of her particular infant, it is impossible for manufactured formula to duplicate the nutritional and immunological benefits of human milk.

The important findings noted in the Herald article should not frighten or discourage women who are currently nursing or pregnant. Our society must focus our attention on reducing toxins in the environment, which is the most effective way to protect babies and mothers from harm.

Kimberly G Lee, MD, MS, IBCLC

Associate Director, Newborn Nursery

Beth Israel Deaconess Medical Center, Boston

Cynthia Turner-Maffei, MA, IBCLC

Baby Friendly USA,

E. Sandwich, MA

(The above article is adapted from a letter to the Boston Herald by Dr. Kim Lee and
Cindy Turner-Maffei which was published on May 27, 2003)

Peanut Allergy and Breastfeeding

Mar 25, 2003

Recently, increasing rates of peanut allergy in children have been linked to breastfeeding. Allergies involve a reaction to a substance that someone has been exposed to at least once in the past.

The appearance of documented peanut allergy in very young children has led scientists to wonder how the children may have gotten their first exposure to peanuts.

It is now clear that the substances in peanuts which cause the allergy can be transmitted to the child even before birth, and the substances can also be found in small amounts in the breastmilk of women who have just eaten peanuts. Therefore, sensitization to peanuts can occur both during pregnancy and breastfeeding.

Often people with one allergy may have others, too, and may also have higher rates of eczema and asthma. This predisposition is known as “atopy.” Atopy tends to run in families.

It is unclear whether children with no family history of atopy or allergy are at increased risk of peanut allergy if they are breastfed, as opposed to formula-fed, especially if the mother ate peanuts during pregnancy. Previous data suggest that allergies and atopy tend to be more common in children who are fed formula, as compared to children who were exclusively breastfed – that is, they got no other food or drink besides breastmilk.

Peanuts have become an increasingly important part of the diet in the industrialized world. This probably accounts for at least some of the increasing incidence of peanut allergy. In addition, some foods may contain traces of peanuts, but are not labeled as such.

Of note, a recent study in the New England Journal of Medicine found that peanut allergy was independently associated with intake of soy formula or soy milk. Researchers believe that the association could arise cross-sensitization from certain particles in soy with the particles in peanuts that cause allergy. In other words, researchers speculate that certain particles in soy formula may be similar enough to peanuts that the body may develop an allergy to peanuts, just from exposure to soy formula or soy milk.

If a mother or her pediatrician is concerned about the development of peanut allergy in her child because of a history of allergies in the family, the best current advice would be to avoid peanuts during pregnancy and breastfeeding, and to delay introducing peanuts into the child’s diet. There is currently no evidence to support a recommendation that such women should not breastfeed.

Melissa Bartick, MD, MS

Nashoba Valley Medical Center

Department of Internal Medicine

Kimberly Lee, MD, MS, IBCLC

Beth Israel Deaconess Medical Center

Department of Neonatology

References

  • Sampson, HA. Peanut allergy. NEJM 2002 Apr 25;346(17):1294-99.
  • Vadas P, Wai Y, Burks W, Perelman B. Detection of peanut allergens in breast milk of lactating women. JAMA 2001 Apr 4;285(13):1746-8.
  • Frank L, Arian A, Visser M, et al. Exposure to peanuts in utero and in infancy and the development of sensitization to peanut allergens in young children. Pediatr Allergy Immunol 1999 Feb:10(1):27-32
  • Lack G, Fox D, et al. Factors associated with the development of peanut allergy in childhood. NJEM 2003, Mar 13;348:977-86

Breastfeeding and the West Nile Virus

October 4, 2002

The Centers for Disease Control and Prevention and the Michigan Department of Community Health have reported that a woman received a blood transfusion containing West Nile virus (WNV) shortly after she gave birth to her baby on 9/2/02. The mother was breastfeeding her baby for the first 17 days, until she was hospitalized for severe persistent headaches and high fever and found to have WNV infection. Evidence of the virus was found in the mother’s milk, but her milk also contained specific antibodies to the virus.

The baby has not become ill. In fact, samples of the baby’s blood at 25 days of age contained WNV antibodies which were likely produced by the baby’s own immune system. This suggests that the baby was exposed to the virus through the mother’s milk but successfully fought it off after being given a “head start” by the antibodies in the milk. The baby continues to be closely monitored for signs of illness.

One of the specific benefits of breast milk is that it contains the mother’s antibodies against illnesses to which she (and hence her baby) may have been exposed. This is why so many studies have shown that breastfed babies are much less likely to become ill (with colds, ear infections, diarrhea, pneumonia, meningitis and other infections) than babies who receive formula.

This is also why the CDC’s statement1 makes a point of reaffirming the health benefits of breastfeeding.

For more information, click here: CDC Questions and Answers

Kimberly G Lee, MD, MS

Neonatologist, Beth Israel Deaconess Medical Center

MBC Board of Directors

References

  1. Centers for Disease Control and Prevention. Possible West Nile Virus transmission to an infant through breastfeeding. MMWR 2002; 51:877-8. Available online at CDC West Nile Virus article.

Breastfeeding and Asthma

Sept 27, 2002

A study by Malcolm Sears and others, recently published in the September 21, 2002 issue of the British medical journal, The Lancet concluded that “breastfeeding does not protect children against atopy [allergic diseases] and asthma and may even increase the risk.” The Massachusetts Breastfeeding Coalition has reviewed this study and finds it to be flawed, because the study states that “many newborns who were breastfed received a nightly formula feed while in hospital to allow the mother to sleep.”

There have been numerous studies showing a reduction in asthma in children who were exclusively breastfed, that is, they did not receive any formula at all. This suggests that early exposure to formula may increase the risk of asthma. For example, recent study by Wendy Oddy and others, out of Australia, studied twice as many children as The Lancet study, and found a significant reduction in the risk of asthma in 6 year old children who were exclusively breastfed. (see the Public Health section of our website for references).

An unspecified, significant number of the children in The Lancet study were not exclusively breastfed – and in fact received formula in the early newborn period when their immune systems were the most vulnerable and immature, and when their guts were most permeable. Even one bottle of supplemental formula has been shown to alter the pH of the gut. Two bottles may be all it takes to sensitize an already allergy-prone baby. As with the relationship between breastfeeding and other diseases, it is clear that exclusive breastfeeding should be the reference standard.

The Massachusetts Breastfeeding Coalition believes the study in The Lancet by Malcolm Sears and others does not contradict the numerous earlier studies in which exclusive breastfeeding is linked to significant reductions in the risk of asthma in later life.