WALMART PRESENTATION Recombinant Bovine Growth Hormone Martin Donohoe

WAL-MART PRESENTATION Recombinant Bovine Growth Hormone Martin Donohoe, MD, Kaiser Permanente, Oregon Physicians for Social Responsibility Michael Hansen, Ph. D, Consumers Union Rick North, Oregon Physicians for Social Responsibility

RECOMBINANT BOVINE GROWTH HORMONE (r. BGH Or r. BST) · Genetically engineered drug developed by Monsanto, sold to Elanco (Eli Lilly) Oct. ‘ 08 · Increases milk production 5 -15% · Estimated 9 -12% of operations use it; 1014% of dairy cows injected nationwide

r. BGH USE USDA 2007 SURVEY Fewer than 100 cows: Operations: 9. 1% Cows: 6. 2% 100 – 499 cows: Operations: 28. 8% Cows: 17. 7% 500 + cows: Operations: 42. 7% Cows: 22. 6%

THE QUESTION OF PROFITABILITY Independent Studies Changes to net farm income “not statistically different from zero. ” – Tauer/Knoblauch study – New York – 1998 “No evidence that it (r. BGH) increases profits on a per cow basis. ” – Foltz/Chang study – Connecticut – 2002 “The impact on financial performance. . . was not statistically significant. ” – Mc. Bride et al study – Nationwide - 2004

THE PROBLEMS WITH r. BGH n Increases rates of 16 medical conditions occurring in cows – reduced pregnancy rates and birth weight of calves, increased diarrhea, foot disorders, lesions, somatic cell counts (pus), mastitis. Posilac® package insert explaining harmful effects to cows required by the FDA n Mastitis/antibiotic resistance connection in humans n IGF-1 and cancer in humans

r. BGH, IGF-1 AND CANCER NOT IN DISPUTE n. IGF-1 is present and identical in cows and humans nr. BGH increases IGF-1 in cows’ milk n. Elevated IGF-1 promotes cancer in humans Elevated IGF-1 In humans r. BGH Increases IGF-1 in cows’ milk Promotes cancer in humans IGF-1 survive digestion?

CASEIN PROTECTS IGF-1 “Casein (was) effective in preserving IGF 1 structural integrity (80%) and receptor binding activity. . . ” (C. J. Xian et al, “Degradation of IGF-1 in the adult rat gastrointestinal tract is limited by a specific antiserum or the dietary protein casein, ” Journal of Endocrinology, v. 146, 1995. ) “This paper clearly showed that IGF-1 can survive digestion (67%) when in the presence of casein. ” (Michael Hansen, Consumer Policy Institute, Letter to Maine Attorney General G. Steven Rowe, Feb. 11, 2003, citing T. Kimura et al, Journal of Pharmacology and Experimental Therapeutics, v. 283, 1997. )) “Casein greatly enhanced the stability of IGF -1. . . ” (P. Anderle et al, “In Vitro Assessment of Intestinal IGF-1 Stability, ” Journal of Pharmaceutical Sciences, v. 91, 2002. )

FDA

THE MONSANTO-FDA REVOLVING DOOR Michael Taylor Margaret Miller FDA Branch Chief for Hormones and Pharmacological Agents, other positions (1989 - ). Worked for Monsanto from 1985 -89. FDA Deputy Commissioner For Policy (1991 -94). Previously a partner at King & Spalding representing Monsanto. (Now in Obama administration) Suzanne Sechen www. infosecuritymag. com FDA Primary Review Officer for r. BGH (1988 -90). Previously a graduate student at Cornell doing r. BGH research.

CONGRESSIONAL INVESTIGATIONS – GAO www. hm-usa. nl On animal deformities: “. . . we were unable to acquire the data from either the University of Vermont or from Monsanto. . . ” (Eleanor Chelimsky, “r. BGH Vermont Review, Chronology of Events, ” Memorandum from the U. S. General Accounting Office to U. S. Rep. Bernard Sanders, Oct. 27, 1992. ) On antibiotic use “The approval of r. BGH products should not be forthcoming until the antibiotic risk is validly assessed . . . our recommendations have not been seriously addressed. ” (Eleanor Chelimsky, Letter to Donna Shalala, Sec’y. of Health/Human Services, March 2, 1993

