Staff may not realized that free samples are linked with earlier use of formula among nursing mothers in randomized controlled trials. Professionals who have never purchased formula may not realize that name-brand products cost a third more than store-brand products, raising costs considerably for bottle-feeding families. Educating care providers and hospital adminsitrators about these issues is the first step toward eliminating these marketing practices. To start the conversation, review our talking points.

This tool kit includes materials developed by the Massachusetts Breastfeeding Coalition and Ban the Bags, as well as letters of support from regional and national organizations.

Whether you are a parent, a concerned citizen, a public health advocate or a health care provider, you can change this practice. Browse our materials for ideas and inspiration, or Download Our Complete Tool Kit for background information, supporting data and educational materials to start lobbying for change in your community.

February, 2007 — In Massachusetts, getting hospitals to stop marketing baby formula became a battle of words fought in the press and in the corridors of the State House. In February 2006, then-Governor Mitt Romney directed our state’s Public Health Council to rescind the country’s first state regulation to ban hospital distribution of formula company discharge bags. Romney, his spokesman, and other opponents of the ban argued that women should be “free to choose” how they feed their babies, and that women should not be “forced” to breastfeed.

Freedom of choice is a concept that is frequently raised by proponents of baby formula, as well as by manufacturers of other unhealthy products, such as fast food, soft drinks, and tobacco. These corporations like to say that healthy choices are the individual’s personal responsibility. They minimize the effect their marketing has on consumer behavior, despite the fact that they spend huge sums of money to get people to purchase their unhealthy products. Because companies cannot admit that they want to get people to buy as much of their unhealthy product as possible, the best they can do is to describe their marketing efforts as a way “simply to educate” the public about their products. By emphasizing “freedom,” “choice” and “individual responsibility,” they tap into classic American values.

The strategy is effective, in part because consumers do not want to admit that they are vulnerable to the effects of advertising, even though, clearly, those vast sums spent on marketing are not for nothing. One Romney staffer even told us, “Women are too smart for that.” She turned unethical marketing on its head by praising women’s “intelligence,” even though effects of marketing often play on a consumer’s emotional vulnerabilities, which has nothing to do with intelligence.

During the formula marketing debate in Massachusetts, Romney received letters in support of the marketing ban from the CDC, the president of the American Public Health Association, and the state chapters of the American Academy of Pediatrics, American College of Obstetricians and Gynecologists, the Massachusetts Public Health Association among others. Despite knowing of all this support for the ban, the governor’s spokesman repeatedly characterized proponents of the ban as “a small but vocal group” of “liberal” activists, and not the mainstream. So, how did we respond? We learned a lot of lessons in language.

Reframe, don’t react:

One of the biggest lessons we learned was that we needed to reframe the argument, rather than react to our opponents’ charges. When you reframe the argument, you are in control of the message you give; when you respond directly to their charges, they are in control of your message.

For example, countering “women are smart” with “women are vulnerable” is a no-win argument. Similarly, countering “freedom of choice” with assurances that we support choice deprives us of many more powerful arguments. It also deflates our message by turning it into just part of our opponent’s message.

Ultimately, we learned that the best response was to avoid using the word “choice” at all. In fact, it helped to listen carefully to the language used by our opponents, and then avoid repeating it altogether. There are many ways to frame the bag issue more effectively. Here are some of them:

Unethical marketing and the badness of Big Pharma:
Many people do not realize that the name-brands advertised on most formula bags are owned by two pharmaceutical giants: Abbott Labs (Ross/Similac) and Bristol-Myers Squibb (Mead Johnson/Enfamil). We knew that there was a growing movement against the unethical marketing techniques employed by the pharmaceutical industry. To build on that momentum, we reframed the discussion:

“Why are hospitals marketing baby formula?” The very question makes a powerful statement.

“Hospitals should market health and nothing else.”

“The only way to sell more formula is to sell less breastfeeding.”

“Formula companies aren’t giving away freebies just to be nice; they’re doing it to build profits.”

“We would never tolerate the idea of giving out coupons for Big Macs on the cardiac unit.”

“People, not profits.”

