December 2007

Food and Nutrition Science: Does it Matter Who Pays the Bill?
By Sharon Palmer, RD
Today’s Dietitian
Vol. 9 No. 12 P. 48

Some may question its credibility, but research is undeniably beneficial to dietetics—perhaps even when it’s funded by industry.

During the past decade, unethical practices in the political and corporate worlds have unfolded in the public eye, helping to nurture a distrust of powerful people in the right places. So it’s only natural that the ethics of scientific research might come under scrutiny, especially if it appears that the party footing the bill has something at stake. “Some people wonder, ‘If the research is funded by industry, can I really trust the results?’” says Daniel Fabricant, PhD, vice president of scientific and regulatory affairs for the Natural Products Association in Washington, D.C.

There’s no doubt that industry enjoys its just desserts when the sweet kiss of science is bestowed on a product line. Just look at the popularity that omega-3 fatty acids and blueberries have enjoyed since the release of favorable studies on their health benefits. Due to the onslaught of scientific studies being reported in mainstream media outlets, consumers are getting savvy about science. And research helps sell products. “Products with science behind them have risen to the top,” Fabricant says.

When Good Science Goes Wrong
Concerns over ethics in research are nothing new, thanks to a few high-profile cases splashed in newspapers in which researchers falsified data—and then some. On April 10, 1997, the Securities and Exchange Commission filed the first case ever brought against a biomedical researcher from Wayne State University on allegations of insider trading. The commission charged that the investigator and his wife had alerted at least six people that the clinical trial on which he was lead investigator had failed to demonstrate the effectiveness of the drug.

The pharmaceutical industry has taken a few hits when it comes to its potential influence on the research world. In 2004, New York Attorney General Eliot Spitzer took on GlaxoSmithKline PLC, filing a lawsuit that Glaxo had committed fraud by withholding negative information and misrepresenting data on prescribing its antidepressant Paxil to children. The lawsuit indicated that Glaxo had suppressed four studies failing to demonstrate the drug was effective in treating children and adolescents and suggesting a possible increase of suicidal thinking and acts. The lawsuit also referred to an internal 1999 Glaxo document showing that the company intended to “manage the dissemination of data in order to minimize any potential negative commercial impact.”1

In a systematic review published in BMJ in 2003, researchers from York University in Toronto; the University of California, San Francisco; the University of South Florida in Tampa; and Instituto do Radium de Campinas in Brazil investigated whether the funding of drug studies by the pharmaceutical industry is associated with outcomes that are favorable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support.

In the 30 studies, the researchers discovered that research funded by drug companies was less likely to be published than research funded by other sources and that studies sponsored by pharmaceutical companies were more likely to have outcomes favoring the sponsor than were studies with other sponsors. The authors concluded that systematic bias favors products made by the company funding the research. Possible explanations for these findings included inappropriate comparators to the product being investigated, publication bias, and poor-quality research conducted by the industry.2

In a high-profile British case reported in The Times Higher Education Supplement in 2005, Aubrey Blumsohn, MBBCh, BSc(hon), MSc, PhD, MRCPath, senior lecturer at Sheffield University’s Bone Metabolism Research Unit, went public with his concerns about the conduct of a Sheffield University study with the drug company Procter & Gamble. Blumsohn was suspended when he rejected a £145,000 payment from his university to hand over research data.

The Times Higher Education Supplement reported that findings on Procter & Gamble’s osteoporosis drug Actonel had been released under the name of Sheffield researchers, but the researchers had not carried out their own independent analysis of the drug-trial data.3 A variety of issues relating to the influence of the pharmaceutical industry were raised in the 126-page House of Commons Health Committee report, in which many recommendations were made to help make reforms.4

Researchers investigated the association between industry funding and statistically significant proindustry findings in medical and surgical randomized trials in a 2004 article published in the Canadian Medical Association Journal. Three hundred and thirty-two randomized trials published between January 1999 and June 2001 in eight leading surgical journals and five medical journals were included. In 37% of the trials, authors declared industry funding. The researchers concluded that industry-funded trials were more likely to be associated with statistically significant proindustry findings, both in medical trials and surgical interventions.5