CANADIAN SCIENTISTS QUESTION r. BGH SAFETY www. tycohealthcare. com “Both procedural and data gaps were found which fail to properly address the human safety requirements of this drug. . . ” “. . . sterility, infertility, birth defects, cancer and immunological derangements were not addressed. ” “IGF-1 also can survive the GI tract. . . The full significance of this finding also was not investigated. ” (“r. BST ‘Gaps Analysis’ Report, ” Internal Review Team, Health Canada, April 21, 1998. )

EU SCIENTISTS QUESTION r. BGH SAFETY www. padav. demon. co. uk “. . . an association between IGF-1 and breast and prostate cancer is supported by epidemiological studies. ” “An increased use of antimicrobial substances in the treatment of r. BST related mastitis which might lead to an increased risk of residue formation in milk and to the selection of resistant bacteria. ” (EU Scientific Committee on Veterinary Measures relating to Public Health, Report on Public Health Aspects of the Uses of Bovine Somatotropin, March 15 -16, 1999. )

INTERNATIONAL OPPOSITION Codex Alimentarius Commission, the U. N. ’s main food safety body, determined there was no consensus r. BGH was safe in 1997 and 1999. It hasn’t been voted on since. Industrialized nations disallowed r. BGH: European Union (27 nations), including Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom www. un. org Canada New Zealand Japan Switzerland Norway Australia

HEALTH CARE WITHOUT HARM June 2005 Position Statement “Health Care Without Harm opposes the use of recombinant Bovine Growth Hormone, (r. BGH or r. BST). . . due to its adverse impacts on animals and potential harm to humans. We therefore encourage health care providers to purchase non -r. BGH milk from suppliers. ” Over 250 hospitals in 23 states pledge to go r. BGH-free

AMA, ANA STATEMENTS AMA – No official policy; Ron Davis, MD, 2007 -2008 President: “Hospitals should. . . use milk produced without bovine growth hormone. . . ” (AMA e. Voice column 4/24/08) ANA – Official resolution opposing r. BGH passed by House of Delegates: “Support. . . laws, regulations and policies that specifically reduce the use of r. BGH. . . ” (enacted June 2008)

APHA POSITION STATEMENT n n n “APHA is therefore opposed to the use of hormone growth promoters in beef and dairy production. . . ” “The FDA should act with public health precaution to ban the use of hormone growth promoters. . . ” “Hospitals, schools and other institutions, especially those serving children, preferentially purchase food products from beef and dairy cattle produced without such hormones. ” - November 2009

ELANCO’S REPORT “Elanco, the company that manufactures and markets rb. ST, initiated an assessment with a group of independent scientific experts to develop an expert paper. . . ” n n All eight authors were paid by Elanco Seven of the eight authors were paid by Monsanto to research rb. ST

ELANCO’S REPORT Elanco “Its (r. BGH’s) safety for human consumption is endorsed by. . . American Academy of Pediatrics, American Cancer Society, American Medical Association. . . ” - July 14, 2009 Bioscience Resource Project “ ‘The American Cancer Society has no formal position regarding r. BGH’ stated the e-mail’. . . ‘I can confirm the AAP does not endorse the safety of rb. GH’, wrote an AAP spokesperson. . . The AMA has no policy on r. BGH. . . ” – Feb. 22, 2010

ELANCO REPORT’S AUTHORS Stephen Nickerson – “unaware of any errors” Connie Bales – “declined to answer questions via email or on the telephone” David Clemmons – “the AMA, the AAP and the ACS endorsements were ‘technically untrue’” “We counted endorsement as failure to oppose rb. GH. ” Kristen Sejrsen – “It’s only a scientific paper. ” Richard Raymond – “the authors stood by all the endorsements excepting that of the AAP. ” - Jonathan Latham, “Strangely like Fiction: Elanco-sponsored authors admit falsely claiming rb. GH safety, ” The Bioscience Resource Project News Service, Feb. 22, 2010.

