FDA’s long-ago rBGH human safety precepts were faulty
The central thesis of this report is that the FDA’s basic rbGH human safety presumptions are faulty. Rather than perform the legally mandated role as the overseer of the safety of veterinary drugs and the nation’s food supply, FDA employees have served as “pom-pom girls”—cheering on the approval and marketing of this powerful synthetic hormone drug.
Failed oversight of human and veterinary drugs has, unfortunately, become “business as usual” at FDA. Public confidence is at an all-time low, following repeated revelations of inadequate safety-testing of drugs by the agency. Let’s summarize some of the “worst of the worst” failures in FDA’s human safety oversight for Monanto’s rbGH:
* No mandatory residue assay required.
FDA specifically violated its own rules by failing to require Monsanto to develop a mandatory detection test for drug residues in the milk and meat of treated dairy cows. Failure to require a rbGH residue detection test—which dates back to roughly 1987—has broad implications even today. There is no test to verify the accuracy of dairy processors’ claims milk labeled “rbGH-Free” is in fact from dairy herds that have not been injected with Posilac.
FDA’s failure to require drug companies developing rbGH mandatory drug residue test for rbGH is a violation of Section 512 of the 1968 Animal Drug Amendments of the 1938 Federal Food, Drug and Cosmetic Act.
Without a residue assay, the myth, indeed the fabrication, that milk from rbGH-injected cows is “the same” as normal cows’ milk is perpetuated. Specifically, FDA’s rules mandate that the developer of an “investigative new animal drug” must create a test to measure for drug residues, before any products from animals receiving the research drug may be used in the human food chain. But FDA never required that test for rbGH. Rather, based on limited rat-feeding tests, in 1987, FDA officials approved human consumption of milk/meat from rbGH-treated cows in experiments conducted at Monsanto’s research facility in Missouri, at many university dairy herds, and numerous private dairy farms.
Lack of a mandatory, drug residue test has created the most problematic headache for the dairy industry: no test to verify claims by an increasing number of firms (like Kroger and Starbucks) that their products are “rBGH-free.” Thus, the trust of the public in its dairy product supply is without any verification. Europe uses at least two different tests for determining whether dairy products have been processed from rBGH-treated cows’ milk. A Cornell University scientist, Dr. Ron Gorewit, patented an rBGH-detection assay with a colleague, but FDA has refused to acknowledge the validity of that test. FDA recognizes no test for the presence of rBGH residues in milk, period.
Thus, when Monsanto (and others), contend that milk from rbGH-treated cows is “the same” as normal cows’ milk, as far as actual drug residues goes, that claim must be considered without scientific substantiation.
* 1990 Science article on rbGH “human safety”— flawed
The above-cited quotation from Henry I. Miller in the June 29, 2007 issue of The New York Times is instructive. Miller headed FDA’s Office of Biotechnology from 1989 to 1993—a key period when FDA was finalizing its rbGH human safety review. Miller refers to FDA-written article that appeared in the journal Science on August 24, 1990 as having “… summarized more than 120 studies showing that rBST poses no risk to human health.”
Science graced its pages with a ten-page article titled, “Bovine Growth Hormone: Human Food Safety Evaluation.” This article represented a response to the white-hot public safety issue for FDA. Never before had the agency addressed human safety concerns of an animal drug still under review. Commercial sale of rbGH was still three and a half years into the future.
Miller’s recent assertions, to the benefit of rBGH critics, show that Monsanto, FDA and the supporters of rBGH truly have almost nothing new to say in the past 17 years, except to regurgitate the standard party line, “rBGH is safe because FDA says it’s safe.”
When scrutinized in detail, that long-ago article in Science—FDA’s “all clear” prognosis for human safety issues—fails miserably in efforts to assuage human safety concerns regarding rBGH. Here’s why:
—FDA’s Science article cited, as proof of “human safety” of the biotechderived cow hormone, research conducted many years earlier, in which human dwarfs were injected with natural cow growth hormones. FDA noted that the dwarfs did not grow, in response to receiving the injections, which were extracted from the pituitary glands of dead cows.
Trouble is: that research article noted that a large percentage of the dwarfs in the experiment died of Creutzfeld-Jakobs Disease—the human equivalent of “mad cow disease.”