Concerns about ethics in medical research also extend to patient health information. According to a cross-sectional survey published in BMC Public Health in 2006, 69 patient organizations covering 10 disease states based in the United States, the United Kingdom, Australia, Canada, and South Africa were assessed for indicators of transparency, advertising, and disclosure of pharmaceutical funding. While patient organizations’ Web sites were clear about their identity, target audience, and intention, only one third were clear about how they obtained their funds. Only four of 69 Web sites stated advertising and conflict of interest policies. One third of Web sites showed one or more company logos and/or had links to pharmaceutical Web sites.6

Food and nutrition research joined the suspicion club when an article was published in PLOS Medicine in January exploring the relationship between funding source and conclusion among nutrition studies. Based on searches of worldwide literature, three article types about soft drinks, juice, and milk published between January 1, 1999, and December 31, 2003, were identified, for a total of 206 articles. It was discovered that the funding source was significantly related to study conclusions. For interventional studies, the proportion with unfavorable conclusions was 0% for all industry funding vs. 37% for no industry funding. The researchers concluded that industry funding of nutrition-related scientific articles may bias conclusions in favor of sponsors’ products.7

In an article published in the same issue, Martijn B. Katan, PhD, a Royal Netherlands Academy of Sciences professor of nutrition at Vrije Universiteit in Amsterdam, reported: “When an industry is the major sponsor of research on its own product, unfavorable effects of that product are less likely to be investigated.”

Weeding Out the Problems
To combat a negative image, a new emphasis has been placed on eliminating potential ethical conflict in research. Nutrition and medical conference organizers often request speakers to disclose information on funding and potential conflicts of interest, and scientific journals are doing the same with their authors. For example, the Journal of the American Dietetic Association (JADA) requires financial disclosure for all authors of articles before publication. Such disclosure includes any conflict or duality of interest that may be perceived as affecting the author’s objectivity and credibility or as creating an appearance of external influence.

Some researchers believe the high level of scrutiny among peer-reviewed journals will squash the potential for lapses in ethics. The International Committee of Medical Journal Editors provides standard guidelines for practices at medical journals, including a section on sponsorship, authorship, and accountability. The Committee on Publication Ethics allows journal editors to discuss issues related to the integrity of scientific publications and provides guidelines for editors. And the Good Publication Practice guidelines supply standards for responsible publication of studies sponsored by industry.

“In the last 10 years, there is a real increase in transparency. Now, studies published in journals like JADA, NEJM [The New England Journal of Medicine], and JAMA [The Journal of the American Medical Association] state the sources of all funding and the contributions of all authors. Each author has to state conflict of interests. Researchers may not hold stock in the company where they do research. There is more confidence now than 10 years ago. The scandals in NIH [National Institutes of Health] in a separate number of cases in the last 10 years in which data was falsified had nothing to do with where the funding came from,” says Bernadette Marriott, PhD, principal associate of nutrition and health research at Abt Associates, Inc., in Durham, N.C.

“I think you’re seeing an increase in ethics guidelines when it comes to designing studies. There are some issues where bias could be introduced in the study, but the science will eventually weed it out,” says Fabricant.

“Authors of studies have to disclose any conflict of interest and follow good standards of practice,” says Cheryl Reifer, PhD, RD, LD, director of Sprim USA, an independent research-driven company focused on health.

One major concern is when industry funds a study that produces negative results for the industry’s product. “It is important that there is a relationship between the university and scientist that results in publication of findings, no matter what they are,” says Marriott.

The NIH developed the Clinical Research Guide with Good Clinical Practices (GCP) to help guide researchers to ensure the quality and integrity of data obtained from clinical testing and protect the rights and welfare of clinical subjects. GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The objective is to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by their regulatory authorities.

Bottom Line: Look at the Study
Researchers stress that instead of paying attention to who is financing the study, it may be more important to dig into the study itself. “The issue is the total weight of the study, not whether it was industry-funded. It is a quality issue rather than a funding issue,” says Fabricant.

He suggests that instead of looking at one study in and of itself, look at the larger body of science. “Look at the total body of literature, all studies at hand, one by one. Look to see if there is good science, a good hypothesis, measurable outcome, and that a study is not self-seeking,” he says. Professionals may benefit from referring to resources such as the NIH Office of Dietary Supplements or Medline to source valid data on nutrition research. Reifer emphasizes that experts in the field can also help validate the science.

