|Pressure on science - Arpad Pusztai (9/3/2008)|
1.Pressure on science - Arpad Pusztai 2.Does Industry Sponsorship Undermine the Integrity of Nutrition Research? NOTE: Dr. Pusztai's article is a response to a previously published article by Martijn Katan, Professor of Nutrition at Vrije Universiteit, Amsterdam (item 2). ---
1.Pressure on science - Arpad Pusztai
2.Does Industry Sponsorship Undermine the Integrity of Nutrition Research?
NOTE: Dr. Pusztai's article is a response to a previously published article by Martijn Katan, Professor of Nutrition at Vrije Universiteit, Amsterdam (item 2).
---1.Pressure on science
As research has become expensive and state funding has been drying up, most scientists welcome the influx of industrial money. However, this also has a number of not-so-welcome consequences. Understandably industry feels that the results of research financed by them are 'confidential business information'. However, lack of transparency in research, particularly on important biological issues without scientific consensus may not only jeopardize human/animal health and lead to environmental damage, but is also against the interest of science. This prevents the exchange of results and views between scientists—the lifeline of science, without which no scientific progress is possible. Selective publication of data favourable to the sponsor is serious for society and also distorts science. One recent such paper that is typical of many suggests that selective reporting of the results of antidepressant drug trials could have had serious consequences for researchers, health care professionals and patients (1). Hiding data indicating the dangers of smoking, or that of BSE (bovine spongiform encephalitis), or that the genetically engineered tryptophan supplement was involved in the eosinophylia myalgia syndrome or not publishing the significant differences between some health-defining constituents of GE- and non-GE-soybeans, all had serious consequences for science and society (2).
Financing of research by industry does undoubtedly have a positive contribution to science but its distorting effects may also lead to the corruption of values and even the scientists (3,4). Thus, the Director of Public Employees for Environmental Responsibility (PEER) and Union of Concerned Scientists stated that a disinformation syndrome afflicts science and government scientists (5) because their survey showed that one in five scientists had been directed to exclude or alter information in a scientific document and more than half reported cases where commercial interests had induced the reversal or withdrawal of research conclusions. Moreover, a third had been stopped to openly express opinion in public or some even within the agency. An article in Nature (3) reported that more than 15 percent of the 3,247 respondents had been directed to change the design, methodology or reverse or withdraw research conclusions due to commercial interests and political intervention and 1.5 percent admitted falsification of data or plagiarism. A recent paper on the relationship between funding source and conclusion in nutrition-related articles concluded 'Industry funding of nutrition-related scientific articles may bias conclusions in favour of sponsors’ products, with potentially significant implications for public health' (6).
Peoples' views on science are undeniably influenced by media reports. Thus, the survey of the Institute of Professional Managers and Specialists in 2000 showing that 30 percent of the 500 respondents had been asked to tailor their research conclusions, 17 percent to change them to suit the customer's preferred outcome, or if they wanted a further contract, and 3 percent were told not to publish 'unwelcome' results, was seriously damaging for science. Similarly, the U.S. Fish and Wildlife Service reported that 44 percent of the respondents have been directed to withhold data that indicated the need for protection of species and 20 percent to compromise their integrity by excluding or altering data. An investigation of 103 government scientists by the National Institutes of Health revealed that 44 government scientists violated ethics rules when working with pharmaceutical companies, and nine may have violated criminal laws. Many world-famous scientists, including Sir Richard Doll, had received financial payments from relevant industries whose products they investigated but without disclosing this in publications (7). The damaging consequences could be further exacerbated because of the 274 complaints of misconduct the Department of Health and Human Services could only investigate 23, due to staffing shortage.
This issue can no longer be ignored. A solution must be found for maximizing the benefits of industrial sponsorship but without jeopardizing the credibility of the research and the scientists. Questions, such as whether the lure of profits could corrupt biomedical research (8,9) or whether industry sponsorship could undermine the integrity of nutrition research (10) must be settled to the satisfaction of both society and science. The previous high standing of scientists can only be restored if we return to the principles of openness and transparency.
