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Tackling conflict of interest in infant nutrition

Tackling conflict of interest in infant nutrition. One Asia Breastfeeding Partners Forum 6 Colombo, Sri Lanka M. Q-K Talukder. Definition of conflict of interest.

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Tackling conflict of interest in infant nutrition

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  1. Tackling conflict of interest in infant nutrition One Asia Breastfeeding Partners Forum 6 Colombo, Sri Lanka M. Q-K Talukder

  2. Definition of conflict of interest A set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Institute of Medicine as quoted in NEJM 2009, 306: 2160-2163 Professionals have a conflict of interest when their interests or commitments compromise their independant judgement or their loyalty to whom they have an ethical and/or legal duty to serve. Rodwin MA

  3. History of infant feeding practices

  4. 1925BC: Allah inspired Moses’ mother to breastfeed her son after birth. In the house of pharaoh Moses’ mother was unknowingly recruited to breastfeed Moses • In Bible timesbreastfeeding was recognized as the best feeding for infants • 640AD: Allah says “The mothers shall give suck to their offspring for two whole years, if they desire to complete the term.” • 1500-1943:Mostly, periods of lactational failure described as manmade error. AL Qur’an Surah Qasas Ayat 7 & 12 Barnes LA 1987 History Of Infantfeeding Practice AJCN 46;168-70 AL Qur’an Surah Bakarah, Ayat 233 Wickes Arch dis child1953:28;495-502

  5. 1784 Underwood (England), a physician, recommends cow’s milk as alternative to breastfeeding • 1800 Glass feeding bottles • 1838 Simon (Germany) determines cow’s milk has more protein than human milk. • 1845 Pratt (United states) patents rubber nipple • 1856 Borden co-patents condensed milk • 1867 Von Liebig (Germany) markets prepared food • 1867 Henri Nestle (Germany) prepared the commercial infant formula

  6. 1881 attempts at artificial feeding in the first weeks of life resulted in the death of almost 100% of infants Radbill SX. Infant feeding through the ages. Clin Pediatr 1981; 20: 613-21 Quoted by Barness LA history of infant feeding practices. AJCN 1987;46: 168-70

  7. at death’s door as was not breastfed

  8. One year old child weighing 4 kg Wasted buttock and loose skin

  9. 1883 Meyenberg (Germany) patents evaporated goat’s milk • 1885 Meigs (United states) analyses human milk: 1.1% protein, 4.7% fat, 6.2% sugar • 1897 Finkelstein(Germany) notes importance of care and attention to infant welfare • 1898 Multiple patented foods introduced (e.g., Mellin’s food) • 1903 International congress of obstetricians concerned about artificial feeding at the expense of breastfeeding. • 1904 Rotch (United States) distributes percentage formulas for infant feeding. • 1911 Dextri-maltose introduced in United states by Mead Johnson. • 1915 Gestenberger (United States) introduces synthetic milk adapted (SMA) formula; need only add water

  10. 1920 SMA introduced by Wyeth • 1920s: Publications - “Later development of breastfed and artificially fed infants” JAMA1929: 92,615. -“Breastfeeding in the reduction of infant mortality” AJPH 1921:11, 153 -“Infant mortality in relation to Breastfeeding” New York State Journal of Medicine 1924:24, 433. • 1925 Similac marketed in United states by Ross Labs. • 1929 Mead Johnson introduce Sobee “hypoallergenic” formula • 1930-1960 Concentrated liquid formulas, hydrolysed formulas, elemental formulas, and ready-to-feed formulas introduced

  11. 1939: Cicely Williams MD, FRCP at Singapore Rotary club Lecture on MILK AND MURDER • “If your lives were embittered as mine is, by seeing day after day this massacre of the innocents by unsuitable feeding, then I believe you would feel as I do that misguided propaganda on infant feeding should be punished as the most criminal form of sedition, and that those deaths should be regarded as murder”

  12. 1940: Rooming in project in USA by Edith Jackson • 1953: “Management of breastfeeding” JAMA 1953:151, 192 • 1956: LLLI founded; Core principle is mother support • 1968:Derrick Jelliffe coins the term “commerciogenic malnutrition to describe the impact of industry” • 1970: UN protein-calorie group convenes a meeting which raised concern about industry practices • 1973: UK New Internationalist magazine in 1973 ran a cover page of powder milk tragedy as BABY KILLER

  13. 1974: War on Want publishes The baby killer: a report on infant malnutrition and promotion of artificial feeding practices in the third world • 1976: Law suit filed against Bristol-Myers for promotional activities in the third world • 1977: Nestle Boycott begins in the US followed by other countries.

  14. 1979 First WHO and UNICEF meeting for promotion, protection and support of breastfeeding and complementary feeding with call for severe restrictions on infant formula making. • 1981:WHO adopts the International Code on Marketing of Breastmilk Substitutes

  15. 1982: Child survival revolution by UNICEF with GOBI-FFF concept

  16. 1984: Bangladesh ordinance on the code for the marketing of breastmilk substitutes (BMS Code) 1990: BMS Code partially revised and passed in the parliament

  17. 1980s-2008 Violation of the BMS Code by milk companies and the medical profession continues

  18. 1980s-2009 Infant formula contaminants • Materials: Broken glass, Fragments of metals • Metals: Aluminum, Manganese, Cadmium, Lead, Mercury, Arsenic • Chemicals: Melamine, Nitrates, MSG Neurotoxins, Phthalates and Bisphenol A, Phytoestrogens in Soya based formula, Pesticides, weedkillers, insecticides, solvents, chlorine biproducts

  19. 1980-2009 Infant formula contaminants: Microbes: E. sagazaki, Salmonella E. Coli,Citrobactor, Clos butolinum Cryptosporidium, Giardia

