Actors and Regulation Relevant to Milk-Sharing Policy and Development (Week 3)

Provided bags for milk storage and shipping container from Mother’s Milk Bank, Dnver, CO. (2011).

Actors with a vested interest in PAMS policy include, are not limited to, and listed in no particular order of efficacy are PAMS donors and recipient families, recipient infants, professional organizations of health care providers, state and federal departments of public health, state and federal legislators, state and federal food safety departments, researchers in the field of lactation, the Human Milk Banking Association of North America (HMBANA), for profit milk banks and cooperatives, lactation freedom and rights activists, the media, and private sellers of breastmilk. Discussing the level of involvement and impact of each of these actors is beyond the scope of this blog, but I will offer a few thoughts concerning the media, research, and milk banks/cooperatives (HMBANA, Prolacta Bio Sciences, and Mother’s Milk Cooperative). Inaccurate interchange of PAMS and private sale of milk intentionally or out of ignorance found everywhere from the blogging community to well respected research journals, to intended legislation (Geraghty et al., 2011, Keim et al., 2013a; Keim et al., 2013b; Assembly Bill 1857), fuels confusion and reduces efficacy of dialog surrounding PAMS.

The media has a delicate place in PAMS policy. In the short history of PAMS, it has been labeled as risky (“Milk Sharing for Babies Risky, FDA Says”, “ Booming Demand For Donated Breast Milk Raises Safety Issues”, “Websites for Sharing Breast Milk Raise Concerns About Health Risks”) or sensationalized for the potential involvement of lactophiles. Attempts to discuss milk-sharing risks in context are not well received. The role of the media in matters of lactation in general is not a positive one. Breastfeeding rarely appears in modern television. Predatory advertisement by formula companies airs frequently. Unfortunately, this type of media attention creates great difficulty in beginning dialog which would be conducive to an informed and activated public, and responsive political representatives (Kingdon,  2003).
As a researcher involved in an area facing questions of policy, I have a bit of a bias as to how important research should be in making policy. The nature of breastmilk as a biological resource, source of nourishment, and commodity makes a brief discussion of the role of research difficult. With respect to PAMS in the current environment, the role of research comes down to a few key need-to-knows-

  • What is PAMS?
  • Who is participating in PAMS, how are they participating, and what impact is PAMS milk having on infant feeding practices?
  • What precautions are being taken in screening of participants and handling of milk to mitigate risks to participants and recipient infants?
  • What does the practice of PAMS mean for families involved?
  • What are the potential and probable health impacts of PAMS in the context of the current extent of involvement of the child rearing community?

The answers to these questions will make it possible to determine the urgency of policy and potential regulation, as well as the most effective means to reach participants and providers to facilitate infant safety without alienating a sub-culture or infringing on the rights of families.
Milk banks associated with HMBANA are currently the only recommended source of obtaining breastmilk outside the breastfeeding dyad in the United States (FDA, AAP, CDC, etc). These 11 banks are not capable of consistently meeting the needs of the hospitalized infants that make up the primary recipients of their milk, let alone providing milk for otherwise healthy infants. Availability from cooperative sources or from for-profit banks has not been documented. The restrictions placed on donors by these centralized organizations are many. These restrictions create a lack of available donors meeting acceptance criteria. Not all of the restriction to donation, such as history of residence in the United Kingdom,  are particularly well grounded in evidence. These restrictions create a forced shortage of an already precious commodity. It is not surprising then that HMBANA would seek, even in light of there being no evidence of significant overlap of the donor populations of the bank v. PAMS to date (Gribble, 2013), to discourage the practice

The practice of casual sharing of milk or procuring milk from any source other than an
established donor human milk bank operating under HMBANA Guidelines, or similar guidelines
established in other countries, has potential risks for both the recipient and the donor or her
child. HMBANA does not endorse the practice of selling or purchasing human milk, human milk components or human milk by-products.