The experience of those dwarfs who died following injections of natural cow growth hormones has a chilling parallel. In the early 1980s, French youths injected with synthetic human growth hormones also developed degenerative brain-wasting diseases.
Above article continued HERE…
Just what is so bad about rBGH anyway?
Cows injected with rBGH produce milk under severe physical and mental strain from cramped quarters. They’re subject to more disease and antibiotic resistance from repeated use of antibiotics by handlers hoping to quell chronic infection like mastitis, (an infection of the milk ducts that in nursing human moms can be highly painful). rBGH has also been linked to reproductive problems in cows.
In humans, studies indicate milk from cows treated with rBGH may contain elevated levels of insulin-like growth factor-1 (IFG-1), which can increase the risk of breast cancer and other types of cancer.
Where did rBGH come from?
rBGH was first developed by the agricultural biotech corporation Monsanto to increase milk output in dairy cows. Monsanto’s production history includes the notoriously dangerous Agent Orange, PCB, Terminator seed: a sterile seed forcing farmers to purchase additional seed each year, Roundup: one of the most commonly used pesticides worldwide, and the pesticide DDT.
In Illinois, Monsanto was sued for their lengthy history of toxic environmental pollution in the tiny town of Sauget, where a Monsanto plant has stood for years. Residents of the town who filed the suit say the company’s factories released PCB and other toxic chemicals into the environment around the town for over 70 years.
As William Spain of the Wall Street Journal describes, “the village was created to offer Monsanto a tax- and regulation-free dumping location at a time when environmental rules existed mainly at the local level.”
The Center for Global Food Issues, funded in part by Monsanto, assists the fight to label organic milk with the “Milk is Milk” website, which attempts to refute the healthfulness of organic milk.
Through the years, Monsanto has also received help from the FDA. One example of that connection: Michael R. Taylor, now a professor at George Washington School of Public Health once worked for the FDA, later represented Monsanto as a lawyer, then went back to the FDA installed as Deputy Commissioner for Policy when rBGH was granted approval.
An excerpt from a 1998 article in The Ecologist magazine details Taylor’s journey and its significance:
“In March 1994, Taylor was publicly exposed as a former lawyer for the Monsanto corporation for seven years. While working for Monsanto, Taylor had prepared a memo for the company as to whether or not it would be constitutional for states to erect labeling laws concerning rBGH dairy products. In other words. Taylor helped Monsanto figure out whether or not the corporation could sue states or companies that wanted to tell the public that their products were free of Monsanto’s drug.”
Of course, Monsanto and the dairy industry lobbying collective International Dairy Foods Association (IDFA), would love for consumers to believe rBGH is harmless and that labeling it in food is unnecessary.
The IDFA’s “organic milk FAQ page” highlights a feeble link to the American Dietetic Association’s position on organic foods as firm proof of non-existent health benefits to eating organic. But wouldn’t you know, this is the same American Dietetic Association dispensing nutritional advice and proudly displaying its major corporate sponsorship— sponsorship that includes soft-drink giants Coca-Cola and PepsiCo. (Not exactly the most nutritious beverage choices.)
Source: The Tale of rBGH, Milk, Monsanto and the Organic Backlash; by Christine Escobar Founder and editor of Green Parent Chicago.com
Facts about Bovine Growth Hormone
Since bovine growth hormone received FDA approval in 1993, three disturbing health trends have emerged. Cancer cases continue to increase, obesity has become an epidemic and early onset puberty has become the norm.    Related? Maybe, maybe not. You can be the judge as you read through the following 8 facts about the substance known as BGH, or rBGH. Whatever conclusion you arrive at, you’ll probably agree that keeping this substance far away from you and your family is good practice.
Bovine Growth Hormone is a GMO
Monsanto created rBGH to stimulate milk production in cows. At least that’s the nice way of saying it. Bovine growth hormone occurs naturally in cows, the same way human growth hormone occurs naturally in humans. To make it more “effective”, Monsanto genetically modified BGH to create recombinant Bovine Growth Hormone, or rBGH or rBST (recombinant bovine somatotrophin). This more potent GMO version of BGH is not a naturally occurring substance and does more than increase ol’ Bessie’s milk production.