We also had a graphic of the bags on our website, accompanied by the phrase, “Compliments of Big Drug Companies.”

Once we framed the issue as drug company marketing, and not “feeding choice,” we were in control of the discussion.

Do you want to be used?

“You went to nursing school (or medical school) to take care of patients, not to peddle baby formula.”

We found that hospital staff bristle at the idea of being manipulated by the formula industry. Health professionals shudder when they hear the quote from a Ross training manual that was cited in a Texas court case:

“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)

Nobody wants to be “sold and serviced.”

Help women follow medical recommendations:
Research shows that when breastfeeding moms get commercial bags, they are more likely to start using formula. The effect is so powerful that it persists even if formula is not in the bag. The result? Women who get bags will be less likely to breastfeed exclusively for the first 6 months, which is the recommendation of all major medical groups. Since health care providers are expected to practice evidence-based medicine, there’s no way for an educated provider to support giving out the bags.

Many people also do not realize that research shows that breastfeeding information provided by formula companies is associated with lower breastfeeding rates than when it comes from a non-commercial source. Having a breastfeeding book or pamphlet in the bag does not actually help breastfeeding mothers.

This data was especially powerful when talking to individual women who argued, “I got a bag, and I liked it, and I still breastfed.”

We countered, “It’s great that you succeeded in spite of the bags. But in carefully designed studies of large groups of new mothers, the bags interfere with breastfeeding.”

“Evidence-based medicine shows that the bags hurt our patients.”

“The bags undermine the advice we give our patients. How can we tell them breastfeed exclusively for 6 months, then hand them a formula bag?”

“We want to support mothers so they can succeed in following medical recommendations.”

The bags advertise only pricey name-brands:
Our opponents often argued that taking the bags away from indigent mothers will hurt them financially. In fact, the bags encourage all parents to spend more money, an average of $700 more a year above store brands.

We found that reporters did not seem to care about the price differential, but women cared deeply. When we exhibited at the American Baby Faire in the spring of 2006, the only thing that grabbed people’s attention as they made a beeline for the Enfamil exhibit was our sign that said, “This free bag costs $700.” Before we put that sign up, people just walked on by.

“The bags aren’t free.”

“This free bag costs you $700.”

In the CDC Guide to Breastfeeding Interventions, it’s noted that the women most susceptible to the effects of the bags are those who are most vulnerable: non-white women, primiparas, and those with illness or complications. Indeed, the bags increase health disparities, not close them.

Breastfeeding is normal:
In 1996, Diane Wiessinger published her seminal treatise, “Watch Your Language,” in the Journal of Human Lactation. She persuasively argues that we should not talk about the “benefits of breastfeeding,” because that implies that formula is normal and breastfeeding is just something “extra.” The American Academy of Family Physicians and the American Academy of Pediatrics both note that breastfeeding is the norm against which all other feeding methods must be compared in terms of health outcomes.

Instead of talking about the “benefits of breastfeeding,” talk about the risks of not breastfeeding.

Instead of breastfeeding “preventing” breast cancer, we should note that breast cancer risk increases with shorter durations of breastfeeding. Instead of “preventing” obesity, we need to talk about “increased risk” with shorter durations of breastfeeding.

Weissinger notes that even the formula industry describes breastfeeding as “optimal” “special,” all of which paints breastfeeding as an unattainable ideal. The undercurrent to this language is that most people just want to settle for “regular” and are not interested in going the extra mile for something “optimal” “ideal” or “special.” As Weissinger notes, “special” requires extra effort.

Breastfeeding is a public health challenge:

The human cost of not breastfeeding can be enormous. The financial costs of the excess disease burden can be eye-opening.

Cite the risks of not breastfeeding, both to mothers and to children, both for acute illnesses and chronic illnesses. When you factor in such big-ticket items as maternal breast cancer and childhood obesity, and the costs become too great to ignore.

The AAP notes that lack of breastfeeding costs the US about $3.6 billion a year in excess health care costs. Other research notes that mothers who aren’t breastfeeding have much higher absenteeism from work.