ENVIRONMENTAL CLAIMS Elanco “. . . practices like rb. ST. . . increase the efficiency of food production while mitigating the environmental impact. . . ” - - - Recombinant Bovine Somatotropin (rb. ST): A Safety Assessment July 14, 2009 FDA “. . . You (Monsanto) found no statistical differences between treatment groups for feed efficiency . . . ” - - Letter from Richard Lehmann, FDA to Terence Harvey, Monsanto April 3, 1988

8% ? “According to (Elanco’s Mike) Mc. Carty, only 8% of consumers purchasing organic milk do so out of actual concern over the use of recombinant bovine somatotropin (rb. ST) in the herd. . . ” Feedstuffs – May 5, 2010

HARTMAN GROUP STUDY PRIMARY SHOPPERS - 2010 Q: “What are the main reasons you buy organic foods and beverages? ” A: “To avoid products that rely on growth hormones. ” – 42% (unaided responses) - The Hartman Group, Beyond Natural and Organic 2010

WASHINGTON DAIRY PRODUCTS COMMISSION SURVEY - 2010 n n 73% aware of r. BGH Of those, 28% changed their buying decisions because of the hormone 17% buying r. BGH-free conventional n 11% buying organic n

OTHER STUDIES n n 55% would buy milk labeled without bovine growth hormone if available – Consumer Reports -2007 58% disagreed with “I’m not concerned about consuming milk from cows given growth hormone. ” – Ohio State U. – 2007

CORPORATE STUDIES Challenge Butter – “Our independent research indicates that 70% of butter customers are concerned about the use of rb. ST, 60% want no added hormones or rb. ST in dairy foods. . . ” - www. challengedairy. com/faqs/rbst Chipotle Restaurants – Assuming little, if any price difference, 81% would prefer to buy dairy products from cows not treated with synthetic hormones. – Caravan Research Corporation - 2007

POSITIVE PRESS USA Today – March 16, 2009 “Among those dropping rb. ST: Wal-Mart. Last year, the retailer said its store brand, Great Value, has eliminated rb. ST. ” New York Times – March 9, 2008 “The marketplace has responded, and now everyone from Whole Foods Market to Wal-Mart Stores sells (r. BGH-free) milk. . . ” Prevention Magazine – Nov. 2009 “ 7 Foods That Should Never Cross Your Lips (r. BGH): Budget Tip: Try Wal-Mart’s Great Value Label, which does not use r. BGH. ”

POSITIVE PRESS - 2 Wikipedia – Accessed May 15, 2010 “Wal-Mart and Sam’s Club stores featured hormone-free “Great Value brand milk. . . ” The Daily Green – March 21, 2008 “At a time when hormone-free milk labeling is under assault by Monsanto and its allies, Wal-Mart has taken a stand in favor of its consumers. All Great Value-brand milk sold at Wal-Mart and Sam’s Club will be free of r. BST. . . ” Consumer Reports – August 2008 “WHERE TO FIND PRODUCTS WITHOUT rb. ST/rb. GH: Retailers that carry the products include Wal-Mart and its affiliated Sam’s Club. . . ”

“Maybe the most important way in which we at Wal-Mart believe in giving something back is through our commitment to using the power of this enormous enterprise as a force for change. ” - Sam Walton

WAL-MART DECISIONS n Deodorants without boxes n Additional beef safety measures to protect consumers against illness n r. BGH?

WHAT WE ASK Make all Great Value dairy products r. BGH-free - be a “force for change” – a choice: For public health n For animal welfare n For all consumers n

ADDITIONAL SLIDES

BRITISH MEDICAL JOURNAL www. hrw. org 2000 EDITORIAL “Given the increasing evidence of the risk of cancer, caution should be exercised in the exogenous use of either insulin-like growth factor-1 or substances that increase concentrations of it. ” (George Smith et al, Editorial: “Cancer and insulin-like growth factor-1, ” British Medical Journal, vol. 321, October 7, 2000. )

www. gnb. ca JOURNAL OF THE NATIONAL CANCER INSTITUTE 2000 REVIEW “Laboratory studies have shown that IGF’s exert strong mitogenic and antiapoptotic actions on various cancer cells. ” “The role of IGF’s in cancer is supported by epidemiologic studies, which have found that high levels of IGF-1. . . are associated with increased risk of several common cancers. . . ” (Herbert Yu, Thomas Rohan, “Role of the Insulin-Like Growth Factor Family in Cancer Development and Progression, ” Journal of the National Cancer Institute, v. 92, Sept. 20, 2000. )

ONCOLOGY www. longfellow. d 21. k 12. il. us 2002 REVIEW “Recent evidence from epidemiologic studies has confirmed an association between serum levels of IGF’s and several malignancies. . . ” “It is now well established that IGF-1 enhances mitogenicity of breast cancer cells via a variety of mechanisms. ” (S. Moschos and C. Mantzoros, “The Role of the IGF System in Cancer: From Basic to Clinical Studies and Clinical Applications, ” Harvard Medical School, Oncology, v. 63, n. 4, 2002. )