Rapid Responses to:

EDUCATION AND DEBATE:
Christopher J Proctor, Tom Sorell, Hurst Hannum, Griffith Edwards, Alan Lucas, and Patti Rundall
Ethical debate: Should industry sponsor research? Tobacco industry research: collaboration, not confrontation, is the best approach Tobacco company sponsorship discredits medical but not all research Condemning the drinks industry rules out potentially useful research If the drinks industry does not clean up its act, pariah status is inevitable Collaborative research with infant formula companies should not always be censored How much research in infant feeding comes from unethical marketing?
BMJ 1998; 317: 333-339 [Full text]
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Rapid Responses published:

[Read Rapid Response] Title of article does not reflect my views
Alan Lucas   (31 July 1998)
[Read Rapid Response] Untitled
John Dobbing   (4 August 1998)
[Read Rapid Response] Untitled
Jean Coussins   (5 August 1998)
[Read Rapid Response] Collaborative research with infant formula companies
Tony Waterston   (18 August 1998)
[Read Rapid Response] Funding of Research by Infant Formula Companies is Ethical.
David C A Candy   (7 September 1998)
[Read Rapid Response] Good Research Practice Promotes Individual Responsibility
Phyll Buchanan, Magda Sachs   (1 October 1998)
[Read Rapid Response] Breast feeding: the baby friendly initiative
John Dobbing   (16 November 1998)
[Read Rapid Response] Formula companies have a duty to undertake research
Anthony F Williams   (16 December 1998)

Title of article does not reflect my views 31 July 1998
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Alan Lucas,
MRC clinical research professor
Institute of Child Health, London

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Re: Title of article does not reflect my views

The title of my recent article "Collaborative research with infant formula companies should not always be censored" was added by the BMJ and does not reflect my views.(1) It implies that in most or many instances censorship is or should be in operation. I would have chosen as a title "Collaborative research with infant formula companies should be encouraged"; as in pharmaceutical research, high quality product development is in the interests of child health.

1 Lucas A. Should industry sponsor research? Collaborative research with infant formula companies should be encouraged. BMJ 1998;317:337-8. (1 August.)

Untitled 4 August 1998
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John Dobbing

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Re: this article

EDITOR – Professor Lucas is to be congratulated on braving the fury of that noisy band of anti formula company activists by accepting the Industry's support of research and other academic activities (1). None of my own published research has been Industry supported, although I have more recently organised Workshops and published about a dozen related books, some of which were sponsored by Industry (see e.g. 2). In none of these did any of the sponsors attempt to interfere with either their organisation or their publication.

The BMJ has led the world in setting out strict ethical standards for scientific publication: but I fear that it has lately been guilty of double standards. In the matter of duplicate or redundant publication, its publishing of the article by Taylor (3) is a case in point. All the research results in that paper had already been exactly and prominently published internationally about 15 months earlier (4). Regarding 'conflict of interest', that article and the accompanying Leader also transgress the BMJ's own rules. The article, describing a large international study, purports to be written by a solo author, with only an MSc and with no academic or medical affiliation, quite a departure for the BMJ which almost always sets out affiliation to lend credibility to a paper. That this is unlikely to be the whole story is confirmed in an acknowledgement that Dr Anthony Williams and Professor Andrew Tomkins 'gave editorial assistance'. I wonder why they eschewed declared authorship? Was it because Tomkins' own Reader, Costello. wrote the accompanying Leader? How could the BMJ not recognise Costello's conflict of interest?

In a press release dated 10 April journalists are invited to contact Tomkins and not the paper's author for further details! And in your own somewhat holier than thou Leader today the editor writes 'we try to avoid having an editorial written by somebody with a major conflict of interest etc.' (5). Really? Then how did Costello get to write a Leader on his own partner's 'edited' article? He couldn't even get the title of the article he was commenting on right, and the Editorial staff didn't spot this! Sloppy editing! I am unworthily suspicious that the editor is not unbiased in this matter, based on much recent evidence. The latest is the fabrication of the title of Lucas' article (1), directly contrary to the author's wishes, as set out in his protest on your web site dated 31 July.

