This genetically engineered cattle drug is banned both in Canada and the European Union and now Monsanto has drastically cut back on supplies to US farmers.
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FDA, Monsanto need to reveal truth about growth hormone
By Peter Hardin
The Capital Times, February 2, 2004
http://www.madison.com/captimes/opinion/column/guest/66560.php

Monsanto has announced a 50 percent cutback in sales of its recombinant [is genetically engineered] bovine growth hormone. The veterinary drug is trademarked and sold as Posilac.

About 22 percent of U.S. dairy cows receive Posilac injections every two weeks, to boost milk output.

What's gone wrong with Monsanto's rbGH?

This biotech cow hormone has rocked the dairy industry and consumers since the mid-1980s. The U.S. Food and Drug Administration admits the hormone has been its biggest-ever consumer food safety controversy. Monsanto's rbGH was the first major biotech food production "tool" approved by the FDA.  Three potential problem areas come to mind: human safety, animal safety and quality control.

In my opinion, the FDA's human safety oversight of rbGH has been flawed from the beginning.

In the mid-1980s, the FDA failed to require a mandatory residue test for rbGH. Yet Monsanto and government officials claim there is "no difference" in the milk from untreated and rbGH-injected cows.  To counter intense public skepticism about rbGH, the FDA published a 10-page summary of its human safety determinations in the journal Science in August 1990. Among the findings, the agency said that the rbGH in the milk of injected cows was degraded by commercial pasteurization. The sole research cited for this claim was that of a Canadian graduate student, whose master's thesis studied the feeding of rbGH-derived milk to calves (not humans). This study erroneously heated milk for 30 minutes at the 15-second pasteurization temperature.

The greatest human safety issue regarding consumption of milk from rbGH-injected cows focuses on a secondary hormone: insulin-like growth factor-one, called IGF-1.

Growth hormones (natural and synthetic) regulate bodily production of IGF-1. IGF-1 is a miraculous, blood-borne "messenger" hormone that regulates cellular growth and function. Increased growth hormone levels (natural or synthetic) mean more IGF-1-spurring metabolism in mammary tissue, bones and elsewhere.

Structurally, IGF-1 is identical for cows and humans. Some IGF-1 naturally occurs in cow's milk. Data suggest higher IGF-1 levels are found in rbGH-injected cows' milk, compared to normal milk. Thousands of research studies probing potential links between IGF-1 and cancer development have been published in scientific and medical journals.

With regard to animal safety, injections of rbGH spur dairy cow metabolism. One-third more blood is pumped through injected cows' hearts. This synthetic hormone is so powerful it kills muscle tissue at injection sites.

In early 1990, my newspaper, The Milkweed, published stolen Monsanto animal health research files. Those files showed dramatic increases in weights of many key organs and glands of treated cows, compared to control groups.

Increased IGF-1 circulating in rbGH-injected cows' milk leaves mammary tissue and bones at greater risk for health problems, according to Michael Hansen of the Consumers Union. The modern U.S. dairy cow is under many stresses, even before she may be poked with Monsanto's biotech hormone to induce greater milk output.

Two instances of rbGH quality control problems have surfaced.

In summer 1993 - just before the FDA's approval of recombinant bovine growth hormone - confidential company documents revealed nearly a ton of dry rbGH had been contaminated at the manufacturing plant in Austria.  And in 1994, Monsanto scientist Bernard Violand reported aberrant amino acid sequences - an unintended result that his article in Protein Science acknowledged researchers did not fully understand.

Making batches of recombinant hormones using E. coli as media is not like making Jell-O.

What's gone wrong with Monsanto's rbGH? Synthetic hormones used in our food-producing livestock pose risks too serious to cover up. If a serious problem exists, why has only 50 percent of rbGH sales been curtailed, instead of 100 percent? Consumers and dairy farmers deserve a complete and honest explanation of why the FDA has restricted this drug.

A perceived cover-up by the FDA and Monsanto will only invite legal challenges and worst-case rumors. Biotechnology's long-term interests are best served by full disclosure.

Peter Hardin lives near Brooklyn. He is the editor/publisher of The Milkweed, a monthly milk pricing report.  

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