Should industry sponsor research?

Opinions are divided on whether research and educational material funded by the tobacco, alcohol, or infant formula industries can be scientifically sound or whether it is inevitably tainted. Here, doctors, researchers, and a member of a pressure group argue the pros and cons.

Tobacco industry research: collaboration, not confrontation, is the best approach

Editorial by Smith Letters(p 344 Filler (p 318 News (p 301

Smoking is strongly associated with several diseases, sufficiently so for public health authorities to say that smoking is a cause of disease and to have warned the public for many years of the dangers of smoking. British American Tobacco respects these actions. Yet science has still to ascertain precise biological mechanisms whereby prolonged exposure to constituents of tobacco smoke causes these diseases. Science has also yet to determine why, for most diseases associated with smoking, the overwhelming majority of lifetime smokers do not contract the diseases, and why there are geographical differences in the incidence of many diseases that are related to smoking.

The public health conclusion that smoking is a cause of disease can lead to two quite different approaches. One approach determines that nothing can be gained from a greater understanding of the relation between smoking and disease, that no one should smoke, and that all efforts should focus on persuading people not to smoke. The second approach continues to persuade people not to smoke but accepts that smoking is a popular custom and seeks to discover more about the association between smoking and various diseases in order to determine what changes to tobacco products might be introduced to reduce the risks associated with smoking.

Historically, British governments have taken the second approach, working with tobacco companies and supporting the funding of biomedical research related to tobacco modification. This has led to a greater understanding of smoking behaviour, constituents of smoke, and possible mechanisms of disease. This knowledge has led to recommendations that smokers should choose low tar cigarettes. The work of Britain's Tobacco Products Research Trust is well documented as a sustained effort to address smoking and health issues in a practical manner.1

The question today is whether there is value in biomedical research seeking to identify precisely the biological mechanisms whereby long term exposure to constituents of tobacco smoke may contribute to the development of disease. For British American

Tobacco, such an effort is clearly worth while as such investigations may lead to support from public health authorities for product modifications. For biomedical researchers, we also think that there is value as such efforts should lead to a greater understanding of disease and hence to the reduction of disease incidence and improvements in treatment.

If it is agreed that such research is worth doing then the only arguments against the tobacco industry contributing to the support of such research would be either that the results of such research may be presented in a skewed manner or that the results could in some way confuse the public health message.

As far as the first point is concerned, fundamental biomedical research has little value if the results are not peer reviewed and published for general consideration. The second point requires a trust in the integrity of scientific researchers and the peer review process.2

Irrespective of the outcome of any particular scientific research, the loss of mutual scientific respect between British American Tobacco and public health authorities would be a disadvantage to the community; surely collaboration, not confrontation, is the best approach to making scientifically worthwhile progress on smoking and health.

Tobacco company sponsorship discredits medical but not all research

Perhaps the most straightforward objection to sponsorship of medical research by tobacco companies is that as soon as the source of the funding is known the research is discredited. The tobacco industry has only itself to blame, for over the decades it has put its own spin on damaging evidence. In the United States especially, it has engaged scientists to publish papers calling into question the many studies that have shown the addictiveness of nicotine and the connection between heart and lung disease and active and passive smoking. Rather like lawyers arguing a case according to clients' instructions, the hired researchers have often claimed that the apparently damaging evidence is not full enough or have brought up arcane methodological objections. And the partisanship of some of these papers has often been concealed. The links of the authors with the tobacco industry have been covered up.

Condemning the drinks industry rules out potentially useful research

Almost all funding comes with strings attached. At a minimum, the recipient must be accountable for how grants are spent. At a maximum, the recipient must deliver a particular product that is acceptable to the donor. Whether funds are received from the researcher's university, the government, an intergovernmental organisation, industry, or a private donor, the research that is carried out must be of a professional standard and —particularly if additional funding will be sought in the future —should be relevant to the concerns of the funder or science generally.

