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
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
History of infant feeding practices
• 1925 BC: 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 times breastfeeding was recognized as the best feeding
for infants
• 640 AD: 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
• 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
• 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
at death’s door as was not breastfed
One year old child
weighing 4 kg
Wasted buttock and loose
skin
• 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
• 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
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”
• 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
• 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.
• 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
1982: Child survival
revolution by UNICEF with
GOBI-FFF concept
1984: Bangladesh ordinance on the
code for the marketing of breastmilk
substitutes (BMS Code)
1990: BMS Code partially revised and
passed in the parliament
1980s-2008
Violation of the BMS Code by
milk companies and the medical
profession continues
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
• 1980-2009 Infant formula contaminants:
Microbes: E. sagazaki, Salmonella E.
Coli,Citrobactor, Clos butolinum
Cryptosporidium, Giardia
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
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”
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
Melamine found in 8 brands of
powder milk in Bangladesh
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
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
• 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.
• 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
“There is no such thing as a free lunch”
-Milton Friedman
“Better starve free than be a fat slave”
-Aesop
Tackling conflicts of interest:
2 case studies
1st case study:
25TH INTERNATIONAL PEDIATRIC
ASSOCIATION (IPA) CONGRESS
25th IPA
congress
Conflict of interest
• 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
25th IPA
congress
Measures taken
• 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
25th IPA
congress
IPA reply to WABA
and IBFAN Asia
• 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
25th IPA
congress
IPA kept its promise
• 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.”
25th IPA
congress
What we should be
doing now
• 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
2nd case study:
19TH INTERNATIONAL CONGRESS OF
NUTRITION (ICN)
19th ICN
Conflict of interest
• The 19th International
Congress of Nutrition,
Bangkok Oct 2009, attended
by over 4,000 participants,
was funded by milk
companies
• Arun Gupta from IBFAN Asia sent a
protest note to the IUNS and the
th
19 ICN
organisers of the 19th ICN asking them
Measures taken 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
19th ICN
Measures taken
• 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
19th ICN
Result
• 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
19th ICN
Future action
required
• 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
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
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
• 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
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
“…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
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
— Goethe