Thursday, September 17, 2015

Is This Epic Study Disclosure Statement the World's Greatest or Most Absurd?

And I'm not asking snarkily, I honestly don't know.

Thanks to Marion Nestle for sending my way the disclosure statement (all 1,349 words of it) that's attached to a recent meta-analysis of controlled feeding trials and the impact of fructose on lipid levels and published in The Journal of the American Heart Association.

Given of late there has been a great deal more media scrutiny around conflicts of interest and science, perhaps this epic statement, which includes the disclosure of a second place win in the student food competition "Mission Impulsible", is meant to protect researchers against any suggestion shy of total disclosure. That said, given the disclosure statement's incredible size and scope, I wonder if it helps readers?

To provide an expert opinion I asked business professor/philosopher/ethicist Chris MacDonald for his thoughts, and more specifically asked him the question,
"Does this level of disclosure raise the bar for disclosure and provide readers with valuable information, or does it instead venture, whether intentional or not, into a degree of disclosure that borders on the absurd and consequently unhelpful?"
He was kind enough to read and here are some of his more expert thoughts:
"Listing grants from government agencies and listing scholarships seems odd, but perhaps that's normal?

Anyway, the net effect -- intentional or not -- is that the disclosure amounts to information overload. It's a bit like a physician answering a patient's questions about side-effects by handing him or her a long fact sheet from the pharmaceutical company. It's hard for the reader to sort out what matters and what doesn't. Perhaps the authors' fellow scientists would know what to look for -- whether there are financial ties that are worrisome. But to most readers, it would just be overload.

To a non-scientist, it reads like a bit of a joke. Maybe the authors are tweaking the noses of the editors, and of those who think disclosure of financial ties is an important thing.
"
He also had this last point, one that I think cuts right to the quick,
"If we take disclosure seriously, we need to make sure that we do it in a way that is useful to interested stakeholders. Simply dumping information on people is a poor way to satisfy the relevant obligations."
[Full text of the disclosure below - and yes, it's written as one long, 1,350 word, paragraph in the journal as well]

