SRA Round Table Panel Symposium: Joint Regional Organization … · 2017-12-10 · SRA Round Table...
Transcript of SRA Round Table Panel Symposium: Joint Regional Organization … · 2017-12-10 · SRA Round Table...
SRA Round Table Panel Symposium: Joint Regional Organization Project on Microbiota of Milks
1
Title: Deliberating Evidence for Risks and Benefits Posed by Microbiota of Milks
Organizer: Peg Coleman, Upstate NY SRA/Coleman Scientific Consulting ([email protected])
Moderators: SRA Past-Presidents
Ann Bostrom ([email protected]) and
Warner North ([email protected])
Description: Regulators and stakeholders around the world differ in their perceptions of risks and
benefits of fresh unprocessed milks (human and bovine) and pasteurized milks. A joint SRA RO project
began outreach documenting the state of the science on the microbiota of milks and engaging in dialogue
with SRA practitioners and other stakeholders through a webinar series (podcasts, slide sets available).
Two SRA Past-Presidents will moderate discussions of the evidence for risks and benefits of fresh
unprocessed mother’s milk to infants. Evidence of benefits includes multiple clinical studies from
hospitals around the world with preterm neonates in NICU environments. Further, these clinical studies
demonstrate loss of benefits for NICU infants ingesting donor milk that is Holder pasteurized (heated to
62.5°C for 30 minutes). The moderators and panelists will discuss rationales for and against
pasteurization in light of an emerging dimension: the microbiota of milks. Discussions will be grounded
in the major elements of risk communication (trust, fairness, and emotionality). Various risk
communication approaches (evidence mapping, mental modeling) will be considered. Also of keen
interest is evidence for risks and benefits of fresh unprocessed bovine milk for consumers, including
children and adults. Evidence mentioned in the symposium for human milks will be included, along with
additional evidence for bovine milks, in exercises of analytic-deliberative process in the next phase of this
multi-year joint RO project (a 2.5-day stand-alone SRA workshop in 2018). Participants in the symposium
will discuss what is known about the healthy human milk microbiome, research gaps, researchable
questions, and potential improvements in developing evidence-based policies and risk communications.
Panelists include:
Risk communicator Bill Hallman (Rutgers University)
Risk assessors Peg Coleman (Upstate NY SRA) and Tanya Soboleva (Australia/New Zealand SRA)
Microbiome researcher Carmen Tartera (FDA/CFSAN)
Independent scholar Katya Tsaioun (Johns Hopkins University)
Scope and Structure of Round Table Panel Discussions
The symposium is sponsored by the Risk Communication Specialty Group (RCSG). The panel will
consider the scientific evidence in light of the key principles of risk communication:
trust
fairness and
emotionality.
Moderators Ann Bostrom and Warner North both served as past presidents of SRA and offer decades of
expertise in risk communication for controversial issues and analytic deliberative process. They will keep
SRA Round Table Panel Symposium: Joint Regional Organization Project on Microbiota of Milks
2
discussion focused on the evidence rather than on positions and perceptions. After an introduction
providing context for the project, the moderators will pose the appended questions to the panel. As time
permits, questions will be posed by the risk practitioners in the SRA audience.
The focus for the round table panel symposium is on evidence for risks and benefits from fresh
unprocessed and pasteurized human milks for infants (NICU and others). Input will be sought on the
state of the evidence and key researchable questions necessary to inform evidence-based decision
making for human donor milk in this phase of the project, and for bovine milk in the next stage of the
project, the 2018 workshop.
Key references are appended from a working draft bibliography prepared for the project (posted on
Upstate NY SRA website at http://sra.org/upstateny), and panelists (and SRA participants) are invited to
offer additional studies before, during, and after the symposium. Some findings from these key studies
will be provided in the symposium slide set.
Studies conducted around the world document increased risks to preterm infants without access to fresh
breast milk for failure to thrive, and morbidity and mortality due primarily to necrotizing enterocolitis
(NEC) and late-onset sepsis (LOS). Limited data exist on protection against severe retinopathy and
bronchopulmonary dysplasia, neurocognitive and cardiovascular damage, and infectious disease agents
including those causing typical foodborne enteric diseases. In many countries, breast milk donors are
routinely screened for infectious diseases by similar methods as for blood donation, and donor milk may
be screened for the presence and levels of indicator bacteria and potential pathogens. The apparent
rationale for pasteurization of donor milks is that pathogens may be present in fresh milks.