It’s Banned in the European Union and Around the World
Originally approved by many countries shortly after its release, rBGH has since been banned by the European Union, Canada, Australia, Japan, New Zealand and Israel. Most of these bans went into effect in 2000, some earlier. It didn’t take their scientists long to figure out this stuff isn’t quite right.
Medical Experts Have Declared it Unsafe
In 2007, Dr. Samuel Epstein exposed the dangers of rBGH in his book What’s in your Milk?. This book reveals the science, politics, and corporate greed behind the creation and approval of rBGH.  Since then, many milk producers have decided to sell only rBGH-free milk; and Monsanto sold its rBGH business unit to Eli Lilly.  But don’t be fooled, it’s still out there and likely to remain out there and in the food supply until a full ban is established.
A Human danger: Contains Insulin Like Growth Factor (IGF-1)
Milk from cows treated with rBGH contains higher levels of IGF-1. The American Cancer Society reports early studies linked IGF-1 as a contributor to tumor development, specifically breast, prostate and colorectal cancers.  While research has not clarified the connection, continuing efforts support these studies…
Links to Various Types of Cancer
Insulin like growth factor has a multitude of problems. A recently published scientific review focused on the relation of IGF-1 (and IGF-2) to breast cancer tumor formation. These insulin growth factors are known to stimulate cell differentiation. It appears IGFs have a unique interaction with estrogen which may contribute to tumor development in women. 
A 2013 study evaluated the relation of IFG and prostate cancer. Little if any IGF was observed in healthy prostate tissue. Advanced tumors demonstrated a high presence of IGF-1, while smaller localized prostate cancer tumors showed a lesser density of IGF-1. Ultimately the study concluded higher concentrations of IGF-1 do have a correlation to the presence of prostate cancer. 
Like prostate cancer, advanced colorectal cancers have shown a direct relationship with higher levels of IGF-1. One particular study demonstrated higher levels in men, patients over 60 and those with cancers stemming from damage to the mucus layer of the colon. The researchers determined IGF-1 levels can indicate and help identify the presence of colorectal cancers. 
Linked to Lung Cancer Too?
Although not one of the original cancers linked to insulin like growth factor, recent research from China has found that IGF-1 plays a significant role in non-small cell lung cancer. Lung cancer patients in this study had much higher blood serum levels of IGF-1 than the control group.  While this study is relatively new, it does suggest IGF-1 may play a larger role in cancers than previously thought. It also raises additional concerns and questions about the role of increased consumption of IGF as a result of genetically modified cows.
Diabetes as a Result of BGH?
FDA and Monstanto scientists determined the rBGH used on cows wouldn’t transfer or affect humans, especially through milk. They also stated that bovine growth hormone wouldn’t affect humans even if ingested. A case documented in 2011 suggests otherwise.
A 33 year-old man found himself in the ER reporting a range of symptoms including nausea, headaches, blurry vision, and more. In the course of the examination, the patient admitted taking anabolic steroids –- which included bovine growth hormone. (Apparently body builders know something more about the effect of bovine growth hormone on humans than government and corporate researchers!) As a result of the use, he began a new life with diabetes. 
While this is a very unique case, it does show that bovine growth hormone, whether introduced via milk (which we’ve been told it won’t be) or through other means can have serious effects on human health.
Other Side Effects: Milk Contamination, Mastitis, and Antibiotics
Cows given rBGH are more likely to develop mastitis, an inflammation and infection of mammary tissue. Early studies found this led to bacteria and potential pus in milk. While laws prohibit distribution of contaminated milk, the simple fact is that milk from cows treated with rBGH are more likely to suffer contamination than others. This problem was one of the reasons the European Union and other countries banned it. 
rBGH also causes a wide range of health problems for cows, requiring the use of antibiotics. Fortunately, most producers label their milk, so it is easy to find non-rBGH/rBST milk. Of course, the easiest way is to buy organic or raw. Better yet — choose organic goat’s milk.
by Dr. Edward Group DC, NP, DACBN, DCBCN, DABFM
Published on January 2, 2014, Last Updated on November 24, 2015
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