The argument has been advanced that funding from the drinks industry is somehow so tainted that it corrupts any research endeavour and should be rejected. It is difficult to understand, however, why money from the drinks industry is any more corrupting than money from the pharmaceutical, food, car, or chemical industries, each of which also has profitmaking as its primary corporate goal. And, if the profit motive can bias research then certainly the possible ideological bias of governments —for example, alcohol or high energy consumption is in itself undesirable —must be equally suspect.

There seem to be two primary arguments against industry funding of alcohol research: (a) that researchers who receive such funding engage in poor biased science, which can mislead the public and policymakers; and (b) that industry funding improperly distorts the scientific research agenda, to the detriment of public health.

The first objection, if true, should be met by applying the same professional standards applicable to any research, whatever the source of funding. Whether the results are published in peer-reviewed journals or by advocacy organisations, the quality of scientific research should be judged on its own merits. Sloppy or slanted research should be rejected, and it is doubtful whether the personal reputation of any researcher could survive well founded allegations of bias.

The second objection seems to be based on an exaggerated premise, since research funded by the drinks industry pales beside that supported either by other industries, such as the pharmaceutical industry, or national governments. For example, the Alcohol Beverage Medical Research Foundation (the major industry funder of scientific research in the United States) contributed about $2m (£1.3m) to alcohol research in 1995; and the National Institute on Alcohol Abuse and Alcoholism (funded by the US government) spent nearly $200m in 1996, most of which was devoted to research. In any case, the logical response to inappropriate research (research that answers questions the critics would rather not have asked) or inadequate research is to increase funding from other sources, not to diminish the total pool of available knowledge.

None the less, the suspicion remains that the source of money may call into question the integrity of the recipient, whether it is industry funding of alcohol research or government funding of human rights organisations. This suspicion is deepened if an organisation tries to conceal the source of funding or when an individual or organisation comes to rely too heavily on a single, interested source. It is also true that some companies and other interested parties do attempt to manipulate scientific research and mislead the public.

The response to these concerns should not be to prohibit research that is needed but rather to develop ethical principles to protect the integrity of donors and recipients. To this end, a meeting of 24 experts —including scientists, industry executives, government officials, public health experts, and individuals from intergovernmental and non-governmental organisations —adopted a set of “Principles of Cooperation among the Beverage Alcohol Industry, Governments, Scientific Researchers, and the Public Health Community” in Dublin in May 1997. These “Dublin Principles” recognise the social responsibility of the private sector, as well as of researchers, “to further public knowledge about alcohol and prevent its misuse.” This responsibility includes the presentation of information to the public on the health and societal impact of alcohol in an “accurate and balanced manner.”

Funding from the drinks industry stems from profits derived from the sale of morbidity and mortality

• Download figure
• Open in new tab
• Download powerpoint

The Dublin Principles call on industry, governments, and non-governmental organisations to support independent scientific research on “the use, misuse, effects, and properties of alcohol and the relationships among alcohol, health, and society.” They mandate full disclosure of funding sources and of any potential conflicts of interest when seeking funding, and they set forth the basic principle that researchers should be free to disseminate and publish the results of their work. The effect of these principles will depend on their acceptance by industry and researchers and, ultimately, on a mechanism to monitor compliance with their provisions.

A blanket prohibition of industry funding may be simpler than directly addressing the ethical issues surrounding the relationship between funder and recipient. We should also respect the beliefs of those who argue against drinking on moral or religious grounds. However, a condemnation of the drinks industry and thereby elimination of potentially useful research because of moralistic ideology should be rejected by anyone who claims to serve the interests of science.

If the drinks industry does not clean up its act, pariah status is inevitable

Should researchers take money from the drinks industry? Alcohol always excites passion. I will try to identify some of the issues that may properly bear on deciding how to answer that question.

