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RECOMBINANT BOVINE GROWTH HORMONE (rBGH or rBST)

RECOMBINANT BOVINE GROWTH HORMONE (rBGH or rBST). Slides prepared by Rick North, Oregon Physicians for Social Responsibility Health Care Without Harm rBGH Coordinator. RECOMBINANT BOVINE GROWTH HORMONE (rBGH) Or rBST.

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RECOMBINANT BOVINE GROWTH HORMONE (rBGH or rBST)

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  1. RECOMBINANT BOVINE GROWTH HORMONE (rBGH or rBST) Slides prepared by Rick North, Oregon Physicians for Social Responsibility Health Care Without Harm rBGH Coordinator

  2. RECOMBINANT BOVINE GROWTH HORMONE (rBGH) OrrBST · Genetically engineered drug developed by Monsanto, sold to Elanco (Eli Lilly) Oct. ‘08 · Increases milk production 5-15% · Estimated 15% of dairy cows injected nationwide; 0-5% in Oregon, Washington

  3. OUR GOAL Discontinue the production of any dairy products from cows treated with rBGH

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

  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. 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?

  7. 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.)

  8. FDA

  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. 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

  14. 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.)

  15. 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.)

  16. INTERNATIONAL OPPOSITION The Codex Alimentarius Commission, the U.N.’s main food safety body, declined to declare rBGH safe in 1997 and 1999. It has not been brought up since. Industrialized nations banning rBGH:  European Union (27 nations), includingAustria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom New Zealand Japan Canada Australia www.un.org

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

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

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

  20. NORTHWEST rBGH-FREE RESPONSE • April ‘05: Tillamookcheese, followed by ice cream, butter, yogurt • June ‘05: Eberhard totally • Nov. ‘05: Alpenrose totally • Nov. ’05: Darigold starts one line of milk; Feb. ’06: all yogurt; Dec. ‘08 all products • July ’06: Wilcox totally • Jan. ’07: Safeway (NW) milk only • Jan. ’07: Starbucks asks all suppliers nationwide

  21. 2006-09 NATIONWIDE RIPPLE EFFECT • June ’06: Darigold, Meadow Gold – Montana April ‘08: WalMart • June ’06: Garelick – New Jersey April ‘09: Glanbia • Oct. ’06: Hood, Garelick – New England Aug. ‘09: Yoplait • Oct. ’06: Dean Foods– Texas, New Mexico Dec. ‘09: Dannon • Feb. ’07: Byrne – New York • Feb. ’07: Sinton – Colorado • Mar. ’07: Price Chopper – New York • Aug. ’07: California Dairies, Inc. – California • April ’07: Publix Super Markets – Florida • Sept. ’07: Southeast Milk, Inc. – Florida • Oct. ‘07: Wawa, Turner - Pennsylvania • Feb. ‘08: Kroger - Ohio

  22. WE’VE COME A LONG WAY • 57 out of Top 100 Completely or Partially rBGH-Free • 65% - 75% Fluid Milk Completely • 75% Yogurt Completely

  23. NEXT STEPSWHAT DO YOU THINK? • rBGH-free products in all five major categories – milk, yogurt, cheese, butter, ice cream • Line-item identification for all rBGH-free products

  24. ADDITIONALSLIDES

  25. 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

  26. 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.)

  27. 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.)

  28. 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)

  29. 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)

  30. 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.)

  31. 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.)

  32. 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.)

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