Also documented in the published literature are multiple studies demonstrating the presence of up to
700 species of non-pathogenic or commensal bacteria in fresh milks and their functionality for offspring,
particularly immune modulation and establishment of a symbiotic gut microbiota. Clinical trials, many
conducted prior to the advances in the ‘microbiome revolution’ of the recent decade, demonstrate
protective effects of fresh breast milks against many diseases in neonates. Multiple studies demonstrate
dose-dependent protections of breastfed infants and provide explanatory evidence on potential
mechanisms influenced by the milk microbiota. Recent studies considering breast milk culture results
and incidence of disease in preterm infants found that presence of potential bacterial and viral pathogens
was not predictive of illness. Participants will consider evidence and gaps in knowledge of the diverse
and abundant microbiota of milk as predictors of protection for fresh breast milks.
Participants in the SRA symposium will discuss what is known about the healthy human milk
microbiome, research gaps, researchable questions, and potential improvements for developing
evidence-based policies and risk communications for milks. Panelists and participants will consider: 1)
evidence on risks and benefits of fresh unprocessed or Holder pasteurized human milk on preterm
infants (NICU and others); 2) researchable questions to reduce uncertainties for risks and benefits and
strengthen the scientific basis for evidence-based decisions for breast milk banks; 3) evidence for other
SRA Round Table Panel Symposium: Joint Regional Organization Project on Microbiota of Milks
3
milks (bovine); and 4) how stakeholders can contribute to assessing and balancing risks and benefits for
the microbiota of milks in the 21st century.
The SRA project will continue in 2018 with a 2.5-day SRA workshop to exercise analytic-deliberative
process considering extensive bodies of evidence for both human and bovine milks. International experts
from diverse disciplines (predictive microbiology, microbial ecology of milks, immunology, neonatology,
food safety), as well as microbial risk assessors, risk communicators, and risk managers, will present and
participate in interdisciplinary exercises with stakeholders to ‘let the data speak’. As demonstrated for
other controversial societal issues, the vision and goals of SRA (http://www.sra.org/about-society-risk-
analysis) align well with providing a respectful meeting place to air competing views of the bodies of
evidence supporting divergent positions about the safety of milks around the globe. The deliberations of
participants may identify points of convergence, researchable questions, and communication and
management options to balance risks and benefits and promote evidence-based decision making
informed by advances in understanding of microbiota compositions and functions. Presenters will
contribute manuscripts from the workshop exercises in a special collection for submission to the SRA
journal Risk Analysis in 2019.
For updates and further information, check Upstate NY SRA website (http://sra.org/upstateny) or email
inquiries to [email protected].
Questions for the Panel:
1. What changes are induced in breast milk by Holder pasteurization? What uncertainties remain in our
knowledge of the effects of pasteurization on breast milk with regard to infant health and disease?
2. What are the risks and benefits of pasteurizing donor breast milk for infants (NICU and others)? How
does pasteurization affect the development of infant microbiota, immune, and gastrointestinal
systems? Transmission of and resistance to disease? The ability of infants to grow and thrive?
3. Why did human milk banks in Australia, New Zealand, and US decide to require pasteurization of
donor breast milk? Why did human milk banks in Norway decide not to require pasteurization of
donor breast milk? What trends are observed for health and disease under the different risk
management strategies?
4. What researchable questions might reduce uncertainties for risks and benefits and strengthen the
scientific basis for evidence-based decision making?
5. Next topic (2018 workshop): What is evidence on risks and benefits of other milks (e.g., bovine)? How
can stakeholders contribute to assessing and balancing risks and benefits for the microbiota of milks
in the 21st century?
Key References 1. Addis MF, Tanca A, Uzzau S, Oikonomou G, Bicalho RC, Moroni P. 2016. The bovine milk microbiota: insights and perspectives from –
omics studies. 12(8):2359-72.
2. American Academy of Pediatrics (AAP), Committee on Nutrition, AAP Section on Breastfeeding, AAP Committee on Fetus and
Newborn. 2017. Donor Human Milk for the High-Risk Infant: Preparation, Safety, and Usage Options in the United States. Pediatrics
139(1):e20163440.
SRA Round Table Panel Symposium: Joint Regional Organization Project on Microbiota of Milks
4
3. Australia Department of Health. 2014. Donor Human Milk Banking in Australia- Issues and Background Paper. Available at
http://www.health.gov.au/internet/main/Publishing.nsf/Content/
D94D40B034E00B29CA257BF0001CAB31/$File/Donor%20Human%20Milk%20Banking%20in%20Australia%20paper%20(D14-
1113484).pdf.