1. Turner EH, Matthews AM, Linadartos E, Tell RA, Rosenthal R (2008) Selective publication of antidepressant trials and its influence on apparent efficacy. New England J.Med 358, 252-260
2. Pusztai A, Bardocz S (2006)'GMO in Animal Nutrition: Potential Benefits and Risks, In Biology of Nutrition in Growing Animals, ed. R. Mosenthin, J. Zentek, and T. Zebrowska (London: Elsevier Limited), 513–540.
3. Wadman M (2005)'One in Three Scientists Confesses to Having Sinned,' Nature 435, 718–719.
4. Pusztai A (2002) GM food safety: Scientific and institutional issues. Science as Culture, 11, 70-91.
6. Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS (2007) Relationship between funding source and conclusions among nutrition-related scientific articles. PLoS Medicine, www.plosmedicine.org. Volume 4, issue 1/e5, 0001-0005.
7. Hardell L (2006) 'Secret Ties to Industry and Conflicting Interests in Cancer Research,' American Journal of Industrial Medicine, http://www3.interscience.wiley.com/cgi-bin/abstract/113451325/ABSTRACT.
8. Krimsky S, Rothenberg LS (2001) Conflict of interest policies in science and medical journals. Editorial practices and author disclosures. Science and Engineering Ethics, 7, 205-218.
9. Krimsky S (2003) Science in the private interest; has the lure of profits corrupted biomedical research? New York, Rowman & Littlefield 2003. ISBN 074251479X.
10. Katan MB, (2007) Does industry sponsorship undermine the integrity of nutrition research? PLoS Medicine (www.plosmedicine.org). January 2007. Volume 4, issue 1/e6, 0001-0002.
2.Does Industry Sponsorship Undermine the Integrity of Nutrition Research?
The commercial success of foods depends more and more on what science says about the effects of these foods on health. Drug companies have tried to influence the scientific record so as to make their products look healthier [1,2]; are food companies doing the same? In a study published in PLoS Medicine, Lesser et al.  investigated this by analyzing 206 publications on the health effects of milk, soft drinks, and fruit juices. Twenty-four of these studies had been funded solely by the industry whose product was investigated, while 52 of the papers declared that they had had no industrial support. The other papers had mixed support or did not declare sponsorship.
The odds that a paper would report a favorable outcome were four to eight times higher when the study was funded by the manufacturer of the beverages in question than when the study was not funded by industry. Out of the 35 interventional studies, which included human trials, industry was the sole sponsor of 16, and none of these 16 reported an unfavorable outcome. In contrast, seven of the 19 interventional studies with mixed or no industry funding found an unfavorable effect. Thus, papers sponsored by industry were more likely to report favorable outcomes for that industry's beverages than papers with other sources of funding.
The study by Lesser et al. was carefully done, the number of articles was sufficiently large, the analyses were straightforward, and they agree with the outcomes of earlier, smaller studies. However, an association between funding and outcome does not by itself prove bias. First, five of the papers dealt with outbreaks of food poisoning and none of these studies was funded by industry, which strengthened the correlation of unfavorable outcomes with the absence of industry funding. But industry was, of course, never asked to fund these studies and therefore bias was not an issue. Second, when producers plan to fund a nutrition study, they will naturally select a product with a potentially favorable nutritional profile.
However, such selection is the start of a slippery slope. When an industry is the major sponsor of research on its own product, unfavorable effects of that product are less likely to be investigated. The next step down the slope is adjustment of designs. The dosage of the product and the nature of control treatments may be adjusted so as to increase the chance that the study will demonstrate benefits of the product or that adverse effects will not reach statistical significance. Also, unfavorable data may be deemed less relevant and may be left out of the abstract and the press release, or out of the paper itself. Finally, the whole publication may be cancelled or seriously delayed when the outcome is disappointing to the sponsor. Innocuous-sounding clauses in the contract may give the company such a veto right, and investigators may not fully realize the consequences of what they are signing. Some contract research organizations grant the sponsor that veto right up front. Even if researchers can legally publish the data, they may be reluctant to antagonize a major sponsor.