When citing health risks, include specific statistics rather than just general language about risk. By itself, saying “there are risks of not breastfeeding” may be interpreted as a value judgement. By contrast, saying “babies who are formula-fed have double the risk of diarrhea” sounds informative and scientific.

When the National Breastfeeding Awareness Campaign spoke of the risks of not breastfeeding, critics charged that this language was upsetting to many women. In fact, the original campaign contained statistics about specific health risks, but they were all eliminated following pressure from the formula industry, thereby weakening the campaign and leading to charges that it made women feel guilty. We can take a cue from the formula industry here: the numbers are powerful—use them whenever you can.

Reframe guilt as anger or grief:
Women face countless barriers inhibiting them from following medical recommendations to breastfeed. With the rise of formula, we’ve lost the idea that breastfeeding is normal, and with it, we’ve lost the expertise of grandmothers, aunts, doctors, and nurses. Our society does not readily tolerate breastfeeding in public, and employers too often make it difficult for moms to continue breastfeeding. When women fail at breastfeeding, they often grieve the loss of this precious opportunity. Too often they blame themselves, rather voicing their anger at the myriad roadblocks they face in contemporary American society.

People are often concerned with inducing feelings of “guilt” in women who choose not to breastfeed, or who fail at doing so. But, as Linda Smith of the US Breastfeeding Committee asks, “how much of this guilt is really anger or grief” that women were not supported? Indeed, people feel guilt when they blame themselves for their failings. When a woman recognizes how others have failed her and her baby, she doesn’t feel guilty – she feels angry. Rather than talking about guilt, we need to talk about supporting new mothers so that every mother can breastfeed.

Stand up for mothers and children:
Mitt Romney went so far as to fire one-third of the state’s Public Health Council just before the final vote on the bags, to ensure that women keep getting these marketing message.

The Boston Globe ran a story about Romney’s last minute firings on May 20, 2006. In it, I was quoted as saying, “I think the governor is clearly illustrating that he is more interested in protecting the pharmaceutical industry than in standing up for the children and mothers of Massachusetts.”

What’s your opponent’s real agenda?

Why did Romney go to such extreme measures to make sure women got their bags? We will never know for sure, but 10 days after he quashed the ban in May 2006, he proudly announced a $660 million deal with Bristol-Myers Squibb, the nation’s largest formula maker, to build a pharmaceutical plant in Massachusetts. Such a deal conveniently allows Romney to boast that he “brought jobs to Massachusetts” during his bid for the White House. The plant may bring jobs, but it will bring them at the expense of the 80,000 children born each year in Massachusetts, and at the expense of their mothers, whose commitment to breastfeed their infants continues to be undermined to protect the interests of Big Pharma .

Summary:
Reframe, don’t react. Don’t use your opponent’s language. Cite the research that giving out bags runs counter to evidence-based practices, and remind people that exclusive breastfeeding for six months is the medical recommendation. Breastfeeding is a serious public health challenge. We cannot allow ourselves, as a society, to be manipulated by big corporations that put profits before of the health of mothers and children.

Hospital-Based Marketing of Infant Formula

Benefits for hospitals for not distributing commercial discharge bags

• Allows hospitals to deliver quality health care rather than being used by pharmaceutical manufacturers as a conduit for marketing infant formula to vulnerable and susceptible patients
• Retains dignity and respect for physicians and nurses. An old Ross Employee Manual states that…”A nurse who supports Ross is like another salesman.”
• Promotes the ethical practice of medicine and nursing without commercial conflicts of interest
• Keeps hospitals within safe parameters of corporate compliance. As with pharmaceuticals, infant formula is marketed to and through health care professionals, mothers often purchase infant formula based on health provider recommendations, and infant formula is paid for by federally funded programs such as Medicaid and WIC. Therefore, there are a number of laws, regulations, and guidelines that may be violated when discharge bags are distributed. These include the Federal anti-kickback statute and the OIG Compliance Program Guidance. HIPAA defines discharge bag distribution as “marketing.” Many hospitals would rather market health and nothing else.
• Most hospitals lack stock control procedures and do not record lot numbers of formula or formula bags. When a recall occurs (like the recent Ross Products recall of formula and formula bags) the hospital has no mechanism to inform patients that they have received a recalled product. As the powdered infant formula in some bags is not sterile, infants can and have been sickened from this “gift”, placing the hospital in a position to be sued
• Hospitals must pay nurses to stock and handle the bags as well as record all lot numbers of all products distributed to patients in case of a recall. This is very expensive and takes time away from patient care

Cost analysis: why get rid of the bags when they have free formula in them?