4. Bode L, McGuire M, Rodriguez JM, et al. 2014. It’s alive: Microbes and cells in human milk and their potential benefits to mother and
infant. Advances in Nutrition 5(5):571-3.
5. KH, Black RE, de Romaña GL, de Kanashiro HC. 1989. Infant-feeding practices and their relationship with diarrheal and other diseases
in Huascar (Lima), Peru. Pediatrics 83(1):31-40.
6. Cacho NT, Lawrence RM. 2017. Innate Immunity and Breast Milk. Frontiers in Immunology 8(584)1-10.
7. Cossey V, Vanhole C, Eerdekens A, Rayyan M, Fieuws S, Schuermans A. 2013. Pasteurization of mother’s own milk for preterm
infants does not reduce the incidence of late-onset sepsis. Neonatology 103(3):170-6.
8. Costard S, Espejo L, Groenendaal H, Zagmutt FJ. 2017. Outbreak-related disease burden associated with consumption of
unpasteurized cow’s milk and cheese, United States, 2009–2014. Emerging Infectious Diseases 23(6):957.
9. Dietert RR. 2016. The Human Superorganism: How the Microbiome is Revolutionizing the Pursuit of a Health Life. Dutton, NY, NY.
341 p.
10. Dietert RR. 2013. Natural childbirth and breastfeeding as preventive measures of immune-microbiome dysbiosis and misregulated
inflammation. Journal of Ancient Diseases & Preventive Remedies. 1(2):1-8.
11. Elahi S, Ertelt JM, Kinder JM, et al. 2013. Immunosuppressive CD71+ erythroid cells compromise neonatal host defence against
infection. Nature 504(7478):158-162. doi:10.1038/nature12675.
12. Frei R, Roduit C, Bieli C, et al. 2014. Expression of genes related to anti-inflammatory pathways are modified among farmers’
children. Moser M, ed. PLoS ONE 9(3):e91097. doi:10.1371/journal.pone.0091097.
13. Food and Drug Administration (FDA). 2011. Communicating Risks and Benefits: An Evidence-Based User’s Guide. Available at:
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm268078.htm.
14. Food Standards Agency (UK/FSA). 2015. Update on FSA Review of Controls for Raw Drinking Milk. FSA 15/07/04. Available at:
https://www.food.gov.uk/news-updates/news/2015/14132/fsa-board-discussion-on-raw-milk.
15. Gomez-Gallego C, Garcia-Mantrana I, Salminen S, Collado MC. 2016. The human milk microbiome and factors influencing its
composition and activity. InSeminars in Fetal and Neonatal Medicine 21(6):400-405. WB Saunders.
16. Gribble KD, Hausman BL. 2012. Milk sharing and formula feeding: infant feeding risks in comparative perspective? The Australasian
Medical Journal 5(5):275.
17. Grøvslien AH, Grønn M. 2009. Donor milk banking and breastfeeding in Norway. Journal of Human Lactation 25(2):206-10.
18. Gregory KE, Samuel BS, Houghteling P, Shan G, Ausubel FM, Sadreyev RI, Walker WA. 2016. Influence of maternal breast milk
ingestion on acquisition of the intestinal microbiome in preterm infants. Microbiome 4(1):68.
19. Houghteling PD, Walker WA. 2015. Why is initial bacterial colonization of the intestine important to the infant's and child's health?
Journal of Pediatric Gastroenterology 60(3), 294-307. http://doi.org/10.1097/MPG.0000000000000597.
20. Hourigan SK, Chen LA, Grigoryan Z, Laroche G, Weidner M, Sears CL, Oliva‐Hemker M. 2015. Microbiome changes associated with
sustained eradication of Clostridium difficile after single faecal microbiota transplantation in children with and without inflammatory
bowel disease. Alimentary Pharmacology & Therapeutics 42(6):741-52.
21. Hunt KM, Foster JA, Forney LJ, Schütte UME, Beck DL, McGuire MK, McGuire MA. 2011. Characterization of the diversity and
temporal stability of bacterial communities in human milk. PLoS ONE 6(6): e21313.