John Dobbing.

Emeritus Professor of Child Growth and Development, University of Manchester. e-mail: john@nwpsu.u-net.com

References 1. Lucas, A. Collaborative research with infant formula companies should not always be censored. BMJ 1998; 317:337-338. (see amended title on BMJ website, 31 July, 1998). 2. Dobbing, J. (Ed) Developing Brain and Behaviour: The Role of Lipids in Infant Formula. London, Academic Press. 1997. 3. Taylor, A. Violations of the international code of marketing of breast milk substitutes: prevalence in four countries. BMJ 1998; 316:1117-1122. 4. Cracking the Code. Interagency Group on Breastfeeding Monitoring. London, January 1997. 5. Smith, R. Beyond conflict of interest. BMJ 1998; 317:291-292.

Untitled 5 August 1998
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Jean Coussins,
Director

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Re: this article

Far from being a 'front organisation' for the drinks industry, as alleged by Griffith Edwards (BMJ, 1 August), The Portman Group has always been open in acknowledging that it is funded by the leading drinks producers. It must surely be right that these companies play their part, alongside parents, health professionals and others, in promoting sensible drinking and helping to prevent alcohol misuse.

Our work is carried out irrespective of the commercial consequences to the industry, as those companies who have been forced to spend considerable sums of money on modifying or scrapping drinks whose name and packaging failed to meet our standards of social responsibility in marketing could testify.

Professor Edwards is well short of the mark in accusing the drinks industry of using tobacco industry tactics. Those who produce and sell alcohol have no need to resort to such tactics. There is now a vast body of research demonstrating that alcohol in moderation is perfectly compatible with a healthy lifestyle for most people.

It is not the drinks industry but Professor Edwards himself who is so notably isolated in his reluctance to accept the overwhelming consensus of scientific, academic, medical and health promotion opinion which informed and supports the Government's balanced guidelines on sensible drinking.

Yours faithfully,

JEAN COUSSINS Director The Portman Group 2d Wimpole Street London W1M 7AA

Collaborative research with infant formula companies 18 August 1998
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Tony Waterston

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Re: Collaborative research with infant formula companies

The issue which Lucas (BMJ 1st August, p 337) fails to tackle is conflict of interest in relation to research. Much of his paper justifies the need for bottle feeding (with which no-one would argue), plays up the educational role of formula manufacturers (highly questionable as their material has been shown to have biased content), and casts doubt on the long term benefits of breast feeding (not relevant to the key issue). He strays into the area of educational sponsorship where there is far less justification for industry support than in research, which is notoriously difficult to fund.

Lucas makes virtually no mention of what the opponents of sponsorship are worried about: the aggressive sales tactics of formula manufacturers in poor developing countries (now confirmed in a global study1 which has been endorsed by UNICEF) and the inevitability of a bias towards formula feeding in those who take industry money. It is a blot on the reputation of paediatricians world wide that they have been seen to side with milk companies in what is a highly unbalanced marketing struggle: the example of the Indian Paediatric Association is a shining exception.

For the vast majority of babies who need artifical milk, the present formulas serve them well and there would seem no need of further modification. Perhaps a compromise approach is possible for the small number of research centres which are working on new preterm formulas Could the formula company funds be channeled through an independent organisation and the company remain anonymous ? It is essential that not only is there no conflict of interest, but that researchers are seen to recognise the damage that can be done internationally by overt association between paediatricians and formula manufacturers.

We hope that the new sponsorship policy being worked on by the Royal College of Paediatrics and Child Health will clarify these issues and take a strong stand for breast feeding.