• Neither the bags nor the formula are free. Over 95% of mothers will stick with the formula given to them by the hospital, which is the most expensive name brand formula.
• The bags cost the manufacturer less than $7
• The bags will cost the mother ~$700 more than store brand formula for the first year, a 1000% profit for formula companies

Item	Brand Name Formula	Generic
Diaper bag	Free	$20
Sample of formula	Free	$11
1 year’s supply (first can of brand name formula is free)	$2000	$1200

Why should the hospital pay for formula?

Why does it matter if we give out the bags and babies go home on formula?

• Hospitals are responsible and accountable to their patients to deliver care that does not encourage poor health outcomes following discharge
• Exclusive breastfeeding is reduced at all points measured between 0-6 months
• Babies not exclusively breastfed become sick more often and cost insurers ~$475 in excess sick visits

What if mothers ask for the bag and the hospital does not have it?

• Hospitals find that explaining to parents why the gift bag is not distributed is easily accepted
• Many hospitals distribute their own bag to market their exemplary childbirth services
• Mothers can call the 800 number of the formula company if they must have a bag

List of institutions not giving out formula discharge bags

• Can be found at www.banthebags.org where 101 hospitals are listed as not distributing these bags

Nurse Manager
Maternity

Dear Nurse Manager,

I recently had a baby at your hospital, and am writing this letter to express my disapproval about the “free” infant formula bag I received at discharge. Even though I am planning to breastfeed, I was given a diaper bag filled with commercial infant formula. I think it is wrong that we new mothers get these gift bags. It seems like you are letting the baby formula companies use us as an advertising trick. I don’t understand how they can get the hospitals to give out these bags. It suggests that your hospital approves of formula, and of this particular brand of formula. We all know that breastfeeding is much better for the baby, and I think your practices should reflect that.

I trust you will take into consideration my negative experience, and adjust your hospital policy regarding free infant formula bags. Please acknowledge my letter and let me know what your plans are for stopping this practice.

Thank you for your time.

Sincerely,

Send a copy to your doctors, too. They want to know what mothers think, and they will listen to your opinion!

Download a copy of the letter to edit and send.

Healthcare recommendations and decisions should be made without financial conflicts of interest or commercial bias. Infant formula is viewed very much like pharmaceuticals for the purpose of compliance with healthcare laws, regulations, and guidelines. As with pharmaceuticals, infant formula is marketed to and through health care professionals, mothers often purchase infant formula based on health provider recommendations, and infant formula is paid for by federally funded programs such as Medicaid and WIC. Therefore, there are a number of laws, regulations, and guidelines that may be helpful to use in your work to eliminate hospital distribution of commercial discharge bags.

The Federal Anti-Kickback Statute is a federal law that makes it a felony to give or receive a “kickback” to induce or reward the purchase of items covered by a federal health care program. Specifically, it prohibits offering, paying, soliciting, or receiving:

…. any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person…. to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program…. [42 U.S.C. § 1320a-7b(b)(2).

This statute may apply to discharge bags because mothers can perceive that they are a recommendation to purchase the product. Mothers may wish to use the product after discharge and such usage may be funded by Federal programs. Thus the statute applies to hospitals and health providers who treat infants eligible for the Medicaid or WIC program. Almost half of the infants in the US are serviced by WIC.

Certain purchasing agreements between hospitals and formula companies also violate this statute, such as offering free samples of one product (infant formula for the nursery) on the condition that the hospital distribute samples (discharge bags) of other products from the same manufacturer. Compensation given to healthcare providers for recommending products violates this statute. Mothers may perceive that the distribution of formula discharge bags is a recommendation to purchase the product.