It is useful to distinguish between the inherent ethicality of a product and that of the industry which manufactures and markets that product. Alcohol is in ethical terms an unusually ambiguous commodity. It provides employment, gives pleasure, can be consumed without harm, and may even perhaps confer health benefit. But it is also a toxic and addictive substance that causes illness, accident, violence, death, family suffering, and social costs —on a vast scale. And despite the disingenuous attempts of the drinks industry to uncouple “use” from “misuse” there is compelling research evidence showing that the greater the population's per capita consumption of alcohol, the greater the related harm will be. Alcohol use has a lot to do with the burden of alcohol problems.

Alcohol is not as dirty a product as tobacco, but if we choose to take money from the drinks industry we should be willing to admit that the money stems from profits derived not only from the marketing of fun but also from the sale of morbidity and mortality. Hence the ambiguity. And yet are we not indirectly taking drinks and tobacco money all the time, with the chancellor our collecting agent?

And what of the people who work in the drinks industry? Are they the sort of individuals with whom researchers should be willing to sip and sup? If we take the industry's money we inevitably confer on those individuals a little bit of respectability. Some of us who have had recent experience of the industry's machinations are likely to contend that it has, over the past few years, too often behaved as if it were on a convergent path with the worst practices of the tobacco industry. The drinks conglomerates are very clearly targeting young people, as witnessed by their woeful behaviour over “alcopops.” They are trying to target the developing world in a way highly reminiscent of the tobacco manufacturers.3They are denying the relevance of scientific evidence of population consumption for public health in a manner strikingly reminiscent of the feigned blindness of the tobacco industry to the addictiveness of nicotine. They have set up front organisations, such as the Washington based International Center for Alcohol Policies, the Amsterdam Group, and the Portman Group, which are willing to clone the tobacco industry tactics.

Amusingly, the Portman Group is to be found in the 1995 telephone directory under its true colours as “research and media releases for the drinks industry,” but it has since put on a new disguise and re-emerged as “the industry's watch dog.” And it was of course the Portman Group that in 1994 sought to pay academics £2000 each for joining an anonymous attack on a report by the World Health Organisation4 that had documented evidence on the relation between alcohol consumption and drinking problems.5

So should researchers take research money from a tainted industry which exploits vulnerable populations, mounts attacks on valid research and independent researchers, and which, through its front organisations, tries to distort the truth? Those considerations suggest perhaps an answer tilting towards a “no” in a more obvious way than some scientists might on first inspection have thought.

Here, however, are some linked proposals for an interim solution to the dilemma. Firstly, it could be agreed that no one should accept money direct from the drinks industry. Direct funding of that kind is seldom adequately refereed and is often aimed at biasing activity in the field.6Secondly, funding at arm's length through an intermediary organisation might be seen as acceptable, provided that the intermediary is genuinely free from direct or indirect influence from the drinks industry. Thirdly, the industry should be invited to dismantle its front organisations before they are forced in that direction, as happened in a recent court agreement in the United States with the tobacco industry.

Any middle way can indeed only be provisional. If the drinks industry goes on behaving in Britain and in other countries in its present unethical manner, it will inevitably and deservedly join the tobacco industry in a pariah status.

Collaborative research with infant formula companies should not always be censored

Companies have in the past received intense criticism over the marketing of infant formula in developing countries, where reduction in breast feeding has been associated with morbidity and shorter intervals between births. Despite official intervention, international codes of practice, national legislation, and a code drawn up by the manufacturers of infant formula, political debate continues. An investigation last year of infringements of the World Health Organisation's code in five countries7—although criticised for flawed science8 —has further fanned the flames.

Sponsorship remains an emotive issue. Some contend that it is wholly improper for clinical research, scientific meetings, or professional organisations to be financially assisted by formula companies. Conversely, the editor of an international paediatric journal, supporting sponsorship, stated: “It is quite extraordinary how in such a serious debate over the years, these aggressive attacks [on the infant formula industry] have been led by groups with scanty scientific-epidemiological evidence, together with a most unwelcome emotional component.”9 As director of a politically “neutral” government-funded (MRC) Childhood Nutrition Centre, I shall attempt to steer among these polarised views.

