Martin Donohoe, MD, Kaiser Permanente, Oregon
Physicians for Social Responsibility
Michael Hansen, PhD, Consumers Union
Rick North, Oregon Physicians for Social
Responsibility

 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; 10-
14% of dairy cows injected nationwide

Fewer than 100 cows:
Operations: 9.1%
Cows: 6.2%
100 – 499 cows:
Operations: 28.8%
Cows:
500 + cows:
17.7%
Operations: 42.7%
Cows: 22.6%

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

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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

Mastitis/antibiotic resistance connection in humans

IGF-1 and cancer in humans

rBGH
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
IGF-1 survive digestion?

“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

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

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, “rBGH 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 rBGH 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

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.”
(“rBST ‘Gaps Analysis’ Report,” Internal Review Team, Health Canada, April 21, 1998.)

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.”
(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.)

Codex Alimentarius Commission, the U.N.’s main food safety body, determined there was no consensus rBGH was safe in 1997 and 1999. It hasn’t been voted on since.
Industrialized nations disallowed rBGH:
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

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

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)

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“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, the company that manufactures and markets rbST, initiated an assessment with a group of independent scientific experts to develop an expert paper . . .”

All eight authors were paid by Elanco

Seven of the eight authors were paid by
Monsanto to research rbST

Elanco
“Its (rBGH’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 rBGH’ stated the e-mail’ . . . ‘I can confirm the AAP does not endorse the safety of rbGH’, wrote an AAP spokesperson . . . The
AMA has no policy on rBGH . . .” – Feb. 22,
2010

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 rbGH .”
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 rbGH safety,” The Bioscience Resource Project News
Service, Feb. 22, 2010.

Elanco
-
-
“. . . practices like rbST . . . increase the efficiency of food production while mitigating the environmental impact . .
.”
- Recombinant Bovine
Somatotropin (rbST): 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

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


73% aware of rBGH

Of those, 28% changed their buying decisions because of the hormone


17% buying rBGH-free conventional
11% buying organic


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

Challenge Butter – “Our independent research indicates that 70% of butter customers are concerned about the use of rbST, 60% want no added hormones or rbST 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

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

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 rBST . . .”
Consumer Reports – August 2008
“WHERE TO FIND PRODUCTS WITHOUT rbST/rbGH: Retailers that carry the products include Wal-Mart and its affiliated Sam’s Club . .
.”

Sam Walton

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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
“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.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.)