The courts have identified a number of considerations that help identify arrangements at greatest risk of prosecution:

• Does the arrangement have a potential to interfere with or skew clinical decision-making? The bags are often part of a hospital culture that requires provider neutrality on infant feeding, preventing providers from unequivocal support of breastfeeding. Bags could be given in lieu of expert lactation care and services
• Does the arrangement have the potential to increase costs to Federal health care programs or enrollees? Discharge bags market the most expensive brands of infant formula. When only these are provided to Federal programs the costs of the formula are increased. Mothers who purchase the formula incur increased costs over store brand formulas
• Does the arrangement raise patient safety concerns? Powdered infant formula in discharge bags is not sterile and can and has resulted in infant infections with Enterobacter sakazakii. Lot numbers of formula in the bags are not routinely recorded so parents cannot be informed of formula recalls in a timely manner. Mothers are not asked if they have a history of allergies or diabetes in the family prior to the distribution of the formula bags. Sensitization of breastfed infants from susceptible families can occur with just one bottle made from this formula

Suspected violations of this statute should be reported to the Inspector General of the Department of Health and Human Services at: esec@os.dhhs.gov

Federal Antitrust Laws are a group of laws insuring fair competition in the marketplace. Some purchasing arrangements between hospitals and infant formula manufacturers may violate antitrust laws. These usually involve agreements (bundling, tie-in) where the hospital receives discounts on one item if it agrees to use that same manufacturer’s products from another category

PhRMA Code is a voluntary guide for the pharmaceutical industry regarding relationships with physicians and other health care providers. It was adopted in 2002 in response to closer scrutiny by the federal government of questionable and excessive promotional activities by the pharmaceutical industry. Because it is voluntary and written by an industry that should receive oversight from objective sources, this code remains broad with no penalties or recourse for violations

OIG Compliance Program Guidance
The Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) issued Publication of the OIG Compliance Program Guidance for Hospitals. and OIG Supplemental Compliance Program Guidance for Hospitals which recommend and model internal compliance programs in hospitals. Other guidance documents were issued for pharmaceutical manufacturers and small-group physician practices. None of these are mandatory. Infant formula companies are specifically mentioned

Health Insurance Portability and Accountability Act (HIPAA)
The privacy rule with HIPAA defines marketing as “making a communication about a product or service that encourages recipients of the communication to purchase or use the product or service.” If the communication is “marketing” then the communication can occur only if the covered entity first obtains an individual’s “authorization.” HIPAA however goes on to exempt certain situations from the requirement of prior authorization, even if it is marketing, if it is in the form of a face-to-face communication made by a covered entity to an individual, or a promotional gift of nominal value provided by the covered entity. No prior authorization is necessary “when a hospital provides a free package of formula and other baby products to new mothers as they leave the maternity ward.” This means that even though discharge bags are a form of marketing, mothers do not have to be informed that the “gift” is actually an inducement to purchase the formula following discharge. Mothers may think that it is a health provider recommendation rather than a sales pitch.

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Industry Assertion: Attempts to ban free formula gift packs are “anti-business”; formula companies have a responsibility to communicate their product innovations
Counter: Permitting the practice undermines the public health, which is costly, unethical, and, ultimately, bad for business. Marketing to mothers through the health care system exploits women’s fears and insecurities during the transition to motherhood

Industry Assertion: The Ban the Bags movement is anti-choice.
Counter: We avoid engaging in any exchange that borrows the language of the abortion debate. If necessary, identify your refusal to engage in a discussion using this language precisely because it co-opts the emotional language of the other, totally unrelated issue.
Appropriate response: Regulating advertising that negatively affects the health of vulnerable women and children has little to do with personal choice. It is about prohibiting unethical marketing practices to vulnerable populations.

Industry Assertion: Creating government regulations to control marketing practices is intrusive and unnecessary.
Counter: Market forces cannot be depended upon to protect vulnerable populations. Because the infant is most affected when breastfeeding is undermined, regulation is a sensible measure to protect the public health. This issue is similar to the regulations concerning exposure to passive smoke.