The importance of infant formula and of manufacturers of infant formula, at least in the West, deserves emphasis. Regular cows' milk is not now recommended for babies aged under 12 months, so unless all mothers were persuaded to breast feed for a year regardless of personal circumstances, we need infant formula. We also need it in cases of lactational failure and maternal death (0.5 million cases a year worldwide) and when breast milk endangers the infant —for example, if the mother has HIV infection or is taking certain drugs or if the infant has certain rare inborn errors of metabolism. In premature babies, human milk requires supplementation with formula products to meet the infants' special needs and prevent substantial undernutrition. Even in developing countries, infant formula is safer than alternatives when breast feeding is impossible or inadvisable—though risks of introducing formulas into such environments are well recognised. In the United Kingdom in 1995 the prevalence of breast feeding at 4 months was only 27%,10so most babies will need formula milk for most of infancy, even those initially breast fed.

Furthermore, although formula manufacturers cannot by law advertise to mothers, of the 750 000 women who become pregnant annually in Britain, 350 000 approach the industry directly for advice. Indeed, since paediatric nutrition has no formal subspecialty status and little specialist medical training exists, the infant formula industry is an important information source for parents. In 1997 a leading baby milk manufacturer distributed 300 000 articles to British parents in support of breast feeding.

The low prevalence of breast feeding causes concern, and some find the industrial input to maternal education upsetting.But in reality, manufacturers of infant formula have a major role in the health care of infants.

As infant formula is the commonest food used for Western infants, research into its efficacy and safety is essential. Evidence that nutrition during critical, early stages may have important programming effects on adult health 11 12puts a new onus on formula manufacturers to carry out high quality outcome studies. The design of the formula can have significant effects in premature babies on cognitive, immunological, and bone outcomes years later.5 13 14Interestingly, in baboons, breast feeding followed by an “unphysiological” Western-style diet (as, arguably, occurs in humans)resulted in more atherosclerosis in adulthood than in those fed formula15;and in humans, males who were breast fed beyond a year were at increased risk of cardiovascular disease.16Although these preliminary observations should not influence practice, they signal that even the most cherished views should not be immune to future critical research.

Fully adjusted risk of stroke in the Korean national health system study,1986-2001

• Download figure
• Open in new tab
• Download powerpoint

Research into infant nutrition is fast moving, requiring substantial investment and close collaboration between responsible clinical scientists and industry. Manufacturers cannot and should not operate independently. The WHO recognises the need for quality feeding products for infants, implying a research need. Provided that researchers declare their funding sources, they should not be censored for industrial collaborative research into child health. Indeed, influential findings on the importance of breast milk come from industrially supported studies. 17 18

Educational sponsorship is contested. One breast feeding organisation contends that a medical conference is not “baby friendly” if the baby food industry acts as a sponsor or has a commercial presence —for example, through stalls,advertising,etc.Educational achievements of the industry have, however,been impressive. Over 100 Ross conferences in the United States,about 50 Nestlé workshops, and major inputs from other infant formula manufacturers have produced prominent publications, objective discussion, and policymaking over wide ranging issues, including breast feeding—with undoubted contribution to health care.

Sponsorship of major professional organisations, however, is more problematic. Whereas some wish to see these independent of any commercial input, others argue that we should encourage the infant formula industry and the medical profession to work together by allowing the industry to be part of the scientific community.

The real conflict is that some still contend that manufacturers of infant formula damagingly compete with breast feeding worldwide and that company affiliations affect the independence of health professionals. The counter view is that formula manufacturers now in general act responsibly, within local laws, and —unlike,say,tobacco companies —answer a clinical need. The issues require sensitive consideration. Nevertheless it is my observation that most clinicians, including me, believe that formula companies provide a critical contribution to infant health care, health education, and high quality research.

How much research in infant feeding comes from unethical marketing?