“Go right to the method section of the study,” says Marriott. “Look at the measure, outcome, and research design. Go through six to 10 studies. In this day and age, you should find good method sections. If you submit a paper to a journal like JAMA, you have to have a good method section.”

If you’re scanning the research available on a food or dietary supplement company’s Web site, the same rules apply. “I don’t think you have to automatically suspect science on a company’s Web site, but go to excellent, unbiased resources to verify the science,” suggests Marriott.

A Place for Industry in Research
Let’s face it: With the help of industry-funded research, we’ve come a long way on the path to evidence-based nutrition. Large food companies—from Kellogg’s to Gatorade—pour millions into food and nutrition research centers that supply valuable information dietitians may rely on regularly. Reifer says that many large food companies have their own research institutes and are leaders in conducting unbiased studies in conjunction with hospitals and universities.

Industry also helps fill the gap when food and nutrition research dollars from government just aren’t enough. “Though there is a significant amount of government-funded research, the industry-funded research is making progressive steps in fields of research,” reports Fabricant. “The percentage of grant applications funded by government has gone down, so it results in a plateau in funding of new research,” adds Marriott, who notes that in other countries, such as Japan, industry funds research that has nothing to do with their product line. For instance, a car maker may fund wildlife research. It’s all about reaching into deep pockets and giving back to society.

In an article published on NutraIngredients.com, Stephen Daniells, PhD, a food science reporter, discussed the PLOS Medicine article on funding and nutrition studies, saying, “The final point to note is that research is driven by industry. Sources of independent funding for many, many university researchers are few and far between, and many are very grateful for industry sponsorship. Such partnerships are vital, and companies that put money up for university-based research should be applauded.”8

According to Fabricant, collaborative studies with academia and industry are ideal, as they both bring something unique to the research table. “It used to be the viewpoint that universities were afraid of industry-funded research. But it has changed dramatically. There is a more mature attitude that joint research is beneficial all the way around,” he adds.

Maurizio S. Tonetti, DMD, PhD, editor-in-chief of the Journal of Clinical Periodontology, sums it all up in an article he wrote about the integrity of research findings: “Advances in biomedical research are the result of a complex interdependent relationship between individual investigators, academic institutions, funding agencies, and industry. This relationship has been largely positive and has allowed quantum increments in scientific knowledge and undeniable progress in clinical practice. We all are grateful for the opportunities that this has offered to our patients and to the population as a whole. Recently, both the consumers (the public and clinicians) and the producers (the investigators) of research findings have identified the dangers of gray areas arising from the potential conflict of interests—personal career, financial well-being of the institution, commercial interests—competing with the primary objective of generating useful knowledge for patient care. Universities around the world have taken vigorous steps to ensure that potential conflicts of interest do not arise, are appropriately managed, and thus that the integrity of research findings is ensured. Indeed, only robust evidence of efficacy and effectiveness can be the basis of a solid business model for industry and the profession.”9

— Sharon Palmer, RD, is a contributing editor at Today’s Dietitian and a freelance food and nutrition writer in southern California.

References

1. Associated Press. Spitzer sues GlaxoSmithKline over Paxil. MSNBC.com. June 2, 2004. Available here.

2. Lexchin J, Bero LA, Djulbegovic B, et al. Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ. 2003;326(7400):1167-1170.

3. Baty P. Gag money rejected. The Times Higher Education Supplement. December 16, 2005.

4. The House of Commons Health Committee. The influence of the pharmaceutical industry, fourth report of session 2004-05. March 22, 2005. Available here.

5. Bhandari M, Busse JW, Jackowski D, et al. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. CMAJ. 2004;170(4):477-480.

6. Ball DE, Tisocki K, Hexheimer A. Advertising and disclosure of funding on patient organisation websites: a cross-sectional survey. BMC Public Health. 2006; 6:201.

7. Lesser LI, Ebbeling CB, Goozner M, et al. Relationship between funding source and conclusion among nutrition-related scientific articles. PLOS Med. 2007;4(1):e5.

8. Daniells S. Death to the industry conspiracy theories! Nutraingredients.com. Available here.

9. Tonetti M. Integrity of research findings: transparency and disclosure of potential conflict as best practice. J Clin Periodontol. 2006;33(7):461.