Industry Assertion: Ban the Bags makes women feel guilty.
Counter: Health professionals work hard to help women breastfeed, and are well aware of the problems that can occur to prevent success. What we seek to prevent is the deliberate undermining of breastfeeding by an industry that profits when breastfeeding fails. Industry would not provide the bags if they did not subvert breastfeeding. The “guilt” argument is used to dodge the issue of failure to fully inform women of the risks of formula feeding.

Industry Assertion: Ban the Bags is elitist because it deprives poor women of a free present they look forward to receiving.
Counter: Undermining breastfeeding and depriving low-income families of the numerous health and economic protections that breastfeeding provides is profoundly exploitative, especially to non-Hispanic black women, who have the lowest breastfeeding rates in the US. The increased health care costs incurred by the uninsured burden the whole country. These bags are NOT free! We are all paying for their hidden costs in terms of a seriously strained health care system.

Industry Assertion: Maternal employment, not formula gift bags, is the major barrier to breastfeeding, especially for working class women with few workplace accommodations.
Counter: Society needs to work harder to ensure that employed mothers and their babies have equal rights with regard to the opportunity to breastfeed. Women planning to return to jobs deserve the right to establish a full milk supply. Early formula supplementation interferes with the establishment of a full milk supply and can compromise their ability to continue breastfeeding when they return to work.

Industry Assertion: Formula is safe and healthy, and many US citizens were raised on it.
Counter: An epidemic of childhood obesity demands that we re-examine the foods and feeding methods that currently predominate. Breastfeeding is one of the stated “pillars” of the US Public Health system’s childhood anti-obesity campaign. The US healthcare system spends an additional $3 billion on diseases and conditions that are increased due to not breastfeeding

Hospital Assertion: We need to give out these bags to obtain discounted materials and supplies when purchasing items from pharmaceutical companies.
Counter: This practice may violate OIG, Anti-Kickback and FTC gifts and advertising prohibitions.

Hospital Assertion: We have a contract with formula companies. Under the contracts clause of the US Constitution, a government agency is barred from impeding that contract
Counter: Allow the contract to run out and do not renew it. It is unethical to place commercial interests above patient interest.

Hospital Assertion: The Department of Public Health should not be regulating commercial endeavors as long as they are consistent with hospital operations and not related to harming the health or safety of a patient
Counter: Patient health and safety can be compromised by failure to exclusively breastfeed or from contaminated powdered infant formula that is not sterile

Hospital Assertion: Removal of the bags interferes with the doctor patient relationship and restricts physicians from counseling patients with whatever type of information on infant feeding options that they believe is necessary
Counter: The bags in no way interfere with the communication between health care providers and patients. Discharge bags are a marketing tool to cause mothers to purchase expensive brands of infant formula under the guise of a medically sanctioned and recommended action

Hospital Assertion: Discharge bags are given when women leave the hospital, therefore they cannot negatively influence breastfeeding behavior while in the hospital.
Counter: While some progress has been made increasing breastfeeding initiation rates, few women are exclusively breastfeeding by the end of the 2nd week postpartum. Formula samples in the discharge bags may undermine mothers decision to exclusively during the vulnerable time when they are transitioning home. Exclusive breastfeeding confers the greatest benefits to mothers and babies.

Conclusion:

Promotional items are inappropriate in a medical environment and should not be used as patient education materials.

Formula reps have unparalleled access to maternity staff in hospitals. Reps are vendors. They should not be treated as part of the healthcare team. They have succeeded in getting hospital staff to market for them. Hospital staff and health care providers should not be acting as formula marketers, nor should they lend their prestige to a product that undermines the health of our nation’s infants and mothers.

Supportive references:

According to the American Academy of Pediatrics, “Prevention is one of the hallmarks of pediatric practice. Documented trends in increasing prevalence of overweight…mean pediatricians must focus preventive efforts on childhood obesity.” Preventive recommendations include: “Encourage, support and protect breastfeeding.” American Academy of Pediatrics, Committee on Nutrition: Prevention of Pediatric Overweight and Obesity, Pediatrics 2003; 112(2):424-429.

A minimum of $3.6 billion annually in health care costs would be saved if the prevalence of exclusive breastfeeding increased from current rates to the Surgeon General’s target goals. Weimer J: The economic benefits of breastfeeding: A review and analysis. USDA, Nutrition Research Report No. 13. 1800 M St. NW, Washington DC, 2001.

