RECOMBINANT BOVINE GROWTH HORMONE

1. RECOMBINANT BOVINE GROWTH HORMONE Physicians For Social Responsibility Oregon Chapter Rick North, Project Director Campaign For Safe Food

2. OUR GOAL Discontinue the production of any dairy products in Oregon from cows treated with rBGH www.freepages.genealogy.rootsweb.com

3. OUR METHOD Grassroots education campaign so that citizens can make an informed decision www.pluk.org

4. RECOMBINANT BOVINE GROWTH HORMONE (rBGH) OrrBST · Genetically engineered drug produced by Monsanto · Increases milk production 5-15% · Estimated 10-15% of Oregon dairy cows injected

5. THE PROBLEMS WITH rBGH • 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. Condemned by: • Humane Society of U.S. • Humane Farming Association • Farm Sanctuary • Mastitis/antibiotic resistance connection in humans • IGF-1 and cancer in humans

6. IGF-1 QUESTIONS • rBGH increase IGF-1? • Excessive IGF-1 promote cancer? • IGF-1 survive digestion? • Are the amounts high enough? • Other factors

7. FDA

8. FDA 1994 RULING ON LABELING FDA does not require labeling of any product from cows treated with rBGH – it is voluntary. FDA recommendation for dairies not using rBGH:  “No significant difference has been shown between milk derived from cows treated with rBGH and those not treated with rBGH.” www.runnerduck.com

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

10. DISSENT WITHIN THE FDA Alexander Apostolou, Director of Toxicology: “Sound scientific procedures for evaluating human food safety of veterinary drugs have been disregarded.” - Forced to quit FDA Joseph Settapani, Chemist in charge of quality control : Described “a systematic human food-safety breakdown at the Center for Veterinary Medicine. Dissent is not tolerated if it could seriously threaten industry profits.” – Reprimanded, threatened with dismissal, stripped of duties as supervisor (Craig Canine, “Hear No Evil,” Eating Well, July/August 1991.)

11. DISSENT WITHIN THE FDA Richard Burroughs, Reviewer for rBGH for nearly five years: “. . . the Center decided to cover up inappropriate studies and decisions.” Officials “suppressed and manipulated data . . .” – Fired  (Jeffrey Smith, Seeds of Deception, Chelsea Green Publishing, 2003.)

12. CONGRESSIONAL INVESTIGATION – GAO www.hm-usa.nl On human food safety risks: “. . . we were unable to acquire the data from either the University of Vermont or from Monsanto . . .” (Eleanor Chelimsky, “rBGH Vermont Review, Chronology of Events,” Memorandum from the U.S. General Accounting Office to U.S. Rep. Bernard Sanders, Oct. 27, 1992.) “These risks are not covered by the FDA guidelines and have not been addressed for rBGH.” (GAO, “Recombinant Bovine Growth Hormone, FDA Approval Should Be Withheld Until the Mastitis Issue Is Resolved,” August 6, 1992.) 

13. www.tycohealthcare.com CANADIAN SCIENTISTS QUESTION rBGH SAFETY “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.” (“rBST ‘Gaps Analysis’ Report,” Internal Review Team, Health Canada, April 21, 1998.)

14. EU SCIENTISTS QUESTION rBGH 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 rBST related mastitis which might lead to an increased risk of residue formation in milk and to the selection of resistant bacteria.” (The European Commission, Report on Public Health Aspects of the Uses of Bovine Somatotropin, “Food Safety: From the Farm to the Fork,” March 15-16, 1999.)

15. INTERNATIONAL OPPOSITION The Codex Alimentarius Commission, the U.N.’s main food safety body, declined to declare rBGH safe in 1995, 1997 and 1999. Industrialized nations banning rBGH:  European Union (25 nations), includingAustria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom New Zealand Japan Canada Australia www.un.org

16. 2005: OREGON DAIRIES RESPOND • April 1: Tillamook goes rBGH-free for cheese (not ice cream, butter, yogurt, sour cream) • June 1: Eberhard goes rBGH-free for all products • Nancy’s Yogurt and Lochmead start labeling their products rBGH-free

17. WHAT YOU CAN DO Buy dairy products from dairies not using rBGH Tell people you know Stay informed – get on the PSR e-mail update list (approx. 2x per month) Set up presentations to other groups

19. ADDITIONALSLIDES

20. “Problems cannot be solved at the same level of awareness that created them.” - Albert Einstein www.pmel.noaa.gov

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

22. 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.)

23. 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.)

