In May 2007, I 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, I 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. I requested his review and support of an early ban of Posilac.
This Petition requested the Secretary of Health and Human Services, and the Commissioner of Food and Drugs to take the following action:
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
1. 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.
2. 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.
3. INCREASED LEVELS OF 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 Eli Lilly, in application for marketing authorization in the European Community. It should also be noted that pasteurization increases IGF-1 levels.
4. 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.
5. 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.
6. 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.
7. 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."
8. 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 percent of which is rBGH.
9. 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, 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
Organic Consumers Association
Family Farm Defenders
Arpad Pusztai, PhD, FRSE
Institute for Responsible Technology
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