It is a stated goal of US Public Health Policy to achieve exclusive breastfeeding rates of 75% at hospital discharge and 50% at 6 months. US Department of Health and Human Services, Healthy People 2010. Conference Edition – Vols I and II. Washington, DC. Public Health Service. Office of the Assistant Sec. for Health, Jan 2000, pp 2, 47-48.

“The new multimedia public advertising campaigns may increase the cost of infant formula to the general public…” Greer F, Apple R: Physicians, Formula Companies, and Advertising, AJDC 1991; 145:282-286.

“Gifts cost patients money, and they may change society’s perception of the [medical] profession as serving the best interest of patients.” Chren M, Landefeld S, Murray T: JAMA 1989; 262(24):3448-3451.

“Pharmaceutical companies are not charitable foundations. They do what they do to make money for their stockholders…As a result, they can act in ways that are not in the best interest of patients as a whole.” Kramer, T: Practitioners and the Pharmaceutical Industry, Medscape Psychiatry & Mental Health eJournal 2002; 7(3).

“…companies are responsible…for sales agents … who ”engage in improper marketing and promotional activites”…for example, under new proposed guidelines, a drug maker cannot give golf balls emblazoned with the company’s name to doctors because the products do not provide a benefit to patients.” Pear R: Drug Industry is Told to Stop Gifts to Doctors. NY Times Oct 1, 2002

“Conflict of interest has been defined as “a set of conditions in which professional judgment concerning a primary interest (such as patients’ welfare) tends to be unduly influenced by a secondary interest (such as financial gain” Smith R: Beyond Conflict of Interest, BMJ 1998; 317:291-292.

Nader R. Consumer born every minute. San Francisco Bay Guardian, August 24, 1999.

The US National Immunization Survey (NIS) tracks breastfeeding data. While initation rates indicate that approximately 65% of US children have ever been breastfed, only 60% have ever been exclusively breastfed. By 7 days breastfeeding rates are 59.3%, indicating an early drop off in exclusivity, a trend that continues over the period of the the first 6 months. Only 8% are exclusively breastfed by 6 months. Non-Hispanic blacks have the lowest rates of breastfeeding initiation and continuation. The authors state: “The health care system has an important role to play in the promotion and support of breastfeeding. Maternity care and newborn facilities should follow practices that are conducive to proper lactation, and all health care providers who interact with women or infants should be knowledgeable…about breastfeeding and lactation and in providing medical care to breastfeeding women [in order to] identify the social, cultural, economic, and psychological barriers to breastfeeding that all women face, especially black women.” Ruowei L, Zhao Z, Mokdad A, et al. Prevalence of breastfeeding in the United States: The 2001 National Immunization Survey, Pediatrics 2003; 111(5):1198-1201.

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Government Legislation

• State legislation is one route to use for mandating the elimination of commercial discharge bags from the hospital. Write to your state legislators asking that such a bill be introduced
• California’s Senate Bill 1275 (Ortiz) in 2004 contains model language for state legislation:
  http://www.leginfo.ca.gov/cgi-bin/postquery?bill_number=sb_1275&sess=PREV&house=B&author=ortiz

The Right to Informed Infant Feeding Choices

1. Inclusion of Disclaimer Notice. Requires infant formula companies that market and distribute infant formula in a hospital to include a single, prominent notice on their marketing discharge bags that will state that “the distribution of formula or the marketing materials in a hospital setting does not necessarily mean that the hospital or health care providers endorse the company or the product that is being distributed.”
2. A hospital’s maternity unit or nursery may not be used for display of products (promotional items), or placards or posters concerning these products, provided by a manufacturer or distributor of infant formula.
   www.breastfeedingtaskforla.org

Policy

• State perinatal regulations are operating mandates to hospitals that can be used to specify the elimination of commercial discharge bags. Both New York and Massachusetts have state perinatal regulations that contain statements to curb the hospital distribution of commercial bags. These state that breastfeeding mothers should not be given commercial discharge bags unless prescribed by the physicians or requested by the mother. http://www.massbfc.org/news/perinatalRegs.html