  20. 2004: WHO and FAO stated • Infant formula is not a sterile product and there may be microbes in the powder milk • No technology is available at present to produce sterile powder milk

  21. One milk company in UK puts notice on the tin labels “ Powder baby milk formulas are not sterile and reconstituted feeds are at risk of infection”

  22. 2008 Melamine tragedy In China • Child life tragedy for profit • At least 14 children have died • Over 50000 became sick • Children in Thousands developed renal failure • Children in Thousands developed renal stones

  23. Melamine found in 8 brands of powder milk in Bangladesh

  24. Definition of conflict of interest A set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. Institute of Medicine as quoted in NEJM 2009, 306: 2160-2163 Professionals have a conflict of interest when their interests or commitments compromise their independant judgement or their loyalty to whom they have an ethical and/or legal duty to serve. Rodwin MA

  25. Global and national legal systems re: conflicts of interest in infant nutrition International code of marketing of BMS • Articles 7.3, 7.5 WHA resolutions: • WHA 49.15,1996 • WHA 54.2, 2001

  26. WHA 58.32, 2005 “to ensure that financial support and other incentives for programmes and health professionals working in infant and young child health do not create conflict of interest”. This resolution underlines that sponsorship by baby food manufacturing companies of research, conferences, seminars, workshops or other scientific meetings that deal with any aspect of infant and young child health and nutrition can lead to potential conflict of interest.

  27. WHA 61.20,2008 Global strategy for infant and young child feeding 2002 IMS Act India 1992 ammended in 2003 Prohibited, by law, all actions related to conflicts of interest

  28. “There is no such thing as a free lunch” -Milton Friedman “Better starve free than be a fat slave” -Aesop

  29. Tackling conflicts of interest: 2 case studies

  30. 1st case study: 25th International Pediatric Association (IPA) Congress

  31. 25th IPA congress • 25th IPA congress in 2007 attended by over 6,000 Pediatricians at Athens sponsored by milk companies • All 24 previous congresses were sponsored by milk companies Conflict of interest

  32. 25th IPA congress • Letter of protest and appeal to IPA executives from WABA signed by the President and 8 Pediatricians • Letter of protest and appeal to IPA executives from IBFAN Asia and BPNI by Arun Gupta and JP Dadhich not to accept sponsorship from formula industry Measures taken

  33. 25th IPA congress • IPA offered breastfeeding symposium at the Congress • IPA offered booth to disseminate information on breastfeeding • IPA offered to jointly organise workshop and courses for Pediatricians at the national and regional levels • From next IPA congress in 2010, IPA itself will handle sponsorship IPA reply to WABA and IBFAN Asia

  34. 25th IPA congress • This year (2009) the IPA President has said, “…companies that produce breast milk substitutes for infants are strictly banned (from sponsoring the IPA congress) since their activities conflict with our goals on exclusive breastfeeding for babies.” IPA kept its promise

  35. 25th IPA congress • WABA and IBFAN Asia should write letters congratulating the IPA • BF groups should attend the IPA congress in 2010 (attendance at the last congress over 6,000) with submission of research papers What we should be doing now

  36. 2nd case study: 19th International Congress of Nutrition (ICN)

  37. 19th ICN • The 19th International Congress of Nutrition, Bangkok Oct 2009, attended by over 4,000 participants, was funded by milk companies Conflict of interest

  38. 19th ICN • Arun Gupta from IBFAN Asia sent a protest note to the IUNS and the organisers of the 19th ICN asking them to abstain from taking sponsorship from the milk companies • Several participants attending the ICN spoke at various sessions on the conflicts of interest in infant nutrition Measures taken

  39. 19th ICN • Many participants expressed views against the use of RUTF • Some participants spoke to the key persons of the IUNS and ICN against the conflicts of interest • Participants spoke of the conflicts of interest at the annual meeting of the SCN Measures taken

  40. 19th ICN • The IUNS and ICN executives listened and said they would see what should be done • SCN Chairman Alexander Muller said they would be minimising conflicts of interest from now on and would be asking the non-food corporates to sponsor the congress Result

  41. 19th ICN • We should be writing to the IUNS, ICN and SCN executives about how they can help the world’s malnourished children by avoiding conflicts of interest Future action required

  42. Areas of conflicts of interest in infant nutrition • Infant formula, Powder milk • Commercial complementary foods • Micronutrient sprinkles • Fortified high energy biscuits • RUTF • Vitamin A in the newborn period • Research publications in medical journals eg on RUTF, any other publication funded by milk company or food industry • Accepting sponsorships by International and National Medical Associations from milk companies to hold seminars, conferences

  43. Whom to tackle on conflicts of interest • Pediatricians • Obstetricians • Doctors at large • WHO • UNICEF • WFP • ACC SCN • Codex Alimentarius • Bilateral agencies • Milk companies • Governments • Politicians • Research funding agencies • Journal editors

  44. New England Journal of Medicine • The Medical Journal of Australia • World Association of Medical Editorss • Journal of the Danish Medical Association • Croatian Medical Journal • Annals of Internal Medicine • National Library of Medicine • The Lancet • Canadian Medical Association Journal • Norwegian Medical Journal • BMJ • The New Zealand Medical Journal • Dutch Journal of Medicine • JAMA

  45. ICMJE Uniform Disclosure Form for Potential Conflicts of Interest Information about: • The author • The support of the work • Relevant financial relationships outside the submitted work • Financial relationships involving spouse, partner or children • Relevant non-financial associations

  46. “…We also realize .....there may be situations that are not covered by the form....” October 2009 ICMJE Opportunity for us To send suggestions to ICMJE regarding publications on infant nutrition with conflict of interest before April 2010. www.icmje.org

  47. “Knowing is not enough; we must apply.Willing is not enough; we must do.”— Goethe

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