Sponsorship is “a payment by a business firm … for the purpose of promoting its name, products or services. It is a commercial deal, not a philanthropic gift.” This is how the British government described sponsorship in a 1986 leaflet issued by the Office of Arts and Libraries.

Sponsorship is vital to a company's marketing strategies, and it affects not only our health, and our environment but also whether people live or die. Because so many influential health professional bodies and doctors in industrialised countries have given up the fight for adequate public funding of essential research, training, and information —and have become dependent on corporate finance —those who should be speaking out on behalf of public health are often silent when debates arise about legislation to control corporate sponsors and stop commercial exploitation.

Some scientists argue that it is a public health duty to work with companies to improve the quality of products. They are affronted by any suggestion that such involvement might constitute a conflict of interest. In the case of infant feeding, however, the nutritional advantages of one brand of artificial formula over another and the development of niche products such as specialised formulas — the focus of so much research —have far less impact on world health compared with the enormous benefits derived by infants if they have access to their mothers' milk. This is especially true when mothers cannot read or have no access to sanitation or money to buy sufficient quantities of the product. Yet much of the money that funds research in infant feeding is profit from the unethical marketing of breast milk substitutes to the world's poorer populations.19 21

Is it reasonable to believe that development of formulas is driven by concern for health? If it is, why do leading companies allow the composition of their brands to vary from country to country? Why are expensive ingredients added only if accompanied by health claims, which will result in increased sales? Why do infant formulas contain cheap ingredients, such as sucrose, when sold in Asia, but not when sold in Europe? Can it be ethical that better quality formulas are the prerogative of rich populations? And when problems of contamination arise, why do companies have to be forced to reveal the extent of the problem?

How is it that scientists, who pride themselves on their academic rigour in the laboratory, so often seem to be unaware of these issues? Why do so many fail to monitor the activities of their sponsors or acknowledge the impact that their involvement might have in the global context? Why are the bland corporate assurances that these products will answer world hunger, or that they adhere to UN resolutions, believed by so many? Why is it only the non-profit, non-governmental organisations that publicise and expose marketing activities and call for stricter controls?

Companies —especially those that are the subject of criticism —have a particular need to offer sponsorship, knowing that it works on many levels. Without it, they would find it much harder to silence potential critics;create the image that they are responsible “corporate citizens” who can be trusted to regulate themselves; influence public health policies and priorities; link their name to prestigious non-governmental organisations, United Nations agencies, and doctors;affect the direction and outcome of research; create dependency;create public confusion about the real causes of poverty.

Of course they have a responsibility to research and improve products, and of necessity they must employ scientists. But such involvement inevitably creates a conflict of interest, and this is why corporations go to such lengths to ensure that their scientists sit on influential committees such as the Committee on Medical Aspects of Food, Codex Alimentarius Commission (the commission that produces recommended food standards for the world), the new Food Standards Agency, or the European Scientific Committee for Food. Some of these committees have already had an important influence on food laws and the public and are part of the reason that UK law is so weak and that so few women in Britain breast feed. Surely the public should be able to trust that such public bodies do not favour commercial interests over public health.

As long ago as 1983, Professor John Reid of the University of Cape Town said to industry representatives at the 12th annual meeting of the World Sugar Research Organisation: “There is a hidden agenda in the research support business. Those who accept your [industries']support are often perceived to be less likely to give you a bad scientific press. They may come up with the results that cause you problems, but they will put them in a context in a way that leaves you happier than had they emanated from someone not receiving your support. My own observation and comment is that this hidden effect is powerful, more powerful certainly than we care to state loudly, from the point of view of honour either in science or in industry. It takes a lot to bite the hand that feeds you.”

The world is facing many difficult problems that need the close attention of everyone concerned with public health. If sustainable solutions are to be found, surely it is imperative that adequate public funds are set aside for this purpose —instead of money that has already been allocated by industry for an entirely different purpose, namely marketing.