SRA Round Table Panel Symposium: Joint Regional Organization Project on Microbiota of Milks
5
22. Jeurink, P.V. et al. 2013. Human milk: A source of more life than we can imagine. Beneficial Microbes 4(1):17-30.
23. Jiménez E, de Andrés J, Manrique M, Pareja-Tobes P, Tobes R, Martínez-Blanch JF, Codoñer FM, Ramón D, Fernández L, Rodríguez
JM. 2015. Metagenomic analysis of milk of healthy and mastitis-suffering women. Journal of Human Lactation 31(3):406-15.
24. Jost T, Lacroix C, Braegger C, Chassard C. 2013. Assessment of bacterial diversity in breast milk using culture-dependent and culture-
independent approaches. British Journal of Nutrition 110:1253-62.
25. Kamada, N., Chen, G.Y., Inohara, N., Núñez, G. 2013. Control of pathogens and pathobionts by the gut microbiota. Nature
Immunology 14(7), 685-90.
26. Kurath S, Halwachs‐Baumann G, Müller W, Resch B. 2010. Transmission of cytomegalovirus via breast milk to the prematurely born
infant: a systematic review. Clinical Microbiology and Infection 16(8):1172-8.
27. Ladomenou F, Moschandreas J, Kafatos A, et al 2010. Protective effect of exclusive breastfeeding against infections during infancy: a
prospective study. Archives of Disease in Childhood 95(12):1004-8.
28. Landers S, Updegrove K. 2010. Bacteriological screening of donor human milk before and after Holder pasteurization. Breastfeeding
Medicine 5(3):117-21.
29. Langer AJ, Ayers T, Grass J, Lynch M, Angulo FJ, Mahon BE. 2012. Nonpasteurized dairy products, disease outbreaks, and state
laws—United States, 1993–2006. Emerging Infectious Diseases 18(3):385-91.
30. Lawley TD, Walker AW. 2012. Intestinal colonization resistance. Immunology. 138(1):1-11. doi:10.1111/j.1365-2567.2012.03616.x.
31. Levitan D. 2017. Not a Scientist: How Politicians Mistake, Misrepresent, and Utterly Mangle Science. WW Norton & Company, New
York, NY. 256 p.
32. Loss G, Depner M, Ulfman LH, van Neerven RJ, Hose AJ, Genuneit J, Karvonen AM, Hyvärinen A, Kaulek V, Roduit C, Weber J, Lauener
R, Pfefferle PI, Pekkanen J, Vaarala O, Dalphin JC, Riedler J, Braun-Fahrländer C, von Mutius E, Ege MJ. 2015. PASTURE study group.
Consumption of unprocessed cow's milk protects infants from common respiratory infections. Journal of Allergy Clinical Immunology
135(1):56-62. doi: 10.1016/j.jaci.2014.08.044. Epub 2014 Oct 19. PubMed PMID: 25441645.
33. McGuire MK, McGuire MA. 2015. Human milk: mother nature’s prototypical probiotic food? Advances in Nutrition 6(1):112-23.
doi:10.3945/an.114.007435.
34. Meier P, Patel A, Esquerra-Zwiers A. 2016. Donor human milk update: evidence, mechanisms, and priorities for research and
practice. The Journal of Pediatrics 180:15-21.
35. Menon G, Williams TC. 2013. Human milk for preterm infants: why, what, when and how? Archives of Disease in Childhood-Fetal
and Neonatal Edition 98(6):F559-62.
36. Montjaux-Régis, N., Cristini, C., Arnaud, C., Glorieux, I., Vanpee, M. and Casper, C. 2011. Improved growth of preterm infants
receiving mother’s own raw milk compared with pasteurized donor milk. Acta Paediatrica, 100: 1548–54. doi:10.1111/j.1651-
2227.2011.02389.x.
37. Moro GE, Arslanoglu S, Bertino E, Corvaglia L, Montirosso R, Picaud JC, Polberger S, Schanler RJ, Steel C, van Goudoever J, Ziegler EE.
2015. XII. Human milk in feeding premature infants: consensus statement. Journal of Pediatric Gastroenterology and Nutrition
61:S16-9.
38. Narayanan I, Murthy NS, Prakash K, Gujral VV. 1984. Randomised controlled trial of effect of raw and holder pasteurised human milk
and of formula supplements on incidence of neonatal infection. Lancet 324(8412):1111-13.
39. Omarsdottir S, Casper C, Åkerman A, Polberger S, Vanpée M. 2008. Breastmilk handling routines for preterm infants in Sweden: a
national cross-sectional study. Breastfeeding Medicine 3(3):165-70.