Yours sincerely

Tony Waterston Consultant Paediatrician, Arthur's Hill Clinic, Douglas Terrace, Newcastle upon Tyne NE4 6BT Tel 0191 219 5196

Dr Ashok Nathwani Consultant Paediatrician

Professor David Morley 51 Eastmoor Park, Harpenden, Herts AL5 1BN

Dr Neela Shabde Consultant Paediatrician Albion Rd Clinic, Albion Rd, North Shields NE 29 0HG

Prof Nick Spencer Dept of Community Paediatrics, University of Warwick

Dr Gilles de Wildt General Practitioner 17 Jiggins Lane Surgery Bartley Green, Birmingham B31 2EB

Dr Pam Zinkin Retired Senior Lecturer in Child Health 45 Anson Rd, London N7 0AR

Reference

1. Taylor A. Violations of the international code of marketing of breast milk substitutes: prevalence in four countries. BMJ 1998; 316:1117-9

Funding of Research by Infant Formula Companies is Ethical. 7 September 1998
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David C A Candy,
Consultant Paediatrician
St Richards Hospital, Chichester

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Re: Funding of Research by Infant Formula Companies is Ethical.

81 Lauderdale Tower, Barbican, London EC2Y 8BY Tel: 0171 588 9315 Work: 0171 346 3563 Fax: 0171 346 3643

17 August 1998

The Editor British Medical Journal BMA House Tavistock Square London EC1H 9JR

Dear Sir

REF: Funding of research by infant formula companies

The funding of research by infant formula companies is necessary, unavoidable and beneficial(1). In spite of the importance of nutrition in medicine, and the depth of understanding of nutritional processes on a molecular level, funding for nutritional research is difficult to obtain in competition with molecular biology. Applied nutritional research is anyway most appropriately funded by industry. The scientific staff of infant formula companies bring extensive expertise to nutritional research collaboration.

Your editorial on this subject was informed by Professor Alan Lucas, whose most celebrated research was supported by infant formula companies. Amongst many other conclusions, breast milk was shown to have vital benefits in the nutrition of low-birth-weight infants(2).

The counter argument was posed by Ms Patti Rundall, whose organisation is engaged in advocacy and lobbying rather than nutritional research(3). This follows the recent outdated and flawed publication on the infant formula code(4). Your correspondent is forced to speculate that academic nutritionists prepared to communicate their opposition to research support by the infant formula industry could not be found.

In the same issue, the importance of disclosure of conflict of interest is covered in a constructively worded editorial(5). Professor Lucas’ article clearly identifies his position. The qualification of Ms Patti Rundall is more opaque perhaps because the last ten years of her very high profile campaign against the infant food industry might, in some of your readers’ minds, have disqualified her as an objective commentator.

Yours sincerely,

David C A Candy. Consultant Paediatrician St Richard’s Hospital, Chichester (298 words)

Conflict of Interest: Member of Professional Advisory Panel, Nestlé UK Ltd

(1)Lucas A. Collaborative research with infant formula companies should not always be censored. BMJ 1998;317:337-338.

(2)Lucas A, Cole TJ. Breast milk and neonatal necrostising enterocolitis. Lancet 1990;336@1519-23.

(3)Rundall P. How much research in infant feeding comes from unethical marketing? BMJ 1998;317:338-9.

(4)Wise J. Baby milk companies accused of breaching marketing code. BMJ 1997;314:167.

(5) Smith R. Beyond conflict of interest. BMJ 1998;317:291-2.

Good Research Practice Promotes Individual Responsibility 1 October 1998
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Phyll Buchanan,
Breastfeeding Supporters
The Breastfeeding Network,
Magda Sachs

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Re: Good Research Practice Promotes Individual Responsibility

In the correspondence following the articles by Lucas and Rundall (BMJ 1st Aug 98), it is interesting to note that the assumption is that anyone who raises the difficulties of commercially funded research in the field of infant feeding is seen as anti-formula rather than pro-good research.

The emphasis of industry driven research is generally about finding answers which are useful to the company concerned. The ultimate mandate of a company is to earn profits for shareholders and the explicit agenda is seeking to gain an edge over others - which may involve documenting the superiority of some element of their product through research.

Those working with parents who are making choices about feeding their babies find that trial outcomes of industry supported research are often unhelpful, as useful outcomes are not included in the trials. We suggest that implementing the recommendations of DoH Report 47 "Guidelines on the Nutritional Assessment of Infant Formulas" could resolve this, and enable parents to actively choose for their babies. (The government Green Paper "Our Healthier Nation" encourages individuals to take responsibility for their own health).

