In May 2007, Samuel S. Epstein, MD, Chairman of the
Cancer Prevention Coalition, and four other leading national experts on
genetically-engineered, recombinant bovine growth hormone (rBGH) milk
filed a Petition to the Food and Drug Administration (FDA), “Petition
Seeking the Withdrawal of the New Animal Drug Application Approval for
Posilac®-Recombinant Bovine Growth Hormone (rBGH).”
In the absence of any response, on January 12, 2010, Dr. Epstein
resubmitted this Petition to Michael Taylor, Deputy Commissioner of the
Food and Drug Administration.
As detailed in this Petition, Posilac® poses major public health
hazards. Dr. Epstein requested his review and support of an early ban
of Posilac®.
This Petition requests the Secretary of Health and Human
Services, and the Commissioner of Food and Drugs to suspend the
approval of rBGH, a genetically engineered bovine growth hormone, and
require milk and other dairy products produced with its use to be
labeled with a warning such as, “Produced with the use of rBGH, and
contains elevated levels of insulin-like growth factor, IGF-1, which
poses major risks of breast, prostate, and colon cancers.”
STATEMENT OF GROUNDS
- THE VETERINARY TOXICITY OF rBGH
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.”Details of these toxic effects were subsequently admitted by Monsanto,
and by the FDA, and were disclosed on the drug’s veterinary label
(Posilac®) in November, 1993. These toxic effects include injection
site lesions, a wide range of other toxic effects, and an increased
incidence of mastitis requiring the use and antibiotics, with resulting
contamination of milk. - ABNORMALITIES IN rBGH MILK
A January 1994 Monsanto Executive Summary on rBGH, 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. These include: reduction
in short-chain fatty acid and increase in long-chain fatty acid levels;
increase in levels of a thyroid hormone enzyme; contamination with
unapproved drugs for treating mastitis; and frequency of pus cells due
to mastitis. - INCREASED LEVELS OF INSULIN-LIKE GROWTH FACTOR 1 (IGF-1) IN rBGH MILK
A wide range of publications have documented excess levels of IGF-1 in
rBGH milk, 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. These increases were also admitted
by the pharmaceutical company Eli Lilly, in application for marketing
authorization in the European Community. It should also be noted that
pasteurization of milk increases IGF-1 levels. - IGF-1 IS READILY ABSORBED FROM THE INTESTINE INTO THE BLOOD
IGF-1 is a small protein component known as a peptide. As such it is
readily absorbed into the blood. It survives digestion, and has marked
growth promoting effects following short-term feeding tests in rats. - INCREASED IGF-1 LEVELS IN MILK INCREASE RISKS OF BREAST, COLON AND PROSTATE CANCERS
Increased levels of IGF-1 have been shown to increase risks of breast
cancer in 19 scientific publications, risks of colon cancer in 10
publications, and prostate cancer in 7 publications. - INCREASED IGF-1 LEVELS INHIBIT “APOPTOSIS”
Of critical importance is the fact that increased IGF-1 levels block
natural defense mechanisms, known as apoptosis, against early
submicroscopic cancers. - rBGH INCREASES TWINNING RATES
An increased rate of twinning in cows injected with rBGH was admitted
by Monsanto on its November 1993 Posilac® label, and the incidence of
fraternal twins. Monsanto also admitted that it increases “and
complications such as premature delivery, congenital defects and
pregnancy-induced hypertension.” - THE INTERNATIONAL BAN ON THE USE AND IMPORTS OF U.S. rBGH DAIRY PRODUCTS
Based on well-documented veterinary and public health concerns, in June
30, 1999, the United Nations Food Safety Agency, representing 101
nations worldwide, ruled unanimously not to endorse or set a safety
standard for rBGH milk. Effectively, this has resulted in an
international ban on U.S. milk, approximately 20% of which is rBGH. - FDA POLICY ON LABELING rBGH MILK
The FDA continues to mislead dairy producers and consumers with regard
to its requirement for labeling of rBGH milk, with its deliberately
false claim that “No significant difference has been shown between milk
derived from rBST-treated and non-rBST treated cows.”
“In fact,” warns Dr. Epstein, “rBGH milk continues to pose major cancer and other risks to the entire U.S. population.”
The 2007 Petition has been endorsed by four other leading experts on
genetically-engineered, recombinant bovine growth hormone (rBGH) milk.
We look forward to a response.
Samuel S. Epstein, M.D.
Professor emeritus Environmental and Occupational Health
University of Illinois School of Public Health
Chairman, Cancer Prevention Coalition
Chicago, IL
Email: epstein@uic.edu
Web: http://www.preventcancer.com
Ronnie Cummins
National Director
Organic Consumers Association
Finland, MN
Email: ronnie@organicconsumers.org
Web: http://organicconsumers.org
John Kinsman
President
Family Farm Defenders
Madison, WI
Email: jepeck@students.wisc.edu
Web: http://www.www.familyfarmdefenders.org
Arpad Pusztai, PhD, FRSE
Consultant Biologist
Scotland
Email: a.pusztai@freenet.co.uk
Jeffrey Smith
Executive Director
Institute for Responsible Technology
Fairfield, IA
Email: jeffrey@seedsofdeception.com
Web: http://www.seedsofdeception.com
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