Again, note the incorrect assumption that PAMS = selling milk. Also note the language of exclusion in assuming that the practice of distributing breastmilk is solely the undertaking of women, presumed to be the mothers.

Regulation and Statute of Human Milk
David (2011) describes the current statute and regulation of selling milk in the United States regarding potential for litigation. In short –

  • The National Organ Transplant Act and state interpretations of it does not cover the sale [or sharing] and transportation of breastmilk, semen, hair and other replenishing body fluids.
  • Criminal liability could be sued on the grounds of having knowingly sold [or shared] breastmilk when the donor has tuberculosis, syphilis, HIV, or other infectious disease which may be transmitted in breastmilk. Federal jurisdiction over shipping an infectious fluid may be arguable in these circumstances as well.
  • Tax law could be used to hold sellers responsible for profits of milk sales.
  • Laws in Texas, California, and New York regarding sale [or sharing] of human milk only apply to licensed donor banks.

In 2010, a bill was introduced in Tennessee that would have made selling human milk a misdemeanor. It did not pass committee. In 2013, a bill was passed in the New Jersey State Assembly to create a public health education campaign regarding the dangers of PAMS and of private sale of human milk. This bill was not voted on by the state Senate. In 2014, this bill was renamed and reintroduced for consideration by committee.
Commentary regarding the safety of PAMS in comparison to HMBANA banks reference the standards of screening and handling which are assumed to be exceptional, and the regulation of the banks. HMBANA is a professional organization which acts as a liason between member banks and federal agencies of potential oversight and regulation. Regulation of HMBANA does not exist beyond the legislation in California, Texas, and New York regarding donor recruitment and milk sales practices. In the case of California and Texas, the standards set by HMBANA for their own processing are the standards used in the legislation (FDA, 2010). Contrary to the assertions of many authors, adherence to HMBANA standards is NOT compulsory, even for member banks (FDA, 2010). By contrast, as a for-profit entity, Prolacta Biosciences is subject not only to the standards of HMBANA by proxy of those being the regulatory standards legislated in California, but by direct oversight of the FDA (Prolacta, 2013). As a result of the increased scrutiny Prolacta operates under, additional safety and accountability measures (such as DNA matching received serum samples to the accompanying milk) are undertaken (Prolacta, 2013). Mother’s Milk Cooperative was founded by former associates of Prolacta, and operates with greater attention to control and assessment of milk quality than HMBANA. It should be noted that the additional scrutiny in milk banking is not supported by evidence, as there have been no reports of infant illness or death attributed to milk obtained from milk banks in the United states.

Closing Thoughts
There are many actors involved in the pending process of health policy making concerning PAMS and the distinct but related practice of private milk selling. Some actors have a vested interest in discouraging the practice, potentially to the extent of seeking to outlaw it. The differential of power and motivation of all actors has yet to be explored with respect to policy making. Current policy regarding regulation of milk banking, its application to PAMS, and even its efficacy for milk banks is ambiguous. This shaky foundation and lack of clear definition of actors and statute create unique challenges to expediency and opportunities for closing gaps in consistent application of health policy regarding human milk.

References
A.R. 1857, 216th Legislature (New Jersey 2014).

David, S. D. (2011). Legal commentary on the internet sale of human milk. Public Health Reports (Washington, D.C. : 1974), 126(2), 165-166.

Food and Drug Administration. (2010). Banked Human Milk Backgrounder.

Gribble, K. D., & Hausman, B. L. (2012). Milk sharing and formula feeding: Infant feeding risks in comparative perspective? The Australasian Medical Journal, 5(5), 275-283.

H.R. 3704, 106th General Assembly (Tennessee 2010).

Keim SA, McNamara KA, Jayadeva CM, Braun AC, Dillon CE, Geraghty SR. (2013) Breast milk sharing via the Internet: the practice and health and safety considerations. Maternal Child Health.