• Contact your state department of public health for a copy of your own state’s perinatal regulations and work with that agency to change hospital policy

State Breastfeeding Coalitions and Task Forces

• The Massachusetts Breastfeeding Coalition worked closely with the state department of public health to revise the state perinatal regulations. While not able to strengthen the prohibition on commercial discharge bags due to interference from the Governor, the regulations have considerably improved what hospitals must provide to breastfeeding mothers.
  http://www.massbfc.org/news/perinatalRegs.html
• The New Mexico Breastfeeding Taskforce has a project called The Discharge Pack Initiative that trades a free T-shirt for baby for a commercial discharge bag. The bags are sent back to the formula manufacturer.
  www.breastfeedingnewmexico.org

Maternity Hospitals

• Check your institution or agency’s policy on selling or marketing products to patients. Since discharge packs are forms of marketing, employees may be unknowingly violating institutional policy.
• Check your job description. Does it mention marketing of products as a requirement of the job? If not, do not do it. Does your job description or any document you signed as a condition of employment prohibit marketing of products? If not, you may wish to add this to it for patient protection. If it does, then avoid giving out discharge packs from commercial interests.
• Most hospitals have provisions for conscientious objection to performing care that violates your ethical or moral principles. Check your hospital’s policy and record your objection to this practice
  Waller-Wise R. Conscientious objection: do nurses have the right to refuse to provide care? AWHONN Lifelines 2005; 9:283-286
• HIPAA regulations consider formula discharge bags as a form of marketing. Remind your hospital that distribution of these bags facilitates a marketing opportunity for corporations. http://www.hhs.gov/ocr/hipaa/guidelines.pdf
• Obtain the mission statement of the hospital, agency, or program where you work. Does it mention promotion of health as a goal? If so, ask how marketing formula promotes a health goal. Does it mention marketing commercial products as a means to this goal? If not, avoid using formula company items.
• If you are a nurse, contact your state nurse’s association regarding the marketing of products to patients. Does this fall within the scope of practice of a nurse? Does it fit in with the ethical practice of the nursing profession? If not, ask them for a statement to this effect for your use
• The federal anti-kickback statute (The Medicare and Medicaid Patient Protection Act of 1987 as amended, 42 U.S.C. 1320a-7b) is a criminal statute that applies to health care providers, hospitals, clinics, etc. Several common practices may violate this law – giving formula discharge bags to patients, accepting free formula for use in the hospital, soliciting or receiving gifts from formula companies, accepting cash from vendors. Check with your hospital’s attorney to see if your institution is in violation of this statute. If so, report this to the Inspector General’s Office of the Department of Health and Human Services at:
  esec@os.dhhs.gov
• Ask your purchasing department if your hospital has a contract with a formula company. Request a written copy of this. Ask if any other units have a contract with a supplier to accept free goods in return for marketing their products. Ask what the cash is used for and who is accountable for it. All other units pass on the cost of food to the insurer. Food trays are part of the room and board charge. Why doesn’t the nursery?
• Ask your purchasing department if the hospital has an agreement with a service that purchases supplies in bulk quantities for many hospitals. Formula companies often require hospitals to give out formula-containing discharge bags to breastfeeding mothers as a condition of the discount received on other supplies.
• Has your unit been approached to change its breastfeeding policy to allow distribution of formula-containing discharge packs? Formula companies have offered cash to maternity units for “educational” purposes in return for changing established unit policy to require giving breastfeeding mothers commercial discharge packs. This type of bribe can set a dangerous precedent whereby formula companies may pressure cash-strapped maternity units to change breastfeeding management guidelines to increase the chances that a mother would need or want to supplement her baby with formula.
• Contact both the ethics committee and your hospital’s attorney and ask for a statement on the legality and ethical principles behind the issue of the hospital endorsing products for financial gain, either directly by accepting infant formula at no cost and distributing commercial discharge bags, or indirectly by accepting cash grants and additional services.
• Form a hospital task force or contact your Quality Improvement department to begin the process of eliminating the distribution of commercial discharge bags from your hospital.

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