24. www.gnb.ca JOURNAL OF THE NATIONAL CANCER INSTITUTE2000 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 epidemiologicstudies, 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,” Journalof the National Cancer Institute, v. 92, Sept. 20, 2000.)

25. ONCOLOGY www.longfellow.d21.k12.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.)

26. SIGNIFICANCE OF IGF-1 LEVELS FROM MILK “Serum IGF-1 levels increased significantly in milk drinkers, an increase of about 10 percent above baseline.”  (Robert Heaney et al, “Dietary changes favorably affect bone remodeling in older adults,” Journal of the American Dietetic Association, v. 99, October 1999.)  “Our most consistent dietary finding was the positive association of IGF-1 levels with total dairy and milk intake (9.3%).” (Michelle Holmes et al, “Dietary correlates of plasma insulin-like growth factor 1 and insulin-like growth factor binding protein 3 concentrations,” Cancer Epidemiology, Biomarkers and Prevention, v. 11, 2002.)

27. ANTIBIOTIC RESISTANCEMOST AT-RISK POPULATIONS Children Seniors People with allergies Cancer patients www.sjhs.com “The additional antibiotic use due to rBST use cannot help but contribute to the general problem of antibiotic resistance in pathogenic bacteria.” (Michael Hansen, Ph.D., et al, “Potential Public Health Impacts of the Use of Recombinant Bovine Somatotropin in Dairy Production,” Consumer Policy Institute, September 1997.) USDA

28. ANTIBIOTIC RESISTANCE rBGH In cows: Increased infections and pus in milk Increased use of antibiotics Increased antibiotic resistance in bacteria In humans: IconBAZAAR • Increased antibiotic resistance . . . an increasing, multi-billion dollar per year problem www2.wgbh.org

29. THE rBGH DIFFERENCE IN MILK Monsanto’s rBGH adds one amino acid to the cow’s natural growth hormone protein. rBGH is twice as immunogenic for certain antibodies than natural BGH. IGF-1 levels in milk from rBGH-treated cows significantly increased (Michael Hansen, Senior Research Associate, Consumer Policy Institute, Letter to Maine Attorney General G. Steven Rowe, Feb. 11, 2003, citing M.H. Erhard et al, Journal of Immunoessay, v. 15, 1994 and four Monsanto studies from 1988-1993.)

30. rBGH’s HARMFUL EFFECTS ON COWS 16 listed on original warning label – increases in: Uterine infections Diarrhea Lesions Foot disorders Birth disorders Cystic ovaries Somatic cell count (pus in milk) Mastitis (79% increase) (Monsanto’s original Posilac® warning label; FDA Freedom of Information Summary NADA 140-872 Posilac®) Opposed by: Humane Society of the U.S. Humane Farming Association Farm Sanctuary

31. A DECADE OF CONTROVERSY Nov. 5, 1993 – FDA approves rBGH 1994 - Monsanto sues dairies in Texas and Iowa for advertising their milk as rBGH-free 1994 - Monsanto sends warning letters to dairies all over the country  1997 - Monsanto threatens to sue Fox News for running an rBGH exposé in Tampa. The story is killed and the two reporters are fired. 1998 -Center For Food Safety files request to FDA to suspend use of rBGH. 2003- Monsanto sues Oakhurst for label: “Our Farmers’ Pledge: No Artificial Growth Hormones.”

32. MAINE:THE OAKHURST CONTROVERSY www.barkbytes.com 2000: Oakhurst goes rBGH-free Their label: “Our Farmers’ Pledge: No Artificial Growth Hormones” July 2003: Monsanto sues, saying Oakhurst is misleading the public December 2003: Lawsuit settled, Oakhurst keeps label, adds FDA disclaimer

33. MAINE:CONSUMERS SPEAK, DAIRIES LISTEN www.barkbytes.com Shaw’s Supermarkets: -6 milk brands, no rBGH Hanniford’s Supermarkets: -9 milk brands, no rBGH

34. SCANDAL IN CANADA • “The senators sat dumbfounded as Dr. Margaret Haydon told of being in a meeting when officials from Monsanto, Inc., the drug’s manufacturer, made an offer of between $1 million and $2 million to the scientists from Health Canada – an offer she told the senators could only have been interpreted as a bribe.” • (“Monsanto Accused of Attempt to Bribe Health Canada for rBGH Approval,” The Ottawa Citizen, Ottawa, Canada, Oct. 23, 1998)