Kingdon, J. W. (2003). Agendas, alternatives, and public policies. New York: Longman.

Prolacta Biosciences. (2013). Prolacta’s state-of-the-art testing, screening, and standardized production process. Retrieved from http://www.prolacta.com/quality/

Sakamoto, P. (2010). Human milk banking association of North America. Brief for the United States Food and Drug Administration.

Advertisements

5 thoughts on “Actors and Regulation Relevant to Milk-Sharing Policy and Development (Week 3)

  1. You brought up some excellent points as to the actors in this drama, but I did not see any mention of the pharmaceutical industry, i.e. formula companies, except in regard to commercials on TV. With the risk of sounding like a conspiracy theorist, wouldn’t they have a lot to lose if PAMS becomes standardized and embraced by more women? Who is funding some of the organizations speaking out against it? For example, we have seen the AAP caught with their hand in the proverbial cookie jar as they accepted cash, etc. from formula/pharmaceutical companies, while their other hand was writing a policy statement on the promotion of breastfeeding. Who provided the start-up capital for Company X using human milk to make fortifier? Just asking…
    This week’s readings does stir up some provocative ideas!

    • You ask a brilliant question, Janet! I thought long and hard about including discussion of what the formula industry does or does not stand to lose if PAMS becomes the norm. My conclusion was that I had already turned a 700 word blog into a 1200 word essay, and so decided to leave it out. Since you asked –

      It is estimated that PAMS participation globally is around 130,000 families (Bond unpublished, 2013). In the United States alone, there are over 3 million babies born every year (CDC, 2011) and 75% of them are formula fed in part or in full (Breastfeeding report card, 2013). In the short term, I don’t see formula manufacturers caring much. The reason many families formula feed is obstacles to expressing milk after returning to work, which you know better than I do! Most recipients obtain milk from multiple donors to meet the needs of their infant all or in part. So if, as preliminary analysis seems to indicate, we would need 3 donors for every recipient infant. That is a HUGE increase in number of donors as well as breastfeeding rates to enable formula manufacturer impact!

      The funding sources for Prolacta and Mother’s Milk Cooperative is tricky to find, although the dollars coming in from various stages topped $15 million in 2011.

  2. Angie, what an absolutely fascinating subject you have chosen to highlight in your blog. I agree with your statement regarding the media’s poor portrayal of lactation in general, and the only mention of milk-sharing I’ve encountered (either positive or negative) is on social media, through friends’ Facebook pages. I do remember watching The Hand that Rocks the Cradle as a teenager, shifting uncomfortably during a scene where the nanny breastfeeds the new mother’s child in secret. The infant, already sated by the nanny’s milk, refuses his own mother’s breast when offered. Fast forward twenty years, and after two children and four years of combined breastfeeding, I experienced a visceral reaction while watching the same scene. With such a paucity of information or education on the subject of milk-sharing, I wonder if my gut reaction to one woman nursing and bonding with another woman’s baby is a publicly held perception of milk-sharing, leading to ignorance and fear on the subject. We don’t think twice about plasma or sperm donation (selling is legal in both instances), but when the bodily fluid in question is milk, from a woman’s breast, and the intended recipient is a child, there seems to be much more opposition.

    As a future APRN, I would like to add myself to the list of actors, as someone who can learn from your blog, educate patients and the public, and dispel any myths surrounding milk-sharing. The examples of double mastectomy or maternal death may seem extreme, however by illustrating that these are some circumstances when milk-sharing can occur, perhaps feelings of empathy and concern for the infant may replace confusion or ignorance on the subject (Akre, Gribble, & Minchin, 2011). While opinions on the matter may still remain divided, at least progress can be made towards evidence-based policymaking in the best interest of infants and families.

    References

    Akre, J. A., Gribble, K. D., Minchin, M. (2011). Milk sharing: From private practice to public pursuit. International Breastfeeding Journal, 6. doi: 10.1186/1746-4358-6-8

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s