Disclosures

Chiavaroli has received research support from the Canadian Institutes of Health Research (CIHR) and is a clinical research coordinator at Glycemic Index Laboratories, Toronto, Ontario, Canada. Ha has received funding from the CIHR, McMaster University, Province of Ontario, and the University of Toronto. She is the recipient of The Ashbaugh Graduate Scholarship. She has received payment from the World Health Organization (WHO) for work on a systematic review and meta-analysis commissioned by the WHO for work on the relation of saturated fatty acids with health outcomes. She and her colleagues received a cash prize for placing second in the regional “Mission Impulsible” Competition where they conceived and developed a marketable food product that contained dietary pulses. She received a travel award to attend the “Journey Through Science Day” hosted by PepsiCo and the New York Academy of Sciences as well as the Nutrica Travel Award from the Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD). de Souza was funded by a CIHR Postdoctoral Fellowship Award and has received research support from the CIHR, the Calorie Control Council (CCC), the Canadian Foundation for Dietetic Research, and the Coca-Cola Company (investigator initiated, unrestricted grant). He has served as an external resource person to WHO’s Nutrition Guidelines Advisory Group and received travel support from WHO to attend group meetings. He is the lead author of 2 systematic reviews and meta-analyses commissioned by WHO on the relation of saturated fatty acids and trans fatty acids with health outcomes. A.L. Jenkins is part owner and vice-president of Glycemic Laboratories, Inc, a clinical research organization. She has received grant support from the Canadian Diabetes Association (CDA). Wolever is a part owner and the President of Glycemic Index Laboratories, Inc, Toronto, Canada, and has authored several popular diet books on the glycemic index for which he has received royalties from Phillipa Sandall Publishing Services and CABI Publishers. He has received consultant fees, honoraria, travel funding, or research support from or served on the scientific advisory board for CIHR, CDA, Dairy Farmers of Canada, McCain Foods, Temasek Polytechnic, Northwestern University, Royal Society of London, Glycemic Index Symbol program, CreaNutrition AG, McMaster University, Canadian Society for Nutritional Sciences, National Sports and Conditioning Association, Faculty of Public Health and Nutrition—Autonomous University of Nuevo Leon, Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD). Beyene has received research support from the CIHR, CCC, and The Coca-Cola Company (investigator initiated, unrestricted). Kendall has received research support from the Advanced Foods and Material Network, Agrifoods and Agriculture Canada, the Almond Board of California, the American Pistachio Growers, Barilla, the California Strawberry Commission, the CCC, CIHR, the Canola Council of Canada, the Coca-Cola Company (investigator initiated, unrestricted grant), Hain Celestial, the International Tree Nut Council Nutrition Research and Education Foundation, Kellogg, Kraft, Loblaw Companies Ltd, Orafti, Pulse Canada, Saskatchewan Pulse Growers, Solae, and Unilever. He has received travel funding, consultant fees, or honoraria from Abbott Laboratories, the Almond Board of California, the American Peanut Council, the American Pistachio Growers, Barilla, Bayer, the Canola Council of Canada, the Coca-Cola Company, Danone, General Mills, the International Tree Nut Council Nutrition Research and Education Foundation, Kellogg, Loblaw Companies Ltd, Nutrition Foundation of Italy (NFI), Oldways Preservation Trust, Orafti, Paramount Farms, the Peanut Institute, PepsiCo, Pulse Canada, Sabra Dipping Co, Saskatchewan Pulse Growers, Solae, Sun-Maid, Tate and Lyle, and Unilever. He is on the Dietary Guidelines Committee for the DNSG of the EASD and has served on the scientific advisory board for the Almond Board of California, the International Tree Nut Council, Oldways Preservation Trust, Paramount Farms, and Pulse Canada. He is a member of the International Carbohydrate Quality Consortium (ICQC) and Board Member of the DNSG of the EASD. D.J.A. Jenkins has received research grants from Saskatchewan Pulse Growers, the Agricultural Bioproducts Innovation Program through the Pulse Research Network, the Advanced Foods and Material Network, Loblaw Companies Ltd, Unilever, Barilla, the Almond Board of California, Agriculture and Agri-food Canada, Pulse Canada, Kellogg’s Company, Canada, Quaker Oats, Canada, Procter & Gamble Technical Centre Ltd., Bayer Consumer Care, Springfield, NJ, Pepsi/Quaker, International Nut & Dried Fruit (INC), Soy Foods Association of North America, the CocaCola Company (investigator initiated, unrestricted grant), Solae, Haine Celestial, the Sanitarium Company, Orafti, the International Tree Nut Council Nutrition Research and Education Foundation, the Peanut Institute, the Canola and Flax Councils of Canada, the CCC, the CIHR, the Canada Foundation for Innovation, and the Ontario Research Fund. He has been on the speaker’s panel, served on the scientific advisory board and/or received travel support and/or honoraria from the Almond Board of California, Canadian Agriculture Policy Institute, Loblaw Companies Ltd, the Griffin Hospital (for the development of the NuVal scoring system, the Coca-Cola Company, Saskatchewan Pulse Growers, Sanitarium Company, Orafti, the Almond Board of California, the American Peanut Council, the International Tree Nut Council Nutrition Research and Education Foundation, the Peanut Institute, Herbalife International, Pacific Health Laboratories, Nutritional Fundamental for Health, Barilla, Metagenics, Bayer Consumer Care, Unilever Canada and Netherlands, Solae, Kellogg, Quaker Oats, Procter & Gamble, the Coca-Cola Company, EPICURE, the Griffin Hospital, Abbott Laboratories, the Canola Council of Canada, Dean Foods, the California Strawberry Commission, Haine Celestial, PepsiCo, the Alpro Foundation, Pioneer Hi-Bred International, DuPont Nutrition and Health, Spherix Consulting and WhiteWave Foods, the Advanced Foods and Material Network, the Canola and Flax Councils of Canada, the Nutritional Fundamentals for Health, Agri-Culture and Agri-Food Canada, the Canadian Agri-Food Policy Institute, Pulse Canada, the Saskatchewan Pulse Growers, the Soy Foods Association of North America, the Nutrition Foundation of Italy (NFI), Nutra-Source Diagnostics, the McDougall Program, the Toronto Knowledge Translation Group (St. Michael’s Hospital), the Canadian College of Naturopathic Medicine, The Hospital for Sick Children, the Canadian Nutrition Society (CNS), the American Society of Nutrition (ASN), Arizona State University, Paolo Sorbini Foundation, and the Institute of Nutrition, Metabolism and Diabetes. He received an honorarium from the US Department of Agriculture to present the 2013 W.O. Atwater Memorial Lecture. He received the 2013 Award for Excellence in Research from the International Nut and Dried Fruit Council. He received funding and travel support from the Canadian Society of Endocrinology and Metabolism to produce mini cases for the CDA. He is a member of the ICQC. His wife, ALJ, is a director and partner of Glycemic Index Laboratories, Inc, and his sister received funding through a grant from the St. Michael’s Hospital Foundation to develop a cookbook for one of his studies. Sievenpiper has received research support from the CIHR, CCC, American Society of Nutrition (ASN), CDA, The CocaCola Company (investigator initiated, unrestricted), Dr Pepper Snapple Group (investigator initiated, unrestricted), Pulse Canada, and The International Tree Nut Council Nutrition Research & Education Foundation. He has received reimbursement of travel expenses, speaker fees, and/or honoraria from the American Heart Association, American College of Physicians, ASN, National Institute of Diabetes and Digestive and Kidney Diseases, CDA, Canadian Nutrition Society, University of South Carolina, University of Alabama at Birmingham, Oldways Preservation Trust, Nutrition Foundation of Italy, CCC, DNSG of the EASD, International Life Sciences Institute (ILSI) North America, ILSI Brazil, Abbott Laboratories, Pulse Canada, Canadian Sugar Institute, Dr Pepper Snapple Group, The Coca-Cola Company, Corn Refiners Association, World Sugar Research Organization, Dairy Farmers of Canada, Societ a Italiana di Nutrizione Umana, III World Congress of Public Health Nutrition, C3 Collaborating for Health, White Wave Foods, Rippe Lifestyle, and mdBriefcase. He has ad hoc consulting arrangements with Winston & Strawn LLP, Perkins Coie LLP, and Tate & Lyle. He is on the Clinical Practice Guidelines Expert Committee for Nutrition Therapy of both the CDA and EASD, and Canadian Cardiovascular Society, as well as being on an ASN writing panel for a scientific statement on sugars. He is a member of the International Carbohydrate Quality Consortium (ICQC) and Board Member of the DNSG of the EASD. He serves an unpaid scientific advisor for the ILSI North America, Food, Nutrition, and Safety Program and the Technical Committee on Carbohydrates. His wife is an employee of Unilever Canada. None of the other authors had a relevant disclosure to report

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