Outcomes measured could be long-term measures of child health, and might include other outcomes of interest to parents, eg. changes in the taste of formulas, increase in allergenic responses, and incidence of constipation. Above all, trials should include a comparison group of children exclusively breastfed for 4 to 6 months (the physiologically normal standard). It is this reference to the standard which is often missing from commercially funded research, but which can inform the choices of parents, by placing the findings in context.

Your correspondent David Candy points out that Patti Rundall works for an 'advocacy and lobbying group'. The point is not that her concerns may have been informed in a particular manner and direction, but that we must each recognise our own potential for bias and strive to declare our position and interests openly. We congratulate the BMJ for producing the 'guidance for declaration of competing interest' as a safeguard designed to raise standards.

Breast feeding: the baby friendly initiative 16 November 1998
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John Dobbing

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Re: Breast feeding: the baby friendly initiative

EDITOR: In my letter of 4th August last commenting on an article from Alan Lucas on collaborative research with infant food companies (1) (which you for some reason mistakenly published on the Internet as a response to a quite different article on tobacco research by Christopher Proctor) I referred to 'that noisy band of anti formula company activists'. Three more band members (2) have now surfaced, unable as usual to avoid putting the same kind of 'spin' on the subject to which we are more accustomed from the advertising industry or the party politicians.

Regarding the breast feeding initiative, they try to persuade us of the 'great progress made'. 'Eleven British maternity units', they tell us, 'have achieved the required standard'. True, they do accept that a former, stringent criterion of a 75% breastfeeding rate (whatever that means) has had to be relaxed in order to achieve this result, which begins to give the game away.

What they do not say is that in the United Kingdom we have about 340 hospitals, of which as many as 278 have maternity units. While (or perhaps because) I wish any breast feeding initiative well, I think for them to have only enrolled 11 out of 278 maternitiy hospitals over all these years is a dismal performance, considering (or perhaps because of?) all their activism and zeal. When they have a reasonable achievement, would they perhaps write to us again?

John Dobbing

Emeritus Professor of Child Growth and Development, University of Manchester. E-mail: john@nwpsu.u-net.com

1. Lucas, A. Collaborative research with infant formula companies should not always be censored. BMJ 1998; 317:337-338.

2. Radford, A., Rickitt, C., Williams, A. Unicef's baby friendly initiative is making great progress in UK. BMJ; 317:1385.

Formula companies have a duty to undertake research 16 December 1998
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Anthony F Williams,
Senior Lecturer & Consultant in Neonatal Paediatrics
Department of Child Health, St George's Hospital Medical School, Cranmer Terrace, London SW17 0RE

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Re: Formula companies have a duty to undertake research

Sir,

In his rapid response of 16 November Professor Dobbing describes me (in a curious mixed metaphor) as a "noisy anti-formula company activist" who has "surfaced" to "put a spin" on breastfeeding.

I am sorry he chooses to trivialise and polarise a complex issue in this way. I would like to assure him that I am not "anti-formula company" but fully acknowledge the important role and achievements of industry in developing artificial diets for healthy and sick infants. It has a responsibility to undertake clinical research during the process of product development, as recommended by the COMA report to which I contributed [1]. It follows that individual paediatricians and other scientists must work with industry to achieve this goal.

What I oppose is the advertising and promotion of breastmilk substitutes to parents. In accordance with the International Code" [2] I believe they are entitled to receive clear factual and scientific information about infant feeding from an independent health professional, not from a source with a commercial interest. It is unfortunate that this key principle is still incompletely enacted in European and United Kingdom legislation.

Yours faithfully

Anthony F Williams

1. Department of Health. Guidelines on the nutritional assessment of infant formulas. Rep. Hlth. Soc. Subj. 47. The Sationery Office, London, 1996.

2. World Health Organisation. International Code of Marketing of Breastmilk Substitutes. Geneva, 1981.