For those who don't know about it, rBGH is a genetically engineered bovine hormone approved during the Clinton administration when Clinton appointed Monsanto-connected-employees to run the FDA and they then approved Monsanto's own product over scientific objections about increased cancer risk. Despite those links to cancer, the Clinton administration did not withdraw the hormone or warn the public or label the milk.
To learn how Monsanto pushed its genetically engineered hormone on the American public: http://video.google.com/...
To learn more about Monsanto, you can see Vanity Fair's green issue this month: http://www.vanityfair.com/... features/2008/05/monsanto200805
The 2007 Citizen's petition to the FDA requesting the withdrawal of approval for rBGH (the first genetically engineered product ever approved by the FDA: http://www.fda.gov/...
Before reading the petition, realize that it is brought by scientists who even in 1996, during the Clinton administration, were saying this GE-hormone was dangerous and should be withdrawn.
And Hillary Clinton, someone who says she particularly cares about women, has been silent about this risk to American women, including those who have breast cancer or are survivors. What's more, she has been advised for years by Mark Penn, CEO of Burson-Marsteller, the Monsanto PR firm which has been involved in pushing rBGH on the public.
So, this issue not only began during Clinton's time in office but continues up to today. Monsanto has sued farmers for labeling their milk rBGH-free and is pushing bans on labeling of milk in many states, and meanwhile it is very close to Hillary Clinton, and could end up, as it did under Bill Clinton, in charge of food agencies, including of her proposed centralized "food safety" agency.
The following petition is not just about 2007, then, but about the political corruption during the Clinton administration, and the costs to us all, up to today. We literally have to "eat" what they did then, and the on-going corruption is visible and powerful still in whom Hillary Clinton uses to guide her. And the serious risks from Monsanto's hormone and the Clinton's corporate ties continue.
The next time you hear Hillary's Clinton express concern for our "food safety," or read about the FDA raiding the property of and arresting some small dairy farmer for selling unpasteurized milk (easily heated for any problem) to a neighbor, think of rBGH and the multiple cancer risks cited by all the journals you'll see quoted below, and wonder a bit what is really going on.
Petition Seeking the Withdrawal of the New Animal Drug Application Approval for
Posilac - Recombinant Bovine Growth Hormone (rBGH)
?066 7 MAY 1S A9.27
May 11, 2007
Mike Leavitt
Secretary of Health and Human Services
U.S. Department of Health and Human Services
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
Dockets Management Branch
Food and Drug Administration, Room 1061
5630 Fishers Lane
Rockville, MD 20852
Citizen Petition
The undersigned submits this petition on behalf of the Cancer Prevention Coalition,
Samuel S. Epstein, M.D., Chair; the Organic Consumers Association, Ronnie Cummins,
Executive Director; Family Farm Defenders, John Kinsman, President; Arpad Pusztai,
PhD, FRSE; Institute for Responsible Technology, and Jeffrey M. Smith, Executive
Director.
This petition is based on scientific evidence of increased risks of cancer, particularly
breast, colon, and prostate, from the consumption of milk from cows injected with
PosilacS, the genetically modified recombinant bovine growth hormone (also known as
rBGH, sometribove, recombinant bovine somatotropin, or rbST).
Posilac@ is the trademark for Monsanto's rBGH product, registered with the U.S. Patent and Trademark Office, and is approved for marketing by the Food and Drug Administration (FDA). This petition is also based on abnormalities in the composition of rBGH milk, resulting from the recognized veterinary toxicity of rBGH, particularly increased levels of IGF-1.
The undersigned submit this petition under section 512(e)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360b(e)(1)(A)), to request the Secretary to immediately
suspend approval of PosilacS based on imminent hazard; and under section 21 U.S.C.
321 (n), 361, 362, and 371 (a), 21 CFR 740.1, 740.2 of 21 CFR 10.30 of the Federal
Food, Drug, and Cosmetic Act to request the Commissioner of the Food and Drug
Administration to label milk and other dairy products produced with the use of Posilac(& with a cancer risk warning.
page 2
A. AGENCY ACTION REQUESTED
This petition requests the Secretary and the Commissioner to take the following action:
Suspend approval of PosilacS, and/or require milk and other dairy products produced
with the use of PosilacS to be labeled with warnings such as, "Produced with the use of
PosilacS, and contains elevated levels of IGF-1, a major risk factor for breast, prostate,
and colon cancers."
B. STATEMENT OF GROUNDS
1. The Veterinary Toxicity of PosilacS
Evidence of these toxic effects was first detailed in confidential Monsanto reports, based
on records of secret nationwide rBGH veterinary trials, submitted to the FDA prior to
October 1989 when they were leaked to one of the petitioners, Dr. Epstein. He then
made these reports available to Congressman John Conyers, Chairman of the House
Committee on Government Operations. On May 8, 1990, Congressman Conyers issued
the following statement. "I find it reprehensible that Monsanto and the FDA have chosen
to suppress and manipulate animal health test data" (1). Details of these toxic effects
were subsequently admitted by Monsanto and the FDA, and disclosed on the drug's
veterinary label (Posilac) in November, 1993. These include injection site lesions, a wide
range of other toxic effects, and an increased incidence of mastitis, requiring the use of
medication and antibiotics, and resulting in their contamination of milk.