SRA Round Table Panel Symposium: Joint Regional Organization Project on Microbiota of Milks
6
40. Pannaraj PS, Li F, Cerini C, Bender JM, Yang S, Rollie A, Adisetiyo H, Zabih S, Lincez PJ, Bittinger K, Bailey A. 2017. Association
between breast milk bacterial communities and establishment and development of the infant gut microbiome. JAMA Pediatrics.
Published online May 8, 2017. doi:10.1001/jamapediatrics.2017.0378.
41. Pricope-Ciolacu L, Nicolau AI, Wagner M, Rychli K. 2013. The effect of milk components and storage conditions on the virulence of
Listeria monocytogenes as determined by a Caco-2 cell assay, International Journal of Food Microbiology 166(1):59-64.
42. Quigley L, McCarthy R, O'Sullivan O, Beresford TP, Fitzgerald GF, Ross RP, Stanton C, Cotter PD. 2013. The microbial content of raw
and pasteurized cow milk as determined by molecular approaches. Journal of Dairy Science 96(8):4928-37.
43. Schanler RJ, Lau C, Hurst NM, Smith EOB. 2005. Randomized trial of donor human milk versus preterm formula as substitutes for
mothers' own milk in the feeding of extremely premature infants. Pediatrics 116(2):400-5.
44. Schanler RJ, Fraley JK, Lau C, Hurst NM, Horvath L, Rossmann SN. 2011. Breastmilk cultures and infection in extremely premature
infants. Journal of Perinatology 31(5):335-8.
45. Small MJ, Güvenç Ü, DeKay ML. 2014. When can scientific studies promote consensus among conflicting stakeholders? Risk Analysis
34:1978-94.
46. Sozańska B, Pearce N, Dudek K, Cullinan P. 2013. Consumption of unpasteurized milk and its effects on atopy and asthma in children
and adult inhabitants in rural Poland. Allergy 68:644-50.
47. Squires LS. 2017. Modeling adverse outcomes in very low birth weight infants based on an infant diet of mother’s breast milk and
donor breast milk (Doctoral dissertation, University of Washington).
48. Stasiewicz MJ, Martin N, Laue S, Gröhn YT, Boor KJ, Wiedmann M, et al. 2014. Responding to bioterror concerns by increasing milk
pasteurization temperature would increase estimated annual deaths from listeriosis. Journal of Food Protection 77:696e–712.
49. Strand TA, Sharma PR, Gjessing HK, Ulak M, Chandyo RK, et al. 2012. Risk Factors for Extended Duration of Acute Diarrhea in Young
Children. PLoS ONE 7(5): e36436. doi:10.1371/journal.pone.0036436
50. Thorley V. 2012. Human milk banking to 1985. Breastfeeding Review 20(1):17-23.
51. Turin CG, Ochoa TJ. 2014. The role of maternal breast milk in preventing infantile diarrhea in the developing world. Current Tropical
Medicine Reports 1(2):97-105.
52. Unger K. 2010. Human milk banking. Paediatric Child Health 15(9):595-8.
53. Urbaniak C, Cummins J, Brackstone M, et al. 2014. Microbiota of human breast tissue. Macfarlane GT, ed. Applied and
Environmental Microbiology 80(10):3007-14.
54. Van der Waaij D, Vries JMB, der Wees JECL. 1971. Colonization resistance of the digestive tract in conventional and antibiotic-
treated mice. The Journal of Hygiene 69(3):405-11.
55. Wahl A, Baker C, Spagnuolo RA, Stamper LW, Fouda GG, Permar SR, Hinde K, Kuhn L, Bode L, Aldrovandi GM, Garcia JV. 2015. Breast
milk of HIV-positive mothers has potent and species-specific in vivo HIV-inhibitory activity. Journal of Virology 89(21):10868-78.
56. Walker WA, Iyengar RS. 2015. Breast milk, microbiota, and intestinal immune homeostasis. Pediatric Research 77(1-2):220-8.
57. Ward TL, Hosid S, Ioshikhes I, Altosaar I. 2013. Human milk metagenome: a functional capacity analysis. BMC Microbiology
13(1):116.
58. World Health Organization, UNICEF. 2003. Global strategy for infant and young child feeding. World Health Organization; Geneva.
59. Wiedemann P, Schütz H, Spangenberg A and Krug HF. 2011. Evidence maps: communicating risk assessments in societal
controversies: the case of engineered nanoparticles. Risk Analysis 31:1770-83. doi:10.1111/j.1539-6924.2011.01725.x.