There are indications that all these things happen [4,5], but there are few hard quantitative data to prove it. As Marion Nestle said in her landmark book : 'I could not find anyone who would speak to me ‘on the record’ for this book. When I told friends in government, food companies, and academia that I was writing a book about how the food industry affects nutrition and health, they offered to tell me anything I wanted to know, but not for attribution.' We obviously need more studies of the relations between industry and nutrition research, and they may need to go beyond the data made public in scientific journals. Meanwhile, what should we do? My personal experience makes me reluctant to support a blanket condemnation of industry-supported research, because collaboration with industry has allowed me to discover things that I could not have found otherwise. We discovered the effects of trans fatty acids on heart disease risk  thanks to the expertise of Unilever, and the cholesterol-raising factor in unfiltered coffee  thanks to Nestlé.
But researchers dealing with industry may be subjected to pressure, and they need help to resist such pressure. Most universities now have a code of conduct on relations with industry and conflicts of interest, but when the negotiations come down to the wire, and money and jobs are at stake, then a code of conduct may not be enough to keep a researcher on the straight and narrow. The Royal Netherlands Academy of Sciences has put forth an innovative proposal on how to supervise relations between researchers and their sponsors . For now, the Lesser et al. study raises serious concerns that some food industries may distort the scientific record on diet and health. Such concerns affect nutrition science as a whole, if only because they threaten public confidence in nutrition research, and once that confidence is gone nutrition research becomes irrelevant.
Bodenheimer T (2000) Uneasy alliance—Clinical investigators and the pharmaceutical industry. N Engl J Med 342: 1539–1544. Find this article onlineLexchin J, Bero LA, Djulbegovic B, Clark O (2003) Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ 326: 1167–1170. Find this article onlineLesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS (2007) Relationship between funding source and conclusion among nutrition-related scientific articles. PLoS Med 4: e5. doi:10.1371/journal.pmed.0040005. Find this article online Nestle M (2002) Food politics: How the food industry influences nutrition and health Berkeley: University of California Press. 469. p.
Royal Netherlands Academy of Arts and Sciences (2005) [Science on demand]. In Dutch, with English summary Available: http://www.knaw.nl/publicaties/pdf/20051083.pdf. Accessed 7 December 2006.
Mensink RP, Katan MB (1990) Effect of dietary trans fatty acids on high-density and low-density lipoprotein cholesterol in healthy subjects. New Engl J Med 323: 439. Find this article onlineWeusten-van der Wouw MPME, Katan MB, Viani R, Huggett AC, Liardon R, et al. (1994) Identity of the cholesterol-raising factor from boiled coffee and its effects on liver function enzymes. J Lipid Res 35: 721. Find this article onlinevan der Meer JWM, de Gier AM, van Swaaij WPM, Katan MB (2007) Independent medical research? Neth J Med In press.
*Funding: The author received no specific funding for this article.
Competing Interests: The author has three projects funded by the Wageningen Centre for Food Sciences, an alliance of major Dutch food industries, research institutes, and the Dutch government. None was involved in this editorial. In the past 25 years he has received funding or research materials from Unilever, Nestlé, the Netherlands Dairy Organization, Campina BV, Friesland Foods, the European coffee industry, and the olive oil council, and he has spoken at expenses-paid meetings of these industries, as well as the tea council and the chocolate industry. He sometimes gives unpaid informal advice to colleagues in the food industry. He does not consult or testify for industries, accepts no money or gifts beyond a bottle of wine or book token, and has no stocks or other financial interests in food or beverage companies.
Martijn B. Katan is Royal Netherlands Academy of Sciences Professor of Nutrition at Vrije Universiteit, Amsterdam, The Netherlands. E-mail: [email protected]