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

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Presentation on theme: "RECOMBINANT BOVINE GROWTH HORMONE (rBGH or rBST) Slides prepared by Rick North, Oregon Physicians for Social Responsibility Health Care Without Harm rBGH."— Presentation transcript:

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) Or rBST  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 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: 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 Society of U.S. Humane Farming Association Humane Farming Association Farm Sanctuary Farm Sanctuary Mastitis/antibiotic resistance connection in humans Mastitis/antibiotic resistance connection in humans IGF-1 and cancer in humans IGF-1 and cancer in humans

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

7 CASEIN PROTECTS IGF-1 “ Casein (was) effective in preserving IGF-1 structural integrity (80%) and receptor binding activity...” “ 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.) (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.” “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 THE MONSANTO-FDA REVOLVING DOOR Suzanne Sechen FDA Primary Review Officer for rBGH (1988-90). Previously a graduate student at Cornell doing rBGH research. Michael Taylor FDA Deputy Commissioner For Policy (1991-94). Previously a partner at King & Spalding representing Monsanto FDA Deputy Commissioner For Policy (1991-94). Previously a partner at King & Spalding representing Monsanto. Margaret Miller FDA Branch Chief for Hormones and Pharmacological Agents, other positions (1989 - ). Worked for Monsanto from 1985-89. 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 – Fired ( Jeffrey Smith, Seeds of Deception, Chelsea Green Publishing, 2003.)

12 CONGRESSIONAL INVESTIGATION – GAO 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.) (GAO, “Recombinant Bovine Growth Hormone, FDA Approval Should Be Withheld Until the Mastitis Issue Is Resolved,” August 6, 1992.) www.hm-usa.nl

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

14 CANADIAN SCIENTISTS QUESTION rBGH SAFETY 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.” “... 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.” “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.) www.tycohealthcare.com

15 EU SCIENTISTS QUESTION rBGH SAFETY “... 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.” “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.) www.padav.demon.co.uk

16 INTERNATIONAL OPPOSITION 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: Industrialized nations banning rBGH: European Union (27 nations), including Austria, 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.” “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 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... “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... 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.” Hospitals, schools and other institutions, especially those serving children, preferentially purchase food products from beef and dairy cattle produced without such hormones.” - November 2009 - November 2009

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

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

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

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

24 ADDITIONAL SLIDES

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) Stay informed – get on the PSR e-mail update list (approx. 2x per month) Set up presentations to other groups Set up presentations to other groups

26

27 THE rBGH DIFFERENCE IN MILK THE rBGH DIFFERENCE IN MILK Monsanto’s rBGH adds one amino acid to the cow’s natural growth hormone protein. 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. rBGH is twice as immunogenic for certain antibodies than natural BGH. IGF-1 levels in milk from rBGH-treated cows significantly increased 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.) (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.)

28 CONGRESSMEN RESPOND Representatives George Brown, David Obey and Bernard Sanders: 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: Representative Sanders: “The FDA allowed corporate influence to run rampant in its approval of rBGH.” “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.)

29 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.” “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) (“Monsanto Accused of Attempt to Bribe Health Canada for rBGH Approval,” The Ottawa Citizen, Ottawa, Canada, Oct. 23, 1998)

30 30 RATS IN 90 DAYS CPI, 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...” 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) (Michael Hansen, Ph. D., Research Associate, “FDA’s Safety Assessment of Rcombinant Bovine Growth Hormone,” Consumer Policy Institute, December 15, 1998)

31 BRITISH MEDICAL JOURNAL 2000 EDITORIAL 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.hrw.org

32 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.) www.gnb.ca

33 ONCOLOGY 2002 REVIEW “Recent evidence from epidemiologic studies has confirmed an association between serum levels of IGF’s and several malignancies...” “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.) www.longfellow.d21.k12.il.us


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