35. 30 RATS IN 90 DAYSCPI, CANADIANS QUESTION • Consumer Policy Institute: “ . . . 20 to 30 percent of the rats in the high dose group developed primary antibody responses to rBGH, suggesting it was being absorbed into the bloodstream. In the view of the Canadian scientists, and in our view as well, these are toxicologically significant changes, and should have triggered a full human health review . . .” • (Michael Hansen, Ph. D., Research Associate, “FDA’s Safety Assessment of Rcombinant Bovine Growth Hormone,” Consumer Policy Institute, December 15, 1998)

36. Standard Pasteurization 162° F. 15 seconds FDA Test Pasteurization 162° F. 30 minutes (Paul Groenewegen et al, Journal of American Institute of Nutrition, v. 120, 1990) “. . . At least 90% of bGH activity is destroyed upon pasteurization of milk. Therefore bGH residues do not present a human food safety concern.”Judith Juskevich, C. Greg Guyer, “Bovine Growth Hormone: Human Food Safety Evaluation, Science, v. 249, Aug. 24, 1990)

37. FDA/MONSANTO STATEMENTS Monsanto: “Posilac® does not alter the chemical composition of milk.” (www.monsanto.com) Monsanto/FDA: “Dietary IGF-1 in milk and meat is broken down in the gastrointestinal tract by digestion.” (“Questions And Answers About bST From The United States Food and Drug Administration,” www.monsanto.com, Nov. 18, 2003) 

38. FDA/MONSANTO STATEMENTS Monsanto/FDA: “There is absolutely no possibility that the consumption of milk from rBST-treated cows could increase the risk of breast cancer.” (“Questions And Answers about bST From The United States Food and Drug Administration,” www.monsanto.com, Nov. 18, 2003.) FDA: “FDA has examined the literature and finds no definite evidence of any direct link between IGF-1 and breast cancer.” (“Report on the Food and Drug Administration’s Reviews of the Safety of Recombinant Bovine Somatotropin,” www.fda.gov, FDA Center For Veterinary Medicine, Nov. 18, 2003.)

39. SECOND GAO INVESTIGATION www.click2disasters.com On conflict of interest: “The General Accounting Office found that two other FDA employees, Dr. Margaret Miller and Susan Sechen, had violated ethics rules 11 times.” (Andrew Christiansen, “Recombinant Bovine Growth Hormone,” for Rural Vermont, July 1995.)  “GAO investigators were even more troubled by issues related to the role of Michael Taylor.” (Marion Nestle, Safe Food, U. of California Press, 2003.)

40. CONGRESSMEN RESPOND Representatives George Brown, David Obey and Bernard Sanders:  “The entire FDA review of rBGH seemingly has been characterized by misinformation and questionable actions on the part of both FDA and the Monsanto Company officials.” (Letter to GAO comptroller general Charles Bowsher, April 15, 1994.) Representative Sanders:   “The FDA allowed corporate influence to run rampant in its approval of rBGH.” (Bernard Sanders, Press Release, “GAO Uncovers Appearances Of Impropriety In FDA’s Approval Of RBGH, “ Oct. 30, 1994.)

41. PRESSURE FROM THE TOP www.rimag.com Dan Glickman, Secretary of Agriculture, 1995-2000: “There was a lot of money invested in this (biotech), and if you’re against it . . . you’re stupid. That, frankly, was the side our government was on. You felt like you were almost an alien, disloyal, by trying to present an open-minded view on some of the issuesbeing raised.” (Bill Lambrecht, Dinner At the New Gene Café, Thomas Dunne Books, 2002.)

42. PRESSURE FROM THE TOP www.the-scientist.com Henry Miller, FDA Office of Biotechnology Director, 1989 - 1994: “In this area (biotech issues), the U.S. government agencies have done exactly what big agribusiness has asked them to do and told them to do.” (Kurt Eichenwald et al, “Biotechnology Food: From the lab to a debacle,” New York Times, January 25, 2001.)

43. The Precautionary Principle • State the goal • Engage appropriate public participation to evaluate all alternatives • Gather scientific, technical socioeconomic information; assess benefits, risks, costs • Decide upon least hazardous alternative; when in doubt, protect health and the environment

44. The Precautionary Principle “Even in the face of scientific uncertainty, society should take reasonable actions to avert risks where the potential harm to human health or the environment is thought to be serious or irreparable.” U.S. Presidents’ Council on Sustainable Development (1996) Better Safe Than Sorry

46. IconBAZAAR

48. PSR’S FOUNDATIONS • Scientific/medical, historical, social data • The Precautionary Principle

49. ACKNOWLEDGMENTS Martin Donohoe, M.D. – Oregon PSR Michael Hansen, Ph.D. – Consumer Policy Institute Ellen Kittredge – Center For Food Safety Louisa Silva, M.D. – Oregon PSR