2. Abnormalities in rBGH Milk
In a Monsanto Executive Summary, Posilac, January 1994, it was claimed that "natural
milk is indistinguishable" from rBGH milk and that "There is no legal basis requiring its
labeling." However, there are a wide range of well-documented abnormalities in rBGH
milk, apart from increased IGF-1 levels (2-11). These include: reduction in casein;
reduction in short-chain fatty acid and increase in long-chain fatty acid levels; increase in
levels of the thyroid hormone triiodothyronine enzyme; contamination with unapproved
drugs for treating mastitis; and frequency of pus cells due to mastitis.
3. Increased Levels of IGF-1 in rBGH Milk
A wide range of publications have documented excess levels of IGF-1 in rBGH milk (10-
22), with increases ranging from four- to 20-fold. Based on six unpublished industry
studies, FDA admitted that IGF-1 levels in rBGH milk were consistently and statistically
increased, and that these were further increased by pasteurization (16); these increases
were also admitted by others (17, 18). Included among these is one by Lilly Industries,
in its application for marketing authorization to the European Community Committee for
Veterinary Products, admitting that rBGH milk may contain more than a 10-fold increase
in IGF-1 levels (20). It should also be noted that pasteurization increases IGF-1 levels by
page3
a further 70% (16), presumably by disrupting protein binding, and since standard analytic
techniques forIGF- 1 in rBGH milk may underestimate its levels by up to 40-fold (9, 15).
4. IGF-1 is Readily Absorbed from the Intestine into the Blood
Contrary to Section 2 of FDA's 6/8/2000 Docket No. 98P-1194 response to the
December 5, 1998 Citizen Petition of the Center for Food Safety, IGF-1 is a peptide and
not a protein, and as such is readily absorbed into the blood. Even more compelling is
evidence of marked growth promoting effects following short-term feeding tests in rats
(16, 22). FDA's Section 2 thus reflects a misunderstanding relating to "the possibility of
IGF-1 surviving digestion."
5. Increased IGF-1 Levels Increase Risks of Breast, Colon and Prostate Cancers
Thus, increased levels of IGF-1 have been shown to increase risks of breast cancer by up
to seven-fold in 19 publications (23-41), risks of colon cancer in 10 publications (42-51),
and prostate cancer in 7 publications (52-57).
6. Increased IGF-1 Levels Inhibit Apoptosis
Of generally unrecognized, critical importance is the fact that increased IGF-1 levels
block natural defense mechanisms against the growth and development of early
submicroscopic cancers, known as apoptosis or programmed self destruction (53, 58, 59).
7. Bovine Growth Hormone Increases Twinning Rates
An increased rate of twinning in cows injected with rBGH was admitted by Monsanto on
its November 1993 Posilac label. rBGH increases ovulation and embryo survival, and
increases the incidence of fraternal twins (60). "Because multiple gestations are more
prone to complications such as premature delivery, congenital defects and pregnancy-
induced hypertension in the mother than singleton pregnancies, the findings of this study
suggest that women contemplating pregnancy might consider substituting meat and dairy
products with other protein sources, especially in countries that allow growth hormone
administration to cattle." (61).
8. The International Ban on the Use and Imports of rBGH Dairy Products
Based on the veterinary and public health concerns detailed in this Petition, the use and
import of rBGH dairy products has been banned by Canada, 29 European nations,
Norway, Switzerland, Japan, New Zealand, and Australia.
It should further be noted that on June 30, 1999, the Codex Alimentarius Commission,
the United Nations Food Safety Agency representing 101 nations worldwide, ruled
unanimously not to endorse or set a safety standard for rBGH milk.
page 4
9. The FDA Policy on Labeling rBGH Milk
The FDA has misled dairy producers and consumers with regard to its requirement for
labeling of rBGH milk, to the effect that "No significant difference has been shown
between milk derived from rBST-treatedand non-rBST treated cows." This, however, is
misleading in extreme as the "FDA has determined it lacks the basis for requiring such
labeling in its statute." This was admitted in a7/27/94 letterby Jerold R. Mande,
Executive Directorto the FDA Commissioner, to Harold Rudnick, State ofNew York
Department of Agricultureand Markets.
C. CLAIM FOR CATEGORICAL EXCLUSION
A claim for categorical exclusion is asserted pursuant to 21 CFR 25. 24(a)11.
D. CERTIFICATION
The undersigned certify (page 9), that, to their best knowledgeand belief, this petition
includes all informationand views on which the petition relies, and also that it includes
representative dataand information known to the petitioner which are unfavorable to the
petition.
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page6
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page8
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nage 9
Signature
Samuel S. Epstein, M.D.
Cancer Prevention Coalition
c/o University of Illinois at Chicago
School of Public Health, MC 922
2121 West Taylor Street
Chicago, IL 60612
312-996-2297; epstein@uic.edu
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page 10
This Petition is submitted by:
Samuel S. Epstein, M.D.
Chairman, Cancer Prevention Coalition
c/o University of Illinois at Chicago
School of Public Health, MC 922
2121 West Taylor Street
Chicago, IL 60612
312-996-2297; fax 312-413-9898
e-mail epstein@uic.edu